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MS212300 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Sixty subjects were run in a study comparing the use of nicotine gum with placebo gum during cessation from smoking . Subjects were given clinic support and chewed the gum ad libitum . A survival analysis showed the two groups differed significantly in successful abstinence over time ( p less than .03 ) . Differences between groups appeared early ( within weeks ) and , at six months , a 28 % superiority of nicotine over placebo gum was demonstrated with mean success rates of 48 % and 20 % , respectively . Between six months and one year , relapse in the nicotine group accounted for the 30 % vs. 20 % success rates for nicotine and placebo observed at one year . In a pilot study ( " dispensary " ) testing the efficacy of the two gums when intervention was minimal , subjects in both groups resumed smoking within the first two weeks . The enhanced short-term success rates with nicotine gum in the clinic study are attributed to an effective interaction between use of the active preparation and clinic support . Long-term cessation may require extended maintenance procedures and /or an identification of optimal gum use A non-combustible nicotine inhaler , administered orally , has been developed for treatment of smokers . The inhaler allows weaning from nicotine while maintaining partial reinforcement of the ritual/sensory phenomena of smoking . Subjects were r and omly assigned to active ( n = 112 ) and placebo ( n = 111 ) groups . Some behavioral intervention occurred as a function of participation . Strict abstinence ( primary outcome criterion ) was defined by CO < or = 8 ppm with no slips allowed at any time and cotinine values < or = 14 at 1 year . Survival analysis showed active inhaler was superior to placebo ( p < 0.01 ) . Active vs. placebo success rates were : 63 % vs. 47 % ( day 3 ) , 46 % vs. 28 % ( week 1 ) , 36 % vs. 19 % ( week 2 ) , 33 % vs. 16 % ( week 3 ) , 29 % vs. 14 % ( week 6 ) , 24 % vs. 10 % ( 3 months ) , 17 % vs. 9 % ( 6 months ) and 13 % vs. 8 % ( 1 year ) . chi 2 analyses were significant through 3 months but not at 6 months ( p < 0.08 ) or 1 year . Craving was relieved with active inhalers at day 3 and week 1 . Subjects averaged six inhalers/day . Cotinine levels were 57 - 61 % of smoking levels . Common side effects included throat/mouth irritation and coughing . Failure was predicted by early slips . The inhaler is clearly useful for short-term smoking cessation with potential for long-term efficacy . Extended access to the inhaler and relapse prevention training could improve success rates . Another promising approach would be to combine the inhaler with a nicotine patch BACKGROUND Altering the macronutrient composition of the diet influences hunger and satiety . Studies have compared high- and low-protein diets , but there are few data on carbohydrate content and ketosis on motivation to eat and ad libitum intake . OBJECTIVE We aim ed to compare the hunger , appetite , and weight-loss responses to a high-protein , low-carbohydrate [ ( LC ) ketogenic ] and those to a high-protein , medium-carbohydrate [ ( MC ) nonketogenic ] diet in obese men feeding ad libitum . DESIGN Seventeen obese men were studied in a residential trial ; food was provided daily . Subjects were offered 2 high-protein ( 30 % of energy ) ad libitum diets , each for a 4-wk period-an LC ( 4 % carbohydrate ) ketogenic diet and an MC ( 35 % carbohydrate ) diet-r and omized in a crossover design . Body weight was measured daily , and ketosis was monitored by analysis of plasma and urine sample s. Hunger was assessed by using a computerized visual analogue system . RESULTS Ad libitum energy intakes were lower with the LC diet than with the MC diet [ P=0.02 ; SE of the difference ( SED ) : 0.27 ] at 7.25 and 7.95 MJ/d , respectively . Over the 4-wk period , hunger was significantly lower ( P=0.014 ; SED : 1.76 ) and weight loss was significantly greater ( P=0.006 ; SED : 0.62 ) with the LC diet ( 6.34 kg ) than with the MC diet ( 4.35 kg ) . The LC diet induced ketosis with mean 3-hydroxybutyrate concentrations of 1.52 mmol/L in plasma ( P=0.036 from baseline ; SED : 0.62 ) and 2.99 mmol/L in urine ( P<0.001 from baseline ; SED : 0.36 ) . CONCLUSION In the short term , high-protein , low-carbohydrate ketogenic diets reduce hunger and lower food intake significantly more than do high-protein , medium-carbohydrate nonketogenic diets The authors examine weight gains associated with smoking cessation in the Lung Health Study ( 1986 - 1994 ) over a 5-year follow-up period . A cohort of 5,887 male and female smokers in the United States and Canada , aged 35 - 60 years , were r and omized to either smoking intervention or usual care . Among participants who achieved sustained quitting for 5 years , women gained a mean of 5.2 ( st and ard error , 5.0 ) kg in year 1 and a mean of 3.4 ( st and ard error , 5.5 ) kg in years 1 - 5 . Men gained a mean of 4.9 ( st and ard error , 4.9 ) kg in year 1 and a mean of 2.6 ( st and ard error , 5.8 ) kg in years 1 - 5 . In regression analyses , smoking-change variables were the most potent predictors of weight change . Participants going from smoking to quit-smoking in a given year had mean weight gains of 2.95 kg/year ( 3.61 % ) in men and 3.09 kg/year ( 4.69 % ) in women . Over 5 years , 33 % of sustained quitters gained > or = 10 kg compared with 6 % of continuing smokers . Also among sustained quitters , 7.6 % of men and 19.1 % of women gained > or = 20 % of baseline weight ; 60 % of the gain occurred in year 1 , although significant weight gains continued through year 5 . The average gains and the high proportions of sustained and intermittent quitters who gained excessive weight suggest the need for more effective early interventions that address both smoking cessation and weight control Three smoking cessation interventions design ed for use by general practitioners ( GPs ) within the routine consultation were evaluated in a field setting using 26 GPs throughout metropolitan Sydney . A total of 450 smoking patients were allocated to either Structured Behavioral Change with nicotine gum ( Group SBCN ) , Structured Behavioral Change without nicotine gum ( Group SBC ) , or GP advice with nicotine gum ( Group AN ) . Although significant differences in the percentage of abstainers were observed between Groups SBCN and SBC three weeks after treatment ( 39 % vs. 26 % ) , the point prevalence abstinence rate for patients at 12 months declined to 19 , 18 , and 12 % for Groups SBCN , SBC , and AN , respectively . Continuous abstinence to the end of the 12-month period was 9 % for Groups SBCN and SBC , and 6 % for Group AN . Forty-eight percent of the 450 patients made an attempt to stop smoking , and 89 % reduced their cigarette consumption at some point during the study . Examination of 132 self- selecting patients who fully participated in the three interventions and attended all scheduled visits , revealed significantly larger proportions of abstainers within Groups SBCN ( 34 % ) and SBC ( 33 % ) than in Group AN ( 15 % ) at the 12-month follow-up BACKGROUND St John 's wort is an effective antidepressant that can reduce tobacco withdrawal symptoms , but it is not known whether it assists cessation . Chromium assists weight loss and might limit post cessation weight gain . METHODS In a factorial design , we r and omised smokers stopping smoking to 900 mg St John 's wort ( SJW ) active or placebo and also r and omised them to 400 microm chromium or placebo daily . Treatment started 2 weeks prior to quit day and continued for 14 weeks . Participants and research ers were blind to treatment allocation . All participants received weekly behavioural support . The primary endpoints were biochemically confirmed prolonged abstinence and mean weight gain in abstinent smokers 4 weeks after quitting . RESULTS 6/71 ( 8.5 % ) participants on active SJW and 9/72 ( 12.5 % ) on placebo achieved prolonged abstinence at 4 weeks , an odds ratio ( OR ) ( 95 % confidence interval ) of 0.65 ( 0.22 - 1.92 ) . At 6 months , 3 ( 4.2 % ) SJW active and 6 ( 8.3 % ) SJW placebo participants were still abstinent , an OR of 0.49 ( 0.12 - 2.02 ) . Among these participants , the mean difference in weight gain between active chromium and placebo was -0.8 1 kg ( -3.79 to 2.18 ) at 4 weeks and -3.88 kg ( -12.13 to 4.38 ) at 6 months . CONCLUSIONS Taking together the absolute quit rates , the small difference between active and placebo , and lack of effects on withdrawal shows that SJW is ineffective for smoking cessation . Insufficient people stopped smoking to properly test the efficacy of chromium in preventing weight gain , but the point estimate indicates a potentially worthwhile benefit BACKGROUND Nicotine replacement therapies are efficacious for treating nicotine dependence . However , limited data exist on benefits of different NRTs and predictors of treatment outcome . This study compared the effectiveness of transdermal nicotine vs. nicotine lozenge for smoking cessation and identified predictors of treatment response . METHODS A r and omized , open-label effectiveness trial was conducted at 12 medical sites participating in the National Cancer Institute 's Community Clinical Oncology Program . The sample consisted of 642 treatment-seeking smokers r and omized to 12 weeks of transdermal nicotine or nicotine lozenge . RESULTS Smoker characteristics were assessed at baseline , and 24-h point prevalence abstinence confirmed with breath carbon monoxide ( CO ) was evaluated at end of treatment ( EOT ) and at a 6-month follow-up . There was a trend for higher quit rates for transdermal nicotine vs. nicotine lozenge at EOT ( 24.3 % vs. 18.7 % , p=.10 ) and 6 months ( 15.6 % vs. 10.9 % , p=.10 ) . A logistic regression model of EOT quit rates showed smokers who preferred transdermal nicotine , were not reactive to smoking cues , and did not use nicotine to alleviate distress or stimulate cognitive function had higher quit rates on transdermal nicotine . A logistic regression model of 6-month quit rates showed smokers who preferred transdermal nicotine had higher quit rates on transdermal nicotine , and smokers who used nicotine to alleviate distress or stimulate cognitive processes had lower quit rates on nicotine lozenge . CONCLUSIONS Transdermal nicotine may be more effective than nicotine lozenge for smokers who prefer transdermal nicotine and do not smoke to alleviate emotional distress or stimulate cognitive function BACKGROUND Cigarette smoking is an established predictor of incident type 2 diabetes mellitus , but the effects of smoking cessation on diabetes risk are unknown . OBJECTIVE To test the hypothesis that smoking cessation increases diabetes risk in the short term , possibly owing to cessation-related weight gain . DESIGN Prospect i ve cohort study . SETTING The ARIC ( Atherosclerosis Risk in Communities ) Study . PATIENTS 10,892 middle-aged adults who initially did not have diabetes in 1987 to 1989 . MEASUREMENTS Smoking was assessed by interview at baseline and at subsequent follow-up . Incident diabetes was ascertained by fasting glucose assays through 1998 and self-report of physician diagnosis or use of diabetes medications through 2004 . RESULTS During 9 years of follow-up , 1254 adults developed type 2 diabetes . Compared with adults who never smoked , the adjusted hazard ratio of incident diabetes in the highest tertile of pack-years was 1.42 ( 95 % CI , 1.20 to 1.67 ) . In the first 3 years of follow-up , 380 adults quit smoking . After adjustment for age , race , sex , education , adiposity , physical activity , lipid levels , blood pressure , and ARIC Study center , compared with adults who never smoked , the hazard ratios of diabetes among former smokers , new quitters , and continu
Output:
| Behavioural interventions of general advice only are not effective and may reduce abstinence .
Individualized interventions , very low calorie diets , and CBT may be effective and not reduce abstinence .
Exercise interventions are not associated with reduced weight gain at end of treatment , but may be associated with worthwhile reductions in weight gain in the long term , Bupropion , fluoxetine , nicotine replacement therapy , and probably varenicline all reduced weight gain while being used .
Although this effect was not maintained one year after quitting for bupropion , fluoxetine , and nicotine replacement , the evidence is insufficient to exclude a modest long-term effect . |
MS212301 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background A few observational studies have found an inverse association between adherence to a Mediterranean diet and the risk of depression . R and omized trials with an intervention based on this dietary pattern could provide the most definitive answer to the findings reported by observational studies . The aim of this study was to compare in a r and omized trial the effects of two Mediterranean diets versus a low-fat diet on depression risk after at least 3 years of intervention . Methods This was a multicenter , r and omized , primary prevention field trial of cardiovascular disease ( Prevención con Dieta Mediterránea ( PREDIMED Study ) ) based on community-dwelling men aged 55 to 80 years and women aged 60 to 80 years at high risk of cardiovascular disease ( 51 % of them had type 2 diabetes ; DM2 ) attending primary care centers affiliated with 11 Spanish teaching hospitals . Primary analyses were performed on an intention-to-treat basis . Cox regression models were used to assess the relationship between the nutritional intervention groups and the incidence of depression . Results We identified 224 new cases of depression during follow-up . There was an inverse association with depression for participants assigned to a Mediterranean diet supplemented with nuts ( multivariate hazard ratio ( HR ) 0.78 ; 95 % confidence interval ( CI ) 0.55 to 1.10 ) compared with participants assigned to the control group , although this was not significant . However , when the analysis was restricted to participants with DM2 , the magnitude of the effect of the intervention with the Mediterranean diet supplemented with nuts did reach statistical significance ( multivariate HR = 0.59 ; 95 % CI 0.36 to 0.98 ) . Conclusions The result suggest that a Mediterranean diet supplemented with nuts could exert a beneficial effect on the risk of depression in patients with DM2.Trial registration This trial has been registered in the Current Controlled Trials with the number IS RCT N BACKGROUND Although individual nutrients have been investigated in relation to depression risk , little is known about the overall role of diet in depression . OBJECTIVE We examined whether long-term dietary patterns derived from a food-frequency question naire ( FFQ ) predict the development of depression in middle-aged and older women . DESIGN We conducted a prospect i ve study in 50,605 participants ( age range : 50 - 77 y ) without depression in the Nurses ' Health Study at baseline ( 1996 ) who were followed until 2008 . Long-term diet was assessed by using FFQs every 4 y since 1986 . Prudent ( high in vegetables ) and Western ( high in meats ) patterns were identified by using a principal component analysis . We used 2 definitions for clinical depression as follows : a strict definition that required both a reported clinical diagnosis and use of antidepressants ( 3002 incident cases ) and a broad definition that further included women who reported either a clinical diagnosis or antidepressant use ( 7413 incident cases ) . RESULTS After adjustment for age , body mass index , and other potential confounders , no significant association was shown between the diet patterns and depression risk under the strict definition . Under the broad definition , women with the highest scores for the Western pattern had 15 % higher risk of depression ( 95 % CI : 1.04 , 1.27 ; P-trend = 0.01 ) than did women with the lowest scores , but after additional adjustment for psychological scores at baseline , results were no longer significant ( RR : 1.09 ; 95 % CI : 0.99 , 1.21 ; P-trend = 0.08 ) . CONCLUSION Overall , results of this large prospect i ve study do not support a clear association between dietary patterns from factor analysis and depression risk BACKGROUND Studies of diet and depression have focused primarily on individual nutrients . AIMS To examine the association between dietary patterns and depression using an overall diet approach . METHOD Analyses were carried on data from 3486 participants ( 26.2 % women , mean age 55.6 years ) from the Whitehall II prospect i ve cohort , in which two dietary patterns were identified : ' whole food ' ( heavily loaded by vegetables , fruits and fish ) and ' processed food ' ( heavily loaded by sweetened desserts , fried food , processed meat , refined grains and high-fat dairy products ) . Self-reported depression was assessed 5 years later using the Center for Epidemiologic Studies - Depression ( CES-D ) scale . RESULTS After adjusting for potential confounders , participants in the highest tertile of the whole food pattern had lower odds of CES-D depression ( OR = 0.74 , 95 % CI 0.56 - 0.99 ) than those in the lowest tertile . In contrast , high consumption of processed food was associated with an increased odds of CES-D depression ( OR = 1.58 , 95 % CI 1.11 - 2.23 ) . CONCLUSIONS In middle-aged participants , a processed food dietary pattern is a risk factor for CES-D depression 5 years later , whereas a whole food pattern is protective BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality Introduction Recent research suggests that diet quality influences depression risk ; however , a lack of experimental evidence leaves open the possibility that residual confounding explains the observed relationships . The aim of this study was to document the cross-sectional and longitudinal associations between dietary patterns and symptoms of depression and to undertake a detailed examination of potential explanatory factors , particularly socioeconomic circumstances , in the diet-depression relationship . Methods Data were drawn from the Personality and Total Health ( PATH ) Through Life Study , a longitudinal community study following three age cohorts ( 20 + ; 40 + ; 60+yrs ) from south-eastern Australia over three assessment periods ( n = 3663 ) . Regression analyses evaluated the cross-sectional and longitudinal relationships between dietary patterns , depressive symptoms , age , detailed measures of socioeconomic circumstances , other health behaviours , and cardiovascular risk factors . Results The lowest tertile of prudent ( healthy ) dietary pattern and the highest tertile of western ( unhealthy ) dietary pattern were associated with an increased likelihood of depressive symptoms . However , these contemporaneous associations were explained by adjustment for detailed measures of socioeconomic circumstances and physical activity . In prospect i ve analyses , lower scores on the healthy dietary pattern and higher scores on the unhealthy dietary pattern independently predicted increased depressive symptoms across time , before and after adjustment for potential confounders and baseline depressive symptoms , but only for those in the oldest cohort . Dietary patterns did not explain the relationship between socioeconomic position and depressive symptoms . Conclusion The results of this study confirm that the relationship between habitual dietary intake and depressive symptoms is somewhat explained by socioeconomic circumstances and other health behaviours , but suggest that long term exposure to unhealthy dietary habits independently predisposes to depression over the lifecourse Emerging evidence relates some nutritional factors to depression risk . However , there is a scarcity of longitudinal assessment s on this relationship . Objective To evaluate the association between fatty acid intake or the use of culinary fats and depression incidence in a Mediterranean population . Material and Methods Prospect i ve cohort study ( 1999–2010 ) of 12,059 Spanish university graduates ( mean age : 37.5 years ) initially free of depression with permanently open enrolment . At baseline , a 136-item vali date d food frequency question naire was used to estimate the intake of fatty acids ( saturated fatty acids ( SFA ) , polyunsaturated fatty acids ( PUFA ) , trans unsaturated fatty acids ( TFA ) and monounsaturated fatty acids ( MUFA ) and culinary fats ( olive oil , seed oils , butter and margarine ) During follow-up participants were classified as incident cases of depression if they reported a new clinical diagnosis of depression by a physician and /or initiated the use of antidepressant drugs . Cox regression models were used to calculate Hazard Ratios ( HR ) of incident depression and their 95 % confidence intervals ( CI ) for successive quintiles of fats . Results During follow-up ( median : 6.1 years ) , 657 new cases of depression were identified . Multivariable-adjusted HR ( 95 % CI ) for depression incidence across successive quintiles of TFA intake were : 1 ( ref ) , 1.08 ( 0.82–1.43 ) , 1.17 ( 0.88–1.53 ) , 1.28 ( 0.97–1.68 ) , 1.42 ( 1.09–1.84 ) with a significant dose-response relationship ( p for trend = 0.003 ) . Results did not substantially change after adjusting for potential lifestyle or dietary confounders , including adherence to a Mediterranean Dietary Pattern . On the other h and , an inverse and significant dose-response relationship was obtained for MUFA ( p for trend = 0.05 ) and PUFA ( p for trend = 0.03 ) intake . Conclusions A detrimental relationship was found between TFA intake and depression risk , whereas weak inverse associations were found for MUFA , PUFA and olive oil . These findings suggest that cardiovascular disease and depression may share some common nutritional determinants related to subtypes of fat intake BACKGROUND Previous studies on diet and coronary heart disease ( CHD ) focused primarily on individual nutrients or foods . OBJECTIVE We examined whether overall dietary patterns derived from a food-frequency question naire ( FFQ ) predict risk of CHD in men . DESIGN This was a prospect i ve cohort study of 44875 men aged 40 - 75 y without diagnosed cardiovascular disease or cancer at baseline in 1986 . RESULTS During 8 y of follow-up , we documented 1089 cases of CHD ( nonfatal myocardial infa rct ion and fatal CHD ) . Using factor analysis , we identified 2 major dietary patterns using dietary data collected through a 131-item FFQ . The first factor , which we labeled the " prudent pattern , " was characterized by higher intake of vegetables , fruit , legumes , whole grains , fish , and poultry , whereas the second factor , the " Western pattern , " was characterized by higher intake of red meat , processed meat , refined grains , sweets and dessert , French fries , and high-fat dairy products . After adjustment for age and CHD risk factors , the relative risks from the lowest to highest quintiles of the prudent pattern score were 1.0 , 0 . 87 , 0.79 , 0.75 , and 0.70 ( 95 % CI : 0.56 , 0.86 ; P : for trend = 0.0009 ) . In contrast , the relative risks across increasing quintiles of the Western pattern score were 1.0 , 1.21 , 1.36 , 1.40 , and 1.64 ( 95 % CI : 1.24 , 2.17 ; P : for trend < 0.0001 ) . These associations persisted in subgroup analyses according to cigarette smoking , body mass index , and parental history of myocardial infa rct ion . CONCLUSIONS These data suggest that major dietary patterns derived from the FFQ predict risk of CHD , independent of other lifestyle variables Background : It has been suggested that dietary patterns are associated with future risk of depressive symptoms . However , there is a paucity of prospect i ve data that have examined the temporality of this relation . Objective : We examined whether adherence to a healthy diet , as defined by using the Alternative Healthy Eating Index ( AHEI ) , was prospect ively associated with depressive symptoms assessed over a 5-y period . Design : Analyses were based on 4
Output:
| Some previously described food patterns , specifically the Mediterranean Food Pattern , the Alternative Healthy Eating Index , the Prudent diet or the Provegetarian Food Pattern may be effective to reduce the future risk of depression .
Among them , only the Mediterranean Food Pattern has been tested for primary prevention in a large r and omised trial , but the inverse association found was not statistically significant .
Notwithst and ing , this field is promising and , according to large and well-conducted observational studies , food patterns potentially associated with reduced risk of depression are those emphasising seafood , vegetables , fruits and nuts . |
MS212302 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 : Although early gastric cancer ( T1 , NX ) in Japan has been reported to have an excellent prognosis , the experience with this cancer in the United States is limited . The treatment of these tumors in Japan is becoming less aggressive as “ good prognostic factors ” are increasingly recognized . Our objective was to identify predictors of nodal disease and survival in a large cohort of Western patients with T1 tumors . Methods : A retrospective review of our prospect i ve data base from July 1985 to March 1998 revealed 165 patients undergoing surgical resection for T1 gastric tumors . Clinicopathological factors analyzed and compared included presence of positive nodes , tumor size ( 4.5 vs.,4.5 cm ) , depth ( mucosal vs. submucosal ) , grade ( poor vs. moderate and well ) , and tumor site ( proximal vs. distal ) , presence of venous or perineural invasion , and Lauren ’s classification . Factors predicting lymph node involvement and disease-specific survival were evaluated by univariate and multivariate analysis . Results : Median follow-up time was 36 months . The actuarial 5-year survival was 88 % . Thirteen patients ( 8 % ) died of disease . Lymph node involvement was present in 31 tumors ( 19 % ) , with a 5-year survival of 91 % with negative nodes vs. 78 % with positive nodes . On univariate and multivariate analysis , the presence of tumor submucosal invasion ( P,.05 ) , venous invasion ( P 5.02 ) , and size of 4.5 cm and larger ( P 5.02 ) was significantly associated with an increased risk for nodal positivity . On univariate analysis of survival , node-positive tumors ( P 5.02 ) and tumors 4.5 cm and larger ( P 5.008 ) were significantly associated with decreased survival . On multivariate analysis , only node-positive tumors were significantly ( P 5.01 ) associated with decreased survival . Those tumors that were limited to the mucosa and less than 4.5 cm in size ( n = 47 ) had a 4 % rate of positive nodes . In contrast , those tumors that were 4.5 cm and larger and had penetrated into the submucosa ( n = 16 ) had a 56 % chance of positive nodes . Conclusions : Early gastric carcinoma in North America has an excellent prognosis , similar to that in Japan . Tumors that are limited to the mucosa and smaller than 4.5 cm could be considered for limited resection without lymphadenectomy BACKGROUND In Japan the surgical approach to treatment of potentially curable gastric cancer , including extended lymphadenectomy , seems in retrospective surveys to give better results than the less radical procedures favoured in Western countries . There has , however , been no evidence from r and omised trials that extended lymphadenectomy ( D2 gastric resection ) confers a survival advantage . This question was addressed in a trial involving thirty-two surgeons in Europe . METHODS In a prospect i ve r and omised controlled trial , D1 resection ( level 1 lymphadenectomy ) was compared with D2 resection ( levels 1 and 2 lymphadenectomy ) . Central r and omisation ( 200 patients in each arm ) followed a staging laparotomy . FINDINGS The D2 group had greater postoperative hospital mortality ( 13 % vs 6.5 % ; p=0.04 [ 95 % Cl 9 - 18 % for D2 , 4 - 11 % for D1 ] and higher overall postoperative morbidity ( 46 % vs 28 % ; p<0.001 ) ; their postoperative stay was also longer . The excess postoperative morbidity and mortality in the D2 group was accounted for by distal pancreaticosplenectomy and splenectomy . In the whole group ( 400 patients ) , survival beyond three years was 30 % in patients whose gastrectomy included en-bloc pancreatico-splenic resection versus 50 % in the remainder . INTERPRETATION D2 gastric resections are followed by higher morbidity and mortality than D1 resections . These disadvantages are consequent upon additional pancreatectomies and distal splenectomies , and in long-term follow-up the higher mortality when the pancreas and spleen are resected may prove to nullify any survival benefit from D2 procedures The contention that the R2 radical gastrectomy for localized and potentially curable gastric carcinoma may be superior to gastrectomy without lymphadenectomy ( R1 ) was assessed by r and omized trial . Five years after commencement 403 patients have been evaluated at surgery and only 43 ( 11 per cent ) found eligible ( S0–2 , P0 , H0 , N0–1 ) , 22 of whom underwent R1 and 21 R2 gastrectomy . Seven patients had final histological stages in excess of the protocol . The R2 group had a longer operating time ( P<0.005 ) , a greater blood transfusion requirement ( P<0.005 ) , a longer hospital stay ( 0.05>P>0.025 ) and required reoperation in four cases . There were no postoperative deaths . Four patients have died from the disease in the R1 group and five in the R2 group , there being no difference in the probability of survival at a median follow‐up of 3.1 years . The small proportion of patients suitable for radical R2 surgery , the high associated morbidity and the fact that survival advantage has yet to be proven in trial suggest that this procedure should not yet be performed outside of controlled clinical trials This prospect i ve r and omized study compared the survival of patients with tumour node metastasis ( TNM ) stage T2 N1–2 gastric cancer treated by gastrectomy alone or gastrectomy followed by uracil – tegafur BackgroudApplication of laparoscopy-assisted distal gastrectomy ( LADG ) for early gastric cancer ( EGC ) is still controversial because of scant evidence of long-term safety and feasibility . We evaluated the long-term outcome of LADG compared with conventional open distal gastrectomy ( ODG ) for EGC . Methods Between March 1999 and July 2006 , 106 patients underwent LADG and 105 patients underwent ODG for EGC . Clinicopathologic characteristics , postoperative outcomes , hospital course , postoperative morbidity , postoperative mortality , and long-term outcomes , including cancer recurrence and survival , were retrospectively compared between the two groups . Survival of all patients was confirmed with 55-month median follow-up . Results Postoperative recovery was significantly faster in the LADG group ; passing flatus occurred earlier , starting a liquid diet began sooner , and postoperative hospital stay was shorter ( p < 0.05 ) . Mean operation time was significantly longer in the LADG group . Postoperative complications in the LADG group occurred less frequently compared with in the ODG group ( 4.7 % versus 13.3 % , p = 0.046 ) . Tumor recurrence occurred in two cases ( 0.9 % ) and death related to recurrence occurred in only one patient ( 0.5 % ) . Overall 5-year survival rate ( 5-YSR ) of all patients was 95.5 % , while disease-specific 5-YSR was 98.8 % . There was no significant difference in survival rates between the two groups ; overall 5-YSR of the ODG and LADG groups was 94.9 % and 95.9 % , respectively . Conclusions Our data suggest that LADG for EGC is feasible and safe . We expect the results of the present study to be confirmed by prospect i ve r and omized analysis Curative resection is the treatment of choice for potentially curable gastric cancer . Two major Western studies in the 1990s failed to show a benefit from D2 dissection . They showed extremely high postoperative mortality after D2 dissection , and were criticised for the potential inadequacy of the pretrial training in the new technique of D2 dissection , prior to the phase III studies being initiated . The inclusion of pancreatectomy and splenectomy in D2 dissection was associated with increased morbidity and mortality . Following these results , we started a phase II trial to evaluate the safety and efficacy of pancreas-preserving D2 dissection . The results of this trial regarding the safety of pancreas preserving D2 dissection were published in 1998 . In this paper , we present the survival results of this phase II trial to confirm the rationale of carrying out a phase III study comparing D1 vs D2 dissection for curable gastric cancer . Italian patients with histologically proven gastric adenocarcinoma were registered in the Italian Gastric Cancer Study Group Multicenter trial . The study was carried out based on the General Rules of the Japanese Research Society for Gastric Cancer . A strict quality control system was achieved by a supervising surgeon of the reference centre who had stayed at the National Cancer Center Hospital , Tokyo , to learn the st and ard D2 gastrectomy and the postoperative management . The st and ard procedure entailed removal of the first and second tier lymph nodes . During total gastrectomy , the pancreas was preserved according to the Maruyama technique . Complete follow-up was available to death or 5 years in 100 % of patients and the median follow-up time was 4.38 years . Out of 297 consecutive patients registered , 191 patients were enrolled in the study between May 1994 and December 1996 . The overall morbidity rate was 20.9 % . The postoperative in-hospital mortality was 3.1 % . The overall 5-year survival rate among all eligible patients was 55 % . Survival was strictly related to stage , depth of wall invasion , lymph node involvement and type of gastrectomy ( distal vs total).Our results suggest a survival benefit for pancreas-preserving D2 dissection in Italian patients with gastric cancer if performed in experienced centres . A phase III trial among exclusively experienced centres is urgently needed BACKGROUND A multicenter , r and omized , clinical trial was initiated to evaluate the possible benefits of extended D2 ( D2 + ) lymphadenectomy after potentially curative resection of gastric cancer . METHODS St and ard D2 lymphadenectomy was defined according to the Japanese Gastric Cancer Association classification . D2 + lymph node dissection additionally included the removal of para-aortic nodes . RESULTS Of 781 patients screened , 275 were r and omized to st and ard D2 ( n = 141 ) or extended D2 + ( n = 134 ) lymphadenectomy . The overall morbidity rates were comparable in D2 ( 27.7 % ; 95 % confidence interval [ CI ] , 20.3 - 35.1 ) and D2 + ( 21.6 % ; 95 % CI , 13.7 - 29.5 ) groups ( P = .248 ) . Pre-existing cardiac disease , splenectomy , and excessive blood loss were identified as risk factors for overall and nonsurgical complications . Postoperative mortality rates were 4.9 % ( 95 % CI , 1.4 - 8.5 ) and 2.2 % ( 95 % CI , 0 - 4.7 ) , respectively ( P = .376 ) . CONCLUSIONS The interim safety analysis failed to show any significant difference with regard to the extent of lymph node dissection . The surgical outcome was not different between the 2 surgeries Background The prognosis of patients with gastric cancer and para-aortic lymph node ( PALN ) metastasis is poor . Recent Japanese r and omized trials concluded that prophylactic PALN dissection is not effective for curable advanced gastric cancer . However , the value of curative resection in patients with pathologically positive PALN is not determined yet . Methods We retrospectively identified 178 patients with pathologically positive PALN who underwent curative resection at the Cancer Institute Hospital from 1980 to 2004 . Patient characteristics were analyzed and independent prognostic factors for death were identified by Cox proportional hazard model . Results Partial gastrectomy was the most frequently performed procedure ( 142 of 178 ) . Postoperative morbidity and mortality rates were 30 and 2 % , respectively , with a 5-year survival rate of 13.0 % . Multivariate analysis revealed the total number of positive nodes ( hazard ratio , 1.804 ; 95 % confidence interval , 1.221–2.665 ) and macroscopic type ( hazard ratio , 1.697 ; 95 % confidence interval , 1.138–2.530 ) as independent prognostic factors , while age , sex , histology , pathological tumor depth , and degree of PALN dissection were not statistically significant . The 5-year survival rate increased to 28.6 % in patients with ≤15 positive nodes and macroscopic type other than type 4 . Conclusions Prophylactic PALN dissection can not be justified in curable advanced gastric cancer . However , R0 resection including PALN retrieval might be beneficial in patients with pathologically positive PALN , providing patients are carefully selected and operations are performed safely BACKGROUND / AIMS A r and omized study was performed to evaluate morbidity and mortality after D2 ( level 1 and 2 lymphadenectomy ) and D4 ( D2 plus lymphadenectomy of para-aortic lymph nodes ) dissection for advanced gastric cancer . METHODOLOGY Two hundred and fifty-six patients with advanced gastric adenocarcinoma were enrolled ( 128 to each group ) . Patients were r and omly allocated into D2 ( N = 128 ) or D4 ( N = 128 ) group . The first and second tiers of lymph nodes
Output:
| Two large western r and omized trials , meta-analyses and a recent systematic review were unable to demonstrate overall benefit from extended lymphadenectomy . |
MS212303 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: PURPOSE We determined the preferred treatment of staghorn calculi . MATERIAL S AND METHODS Between January 1992 and December 1994 we performed a prospect i ve , r and omized , single center study involving 50 kidneys with complete staghorn calculi : 27 renal units were treated with extracorporeal shock wave lithotripsy ( ESWL ) monotherapy ( group 1 ) and 23 were treated with combined ( initial ) percutaneous nephrostolithotomy with ESWL ( group 2 ) . The 2 treatment groups were compared regarding stone size , grade of collecting system dilatation and urine culture at presentation . The number of treatment sessions , narcotic doses , renal colic episodes , septic complications , unplanned ancillary procedures , length of hospitalization , total treatment duration and stone-free rate at 6 months were recorded and compared . RESULTS At the conclusion of therapy the stone-free rate was significantly greater in group 2 than in group 1 ( 74 versus 22 % , respectively , p = 0.0005 ) . The complication rate was significantly greater in group 1 , with 15 septic complications ( fever greater than 38.5C for longer than 3 days ) in 10 patients compared to only 2 episodes in group 2 ( p = 0.007 ) . The unplanned ancillary procedure rate was significantly greater in group 1 ( 8 procedures in 7 patients versus 1 procedure in group 2 , p = 0.03 ) . The overall treatment length was significantly shorter in group 2 ( 1 versus 6 months , p = 0.0006 ) . There was no significant difference in the number of procedures performed with anesthesia or in the number of hospitalization days between the 2 treatment groups . CONCLUSIONS Combined percutaneous nephrostolithotomy and ESWL should be recommended as the first line treatment choice for most patients with staghorn stones PURPOSE We compared the efficacy of shock wave lithotripsy and ureteroscopy for treatment of distal ureteral calculi . MATERIAL S AND METHODS A total of 64 patients with solitary , radiopaque distal ureteral calculi 15 mm . or less in largest diameter were r and omized to treatment with shock wave lithotripsy ( 32 ) using an HM3 lithotriptor ( Dornier MedTech , Kennesaw , Georgia ) or ureteroscopy ( 32 ) . Patient and stone characteristics , treatment parameters , clinical outcomes , patient satisfaction and cost were assessed for each group . RESULTS The 2 groups were comparable in regard to patient age , sex , body mass index , stone size , degree of hydronephrosis and time to treatment . Procedural and operating room times were statistically significantly shorter for the shock wave lithotripsy compared to the ureteroscopy group ( 34 and 72 versus 65 and 97 minutes , respectively ) . In addition , 94 % of patients who underwent shock wave lithotripsy versus 75 % who underwent ureteroscopy were discharged home the day of procedure . At a mean followup of 21 and 24 days for shock wave lithotripsy and ureteroscopy , respectively , 91 % of patients in each group had undergone imaging with a plain abdominal radiograph , and all studies showed resolution of the target stone . Minor complications occurred in 9 % and 25 % of the shock wave lithotripsy and ureteroscopy groups , respectively ( p value was not significant ) . No ureteral perforation or stricture occurred in the ureteroscopy group . Postoperative flank pain and dysuria were more severe in the ureteroscopy than shock wave lithotripsy group , although the differences were not statistically significant . Patient satisfaction was high , including 94 % for shock wave lithotripsy and 87 % for ureteroscopy ( p value not significant ) . Cost favored ureteroscopy by $ 1,255 if outpatient treatment for both modalities was assumed . CONCLUSIONS Ureteroscopy and shock wave lithotripsy were associated with high success and low complication rates . However , shock wave lithotripsy required significantly less operating time , was more often performed on an outpatient basis , and showed a trend towards less flank pain and dysuria , fewer complications and quicker convalescence . Patient satisfaction was uniformly high in both groups . Although ureteroscopy and shock wave lithotripsy are highly effective for treatment of distal ureteral stones , we believe that HM3 shock wave lithotripsy , albeit slightly more costly , is preferable to manipulation with ureteroscopy since it is equally efficacious , more efficient and less morbid BACKGROUND To establish the best treatment modality in our hospitals for patients with proximal-ureteral calculi 5 to 10 mm , we compared the treatment outcome in those who underwent primary ureteroscopy ( URS ) with that in patients who underwent primary in-situ SWL . The primary endpoints were stone-free rates at 3 weeks and 3 months and the subjective patient experience . PATIENTS AND METHODS The study was a prospect i ve patient-preference trial . From September 2002 to May 2005 , 80 patients were included , of whom 71 could be evaluated . Thirty-three patients were treated with SWL and 38 with semirigid or flexible URS . Stone status was evaluated with excretory urography or noncontrast helical CT . The bother score of urinary-tract symptoms was recorded on a visual analog scale . RESULTS The stone-free rate at 3 weeks was 58 % and 78 % ( P = 0.061 ) and at 3 months 88 % and 89 % ( P = 1 ) for SWL and URS , respectively . The percentage of patients in need of analgesics was 30 % and 49 % ( P = 0.118 ) at 3 weeks and 9 % and 21 % ( P = 0.181 ) at 3 months for the SWL and the URS group , respectively . The bother score regarding dysuria , hematuria , and flank pain were statistically significant in favor of SWL . CONCLUSION Ureteroscopy tends to make patients stone free faster , but SWL is preferred by most patients because there is less discomfort after treatment OBJECTIVES To conduct a prospect i ve and r and omized trial to compare the efficiency quotient and cost-effectiveness index of shock wave lithotripsy ( SWL ) and ureteroscopic lithotripsy ( URSL ) for the treatment of large upper third ureteral stones . METHODS A total of 35 male patients and 7 female patients with a solitary , radiopaque upper ureteral stone , 15 mm or more in diameter , who underwent SWL or URSL were enrolled in this study . The mean patient age was 53.1 + /- 14.5 years . The endpoint of the study was for the patient to be stone free or to have insignificant residual stone ( 3 mm or less ) within the kidney . RESULTS The mean stone length + /- SD was 17.9 + /- 3.9 cm in the SWL group and 18.5 + /- 2.9 cm in the URSL group ( P > 0.05 ) . The efficiency quotient for SWL and URSL was 0.61 and 0.63 , respectively . The cost-effectiveness index , treatment time , pain score , and hospital stay were greater in the URSL group . However , the degree of hydronephrosis significantly influenced the success rate of SWL . All patients with severe hydronephrosis in the SWL group needed auxiliary surgical procedures to become stone free . CONCLUSIONS The efficiency quotients of SWL and URSL were comparable in the treatment of large upper third ureteral stones . However , SWL should not be recommended as the first-line treatment option for the management of upper third ureteral stones larger than 1.5 cm with severe hydronephrosis . Underst and ing the cost-effectiveness , success rate , pain score , and patient satisfaction score for the two different approaches constitutes the indispensable requisites for choosing the optimal first-line therapeutic strategy PURPOSE We determined the natural course and compared the deleterious effects in kidneys of shock wave lithotripsy , percutaneous nephrolithotomy and observation for asymptomatic lower caliceal stones . MATERIAL S AND METHODS Between April 2007 and August 2008 patients with asymptomatic lower caliceal calculi were enrolled in the study . To assess stone status noncontrast abdominal helical computerized tomography was done 3 and 12 months after intervention . All patients were evaluated by dimercapto-succinic acid renal scintigraphy 6 weeks and 12 months after intervention . RESULTS A total of 94 patients were prospect ively r and omized to percutaneous nephrolithotomy ( 31 ) , shock wave lithotripsy ( 31 ) and observation ( 32 ) . Mean + /- SD followup was 19.3 + /- 5 months ( range 12 to 29 ) . In the percutaneous nephrolithotomy group all patients were stone-free at month 12 . Scintigraphy revealed a scar in 1 patient ( 3.2 % ) on month 3 followup imaging . In the shock wave lithotripsy group the stone-free rate was 54.8 % . Scintigraphy revealed scarring in 5 patients ( 16.1 % ) . In the observation group 7 patients ( 18.7 % ) required intervention during followup . Median time to intervention was 22.5 + /- 3.7 months ( range 18 to 26 ) . One patient ( 3.1 % ) had spontaneous stone passage . Scintigraphy did not reveal scarring in any patient . CONCLUSIONS Stone related events were noted in more than 20 % of patients with asymptomatic lower caliceal stones observed expectantly . To manage lower caliceal stones percutaneous nephrolithotomy has a significantly higher stone-free rate with less renal scarring than shock wave lithotripsy . Thus , patients with asymptomatic lower caliceal stones must be informed in detail about all management options , especially focusing on percutaneous nephrolithotomy with its outst and ing outcome PURPOSE The efficacy of shock wave lithotripsy and percutaneous stone removal for the treatment of symptomatic lower pole renal calculi was determined . MATERIAL S AND METHODS A prospect i ve r and omized , multicenter clinical trial was performed comparing shock wave lithotripsy and percutaneous stone removal for symptomatic lower pole only renal calculi 30 mm . or less . RESULTS Of 128 patients enrolled in the study 60 with a mean stone size of 14.43 mm . were r and omized to percutaneous stone removal ( 58 treated , 2 awaiting treatment ) and 68 with a mean stone size of 14.03 mm . were r and omized to shock wave lithotripsy ( 64 treated , 4 awaiting treatment ) . Followup at 3 months was available for 88 % of treated patients . The 3-month postoperative stone-free rates overall were 95 % for percutaneous removal versus 37 % lithotripsy ( p < 0.001 ) . Shock wave lithotripsy results varied inversely with stone burden while percutaneous stone-free rates were independent of stone burden . Stone clearance from the lower pole following shock wave lithotripsy was particularly problematic for calculi greater than 10 mm . in diameter with only 7 of 33 ( 21 % ) patients becoming stone-free . Re-treatment was necessary in 10 ( 16 % ) lithotripsy and 5 ( 9 % ) percutaneous cases . There were 9 treatment failures in the lithotripsy group and none in the percutaneous group . Ancillary treatment was necessary in 13 % of lithotripsy and 2 % percutaneous cases . Morbidity was low overall and did not differ significantly between the groups ( percutaneous stone removal 22 % , shock wave lithotripsy 11 % , p = 0.087 ) . In the shock wave lithotripsy group there was no difference in lower pole anatomical measurements between kidneys in which complete stone clearance did or did not occur . CONCLUSIONS Stone clearance from the lower pole following shock wave lithotripsy is poor , especially for stones greater than 10 mm . in diameter . Calculi greater than 10 mm . in diameter are better managed initially with percutaneous removal due to its high degree of efficacy and acceptably low morbidity PURPOSE We compared the long-term impact on renal function after shock wave lithotripsy , percutaneous nephrolithotomy or the 2 techniques combined in patients with a solitary kidney . MATERIAL S AND METHODS A total of 45 women and 38 men 15 to 86 years old ( mean age 56.1 ) with a solitary kidney were treated with shock wave lithotripsy ( 53 ) , percutaneous nephrolithotomy ( 18 ) or the 2 techniques combined ( 12 ) . Before and after treatment serum creatinine , blood pressure and the calculated glomerular filtration rate were determined , and raw and calculated data were compared by the Kruskal-Wallis , Fisher exact and Wilcoxon rank sum tests , and the Spearman correlation coefficient . Followup was 1 to 166.5 months ( mean 53.0 , median 46.9 ) overall and statistically equivalent in the 3 treatment arms . RESULTS Treatment groups were comparable in regard to patient age , sex distribution , weight , blood pressure and pretreatment serum creatinine . There was no significant difference in any evaluated pretreatment or posttreatment parameters and no difference in the change in any parameter after treatment . Stratifying patients to pretreatment serum creatinine less or greater than 2 m
Output:
| Results from five small studies , with low method ological quality , indicated ESWL is less effective for kidney stones than PCNL but not significantly different from RIRS .
Hospital stay and duration of treatment was less with ESWL . |
MS212304 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE The circadian clock regulates glucose metabolism by mediating the activity of metabolic enzymes , hormones , and transport systems . Breakfast skipping and night eating have been associated with high HbA1c and postpr and ial hyperglycemia after lunch and dinner . Our aim was to explore the acute effect of breakfast consumption or omission on glucose homeostasis and clock gene expression in healthy individuals and individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS In a crossover design , 18 healthy volunteers and 18 volunteers with 14.5 ± 1.5 years diabetes , BMI 30.7 ± 1.1 kg/m2 , and HbA1c 7.6 ± 0.1 % ( 59.6 ± 0.8 mmol/mol ) were r and omly assigned to a test day with breakfast and lunch ( YesB ) and a test day with only lunch ( NoB ) . Postpr and ial clock and clock-controlled gene expression , plasma glucose , insulin , intact glucagon-like peptide 1 ( iGLP-1 ) , and dipeptidyl peptidase IV ( DPP-IV ) plasma activity were assessed after breakfast and lunch . RESULTS In healthy individuals , the expression level of Per1 , Cry1 , Rorα , and Sirt1 was lower ( P < 0.05 ) but Clock was higher ( P < 0.05 ) after breakfast . In contrast , in individuals with type 2 diabetes , Per1 , Per2 , and Sirt1 only slightly , but significantly , decreased and Rorα increased ( P < 0.05 ) after breakfast . In healthy individuals , the expression level of Bmal1 , Rorα , and Sirt1 was higher ( P < 0.05 ) after lunch on YesB day , whereas the other clock genes remained unchanged . In individuals with type 2 diabetes , Bmal1 , Per1 , Per2 , Rev-erbα , and Ampk increased ( P < 0.05 ) after lunch on the YesB day . Omission of breakfast altered clock and metabolic gene expression in both healthy and individuals with type 2 diabetes . CONCLUSIONS Breakfast consumption acutely affects clock and clock-controlled gene expression leading to normal oscillation . Breakfast skipping adversely affects clock and clock-controlled gene expression and is correlated with increased postpr and ial glycemic response in both healthy individuals and individuals with diabetes Background There is no data on diet- and activity-related behaviors associated with overweight and obesity among Pakistani school-aged children . The study aim ed to explore dietary behaviors , physical activity and sedentary lifestyle associated with overweight and obesity , and their socio-demographic correlates , among Pakistani primary school children . Methods A population -based cross-sectional study was conducted with a representative multistage r and om cluster sample of 1860 children aged five to twelve years in Lahore , Pakistan . Overweight ( > + 1 SD ) and obesity ( > + 2 SD ) were defined using the World Health Organization reference 2007 . Chi-square test was used as the test of trend . Linear regression was used to examine the predictive power of independent variables in relation to body mass index ( BMI ) . Logistic regression was used to quantify the independent predictors and adjusted odds ratios ( aOR ) with 95 % confidence intervals ( CI ) were obtained . Statistical significance was considered at P < 0.05 . Results Children skipping breakfast ( 8 % ) , eating fast food and snacks ≥ once a week ( 43 % ) and being involved in sedentary lifestyle > one hour a day ( 49 % ) were significantly more likely to be overweight and obese while those participating in physical activity > twice a week ( 53 % ) were significantly less likely to be overweight and obese ( all P < 0.01 ) . Skipping breakfast ( P < 0.001 ) , eating fast food and snacks ( P = 0.001 ) and sedentary lifestyle ( P < 0.001 ) showed an independent positive association with BMI while physical activity showed an independent inverse association ( P = 0.001 ) . Skipping breakfast ( aOR 1.82 , 95 % CI 1.22 - 2.71 ) , eating fast food and snacks ≥ once a week ( OR 1.41 , 95 % CI 1.07 - 1.86 ) , physical activity > twice a week ( aOR 0.49 , 95 % CI 0.34 - 0.70 ) and sedentary lifestyle > one hour a day ( aOR 1.56 , 95 % CI 1.19 - 2.03 ) were independent predictors of being overweight . Skipping breakfast had independent inverse association with physical activity ( aOR 0.63 , 95 % CI 0.45 - 0.89 ) and eating fast food and snacks had independent positive association with sedentary lifestyle ( aOR 1.79 , 95 % CI 1.49 - 2.16 ) . Female gender was independently associated with skipping breakfast ( aOR 1.50 , 95 % CI 1.04 - 2.16 ) . Male gender ( aOR 1.64 , 95 % CI 1.33 - 2.02 ) , urban area with high SES ( aOR 5.09 , 95 % CI 3.02 - 8.60 ) and higher parental education ( aOR 1.74 , 95 % CI 1.12 - 2.68 ) were significant independent predictors of eating fast food and snacks ≥ once a week . Living in the rural area was independently associated ( aOR 2.51 , 95 % CI 1.71 - 3.68 ) with physical activity > twice a week . Male gender ( aOR 1.60 , 95 % CI 1.31 - 1.95 ) , urban area with low SES ( aOR 1.46 , 95 % CI 1.02 - 2.09 ) , high-income neighborhoods ( aOR 1.52 , 95 % CI 1.02 - 2.25 ) , higher parental education ( aOR 1.55 , 95 % CI 1.03 - 2.34 ) and fewer siblings ( aOR 1.38 , 95 % CI 1.10 - 1.73 ) were independent predictors of sedentary lifestyle > one hour a day . Conclusions Dietary behaviors , physical activity and sedentary lifestyle are independent predictors of overweight and higher BMI among Pakistani primary school children , and are significantly affected by the child 's socio-demographic characteristics . These findings support the urgent need to develop a National strategy for diet and physical activity and to implement culturally relevant behavioral interventions in the re source -poor developing country setting OBJECTIVE To assess the prospect i ve associations of breakfast , lunch , and dinner skipping at age 4 years with body fat ( ie , percent fat mass , body mass index [ BMI ] , and weight status ) at age 6 years . STUDY DESIGN Data were analyzed from 5913 children participating in the Generation R Study , a population -based prospect i ve cohort study in Rotterdam , The Netherl and s. Meal-skipping behaviors were assessed through parent-report question naires . Children 's weight and height were objective ly measured and converted to BMI SDSs . Weight status ( ie , overweight or normal weight ) was defined according to age- and sex-specific cutoff points . At age 6 years , percent fat mass was assessed by dual-energy X-ray absorptiometry . Linear and logistic regression analyses were performed , adjusting for covariates and BMI at age 4 years . RESULTS Breakfast skipping at age 4 years was associated with a higher percent fat mass at age 6 years ( β = 1.38 ; 95 % CI , 0.36 - 2.40 ) . No associations were found with BMI or weight status . Furthermore , no associations were found between lunch and dinner skipping at age 4 years and body fat at age 6 years . CONCLUSION Breakfast skipping at age 4 years is associated with a higher percent fat mass at age 6 years . Further prospect i ve studies , including intervention studies , are warranted to extend the evidence base on the directionality and causality of this association Introduction The study aim was to evaluate risk factors of obesity in Polish children aged 7 to 9 years . Material and methods A representative group of 2571 children ( 1268 girls and 1303 boys ) was r and omly selected according to the European Childhood Obesity Group protocol . Weight and height were measured and body mass index ( BMI ) was calculated . A question naire was completed by the children 's parents with respect to behavioural and family-related risk factors of obesity . International Obesity Task Force criteria were used for classification of children 's obesity . Results Obesity was found in 3.7 % of girls and 3.6 % of boys . There was a statistically significant association between the prevalence of obesity in girls and their mother 's obesity : OR = 5.06 ( 1.96–13.05 ) , p < 0.001 , father 's obesity : OR = 5.19 ( 1.96–13.69 ) , p < 0.001 , and both parents ’ obesity : OR = 5.43 ( 1.39–21.29 ) , p = 0.01 . Obesity in boys was significantly associated with mother 's obesity : OR = 5.6 ( 2.6–12.02 ) , p < 0.001 , father 's obesity : OR = 6.21 ( 2.89–13.37 ) , p < 0.001 , and both parents ’ obesity : OR = 7.22 ( 2.44–31.33 ) , p < 0.001 . Skipping or irregular eating of breakfast was a risk factor for obesity in girls with OR = 2.71 ( 1.33–5.51 ) , p = 0.005 . Neither family income nor parents ’ education level was related to their offspring 's obesity . TV watching , physical activity level and eating in fast food places were not significant risk factors for obesity . Conclusions Eating breakfast regularly seems to protect girls from obesity development while low physical activity is not a significant obesity risk factor in this age group for either boys or girls . This finding stresses the more important role of healthy diet than physical activity promotion in obesity prevention in prepubertal children Background / Objectives : Childhood obesity is prevalent , and dietary habits are a key determinant . Some children skip breakfast for weight control , but studies have shown mixed results . Therefore , we assessed the association between breakfast skipping and body mass index ( BMI ) among young Chinese children in Hong Kong . Design /Subjects and Methods : A cohort of 113 457 primary 4 participants of the Department of Health Student Health Service in 1998–2000 was followed up for 2 years , with 68 606 ( 60.5 % ) participants available for analysis in primary 6 . The sociodemographic characteristics for traced and untraced participants were similar . At baseline and follow-up , students reported breakfast habit ( consumed vs skipped ) and other lifestyle characteristics using a st and ardized question naire . BMI was derived using height and weight measured by trained nurses . Multivariable linear regression was used to examine the cross-sectional relationship between breakfast habit and BMI , as well as the prospect i ve association between baseline breakfast habit and change in BMI . Models adjusted for demographic , socioeconomic and lifestyle characteristics . Results : A total of 1805 ( 5.3 % ) boys and 1793 ( 5.2 % ) girls skipped breakfast at baseline . In cross-sectional analyses , breakfast skippers had a higher mean BMI than did eaters among both primary 4 ( β=0.77 , 95 % confidence interval ( 95 % CI ) : 0.67–0.87 ) ( P<0.001 ) and primary 6 children ( β=0.86 , 95 % CI : 0.78–0.95 ) ( P<0.001 ) . Compared with eaters , baseline breakfast skippers experienced a greater increase in BMI in the subsequent 2 years ( β=0.11 , 95 % CI : 0.07–0.16 ) ( P<0.001 ) , and this association was stronger among lunch skippers than eaters ( P for interaction=0.04 ) . Conclusion : Our study provided prospect i ve evidence that skipping breakfast predicts a greater increase in BMI among Hong Kong children . As breakfast is a modifiable dietary habit , our results may have important implication s for weight control . However , the underlying mechanism of this effect warrants further BACKGROUND Breakfast is associated with lower body weight in observational studies . Public health authorities commonly recommend breakfast consumption to reduce obesity , but the effectiveness of adopting these recommendations for reducing body weight is unknown . OBJECTIVE We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting . DESIGN We conducted a multisite , 16-wk , 3-parallel-arm r and omized controlled trial in otherwise healthy overweight and obese adults [ body mass index ( in kg/m² ) between 25 and 40 ] aged 20 - 65 y. Our primary outcome was weight change . We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [ no breakfast ( NB ) ] . R and omization was stratified by prer and omization breakfast eating habits . A total of 309 participants were r and omly assigned . RESULTS A total of 283 of the 309 participants who were r and omly assigned completed the intervention . Treatment assignment did not have a significant effect on weight loss , and there was no interaction between initial
Output:
| Skipping breakfast was associated with a worse lipid profile , blood pressure levels , insulin-resistance , and metabolic syndrome .
This review supports skipping breakfast as an easy marker of the risk of OW/OB and metabolic diseases , whether or not it is directly involved in causality . |
MS212305 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIMS To review the patient choice , clinical outcomes and satisfaction rate between adjustable and non-adjustable male sling ( MS ) with a minimum follow up of 24 months . METHODS A prospect i ve review of clinical parameters in all male patients who underwent MS surgery between January 2009 and December 2011 was undertaken . Vali date d instruments were utilized in the follow-up survey . RESULTS A total of 44 MS were inserted with 25 men choosing adjustable Argus ( Promedon , Cordoba , Argentina ) and 19 men received non-adjustable AdVance ( American Medical Systems , Minnetonka , MN ) MS . The mean age and follow-up for men in the Argus group were 65.4 years and 36.2 months , and in AdVance group were 63.8 years and 33.1 months . Revision surgery was performed in six Argus MS for recurrent urinary incontinence . Social continence ( defined as 0 to 1 urinary pad use ) was achieved in 23 patients ( 92 % ) with Argus MS and 16 patients ( 84 % ) with AdVance MS ( P = 0.45 ) . The overall satisfaction rate on a 5-point scale was 4.5 in Argus and 4.3 in AdVance patients , and there was no significant difference in the PGI-I score between the two groups ( P = 0.36 ) . Kaplan-Meier analysis of urinary continence and patient satisfaction rates were not statistically significant between Argus and AdVance slings ( P = 0.76 and P = 0.38 ) . CONCLUSIONS Given the choice between the two types of MS , more men chose adjustable Argus over non-adjustable AdVance sling . There was no significant difference in the clinical outcome , social continence and overall patient satisfaction rates between the two types of MS in the short term . Neurourol . Urodynam . 35:482 - 486 , 2016 . © 2015 Wiley Periodicals , OBJECTIVE To evaluate the efficacy and safety of the adjustable suburethral sling Remeex ® in the treatment of male stress urinary incontinence ( SUI ) . PATIENTS AND METHODS Single-center prospect i ve study of patients treated for SUI after radical prostatectomy or transurethral resection of prostate . The severity of incontinence was evaluated by the number of pads used per day . Success rate , complications and number of adjustments were studied . RESULTS From February 2011 to May 2015 , Remeex ® was implanted in 25 patients . The average preoperative number of pads used per day was 3,8 ( ±1,8 ) . Sling tension has been adjusted the day after surgery in all patients . Mean follow-up was 31 months ( ±15 ) . During follow-up , 6 patients did not need any readjustment ( 24 % ) and 15 patients ( 60 % ) had to be readjusted . One Remeex system had to be completely removed because of a sub-occlusive syndrome . Three patients had early infection requiring partial system removal ( Varitensor ) . At the end of follow-up , 9 patients were cured ( 36 % ) , 9 patients ( 36 % ) were significantly improved and 7 patients ( 28 % ) were not improved . Five patients are waiting for a new readjustment . CONCLUSION In this short series of patients who had prostatic surgery , at mid-term follow-up , the placement of a BSUA-R was associated with an improvement or cure of urinary incontinence symptoms in two-thirds of cases . LEVEL OF EVIDENCE 4 PURPOSE To report long-term results of the Argus T adjustable system for treatment of post-prostatectomy urinary incontinence ( PPI ) . MATERIAL S AND METHODS From October 2007 to August 2008 , 37 patients with PPI were included in a prospect i ve , single-arm , multicenter trial of treatment with the Argus T adjustable system ( Promedon , Argentina ) . Preoperative evaluation included urine culture , urethrocystoscopy , urodynamic testing , 24-h pad weight test ( PWT ) and quality of life question naires . Patients were stratified according to baseline degree of incontinence ( mild-moderate or severe ) . Postoperative evaluation included immediate PWT , quality of life question naires and daily use of pads at 1 , 12 and 30 months . RESULTS AND CONCLUSIONS One patient was lost to follow-up . At the 30-month follow-up , 24/31 patients ( 77 % ) were dry , 3/31 ( 10 % ) improved and 4/31 ( 13 % ) were failures . In particular , in the mild-moderate group , 8/8 ( 100 % ) patients were dry . In the severe group , 20/28 patients ( 71 % ) were dry , 3/28 ( 11 % ) improved and 5/28 ( 18 % ) were failures . Median visual analogue scale ( VAS ) scores dropped from 9 ( 4 - 10 ) to 0.5 ( 0 - 10 ) and International Consultation on Incontinence Question naire Short Form scores from ( ICIQ-SF ) 19 ( 12 - 21 ) to 1 ( 0 - 10 ) . Retro grade leak point pressure increased from 18 ( 5 - 29 ) to 35 ( 22 - 45 ) cm H2O after intraoperative adjustment . Complications included immediate postoperative infection in 2/36 patients ( 6 % ) and transient inguinal and /or perineal pain in 22/36 patients ( 61 % ) . Argus T has a long-term high success rate ( 86 % cure + improvement at the 30-month follow-up ) . Good outcomes were achieved even in severe incontinence cases and maintained for over 30 months PURPOSE We report on our initial experience in terms of efficacy and safety with a new , self-anchoring adjustable transobturator male system ( A.M.I. ® ATOMS System ) for the treatment of male stress urinary incontinence after prostate surgery . MATERIAL S AND METHODS In this prospect i ve , nonr and omized single center study conducted between March and December 2009 , patients with stress urinary incontinence secondary to prostatic surgery were treated with the ATOMS device . Urethroscopy , filling and voiding cystometry were performed preoperatively for all patients . In addition , incontinence symptoms were assessed , and a physical examination , 24-hour pad test and 24-hour pad count were performed before and after surgery . RESULTS A total of 38 patients were included in the study ( 36 after radical prostatectomy , 2 after benign prostatic hyperplasia surgery ) . No intraoperative complications occurred . Mean number of adjustments during followup was 3.97 ( range 0 to 9 ) . At a mean followup of 16.9 months ( range 13 to 21 ) the overall success rate was 84.2 % . Of the successful cases 60.5 % were considered dry ( 0 to 1 pad and less than 15 ml/24-hour pad test ) and 23.7 % improved ( more than 1 pad per 24 hours but more than 50 % decrease in pad use and less than 100 ml per 24-hour pad test ) . In 15.8 % of the patients the treatment was considered to have failed ( more than 2 pads daily and greater than 100 ml on 24-hour pad test ) . CONCLUSIONS The treatment of male stress urinary incontinence with the ATOMS is safe and effective . It is an excellent first or second line treatment for mild to moderate male stress urinary incontinence , even after external irradiation . The option of long-term , minimally invasive adjustment to respond to patient needs is a significant advantage of this new implant AIMS We explored re- interventions and short and long term adverse events associated with procedures for male incontinence among Medicare beneficiaries . METHODS All inpatient and outpatient cl aims for a simple r and om sample of Medicare beneficiaries for 2000 - 2011 were queried to identify patients of interest . All male patients with an International Classification of Diseases , 9th Edition ( ICD-9 ) diagnosis code for stress incontinence or mixed incontinence were included . Artificial urinary sphincter recipients , patients who underwent a sling operation and those receiving an injection of a bulking agent were identified with Current Procedure Terminology ( CPT-4 ) and ICD-9 Procedure Codes . RESULTS The entire cohort of 1,246 patients were operated on between 2001 and 2011 . 34.9 % of them received an artificial urinary sphincter ( AUS ) , 28.7 % with a bulking agent , and 36.4 % with a sling . There were no statistically significant differences in demographics or comorbidities between the treatment groups , except that more sling patients were obese ( P = 0.006 ) and fewer bulk patients had diabetes ( P = 0.007 ) . There are , however , significant changes in procedures selected over time ( P < 0.001 ) . In the first year and over the entire follow-up after surgery , patients treated with bulking agents had the most subsequent interventions ( 40.1 % and 52.9 % ) , followed by sling ( 10.4 % and 15.5 % ) , and AUS ( 2.3 % and 20 % ) ( P < 0.001 ) . Post-operative and 90 day complications were low . CONCLUSIONS All three treatments seem to be safe among Medicare beneficiaries with multiple comorbidities . The urological , infectious , and neurological complication occurrences were low PURPOSE Many investigators have used the number of pads to determine the severity of post-prostatectomy incontinence and yet the accuracy of this tool remains unproven . We determined whether the patient perception of pad use and urine loss reflects actual urine loss . We also identified a quality of life measure that distinguishes patients by severity of incontinence . MATERIAL S AND METHODS We prospect ively enrolled 235 men from a total of 18 sites 6 months or more after radical prostatectomy who had incontinence requiring protection . Patients completed a question naire on the perception of pad number , size and wetness , a quality of life question , several st and ardized incontinence question naires and a 24-hour pad test that assessed pad number , size and weight . SPSS ® was used for statistical analysis . RESULTS Perception of the number of pads used closely agreed with the number of pads collected during a 24-hour pad test . Perceived and actual pad size had excellent concordance ( 76 % , p < 0.001 ) . Patients with wet and soaked pads had statistically and clinical ly significantly different pad weights that were uniquely different from each other and from those of patients who were almost dry and slightly wet . Response to the quality of life question separated the men into 4 statistically significantly different groups based on mean 24-hour pad weight . CONCLUSIONS Patients accurately described the number , size and degree of wetness of pads collected during a 24-hour pad test . These values correlated well with actual urine loss . The single question , " To what extent does urine loss affect your quality of life ? " separated men into distinct categories PURPOSE We prospect ively assessed the role of nerve sparing surgery on urinary continence after open radical retropubic prostatectomy . MATERIAL S AND METHODS We evaluated a consecutive series of 536 patients who underwent open radical retropubic prostatectomy with attempted bilateral , unilateral or no nerve sparing , as defined by the surgeon , without prior radiotherapy at a minimum followup of 1 year with documented assessment of urinary continence status . Because outlet obstruction may influence continence rates , its incidence and management was also evaluated . RESULTS One year after surgery 505 of 536 patients ( 94.2 % ) were continent , 27 ( 5 % ) had grade I stress incontinence and 4 ( 0.8 % ) had grade II stress incontinence . Incontinence was found in 1 of 75 ( 1.3 % ) , 11 of 322 ( 3.4 % ) and 19 of 139 patients ( 13.7 % ) with attempted bilateral , attempted unilateral and without attempted nerve sparing , respectively . The proportional differences were highly significant , favoring a nerve sparing technique ( p < 0.0001 ) . On multiple logistic regression analysis attempted nerve sparing was the only statistically significant factor influencing urinary continence after open radical retropubic prostatectomy ( OR 4.77 , 95 % CI 2.18 to 10.44 , p = 0.0001 ) . Outlet obstruction at the anastomotic site in 33 of the 536 men ( 6.2 % ) developed at a median of 8 weeks ( IQR 4 to 12 ) and was managed by dilation or an endoscopic procedure . CONCLUSIONS The incidence of incontinence after open radical retropubic prostatectomy is low and continence is highly associated with a nerve sparing technique . Therefore , nerve sparing should be attempted in all patients if the principles of oncological surgery are not compromised ABSTRACT Objective To compare the results of two slings , Argus T ® and Advance ® , for the treatment of postprostatectomy urinary incontinence ( PPUI ) . Material and Methods : From December 2010 to December 2011 , 22 patients with PPUI were r and omized as follows : 1
Output:
| Evidence of low quality indicates that adjustable slings are effective for treating post-prostatectomy urinary incontinence , with frequency of adverse events similar to the surgical option considered gold st and ard ( the artificial urinary sphincter implant ) |
MS212306 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 literature reports that flapless compared with traditional implant surgery can be associated with several advantages , including the maintenance of peri-implant hard tissues . This study investigated vertical bone resorption during long-term follow-up after implant placement with flapless versus traditional surgery . MATERIAL AND METHODS In this prospect i ve , r and omized controlled clinical trial , 40 patients underwent implant placement at the Maxillofacial Department Surgery of the Istituto Stomatologico Italiano Hospital in Milan , Italy . Patients were r and omly assigned to the control or experimental group . The control group had implants placed with open flap surgery ( traditional surgery ) , whereas the experimental group had implants placed with flapless surgery . The distance between the first implant thread and the marginal crestal bone level was measured at the basal , loading , and long-term control points . The basal recording was performed just after implant placement . The loading measurement was recorded at the time of implant loading , after 2 months of healing for the lower jaw and after 3 months of healing for the upper jaw , and the long-term control record was registered 36 months after implant placement . Statistical analysis was performed using mean values and st and ard deviations based on bone resorption in the 2 groups . To detect statistical differences , the Student t test was applied . Differences were considered significant if P values were less than .05 . RESULTS The control group ( open flap surgery ) was comprised of 19 patients , and the experimental group ( flapless surgery ) was comprised of 21 patients . No statistical differences were found in peri-implant bone resorption between the 2 groups at the basal , implant loading , and 3-year control recordings . CONCLUSION According to this study , the approach to implant surgery does not seem to influence peri-implant bone resorption in humans , at least for the period measured in this study PURPOSE To compare the efficacy of immediate functionally loaded implants placed with a flapless procedure ( test group ) versus implants placed after flap elevation and conventional load-free healing ( control group ) in partially edentulous patients . MATERIAL S AND METHODS Forty patients were r and omized : 20 to the flapless immediately loaded group and 20 to the conventional group . To be immediately loaded , implants had to be inserted with a minimum torque > 45 Ncm . Implants in the immediately loaded group were provided with full acrylic resin temporary restorations the same day . Implants in the conventional group were submerged ( anterior region ) or left unsubmerged ( posterior region ) and were left load-free for 3 months ( m and ibles ) or 4 months ( maxillae ) . Provisional restorations were replaced with definitive single metal-ceramic crowns 1 month postloading . Outcome measures were prosthesis and implant failures , biological and prosthetic complications , postoperative edema , pain , and use of analgesics . Independent sample chi2 tests , Mann-Whitney tests , t tests , and paired t tests were used with a significance level of .05 . RESULTS Fifty-two implants were placed in the flapless group and 56 in the conventionally loaded group . In the flapless group , 1 flap had to be raised to control the direction of the bur and 1 implant did not reach the planned primary stability and was treated as belonging to the conventional group . After 3 years no dropouts or failures occurred . There was no statistically significant difference for complications ; however , patients in the conventional group had significantly more postoperative edema and pain and consumed more analgesics than those in the flapless group . Osstell values were significantly higher at baseline in the flapless group ( P = .033 ) . When comparing baseline data with years 1 , 2 , and 3 within each group , mean Osstell values of the flapless group did not increase , whereas there were statistically significant increases in the Periotest values . CONCLUSIONS Implants can be successfully placed flapless and loaded immediately without compromising success rates ; the procedure decreases treatment time and patient discomfort PURPOSE The purpose of this 2-year r and omized controlled clinical trial was to assess the differences in implant survival rates , soft tissue preservation , patient centered outcome and crestal bone changes applying the minimally invasive ( MI ) flapless approach for single implant placement compared to flapped implant surgery ( FS ) . MATERIAL S AND METHODS Subjects eligible for this study were r and omly assigned into two groups : MI or FS . Items of evaluation were the following : implant installation position , soft tissue healing , post-surgical pain , soft tissue outcome , marginal bone loss ( MBL ) , and implant survival rate . RESULTS Forty subjects ( 14 women and 26 men , 20 in MI group and 20 in FS group with a mean of 39 ± 13.2 years old ) were included in the study . None of the implants demonstrated dehiscence or loss during the follow-up . Subjects in MI group showed significantly lower post-surgical pain and significantly less wound healing index scores at 1-week follow-up . The width of keratinized mucosa decreased from a mean of 4.2 ± 1.6 mm pre-surgically to 3.7 ± 1.1 mm at crown delivery but remained stable at 2-year follow-up in MI group . At every appointment in the study , no statistical significant difference of PD and MBL was found between the two groups . CONCLUSION Compared with FS , single implants placed applying the MI technique in selected subjects showed advantages in improving patient comfort and decreasing post-implant placement soft tissue reaction . Meanwhile , implants with MI approach have the same level of MBL and high success rates as FS procedure at 2-year follow-up . The deduction of keratinized mucosa is very limited and the width of KM remained stable with MI approach at 2-year follow-up PURPOSE The aim of this prospect i ve clinical study was to evaluate the 3-year outcome of fixed partial prostheses supported by implants with immediate provisionalization without occlusal contacts inserted in predominantly soft bone with flap and flapless protocol s. MATERIAL S AND METHODS Forty-one patients partially rehabilitated with 72 NobelSpeedy implants ( 51 maxillary ; 21 m and ibular ) were consecutively included and treated with a flapless surgical protocol ( n = 20 patients ; 32 implants ) and flapped surgical protocol ( n = 21 patients ; 40 implants ) . Primary outcome measure was implant survival ; secondary outcome measures were marginal bone resorption ( comparing the bone levels at 1 and 3 years with baseline ) and the incidence of biological , mechanical , and esthetic complications . Survival was computed through life tables ; descriptive statistics were applied to the remaining variables of interest . RESULTS Eight patients with eight implants dropped out of the study . One implant failed in one patient ( flapless group ) giving an overall cumulative survival rate ( CSR ) of 98.6 % . No failures were noted with the flapped protocol ( CSR 100 % ) , while for the implants placed with the flapless surgical technique , a 96.9 % CSR was registered . The overall average marginal bone resorption at 3 years was 1.37 mm ( SD = 0.94 mm ) , with 1.14 mm ( SD = 0.49 mm ) and 1.60 mm ( SD = 1.22 mm ) for the flap and flapless groups , respectively . Mechanical complications occurred in nine patients ( n = 5 patients in the flapless group ; n = 4 patients in the flap group ) . Implant infection was registered in three implants and three patients ( flapless group ) , who exhibited inadequate oral hygiene levels . CONCLUSIONS Partial edentulism rehabilitation through immediate provisionalization fixed prosthesis supported by dental implants inserted through flap or flapless surgical techniques in areas of predominantly soft bone was viable at 3 years of follow-up . The limitations and risks of the " free-h and " method in flapless surgery should be considered when planning implant-supported fixed prosthetic reconstructions In this issue , we answer three questions with respect to loss to follow-up in a clinical trial : How important is loss to follow-up ? How is loss to follow-up calculated ? How many patients can be lost to follow-up without mistrusting the results ? 1 . How important is loss to follow-up ? The simple answer to this question is “ very important ” because loss to follow-up can severely compromise a study 's validity . Incomplete follow-up biases the results when either : The dropout rates are different between study groups ; or The patients who drop out are different from those who do not drop out . Why do these situations make a difference ? Because in each situation , those lost to follow-up often have a different prognosis than those who complete the study . For example , patients who receive treatment for cervical myelopathy may not return for follow-up because they became asymptomatic and felt no need to return to see the surgeon . Conversely , some patients may not return because they had a particularly bad outcome ( worse pain or function ) or complication , or because they died . In either case , bias can affect the validity of the inferences drawn from the study . 2 . How is loss to follow-up calculated ? There is much confusion about how to determine the proportion of patients lost to follow-up . In order to correctly calculate the follow-up rate , one needs to know the denominator . In a r and omized controlled trial ( RCT ) , the denominator for each group is the number of patients who were r and omized , not the number who received the treatment . For example , suppose we have an RCT comparing two treatment groups , Group A and Group B. The investigators evaluate 178 patients and r and omize 120 ; 61 to Group A and 59 to Group B ( Fig 1 ) . Following the figure , we note that 49 patients received treatment A and 52 received treatment B. At the final follow-up 40 were analyzed in Group A and 41 in Group B. How many were considered lost to follow-up ? Many would consider the loss to follow-up rate to be 9 ( 18 % ) of 49 in treatment A and 11 ( 21 % ) of 52 in treatment B using as the denominator only those that were treated . However , the real proportion lost to follow-up must consider those who were r and omly assigned , even if they did not receive treatment . In the present example , this is calculated as 21 ( 34 % ) of 61 for treatment A and 18 ( 31 % ) of 59 for treatment B. Fig 1 Hypothetical example of patients lost to follow-up in a r and omized controlled trial . When calculating loss to follow-up in a retrospective cohort study , all individuals receiving treatment during the study period should be used as the denominator , not just those with complete data . For example , let 's say you want to compare decompression plus lumbar fusion with decompression alone in disc herniation and the data available are all patients receiving either treatment in the last 5 years ( N = 275 ) . However , the data base from which the data are obtained is incomplete and only 190 have the necessary data available . Since the investigators stated as part of the inclusion criteria that only those patients with complete data are included , they consider the follow-up to be 100 % ( 190/190 ) . This conclusion is wrong . The denominator should include all patients who underwent the surgery irrespective of completeness of data . The follow-up rate for this example is 69 % ( 190/275 ) . 3 . How many patients can be lost to follow-up without mistrusting the results ? Some have suggested that 20 % poses serious threats to validity 1 . This may be a good rule of thumb , but keep in mind that even small proportions of patients lost to follow-up can cause significant bias 2 . One way to determine if loss to follow-up can seriously affect results is to assume a worst-case scenario with the missing data and look to see if the results would change . Here is an example : Let 's assume a multicenter study enrolled 500 patients into each arm of a study comparing artificial disc replacement ( ADR ) with fusion , and the end point is adjacent segment disease ( ASD ) . The trial numbers are found in Fig 2 . Fig 2 Hypothetical example of the effect of loss to follow-up considering a worst-case scenario . ADR indicates artificial disc replacement ; ASD , adjacent segment disease . The proportion of patients with ASD in the ADR group is half as much versus the fusion group , 25 % ( 100/400 ) compared with 50 % ( 200/400 ) . If we assume that the 100 lost to follow-up in the ADR group had ASD and the 100 lost to follow-up in the fusion group did not , then the rate of ASD in each group would be 40 % ( 200/500 ) . In this case , adopting the worst-case scenario for the intervention group with respect to those lost to follow-up causes the results to change significantly from half the rate of ASD with ADR to the same rate . When this happens , loss to follow-up can threaten the internal validity of the trial . Only when the worst case does not change the inferences derived from the results is lost to follow-up not a problem PURPOSE To compare outcomes for immediately loaded one-piece implants ( OPI ) , placed flapless , and conventionally loaded two-piece implants ( TPI ) , placed after two-stage flapped surgery . MATERIAL S AND METHODS Thirty-eight participants were r and omised to receive either one OPI ( 19 participants , OPI group ) or one TPI ( 19 participants , TPI group ) inserted in the posterior m and ible with a torque of at least 35 Ncm according to a parallel group design . OPI were immediately loaded with non-occluding temporary crowns . After 3 months , TPI were exposed and implants in both groups were occlusally loaded with zirconia crowns . Outcome measures were implant failure , prosthesis failure , any complication and changes of probing pocket depth ( PPD ) , plaque index ( PI ) , gingiva index ( GI ) , and peri-implant marginal bone level , recorded by unblinded assessors .
Output:
| The flapless surgery and conventional approach had comparable clinical performance over three years or more .
The guided or free-h and technique does not significantly affect the long-term outcomes of flapless surgery |
MS212307 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND Since the 1990s , fluorouracil-based adjuvant chemotherapy has significantly reduced the risk of tumour recurrence in patients with stage III colon cancer . We aim ed to assess whether the addition of cetuximab to st and ard adjuvant oxaliplatin , fluorouracil , and leucovorin chemotherapy ( FOLFOX4 ) in patients with stage III colon cancer improved disease-free survival ( DFS ) . METHODS For this open-label , r and omised phase 3 study done in nine European countries , we enrolled patients through an interactive voice response system to the central r and omisation centre , with a central stratified permuted block r and omisation procedure . We r and omly assigned patients with resected ( R0 ) stage III disease ( 1:1 ) to receive 12 cycles of FOLFOX4 twice a week with or without cetuximab . Patients were stratified by N-status ( N1 vs N2 ) , T-status ( T1 - 3 vs T4 ) , and obstruction or perforation status ( no obstruction and no perforation vs obstruction or perforation or both ) . A protocol amendment ( applied in June , 2008 , after 2096 patients had been r and omly assigned to treatment-restricted enrolment to patients with tumours wild-type at codons 12 and 13 in exon 2 of the KRAS gene ( KRAS exon 2 wild-type ) . The primary endpoint was DFS . Analysis was intention to treat in all patients with KRAS exon 2 wild-type tumours . The study is registered at EudraCT , number 2005 - 003463 - 23 . FINDINGS Between Dec 22 , 2005 , and Nov 5 , 2009 , 2559 patients from 340 sites in Europe were r and omly assigned . Of these patients , 1602 had KRAS exon 2 wild-type tumours ( intention-to-treat population ) , 791 in the FOLFOX4 plus cetuximab group and 811 in the FOLFOX4 group . Median follow-up was 3·3 years ( IQR 3·2 - 3·4 ) . In the experimental and control groups , DFS was similar in the intention-to-treat population ( hazard ratio [ HR ] 1·05 ; 95 % CI 0·85 - 1·29 ; p=0·66 ) , and in patients with KRAS exon 2/BRAF wild-type ( n=984 , HR 0·99 ; 95 % CI 0·76 - 1·28 ) or KRAS exon 2-mutated tumours ( n=742 , HR 1·06 ; 95 % CI 0·82 - 1·37 ) . We noted heterogeneous responses to the addition of cetuximab in preplanned subgroup analyses . Grade 3 or 4 acne-like rash ( in 209 of 785 patients [ 27 % ] vs four of 805 [ < 1 % ] ) , diarrhoea ( 113 [ 14 % ] vs 70 [ 9 % ] ) , mucositis ( 63 [ 8 % ] vs 10 [ 1 % ] ) , and infusion-related reactions ( 55 [ 7 % ] vs 30 [ 4 % ] ) were more frequent in patients treated with FOLFOX4 plus cetuximab than in those patients who received FOLFOX4 alone . INTERPRETATION The addition of cetuximab to FOLFOX4 did not improve DFS compared with FOLFOX4 alone in patients with KRAS exon 2 wild-type resected stage III colon cancer . This trial can not conclude on the benefit of cetuximab in the studied population , but the heterogeneity of response suggests that further investigation of the role of FOLFOX4 plus cetuximab in specific patient subgroups is warranted . FUNDING Fédération Francophone de Cancérologie Digestive ( FFCD ) , Merck KGaA , and Sanofi-Aventis
Output:
| mCRC Patients with left-sided , wild type Kras have a better prognosis than those with right-sided diseases when treated with cetuximab . |
MS212308 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: A linear analogue for rating pain with 10 , 15 and 20 cm lines is significantly less variable than a 5 cm line ( mean error of 15 cm line is 0 - 19 % , 95 % confidence limits for the group + /- 2 % and an inood correlation between repeated ratins of a recalled pain distant in time . The variance of the rating is significantly less than the repeated rating of a r and om mark . The linear analogue rating of a constant pain stimulus is reproducible and changes in rating are likely to be real changes of opinion . Pethidine 150 mg intramuscularly had no significant effect , tested 30 minutes after the administration , on the accuracy or reproducibility of the analogue rating . A linear analogue seems a suitable method of recording the patient 's opion of a severe pain such as that of labour Controversy exists concerning pin placement for supracondylar humerus fractures in children . Both crossed pin and lateral only pin configurations have shown good results ; however , prospect i ve studies are lacking . We present a prospect i ve , surgeon-r and omized study comparing crossed pin ( group A , n = 20 ) versus preferential lateral only pin ( group B , n = 20 ) fixation for displaced supracondylar humerus fractures . There was no difference in Baumann 's angle ( P>0.75 ) , the humerotrochlear angle ( P>0.85 ) , or final elbow range of motion ( P>0.25 ) . Both groups had stable reductions and clinical ly normal alignment . The only complication in both groups was a transient ulnar nerve irritation , despite no intraoperative evidence of nerve violation with a nerve stimulator . One patient in each group required modification of the operative plan . In group B , one patient had a medial pin inserted because of medial comminution extending proximally limiting available lateral pin placement . In group A , the surgeon elected to use lateral pins only because of an obviously subluxating ulnar nerve . In conclusion , we recommend orthopedic surgeons treating unstable pediatric supracondylar humerus fractures be facile with both medial and lateral pin placement INTRODUCTION Closed reduction and percutaneous pinning are the most widely used treatment options for displaced supracondylar humerus fractures in children , but there is still no consensus concerning the most preferred technique in injuries of the extension type . OBJECTIVE The aim of this study was to compare three common orthopaedic procedures in the treatment of displaced extension type supracondylar humerus fractures in children . METHODS Total of 93 consecutive patients ( 66 boys and 27 girls ) referred to our hospital with Gartl and type II or III extension supracondylar humeral fractures were prospect ively included in the study over a six-year period . At initial presentation 48 patients were classified as Gartl and type II and 45 as Gartl and type III fractures . The patients were subdivided into three groups based on the following treatment modality : closed reduction with percutaneous pinning , open reduction with Kirschner wires ( K-wires ) fixation , and closed reduction with cast immobilisation . The treatment outcome and clinical characteristics were compared among groups , as well as evaluated using Flynn 's criteria . RESULTS Excellent clinical outcome was reported in 70.3 % of patients treated with closed reduction with percutaneous pinning and in 64.7 % of patients treated with open reduction with K-wire fixation . The outcome was significantly worse in children treated with closed reduction and cast immobilisation alone , as excellent outcome is achieved in just 36.4 % of cases ( p = 0.011 ) . CONCLUSION Closed reduction with percutaneous pinning is the method of choice in the treatment of displaced pediatric supracondylar humeral fracture , while open reduction with K-wire fixation is as a good alternative in cases with clear indications
Output:
| This study may provide surgical treatment effects evidence for SHFC . |
MS212309 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: PURPOSE This study 's purpose was to test silver diammine fluoride ( SDF ) in arresting incipient occlusal caries in erupting permanent first molars and to compare it with other approaches . METHODS Sixty-six first erupting permanent molars were r and omly divided into 3 groups : cross tooth-brushing technique ( CTT ) , application of SDF , and glass ionomer fissure sealant ( GIC ) . The clinical procedures were conducted by the same dentist . Teeth were assessed clinical ly by 1 blinded examiner using visual inspection at baseline and after 3 , 6 , 12 , 18 , and 30 months and radiographically at 6- , 12- , and 30-month follow-up evaluations . The Kruskall-Wallis test was used to compare noninvasive treatments , and the Friedman test was performed to evaluate differences for each group during different follow-up periods . RESULTS A reduced number of active caries lesions was noted in all groups . After 3 and 6 months , SDF showed a significantly greater capacity for arresting caries lesions than CTT and GIC . At 18- and 30-month evaluations , no differences were observed among the 3 groups . All groups showed differences between baseline and all follow-up re-examinations . CONCLUSIONS All the tested techniques are equally efficient in controlling initial occlusal caries in erupting permanent first molars after 30-months of follow-up The aim of this double-blind r and omized clinical trial was to evaluate the efficacy of 1.23 % APF gel application on the arrest of active incipient carious lesions in children . Sixty 7- to 12-year-old children , with active incipient lesions were included in the study . Children were divided r and omly into 2 groups : 1.23 % APF gel and placebo gel applications . Each group received 8 weekly applications of treatment . The lesions were re-evaluated at the 4th and 8th appointments . Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions . Groups showed similar results ( PR = 1.67 ; CI 95 % 0.69 - 3.98 ) . The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline ( PR = 2.67 ; CI 95 % 1.19 - 6.03 ) , but not with sugar intake ( PR = 1.06 ; CI 95 % 0.56 - 2.86 ) and previous exposure to fluoride dentifrice ( PR = 1.26 ; CI 95 % 0.49 - 2.29 ) . The trial demonstrates the equivalence of the treatments . The use of the APF gel showed no additional benefits in this sample of children exposed to fluori date d water and dentifrice . The professional dental plaque removal in both groups may also account for the result ing equivalence of the treatments OBJECTIVE To compare the effectiveness of annual topical application of silver diamine fluoride ( SDF ) solution , semi-annual topical application of SDF solution , and annual application of a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth . METHODS A total of 212 children , aged 3 - 4 years , were r and omly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth : Gp1-annual application of SDF , Gp2-semi-annual application of SDF , and Gp3-annual application of glass ionomer . Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested . RESULTS After 24 months , 181 ( 85 % ) children remained in the study . The caries arrest rates were 79 % , 91 % and 82 % for Gp1 , Gp2 and Gp3 , respectively ( p=0.007 ) . In the logistic regression model using GEE to adjust for clustering effect , higher caries arrest rates were found in lesions treated in Gp2 ( OR=2.98 , p=0.007 ) , those in anterior teeth ( OR=5.55 , p<0.001 ) , and those in buccal/lingual smooth surfaces ( OR=15.6 , p=0.004 ) . CONCLUSION Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries . Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application . CLINICAL SIGNIFICANCE Arrest of active dentine caries in primary teeth by topical application of SDF solution can be enhanced by increasing the frequency of application from annually to every 6 months , whereas annual paint-on of a flowable glass ionomer can also arrest active dentine caries and may provide a more aesthetic outcome Background Dental caries is a major public health problem in many countries . Since the last territority-wide dental survey of Hong Kong preschool children was conducted in 2001 , a survey to up date the information is necessary . This study aim ed to describe the dental caries experience of preschool children in Hong Kong and factors affecting their dental caries status . Methods A stratified r and om sample of children from seven kindergartens in Hong Kong was surveyed in 2009 . Ethical approval from IRB and parental consent was obtained . Clinical examinations of the children were performed by two calibrated examiners using disposable dental mirrors , an intra-oral LED light and ball-ended periodontal probes . A question naire to investigate possible explanatory factors for caries status was completed by the children ’s parents . Caries experience was recorded using the dmft index . Multifactor-ANOVA was used to study the relationship between dental caries experience , and the background and oral health-related behaviours of the children . Results Seven hundred children ( 53 % boys ) , mean age 5.3 ± 0.7 years were examined . The mean dmft score of the surveyed children was 2.2 and 51 % of them had no caries experience ( dmft = 0 ) . Most ( > 95 % ) of the decayed teeth were untreated . Statistically significant correlations were found between dental caries experience of the children and their oral health-related habits , family income , parental education level and parental dental knowledge . Conclusions Early childhood dental caries was prevalent among the preschool children in Hong Kong . Their caries experience was associated with their oral health-related behaviours , socio-economic background , and parental education and dental knowledge Arresting Caries Treatment ( ACT ) has been proposed to manage untreated dental caries in children . This prospect i ve r and omized clinical trial investigated the caries-arresting effectiveness of a single spot application of : ( 1 ) 38 % silver diamine fluoride ( SDF ) with tannic acid as a reducing agent ; ( 2 ) 38 % SDF alone ; ( 3 ) 12 % SDF alone ; and ( 4 ) no SDF application in primary teeth of 976 Nepalese schoolchildren . The a priori null hypothesis was that the different treatments have no effect in arresting active cavitated caries . Only the single application of 38 % SDF with or without tannic acid was effective in arresting caries after 6 months ( 4.5 and 4.2 mean number of arrested surfaces ; p < 0.001 ) , after 1 year ( 4.1 and 3.4 ; p < 0.001 ) , and after 2 years ( 2.2 and 2.1 ; p < 0.01 ) . Tannic acid conferred no additional benefit . ACT with 38 % SDF provides an alternative when restorative treatment for primary teeth is not an option The aim of this r and omized clinical trial study was to evaluate the therapeutic effect of two varnish formulations ( G1 = 5 % NaF , G2 = 6 % NaF + 6 % CaF(2 ) ) on the remineralization of white spot lesions ( WSL ) . The sample was composed of 15 ( 7- to 12-year-old ) children with 45 active WSL in anterior permanent teeth . The children were r and omly divided into two groups providing 22 lesions for G1 and 23 for G2 . The children were su bmi tted to weekly varnish applications 4 times . The WSL were evaluated twice : baseline and on week 4 . Maximum lesion dimensions ( mesiodistal and incisogingival ) were measured in millimeters and classified in four grade s of size . WSL were also assessed regarding lesion activity by one calibrated examiner . The Pearson chi-square and Fisher 's exact tests were used ( P < 0.01 ) . WSL reductions were observed in both varnish groups ( Chi-square = 0.15 , d.f . = 1 , P = 0.90 ) , and with similar magnitude ( in mm ) : 1.19 and 1.29 for G1 and G2 , respectively . Thirty-six WSL ( 15 in G1 and 21 in G2 ) were classified as inactive on week 4 , reaching an overall value of 80 % . No difference was observed between G1 and G2 regarding activity scores ( Fisher 's exact test , p > 0.01 ) . It was concluded that after 4 applications the two varnish formulations tested produced similar clinical effects , indicating the reduction and the control of carious activity in most WSL AIM The aim of this study is to assess the effects of fluoride varnishes on enamel caries lesions on permanent dentition . MATERIAL S AND METHODS 92 children from primary school ( Vasil Shanto , Tirana , Albania ) aged 11 - 12 years were divided into varnish ( experimental ) and control group . The experiment group received the first fluoride varnish application ( Fluoridin , Voco ) at baseline , the second application after 3 months and the third application at 6 months from baseline , while the children in the control group received no professional fluoride application . Examinations were performed at baseline and after 7 months . RESULTS We observed a slight increase in caries prevalence in the control group compared with the varnish group at the 7 month interval ( P < 0.1 for DMFT and P < 0.5 for DMFS and DS ) . When enamel lesions were included the mean of DeMFT , DeMFS , DeS the caries prevalence was significantly lower in the varnish group after 7 months ( P < 0.001 for DeMFT , DeMFS ) . CONCLUSION Fluoride varnish is an effective mean for arresting early enamel lesions . It is a safe , convenient and well accepted method by patients The aim of this study was to assess in vivo the therapeutic effect of three fluoride varnishes available in the Brazilian market on the performance of white spot lesions ( WSL ) . The sample included 36 children aged 7 to 13 years old , with a total of 67 active WSL in permanent anterior teeth . The children were r and omly divided into 3 groups , according to fluoride varnish used : FL- Fluorniz ( n=24 ) , DUO - Duofluorid XII ( n=22 ) and DF - Durafluor ( n=21 ) . Maximum WSL dimensions ( mesiodistal and incisogingival ) were measured in millimeters by a previously calibrated single examiner using a periodontal probe . WSL were also assessed regarding lesion activity . Initial and final S-OHI ( Simplified Oral Hygiene Index ) scores were recorded . Pearson 's chi-square test revealed no statistically significant differences ( p>0.05 ) in the performance of the varnishes . At the end of the 5th week , FL had 6 active and 18 inactive WSL ; DUO had 7 active and 15 inactive WSL ; and DL had 6 active and 15 inactive WSL . Taking into account all lesions , there was a 45.7 % reduction in WSL dimensions . Paired Student 's t-test revealed a statistically significant difference ( p<0.05 ) between the initial size ( 1.88 ) and final size ( 1.02 ) . After four applications , all varnishes obtained similar clinical results Objective To describe the dental caries status of preschool children in Hong Kong and factors which affect their caries status . Design 658 preschool children aged 4 to 6 years from six r and omly selected kindergartens in Hong Kong were surveyed in December 1997 . A question naire to investigate possible explanatory variables for caries status was completed by their parents . Dental caries was diagnosed according to the criteria recommended by the World Health Organization ( 1997 ) . Result Caries experience as measured by the mean number of decayed , missing and filled primary teeth ( dmft ) of the 4- , 5- , and 6-year-old children were found to be 0.9 , 1.8 , and 3.3 respectively . Overall , 61 % of the children had a zero dmft score . Children born in Mainl and China had a higher mean dmft score ( 4.6 ) than those born in Hong Kong ( 1.4 ) . Statistically significant correlations were found between the children 's dental caries status and their oral health practice s as well as their socio-economic background . Parents ' education level , dental knowledge and attitudes were also associated with the children 's dental caries experience . Conclusion In general , the caries status of Hong Kong Chinese preschool children was similar to that of children in industrialised countries and was better than that of children in the nearby areas . However , special dental programmes should be made available to children from lower socio-economic classes and new immigrants from Mainl and China because they are the high risk groups for caries in Hong Kong BACKGROUND Plaque control and caries arrest still remain a challenge for dentists . OBJECTIVE This study was conducted to assess the effect of the combined use of chlorhexidine varnish and fluoride varnish on the visible plaque index ( VPI ) and white spot lesion ( WS ) remineralization in primary
Output:
| Conclusion Professionally applied 5 % sodium fluoride varnish can remineralise early enamel caries and 38 % silver diamine fluoride is effective in arresting dentine caries |
MS212310 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 process of implementation of the modified London Stroke Carers Training Course ( LSCTC ) in the Training Caregivers After Stroke ( TRACS ) cluster r and omised trial and contribute to the interpretation of the TRACS trial results . The LSCTC was a structured competency-based training programme design ed to help develop the knowledge and skills ( eg , patient h and ling or transfer skills ) essential for the day-to-day management of disabled survivors of stroke . The LSCTC comprised 14 components , 6 were m and atory ( and delivered to all ) and 8 non-m and atory , to be delivered based on individual assessment of caregiver need . Design Process evaluation using non-participant observation , documentary analysis and semistructured interviews . Participants Patients with stroke ( n=38 ) , caregivers ( n=38 ) , stroke unit staff ( n=53 ) . Setting s 10 of the 36 stroke units participating in the TRACS trial in four English regions ( Yorkshire , North West , South East and South West , Peninsula ) . Results Preparatory cascade training on delivery of the LSCTC did not reach all staff and did not lead to multidisciplinary team ( MDT ) wide underst and ing of , engagement with or commitment to the LSCTC . Although senior therapists in most intervention units observed developed ownership of the LSCTC , MDT working led to separation rather than integration of delivery of LSCTC elements . Organisational features of stroke units and professionals ’ patient-focused practice s limited the involvement of caregivers . Caregivers were often invited to observe therapy or care being provided by professionals but had few opportunities to make sense of , or to develop knowledge and stroke-specific skills provided by the LSCTC . Where provided , caregiver training came very late in the inpatient stay . Assessment and development of caregiver competence was not commonly observed . Conclusions Context ual factors including service improvement pressures and staff perceptions of the necessity for and work required in caregiver training impacted negatively on implementation of the caregiver training intervention . Structured caregiver training programmes such as the LSCTC are unlikely to be practical in setting s with short inpatient stays . Stroke units where early supported discharge is in place potentially offer a more effective vehicle for introducing competency based caregiver training . LINKED TRACS Cluster r and omised controlled trial number IS RCT N49208824 The adoption of evidence -based hierarchies and research methods from other disciplines may not completely translate to complex palliative care setting s. The heterogeneity of the palliative care population , complexity of clinical presentations , and fluctuating health states present significant research challenges . The aim of this narrative review was to explore the debate about the use of current evidence -based approaches for conducting research , such as r and omized controlled trials and other study design s , in palliative care , and more specifically to ( 1 ) describe key myths about palliative care research ; ( 2 ) highlight substantive challenges of conducting palliative care research , using case illustrations ; and ( 3 ) propose specific strategies to address some of these challenges . Myths about research in palliative care revolve around evidence hierarchies , sample heterogeneity , r and om assignment , participant burden , and measurement issues . Challenges arise because of the complex physical , psychological , existential , and spiritual problems faced by patients , families , and service providers . These challenges can be organized according to six general domains : patient , system/organization , context / setting , study design , research team , and ethics . A number of approaches for dealing with challenges in conducting research fall into five separate domains : study design , sampling , conceptual , statistical , and measures and outcomes . Although r and omized controlled trials have their place whenever possible , alternative design s may offer more feasible research protocol s that can be successfully implemented in palliative care . Therefore , this article highlights " outside the box " approaches that would benefit both clinicians and research ers in the palliative care field . Ultimately , the selection of research design s is dependent on a clearly articulated research question , which drives the research process The aim of this editorial is to highlight several research priorities and key implication s for policy and practice that inform an agenda to improve family carer support . The development of systematic approaches to identify carers who are at risk of poor psychosocial outcomes is a priority . Family caregiving should not be pathologised as an inherently negative experience ; however , it would be a breach of care if more than 40 % of carers who appear to meet the criteria for psychological distress1 are not offered suitable supports . Related to this is the urgent need for greater investment in bereavement research ; while bereavement support is integral to palliative care , it is typically under-re source d , under-investigated and not systematic ally applied . We know that routine intervention for all bereaved carers is not warranted . The challenge is to discern those carers who are ‘ at risk ’ prior to the death of the patient and to identify suitable evidence -based strategies to assist them . Research indicates that carer re sources , rather than patient diagnosis or illness severity , are the primary predictors of carer burden and other carer outcomes . This implies that although the specific content may need to vary to suit the context , the core elements of family carer interventions may be relevant across disease groups . It is also apparent that the perceived quality of social support is more important than the size of the social network in improving carer outcomes .2 Current indications are that palliative care providers should assist carers by targeting social support and re sources and provide education that focuses on coping strategies and preparation for the carer role . In many countries , family carers are well prepared for the beginning of life when , for example , prospect i ve parents are routinely offered parenting classes . It is also not uncommon to assist carers prepare for and support relatives having major heart surgery . However , preparation for supporting a relative/ friend at the end of their life is not routinely offered . Carers typically want to know what the role entails , how to manage symptoms , signs of imminent death and re sources and strategies to sustain their own well-being . Given the majority of patients want to be cared for in their home environment , initiatives that assist carers to achieve this are needed . The period of time most people receive palliative care services is typically quite short ; hence , the challenge is to design interventions that are as brief as possible , readily accessible and easily delivered . The significant number of carers who support patients in the hospital/hospice setting should also not be neglected ; their needs are often hidden . Other valuable insights regarding how we deliver interventions are surfacing . For example , the conception that face-to-face carer support is the gold st and ard is being challenged . Emerging evidence suggests that telephone and video phone support may be equally effective in some circumstances.1,3 Emphasis on the development of a strategic , coordinated and priority-driven family carer research agenda is also important.4 The role of formal research collaborations may be a vehicle to foster this . Much of the carer research seems to be first-world centric . More attention needs to be directed towards family caregiving in under-re source d countries and in other under-represented population s such as ethnic minority groups . Several important policy and clinical matters warrant consideration if palliative care is to foster improved carer support . One of the core questions for policymakers and clinicians is whether or not it is feasible for palliative care to be expected to meet the needs of the patients ’ entire family . It has been recommended that given re source constraints , the focus should be on the primary family carer ( as identified by the patient ) and where possible extended to other family members.5 Consideration might also be given to revising expectations about the goal of family support . The current World Health Organization definition of palliative care advocates that families ’ quality of life be improved ; perhaps a more realistic objective may be to aim to reduce the psychosocial burden of primary family carers . A related question is how to effectively legitimise family carer support . Most family carers do not want to discuss their needs and concerns in front of their relative ; they therefore need one-to-one time with healthcare and socialcare professionals . It is also clear that many healthcare workers find supporting carers challenging . Hence , where pertinent , consideration should be given to the potential merits of officially recognising family carers as ‘ care recipients ’ ; therefore , they are formally acknowledged as ‘ worthy ’ within the healthcare system . This may help justify much needed re sources and allow healthcare workers to allocate time and where pertinent offer interventions . In 488855 PMJ27710.1177/0269216313488855Palliative MedicineEditorial CONTEXT Concerns about pain medications are major barriers to pain management in hospice , but few studies have focused on systematic methods to address these concerns . OBJECTIVES The objective of this study was to test the preliminary efficacy of the Effective Management of Pain : Overcoming Worries to Enable Relief ( EMPOWER ) intervention , which included hospice staff education , staff screening of barriers to pain management at admission , and discussion about misunderst and ings regarding pain management with family caregivers and patients . METHODS We conducted a pilot , cluster r and omized , controlled trial with four hospices . One hundred twenty-six family caregivers ( 55 interventions and 71 controls ) were interviewed at two weeks after admission . If patients survived three months after admission , caregivers were reinterviewed . RESULTS At two weeks , caregivers in the intervention group reported better knowledge about pain management ( P = 0.001 ) , fewer concerns about pain and pain medications ( P = 0.008 ) , and lower patient pain over the past week ( P = 0.014 ) and trended toward improvement in most other areas under study . Exploratory analyses suggest that EMPOWER had a greater effect for black subjects ( vs. whites ) on reducing concern about stigma . At three months , the intervention group trended better on most study outcomes . CONCLUSION EMPOWER is a promising model to reduce barriers to pain management in hospice The shift of health care burden from acute to chronic conditions is strongly linked to lifestyle and behaviour . As a consequence , health services are attempting to develop strategies and interventions that can attend to the complex interactions of social and biological factors that shape both . In this paper we trace one of the most influential incarnations of this ‘ turn to the complex ’ : the Medical Research Council ( MRC ) guidance on developing and evaluating complex interventions . Through an analysis of the key publications , and drawing on social scientific approaches to what might constitute complexity in this context , we suggest that such initiatives need to adjust their conceptualisation of ‘ the complex ’ . We argue that complexity needs to be understood as a dynamic , ecological system rather than a stable , albeit complicated , arrangement of individual elements . Crucially , in contrast to the experimental logic embedded in the MRC guidance , we question whether the R and omised Controlled Trial ( RCT ) is the most appropriate method through which to engage with complexity and establish reliable evidence of the effectiveness of complex interventions Background Being a family carer to a patient nearing the end of their life is a challenging and confronting experience . Studies show that caregiving can have negative consequences on the health of family carers including fatigue , sleep problems , depression , anxiety and burnout . One of the goals of palliative care is to provide psychosocial support to patients and families facing terminal illness . A systematic review of interventions for family carers of cancer and palliative care patients conducted at the start of this millennium demonstrated that there was a dearth of rigorous inquiry on this topic and consequently limited knowledge regarding the types of interventions likely to be effective in meeting the complex needs of family carers . We wanted to discern whether or not the evidence base to support family carers has improved . Furthermore , undertaking this review was acknowledged as one of the priorities for the International Palliative Care Family Carer Research Collaboration http://www.centreforpallcare.org . Methods A systematic review was undertaken in order to identify developments in family carer support that have occurred over the last decade . The focus of the review was on interventions that targeted improvements in the psychosocial support of family carers of palliative care patients . Studies were grade d to assess their quality . Results A total of fourteen studies met the inclusion criteria . The focus of interventions included psycho-education , psychosocial support , carer coping , symptom management , sleep promotion and family meetings . Five studies were r and omised controlled trials , three of which met the criteria for the highest quality evidence . There were two prospect i ve studies , five pre-test/post-test projects and two qualitative studies . Conclusions The systematic review identified a slight increase in the quality and quantity of psychosocial interventions conducted for family carers in the last decade . More rigorous intervention research is required in order to meet the supportive care needs of family carers of palliative care patients PURPOSE / OBJECTIVES To examine the impact of pain education on family members providing home care to elderly patients with cancer . DESIGN Quasiexperimental . SETTING Homes of selected patients from two California medical centers . SAMPLE Fifty family caregivers of patients experiencing cancer-related pain . METHODS The pain education program included three components : pain assessment , pharmacologic interventions , and nonpharmacologic interventions . Patients and their family caregivers were evaluated prior to initiation of the program and at one and three weeks following the interventions . MAIN RESEARCH VARIABLES Quality of life ( QOL ) ; knowledge and attitudes about pain ; and caregiver burden . FINDINGS Findings based on measures of QOL and caregiver burden demonstrated the physical and psychological impact of family caregiving and pain management . Comparison between elderly patients with cancer and family caregivers revealed the pain experience 's significant impact on family members caring for a loved one in pain . CONCLUSIONS The pain education program was effective in improving knowledge and attitudes regarding pain management . IMPLICATION S FOR NURSING PRACTICE Pain management is a priority for nurses , and use of interventions such as structured pain education improves QOL outcomes for elderly patients and their family caregivers 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
Output:
| It was not possible to discern any association between particular intervention characteristics and family carer outcomes .
Current evidence is limited , but overall suggests face-to-face educational interventions supported by written and /or other re sources have potential to improve carers ' knowledge and self-efficacy for pain management . |
MS212311 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Summary Back pain due to vertebral collapse is the main symptom of postmenopausal osteoporosis . The clinical picture in these crush fractures varies , depending on the type and the location of fracture , but in general , a new vertebral crush fracture gives rise to severe pain that immobilizes the patient and necessitates bedrest . In this double-blind controlled clinical trial , 56 patients who had recently ( within the last 3 days ) suffered an osteoporotic vertebral fracture were hospitalized for a period of 14 days . Salmon calcitonin ( 100 IU ) or placebo injections were given daily . Pain was rated daily on a 10-point scale by the same observers . Blood and urinary parameters were also evaluated . The results showed a significant ( P<0.001 ) difference in pain intensity between the calcitonin group and the placebo group . This beneficial effect was generally apparent from the second day of treatment onward , and over the following 2 weeks , the patients were able to sit and st and , and gradually started to walk again . A significant decrease in urinary hydroxyproline and urinary calcium was also noted in the calcitonin group . It is concluded that calcitonin exerts a beneficial effect on back pain following a vertebral crush fracture The aim of this study was to investigate the effect of nasal calcitonin on chronic back pain and disability attributed to osteoporosis . The study design involved three groups of osteoporotic postmenopausal women suffering from chronic back pain . Group I consisted of 40 women with vertebral fractures , group II of 30 women with degenerative disorders and group III of 40 patients with non specific chronic back pain and without abnormality on plain X-rays . Pain intensity was measured using a numerical rating scale ( NRS ) and disability due to back pain was measured using the Oswestry disability question naire . The patients were r and omly assigned to receive , for three months , either 200 IU intranasal salmon calcitonin and 1,000 mg of oral calcium daily ( groups IA , IIA , IIIA ) or 1,000 mg of oral calcium daily ( groups IB , IIB , IIIB ) . Repeated measures ANOVA showed that there were no significant time , group or interaction effects for pain intensity and disability in any of the groups studied . Mean Oswestry and NRS scores were reduced during the follow-up period in the groups IA , IIIA , but the differences between the two time points were not statistically significant . Intranasal calcitonin has no effect on chronic back pain intensity and functional capacity of osteoporotic women regardless of the presence of fractures , degenerative disorders or chronic back pain of non-specific etiology The purpose of this study was to evaluate the efficacy of calcitonin on β-endorphin levels in female patients experiencing back pain associated with postmenopausal osteoporosis . The secondary purpose was to assess the pain and quality of life in these patients . There were 30 patients with a mean age of 58.2±5.4 years in the treatment group and 26 patients with a mean age of 58.8±5.2 years in the placebo group in this r and omized , placebo-controlled study . The patients subcutaneously received 100 IU salmon calcitonin or placebo injections and 1,000 mg elementary calcium for 2 weeks . Baseline plasma β-endorphin levels were measured and repeated after 2 weeks . Patients ’ pain and quality of life ( QOL ) were evaluated by using the Visual Analogue Scale , Modified Face Scale , Beck Depression Index , and Nottingham Health Profile . Patients ’ global assessment of disease activity was also performed at baseline and at the end of the first and second week . We found that plasma β-endorphin levels in the treatment group were significantly higher than the placebo group at the end of the second week ( p<0.001 ) . Although pain and QOL scores were improved at the end of the second week in both groups ( p<0.05 ) , the improvement in the treatment group was more significant when compared with the placebo group ( p<0.05 ) . Therefore , calcitonin is an analgesic agent , as it increases the plasma β-endorphin levels in patients with postmenopausal osteoporosis , which consequently improves QOL Our aim was to compare the analgesic efficacy of pamidronate ( PAM ) and synthetic human calcitonin ( CT ) in intravenous infusion for recent painful benign vertebral compression in a r and omised prospect i ve double-blind study . Twenty-seven patients aged 49–85 years with painful benign non-traumatic vertebral compression were included in the study . They received either PAM ( 1 mg/kg ) or synthetic human CT ( 1.5 mg ) as an intravenous infusion . Pain and functional disability were evaluated before infusion , and 4 and 30 days afterwards . The pain score assessed on a visual analogue scale at day 0 was 5.94±2.47 in patients treated with PAM and 6.27±2.50 in patients treated with CT ( p=0.74 ) ; at day 4 , 4.8±2.80 with PAM vs 3.9±2.68 with CT ( p=0.37 ) ; and at day 30 , 3.6±3.13 with PAM vs 3.10±2.76 with CT ( p=0.70 ) . Spinal function scores were 18.21±3.17 at day 0 in patients treated with PAM vs 17.23±4.42 in patients treated with CT ( p=0.69 ) and at day 30 , 13.7±5.36 with PAM vs 12.33±3.22 with CT ( p=0.68 ) . We found no advantage of PAM over CT in a single intravenous infusion for the treatment of painful recent benign vertebral compression . Since CT is ten times less costly , its use should be preferred Summary A placebo-controlled , double-blind study was carried out over 4 months to evaluate two doses of synthetic human calcitonin ( 0.25 and 0.125 mg ) given s.c . three times per week . Enrolled were 60 women , aged 56–82 years , who had experienced a vertebral fracture due to low-energy trauma within the preceding year . During active treatment there was within the first month a dose-dependent decrease of the indices of bone resorption ( fasting urinary calcium and hydroxyproline excretions ) , whereas only the higher dose and a treatment period of 4 months produced a reduction of bone formation ( serum osteocalcin ) . The bone mineral content ( BMC ) of the nondominant forearm was unchanged . Treatment with calcitonin also had significant , dosedependent , analgetic effects . The amelioration of pain was , in multivariate analyses , related to a reduction in parameters felt to be markers for bone resorption . In the placebo group there was a significant reduction of the BMC of the forearm but no changes of any of the biochemical markers for bone turnover and no improvement of pain . In conclusion , treatment with two low doses of calcitonin induced changes of the biochemical markers of bone turnover in a dosedependent manner . The analgetic properties of calcitonin were also of salient clinical importance . The knowledge derived from this study could be adapted to the dosage schedule in long-term trials in osteoporosis Radiographically detected vertebral fractures ( hereafter referred to as vertebral fractures ) are a hallmark of postmenopausal osteoporosis and an important end point in clinical trials of osteoporosis treatment . Women with vertebral fractures have low bone mass compared with women without these fractures and , independently of bone mass , have an increased risk for additional vertebral and other fractures [ 1 - 4 ] . Vertebral fractures are common : Five percent of 50-year-old white women and 25 % of 80-year-old women have had at least one vertebral fracture [ 5 ] . Surprisingly , however , the manner in which vertebral fractures affect health remains uncertain . Cross-sectional studies in community-derived sample s of older women have demonstrated only a modest association [ 6 - 8 ] or no association [ 9 - 11 ] between prevalent vertebral fractures and back pain or disability . Cross-sectional studies do not distinguish more recent fractures from older vertebral fractures and may fail to capture transient increases in pain or disability [ 12 ] , a limitation that may underestimate the clinical effect of these fractures [ 13 ] . Back pain is common among elderly women [ 14 ] , and frequent causes of back pain , such as degenerative disc disease , facet joint osteoarthritis , spinal stenosis , and scoliosis , may obscure the impact of vertebral fracture . Only about one third of new vertebral fractures come to medical attention [ 15 , 16 ] , suggesting that most vertebral fractures are asymptomatic . However , attitudes toward back pain in older women and access to health care may also play a role in determining whether vertebral fractures come to medical attention . We examined the effect of incident vertebral fractures on back pain and back-related functional limitations in a large community-based sample of elderly women who underwent serial spinal radiography and annual assessment s of back pain and disability over the same period . Methods Participants Study patients were participants in the Study of Osteoporotic Fractures , a cohort recruited from population -based listings in four U.S. metropolitan areas . Details of the design of this study are published elsewhere [ 17 ] . Lateral spine radiographs were obtained for 9677 white women between the ages of 65 and 99 years ( median age , 70 years ) who underwent baseline examination between 1986 and 1988 . Repeated spinal radiographs suitable for morphometry were obtained for 7223 women ( 75 % of the original cohort ) at a follow-up clinic visit held an average of 3.7 years ( range , 1.3 to 5.1 years ) later . All participants gave informed consent . Vertebral Morphometry Lateral radiographs of the thoracic and lumbar spine were obtained in accordance with current guidelines [ 18 ] . Quantitative vertebral morphometry was performed using six-point digitization as described elsewhere [ 3 , 19 ] to calculate the anterior ( Ha ) , mid- ( Hm ) , and posterior ( Hp ) height for each vertebral body from T4 to L4 . A system of triage of radiographs , described elsewhere [ 3 , 20 ] , was used to reduce the number of radiographs requiring morphometric measurements . Briefly , trained technicians separated sets of radiographs into normal , uncertain , or probably fractured groups on the basis of a limited semiquantitative grading scheme that categorized women by the most abnormal vertebral level [ 20 ] . Uncertain grade s were further categorized by the study radiologist as normal or probably fractured . Morphometry was done on the radiograph pairs that were categorized as probably fractured ( 42 % ) . In a r and om sample of 503 women whose radiographs were triaged and then digitized , triage missed no incident fractures according to the study definition . Definition of Vertebral Fracture A vertebra was classified as having a prevalent fracture on the baseline radiograph if any of the following ratios were more than 3 SDs ( > 4 SDs for severe fractures ) below the normal mean for that vertebral level : ( Ha/Hp ) , ( Hm/Hp ) , or a combination of ( H/H [ ] 1 ) and ( Hai/Hai 1 ) [ 3 , 21 ] . A new ( incident ) fracture was identified if any of the three vertebral heights ( Ha , Hm , or Hp ) on follow-up radiographs decreased by 20 % or more and by at least 4 mm compared with the baseline height . Incident fractures identified by morphometry were review ed by a radiologist to exclude imaging artifacts or such conditions as osteophytosis and Scheuermann disease ; 7 % of vertebrae meeting the morphometric criteria for incident fracture were reclassified as not fractured . Incident Clinical Fractures We used previously described methods [ 22 ] to assess the occurrence of clinical fractures of any bone during follow-up . Women were considered to have a clinical vertebral fracture if they reported a new diagnosis of spinal fracture and a clinical radiology report confirmed that a vertebral fracture was present . Measurements of Pain , Disability , and Limited Activity We evaluated outcome measures by using a previously described question naire [ 7 , 23 ] that asked about back pain and back-related disability in the past 12 months and the number of days of limited activity due to back pain . The question naire was administered at baseline and at three annual follow-up contacts held before assessment of vertebral fractures . The third follow-up contact coincided with follow-up radiography . Back pain was assessed on scales of frequency ( 0 , never or rarely ; 1 , some of the time ; 2 , most of the time ; or 3 , all of the time ) and severity ( 0 , no pain ; 1 , mild pain ; 2 , moderate pain ; or 3 , severe pain ) . The two pain questions had high internal consistency ( Cronbach = 0.81 ) and were summed for a total score that could range from 0 to 6 . We defined clinical ly significant back pain as pain that was experienced most or all of the time or pain that was moderate or severe . Women without significant back pain at baseline were considered to have increased back pain if clinical ly significant pain had developed between any follow-up contacts . For women with clinical ly significant back pain at baseline , increased back pain was defined as an increase in total pain score of at least two points . Both types of increase had a similar association with incident fractures and thus were combined for a single outcome . Back-related disability was assessed with questions about the
Output:
| The combined results from 13 trials ( n = 589 ) determined that calcitonin significantly reduced the severity of acute pain in recent OVCFs .
Side effects were mild , with enteric disturbances and flushing reported most frequently .
Although calcitonin has proven efficacy in the management of acute back pain associated with a recent OVCF , there is no convincing evidence to support the use of calcitonin for chronic pain associated with older fractures of the same origin |
MS212312 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Inconsistent associations between smoking and telomere length ( TL ) have been reported in epidemiologic studies , perhaps because of the time-varying nature of smoking behaviors . We estimated the associations of TL , which was measured by quantitative polymerase chain reaction using saliva DNA , with concurrent and past smoking status reported biennially for up to 16 years before TL measurement in 5,624 participants in the Health and Retirement Study ( 1992 - 2008 ) . Smoking was associated with reduced TL when we used prospect i ve data on smoking statuses among men and women , but the association was strongly attenuated among men in cross-sectional analyses . This attenuation was largely due to a higher rate of smoking cessation during the study period among men with shorter TL than among men with longer TL . Short TL was also associated with poorer overall health in men , which suggests that male smokers with short TL were more likely to quit smoking because of poor health . Analyses of years since cessation , smoking duration , and pack-years of smoking all support the hypothesis that increased cigarette use shortens TL . Our results provide a potential explanation for the inconsistent associations between smoking and TL reported in previous cross-sectional studies . Time-varying associations should be considered in future studies of smoking behavior , TL , aging , and disease risk Background : Within-person variability in biomarkers results in r and om error that can attenuate estimates of association . Little information on such variability is available for a number of nutrition-related biomarkers . Methods : Blood sample s obtained 2 to 4 weeks apart were analyzed for tocopherols , carotenoids , ascorbate , lipids , cotinine , C-reactive protein , and oxidative stress . Subjects ( n = 206 men and women , mean age 45.4 years ) were either smokers or passively exposed to smoke . We calculated intraindividual and interindividual variability and the number of measurements required to reduce attenuation . Results : For most biomarkers , 2 measurements would be required to limit the attenuation of correlation coefficients to no lower than 90 % of the true correlation . If only one measurement were obtained , observed correlations would be approximately 80–88 % of true correlations . For regression coefficients , 3 or 4 measures would be required . Exceptions were ascorbic acid and malondialdehyde , for which a single measure result ed in little attenuation . Conclusions : For most serum markers , collection of 2 or more measurements per person is desirable to increase the ability to detect associations between biomarkers and health-related variables . If only one measure is possible , sample sizes should be planned to permit detection of associations that are likely to be observed , not the theoretical true associations . The results of this study , in which measurements were obtained 2 to 4 weeks apart , are relevant for epidemiologic research in which the exposure of interest is the subject ’s baseline or current status . It is likely that within-person variability would be greater over a period of months or years
Output:
| Similarly , shorter telomere length was found among smokers compared to non‐smokers , and among current smokers compared to never or former smokers .
Dose‐response meta‐ analysis suggested an inverse trend between pack‐years of smoking and telomere length .
Conclusion Shorter telomeres among ever smokers compared to those who never smoked may imply mechanisms linking tobacco smoke exposure to ageing‐related disease .
Telomere length was shorter in ever smokers compared to never smokers .
Among ever smokers , current smokers had shorter mean telomeres than former smokers .
An inverse trend was indicated between pack‐years of smoking and telomere length |
MS212313 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective : To evaluate whether levels of n-6 long chain polyunsaturated fatty acids ( LCPs ) in human breast milk are related to the mother ’s atopic constitution , and whether a decreased level can be restored by gamma-linolenic acid supplementation . Design : Cross-sectional study and dietary supplementation trial . Subjects : 20 atopic mothers and 20 non-atopic mothers ( controls ) , all lactating . Setting : General population . Interventions : The atopic mothers were r and omly assigned to low ( n=10 ) or high ( n=10 ) dosage oral supplementation with oral borage oil for one week ( 230 or 460 mg gamma-linolenic acid ( 18:3n-6 ) per day).Main outcome measures : Essential fatty acid composition of the breast milk total fat fraction , determined by gas liquid chromatography . Results : Arachidonic acid ( 20:4n-6 ) was lower in breast milk of atopic mothers compared with non-atopic mothers ( 0.39 wt% vs 0.46 wt% , difference −0.07 % wt% ( 95 % confidence limits −0.13 , −0.01 wt% ; P<0.05 ) . The ratio between linoleic acid and the sum of n-6 derivatives did not differ between these groups , indicating no difference in delta-6-desaturase ( D6D ) activity . Supplementation of the atopic mothers significantly increased the levels of gamma-linolenic acid and dihomo-gamma-linolenic acid in breast milk in a dose-related way , but the level of arachidonic acid was not increased . Conclusion : We found a decreased level of arachidonic acid in breast milk in atopic compared to non-atopic mothers , but no indication that the rate-limiting enzymatic step ( D6D ) is involved . Supplementation increased the precursor pool but did not restore the level of arachidonic acid . We conclude that atopy is related to a metabolic disturbance beyond the D6D enzymatic step . A low level of arachidonic acid in breast milk may be a risk factor for the development of atopy in the infant , especially when the possible underlying metabolic disturbance of EFA metabolism is inherited by the child . Sponsorship : F Hoffman-La Roche ( Basel , Switzerl and ) and Friesl and Dairy Foods ( Leeuwarden , The Netherl and s).European Journal of Clinical Nutrition ( 2000 ) 54 , BACKGROUND There is controversy regarding the relationship of the effect of breast-feeding on markers of allergy such as total serum IgE in childhood . OBJECTIVE This study , using longitudinal data , tested the hypothesis that the relation of breast-feeding to IgE in childhood differs depending on maternal total IgE level . METHODS Total serum IgE was assessed with the paper radioimmunosorbent test at 4 ages in nonselected children enrolled at birth into the prospect i ve Tucson Children 's Respiratory Study . Children were classified as never breast-fed , breast-fed less than 4 months , or breast-fed 4 months or longer , on the basis of physician report or question naires completed by parents by the time the child was 18 months old . A longitudinal r and om effects model was used to test for group differences and temporal trends in IgE for children classified with reference to maternal IgE ( high tertile vs all others ) and breast-feeding history . A total of 664 children with 1457 observations were included . RESULTS Among children whose mothers were in the 2 lower tertiles of IgE , breast-feeding was associated with lower total serum IgE at age 6 years ( 24.2 vs 44.3 IU/mL for never breast-fed children ; P < .02 ) ; similar trends existed at age 11 years . In contrast , for children whose mothers were in the highest tertile of IgE , breast-feeding of 4 months or longer was associated with higher IgE levels in the child compared with those never breast-fed or breast-fed less than 4 months ( 97.0 vs 38.9 IU/mL ; P < . 005 ) . These cross-sectional analyses were confirmed with the longitudinal r and om effects model , which also showed no effect of confounders . Paternal IgE showed no similar relation with child IgE. CONCLUSION Breast-feeding appears to have paradoxic relations with IgE in childhood , depending on maternal IgE level . These findings may help explain the contradictory results found in other investigations of the relation of breast-feeding to allergic symptoms and markers BACKGROUND Opinions and recommendations about the optimal duration of exclusive breastfeeding have been strongly divided , but few published studies have provided direct evidence on the relative risks and benefits of different breastfeeding duration s in recipient infants . OBJECTIVE We examined the effects on infant growth and health of 3 compared with 6 mo of exclusive breastfeeding . DESIGN We conducted an observational cohort study nested within a large r and omized trial in Belarus by comparing 2862 infants exclusively breastfed for 3 mo ( with continued mixed breastfeeding through > /= 6 mo ) with 621 infants who were exclusively breastfed for > /= 6 mo . Regression to the mean , within-cluster correlation , and cluster- and individual-level confounding variables were accounted for by using multilevel regression analyses . RESULTS From 3 to 6 mo , weight gain was slightly greater in the 3-mo group [ difference : 29 g/mo ( 95 % CI : 13 , 45 g/mo ) ] , as was length gain [ difference : 1.1 mm ( 0.5 , 1.6 mm ) ] , but the 6-mo group had a faster length gain from 9 to 12 mo [ difference : 0.9 mm/mo ( 0.3 , 1.5 mm/mo ) ] and a larger head circumference at 12 mo [ difference : 0.19 cm ( 0.07 , 0.31 cm ) ] . A significant reduction in the incidence density of gastrointestinal infection was observed during the period from 3 to 6 mo in the 6-mo group [ adjusted incidence density ratio : 0.35 ( 0.13 , 0.96 ) ] , but no significant differences in risk of respiratory infectious outcomes or atopic eczema were apparent . CONCLUSIONS Exclusive breastfeeding for 6 mo is associated with a lower risk of gastrointestinal infection and no demonstrable adverse health effects in the first year of life The aim of this study was to assess the preventive effect of exclusive breast-feeding and early solid food avoidance on atopic dermatitis ( AD ) in infancy . This study is part of a dietary clinical trial in a prospect i ve cohort of healthy term newborns at risk of atopy . It was recommended to breast-feed for at least 4 months and to avoid solid food in the same time-period . Eight hundred and sixty-five infants exclusively breast-fed , and 256 infants partially or exclusively formula-fed , were followed-up until the end of the first year following birth . AD and sensitization to milk and egg were considered as study end-points . The 1-year incidence of AD was compared between the two study groups . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were calculated by multiple logistic regression . The incidence of AD was calculated in relation to age at introduction of solid food and amount of food given . In the breast-fed group , the adjusted OR for AD was 0.47 ( 95 % CI 0.30 - 0.74 ) . The strongest risk factor was the occurrence of AD in the subject 's core family . The risk of infants with AD to be sensitized to milk was four times higher , and to egg eight times higher , than in infants without AD . Age at first introduction of solid food and diversity of solid food showed no effect on AD incidence . We conclude that in infants at atopic risk , exclusive breast-feeding for at least 4 months is effective in preventing AD in the first year of life PURPOSE To identify factors that might be targeted for intervention to increase breastfeeding among black mothers . DESIGN Secondary analysis of the 1988 National Maternal Infant Health Survey . PARTICIPANTS Black mothers ( N = 5,142 ) from a nationally representative sample of mothers who had births in 1988 . MAIN OUTCOME MEASURES Breastfeeding rates RESULTS Factors associated with breastfeeding included a mother 's plan to breastfeed ; Women , Infants and Children ( WIC ) advice , or advice from a prenatal-care provider on breastfeeding ; and discussion of breastfeeding practice s at prenatal birth classes . CONCLUSIONS The results suggest that the prenatal period may be a critical time to influence a prospect i ve black mother 's decision to breastfeed her infant Abstract . One hundred and twenty‐one women with history of a previous child with atopic disease were r and omly allocated during the next pregnancy to antigen avoidance or control groups . Dietary advice consisted of almost complete exclusion of milk and dairy products , egg , fish , beef and peanut throughout pregnancy and lactation . A total of 109 completed the study . Maternal antigen avoidance was associated with reduced occurrence of atopic eczema and the skin involvement was less extensive and milder . The beneficial effect was observed mainly in the breast‐fed group . Among the fifty‐five who completed the trial of antigen avoidance , seventeen infants developed atopic eczema , five out of thirty‐five who were breast‐fed and twelve out of twenty who were formula‐fed . Among the offspring of fifty‐four control mothers given no dietary restriction , eczema was observed in twenty‐four infants , eleven out of thirty‐six breast‐fed and thirteen of eighteen formula‐fed . Avoidance of common dietary allergens during pregnancy and lactation enhanced the preventive beneficial effect of exclusive breast feeding on the incidence of atopic eczema among infants at high risk ABSTRACT A prospect i ve case‐control study is presented to assess an allergy prevention programme in children up to 36 months of age . Infants born at three maternity hospitals were followed from birth : 279 infants with high atopic risk ( intervention group ) were compared with 80 infants with similar atopic risk but no intervention ( non‐intervention group ) . The intervention programme included dietary measures ( exclusive and prolonged milk feeding diet followed by a hypoantigenic weaning diet ) and environmental measures ( avoidance of parental smoking in the presence of the babies , day care > 2 years of life ) . Mothers in this group who had insufficient breast milk were r and omly assigned to one of two coded formulas : either a hydrolysed milk formula ( Nidina HA , Nestlé ) or a conventional adapted formula ( Nan , Nestlé ) . Other environmental measures remained the same as for the breastfeeding mothers . The non‐intervention group were either breastfed or received the usual Italian milk feeding and weaning diet , without environmental advice . The main outcome measures were anthropometric measurements and allergic disease manifestations . Normal anthropometric data were observed both in the intervention group and in the nonintervention group . The incidence of allergic manifestations was much lower in the intervention group than in the nonintervention group at 1 year ( 11.5 versus 54.4 % , respectively ) and at 2 years ( 14.9 versus 65.6 % ) and 3 years ( 20.6 versus 74.1 % ) . Atopic dermatitis and recurrent wheezing were found in both the intervention group and the non‐intervention group from birth up to the second year of life , while urticaria and gastrointestinal disorders were only present in the non‐intervention group in the first year of life . Conjunctivitis and rhinitis were present after the second year in both the intervention group and the non‐intervention group . Relapse of the same allergic symptom was less in the intervention group ( 13.0 % ) than in the non‐intervention group ( 36.9 % ) . In comparison to the non‐intervention group , there were fewer intervention group cases with two or more different allergic symptoms ( 8.7 versus 32.6 % ) , and they were more likely to avoid steroid treatment ( 0 versus 10.8 % ) and hospital admission ( 0 versus 6.5 % ) . Babies in the non‐intervention group fed with adapted formula were more likely to develop allergies than breastfed babies in the same group . In the intervention group the breastfed infants had the lowest incidence of allergic symptoms , followed by the infants fed the hydrolysed formula ( ns ) . Infants in the intervention group fed the adapted formula had significantly more allergies than the breastfed and hydrolysed milk fed infants , although less than their counterparts in the non‐intervention group . Of the affected subjects in the intervention group , 80.4 % were RAST and /or Prick positive to food or inhalant allergens . Total serum IgE values detected at birth in the intervention group were not predictive , but at 1 and 2 years of age , IgE values more than 2 SD above the mean in asymptomatic babies were found to predictive for later allergy . In breastfed babies the total IgE level at 1 and 2 years of age was lower than in the other two feeding groups . Of the various factors tested in the non‐intervention group , the following were the most important in the pathogenesis of allergic symptoms : ( i ) formula implementation begun in the first week of life ; ( ii ) early weaning ( < 4 months ) ; ( iii ) feeding beef ( < 6 months ) ; ( iv ) early introduction of cow 's milk ( < 6 months ) ; and ( v ) parental smoking in the presence of the babies and early day care admission ( < 2 years of life ) . All the preventive measures used in this study ( exclusive breastfeeding and /or hydrolysed milk feeding , delayed and selective introduction of solid foods , and environmental advice ) were effective at the third year of follow‐up , greatly reducing allergic
Output:
| There is no strong evidence of a protective effect of exclusive breastfeeding for at least 3 months against AD , even among children with a positive family history |
MS212314 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background A protective effect on injury risk in youth sports through neuromuscular warm-up training routines has consistently been demonstrated . However , there is a paucity of information regarding the quantity and quality of coach-led injury prevention programmes and its impact on the physical performance of players . Objective The aim of this cluster-r and omised controlled trial was to assess whether different delivery methods of an injury prevention programme ( FIFA 11 + ) to coaches could improve player performance , and to examine the effect of player adherence on performance and injury risk . Method During the 2011 football season ( May – August ) , coaches of 31 tiers 1–3 level teams were introduced to the 11 + through either an unsupervised website or a coach-focused workshop with and without additional on-field supervisions . Playing exposure , adherence to the 11 + , and injuries were recorded for female 13-year-old to 18-year-old players . Performance testing included the Star Excursion Balance Test ( SEBT ) , single-leg balance , triple hop and jumping-over-a-bar tests . Results Complete preseason and postseason performance tests were available for 226 players ( 66.5 % ) . Compared to the unsupervised group , single-leg balance ( OR=2.8 ; 95 % CI 1.1 to 4.6 ) and the anterior direction of the SEBT improved significantly in the onfield supervised group of players ( OR=4.7 ; 95 % CI 2.2 to 7.1 ) , while 2-leg jumping performance decreased ( OR=−5.1 ; 95 % CI −9.9 to −0.2 ) . However , significant improvements in 5 of 6 reach distances in the SEBT were found , favouring players who highly adhered to the 11 + . Also , injury risk was lower for those players ( injury rate ratio , IRR=0.28 , 95 % CI 0.10 to 0.79 ) . Conclusions Different delivery methods of the FIFA 11 + to coaches influenced players ’ physical performance minimally . However , high player adherence to the 11 + result ed in significant improvements in functional balance and reduced injury risk BACKGROUND Ankle injuries account for 30 to 60 % of all parachuting injuries . This study was design ed to determine if outside-the-boot ankle braces could reduce ankle sprains during Army paratrooper training . METHODS The r and omized trial involved 777 volunteers from the U.S. Army Airborne School , Fort Benning , Ga. Of this group , 745 completed all study requirements ( 369 brace-wearers and 376 non-brace-wearers ) . Each volunteer made five parachute jumps , for a total of 3,674 jumps . RESULTS The incidence of inversion ankle sprains was 1.9 % in non-brace-wearers and 0.3 % in brace-wearers ( risk ratio , 6.9 ; p = 0.04 ) . Other injuries appeared unaffected by the brace . Overall , 5.3 % of the non-brace group and 4.6 % of the brace group experienced at least one injury . The risk ratio for injured individuals was 1.2:1 ( non-brace to brace groups ; p = 0.65 ) . CONCLUSION Inversion ankle sprains during parachute training can be significantly reduced by using an outside-the-boot ankle brace , with no increase in risk for other injuries Background This study was conducted to investigate whether the most common injuries in soccer could be prevented , and to determine if a simple question naire could identify players at increased risk . Hypothesis Introduction of targeted exercise programs to male soccer players with a history of previous injury or reduced function in the ankle , knee , hamstring , or groin will prevent injuries . Study Design R and omized controlled trial ; Level of evidence , 2 . Methods A total of 508 players representing 31 teams were included in the study . A question naire indicating previous injury and /or reduced function as inclusion criteria was used to divide the players into high-risk ( HR ) ( 76 % ) and low-risk ( LR ) groups . The HR players were r and omized individually into an HR intervention group or HR control group . Results A total of 505 injuries were reported , sustained by 56 % of the players . The total injury incidence was a mean of 3.2 ( 95 % confidence interval [ CI ] , 2.5–3.9 ) in the LR control group , 5.3 ( 95 % Cl , 4.6–6.0 ) in the HR control group ( P = .0001 vs the LR control group ) , and 4.9 ( 95 % Cl , 4.3–5.6 ) in the HR intervention group ( P = .50 vs the HR control group ) . For the main outcome measure , the sum of injuries to the ankle , knee , hamstring , and groin , there was also a significantly lower injury risk in the LR control group compared with the 2 other groups , but no difference between the HR intervention group and the HR control group . Compliance with the training programs in the HR intervention group was poor , with only 27.5 % in the ankle group , 29.2 % in the knee group , 21.1 % in the hamstring group , and 19.4 % in the groin defined as having carried out the minimum recommended training volume . Conclusion The players with a significantly increased risk of injury were able to be identified through the use of a question naire , but player compliance with the training programs prescribed was low and any effect of the intervention on injury risk could not be detected BACKGROUND Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems . One review concludes that the former is clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires at initiation of the study and 3 months later . Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period . No intervention was provided for the control group . Differences between the 2 groups were tested with the chi-square test , and statistical significance was accepted at P < .05 . Risk ratio ( RR ) , risk difference ( ARR ) , numbers needed to prevent ( NNP ) , and cost per successfully prevented case were calculated . OUTCOME VARIABLES Outcome variables included self-reported back and /or lower extremity problems ; specific problems in the back or knees or shin splints , Achilles tendonitis , sprained ankle , or other problems in the lower extremity ; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems . RESULTS Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems ( RR 0.7 , ARR 19 % , NNP 5 , cost 98 US dollars ) ; number of subjects with shin splints ( RR 0.2 , ARR 19 % , NNP 5 , cost 101 US dollars ) ; number of off-duty days because of back or lower extremity problems ( RR 0.6 , ARR < 1 % , NNP 200 , cost 3750 US dollars ) . In an intention-to-treat analysis , a significant difference was found for only number of subjects with shin splints ( RR 0.3 , ARR 18 % , NNP 6 cost 105 US dollars ) , whereas a worst-case analysis revealed no significant differences between the study groups . CONCLUSIONS This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses . However , because care-seeking for lower extremity problems is rare , using this method of prevention in military conscripts would be too costly . We also noted that the choice of statistical approach determined the outcome To study the efficacy of an injury prevention program in a r and omized trial , 12 teams ( 180 players ) in a male senior soccer division were followed up for 6 months . The 12 teams were allocated at r and om to two groups of six teams , one being given a prophylactic program and the other serving as control . The program was based on previous studies of injury mechanisms . It comprised ( 1 ) correction of training , ( 2 ) provision of optimum equipment ; ( 3 ) prophylactic ankle taping ; ( 4 ) controlled rehabilitation ; ( 5 ) exclusion of players with grave knee instability ; ( 6 ) information about the impor tance of disciplined play and the increased risk of injury at training camps ; and ( 7 ) correction and supervision by doctor(s ) and physiotherapist(s ) . The injuries in the test teams were 75 % fewer than in the controls . The most common types of soccer injuries , sprains and strains to ankles and knees , were all significantly reduced . It is concluded that the pro posed prophylactic program , including close supervi sion and correction by doctors and physiotherapists , significantly reduces soccer injuries 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 BACKGROUND Concussion is a serious problem in many contact sports , including rugby union football . The study 's primary aim was to measure the efficacy of padded headgear in reducing the rates of head injury or concussion . METHODS A cluster r and omized controlled trial with three arms was conducted with rugby union football teams as the unit of r and omization . Teams consisted of males participating in under 13- , 15- , 18- , and 20-yr age group competitions . The interventions were " st and ard " and " modified " padded headgear . Headgear wearing and injury were measured for each study team at each game over two seasons . RESULTS Eighty-two teams participated in year 1 and 87 in year 2 . A total of 1493 participants ( 10,040 player hours ) were in the control group , 1128 participants ( 8170 player hours ) were assigned to the st and ard headgear group , and 1474 participants ( 10,650 player hours ) were assigned to the modified headgear group . The compliance rates were low in all groups , but 46 % of participants wore st and ard headgear . An intention-to-treat analysis showed no differences in the rates of head injury or concussion between controls and headgear arms . Incidence rate ratios for st and ard headgear wearers referenced to controls were 0.95 and 1.02 for game and missed game injuries . Analyses of injury rates based on observed wearing patterns also showed no significant differences . Incidence rate ratios for st and ard headgear wearers referenced to nonwearers were 1.11 and 1.10 for game and missed game injuries . CONCLUSIONS Padded headgear does not reduce the rate of head injury or concussion . The low compliance rates are a limitation . Although individuals may choose to wear padded headgear , the routine or m and atory use of protective headgear can not be recommended Objective To evaluate the effectiveness of neuromuscular training in reducing the rate of acute knee injury in adolescent female football players . Design Stratified cluster r and omised controlled trial with clubs as the unit of r and omisation . Setting 230 Swedish football clubs ( 121 in the intervention group , 109 in the control group ) were followed for one season ( 2009 , seven months ) . Participants 4564 players aged 12 - 17 years ( 2479 in the intervention group , 2085 in the control group ) completed the study . Intervention 15 minute neuromuscular warm-up programme ( targeting core stability , balance , and proper knee alignment ) to be carried out twice a week throughout the season . Main outcome measures The primary outcome was rate of anterior cruciate ligament injury ; secondary outcomes
Output:
| Conclusions This meta- analysis showed that certain interventions can reduce the risk of sports injuries . |
MS212315 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Early changes in coagulation were found in patients following a paracetamol overdose . Low levels of clotting factors II , V and VII were present within 24 hours of the overdose . As the levels of factor II correlated with plasma fibrinogen values at this time , it is possible that they were consumed in the process of intravascular coagulation , although this was not supported by the presence of raised titres of fibrin degradation products . The prothrombin time ratio was greater than 2 - 2 within 30 hours of ingestion of the overdose in all patients who eventually died , whereas it was less than this in those developing only moderate liver damage . The administration of fresh frozen plasma to patients did appear to reduce the maximum abnormality of the prothrombin time ratio , which was significantly less three days after the overdose in the group receiving fresh frozen plasma . However , the coagulation disturbance was of short duration , and the prothrombin time ratio had also returned to normal within one week of the overdose in the control patients , and the administration of fresh frozen plasma did not appear to reduce the morbidity or mortality in the treated patients A prospect i ve study to evaluate efficacy and safety of partial exchange blood transfusion ( PEBT ) with normal saline or plasma was conducted in 30 symptomatic polycythemic newborns . Babies were r and omly assigned to receive PEBT either with normal saline or plasma . Both groups were comparable in terms of birth weight , gestational age , preexchange hematocrit and viscosity . A significant fall in hematocrit and viscosity was noticed at 6 hours following PEBT which persisted even at 24 hours ( P < 0.001 ) . Hematocrit and viscosity were comparable in the two groups at 6 and 24 hours ( p > 0.05 for both ) . Majority of babies became asymptomatic after 24 hours of PEBT , but one baby in the saline group remained polycythemic and symptomatic requiring repeat PEBT . No complications related to the procedure were encountered in the two groups . Partial exchange with normal saline was as effective and safe as plasma in symptomatic polycythemic newborns Thrombotic thrombocytopenic purpura ( TTP ) is a potentially fatal disease that is treated with plasma exchange and typically with replacement with fresh frozen plasma ( FFP ) . This approach results in an approximate 50 % response rate following 1 week of therapy and 80 % survival . Cryoprecipitate poor plasma ( CPP ) is plasma from which the cryoprecipitate fraction is removed . CPP has been reported to be successful as salvage therapy in refractory TTP and has been suggested to be superior to FFP in retrospective studies . The present report compares initial therapy of TTP with exchange using replacement with either FFP or CPP in a multi-institutional prospect i ve r and omized study performed by the North American TTP Group ( NATG Group ) from 1993 to 1995 . Initial therapy also included corticosteroids . Antiplatelet drugs or vinca alkaloids were not employed . A severity score index , response score , and individual clinical parameters ( platelet count , LDH x upper limit of normal , hemoglobin level , and creatinine ) were compared at their nadir or peak values , baseline , and days + 6 and + 13 of therapy . Thirteen patients were r and omized to FFP exchange and 14 to CPP exchange . Results were equivalent for all parameters . Survival was equal with three deaths in each group . These data indicate that the efficacy of FFP and CPP are the same in the initial treatment of TTP in adults OBJECTIVES To assess the benefits of withdrawn autologous plasma , the objective of this study was to investigate whether withdrawal of acutely performed platelet-rich or platelet-poor plasmapheresis allays changes in the protein C-thrombomodulin and fibrinolytic systems after retransfusion secondary to cardiopulmonary bypass ( CPB ) . In addition , the study attempted to determine the influence of acute plasmapheresis ( APP ) on the protein C-thrombomodulin and fibrinolytic systems as well as on homologous blood consumption and perioperative blood loss in elective aortocoronary bypass patients . DESIGN The investigation was scheduled as a prospect i ve , r and omized , unblinded study . SETTING This single investigation was conducted in the Department of Anesthesiology and Intensive Care Medicine at a university in Germany . The study protocol was approved by the Ethics Committee of the hospital , and informed consent was obtained . PARTICIPANTS Sixty male patients scheduled for elective coronary artery bypass grafting with extracorporeal circulation were included in the study . INTERVENTIONS APP was performed between induction of anesthesia and incision , collecting either 10 mL/kg of autologous platelet-poor plasma ( PPP patients , group 1 ; n = 20 ) or the same amount of platelet-rich plasma ( PRP patients , group 2 ; n = 20 ) . Patients of group 3 ( n = 20 ) had no APP ( control group ) . All patients were maintained on their usual regimen of cardiac drugs until the morning of surgery . To preserve hemodynamic stability and restore the intravascular oncotic pressure , the separated plasma was replaced by infusion of an equal amount of hydroxyethyl starch solution ( HES ) ( 6 % HES , molecular weight 2 x 10(5 ) , substitution rate 0.5 % ) . In all operations , the same surgical procedure was chosen . For all patients , induction and maintenance of anesthesia were similar , consisting of weight-related doses of fentanyl ( 35 micrograms/kg ) , midazolam ( 0.65 mg/kg ) , and pancuronium bromide ( 0.15 mg/kg ) . The lungs of all patients were mechanically ventilated during the first 5 hours after the end of the operation . MEASUREMENTS AND MAIN RESULTS All patients had serial coagulation studies including antithrombin ( AT ) III-activity , prekallikrein , factor XII , and immunologic tests such as thrombin-antithrombin III ( TAT ) , fibrinopeptide A ( FPA ) , protein C and S ( PC and PS ) , thrombomodulin ( TM ) , tissue-plasminogen-activator ( t-PA ) , plasminogen-activator-inhibitor ( PAI 1 ) , fibrinopeptide B beta 15 - 42 ( FPB beta 15 - 42 ) , D-dimers , and hemoglobin and platelet counts determined intraoperatively and postoperatively . Chest tube drainage and transfusion requirements were recorded . APP had no negative effects on the quality of PPP and PRP plasma . The platelet count of the withdrawn plasma was 28 + /- 12 x 10(9)/L ( PPP group ) and 245 + /- 36 x 10(9)/L ( PRP group ) . At the end of the operation ( after retransfusion of autologous plasma ) and on the morning of the first postoperative day , platelet counts were significantly higher ( p > 0.05 ) in the PRP than in the PPP and control groups . Plasma concentrations of TAT and FPA increased ( ranging from + 185 % to + 340 % from baseline values ) and AT III-activity , PC , PS , and TM antigen decreased ( ranging from -8 % to -55 % from baseline values ) to a different extent for all three groups throughout CPB . t-PA-activity increased with a maximum at the end of CPB ( PPP group , 6.9 + /- 1.5 IU/mL : PRP group , 3.8 + /- 0.8 IU/mL ; control group , 10.9 + /- 2.8 IU/mL ) . Fibrin and fibrinogen degradation markers such as D-dimers and FPB beta 15 to 42 occurred in peak concentrations after neutralization of heparin by protamine . Only PRP patients showed baseline concentrations of coagulation parameters the next morning ( p < 0.05 ) . Total postoperative blood loss within the first 24 hours reached 482 + /- 273 mL ( PRP group ) , 775 + /- 256 mL ( PPP group ) , and 948 + /- 342 mL in the control group ( p < 0.05 ) . ( ABSTRACT TRUNCATED In thrombotic microangiopathies hemolytic uremic syndrome and thrombocytopenic purpura , plasma exchange ( PE ) therapy using fresh frozen plasma is st and ard . In almost 20 % of the patients , however , this approach is ineffective . This prospect i ve , r and omized study for the treatment of patients with thrombotic microangiopathies ( PRODROMI ) compares PE with fresh frozen plasma ( A ) and cryosupernatant ( B ) . The participating centers were the University Clinics of Freiburg , Hamburg , Düsseldorf , Essen , Göttingen , Mannheim , Ulm , Jena , Tübingen , Würzburg , Kreiskrankenhaus Offenburg , Städt Klinikum Karlsruhe , and Horst-Schmidt Kliniken in Wiesbaden , Germany . Patients ( 18 to 80 years ) were diagnosed by the individual centers based on clinical and laboratory findings ( thrombocyte/fragmentocyte count , hemoglobin , serum creatinine , haptoglobin and lactate dehydrogenase levels ; negative Coombs-test is obligatory ) . HIV infection , bone marrow , or solid organ transplantation were exclusion criteria . After written consent , patients were r and omized in the A or B group . All patients received 1.5 mg/kg methylprednisolone as a basic therapy . The first PE always was performed with fresh frozen plasma ( 50 ml/kg ) . A minimum of 5 and a maximum of 10 PEs were required . Thrombocyte count above 150,000/microl was considered to be a successful therapy . Treatment failure was defined as not responding to 10 PE with a thrombocyte count above 150,000/microl or a fall below this value within 30 days after stopping PE . Patients with clinical and laboratory signs of thrombotic microangiopathy occurring later than 30 days after having stopped PE were considered to have a relapse . Primary endpoints were survival , intensity of required PE sessions ( duration , volume , and number ) , and relapse rate . Follow-up of clinical outcome was 2 years ; von Willebr and Factor ( vWF ) , vWF-cleaving-protease activity , and Factor H were determined The use of partial plasma exchange transfusion in newborns with polycythemia and hyperviscosity was evaluated . Ninety-three infants with polycythemia and hyperviscosity were r and omly assigned to receive either partial plasma exchange transfusion or symptomatic treatment ; the infants were matched with control infants without polycythemia . Neonatal course and outcome at 1 and 2 years were evaluated for each of the three groups . Polycythemic infants had more fine motor and speech problems at 1 year of age than did control infants . At 2 years of age , polycythemic infants had more gross motor delays , neurologic diagnoses , fine motor abnormalities , and speech delays than did the control infants . There was no significant difference at 1 year between the polycythemic infants who had received partial plasma exchange transfusion and those given only symptomatic care . At 2 years , the group receiving partial plasma exchange transfusion had fewer neurologic diagnoses and fine motor abnormalities Seventy three preterm infants weighing less than 1500 g or less than 32 weeks ' gestation , or both , were allocated r and omly to treatment ( fresh frozen plasma 10 ml/kg on admission and at 24 hours of age ) or control groups . Fifteen ( 41 % ) out of 37 control patients sustained intraventricular haemorrhage compared with five ( 14 % ) of 36 patients receiving treatment ( X2 = 5.24 , P = 0.022 ) . No difference was found in coagulation factors measured at birth or at 48 hours of age in both groups . Fresh frozen plasma appears to have a beneficial effect in the prevention of intraventricular haemorrhage Colloid infusions are often given to treat hypotension in preterm infants . The aim of this work was to assess whether it was the amount of protein or the volume of the colloid infused which accounted for the observed increase in blood pressure . Sixty preterm infants were r and omised ( 20 in each group ) to receive 5 ml/kg 20 % albumin , 15 ml/kg fresh frozen plasma , or 15 ml/kg 4.5 % albumin . All infusions were given at a rate of 5 ml/kg/hour in addition to maintenance fluids . The infants were r and omised when hypotensive ( systolic blood pressure less than 40 mm Hg for two hours ) . There was no significant difference in the blood pressure of the three groups before or one hour after beginning the infusion . The mean increase in blood pressure one hour after completing the infusion , however , was significantly lower in infants receiving 20 % albumin : 9 % compared with 17 % in the group receiving 4.5 % albumin , and 19 % in the group receiving fresh frozen plasma . It is concluded that the volume infused rather than albumin load is important in producing a sustained increase in blood pressure The goals of this multicenter controlled trial were : ( 1 ) to study the short‐term effect of plasma exchange in the Guillain‐Barré syndrome when applied alone within 17 days of onset of the disease ; and ( 2 ) to compare two replacement fluids , diluted albumin and fresh frozen plasma ( FFP ) with regard to efficacy and morbidity . Two hundred twenty patients were included , 11
Output:
| In particular , there is little evidence for the effectiveness of the prophylactic use of FFP . |
MS212316 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Primary pulmonary hypertension is a progressive disease for which no treatment has been shown in a prospect i ve , r and omized trial to improve survival . METHODS We conducted a 12-week prospect i ve , r and omized , multicenter open trial comparing the effects of the continuous intravenous infusion of epoprostenol ( formerly called prostacyclin ) plus conventional therapy with those of conventional therapy alone in 81 patients with severe primary pulmonary hypertension ( New York Heart Association functional class III or IV ) . RESULTS Exercise capacity was improved in the 41 patients treated with epoprostenol ( median distance walked in six minutes , 362 m at 12 weeks vs. 315 m at base line ) , but it decreased in the 40 patients treated with conventional therapy alone ( 204 m at 12 weeks vs. 270 m at base line ; P < 0.002 for the comparison of the treatment groups ) . Indexes of the quality of life were improved only in the epoprostenol group ( P < 0.01 ) . Hemodynamics improved at 12 weeks in the epoprostenol-treated patients . The changes in mean pulmonary-artery pressure for the epoprostenol and control groups were -8 percent and + 3 percent , respectively ( difference in mean change , -6.7 mm Hg ; 95 percent confidence interval , -10.7 to -2.6 mm Hg ; P < 0.002 ) , and the mean changes in pulmonary vascular resistance for the epoprostenol and control groups were -21 percent and + 9 percent , respectively ( difference in mean change , -4.9 mm Hg/liter/min ; 95 percent confidence interval , -7.6 to -2.3 mm Hg/liter/min ; P < 0.001 ) . Eight patients died during the study , all of whom had been r and omly assigned to conventional therapy ( P = 0.003 ) . Serious complications included four episodes of catheter-related sepsis and one thrombotic event . CONCLUSIONS As compared with conventional therapy , the continuous intravenous infusion of epoprostenol produced symptomatic and hemodynamic improvement , as well as improved survival in patients with severe primary pulmonary hypertension Background — Eisenmenger syndrome is characterized by the development of pulmonary arterial hypertension with consequent intracardiac right-to-left shunt and hypoxemia in patients with preexisting congenital heart disease . Because Eisenmenger syndrome is associated with increased endothelin expression , patients may benefit from endothelin receptor antagonism . Theoretically , interventions that have some effect on the systemic vascular bed could worsen the shunt and increase hypoxemia . Methods and Results — The Bosentan R and omized Trial of Endothelin Antagonist Therapy-5 ( BREATHE-5 ) was a 16-week , multicenter , r and omized , double-blind , placebo-controlled study evaluating the effect of bosentan , a dual endothelin receptor antagonist , on systemic pulse oximetry ( primary safety end point ) and pulmonary vascular resistance ( primary efficacy end point ) in patients with World Health Organization functional class III Eisenmenger syndrome . Hemodynamics were assessed by right- and left-heart catheterization . Secondary end points included exercise capacity assessed by 6-minute walk distance , additional hemodynamic parameters , functional capacity , and safety . Fifty-four patients were r and omized 2:1 to bosentan ( n=37 ) or placebo ( n=17 ) for 16 weeks . The placebo-corrected effect on systemic pulse oximetry was 1.0 % ( 95 % confidence interval , −0.7 to 2.8 ) , demonstrating that bosentan did not worsen oxygen saturation . Compared with placebo , bosentan reduced pulmonary vascular resistance index ( −472.0 dyne · s · cm−5 ; P=0.0383 ) . The mean pulmonary arterial pressure decreased ( −5.5 mm Hg ; P=0.0363 ) , and the exercise capacity increased ( 53.1 m ; P=0.0079 ) . Four patients discontinued as a result of adverse events , 2 ( 5 % ) in the bosentan group and 2 ( 12 % ) in the placebo group . Conclusions — In this first placebo-controlled trial in patients with Eisenmenger syndrome , bosentan was well tolerated and improved exercise capacity and hemodynamics without compromising peripheral oxygen saturation Background — Pulmonary hypertension ( PH ) is associated with restricted physical capacity , limited quality of life , and a poor prognosis because of right heart failure . The present study is the first prospect i ve r and omized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH . Methods and Results — Thirty patients with PH ( 21 women ; mean age , 50±13 years ; mean pulmonary artery pressure , 50±15 mm Hg ; mean World Health Organization [ WHO ] class , 2.9±0.5 ; pulmonary arterial hypertension , n=23 ; chronic thromboembolic PH , n=7 ) on stable disease-targeted medication were r and omly assigned to a control ( n=15 ) and a primary training ( n=15 ) group . Medication remained unchanged during the study period . Primary end points were the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality -of-life question naire . Changes in WHO functional class , Borg scale , and parameters of echocardiography and gas exchange also were assessed . At week 15 , patients in the primary and secondary training groups had an improved 6-minute walking distance ; the mean difference between the control and the primary training group was 111 m ( 95 % confidence interval , 65 to 139 m ; P<0.001 ) . Exercise training was well tolerated and improved scores of quality of life , WHO functional class , peak oxygen consumption , oxygen consumption at the anaerobic threshold , and achieved workload . Systolic pulmonary artery pressure values at rest did not change significantly after 15 weeks of exercise and respiratory training ( from 61±18 to 54±18 mm Hg ) within the training group . Conclusions — This study indicates that respiratory and physical training could be a promising adjunct to medical treatment in severe PH . The effects add to the beneficial results of modern medical treatment RATIONALE A previous trial of bosentan in idiopathic pulmonary fibrosis ( IPF ) showed a trend to delayed IPF worsening or death . Also , improvements in some measures of dyspnea and health-related quality of life were observed . OBJECTIVES To demonstrate that bosentan delays IPF worsening or death . METHODS Prospect i ve , r and omized ( 2:1 ) , double-blind , placebo-controlled , event-driven , parallel-group , morbidity-mortality trial of bosentan in adults with IPF of less than 3 years ' duration , confirmed by surgical lung biopsy , and without extensive honeycombing on high-resolution computed tomography . The primary endpoint was time to IPF worsening ( a confirmed decrease from baseline in FVC ≥ 10 % and diffusing capacity of the lung for carbon monoxide ≥ 15 % , or acute exacerbation of IPF ) or death up to End of Study . Effects of bosentan on health-related quality of life , dyspnea , and the safety and tolerability of bosentan were investigated . MEASUREMENTS AND MAIN RESULTS Six hundred sixteen patients were r and omized to bosentan ( n=407 ) or placebo ( = 209 ) . No significant difference between treatment groups was observed in the primary endpoint analysis ( hazard ratio , 0.85 ; 95 % confidence interval , 0.66 - 1.10 ; P=0.2110 ) . No treatment effects were observed on health-related quality of life or dyspnea . Some effects of bosentan treatment were observed in changes from baseline to 1 year in FVC and diffusing capacity of the lung for carbon monoxide . The safety profile for bosentan was similar to that observed in other trials . CONCLUSIONS The primary objective in the Bosentan Use in Interstitial Lung Disease-3 trial was not met . Bosentan was well tolerated . Clinical trial registered with www . clinical trials.gov ( NCT 00391443 ) OBJECTIVE Recurrent digital ulcers are a manifestation of vascular disease in patients with systemic sclerosis ( SSc ; scleroderma ) and lead to pain , impaired function , and tissue loss . We investigated whether treatment with the endothelin receptor antagonist , bosentan , decreased the development of new digital ulcers in patients with SSc . METHODS This was a r and omized , prospect i ve , placebo-controlled , double-blind study of 122 patients at 17 centers in Europe and North America , evaluating the effect of treatment on prevention of digital ulcers . The primary outcome variable was the number of new digital ulcers developing during the 16-week study period . Secondary assessment s included healing of existing digital ulcers and evaluation of h and function using the Scleroderma Health Assessment Question naire . RESULTS Patients receiving bosentan had a 48 % reduction in the mean number of new ulcers during the treatment period ( 1.4 versus 2.7 new ulcers ; P = 0.0083 ) . Patients who had digital ulcers at the time of entry in the study were at higher risk for the development of new ulcers ; in this subgroup the mean number of new ulcers was reduced from 3.6 to 1.8 ( P = 0.0075 ) . In patients receiving bosentan , a statistically significant improvement in h and function was observed . There was no difference between treatment groups in the healing of existing ulcers . Serum transaminase levels were elevated to > 3-fold the upper limit of normal in bosentan-treated patients ; this elevation is comparable with that observed in previous studies of this agent . Other side effects were similar in the 2 treatment groups . CONCLUSION Endothelins may play an important role in the pathogenesis of vascular disease in patients with SSc . Treatment with the endothelin receptor antagonist bosentan may be effective in preventing new digital ulcers and improving h and function in patients with SSc Background — The degree of pulmonary hypertension in healthy subjects exposed to acute hypobaric hypoxia at high altitude was found to be related to increased plasma endothelin (ET)-1 . The aim of the present study was to investigate the effects of ET-1 antagonism on pulmonary hypertension , renal water , and sodium balance under acute and prolonged exposure to high-altitude – associated hypoxia . Methods and Results — In a double-blind fashion , healthy volunteers were r and omly assigned to receive bosentan ( 62.5 mg for 1 day and 125 mg for the following 2 days ; n=10 ) or placebo ( n=10 ) at sea level and after rapid ascent to high altitude ( 4559 m ) . At sea level , bosentan did not induce any significant changes in hemodynamic or renal parameters . At altitude , bosentan induced a significant reduction of systolic pulmonary artery pressure ( 21±7 versus 31±7 mm Hg , P<0.03 ) and a mild increase in arterial oxygen saturation versus placebo after just 1 day of treatment . However , both urinary volume and free water clearance ( H2OCl/glomerular filtration rate ) were significantly reduced versus placebo after 2 days of ET-1 antagonism ( 1100±200 versus 1610±590 mL ; −6.7±3.5 versus −1.8±4.8 mL/min , P<0.05 versus placebo for both ) . Sodium clearance and segmental tubular function were not significantly affected by bosentan administration . Conclusions — The present results indicate that the early beneficial effect of ET-1 antagonism on pulmonary blood pressure is followed by an impairment in volume adaptation . These findings must be considered for the prevention and treatment of acute mountain sickness BACKGROUND Patients with precapillary pulmonary hypertension ( PH ) exhibit a poor exercise capacity due to an impaired vasodilatory response of their pulmonary arteries . By causing the pulmonary artery to dilate , inhaled nitric oxide ( NO ) may allow an increase in exercise capacity in patients with PH . METHODS AND RESULTS On 2 separate days , 3 days apart , 14 patients with precapillary PH ( 10 primary PH , 4 residual PH after correction of an intracardiac shunt ; age , 40+/-12 years ; mean pulmonary artery pressure , 60+/-23 mm Hg ) performed exercise , with and without inhalation of 20 ppm NO , on a cycle ergometer . The work rate was increased 15 W/min until their symptom-limited maximum , with breath-by-breath gas analysis . Patients were r and omly and blindly selected to inhale NO on either their first or second test . Peak exercise load and anaerobic threshold tended to increase , but not significantly . Peak oxygen consumption ( f1.gif " BORDER="0" > O(2 ) ) and Deltaf1.gif " BORDER="0" > O(2)/DeltaW ratio increased significantly , by 18 % and 22 % , respectively ( peak f1.gif " BORDER="0" > O(2 ) , 13.6+/-3.6 to 16.0+/-4 . 1 mL. kg(-1 ) . min(-1 ) ; Deltaf1.gif " BORDER="0" > O(2)/DeltaW ratio , 5 . 8+/-2.4 to 7.1+/-2.3 mL. kg(-1 ) . min(-1 ) . W(-1 ) ; both P
Output:
| There was a reduction in mortality that did not reach statistical significance on endothelin receptor antagonists ( OR 0.57 ; 95 % CI 0.26 to 1.24 ) , and limited data suggest that endothelin receptor antagonists improve the Borg dyspnoea score and cardiopulmonary haemodynamics in symptomatic patients .
Hepatic toxicity was not common , and endothelin receptor antagonists were well tolerated in this population .
Endothelin receptor antagonists can increase exercise capacity , improve WHO/NYHA functional class , prevent WHO/NYHA functional class deterioration , reduce dyspnoea and improve cardiopulmonary haemodynamic variables in patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III .
However , there was only a trend towards endothelin receptor antagonists reducing mortality in patients with pulmonary arterial hypertension .
Efficacy data are strongest in those with idiopathic pulmonary hypertension .
The irreversible liver failure caused by sitaxsentan and its withdrawal from global markets emphasise the importance of hepatic monitoring in patients treated with endothelin receptor antagonists |
MS212317 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Low-fat ( LF ) and high-fat ( HF ) weight loss diets improve brachial artery flow-mediated dilation ( FMD ) in obese individuals , although results are conflicting . Moreover , the role that adipose tissue plays in mediating these diet-related effects are unknown . Objective This study examined how modulations in FMD by HF and LF diets relate to changes in adipocyte parameters . Design Obese subjects ( n = 17 ) were r and omized to a HF diet ( 60 % kcal as fat ) or a LF diet ( 25 % kcal as fat ) for 6 weeks . Both groups were restricted by 25 % of energy needs . Results Body weight decreased ( P < 0.05 ) in both groups ( HF : -6.6 ± 0.5 kg , LF : -4.7 ± 0.6 kg ) . Fat mass and waist circumference were reduced ( P < 0.05 ) in the LF group only ( -4.4 ± 0.3 kg ; -3.6 ± 0.8 cm , respectively ) . FMD improved ( P < 0.05 ) in the LF group ( 7.4 ± 0.8 % to 9.8 ± 0.8 ; 32 % increase ) and was impaired in the HF group ( 8.5 ± 0.6 % to 6.9 ± 0.7 ; 19 % reduction ) . Increases in plasma adiponectin ( P < 0.05 , 16 ± 5 % ) , and decreases in resistin ( P < 0.05 , -26 ± 11 % ) , were shown by the LF diet only . Greater decreases in leptin were observed with LF ( -48 ± 9 % ) versus HF ( -28 ± 12 % ) ( P < 0.05 , diet × time ) . Increased FMD by the LF diet was associated with increased adiponectin , and decreased fat mass , waist circumference , leptin , and resistin . Conclusion Beneficial modulations in vascular health by LF diets may be mediated by improvements in adipocyte parameters CONTEXT Obesity in the United States has increased dramatically during the past several decades . There is debate about optimum calorie balance for prevention of weight gain , and proponents of some low-carbohydrate diet regimens have suggested that the increasing obesity may be attributed , in part , to low-fat , high-carbohydrate diets . OBJECTIVES To report data on body weight in a long-term , low-fat diet trial for which the primary end points were breast and colorectal cancer and to examine the relationships between weight changes and changes in dietary components . DESIGN , SETTING , AND PARTICIPANTS R and omized intervention trial of 48,835 postmenopausal women in the United States who were of diverse background s and ethnicities and participated in the Women 's Health Initiative Dietary Modification Trial ; 40 % ( 19,541 ) were r and omized to the intervention and 60 % ( 29,294 ) to a control group . Study enrollment was between 1993 and 1998 , and this analysis includes a mean follow-up of 7.5 years ( through August 31 , 2004 ) . INTERVENTIONS The intervention included group and individual sessions to promote a decrease in fat intake and increases in vegetable , fruit , and grain consumption and did not include weight loss or caloric restriction goals . The control group received diet-related education material s. MAIN OUTCOME MEASURE Change in body weight from baseline to follow-up . RESULTS Women in the intervention group lost weight in the first year ( mean of 2.2 kg , P<.001 ) and maintained lower weight than control women during an average 7.5 years of follow-up ( difference , 1.9 kg , P<.001 at 1 year and 0.4 kg , P = .01 at 7.5 years ) . No tendency toward weight gain was observed in intervention group women overall or when stratified by age , ethnicity , or body mass index . Weight loss was greatest among women in either group who decreased their percentage of energy from fat . A similar but lesser trend was observed with increases in vegetable and fruit servings , and a nonsignificant trend toward weight loss occurred with increasing intake of fiber . CONCLUSION A low-fat eating pattern does not result in weight gain in postmenopausal women . Clinical Trial Registration Clinical Trials.gov , NCT00000611 Dietary glycemic load , the mathematical product of the glycemic index ( GI ) of a food and its carbohydrate content , has been proposed as an indicator of the glucose response and insulin dem and induced by a serving of food . To vali date this concept in vivo , we tested the hypotheses that 1 ) . portions of different foods with the same glycemic load produce similar glycemic responses ; and 2 ) . stepwise increases in glycemic load for a range of foods produce proportional increases in glycemia and insulinemia . In the first study , 10 healthy subjects consumed 10 different foods in r and om order in amounts calculated to have the same glycemic load as one slice of white bread . Capillary blood sample s were taken at regular intervals over the next 2 h. The glycemic response as determined by area under the curve was not different from that of white bread for nine foods . However , lentils produced lower than predicted responses ( P < 0.05 ) . In the second study , another group of subjects was tested to determine the effects of increasing glycemic load using a balanced 5 x 5 Greco-Latin square design balanced for four variables : subject , dose , food and order . Two sets of five foods were consumed at five different glycemic loads ( doses ) equivalent to one , two , three , four and six slices of bread . Stepwise increases in glycemic load produced significant and predictable increases in both glycemia ( P < 0.001 ) and insulinemia ( P < 0.001 ) . These findings support the concept of dietary glycemic load as a measure of overall glycemic response and insulin dem and BACKGROUND The role of glycemic index ( GI ) in appetite and body-weight regulation is still not clear . OBJECTIVE The objective of the study was to investigate the long-term effects of a low-fat , high-carbohydrate diet with either low glycemic index ( LGI ) or high glycemic index ( HGI ) on ad libitum energy intake , body weight , and composition , as well as on risk factors for type 2 diabetes and ischemic heart disease in overweight healthy subjects . DESIGN The study was a 10-wk parallel , r and omized , intervention trial with 2 matched groups . The LGI or HGI test foods , given as replacements for the subjects ' usual carbohydrate-rich foods , were equal in total energy , energy density , dietary fiber , and macronutrient composition . Subjects were 45 ( LGI diet : n = 23 ; HGI diet : n = 22 ) healthy overweight [ body mass index ( in kg/m(2 ) ) : 27.6 + /- 0.2 ] women aged 20 - 40 y. RESULTS Energy intake , mean ( + /- SEM ) body weight ( LGI diet : -1.9 + /- 0.5 kg ; HGI diet : -1.3 + /- 0.3 kg ) , and fat mass ( LGI diet : -1.0 + /- 0.4 kg ; HGI diet : -0.4 + /- 0.3 kg ) decreased over time , but the differences between groups were not significant . No significant differences were observed between groups in fasting serum insulin , homeostasis model assessment for relative insulin resistance , homeostasis model assessment for beta cell function , triacylglycerol , nonesterified fatty acids , or HDL cholesterol . However , a 10 % decrease in LDL cholesterol ( P < 0.05 ) and a tendency to a larger decrease in total cholesterol ( P = 0.06 ) were observed with consumption of the LGI diet as compared with the HGI diet . CONCLUSIONS This study does not support the contention that low-fat LGI diets are more beneficial than HGI diets with regard to appetite or body-weight regulation as evaluated over 10 wk . However , it confirms previous findings of a beneficial effect of LGI diets on risk factors for ischemic heart disease The National Weight Control Registry ( NWCR ) is , to the best of our knowledge , the largest study of individuals successful at long-term maintenance of weight loss . Despite extensive histories of overweight , the 629 women and 155 men in the registry lost an average of 30 kg and maintained a required minimum weight loss of 13.6 kg for 5 y. A little over one-half of the sample lost weight through formal programs ; the remainder lost weight on their own . Both groups reported having used both diet and exercise to lose weight and nearly 77 % of the sample reported that a triggering event had preceded their successful weight loss . Mean ( + /-SD ) current consumption reported by registry members was 5778 + /- 2200 kJ/d , with 24 + /- 9 % of energy from fat , Members also appear to be highly active : they reported expending approximately 11830 kJ/wk through physical activity . Surprisingly , 42 % of the sample reported that maintaining their weight loss was less difficult than losing weight . Nearly all registry members indicated that weight loss led to improvements in their level of energy , physical mobility , general mood , self-confidence , and physical health . In summary , the NWCR identified a large sample of individuals who were highly successful at maintaining weight loss . Future prospect i ve studies will determine variables that predict continued maintenance of weight loss BACKGROUND The optimal nutritional approach for the prevention of cardiovascular disease among obese persons remains a topic of intense controversy . Available approaches range from conventional low-fat to very-low-carbohydrate diets . OBJECTIVE The aim of this pilot study was to evaluate the efficacy of an ad libitum low-glycemic load diet , without strict limitation on carbohydrate intake , as an alternative to a conventional low-fat diet . DESIGN A r and omized controlled trial compared 2 dietary treatments in obese young adults ( n = 23 ) over 12 mo . The experimental treatment emphasized ad libitum consumption of low-glycemic-index foods , with 45 - 50 % of energy from carbohydrates and 30 - 35 % from fat . The conventional treatment was restricted in energy ( 250 - 500 kcal/d deficit ) and fat ( < 30 % of energy ) , with 55 - 60 % of energy from carbohydrate . We compared changes in study outcomes by repeated- measures analysis of log-transformed data and expressed the results as mean percentage change . RESULTS Body weight decreased significantly over a 6-mo intensive intervention in both the experimental and conventional diet groups ( -8.4 % and -7.8 % , respectively ) and remained below baseline at 12 mo ( -7.8 % and -6.1 % , respectively ) . The experimental diet group showed a significantly greater mean decline in plasma triacylglycerols than did the conventional diet group ( -37.2 % and -19.1 % , respectively ; P = 0.005 ) . Mean plasminogen activator inhibitor 1 concentrations decreased ( -39.0 % ) in the experimental diet group but increased ( 33.1 % ) in the conventional diet group ( P = 0.004 ) . Changes in cholesterol concentrations , blood pressure , and insulin sensitivity did not differ significantly between the groups . CONCLUSION An ad libitum low-glycemic load diet may be more efficacious than a conventional , energy-restricted , low-fat diet in reducing cardiovascular disease risk The effects of macronutrient composition on fasting and postpr and ial activities of adipose tissue lipoprotein lipase ( ATLPL ) and skeletal muscle LPL ( SMLPL ) and on insulin sensitivity ( S(I ) ) were studied in 25 normal-weight subjects . Each subject was fed a high-carbohydrate ( HC ) diet for 16 d and a high-fat ( HF ) diet for 16 d , in r and omized order . On day 15 of each diet , biopsies for ATLPL and SMLPL were done in the fasted state and 6 h postpr and ially . On day 16 of each diet , a euglycemic clamp was used to measure S(I ) . There was no effect of diet composition on fasting ATLPL or SMLPL . With both diets and in both tissues , LPL increased significantly from fasting to 6 h postpr and ially . In adipose tissue only there was a significant difference between the 2 diets in LPL meal response ( HC > HF , P = 0.024 ) . There was no effect of diet composition on S(I ) . After the HC diet only , there were significant correlations between fasting SMLPL and S(I ) , but not ATLPL . After the HF diet , associations between insulin action and LPL were evident only in the postpr and ial state . In summary , 16 d of HC compared with HF feeding in normal-weight subjects increased the responsiveness of ATLPL to an HC compared with an HF meal . However , the same diets had no effect on fasting ATLPL or SMLPL , the responsiveness of SMLPL to a meal , or S(I ) . These data suggest that in normal-weight subjects habitual dietary carbohydrate intake may have a stronger effect on subcutaneous fat storage than does dietary fat intake OB
Output:
| In a systematic review to estimate the optimal dietary fat to carbohydrate ratio , it was found that obese subjects with hyperinsulinemia ( or insulin resistance ) lost more weight on a mild low-carbohydrate ( LC ) ( or low-glycemic load diet ; 40 % carbohydrate , 30 - 35 % fat ) than on a low-fat ( LF ) diet ( 55 - 60 % carbohydrate , 20 % fat ) , whereas those without hyperinsulinemia showed the opposite .
In non-obese primarily insulin-sensitive subjects , decreasing fat rather than carbohydrate intake is generally more effective to prevent obesity .
Physiological and molecular evidence supports this conclusion .
Increased carbohydrate intake , especially in high-glycemic food , leads to postpr and ial hyperglycemia and hyperinsulinemia , which are exaggerated in obese insulin-resistant subjects .
Even in an insulin-resistant state , insulin is able to stimulate fatty acid synthesis in liver , activate lipoprotein lipase , and prevent lipolysis in adipose tissues , which all facilitate adipose tissue enlargement . |
MS212318 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Objectives Possible association between diabetes mellitus ( DM ) and Alzheimer ’s disease ( AD ) has been controversial . This study used a nationwide population -based data set to investigate the relationship between DM and subsequent AD incidence . Methods Data were collected from Taiwan ’s National Health Insurance Research Data base , which released a cohort data set of 1,000,000 r and omly sample d people and confirmed it to be representative of the Taiwanese population . We identified 71,433 patients newly diagnosed with diabetes ( age 58.74±14.02 years ) since January 1997 . Using propensity score , we matched them with 71,311 non-diabetic subjects by time of enrollment , age , gender , hypertension , hyperlipidemia , and previous stroke history . All the patients were followed up to December 31 , 2007 . The endpoint of the study was occurrence of AD . Results Over a maximum 11 years of follow-up , diabetic patients experienced a higher incidence of AD than non-diabetic subjects ( 0.48 % vs. 0.37 % , p<0.001 ) . After Cox proportional hazard regression model analysis , DM ( hazard ratio [ HR ] , 1.76 ; 95 % confidence interval [ CI ] , 1.50–2.07 , p<0.001 ) , age ( HR , 1.11 ; 95 % CI , 1.10–1.12 , p<0.001 ) , female gender ( HR , 1.24 ; 95 % CI , 1.06–1.46 , p = 0.008 ) , hypertension ( HR , 1.30 ; 95 % CI , 1.07–1.59 , p = 0.01 ) , previous stroke history ( HR , 1.79 ; 95 % CI , 1.28–2.50 , p<0.001 ) , and urbanization status ( metropolis , HR , 1.32 ; 95 % CI , 1.07–1.63 , p = 0.009 ) were independently associated with the increased risk of AD . Neither monotherapy nor combination therapy with oral antidiabetic medications were associated with the risk of AD after adjusting for underlying risk factors and the duration of DM since diagnosis . However , combination therapy with insulin was found to be associated with greater risk of AD ( HR , 2.17 ; 95 % CI , 1.04–4.52 , p = 0.039 ) . Conclusion Newly diagnosed DM was associated with increased risk of AD . Use of hypoglycemic agents did not ameliorate the risk Background : Several lines of evidence have linked cholesterol to dementia . Objective : To investigate lipid-lowering drug use and dementia development in a Finnish population . Methods : FINRISK is a large population -based survey of cardiovascular risk factors carried out since 1972 every 5 years using independent , r and om and representative population sample s from different parts of Finl and . Several cohorts were part of the WHO-MONICA study . Data from cohorts 1972–2002 were linked to the Hospital Discharge Registry and Drug Reimbursement Registry ( 1995–2007 ) to ascertain dementia diagnoses and lipid-lowering treatment . Selection criteria for the study were : ( 1 ) alive and without dementia in 1995 ; ( 2 ) age ≧60 years ( in 1995 for earlier cohorts and in 1997 or 2002 for later cohorts ; ( 3 ) treatment prescribed at least 1 year before dementia diagnosis . Results : 17,597 persons were included in the study . Lipid-lowering treatment was related to decreased dementia risk . In Cox proportional hazards model , hazard ratio ( 95 % CI ) was 0.42 ( 0.37–0.49 ; controlled for age , sex , education , survey region , survey year , baseline cholesterol , body mass index and systolic blood pressure ) . Conclusion : Preliminary results from the FINRISK study indicate that lipid-lowering drugs may have a beneficial effect in dementia prevention . Further data linkage is ongoing in order to investigate the roles of different types of lipid-lowering drugs The aim of this prospect i ve cohort study was to evaluate the effects of lipid lowering agent ( LLA ) intake on cognitive function in 6,830 community-dwelling elderly persons . Cognitive performance ( global cognitive functioning , visual memory , verbal fluency , psychomotor speed , and executive function ) , clinical diagnosis of dementia , and fibrate and statin use , were evaluated at baseline , and 2 , 4 , and 7 year follow-up . Multivariate Cox models were stratified by gender and adjusted for sociodemographic characteristics , mental and physical health including vascular risk factors , and genetic vulnerability ( apolipoprotein E and cholesteryl ester transfer protein ) . For women but not men , fibrate use was specifically associated with an increased risk over 7 years of decline in visual memory only ( HR = 1.29 , 95 % CI = 1.09 - 1.54 , p = 0.004 ) , and did not increase risk for incident dementia . This association was independent of genetic vulnerability related to apolipoprotein E and cholesteryl exchange transfer protein polymorphisms and occurred only in women with higher low density lipoprotein (LDL)-cholesterol levels and treated with fibrate ( HR = 1.39 , 95 % CI = 1.08 - 1.79 , p = 0.01 ) and not in those with lower LDL-cholesterol levels irrespective of fibrate treatment . For both genders , no significant associations were found between statins ( irrespective of their lipophilicity ) and either cognitive decline or dementia incidence . This prospect i ve study , adjusting for multiple confounders , found no evidence that LLA given in late life reduced the risk of cognitive decline and dementia , but did raise the possibility that women with treatment-resistant high LDL-cholesterol may be at increased risk of decline in visual memory Background : Previously reported associations between statin use and incident dementia or cognitive decline have been inconsistent . We report the results from a 3-year prospect i ve study on the association of statin use on cognitive decline and incident dementia in elderly African Americans . Methods : A community-based cohort of 1,146 African Americans aged 70 and older living in Indianapolis , Indiana , was evaluated in 2001 and 2004 . The instrument used for cognitive assessment was the Community Screening Interview for Dementia ( CSI-D ) . Cognitive decline was defined as CSI-D scores measured at 2001 minus scores at 2004 . Measurements of low-density lipoprotein cholesterol ( LDL-C ) and C-reactive protein ( CRP ) were obtained from baseline blood sample s. Results : Adjusting for age at baseline , gender , education , and the possession of ApoE ε4 allele , baseline statin use was associated with less cognitive decline ( p = 0.0177 ) . There were no significant interactions of statin use when LDL-C and CRP were included . Logistic regression with the four independent variables showed that statin use may be associated with a reduction in incident dementia ( OR = 0.32 ; p = 0.0673 ) . Association with cognitive decline was less clear when investigating statin use over time . Significance remained only for those who discontinued prior to follow-up compared to continuous users or users who started after baseline . Conclusions : The relationship between statin use and cognitive decline is complex and subjected to unknown confounders . This effect may not be associated with the cholesterol lowering or anti-inflammatory action of statins . GLOSSARY : AD = Alzheimer disease ; ANCOVA = analysis of covariance ; BMI = body mass index ; CAMDEX = Cambridge Examination for Mental Disorders of the Elderly informant interview ; CERAD = Consortium to Establish a Registry for Alzheimer ’s Disease ; CHIF = Clinician Home-based Interview to assess Function ; CRP = C-reactive protein ; CSI-D = Community Screening Instrument for Dementia ; HDL = high-density lipoprotein ; HMG-CoA = 3-hydroxy-3-methylglutaryl-coenzyme A ; LDL-C = low-density lipoprotein cholesterol ; LLAs = lipid-lowering agents ; NSAIDs = nonsteroidal anti-inflammatory drugs BACKGROUND Prior reports suggest reduced occurrence of dementia and Alzheimer disease ( AD ) in statin users , but , to our knowledge , no prospect i ve studies relate statin use and dementia incidence . OBJECTIVE To examine the association of statin use with both prevalence and incidence of dementia and AD . DESIGN Cross-sectional studies of prevalence and incidence and a prospect i ve study of incidence of dementia and AD among 5092 elderly residents ( aged 65 years or older ) of a single county . Participants were assessed at home in 1995 - 1997 and again in 1998 - 2000 . A detailed visual inventory of medicines , including statins and other lipid-lowering agents , was collected at both assessment s. MAIN OUTCOME MEASURES Diagnosis of dementia and of AD . RESULTS From 4895 participants with data sufficient to determine cognitive status , we identified 355 cases of prevalent dementia ( 200 with AD ) at initial assessment . Statin use was inversely associated with prevalence of dementia ( adjusted odds ratio , 0.44 ; 95 % confidence interval , 0.17 - 0.94 ) . Three years later , we identified 185 cases of incident dementia ( 104 with AD ) among 3308 survivors at risk . Statin use at baseline did not predict incidence of dementia or AD ( adjusted hazard ratio for dementia , 1.19 ; 95 % confidence interval , 0.53 - 2.34 ; adjusted hazard ratio for AD , 1.19 ; 95 % confidence interval , 0.35 - 2.96 ) , nor did statin use at follow-up ( adjusted odds ratio for dementia , 1.04 ; 95 % confidence interval , 0.56 - 1.81 ; adjusted odds ratio for AD , 0.85 ; 95 % confidence interval , 0.32 - 1.88 ) . CONCLUSIONS Although statin use might be less frequent in those with prevalent dementia , we found no association between statin use and subsequent onset of dementia or AD . Further research is warranted before costly dementia prevention trials with statins are undertaken We investigated whether angiotensin II receptor blockers ( ARBs ) and angiotensin converting enzyme inhibitors ( ACE-Is ) are more strongly associated with Alzheimer 's disease ( AD ) , vascular dementia ( VaD ) , and other dementias , than other anti-hypertensive drugs . We conducted a nested case-control analysis within the UK general practice research data base , with prospect ively recorded anti-hypertensive prescribing data . We sample d cases aged ≥60 years and diagnosed between 1997 - 2008 ( 5,797 with AD , 2,186 with VaD , 1,214 with unspecified/other dementia ) which were matched to up to four controls by age , general practice and gender . We computed odds-ratios and dose response effects for AD , vascular and unspecified/other dementia , comparing those prescribed ARBs or ACE-Is for at least six months with patients prescribed other anti-hypertensives . We controlled for matching factors , co-morbidities , smoking status , an area measure of socioeconomic status , consultation rate and blood pressure and accounted for reverse causality by introducing time-lags of up to eight years prior to diagnosis/index date . Patients diagnosed with AD , vascular and unspecified/other dementia had fewer prescriptions for ARBs and ACE-Is . Inverse associations with AD were strongest for ARBs ( odds-ratio ; 0.47 , 95%CI , 0.37 - 0.58 ) compared with ACE-Is ( odds-ratio ; 0.76 , 95%CI , 0.69 - 0.84 ) ( p(difference ) < 0.001 ) . Associations of ARBs with AD were stronger than for vascular dementia ( p(difference ) = 0.01 ) and unspecified/other dementia ( p(difference ) = 0.23 ) . There were inverse dose-response relationships between ARBs and ACE-Is with AD ( both p(trend ) < 0.01 ) . The inverse association of ACE-Is with AD diminished when using longer time lags but the ARB-AD association persisted . Patients with AD were around half as likely to be prescribed ARBs . Further r and omized controlled trial evidence is required to rigorously test these findings BACKGROUND Dementia affects an estimated 10 % of the population older than 65 years . Because vascular and lipid-related mechanisms are thought to have a role in the pathogenesis of Alzheimer 's disease and vascular dementia , we did an epidemiological study of the potential effect of HMGCoA ( 3 hydroxy-3methylglutaryl-coenzyme A ) reductase inhibitors ( statins ) and other lipid-lowering agents on dementia . METHODS We used a nested case-control design with information derived from
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| CONCLUSION Current evidence indicates that antihypertensives and statins might reduce the incidence of dementia and AD . |
MS212319 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE : To compare induction of labor at gestational age 41 weeks with expectant management in regard to neonatal morbidity . Secondary aims were to assess the effect of these managements on mode of delivery and maternal complications . METHODS : Between September 2002 and July 2004 , postterm women with singleton cephalic presentation and no prelabor rupture of membranes were r and omly assigned to induction of labor at 289 days or antenatal fetal surveillance every third day until spontaneous labor . Main outcome measures were neonatal morbidity , operative delivery rates , and maternal complications . RESULTS : Five hundred eight women were r and omly assigned , 254 in each group . No differences of clinical importance were observed in women in whom labor was induced compared with women who were expectantly managed with regard to the following outcomes : neonates whose 5-minute Apgar score was less than 7 ( three neonates in the induction group compared with four in the monitoring group , P=.72 ) ; neonates whose umbilical cord pH was less than 7 ( three compared with two , P=.69 ) ; prevalence of cesarean delivery ( 28 compared with 33 , P=.50 ) ; or prevalence of operative vaginal delivery ( 32 compared with 27 , P=.49 ) . In the induction group more women had precipitate labors ( 33 compared with 12 , P<.01 ; number needed to treat was 13 ) , and the duration of second stage of labor was more often less than 15 minutes ( 94 compared with 56 , P<.01 ; number needed to treat was 7 ) . CONCLUSION : No differences were found between the induced and monitored groups regarding neonatal morbidity or mode of delivery , and the outcomes were generally good . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00385229 LEVEL OF EVIDENCE : OBJECTIVE To clarify the safety of elective induction of labor at 39 weeks of gestation . STUDY DESIGN Prospect i ve r and omized study . SUBJECTS AND METHODS Uncomplicated nulliparas ( N = 194 ) were r and omly assigned at 36 weeks of gestation . Labor was electively induced in 63 women at 39 weeks of gestation in the active management group ( I group , N = 98 ) . Spontaneous labor onset was expected with semi-weekly nonstress test ( NST ) and amniotic fluid index ( AFI ) by 42 weeks of gestation in the expectant group ( E group , N = 96 ) . Perinatal events were compared between the 2 groups . RESULTS A significantly higher incidence of meconium-stained amnios ( 19.4 % vs 3.2 % ) and fetal resuscitation ( 16.7 % vs 4.8 % ) was found in the E group than in the I group . Also , although a significantly higher incidence of epidural analgesia was noted in the I group ( 89 % ) than in the E group ( 54 % ) ( labor onset > or = 39 weeks , N = 72 ) , the duration of the 1st stage was shorter in I group and the duration of the 2nd stage was not significantly different . No other significant difference was noted between the 2 groups in terms of the rate of C-section , blood loss , incidence of pathological FHR , birth weight , Apgar score , umbilical arterial pH , or admission to NICU . CONCLUSION Active management of labor at 39 weeks could be made as safely as expectant management with modified biophysical profile monitoring OBJECTIVE Management of the uncomplicated pregnancy prolonged beyond the estimated date of confinement is controversial , particularly when the cervix is unfavorable for induction . The benefit of reducing potential fetal risk with induction of labor must be balanced against the morbidity associated with this procedure . The objective of this study was to compare two strategies for managing postterm pregnancy ( i.e. , immediate induction and expectant management ) . STUDY DESIGN Four hundred forty patients with uncomplicated pregnancies at 41 weeks ' gestation were r and omized to either immediate induction of labor ( n = 265 ) or expectant management ( n = 175 ) . Patients with expectant management underwent nonstress testing and amniotic fluid volume assessment twice per week . Patients in the induction group underwent induction within 24 hours of r and omization . To evaluate the efficacy of intracervical prostagl and in E2 gel , patients in the induction group were r and omized in a 2:1 scheme to receive either 0.5 mg prostagl and in E2 gel or placebo gel intracervically 12 hours before induction of labor with oxytocin . RESULTS The incidence of adverse perinatal outcome ( neonatal seizures , intracranial hemorrhage , the need for mechanical ventilation , or nerve injury ) was 1.5 % in the induction group and 1 % in the expectant management group ( p > 0.05 ) . There were no fetal deaths in either group . There were no differences in mean birth weight or the frequency of macrosomia ( birth weight > or = 4000 gm ) between the two groups ( p > 0.05 ) . Regardless of parity , prostagl and in E2 intracervical gel was not more effective than placebo in ripening the cervix . The cesarean delivery rate was not significantly different in the expectant ( 18 % ) , prostagl and in E2 gel ( 23 % ) , or placebo gel ( 18 % ) groups . CONCLUSIONS Adverse perinatal outcome in otherwise uncomplicated pregnancies of > or = 41 weeks is very low with either of the management schemes described . Thus from the perspective of perinatal morbidity or mortality either management scheme is acceptable In 345 women with a favorable cervical score at due date , labor was either induced by means of intravaginal application of tablets containing 3 mg of prostagl and in E2 or spontaneous onset of labor was awaited until the 42nd week of pregnancy . Eighty percent of the nulliparae and 96.3 % of the multiparae of the induction group gave birth within 24 h of the administration of the first tablet . All pertinent delivery intervals were significantly shorter in this group compared to those women where spontaneous onset of labor was awaited . The rate of operative deliveries was lower in the induction group . With the exception of 1 fetal death 3 days after due date , fetal outcome was excellent in both groups . Elective induction was at least equivalent to awaiting the onset of spontaneous labor and was not associated with higher complication rates due to the method of induction Labor characteristics after intracervical application of 0.5 mg prostagl and in ( PG ) E2 gel ( n = 83 ) versus intravenous administration of oxytocin ( n = 82 ) for labor induction were investigated in uncomplicated prolonged pregnancies with unripe cervix . The induction to delivery time as well as the total oxytocin dose were significantly reduced in the PGE2 group ( p < 0.001 ) . Cesarean sections , instrumental deliveries and fetal distress had the same frequency , but the failures of trial were significantly higher in the oxytocin group than in the PGE2 group ( 20.7 vs. 6 % , p < 0.01 ) . Twenty-four percent of women needed a second PGE2 dose , and almost half of the women in the PGE2 group experienced ' spontaneous ' labor . More neonates in the oxytocin group had 5-min Apgar scores < 7 ( p < 0.05 ) . Intracervical PGE2 gel application is superior to intravenous oxytocin in terms of shortening the induction-delivery interval and increasing the frequency of successful vaginal delivery . In addition , it is safe for mother and fetus Two hundred consecutive women with uncomplicated pregnancies , at or within 4 days of their expected date of confinement , were prospect ively r and omized into 2 groups . One group had expectant management , with twice weekly surveillance tests , while the other group had 3 mg of vaginal prostagl and in E2 as outpatient treatment . There were 104 women in the expectant group and 70 in the induction group ( 26 women allocated to induction preferred no treatment ) . The average number of days to delivery was 1.6 in the induction group and 5.2 in the expectant group ( p < 0.001 ) . While meconium was much less frequent in the induction group ( p < 0.002 ) , all other outcome measures , including cesarean section rates , incidence of macrosomia , and Apgar scores , were similar in the two groups A prospect i ve r and omized controlled trial design ed to investigate selective planned delivery is reported : 264 obstetrically normal women in the 38th week of pregnancy were admitted to this trial and 184 completed it . The infants of mothers in the planned delivery group had higher serum bilirubin levels on the fifth day post partum than control infants but no baby required treatment for hyperbilirubinaemia . Mothers in the planned delivery group required significantly greater amounts of pethidine while control mothers had a significantly higher incidence of meconium staining of the amniotic fluid . However , the infants in the two groups had similar Apgar scores at birth . There was one stillbirth in the control group ; this was due to unrecognized fetal hypoxia during labour induced at 42 weeks for postmaturity In a prospect i ve r and omized study , pregnancies with unfavorable cervix and well established gestational age of at least 42 weeks were selected for management by either antepartum fetal testing or prostagl and in gel induction of labor . Of the 108 pregnancies studied , 57 ( 53 % ) had labor induced and 51 ( 47 % ) continued without intervention . Comparison of the two groups showed no difference in meconium staining , fetal distress , length of first stage of labor , the need for intervention , or the mode of delivery . In terms of Apgar score the neonatal outcome was not significantly different but a greater proportion of the babies ( 7.8 % versus 1.8 % ) in the noninduced group required intubation . Our data show that there is no particular advantage in letting the pregnancy go beyond 42 completed weeks of gestation especially if prostagl and in is available for induction of labor OBJECTIVE To study the cesarean rate between expectant management and immediate induction in the otherwise uncomplicated postterm pregnancy with favorable cervix . STUDY DESIGN A total of 249 women with uncomplicated pregnancies at 41 weeks plus 3 days ( 290 days ) with favorable cervix ( Bishop score > or = 6 ) were r and omized to either expectant management ( n=125 ) or immediate induction of labor ( n=124 ) . The women in the induction group were sent to labor ward for induction by artificial rupture of membranes ( ARM ) and /or oxytocin infusion . The women with expectant management had nonstress test ( NST ) and amniotic fluid index ( AFI ) performed once a week and twice a week after 43 weeks of gestation until spontaneous labor . RESULTS The cesarean rate was not different between expectant management and immediate induction ( 21.6 % versus 26.6 % ; P=0.36 ) . Ninety-five percent of the expectant group delivered within 1 week after enrollment , and all of them delivered within 9 days after r and omization . Maternal and fetal complications in both groups were not different . There was also no difference in the mean birth weight ( P=0.24 ) and the frequency of macrosomia ( birth weight > or = 4000 g ) between the two groups ( P=0.23 ) . CONCLUSION Cesarean section rate between expectant management and immediate induction in the otherwise uncomplicated postterm pregnancy with favorable cervix was not different . Due to the very low adverse perinatal outcome , both expectant management and immediate induction are acceptable Objecfive To determine the proper management of pregnancy in uncomplicated cases going beyond 42 weeks Objective To assess the efficacy of sweeping of membranes beyond 40 weeks of gestation in reducing the incidence of induction of labour , when induction was planned at 42 weeks Background British women are increasingly delaying childbirth . The proportion giving birth over the age of 35 rose from 12 % in 1996 to 20 % in 2006 . Women over this age are at a higher risk of perinatal death , and antepartum stillbirth accounts for 61 % of all such deaths . Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks . Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk . In a national survey of obstetricians 37 % already induce women aged 40–44 years . A substantial minority of parents support such a policy , but others do not on the grounds that it might increase the risk of Caesarean section . However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections , rather the reverse . If induction for women over 35 did not increase Caesareans , or even reduced them , it would plausibly improve perinatal outcome and be an acceptable intervention . We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates . This trial is funded by the NHS Research for Patient Benefit ( RfPB ) Programme . Design The 35/39 trial is a multi-centre , prospect i ve , r and omised controlled trial . It is being run in twenty UK centres and we aim to recruit 630 nulliparous women ( 315 per group ) aged over 35 years of age , over two years . Women will be r and omly allocated to one of two groups : Induction of labour between 390/7 and 396/7weeks gestation . Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessit
Output:
| However , operative vaginal birth was more common in the inductions at < 41 weeks ' gestation subgroup compared with inductions at later gestational ages .
A policy of labour induction at or beyond term compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections ; but more operative vaginal births .
NICU admissions were lower and fewer babies had low Apgar scores with induction . |
MS212320 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Sharing information with the team is critical in developing a shared mental model in an emergency , and fundamental to effective teamwork . We developed a structured call-out tool , encapsulated in the acronym ' SNAPPI ' : Stop ; Notify ; Assessment ; Plan ; Priorities ; Invite ideas . We explored whether a video-based intervention could improve structured call-outs during simulated crises and if this would improve information sharing and medical management . METHODS In a simulation-based r and omized , blinded study , we evaluated the effect of the video-intervention teaching SNAPPI on scores for SNAPPI , information sharing , and medical management using baseline and follow-up crisis simulations . We assessed information sharing using a probe technique where nurses and technicians received unique , clinical ly relevant information probes before the simulation . Shared knowledge of probes was measured in a written , post-simulation test . We also scored sharing of diagnostic options with the team and medical management . RESULTS Anaesthetists ' scores for SNAPPI were significantly improved , as was the number of diagnostic options they shared . We found a non-significant trend to improve information-probe sharing and medical management in the intervention group , and across all simulations , a significant correlation between SNAPPI and information-probe sharing . Of note , only 27 % of the clinical ly relevant information about the patient provided to the nurse and technician in the pre-simulation information probes was subsequently learnt by the anaesthetist . CONCLUSIONS We developed a structured communication tool , SNAPPI , to improve information sharing between anaesthetists and their team , taught it using a video-based intervention , and provide initial evidence to support its value for improving communication in a crisis It is important to underst and the effects of a new care model on health professionals ' satisfaction , which may help inform organizations ' decisions regarding the adoption of the model . This study evaluates the effect of the Guided Care model of primary care on physicians ' , Guided Care Nurses ' and practice staff satisfaction with processes of care for chronically ill older patients . In Guided Care , a specially educated registered nurse works with 2 - 5 primary care physicians , performing 8 clinical activities for 50 - 60 chronically ill older patients . This model was tested in a 3-year matched-pair cluster-r and omized controlled trial with 14 pods ( teams of physicians and staff ) r and omly assigned , within pairs , to provide Guided Care or usual care . Physicians and Guided Care Nurses were surveyed at baseline and annually for 3 years . Staff were surveyed at baseline and 2 years later . Physicians ' satisfaction with chronic care processes , knowledge of patients , and care coordination were measured , as well as Guided Care Nurses ' satisfaction with chronic care processes and staff perceptions of quality of care . Findings suggest that Guided Care improved physician satisfaction with patient/family communication and management of chronic care , and it may bolster staff beliefs that care is patient oriented . Differences in other aspects of care were not statistically significant BACKGROUND Previous research has shown that communication between members of multidisciplinary teams ( MDTs ) is often suboptimal and communication about trials between MDTs and their patients is difficult . Educational interventions can help dyadic exchanges with different aspects of trial recruitment but less work has focussed on team interventions . METHODS 22 multidisciplinary cancer teams in the UK participated in an RCT of a novel Teams Talking Trials ( TTT ) Workshop aim ed at improving the following : awareness , involvement , communication and recruitment to cancer trials . MDTs were r and omised following either 6 or 12 months of audits , which were repeated after the intervention . Audits included numbers approached about trials , team members ' attitudes , involvement and awareness of their teams ' trial portfolios . RESULTS There was no significant difference in the rate of approaching patients about trials post workshop ( estimated improvement 22 % higher regression coefficient of 0.2 , exp . (0.2)=1.22 ) . There was improvement in team members ' involvement in trials in 4 areas ( p≤0.04 ) : the pressure to enter patients into RCTs , the likelihood of a start-up meeting to discuss a newly accepted trial , the informational role played by individuals and recognition of this HCP 's role by other team members . Also , confidence in communication about RCTS increased and awareness of different aspects of trial management improved on all 14 aspects ( p=0.001 ) . CONCLUSION Attendance by teams at focussed workshops design ed to enhance communication and trial recruitment improved several aspects of team functioning , but a significant impact on the number of patients approached could not be demonstrated Background Crew re source management ( CRM ) has the potential to enhance patient safety in intensive care units ( ICU ) by improving the use of non-technical skills . However , CRM evaluation studies in health care are inconclusive with regard to the effect of this training on behaviour and organizational outcomes , due to weak study design s and the scarce use of direct observations . Therefore , the aim of this study is to determine the effectiveness and cost-effectiveness of CRM training on attitude , behaviour and organization after one year , using a multi- method approach and matched control units . The purpose of the present article is to describe the study protocol and the underlying choices of this evaluation study of CRM in the ICU in detail . Methods / Design Six ICUs participated in a paired controlled trial , with one pre-test and two post test measurements ( respectively three months and one year after the training ) . Three ICUs were trained and compared to matched control ICUs . The 2-day classroom-based training was delivered to multidisciplinary groups . Typical CRM topics on the individual , team and organizational level were discussed , such as situational awareness , leadership and communication . All levels of Kirkpatrick 's evaluation framework ( reaction , learning , behaviour and organisation ) were assessed using question naires , direct observations , interviews and routine ICU administration data . Discussion It is expected that the CRM training acts as a generic intervention that stimulates specific interventions . Besides effectiveness and cost-effectiveness , the assessment of the barriers and facilitators will provide insight in the implementation process of CRM.Trial registration Netherl and s Trial Register ( NTR ) : Promotoras from the communities in which interventions are implemented can be effective contributors to validity and fidelity efforts . This article describes a 48-week r and omized controlled trial Madres para la Salud ( Mothers for Health ) and illustrates the use of promotoras as collaborative members of the research team to contribute to attaining integrative validity and treatment fidelity . Madres para la Salud implements a culturally tailored physical activity program to effect changes in body fat , systemic and fat tissue inflammation , and depression symptoms . The significance of Madres para la Salud treatment validity and fidelity processes includes cultural tailoring of a social support intervention , and a promotora model to incorporate initial and ongoing fidelity monitoring OBJECTIVE The aim of the study was to evaluate the interprofessional SDM training program " Fit for SDM " in medical rehabilitation , which was implemented in two steps : ( 1 ) university staff trained providers in executive positions as trainers and ( 2 ) the providers trained their staff . METHODS For the evaluation of the first step a question naire for shared decision-making ( SDM ) skills and satisfaction with the training was completed by the providers in executive positions . A staff survey was used in a cluster-r and omized controlled study to determine the overall impact of the train-the-trainer program on internal and external participation in the team . RESULTS The providers in the six clinics evaluated their SDM competences and satisfaction very positively after training ( step 1 ) . External participation was enhanced by application of the training content , with significant changes recorded for females and nurses in particular . However , it had no direct influence on internal participation . CONCLUSIONS This is the first interprofessional SDM train-the-trainer program in Germany to bridge interprofessionalism ( internal participation ) and SDM ( external participation ) ; it was implemented successfully and evaluated positively . PRACTICE IMPLICATION S Establishing interprofessional SDM training programs should be encouraged for all health care professionals . Implementation in the interprofessional setting should consider interprofessional team factors There is evidence for a team-based approach in the management of chronic disease in primary health care . However , the st and ard of care is variable , probably reflecting the limited organisational capacity of health services to provide the necessary structured and organised care for this group of patients . This study aim ed to evaluate the impact of a structured intervention involving non-GP staff in GP practice s on the quality of care for patients with diabetes or cardiovascular disease . A cluster r and omised trial was undertaken across 60 GP practice s. The intervention was implemented in 30 practice s with staff and patients interviewed at baseline and at 12 - 15 months follow up . The change in team roles was evaluated using a question naire completed by practice staff . The quality of care was evaluated using the Patient Assessment of Chronic Illness Care question naire . We found that although the team roles of staff improved in the intervention practice s and there were significant differences between practice s , there was no significant difference between those in the intervention and control groups in patient-assessed quality of care after adjusting for baseline-level score and covariates at the 12-month follow up . Practice team roles were not significantly associated with change in Patient Assessment of Chronic Illness Care scores . Patients with multiple conditions were more likely to assess their quality of care to be better . Thus , although previous research has shown a cross-sectional association between team work and quality of care , we were unable to replicate these findings in the present study . These results may be indicative of insufficient time for organisational change to result in improved patient-assessed quality of care , or because non-GP staff roles were not sufficiently focussed on the aspects of care assessed . The findings provide important information for research ers when design ing similar studies IMPORTANCE Hospital readmissions are common and costly , and no single intervention or bundle of interventions has reliably reduced readmissions . Virtual wards , which use elements of hospital care in the community , have the potential to reduce readmissions , but have not yet been rigorously evaluated . OBJECTIVE To determine whether a virtual ward-a model of care that uses some of the systems of a hospital ward to provide interprofessional care for community-dwelling patients -can reduce the risk of readmission in patients at high risk of readmission or death when being discharged from hospital . DESIGN , SETTING , AND PATIENTS High-risk adult hospital discharge patients in Toronto were r and omly assigned to either the virtual ward or usual care . A total of 1923 patients were r and omized during the course of the study : 960 to the usual care group and 963 to the virtual ward group . The first patient was enrolled on June 29 , 2010 , and follow-up was completed on June 2 , 2014 . INTERVENTIONS Patients assigned to the virtual ward received care coordination plus direct care provision ( via a combination of telephone , home visits , or clinic visits ) from an interprofessional team for several weeks after hospital discharge . The interprofessional team met daily at a central site to design and implement individualized management plans . Patients assigned to usual care typically received a typed , structured discharge summary , prescription for new medications if indicated , counseling from the resident physician , arrangements for home care as needed , and recommendations , appointments , or both for follow-up care with physicians as indicated . MAIN OUTCOMES AND MEASURES The primary outcome was a composite of hospital readmission or death within 30 days of discharge . Secondary outcomes included nursing home admission and emergency department visits , each of the components of the primary outcome at 30 days , as well as each of the outcomes ( including the composite primary outcome ) at 90 days , 6 months , and 1 year . RESULTS There were no statistically significant between-group differences in the primary or secondary outcomes at 30 or 90 days , 6 months , or 1 year . The primary outcome occurred in 203 of 959 ( 21.2 % ) of the virtual ward patients and 235 of 956 ( 24.6 % ) of the usual care patients ( absolute difference , 3.4 % ; 95 % CI , -0.3 % to 7.2 % ; P = .09 ) . There were no statistically significant interactions to indicate that the virtual ward model of care was more or less effective in any of the prespecified subgroups . CONCLUSIONS AND RELEVANCE In a diverse group of high-risk patients being discharged from the hospital , we found no statistically significant effect of a virtual ward model of care on readmissions or death at either 30 days or 90 days , 6 months , or 1 year after hospital discharge . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01108172 A project based at the Alfred Emergency and Trauma Centre in Melbourne , Australia aim ed to st and ardise trauma resuscitation , documentation and interventions by developing best practice algorithms . The primary study objective was to demonstrate a reduction in management errors using a real-time computer based algorithm ( the study group ) compared to the control group in an open r and omised controlled interventional study . A baseline control group was also used for comparison with usual ( current ) practice . In order to examine the existing evidence and algorithms in trauma care , nine teams of emergency nurses and doctors were formed . Specific literature search es performed by each team revealed a paucity of evidence supporting clinical practice in the trauma setting for procedures . Subsequently , the multidisciplinary teams worked together and developed algorithms based on best practice . The process revealed three main areas of challenges in the development of algorithms : ( i ) clinical , ( ii ) research and ( iii ) nursing challenges . The completion of the project demonstrated benefits in the real-time computer based algorithm with a reduction in the error rate per patient from the baseline control group to the intervention study group ( 2.30 vs. 2.13 , p=0.04 ) and error-free resuscitations increasing from 16 % to 21.8 % ( p=.049 ) . This project supported the implementation of a real-time computer based algorithm system with improved protocol compliance and reduced errors and morbidity Background There are many avoidable deaths in hospitals because the care team is not well attuned . Training in emergency situations is generally followed on an individual basis . In practice , however , hospital patients are treated by a team composed of various disciplines . To prevent communication errors , it is important
Output:
| Compared to multidisciplinary audio conferencing , multidisciplinary video conferencing may reduce the average length of treatment and may reduce the number of multidisciplinary conferences needed per patient and the patient length of stay .
Given that the certainty of evidence from the included studies was judged to be low to very low , there is not sufficient evidence to draw clear conclusions on the effects of IPC interventions . |
MS212321 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review OBJECTIVES To evaluate the effectiveness of a back school program in pain , functional status , quality of life , and in anxiety and depression in patients with non-specific low back pain . METHODS Sixty patients with low back pain were r and omized to an intervention and control group . The intervention group underwent a five-weekly back school program . The control group was seen in weekly medical visits , without educative approaches . Both groups took acetaminophen as analgesic medication . All subjects were evaluated by a blind physiotherapist after r and omization , 30 , 60 and 120 days . Roll and -Morris , SF-36 , STAI and Beck question naires , pain visual analogical scale and Schober 's test were applied . Non-steroidal anti-inflammatory drugs ( NSAID ) consumption was considered co-intervention . The statistical analyses were performed using Pearson 's Chi-Square analysis and Student 's t-test to compare the baseline characteristics of the groups and the analysis of variance ( ANOVA ) with repeated measures to assess changes inter/intra groups . RESULTS There were no significant differences in the baseline characteristics between the two groups . Fifty-five patients completed the study . The intervention group showed a significant improvement in the general health domain , assessed by SF-36 , and also in the reduction of acetaminophen and NSAID intake . There was no significant difference between the groups in pain , functional status , anxiety or depression . CONCLUSION The back school program was more effective than any educational intervention in general health status and in decreasing acetaminophen and NSAID intake . It was ineffective in the other quality of life domains , in pain , functional status , anxiety and depression In a prospect i ve trial , 222 adults with low-back pain of at least 2 weeks ' duration in a Health Maintenance Organization ( HMO ) were r and omly assigned to usual care ( UC ) , a 4-hour back school psychoeducational session ( LBS ) , or the same back school plus a 1-year “ compliance package ” program design ed to encourage appropriate self-management for back pain ( CP ) . Sixty-four percent of LBS and CP subjects attended their back school sessions . Follow-up measurement of pain level ( using the Visual Analogue Scale ) , functional status ( using the Sickness Impact Profile ) , and various other indicators of health status showed no measurable effect of either treatment condition ( LBS or CP ) compared with UC at 3 , 6 , 12 , and 18 months after entry into the study . Initial disability resolved by 3 months in most patients , and a minority of subjects ( 10–15 % ) showed residual or recurrent functional Impairment 1 year after entry . Health care utilization tended to be slightly higher after intervention In the CP group . With or without follow-up encouragement , back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO Background Different interventions can reduce the burden of the chronic low back pain . One example is the use of a ' Back School Programme ' . This is a brief therapy that uses a health education method to empower participants through a procedure of assessment , education and skill development . This study aim ed to evaluate to what extent the programme could improve quality of life in those who suffer from the condition . Methods This was a r and omized controlled trial . One-hundred and two female patients with low back pain ( n = 102 ) were r and omly allocated into two groups , matched in terms of age , weight , education , socioeconomic status , occupation and some aspects of risk behavior . Group 1 ( back school group , n = 50 ) but not group 2 ( clinic group , n = 52 ) received the ' Back School Programme ' . Then quality of life using the Short Form Health Survey ( SF-36 ) was assessed at two time points : at baseline and at three months follow-up . The findings were compared both within and between two groups . Results The ' Back School Programme ' was effective in improving patients ' quality of life ; significant differences were found on all eight subscales of the SF-36 for group 1 . In the clinic group ( group 2 ) , improvement was observed on three scales ( bodily pain , vitality and mental health ) but these improvements were less than in group 1 . The mean improvement over all eight subscales of the SF-36 was significantly better for the ' Back School Programme ' group . Conclusion The ' Back School Programme ' is an effective intervention and might improve the quality of life over a period of 3 months in patients who experience chronic low back pain The purpose of this study was to assess the effects of two different treatment modalities on the rehabilitation process of chronic sacroiliac joint patients . The treatment modalities included spinal manipulative therapy given by a chiropractor and a program of back school therapy given by a physiotherapist . The rehabilitation process was assessed using clinical and biomechanical measures . It was found that back school therapy was a better treatment modality than the spinal manipulative therapy , according to the clinical measures of rehabilitation . Precisely the opposite result was found for the biomechanical measures The aim of this trial was to determine whether social interaction between patients with long-lasting nonspecific back pain reduces subjective or objective disability . The participants were selected from persons visiting an occupational health care unit because of back pain . After a clinical examination in a university clinic , subjects without a specific diagnosis and having no disabilities preventing active rehabilitation were selected for study . The subjects ( n = 108 ) were r and omized into treatment ( n = 54 ) and control groups ( n = 54 ) . Altogether 18 study groups , 9 treatment groups and 9 groups for controls , were formed . Before starting the back schools altogether 15 subjects dropped out . Both the treatment groups ( n = 47 ) and the controls ( n = 46 ) attended a back school consisting of 10 lessons and demonstrations supervised by a physiotherapist . The participants in treatment groups , but not the controls , had physical exercise and social intercourse with other members within the group . The clinical examination was repeated after 6 and 12 months . Both the treatment groups and the controls showed improvement in perceived functional capacity ( assessed with Oswestry disability question naire ) and in perceived life quality ( assessed with 15D score ) . At the 6-month follow-up life quality had improved statistically significantly more among the participants in treatment groups than among the controls , and at the 12-month follow-up the Oswestry index showed corresponding improvement . Among subjects suffering from nonspecific back pain , social support improves the results of active rehabilitation 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 Study Design . R and omized controlled trial . Objectives . To compare high- and low-intensity back schools with usual care in occupational health care . Summary of Background Data . The content and intensity of back schools vary widely and the method ologic quality of r and omized controlled trials is generally weak . Until now , no back school has proven to be superior for workers sick-listed because of subacute nonspecific low back pain . Methods . Workers ( n = 299 ) sick-listed for a period of 3 to 6 weeks because of nonspecific low back pain were recruited by the occupational physician and r and omly assigned to a high-intensity back school , a low-intensity back school , or care as usual . Outcome measures were days until return to work , total days of sick-leave , pain , functional status , kinesiophobia , and perceived recovery and were assessed at baseline and at 3 and 6 months of follow-up . Principal analyses were performed according to the intention-to-treat principle . Results . We r and omly allocated 299 workers . Workers in the low-intensity back school returned to work faster compared with usual care and the high-intensity back school , with hazard ratios of 1.4 ( P = 0.06 ) and 1.3 ( P = 0.09 ) , respectively . The comparison between high-intensity back school and usual care result ed in a hazard ratio of 1.0 ( P = 0.83 ) . The median number of sick-leave days was 68 , 75 , and 85 in the low-intensity back school , usual care , and high-intensity back school , respectively . Beneficial effects on functional status and kinesiophobia were found at 3 months in favor of the low-intensity back school . No substantial differences on pain and perceived recovery were found between groups . Conclusions . The low-intensity back school was most effective in reducing work absence , functional disability , and kinesiophobia , and more workers in this group scored a higher perceived recovery during the 6-month follow-up Low back injury is the leading cause of compensable injury . A National Health Objective for the year 2000 is to increase to at least 50 % the number of worksites offering back injury protection programs . The 6 week Back School intervention included exercise and education . A portion of the sample of 74 back injured municipal employees also was assigned r and omly to a counseling intervention . Pre-intervention and post-intervention testing revealed significant posttest increases in back strength and flexibility . Significant improvements also were noted in psychological well being , depression , anxiety , and perceptions of pain . No significant differences were found , on any of the measures , between employees who did and who did not receive the counseling intervention . Method ological concerns relate to the possibility of sampling bias and instrumentation . Future research with control groups is needed , as well as the testing of interventions that may be both effective and require less work release time Inpatient and outpatient treatments were compared with a control intervention in 288 men and 168 women , aged 35 - 54 , who were at work , but suffered from chronic or recurrent low back pain . Physical measurements and back pain assessment s were carried out before the intervention and at a 3-month follow-up . Physical fitness improved most in the in patients , but the out patients did not differ from the controls . Correlations between back pain and physical measurements indicated that increase of lumbar and hip mobility was more important than increase of trunk strength for subjective progress in these patients . Increased trunk extension strength correlated significantly with subjective progress in women , who also had higher correlations between improved physical fitness and progress than men Ninety-two chronic low back pain patients were r and omly allocated to two groups to evaluate the effectiveness of a back school compared with an exercise-only regimen according to specified outcome variables . The data from 78 patients with 7 years mean duration of symptoms was analyzed . Three assessment s were made : before treatment and 6 and 16 weeks after treatment . Changes in patients ' levels of pain , functional disability , and other related variables were compared in the two groups . Almost all variables showed an improvement at 6 weeks . At 16 weeks , functional disability and pain levels showed a significant difference . Back school patients continued to make an improvement . This method of managing low back pain makes maximal use of limited re sources and appears to be effective , especially in the longer term OBJECTIVE To assess the efficacy of a back school program for patients with a first episode of acute work-related low back pain requiring compensation . DESIGN A r and omized single-blind controlled trial . SETTING A private physiatrics outpatient clinic . PATIENTS The mean duration of low back pain was 15 days . INTERVENTION Eligible patients were r and omized to a st and ard treatment program that included daily physiotherapy ( n = 86 ) or the same program with the addition of back school ( n = 82 ) . The back school program consisted of three 90-minute sessions given by a single trained instructor at 0 , 1 , and 8 weeks . MAIN OUTCOME MEASURES The primary outcomes were the time off work for the presenting episode of back pain and the number and duration of recurrences in the year following the study onset . Secondary
Output:
| The results indicate that there is very low quality evidence that back schools are no more effective than a placebo ( or sham or attention control ) or another treatment ( physical therapies , myofascial therapy , joint manipulations , advice ) on pain , disability , work status and adverse events at short-term , intermediate-term and long-term follow-up .
There is very low quality evidence that shows a statistically significant difference between back schools and a placebo ( or sham or attention control ) for return to work at short-term follow-up in favour of back school .
Very low quality evidence suggests that back school added to a back care programme is more effective than a back care programme alone for disability at short-term follow-up .
Very low quality evidence also indicates that there is no difference in terms of adverse events between back school and myofascial therapy , joint manipulation and combined myofascial therapy and joint manipulation .
AUTHORS ' CONCLUSIONS It is uncertain if back schools are effective for acute and subacute non-specific LBP as there is only very low quality evidence available . |
MS212322 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Few studies have evaluated the prevention of upper gastrointestinal complications ( UGIC ; bleeding or perforation ) in patients with uncomplicated peptic ulcer ( PU ) . We assessed the effect of proton pump inhibitors ( PPI ) in a non-r and omized setting . To maximize exchangeability of exposed and unexposed groups we restricted the study to patients with a new diagnosis of PU , i.e. , a clear indication . To minimize selection bias we mimicked an intention to treat approach by assessing the effect of PPI prescription after PU diagnosis . Methods Within a population of subjects aged 40–84 years from The Health Improvement Network data base , 1997–2006 , we identified 3,850 patients with incident PU . Among them , we confirmed 74 first UGIC episodes during a mean follow-up of 4 years . Exposure was prescription coverage during the month following PU diagnosis . We performed a nested case – control analysis and compared UGIC cases with 400 controls matched for age , sex , year and duration of follow-up . Relative risks ( RR ) and 95 % confidence intervals ( CI ) were estimated . Results The overall incidence of UGIC was 4.6 cases/1,000 person-years ; it was highest during the months after PU diagnosis , increased with age , and it was higher in men and subjects with Helicobacter pylori infection , anemia , and alcohol use at PU diagnosis . The RR for UGIC associated with PPI prescriptions during the month after PU diagnosis was 0.56 ( 95 % CI 0.31–1.0 ) . The RR for NSAIDs with and without a PPI was 1.72 ( 0.68–4.45 ) and 3.27 ( 0.85–12.67 ) , respectively . Conclusions Findings suggest that prescription of PPIs after a PU diagnosis is associated with a reduced risk of UGIC Background Emergency surgery or transarterial embolization ( TAE ) are options for the treatment of recurrent or refractory nonvariceal upper gastrointestinal bleeding . Surgery has the disadvantage of high rates of postoperative morbidity and mortality . Embolization has become more available and has the advantage of avoiding laparotomy in this often unfit and elderly population . Objective To carry out a systematic review and meta- analysis of all studies that have directly compared TAE with emergency surgery in the treatment of major upper gastrointestinal bleeding that has failed therapeutic upper gastrointestinal endoscopy . Methods A literature search of Ovid MEDLINE , Embase , and Google Scholar was performed . The primary outcomes were all-cause mortality and rates of rebleeding . The secondary outcomes were length of stay and postoperative complications . Results A total of nine studies with 711 patients ( 347 who had embolization and 364 who had surgery ) were analyzed . Patients in the TAE group were more likely to have ischemic heart disease ( odds ratio [ OR ] = 1.99 ; 95 % confidence interval [ CI ] : 1.33 , 2.98 ; P=0.0008 ; I2=67 % [ r and om effects model ] ) and be coagulopathic ( pooled OR = 2.23 ; 95 % CI : 1.29 , 3.87 ; P=0.004 ; I2=33 % [ fixed effects model ] ) . Compared with TAE , surgery was associated with a lower risk of rebleeding ( OR = 0.41 ; 95 % CI : 0.22 , 0.77 ; P<0.0001 ; I2=55 % [ r and om effects ] ) . There was no difference in mortality ( OR = 0.70 ; 95 % CI : 0.48 , 1.02 ; P=0.06 ; I2=44 % [ fixed effects ] ) between TAE and surgery . Conclusion When compared with surgery , TAE had a significant increased risk of rebleeding rates after TAE ; however , there were no differences in mortality rates . These findings are subject to multiple sources of bias due to poor quality studies . These findings support the need for a well- design ed clinical trial to ascertain which technique is superior This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy ( ASGE ) prepared this text . In preparing this guideline , a search of the medical literature was performed by using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When few or no data exist from well- design ed prospect i ve trials , emphasis is placed on results from large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations are based on review ed studies and are grade d on the quality of the supporting evidence ( Table 1 ) . The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms . Weaker recommendations are indicated by phrases such as ‘ ‘ we suggest , ’ ’ whereas stronger recommendations are typically stated as ‘ ‘ we recommend . ’ ’ This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients . This guideline is not a rule and should not be construed as establishing a legal st and ard of care or as encouraging , advocating , requiring , or discouraging any particular treatment . Clinical decisions in any particular case involve a complex analysis of the patient ’s condition and available courses of action . Therefore , clinical considerations may lead an endoscopist to take a course of action that varies from this guideline . Upper GI endoscopy has largely replaced upper GI barium x-ray series for the evaluation of upper GI tract disease or symptoms because it allows direct visualization , tissue acquisition , and therapeutic interventions . This guideline is an up date of a previous ASGE document and defines the role of upper GI endoscopy in the OBJECTIVES Primary : to assess the necessity of a second endoscopy with a pathology study to confirm the healing of all gastric ulcers previously diagnosed through endoscopy in a population at intermediate risk for gastric cancer . Secondary : to assess correlation between endoscopic findings and pathology diagnosis . PATIENTS AND METHODS a prospect i ve analysis of patients diagnosed with gastric ulcer through endoscopy at Hospital General de Ciudad Real ( Spain ) over three years . We collected demographic , clinical , endoscopic , and pathological data for the first and subsequent endoscopies . We collected at least six biopsies obtained from ulcer margins , and assessed H. pylori infection . RESULTS Three hundred and two patients were included in this study . H. pylori infection was diagnosed in 173 ( 57 % ) , and 113 ( 37 % ) patients had used NSAIDs . The positive and negative predictive value for malignancy of endoscopic diagnosis regarding ulcer fold , base , and margins were 34 and 97 % , respectively . Only one patient was diagnosed with a tumor during the second endoscopy . At the end of follow-up , the etiology of the ulcer was considered as peptic in 276 patients ; Crohn s disease-related in one , and neoplastic in 25 patients ( 21 adenocarcinomas , 4 lymphomas ) . CONCLUSIONS in an intermediate-risk population for gastric cancer a second endoscopy is not justified for gastric ulcer patients when endoscopy and biopsy results do not suggest malignancy 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 . Abstract Objective . Morbidity and mortality following perforated peptic ulcer ( PPU ) remain substantial . In the recently published PULP trial , 30-day mortality in patients surgically treated for PPU decreased from 27 % to 17 % following the implementation of a perioperative care protocol based on The Surviving Sepsis Guidelines . The objective of the present study was to evaluate long-term mortality in the PULP trial intervention and control cohort . Material and methods . Design : nationwide follow-up study of a multicenter , non-r and omized , clinical trial with external controls . Setting : Danish patients surgically treated for PPU between 1 January 2008 and 31 December 2009 . Patients : 117 patients in the intervention group and 512 in the control group . Intervention : a perioperative care protocol based on The Surviving Sepsis Guidelines . Outcome measures : 60-day , 90-day , 180-day , 1-year , and 2-year mortality rates . Statistical analysis : survival statistics . Results . Baseline characteristics , clinical , and perioperative data were in general , similar in the intervention and control group . Sixty days postoperatively , the originally observed difference in 30-day mortality had diminished ( 25 % vs. 30 % , p = 0.268 ) . After 180 days , the mortality difference was reduced additionally ( 31 % vs. 33 % , p = 0.645 ) , and one year postoperatively , a mortality difference was no longer present ( 36 % in both groups , p = 0.993 ) . Two years postoperatively , the mortality rate in the intervention group was 44 % , as compared to 40 % in the control group ( p = 0.472 ) . Conclusions . The survival benefit associated with a perioperative care protocol in patients treated for PPU decreases progressively after 30 days and is no longer present after one year . Registration number : NCT00624169 ( http://www . clinical trials.gov ) BACKGROUND AND AIM This prospect i ve cohort observational study , set in a district hospital , presents our experience ( 1976 - 1993 ) of duodenal ulcer refractory to histamine H2 receptor antagonists ( defined as not healed after 3 months ' treatment ) and comments on onset , outcome and spontaneous decline . METHODS Patients were treated mainly with cimetidine , the dose being titrated ( up to 3.2 g daily ) according to response , and followed by serial check endoscopy and clinical assessment . RESULTS A total of 782 of the 4032 duodenal ulcer patients seen ( 19 % ) were refractory ; the incidence declined over time : 1976 - 1978 : 124/379 ( 33 % ) ; 1979 - 1983 : 390/1240 ( 31 % ) ; 1984 - 1988 : 190/1295 ( 15 % ) ; 1989 - 1993 : 78/1118 ( 7 % ) . A total of 344 were refractory for the first time on their first healing course and 174 on their second . Healing was achieved in two-thirds after a mean of 7 months ' treatment with cimetidine 1 g ; treatment for 12 - 18 months with higher doses was needed in the remainder . Relapse occurred in up to three-quarters of patients despite maintenance cimetidine up to 3 g daily . Eventually 47 patients were operated upon but good results ( i.e. , no ulcer , no symptoms ) were achieved in only 11 . CONCLUSION Refractoriness was common until recently . Its incidence has declined dramatically , the fall preceding the newer more powerful treatment with proton pump inhibitors and with Helicobacter pylori eradication . We suggest this phenomenon is a modern example of a spontaneous change in the natural history of the disease In a prospect i ve controlled trial 86 duodenal ulcer patients with symptoms severe enough to indicate surgery were r and omized to a full-dose cimetidine course followed by maintenance therapy for 1 year or parietal cell vagotomy ( PCV ) . The average follow-up period was 57 months . In the group assigned to medical therapy 62 % of the patients were free of symptoms during maintenance therapy , and 12 % remained well during the follow-up period . Operation was later performed in 35 % , whereas 53 % had symptomatic recurrence dem and ing medical treatment regularly . After PCV no patient died , and there were no serious sequelae . The overall recurrence rate was 17 % ; after treatment of failures 9 % continued to have dyspepsia . Since nearly 3/4 of the patients were free of symptoms after PCV , operation seems to be the method of choice in patients with a severe history and fast recurrence after medical therapy . However , the aged and those at high risk of surgery may benefit from cimetidine maintenance therapy
Output:
| It appears that the participants did not have previous complications such as bleeding or perforation .
We found no studies that provide the relative benefits and harms of medical versus surgical treatment for recurrent or refractory peptic ulcers . |
MS212323 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The aim of the present study was to evaluate the effects of a normal-sodium ( 120 mmol sodium ) diet compared with a low-sodium diet ( 80 mmol sodium ) on readmissions for CHF ( congestive heart failure ) during 180 days of follow-up in compensated patients with CHF . A total of 232 compensated CHF patients ( 88 female and 144 male ; New York Heart Association class II-IV ; 55 - 83 years of age , ejection fraction < 35 % and serum creatinine < 2 mg/dl ) were r and omized into two groups : group 1 contained 118 patients ( 45 females and 73 males ) receiving a normal-sodium diet plus oral furosemide [ 250 - 500 mg , b.i.d . ( twice a day ) ] ; and group 2 contained 114 patients ( 43 females and 71 males ) receiving a low-sodium diet plus oral furosemide ( 250 - 500 mg , b.i.d . ) . The treatment was given at 30 days after discharge and for 180 days , in association with a fluid intake of 1000 ml per day . Signs of CHF , body weight , blood pressure , heart rate , laboratory parameters , ECG , echocardiogram , levels of BNP ( brain natriuretic peptide ) and aldosterone levels , and PRA ( plasma renin activity ) were examined at baseline ( 30 days after discharge ) and after 180 days . The normal-sodium group had a significant reduction ( P<0.05 ) in readmissions . BNP values were lower in the normal-sodium group compared with the low sodium group ( 685+/-255 compared with 425+/-125 pg/ml respectively ; P<0.0001 ) . Significant ( P<0.0001 ) increases in aldosterone and PRA were observed in the low-sodium group during follow-up , whereas the normal-sodium group had a small significant reduction ( P=0.039 ) in aldosterone levels and no significant difference in PRA . After 180 days of follow-up , aldosterone levels and PRA were significantly ( P<0.0001 ) higher in the low-sodium group . The normal-sodium group had a lower incidence of rehospitalization during follow-up and a significant decrease in plasma BNP and aldosterone levels , and PRA . The results of the present study show that a normal-sodium diet improves outcome , and sodium depletion has detrimental renal and neurohormonal effects with worse clinical outcome in compensated CHF patients . Further studies are required to determine if this is due to a high dose of diuretic or the low-sodium diet Low-salt ( LS ) diet activates the renin-angiotensin-aldosterone and sympathetic nervous systems , both of which can increase insulin resistance ( IR ) . We investigated the hypothesis that LS diet is associated with an increase in IR in healthy subjects . Healthy individuals were studied after 7 days of LS diet ( urine sodium < 20 mmol/d ) and 7 days of high-salt ( HS ) diet ( urine sodium > 150 mmol/d ) in a r and om order . Insulin resistance was measured after each diet and compared statistically , unadjusted and adjusted for important covariates . One hundred fifty-two healthy men and women , aged 39.1 ± 12.5 years ( range , 18 - 65 ) and with body mass index of 25.3 ± 4.0 kg/m(2 ) , were included in this study . Mean ( SD ) homeostasis model assessment index was significantly higher on LS compared with HS diet ( 2.8 ± 1.6 vs 2.4 ± 1.7 , P < .01 ) . Serum aldosterone ( 21.0 ± 14.3 vs 3.4 ± 1.5 ng/dL , P < .001 ) , 24-hour urine aldosterone ( 63.0 ± 34.0 vs 9.5 ± 6.5 μg/d , P < .001 ) , and 24-hour urine norepinephrine excretion ( 78.0 ± 36.7 vs 67.9 ± 39.8 μg/d , P < .05 ) were higher on LS diet compared with HS diet . Low-salt diet was significantly associated with higher homeostasis model assessment index independent of age , sex , blood pressure , body mass index , serum sodium and potassium , serum angiotensin II , plasma renin activity , serum and urine aldosterone , and urine epinephrine and norepinephrine . Low-salt diet is associated with an increase in IR . The impact of our findings on the pathogenesis of diabetes and cardiovascular disease needs further investigation This is a report of the effects of sugars on salt metabolism and on blood pressure . Twenty young men , none of whom had a personal or family history of hypertension , were orally hydrated after an overnight fast and required to lie recumbent for 6 h except for urinary voiding and blood pressure measurements which were performed at 1/2 h intervals . Venous blood sample s were drawn at hourly intervals . The volunteers were kept constantly hydrated by giving them water to drink equivalent to the volumes of urine voided . Two hours from the start of the experiment each subject was given one of the following sugars : glucose , fructose , sucrose , galactose , lactose , or water alone . After oral hydration the subjects appeared to develop natriuresis and kaliuresis . This was quickly abolished by ingestion of either glucose , fructose , sucrose , or lactose , but not by galactose or water alone . Fructose was the most potent antinatriuretic agent . Both glucose and sucrose significantly elevated systolic blood pressure . This lasted for 2 h after glucose ingestion and 1 h after sucrose ingestion Introduction : Hypertonic saline solution ( HSS ) and a moderate Na restriction plus high furosemide dose showed beneficial effects in compensated heart failure ( HF ) , in short and long terms . The study was aim ed to verify the effects of this combination on hospitalization time , readmissions and mortality in patients in New York Heart Association ( NYHA ) class III . Method : Chronic ischemic or nonischemic cardiomyopathy uncompensated patients with HF in NYHA III functional class with ejection fraction < 40 % , serum creatinine < 2.5 mg/dL , blood urea nitrogen < 60 mg/dL and reduced urinary volume were single-blind r and omized in 2 groups : the first group received a 30-minute intravenous infusion of furosemide ( 250 mg ) plus HSS ( 150 mL ) twice daily and a moderate Na restriction ( 120 mmol ) ; the second group received furosemide intravenous bolus ( 250 mg ) twice a day , without HSS and a low Na diet ( 80 mmol ) ; both groups received a fluid intake of 1000 mL/d . After discharge , the HSS group continued with 120 mmol Na/d ; the second group continued with 80 mmol Na/d . Results : A total of 1771 patients ( 881 HSS group and 890 without HSS group ) met inclusion criteria : the first group ( 881 patients ) , compared with the second ( 890 patients ) , showed an increase in diuresis and serum Na levels , a reduction in hospitalization time ( 3.5 + 1 versus 5.5 + 1 days , P < 0.0001 ) and , during follow-up ( 57 + 15 months ) , a lower rate in readmissions ( 18.5 % versus 34.2 % , P < 0.0001 ) and mortality ( 12.9 % versus 23.8 % , P < 0.0001 ) ; the second group also showed a significant increase in blood urea nitrogen and serum creatinine . Conclusion : This study suggests that in-hospital HSS administration , combined with moderate Na restriction , reduces hospitalization time and that a moderate sodium diet restriction determines long-term benefit in patients with NYHA class III HF OBJECTIVES The aim of this study was to evaluate the effect of a new treatment for refractory congestive heart failure ( CHF ) on brain natriuretic peptide ( BNP ) plasma levels and hydration station . BACKGROUND The study was aim ed at evaluating the effects of the combination of high-dose furosemide and small-volume hypertonic saline solution ( HSS ) in refractory CHF patients . METHODS A total of 94 patients ( 34 women/60 men ) with refractory CHF ( age 55 to 80 years ) were enrolled . They had to have an ejection fraction < 35 % , serum creatinine < 2 mg/dl , blood urea nitrogen < 60 mg/dl , a reduced urinary volume , and a low natriuresis ( < 500 ml/24 h and < 60 mEq/24 h , respectively ) . Patients were divided ( double-blind ) into two groups : group 1 ( 18 women/30 men ) received an intravenous furosemide ( 500 to 1,000 mg ) plus HSS twice a day in 30 min . Group 2 ( 16 women/30 men ) received an intravenous bolus of furosemide ( 500 to 1,000 mg/twice a day ) alone , for four to six days . At entry , body weight , blood pressure , heart rate , and laboratory parameters were checked during hospitalization ; BNP levels were measured on admission , 6 and 30 days after discharge , while on admission and 6 days after , impedance plethysmography was performed . The HSS group received 120 mmol of Na intake versus 80 mmol in non-HSS group . Fluid intake of 1,000 was given to both groups . RESULTS The groups were similar for clinical characteristics . A significant increase in daily diuresis and natriuresis was observed in HSS group , p < 0.05 . The BNP values showed significant intragroup and intergroup differences , 6 and 30 days after treatment . The patients from the HSS group reached a better hydration state than the non-HSS group after six days . In addition , the HSS group showed a significant reduction in hospitalization time and readmission rate . CONCLUSIONS Our data show that the HSS group reached dry weight more rapidly , a significantly faster reduction in BNP levels , shorter hospitalization stay , and lower incidence in readmissions in the 30-day study period BACKGROUND Diuretics have been accepted as first-line treatment in refractory congestive heart failure ( CHF ) , but a lack of response to them is a frequent event . A r and omized , single-blind study was performed to evaluate the effects of the combination of high-dose furosemide and small-volume hypertonic saline solution ( HSS ) infusion in the treatment of refractory New York Heart Association ( NYHA ) class IV CHF and a normosodic diet during follow-up . Material s and Methods One hundred seven patients ( 39 women and 68 men , age range 65 - 90 years ) with refractory CHF ( NYHA class IV ) of different etiologies , who were unresponsive to high oral doses of furosemide , angiotensin-converting enzyme inhibitors , digitalis , and nitrates , were enrolled . Inclusion criteria included an ejection fraction ( EF ) < 35 % , serum creatinine level < 2 mg/dL , blood urea nitrogen level < or = 60 mg/dL , reduced urinary volume , and low natriuresis . The patients were r and omized in 2 groups ( single-blind ) . Patients in group 1 ( 20 women and 33 men ) received an intravenous ( IV ) infusion of furosemide ( 500 - 1000 mg ) plus HSS ( 150 mL of 1.4%-4.6 % NACl ) twice a day in 30 minutes . Patients in group 2 ( 19 women and 35 men ) received an IV bolus of furosemide ( 500 - 1000 mg ) twice a day , without HSS , during a period lasting 6 to 12 days . Both groups received IV KCl ( 20 - 40 mEq ) to prevent hypokalemia . At study entry , all patients underwent a physical examination and measurement of body weight ( BW ) , blood pressure ( BP ) , and heart rate ( HR ) , an evaluation of signs of CHF , and measurement of control levels of serum Na , K , Cl , bicarbonate , albumin , uric acid , creatinine , urea , and glycemia daily during hospitalization , and measurements of the daily output of urine for Na , K , and Cl . A chest radiograph , electrocardiogram , and echocardiogram were obtained at study entry , during hospitalization , and at the time of discharge from the hospital . During the treatment and after discharge , the daily dietary Na intake was 120 mmol in group 1 versus 80 mmol in group 2 , with a fluid intake of 1000 mL daily in both groups . An assessment of BW and 24-hour urinary volume , serum , and urinary laboratory parameters were performed daily until patients reached a compensated state , when IV furosemide was replaced with oral administration ( 250 - 500 mg/d ) . After discharge from the hospital , patients were observed as out patients weekly for the first 3 months and , subsequently , once a month . RESULTS The groups were similar
Output:
| Preuss HG , Knapka JJ , MacArthy P , Yousufi AK , Sabnis SG , Antonovych TT .
High sucrose diets increase blood pressure of both salt-sensitive and salt-resistant rats .
Rebello T , Hodges RE , Smith JL .
Short-term effects of various sugars on antinatriuresis and blood pressure changes in normotensive young men .
BunagRD , Tomita T , Sasaki S.Chronic sucrose ingestion induces mild hypertension and tachycardia in rats .
Fructose-induced leptin resistance exacerbates weight gain in response to subsequent high-fat feeding .
Lana A , Rodriguez-Artalejo F , Lopez-Garcia E. Consumption of sugar-sweetened beverages is positively related to insulin resistance and higher plasma leptin concentrations inmen and nonoverweight women .
Ekinci EI , Clarke S , Thomas MC , Moran JL , Cheong K , MacIsaac RJ , Jerums G. Dietary salt intake and mortality in patients with type 2 diabetes .
Paterna S , Gaspare P , Fasullo S , Sarullo FM , Di Pasquale P. Normal-sodium diet compared with low-sodium diet in compensated congestive heart failure : is sodium an old enemy or a new friend ?
Garg R , Williams GH , Hurwitz S , Brown NJ , Hopkins PN , Adler GK .
Low-salt diet increases insulin resistance in healthy subjects .
Graudal NA , Hubeck-Graudal T , Jurgens G. Effects of low sodium diet versus high sodium diet on blood pressure , renin , aldosterone , catecholamines , cholesterol , and triglyceride . |
MS212324 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 prospect i ve study compared the diagnostic and predictive potential of sperm morphology assessment s in a fertile vs. a subfertile population , evaluated in three different laboratories . The fertile population included 144 men who had recently fertilized their partners . As subfertile controls , 136 men with a history of subfertility for more than 12 months were used . All semen sample s ( 280 ) were evaluated in three different centres in a blind fashion , without any patient information . The evaluation of sperm morphology was performed according to the criteria normally used in the different laboratories : WHO ( 1992 ) criteria for laboratory A , and Tygerberg strict criteria for laboratories B and C. Using ROC analysis , the predictive power of sperm morphology turned out to be different in the three laboratories ( area under ROC curve : 69 % for lab A , 72 % for lab B and 78 % for lab C ) . Using percentile 10 of the fertile population as the cut-off value for normality , we obtained the following results : 2 , 1 and 5 % for laboratories A , B and C , respectively . Using ROC analysis cut-off values with optimal specificity and sensitivity were 6 , 1 and 10 % , respectively . Although our data highlight a reasonable predictive power of sperm morphology in centres using different or the same criteria , cut-off values for normality were different , even when the same criteria were applied . These results stress the importance of st and ardization in sperm morphology evaluation and the need for examining a reference population in estimating the real threshold value in different laboratories OBJECTIVE To examine the effects of increased sperm DNA damage in relation to seminal oxidative stress in men with idiopathic and male factor infertility . Prospect i ve study . SETTING S Infertility clinic at a tertiary care academic institution . PATIENT(S ) Ninety-two infertile men with normal female partners . Sixteen fertile donors served as the control group . INTERVENTION(S ) St and ard semen analysis and assessment of levels of seminal oxidative stress . Assisted reproductive techniques in 33 of the 92 patients ( IUI [ n = 19 ] , IVF [ n = 10 ] , and intracytoplasmic sperm injection [ n = 4 ] ) . MAIN OUTCOME MEASURE(S ) Sperm DNA damage by sperm chromatin structure assay . Results were expressed as DNA fragmentation index . RESULT ( S ) Patients were classified as having either idiopathic ( n = 23 ) or male factor infertility ( n = 69 ) . Patients with idiopathic and male factor infertility had significantly higher DNA fragmentation index and oxidative stress compared with the case of fertile donors . A clinical pregnancy was achieved in 9 ( 27 % ) of 33 patients with assisted reproductive techniques . Significantly higher DNA fragmentation index and oxidative stress were found in men who failed to initiate a pregnancy after assisted reproductive techniques ( n = 24 ) , compared with the cases of those who succeeded and of the fertile donors . DNA fragmentation index was correlated positively with oxidative stress ( r = 0.27 ) , and negatively with fertilization ( r = -0.70 ) and embryo quality ( r = -0.70 ) . CONCLUSION ( S ) Sperm DNA damage is significantly increased in men with idiopathic and male factor infertility and in men who failed to initiate a pregnancy after assisted reproductive techniques . Such an increase may be related to high levels of seminal oxidative stress OBJECTIVE To assess the prognostic value of strict sperm morphology analysis in intrauterine insemination with husb and 's sperm ( IUI ) cycles performed because of male infertility . DESIGN Prospect i ve study . SETTING Academic tertiary hospital . PATIENTS Seventy-four consecutive couples subjected to 271 IUI cycles because of male infertility . MAIN OUTCOME MEASURE Strict morphology analysis 1 month before the beginning of IUI following the criteria of Kruger et al. RESULTS Pregnancy and no pregnancy couples were similar regarding strict normal forms ( 2.85 % + /- 2.07 % versus 3.13 % + /- 2.63 % ) , slightly amorphous forms , and the morphology index ( 11.79 + /- 6.06 versus 12.04 + /- 7.13 ) . Pregnancy rates ( PRs ) were similar when normal forms were < 4 % ( 39.1 % ) or > 4 % ( 35.7 % ) . The PR , although higher in the group with morphology index > 10 % ( 41.4 % ) than in the group < 10 % ( 33.3 % ) , lacked statistical significance . In pure male infertility group , mean values of morphology were similar in pregnancy and nonpregnancy group . A not significant trend was detected toward higher PRs in morphology index > 10 % ( 50.0 % ) than in the group < 10 % ( 33.3 % ) . CONCLUSION Strict morphology analysis 1 month before the beginning of IUI is not a useful prognostic factor in IUI performed because of male infertility Abstract Purpose : The purpose of this study was to assess the predictive value of a modified form of Kruger 's strict criteria for sperm morphology for pregnancy outcomes after intrauterine insemination ( IUI ) and controlled ovarian hyperstimulation ( COH ) in the presence of normal sperm concentration and motility . Material s and Methods : A retrospective review of 42 couples undergoing COH/IUI was stratified by favorable or unfavorable sperm morphology . End points were pregnancy or failure of treatment as defined by four or more cycles of COH/IUI without pregnancy . Results : An unfavorable morphology ( < 4 % ) was highly predictive of failure during COH-IUI ( 94.45 % ; 17/18 ) . A normal PIF was a sensitive indicator of those patients who became pregnant ( 93.8 % ; 15/16 ) and had a fair specificity for failure to achieve pregnancy after four cycles of treatment ( 65.4 % ; 17/26 ) . Couples with a favorable sperm morphology were 28.3 times as likely to achieve a pregnancy within four cycles of treatment as those with unfavorable sperm morphology [ 95 % confidence limits , 3.2 to 250.5 ; P<0.001 ] . Conclusions : Abnormal strict morphologic assessment is both sensitive and specific for pregnancy outcomes in couples undergoing COH/IUI . Couples with persistently unfavorable sperm morphology should be counseled appropriately and would be better served by more aggressive treatment with in vitro fertilization and embryo transfer OBJECTIVE To develop a rapid , sensitive , and reproducible hypoosmotic swelling test kit for the assessment of plasma membrane integrity of human sperm in vitro . DESIGN Prospect i ve comparison of results with the World Health Organization ( WHO ) method , performed simultaneously . SETTING Infertility center in a major city in India . PATIENT(S ) Couples who presented for infertility evaluation . INTERVENTION(S ) The sperm tail-coiling pattern representing sperm plasma membrane integrity was analyzed by using different concentrations of NaCl and also with plain double distilled water ( ddH(2)O ) . Hypoosmotic swelling solution with 2 % NaCl in ddH(2)O equivalent to 68 Osm/L was selected for further analysis because it provided the highest and the qualitatively best type ( g ) of tail coiling among the various other options tried in comparison . MAIN OUTCOME MEASURE(S ) A rapid laboratory test kit for the assessment of plasma membrane integrity of sperm was developed that is equally sensitive and reproducible as that described in the WHO protocol . The test was vali date d by using different normal and subnormal semen sample s and in comparison with the st and ard WHO protocol . RESULT ( S ) After the screening with different hypoosmotic solutions by using semen sample s from fertile volunteers , NaCl ( 2 % ) provided the highest and the best types of typical tail coiling , characteristic of sperm with good plasma membrane integrity . The study was then extended to 60 normozoospermic semen sample s , which demonstrated a hypoosmotic swelling response of 69.5 % + /- 5.23 % and 71.5 % + /- 4.89 % , as per WHO or the present modified method , respectively ( coefficient of correlation , r = 0.741 ) . In 13 oligospermic and 18 teratozoospermic subjects , the hypoosmotic swelling response of sperm as per the new method were 36.4 % + /- 5.75 % and 34.2 % + /- 7.78 % , respectively , which were comparable to those obtained through the WHO method . There was a 15 % drop in viability of sperm after the hypoosmotic challenge ( 5 min ) , irrespective of the hypoosmotic solution used . No other morphological alterations in sperm were observed after the hypoosmotic challenge . CONCLUSION ( S ) The new test kit can be used routinely in laboratories for assessment of plasma membrane integrity of sperm in vitro OBJECTIVE To determine if a simple screening test of sperm recovery through a density gradient preparation and sperm survival after a 24-hour incubation is predictive of IUI success . DESIGN Prospect i ve nonr and omized descriptive study . SETTING Tertiary assisted reproductive technology center . PATIENT(S ) Four hundred fourteen couples undergoing IUI for male factor and unexplained infertility . INTERVENTION(S ) An advanced semen analysis , which consisted of a basic semen analysis , sperm processing through a density gradient preparation , and a 24-hour sperm incubation , was performed on all couples before beginning IUIs . MAIN OUTCOME MEASURE(S ) Cumulative and per cycle pregnancy rates ( PRs ) were calculated for routine semen parameters , number of sperm processed through density gradient , and percent motile sperm after a 24-hour incubation . RESULT ( S ) None of the basic semen analysis parameters accurately predicted IUI success . When the processed total motile sperm available for insemination was > or = 10 x 10(6 ) and their 24-hour survival was > or = 70 % , 89 % ( 162 of 182 ) of couples achieved a pregnancy with a 21.4 % ( 162 of 757 ) per cycle PR compared to a 2.8 % ( 11 of 403 ) per cycle PR and 4.7 % total PR when survival was < 70 % . With use of these cutoff values for the advanced semen analysis , the test had a sensitivity of 94 % and specificity of 86 % . CONCLUSION ( S ) The number of motile sperm available for insemination and especially their 24-hour survival are highly predictive of IUI success . This advanced semen analysis is an excellent screening test to evaluate couples considering IUI OBJECTIVE To evaluate levels of sperm nuclear DNA damage in infertile men with normal and abnormal st and ard semen parameters . DESIGN Prospect i ve study . SETTING Male infertility clinic . PATIENT(S ) Ninety-two men seeking infertility treatment and 16 fertile volunteers . INTERVENTION(S ) St and ard semen analysis was performed according to the World Health Organization guidelines . MAIN OUTCOME MEASURE(S ) Sperm DNA damage was assessed by sperm chromatin structure assay and the results expressed as % DFI . RESULT ( S ) Of the 92 patients , 21 ( 23 % ) had normal st and ard sperm parameters ( concentration , motility , and normal sperm forms ) , while 71 ( 77 % ) had an abnormality in one or more of these parameters . The % DFI [ median ( 25th and 75th percentiles ) ] in infertile men with normal sperm parameters [ 23 ( 15 , 32 ) ] was significantly higher than fertile donors [ 15 ( 11 , 20 ) ] ( P=.02 ) , but not significantly different from infertile men with abnormal sperm parameters [ 28 ( 18 , 41 ) ] ( P=.27 ) . CONCLUSION ( S ) The results of this study indicate that a significant increase in SCSA-defined DNA damage can be found in sperm from infertile men with normal st and ard sperm parameters . Therefore , sperm DNA damage analysis may reveal a hidden abnormality of sperm DNA in infertile men classified as idiopathic based on apparently normal st and ard sperm parameters Summary . Artificial insemination with husb and 's semen into the cervical canal and uterine cavity ( high AIH ) was assessed by a r and omized controlled prospect i ve study in 46 couples whose infertility was due to failure of sperm mucus penetration , as defined by negative postcoital tests , after excluding all interfering female factors and men with sperm density < 1 × 106/ml . Seminal analysis was abnormal in 18 of the 46 men and sperm antibodies in semen were detected in 19 of the remaining 28 with normal seminal analysis . Overall , the cumulative conception rate after 6 months with AIH was 4·7 ( SE 3·8)% and without treatment was 6·6 ( SE 3·9)% . The results were unaffected by the findings on seminal analysis or by the presence or absence of sperm antibodies in semen . AIH appeared to be of no benefit
Output:
| In couples treated with IUI , the clinical validity of SCSA is higher than that of sperm morphology alone , but not enough to introduce SCSA as a test in male infertility work-up |
MS212325 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To evaluate the effectiveness of home delivered pragmatic rehabilitation — a programme of gradually increasing activity design ed collaboratively by the patient and the therapist— and supportive listening — an approach based on non-directive counselling — for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis ( CFS/ME ) . Design Single blind , r and omised , controlled trial . Setting 186 general practice s across the north west of Engl and between February 2005 and May 2007 . Participants 296 patients aged 18 or over with CFS/ME ( median illness duration seven years ) diagnosed using the Oxford criteria . Interventions Participants were r and omly allocated to pragmatic rehabilitation , supportive listening , or general practitioner treatment as usual . Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months ’ training , including supervised practice , in each of the interventions . GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period . Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment ( 20 weeks ) and 70 weeks from recruitment compared with GP treatment as usual . Lower fatigue scores and higher physical functioning scores denote better outcomes . Results A total of 257 ( 87 % ) of the 296 patients who entered the trial were assessed at 70 weeks , the primary outcome point . Analysis was on an intention to treat basis , with robust treatment effects estimated after adjustment for missing data using probability weights . Immediately after treatment ( at 20 weeks ) , patients allocated to pragmatic rehabilitation ( n=95 ) had significantly improved fatigue ( effect estimate -1.18 , 95 % confidence interval -2.18 to -0.18 ; P=0.021 ) but not physical functioning ( -0.18 , 95 % CI -5.88 to + 5.52 ; P=0.950 ) compared with patients allocated to treatment as usual ( n=100 ) . At one year after finishing treatment ( 70 weeks ) , there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual ( -1.00 , 95 % CI -2.10 to + 0.11 ; P=0.076 and + 2.57 , 95 % CI 3.90 to + 9.03 ; P=0.435 ) . At 20 weeks , patients allocated to supportive listening ( n=101 ) had poorer physical functioning than those allocated to treatment as usual ( -7.54 , 95 % CI -12.76 to -2.33 ; P=0.005 ) and no difference in fatigue . At 70 weeks , patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome . Conclusions For patients with CFS/ME in primary care , pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual , but the effect is small and not statistically significant at one year follow-up . Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME . Trial registration International St and ard R and omised Controlled Trial Number I RCT N74156610 BACKGROUND Reports of mild hypocortisolism in chronic fatigue syndrome led us to postulate that low-dose hydrocortisone therapy may be an effective treatment . METHODS In a r and omised crossover trial , we screened 218 patients with chronic fatigue . 32 patients met our strict criteria for chronic fatigue syndrome without co-morbid psychiatric disorder . The eligible patients received consecutive treatment with low-dose hydrocortisone ( 5 mg or 10 mg daily ) for 1 month and placebo for 1 month ; the order of treatment was r and omly assigned . Analysis was by intention to treat . FINDINGS None of the patients dropped out . Compared with the baseline self-reported fatigue scores ( mean 25.1 points ) , the score fell by 7.2 points for patients on hydrocortisone and by 3.3 points for those on placebo ( paired difference in mean scores 4.5 points [ 95 % CI 1.2 - 7.7 ] , p=0.009 ) . In nine ( 28 % ) of the 32 patients on hydrocortisone , fatigue scores reached a predefined cut-off value similar to the normal population score , compared with three ( 9 % ) of the 32 on placebo ( Fisher 's exact test p=0.05 ) . The degree of disability was reduced with hydrocortisone treatment , but not with placebo . Insulin stress tests showed that endogenous adrenal function was not suppressed by hydrocortisone . Minor side-effects were reported by three patients after hydrocortisone treatment and by one patient after placebo . INTERPRETATION In some patients with chronic fatigue syndrome , low-dose hydrocortisone reduces fatigue levels in the short term . Treatment for a longer time and follow-up studies are needed to find out whether this effect could be clinical ly useful Background Chronic fatigue is common in the general population . Complementary therapies are often used by patients with chronic fatigue or chronic fatigue syndrome to manage their symptoms . Purpose This study aim ed to assess the effect of a 4-month qigong intervention program among patients with chronic fatigue or chronic fatigue syndrome . Methods Sixty-four participants were r and omly assigned to either an intervention group or a wait list control group . Outcome measures included fatigue symptoms , physical functioning , mental functioning , and telomerase activity . Results Fatigue symptoms and mental functioning were significantly improved in the qigong group compared to controls . Telomerase activity increased in the qigong group from 0.102 to 0.178 arbitrary units ( p < 0.05 ) . The change was statistically significant when compared to the control group ( p < 0.05 ) . Conclusion Qigong exercise may be used as an alternative and complementary therapy or rehabilitative program for chronic fatigue and chronic fatigue syndrome Abstract Objective : To assess the efficacy of an educational intervention explaining symptoms to encourage grade d exercise in patients with chronic fatigue syndrome . Design : R and omised controlled trial . Setting : Chronic fatigue clinic and infectious diseases outpatient clinic . Subjects : 148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome . Interventions : Patients r and omised to the control group received st and ardised medical care . Patients r and omised to intervention received two individual treatment sessions and two telephone follow up calls , supported by a comprehensive educational pack , describing the role of disrupted physiological regulation in fatigue symptoms and encouraging home based grade d exercise . The minimum intervention group had no further treatment , but the telephone intervention group received an additional seven follow up calls and the maximum intervention group an additional seven face to face sessions over four months . Main outcome measure : A score of 25 or an increase of 10 on the SF-36 physical functioning subscale ( range 10 to 30 ) 12 months after r and omisation . Results : 21 patients dropped out , mainly from the intervention groups . Intention to treat analysis showed 79 ( 69 % ) of patients in the intervention groups achieved a satisfactory outcome in physical functioning compared with two ( 6 % ) of controls , who received st and ardised medical care ( P<0.0001 ) . Similar improvements were observed in fatigue , sleep , disability , and mood . No significant differences were found between the three intervention groups . Conclusions : Treatment incorporating evidence based physiological explanations for symptoms was effective in encouraging self managed grade d exercise . This result ed in substantial improvement compared with st and ardised medical care Background The causes of chronic fatigue syndrome ( CFS ) and idiopathic chronic fatigue ( ICF ) are not clearly known , and there are no definitive treatments for them . Therefore , patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine . For this reason , the effectiveness of complementary and alternative treatments should be verified . We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone . Methods A three-arm parallel , non-blinded , r and omized controlled trial was performed in four hospitals . We divided 150 participants into treatment and control groups at the same ratio . The treatment groups ( Group A , body acupuncture ; Group B , Sa-am acupuncture ) received 10 sessions for 4 weeks . The control group ( Group C ) continued usual care alone . The primary outcome was the Fatigue Severity Scale ( FSS ) at 5 weeks after r and omization . Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory ( SRI ) , the Beck Depression Inventory ( BDI ) , the Numeric Rating Scale ( NRS ) , and the EuroQol-5 Dimension ( EQ-5D ) at 5 and 13 weeks . Results Group A showed significantly lower FSS scores than Group C at 5 weeks ( P = 0.023 ) . SRI scores were significantly lower in the treatment groups than in the control group at 5 ( Group A , P = 0.032 ; B , P < 0.001 ) and 13 weeks ( Group A , P = 0.037 ; B , P < 0.001 ) . Group B showed significantly lower BDI scores than Group C at 13 weeks ( P = 0.007 ) . NRS scores from the treatment groups were significantly reduced compared to control at 5 ( Group A and B , P < 0.001 ) and 13 weeks ( Group A , P = 0.011 ; B , P = 0.002 ) . Conclusions Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients .Trial registration Clinical Research Information Service ( CRIS ) KCT0000508 ; Registered on 12 August 2012 CONTEXT Given that the etiology of chronic fatigue syndrome ( CFS ) is believed to be multidimensional , interventions generally have been nonspecific and typically produce only mild to moderate effects . In medical practice , treatment for CFS remains largely symptomatic . Preliminary evidence of the efficacy of acupuncture for CFS is available , but the field has lacked high- quality trials . OBJECTIVE The research team conducted the study to determine the efficacy of acupuncture for CFS . DESIGN A two-arm , r and omized , controlled , singleblinded design was adopted . SETTING The study took place in a teaching laboratory at the School of Chinese Medicine at the University of Hong Kong , Hong Kong , China . PARTICIPANTS Recruited through press publicity in Hong Kong , 127 individuals--40 men and 87 women -- participated in the study . Intervention Through careful implementation of sham acupuncture in the control group ( CG ) , the study blinded all participants with regard to their experimental or control status . The treatment regime was 2 sessions/wk for 4 consecutive wk . OUTCOME MEASURES Measures of fatigue ( Chalder 's Fatigue Scale ) , health-related quality of life ( SF-12 ) , and general mental health ( GH Q-12 ) were taken at baseline and upon completion of treatment . RESULTS Ninety-nine participants completed the interventions , with 50 and 49 participants in the experimental group ( EG ) and CG respectively . Repeated measures ANOVA revealed a significant decrease in physical ( F(1,93 ) = 4.327 ; P = .040 ) and mental fatigue ( F(1,96 ) = 10.451 ; P = .002 ) and improvement in the physical component score of SF-12 ( F(1,93 ) = 4.774 ; P = .031 ) . Considerable effects with Cohen 's d were observed in the sham-control group : 0.92 , 0.78 , and 0.38 for the three scores , respectively . These positive effects could have included some therapeutic effects due to pressure on the acupuncture points from the sham needles in addition to normal placebo effects . The EG showed moderate net effect sizes with Cohen 's d : 0.52 , 0.63 , and 0.54 for the three outcome measures , respectively . CONCLUSION Despite considerable positive effects for the CG , the EG demonstrated significant net-effect sizes at a moderate magnitude in physical and mental fatigue and in the physical component of health-related quality of life . The impacts on general mental health outcomes appeared to be smaller OBJECTIVE Cognitive behavior therapy for chronic fatigue syndrome was compared with relaxation in a r and omized controlled trial . METHODS Sixty patients with chronic fatigue syndrome were r and omly assigned to 13 sessions of either cognitive behavior therapy ( grade d activity and cognitive restructuring ) or relaxation . Outcome was evaluated by using measures of functional impairment , fatigue , mood , and global improvement . RESULTS Treatment was completed by 53 patients . Functional impairment and fatigue improved more in the group that received cognitive behavior therapy . At final follow-up , 70 % of the completers in the cognitive behavior therapy group achieved good outcomes ( substantial improvement in physical functioning ) compared with 19 % of those in the relaxation group who completed treatment . CONCLUSIONS Cognitive behavior therapy was more effective than a relaxation control in the management of patients with chronic fatigue syndrome . Improvements were sustained over 6 months of follow-up CONTEXT Chronic fatigue syndrome ( CFS ) is associated with a dysregulated hypothalamic-pituitary adrenal axis and hypocortisolemia . OBJECTIVE To evaluate the efficacy and safety of low-dose oral hydrocortisone as a treatment for CFS . DESIGN A r and omized , placebo-controlled , double-bl
Output:
| However , there was no definitely effective intervention with coherence and reproducibility . |
MS212326 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Sixty percent to 70 % of pedestrian injuries in children under the age of 10 years are the result of the child either improperly crossing intersections or dashing out in the street between intersections . The purpose of this injury prevention research study was to evaluate a desktop virtual reality ( VR ) program that was design ed to educate and train children to safely cross intersections . Specifically , the objectives were to determine whether children can learn pedestrian safety skills while working in a virtual environment and whether pedestrian safety learning in VR transfers to real world behavior . Following focus groups with a number of key experts , a virtual city with eight interactive intersections was developed . Ninety-five children participated in a community trial from two schools ( urban and suburban ) . Approximately half were assigned to a control group who received an unrelated VR program , and half received the pedestrian safety VR intervention . Children were identified by group and grade by colored tags on their backpacks , and actual street crossing behavior of all children was observed 1 week before and 1 week after the interventions . There was a significant change in performance after three trials with the VR intervention . Children learned safe street crossing within the virtual environment . Learning , identified as improved street-crossing behavior , transferred to real world behavior in the suburban school children but not in the urban school . The results are discussed in relation to possibilities for future VR interventions for injury prevention Objective : to evaluate the effectiveness of a school-based injury prevention program . Design : Cluster r and omised controlled trial . Setting : 20 primary schools in Nottingham , UK . Participants : 459 children aged 7 to 10 years . Intervention : The “ Risk Watch ” program delivered by teachers , aim ed at improving bike and pedestrian , falls , poisoning and fire and burns safety . Main outcome measures : Safety knowledge , observed safety skills and self-reported safety behaviour . Results : At follow-up , intervention group children correctly answered more fire and burn prevention knowledge questions than control group children ( difference between means 7.0 % ( 95 % CI 1.5 % to12.6 % ) ) . Children in intervention group schools were more likely to know the correct actions to take if clothes catch fire and the correct way to wear a cycle helmet ( difference between school means 35.3 % ( 95 % CI 22.7 % to 47.9 % ) and 6.3 % ( 95 % CI 1.4 % to 11.1 % ) respectively ) . They were also more likely to know the correct actions to take in a house fire and on finding tablets ( OR 2.80 ( 95 % CI 1.08 to 7.22 ) and OR 3.50 ( 95 % CI 1.18 to 10.38 ) respectively ) and correctly demonstrated more safety skills than control group children ( difference between means 11.9 % ( 95 % CI 1.4 % to 22.5 % ) ) . There was little evidence to suggest the first year of the program impacted on self-reported safety behaviours . Conclusions : The Risk Watch program delivered by teachers in primary schools increased some aspects of children ’s safety knowledge and skills and primary schools should consider delivering this program . Longer term , larger scale evaluations are required to examine retention of knowledge and skills and impact on safety behaviours and child injury rates It was hypothesized that practical training is effective in improving children 's pedestrian skills because adult scaffolding and peer discussion during training specifically promote E3 level representation ( linguistically-encoded , experientially-grounded , generalizable knowledge ) , as defined by Karmiloff-Smith 's ( 1992 ) representational redescription ( RR ) model . Two studies were conducted to examine in detail the impact of this social input in the context of simulation-based training in roadside search skills . A group of 5 - 8-year-olds were pre-tested on ability to detect relevant road-crossing features . They then participated in four training sessions design ed to promote attunement to these , under peer discussion versus adult guidance conditions ( Study 1 ) , and adult-child versus adult-group conditions ( Study 2 ) . Performance at post-test was compared with that of controls who underwent no training . Study 1 found that children in the adult guidance condition improved significantly more than those in the peer discussion or control conditions , and this improvement was directly attributable to appropriation of E3 level representations from adult dialogue . Study 2 found that progress was greater still when adult scaffolding was supplemented by peer discussion , with E3 level representation attributable to the children 's exploration of conflicting ideas . The implication s of these findings for the RR model and for practical road safety education are discussed OBJECTIVE Child pedestrian injury is a global public health challenge . This r and omized , controlled trial considered comparative efficacy of individualized streetside training , training in a virtual pedestrian environment , training using videos and Web sites , plus no-training control , to improve children 's street-crossing ability . METHODS Pedestrian safety was evaluated among 231 7- and 8-year-olds using both streetside ( field ) and laboratory-based ( virtual environment ) trials before intervention group assignment , immediately posttraining , and 6 months posttraining . All training groups received 6 30-min sessions . Four outcomes assessed pedestrian safety : start delay ( temporal lag before initiating crossing ) , hits/close calls ( collisions/near-misses with vehicles in simulated crossings ) , attention to traffic ( looks left and right , controlled for time ) , and missed opportunities ( safe crossing opportunities that were missed ) . RESULTS Results showed training in the virtual pedestrian environment and especially individualized streetside training result ed in safer pedestrian behavior postintervention and at follow-up . As examples , children trained streetside entered safe traffic gaps more quickly posttraining than control group children and children trained streetside or in the virtual environment had somewhat fewer hits/close calls in postintervention VR trials . Children showed minimal change in attention to traffic posttraining . Children trained with videos/websites showed minimal learning . CONCLUSION Both individualized streetside training and training within virtual pedestrian environments may improve 7- and 8-year-olds ' street-crossing safety . Individualized training has limitations of adult time and labor . Virtual environment training has limitations of accessibility and cost . Given the public health burden of child pedestrian injuries , future research should explore innovative strategies for effective training that can be broadly disseminated Using a simulation game design ed to teach children to obey certain traffic safety rules , an experimental study was conducted with 136 five-year-old children in four Quebec schools . Within each classroom , subjects were r and omly divided into four groups : three intervention groups and one control group . Each of the experimental groups was subjected to a different intervention with outcome measured using three instruments related to attitudes , behavior , and transfer of learning of pedestrian traffic safety . Results suggest that simulation games including role-playing/group dynamics and modeling/training can change attitudes and modify behavior in the area of pedestrian traffic safety in children of this age Pedestrian injuries contribute greatly to child morbidity and mortality . Recent evidence suggests that training within virtual pedestrian environments may improve children ’s street crossing skills , but may not convey knowledge about safety in street environments . We hypothesized that ( a ) children will gain pedestrian safety knowledge via videos/software/internet websites , but not when trained by virtual pedestrian environment or other strategies ; ( b ) pedestrian safety knowledge will be associated with safe pedestrian behavior both before and after training ; and ( c ) increases in knowledge will be associated with increases in safe behavior among children trained individually at streetside locations , but not those trained by means of other strategies . We analyzed data from a r and omized controlled trial evaluating pedestrian safety training . We r and omly assigned 240 children ages 7–8 to one of four training conditions : videos/software/internet , virtual reality ( VR ) , individualized streetside instruction , or a no-contact control . Both virtual and field simulations of street crossing at 2-lane bi-directional mid-block locations assessed pedestrian behavior at baseline , post-training , and 6-month follow-up . Pedestrian knowledge was assessed orally on all three occasions . Children trained by videos/software/internet , and those trained individually , showed increased knowledge following training relative to children in the other groups ( ps < 0.01 ) . Correlations between pedestrian safety knowledge and pedestrian behavior were mostly non-significant . Correlations between change in knowledge and change in behavior from pre- to post-intervention also were non-significant , both for the full sample and within conditions . Children trained using videos/software/internet gained knowledge but did not change their behavior . Children trained individually gained in both knowledge and safer behavior . Children trained virtually gained in safer behavior but not knowledge . If VR is used for training , tools like videos/internet might effectively supplement training . We discovered few associations between knowledge and behavior , and none between changes in knowledge and behavior . Pedestrian safety knowledge and safe pedestrian behavior may be orthogonal constructs that should be considered independently for research and training purpose BACKGROUND Programmes design ed to teach children about road safety have often failed to assess their effectiveness in terms of either an increase in children 's knowledge or an improvement in children 's behaviour . AIM The two studies reported here sought to address both issues , by focusing on the abilities of Primary 1 children ( 5 years old ) . SAMPLE A total of 120 Primary 1 children within the age range 4 - 5 years old participated in this study , drawn from three different primary schools within an educational district of Scotl and . METHODS In the first study the effects of three different road safety interventions were tested , all of which employed commercially marketed products : 1 ) a three-dimensional model of the traffic environment ; 2 ) a road safety board game ; and 3 ) illustrated posters and flip-chart material s. In the second study the transfer of knowledge to children 's behaviour in a real-life traffic environment was tested , using a sub sample of 47 children who had taken part in the first study . RESULTS Results from the first study showed , surprisingly , that all three interventions were effective in increasing children 's knowledge about safe and dangerous locations at which to cross the street , and that this knowledge was retained for a period of six months . Study 2 , however , showed that increased knowledge did not result in improved traffic behaviour . Children who had received training performed no better than children in a control group . CONCLUSION These findings highlight the need to distinguish between children 's road safety knowledge and their behaviour , particularly for teachers and parents , who may mistakenly believe that children who know more will be safer on the road Background Pedestrian injuries are among the leading causes of morbidity and mortality in middle childhood . One limitation to existing pedestrian safety interventions is that they do not provide children with repeated practice needed to develop the complex perceptual and cognitive skills required for safe street crossing . Virtual reality offers training through repeated unsupervised practice without risk , automated feedback on success of crossings , adjustment of traffic to match children 's skill and a fun , appealing environment for training . Objective To test the efficacy of virtual reality to train child pedestrians in safe street crossing . Setting Birmingham , Alabama , USA . Methods A r and omised controlled trial is underway with an expected sample of four groups of 60 children aged 7–8 years ( total N=240 ) . One group receives training in an interactive , immersive virtual pedestrian environment . A second receives pedestrian safety training via widely used video and computer strategies . The third group receives what is judged to be the most efficacious treatment currently available , individualised behavioural training at streetside locations . The fourth group serves as a no-contact control group . All participants are exposed to a range of field and laboratory-based measures of pedestrian skill during baseline and post-intervention visits , as well as during a 6-month follow-up assessment . Outcome Measures Primary analyses will be conducted through linear mixed models testing change over time in the four intervention groups . Three pedestrian safety measures will serve as primary outcomes : temporal gap before initiating crossing , temporal gap remaining after crossing and attention to traffic while waiting to cross . Clinical Trial Registration This study is registered at the US government website , www . clinical trials.gov , under the title ‘ Using virtual reality to train children in pedestrian safety ’ , registration number NCT00850759 BACKGROUND Young children in the 5 - 9 age range are particularly vulnerable to road accidents as pedestrians and previous research has identified a range of motivational and cognitive skill factors which may play a part in this . AIMS The present study aim ed to examine the extent to which the development of pedestrian skills in young children was related to individual differences in visual search strategies . SAMPLE A sample of 180 children aged 4/5 , 7/8 and 10/11 years was presented with tasks intended to assess their pedestrian skills . From this analysis a subset of 60 children was selected who had particularly high or low levels of pedestrian skills , together with a r and om sample of 10 adults , for more detailed analysis of their visual search strategies when confronted with the problem of crossing a road safely . METHOD The children 's pedestrian skills were assessed using three tasks based on slide and video presentations of real roadside situations ; these tasks assessed the ability to identify safe places to cross the road , and to decide when it was safe to cross based on the ability to detect dangerous traffic and to co-ordinate information from different directions . Visual search strategies were assessed using a ' spot the difference ' test and by analysing the head and eye movements of children and adults while they were carrying out the video task requiring them to co-ordinate information from different directions . This task was also used to make an assessment of individuals ' processing speeds by measuring the time it took to make decisions that it was safe to cross the road . RESULTS Significant differences emerged in strategic approaches between children in different age groups , and those who had high and low levels of pedestrians skills . A significant strategic shift appeared to be occurring around the age of 7/8 years . CONCLUSIONS The results indicate that the explicit training of visual search strategies might well be beneficial , but that these can not simply be the strategies of the adult pedestrian . Children may need to master simpler strategies which their slower processing speeds allow them to manage before they proceed on to the more sophisticated strategic approaches , typically involving predictions , used by older children and adults OBJECTIVE This r and omized controlled trial examined one aspect of child pedestrian behavior , route selection across intersections , to evaluate whether a combination of widely-available videos and websites effectively train children in safe pedestrian route selection compared to active pedestrian safety control training and a no-contact control group . METHODS A sample of 231 seven- and eight-year-olds were r and omly assigned to one of four groups : training with videos and internet websites , active control groups of individualized streetside training or
Output:
| RESULTS Behavioral interventions generally improve children 's pedestrian safety , both immediately after training and at follow-up several months later .
Available evidence suggested interventions targeting dash-out prevention , crossing at parked cars , and selecting safe routes across intersections were effective .
Individualized/small-group training for children was the most effective training strategy based on available evidence .
Behaviorally based interventions improve children 's pedestrian safety . |
MS212327 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Combination therapy has been widely used for the clinical management of acute pain . By combining 2 drugs with different mechanisms of action , such therapy provides additive analgesic effects while reducing the risk for adverse effects . OBJECTIVE This study compared the efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg with those of oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , and placebo in a dental pain model . METHODS This was a multicenter , r and omized , double-blind , placebo- and active-controlled , parallel-group , single-dose study in patients experiencing moderate to severe pain after surgical removal of > or = 2 ipsilateral impacted third molars . Patients were r and omly assigned to receive oxycodone 5 mg/ibuprofen 400 mg , oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , or placebo . The primary outcome measures were total pain relief through 6 hours after dosing ( TOTPAR6 ) , sum of pain intensity differences through 6 hours ( SPID6 ) , and adverse events . Secondary efficacy measures included SPID3 and TOTPAR3 , peak pain relief , peak pain intensity difference , time to onset of pain relief , time to use of rescue medication , proportion of patients reporting pain half gone , and the patient 's global evaluation . RESULTS Two hundred forty-nine patients ( 43.5 % male ; 87.5 % white ; mean age , 19.1 years ; mean body weight , 153.6 pounds ) were r and omized to treatment as follows : 62 to oxycodone 5 mg/ibuprofen 400 mg , 61 to oxycodone 5 mg/acetaminophen 325 mg , 63 to hydrocodone 7.5 mg/acetaminophen 500 mg , and 63 to placebo . Oxycodone 5 mg/ibuprofen 400 mg provided significantly greater analgesia compared with oxycodone 5 mg/acetaminophen 325 mg , hydrocodone 7.5 mg/acetaminophen 500 mg , and placebo ( mean [ SD ] TOTPAR6 , 14.98 [ 5.37 ] , 9.53 [ 6.77 ] , 8.36 [ 6.68 ] , and 5.05 [ 6.49 ] , respectively ; P < 0.001 , oxycodone 5 mg/ibuprofen 400 mg vs all other treatments ) . SPID6 values also differed significantly for oxycodone 5 mg/ibuprofen 400 mg compared with all other treatments ( mean : 7.78 [ 4.11 ] , 3.58 [ 4.64 ] , 3.32 [ 4.73 ] , and 0.69 [ 4.85 ] ; P < 0.001 ) . Oxycodone 5 mg/ibuprofen 400 mg was significantly more effective compared with the other treatments on all secondary end points ( P < 0.001 , all variables except peak PID vs oxycodone 5 mg/acetaminophen 325 mg [ P = 0.006 ] ) , with the exception of the time to onset of analgesia . The lowest frequency of nausea and vomiting occurred in the groups that received oxycodone 5 mg/ibuprofen 400 mg ( 6.5 % and 3.2 % , respectively ) and placebo ( 3.2 % and 1.6 % ) . Rates of nausea and vomiting were significantly lower with oxycodone 5 mg/ibuprofen 400 mg compared with oxycodone 5 mg/acetaminophen 325 mg ( P = 0.011 and P = 0.009 , respectively ) but not with hydrocodone 7.5 mg/acetaminophen 500 mg . CONCLUSIONS In this study in patients with moderate to severe pain after surgery to remove impacted third molars , oxycodone 5 mg/ibuprofen 400 mg provided significantly better analgesia throughout the 6-hour study compared with the other opioid/nonopioid combinations tested , and was associated with fewer adverse events BACKGROUND The aim of this study was to evaluate the comparative efficacy of three commonly used analgesics ( Panadeine , Diflunisal and Etodolac ) in the control of pain after third molar surgery under local anaesthesia . METHODS A r and omized control study . Outcome of primary efficacy was judged by overall assessment of the area under the curve of graphs for pain intensity , measured from serial visual analogue scales over a 24-hour period . Other measures of efficacy included the number ( per cent ) of patients who took ' additional ' analgesics and the incidence of adverse effects occurring in each treatment group over the study period . RESULTS The three drugs were effective in the control of post-operative pain ( p<0.01 ) . Variations in pain intensity and the use of additional medication between the treatment groups were observed over the study period . The Diflunisal group experienced less pain than the Panadeine or Etodolac group ( p<0.01 ) . Furthermore , a lesser number of those in the Diflunisal group used additional medication compared to the other two groups ( p<0.01 ) . The incidence of side effects from all three drugs was low . CONCLUSION Diflunisal is superior in the control of pain following third molar surgery under local anaesthesia than either Panadeine or Etodolac , and has few side effects BACKGROUND Butorphanol tartrate , a mixed synthetic agonistantagonist opioid analgesic has been used for management of postoperative pain in minor and major surgical procedures .(14,20 ) Tramadol hydrochloride is a central ly acting opioid which is effectively used in postoperative pain in various minor and major surgeries . MATERIAL S AND METHODS Twenty subjects selected r and omly received butorphanol tartrate 1 mg intramuscular and 20 subjects received tramadol hydrochloride 50 mg intramuscular after the removal of m and ibular third molars . Time of injection , amount of anesthetic injected , duration of surgery , adverse effects were recorded.(21 ) RESULTS The mean amount of LA administered in butorphanol group was 2.6450 ml and in tramadol group was 2.640 ml respectively , the mean duration for surgery was 56.75 and 53.5 minutes for butorphanol and tramadol groups respectively which was statistically not significant . Pain assessment was done with VAS which showed mean of 19.2 and 15.5 mm ( p = 0.001 ) which was significant for butorphanol and tramadol respectively after 12 hours . The mean time for rescue medication requirement was 5.9 hours ( for tramadol ) and 8.4 hours ( for butorphanol ) . Effective analgesic activity was seen by butorphanol 1 mg intramuscular then tramadol 50 mg . CONCLUSION Butorphanol 1 mg was more effective than tramadol 50 mg in respect to postoperative analgesia We conducted a r and omised double-blind placebo-controlled single-centre study to compare the effect of preoperative ibuprofen 600 mg , diclofenac 100 mg , paracetamol 1 g with codeine 60 mg or placebo ( Vitamin C 50 mg ) tablets for relief of postoperative pain in 119 patients who had day case operations under general anaesthesia for removal of impacted third molars . Patients were given the tablets 1 h before operation . Pain was assessed using visual analogue scales and verbal rating scales preoperatively at 15 and 30 min and 1 and 3 h postoperatively . After they had gone home , patients were contacted by telephone at 6 and 24 h postoperatively to find out whether they had any adverse effects from the analgesics . There was no significant difference in the extent of postoperative pain among the four groups , but the placebo group had significantly shorter times before their first request for postoperative analgesics ( median 17 min , range 14 - 90 ) than the diclofenac group ( median 32 , range 15 - 150 ) . Preoperative analgesics at the stated doses are effective in providing immediate postoperative pain control after operations on third molars . There were , however , some side-effects including nausea , vomiting , headaches , and gastrointestinal discomfort , but there were no significant differences among the active analgesic groups with respect to adverse events either shortly after operation or at 6 or 24 Tramadol hydrochloride is a novel , central ly acting analgesic with two complementary mechanisms of action : opioid and aminergic . Relative to codeine , tramadol has similar analgesic properties but may have fewer constipating , euphoric , and respiratory depressant effects . A two-center r and omized double-blind controlled clinical trial was performed to assess the analgesic efficacy and reported side effects of tramadol 100 mg , tramadol 50 mg , codeine 60 mg , aspirin ( ASA ) 650 mg with codeine 60 mg , and placebo . Using a third molar extraction pain model , 200 healthy subjects were enrolled in a 6-hour evaluation after a single dose of drug . Of the 200 patients enrolled , seven provided incomplete efficacy data or discontinued prematurely and one was lost to follow-up . Using st and ard measures of analgesia , including total pain relief score ( TOTPAR ) , maximum pain relief score ( MaxPAR ) , sum of pain intensity difference scores ( SPID ) , peak pain intensity difference ( Peak PID ) , remedication , and global evaluations , all active treatments were found to be numerically superior to placebo . ASA/codeine was found to be statistically superior to placebo for all measures of efficacy . Tramadol 100 mg was statistically superior to placebo for TOTPAR , SPID , and time of remedication , whereas tramadol 50 mg was statistically superior to placebo onlyfor remedication time . Codeine was not found to be statistically superior to placebo for any efficacy measure . A greater TOTPAR response compared with all other active measures was seen for ASA/codeine during the first 3 hours of study . The 6-hour TOTPAR scores for the tramadol groups and ASA/ codeine group were not significantly different . Gastrointestinal side effects ( nausea , dysphagia , vomiting ) were reported more frequently with tramadol 100 mg , ASA/ codeine , and codeine 60 mg than with placebo 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 . METHODS These were 2 r and omized , double-blind , placebo-controlled , single-dose clinical trials that assigned participants ( 2:2:1 ) to receive either aspirin ( 1000 mg ) , acetaminophen ( 300 mg ) with codeine ( 30 mg ) , or placebo . The primary efficacy end point was the sum of pain intensity differences from baseline ( SPID ) over 6 hours for the dental pain study and over 4 hours for the tension-type headache study . Other common analgesic measures , in addition to safety , were also evaluated . RESULTS The results of the dental pain study for aspirin and acetaminophen with codeine suggest statistically significant efficacy for all measures compared with placebo at all time points . Aspirin provided statistically significant efficacy compared with acetaminophen with codeine for SPID(0 - 4 ) ( P = 0.028 ) . In the tension-type headache study , aspirin and acetaminophen with codeine provided statistically significant efficacy compared with placebo for SPID(0 - 4 ) and SPID(0 - 6 ) ( P < 0.001 ) and for total pain relief ( P < 0.001 ) . There were no significant differences between aspirin and acetaminophen with codeine at any evaluation of SPID ( P ≥ 0.070 ) , complete relief ( P ≥ 0.179 ) , or time to meaningful relief ( P ≥ 0.245 ) . Regarding safety , there were no statistically significant differences between treatment groups in the incidence of adverse events in the dental pain and tension-type headache studies . CONCLUSIONS These 2 r and omized , double-blind , placebo-controlled studies demonstrate that treatment with aspirin ( 1000 mg ) provides statistically significant analgesic efficacy compared with placebo use and comparable efficacy with acetaminophen ( 300 mg ) with codeine ( 30 mg ) therapy after impacted third molar extraction and in tension- type headache Three hundred fifty out patients with postoperative pain after the surgical removal of impacted third molars were r and omly assigned , on a double-blind basis , to receive a single oral dose of aspirin 650 or 1000 mg , caffeine 65 mg , a combination of asp
Output:
| Ibuprofen 200 mg with caffeine 100 mg or 200 mg had a reasonable analgesic effect with fewer side effects .
It was found in this systematic review Ibuprofen 400 mg combined with oxycodone HCL 5 mg has superior analgesic efficacy when compared to the other analgesic combinations included in this study |
MS212328 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Pulmonary rehabilitation programmes improve the health of patients disabled by lung disease but their cost effectiveness is unproved . We undertook a cost/utility analysis in conjunction with a r and omised controlled clinical trial of pulmonary rehabilitation versus st and ard care . METHODS Two hundred patients , mainly with chronic obstructive pulmonary disease , were r and omly assigned to either an 18 visit , 6 week rehabilitation programme or st and ard medical management . The difference between the mean cost of 12 months of care for patients in the rehabilitation and control groups ( incremental cost ) and the difference between the two groups in quality adjusted life years ( QALYs ) gained ( incremental utility ) were determined . The ratio between incremental cost and utility ( incremental cost/utility ratio ) was calculated . RESULTS Each rehabilitation programme for up to 20 patients cost £ 12 120 . The mean incremental cost of adding rehabilitation to st and ard care was £ –152 ( 95 % CI –881 to 577 ) per patient , p = NS . The incremental utility of adding rehabilitation was 0.030 ( 95 % CI 0.002 to 0.058 ) QALYs per patient , p=0.03 . The point estimate of the incremental cost/utility ratio was therefore negative . The bootstrapping technique was used to model the distribution of cost/utility estimates possible from the data . A high likelihood of generating QALYs at negative or relatively low cost was indicated . The probability of the cost per QALY generated being below £ 0 was 0.64 . CONCLUSIONS This outpatient pulmonary rehabilitation programme produces cost per QALY ratios within bounds considered to be cost effective and is likely to result in financial benefits to the health service Pulmonary rehabilitation is beneficial for patients with chronic lung disease . However , long-term maintenance has been difficult to achieve after short-term treatment . We evaluated a telephone-based maintenance program after pulmonary rehabilitation in 172 patients with chronic lung disease recruited from pulmonary rehabilitation graduates . Subjects were r and omly assigned to a 12-month maintenance intervention with weekly telephone contacts and monthly supervised reinforcement sessions ( n = 87 ) or st and ard care ( n = 85 ) and followed for 24 months . Except for a slight imbalance between sexes , experimental and control groups were equivalent at baseline and showed similar improvements after rehabilitation . During the 12-month intervention , exercise tolerance ( maximum treadmill workload and 6-minute walk distance ) and overall health status ratings were better maintained in the experimental group together with a reduction in hospital days . There were no group differences for other measures of pulmonary function , dyspnea , self-efficacy , generic and disease-specific quality of life , and health care use . By 24 months , there were no significant group differences . Patients returned to levels close to but above prerehabilitation measures . We conclude that a maintenance program of weekly telephone calls and monthly supervised sessions produced only modest improvements in the maintenance of benefits after pulmonary rehabilitation Objective To determine the feasibility and efficacy of a six-month , cell phone-based exercise persistence intervention for patients with chronic obstructive pulmonary disease ( COPD ) following pulmonary rehabilitation . Methods Participants who completed a two-week run-in were r and omly assigned to either MOBILE-Coached ( n = 9 ) or MOBILE-Self-Monitored ( n = 8) . All participants met with a nurse to develop an individualized exercise plan , were issued a pedometer and exercise booklet , and instructed to continue to log their daily exercise and symptoms . MOBILE-Coached also received weekly reinforcement text messages on their cell phones ; reports of worsening symptoms were automatically flagged for follow-up . Usability and satisfaction were assessed . Participants completed incremental cycle and six minute walk ( 6MW ) tests , wore an activity monitor for 14 days , and reported their health-related quality of life ( HRQL ) at baseline , three , and six months . Results The sample had a mean age of 68 ±11 and forced expiratory volume in one second 18 % predicted . Participants reported that logging their exercise and symptoms ( FEV1 ) of 40 ± was easy and that keeping track of their exercise helped them remain active . There were no differences between groups over time in maximal workload , 6MW distance , or HRQL ( p > 0.05 ) ; however , MOBILE-Self-Monitored increased total steps/day whereas MOBILE-Coached logged fewer steps over six months ( p = 0.04 ) . Conclusions We showed that it is feasible to deliver a cell phone-based exercise persistence intervention to patients with COPD post-rehabilitation and that the addition of coaching appeared to be no better than self-monitoring . The latter finding needs to be interpreted with caution since this was a purely exploratory study . Trial registration Clinical Trials.gov ( NCT00373932 ) Objectives Pulmonary rehabilitation ( PR ) provides benefit for patients with chronic obstructive pulmonary disease ( COPD ) in terms of quality of life ( QoL ) and exercise capacity ; however , the effects diminish over time . Our aim was to evaluate a maintenance programme for patients who had completed PR . Setting Primary and secondary care PR programmes in Norfolk . Participants 148 patients with COPD who had completed at least 60 % of a st and ard PR programme were r and omised and data are available for 110 patients . Patients had greater than 20 pack year smoking history and less than 80 % predicted forced expiratory volume in 1 s but no other significant disease or recent respiratory tract infection . Interventions Patients were r and omised to receive a maintenance programme or st and ard care . The maintenance programme consisted of 2 h ( 1 h individually tailored exercise training and 1 h education programme ) every 3 months for 1 year . Primary and secondary outcome measures The Chronic Respiratory Question naire ( CRQ ) ( primary outcome ) , endurance shuttle walk test ( ESWT ) , EuroQol ( EQ5D ) , hospital anxiety and depression score ( HADS ) , body mass index ( BMI ) , body fat , activity levels ( overall score and activity diary ) and exacerbations were assessed before and after 12 months . Results There was no statistically significant difference between the groups for the change in CRQ dyspnoea score ( primary end point ) at 12 months which amounted to 0.19 ( −0.26 to 0.64 ) units or other domains of the CRQ . There was no difference in the ESWT duration ( −10.06 ( −191.16 to 171.03 ) seconds ) , BMI , body fat , EQ5D , MET-minutes , activity rating , HADS , exacerbations or admissions . Conclusions A maintenance programme of three monthly 2 h sessions does not improve outcomes in patients with COPD after 12 months . We do not recommend that our maintenance programme is adopted . Other methods of sustaining the benefits of PR are required . Trial registration number NCT00925171 Background Chronic obstructive pulmonary disease ( COPD ) and chronic heart failure ( CHF ) frequently coexist , significantly reducing patients ’ quality of life and increasing morbidity and mortality . For either single disease , a multidisciplinary disease-management approach supported by telecommunication technologies offers the best outcome in terms of prolonged survival and reduced hospital readmissions . However , no data exist in patients with combined COPD /CHF.We planned a r and omized controlled trial to investigate the feasibility and efficacy of an integrated , home-based , medical/nursing intervention plus a rehabilitation program versus conventional care in patients with coexisting COPD /CHF . The purpose of the paper is to describe the rationale and design of the trial . Methods / design s Patients , after inpatient rehabilitation , were r and omly assigned to the intervention or control group , followed for 4 months at home , then assessed at 4 and 6 months . The intervention group followed a telesurveillance ( telephone contacts by nurse and remote monitoring of cardiorespiratory parameters ) and home-based rehabilitation program ( at least three sessions/week of mini-ergometer exercises , callisthenic exercises and twice weekly pedometer-driven walking , plus telephone contacts by a physiotherapist ) . Telephone follow-up served to verify compliance to therapy , maintain exercise motivation , educate for early recognition of signs/symptoms , and verify the skills acquired . At baseline and 4 and 6 months , the 6-min Walk Test , dyspnea and fatigue at rest , oxygenation ( PaO2/FiO2 ) , physical activity profile ( PASE question naire ) , and QoL ( Minnesota and CAT question naires ) were assessed . During the study , serious clinical events ( hospitalizations or deaths ) were recorded . Discussion Currently , no studies have assessed the impact of a telehealth program in patients with combined COPD and CHF . Our study will show whether this approach is effective in the management of such complex , frail patients who are at very high risk of exacerbations . Trial registration Network per la prevenzione e la sanità pubblica , CCM , Ministero della Salute “ Modelli innovativi di gestione integrata telegestita ospedale-territorio del malato cronico a fenotipo complesso : studio di implementazione , validazione e impatto , ” registered on 14 January 2014 . Clinical Trials.gov Identifier : NCT02269618 , registered on 17 October 2014 Background Pulmonary Rehabilitation for moderate Chronic Obstructive Pulmonary Disease in primary care could improve patients ’ quality of life . Methods This study aim ed to assess the efficacy of a 3-month Pulmonary Rehabilitation ( PR ) program with a further 9 months of maintenance ( RHBM group ) compared with both PR for 3 months without further maintenance ( RHB group ) and usual care in improving the quality of life of patients with moderate COPD .We conducted a parallel-group , r and omized clinical trial in Majorca primary health care in which 97 patients with moderate COPD were assigned to the 3 groups . Health outcomes were quality of life , exercise capacity , pulmonary function and exacerbations . Results We found statistically and clinical ly significant differences in the three groups at 3 months in the emotion dimension ( 0.53 ; 95%CI0.06 - 1.01 ) in the usual care group , ( 0.72 ; 95%CI0.26 - 1.18 ) the RHB group ( 0.87 ; 95%CI 0.44 - 1.30 ) and the RHBM group as well as in fatigue ( 0.47 ; 95%CI 0.17 - 0.78 ) in the RHBM group . After 1 year , these differences favored the long-term rehabilitation group in the domains of fatigue ( 0.56 ; 95%CI 0.22 - 0.91 ) , mastery ( 0.79 ; 95%CI 0.03 - 1.55 ) and emotion ( 0.75 ; 95%CI 0.17 - 1.33 ) . Between-group analysis only showed statistically and clinical ly significant differences between the RHB group and control group in the dyspnea dimension ( 0.79 95%CI 0.05 - 1.52 ) . No differences were found for exacerbations , pulmonary function or exercise capacity . Conclusions We found that patients with moderate COPD and low level of impairment did not show meaningful changes in QoL , exercise tolerance , pulmonary function or exacerbation after a one-year , community based rehabilitation program . However , long-term improvements in the emotional , fatigue and mastery dimensions ( within intervention groups ) were identified . Trial registration IS RCT Background Interventions for preventing falls in older people often involve several components , multidisciplinary teams , and implementation in a variety of setting s. We have developed a classification system ( taxonomy ) to describe interventions used to prevent falls in older people , with the aim of improving the design and reporting of clinical trials of fall-prevention interventions , and synthesis of evidence from these trials . Methods Thirty three international experts in falls prevention and health services research participated in a series of meetings to develop consensus . Robust techniques were used including literature review s , expert presentations , and structured consensus workshops moderated by experienced facilitators . The taxonomy was refined using an international test panel of five health care practitioners . We assessed the chance corrected agreement of the final version by comparing taxonomy completion for 10 r and omly selected published papers describing a variety of fall-prevention interventions . Results The taxonomy consists of four domains , summarized as the " Approach " , " Base " , " Components " and " Descriptors " of an intervention . Sub-domains include ; where participants are identified ; the theoretical approach of the intervention ; clinical targeting criteria ; details on assessment s ; descriptions of the nature and intensity of interventions . Chance corrected agreement of the final version of the taxonomy was good to excellent for all items . Further independent evaluation of the taxonomy is required . Conclusions The taxonomy is a useful instrument for characterizing a broad range of interventions used in falls prevention . Investigators are encouraged to use the taxonomy to report their interventions BACKGROUND Persons with chronic obstructive pulmonary disease ( COPD ) have reduced exercise capacity and levels of physical activity . Supervised , facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea , but novel long-term strategies are needed to maintain the benefits gained . Mind-body modalities such as Tai Chi which combine aerobic activity , coordination of breathing , and cognitive techniques that alleviate the physical inactivity , dyspnea , and anxiety and depression that are the hallmarks of COPD are promising strategies . METHODS / DESIGN We have design ed a r and omized controlled study to examine whether Tai Chi will maintain exercise capacity in persons with COPD who have recently completed a supervised pulmonary rehabilitation program , compared to st and ar
Output:
| Conclusion In the first systematic review of the area , current evidence demonstrates that continued supervised maintenance exercise compared to usual care following pulmonary rehabilitation reduces health care use in COPD . |
MS212329 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Aim To assess the extent to which bone marrow scintigraphy ( BMS ) makes the interpretation of leucocyte scintigraphy ( LS ) easier and improves its diagnostic value . Methods Seventy-three 111In LSs , 99mTc hydroxymethylene diphosphonate bone scintigraphies ( BSs ) and 99mTc sulfur colloid BMSs were performed in 60 patients with suspected infection related to a hip prosthesis or knee prosthesis , either in situ ( + group , n=43 ) or after removal for septic loosening ( −group , n=30 ) . Bacteriological sample s were obtained from all patients . LS was interpreted together with BS ( LS-BS ) or with BMS ( LS-BMS ) by three independent readers . Results The concordance among readers , estimated by the kappa test , was average with LS-BS ( κ/κm coefficients=0.58 , 0.58 and 0.46 , respectively , for the three pairs of readers ) and excellent with LS-BMS ( κ/κm coefficients=1.00 for the three pairs of readers ) . With LS-BS , 64/219 interpretations were equivocal whereas only one was equivocal with LS-BMS . Sensitivity , specificity and accuracy of LS-BMS were , respectively , 80 % , 94 % and 91 % in the+group , and 33 % , 100 % and 93 % in the−group . Conclusion We conclude that ( 1 ) the interpretation of the results for LS-BMS is very easy , in contrast to LS-BS ; ( 2 ) the diagnostic value of LS-BMS for detecting infected joint prostheses is good ; and ( 3 ) additional data are needed to assess the accuracy of LS-BMS when the prosthesis has been removed Purpose This study aims to assess and compare the value of FDG PET with combined 111In-labeled leukocyte/99mTc-sulfur colloid bone marrow ( WBC/BM ) imaging for diagnosing infection in hip and knee prostheses . Methods In this prospect i ve study , patients with painful hip or knee arthroplasty , who were scheduled to undergo clinical and diagnostic evaluation for prosthesis revision , were included . They have been studied by using FDG PET and WBC/BM scan . This study was institutional review board approved and Health Insurance Portability and Accountability Act compliant . All patients provided written informed consent . Results A total of 134 hip and 87 knee prostheses , suspected of being either infected or noninfectious loosening , were evaluated . All 221 prostheses underwent FDG PET , whereas both WBC/BM imaging and FDG PET were performed in 88 prostheses . The initial analysis of data from the WBC/BM images demonstrated somewhat suboptimal results compared with those of FDG PET scans on 88 patients . In addition , some patients were not willing to undergo both procedures and therefore participate in this study . Therefore , a decision was made to eliminate WBC/BM imaging from the procedures for the remainder of this research study . This decision was reached partly because of the significant radiation dose delivered from labeled WBC and safety issues related to preparing these labeled cells . Final diagnosis was based on microbiological examinations of the surgical specimens in 125 prostheses and joint aspirations combined with the clinical follow-up of 6 months or more in 86 prostheses . The sensitivity , specificity , positive predictive value , and negative predictive value of FDG PET in hip prostheses were 81.8 % , 93.1 % , 79.4 % , and 94.0 % , respectively , and in knee prostheses were 94.7 % , 88.2 % , 69.2 % , and 98.4 % , respectively . The sensitivity , specificity , positive predictive value , and negative predictive value of WBC/BM imaging in hip prostheses were 38.5 % , 95.7 % , 71.4 % , and 84.6 % , respectively , and in knee prostheses were 33.3 % , 88.5 % , 25.0 % , and 92.0 % , respectively . In those cases that underwent both FDG PET and WBC/BM imaging , there was a trend ( P = 0.0625 ) toward a higher sensitivity for FDG PET in hip prostheses , whereas other comparisons did not show any significant differences between the 2 imaging modalities . Conclusions Based on this study , the diagnostic performance of FDG PET scan in detecting infection in painful hip and knee prostheses is optimal for routine clinical application . Considering the complexity and costs of WBC/BM imaging and related safety issues associated with this preparation , FDG PET seems to be an appropriate alternative for assessing these patients PURPOSE To prospect ively determine the accuracy of computed tomography ( CT ) in the detection of painful infection at the site of hip prosthesis before surgery . MATERIAL S AND METHODS Helical CT examinations of hip prostheses were prospect ively performed before surgery after a st and ard clinical and radiologic examination of 65 patients . CT scans and conventional radiographs were review ed for periprosthetic bone abnormalities , and CT scans were review ed for periprosthetic soft-tissue abnormalities ( joint distention , fluid-filled bursae , and fluid collection in muscles and perimuscular fat ) . Patients subsequently underwent revision arthroplasty within 1 month , and infection was diagnosed in 12 ( 19 % ) patients . RESULTS Infection was detected clinical ly in 25 % of patients . Periprosthetic bone abnormalities did not allow differentiation of infection from complications not related to sepsis , except for periostitis , with 100 % specificity but only 16 % sensitivity . Soft-tissue findings were accurate for detection of infection , with 100 % sensitivity and 87 % specificity . Fluid collection in muscles and perimuscular fat had a 100 % positive predictive value , and absence of joint distention had a 96 % negative predictive value . CONCLUSION CT is accurate in the diagnosis of painful infection at the site of a hip prosthesis on the basis of soft-tissue findings , whereas periprosthetic bone abnormalities are not useful Aim To analyse the role played by bone scintigraphy in the diagnosis of infected joint prostheses . Methods The study included 77 patients , aged 32–77 years , in whom infection of a joint prosthesis ( 48 hip , 29 knee ) was suspected . In all patients the following examinations were performed consecutively : a two-phase 99mTc methylene diphosphonate ( 99mTc-MDP ) bone scan , a 99mTc hexamethylproplyene amine oxime ( 99mTc-HMPAO ) labelled white blood cell ( WBC ) scan , and a 99mTc microcolloid bone marrow ( BM ) scan . The minimum interval between examinations was 48 h. The diagnoses were based on data obtained from bacteriological cultures . Results The bone scan was positive in all patients and 28 of them had an infection ( sensitivity 100 % , specificity 0 % ) . The WBC scan was positive in 61 patients but only 27 had an infection . The WBC scan was negative in 16 patients , and the possibility of infection was discarded in 15 of these cases ( sensitivity 96 % , specificity 30 % ) . The results of the bone marrow scan were not compatible with those of the WBC scan ( suggestive of infection ) in 27 patients : 26 of them had prosthesis infection . The results of both examinations were compatible in the other 34 patients and the possibility of infection was discarded in 33 of these patients ( sensitivity 92.8 % , specificity 98 % ) . The addition of a BM scan to a WBC scan decreased the sensitivity from 96 % to 92.8 % but increased specificity from 30 % to 98 % . The addition of a bone scan to this dual combination did not alter the results . Conclusions When infection of a prosthesis is suspected the diagnostic procedure should start with a WBC scan followed , if positive , by a BM scan . This procedure reduces the cost , the time required for a diagnosis , and the dose of radiation received by the patient Ten per cent of patients with hip replacement will eventually complain of significant pain after surgery , often requiring a revision arthroplasty . The majority of these patients experience aseptic loosening rather than infection . Despite significant advances made in diagnostic imaging , distinguishing infection from aseptic loosening remains a significant challenge . Imaging using fluorodeoxyglucose ( FDG ) positron emission tomography ( PET ) has been reported to have excellent sensitivity in detecting infections associated with hip prostheses . However , in some studies , a high rate of false positive results has been reported , especially when increased tracer uptake adjacent to the prosthesis ( which is not surrounded by bone ) is used as the sole criterion for diagnosing infection . The objective of this investigation was to determine the optimal criteria for diagnosing periprosthetic infection , thereby avoiding false positive results in this setting . A total of 41 total hip arthroplasties from 32 patients and for whom complete clinical follow-up was available were included in this analysis . The location and intensity of FDG uptake were determined for each scan . Final diagnosis was made by microbiology , histopathology , surgical findings and clinical follow-up . Patients who did not undergo surgery were followed up to at least 9 months . Twelve patients were proven eventually to have periprosthetic infection . Images from 11 of these patients displayed increased tracer uptake along the interface between bone and prosthesis . The intensity of the increased tracer uptake varied from mild to moderate , with st and ardized uptake values less than 2 . In contrast , images from uninfected , loose hip prostheses revealed very intense uptake around the head or neck of the prosthesis with st and ardized uptake values as high as 7 . It is concluded that the intensity of increased FDG uptake is less important than the location of increased FDG uptake when FDG PET is used to diagnose periprosthetic infection in patients with hip arthroplasty . Using increased uptake as the sole criterion for diagnosing infection will result in false positive results in this setting To determine the value of immunoscintigraphy ( IS ) with antigranulocyte monoclonal antibodies ( Mab ) in the diagnosis of subacute or chronic infection of hip prostheses , we prospect ively studied 57 patients ( 23 women and 34 men ; age 29–92 years , mean 72.7 years ) sent to our institution in the past 6 years for clinical suspicion of septic loosening of a hip prosthesis . Nineteen patients had bilateral prostheses and one of them was studied twice . A total of 78 prostheses were examined . All patients had three-phase bone scans followed by IS with technetium-99 m antigranulocyte Mab BW 250/183 . Intervals between bone scans and IS varied from 2 days to 4 weeks . Final diagnosis was assessed by culture in 48 cases ( articular puncture or intraoperative sampling ) and by clinical follow-up of at least 8 months in 30 cases . Twelve prostheses were considered septic and 66 non-septic . The overall sensitivity and specificity were 92 % and 64 % respectively for bone scans , 67 % and 75 % for IS and 67 % and 84 % for both modalities together . In three cases , IS was doubtful and the final clinical diagnosis was negative for infection . False-positive results were observed in the presence of massive loosening of the prosthesis or in association with metaplastic peri-articular bone formation . In three of the four false-negative results , infection was proven only after enrichment of the culture , and the bacterium wasStaphylococcus epidermidis . In 12/33 ( 36 % ) positive bone scans IS allowed the diagnosis of infection to be excluded . Overall accuracy of both modalities together was 81 % and the negative predictive value was 93 % , which compares favourably with the results reported for other non-invasive methods We compared the accuracy of fluorine-18 labelled 2-fluoro-2-deoxy-d-glucose positron emission tomography ( 18FDG PET ) with that of technetium-99 m hexamethylpropylene amine oxime leucocyte scintigraphy ( LS ) in the detection of infected hip prosthesis . Seventeen patients with a hip prosthesis suspected for infection were prospect ively included and underwent 99mTc-methylene diphosphonate bone scintigraphy ( BS ) , LS and an 18FDG-PET scan within a 2-week period . Seven volunteers with ten asymptomatic hip prostheses were used as a control group and underwent BS and an 18FDG-PET scan . Bacteriology of sample s obtained by surgery or by needle aspiration and /or clinical follow-up for up to 6 months were used as the gold st and ard . Planar images of BS and LS ( 4 and 24 h p.i . ) were acquired , followed by single-photon emission tomography ( SPET ) LS images ( after 4 h ) . These images were scored as positive or negative by two experienced readers . The 18FDG-PET scans of the patients were compared with the tracer distribution pattern in the asymptomatic control group and with
Output:
| Of the currently used imaging techniques , leukocyte scintigraphy has satisfactory accuracy in confirming or excluding periprosthetic hip infection .
Although not significantly different , combined leukocyte and bone marrow scintigraphy was the most specific imaging technique .
FDG PET has an appropriate accuracy in confirming or excluding periprosthetic hip infection , but may not yet be the preferred imaging modality because of limited availability and relatively higher cost . |
MS212330 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 r and omised control trial evaluated the effectiveness of a theory-based persuasive leaflet design ed to encourage students to undertake at least one additional physical exercise session a week . Participants were 503 secondary school students attending a school in South-East Engl and . The leaflet was written to target potentially modifiable cognitive antecedents of exercise specified by the Theory of Planned Behaviour . It was separately augmented with two cognitive change techniques , result ing in three intervention conditions , leaflet alone ; leaflet plus motivational quiz , and leaflet plus implementation intention prompt , as well as a no-leaflet control condition . Cognitions and behaviour were measured immediately before and 3 weeks after intervention . The results showed that all three-leaflet interventions significantly increased reported exercise , intention to exercise and related cognitions , compared to the control condition , but did not differ in their impact . Mediation analysis showed that intervention effects on exercise were partially mediated by intentions and perceived behavioural control OBJECTIVES ICAPS ( Intervention Centred on Adolescents ' Physical activity and Sedentary behaviour ) is aim ed at preventing excessive weight gain and cardiovascular risk in adolescents by promoting physical activity ( PA ) with an emphasis on recreational and daily-life PA , with a lifelong perspective . DESIGN R and omized study design ed to last for four years . Study cohort constituted of 954 first-level students ( 91 % of eligible pupils ) , aged 11.7 + /- 0.6 y ( mean + /- SD ) from four pairs of schools r and omly selected in eastern France , after sociogeographical stratification . In each pair , intervention status was r and omised at school-level . The program , not limited to school setting s , involves multiple partners with three objectives : 1 ) changing attitudes through debates and access to attractive activities during breaks and after-school hours , 2 ) encouraging social support , 3 ) providing environmental conditions that enable PA . Adapted times and places , open participation , emphasis on fun , meeting with others and absence of competitive aspects are used to reduce usual barriers to PA . Accessibility and safety are permanent concerns . RESULTS Prevalence of overweight was 23.7 % . High participation rates were attained ( 50 % participated in at least one weekly activity ) . At six-month , the proportion of intervention adolescents not performing supervised PA out of academic PA was reduced by half ( 36 % to 17 % vs 42 % to 42 % in controls P < 10 - 4 ) ; the proportion of those spending > 3 h/day in sedentary occupations decreased ( 34 % to 28 % vs 27 % to 36 % ; P < 10 - 4 ) . CONCLUSION These data demonstrate the feasibility of implementing a multilevel PA intervention program in adolescents . Six-month results document increased PA and decreased sedentary behaviour Abstract Objectives : To evaluate the effectiveness of inviting teenagers to general practice consultations to discuss health behaviour concerns and appropriate follow up care . Design : R and omised controlled trial , with participants r and omised to a consultation ( intervention ) or usual care ( control ) . Question naires completed at baseline , 3 months , and 12 months . Setting : Eight general practice s in Hertfordshire , Engl and . Participants : 1516 teenagers aged 14 - 15 years . Intervention : Consultations with practice nurses to discuss health concerns and develop plans for healthier lifestyles . Main outcome measures : Mental and physical health , “ stage of change ” for health related behaviour , and use of health services . Results : At baseline 970 teenagers completed question naires ; 23 % smoked , 35 % had been drunk in the previous three months , 64 % considered they ate unhealthily , 39 % took little exercise , and 36 % had possible depression . 41 % ( 304 ) of teenagers invited attended for a consultation ; over one third ( 112 ) were offered follow up care . More intervention group teenagers reported positive movement in stage of change for diet and exercise and in at least one of four behaviours ( diet , exercise , smoking , drinking alcohol ) at 3 months ( 41 % v 31 % , P<0.01 ) , but this did not persist at 12 months . There was marginally more positive change in actual behaviour by intervention teenagers at 3 months ( 16 % v 12 % , P=0.06 ) . Recognition of possible depression result ed in improved mental health outcomes at 3 and 12 months . 97 % of attenders said they would recommend the intervention to a friend . Conclusions : Change in behaviour was slight but encouraging , and the intervention was well received and relatively cheap Interventions to promote physical activity are important in preventing children from becoming overweight . Many projects have been developed but only a few showed ( moderate ) effects . JUMP-in is a systematic ally developed primary -school-based intervention that focuses on the use of theory , environmental changes , parental influences and cooperation with multi-level parties in intervention development . The effects of JUMP-in were evaluated with a quasi-experimental pre-test/post-test research design . In total , 510 children from Grade s 4 , 5 and 6 of four intervention schools and two control schools in Amsterdam were followed for an intervention period of one school year . Changes in physical activity as well as in the social cognitive determinants were assessed using self-reports . In addition , a process evaluation has been executed . The results show that JUMP-in was effective in influencing physical activity , especially among children from Grade 6 . Children in the control group decreased their level of physical activity considerably , while activity levels in intervention children from Grade 6 remained stable . The intervention effects could not be explained by changes in the measured social cognitive determinants . In contrast , process information illuminated differences in intervention effects between the participating schools . The results from the JUMP-in study show the importance of intervention design s that focus on a theory-based mix of relevant environmental and social cognitive factors Physical activity levels in young adults are low . Research supports the use of the Transtheoretical Model of behaviour change ( TM ) in design ing physical activity interventions . This study used a pre-post r and omized control design to investigate the effectiveness of a self-instructional intervention for helping sedentary young adults to initiate physical activity . Post-intervention , significantly more of the experimental group ( 80 % ) , in comparison to the control group ( 68 % ) , improved their exercise stage of change ( SOC ) from baseline ( P < 0.05 ) . Discriminant analyses revealed that discrimination between stage improvement/non-improvement was possible using the processes of change data . Stage improvers scored significantly higher on all of the behavioral and four out of five of the cognitive processes of change . For stage improvers , the processes of self-re-evaluation and self-liberation were most frequently used , whilst social liberation was used significantly more by the experimental than the control group . This inexpensive , self-instructional intervention , based on the TM and the ' active living message ' , is an effective method of assisting sedentary young adults to progress through the exercise SOC Low levels of physical activity coupled with high levels of television viewing have been linked with obesity in children . The objective of this study was to assess the efficacy of ' Switch Off-Get Active ' , a 16-week controlled health education intervention , in increasing physical activity and reducing screen time and BMI in primary school children . A secondary objective was to compare children with high and low screen time . Participants were 312 children aged 10.2+/-0.7 years , attending nine schools in areas of social disadvantage . The 10-lesson , teacher-led intervention , conducted in spring 2003 , emphasised self-monitoring , budgeting of time and selective viewing . Differences , adjusted for baseline values by ANCOVA , existed between intervention and control children at follow-up for self-reported physical activity ( intervention + 0.84 30 min blocks/day , 95%CI 0.11 - 1.57 , p<0.05 ) and self-efficacy for physical activity ( p<0.05 ) but not self-reported screen time ( intervention--0.41 blocks/day , 95%CI--0.93 - 0.12 , p=0.13 ) or BMI ( p=0.63 ) . Cross-sectional comparisons at baseline indicated lower physical activity , self-efficacy for physical activity and aerobic fitness and a higher BMI in children with high screen time . In conclusion , health education interventions can increase physical activity in primary school children but follow-ups of longer duration may be needed to demonstrate intervention effects on BMI Background Aim ing at an active lifestyle , healthy food habits and non-smoking among Swedish children , the Swedish Heart Lung Foundation initiated the health educational programme ‘ An adventure with Pelle Pump ' . A study kit , including theoretical and practical material on heart-lung function and healthy behaviour , was offered to all fourth grade rs in Sweden . The impact of the programme was examined by study ing health behaviours and health knowledge among programme participants using non- participants as a control population . Methods A question naire on health behaviour and health knowledge was answered by a r and om sample of 1369 children from different social classes and living conditions . Children subjected to the programme formed the programme group ( n = 523 ) and those without exposure served as a control group ( n = 846 ) . Results Children in the programme group had a significantly higher level of knowledge ( P < 0.001 ) on questions relating to health behaviour and bodily functions . The actual health behaviour was , however , not affected by the programme . Conclusion Children exposed to a health education programme had , compared with a control population , 2 years after completing the programme , an increased level of knowledge ; however , no difference was found in health behaviour PURPOSE To evaluate the effects of a middle school physical activity intervention , new in combining an environmental and computer tailored component ; and to evaluate the effects of parental involvement . METHODS A clustered r and omized controlled design was used . A r and om sample of 15 schools with 7th and 8th grade rs was r and omly assigned to one of three conditions : ( a ) intervention with parental support , ( b ) intervention alone , and ( c ) control group . The intervention was new in combining environmental strategies with computer-tailored feedback to increase levels of moderate to vigorous physical activity . The intervention was implemented by the school staff . Physical activity was measured through a question naire in the total sample and with accelerometers in a sub sample of adolescents . RESULTS The intervention with parental support led to an increase in self-reported school-related physical activity of , on average , 6.4 minutes per day ( p < or = .05 , d = .40 ) . Physical activity of light intensity measured with accelerometers decreased with , on average , 36 minutes per day as a result of the intervention with parental support ( p < or = .05 , d = .54 ) . Physical activity of moderate to vigorous intensity measured with accelerometers significantly increased with on average 4 minutes per day in the intervention group with parental support , while it decreased with almost 7 minutes per day in the control group ( p < or = .05 , d = .46 ) . CONCLUSIONS The physical activity intervention , implemented by the school staff , result ed in enhanced physical activity behaviors in both middle school boys and girls . The combination of environmental approaches with computer-tailored interventions seemed promising OBJECTIVE To evaluate acceptability , feasibility and effectiveness of computer-tailored physical activity education among adolescents . METHODS Two classes of 7th grade rs from 10 r and omly selected schools were assigned to the intervention ( computer-tailored intervention , n=139 ) or control ( no-intervention , n=142 ) condition . Question naires were completed 1 week before and 3 months after the intervention . The computer-tailored intervention was completed during classes . RESULTS Students had few problems with the diagnostic questions and with the use of a computer . About half of the students evaluated the advice as interesting and easy to underst and and about 40 % as personally relevant , easy to use and credible . Half of students evaluated the advice as too long and only 33 % reported to have used the advice . The computer-tailored intervention was effective for increasing school related physical activity levels with on average 25 min per week ( F=3.4 , P < or = .05 ) , but not for increasing total physical activity or leisure time physical activity . CONCLUSIONS A 1-h computer-tailored intervention offered during class-time has the potential to increase school related physical activity . PRACTICE IMPLICATION S Although favourable effects of large scale implementation may be expected , some adaptations that might increase effectiveness should be investigated in the future PURPOSE To investigate the effect of a six-month teacher-led osteogenic physical activity program , vs. a self-led activity program , on ultrasound measurements of bone in inactive teenage girls . METHODS Ninety sedentary girls [ mean ( SD ) age 16.3 ( .6 ) years ] were identified from 300 assessed for physical activity across five schools in southeast Irel and . Schools were matched and r and omly assigned to a teacher-led physical activity ( TLPA ) program , a self-led physical activity ( SLPA ) program , or a control group . Broadb and ultrasound attenuation ( BUA ) , speed of sound ( SOS ) , and os calcis stiffness index ( OCSI ) were measured using a portable ultrasound machine . Anthropometry , aerobic fitness , calcium intake , and physical activity were assessed , and focus groups held one month after program completion . Descriptive statistics , paired t-tests , and analysis of variance were used to analyze the data . RESULTS Both intervention groups demonstrated significant improvements ( p < .05 ) in BUA , SOS , OCSI and aerobic fitness , i.e. , TLPA : + 14.9 % , + 21.9 % , + 15.9 % , and + 8.5 % , respectively , and SLPA : + 10.6 % , + 30.3 % , + 15.6 % , and + 5.1 % , respectively , with no change in controls . Differences between intervention groups and controls were significant for BUA and OCSI ( p < .0
Output:
| The main findings based on this evidence were : ( 1 ) school-based interventions generally lead to short term improvement in physical activity levels , but there were large differences between interventions with regard to effect sizes ; ( 2 ) a multi-component approach ( including environmental components ) generally result ed in larger effect sizes , thereby providing evidence for the assumption that a multi-component approach should produce synergistic results ; and ( 3 ) if an intervention aim ed to affect more health behaviours besides physical activity , then the intervention appeared to be less effective in favour of physical activity |
MS212331 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: AIMS Despite widespread prevention efforts to decrease adolescent risk-taking , substance use and driving after drinking ( DD ) are prevalent in the United States . The current study compared the efficacy of an abbreviated version of Drug Abuse and Resistance Education ( DARE-A ) to a new Risk Skills Training Program ( RSTP ) . DESIGN Adolescent participation in drinking , drug use , DD and riding with a drunk driver was examined longitudinally . After baseline assessment s , adolescents were r and omly assigned to the RSTP . DARE-A or a no intervention control group and then completed 2-month post-test and 6-month follow-up assessment s. SETTING Adolescents attended a mid-sized suburban high school . PARTICIPANTS The sample ( N = 300 ) was comprised of 58 % females and the age range was 14 - 19 years . INTERVENTION The RSTP was developed to target several risk behaviors and to examine the feasibility of conducting a brief personalized prevention program in a group setting . DARE-A focused on increasing knowledge and underst and ing the deleterious effects of substance use . MEASUREMENTS Risk-taking behavior , perception of peer risk-taking and positive and negative alcohol expectancies were assessed . FINDINGS RSTP participants decreased participation in several risk behaviors at post-test , but reductions were not maintained at 6-month follow-up . The control and DARE-A groups increased their positive and decreased their negative alcohol expectancies . The control group increased their alcohol consumption . CONCLUSIONS Results suggest that a brief , personalized , group prevention program is a feasible approach to reducing adolescent risk-taking . Strategies must be developed to solidify these positive changes so that they are longer-lasting OBJECTIVE To evaluate the effect of the middle and junior high school Drug Abuse Resistance Education ( D.A.R.E. ) and D.A.R.E. Plus programs on drug use and violence . DESIGN R and omized controlled trial of 24 schools , with 3 conditions : D.A.R.E. only , D.A.R.E. Plus , and delayed program control . SETTING Schools and neighborhoods , primarily in Minneapolis-St Paul . PARTICIPANTS All seventh- grade students in 24 schools in the academic year 1999 - 2000 ( N = 6237 at baseline , 67.3 % were white , and there was 84.0 % retention at final follow-up ) . INTERVENTIONS The middle and junior high school D.A.R.E. curriculum in the 16 schools that received D.A.R.E. only and D.A.R.E. Plus . In the 8 schoolts that received D.A.R.E. Plus , additional components included a peer-led parental involvement classroom program called " On the VERGE , " youth-led extracurricular activities , community adult action teams , and postcard mailings to parents . The interventions were implemented during 2 school years , when the cohort was in the seventh and eighth grade s. MAIN OUTCOME MEASURES Self-reported tobacco , alcohol , and marijuana use ; multidrug use ; violence ; and victimization , assessed at the beginning and end of seventh grade and at the end of eighth grade . Growth curve analytic methods were used to assess changes over time by condition . RESULTS There were no significant differences between D.A.R.E. only and the controls ; significant differences among boys between D.A.R.E. Plus and controls for tobacco , alcohol , and multidrug use and victimization ; significant differences among boys between D.A.R.E. Plus and D.A.R.E. only in tobacco use and violence ; and no significant behavioral differences among girls . CONCLUSION D.A.R.E. Plus significantly enhanced the effectiveness of the D.A.R.E. curriculum among boys and was more effective than the delayed program controls , underscoring the potential for multiyear , multicomponent prevention programs and demonstrating sex differences in response to intervention programs Outcome research has shown that drug prevention programs based on theories of social influence often prevent the onset of adolescent drug use . However , little is known empirically about the processes through which they have their effects . The purpose of the present study was to evaluate intervening mechanism theories of two program models for preventing the onset of adolescent drug use . Analyses based on a total of 3077 fifth grade rs participating in the Adolescent Alcohol Prevention Trial revealed that both normative education and resistance training activated the causal processes they targeted . While beliefs about prevalence and acceptability significantly mediated the effects of normative education on subsequent adolescent drug use , resistance skills did not significantly predict subsequent drug use . More impressively , this pattern of results was virtually the same across sex , ethnicity , context ( public versus private school students ) , drugs ( alcohol , cigarettes , and marijuana ) and levels of risk and was durable across time . These findings strongly suggest that successful social influence-based prevention programs may be driven primarily by their ability to foster social norms that reduce an adolescent 's social motivation to begin using alcohol , cigarettes , and marijuana An interactive CD-ROM program design ed to reduce adolescent substance use was developed and evaluated . The program uses video vignettes to teach refusal skills and socially acceptable responses to substance use situations , specifically offers of marijuana . In a r and omized pretest-to-posttest experiment with 74 public school students from six classes in three high schools , significant changes were observed at posttest on ( 1 ) the adolescent 's personal efficacy to refuse the offer of marijuana , ( 2 ) the adolescent 's intention to refuse marijuana if offered , and ( 3 ) the adolescent 's perceptions of the social norms associated with substance use and the importance of respecting another 's decision to refuse a drug offer . In addition , adolescents in the treatment condition were able to recall approximately 50 % of the portrayed refusal strategies . Findings are discussed with regard to the potential benefits of an interactive multimedia approach for conducting substance use interventions The central aim of this study was to evaluate Project PRIDE , a school-based affective education program offered in select schools since 1970 and throughout the entire Philadelphia Public School System since 1981 . The primary purpose of the program is to increase youth 's resistance to drug use and abuse through weekly small group counseling sessions . The 12 weekly student sessions focused on developing self-awareness , life skills , knowledge , and appropriate attitudes about drugs . Project PRIDE also developed training modules for teachers and parents . Evaluation was by means of a true experimental pretest-posttest design , with r and om assignment to treatment and control groups . Measures of attitudes , self-reported drug use , and behavioral intentions were administered to students , teachers , and parents ; process evaluation measures of the student component were collected throughout the treatment period as well . Data analyses indicate that , while a few of the broad aims of the prevention program were not met , there were reliable changes in the intended direction in many of the students ' attitudes and intentions . Student attitudes toward drug use and knowledge about drugs both improved . Project PRIDE participation was associated with a relative decrease in willingness to experiment with drugs , even though all groups showed strongly negative attitudes toward drug use . Treatment interacted with sex of student and /or SES on a number of items . Generally , effects were more pronounced for girls and for low SES students . All groups of participants felt they gained significant knowledge and skills from the program . Other effects for parents and teachers were infrequent and inconsistent A grade five through eight substance abuse prevention program , later incorporated into the Michigan Model for Comprehensive School Health Education , was developed , implemented , and evaluated . Results focus on students who received seven lessons on alcohol in grade six , and eight lessons on tobacco , alcohol , marijuana , and cocaine in grade seven taught by their regular classroom teachers ( after a 6-hour training in the social pressures resistance skills curriculum ) . Students ( N = 442 ) received either two years of the program or none , and completed individually-coded question naires . Repeated measures analysis of variance result ed in significant treatment by occasion interactions on the use of alcohol , cigarettes , marijuana , cocaine , and other drugs , as well as on knowledge . At the end of grade seven , program students ' rates of substance use had increased significantly less and knowledge of alcohol pressures , effects , and skills to resist had increased significantly more than those of comparison students The research community has criticized Drug Abuse Resistance Education ( D.A.R.E. ) because the extant literature indicates a lack of evidence that the elementary school program prevents drug use . Yet D.A.R.E. continues to be the most widely implemented drug use prevention program in the United States and has considerable community support . To date , the junior high D.A.R.E. program has not been evaluated . The Minnesota DARE PLUS Project is a r and omized trial of 24 schools and communities . During 1999 - 2001 , students in eight schools will receive the junior high D.A.R.E. curriculum in 7th grade ; eight schools also will receive the curriculum as well as additional parent involvement , peer leadership , and community components in the 7th and 8th grade s ; and eight schools will serve as controls . This article describes the background and conceptualization , the curriculum and additional intervention components , and the evaluation methods of the DARE PLUS Project OBJECTIVES This paper presents the 1-year outcomes evaluation of Project Towards No Drug Abuse ( Project TND ) , a large-scale indicated drug abuse prevention program in southern California applied to continuation high school youth , who are at high risk for drug abuse . METHODS The efficacy of nine-lesson health motivation -- social skills -- decision-making curriculum was evaluated in a three-condition experimental design . Twenty-one schools were r and omly assigned by block to one of three conditions -- st and ard care ( control ) , classroom program , and classroom program plus a semester-long school-as-community component . A pretest was followed by a 3-week-long drug abuse prevention program and then a posttest at 14 continuation high schools . The 7 st and ard care schools received only the pretest followed by the posttest ( same time duration ) . Subjects were followed up 1 year later . RESULTS Changes in use of cigarettes , alcohol , marijuana , and hard drugs were assessed in a pretest-1-year follow-up time interval . The follow-up rate was 67 % ( analysis n = 1,074 ) . Indicated preventive effects were found on alcohol and hard drug use . No differences were found across the two program conditions . CONCLUSIONS Project TND is the first program to demonstrate 1-year self-reported behavioral effects on alcohol use and hard drug use among older , high-risk youth by using a school-based , limited-session model OBJECTIVE To provide a review of the evidence from 3 experimental trials of Project Towards No Drug Abuse ( TND ) , a senior-high-school-based drug abuse prevention program . METHODS Theoretical concepts , subjects , design s , hypotheses , findings , and conclusions of these trials are presented . A total of 2,468 high school youth from 42 schools in southern California were surveyed . RESULTS The Project TND curriculum shows reductions in the use of cigarettes , alcohol , marijuana , hard drugs , weapon carrying , and victimization . Most of these results were replicated across the 3 trials . CONCLUSION Project TND is an effective drug and violence prevention program for older teens , at least for one-year follow-up An amenability to treatment model stipulates that interventions may be differentially effective for subgroups of individuals with similar characteristics . Using such a model , the present study tests the impact of two social-cognitive interventions implemented in the sixth ( Intervention I ) and eighth/ninth ( Intervention II ) grade s on students ' skill acquisition and on their ninth and tenth grade substance use . A r and omized factorial design was used to examine main and interaction effects within the context of student family household status and gender . Positive program effects were found for Intervention II on skill acquisition and overall drug involvement . Interaction effects of Intervention II x Family Household Status provided support for the amenability to treatment model , but no support for the model was observed based on student gender . Possible explanations for the study findings are presented and future research directions are proposed to address why differences emerge in amenability to intervention and why such differences occur for specific subgroups BACKGROUND Universal school-based prevention programs for alcohol , tobacco , and other drug use are typically design ed for all students within a particular school setting . However , it is unclear whether such broad-based programs are effective for youth at high risk for substance use initiation . METHOD The effectiveness of a universal drug abuse preventive intervention was examined among youth from 29 inner-city middle schools participating in a r and omized , controlled prevention trial . A sub sample of youth ( 21 % of full sample ) was identified as being at high risk for substance use initiation based on exposure to substance-using peers and poor academic performance in school . The prevention program taught drug refusal skills , antidrug norms , personal self-management skills , and general social skills . RESULTS Findings indicated that youth at high risk who received the program ( n = 426 ) reported less smoking , drinking , inhalant use , and polydrug use at the one-year follow-up assessment compared to youth at high risk in the control condition that did not receive the intervention ( n = 332 ) . Results indicate that a universal drug abuse prevention program is effective for minority , economically disadvantaged , inner-city youth who are at higher than average risk for substance use initiation . CONCLUSIONS Findings suggest that universal prevention programs can be effective for a range of youth along a continuum of risk Longitudinal studies aim ed at assessing the impact of interventions on disease risk factors often confront several statistical problems . These problems include 1 ) dependent variables measured by ordered categories , 2 ) numerous potentially relevant patterns of transition between outcome levels , 3 ) mixed units of analysis ( e.g. , assignment by social unit while theorizing in terms of individuals ) , 4 ) incomplete r and omization , and 5 ) correlated estimates for successive occasions of longitudinal measurement . Longitudinal data on use of cigarettes , alcohol , and mariju
Output:
| Skills based programs appear to be effective in deterring early-stage drug use . |
MS212332 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Fifteen preterm infants with patent ductus arteriosus and respiratory distress syndrome were given indomethacin ( 0.2 mg/kg ) at 12 h intervals up to three times , either orally or intravenously , in an uncontrolled , non-r and omized study . Serum indomethacin concentrations were determined in blood sample s taken 12 h after dosing . There was considerable variability in the serum indomethacin concentrations , especially after oral administration , although the mean concentrations after each of the three doses were similar after both oral and intravenous administration . The frequency of closures and transient closures of the ductus arteriosus was also similar for both routes of administration . There was , however , no relation between concentration and effect in individual patients . The sustained exposure to indomethacin which appears to be necessary for ductal closure can sometimes be attained by oral administration To determine if dopamine would prevent the renal side effects of indomethacin , fifteen preterm infants were r and omized into two groups : seven received indomethacin alone , and eight received indomethacin together with low dose dopamine infusion . Infants who received indomethacin together with dopamine had significantly higher UV ( p less than 0.005 ) , CNa ( p less than 0.005 ) , Cosm ( p less than 0.005 ) and FENA ( p less than 0.005 ) than those of infants who received indomethacin alone . There was , however , no significant difference in Ccr and FNa between the groups . These data indicate that dopamine overcomes indomethacins renal side effects of tubular origin , but it can not prevent the renal vasoconstrictive action of vasoconstrictor hormones following the inhibition of prostagl and in synthesis by indomethacin . Considering that RBF and GFR turn to normal approximately 12 hours after the last dose of indomethacin , and that with the use of dopamine systemic blood pressure and peripheral circulation can also be normalized and to some extent myocardiac contractility improved , low doses of dopamine can be used instead of furosemide in the sick preterm infant with PDA when indomethacin therapy is indicated Furosemide stimulates the renal synthesis of prostagl and in E2 , a potent dilator of the ductus arteriosus . We administered this drug to 33 premature infants with the respiratory-distress syndrome , to determine whether it increased the incidence of patent ductus arteriosus . Chlorothiazide , a diuretic that does not stimulate prostagl and in E synthesis , was used as the control drug in 33 other infants . During the study , the incidence of patent ductus arteriosus was significantly higher ( P less than 0.02 ) in the furosemide group ( 18 of 33 infants ) than in the chlorothiazide group ( 8 of 33 ) . Eleven infants in the furosemide group and seven in the chlorothiazide group required ductal ligation ( P greater than 0.2 ) . An additional six infants ( all from the furosemide group ) who did not have evidence of a patent ductus during the study were later found to have one . Overall survival was 76 and 61 per cent in the furosemide and chlorothiazide groups , respectively ( P greater than 0.2 ) . Small ( less than twofold ) increases in the urinary excretion of prostagl and in E were seen after the initial dose of both drugs . When the analysis was repeated after the fifth day of life , prostagl and in E excretion tripled after furosemide administration , whereas no increase occurred with chlorothiazide . We conclude that furosemide increases the incidence of patent ductus arteriosus in premature infants with the respiratory-distress syndrome , probably through a prostagl and in-mediated process The relative potency of four non-steroidal anti-inflammatory drugs ( NSAIDs ) - indomethacin , flurbiprofen , sulindac and piroxicam - in inhibiting frusemide-stimulated natriuresis and creatinine clearance was investigated in a placebo controlled cross-over study using healthy volunteers . All four drugs tested significantly inhibited the action of frusemide and they were equipotent in their effects . If it is accepted that sulindac is renal sparing with respect to inhibition of prostagl and in synthesis , our observations raise two possibilities concerning the underlying mechanism of antagonism : a ) that inhibition of renal prostagl and in synthesis is not important ; b ) that sulindac interacts with frusemide in a manner different from other NSAIDs To determine if furosemide would prevent the renal side effects of indomethacin therapy in premature infants with patent ductus arteriosus , 19 premature infants were r and omized into two groups : nine received indomethacin alone , and ten received indomethacin followed immediately by furosemide . There was no significant difference between the groups in birth weight , gestational age , postnatal age , and in cardiopulmonary or renal status at the time of study . Infants who received indomethacin and furosemide had significantly higher urine output ( P less than 0.05 ) , higher FENa and FECl ( P less than 0.01 ) , and higher glomerular filtration rate ( P less than 0.05 ) than those of infants who received indomethacin alone . Seven infants in each group responded to indomethacin therapy with disappearance of PDA murmur and improvement of cardiovascular status . The results of this study suggest that furosemide may prevent the renal side effects of indomethacin therapy and yet not affect the efficacy of indomethacin in the closure of a PDA Renal function and changes in the activity of selected vasoactive hormones during prolonged indomethacin therapy ( 1 week ) were studied in 11 very-low-birth-weight infants with symptomatic patent ductus arteriosus . The initiation of indomethacin therapy was associated with a reduction in diuresis , a transient decrease in creatinine clearance , and an increase in body weight ( P less than 0.01 ) . Furthermore , there was a transient trend toward hyponatremia and hyperkalemia . This acute renal dysfunction was compatible with a complex picture of renal hypoperfusion associated with a fall of plasma renin activity from high levels prior to indomethacin treatment , with a transient rise in the plasma level of arginine vasopressin and with suppressed renal and systemic prostagl and in synthesis . During treatment , an effective circulatory volume was restored by closing the ductus . In parallel , PRA and AVP plasma concentrations returned to nearly normal values . Subsequently , kidney function was not further impaired despite continued indomethacin therapy . These observations suggest that prolonged indomethacin therapy for prevention of sPDA relapse probably constitutes no further risk to kidney function after successful pharmacologically induced ductal constriction To determine whether furosemide could prevent renal side effects of indomethacin ( INN , indometacin ) used for the pharmacologic closure of the patent ductus arteriosus ( PDA ) in preterm infants Nonsteroidal anti-inflammatory drugs ( NSAID ) suppress prostagl and in-dependent renal blood flow and furosemide-induced diuresis in patients with cirrhosis and ascites . Since sulindac may selectively spare inhibition of renal prostagl and ins , we evaluated the interactions of acute administration of sulindac or indomethacin with furosemide in 15 patients with cirrhosis and ascites . Prior to furosemide , indomethacin reduced creatinine clearance ( by 55 % ) , urinary volume ( by 82 % ) , sodium ( by 93 % ) , and prostagl and in E2 ( by 87 % ) ( all P less than 0.05 ) , whereas sulindac had no effect . However , both drugs reduced furosemide-induced diuresis . Indomethacin appeared slightly more potent in reducing the diuresis ( 55 % v 38 % ) , natriuresis ( 67 % v 52 % ) , and prostagl and in E2 ( PGE2 ) release ( 81 % v 74 % ) . In a similar protocol in healthy subjects , furosemide-induced diuresis and natriuresis were also blunted by both drugs . Thus , under conditions of enhanced prostagl and in activity from furosemide , sulindac does affect renal function . These data suggest that renal function should be monitored in patients with cirrhosis and ascites who receive sulindac as well as other NSAID
Output:
| After the first dose of indomethacin , patients receiving furosemide had higher urine output , fractional excretion of sodium , and osmolar clearance than controls .
Thus , dehydration appears to be a contraindication for furosemide administration in premature infants treated with indomethacin for symptomatic PDA . |
MS212333 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Radical cystectomy ( RC ) for bladder cancer is frequently associated with delayed gastrointestinal ( GI ) recovery that prolongs hospital length of stay ( LOS ) . OBJECTIVE To assess the efficacy of alvimopan to accelerate GI recovery after RC . DESIGN , SETTING , AND PARTICIPANTS We conducted a r and omized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics . INTERVENTION Oral alvimopan 12 mg ( maximum : 15 inpatient doses ) versus placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The two-component primary end point was time to upper ( first tolerance of solid food ) and lower ( first bowel movement ) GI recovery ( GI-2 ) . Time to discharge order written , postoperative LOS , postoperative ileus (POI)-related morbidity , opioid consumption , and adverse events ( AEs ) were evaluated . An independent adjudication of cardiovascular AEs was performed . RESULTS AND LIMITATIONS Patients were r and omized to alvimopan ( n=143 ) or placebo ( n=137 ) ; 277 patients were included in the modified intention-to-treat population . The alvimopan cohort experienced quicker GI-2 recovery ( 5.5 vs 6.8 d ; hazard ratio : 1.8 ; p<0.0001 ) , shorter mean LOS ( 7.4 vs 10.1 d ; p=0.0051 ) , and fewer episodes of POI-related morbidity ( 8.4 % vs 29.1 % ; p<0.001 ) . The incidence of opioid consumption and AEs or serious AEs ( SAEs ) was comparable except for POI , which was lower in the alvimopan group ( AEs : 7 % vs 26 % ; SAEs : 5 % vs 20 % , respectively ) . Cardiovascular AEs occurred in 8.4 % ( alvimopan ) and 15.3 % ( placebo ) of patients ( p=0.09 ) . Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy . CONCLUSIONS Alvimopan is a useful addition to a st and ardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS , with a safety profile similar to placebo . PATIENT SUMMARY This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer . Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo , with comparable safety . TRIAL REGISTRATION Clinical Trials.gov identifier NCT00708201 Background Postoperative ileus ( POI ) is observed in 20–30 % of patients undergoing colorectal cancer surgery , despite enhanced recovery programs ( ERPs ) . Cyclooxygenase (COX)-2 is identified as a key enzyme in POI , but other arachidonic acid pathway enzymes have received little attention despite their potential as selective targets to prevent POI . The objectives were to compare the expression of arachidonic acid metabolism ( AAM ) enzymes ( 1 ) between patients who underwent colorectal cancer surgery and followed an ERP or not ( NERP ) , ( 2 ) and between ERP patients who experimented POI or not and ( 3 ) to determine the ability of antagonists of these pathways to modulate contractile activity of colonic muscle . Methods This was a translational study . Main outcome measures were gastrointestinal motility recovery data , mRNA expressions of key enzymes involved in AAM ( RT-qPCR ) and ex vivo motility values of the circular colon muscle . Twenty-eight prospect ively included ERP patients were compared to eleven retrospectively included NERP patients that underwent colorectal cancer surgery . Results ERP reduced colonic mucosal COX-2 , microsomal prostagl and in E synthase ( mPGES1 ) and hematopoietic prostagl and in D synthase ( HPGDS ) mRNA expression . mPGES1 and HPGDS mRNA expression were significantly associated with ERP compliance ( respectively , r2 = 0.25 , p = 0.002 and r2 = 0.6 , p < 0.001 ) . In muscularis propria , HPGDS mRNA expression was correlated with GI motility recovery ( p = 0.002 ) . The pharmacological inhibition of mPGES1 increased spontaneous ex vivo contractile activity in circular muscle ( p = 0.03 ) . Conclusion The effects of ERP on GI recovery are correlated with the compliance of ERP and could be mediated at least in part by mPGES1 , HPGDS and COX-2 . Furthermore , mPGES1 shows promise as a therapeutic target to further reduce POI duration among ERP patients INTRODUCTION While enhanced recovery after surgery ( ERAS ) has been proven to improve results in colorectal operations with regard to morbidity and duration of hospital stay , its impact on recovery of bowel motility is poorly documented . The aims of this study were to assess the impact of ERAS on bowel motility recovery , and to assess the consequences of the definition of postoperative ileus on its reported incidence in the literature . MATERIAL AND METHODS This is a single-center prospect i ve observational study of consecutive patients who underwent colorectal resection with anastomosis over a period of 17 months . Global resumption of intestinal transit ( GROT ) was defined as passage of stool combined with alimentary tolerance of solid food . RESULTS One hundred and thirty-one patients were included . A median of 14 items ( range : 13 - 16 ) was complied out of 19 observable items in the protocol . Median time to passage of flatus ( MTPF ) was 2 days and the GROT was 3 days . The time interval to MTPF as well as to GROT decreased as adherence to the ERAS protocol increased ( respectively P<0.001 , r2=0.11 and P=0.04 , r2=0.06 ) . The incidence of postoperative " ileus " varied from 1.5 % to 61.8 % depending on the interval chosen to define ileus ( cut-off from 1 to 7 days ) . Adherence to≥85 % of the items in the ERAS protocol protected patients from " prolonged ileus " , i.e. , lasting≥4 days ( OR=0.35 ; 95 % CI=0.15 to 0.83 ) . CONCLUSION The implementation of and compliance with an ERAS protocol allowed a reduction in the time to GROT . There is a need for a consensual definition of postoperative ileus BACKGROUND : Nonsteroidal anti-inflammatory drugs have become an important component of narcotic-sparing postoperative pain management protocol s. However , conflicting evidence exists regarding the adverse association of nonsteroidal anti-inflammatory drug use with intestinal anastomotic healing in colorectal surgery . OBJECTIVE : This study compares patients receiving nonsteroidal anti-inflammatory drugs on postoperative day 1 with patients who did not receive nonsteroidal anti-inflammatory drugs with regard to the occurrence of anastomotic leaks . DESIGN : This is a retrospective study from a protocol -driven prospect ively collected statewide data base . A propensity score model was used to adjust for differences between the groups in patient demographics , characteristics , comorbidities , and laboratory values . SETTING S : The multicenter data set used in this analysis represents a variety of academic and community hospitals within the state of Michigan from July 2012 through February 2014 . PATIENTS : Nonpregnant patients over the age of 18 who underwent colon and rectal surgery with bowel anastomosis were selected . MAIN OUTCOME MEASURES : Occurrence of anastomotic leak , composite surgical site infection , sepsis , and death within 30 days of surgery were the primary outcomes measured . RESULTS : A total of 4360 patients met inclusion criteria , of which 1297 ( 29.7 % ) received nonsteroidal anti-inflammatory drugs and 3063 ( 70.3 % ) did not receive nonsteroidal anti-inflammatory drugs . There was no statistically significant difference between the 2 groups in the proportion of cases with anastomotic leak ( OR , 1.33 ; CI , 0.86–2.05 ; p = 0.20 ) , composite surgical site infection ( OR , 1.26 ; CI , 0.96–1.66 ; p = 0.09 ) , or death within 30 days ( OR , 0.58 ; CI , 0.28–1.19 ; p = 0.14 ) . There was a significantly greater risk of sepsis for patients given nonsteroidal anti-inflammatory drugs than for those patients not given nonsteroidal anti-inflammatory drugs ( OR , 1.47 ; CI , 1.05–2.06 ; p = 0.03 ) . LIMITATIONS : This is a nonr and omized study performed retrospectively , and it is based on data collected only within a subset of hospitals in the state of Michigan . CONCLUSIONS : No statistically significant increase in the proportion of patients with anastomotic leak was observed when prescribing nonsteroidal anti-inflammatory drugs for analgesia in the early postoperative period for patients undergoing elective colorectal surgery . Unexpectedly , there was an increased risk of sepsis that warrants further investigation ( see video , Supplemental Digital Content 1 , http://links.lww.com/DCR/A192 , for a synopsis of this study ) 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 Endogenous prostagl and ins regulate smooth muscle activity ; prostagl and ins and cyclooxygenase ( COX ) inhibitors influence gastrointestinal motility in inflammatory states such as postoperative ileus in animal models . The objective of this study was to evaluate the effects of two COX-2 inhibitors on gastric emptying and intestinal transit in healthy humans . In a double-blind , placebo-controlled , parallel-group study , 66 healthy volunteers were r and omized to one of two commercially available oral COX-2 inhibitors ( celecoxib and rofecoxib ) , cisapride ( positive control ) , or placebo . Following 7 days on therapy , study participants underwent a test of gastric emptying and small bowel transit of liquids and solids using scintigraphy . Data were analysed using Kruskal-Wallis ( ANOVA on ranks ) and Mann-Whitney rank sum tests . There were significant group effects on transit of solids : gastric emptying ( ANOVA , P = 0.005 ) and small bowel transit ( ANOVA , P = 0.056 ) . However , neither COX-2 inhibitor significantly accelerated the liquid or solid gastric emptying or small bowel transit compared with placebo . The positive control , cisapride , accelerated gastric emptying of solids ( post-lag slope of gastric emptying , P < 0.05 ) , and small bowel transit of solids ( t10 % , P = 0.016 ) . At maximum clinical ly approved dosages , celecoxib and rofecoxib have no significant effects on gastric emptying or small intestinal transit in healthy humans . Cisapride accelerates gastric emptying and small bowel transit in healthy humans Abstract Currently , there is a paucity of study investigating postoperative ileus in gastric cancer surgery . This prospect i ve study aims to identify the risk factors for prolonged postoperative ileus ( PPOI ) and to use these risk factors to generate a risk stratification scoring system for the occurrence of PPOI . Patients who underwent radical gastrectomy for gastric cancer were included in this study . A multivariate logistic analysis was applied to identify independent risk factors for PPOI and to generate the scoring system . A receiver operating characteristic curve was generated and the area under the curve was calculated to demonstrate the predictive power of the scoring system . Finally , 296 patients were included and analyzed , of whom 96 ( 32.4 % ) developed PPOI . The multivariate analysis showed that age ≥65 years , operative duration ≥4 hours , tumor – node – metastasis ( TNM ) stage = III , open/converted operative technique , and total postoperative opiates dose ( TOD ) ≥0.3 mg/kg were independent risk factors for PPOI . Based on these factors , a risk stratification scoring system was generated , classified by low-risk ( score 0–2 ) , moderate-risk ( score 3–4 ) , and high-risk ( score 5–6 ) groups . The incidence of PPOI increased by 7.5-fold from low-risk to high-risk group . The area under the curve of the scoring system was 0.841 ( 95 % CI , 0.793–0.890 ) , indicating a good predictive capability for the occurrence of PPOI.We have identified independent risk factors for the occurrence of PPOI and used these factors to construct a risk stratification scoring system BACKGROUND Selective cyclooxygenase-2 ( COX-2 ) inhibitors have come under scrutiny because of reports suggesting an increased cardiovascular risk associated with their use . Experimental research suggesting that
Output:
| NSAIDs significantly improve time to gut recovery after elective colorectal surgery .
Current evidence is not adequate to identify whether selective or nonselective drugs should be recommended . |
MS212334 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Purpose and Methods . To describe medication profile , diet , and exercise/physical activity in hypertensive Korean Americans , a convenience sample of 100 hypertensive Korean Americans ( KAs ) at two KA health clinics were interviewed by bilingual Korean nurses using questions from the 1988 - 1994 Third National Health and Nutrition Examination Survey ( NHANES III ) . One hundred age- and gender-matched hypertensive non-Hispanic Whites and 100 Blacks were r and omly selected from the NHANES III data set , and results were compared to describe the health disparities in lifestyle choices among the three groups . Results . The medication profile among the three groups was similar . A majority of members of all three groups had been told by health professionals to exercise for hypertension . KAs made significantly less effort to reduce salt in their diets than did members of the other two groups ( p < .05 ) . Fewer KAs than non-Hispanic Whites or Blacks were following their health professionals’advice to control or lose weight for their high blood cholesterol levels . KAs had the lowest body mass index and were older and more educated than members of the other two groups . KAs ’ primary reasons for using the KA clinic were the respect they received and the use of the Korean language . Implication s. KA health professionals need to teach their patients more about the importance of health-promoting lifestyles for hypertension and its contributing factors . More KA hypertensive patients should follow the advice of health professionals on healthy lifestyles . Nurses should continue to treat patients with respect and provide care with sensitivity to language needs of patients INTRODUCTION Korean Americans are one of the most underserved ethnic/linguistic minority groups owing to cultural and institutional barriers ; there is an urgent need for culturally competent diabetes management programs in the Korean American community for those with type 2 diabetes . The purpose of this study was to test the effectiveness of a community-based , culturally tailored , multimodal behavioral intervention program in an ethnic/linguistic minority group with type 2 diabetes . DESIGN An RCT with waitlist comparison based on the Predisposing , Reinforcing , and Enabling Constructs in Education/environmental Diagnosis and Evaluation (PRECEDE)-Policy , Regulatory , and Organizational Constructs in Educational and Environmental Development ( PROCEED ) and self-help models . Data were collected between September 2010 and June 2013 and were analyzed in August-December 2014 . Statistical significance was set at p<0.05 . SETTING / PARTICIPANTS In a naturally occurring community setting , a total of 250 Korean Americans with type 2 diabetes were r and omized into an intervention group ( n=120 ) or a control group ( n=130 ) . INTERVENTION The intervention consisted of key self-management skill-building activities through 12 hours of group education sessions , followed by integrated counseling and behavioral coaching by a team of RNs and community health workers . MAIN OUTCOME MEASURES Primary ( clinical ) outcomes were hemoglobin A1c , glucose , total cholesterol , and low-density lipoprotein at baseline and at 3 , 6 , 9 , and 12 months . Secondary ( psychosocial and behavioral ) outcomes included diabetes-related quality of life , self-efficacy , adherence to diabetes management regimen , and health literacy . RESULTS During the 12-month project , the intervention group demonstrated 1.0%-1.3 % ( 10.9 - 14.2 mmol/mol ) reductions in hemoglobin A1c , whereas the control group achieved reductions of 0.5%-0.7 % ( 5.5 - 7.7 mmol/mol ) . The differences between the two groups were statistically significant . The intervention group showed statistically significant improvement in diabetes-related self-efficacy and quality of life when compared with the control group . CONCLUSIONS RN/community health worker teams equipped with culturally tailored training can be effective in helping an ethnic/linguistic minority group manage diabetes in the community Objectives To determine the relationship between the reduction in salt intake that occurred in Engl and , and blood pressure ( BP ) , as well as mortality from stroke and ischaemic heart disease ( IHD ) . Design Analysis of the data from the Health Survey for Engl and . Setting and participants Engl and , 2003 N=9183 , 2006 N=8762 , 2008 N=8974 and 2011 N=4753 , aged ≥16 years . Outcomes BP , stroke and IHD mortality . Results From 2003 to 2011 , there was a decrease in mortality from stroke by 42 % ( p<0.001 ) and IHD by 40 % ( p<0.001 ) . In parallel , there was a fall in BP of 3.0±0.33/1.4±0.20 mm Hg ( p<0.001/p<0.001 ) , a decrease of 0.4±0.02 mmol/L ( p<0.001 ) in cholesterol , a reduction in smoking prevalence from 19 % to 14 % ( p<0.001 ) , an increase in fruit and vegetable consumption ( 0.2±0.05 portion/day , p<0.001 ) and an increase in body mass index ( BMI ; 0.5±0.09 kg/m2 , p<0.001 ) . Salt intake , as measured by 24 h urinary sodium , decreased by 1.4 g/day ( p<0.01 ) . It is likely that all of these factors ( with the exception of BMI ) , along with improvements in the treatments of BP , cholesterol and cardiovascular disease , contributed to the falls in stroke and IHD mortality . In individuals who were not on antihypertensive medication , there was a fall in BP of 2.7±0.34/1.1±0.23 mm Hg ( p<0.001/p<0.001 ) after adjusting for age , sex , ethnic group , education , household income , alcohol consumption , fruit and vegetable intake and BMI . Although salt intake was not measured in these participants , the fact that the average salt intake in a r and om sample of the population fell by 15 % during the same period suggests that the falls in BP would be largely attributable to the reduction in salt intake rather than antihypertensive medications . Conclusions The reduction in salt intake is likely to be an important contributor to the falls in BP from 2003 to 2011 in Engl and . As a result , it would have contributed substantially to the decreases in stroke and IHD mortality OBJECTIVE We estimated the prevalence and incidence of diabetes among specific subgroups of Asians and Pacific Isl and ers ( APIs ) in a multiethnic U.S. population with uniform access to care . RESEARCH DESIGN AND METHODS This prospect i ve cohort analysis included 2,123,548 adult members of Kaiser Permanente Northern California , including 1,704,363 with known race/ethnicity ( white , 56.9 % ; Latino , 14.9 % ; African American , 8.0 % ; Filipino , 4.9 % ; Chinese , 4.0 % ; multiracial , 2.8 % ; Japanese , 0.9 % ; Native American , 0.6 % ; Pacific Isl and er , 0.5 % ; South Asian , 0.4 % ; and Southeast Asian , Korean , and Vietnamese , 0.1 % each ) . We calculated age-st and ardized ( to the 2010 U.S. population ) and sex-adjusted diabetes prevalence at baseline and incidence ( during the 2010 calendar year ) . Poisson models were used to estimate relative risks . RESULTS There were 210,632 subjects with prevalent diabetes as of 1 January 2010 and 15,357 incident cases of diabetes identified during 2010 . The crude diabetes prevalence was 9.9 % and the incidence was 8.0 cases per 1,000 person-years and , after st and ardizing by age and sex to the 2010 U.S. Census , 8.9 % and 7.7 cases per 1,000 person-years . There was considerable variation among the seven largest API subgroups . Pacific Isl and ers , South Asians , and Filipinos had the highest prevalence ( 18.3 , 15.9 , and 16.1 % , respectively ) and the highest incidence ( 19.9 , 17.2 , and 14.7 cases per 1,000 person-years , respectively ) of diabetes among all racial/ethnic groups , including minorities traditionally considered high risk ( e.g. , African Americans , Latinos , and Native Americans ) . CONCLUSIONS High rates of diabetes among Pacific Isl and ers , South Asians , and Filipinos are obscured by much lower rates among the large population of Chinese and several smaller Asian subgroups BACKGROUND National health in the United States is influenced by the dietary norms brought into the country by an increasing number of immigrants . OBJECTIVES This cross-sectional study aim ed to document dietary changes and disease prevalence in relation to the length of residence in the United States for Korean Americans in Michigan . DESIGN Of 1,860 question naires mailed out , 637 ( 34.3 % ) were returned with respondent-reported information , including demographics , weight and height , chronic diseases , and dietary patterns . SUBJECTS/ SETTING Included in the final analyses were 497 first-generation Korean-American immigrants ( 263 men , 234 women , aged 30 to 87 years ) . STATISTICAL ANALYSES PERFORMED Analysis of covariance with the Tukey test and logistic regression models provided sex-specific analysis of dietary changes and disease patterns . All statistical analyses were adjusted for age . RESULTS Chronic diseases reported most frequently by men and women , respectively , were hypertension , digestive diseases , arthritis , and diabetes . Length of residence in the United States ( < or=15 years , 16 to 25 years , or > or=26 years ) was inversely associated with the prevalence of digestive diseases in men ( P=0.017 ) and women ( P=0.001 ) , and positively with respiratory diseases in men and thyroid disease in women ( P<0.05 ) . Length of residence in the United States was inversely associated with intake of rice/rice dishes in both men ( servings per week , P<0.001 ) and women ( P=0.012 ) . The prevalence of digestive diseases associated inversely with length of residence and positively with servings of rice/rice dishes consumed for Korean-American men . The age-adjusted odds ratio for digestive diseases was highest among men who had the shortest length of residence in the United States ( < or=15 years ) and greater consumption of rice/rice dishes ( > 2 servings per day ) ( odds ratio 12.10 ; P=0.03 ) . CONCLUSIONS Dietary changes of Korean-American immigrants in the United States over time were associated with changes in their chronic disease patterns . These findings may help food and nutrition professionals who work with minority immigrants because they identify factors that affect changes in dietary patterns and work toward preventing diet-related diseases . Prospect i ve studies could address underlying mechanisms of the observed diet-disease relationship with subsequent generations of Korean Americans , as well as various ethnic minority immigrants in the United States
Output:
| Moreover , they were less likely to receive counseling about their diseases from healthcare providers and modify their lifestyle ( eg , reduce their diet sodium intake , control their weight ) to manage their diseases than were other ethnic population s. Individual- , interpersonal- , community- , and societal-level influences contributed to the high prevalence of cardiovascular risk factors . |
MS212335 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: As concomitant chemoradiotherapy for stage III NSCLC is associated with survival advantage in comparison to a sequential approach , we conducted a phase III r and omised study aim ing to determine the best sequence and safety of chemotherapy ( CT ) and chemoradiotherapy ( CT-RT ) , using a regimen with cisplatin ( CDDP ) , gemcitabine ( GEM ) and vinorelbine ( VNR ) . Unresectable stage III NSCLC patients received CDDP ( 60 mg/m(2 ) ) , GEM ( 1g/m(2 ) , days 1 and 8) and VNR ( 25mg/m(2 ) , days 1 and 8) with reduced dosage of GEM and VNR during radiotherapy ( 66Gy ) . Two cycles of CT with radiotherapy followed by two further cycles of CT alone were administered in arm A or the reverse sequence in arm B. The study was prematurely closed for poor accrual due to administrative problems . Forty-nine eligible patients were r and omised . Response rates and median survival times were , respectively 57 % ( 95 % CI : 36 - 78 % ) and 17 months ( 95 % CI : 9.3 - 24.6 months ) in arm A and 79 % ( 95 % CI : 64 - 94 % ) and 23.9 months ( 95 % CI : 13.3 - 34.5 months ) in arm B ( p>0.05 ) . Chemotherapy dose-intensity was significantly reduced in arm A. Grade 3 - 4 oesophagitis occurred in 5 patients . One case of grade 5 radiation pneumonitis was observed . In conclusion , chemoradiotherapy with CDDP , GEM and VNR appears feasible as initial treatment or after induction chemotherapy . Consolidation chemoradiotherapy seems less toxic with a better observed response rates and survival although no valid conclusion can be drawn from the comparison of both arms PURPOSE We conducted a phase III study to compare the survival impact of concurrent versus sequential treatment with radiotherapy ( RT ) and chemotherapy ( CT ) in unresectable stage III non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS Patients were r and omly assigned to one of the two treatment arms . In the sequential arm , patients received induction CT with cisplatin ( 120 mg/m2 ) on days 1 , 29 , and 57 , and vinorelbine ( 30 mg/m2/wk ) from day 1 to day 78 , followed by thoracic RT at a dose of 66 Gy in 33 fractions ( 2 Gy per fraction and 5 fractions per week ) . In the concurrent arm , the same RT was started on day 1 with two concurrent cycles of cisplatin 20 mg/m2/d and etoposide 50 mg/m2/d ( days 1 to 5 and days 29 to 33 ) ; patients then received consolidation therapy with cisplatin 80 mg/m2 on days 78 and 106 and vinorelbine 30 mg/m2/wk from days 78 to 127 . RESULTS Two hundred five patients were r and omly assigned . Pretreatment characteristics were well balanced between the two arms . There were six toxic deaths in the sequential arm and 10 in the concurrent arm . Median survival was 14.5 months in the sequential arm and 16.3 months in the concurrent arm ( log-rank test P = .24 ) . Two- , 3- , and 4-year survival rates were better in the concurrent arm ( 39 % , 25 % , and 21 % , respectively ) than in the sequential arm ( 26 % , 19 % , and 14 % , respectively ) . Esophageal toxicity was significantly more frequent in the concurrent arm than in the sequential arm ( 32 % v 3 % ) . CONCLUSION Although not statistically significant , clinical ly important differences in the median , 2- , 3- , and 4-year survival rates were observed , with a trend in favor of concurrent chemoradiation therapy , suggesting that is the optimal strategy for patients with locally advanced NSCLC The optimal schedule and regimen of chemotherapy ( CT ) in association with chemoradiation has not been established in stage III non-small-cell lung cancer ( NSCLC ) . We have compared three schedules of non-platinum-based CT plus either radiotherapy or chemoradiation . From May 2001 to June 2006 , 158 patients with unresectable stage III NSCLC were enrolled in a r and omized phase II trial with overall response rate ( ORR ) as the primary endpoint . The initial design included three arms : sequential CT followed by thoracic radiation ( TRT ) ; concurrent CT/TRT followed by consolidation CT ; and induction CT followed by concurrent CT/TRT . However , based on the preliminary results of the RTOG 9410 trial , the sequential arm was closed when 19 patients had been enrolled . All patients received two cycles of docetaxel 40 mg/m(2 ) days 1 and 8 plus gemcitabine 1200 mg/m(2 ) days 1 and 8 , as either induction or consolidation therapy . Concurrent CT/TRT consisted of docetaxel 20 mg/m(2 ) and carboplatin AUC 2 weekly plus 60 Gy TRT . No differences were found in ORR between the two arms ( 56 % and 57 % ) . Hematological toxicity was mild but significantly superior with consolidation CT ; the esophagitis rate was similar in both arms ( 16 % and 15 % ) . With a median follow-up of 57 months , no differences were found in median survival ( 13.07 and 13.8 months ) or 5-year survival ( 16.4 % and 22 % ) . This regimen can not be recommended as an alternative to platinum-based CT/TRT although it has an acceptable toxicity profile and encouraging long-term survival data ( Clinical Trials.gov NCT01652820 ) Introduction : The aim of this multicenter phase II trial was to evaluate the combination of oral vinorelbine and cisplatin with radiotherapy ( RT ) after cisplatin-docetaxel induction chemotherapy ( CT ) in patients with locally advanced non-small cell lung cancer ( NSCLC ) . Patients and Methods : Patients with previously untreated , inoperable , histologically or cytologically confirmed stage IIIA or IIIB NSCLC , with performance status ≤1 and weight loss ≤10 % received two cycles of induction CT with cisplatin ( 75 mg/m2 ) and docetaxel ( 75 mg/m2 ) every 3 weeks . Patients with a tumor response or stabilization continued to receive cisplatin ( 80 mg/m2 ) and oral vinorelbine ( 40 mg/m2 ) on days 1 and 8 for two cycles , with concomitant thoracic RT ( 2 Gy/d , 5 d/wk , and total dose 66 Gy ) . Results : Fifty-six patients were enrolled . All patients ( n = 38 ) who received CT-RT were assessable for the tumor response . There were no complete responses . In the intent-to-treat analysis , the response rates were 32.1 % after induction CT and 41.1 % after CT-RT . The median progression-free and overall survival times were 9.2 months ( 95 % confidence interval : 7–14 ) and 20.8 months ( 95 % confidence interval : 13.7–24.1 ) , respectively . Adverse effects of RT-CT were grade s 3 to 4 neutropenia ( four patients ) and grade 3 esophageal toxicity ( one patient ) . No treatment-related deaths occurred . Conclusion : The oral vinorelbine-cisplatin combination with concurrent RT is feasible and has a favorable risk-benefit ratio in stage IIIA/IIIB NSCLC PURPOSE This phase II noncomparative r and omized trial was conducted to determine the optimal sequencing and integration of paclitaxel/carboplatin with st and ard daily thoracic radiation therapy ( TRT ) , in patients with locally advanced unresected stage III non-small-cell lung cancer ( NSCLC ) . Survival data were compared with historical st and ard sequential chemoradiotherapy data from the Radiation Therapy Oncology Group . PATIENTS AND METHODS Patients with unresected stages IIIA and IIIB NSCLC , with Karnofsky performance status > or = 70 % and weight loss < or = 10 % , received two cycles of induction paclitaxel ( 200 mg/m2)/carboplatin ( area under the plasma concentration time curve [ AUC ] = 6 ) followed by TRT 63.0 Gy ( arm 1 , sequential ) or two cycles of induction paclitaxel ( 200 mg/m2)/carboplatin ( AUC = 6 ) followed by weekly paclitaxel ( 45 mg/m2)/carboplatin ( AUC = 2 ) with concurrent TRT 63.0 Gy ( arm 2 , induction/concurrent ) , or weekly paclitaxel ( 45 mg/m2)/carboplatin ( AUC = 2)/TRT ( 63.0 Gy ) followed by two cycles of paclitaxel ( 200 mg/m2)/carboplatin ( AUC = 6 ; arm 3 , concurrent/consolidation ) . RESULTS With a median follow-up time of 39.6 months , median overall survival was 13.0 , 12.7 , and 16.3 months for arms 1 , 2 , and 3 , respectively . During induction chemotherapy , grade 3/4 granulocytopenia occurred in 32 % and 38 % of patients on study arms 1 and 2 , respectively . The most common locoregional grade 3/4 toxicity during and after TRT was esophagitis , which was more pronounced with the administration of concurrent chemoradiotherapy on study arms 2 and 3 ( 19 % and 28 % , respectively ) . CONCLUSION Concurrent weekly paclitaxel , carboplatin , and TRT followed by consolidation seems to be associated with the best outcome , although this schedule was associated with greater toxicity This is phase II study evaluating a non-platinum-containing regimen , used in conjunction with radiotherapy , in patients with locally advanced non-small cell lung cancer ( NSCLC ) . Patients with non-resectable stage III NSCLC were treated with two cycles of induction gemcitabine ( 1000mg/m(2 ) ) and vinorelbine ( 25mg/m(2 ) ) given on D(1,8 ) every 21 days , followed by thoracic radiotherapy ( 60 - 66Gy ) with concurrent weekly vinorelbine ( 15mg/m(2 ) ) . The primary objective was to assess response rate and secondary objectives to assess tolerability and to determine the progression-free survival ( PFS ) and overall survival ( OS ) . Of the 42 patients enrolled on the study , 15 ( 36 % ) achieved a partial response ( PR ) after induction chemotherapy . After chemo-radiotherapy , five patients had complete response ( CR ) and 19 patients had PR , giving an overall response rate of 52 % . The median PFS was 8 months and median OS was 17 months . The regimen was tolerable , with a 21 % grade 3/4 neutropenia rate and 38 % grade 2/3 esophagitis rate PURPOSE St and ard therapy for unresectable stage III non-small-cell lung cancer includes concomitant chemoradiotherapy . In Cancer and Leukemia Group B 39801 , we evaluated whether induction chemotherapy before concurrent chemoradiotherapy would result in improved survival . PATIENTS AND METHODS Between July 1998 and May 2002 , 366 patients were r and omly assigned to arm A , which involved immediate concurrent chemoradiotherapy with carboplatin area under the concentration-time curve ( AUC ) of 2 and paclitaxel 50 mg/m2 given weekly during 66 Gy of chest radiotherapy , or arm B , which involved two cycles of carboplatin AUC 6 and paclitaxel 200 mg/m2 administered every 21 days followed by identical chemoradiotherapy . The accrual goal was 360 patients . RESULTS Thirty-four percent of patients were female , 66 % were male , and the median age was 63 years . Grade 3 or 4 toxicities during induction chemotherapy on arm B consisted mainly of neutropenia ( 18 % and 20 % , respectively ) . During concurrent chemoradiotherapy , there was no difference in severity of in-field toxicities of esophagitis ( grade 3 and 4 were , respectively , 30 % and 2 % for arm A v 28 % and 8 % for arm B ) and dyspnea ( grade 3 and 4 were , respectively , 11 % and 3 % for arm A v 15 % and 4 % for arm B ) . Survival differences were not statistically significant ( P = .3 ) , with a median survival on arm A of 12 months ( 95 % CI , 10 to 16 months ) versus 14 months ( 95 % CI , 11 to 16 months ) on arm B and a 2-year survival of 29 % ( 95 % CI , 22 % to 35 % ) and 31 % ( 95 % CI , 25 % to 38 % ) . Age , weight loss before therapy , and performance status were statistically significant predictive factors . CONCLUSION The addition of induction chemotherapy to concurrent chemoradiotherapy added toxicity and provided no survival benefit over concurrent chemoradiotherapy alone . The median survival achieved in each of the treatment groups is low , and
Output:
| Our analysis also indicated that induction chemotherapy was as effect as consolidation chemotherapy for patients who received CCRT on overall response and OS .
Conclusion : Five year OS could be improved when induction chemotherapy was added into CCRT for patients of NSCLC .
Except low rate of leucopenia , induction chemotherapy was no difference compared to consolidation chemotherapy in patients with NSCLC treated by CCRT |
MS212336 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year Background Numerous mobile applications have been developed to support diabetes-self-management . However , the majority of these applications lack a theoretical foundation and the involvement of people with diabetes during development . The aim of this study was to develop and test a mobile application ( app ) supporting diabetes self-management among people with newly diagnosed type 2 diabetes using design thinking . Methods The app was developed and tested in 2015 using a design -based research approach involving target users ( individuals newly diagnosed with type 2 diabetes ) , research scientists , healthcare professionals , design ers , and app developers . The research approach comprised three major phases : inspiration , ideation , and implementation . The first phase included observations of diabetes education and 12 in-depth interviews with users regarding challenges and needs related to living with diabetes . The ideation phrase consisted of four interactive workshops with users focusing on app needs , in which ideas were developed and prioritized . Finally , 14 users tested the app over 4 weeks ; they were interviewed about usability and perceptions about the app as a support tool . Results A multifunctional app was useful for people with newly diagnosed type 2 diabetes . The final app comprised five major functions : overview of diabetes activities after diagnosis , recording of health data , reflection games and goal setting , knowledge games and recording of psychological data such as sleep , fatigue , and well-being . Users found the app to be a valuable tool for support , particularly for raising their awareness about their psychological health and for informing and guiding them through the healthcare system after diagnosis . Conclusions The design thinking processes used in the development and implementation of the mobile health app were crucial to creating value for users . More attention should be paid to the training of professionals who introduce health apps . Trial registration : Danish Data Protection Agency : 2012 - 58 - 0004 . Registered 6 February 2016 Numerous diabetes-management systems and programs for improving glycemic control to meet guideline targets have been proposed , using IT technology . But all of them allow only limited-or no-real-time interaction between patients and the system in terms of system response to patient input ; few studies have effectively assessed the systems ' usability and feasibility to determine how well patients underst and and can adopt the technology involved . DialBetics is composed of 4 modules : ( 1 ) data transmission module , ( 2 ) evaluation module , ( 3 ) communication module , and ( 4 ) dietary evaluation module . A 3-month r and omized study was design ed to assess the safety and usability of a remote health- data monitoring system , and especially its impact on modifying patient lifestyles to improve diabetes self-management and , thus , clinical outcomes . Fifty-four type 2 diabetes patients were r and omly divided into 2 groups , 27 in the DialBetics group and 27 in the non-DialBetics control group . HbA1c and fasting blood sugar ( FBS ) values declined significantly in the DialBetics group : HbA1c decreased an average of 0.4 % ( from 7.1 ± 1.0 % to 6.7 ± 0.7 % ) compared with an average increase of 0.1 % in the non-DialBetics group ( from 7.0 ± 0.9 % to 7.1 ± 1.1 % ) ( P = .015 ) ; The DialBetics group FBS decreased an average of 5.5 mg/dl compared with a non-DialBetics group average increase of 16.9 mg/dl ( P = .019 ) . BMI improvement-although not statistically significant because of the small sample size-was greater in the DialBetics group . DialBetics was shown to be a feasible and an effective tool for improving HbA1c by providing patients with real-time support based on their measurements and inputs OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education . In this study we compared a Diabetes Interactive Diary ( DID ) with st and ard carbohydrate counting in terms of metabolic and weight control , time required for education , quality of life , and treatment satisfaction . RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were r and omly assigned to DID ( group A , n = 67 ) or st and ard education ( group B , n = 63 ) and followed for 6 months . A subgroup also completed the SF-36 Health Survey ( SF-36 ) and World Health Organization-Diabetes Treatment Satisfaction Question naire ( WHO-DTSQ ) at each visit . RESULTS Of 130 patients ( aged 35.7 ± 9.4 years ; diabetes duration 16.5 ± 10.5 years ) , 11 dropped out . Time for education was 6 h ( range 2–15 h ) in group A and 12 h ( 2.5–25 h ) in group B ( P = 0.07 ) . A1C reduction was similar in both groups ( group A from 8.2 ± 0.8 to 7.8 ± 0.8 % and group B from 8.4 ± 0.7 to 7.9 ± 1.1 % ; P = 0.68 ) . Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight . No severe hypoglycemic episode occurred . WHO-DTSQ scores increased significantly more in group A ( from 26.7 ± 4.4 to 30.3 ± 4.5 ) than in group B ( from 27.5 ± 4.8 to 28.6 ± 5.1 ) ( P = 0.04 ) . Role Physical , General Health , Vitality , and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education , allowing dietary freedom for a larger proportion of type 1 diabetic patients . DID is safe , requires less time for education , and is associated with lower weight gain . DID significantly improved treatment satisfaction and several quality -of-life dimensions The dem and for new healthcare services is growing rapidly . Improving accessibility of the African population to diabetes care seems to be a big challenge in most countries where the number of care centers and medical staff is reduced . Information and communication technologies ( ICT ) have great potential to address some of these challenges faced by several countries in providing accessible , cost-effective , and high- quality health care services . This paper presents the Mobil Diab system which is a telemedical approach proposed for the management of long-term diseases . The system applies modern mobile and web technologies which overcome geographical barriers , and increase access to health care services . The idea of the system is to involve patients in the therapy process and motivate them for an active participation . For validation of the system in African context , a trial was conducted in the Democratic Republic of Congo . 40 Subjects with diabetes divided r and omly into control and intervention groups were included in the test . Results show that Mobil Diab is suitable for African countries and presents a number of benefits for the population and public health care system . It improves clinical management and delivery of diabetes care services by enhancing access , quality , motivation , reassurance , efficiency , and cost-effectiveness Background Self-management is crucial in the daily management of type 2 diabetes . It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling . Objective The objective of this study was to test whether the use of a mobile phone – based self-management system used for 1 year , with or without telephone health counseling by a diabetes specialist nurse for the first 4 months , could improve glycated hemoglobin A1c ( HbA1c ) level , self-management , and health-related quality of life compared with usual care . Methods We conducted a 3-arm prospect i ve r and omized controlled trial involving 2 intervention groups and 1 control group . Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1 % ( ≥54.1 mmol/mol ) and aged ≥18 years . Both intervention groups received the mobile phone – based self-management system Few Touch Application ( FTA ) . The FTA consisted of a blood glucose – measuring system with automatic wireless data transfer , diet manual , physical activity registration , and management of personal goals , all recorded and operated using a diabetes diary app on the mobile phone . In addition , one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after r and omization . All groups received usual care by their general practitioner . The primary outcome was HbA1c level . Secondary outcomes were self-management ( heiQ ) , health-related quality of life ( SF-36 ) , depressive symptoms ( CES-D ) , and lifestyle changes ( dietary habits and physical activity ) . Data were analyzed using univariate methods ( t test , ANOVA ) and multivariate linear and logistic regression . Results A total of 151 participants were r and omized : 51 to the FTA group , 50 to the FTA-health counseling ( FTA-HC ) group , and 50 to the control group . Follow-up data after 1 year were available for 120 participants ( 79 % ) . HbA1c level decreased in all groups , but did not differ between groups after 1 year . The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age , gender , and education ( P=.04 ) . Other secondary outcomes did not differ between groups after 1 year . In the FTA group , 39 % were substantial users of the app ; 34 % of the FTA-HC group were substantial users . Those aged ≥63 years used the app more than their younger counterparts did ( OR 2.7 ; 95 % CI 1.02 - 7.12 ; P=.045 ) . Conclusions The change in HbA1c level did not differ between groups after the 1-year intervention . Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group . Older participants used the app more than the younger participants did Purpose The purpose of this study was to determine the impact of diabetes self-management education ( DSME ) in improving processes and outcomes of diabetes care as measured by a five component diabetes bundle and HbA1c , in individuals with type 2 diabetes mellitus ( T2DM ) . Methods A retrospective analysis was performed for adult T2DM patients who received DSME training in 2011–2012 from an accredited American Diabetes Association center at Intermountain Healthcare ( IH ) and had an HbA1c measurement within the prior 3 months and 2–6 months after completing their first DSME visit . Control patients were selected from the same clinics as case- patients using r and om number generator to achieve a 1 to 4 ratio . Case and control patients were included if 1 ) pre-education HbA1c was between 6.0%–14.0 % ; 2 ) their main provider was a primary care physician ; 3 ) they met the national Healthcare Effectiveness Data and Information Set criteria for inclusion in the IH diabetes registry . The IH diabetes bundle includes retinal eye exam , nephropathy screening or prescription of angiotensin converting enzyme or angiotensin receptor blocker ; blood pressure < 140/90 mmHg , LDL < 100 mg/dL , HbA1c < 8.0 % . Results DSME patients had a significant difference in achievement of the five element IH diabetes bundle and in HbA1c % compared to those without DSME . After adjusting for possible confounders in a multivariate logistic regression model , DSME patients had a 1.5 fold difference in improvement in their diabetes bundle and almost a 3 fold decline in HbA1c compared to the control group . Conclusion St and ardized DSME taught within an IH American Diabetes Association center is strongly associated with a substantial improvement in patients meeting all five elements of a diabetes bundle and a decline in HbA1c beyond usual care . Given the low operating cost of the DSME program
Output:
| Documentation and inclusion of such vital information will foster a transparent and shared decision-making process that will ultimately lead to the development of practical and user-friendly self-management apps that can enhance the quality of life for diabetes patients |
MS212337 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Fifty-two women undergoing labor induction and vaginal delivery at term were r and omized between two oxytocin infusion protocol s , involving hourly versus quarter-hourly increases in dose . Potential differences were sought for duration of labor , amount of uterine activity generated , and amount of oxytocin required . Starting at 0.5 mU/minute , oxytocin infusion was increased regularly in small increments every hour or every 15 minutes , according to group assignment . No differences were observed in potentially confounding clinical and demographic factors between the groups , including time to ruptured membranes . There were no clinical ly or statistically significant differences found for the duration of any phase or stage of labor , quantitative assessment of uterine activity , incidence of hyperstimulation , or neonatal outcome . The average dose of oxytocin used was lower in the hourly than in the quarter-hourly protocol ( 4.4 versus 6.7 mU/minute ; P<.005 ) . Significantly fewer patients on the hourly protocol required a maximum infusion rate exceeding 8 mU/minute ( P<.05 ) . More patients on the hourly protocol either had oxytocin discontinued completely or were maintained at 4 mU/minute or less during the active phase of labor ( P<.05 and P<.001 , respectively ) . We conclude that a slower rate of increase in oxytocin administration via continuous infusion results in no prolongation of any phase of induced labor , while permitting lower infusion rates of the drug Summary . A r and omized prospect i ve controlled trial of an automatic feed‐back controlled oxytocin infusion system ( AIS ) for the induction of labour at term was carried out in three hospitals . In primiparae , a four‐fold reduction in the total dose of oxytocin infused , for the same induction‐delivery interval , was achieved with the AIS compared with st and ard labour ward protocol s relying on midwife control of oxytocin infusion rate . In multiparae , the total dose of oxytocin infused was almost halved when the AIS was used , while the mean duration of labour was increased by 1.6 h to 7.5 h. There were no differences in the mode of delivery or Apgar scores . It is concluded that the AIS is a safe technique for induction of labour . Its use has demonstrated that term labour can be induced efficiently with a mean oxytocin infusion rate between 2–5 and 3 mU/min ( max 8.8 mU/min ) and a total oxytocin dose infused of < 5 Abstract A total of 200 women planned for labour induction were r and omised to receive high-dose oxytocin ( 6 mU/min with similar increments every 45 min ) or intermediate-dose oxytocin ( 3 mU/min with similar increments every 45 min ) . Oxytocin solution was prepared with 30 units in 500 ml saline with which the infusion rate in ml/h is numerically equal to oxytocin in mU/min . We observed that the caesarean rate ( 18 % vs 6 % , p = 0.009 ) , contraction abnormalities ( 35 % vs 14 % , p = 0.0005 ) and neonatal bilirubin levels ( 7.99 ± 2.70 vs 6.80 ± 2.65 , p = 0.002 ) were higher with high-dose than with intermediate-dose . The induction – delivery interval ( IDI ) was similar ( 10 h 13 min with high-dose and 11 h 5 min with intermediate-dose ; p = 0.237 , NS ) . Nulliparous women benefited more with intermediate-dose as the caesarean rate was higher with high-dose ( 24.6 % vs 7.9 % , p = 0.011 ) . Although the caesarean rate was higher in multiparous women with high-dose oxytocin , it was statistically not significant ( 5.7 % vs 2.7 % ; p = 0.609 ) . Oxytocin regimens for labour induction are usually high-dose ( 4–6 mU/min ) or low-dose ( 1–1.5 mU/min ) . The former is associated with more contraction abnormalities and the latter with prolonged IDI ; both result in an increased caesarean rate . In order to offset these disadvantages , an intermediate- dose regimen was selected . The increment interval of 45 min was selected in accordance with the pharmacokinetics of oxytocin . We observed a lower caesarean rate when compared with the high-dose regimen , without any increase in the IDI . Hence , we propose that the intermediate-dose oxytocin regimen should be preferred to the high-dose regimen for labour induction OBJECTIVE The objective was to test the safety and efficacy of a pulsatile oxytocin infusion protocol in which a computer-controlled pump adjusts the oxytocin dose rate on the basis of uterine activity . STUDY DESIGN A total of 358 women were enrolled in , and 310 completed , a prospect i ve , r and omized clinical trial comparing three protocol s for the induction of labor with oxytocin : aggressively managed continuous infusion , conservatively managed continuous infusion , and computer-controlled pulsatile infusion . Results were analyzed with Student t and chi 2 " goodness-of-fit " tests . RESULTS Mean doses of oxytocin in the group receiving pulsed oxytocin were approximately 20 % of the dose rates in the continuous infusion protocol s. All protocol s effectively established labor in the majority of patients , although nulliparous women with unfavorable Bishop scores were more likely to fail to establish labor within a 24-hour period when treated with the aggressive continuous protocol . There were no differences in the rates of cesarean section , hyperstimulation , blood gases , or Apgar scores among the three treatment groups . CONCLUSIONS Oxytocin dosage was minimized by use of a computer-controlled pump . With the exception of aggressively managed nulliparous women , there were no differences in the percentages of patients with successful inductions among the three protocol s. The percentage of successful inductions was lower for aggressively managed nulliparous women than for other patient and protocol groups OBJECTIVE To determine whether pulsatile oxytocin infusion improves delivery outcome in women requiring induction or augmentation of labor . STUDY DESIGN Two related r and omized controlled trials undertaken in 2 inner-city United Kingdom university hospitals ( IS RCT N72773405 ; http://www.is rct n.org/ ) . Women were r and omly assigned to a pulsatile or continuous infusion protocol . PRIMARY OUTCOME cesarean section rate ( induction trial ) ; operative delivery rate ( augmentation trial ) . RESULTS For induction , cesarean section rates were similar in women receiving pulsatile ( n = 264 , 38.3 % ) vs continuous infusion of oxytocin ( n = 257 ; 37.7 % ; risk ratio , 1.01 ; 95 % confidence interval , 0.81 - 1.26 ; P = .903 ) , but associated with increased " infusion to time of delivery " intervals ( P < .001 ) in the pulsatile group . For augmentation , pulsatile infusion result ed in higher operative delivery rates ( 70.1 % , n = 251 ) vs continuous infusion ( 62.7 % , n = 249 ; risk ratio , 1.12 ; 95 % confidence interval , 0.99 - 1.27 ; P = .077 ) and increased neonatal morbidity . CONCLUSION For induction , pulsatile infusion of oxytocin is effective , but conferred little clinical benefit . Pulsatile infusion is not recommended for augmentation OBJECTIVE To compare the efficacy and safety of arithmetic and geometric increases in oxytocin infusion dosage during induction of labor . METHODS A total of 120 pregnant women requiring induction of labor at term were r and omly assigned to receive oxytocin at dosages increasing arithmetically or geometrically . Maternal demographics , labor delivery data , and newborn outcomes were compared . The setting was the maternity unit of the Obafemi Awolowo University Teaching Hospitals Complex , Ile-Ife , Nigeria . RESULTS The mean maximum rates of oxytocin delivery needed to achieve adequate uterine contractions were similar in the 2 groups ( 24.66+/-8.34 mU/min vs. 26.38+/-8.77 mU/min , P=0.24 ) . Labor duration was significantly shorter in the geometric progression group ( 496.33+/-54.77 min vs. 421.34+/-63.91 min , P<0.001 ) . There were no differences in the rates of cesarean sections , vaginal deliveries , or uterine hyperstimulation , or in neonatal outcomes . CONCLUSION A geometric rise in the rate of oxytocin infusion delivery reduced the duration of labor without affecting the rates of cesarean sections and uterine hyperstimulation , or newborn outcomes OBJECTIVE Our objective was to compare the safety and efficacy of two accepted oxytocin induction protocol s that differ in oxytocin dose increments . STUDY DESIGN At the Carolinas Medical Center in Charlotte , North Carolina , 151 women with indications for induction of labor were prospect ively r and omized into one of two oxytocin induction protocol s. Safety and efficacy of the two protocol s were analyzed with two-tailed t tests and chi 2 . RESULTS Time from induction to establishment of a regular labor pattern was significantly shorter in the experimental group compared with the traditional group ( p = 0.03 ) . However , no significant difference was seen from onset of induction to time of delivery . Incidences of hyperstimulation were not significantly different between the two protocol s , but there was a trend toward a higher incidence of fetal heart rate changes in the experimental group ( p = 0.08 ) . CONCLUSION These data suggest that induction with larger dose increments will shorten time to adequate labor without an associated increase in uterine hyperstimulation or poor neonatal outcome . The differences in heart rate changes are concerning and merit further investigation . If confirmed by further studies , an increased risk of cord compression could outweigh the benefit of a faster onset of contractions OBJECTIVE To investigate in women of low parity ( para 1 , 2 or 3 ) whether induction of labor using a regimen of intravenous oxytocin , increasing incrementally at 30-min intervals is safer than one increasing at 15-min intervals . METHOD Two hundred and forty-five women of low parity requiring induction of labor by infusion of oxytocin were r and omly allocated to incremental increases at 30-min intervals ( 123 women ) as experimental group or 15-min intervals ( 122 women ) as the control group . In both groups forewater amniotomy was performed synchronously with oxytocin infusion using the allocated regimen . RESULTS The 30-min incremental regimen result ed in less precipitate labor , uterine hyperstimulation and a reduced length of stay in hospital . The induction delivery interval was longer with the experimental group which also had less occurrence of postpartum hemorrhage , perineal tears and puerperal pyrexia . CONCLUSION Oxytocin infusion regimen with 30 min incremental increases is safer than the regimen with 15-min incremental increases The number of cesarean births for dystocia has increased dramatically in the United States . Central to the management of dystocia is correction of ineffective labor by oxytocin administration , and contemporary obstetric practice is to stimulate labor with a low-dose oxytocin regimen . We prospect ively compared a low-dose oxytocin regimen ( 1-mU/ minute dosage increments ) with a high-dose regimen ( 6-mll/ minute dosage increments ) in 2788 consecutive singleton cephalic pregnancies . The low-dose regimen was used first for 5 months in 1251 pregnancies , and the high-dose regimen in 1537 pregnancies during the subsequent 5 months . Indications for oxytocin stimulation were divided into augmentation ( N=1676 ) and induction ( N=1112 ) . Labor stimulation was more than 3 hours shorter ( P<.0001 ) with the high-dose oxytocin regimen and associated with a reduction in neonatal sepsis ( 0.2 versus 1.3 % ; P<.01 ) . Uterine hyperstimulation was more common ( 55 versus 42 % ; P<.0001 ) with the high-dose regimen , but no adverse fetal effects were observed . High-dose augmentation result ed in significantly fewer forceps deliveries ( 12 versus 16 % ; P=.03 ) and fewer cesareans for dystocia ( 9 versus 12 % ; P=.04 ) . Similarly , failed induction was less frequent with high-dose compared with low-dose oxytocin ( 14 versus 19 % ; P=.05 ) . Although the high-dose induction regimen was associated with a significantly increased cesarean incidence for fetal distress ( 6 versus 3 % ; P=.05 ) , the incidence of umbilical artery cord blood acidemia was not increased in this subset . Induction of labor with high-dose oxytocin is problematic because of risk-benefit considerations . Although induction failed less frequently with the high-dose regimen , cesarean for fetal distress was performed more frequently . In contrast , high-dose oxytocin to augment ineffective spontaneous labor minimized the number of cesareans done for dystocia OBJECTIVE To test the hypothesis that high-dose oxytocin , when used in a masked fashion , would result in shorter labors and less need for cesarean delivery . METHODS We conducted r and omized , double-masked trials of high-dose compared with low-dose oxytocin for augmentation and induction of labor . Patients were r
Output:
| AUTHORS ' CONCLUSIONS The findings of our review do not provide evidence that high-dose oxytocin increases either vaginal delivery within 24 hours or the caesarean section rate .
There is no significant decrease in induction to delivery time at meta- analysis but these results may be confounded by poor quality trials .
High-dose oxytocin was shown to increase the rate of uterine hyperstimulation but the effects of this are not clear . |
MS212338 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged PURPOSE To describe our experience with levetiracetam ( LEV ) as initial or conversion monotherapy treatment for juvenile myoclonic epilepsy ( JME ) . Valproate , the usual first line agent for JME , has chronic adverse effects , particularly for women of childbearing potential . Since JME requires lifetime treatment , chronic adverse effects of therapy are important consideration . METHODS We review ed the medical records of patients with JME treated with LEV in the first 4 years after marketing . We recorded demographic data , results of EEG and imaging studies , antiepileptic drug ( AED ) history , LEV initial dose and final dose , side effects related to LEV , and therapeutic response to treatment . We classified JME into definite and probable based on clinical and EEG criteria . The minimum duration of follow up was 1 year . RESULTS LEV was the first therapy in 12 patients and the initial appropriate agent in 16 . Fourteen patients had been treated with another appropriate AED . Eighty percent ( 24/30 ) of patients became seizure free with LEV monotherapy and two additional patients showed improved seizure control . Final therapeutic doses of LEV ranged from 12 to 50mg/(kgday ) . Complete seizure control using LEV was not predicted by previous AED use . Treatment failure with valproate also did not predict failure of LEV . Patients with definite JME responded best within the study group ( 11 of 11 seizure free , p<0.05 ) . CONCLUSIONS This study supports consideration of LEV for first line treatment of JME and suggests the need for a large prospect i ve trial OBJECTIVE The aim of this study was to evaluate the efficacy and tolerability of topiramate ( TPM ) in juvenile myoclonic epilepsy ( JME ) . METHOD We assessed seizure control and adverse effects of TPM in 22 patients ( 18 females ) aged 13 to 53 years . Target TPM dosage was up to 200 mg/day . The patients were subdivided into 3 groups : those treated with seizure control plus side effects ( n=4 ) ; treated with non-controlled seizures ( n=15 ) and with JME newly diagnosed ( n=3 ) . RESULTS Sixteen patients completed the first year of the follow-up . Generalized tonic-clonic seizures were completely controlled in 10 ( 62.5 % ) ; more than 50 % of reduction in 4 ( 25.0 % ) and less than 50 % in 2 ( 12.5 % ) . Myoclonia were controlled in 11 ( 68.8 % ) and persisted in 5 ( 31.2 % ) patients . Absence seizures were present in 5 ( 22.7 % ) of whom 2 ( 9.0 % ) showed more than 50 % of seizure reduction while 3 ( 13.6 % ) presented worsening . Discontinuations were due to inadequate seizure control and adverse events ( N=4 ) , low compliance and loss of follow-up ( N=2 ) and subject choice ( N=1 ) . CONCLUSION TPM showed to be an effective and well-tolerated drug in the treatment of JME . Although frequently observed , TPM side effects were tolerable and the drug could be maintained in the majority of patients BACKGROUND Topiramate is a broad-spectrum agent effective against primarily generalized tonic-clonic seizures ( PGTCS ) as well as partial-onset seizures . Juvenile myoclonic epilepsy is one of the most common idiopathic generalized epilepsies , with most patients experiencing PGTCS . OBJECTIVE To evaluate topiramate as add-on therapy in patients with juvenile myoclonic epilepsy . DESIGN Post-hoc analysis of a patient subset from 2 multicenter , double-blind , r and omized , placebo-controlled , parallel-group trials . SETTING Eighteen centers in the United States ; 10 centers in Europe ; 1 center in Costa Rica ( primary trials ) . PATIENTS A total of 22 patients with juvenile myoclonic epilepsy participating in placebo-controlled trials assessing topiramate ( target dose , 400 mg/d in adults ) in inadequately controlled PGTCS . MAIN OUTCOME MEASURE Reduction of PGTCS . RESULTS A 50 % or more reduction of PGTCS in 8 of 11 topiramate-treated patients ( 73 % ) and 2 of 11 placebo-treated patients ( 18 % ) ( P = .03 ) . Reductions in myoclonic , absence , and total generalized seizures were also observed , although topiramate vs placebo differences did not achieve statistical significance . CONCLUSION As a broad-spectrum agent , topiramate is an effective option for patients with juvenile myoclonic epilepsy Juvenile myoclonic epilepsy ( JME ) is managed with valproate in most patients ; however , valproate is an antiepileptic drug that has relatively severe adverse effects , especially in women . We performed a prospect i ve , open-label , r and omized observational study for comparison of efficacy and tolerability between topiramate and valproate in patients with JME . The inclusion criteria were patients with newly diagnosed JME or previously diagnosed JME with a history of a poor response or adverse effects to other antiepileptic drugs . The primary endpoint of this study was percentage of patients who were free of myoclonic seizures for 24 weeks in the two groups . The frequency and severity of adverse effects were also assessed . Sixteen patients were r and omized to topiramate and 17 to valproate . In the topiramate arm , 11 of 16 patients ( 68.9 % ) completed 24-week maintenance therapy and seven of the 11 ( 64 % ) were seizure-free . In the valproate arm , 16 of 17 patients ( 94.1 % ) completed 24-week follow-up and nine of 16 ( 56 % ) were seizure-free . The difference ( 64 % topiramate versus 56 % valproate ) did not reach statistical significance in this study group ( p = 0.08 , Fisher 's exact test ) . However , the severity of adverse effects was significantly different . Only 1 of 10 adverse effects from topiramate was ranked moderate-to-severe ( 10 % ) , in comparison with severe rankings for 10 of 17 adverse effects from valproate ( 59 % ) ( p = 0.018 , Fisher 's exact test ) . In summary , the efficacy of topiramate and valproate was not different , but the severity of adverse effects was favourable for topiramate . Our findings suggest that valproate may be replaced with topiramate , especially for the patients with JME who do not tolerate valproate Objectives – Based on dose predictions from animal and human volunteer studies , most patients enrolled in initial r and omized controlled trials of topiramate as adjunctive therapy in adults with partial‐onset seizures were r and omized to ≥ 600 mg/day topiramate . Subsequent experience suggests that dosage needs were overestimated . This double‐blind , placebo‐controlled study evaluated 200 mg/day topiramate in adults with treatment‐resistant partial‐onset seizures receiving a concurrent enzyme‐inducing antiepileptic agent ( carbamazepine ) . Material and methods – After a 4‐week baseline , 263 adults receiving carbamazepine who had at least three partial‐onset seizures during the baseline period were r and omized to placebo or one of two topiramate 200 mg/day treatment arms : topiramate escalated weekly 25 mg/day(8‐week escalation ) or 50 mg/day(4‐week escalation ) . Therapy was then maintained for the remainder of the 12‐week double‐blind study . Results – Median percent reduction in seizure frequency from baseline to study end was 44 % with topiramate and 20 % with placebo ( P ≤ 0.001 ) . A significant therapeutic effect was present at 2 weeks with a dose of 100 mg/day . The most common adverse events ( ≥10 % incidence in topiramate‐treated patients ) were somnolence , fatigue , paresthesia , nervousness and anorexia ; 8 % of topiramate‐treated patients and 2 % of placebo‐treated patients discontinued because of adverse events . As a result of the low incidence of adverse events , differences between titration rates in terms of tolerability were not detected . Conclusion – Topiramate 200 mg/day is an appropriate target dose as adjunctive therapy in adults with treatment‐resistant partial‐onset seizures , even when receiving an enzyme‐inducing agent ; 100 mg/day also appears to be effective . A significant therapeutic effect may be seen in the second week of treatment with a dose of 100 mg/day Few r and omized , controlled trials evaluating antiepileptic drug ( AED ) efficacy and tolerability have focused solely on patients with juvenile myoclonic epilepsy ( JME ) . We conducted a pilot , r and omized controlled trial comparing topiramate ( N=19 ) and valproate ( N=9 ) in adolescents/adults with JME to evaluate clinical response when these broad-spectrum agents are titrated to optimal effect . Rating scales were used to systematic ally assess tolerability . Among patients completing 26 weeks of treatment , 8 of 12 ( 67 % ) in the topiramate group and 4 of 7 ( 57 % ) in the valproate group were seizure-free during the 12-week maintenance period . Median daily dose was 250 mg topiramate or 750 mg valproate . Two ( 11 % ) topiramate-treated patients and one ( 11 % ) valproate-treated patient discontinued due to adverse events . Systemic toxicity scores , but not neurotoxicity scores , differed substantially between the two groups ; greater systemic toxicity was associated with valproate . Our preliminary findings that topiramate may be an effective , well-tolerated alternative to valproate warrant validation in a double-blind trial
Output:
| This review does not provide sufficient evidence to support topiramate for the treatment of people with JME .
Based on the current limited available data , topiramate seems to be better tolerated than valproate , but there were no more benefits of efficacy in topiramate compared with valproate . |
MS212339 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Emergency physicians and registrars performed emergency cricothyroidotomy on an artificial airway model using a st and ard surgical approach and three common commercial products , participants had received no refresher training . The order in which the methods were used was r and omised to minimise any learning effect . Three methods ( st and ard surgical , Minitrach II , and Quicktrach ) were universally successful in obtaining ventilation within 150 s , whilst the Melker kit had a 26 % failure rate and significantly longer median time to ventilation ( 126 s vs≤48 s for other methods , p < 0.001 ) . Despite success in using the surgical method , the Quicktrach and Minitrach II were rated as first or second preference by the majority of operators ( 78 % and 70 % respectively ) . Without refresher training emergency physicians and registrars successfully performed emergency cricothyroidotomy using the st and ard surgical method , Quicktrach and Minitrach II kits however the use of the Melker kit under these conditions result ed in significant delays or failure to establish an airway Background To improve the ease and safety of cricothyroidotomy especially in the h and of the inexperienced , new instruments have been developed . In this study , we compared a new indicator-guided puncture technique ( PCK ) with st and ard surgical technique ( ST ) regarding success rate , performance time and complications . Methods Cricothyroidotomy in 30 human cadavers performed by 30 first year anaesthesia residents . The set chosen for use was r and omised : PCK-technique ( n=15 ) and ST ( n=15 ) . Success rates , insertion times and complications were compared . Traumatic lesions were anatomically confirmed after dissection . Results The ST-group had a higher success rate ( 100 % vs 67 % ; p=0.04 ) . There was no difference in time taken to complete the procedure ( PCK 82 s. vs ST 95 s. ; p=0.89 ) . There was a higher complication rate in the PCK-group ( 67 % vs 13 % ; p=0.04 ) . Most frequent complication in the PCK-group was injury to the posterior tracheal wall ( n=8 ) , penetration to the oesophageal lumen ( n=4 ) and injury to the thyroid and /or cricoid cartilage ( n=5 ) . In the ST-group in only 2 cases minor complications were observed ( small vessel injury ) . Conclusions In this human cadaver study the PCK technique produced more major complications and more failures than the ST . In the h and of the inexperienced operator the st and ard surgical approach seems to be a safe procedure , which can successfully be performed within an adequate time . The PCK technique can not be recommended for inexperienced operators BACKGROUND Emergency cricothyroidotomy is a potentially life-saving procedure in the ' can not intubate can not ventilate ( CICV ) ' scenario . Although surgical cricothyroidotomy remains the technique recommended in many ' CICV ' algorithms , the insertion of a tracheostomy as a cannula over a trocar , or using the Seldinger method , may have advantages as they are more familiar to the anaesthetist . We compared the utility of three cuffed cricothyroidotomy devices : cuffed Melker ® , Quicktrach 2 ® , and PCK ® devices , with surgical cricothyroidotomy . METHODS After ethical committee approval and written informed consent , 20 anaesthetists performed cricothyroidotomy with all four devices in r and om order , in a pig larynx and trachea model covered in cured pelt . The primary endpoints were the rate of successful placement of the cricothyroidotomy device into the trachea and the duration of the insertion attempt . RESULTS The Melker ® and Quicktrach 2 ® devices possessed advantages over the surgical approach , in contrast to the PCK ® device , which performed less well . All 20 participants inserted the Melker ® , with 19 being successful using the surgical approach and the Quicktrach 2 ® , whereas only 12 successfully inserted the PCK ® device ( PCK ® vs surgical , P=0.02 ) . The Quicktrach 2 ® had the fastest insertion times and caused least trauma to the posterior tracheal wall . The Melker ® was rated highest by the participants and was the only device rated higher than the surgical technique . CONCLUSIONS The Melker ® and Quicktrach 2 ® devices appear to hold particular promise as alternatives to surgical cricothyroidotomy . Further studies , in more clinical ly relevant models , are required to confirm these initial positive findings STUDY OBJECTIVE To compare the success rate , complication rate and time required for the rapid 4-step technique versus the st and ard technique for cricothyrotomy . METHODS We conducted a prospect i ve , r and omized crossover study . Twenty-seven emergency medicine interns , 1 junior medicine resident , and 4 senior medical students , without prior cricothyrotomy experience , were r and omly divided into 2 groups . Group 1 was initially instructed in and then performed the st and ard technique ; group 2 was initially instructed in and then performed the rapid 4-step technique . Each group was then instructed in and performed the alternate method . Cricothyrotomies were performed on preserved human cadavers . RESULTS A surgical airway was established in 28 of 32 attempts with the use of the rapid 4-step technique ( 88 % ) ; the average time elapsed before tube placement was 43 seconds . Thirty of 32 attempts involving the st and ard technique ( 94 % ) were successful ; the average time to tube placement was 134 seconds ( 95 % confidence interval for a difference of 91 seconds , 63 to 119 ; P < .001 ) . Complications were identified in 12 attempts involving the st and ard technique ( 38 % ; 1 considered major ) and in 12 involving the rapid four-step technique ( 38 % ; 3 considered major ) . The incidence of major complications was 6 % higher for the rapid 4-step technique ( 95 % confidence interval , -9 % to 21 % ) . CONCLUSION In a group of inexperienced subjects working on a preserved human cadaver model , the rapid 4-step technique for cricothyrotomy was performed in about one third the time required for performance of the st and ard technique . This finding was both clinical ly and statistically significant . Although the 2 techniques had similar success and complication rates , we noted a trend toward more severe complications in the rapid 4-step technique OBJECTIVE To compare the speeds and success rates of placement for percutaneous cricothyrotomy versus surgical or open cricothyrotomy . METHODS Twenty-two paramedics ( mean 9.7 years of experience ) , with training in both methods , were timed using a pig trachea in a crossover model . An emergency physician performed timing and documentation of success ; timing commenced after the equipment was ready and the membrane was identified . Paramedics were r and omly assigned by a coin toss to start in either group . All were actively employed by a municipal third-service emergency medical services ( EMS ) agency . Paramedics who did not complete one of the methods correctly were excluded from speed analysis . Data were analyzed using descriptive statistics , a t-test of paired sample s , and confidence intervals for matched sample s. RESULTS Placement of a surgical cricothyrotomy was significantly faster ( mean 28 seconds , range 10 - 78 seconds ) than the percutaneous method ( mean 123 seconds , range 58 - 257 seconds ) ( p < 0.001 ) . Mean difference between the 20 matched percutaneous versus surgical pairs was 93.75 seconds ( 95 % CI 72.3 , 115.2 ) . The surgical route had a 100 % success rate at obtaining airway control , whereas the percutaneous method had a 90.9 % success rate ( p = 0.1 ) . CONCLUSION In an animal model , surgical cricothyrotomy appeared to be a preferable method for establishing a definitive airway over the percutaneous method . Further research is required to define the optimal approach in the prehospital setting for the invasive airway Using an airway mannequin and artificial lung model , we compared surgical cricothyroidotomy with a 6.0‐mm cuffed Portex tracheostomy tube with wire‐guided cricothyroidotomy using a 5.0‐mm cuffed Melker or 6.0‐mm uncuffed Melker tube . The trial was carried out by 27 anaesthetists using a r and omised , crossover design . Surgical cricothyroidotomy proved significantly faster ( mean ( SD ) time to first breath 44.3 ( 12.5 ) s for Portex surgical , 87.2 ( 21.6 ) s for cuffed Melker , 87.8 ( 19.2 ) s for uncuffed Melker , p < 0.001 ) . With a st and ardised ventilator model , the cuffed tubes provided more effective ventilation ( mean ( SD ) tidal volume 446 ( 41 ) ml Portex , 436 ( 52 ) ml cuffed Melker , 19 ( 5 ) ml uncuffed Melker , p < 0.001 ) . Fourteen of the participants preferred the wire‐guided system . We conclude that , in this model , a cuffed device is preferable when cricothyroidotomy is needed . In addition , the surgical method is quicker than a wire‐guided approach The Rapid Four-Step Technique ( RFST ) has been demonstrated to be faster than st and ard open crico thyrotomy technique , but may have a higher incidence of cricoid injury with tracheal hook traction applied caudad . The " Bair Claw " is a novel device that may help eliminate these complications . This r and omized , experimental trial used a fresh-frozen cadaver model of cricothyrotomy to compare speed and safety between RFST using a Bair Claw and st and ard open technique . Outcome measures included time to definitive airway , size of largest endotracheal ( ET ) tube able to be passed , and incidence of complications . We observed that RFST using a Bair Claw was significantly faster than st and ard open technique . There was no significant difference with regard to size of ET tube able to be passed with RFST using a Bair Claw versus st and ard open technique , and there was no damage to trachea or larynx observed with either technique . We concluded that RFST using a Bair Claw is faster and appears to be equally safe when compared to st and ard open technique in a fresh-frozen cadaver model of cricothyrotomy . The two techniques were equal with regard to maximal ET tube size BACKGROUND : We compared two emergency cricothyroidotomy kits design ed to avoid lesions during insertion , one based on the Seldinger technique ( ST ) , the other based on the concept of a mechanical detection of the posterior wall of the larynx , with regard to insertion time , success rate , and complication rate . METHODS : Cricothyroidotomy was performed under fiberoptic control in 40 human cadavers embalmed according to Thiel ’s technique . The set chosen for use was r and omized : new technique ( NT ) or ST . Duration of the procedure , success rates , and incidence of laryngeal injuries were compared . Traumatic lesions observed with the fiberoptic bronchoscope were anatomically confirmed after dissection . RESULTS : The two groups had comparable epidemiological and anatomical records . Cricothyroidotomy was performed faster with the NT than with the ST ( median 54 vs 71 s , P = 0.01 ) . Failure rates were comparable between groups ( 4 vs 1 , P = 0.34 ) , and there were fewer major complications in the posterior tracheal wall with the ST ( 0 vs 8 , P = 0.003 ) . In the ST group , only minor punctiform lesions of the posterior trachea wall were observed in four cases . CONCLUSIONS : In this model , despite a shorter insertion time , the NT produced more lesions and more failures than the ST We compared a wire-guided cricothyrotomy technique vs. st and ard surgical cricothyrotomy in terms of accuracy in placement , complications , performance time , incision length , and user preference . We conducted a r and omized , crossover controlled trial in which Emergency Medicine ( EM ) attendings and residents performed cricothyrotomies by both st and ard and wire-guided techniques ( using a commercially available kit ) on human cadavers after a 15-min training session . Procedure time , incision length , and physician preference were recorded . Cadavers were inspected for accuracy of placement and complications . Airway placement was accurate in 13 of 15 cases for the st and ard technique ( 86.7 % ) , and 14 of 15 cases for the wire-guided technique ( 93.3 % ) . When comparing wire-guided vs. st and ard techniques , there were no differences in complication rates or performance times . The wire-guided technique result ed in a significantly smaller mean incision length than the st and ard technique ( 0.53 vs. 2.53 cm , respectively , p<0.0001 ) . Overall , 14 of 15 physicians stated that they preferred the wire-guided to the st and ard technique . Our data suggest that this wire-guided cricothyrotomy technique is as accurate and timely to use as the st and ard technique and is preferred by our physician operators . In addition , the technique results in a smaller incision on human cadaver models BACKGROUND Emergency cricothyrotomy is the final lifesaving option in " can not intubate-cannot ventilate " situations . Fast , efficient and safe management is indispensable to reestablish oxygenation , thus the quickest , most reliable and safest technique should be used . Several cricothyrotomy techniques exist , which can be grouped into two categories : anatomical-surgical and puncture . M
Output:
| No single method was shown to be better than the others , but the size of the studies makes it impossible to draw firm conclusions . |
MS212340 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To determine if high fidelity simulation based team training can improve clinical team performance when added to an existing didactic teamwork curriculum . Setting : Level 1 trauma center and academic emergency medicine training program . Participants : Emergency department ( ED ) staff including nurses , technicians , emergency medicine residents , and attending physicians . Intervention : : ED staff who had recently received didactic training in the Emergency Team Coordination Course ( ETCC ® ) also received an 8 hour intensive experience in an ED simulator in which three scenarios of graduated difficulty were encountered . A comparison group , also ETCC trained , was assigned to work together in the ED for one 8 hour shift . Experimental and comparison teams were observed in the ED before and after the intervention . Design : Single , crossover , prospect i ve , blinded and controlled observational study . Teamwork ratings using previously vali date d behaviorally anchored rating scales ( BARS ) were completed by outside trained observers in the ED . Observers were blinded to the identification of the teams . Results : There were no significant differences between experimental and comparison groups at baseline . The experimental team showed a trend towards improvement in the quality of team behavior ( p = 0.07 ) ; the comparison group showed no change in team behavior during the two observation periods ( p = 0.55 ) . Members of the experimental team rated simulation based training as a useful educational method . Conclusion : High fidelity medical simulation appears to be a promising method for enhancing didactic teamwork training . This approach , using a number of patients , is more representative of clinical care and is therefore the proper paradigm in which to perform teamwork training . It is , however , unclear how much simulator based training must augment didactic teamwork training for clinical ly meaningful differences to become apparent OBJECTIVE To evaluate the effectiveness of training and institutionalizing teamwork behaviors , drawn from aviation crew re source management ( CRM ) programs , on emergency department ( ED ) staff organized into caregiver teams . STUDY SETTING Nine teaching and community hospital EDs . STUDY DESIGN A prospect i ve multicenter evaluation using a quasi-experimental , untreated control group design with one pretest and two posttests of the Emergency Team Coordination Course ( ETCC ) . The experimental group , comprised of 684 physicians , nurses , and technicians , received the ETCC and implemented formal teamwork structures and processes . Assessment s occurred prior to training , and at intervals of four and eight months after training . Three outcome constructs were evaluated : team behavior , ED performance , and attitudes and opinions . Trained observers rated ED staff team behaviors and made observations of clinical errors , a measure of ED performance . Staff and patients in the EDs completed surveys measuring attitudes and opinions . DATA COLLECTION Hospital EDs were the units of analysis for the seven outcome measures . Prior to aggregating data at the hospital level , scale properties of surveys and event-related observations were evaluated at the respondent or case level . PRINCIPAL FINDINGS A statistically significant improvement in quality of team behaviors was shown between the experimental and control groups following training ( p = .012 ) . Subjective workload was not affected by the intervention ( p = .668 ) . The clinical error rate significantly decreased from 30.9 percent to 4.4 percent in the experimental group ( p = .039 ) . In the experimental group , the ED staffs ' attitudes toward teamwork increased ( p = .047 ) and staff assessment s of institutional support showed a significant increase ( p = .040 ) . CONCLUSION Our findings point to the effectiveness of formal teamwork training for improving team behaviors , reducing errors , and improving staff attitudes among the ETCC-trained hospitals Objective To test an intervention to enhance collaborative communication among nurse and physician leaders ( eg , nurse manager , medical director , clinical nurse specialist ) in two diverse intensive care units ( ICUs ) . Background Collaborative communication is associated with positive patient , nurse , and physician outcomes . However , to date , intervention-focused research that seeks to improve collaborative communication is lacking . Methods A pretest – posttest repeated measures design incorporated baseline data collection , implementation of the intervention over 8 months , and immediate and 6-months-post data collection . Findings Communication skills of ICU nurse and physician leaders improved significantly . Leaders also reported increased satisfaction with their own communication and leadership skills . In addition , staff nurse and physician perceptions of nursing leadership and problem solving between groups increased . Staff nurses reported lower personal stress ( eg , more respect from co-workers , physicians , and managers ) , even though they perceived significantly more situational stress ( eg , less staffing and time ) . Conclusion Study findings provide evidence that nurse – physician collaborative communication can be improved Objective To determine the emergency department ( ED ) environmental factors associated with patient satisfaction . Methods A prospect i ve , observational study in a university-affiliated tertiary-referral ED and associated observation unit ( OU ) . The ED environment was evaluated with a structured question naire , scored using a 100-mm visual analogue scale . Patients who stayed in the ED over 8 h ( long-stay ED ; LSED ) were compared with those who stayed less than 4 h ( short-stay ED ; SSED ) and with a control group admitted to the OU . Results A total of 233 patients was enrolled , overall satisfaction in SSED was 81 % ( 95 % CI 70.1 to 88.7 ) , 69 % in LSED ( 95 % CI 57.4 to 78.7 ) and 84 % in OU ( 95 % CI 73.6 to 91.0 ) . The most important environmental factors were cleanliness ( median importance 95 , interquartile range ( IQR ) 81–98 ) and communication with medical staff ( 94 , IQR 80–98 ) and family ( 92 , IQR 74–98 ) . The least important factors were access to nature ( 38 , IQR 19–65 ) , a natural light source ( 50 , IQR 24–74 ) and ability to sit out of bed ( 52 , IQR 26–75 ) . Factors rated high for importance but low for satisfaction were ED noise levels ( median difference 40 , IQR 3–70 ) , ED trolley comfort ( 19 , IQR 6–50 ) and food quality ( 12 , IQR −4–29 ) . Conclusion Patients who spend over 8 h in the ED are less satisfied with their environment than either those who spend less than 4 h or patients in an OU . Importantly , distinct , amenable factors can be identified . These should be addressed to improve patients ’ overall ED management and satisfaction
Output:
| Environmental design , which involves nurses , support staff , and physicians , is one of the critical factors that promotes the efficiency of teamwork and collaborative communication .
Layout design , visibility , and accessibility levels are the most cited aspects of design which can affect the level of communication and teamwork in healthcare facilities |
MS212341 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 was performed to compare levels of serum homocysteine ( Hcy ) , vitamin B12 and folic acid in patients with primary open-angle glaucoma ( POAG ) , pseudoexfoliative glaucoma ( PEXG ) , normotensive glaucoma ( NTG ) and healthy controls . Methods Twentyfive patients with POAG , 24 with PEXG , and 18 with NTG , along with 19 control healthy subjects were included this prospect i ve study . Levels of serum Hcy were measured using immunoassay , and those of serum vitamin B12 and folic acid were measured using competitive chemiluminescent enzyme immunoassay . Results The mean Hcy concentration in the PEXG group was significantly higher ( P < 0.001 ) as compared to the other groups . There were no significant differences with respect to the mean Hcy concentrations among other groups ( P > 0.05 ) . There were no statistical differences in serum vitamin B12 levels among POAG , PEXG , NTG and control subjects ( P > 0.05).The mean serum folic acid level was significantly lower in the subjects with PEXG ( P < 0.009 ) . However , the mean folic acid concentrations among the other groups did not differ significantly ( P > 0.05 ) . Conclusion Elevated levels of Hcy in PEXG may explain the role of endothelial dysfunction among patients with PEXG IMPORTANCE Nitric oxide signaling alterations in outflow facility and retinal blood flow autoregulation are implicated in primary open-angle glaucoma ( POAG ) . Nitric oxide donation has emerged as a POAG therapeutic target . An exogenous source of nitric oxide is dietary nitrates . OBJECTIVE To evaluate the association between dietary nitrate intake , derived mainly from green leafy vegetables , and POAG . DESIGN , SETTING , AND PARTICIPANTS We followed up participants biennially in the prospect i ve cohorts of the Nurses ' Health Study ( 63 893 women ; 1984 - 2012 ) and the Health Professionals Follow-up Study ( 41 094 men ; 1986 - 2012 ) at each 2-year risk period . Eligible participants were 40 years or older , were free of POAG , and reported eye examinations . EXPOSURES The primary exposure was dietary nitrate intake . Information on diet and potential confounders was up date d with vali date d question naires . MAIN OUTCOMES AND MEASURES The main outcome was the incidence of POAG and POAG subtypes ; 1483 cases were confirmed with medical records and classified into subtypes defined by intraocular pressure ( IOP ) ( ≥22 or < 22 mm Hg ) or by visual field ( VF ) loss pattern at diagnosis ( peripheral loss only or early para central loss ) . Cohort-specific and pooled multivariable rate ratios ( MVRRs ) and 95 % CIs were estimated . RESULTS During 1 678 713 person-years of follow-up , 1483 incident cases of POAG were identified . The mean ( SD ) age for the 1483 cases was 66.8 ( 8.3 ) . Compared with the lowest quintile of dietary nitrate intake ( quintile 1 : approximately 80 mg/d ) , the pooled MVRR for the highest quintile ( quintile 5 : approximately 240 mg/d ) was 0.79 ( 95 % CI , 0.66 - 0.93 ; P for trend = .02 ) . The dose response was stronger ( P for heterogeneity = .01 ) for POAG with early para central VF loss ( 433 cases ; quintile 5 vs quintile 1 MVRR = 0.56 ; 95 % CI , 0.40 - 0.79 ; P for trend < .001 ) than for POAG with peripheral VF loss only ( 835 cases ; quintile 5 vs quintile 1 MVRR = 0.85 ; 95 % CI , 0.68 - 1.06 ; P for trend = .50 ) . The association did not differ ( P for heterogeneity = .75 ) by POAG subtypes defined by IOP ( 997 case patients with IOP ≥22 mm Hg : quintile 5 vs quintile 1 MVRR = 0.82 ; 95 % CI , 0.67 - 1.01 ; P for trend = .11 ; 486 case patients with IOP < 22 mm Hg : quintile 5 vs quintile 1 MVRR = 0.71 ; 95 % CI , 0.53 - 0.96 ; P for trend = .12 ) . Green leafy vegetables accounted for 56.7 % of nitrate intake variation . Compared with consuming 0.31 servings per day , the MVRR for consuming 1.45 or more servings per day was 0.82 for all POAG ( 95 % CI , 0.69 - 0.97 ; P for trend = .02 ) and 0.52 for POAG with para central VF loss ( 95 % CI , 0.29 - 0.96 ; P for trend < .001 ) . CONCLUSIONS AND RELEVANCE Higher dietary nitrate and green leafy vegetable intake was associated with a lower POAG risk , particularly POAG with early para central VF loss at diagnosis Objective : To compare the levels of plasma homocysteine ( Hcy ) , vitamin B6 ( vit-B6 ) , serum vitamin B12 ( vit-B12 ) , and folate in healthy individuals and in patients with normal tension glaucoma ( NTG ) , pseudoexfoliative glaucoma ( PXG ) , or primary open-angle glaucoma ( POAG ) . Study design : A prospect i ve controlled trial . Participants and methods : Forty healthy subjects , 48 patients with NTG , 38 patients with PXG , and 34 patients with POAG were included in the study . Those who used vitamin supplements or medications affecting Hcy and vitamin levels were excluded from the study . The levels of Hcy and vit-B6 were measured by High Performance Liquid Chromatography ( HPLC ) . The levels of serum vit-B12 and folic acid were measured by competitive chemiluminescent enzyme immunoassay ( CEI ) . One-way analysis if variance ( ANOVA ) , analysis of covariance ( ANCOVA ) , and the Tukey honestly significant difference test were used for statistical analysis . Results : The mean Hcy level of the PXG group was 15.46 ± 9.27 μmol/L which was significantly higher ( P = 0.03 ) than that of the control group . There were no statistical differences in serum vit-B12 and folate levels among control subjects and NTG , PXG and POAG groups ( P > 0.05 ) . It was found that the mean plasma vit-B6 level was significantly higher in subjects with NTG ( P = 0.03 ) and POAG ( P = 0.025 ) versus controls . Mean vit-B6 levels in NTG and POAG were 30.50 ± 11.29 μg/L and 30 ± 12.15 μg/L , respectively . Conclusions : The plasma level of Hcy was found to be increased only in PXG patients and the plasma levels of vit-B6 were found to increase in the NTG and POAG sample groups . Using homocysteine and vit-B6 levels as the determinants of hyperhomocysteinemia still needs further research Open-angle glaucoma ( OAG ) is the commonest cause of irreversible blindness worldwide . Apart from an increased intraocular pressure ( IOP ) , oxidative stress and an impaired ocular blood flow are supposed to contribute to OAG . The aim of this study was to determine whether the dietary intake of nutrients that either have anti-oxidative properties ( carotenoids , vitamins , and flavonoids ) or influence the blood flow ( omega fatty acids and magnesium ) is associated with incident OAG . We investigated this in a prospect i ve population -based cohort , the Rotterdam Study . A total of 3502 participants aged 55 years and older for whom dietary data at baseline and ophthalmic data at baseline and follow-up were available and who did not have OAG at baseline were included . The ophthalmic examinations comprised measurements of the IOP and perimetry ; dietary intake of nutrients was assessed by vali date d question naires and adjusted for energy intake . Cox proportional hazard regression analysis was applied to calculate hazard ratios of associations between the baseline intake of nutrients and incident OAG , adjusted for age , gender , IOP , IOP-lowering treatment , and body mass index . During an average follow-up of 9.7 years , 91 participants ( 2.6 % ) developed OAG . The hazard ratio for retinol equivalents ( highest versus lowest tertile ) was 0.45 ( 95 % confidence interval 0.23–0.90 ) , for vitamin B1 0.50 ( 0.25–0.98 ) , and for magnesium 2.25 ( 1.16–4.38 ) . The effects were stronger after the exclusion of participants taking supplements . Hence , a low intake of retinol equivalents and vitamin B1 ( in line with hypothesis ) and a high intake of magnesium ( less unambiguous to interpret ) appear to be associated with an increased risk of OAG The relation between dietary antioxidant intake and primary open-angle glaucoma risk was examined in participants aged over 40 years in the Nurses ' Health Study ( n = 76,200 ) and the Health Professionals Follow-up Study ( n = 40,284 ) . They were followed biennially from 1980 and 1986 , respectively , to 1996 , during periods when they received an eye examination . Dietary intakes were measured repeatedly from 1980 in the Nurses ' Health Study and from 1986 in the Health Professionals Follow-up Study using vali date d food frequency question naires . The authors analyzed 474 self-reported glaucoma cases confirmed by medical chart review to have primary open-angle glaucoma with visual field loss . The authors used Cox proportional hazards models for cohort-specific multivariate analyses , and results were pooled using r and om effects models . The pooled multivariate rate ratios for primary open-angle glaucoma comparing the highest versus lowest quintile of cumulative up date d intake were 1.17 ( 95 % confidence interval ( CI ) : 0.87 , 1.58 ) for alpha-carotene , 1.10 ( 95 % CI : 0.82 , 1.48 ) for beta-carotene , 0.95 ( 95 % CI : 0.70 , 1.29 ) for beta-cryptoxanthin , 0.82 ( 95 % CI : 0.60 , 1.12 ) for lycopene , 0.92 ( 95 % CI : 0.69 , 1.24 ) for lutein/zeaxanthin , 1.05 ( 95 % CI : 0.59 , 1.89 ) for vitamin C , 0.97 ( 95 % CI : 0.62 , 1.52 ) for vitamin E , and 1.11 ( 95 % CI : 0.82 , 1.51 ) for vitamin A. In conclusion , the authors did not observe any strong associations between antioxidant consumption and the risk of primary open-angle glaucoma OBJECTIVE Open-angle glaucoma ( OAG ) is one of the major chronic diseases involving the optic nerve . However , little is known about the association between vitamin D and OAG . The present study was conducted to test the hypothesis that lower vitamin D status is associated with greater prevalence of OAG . DESIGN Cross-sectional study . Multivariable logistic regression was performed to examine the relationship between serum 25-hydroxyvitamin D ( 25(OH)D ) and OAG after adjusting for traditional potential confounders . OAG was defined by the criteria of the International Society for Geographical and Epidemiological Ophthalmology . SETTING The Fifth Korean National Health and Nutrition Examination Survey conducted in 2010 - 2011 . SUBJECTS Six thous and and ninety-four adult participants r and omly selected from 192 surveys in 131 locations in South Korea . RESULTS Multivariable-adjusted odds ratios of OAG across quintiles of decreasing 25(OH)D were 1.26 , 1.00 ( reference ) , 1.31 , 1.36 and 1.69 ( P for quadratic trend < 0.01 ) . The odds ratio for the lowest 25(OH)D quintile was significantly higher than that for the second quintile ( P < 0.01 ) . In addition , we discovered that the predictors for worsening of OAG , such as intraocular pressure or vertical and horizontal cup-to-disc ratios , had a significant relationship with 25(OH)D level . CONCLUSIONS There was a reverse J-shaped association between 25(OH)D levels and the risk of OAG , with significantly elevated risk at lower 25(OH)D. The findings of this research suggest that vitamin D deficiency should be considered as a potential risk factor for the development of OAG . To our knowledge , the present study is the first one that shows an association between
Output:
| However , after addressing heterogeneity , vitamin C showed a protective effect as well .
Especially , foods high in these vitamins ( e.g. , dark green vegetables ) were protective for OAG .
CONCLUSIONS Dietary intake of vitamin A and C showed a beneficial association with OAG ; however , findings on blood levels of vitamins do not show a clear relation with OAG |
MS212342 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Please cite this paper as : Castle P , Bulten J , Confortini M , Klinkhamer P , Pellegrini A , Siebers A , Ronco G , Arbyn M. Age‐specific patterns of unsatisfactory results for conventional Pap smears and liquid‐based cytology : data from two r and omised clinical trials . BJOG 2010;117:1067–1073
Output:
| In the subgroup analyses and meta‐regressions , use of non‐cotton devices for conventional cytology and use of a particular platform for LBC were associated with lower unsatisfactory rates .
Meta‐regression also suggested chronological improvement in unsatisfactory rates for both tests .
In Japanese cervical cancer screening programs , conventional cytology remains prevalent . |
MS212343 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 treatment of acute maxillary sinusitis , azithromycin offers an advantage over phenoxymethylpenicillin in that a complete course of treatment requires drug administration once daily for only three days . In this double-blind , parallel-group , multicenter study , 438 patients with radiographically verified maxillary sinusitis were r and omly assigned to receive either 500 mg azithromycin once daily for three days ( 221 patients ) or 1.3 g phenoxymethylpenicillin three times daily for ten days ( 217 patients ) . Nasal secretion , maxillary tenderness and pain , nasal obstruction , general malaise , and hyposmia , were assessed at the start of the study and on days 4 , 11 , and 25 of treatment . After 11 days 58 % of the patients in the azithromycin group were cured versus 51 % in the penicillin group ; after 25 days the cure rate was 79 % versus 76 % , respectively . When both cure and improvement were considered , the corresponding figures after 11 days were 97 % ( azithromycin ) and 95 % ( penicillin ) ; after 25 days they were 92 % and 88 % , respectively . Adverse events , predominantly gastrointestinal , occurred in 73 ( 33 % ) of the azithromycin-treated patients and in 87 ( 40.1 % ) of those treated with penicillin . No difference in efficacy was found between the two drugs in the treatment of acute maxillary sinusitis , and the adverse effects were comparable . The short duration of treatment with azithromycin offers a significant advantage over treatment with phenoxymethylpenicillin The clinical effect and the penetration of ampicillin into sinus secretion after oral administration of bacampicillin was studied in 47 patients with acute maxillary sinusitis allocated at r and om in treatment with 400 mg bacampicillin 3 times or 1200 mg twice daily . The overall clinical effect was similar and was assessed as " good " in 23/25 patients treated with 400 mg doses and in 19/22 treated with 1200 mg . Adverse reactions were reported by 4 patients . The concentrations of ampicillin obtained in sinus secretion were proportional to the dose given . The highest values after 400 mg bacampicillin were approximately 0.6 mg/l and after 1200 mg about 2 mg/l . Both dosages are applicable to treatment of acute maxillary sinusitis Respiratory tract pathogens ( beta-haemolytic streptococci groups A , C and G , Haemophilus influenzae , Branhamella catarrhalis or pneumococci ) , were isolated from nasopharyngeal and /or throat swabs in 73/138 ( 53 % ) patients greater than 10 years of age with a clinical diagnosis of acute sinusitis , acute tonsillitis , purulent nasopharyngitis or acute bronchitis . Serological evidence of a viral infection ( influenza A and B , parainfluenza 1 , 2 and 3 , respiratory syncytial virus , adenovirus ) or Mycoplasma pneumoniae infection was found in 10 % of the patients . The serum content of C-reactive protein ( S-CRP ) was increased ( greater than 12 mg/l ) in 26/33 ( 79 % ) patients with streptococci and in 22/59 ( 37 % ) patients without respiratory tract bacteria . In patients with a serological evidence of a virus tonsillitis , the S-CRP was also high ( 32 - 64 mg/l ) . At follow-up 10 - 12 days after the first visit , the clinical effect of erythromycin and penicillin V was judged to be similar ( 90 % clinical effect ) . Relapse or re-infection with group A streptococci were seen in 7 patients ( 4 on erythromycin , 3 on penicillin ) . In another 6 patients ( 3 on erythromycin , 3 on penicillin ) , antibiotic treatment was switched owing to persisting symptoms , probably due to H. Influenzae infection in 3 cases . The patients ' own estimates of their symptoms suggested treatment with erythromycin to have a more rapid effect than treatment with penicillin PURPOSE To compare the efficacy and tolerability of a 3-day course of azithromycin with a 10-day course of amoxicillin/clavulanic acid in the treatment of acute sinusitis in adults . PATIENTS AND METHODS One hundred adult patients with acute sinusitis were included in an open , r and omized study . Clinical diagnosis of sinusitis was confirmed by nasal endoscopy , sinus radiography , and ( when possible ) by culture of sinus aspirate . Patients were r and omized to receive azithromycin ( 500 mg once daily for 3 days ) or amoxicillin/clavulanate ( 625 mg every 8 hours for 10 days ) . RESULTS A significantly faster resolution of signs and symptoms of sinusitis was observed in the azithromycin-treated patients . By the end of therapy ( days 10 - 12 ) , 95 % of the patients in the azithromycin group and 74 % in the amoxicillin/clavulanate group were cured . The remaining patients ' conditions were improved . By the follow-up visit , cure was achieved in 98 % of the azithromycin-treated patients , and 91 % of the amoxicillin/clavulanate-treated patients . Treatment failure was observed in three patients from the amoxicillin/clavulanate group , and relapse occurred in one patient from each group . Bacteriologic eradication was achieved in 23 of 23 and 21 of 24 patients treated with azithromycin and amoxicillin/clavulanate , respectively . Both drugs were well tolerated . Two patients ( 4 % ) from the azithromycin group and five patients ( 10 % ) from the amoxicillin/clavulanate group reported mild gastrointestinal disturbances . CONCLUSIONS In adults with acute sinusitis , a 3-day course of azithromycin was as effective and well tolerated as a 10-day course of amoxicillin/clavulanic acid . A significantly simpler dosage regimen and faster clinical effect were the advantages of azithromycin Loracarbef is an oral synthetic beta-lactam antibiotic in the new carbacephem class . We conducted a multicenter , r and omized , double-blind , parallel-group study to compare the efficacy and safety of loracarbef 200 mg twice daily ( BID ) and 400 mg BID when given orally for 10 days to patients 12 years of age and older with acute maxillary sinusitis . Because sinus aspirates for culture are not routinely obtained in the management of acute maxillary sinusitis , antimicrobial therapy usually is selected empirically . This study was design ed to provide data simulating the usual clinical practice of treatment without sinus aspiration . Two hundred nine patients who met the entry criteria , which included abnormal pretherapy sinus radiographs compatible with acute maxillary sinusitis and symptoms of fewer than 4 weeks ' duration , qualified for the clinical analyses . Of the 106 clinical ly qualified patients assigned to the 200-mg BID group , favorable clinical responses ( cure and improvement ) were noted in 86 ( 81.1 % ) patients . Of the 103 clinical ly qualified patients assigned to the 400-mg BID group , 84 ( 81.6 % ) patients had favorable clinical responses . These results compare favorably with accepted clinical response rates of 70 % to 80 % for beta-lactams selected on an empiric basis . At the end of the treatment period , favorable radiologic responses ( resolved and improved ) and favorable clinical responses occurred in 55 ( 51.9 % ) of the 106 clinical ly qualified patients in the 200-mg BID group and in 57 ( 55.3 % ) of the 103 clinical ly qualified patients in the 400-mg BID group . Mean roentgenogram scores for the clinical ly qualified patients were 2.3 for both groups before therapy and 1.3 and 1.5 after therapy for the 200-mg BID and 400-mg BID groups , respectively . The mean change from pretherapy to posttherapy by patient was 1.0 for the 200-mg BID group and 0.8 for the 400-mg BID group . There were no statistically significant differences between treatment groups in the incidence of specific adverse events reported during therapy . These data suggest that loracarbef 200 mg BID is comparable in efficacy and safety to loracarbef 400 mg BID in the treatment of patients with acute maxillary sinusitis The efficacy , tolerability and safety of azithromycin and co-amoxiclav in the treatment of non-severe acute maxillary/ethmoidal sinusitis were compared in a r and omized , open clinical trial in 254 adult patients . The predominant pathogens were Streptococcus pneumoniae and Haemophilus influenzae ( 83 patients ) . Azithromycin was administered orally to 165 patients at a single daily dose of 500 mg for 3 days , and co-amoxiclav ( 4:1 ) to 89 patients , at a dose of 500 mg three times daily for 10 days . The overall clinical response rates were 87.5 % for azithromycin and 83.7 % for co-amoxiclav at follow-up ( day 21–28 ) . Microbiological responses to both drugs were good , with only five patients in each group having a persistent infection after treatment . Both drugs were well tolerated and produced similar incidences of adverse events , which were mostly gastrointestinal . Azithromycin was as effective , and as well tolerated as co-amoxiclav , and its shorter simpler dosing regime may offer advantages in compliance and cost In two ear , nose and throat ( ENT ) divisions , 74 patients affected by acute sinusitis of bacterial origin were selected and , after r and omization in two balanced groups following an open parallel group design , assigned to treatment with brodimorprim and roxithromycin . At the beginning , after 3 days , 7 days and at the end of treatment the following symptoms were evaluated , using a four-step score : intensity of facial pain , headache , nasal stiffness , hyposmia , nasal secretion . The mean treatment period was 8.7 days . Tolerability was evaluated through registration and analysis of side effects and laboratory blood tests . The comparison between groups showed a better activity of brodimoprim on facial pain , headache , nasal stiffness and nasal secretion . The presence of resistant bacterial strains was greater in the group treated with roxithromycin ( 30.8 % ) when compared with the brodimoprim group ( 12.5 % ) . Side effects were reported in 5 patients treated with brodimoprim and in 3 patients in the control group . Lab tests did not show serious variations BACKGROUND The treatment of acute , recurrent , and chronic sinusitis remains controversial because of the presence of a wide variety of aerobic and anaerobic bacteria in the sinuses . DESIGN This double-blind , r and omized trial compared cefaclor with amoxicillin in the treatment of acute , recurrent , and chronic maxillary sinusitis using clinical evaluation , roentgenography , and microbiologic evaluation of antral aspirates . SETTING Outpatient office of five otorhinolaryngologists in Salt Lake City , Utah . PATIENTS One hundred eight adult patients with acute , recurrent , or chronic maxillary sinusitis . INTERVENTION Oral treatment with cefaclor ( 500 mg ) twice daily or amoxicillin ( 500 mg ) three times daily for 10 days . MAIN OUTCOME MEASURE Clinical response to treatment with cefaclor vs amoxicillin . RESULTS Fifty-six patients with acute sinusitis , 25 with recurrent sinusitis , and 15 with chronic sinusitis were evaluable . Although multiple organisms were common in each group , patients with acute sinusitis were more likely to have Haemophilus influenzae or Streptococcus pneumoniae , and patients with recurrent or chronic sinusitis were more likely to have anaerobes in sinus aspirate . Whether treated with cefaclor or amoxicillin , clinical improvement occurred in 86 % of patients with acute sinusitis and 56 % of patients with recurrent sinusitis . Patients with chronic sinusitis were too few to allow statistical analysis of the differences in outcome between them and patients with recurrent or acute sinusitis . Resistance of the cultured organisms to the study drug used was unrelated to treatment outcome . CONCLUSIONS The rate of clinical improvement was high in patients with acute sinusitis but was less favorable in those with recurrent and chronic disease regardless of the study drug used . The susceptibility of organisms isolated to the study drugs was unrelated to outcome PURPOSE This multicenter study compared the clinical and bacteriologic efficacy of two oral antibiotics , cefuroxime axetil and amoxicillin/clavulanate , in the treatment of acute bacterial maxillary sinusitis . PATIENTS AND METHODS Three hundred seventeen patients with clinical and radiographic evidence of acute maxillary
Output:
| Radiographic outcomes were improved by antibiotic treatment .
REVIEW ER 'S CONCLUSIONS For acute maxillary sinusitis confirmed radiographically or by aspiration , current evidence is limited but supports the use of penicillin or amoxicillin for 7 to 14 days . |
MS212344 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE The study objective was to compare the incidence and prognosis of acute myocardial infa rct ion when using high-sensitivity cardiac troponin assays instead of a st and ard cardiac troponin assay for the diagnosis of acute myocardial infa rct ion . METHODS In a prospect i ve international multicenter study , we enrolled 1124 consecutive patients presenting with suspected acute myocardial infa rct ion . Final diagnoses were adjudicated by 2 independent cardiologists 2 times using all available clinical information : first using st and ard cardiac troponin levels and second using high-sensitivity cardiac troponin T levels for adjudication . Patients were followed up for a mean of 19±9 months . RESULTS The use of high-sensitivity cardiac troponin T instead of st and ard cardiac troponin result ed in an increase in the incidence of acute myocardial infa rct ion from 18 % to 22 % ( 242 vs 198 patients ) , a relative increase of 22 % . Of the 44 additional acute myocardial infa rct ions , 35 were type 1 acute myocardial infa rct ions and 9 were type 2 acute myocardial infa rct ions . This was accompanied by a reciprocal decrease in the incidence of unstable angina ( unstable angina , 11 % vs 13 % ) . The most pronounced increase was observed in patients adjudicated with cardiac symptoms of origin other than coronary artery disease with cardiomyocyte damage ( 83 vs 31 patients , relative increase of 268 % ) . Cumulative 30-month mortality rates were 4.8 % in patients without acute myocardial infa rct ion , 16.4 % in patients with a small acute myocardial infa rct ion detected only by high-sensitivity cardiac troponin T but not st and ard cardiac troponin , and 23.9 % in patients with a moderate/large acute myocardial infa rct ion according to st and ard cardiac troponin assays and high-sensitivity cardiac troponin T ( P<.001 ) . CONCLUSIONS The introduction of high-sensitivity cardiac troponin assays leads to only a modest increase in the incidence of acute myocardial infa rct ion . The novel sensitive assays identify an additional high-risk group of patients with increased mortality , therefore appropriately classified with acute myocardial infa rct ion ( Advantageous Predictors of Acute Coronary Syndromes Evaluation ; NCT00470587 ) OBJECTIVES To evaluate the clinical effectiveness and cost-effectiveness of using a point-of-care cardiac marker panel in patients presenting to the emergency department ( ED ) with suspected but not proven acute myocardial infa rct ion ( AMI ) . DESIGN Multicentre pragmatic open r and omised controlled trial and economic evaluation . SETTING Six acute hospital EDs in the UK . PARTICIPANTS Adults presenting to hospital with chest pain due to suspected but not proven myocardial infa rct ion , and no other potentially serious alternative pathology or comorbidity . INTERVENTIONS Participants were allocated using an online r and omisation system to receive either ( 1 ) diagnostic assessment using the point-of-care biochemical marker panel or ( 2 ) conventional diagnostic assessment without the panel . All tests and treatments other than the panel were provided at the discretion of the clinician . MAIN OUTCOME MEASURES The primary outcome was the proportion of patients successfully discharged home after ED assessment , defined as patients who had ( 1 ) either left the hospital or were awaiting transport home with a discharge decision having been made at 4 hours after initial presentation and ( 2 ) suffered no major adverse event ( as defined below ) during the following 3 months . Secondary outcomes included length of initial hospital stay and total inpatient days over 3 months , and major adverse events ( death , non-fatal AMI , life-threatening arrhythmia , emergency revascularisation or hospitalisation for myocardial ischaemia ) . Economic analysis estimated mean costs and quality -adjusted life-years ( QALYs ) , and then estimated the probability of cost-effectiveness assuming willingness to pay of £ 20,000 per QALY gained . RESULTS We r and omised 1132 participants to point of care and 1131 to st and ard care , and analysed 1125 and 1118 , respectively [ mean age 54.5 years , 1307/2243 ( 58 % ) male and 269/2243 ( 12 % ) with known coronary heart disease ( CHD ) ] . In the point-of-care group 358/1125 ( 32 % ) were successfully discharged compared with 146/1118 ( 13 % ) in the st and ard-care group [ odds ratio ( OR ) adjusted for age , gender and history of CHD 3.81 ; 95 % confidence interval ( CI ) 3.01 to 4.82 , p < 0.001 ] . Mean length of the initial hospital stay was 29.6 hours versus 31.8 hours ( mean difference = 2.1 hours ; 95 % CI -3.7 to 8.0 hours , p = 0.462 ) , while median length of initial hospital stay was 8.8 hours versus 14.2 hours ( p < 0.001 ) . More patients in the point-of-care group had no inpatient days recorded during follow-up ( 54 % vs 40 % , p < 0.001 ) , but mean inpatient days did not differ between the two groups ( 1.8 vs 1.7 , p = 0.815 ) . More patients in the point-of-care group were managed on coronary care [ 50/1125 ( 4 % ) vs 31/1118 ( 3 % ) , p = 0.041 ] . There were 36 ( 3 % ) patients with major adverse events in the point-of-care group and 26 ( 2 % ) in the st and ard-care group ( adjusted OR 1.31 ; 95 % CI 0.78 to 2.20 , p = 0.313 ) . Mean costs per patient were £ 1217 with point-of-care versus £ 1006 with st and ard care ( p = 0.056 ) , while mean QALYs were 0.158 versus 0.161 ( p = 0.250 ) . The probability of st and ard care being dominant ( i.e. cheaper and more effective ) was 0.888 . CONCLUSIONS Point-of-care testing increases the proportion of patients successfully discharged home and reduces the median ( but not mean ) length of hospital stay . It is more expensive than st and ard care and unlikely to be considered cost-effective . TRIAL REGISTRATION Current Controlled Trials IS RCT N37823923 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 15 , No. 23 . See the HTA programme website for further project information Objective To investigate whether a high-sensitivity troponin assay , shown to improve early detection of acute myocardial infa rct ion ( AMI ) , permits accelerated rule-in/rule-out of AMI . Methods Patients who presented to the emergency department within 4 h of the onset of chest pain suggestive of acute coronary syndrome were prospect ively recruited from November 2007 to April 2010 . Blood sample s were taken at 0 , 1 , 2 and 12–24 h after presentation and were analysed for clinical ly applied troponin I and for high-sensitivity troponin T ( hsTnT ) . The dynamic change in hsTnT levels between time points was measured . The primary outcome was admission diagnosis of AMI . Results Of the 385 patients recruited , 82 ( 21.3 % ) had AMI . The sensitivity of hsTnT by 2 h was 95.1 % ( 88.7–98.1 % ) , specificity 75.6 % ( 73.8–76.5 % ) , positive predictive value 53.8 % ( 50.2–55.5 % ) and negative predictive value 98.3 % ( 96.0–99.3 % ) . The sensitivity was not statistically different between peak values at 2 h and 24 h. Adding ECG results reduced the false negative rate to 1.2 % . The additional application of ≥20 % delta criterion over the 2 h period for 0–2 h sample s increased specificity to 92.4 % ( 90.2–94.3 % ) but reduced sensitivity to 56.1 % ( 48.0–63.2 % ) . Conclusion hsTnT taken at 0 and 2 h after presentation , together with ECG results , could identify patients suitable for early stress testing with a false negative rate for AMI of 1.2 % . Further trials of such an approach are warranted . The specificity of hsTnT for diagnosing AMI could be improved by the use of a delta of ≥20 % , but at the cost of major reductions in sensitivity Abstract Background : Current hospital practice involves protracted observation of chest-pain patients to rule out myocardial infa rct ion . Concurrent measurement of multiple biomarkers may increase sensitivity and make rapid diagnosis feasible . Objective : We sought to determine the optimal biomarker strategy for highly sensitive , early diagnosis of myocardial injury . Study Design : A prospect i ve evaluation of 171 acute coronary syndrome patients admitted to a single university medical center was performed . Blood tests for creatine kinase ( CK ) , CK myocardial b and isoenzyme ( CK-MB ) , and troponin T were obtained at 0 , 3 , 6 , 8 , and 16 hours after presentation to the emergency department . Myocardial injury was defined as a troponin T level of ≥0.03 ng/mL. Results : Troponin T had sensitivities of 79.7 % , 95.7 % , and 98.4 % at the time of initial presentation , 3 and 6 hours after presentation , respectively . Using a combination of troponin T and CK-MB relative index , sensitivity on presentation was increased to 90.6 % . The sensitivity was improved to 97.9 % and 100 % at 3 and 6 hours , respectively . Conclusion : This study demonstrates that the diagnosis of myocardial injury can be accurately excluded within 6 hours of admission with high sensitivity using troponin T. The combination of troponin T and CK-MB relative index provided the largest improvement in diagnostic sensitivity at patient arrival . These results support the feasibility of rapid , efficient triage for the emergent presentation of patients with chest pain BACKGROUND Cardiac troponin T measured by a high-sensitivity assay ( hs-cTnT ) recently proved to be of prognostic value in several population s. The hs-cTnT assay may also improve risk stratification in acute dyspnea . METHODS We prospect ively studied the prognostic value of hs-cTnT in 678 consecutive patients presenting to the emergency department with acute dyspnea . On the basis of conventional cardiac troponin T assay ( cTnT ) and hs-cTnT assay measurements , patients were divided into 3 categories : ( 1 ) neither assay increased ( cTnT<0.03 μg/L , hs-cTnT<0.016 μg/L ) , ( 2 ) only hs-cTnT increased≥0.016 μg/L ( cTnT<0.03 μg/L ) , and ( 3 ) both assays increased ( cTnT≥0.03 μg/L , hs-cTnT≥0.016 μg/L ) . Moreover , the prognostic value of hs-cTnT was investigated if cTnT was not detectable ( < 0.01 ) . RESULTS One hundred seventy-two patients were in the lowest , 282 patients in the middle , and 223 patients in the highest troponin category . Patients in the second and third categories had significantly higher mortality compared to those in the first category ( 90-day mortality rate 2 % , 10 % , and 26 % in groups 1 , 2 , and 3 , respectively , P<0.001 ; 1-year mortality rate 9 % , 21 % , and 39 % , P<0.001 ) . Importantly , in patients with undetectable cTnT ( n=347 , 51 % ) , increased hs-cTnT indicated worse outcome [ 90-day mortality , odds ratio 4.26 ( 95 % CI 1.19 - 15.21 ) ; 1-year mortality , hazard ratio 2.27 ( 1.19 - 4.36 ) , P=0.013 ] , whereas N-terminal pro-brain-type natriuretic peptide ( NT-proBNP ) was not predictive of short-term outcome . CONCLUSIONS hs-cTnT is associated with mortality in patients presenting with acute dyspnea . hs-cTnT concentrations provide additional prognostic information to cTnT and NT-proBNP testing in patients with cTnT concentrations below the detection limit . In particular , the hs-cTnT cutoff of 0.016 μg/L enables identification of low-risk patients OBJECTIVES The goal of this study was to determine the ability of
Output:
| There is some evidence to suggest that hs-CTn testing may provide an effective and cost-effective approach to early rule-out of AMI . |
MS212345 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: The incidence of brain metastases secondary to small cell lung cancer ( SCLC ) is about 35 % and the treatment strategy of brain irradiation with respect to dose and fractionation is controversial . In order to evaluate treatment outcome of brain irradiation in SCLC patients with brain relapse , we retrospectively evaluated all patients treated with brain irradiation in the eastern part of Denmark from 1988 to 1992 ( PCI patients excluded ) . During this 5-year period , 101 evaluable patients were included ( 44 females , 57 males ) ( median age 61 years ; range , 39 - 75 years ) . Forty-four patients , of whom 43 were in extracerebral complete remission ( CR ) , received extended course ( EC ) brain irradiation ( > 45 Gy , treatment schedule > 4 weeks ) . Fifty-seven patients received short course ( SC ) brain irradiation ( < 30 Gy , treatment schedule < 1 week ) . Among the SC treated patients , 14 were in CR , 20 had partial remission or stable disease and 23 had progressive extracerebral disease . The median survival ( from diagnosis of brain metastases ) in the group receiving irradiation with EC ( 44 patients ) was 160 days ( range , 74 - 2021 days ) , while the 57 patients treated with SC had a median survival of 88 days ( range , 20 - 948 days ) ( P = 0.00001 , Log-Rank analysis ) . In a subgroup of 14 patients in extracerebral CR , receiving SC irradiation , the median survival was 83 days ( range , 15 - 948 days ) . When the latter patients were compared to the 43 patients in CR in the group treated with EC , a statistically significant difference was shown ( P = 0.034 , Log-Rank analysis ) . Using Cox-hazard regression analysis with backward elimination , liver metastases and poor performance status were adverse prognostic signs , although the only significant parameters of survival were gender ( female vs. male , relative risk of dying 1 and 1.52 , P = 0.05 ) and schedule of brain irradiation ( extended course vs. short course , relative risk of dying , 0.36 and 1 , P < 0.001 ) . Extended course irradiation of brain relapse secondary to SCLC seems in general to be of limited value , although a significant prolonged survival at approximately 7 weeks , was obtained . The prolongation of survival does not seem worthwhile considering the length of treatment time ( 5 - 6 weeks ) compared to SC treatment ( 1 week ) . However , the data do not permit evaluation of the quality of life of the patients . This retrospective evaluation suggests the need for r and omized trials with carefully planned quality -of-life assessment BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good .
Output:
| Abstract Should whole brain radiation therapy ( WBRT ) be used as the sole therapy in patients with newly-diagnosed , surgically accessible , single brain metastases , compared with WBRT plus surgical resection , and in what clinical setting s?Target population This recommendation applies to adults with newly diagnosed single brain metastases amenable to surgical resection ; however , the recommendation does not apply to relatively radiosensitive tumors histologies ( i.e. , small cell lung cancer , leukemia , lymphoma , germ cell tumors and multiple myeloma ) .
RecommendationS urgical resection plus WBRT versus WBRT aloneLevel 1 Class I evidence supports the use of surgical resection plus post-operative WBRT , as compared to WBRT alone , in patients with good performance status ( functionally independent and spending less than 50 % of time in bed ) and limited extra-cranial disease .
There is insufficient evidence to make a recommendation for patients with poor performance scores , advanced systemic disease , or multiple brain metastases .
Recommendation Level 1 Class I evidence suggests that altered dose/fractionation schedules of WBRT do not result in significant differences in median survival , local control or neurocognitive outcomes when compared with “ st and ard ” WBRT dose/fractionation . (
If WBRT is used , what impact does tumor histopathology have on treatment outcomes ?
Recommendation Given the extremely limited data available , there is insufficient evidence to support the choice of any particular dose/fractionation regimen based on histopathology .
RecommendationS urgical resection plus WBRT versus surgical resection aloneLevel 1 Surgical resection followed by WBRT represents a superior treatment modality , in terms of improving tumor control at the original site of the metastasis and in the brain overall , when compared to surgical resection alone |
MS212346 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background — Prior primary prevention trials of statin therapy that used cholesterol criteria for enrollment have not reported significant decreases in stroke risk . We evaluated whether statin therapy might reduce stroke rates among individuals with low levels of cholesterol but elevated levels of high-sensitivity C-reactive protein . Methods and Results — In Justification for the Use of statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ( JUPITER ) , 17 802 apparently healthy men and women with low-density lipoprotein cholesterol levels < 130 mg/dL and high-sensitivity C-reactive protein levels ≥2.0 mg/L were r and omly allocated to rosuvastatin 20 mg daily or placebo and then followed up for the occurrence of a first stroke . After a median follow-up of 1.9 years ( maximum , 5.0 years ) , rosuvastatin result ed in a 48 % reduction in the hazard of fatal and nonfatal stroke as compared with placebo ( incidence rate , 0.18 and 0.34 per 100 person-years of observation , respectively ; hazard ratio 0.52 ; 95 % confidence interval , 0.34 to 0.79 ; P=0.002 ) , a finding that was consistent across all examined subgroups . This finding was due to a 51 % reduction in the rate of ischemic stroke ( hazard ratio , 0.49 ; 95 % confidence interval , 0.30 to 0.81 ; P=0.004 ) , with no difference in the rates of hemorrhagic stroke between the active and placebo arms ( hazard ratio , 0.67 ; 95 % confidence interval , 0.24 to 1.88 ; P=0.44 ) . Conclusion — Rosuvastatin reduces by more than half the incidence of ischemic stroke among men and women with low levels of low-density lipoprotein cholesterol levels who are at risk because of elevated levels of high-sensitivity C-reactive protein . Clinical Trial Registration — clinical trial.gov . Unique identifier : NCT00239681 Background Patients with end-stage renal disease ( ESRD ) are at high risk of cardiovascular events . Multiple risk factors for atherosclerosis are present in ESRD and may contribute to the increased risk of cardiovascular mortality in this population . In contrast to patients with normal renal function , the benefits of modifying lipid levels on cardiovascular outcomes in patients with ESRD on haemodialysis have yet to be confirmed in large prospect i ve r and omised trials . A study to evaluate the Use of Rosuvastatin in subjects On Regular haemodialysis : an Assessment of survival and cardiovascular events ( AURORA ) will be the first large-scale international trial to assess the effects of statin therapy on cardiovascular morbidity and mortality in ESRD patients on chronic haemodialysis . Methods More than 2,750 ESRD patients who have been receiving chronic haemodialysis treatment for at least 3 months have been r and omised ( 1:1 ) , irrespective of baseline lipid levels , to treatment with rosuvastatin 10 mg or placebo . The primary study endpoint is the time to a major cardiovascular event ( first occurrence of cardiovascular death , non-fatal myocardial infa rct ion or non-fatal stroke ) . Secondary endpoints include all-cause mortality , major cardiovascular event-free survival time , time to cardiovascular death , time to non-cardiovascular death , cardiovascular interventions , tolerability of treatment and health economic costs per life-year saved . Study medication will be given until 620 subjects have experienced a major cardiovascular event . Conclusion Our hypothesis is that results from AURORA will establish the clinical efficacy and tolerability of rosuvastatin in patients with ESRD receiving chronic haemodialysis and guide the optimal management of this exp and ing population BACKGROUND Clopidogrel is a more potent antiplatelet agent than aspirin , result ing in greater clinical efficacy in patients with atherothrombotic disease . Furthermore , the combination of clopidogrel plus aspirin has been demonstrated to be superior to aspirin alone in the treatment of patients with acute coronary syndromes and after coronary stenting . Whether dual antiplatelet therapy is superior to aspirin monotherapy for high-risk primary prevention and secondary prevention is unknown . METHODS AND RESULTS The Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization , Management , and Avoidance ( CHARISMA ) study was design ed to evaluate the efficacy and safety of clopidogrel plus aspirin versus placebo plus aspirin in patients with established coronary , cerebral , or peripheral arterial disease or in patients with multiple risk factors for atherothrombosis who have not yet sustained an ischemic event . This r and omized , international , multicenter , double-blinded , placebo-controlled study has finished enrolling patients worldwide . A total of 15,603 patients will be followed long term . The primary end point will be the composite of vascular death , myocardial infa rct ion , or stroke . Rates of severe bleeding will also be compared between the two arms of the study . CONCLUSIONS This large-scale trial of patients at high risk for atherothrombotic events will allow determination of the value of a strategy of adding clopidogrel to the current st and ard of care , including low-dose aspirin , for a wide spectrum of patients with atherothrombosis Background and Purpose — Intracerebral hemorrhage ( ICH ) has a 30-day mortality rate of 40 % to 50 % and lacks a proven treatment . We report a preplanned , midpoint analysis of the first population -based , case-control study that examines both genetic and environmental risk factors of ICH . Methods — We prospect ively identified cases of hemorrhagic stroke at all 16 hospitals in the Greater Cincinnati/Northern Kentucky region . All cases underwent medical record and neuroimaging review . Cases enrolled in the direct interview and genetic sampling arm of the study were matched to population -based control subjects by age , race , and sex . Multivariable logistic regression was performed to identify significant independent risk factors . Results — We enrolled 188 cases of ICH ( 67 lobar , 121 nonlobar ) and 366 control subjects in the direct interview arm of the study . Significant independent risk factors for lobar ICH included the presence of an apolipoprotein E2 or E4 allele , frequent alcohol use , prior stroke , and first-degree relative with ICH . Significant independent risk factors for nonlobar ICH were hypertension , prior stroke , and first-degree relative with ICH . An increasing level of education was associated with a decreased risk of nonlobar ICH . The attributable risk of apolipoprotein E2 or E4 for lobar ICH was 29 % , and the attributable risk of hypertension for nonlobar ICH was 54 % . Conclusions — There is significant epidemiological evidence that the pathophysiology of ICH varies by location . We estimate that a third of all cases of lobar ICH are attributable to possession of an apolipoprotein E4 or E2 allele and that half of all cases of nonlobar ICH are attributable to hypertension BACKGROUND The role of lipid modification in stroke prevention is controversial , although increasing evidence suggests that HMG-CoA reductase inhibition may reduce cerebrovascular events in patients with prevalent coronary artery disease . METHODS AND RESULTS To test the hypothesis that cholesterol reduction with pravastatin may reduce stroke incidence after myocardial infa rct ion , we followed 4159 subjects with average total and LDL serum cholesterol levels ( mean , 209 and 139 mg/dL , respectively ) who had sustained an infa rct ion an average of 10 months before study entry and who were r and omized to pravastatin 40 mg/d or placebo in the Cholesterol and Recurrent Events ( CARE ) trial . Using prospect ively defined criteria , we assessed the incidence of stroke , a prespecified secondary end point , and transient ischemic attack ( TIA ) over a median 5-year follow-up period . Patients were well matched for stroke risk factors and the use of antiplatelet agents ( 85 % of subjects in each group ) . Compared with placebo , pravastatin lowered total serum cholesterol by 20 % , LDL cholesterol by 32 % , and triglycerides by 14 % and raised HDL cholesterol by 5 % over the course of the trial . A total of 128 strokes ( 52 on pravastatin , 76 on placebo ) and 216 strokes or TIAs ( 92 on pravastatin , 124 on placebo ) were observed , representing a 32 % reduction ( 95 % CI , 4 % to 52 % , P=0.03 ) in all-cause stroke and 27 % reduction in stroke or TIA ( 95 % CI , 4 % to 44 % , P=0.02 ) . All categories of strokes were reduced , and treatment effect was similar when adjusted for age , sex , history of hypertension , cigarette smoking , diabetes , left ventricular ejection fraction , and baseline total , HDL , and LDL cholesterol and triglyceride levels . There was no increase in hemorrhagic stroke in patients on pravastatin compared with placebo ( 2 versus 6 , respectively ) . CONCLUSIONS Pravastatin significantly reduced stroke and stroke or TIA incidence after myocardial infa rct ion in patients with average serum cholesterol levels despite the high concurrent use of antiplatelet therapy Background —This report describes the effect of intensive cholesterol lowering with atorvastatin on the incidence of nonfatal stroke , a secondary end point , in a r and omized , placebo-controlled trial of patients with unstable angina or non-Q-wave myocardial infa rct ion . The primary end point , a composite of death , nonfatal myocardial infa rct ion , resuscitated cardiac arrest , or recurrent symptomatic myocardial ischemia with objective evidence requiring emergency rehospitalization , was reduced from 17.4 % in the placebo group to 14.8 % in the atorvastatin group over the 16 weeks of the trial ( P = 0.048 ) . Methods and Results —Strokes were adjudicated by a blinded end-point committee using st and ard clinical and imaging criteria . The outcomes of nonfatal stroke and fatal plus nonfatal stroke were analyzed by time to first occurrence during the 16-week trial . Of 38 events ( in 36 patients ) adjudicated as fatal or nonfatal strokes , 3 were classified as hemorrhagic , one as embolic , and 29 as thrombotic or embolic ; 5 could not be categorized . Nonfatal stroke occurred in 9 patients in the atorvastatin group and 22 in the placebo group ( relative risk , 0.40 ; 95 % confidence intervals , 0.19 to 0.88;P = 0.02 ) . Fatal or nonfatal stroke occurred in 12 atorvastatin patients and 24 placebo patients ( relative risk , 0.49 ; 95 % confidence intervals , 0.24 to 0.98;P = 0.04 ) . All 3 hemorrhagic strokes occurred in the placebo group . Conclusion —Intensive cholesterol lowering with atorvastatin over 16 weeks in patients with acute coronary syndromes reduced the overall stroke rate by half and did not cause hemorrhagic stroke . These findings need to be confirmed in future trials The FAST MI registry was design ed to evaluate the ' real world ' management of patients with acute myocardial infa rct ion ( MI ) , and to assess their in-hospital , medium- and long-term outcomes . Patients were recruited consecutively from intensive care units over a period of one month ( from October 2005 ) , with an additional one-month recruitment period for diabetic patients . The study included 3059 MI patients in phase 1 and an additional 611 diabetic patients in phase 2 . Altogether , 53 % of the patients had a final diagnosis of Q wave MI and 47 % had non Q wave MI . Patients with Q wave MI were more likely to be men , younger , more frequently with a family history or a history of smoking . Patients with non Q wave MI had worst baseline demographic and clinical characteristics mainly explained by their older age . Time from symptom onset to hospital admission was less than three hours for 22 % of the patients with Q wave MI and for 14 % of the non Q wave MI patients . Among patients with Q wave MI , 64 % received reperfusion therapy , 35 % with primary percutaneous coronary interventions , 19 % with pre-hospital thrombolysis and 10 % with in-hospital thrombolysis . Over 70 % of patients received statin therapy during the hospital stay and over 90 % anti platelet agents . In-hospital mortality was 5.8 % in patients with Q wave MI and 4.9 % in patients with non Q Wave MI . At discharge beta-adrenergic blockers and statins and , to a lesser extent , medications of the renin angiotensin system were commonly prescribed . Over 90 % received antiplatelet agents BACKGROUND Platelets play a key role in the pathogenesis of atherosclerosis , thrombosis , and acute coronary and cerebrovascular syndromes . Inhibition of platelet function by acetylsalicylic acid ( aspirin ) has been shown to reduce the incidence atherothrombotic
Output:
| We found no evidence that statins were associated with intracerebral hemorrhage ; if such a risk is present , its absolute magnitude is likely to be small and outweighed by the other cardiovascular benefits of these drugs |
MS212347 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Consumers with serious mental illness ( N=166 ) enrolling in two community-based mental health programs , a vocational Program of Assertive Community Treatment and a clubhouse certified by the International Center for Clubhouse Development ( ICCD ) , were asked about their interest in work . About one third of the new enrollees expressed no interest in working . Equivalent supported employment services were then offered to all participants in each program . Stated interest in work and receipt of vocational services were statistically significant predictors of whether a person would work and how long it would take to get a job . Two thirds of those interested in work and half of those with no initial interest obtained a competitive job if they received at least one hour of vocational service . Once employed , these two groups held comparable jobs for the same length of time . These findings demonstrate the importance of making vocational services continuously available to all people with serious mental illness , and the viability of integrating these services into routine mental health care OBJECTIVE This purpose of this study was to determine whether participation in the Work-Ordered Day program of the Clubhouse model has a positive effect on vocational outcomes . METHOD The longitudinal study followed a group of individuals with severe mental illness who were r and omly assigned either to a Clubhouse program or a Program of Assertive Community Treatment team . Study participants were tracked for 135 weeks . These analyses evaluated the relationship between Work-Ordered Day participation and employment duration for the 43 study participants enrolled in the Clubhouse program who were active throughout the study and competitively employed during the study . RESULTS Participation in the Work-Ordered Day program had a significant positive impact on average duration of employment . On average , a 1-hr increase in participation prior to employment led to an increase of 2.3 weeks in competitive employment . CONCLUSIONS AND IMPLICATION S FOR PRACTICE Participants with more Work-Ordered Day program participation prior to employment had significantly longer average competitive employment duration even when controlling for prior work history . Participation in the Work-Ordered Day program is likely to improve work readiness . Further research is warranted to study which elements of the program may foment employment success . This could lead to increased implementation of the Work-Ordered Day program and its elements as precursors to employment for adults with severe mental illness Background Tobacco remains a seemingly intractable problem for individuals living with severe and persistent mental illness . This study evaluated the implementation , technical assistance , and perceived impact of a model curriculum ( " Learning About Healthy Living " ) to promote wellness and motivation to quit tobacco use in psychosocial rehabilitation clubhouses . Methods We used semi-structured interviews ( n = 9 ) with clubhouse staff ( n = 12 ) and a survey of participating clubhouse members ( n = 271 ) in nine clubhouses . Results Fifty-eight percent of clubhouse participants completed surveys . Results showed tobacco users open to tobacco-free policies ( 62 % ) and perceiving more discussion s about quitting tobacco with healthcare providers ( 69 % ) . Analyses of staff interviews and member surveys revealed four key themes : ( 1 ) the curriculum was successfully implemented and appreciated ; ( 2 ) technical assistance kept implementation on track ; ( 3 ) adding wellness content and interactive components should enhance the curriculum ; and , ( 4 ) the curriculum advanced other healthful policies and practice s. Conclusions Mental health setting s are important locations for implementing programs to address tobacco use . In this real-world implementation of a model curriculum in psychosocial rehabilitation clubhouses , the curriculum tested well , was feasible and well-received , and suggests potential impact on tobacco use outcomes . Revision , dissemination , and a r and omized controlled trial evaluation of the model curriculum should now occur The Program Environment Scale ( PES ) was developed for use with clients of community-based programs for the severely mentally ill . It is intended to fill the gap in available tools for assessing clients ' perceptions of program functioning as it affects their “ quality of life ” in a program . Formal pretests were conducted with 121 clients at 12 r and omly selected programs near Washington , DC . The final field test used a revised form ( 29 domains ; 129 items ) with 221 clients in 22 programs selected r and omly throughout the U.S. , including Clubhouse , day treatment , psychosocial rehabilitation , and social club programs . Twenty-three subscales met at least five of eight psychometric criteria for internal consistency and discriminant validity . A 24th subscale was retained because of its substantive importance . Successful subscales cover program atmosphere and interactions ( program cares about me , energy level , friendliness , openness , staff-client and client-client respect , reasonable rules , availability of positive physical contact , protection from bad touch , staff investment in their jobs , and confidentiality ) , client empowerment/staff-client e quality ( program and treatment empowerment , egalitarian space use ) , and service components ( support for paid work , work importance , emergency access , family activities , housing , public benefits , community activities , medications , substance abuse , and continuity ) . Subscale validity is indicated by associations of specific service offerings with scores on scales measuring client perceptions of those services , and by an ability to differentiate among program models ( i.e. , Clubhouses , day treatment programs , and psychosocial rehabilitation programs look different from each other ) . Subscale scores were not influenced by client characteristics ( gender , race , age , diagnosis , number of hospitalizations , length of time in program ) . The final scale has 97 items and takes about 25 minutes to complete . The PES succeeds in measuring different aspects of programs as clients perceive them . In the programs we visited , directors felt the PES covers the important things they want to know about how clients perceive their program . The PES should become a useful tool both for research ers interested in how client responses to programs may influence their therapeutic outcomes , and for practitioners interested in improving their clients ' program experiences and /or increasing convergence of staff and client views of their program OBJECTIVE Despite the large number of Latinos living in the United States , little research has evaluated the effectiveness of different vocational rehabilitation programs for individuals with severe mental illness in this rapidly growing minority population . This article presents a secondary analysis of a r and omized , controlled trial comparing supported employment with 2 other vocational rehabilitation programs in 3 ethnic/racial groups of participants with severe mental illness : Latinos , non-Latino African Americans , and non-Latino Whites . METHOD The data were drawn from a previously published r and omized , controlled trial comparing supported employment with st and ard vocational rehabilitation services and a psychosocial clubhouse program in persons with severe mental illness ( Mueser et al. , 2004 ) , including 64 Latinos , 91 non-Latino African Americans , and 43 non-Latino Whites . Comparisons were made between the 3 groups at baseline on demographic characteristics , clinical and psychosocial functioning , and quality of life . Within each ethnic/racial group , competitive employment and all paid employment outcomes were compared between the 3 vocational rehabilitation programs over the 2-year study period . RESULTS At baseline , the Latino participants had lower levels of education and disability income , were less likely to have worked competitively over the previous 5 years , had more severe symptoms , and worse psychosocial functioning than the non-Latino African American or non-Latino White participants . Latinos r and omized to supported employment had better competitive and all-paid work outcomes than those assigned to either st and ard services or the psychosocial clubhouse program , similar to the non-Latino consumers . Rates of competitive work for consumers in supported employment were comparable across all 3 racial/ethnic groups . DISCUSSION Supported employment is effective at improving competitive work in Latinos with severe mental illness . Efforts should be made to increase access to supported employment in the growing population of Latinos with severe mental illness A r and omized trial comparing a facility-based Clubhouse ( N = 83 ) to a mobile Program of Assertive Community Treatment ( PACT ; N = 84 ) tested the widely held belief that competitive employment improves global quality of life for adults with severe mental illness . R and om regression analyses showed that , over 24 months of study participation , competitively employed Clubhouse participants reported greater global quality of life improvement , particularly with the social and financial aspects of their lives , as well as greater self-esteem and service satisfaction , compared to competitively employed PACT participants . However , there was no overall association between global quality of life and competitive work , or work duration . Future research will determine whether these findings generalize to other certified Clubhouses or to other types of supported employment . Multi-site studies are needed to identify key mechanisms for quality of life improvement in certified Clubhouses , including the possibly essential role of Clubhouse employer consortiums for providing high-wage , socially integrated jobs The authors compared 3 approaches to vocational rehabilitation for severe mental illness ( SMI ) : the individual placement and support ( IPS ) model of supported employment , a psychosocial rehabilitation ( PSR ) program , and st and ard services . Two hundred four unemployed clients ( 46 % African American , 30 % Latino ) with SMI were r and omly assigned to IPS , PSR , or st and ard services and followed for 2 years . Clients in IPS had significantly better employment outcomes than clients in PSR and st and ard services , including more competitive work ( 73.9 % vs. 18.2 % vs. 27.5 % , respectively ) and any paid work ( 73.9 % vs. 34.8 % vs. 53.6 % , respectively ) . There were few differences in nonvocational outcomes between programs . IPS is a more effective model than PSR or st and ard brokered vocational services for improving employment outcomes in clients with SMI Service fit , defined as consistency between mental health services judged needed and services received was measured for a r and om sample of service recipients in a public mental health system ( N = 6588 ) . A variant of small area analysis was used to measure the relationship between catchment area mortality rates from natural causes , suicide , and medicolegal causes and area fit scores for a variety of services . We tested the theory-based hypothesis that service fit would predict interarea variations in mortality better than simple measures of amount of service prescribed and received . We also tested the hypothesis that , controlling for relevant demographic and clinical factors , fit would be protective for mortality from all causes . Findings supported the first hypothesis . With respect to the second , service fit for only certain services was protective . Housing and clubhouses services were particularly protective , suggesting the importance of services providing social support BACKGROUND : Following the lead of evidence -based medicine , practice based on effectiveness research has become the new gold st and ard of contemporary public policy . Studies of this sort are increasingly dem and ed to evaluate services provided by mental health , social services and criminal justice systems . AIMS : The paper questions whether the simple r and omized controlled trial ( RCT ) paradigm as applied in clinical trials can be used " off the rack " to evaluate socially complex service ( SCS ) interventions . These are services that are characterized by complex , diverse and non-st and ardized staffing arrangements ; ambiguous protocol s ; hard-to-define study sample s and unevenly motivated subjects and dependence on broader social environments . The difficulty of ensuring precise protocol s , equivalent groups ( tied to a meaningful target population ) and neutral and equivalent trial environments under real world conditions are explored , as are the implication s of not achieving st and ardization and equivalence . METHODS : Limitations of effectiveness research as a research tool and information source are examined by comparing the assumptions underpinning the simple RCT to the characteristics of SCS interventions , as illustrated by programs targeted to mentally disordered offenders in Britain . RESULTS : SCSs violate the assumptions underpinning the simple RCT model in ways that draw into sharp question the validity , reliability and generalizability of inferences of SCS trials . DISCUSSION : The RCT is not a panacea . Effectiveness research of SCS interventions that is based on the RCT model is unlikely to yield valid , reliable and generalizable inferences without becoming more complex in design and more sensitive to issues of selection bias , unmeasured variables and endogeneity . Ten recommendations are offered for stylizing the RCT design to the characteristics of socially complex services . IMPLICATION S : It remains an empirical issue whether RCT -based services effectiveness research can inform mental health policy . Without major design innovations , it is more likely that the information generated by this research will have limited practical use , especially if the RCT model is unable to control for the effect of social complexity and the interaction between social complexity and dynamic systemic change . Scientific evaluations of services make clinical and economic sense so long as they are design ed to meet the challenges of the services of which they promise greater knowledge OBJECTIVE In a r and omized controlled trial , a vocationally integrated program of assertive community treatment ( ACT ) was compared with a certified clubhouse in the delivery of supported employment services . METHODS Employment rates , total work hours , and earnings for 121 adults with serious mental illness interested in work were compared with published benchmark figures for exemplary supported employment programs . The two programs were then compared on service engagement , retention , and employment outcomes in regression analyses that controlled for background characteristics , program preference , and vocational service receipt . RESULTS Outcomes for 63 ACT and 58 clubhouse participants met or exceeded most published outcomes for specialized supported employment teams . Compared with the clubhouse program , the ACT program had significantly ( p<.05 ) better service engagement ( ACT , 98 percent ; clubhouse , 74 percent ) and retention ( ACT , 79 percent ; clubhouse , 58 percent ) over 24 months , but there was no significant difference in employment rates ( ACT , 64 percent ; clubhouse , 47 percent ) . Compared with ACT participants , clubhouse participants worked significantly longer ( median of 199 days versus 98 days ) for more total hours ( median of 494 hours versus 234 hours ) and earned more ( median of $ 3,456 versus $ 1,252 total earnings ) . Better work performance by clubhouse participants was partially attributable to higher pay . CONCLUSIONS Vocationally integrated ACT and certified clubhouses can achieve employment outcomes similar to those of exemplary supported employment teams . Certified clubhouses
Output:
| RCT results support the efficacy of the Clubhouse Model in promoting employment , reducing hospitalization(s ) , and improving quality of life . |
MS212348 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: 632 Background : Following the BCIRG 001 , PACS 01 and HERA trials , this r and omised , multicentre , open-label , Phase III trial was design ed to demonstrate the benefit of concomitant docetaxel and epirubicin versus anthracyclines , and evaluate the use of sequential trastuzumab . METHODS Patients ( pts ) with localised , resectable , unilateral breast cancer who met the following criteria were eligible : age < 65 years , ≥1 positive node , M0 , adequate heart and organ functions . Pts were r and omised to receive either 6 cycles of 5-fluorouracil-epirubicin-cyclophosphamide ( FEC100 : F and C , 500 mg/m2 , E 100 mg/m2 ) ( Arm A ) or epirubicin-docetaxel ( ET75 : E 75 mg/m2 , T 75 mg/m2 ) ( Arm B ) . Primary prophylaxis with G-CSF was not planned . Radiotherapy was m and atory after conservative surgery and tamoxifen was required in pts with hormone receptor-positive tumours . Pts with HER2-positive disease were then further r and omised to observation only or to 1 year of trastuzumab monotherapy ( 6 mg/kg iv every 3 weeks ) . In HER2-positive pts receiving trastuzumab , left ventricular ejection fraction ( LVEF ) was determined at Cycles 2 , 4 , 8 , 13 , 18 and after 2 years . Otherwise , LVEF was determined at baseline and at 1 year post-surgery . RESULTS Of the 3010 pts recruited ( 2622 evaluable for safety to date ) , 1518 received FEC100 and 1492 received ET75 after the first r and omisation . Haematologic toxicity was the most frequent toxicity in both arms . Grade 3 - 4 toxicities were similar for Arms A and B , except febrile neutropenia ( 10.3 % and 31.4 % , respectively ) and nausea/vomiting ( 13.2 % and 7.5 % , respectively ) . Grade 2 clinical cardiac toxicity ( decreased LVEF ) was observed in 4 pts in Arm A and 5 in Arm B , with median LVEF scores of 63 % in both arms at the end of chemotherapy . HER2-positive pts ( n=500 ) were then r and omised to either receive trastuzumab ( n=259 ) or observation only ( n=241 ) . CONCLUSIONS These preliminary safety data indicate that FEC100 and ET75 were both well tolerated , with acceptable cardiac safety values . The trial is ongoing and further analysis regarding the use of trastuzumab in this setting will be presented . [ Table : see text ] PURPOSE We investigated the incidence of cardiac adverse events in patients with early breast cancer in the Herceptin Adjuvant ( HERA ) trial who were treated with 1 year of trastuzumab after completion of (neo)adjuvant chemotherapy . PATIENTS AND METHODS The HERA trial is a three-group , r and omized trial that compared 1 year or 2 years of trastuzumab with observation in women with human epidermal growth factor receptor-2 ( HER2 ) -positive early breast cancer . Eligible patients had normal left ventricular ejection fraction ( LVEF ; > or= 55 % ) after completion of (neo)adjuvant chemotherapy with or without radiotherapy . Cardiac function was monitored throughout the trial . This analysis considers patients r and omly assigned to 1 year of trastuzumab treatment or observation . RESULTS There were 1,698 patients r and omly assigned to observation and 1,703 r and omly assigned to 1 year of trastuzumab treatment ; 94.1 % of patients had been treated with anthracyclines . The incidence of discontinuation of trastuzumab because of cardiac disorders was low ( 5.1 % ) . At a median follow-up of 3.6 years , the incidence of cardiac end points remained low , though it was higher in the trastuzumab group than in the observation group ( severe CHF , 0.8 % v 0.0 % ; confirmed significant LVEF decreases , 3.6 % v 0.6 % ) In the trastuzumab group , 59 of 73 patients with a cardiac end point reached acute recovery ; of these 59 patients , 52 were considered by the cardiac advisory board ( CAB ) to have a favorable outcome from the cardiac end point . CONCLUSION The incidence of cardiac end points remains low even after longer-term follow-up . The cumulative incidence of any type of cardiac end point increases during the scheduled treatment period of 1 year , but it remains relatively constant thereafter BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . PURPOSE To evaluate the efficacy and safety of docetaxel , cisplatin , and trastuzumab as primary systemic therapy for human epidermal growth factor receptor 2 ( HER2 ) -positive , locally advanced breast cancer ( LABC ) . PATIENTS AND METHODS Forty-eight patients with immunohistochemistry-confirmed HER2-positive LABC or inflammatory breast cancer received 12 weeks of docetaxel , cisplatin , and trastuzumab with filgrastim , followed by surgery , adjuvant doxorubicin and cyclophosphamide , and locoregional radiotherapy with or without tamoxifen . The primary end point was pathologic complete response ( pCR ) in breast . RESULTS Baseline mean tumor size was 9.2 cm ( range , 4 to 32 cm ) . pCR occurred in breast in 11 patients ( 23 % ; 95 % CI , 12 % to 37 % ) and breast and axilla in eight patients ( 17 % ; 95 % CI , 8 % to 30 % ) . pCR rates in breast ( HER2 positive , seven of 30 patients , 23 % v HER2 negative , four of 18 patients , 22 % ; P > .05 ) and breast and axilla ( four of 30 patients , 13 % v four of 18 patients , 22 % , respectively ; P > .05 ) were similar regardless of HER2 status by fluorescence in situ hybridization ( FISH ) . At a median follow-up time of 43 months , 4-year progression-free survival ( PFS ) rate was 81 % ( 95 % CI , 64 % to 90 % ) ; overall survival ( OS ) rate was 86 % ( 95 % CI , 71 % to 94 % ) . In patients with pCR in breast and axilla , PFS and OS rates were 100 % ( 95 % CI , inestimable ) . In patients without pCR , PFS rate was 76 % ( 95 % CI , 57 % to 88 % ; P = .15 , log-rank test ) , and OS rate was 83 % ( 95 % CI , 66 % to 92 % ; P = .21 ) . Survival rates were similar regardless of FISH status . There were only two grade 4 adverse events . CONCLUSION Twelve weeks of docetaxel , cisplatin , and trastuzumab is clinical ly active and leads to excellent survival in patients with large , HER2-positive tumors BACKGROUND Trastuzumab ( T ) combined with chemotherapy has been recently shown to improve outcome in HER2-positive breast cancer ( BC ) . The aim of this study was to evaluate the toxic effects of concurrent radiation therapy ( RT ) and T administration in the adjuvant setting . PATIENTS AND METHODS Data of 146 patients with stages II-III HER2-positive BC were recorded . Median age was 46 years . In all , 32 ( 23 % ) and 114 ( 77 % ) patients received a weekly and a 3-week T schedule , respectively . A median dose of 50 Gy was delivered after surgery . Internal mammary chain ( IMC ) was irradiated in 103 ( 71 % ) patients . RESULTS Grade > 2 dermatitis and esophagitis were noted in 51 % and 12 % , respectively . According to the Common Toxicity Criteria v3.0 scale and HERA ( HERceptin Adjuvant ) trial criteria , respectively , 10 % and 6 % of the patients had a grade > /=2 of left ventricular ejection fraction ( LVEF ) decrease after RT . Multivariate analyses revealed two independent prognostic factors : weekly T administration ( for LVEF decrease ) and menopausal status ( for dermatitis ) . Higher level of T cumulative dose ( > 1600 mg ) was only borderline of statistical significance for acute esophagitis toxicity . CONCLUSION We showed that weekly concurrent T and RT are feasible in daily clinical practice with , however , a decrease of LVEF . Cardiac volume sparing and patient selection s for IMC irradiation are highly recommended . Longer follow-up is warranted to evaluate late toxic effects Despite important progress in underst and ing the molecular factors underlying the development of cancer and the improvement in response rates with new drugs , long-term survival is still disappointing for most common solid tumours . This might be because very little of the modest gain for patients is the result of the new compounds discovered and marketed recently . An assessment of the regulatory agencies ' performance may suggest improvements . The present analysis summarizes and evaluates the type of studies and end points used by the EMEA to approve new anticancer drugs , and discusses the application of current regulations . This report is based on the information available on the EMEA web site . We identified current regulatory requirements for anticancer drugs promulgated by the agency and retrieved them in the relevant directory ; information about empirical evidence supporting the approval of drugs for solid cancers through the central ised procedure were retrieved from the European Public Assessment Report ( EPAR ) . We surveyed documents for drug applications and later extensions from January 1995 , when EMEA was set up , to December 2004 . We identified 14 anticancer drugs for 27 different indications ( 14 new applications and 13 extensions ) . Overall , 48 clinical studies were used as the basis for approval ; r and omised comparative ( clinical ) trial ( RCT ) and Response Rate were the study design and end points most frequently adopted ( respectively , 25 out of 48 and 30 out of 48 ) . In 13 cases , the EPAR explicitly reported differences between arms in terms of survival : the range was 0–3.7 months , and the mean and median differences were 1.5 and 1.2 months . The majority of studies ( 13 out of 27 , 48 % ) involved the evaluation of complete and /or partial tumour responses , with regard to the end points supporting the 27 indications . Despite the recommendations of the current EMEA guidance documents , new anticancer agents are still often approved on the basis of small single arm trials that do not allow any assessment of an ‘ acceptable and extensively documented toxicity profile ’ and of end points such as response rate , time to progression or progression-free survival which at best can be considered indicators of anticancer activity and are not ‘ justified surrogate markers for clinical benefit ’ . Anticipating an earlier than ideal point along the drug approval path and the use of not fully vali date d surrogate end points in nonr and om
Output:
| The two small trials that administered trastuzumab for less than six months did not differ in efficacy from longer studies , but found fewer cardiac toxicities .
Trastuzumab significantly improves OS and DFS in HER2-positive women with early and locally advanced breast cancer , although it also significantly increases the risk of CHF and LVEF decline .
Studies that administered trastuzumab concurrently or sequentially did not differ significantly in efficacy . |
MS212349 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials Background : The effects on morbidity were examined of providing an educational intervention and a written guided self-management plan to the parents of pre-school children following a recent attendance at hospital for asthma or wheeze . Methods : A prospect i ve , r and omised , partially blinded , controlled trial was design ed at two secondary care centres . Over a 13 month period 200 children aged 18 months to 5 years at the time of admission to a children 's ward or attendance at an accident and emergency department or children 's ( emergency ) assessment unit ( A&E/CAU ) with a primary diagnosis of acute severe asthma or wheezing were recruited . 101 children were r and omised into the control group and received usual care and 99 were assigned to the intervention group and received : ( 1 ) a pre-school asthma booklet ; ( 2 ) a written guided self-management plan ; and ( 3 ) two 20 minute structured educational sessions between a specialist respiratory nurse and the parent(s ) and child . Subjects were assessed at 3 , 6 , and 12 months . The main outcomes were GP consultation rates , hospital re-admissions , and attendances at A&E/CAU . Secondary outcomes included disability score , caregivers ' quality of life , and parental knowledge of asthma . Results : There were no statistically significant differences between the two groups during the 12 month follow up period for any of the main or secondary outcome measures . Conclusions : These results do not support the hypothesis that the introduction of an educational package and a written guided self-management plan to the parents of pre-school children with asthma who had recently attended hospital for troublesome asthma or wheeze reduces morbidity over the subsequent 12 months This study was conducted to test the efficacy of AIR WISE , an individually administered asthma self-management program . Subjects were paired and r and omly assigned to either an experimental group ( N = 7 ) or a control group ( N = 7 ) . The frequency of experimental group emergency visits , analyzed over a 12-month posttreatment period , was substantially less than those of the control group , supporting the hypothesis that AIR WISE is effective in high-utilizer children through improved self-management The treatment of an acute asthma attack usually includes bronchodilators and often steroids . We studied 70 children who were r and omly assigned to receive either single dose steroids ( oral prednisone : 20–40 mg ) or placebo on a double blind basis . The time course of the observation was 72 h. We demonstrate that a single dose of steroids , given orally in paediatric community clinics during an acute mild to moderate asthma attack , significantly improves the patient 's course ; deterioration was prevented , symptoms were relieved faster , and hospitalization was not required . We encourage paediatricians in the ambulatory clinics to follow this treatment modality and to give , in addition to other conventional therapy , a single oral dose of steroids early in the asthma attack , in order to relieve and shorten the child 's distress An educational training program for children with asthma , aged between 8 and 13 years , was evaluated in an 18-month r and omized , controlled experiment , including three follow-up evaluations . The objective of the program is to improve coping with asthma in daily life . The program , ten 1-hour sessions , is a combination of self-management training and cognitive behaviour therapy in a group , using games and learning material s specifically design ed for this age group . From 195 asthmatic children , 112 with inadequate self-management abilities were selected ; these children were r and omly divided into an experimental group and two control groups . The results indicated highly significant differences in favor of the experimental group on the psychological and medical variables . There were no drop-outs during the program . The conclusion is that this multi-faceted program is an effective method of teaching children how to cope with their asthma and helping them to achieve a less anxious and more realistic attitude towards their illness Twenty children with severe asthma using continual oral beta 2 agonists were r and omized equally into either a behavioral intervention group or a control group . The behavioral intervention consisted of : symptom discrimination of asthma signals , self-management techniques of breathlessness , and contingency management of asthma-related behavior . The purpose of the study was to evaluate the effects of the behavioral treatment when superimposed on a regular medical treatment . The design consisted of a four-week baseline period , a four-week intervention period , and a four-week follow-up period . Results showed that the group receiving the behavioral intervention significantly reduced their use of beta 2 agonist spray doses and days of school absenteeism without increasing the number of asthma symptoms compared with the control group . It was concluded that children with severe asthma may benefit substantially from a behavioral program in addition to their regular medical treatment Care of asthmatic children is often episodic and more therapeutic than preventive . A 2-year r and omized , controlled trial involving 95 children measured the impact of a comprehensive home and ambulatory program for pediatric asthma management using objective outcome measures . Interventions for the study group during the first year included 3-month clinic visits , education , and home visits by a specially trained research nurse . Control subjects continued to receive regular care from a family physician or pediatrician . Eight-nine subjects ( 93 % ) completed the study . Study subjects had less school absenteeism than control subjects ( 10.7 vs. 16.0 days , P = .04 ) and showed significantly better small airway function after 1 year . Asthma severity improved in 13 study subjects and worsened in 5 . The reverse was true for control subjects . Study subjects exhibited better metered aerosol technique than control subjects ( P = .0005 ) . Fewer days were spent in hospital by the study subjects admitted compared with control subjects ( 3.67 vs 11.2 days , P = .02 ) . After 1 year , more study than control families ( 72.1 % vs 33.1 % , P = .006 ) reported that their asthmatic child took responsibility for the asthma management . The intervention failed to reduce exposure to secondh and smoke or to household pets . There were no significant differences in medical visits , theophylline levels , or records of asthma symptoms . One year after discontinuing the intervention , a marked " washout " effect was observed . Comprehensive ambulatory programs of childhood asthma management can improve objective measures of illness severity but must be sustained A r and omised controlled study of an educational programme for children with asthma and their families was carried out by community child health nurses . Three hundred and sixty eight children aged 2 to 14 years were enrolled in the study after admission to hospital for asthma . The intervention group was visited monthly by a nurse for six months . The subjects were assessed six months later by a postal , self administered question naire . European children in the intervention group were taking significantly more drugs for the treatment of asthma six months after the index admission to hospital than those in the control group ( mean ( SD ) intake 2.7 ( 1.1 ) v 2.1 ( 1.0 ) , respectively ) . In particular , they were using more theophylline ( 56.6 % v 37.0 % ) and inhaled steroids ( 34.9 % v 21.0 % ) . There was no difference between the groups for parental reports of improvement , of missed schooling , and in severe attacks of asthma of not responding to the usual treatment at home . European children in the intervention group used the hospital services for severe attacks of asthma more than controls ( 34.2 % v 10.5 % ) . There were more re-admissions in the European intervention group in the subsequent six months after the index admission than in the control group ( mean ( SD ) 0.51 ( 0.97 ) v 0.29 ( 0.65 ) . Re-admission continued to be higher in the 12 months after the nurse had stopped visiting ( 0.81 ( 1.65 ) v 0.25 ( 0.65 ] . There was no difference in the duration of hospital stay between the intervention and control groups . For Polynesian children there was no difference between the groups for any outcome measures A r and omized control trial of a curriculum , A.C.T. ( Asthma Care Training ) for Kids , was conducted . Seventy-six children between the ages of 8 and 12 years , whose asthma required treatment with medications at least 25 % of the days per month , were r and omly assigned to control and experimental groups . The control group received 4 1/2 hours of lecture presentations on asthma and its management . The experimental groups ( consisting of four to seven children and their parents ) received five 1-hour sessions comprising " the treatment . " Children and their parents were interviewed before the sessions and 3 , 6 , and 12 months after the completion of the experimental treatment . Use of emergency rooms and hospitals was determined by review ing the records of these patients ( all members of the Los Angeles Kaiser Permanente health care system ) for the period of 1 year before and 1 year after the treatment . Results include ( 1 ) equivalent increases in knowledge and changes in beliefs in both groups , ( 2 ) significant changes in the self-reported compliance behaviors of the experimental group only , and ( 3 ) significant reductions in emergency room visits and days of hospitalization among those receiving the experimental treatment , compared with the control group . These changes represent an estimated savings of approximately $ 180 per child per year for those in the experimental group Children with asthma are at special risk for problems in psychological functioning , as are children with other chronic illnesses . We conducted a controlled trial of a combined education and stress management program among children ages 6 to 14 years with asthma . Eighty-one children were r and omly assigned to an intervention or a control group ; 56 children completed data collection , 29 intervention and 27 control . Psychological status was assessed by the Child Behavior Checklist ( CBCL ) before and after the intervention , as were children 's knowledge of asthma , stress ( as measured by children 's life events ) , and functional status ( as indicated by such activities as school attendance , time playing with friends , and daily chore performance ) . Children in the intervention group had a significant improvement in the total Behavior Problems score ( p < .04 ) and Internalizing scale ( p < .01 ) on the CBCL and a significant increase in daily chores ( p < .04 ) compared with the control group . Before intervention , the two groups had statistically significant positive relationships between negative life events and behavior problem scores . After intervention , children in the control group still demonstrated a significant relationship between negative life events and total and Internalizing Behavior Problem scores , although participation in the intervention group negated that relationship . Children in the intervention group whose knowledge of asthma increased were more likely to report an increase in daily chores ( p < .02 ) . We conclude that the intervention had a beneficial effect on psychological status and on children 's daily activities . The effect may have occurred in part by decreasing the likelihood that perceived stress from negative life events led to poorer adjustment OBJECTIVE To conduct a controlled trial of a home-based education program for low-income caregivers of young children with asthma . METHODS Participants were r and omized to treatment-eight weekly asthma education sessions adapted from the Wee Wheezers program ( n = 49)-or usual care ( n = 46 ) . Baseline and 3- and 12-month follow-up data were gathered from caregivers and from children 's medical records . RESULTS Treatment was associated with less bother from asthma symptoms , more symptom-free days , and better caregiver quality of life at follow-up for children 1 - 3 , but not those 4 - 6 , years of age . Treatment and control groups did not differ in caregiver asthma management behavior or children 's acute care utilization . CONCLUSIONS This home-based asthma education program was most effective with younger children ; perhaps their caregivers were more motivated to learn about asthma management . Targeting psychosocial factors associated with asthma morbidity might also enhance the efficacy of asthma education for these families A r and omized trial of an instructional method was conducted in which school nurses taught children asthma self-management principles and skills , including peak flow monitoring , in 20-min , individual sessions over an 8-week period . Thirty-six children participated . An intervention group of 18 children received the teaching sessions . A control group of 18 children received regular care by the nurses , but no teaching sessions . The sample included 64 % boys , 69 % African-Americans , and 69 % Medicaid recipients . The average age of subjects was 10.2 years . The two groups were demographically similar , but despite r and om assignment , the control group had a significantly earlier age of onset of asthma and tended to have had more asthma attacks in the preceding year . These factors were statistically controlled in outcome analyses . Results of group comparisons showed no significant differences in the number of postintervention emergency room visits and days absent from school . However , nurs
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| AUTHORS ' CONCLUSIONS The evidence suggests that symptom-based WAP are superior to peak flow WAP for preventing acute care visits although there is insufficient data to firmly conclude whether the observed superiority is conferred by greater adherence to the monitoring strategy , earlier identification of onset of deteriorations , higher threshold for presentation to acute care setting s , or the specific treatment recommendations |
MS212350 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma . Treating actinic keratoses and the surrounding skin area ( i.e. , field therapy ) can eradicate clinical and sub clinical actinic keratoses . Topical field therapy currently requires weeks or months of treatment . We investigated the efficacy and safety of a new topical field therapy for actinic keratosis , ingenol mebutate gel ( 0.015 % for face and scalp and 0.05 % for trunk and extremities ) . METHODS In four multicenter , r and omized , double-blind studies , we r and omly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo ( vehicle ) , self-applied to a 25-cm(2 ) contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities . Complete clearance ( primary outcome ) was assessed at 57 days , and local reactions were quantitatively measured . RESULTS In a pooled analysis of the two trials involving the face and scalp , the rate of complete clearance was higher with ingenol mebutate than with placebo ( 42.2 % vs. 3.7 % , P<0.001 ) . Local reactions peaked at day 4 , with a mean maximum composite score of 9.1 on the local-skin-response scale ( which ranges from 0 to 4 for six types of reaction , yielding a composite score of 0 to 24 , with higher numbers indicating more severe reactions ) , rapidly decreased by day 8 , and continued to decrease , approaching baseline scores by day 29 . In a pooled analysis of the two trials involving the trunk and extremities , the rate of complete clearance was also higher with ingenol mebutate than with placebo ( 34.1 % vs. 4.7 % , P<0.001 ) . Local skin reactions peaked between days 3 and 8 and declined rapidly , approaching baseline by day 29 , with a mean maximum score of 6.8 . Adverse events were generally mild to moderate in intensity and resolved without sequelae . CONCLUSIONS Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses . ( Funded by LEO Pharma ; Clinical Trials.gov numbers , NCT00742391 , NCT00916006 , NCT00915551 , and NCT00942604 . ) BACKGROUND In r and omized trials , fecal occult-blood testing reduces mortality from colorectal cancer . However , the duration of the benefit is unknown , as are the effects specific to age and sex . METHODS In the Minnesota Colon Cancer Control Study , 46,551 participants , 50 to 80 years of age , were r and omly assigned to usual care ( control ) or to annual or biennial screening with fecal occult-blood testing . Screening was performed from 1976 through 1982 and from 1986 through 1992 . We used the National Death Index to obtain up date d information on the vital status of participants and to determine causes of death through 2008 . RESULTS Through 30 years of follow-up , 33,020 participants ( 70.9 % ) died . A total of 732 deaths were attributed to colorectal cancer : 200 of the 11,072 deaths ( 1.8 % ) in the annual-screening group , 237 of the 11,004 deaths ( 2.2 % ) in the biennial-screening group , and 295 of the 10,944 deaths ( 2.7 % ) in the control group . Screening reduced colorectal-cancer mortality ( relative risk with annual screening , 0.68 ; 95 % confidence interval [ CI ] , 0.56 to 0.82 ; relative risk with biennial screening , 0.78 ; 95 % CI , 0.65 to 0.93 ) through 30 years of follow-up . No reduction was observed in all-cause mortality ( relative risk with annual screening , 1.00 ; 95 % CI , 0.99 to 1.01 ; relative risk with biennial screening , 0.99 ; 95 % CI , 0.98 to 1.01 ) . The reduction in colorectal-cancer mortality was larger for men than for women in the biennial-screening group ( P=0.04 for interaction ) . CONCLUSIONS The effect of screening with fecal occult-blood testing on colorectal-cancer mortality persists after 30 years but does not influence all-cause mortality . The sustained reduction in colorectal-cancer mortality supports the effect of polypectomy . ( Funded by the Veterans Affairs Merit Review Award Program and others . ) BACKGROUND Women 's groups and health education by peer counsellors can improve the health of mothers and children . We assessed their effects on mortality and breastfeeding rates in rural Malawi . METHODS We did a 2 × 2 factorial , cluster-r and omised trial in 185,888 people in Mchinji district . 48 equal-sized clusters were r and omly allocated to four groups with a computer-generated number sequence . 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems . 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care . Primary outcomes for the women 's group intervention were maternal , perinatal , neonatal , and infant mortality rates ( MMR , PMR , NMR , and IMR , respectively ) ; and for the peer counselling were IMR and exclusive breastfeeding ( EBF ) rates . Analysis was by intention to treat . The trial is registered as IS RCT N06477126 . FINDINGS We monitored outcomes of 26,262 births between 2005 and 2009 . In a factorial model adjusted only for clustering and the volunteer peer counselling intervention , in women 's group areas , for years 2 and 3 , we noted non-significant decreases in NMR ( odds ratio 0.93 , 0.64 - 1.35 ) and MMR ( 0.54 , 0.28 - 1.04 ) . After adjustment for parity , socioeconomic quintile , and baseline measures , effects were larger for NMR ( 0.85 , 0.59 - 1.22 ) and MMR ( 0.48 , 0.26 - 0.91 ) . Because of the interaction between the two interventions , a stratified analysis was done . For women 's groups , in adjusted analyses , MMR fell by 74 % ( 0.26 , 0.10 - 0.70 ) , and NMR by 41 % ( 0.59 , 0.40 - 0.86 ) in areas with no peer counsellors , but there was no effect in areas with counsellors ( 1.09 , 0.40 - 2.98 , and 1.38 , 0.75 - 2.54 ) . Factorial analysis for the peer counselling intervention for years 1 - 3 showed a fall in IMR of 18 % ( 0.82 , 0.67 - 1.00 ) and an improvement in EBF rates ( 2.42 , 1.48 - 3.96 ) . The results of the stratified , adjusted analysis showed a 36 % reduction in IMR ( 0.64 , 0.48 - 0.85 ) but no effect on EBF ( 1.18 , 0.63 - 2.25 ) in areas without women 's groups , and in areas with women 's groups there was no effect on IMR ( 1.05 , 0.82 - 1.36 ) and an increase in EBF ( 5.02 , 2.67 - 9.44 ) . The cost of women 's groups was US$ 114 per year of life lost ( YLL ) averted and that of peer counsellors was $ 33 per YLL averted , using stratified data from single intervention comparisons . INTERPRETATION Community mobilisation through women 's groups and volunteer peer counsellor health education are methods to improve maternal and child health outcomes in poor rural population s in Africa . FUNDING Saving Newborn Lives , UK Department for International Development , and Wellcome Trust BACKGROUND Venous thromboembolism is a common , potentially avoidable cause of death and morbidity in patients in hospital , including those with stroke . In surgical patients , intermittent pneumatic compression ( IPC ) reduces the risk of deep vein thrombosis ( DVT ) , but no reliable evidence exists about its effectiveness in patients who have had a stroke . We assessed the effectiveness of IPC to reduce the risk of DVT in patients who have had a stroke . METHODS The CLOTS 3 trial is a multicentre parallel group r and omised trial assessing IPC in immobile patients ( ie , who can not walk to the toilet without the help of another person ) with acute stroke . We enrolled patients from day 0 to day 3 of admission and allocated them via a central r and omisation system ( ratio 1:1 ) to receive either IPC or no IPC . A technician who was masked to treatment allocation did a compression duplex ultrasound ( CDU ) of both legs at 7 - 10 days and , wherever practical , at 25 - 30 days after enrolment . Caregivers and patients were not masked to treatment assignment . Patients were followed up for 6 months to determine survival and later symptomatic venous thromboembolism . The primary outcome was a DVT in the proximal veins detected on a screening CDU or any symptomatic DVT in the proximal veins , confirmed on imaging , within 30 days of r and omisation . Patients were analysed according to their treatment allocation . TRIAL REGISTRATION IS RCT N93529999 . FINDINGS Between Dec 8 , 2008 , and Sept 6 , 2012 , 2876 patients were enrolled in 94 centres in the UK . The included patients were broadly representative of immobile stroke patients admitted to hospital and had a median age of 76 years ( IQR 67 - 84 ) . The primary outcome occurred in 122 ( 8·5 % ) of 1438 patients allocated IPC and 174 ( 12·1 % ) of 1438 patients allocated no IPC ; an absolute reduction in risk of 3·6 % ( 95 % CI 1·4 - 5·8 ) . Excluding the 323 patients who died before any primary outcome and 41 without any screening CDU , the adjusted OR for the comparison of 122 of 1267 patients vs 174 of 1245 patients was 0·65 ( 95 % CI 0·51 - 0·84 ; p=0·001 ) . Deaths in the treatment period occurred in 156 ( 11 % ) patients allocated IPC and 189 ( 13 % ) patients allocated no IPC died within the 30 days of treatment period ( p=0·057 ) ; skin breaks on the legs were reported in 44 ( 3 % ) patients allocated IPC and in 20 ( 1 % ) patients allocated no IPC ( p=0·002 ) ; falls with injury were reported in 33 ( 2 % ) patients in the IPC group and in 24 ( 2 % ) patients in the no-IPC group ( p=0·221 ) . INTERPRETATION IPC is an effective method of reducing the risk of DVT and possibly improving survival in a wide variety of patients who are immobile after stroke . FUNDING National Institute of Health Research ( NIHR ) Health Technology Assessment ( HTA ) programme , UK ; Chief Scientist Office of Scottish Government ; Covidien ( MA , USA ) BACKGROUND We previously reported that integrating antiretroviral therapy ( ART ) with tuberculosis treatment reduces mortality . However , the timing for the initiation of ART during tuberculosis treatment remains unresolved . METHODS We conducted a three-group , open-label , r and omized , controlled trial in South Africa involving 642 ambulatory patients , all with tuberculosis ( confirmed by a positive sputum smear for acid-fast bacilli ) , human immunodeficiency virus infection , and a CD4 + T-cell count of less than 500 per cubic millimeter . Findings in the earlier-ART group ( ART initiated within 4 weeks after the start of tuberculosis treatment , 214 patients ) and later-ART group ( ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment , 215 patients ) are presented here . RESULTS At baseline , the median CD4 + T-cell count was 150 per cubic millimeter , and the median viral load was 161,000 copies per milliliter , with no significant differences between the two groups . The incidence rate of the acquired immunodeficiency syndrome ( AIDS ) or death was 6.9 cases per 100 person-years in the earlier-ART group ( 18 cases ) as compared with 7.8 per 100 person-years in the later-ART group ( 19 cases ) ( incidence-rate ratio , 0.89 ; 95 % confidence interval [ CI ] , 0.44 to 1.79 ; P=0.73 ) . However , among patients with CD4 + T-cell counts of less than 50 per cubic millimeter , the incidence rates of AIDS or death were 8.5 and 26.
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| Conclusions Social characteristics like sex/gender remain hidden from analyses and interpretation in RCTs , with loss of information and embedding of error all along the path from design to interpretation , and therefore , to uptake in clinical practice . |
MS212351 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The present study was performed to determine whether high levels of trait-anger ( T-Anger ) are independently associated with sleep disturbances and quantitative and qualitative measurements of sleep in middle-aged adults . METHODS Enrolled in the study were 2404 men and 2291 women derived from the Korean Health and Genome Study ( KHGS ) , which is an ongoing population -based prospect i ve study . The Spielberger Trait Anger Scale was used to measure T-Anger . RESULTS Sleep disturbances , including difficulty in initiating and maintaining sleep ( DIS and DMS , respectively ) and early morning awakening ( EMA ) , significantly increased with increasing levels of T-Anger ( P<.05 by test for trend ) . Nonrestorative feelings in the morning and excessive daytime sleepiness were also strongly associated with higher levels of T-Anger . After adjusting for other potential risk factors , the high and /or moderate T-Anger showed 40 % to 70 % increases in the odds for sleep disturbances . CONCLUSION The present study provides evidence that high levels of T-Anger are independently associated with symptoms of disturbed sleep in middle-aged adult population Objectives . We explored the prospect i ve , microlevel relationship between nightly sleep quality ( SQ ) and the subsequent day 's stress on positive ( PA ) and negative affect ( NA ) as well as the moderating relationships between nightly SQ , subsequent stress , and subsequent PA on NA . We investigated whether age moderated these relationships . Method . We collected 56 days of sleep , stress , and affect data using daily diary question naires ( N = 552 ) . We used multilevel modeling to assess relationships at the between- and within-person levels . Results . Daily increases in SQ and decreases in stress interacted to predict higher daily PA and lower daily NA . Better SQ in older adults enhanced the benefits of PA on the stress-NA relationship more during times of low stress , whereas better sleep in younger adults enhanced the benefits of PA more during times of high stress . Between-person effects were stronger predictors of well-being outcomes than within-person variability . Discussion . The combination of good SQ and higher PA buffered the impact of stress on NA . The moderating impact of age suggests that sleep and stress play different roles across adulthood . Targeting intervention and prevention strategies to improve SQ and enhance PA could disrupt the detrimental relationship between daily stress and NA The aim of this pilot study was to quantify the impact of sleep deprivation on psychophysiological reactivity to emotional stimuli . Following an adaptation night of sleep in the lab , healthy young adults were r and omly assigned to either one night of total sleep deprivation or to a normal sleep control condition . The next afternoon , responses to positive , negative , and neutral picture stimuli were examined with pupillography , an indicator of cognitive and affective information processing . Only the sleep-deprived group displayed significantly larger pupil diameter while viewing negative pictures compared to positive or neutral pictures . The sleep-deprived group also showed anticipatory pupillary reactivity during blocks of negative pictures . These data suggest that sleep deprivation is associated with increased reactions to negative emotional information . Such responses may have important implication s for psychiatric disorders , which may be triggered or characterized by sleep disturbances The present study investigates whether interepisode mood regulation impairment contributes to disturbances in sleep onset latency ( SOL ) and rapid eye movement ( REM ) sleep . Individuals with interepisode bipolar disorder ( n = 28 ) and healthy controls ( n = 28 ) slept in the laboratory for 2 baseline nights , a happy mood induction night , and a sad mood induction night . There was a significant interaction whereby on the happy mood induction night the bipolar group exhibited significantly longer SOL than did the control group , while there was no difference on the baseline nights . In addition , control participants exhibited shorter SOL on the happy mood induction night compared to the baseline nights , a finding that was not observed in the bipolar group . On the sad mood induction night , participants in both groups had shorter SOL and increased REM density when compared to the baseline nights . Bipolar participants exhibited heightened REM density compared to control participants on both nights . These results raise the possibility that regulation of positive stimuli may be a contributor to difficulties with SOL , while hyperactivity may be characteristic of REM sleep BACKGROUND Insomnia and major depressive disorder ( MDD ) can coexist . This study evaluated the effect of adding eszopiclone to fluoxetine . METHODS Patients who met DSM-IV criteria for both MDD and insomnia ( n = 545 ) received morning fluoxetine and were r and omized to nightly eszopiclone 3 mg ( ESZ+FLX ) or placebo ( PBO+FLX ) for 8 weeks . Subjective sleep and daytime function were assessed weekly . Depression was assessed with the 17-item Hamilton Rating Scale for Depression ( HAM-D-17 ) and the Clinical Global Impression Improvement ( CGI-I ) and Severity items ( CGI-S ) . RESULTS Patients in the ESZ+FLX group had significantly decreased sleep latency , wake time after sleep onset ( WASO ) , increased total sleep time ( TST ) , sleep quality , and depth of sleep at all double-blind time points ( all p < .05 ) . Eszopiclone co-therapy also result ed in : significantly greater changes in HAM-D-17 scores at Week 4 ( p = .01 ) with progressive improvement at Week 8 ( p = .002 ) ; significantly improved CGI-I and CGI-S scores at all time points beyond Week 1 ( p < .05 ) ; and significantly more responders ( 59 % vs. 48 % ; p = .009 ) and remitters ( 42 % vs. 33 % ; p = .03 ) at Week 8 . Treatment was well tolerated , with similar adverse event and dropout rates . CONCLUSIONS In this study , eszopiclone/fluoxetine co-therapy was relatively well tolerated and associated with rapid , substantial , and sustained sleep improvement , a faster onset of antidepressant response on the basis of CGI , and a greater magnitude of the antidepressant effect STUDY OBJECTIVES ( 1 ) To describe the prevalence and prospect i ve course of insomnia in a representative young-adult sample and ( 2 ) to describe the cross-sectional and longitudinal associations between insomnia and depression . DESIGN Longitudinal cohort study . SETTING Community of Zurich , Switzerl and . PARTICIPANTS Representative stratified population sample . INTERVENTIONS None . MEASUREMENTS AND RESULTS The Zurich Study prospect ively assessed psychiatric , physical , and sleep symptoms in a community sample of young adults ( n=591 ) with 6 interviews spanning 20 years . We distinguished 4 duration -based subtypes of insomnia : 1-month insomnia associated with significant distress , 2- to 3-week insomnia , recurrent brief insomnia , and occasional brief insomnia . The annual prevalence of 1-month insomnia increased gradually over time , with a cumulative prevalence rate of 20 % and a greater than 2-fold risk among women . In 40 % of subjects , insomnia developed into more chronic forms over time . Insomnia either with or without comorbid depression was highly stable over time . Insomnia lasting 2 weeks or longer predicted major depressive episodes and major depressive disorder at subsequent interviews ; 17 % to 50 % of subjects with insomnia lasting 2 weeks or longer developed a major depressive episode in a later interview . " Pure " insomnia and " pure " depression were not longitudinally related to each other , whereas insomnia comorbid with depression was longitudinally related to both . CONCLUSIONS This longitudinal study confirms the persistent nature of insomnia and the increased risk of subsequent depression among individuals with insomnia . The data support a spectrum of insomnia ( defined by duration and frequency ) comorbid with , rather than secondary to , depression Although previous research has suggested that presleep negative cognitive activities are associated with poor sleep quality , there is little evidence regarding the association between negative thoughts and sleep in real-life setting s. The present study used experience sampling and long-term sleep monitoring with actigraphy to investigate the relationships among negative repetitive thought , mood , and sleep problems . During a 1-week sampling period , 43 undergraduate students recorded their thought content and mood eight times a day at semir and om intervals . In addition to these subjective reports , participants wore actigraphs on their wrists in order to measure sleep parameters . Analyses using multilevel modeling showed that repetitive thought in the evening was significantly associated with longer sleep-onset latency , decreased sleep efficiency , and reduced total sleep time . Furthermore , impaired sleep quality was significantly associated with reduced positive affect the next morning , and decreased positive affect was indirectly associated with increased repetitive thought in the evening . These findings suggest the existence of a self-reinforcing cycle involving repetitive thought , mood , and impaired sleep quality , highlighting the importance of cognitive and emotional factors in enhancement and maintenance of good- quality sleep BACKGROUND Sleep and mood disturbances in women have often been linked to the menstrual cycle , implying an ovarian hormonal causation . However , most studies in this area have used self-reported menstrual cycle phase rather than direct measurement of ovarian hormone concentrations . Further , many studies have focused primarily on peri- and postmenopausal population s reporting clinical sleep difficulty . In this study , we examined the associations among sleep quality , mood , and ovarian hormone concentration in a r and om sample of community-dwelling , non clinical women of reproductive age . METHODS Our sample consisted of 19 non-help-seeking women aged 18 - 43 years , each contributing an average of 39.5 nights of data . Over the 42 days of the study , we collected self-reported and actigraphic sleep- quality data , concentrations of urinary estrogen and progesterone metabolites ( estrone-3-glucuronide ( E1 G ) and pregnanediol-3-glucuronide [ PdG ] , respectively ) , and daily mood ratings . Linear-mixed models were used to estimate associations , clustering longitudinal observations by the participant . RESULTS We found a significant positive association between Sleep Efficiency and E1 G , and a significant negative association between Sleep Efficiency and PdG. Otherwise , the self-reported and actigraphic sleep measures were not associated with ovarian hormone concentrations . Self-reported sleep was strongly associated with mood , whereas actigraphic sleep was associated with only two of the 11 individual mood items , " Feeling on Top of Things " and " Difficulty Coping . " CONCLUSIONS In this community sample of women of reproductive age , ovarian hormones play little , if any , role in day-to-day sleep quality . Our findings additionally highlight the different associations that self-reported and actigraphic sleep show with hormones and mood Rapid eye movement ( REM ) sleep and dreaming may be implicated in cross-night adaptation to emotionally negative events . To evaluate the impact of REM sleep deprivation ( REMD ) and the presence of dream emotions on a possible emotional adaptation ( EA ) function , 35 healthy subjects r and omly assigned to REMD ( n = 17 ; mean age 26.4 + /- 4.3 years ) and control ( n = 18 ; mean age 23.7 + /- 4.4 years ) groups underwent a partial REMD and control nights in the laboratory , respectively . In the evening preceding and morning following REMD , subjects rated neutral and negative pictures on scales of valence and arousal and EA scores were calculated . Subjects also rated dream emotions using the same scales and a 10-item emotions list . REMD was relatively successful in decreasing REM% on the experimental night , although a mean split procedure was applied to better differentiate subjects high and low in REM% . High and low groups differed - but in a direction contrary to expectations . Subjects high in REMD% showed greater adaptation to negative pictures on arousal ratings than did those low in REMD% ( P < 0.05 ) , even after statistically controlling sleep efficiency and awakening times . Subjects above the median on EA(valence ) had less intense overall dream negativity ( P < 0.005 ) and dream sadness ( P < 0.004 ) than subjects below the median . A correlation between the emotional intensities of the morning dream and the morning picture ratings supports a possible emotional carry-over effect . REM sleep may enhance morning reactivity to negative emotional stimuli . Further , REM sleep and dreaming may be implicated in different dimensions of cross-night adaptation to negative emotions The present study investigated the daily fluctuation of ruminative thinking and its individual differences by using the experience sampling method . Participants recorded their thought contents and negative affect eight times a day for a week at semir and om intervals . High-trait ruminators showed high levels of self-focus , unpleasantness , and uncontrollability in their thoughts over the sampling course . These variables were interacted to predict the levels of concurrent negative affect : Self-focus was strongly associated with increased levels of negative affect when the thought was highly unpleasant and uncontrollable . A composite measure of rumination , including self-focus , unpleasantness , and uncontrollability , exhibited diurnal variation , which was assimilated by a quadratic function of time of day . However , there were differences in the estimated parameters of diurnal trajectories between high and low levels of depression , which indicated that individuals with higher levels of depression are more likely to engage in rumination in the evening , not in the morning , than those with lower levels of depression . These findings suggest that rumination in the evening would play an important role in the exacerbation and maintenance of depression The current study investigated how night-to-night variations in sleep duration relate to affective well-being the next morning as well as how the relationship varies for people of different ages . Using an Experience Sampling approach , 397 participants aged 12 to 88 years reported their sleep duration and their momentary affect on 9 mornings , on average . Associations between sleep duration during the previous night and morning affect differed depending on the participants ' age . For ad
Output:
| Electronic data bases ( EMBASE , PsycINFO , PubMed , and SCOPUS ) were search ed for studies using experience sampling methodology to investigate daily associations between sleep and mood in naturalistic environments in healthy and clinical sample s. Findings of the included studies supported the notion of a reciprocal relationship between subjective sleep variables ( sleep quality , sleep duration and sleep latency ) and daytime affective states over the short term , and highlight the potential clinical importance of daily sleep disturbance in the prediction and prevention of the development of psychopathology in the future |
MS212352 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 effect of a combiphasic oral contraceptive containing ethinylestradiol and desogestrel ( combiphasic EE/DSG ) on acne , compared with a preparation containing ethinylestradiol and cyproterone acetate ( EE35/CPA ) . Methods : An open , r and omized , group-comparative , multicenter study was carried out , with 172 women r and omized to treatment with either combiphasic EE/DSG ( 25 μg desogestrel and 40 μg ethinylestradiol for 7 days followed by 125 μg desogestrel and 30 μg ethinylestradiol for 15 days ) or EE35/CPA ( 2.0 mg cyproterone acetate and 35 μg ethinylestradiol for 21 days ) . Assessment s were performed at pretreatment and after cycles 3 and 6 . Results : The number of comedones , papules , pustules and nodules significantly decreased in both groups over the 6-month study . Compared with pretreatment (= 100 % ) , the relative numbers of comedones , papules , pustules and nodules at cycle 6 significantly decreased to 37 % , 38 % , 19 % and 12.5 % in the combiphasic EE/DSG group and to 24 % , 36 % , 17 % and 1 % in the EE35/CPA group , respectively . All reductions were statistically significant ( p ≤ 0.003 ) at both cycles 3 and 6 , except for nodules at cycle 6 with combiphasic EE/DSG , which probably result ed from differences between the treatment groups at baseline . There were no statistically significant differences between the two treatments . In both groups , the majority of women with severe acne shifted to a less severe acne category . Conclusions : Combiphasic EE/DSG progressively reduced the number and severity of acne lesions during the six cycles of treatment . The reduction in acne with the combiphasic oral contraceptive was comparable to a preparation containing the anti and rogen cyproterone acetate To evaluate and compare the contraceptive efficacy , bleeding pattern , side effects and other positive effects of a combined oral contraceptive ( COC ) containing drospirenone ( DRSP ) [ Yasmin ] with those of a COC containing desogestrel ( DSG ) in healthy Chinese women . This was a r and omized , open-label , controlled , multicentre study of 768 healthy Chinese women requiring contraception . The subjects were r and omized to ethinylestradiol ( EE ) 30 microg/DRSP 3 mg ( n = 573 ) or EE 30 microg/ DSG 150 microg ( n = 195 ) , at a ratio of 3 : 1 . Each individual was treated for 13 cycles . Further visits were required at cycle 4 , cycle 7 , cycle 10 and cycle 13 of treatment . Weight , height and body mass index were evaluated at each visit . The Menstrual Distress Question naire ( MDQ ) was administered at baseline , visit 3 ( cycle 7 ) and visit 5 ( after cycle 13 ) . Baseline characteristics were similar between the two groups ( p > 0.05 ) . The Pearl Index ( method failure ) for EE/DRSP was 0.208 per 100 women-years , which was lower than that for EE/DSG ( 0.601 per 100 women-years ) . There were no significant differences between the treatment groups with regard to bleeding patterns . According to the MDQ subscale , improvements in water retention and increases in appetite during the intermenstrual period and in water retention and general well-being during the menstrual period in the EE/DRSP group ( -0.297 , -0.057 , 0.033 and 0.150 , respectively ) were significantly improved compared with the EE/DSG group ( -0.108 , 0.023 , 0.231 and -0.023 , respectively ) [ all p < 0.05 ] . Other values that improved in both groups , particularly improvement in breast pain and tenderness and skin condition , were more evident in the EE/DRSP group ( 18.0 % , 89/494 ; 12.6 % , 62/494 ) than in the EE/DSG group ( 11.3 % , 19/168 ; 5.4 % , 9/168 ) . Mean weight increased in the EE/DSG group ( 0.57 kg ) while there was a significant decrease in mean weight ( -0.28 kg ) in the EE/DRSP group ( p < 0.01 ) . Both EE/DRSP and EE/DSG have good contraceptive efficacy and a comparable bleeding pattern . EE/DRSP had a more favourable effect on weight and premenstrual symptoms than EE/DSG This was an open-label multicenter study to compare the cycle control and effect on well-being of two oral contraceptives containing gestodene and one containing desogestrel . A total of 2419 healthy women ≤ 41 years of age were r and omized to receive oral contraceptives containing monophasic gestodene ( Minulet ® ; n = 806 , mean age 24.5 years ) , triphasic gestodene ( Tri-Minulet ® ; n = 808 , mean age 24.6 years ) or monophasic desogestrel ( Mercilon ® ; n = 805 , mean age 24.6 years ) . Subjects were to participate in the study for up to 13 treatment cycles . A modified Moos Menstrual Distress Question naire was used to evaluate menstrual symptoms and to assess overall well-being . A total of 698 women were withdrawn from the study , 154 due to adverse events . Cycle control with gestodene was superior to that with desogestrel at almost all time points , particularly for breakthrough bleeding and /or spotting , which occurred significantly less frequently with gestodene than with desogestrel at cycles 1–1 and 9–11 ( p < 0.05 ) . Generally , the proportion of subjects with breakthrough bleeding and /or spotting was almost twice as great with desogestrel as with gestodene . The duration of bleeding was not consistently different between the gestodene and desogestrel groups ; however , the intensity of bleeding was greater with gestodene at all time points ( p < 0.05 ) . The latent period before withdrawal bleeding was significantly longer for monophasic gestodene at cycles 1–5 and 8–10 ( p < 0.05 ) . Treatment significantly improved overall well-being at cycles 6 and 9 with triphasic gestodene and at cycle 13 with desogestrel ; however , no statistically significant differences among treatment groups in overall well-being scores or individual factors of well-being could be identified . All three treatments were well tolerated . The most common drug-related adverse events were headache ( 14.2 % ) , breast pain ( 6.2 % ) , nausea ( 4.1 % ) , metrorrhagia ( 5.9 % ) and abdominal pain ( 3.5 % ) . The incidence of adverse events in all treatment groups was similar , with the exception of metrorrhagia , which occurred in more patients in the desogestrel group than in the gestodene treatment groups ( p < 0.05 ) To study the question of whether one br and of oral contraceptives may be as acceptable as another for use of publicly-assisted family planning programs , a double blind study of two well-known br and s , Ovral and Norinyl , was undertaken in Costa Rica and Trinidad . The pills were r and omly assigned to 1,200 women . Common side effects - nausea , dizziness , vomiting , headaches - were associated with both Norinyl and Ovral . Differences in event rates for these conditions were much more marked by country than by the pill used . Ovral was associated with increases in skin problems , notably chloasma , in Cost Rica . A higher percentage of women using Norinyl reported intermenstrual bleeding and spotting in both countries . In Costa Rica continuation rates for Norinyl were adversely affected by this . With these exceptions there appear to be no important differences between the br and s that would affect their use in family planning programs BACKGROUND Oral contraceptive is the most commonly used method of fertility control . Yasmin is a combination of a novel progestogen with anti- and rogenic and anti-mineralcorticoid activities ( 3 mg Drospirenone ( DRSP ) and 30 microg ethinylestradiol ( EE ) ) . It has been shown in many clinical trials that Yasmin is an efficacious oral contraceptive , lacking undesired effects as with other oral contraceptives such as weight gain . However the effects of Yasmin on sexual desire and libido have not been intensively investigated so far OBJECTIVE Investigate the effects of Yasmin on sexual desire , libido and changes in the free and rogen index ( FAI ) compare to Meliane ( 75 microg gestodene + 20 microg ethinylestradiol ) . MATERIAL AND METHOD The authors ' report the results of a double blind r and omized controlled study using a translated version of the Female Sexual Function Index question naire ( FSFI ) for the assessment of the sexual function . The free and rogen index was calculated from measurements of testosterone and sexual hormone binding globulin . RESULT The result shows statistically significant improvements regarding sexual desire , arousal and overall satisfaction in the Yasmin group . Additionally , an increased frequency of orgasms in the Meliane group was reported . Statistically significant differences between the two treatments regarding changes in the FSFI score and changes in the free and rogen index have not been observed . CONCLUSION The novel oral contraceptive containing drospirenone ( Yasmin ) and the non-anti- and rogenic progestin containing oral contraceptive ( Meliane ) do not show unfavorable effects on sexual response and libido Side effects of combined oral contraceptives are the most common reason why women discontinue them . Over the past half century , an elaborate mythology about these ill effects has evolved , fueled by rumor , gossip and poor- quality research . In contrast , placebo-controlled r and omized trials document that nonspecific side effects are not significantly more common with combined oral contraceptives than with inert pills . These reported nonspecific side effects may reflect the nocebo phenomenon ( the inverse of a placebo ) : if women are told to expect noxious side effects , these complaints occur because of the power of suggestion . Alternatively , nonspecific complaints may simply reflect their background prevalence in the population . Because Level I evidence documents no important increase in nonspecific side effects with oral contraceptives , counseling about these side effects or including them in package labeling is unwarranted and probably unethical . When in doubt , clinicians should err on the side of optimism Three hundred thirteen women participated in an open , multicenter comparison of the incidence of intermenstrual bleeding ( breakthrough bleeding and or spotting ) associated with the use of three triphasic oral contraceptives . Triphasil ( n = 107 ) , containing levonorgestrel and ethinyl estradiol , and Ortho-Novum 7/7/7 ( n = 97 ) and Tri-Norinyl ( n = 109 ) , both of which contain norethindrone and ethinyl estradiol , were administered over four cycles for a total of 1141 cycles . The total incidence of intermenstrual bleeding was significantly lower with Triphasil ( 17.2 % ) than with Ortho-Novum 7/7/7 ( 39.5 % ) or Tri-Norinyl ( 49.0 % ) . The pattern remained the same when findings were analyzed cycle by cycle and for breakthrough bleeding and spotting separately . The incidence of other side effects was comparable for all regimens . Results of this study demonstrate superior cycle control with Triphasil compared with Ortho-Novum 7/7/7 and Tri-Norinyl during the first four cycles of use Norgestimate ( NGM ) , a derivative of 19‐nortestosterone with very specific affinity for the progesterone receptor , has been used in combination with ethinyl estradiol ( EE ) at low doses in both monophasic and triphasic oral contraceptives ( OCs ) . An open‐label comparative clinical trial was conducted with 4,234 healthy women using triphasic levonorgestrel (LNG)/EE and NGM/EE through a total of 22,312 menstrual cycles . Contraceptive efficacy was excellent with both preparations , with no statistically significant between‐regimen differences in pregnancy rates . The theoretical Pearl index was 0.12 for the NGM/EE triphasic , and 0.34 for the LNG/EE triphasic . Adverse experiences in both groups were typical of those that may occur among women taking low‐dose OC agents . The percentage of subjects discontinuing treatment because of use‐related adverse experiences was similar with the two preparations : 8.6 % for the NGM/EE triphasic and 6.8 % for the LNG/EE triphasic . In a separate mechanism of action study , specific endocrine parameters were investigated in 20 subjects using the NGM/EE triphasic for 4 cycles . Ovulation suppression was demonstrated in statistically significant decreases from pre‐treatment values in serum levels of luteinizing hormone , follicle‐stimulating hormone , progesterone , and estradiol . Significant on‐treatment increases in serum levels of sex hormone binding globulin evidence d minimal and rogenicity . All hormonal values returned to or toward normal in the post‐treatment cycle . The study results support those obtained in large noncomparative studies of the NGM/EE triphasic . This phased‐dose combination
Output:
| Women using COCs containing second-generation progestogens may be less likely to discontinue than those using COCs containing first-generation progestogens . |
MS212353 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 research design of the r and omised controlled trial is primarily associated today with medicine . It tends either to be ignored or regarded with suspicion by many in such disciplines as health promotion , public policy , social welfare , criminal justice , and education . However , all professional interventions in people 's lives are subject to essentially the same questions about acceptability and effectiveness . As the social reformers Sidney and Beatrice Webb pointed out in 1932 , there is far more experimentation going on in “ the world sociological laboratory in which we all live ” than in any other kind of laboratory , but most of this social experimentation is “ wrapped in secrecy ” and thus yields “ nothing to science.”1 # # # Summary points Many social scientists argue that r and omised controlled trials are inappropriate for evaluating social interventions , but they ignore a considerable history , mainly in the United States , of the use of r and omised controlled trials to assess different approaches to public policy and health promotion A tradition of experimental sociology was well established by the 1930s , built on the early use of controlled experiments in psychology and education From the early 1960s to early 1980s r and omised experiments were considered the optimal design for evaluating public policy interventions in the United States , and major evaluations using this design were carried out This approach became less popular as policy makers reacted negatively to evidence of “ near zero ” effects Lessons to be learnt about implementing r and omised controlled trials in real life setting s include the difficulty of assessing complex multi-level interventions and the challenge of integrating qualitative data The Webbs argued for a more “ scientific ” social policy , with social scientists being trained in experimental methods and evaluations of social interventions being carried out by independent investigators . They were apparently unaware that a strong tradition in experimental sociology had already been established , mainly in the United States . Reductions in the generosity of fee-for-service insurance lower the use of general medical and mental health services , but do they lead to lower mental health status for the covered population ? We addressed this question using data from the R AND Corporation Health Insurance Experiment . Families in six sites in the United States were r and omly assigned to one of 14 insurance plans for three- or five-year periods . On average , there were no significant adverse effects of cost-sharing plans , relative to a free-care plan , on either psychological well-being or psychological distress , when the cost-sharing plans included full catastrophic coverage . Those with high mental health status but low income at baseline had significantly more favorable mental health outcomes on the cost-sharing plans than on the free-care plan . We can not definitively comment on the effects of insurance generosity for the sick poor . Our findings apply in the context of m and ated comprehensive mental and general health coverage for a general nonelderly , nondisabled household population We assess the impact of the New Hope Project , an antipoverty program tested in a r and om assignment experimental design , on family functioning and developmental outcomes for preschool- and school-aged children ( N = 913 ) . New Hope offered wage supplements sufficient to raise family income above the poverty threshold and subsidies for child care and health insurance to adults who worked full-time . New Hope had strong positive effects on boys ' academic achievement , classroom behavior skills , positive social behavior , and problem behaviors , as reported by teachers , and on boys ' own expectations for advanced education and occupational aspirations . There were not corresponding program effects for girls . The child outcomes may have result ed from a combination of the following : Children in New Hope families spent more time in formal child care programs and other structured activities away from home than did children in control families . New Hope parents were employed more , had more material re sources , reported more social support , and expressed less stress and more optimism about achieving their goals than did parents in the control sample . The results suggest that an anti-poverty program that provides support for combining work and family responsibilities can have beneficial effects on the development of school-age children The present study examined the effectiveness and cost efficiency of three different techniques to encourage low-income rural parents to seek dental care for their children . The families of 51 children who needed immediate dental care ( determined by dental screening at a local school ) were placed into three matched groups and r and omly assigned to the treatment conditions : One Prompt ( Note Only ) , Three Prompt ( Note , Telephone Contact , Home Visit ) , and One Prompt plus $ 5 Incentive- The Three Prompt and One Prompt plus $ 5 Incentive were significantly more effective in initiating dental visits than the Note-Only procedure . Not only was the One Prompt plus $ 5 Incentive technique effective in producing a slightly larger percentage of initial dental visits compared to the Three-Prompt technique , it also produced a significantly larger number of followup visits . Furthermore , the cost-effectiveness analysis showed the Incentive condition to be less costly than the Three-Prompt condition in encouraging initial dental visits This study examined the effect of a time-limited welfare program on school-age children using data on almost 3,000 children ( ages 5 - 17 at the four year follow up-point ) from the r and om assignment evaluation of Florida 's Family Transition Program ( FTP ) . FTP was one of the first welfare reform initiatives to impose a time limit on the receipt of cash assistance , and it combined the time limit with a rich array of m and atory services . The effects of FTP on children were moderated by families ' risk of long-term welfare dependency . Contrary to predictions laid out at the outset , there were few effects of FTP on middle childhood and adolescent children for children of parents most likely to be long-term welfare dependent ( those most likely to hit the time limit ) . However , consistent negative effects on this same age group of children were found for children of parents least likely to be long-term welfare dependent -- parents who had the largest employment gains-- and effects of FTP were most strongly negative for the oldest adolescent children . The findings suggest a different theoretical model for movements into employment than the one suggested in the previous literature for job loss . The findings are discussed in terms of their contribution to research and policy This study examined the effectiveness of short-term contingency management for eliminating cocaine use and increasing full day treatment attendance with pregnant methadone-maintained women r and omly assigned to either an escalating voucher incentive schedule ( n=44 ) or non-incentive ( n=36 ) conditions . Full day treatment attendance and urine toxicology for cocaine and heroin were assessed and consequated for 14 days . The escalating voucher incentive schedule significantly increased full day treatment attendance and drug abstinence compared to the non-incentive schedule . These results suggest that reinforcing the co-occurrence of two required behaviors ( treatment attendance and abstinence from illicit drug use ) is effective , and may be an important adjunct to methadone pharmacotherapy for treating pregnant drug dependent women Approximately 4,000 preschool black children from low-income families in South Memphis participated for three years in a supplementary food program sponsored by the US Department of Agriculture . Part of this group received additional benefit from food stamps , day-care centers , and an infant-feeding program . We evaluated the effects of this participation in 250 children selected r and omly from the enrollment list of the supplemetary program . Each child was examined for height , weight , head circumference , and levels of hemoglobin , serum iron , and vitamins A and C. The data were then compared with those from a similar survey in the same area conducted three years before . The results of this comparison indicate considerable improvements in height and weight and a reduction in the incidence of anemia and in the numbers of children with low plasma vitamin A levels . In the absence of other recognizable intervening factors , we conclude that federal food assistance programs were primarily responsible for the observed nutritional improvements Objective : To raise immunization coverage among children at risk for underimmunization , we evaluated the effectiveness and cost-effectiveness of immunization activities in the Special Supplemental Program for Women , Infants and Children ( WIC ) . Method : A controlled intervention trial was conducted in seven WIC sites in Chicago between October 1990 and March 1994 . At intervention sites , staff screened children for vaccination status at every visit , referred vaccine-eligible children to either an on-site WIC nurse , on-site clinic , or off-site community provider , and issued either a 3-month supply of food vouchers to up-to- date children or a 1-month supply to children not up-to- date —a usual practice for high-risk WIC children . Our primary measure of effectiveness was the change in the baseline percentage of up-to- date children at the second birthday ; cost-effectiveness was approximated for each of the three referral interventions . Results : After one year , up-to- date vaccination coverage increased 23 % above baseline for intervention groups and decreased 9 % in the control group . After the second year , up-to- date vaccination further increased to 38 % above baseline in intervention groups and did not change in the control group . The total cost per additional up-to- date child ranged from $ 30 for sites referring children off-site to $ 73 for sites referring children on-site to a nurse . Conclusion : This controlled intervention trial of screening , referral , and a voucher incentive in the WIC program demonstrated a substantial increase in immunization coverage at a low cost . Continuing to design linkages between WIC and immunization programs by building on WIC 's access to at-risk population s is worth the investment Inner-city infants ( n = 565 ) enrolled in the WIC program were r and omly assigned at 6 months of age to either of 2 groups : ( 1 ) voucher incentive ( frequency of issuance of food vouchers based on immunization status ) plus reminder-recall ( calls and /or letters to families of under-vaccinated children ) or ( 2 ) voucher incentive alone . At 12 months , both groups ' immunization levels were high and not significantly different : 80 % + /- 4 % versus 79 % + /- 5 % ( P = .749 ) Data from the Minnesota Family Investment Program and the New Hope demonstration were used to determine whether experimental effects of antipoverty policies differ by parents ' risk for nonemployment . Using propensity score analysis , increases in employment and income were largest in the harder-to-employ halves of both sample s. However , only children in the moderately hard-to-employ quartiles ( 50th to 75th percentile ) consistently showed improvements in school and behavior outcomes . The very-hardest-to-employ 25 % experienced decreases in school engagement , and increases in aggressive behaviors , despite substantial increases in parental employment and income . In this group , increases in maternal depression , reductions in regular family routines , and smaller increases in job stability and center-based child care occurred . These factors may have counteracted the potential benefits of increased income on children Do Conditional Cash Transfers Improve Child Health ? Evidence from PROGRESA 's Control R and omized Experiment Author(s ) : Paul Gertler Source : The American Economic Review , Vol . 94 , No. 2 , Papers and Proceedings of the One Hundred Sixteenth Annual Meeting of the American Economic Association San Diego , CA , January 3 - 5 , 2004 ( May , 2004 ) , pp . 336 - 341 Published by : American Economic Association Stable URL : http://www.jstor.org/stable/3592906 . Accessed : 13/03/2014 This study examined the age-specific pattern of effects of welfare policies on child achievement . Drawing from 7 r and om-assignment welfare and antipoverty evaluations that provided more than 30,000 observations of children 's achievement , this study found that times of developmental transition are the only periods sensitive to the changes in families brought about by these policies . More specifically , small positive effects of welfare and antipoverty policies were found for children making the transition into middle childhood , and small negative effects of these same policies were found for children making the transition out of middle childhood and into early adolescence . Effects were robust across various program groupings and could not be attributed to family characteristics that differ for children of different ages . This research informs the underst and ing of how changes in employment and income for low-income parents affect development across childhood This prospect i ve longitudinal study , using data from the National Longitudinal Survey of Youth ( NLSY ; N = 614 ) , addresses the gap in the research literature regarding the effects of welfare reform on children . Key questions addressed include whether welfare dynamics and support services relevant to welfare reform , both measured across the first 5 years of life , are associated with mothers ' earnings in the 6th year and three child cognitive outcomes in the 7th and 8th years : Peabody Individual Achievement Test ( PIAT ) math and reading scores , and the Peabody Picture Vocabulary Test ( PPVT ) . Welfare dynamics are represented by total time on welfare , degree of cycling on and off welfare , and degree to which welfare and work are combined . Support services measured include three forms of child care ( relative , babysitter , and center-based ) , as well as three forms of human capital supports ( child support , job training , and education ) . Controlling for a range of background factors and for different patterns of welfare use across the first 5 years , small positive associations with mother 's earnings were found for child support , education , and job training . Small positive associations also were found between child support and both math and reading scores . Finally positive associations of medium effect size were found between center care and both mothers ' earnings and child PPVT scores . Although effect sizes are generally small , the results suggest the potential value of welfare reform approaches that emphasize long-term human capital development . Interactions between welfare dynamics and support services suggest subgroup differences . Specifically , positive effects of support services on earnings are strongest among mothers with higher levels of human capital ( higher levels of work while on welfare , lower total time on welfare ) . Babysitter care appears to have negative effects on both reading and math scores of children whose mothers report low levels of work while on welfare . Implication s for welfare reform policy are discussed The goal of current national and state legislation on welfare reform is to decrease the number of people who are dependent on public assistance , most of whom are mothers and their young children . M
Output:
| No effect was observed on child health , measures of child mental health or emotional state .
Non-significant effects favouring the intervention group were seen for child cognitive development and educational achievement , and a non-significant effect favouring controls in rates of teenage pregnancy .
However , on the basis of current evidence we can not state unequivocally whether financial benefits delivered as an intervention are effective at improving child health or wellbeing in the short term .
We note particular concerns by some authors that sanctions and conditions ( such as working hours ) placed on families may increase family stress |
MS212354 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 effect of a 15-session coping group intervention compared with a 15-session therapeutic support group intervention among HIV-positive men and women with a history of childhood sexual abuse ( CSA ) on sexual transmission risk behavior . Design : A r and omized controlled behavioral intervention trial with 12-month follow-up . Methods : A diverse sample of 247 HIV-positive men and women with histories of CSA was r and omized to 1 of 2 time-matched group intervention conditions . Sexual behavior was assessed at baseline ; immediately after the intervention ; and at 4- , 8- , and 12-month follow-up periods ( 5 assessment s ) . Changes in frequency of unprotected anal and vaginal intercourse by intervention condition were examined using generalized linear mixed models for all partners , and specifically for HIV-negative or serostatus unknown partners . Results : Participants in the HIV and trauma coping intervention condition decreased their frequency of unprotected sexual intercourse more than participants in the support intervention condition for all partners ( P < 0.001 ; d = 0.38 , 0.32 , and 0.38 at the 4- , 8- , and 12-month follow-up periods , respectively ) and for HIV-negative and serostatus unknown partners ( P < 0.001 ; d = 0.48 , 0.39 , and 0.04 at the 4- , 8- , and 12-month follow-up periods , respectively ) . Conclusion : A group intervention to address coping with HIV and CSA can be effective in reducing transmission risk behavior among HIV-positive men and women with histories of sexual trauma We investigated prevalence of sexually transmitted infections ( STI ) in a cohort of HIV-1-infected pregnant women and described factors associated with STI diagnosis , as a nested study within the European Collaborative Study ( ECS ) . The ECS is a cohort study in which HIV-infected pregnant women are enrolled and their children followed from birth , according to st and ard clinical and laboratory protocol s. Information on STIs diagnosed during pregnancy was collected retrospectively from the antenatal records of women enrolling between January 1999 and October 2005 ; other variables were obtained from the ECS prospect i ve data base . A total of 1,050 women were included : 530 in Western Europe and 520 in Ukraine . Syphilis was the most common bacterial STI ( 2 % prevalence , 95 % CI 1.2–3.0 ) . Prevalence of HPV-related genital lesions was 8.6 % ( 95%CI 6.9–10.4 ) and prevalence of Trichomonas vaginalis was 12.1 % ( 95%CI 10.2–14.2 ) . Women in Ukraine ( AOR 10.7 , 95%CI 3.7–30.5 ) , single women ( AOR 3.9 , 95%CI 1.2–12.7 ) , sexual partners of injecting drug users ( AOR 3.8 , 95%CI 1.4–10.4 ) and women with CD4 counts < 200 cells/mm3 ( AOR 5.4 , 95%CI 1.0–28.1 ) were at increased risk of diagnosis with Chlamydia trachomatis , syphilis or Trichomonas vaginalis . African origin ( AOR 1.9 , 95%CI 1.1–3.3 ) and CD4 count < 200 cells/mm3 ( AOR 3.4 , 95%CI 1.5–7.8 ) were associated with HSV-2 and /or HPV-related genital lesions . Antenatal screening should be considered an effective tool for diagnosis , treatment and prevention of further transmission of STIs . HIV-infected women should receive adequate screening for STIs during pregnancy together with appropriate counseling and follow-up for treatment and prevention Background : There is a lack of effective behavioral interventions for HIV-positive injection drug users ( IDUs ) . We sought to evaluate the efficacy of an intervention to reduce sexual and injection transmission risk behaviors and to increase utilization of medical care and adherence to HIV medications among this population . Methods : HIV-positive IDUs ( n = 966 ) recruited in 4 US cities were r and omly assigned to a 10-session peer mentoring intervention or to an 8-session video discussion intervention ( control condition ) . Participants completed audio computer-assisted self-interviews and had their blood drawn to measure CD4 cell count and viral load at baseline and at 3-month ( no blood ) , 6-month , and 12-month follow-ups . Results : Overall retention rates for r and omized participants were 87 % , 83 % , and 85 % at 3 , 6 , and 12 months , respectively . Participants in both conditions reported significant reductions from baseline in injection and sexual transmission risk behaviors , but there were no significant differences between conditions . Participants in both conditions reported no change in medical care and adherence , and there were no significant differences between conditions . Conclusions : Both interventions led to decreases in risk behaviors but no changes in medical outcomes . The characteristics of the trial that may have contributed to these results are examined , and directions for future research are identified Background : Most HIV-infected patients attending a consultation-liaison psychiatry service show symptoms of anxiety and depression . The present study sought to evaluate the immediate and long-term efficacy of a structured cognitive-behavioural group therapy reducing anxiety and depression in HIV-infected patients referred to a consultation-liaison psychiatry department , and to identify baseline variables predictive of greater improvement . Methods : Repeated- measures ANOVA was used to analyse changes in the Beck Depression Inventory ( BDI ) and the state subscale of the State/Trait Anxiety Inventory ( STAI ) administered to 39 participants at 4 time points : T1 ( 1 month before beginning the therapy ) , T2 ( during the first session ) , T3 ( during the last session ) and T4 ( 3 months after the last session ) . The therapy consisted of 16 weekly 2-hour sessions following a structured time-limited cognitive-behavioural group psychotherapy programme . Results : During the intervention time ( between T2 and T3 ) an improvement was observed in depression and anxiety , which persisted after the 3-month follow-up period ( between T3 and T4 ) . No changes were observed during baseline ( between T1 and T2 ) . Patients with higher levels of anxiety at baseline showed greater improvement in STAI state subscale scores . Transmission of HIV infection through intravenous drug use was associated with less improvement on the BDI . Conclusions : This is the first report of an ongoing study which suggests long-lasting efficacy of a structured cognitive-behavioural group psychotherapy programme in a heterogeneous sample of HIV-1-infected patients referred to a consultation-liaison psychiatry unit BACKGROUND As many as one in three HIV-positive people continue unprotected sexual practice s after learning that they are HIV infected . This article reports the outcomes of a theory-based intervention to reduce risk of HIV transmission for people living with HIV infection . METHODS Men ( n=233 ) and women ( n=99 ) living with HIV-AIDS were r and omly assigned to receive either ( 1 ) a five-session group intervention focused on strategies for practicing safer sexual behavior , or ( 2 ) a five-session , contact-matched , health-maintenance support group ( st and ard-of-care comparison ) . Participants were followed for 6 months post-intervention . RESULTS The intervention to reduce risk of HIV transmission result ed in significantly less unprotected intercourse and greater condom use at follow-up . Transmission-risk behaviors with non-HIV-positive sexual partners and estimated HIV transmission rates over a 1-year horizon were also significantly lower for the behavioral risk-reduction intervention group . CONCLUSIONS This study is among the first to demonstrate successful HIV-transmission risk reduction result ing from a behavioral intervention tailored for HIV-positive men and women Testing behavioral interventions to increase safer sex practice s of HIV+ individuals has the potential to significantly reduce the number of new infections . This study evaluated a behavioral intervention design ed to reduce the sexual risk behaviors of HIV+ individuals . HIV+ individuals ( N = 387 ) who reported engaging in unprotected sex with HIV- or partners of unknown serostatus were r and omly assigned to ( a ) a single counseling session targeting problem areas identified by the participant in 3 possible intervention domains ( i.e. , condom use , negotiation , disclosure ) ; ( b ) a single-session comprehensive intervention that covered all 3 intervention domains ; ( c ) the same comprehensive intervention , plus 2 monthly booster sessions ; or ( d ) a 3-session diet and exercise attention-control condition . The median number of unprotectedsex acts decreasedfrom 14 at baseline to6 , 6 , and 4 at 4- , 8- , and 12-month follow-ups , respectively . A repeated measures analysis of variance revealed a significant decrease in unprotected sex acts across all groups across time . A significant Group x Time interaction revealed that the comprehensive-with-boosters group had the most unprotected sex at 8-month follow-up as compared to the other 3 groups . These findings suggest that a brief intervention can result in large reductions in HIV transmission risks among HIV+ individuals , but the relative benefit of one intervention approach over another remains unclear Objective : To evaluate the effectiveness of a clinician-delivered intervention , implemented during routine clinical care , in reducing unprotected sexual behavior of HIV-infected patients . Design : A prospect i ve clinical trial comparing the impact of a clinician-delivered intervention arm vs. a st and ard-of-care control arm on unprotected sexual behavior of HIV-infected patients . Setting : The 2 largest HIV clinics in Connecticut . Participants : A total of 497 HIV-infected patients , aged ≥18 years , receiving HIV clinical care . Intervention : HIV clinical care providers conducted brief client-centered interventions at each clinical encounter that were design ed to help HIV-infected patients reduce unprotected sexual behavior . Main Outcome Measures : Unprotected insertive and receptive vaginal and anal intercourse and unprotected insertive oral sex ; unprotected insertive and receptive vaginal and anal intercourse only . Results : HIV-infected patients who received the clinician-delivered intervention showed significantly reduced unprotected insertive and receptive vaginal and anal intercourse and insertive oral sex over a follow-up interval of 18 months ( P < 0.05 ) . These behaviors increased across the study interval for patients in the st and ard-of-care control arm ( P < 0.01 ) . For the measure of unprotected insertive and receptive vaginal and anal sex only , there was a trend toward a reduction in unprotected sex among intervention arm participants over time ( P < 0.09 ) , and a significant increase in unprotected sex in the st and ard-of-care control arm ( P < 0.01 ) . Conclusions : A clinician-delivered HIV prevention intervention targeting HIV-infected patients result ed in reductions in unprotected sex . Interventions of this kind should be integrated into routine HIV clinical care This study examined whether a culturally adapted version of a previously evaluated efficacious HIV prevention program reduced sexual risk behaviors of youth living with HIV ( YLH ) in Ug and a. YLH , 14 to 21 years , were r and omized to intervention ( N = 50 ) or control ( N = 50 ) conditions . Significantly more YLH in the intervention used condoms consistently and decreased their number of sexual partners in comparison to the control condition . Western interventions can be culturally adapted to retain efficacy in reducing the sexual risk behavior of YLH Child sexual abuse ( CSA ) is associated with HIV risk behaviors [ Bensley , L. , Van Eenwyk , J. , and Simmons , K. W. , 2003 . ] and more prevalent among women living with HIV than in the general population [ Koenig , L. J. , and Clark , H. , 2004 ] . This r and omized Phase ~ I clinical trial tested the impact of a culturally congruent psychoeducational intervention design ed to reduce sexual risks and increase HIV medication adherence for HIV-positive women with CSA histories . An ethnically diverse sample of 147 women were r and omized to two conditions : an 11-session Enhanced Sexual Health Intervention ( ESHI ) or an attention control . Results based on “ intent to treat ’ ’ analysesof pre – post changes are reported here . Additional analyses explored whether theobserved effects might depend on “ intervention dose , ’ ’ i.e. , number of sessions attended . Women in the ESHI condition reported greater sexual risk reduction than women in the control condition . Although there were no differences between women in the ESHI and control groups on medication adherence , women in the ESHI condition who attended 8 or more sessions reported greater medication adherence at posttest than control women . The findings provide initial support for this culturally and gender-congruent psychoeducational intervention for HIV-positive women with CSA , and highlight the importance of addressing the effects of CSA on sexual risk reduction and medicationadherence in preventive interventions for women Background : The impact of antiretroviral therapy ( ART ) on sexual risk behavior and HIV transmission among HIV-infected persons in Africa is unknown . Objective : To assess changes in risky sexual behavior and estimated HIV transmission from HIV-infected adults after 6 months of ART . Design and methods : A prospect i ve cohort study was performed in rural Ug and a. Between May 2003 and December 2004 a total of 926 HIV-infected adults were enrolled and followed in a home-based AR
Output:
| When compared to st and ard care or minimal HIV support intervention , meta- analysis showed that behavioral interventions had no effect on increasing condom use among HIV-positive women .
Meta- analysis shows that behavioral interventions have little effect on increasing condom use among HIV-positive women . |
MS212355 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Greater thoracic kyphosis is associated with increased biomechanical loading of the spine which is potentially problematic in individuals with osteoporotic vertebral fractures . Conservative interventions that reduce thoracic kyphosis warrant further investigation . This study aim ed to investigate the effects of therapeutic postural taping on thoracic posture . Secondary aims explored the effects of taping on trunk muscle activity and balance . METHODS Fifteen women with osteoporotic vertebral fractures participated in this within-participant design study . Three taping conditions were r and omly applied : therapeutic taping , control taping and no taping . Angle of thoracic kyphosis was measured after each condition . Force plate-derived balance parameters and trunk muscle electromyographic activity ( EMG ) were recorded during three static st and ing tasks of 40s duration . RESULTS There was a significant main effect of postural taping on thoracic kyphosis ( p=0.026 ) , with a greater reduction in thoracic kyphosis after taping compared with both control tape and no tape . There were no effects of taping on EMG or balance parameters . CONCLUSIONS The results of this study demonstrate that the application of postural therapeutic tape in a population with osteoporotic vertebral fractures induced an immediate reduction in thoracic kyphosis . Further research is needed to investigate the underlying mechanisms associated with this decrease in kyphosis 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 OBJECT External supports serve as a traditional treatment option for osteoporotic vertebral fractures ( OVFs ) . However , the role of external supports in the treatment of OVF remains inconclusive . The purpose of this study was to determine the role of a rigid external support in the healing of OVFs by prospect ively evaluating union ( fracture settling ) rates and prognostic variables for patients suffering from an incident OVF . METHODS Fifty-five patients with acute back pain were enrolled in this study after being diagnosed with an OVF based on MRI findings . Patients were treated using a plastic thoracolumbosacral orthosis ( TLSO ) and underwent follow-up at 2 , 3 , and 6 months . Vertebrae were referred to as " settled " when there was no dynamic mobility on sitting lateral and supine lateral radiographs . At the time of the 3- and 6-month follow-up visits , the patients were divided into 2 groups , the " settled group " and the " unsettled group . " Patients in these groups were compared with regard to clinical and radiographic features . RESULTS Of the 55 patients enrolled , 53 patients were followed up for 6 months . There were 14 men and 39 women with an average age of 75.3 years . Fracture settling of the affected vertebra was defined in 54.7 % of the patients at 2 months , in 79.2 % at 3 months , and in 88.7 % at 6 months . All 5 components of the Japanese Orthopaedic Association Back Pain Evaluation Question naire improved significantly both at 3 months and 6 months . Patients in the unsettled group exhibited a statistically greater likelihood of having fractures at the thoracolumbar junction , Type A3 fractures , and fractures with a diffuse low-intensity area on T2-weighted MRI studies at 3 months . In contrast , at 6 months , the only statistically significant difference between the groups was patient age . CONCLUSIONS The biomechanical disadvantages of OVFs ( location , type , and size ) adversely influencing the fracture healing were overcome by the treatment using a TLSO within 6 months . The authors ' findings show that a TLSO plays a biomechanical role in the healing of OVFs OBJECTIVE To assess the changes in static and dynamic balance and movement strategies in patients with severe osteoporotic vertebral compression fracture while wearing and not wearing the Knight-Taylor ( K-T ) spinal brace . SUBJECTS 47 patients with severe osteoporotic vertebral compression fracture , which was confirmed on radiographs and with bone density measurements obtained by dual energy X-ray absorption . INTERVENTION Patients were r and omly subjected to computerized dynamic posturography , which contained sensory organization tests , motor control balance test at 75 % limit of stability ( LOS ) in 8 movement directions , and left/right rhythmic weight shift test ( L/R RWS ) , while wearing and not wearing the K-T spinal brace , respectively . RESULTS Patients wearing the spinal brace had significantly increased average stability , significantly increased average maximal stability under the swayed vision with fixed support surface condition and under the eye open with swayed support surface condition , significantly increased ankle strategy and decreased average velocity of COG target sway under the eye open with swayed support surface condition , significantly reduced the frequency of falls under the eye closed with swayed support surface condition and swayed vision with swayed support surface condition , and significantly decreased in the percentage of directional control with no difference of reaction time in the LOS test , and an increase in the on-axis velocity in the L/R RWS test . CONCLUSIONS The K-T spinal brace efficiently enables the subjects to maintain static and dynamic motor balance . Its use decreases the fall frequency but limits the directional control in severe osteoporotic patients with vertebral compression fracture Summary In a prospect i ve cohort study of 395 geriatric out patients , mortality after 3 years was associated with prevalent vertebral fractures at baseline . The mortality risk was independently associated with the presence of three or more vertebral fractures at baseline . In the surviving patients , the risk of incident fractures was noteworthy , occurring in 26 % of these patients . Introduction The purpose of this study is to determine mortality rate and the incidence of vertebral fractures in a geriatric outpatient group , during a 3-year follow-up period , in a teaching hospital in Amsterdam , The Netherl and s. Methods This study includes a prospect i ve cohort study of 395 geriatric patients who had their baseline visit at a diagnostic day hospital in 2007 and 2008 . They were invited for follow-up 3 years later . Lateral X-rays of the lumbar spine and chest were performed at baseline and after 3 years ; vertebral fractures were scored in all patients according to the semi-quantitative method of Genant . Results After 3 years , mortality was 46 % and associated with prevalent vertebral fractures at baseline ( odds ratio ( OR ) , 1.83 ; 95 % CI , 1.23–2.74 ) . The presence of three or more vertebral fractures at baseline was an independent risk factor for mortality ( OR , 3.32 ; 95 % CI , 1.56–7.07 ) . Other independently associated risk factors were greater age , higher co-morbidity score , and having more prescriptions . Higher cognitive capacity protected against mortality after 3 years . In 72 patients , radiography was repeated . Nineteen patients ( 26 % ) had an incident radiographic vertebral fracture : 16 in those with a prevalent fracture , and 3 in those without a prevalent vertebral fracture at baseline . Conclusions In geriatric out patients , mortality after 3 years was associated with prevalent vertebral fractures at baseline , and the mortality risk was independently associated with 3 or more vertebral fractures at baseline . In survivors , the risk of incident fractures was noteworthy , since these occurred in 26 % of the patients , particularly in those with a prevalent vertebral fracture Objectives : We conducted a prospect i ve r and omized study to evaluate the efficacy of two newly developed spinal orthoses in patients with vertebral fractures . Design : We conducted a prospect i ve , r and omized , cross-over study to evaluate the efficacy of two newly developed spinal orthoses in patients with osteoporotic vertebral fractures . Measurements include trunk muscle strength , angle of kyphosis , body height , body sway , and parameters of quality -of-life such as pain , well-being , and limitations of daily living . Results : Wearing the orthosis Spinomed during a 6-mo period ( results of Spinomed active are given in parentheses ) was associated with a 72 % ( 64 % ) increase in back extensor strength ( P < 0.01 ) , a 44 % ( 56 % ) increase in abdominal flexor strength ( P < 0.01 ) , an 11 % ( 11 % ) decrease in the angle of kyphosis ( P < 0.01 ) , a 23 % ( 20 % ) decrease in body sway ( P = 0.03 and P = 0.02 ) , a 19 % ( 18 % ) increase in vital capacity ( P < 0.01 and P = 0.03 ) , a 41 % ( 47 % ) decrease in average pain ( P < 0.01 ) , an 18 % ( 18 % ) increase in well-being ( P < 0.01 ) , and a 49 % ( 54 % ) decrease in limitations of daily living ( P < 0.01 ) , respectively . The overall tolerability of the orthoses was good ; no adverse effects were reported and the dropout rate with 7 % was rather low . Conclusions : The use of an orthosis increases trunk muscle strength and therefore improves posture in patients with vertebral fractures caused by osteoporosis . In addition , a better quality -of-life is achieved by pain reduction , decreased limitations of daily living , and improved well-being . Thereby , the use of an orthosis may represent an efficacious nonpharmacologic treatment option for spinal osteoporosis Pfeifer M , Begerow B , Minne HW : Effects of a new spinal orthosis on posture , trunk strength , and quality of life in women with postmenopausal osteoporosis : A r and omized trial . Am J Phys Med Rehabil 2004;83:177–186 . Objective One fourth of women ≥50 yrs of age in the general population have one or more vertebral fractures . The orthotic treatment modality in the management of vertebral fractures caused by osteoporosis remains subjective because no objective data from clinical trials are available . The objective of this research was to evaluate the efficacy of a newly developed spinal orthosis in patients with osteoporotic vertebral fractures . Design We conducted a study that measured trunk muscle strength , angle of kyphosis , body height , body sway , and variables of quality of life such as pain , well-being , and limitations of daily living . Results Wearing the orthosis for 6-mo period was associated with a 73 % increase in back extensor strength , a 5
Output:
| A wide range of outcomes assessing impairments , activities and participation were assessed but the findings were mixed . |
MS212356 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Time-related effects of a pregnancy on breast cancer risk were examined in a population -based prospect i ve study of 802,457 parous Norwegian women aged 20 - 56 years . The mean follow-up time was 16.4 years . A total of 4787 women were diagnosed with breast cancer . We observed a short-term increase in risk of breast cancer after a full-term pregnancy , with a maximum 3 - 4 years after delivery , followed by a long-lasting decrease in risk . The maximum risk was about twice the risk for women whose last delivery was 20 or more years previously ( incidence rate ratio = 1.99 , 95 % confidence interval = 1.70 - 2.33 ) . Compared with nulliparous women , those with one or two children were at higher risk in the first decade after the last pregnancy , whereas those with three or more children were at lower risk in most categories of time since the last birth . The positive association between breast cancer risk and age at last birth was markedly reduced after adjustment for time since last birth . We conclude that there is a non-linear relationship between breast cancer incidence and time since last birth . Part of the relation with age at last birth may be attributed to the association with time since last birth Results from case-control studies suggest that induced abortion may be associated with a small increase in risk of breast cancer . While risk estimates from cohort studies have generally not observed such an association , these studies have had limited information regarding abortion and possible confounding variables . Therefore , we conducted a study among a cohort of post-menopausal women from whom detailed information regarding pregnancy outcomes as well as risk factors for breast cancer had been collected . The study sample included 37,247 Iowa Women 's Health Study participants , 55 - 64 years of age at baseline in 1986 , who reported no history of breast , or other , cancer ( except non-melanoma skin cancer ) , and for whom information regarding pregnancy outcomes ( that is , live birth , stillbirth , spontaneous abortion , ectopic pregnancy or induced abortion ) was available . We used linkage with records of the State Health Registry of Iowa , part of the National Cancer Institute 's Surveillance , Epidemiology , and End Results ( SEER ) program , to estimate the incidence of breast cancer among cohort members through 1995 . We calculated age-adjusted relative risks and 95 % confidence intervals using Cox proportional hazards regression . Only 653 women ( 1.8 % ) reported an induced abortion . The age-adjusted relative risk of breast cancer among women with prior induced abortion compared with those without was 1.1 ( 95 % CI = 0.8 - 1.6 ) . Relative risks were higher among women whose age at first abortion was less than 20 or at least 30 years , for those whose abortion took place after their first birth or who never gave birth , and for those with early termination ( 0 - 2 months ) . These estimates varied from 1.3 - 1.7 , but the confidence intervals around each were wide . Since most women in this cohort were beyond their reproductive years when abortion became legal in 1973 , the low prevalence of induced abortion argues for a cautious interpretation We investigated whether induced abortion is associated with breast cancer when lifestyle confounders , including smoking and alcohol consumption , are adjusted for . Design . Prospect i ve cohort study Abstract Objective : Previous studies of induced abortion and breast cancer may have been limited by differential reporting of abortion history . We conducted a population -based case – control study to evaluate abortion ( both induced and spontaneous ) and breast cancer risk . Methods : All study subjects were aged 20–69 years and members of Group Health Cooperative of Puget Sound ( GHC ) . Incident invasive breast cancer cases ( n = 138 ) were identified from the linkage between the GHC enrollment file and the Seattle – Puget Sound SEER Cancer Registry . Controls ( n = 252 ) were r and omly selected from GHC enrollment files and matched to cases on age and enrollment period . All subjects had to have been enrolled at GHC for the 2 years preceding diagnosis ( cases ) or reference ( controls ) date . The unified medical record of each case was abstract ed for pregnancy history , including prior induced and spontaneous abortions , menopause status , height and weight , screening practice s , and other risk factors . Results : Compared to all women who had never had an induced abortion , the multivariate adjusted relative risk of breast cancer in women with an induced abortion was 0.9 ( 95 % confidence interval 0.5–1.6 ) . This risk was similar in parous women , and nulliparous women . There was no association between spontaneous abortion and breast cancer risk . Conclusions : These results do not support a relation between induced abortion and breast cancer incidence The possible influence of induced abortion on breast cancer risk was assessed in a cohort of 267 040 women enrolled in a r and omised trial of breast self-examination in Shanghai , China . Based on answers to a baseline question naire , subsequent breast cancer risk was not significantly associated with ever having an induced abortion . After adjustment for potential confounders , the relative risk estimate was 1.06 ( 95 % C.I. : 0.91 , 1.25 ) , and there was no trend in risk with number of abortions . Analysis of data from more detailed interviews of 652 cases and 694 controls from the cohort yielded similar results . There was also no overall increase in risk in women with induced abortion after first birth . Few women had undergone an abortion after 13 weeks gestation or before their first child . Although increases in risk were observed in such women , they were not statistically significant and could have been due to recall bias . Abortions as they have been performed in China are not an important cause of breast cancer Objective : To examine the relationship between breast cancer risk and the cumulative number of cycles before a first full-term pregnancy ( FTP ) and lifetime , taking age at menarche and at onset of regular cycling , periodicity and regularity of cycles , duration of periods of pregnancy , and lactation , oral contraceptive ( OC ) use , and age at menopause into account . Methods : The data were taken from the E3N prospect i ve cohort study of women aged 40–65 years in 1990 . A total of 1718 breast cancer cases were identified during the 579,525 person-years of follow-up . Results : There was a highly significant linear relationship between breast cancer risk and both the cumulative number of cycles before a first FTP ( p for trend < 0.0001 ) and lifetime ( p for trend < 0.001 ) , with multivariate relative risk ( RR ) of a similar magnitude for both variables . Compared to women with a lifetime number of cycles ≤ 402 ( ≤ 30 years ) , the RR for those with a lifetime total of 403–441 , 442–480 , 481–520 , and ≥ 521 cycles were 0.95 ( 0.75–1.21 ) , 1.21 ( 0.97–1.52 ) , 1.23 ( 0.96–1.58 ) , and 1.60 ( 1.25–2.04 ) , respectively . Results restricted to never OC users were similar . Conclusions : Further investigation is needed to clarify whether the underlying factor is repeated exposure to fluctuating hormones , the number of anovular/ovular cycles , or the relative importance of the follicular and luteal phases BACKGROUND Induced abortion has been inconsistently associated with breast cancer risk in case-control studies . Retrospective cohort studies using registry information in Sc and inavia have not suggested an increase in the incidence of breast cancer , although data on individual reproductive factors were not accounted for . METHODS We examined the association between induced and spontaneous abortion and the incidence of breast cancer in a prospect i ve cohort of young women , the Nurses ' Health Study II . The study included 105 716 women 29 to 46 years old at the start of follow-up in 1993 . Information on induced or spontaneous abortions was collected in 1993 and up date d biennially . During 973 437 person-years of follow-up between 1993 and 2003 , 1458 newly diagnosed cases of invasive breast cancer were ascertained . RESULTS A total of 16 118 participants ( 15 % ) reported a history of induced abortion , and 21 753 ( 21 % ) reported a history of spontaneous abortions . The hazard ratio for breast cancer among women who had 1 or more induced abortions was 1.01 ( 95 % confidence interval , 0.88 - 1.17 ) after adjustment for established breast cancer risk factors ; among women with 1 or more spontaneous abortions , the covariate-adjusted hazard ratio was 0.89 ( 95 % confidence interval , 0.78 - 1.01 ) . The relation between induced abortion and the incidence of breast cancer did not differ material ly by number of abortions ( P for trend = .98 ) , age at abortion ( P for trend = .68 ) , parity ( P for interaction = .54 ) , or timing of abortion with respect to a full-term pregnancy ( P for interaction = .10 ) . CONCLUSION Among this predominantly premenopausal population , neither induced nor spontaneous abortion was associated with the incidence of breast cancer Controversy exists over the possible relationship between induced and spontaneous abortion and risk of breast cancer . Thus , the association of fatal breast cancer and spontaneous abortion was examined in a large prospect i ve study of United States adult women . After seven years of follow-up , 1,247 cases of fatal breast cancer were observed among 579,274 women who were cancer-free at interview in 1982 and who provided complete reproductive histories . Results from Cox proportional hazards models , adjusted for other risk factors , showed no association between a history of spontaneous abortion and risk of fatal breast cancer ( rate ratio [RR]=0.89 , 95 percent confidence interval [CI]=0.78–1.02 ) . The RR did not increase with increasing numbers of abortions . Parous women who had a spontaneous abortion before their first term birth were not at increased risk compared with parous women with no history of spontaneous abortion ( RR=0.76 , CI=0.54–1.05 ) . Women whose only pregnancy ended in a spontaneous abortion were not at increased risk compared with women who were never pregnant ( RR=0.61 , CI=0.27–1.38 ) or whose only pregnancy ended in a livebirth ( RR=0.72 , CI=0.32–1.65 ) . These findings do not support an association between spontaneous abortion and fatal breast cancer We recently provided data from a prospect i ve cohort study of postmenopausal women which suggested that a first livebirth at age 30 or older ( cf before age 20 ) was associated with a twofold increased risk of breast cancer in women without a family history , but a 5.8-fold higher risk in women with a positive family history . To address the question of whether these observations reflect difficulty becoming pregnant or maintaining a pregnancy , we performed additional analyses in which the outcome of each pregnancy was considered . During five years of follow-up , 620 incident cases of breast cancer were identified in the 37,105 women at risk . There was little evidence for an increased risk associated with a history of spontaneous abortion ( relative risk [RR]=1.1 ; 95 percent confidence interval [CI]=0.9–1.4 ) , nor was the risk higher among women who reported two or more spontaneous abortions in consecutive pregnancies ( RR=1.0 , CI=0.7–1.4 ) . Although women who reported that they had tried unsuccessfully to become pregnant had only slightly and nonsignificantly elevated risks of breast cancer ( RR=1.1 , CI=0.9–1.3 ) , a more pronounced and statistically significant association was noted in women with a positive family history ( RR=2.0 , CI=1.4–3.2 ) . There was a strong inverse association between failure to become pregnant and parity ( P<0.0001 ) ; nearly 50 percent of the nulliparous married women reported having tried and failed to become pregnant , whereas the frequency was only 6.8 percent among married women with five or more livebirths . Thus , difficulties in becoming pregnant may characterize a subset of women at increased risk of breast cancer , especially in the presence of a family history Studies suggesting a positive association between pregnancy termination and breast cancer risk have often been of retrospective case-control design , so subject to selection and recall biases . We undertook a registry-based analysis with minimal selection bias and prospect i ve record-based ascertainment of terminations . The source population comprised Massachusetts women with a record of giving birth between 1987 and 1999 in the Massachusetts Vital Statistics Registry . Primary breast cancer cases were 25 - 55 years old at diagnosis between 1988 and 2000 and had a record of the diagnosis in the Massachusetts Cancer Registry . We matched 3 controls to each case on maternal age , year of giving birth and birth facility . Information on terminations ( induced and spontaneous ) before the birth of record , the matched factors and potential confounders were collected from the birth certificate . After adjustment for the matched factors , age , parity and maternal and paternal education , the odds ratio associating any termination history with breast cancer risk equaled 0.91 ( 95 % CI = 0.79 - 1.05 ) . The marginally protective adjusted odds ratio largely derived from a protective effect among women with parity equaled to 1 ( OR for any termination = 0.68 ; 95 % CI = 0.45 - 1.03 ) , suggesting a protective effect of terminated pregnancy among women with one live birth Objective : There continues to be controversy about whether induced abortion influences the risk of breast cancer . Because case – control studies of this relation are subject to recall bias , there is a
Output:
| Conclusion The current prospect i ve evidence s are not sufficient to support the positive association between abortion ( including IA and SA ) and breast cancer risk |
MS212357 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical and histopathological measures . METHODS We tested whether the results of a reverse-transcriptase-polymerase-chain-reaction ( RT-PCR ) assay of 21 prospect ively selected genes in paraffin-embedded tumor tissue would correlate with the likelihood of distant recurrence in patients with node-negative , tamoxifen-treated breast cancer who were enrolled in the National Surgical Adjuvant Breast and Bowel Project clinical trial B-14 . The levels of expression of 16 cancer-related genes and 5 reference genes were used in a prospect ively defined algorithm to calculate a recurrence score and to determine a risk group ( low , intermediate , or high ) for each patient . RESULTS Adequate RT-PCR profiles were obtained in 668 of 675 tumor blocks . The proportions of patients categorized as having a low , intermediate , or high risk by the RT-PCR assay were 51 , 22 , and 27 percent , respectively . The Kaplan-Meier estimates of the rates of distant recurrence at 10 years in the low-risk , intermediate-risk , and high-risk groups were 6.8 percent ( 95 percent confidence interval , 4.0 to 9.6 ) , 14.3 percent ( 95 percent confidence interval , 8.3 to 20.3 ) , and 30.5 percent ( 95 percent confidence interval , 23.6 to 37.4 ) . The rate in the low-risk group was significantly lower than that in the high-risk group ( P<0.001 ) . In a multivariate Cox model , the recurrence score provided significant predictive power that was independent of age and tumor size ( P<0.001 ) . The recurrence score was also predictive of overall survival ( P<0.001 ) and could be used as a continuous function to predict distant recurrence in individual patients . CONCLUSIONS The recurrence score has been vali date d as quantifying the likelihood of distant recurrence in tamoxifen-treated patients with node-negative , estrogen-receptor-positive breast cancer BACKGROUND Amplification of the human epidermal growth factor receptor type 2 ( HER2 , also called HER2/neu ) gene and overexpression of its product in breast-cancer cells may be associated with responsiveness to anthracycline-containing chemotherapy regimens . METHODS In the r and omized , controlled Mammary.5 trial , we studied 639 formalin-fixed paraffin-embedded specimens obtained from 710 premenopausal women with node-positive breast cancer who had received either cyclophosphamide , epirubicin , and fluorouracil ( CEF ) or cyclophosphamide , methotrexate , and fluorouracil ( CMF ) as adjuvant chemotherapy . HER2 amplification or overexpression was evaluated with the use of fluorescence in situ hybridization , immunohistochemical analysis , and polymerase-chain-reaction analysis . RESULTS Amplification of HER2 was associated with a poor prognosis regardless of the type of treatment . In patients whose tumors showed amplification of HER2 , CEF was superior to CMF when assessed on the basis of relapse-free survival ( hazard ratio , 0.52 ; 95 percent confidence interval , 0.34 to 0.80 ; P=0.003 ) and overall survival ( hazard ratio , 0.65 ; 95 percent confidence interval , 0.42 to 1.02 ; P=0.06 ) . For women whose tumors lacked amplification of HER2 , CEF did not improve relapse-free survival ( hazard ratio for relapse , 0.91 ; 95 percent confidence interval , 0.71 to 1.18 ; P=0.49 ) or overall survival ( hazard ratio for death , 1.06 ; 95 percent confidence interval , 0.83 to 1.44 ; P=0.68 ) . The adjusted hazard ratio for the interaction between treatment and HER2 amplification was 1.96 for relapse-free survival ( 95 percent confidence interval , 1.15 to 3.36 ; P=0.01 ) and 2.04 for overall survival ( 95 percent confidence interval , 1.14 to 3.65 ; P=0.02 ) . CONCLUSIONS Amplification of HER2 in breast-cancer cells is associated with clinical responsiveness to anthracycline-containing chemotherapy . ( cancer.gov number , NCI-V90 - 0027 . ) PURPOSE Histologic grade , Nottingham Prognostic Index ( NPI ) , estrogen receptor ( ER ) and progesterone receptor ( PgR ) status , and tumor size have previously been shown to be important prognostic indicators for distant recurrence of breast cancer . The purpose of this study was to compare the prognostic value of these factors with flow cytometric S-phase fraction ( SPF ) , urokinase plasminogen activator ( uPA ) , and plasminogen activator inhibitor type 1 ( PAI-1 ) in premenopausal patients with lymph node-negative breast cancer . PATIENTS AND METHODS In 237 consecutive premenopausal patients with lymph node-negative breast cancer and freshly frozen tumor material available , SPF , ER and PgR status , uPA and its inhibitor PAI-1 , histologic grade , and NPI were evaluated . RESULTS SPF was univariately the most powerful prognostic factor for distant recurrence , followed by uPA , histologic grade , PgR , age , ER , NPI , and PAI-1 , the latter being nonsignificant . Multivariate analysis revealed that neither NPI nor histologic grade was significant after adjustment for SPF , a fact that may be explained by the strong association between these factors . uPA was , however , an independent prognostic factor in addition to SPF , NPI , or histologic grade . CONCLUSION In this prospect i ve study , SPF and uPA were found to be independent prognostic factors in premenopausal women with lymph node-negative breast cancer . We suggest that SPF , if performed under st and ardized conditions , can replace histologic grade as a selection instrument for adjuvant medical treatment . The value of the combination of SPF and uPA needs to be confirmed in an independent prospect i ve trial BACKGROUND Abnormal expression of the cell cycle regulatory proteins p27(Kip1 ) ( p27 ) and cyclin E may be associated with breast cancer survival and relapse . We studied these markers in a clinical trial setting with patients with breast cancer treated by a uniform drug regimen so that treatment was not associated with variability in outcome . METHODS We used tissue microarrays to evaluate the expression of p27 and cyclin E proteins by immunohistochemistry in tumor tissue from 2123 ( 68 % ) of 3122 patients with moderate-risk primary breast cancer who were enrolled in Southwest Oncology Group-Intergroup Trial S9313 , in which patients were assigned to receive doxorubicin and cyclophosphamide administered concurrently ( n = 1595 ) or sequentially ( n = 1527 ) . Disease-free and overall survival were equivalent in the two arms . Expression of the proteins was rated on a scale of 1 - 7 , and the median value was used as the cut point . Log-rank tests and Cox regression analyses were used to assess associations with survival . Overall survival was defined as time to death from all causes ; disease-free survival was defined as time to recurrence or death . All P values were from two-sided statistical tests . RESULTS Lower p27 expression was associated with worse overall survival ( unadjusted hazard ratio [ HR ] = 1.50 , 95 % confidence interval [ CI ] = 1.21 to 1.86 ) and disease-free survival ( unadjusted HR = 1.31 , 95 % CI = 1.10 to 1.57 ) than higher p27 expression . Among hormone receptor-positive patients , lower p27 expression was associated with worse overall survival ( HR = 1.42 , 95 % CI = 1.05 to 1.94 ) and worse disease-free survival ( HR = 1.27 , 95 % CI = 0.99 to 1.63 ) than higher p27 expression after adjustment for treatment , menopausal status , tumor size , and number of positive lymph nodes . Among these patients , 5-year overall survival associated with higher p27 expression ( 0.91 , 95 % CI = 0.89 to 0.93 ) was similar to that associated with lower p27 expression ( 0.85 , 95 % CI = 0.82 to 0.87 ) . No association between p27 expression and survival was found in hormone receptor-negative patients . Cyclin E expression was not statistically significantly associated with overall survival ( HR = 1.12 , 95 % CI = 0.91 to 1.38 ) or disease-free survival ( HR = 1.09 , 95 % CI = 0.92 to 1.29 ) . CONCLUSIONS Low p27 expression appears to be associated with poor prognosis , especially among patients with steroid receptor-positive tumors Proteomic analysis of body fluids , including breast nipple aspirate fluid ( NAF ) , holds promise to aid in early cancer detection . We conducted a prospect i ve trial that collected NAF from women scheduled for diagnostic breast surgery to determine 1 ) the consistency of proteomic results , 2 ) protein masses associated with breast cancer , 3 ) subsets of women with a unique proteomic profile and 4 ) a breast cancer predictive model . NAF was collected preoperatively in 114 women and analyzed by SELDI-TOF mass spectrometry over a 3 - 50 kDa range using H4 , NP and SAX ProteinChips . For all 3 chips , the same protein peaks were detected over 90 % of the time in duplicate sample s. The overall coefficient of variation was < or = 0.17 % for each chip for the internal st and ard and < or = 0.29 % for the unknown proteins . Seven c and i date protein ion masses frequently expressed in NAF were identified . Three ( 5,200-H4 , p=.04 , 11,880-H4 , p=.07 and 13,880 Da-SAX , p=.03 ) were differentially expressed in women with/without breast cancer . Protein expression differed between women with/without pathologic nipple discharge ( PND ) , but the 5,200 , 11,880 and 13,880 proteins remained associated with breast cancer even if PND sample s were excluded . Subset analysis identified differences in expression between benign disease and DCIS and between DCIS and invasive cancer for the 5,200 and 33,400 Da proteins . The best cancer detection model included age , parity and the 11,880 Da protein , and excluded women with PND . 1 ) NAF proteomic analysis using SELDI-TOF is reproducible with the same sample set across different platforms , 2 ) differential proteomic expression exists between women/without breast cancer and 3 ) combining proteomic and clinical information that are available before surgery optimizes the prediction of which women have breast cancer BACKGROUND Overexpression of the erbB-2 protein by breast cancer cells has been suggested to be a predictor of response to doxorubicin . A retrospective study was design ed to test this hypothesis . METHODS In National Surgical Adjuvant Breast and Bowel Project protocol B-11 , patients with axillary lymph node-positive , hormone receptor-negative breast cancer were r and omly assigned to receive either L-phenylalanine mustard plus 5-fluorouracil ( PF ) or a combination of L-phenylalanine mustard , 5-fluorouracil , and doxorubicin ( PAF ) . Tumor cell expression of erbB-2 was determined by immunohistochemistry for 638 of 682 eligible patients . Statistical analyses were performed to test for interaction between treatment and erbB-2 status ( positive versus negative ) with respect to disease-free survival ( DFS ) , survival , recurrence-free survival ( RFS ) , and distant disease-free survival ( DDFS ) . Reported P values are two-sided . RESULTS Overexpression of erbB-2 ( i.e. , positive immunohistochemical staining ) was observed in 239 ( 37.5 % ) of the 638 tumors studied . Overexpression was associated with tumor size ( P=.02 ) , lack of estrogen receptors ( P=.008 ) , and the number of positive lymph nodes ( P=.0001 ) . After a mean time on study of 13.5 years , the clinical benefit from doxorubicin ( PAF versus PF ) was statistically significant for patients with erbB-2-positive tumors -- DFS : relative risk of failure (RR)=0.60 ( 95 % confidence interval [CI]=0.44 - 0.83 ) , P=.001 ; survival : RR=0.66 ( 95 % CI=0.47 - 0.92 ) , P = .01 ; RFS : RR=0.58 ( 95 % CI=0.42 - 0.82 ) , P=.002 ; DDFS : RR=0.61 ( 95 % CI=0.44 - 0.85 ) , P=.003 . However , it was not significant for patients with erbB-2-negative tumors-DFS : RR=
Output:
| The following categories showed evidence of clinical utility and were recommended for use in practice : CA 15 - 3 , CA 27.29 , carcinoembryonic antigen , estrogen receptor , progesterone receptor , human epidermal growth factor receptor 2 , urokinase plasminogen activator , plasminogen activator inhibitor 1 , and certain multiparameter gene expression assays .
Not all applications for these markers were supported , however . |
MS212358 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Orientation and mobility training ( O&M-training ) in using an identification cane , also called symbol cane , is provided to people with low vision to facilitate independent participation in the community . In The Netherl and s this training is mainly practice -based because a st and ardised and validly evaluated O&M-training in using the identification cane is lacking . Recently a st and ardised O&M-training in using the identification cane was developed . This training consists of two face-to-face sessions and one telephone session during which , in addition to usual care , the client 's needs regarding mobility are prioritised , and cognitive restructuring techniques , action planning and contracting are applied to facilitate the use of the cane . This paper presents the design of a r and omised controlled trial aim ed to evaluate this st and ardised O&M-training in using the identification cane in older adults with low vision . Methods / design A parallel group r and omised controlled trial was design ed to compare the st and ardised O&M-training with usual care , i.e. the O&M-training commonly provided by the mobility trainer . Community-dwelling older people who ask for support at a rehabilitation centre for people with visual impairment and who are likely to receive an O&M-training in using the identification cane are included in the trial ( N = 190 ) . The primary outcomes of the effect evaluation are ADL self care and visual functioning with respect to distance activities and mobility . Secondary outcomes include quality of life , feelings of anxiety , symptoms of depression , fear of falling , and falls history . Data for the effect evaluation are collected by means of telephone interviews at baseline , and at 5 and 17 weeks after the start of the O&M-training . In addition to an effect evaluation , a process evaluation to study the feasibility of the O&M-training is carried out . Discussion The screening procedure for eligible participants started in November 2007 and will continue until October 2009 . Preliminary findings regarding the evaluation are expected in the course of 2010 . If the st and ardised O&M-training is more effective than the current O&M-training or , in case of equal effectiveness , is considered more feasible , the training will be embedded in the Dutch national instruction for mobility trainers . Trial registration Clinical Trials.gov PURPOSE To provide a comprehensive description of vision function beyond acuity in older individuals . METHODS A sample of 900 individuals between the ages of 58 and 102 years ( mean age of 75.5 ) was binocularly tested wearing habitual correction on a battery of psychophysical tests including high and low contrast acuity , low contrast low luminance acuity , disability glare , contrast sensitivity , color vision , stereoacuity , recovery from glare , and attentional visual fields . RESULTS High contrast acuity is reasonably well maintained on average , even into very old ages . Spatial vision measures under conditions of reduced contrast or luminance , or glare reveal significant impairment in a large portion of the aged . Many older individuals also have greatly reduced stereopsis , poor color discrimination , and severely restricted peripheral fields under conditions of divided attention . A single exponential function relating performance to age fits all spatial vision data sets . The function for individual spatial measures lies at different positions along the age scale . The derived aging function with a time constant of approximately 15 years also fits results from other recent aging studies of acuity and contrast sensitivity . CONCLUSIONS St and ard visual acuity underestimates the degree of vision function loss suffered by many older individuals under the nonoptimal viewing conditions encountered in daily life . All spatial vision functions show a similar rate of decline with age of the population , but the age at which decline begins varies among measures This paper reports two experiments about street crossing under conditions of free flowing traffic , with a focus on modern roundabout intersections . Experiment 1 was conducted at three roundabouts varying in size and traffic volume . Six totally blind and six sighted adults judged whether gaps in traffic were long enough to permit crossing to the median ( splitter ) isl and before the next vehicle arrived . Gap distributions and measures of judgment quality are reported . Overall , blind participants were about 2.5 times less likely to make correct judgments than sighted participants , took longer to detect crossable gaps , and were more likely to miss crossable gaps altogether . However , the differences were significant only at the two higher volume roundabouts . In Experiment 2 , we evaluated the response of drivers to pedestrians with and without mobility devices ( i.e. , long canes , dog guides ) . The experiment was conducted at a single-lane roundabout , a midblock crossing , and a two-way-stop-controlled intersection . Site-specific characteristics appeared to have a greater impact on drivers ' yielding than did a mobility device . Actual or potential applications of this research include the development of methods for assessing pedestrian safety and driver behavior as well as identifying intersections that may require modification in order to be accessible to blind pedestrians
Output:
| Conclusion : Our review of the literature showed a lack of well-described protocol s and studies on orientation and mobility training in identification cane use |
MS212359 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Results of a previous phase I study suggested that a single 3 mg/m2 dose of the humanized non-FcR-binding anti-CD3 monoclonal antibody visilizumab ( Nuvion ) was well tolerated and had efficacy for the treatment of steroid-refractory acute graft-versus-host disease ( GVHD ) . We now report results of a multicenter phase II study in which visilizumab was given to 44 participants with steroid-refractory acute GVHD . Eighty-two percent of the participants had visceral involvement , and 86 % had overall grade III or IV acute GVHD at study entry . The respective complete and overall response rates were 14 % and 32 % at 42 days . Plasma Epstein-Barr virus DNA increased to more than 1000 copies per milliliter in 19 subjects . Seventeen received rituximab , and no fatal lymphoproliferative disorders were observed . Survival at 180 days was 32 % ( 95 % confidence interval , 18%-46 % ) . The administration of visilizumab as used in this study seems to be sufficiently safe and effective to warrant further assessment for treatment or prevention of GVHD Daclizumab , a humanized monoclonal IgG1 directed against the alpha chain of the interleukin-2 receptor ( IL-2R ) , is a competitive inhibitor of IL-2 on activated lymphocytes . To test the hypothesis that specific inhibition of activated lymphocytes in patients with ongoing acute graft-versus-host disease ( GVHD ) might ameliorate the process , we treated 43 patients with advanced or steroid-refractory GVHD with daclizumab . The first cohort of 24 patients was treated with daclizumab 1 mg/kg on days 1 , 8 , 15 , 22 , and 29 . On day 43 , the complete response ( CR ) rate was 29 % ( 95 % confidence interval [ CI ] , 13%-51 % ) . Survival on day 120 was 29 % ( 95 % CI , 13%-51 % ) . A second cohort of 19 patients was treated with daclizumab 1 mg/kg on days 1 , 4 , 8 , 15 , and 22 . For these patients , the CR rate on day 43 was 47 % ( 95 % CI , 24%-71 % ) , and survival on day 120 was 53 % ( 95 % CI , 29%-76 % ) . There were no infusion-related reactions and no serious side effects related to daclizumab . Following treatment , there was a reduction in serum concentrations of soluble IL-2R and peripheral blood CD3 ( + ) 25(+ ) lymphocytes , but these changes were not predictive of response . Daclizumab has substantial activity for the treatment of acute GVHD , and the second regimen evaluated is recommended for a controlled study . ( Blood , 2000 ; 95:83 - 89 BACKGROUND Severe graft-versus-host disease ( GVHD ) is a life-threatening complication after allogeneic transplantation with haemopoietic stem cells . Mesenchymal stem cells modulate immune responses in vitro and in vivo . We aim ed to assess whether mesenchymal stem cells could ameliorate GVHD after haemopoietic-stem-cell transplantation . METHODS Patients with steroid-resistant , severe , acute GVHD were treated with mesenchymal stem cells , derived with the European Group for Blood and Marrow Transplantation ex-vivo expansion procedure , in a multicentre , phase II experimental study . We recorded response , transplantation-related deaths , and other adverse events for up to 60 months ' follow-up from infusion of the cells . FINDINGS Between October , 2001 , and January , 2007 , 55 patients were treated . The median dose of bone-marrow derived mesenchymal stem cells was 1.4x10(6 ) ( min-max range 0.4 - 9x10(6 ) ) cells per kg bodyweight . 27 patients received one dose , 22 received two doses , and six three to five doses of cells obtained from HLA-identical sibling donors ( n=5 ) , haploidentical donors ( n=18 ) , and third-party HLA-mismatched donors ( n=69 ) . 30 patients had a complete response and nine showed improvement . No patients had side-effects during or immediately after infusions of mesenchymal stem cells . Response rate was not related to donor HLA-match . Three patients had recurrent malignant disease and one developed de-novo acute myeloid leukaemia of recipient origin . Complete responders had lower transplantation-related mortality 1 year after infusion than did patients with partial or no response ( 11 [ 37 % ] of 30 vs 18 [ 72 % ] of 25 ; p=0.002 ) and higher overall survival 2 years after haemopoietic-stem-cell transplantation ( 16 [ 53 % ] of 30 vs four [ 16 % ] of 25 ; p=0.018 ) . INTERPRETATION Infusion of mesenchymal stem cells exp and ed in vitro , irrespective of the donor , might be an effective therapy for patients with steroid-resistant , acute GVHD HE EFFICACY and safety of mycophenolate mofetil ( MMF ) in combination with CyA and Prednisolone for the treatment of acute and chronic GVHD ( aGVHD and cGVHD respectively ) after BMT and PBSCT from HLA mismatched and matched donors was evaluated in an open single center trial . Thirty patients , with aGVHD ( n 5 21 ) and cGVHD ( n 5 9 ) were treated with 2 g MMF daily in addition to Cyclosporin A ( CyA ) and Prednisolone . The control group consisted of 21 patients with aGVHD ( n 5 14 ) and cGVHD ( n 5 7 ) treated with Predniosolone and CyA only . Acute GVHD prophylaxis consisted of a combination of MTX , CyA , and Prednisolone . Overall grade improvement of aGVHD was found in 15/21 ( 71 % ) patients treated with MMF and was significantly different compared to the control group . MMF therapy in the treatment of cGVHD lead to moderate improvement in 4 of 8 patients with limited cGVHD . The most common adverse hematologic events of MMF were leukopenia ( n 5 6 ) , anemia ( n 5 4 ) , and thrombocytopenia ( n 5 5 ) . Haematological adverse events were not severe and did not require the discontinuation of MMF . Similar to the study group , leukopenia was found in 4 of the 21 control patients , anemia in 1/21 , and thrombocytopenia in 8/21 patients . In addition , 33 % of the patients in the control group developed severe adverse effects due to Prednisolone therapy , which were not observed in the MMF group . In this preliminary study , we have shown that MMF can be used safely for the treatment of aGVHD . In addition , the MMF therapy result ed in a significant dose reduction of Prednisolone for the treatment of GVHD when compared to a control group of patients . Treatment for GvHD after allogeneic related and unrelated BMT is one of the most critical elements in the reduction of transplant related morbidity and mortality 1 . High incidence of aGVHD indicates that more effective therapy and prevention of this severe complication is needed . MMF is a potent , uncompetitive , reversible inhibitor of eucaryotic inosine monophosphate dehydrogenase and is successfully used in the prevention of acute rejection in renal allograft recipients . 2 However , very little is known about the effect of MMF in prevention or treatment of GVHD in experimental animals . 3 The aim of our study was to evaluate the safety and efficacy of MMF in the treatment of aGVHD and cGVHD in patients after allogeneic BMT . PATIENTS AND METHODS This study included 30 patients given a sibling transplant BM or PBSCT ( n 5 12 ; four of which were HLA mismatched ) as well as allogeneic MUD BM or PBSCT ( n 5 18 ; three of which were HLA mismatched ) . Of these patients , 19 had AML , 7 had CML , and 4 had ALL . The conditioning regimens included TBI and CY in 24/30 patients . A BU/VP16 regimen was used in 3 patients . The control group included 21 patients given allogeneic familiar BM ( n 5 8 , 3 of which were HLA mismatched ) or allogeneic MUD BM ( n 5 13 , 3 of which were HLA mismatched ) . As many variables as possible were matched between the control patients and the patients receiving MMF in the following order of priority : diagnosis , disease phase at transplant , patient age 6 5 years , and type of BMT . Of these patients , 7 had AML , 11 had CML , and 3 had ALL . The conditioning regimens in the control group of patients included TBI and CY in 17/21 patients . A BU/CY regimen was used in 2 patients , and a BU/VP16 regimen was used in 2 patients BACKGROUND AND OBJECTIVES Tumor necrosis factor a is one of the principal cytokines involved in the pathogenesis of acute graft-versus-host-disease ( GVHD ) . Infliximab is an antibody to this cytokine . DESIGN AND METHODS We performed a retrospective analysis to evaluate the activity of infliximab in 32 patients with severe steroid-refractory acute GVHD . The patients received a median of 3 weekly courses of infliximab . The main organs involved in the patients were skin ( n=2 ) liver ( n=1 ) , bowel ( n=19 ) , liver and bowel at the same stage ( n=10 ) . RESULTS Nineteen out 32 patients ( 59 % ) responded to infliximab with 6 ( 19 % ) complete and 13 ( 40 % ) partial responses . Age younger than 35 years , intestinal involvement and a longer time between hematopoietic stem cell transplantation and infliximab administration were factors predicting a favorable response . Infective episodes developed in 23/32 ( 72 % ) patients . All the 13 unresponsive patients died of GVHD shortly after infliximab . Thirteen of 19 responsive patients were alive at a median follow-up of 449 days ( range 155 - 842 ) after infliximab , with no signs of chronic GVHD ( n=5 ) , limited ( n=5 ) or extensive involvement ( n=3 ) . Six patients who responded subsequently died , one of chronic lung GVHD , the others of vascular complications or infections ( 2 fungal diseases ) . INTERPRETATION AND CONCLUSIONS We conclude that infliximab is active in the treatment of severe steroid-refractory acute GVHD , particularly when the intestine is involved . Infections commonly followed its administration . The clinical activity of infliximab and the possibility that it increases the risk of infections are worth investigating in prospect i ve trials Background . Mesenchymal stem cells ( MSC ) have immunomodulatory effects . The aim was to study the effect of MSC infusion on graft-versus-host disease ( GVHD ) . Methods . We gave MSC to eight patients with steroid-refractory grade s III-IV GVHD and one who had extensive chronic GVHD . The MSC dose was median 1.0 ( range 0.7 to 9) × 106/kg . No acute side-effects occurred after the MSC infusions . Six patients were treated once and three patients twice . Two patients received MSC from HLA-identical siblings , six from haplo-identical family donors and four from unrelated mismatched donors . Results . Acute GVHD disappeared completely in six of eight patients . One of these developed cytomegalovirus gastroenteritis . Complete resolution was seen in gut ( 6 ) , liver ( 1 ) and skin ( 1 ) . Two died soon after MSC treatment with no obvious response . One of them had MSC donor DNA in the colon and a lymph node . Five patients are still alive between 2 months and 3 years after the transplantation . Their survival rate was significantly better than that of 16 patients with steroid-resistant biopsy-proven gastrointestinal GVHD , not treated with MSC during the same period ( P=0.03 ) . One patient treated for extensive chronic GVHD showed a transient response in the liver , but not in the skin and he died of Epstein-Barr virus lymphoma . Conclusion . MSC is a very promising treatment for severe steroid-resistant acute GVHD This trial evaluated the feasibility and efficacy of the infusion of mesenchymal stem cells exp and ed using human serum for the treatment of refractory acute or chronic graft-versus-host disease . Twenty-eight expansions were started . In 22 , a minimum of more than 1x106 mesenchymal stem cells/kg were obtained after a median of 26 days ; this threshold was not obtained in the remaining cases . Ten patients received cells for the treatment of refractory or relapsed acute graft-versus-host disease and 8 for chronic disease . One patient treated for acute graft-versus-host disease obtained a complete response , 6 had a partial response and 3 did not respond . One of the chronic patients achieved complete remision , 3 a partial response , and 4 did not respond
Output:
| Age , skin involvement , lower aGVHD grade , and the number of infusions are the main prognostic factors affecting the efficacy of MSC therapy for steroid-refractory aGVHD |
MS212360 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 examined the nurse outcomes of a cancer pain education program for nurses of patients from 11 different ethnic groups . METHODS Four hundred ninety six home , hospital , and hospice nurses participated in a one-day workshop or two half-day workshops on cancer pain assessment and management . Of these , 116 were r and omized to participate in a bedside-precepted visit with an oncology nurse specialist with pain specialization and a focus group to discuss attitudinal issues . Eighty-six nurses served as controls . Pre- , post- and one-year follow-up tests were administered . RESULTS Attitudes , knowledge , and application skills significantly improved for workshop-only and enriched-model nurses relative to controls . CONCLUSION For postgraduate nurses , daylong cancer pain education workshops were , in the group studied , as effective as h and s-on experience in improving cancer pain knowledge and changing attitudes . Both the workshop-only and the enriched-model nurses relative to controls had significantly improved knowledge and changed attitudes towards optimal pain management Abstract The changes in attitudes towards cultural difference of seventeen participants in a three-week community health study abroad program to Nepal were compared with the changes in attitudes of a similar group who did not participate in the tour . Participants in the tour group were surveyed eight weeks prior to departure and in the last week of the tour using a twenty-six item question naire employing a six-point forced-choice response scale . The responses of participants in the lour group showed significant shifts in relation to eight items compared while the responses for the control group showed no significant shifts . Observed student advantages of participation in this study tour included the development of independent behaviour and positive cultural adjustment and adaptation The purpose of this two group intervention study ( N = 94 ) was to determine if RNs who participated in " culture school " improved levels of cultural competence to a greater extent than RNs who attended nursing informatics classes . The Giger and Davidhizar Transcultural Assessment Model/Theory ( GDTAMT ) was the study 's theoretical foundation ( Giger & Davidhizar , 1995 ) . A sample of 94 participants , was identified from a r and omized group of all Jefferson County , Alabama RNs . R and omly assigned participants ( stratified by race ) experienced 8.5 hours of either culture school or nursing informatics classes and completed survey tools in three phases ( pre-intervention , immediate post intervention , three week follow-up ) . The Cultural Self-Efficacy Scale ( CSES ) by Bernal and Froman ( 1987 ) , knowledge base questions by Rooda ( 1990 ) , and demographic profiles were used . Concepts empirically measured using these tools were analyzed by transcultural nursing experts for their congruence with GDTAMT . Using repeated measures analyses of convariance ( race ) , significant differences between groups for both scales were found . Culture school participants demonstrated significantly more cultural self-efficacy and cultural knowledge , and these improvements remained during phase three . Further research is recommended to allow for greater generalizability of findings , an examination of client perceptions , and actual nurse behaviors The objective of the present study was to prepare new doctors with an awareness of cultural and health issues to facilitate positive experiences with indigenous patients . The study incorporated the 1998 intern orientation programs in Queensl and public hospitals . The study method included tier one of the Three Tiered Plan , which was implemented and audited . Indigenous liaison officers , directors of clinical training and medical education officers were surveyed prior to this implementation to determine whether any or similar initiatives had been carried out in previous years and /or were planned . Post-implementation feedback from interns was obtained by using question naires . Follow-up telephone interviews with the directors of clinical training , medical education officers and indigenous hospital liaison officers detailed the format and content of tier one at each hospital . The results indicate that this active intervention improved the implementation rate of tier one from nine of 19 ( 47 % ) Queensl and public hospitals in 1997 to 17 ( 90 % ) in 1998 . The 14 indigenous hospital liaison officers ( 100 % ) involved in the intervention perceived it as beneficial . Forty-three ( 67 % ) of interns who responded to the survey indicated they had encountered an indigenous patient within the last 2 - 4 months . The level of knowledge of indigenous health and culture self-reported by interns was between the categories ' enough to get by ' and ' inadequate ' . In conclusion , it appears that tier one has been successful and is to be a formal component of intern orientations in Queensl and public hospitals . Further initiatives in indigenous health and culture targeting medical staff ( i.e. tier two and tier three ) , are needed
Output:
| CONCLUSIONS Most studies of cultural competence training used self-administered tools that have not been vali date d. The results of cultural competence training could be interpreted more accurately if vali date d tools were used |
MS212361 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 mechanisms thorough which spinal manipulative therapy ( SMT ) exerts clinical effects are not established . A prior study has suggested a dorsal horn modulated effect ; however , the role of subject expectation was not considered . The purpose of the current study was to determine the effect of subject expectation on hypoalgesia associated with SMT . Methods Sixty healthy subjects agreed to participate and underwent quantitative sensory testing ( QST ) to their leg and low back . Next , participants were r and omly assigned to receive a positive , negative , or neutral expectation instructional set regarding the effects of a specific SMT technique on pain perception . Following the instructional set , all subjects received SMT and underwent repeat QST . Results No interaction ( p = 0.38 ) between group assignment and pain response was present in the lower extremity following SMT ; however , a main effect ( p < 0.01 ) for hypoalgesia was present . A significant interaction was present between change in pain perception and group assignment in the low back ( p = 0.01 ) with participants receiving a negative expectation instructional set demonstrating significant hyper algesia ( p < 0.01 ) . Conclusion The current study replicates prior findings of c- fiber mediated hypoalgesia in the lower extremity following SMT and this occurred regardless of expectation . A significant increase in pain perception occurred following SMT in the low back of participants receiving negative expectation suggesting a potential influence of expectation on SMT induced hypoalgesia in the body area to which the expectation is directed INTRODUCTION The aim of the study was to investigate the hypoalgesic effects of a single spinal manipulation treatment on acute inflammatory reactions and pain induced by cutaneous application of capsaicin . METHODS Twenty healthy subjects participated in the experiment , which consisted of 2 sessions . In both sessions , following control measurements , topical capsaicin was applied to the right or left forearm to induce cutaneous inflammatory reactions . The cream was removed after 20 minutes . Then subjects received either spinal manipulation treatment ( SMT ) or " nonspinal manipulation treatment " ( N-SMT ) , respectively . In control as well as pretreatment and posttreatment intervals , the following tests were performed : measurement of the areas of mechanical hyperalgesia and stroking allodynia , assessment of spontaneous pain , and measurement of blood flow . RESULTS The results confirmed that topical capsaicin induced inflammatory reactions based on occurrence of hyperalgesia and allodynia , augmented pain perception , and increased blood flow following capsaicin application compared with the control session . When compared with N-SMT , spontaneous pain was rated significantly lower post-SMT ( P < .014 ) . In addition , areas of both secondary hyperalgesia and allodynia decreased after SMT ( hyperalgesia : P < .007 ; allodynia : P < .003 ) . However , there was no significant treatment effect for local blood flow . CONCLUSION These results suggest hypoalgesic effects following a single SMT . As local vascular parameter was not affected by the single SMT , the hypoalgesic effects appear to be due to central mechanisms The treatment of lateral epicondylalgia , a widely-used model of musculoskeletal pain in the evaluation of many physical therapy treatments , remains somewhat of an enigma . The protagonists of a new treatment technique for lateral epicondylalgia report that it produces substantial and rapid pain relief , despite a lack of experimental evidence . A r and omized , double blind , placebo-controlled repeated- measures study evaluated the initial effect of this new treatment in 24 patients with unilateral , chronic lateral epicondylalgia . Pain-free grip strength was assessed as an outcome measure before , during and after the application of the treatment , placebo and control conditions . Pressure-pain thresholds were also measured before and after the application of treatment , placebo and control conditions . The results demonstrated a significant and substantial increase in pain-free grip strength of 58 % ( of the order of 60 N ) during treatment but not during placebo and control . In contrast , the 10 % change in pressure-pain threshold after treatment , although significantly greater than placebo and control , was substantially smaller than the change demonstrated for pain-free grip strength . This effect was only present in the affected limb . The selective and specific effect of this treatment technique provides a valuable insight into the physical modulation of musculoskeletal pain and requires further investigation Background Current evidence suggests that spinal manipulative therapy ( SMT ) is effective in the treatment of people with low back pain ( LBP ) ; however , the corresponding mechanisms are unknown . Hypoalgesia is associated with SMT and is suggestive of specific mechanisms . Objective The primary purpose of this study was to assess the immediate effects of SMT on thermal pain perception in people with LBP . A secondary purpose was to determine whether the result ing hypoalgesia was a local effect and whether psychological influences were associated with changes in pain perception . Design This study was a r and omized controlled trial . Setting A sample of convenience was recruited from community and outpatient clinics . Participants Thirty-six people ( 10 men , 26 women ) currently experiencing LBP participated in the study . The average age of the participants was 32.39 ( SD=12.63 ) years , and the average duration of LBP was 221.79 ( SD=365.37 ) weeks . Intervention and Measurements Baseline demographic and psychological measurements were obtained , followed by quantitative sensory testing to assess temporal summation and Aδ fiber – mediated pain perception . Next , participants were r and omly assigned to ride a stationary bicycle , perform low back extension exercises , or receive SMT . Finally , the same quantitative sensory testing protocol was reassessed to determine the immediate effects of each intervention on thermal pain sensitivity . Results Hypoalgesia to Aδ fiber – mediated pain perception was not observed . Group-dependent hypoalgesia of temporal summation specific to the lumbar innervated region was observed . Pair-wise comparisons indicated significant hypoalgesia in participants who received SMT , but not in those who rode a stationary bicycle or performed low back extension exercises . Psychological factors did not significantly correlate with changes in temporal summation in participants who received SMT . Limitations Only immediate effects of SMT were measured , so the authors are unable to comment on whether the inhibition of temporal summation is a lasting effect . Furthermore , the authors are unable to comment on the relationship between their findings and changes in clinical pain . Conclusions Inhibition of Aδ fiber – mediated pain perception was similar for all groups . However , inhibition of temporal summation was observed only in participants receiving SMT , suggesting a modulation of dorsal horn excitability that was observed primarily in the lumbar innervated area OBJECTIVE The purpose of this study was to investigate the effects of a spinal thrust manipulation directed to the upper cervical segments ( atlanto-occipital joint ) on active mouth opening and pressure pain sensitivity in a trigeminal nerve innervated region ( sphenoid bone ) in women with mechanical neck pain . METHODS Thirty-seven women , ages 21 to 50 years old ( mean age , 35 + /- 8 years ) with mechanical neck pain were recruited for this study . Participants were r and omly assigned into 1 of 2 groups as follows : an experimental group that received a spinal manipulation of the atlanto-occipital joint and a control group that received a manual contact placebo intervention . Outcomes collected were assessed pretreatment and 5 minutes posttreatment by an assessor blinded to the treatment allocation and included active mouth opening and pressure pain thresholds ( PPTs ) over both sides of the sphenoid bone . A 2-way repeated measures analysis of variance ( ANOVA ) with time ( pre-post ) as the within subjects variable and group ( control , experimental ) as the between subjects variable was used to examine the effects of the intervention . The hypothesis of interest was group-time interaction . RESULTS The ANOVA showed a significant effect for time ( F = 23.1 ; P < .001 ) and an interaction between group and time ( F = 37.7 ; P < .001 ) for active mouth opening as follows : the experimental group showed a greater improvement when compared to the control group . A large positive within-group effect size ( d > 1.5 ) for the experimental group , whereas a negative medium within-group effect size ( d = -0.5 ) for the control group were identified . The ANOVA showed a significant interaction between group and time ( F = 14.4 ; P < .001 ) for PPT levels at the sphenoid bone as follows : the experimental group showed a greater improvement when compared to the control group . A medium positive within-group effect size ( d = -0.5 ) for the experimental group , whereas a negative medium within-group effect size ( d = -0.5 ) for the control group was found . CONCLUSIONS Our findings suggest that the application of an atlantoaxial joint thrust manipulation result ed in an increase in active mouth opening and PPT over a trigeminal nerve distribution area ( sphenoid bone ) in women with mechanical neck pain BACKGROUND CONTEXT Spinal manipulative techniques ( SMT ) have shown clinical effectiveness in some patients with musculoskeletal pain . PURPOSE We performed the current experiment to test whether regional pain modulation is to be expected from thoracic SMT . STUDY DESIGN / SETTING R and omized experimental design performed in a university pain laboratory . OUTCOME MEASURES The primary outcome was experimental pain sensitivity in cervical and lumbar innervated area . METHODS Ninety healthy volunteers were r and omly assigned to receive one of three interventions ( SMT , exercise , or rest ) to the upper thoracic spine . Participants completed question naires about pain-related affect and expectations regarding each of the interventions . We collected experimental pain sensitivity measures of cervical and lumbar innervated areas before and immediately after r and omly assigned intervention . Mixed model analysis of covariance was used to test changes in measures of experimental pain sensitivity . RESULTS No interactions or intervention ( group ) effects were noted for pressure or A-delta-mediated thermal pain responses . Participants receiving SMT had greater reductions in temporal sensory summation ( TSS ) . CONCLUSIONS This present study indicates thoracic SMT that reduces TSS in healthy subjects . These findings extend our previous work in healthy and clinical subjects by indicating change in the nocioceptive afferent system occurred caudal to the region of SMT application . However , the duration of reduction in TSS is unknown , and more work needs to be completed in clinical population s to confirm the relevance of these findings OBJECTIVE The purpose of this study was to evaluate the pain/pressure threshold of selected myofascial points in subjects with chronic mechanical back pain after a single manipulation or mobilization . DESIGN The study design was a r and omized control trial . SETTING Chiropractic College outpatient clinic . PARTICIPANTS Thirty subjects aged 18 - 50 yr ( mean age 31 yr , SD = 7 yr ) with chronic mechanical low back pain ( mean duration of pain 74 months , SD = 83 months ) were r and omized into two groups . One group received a manipulation and the other received a mobilization . OUTCOME MEASURE Pain/pressure threshold of selected myofascial points were measured before , immediately after , and 15 and 30 min postintervention . RESULTS Sixteen patients were allocated to the manipulation group and 14 to the mobilization group . Repeated measured analysis of variance for all locations failed to show clinical or statistical significance ( p > .287 ) . The overall effect between treatments and the interaction between treatment and time was not significant ( p > .268 ) . CONCLUSION The absence of significant changes may be attributed to the selection of myofascial points , the instrument sensitivity to small changes , the differences in baseline measures and the absence of effect from one intervention OBJECTIVE The objective of this study was to determine whether mechanical force , manually-assisted ( MFMA ) spinal manipulative therapy ( SMT ) affects paraspinal muscle strength as assessed through use of surface electromyography ( sEMG ) . DESIGN Prospect i ve clinical trial comparing sEMG output in 1 active treatment group and 2 control groups . SETTING Outpatient chiropractic clinic , Phoenix , AZ . SUBJECTS Forty subjects with low back pain ( LBP ) participated in the study . Twenty patients with LBP ( 9 females and 11 males with a mean age of 35 years and 51 years , respectively ) and 20 age- and sex-matched sham-SMT/control LBP subjects ( 10 females and 10 males with a mean age of 40 years and 52 years , respectively ) were assessed . METHODS Twenty consecutive patients with LBP ( SMT treatment group ) performed maximum voluntary contraction ( MVC ) isometric trunk extensions while lying prone on a treatment table . Surface , linear-enveloped sEMG was recorded from the erector spinae musculature at L3 and L5 during a trunk extension procedure . Patients were then assessed through use of the Activator Methods Chiropractic Technique protocol , during which time they were treated through use of MFMA SMT . The MFMA SMT treatment was followed by a dynamic stiffness and algometry assessment , after which a second or post-MVC isometric trunk extension and sEMG assessment were performed . Another 20 consecutive subjects with LBP were assigned to one of two other groups , a sham-SMT group and a control group . The sham-SMT group underwent the same experimental protocol with the exception that the subjects received a sham-MFMA SMT and dynamic stiffness assessment . The control group subjects received no SMT treatment , stiffness assessment , or algometry assessment intervention . Within-group analysis of MVC sEMG output ( pre-SMT vs post-SMT sEMG output ) and across-group analysis of MVC sEMG output ratio ( post-SMT sEMG/pre-SMT sEMG output ) during MVC was performed through use of a paired observations t test ( POTT ) and a robust analysis of variance ( RANOVA ) , respectively . MAIN OUTCOME MEASURES Surface , linear-enveloped EMG recordings during isometric MVC trunk extension were used as the primary outcome measure . RESULTS Nineteen of the 20 patients in the SMT treatment group showed a positive increase in sEMG output during MVC ( range , -9.7 % to 66.8 % ) after the
Output:
| Meta- analysis was appropriate for studies examining the immediate effect of SMT on mechanical pressure pain threshold ( PPT ) .
SMT demonstrated a favorable effect over other interventions on increasing PPT .
Subgroup analysis showed a significant effect of SMT on increasing PPT at the remote sites of stimulus application supporting a potential central nervous system mechanism . |
MS212362 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Adverse effects of drugs are poorly reported in the literature . The aim of this study was to examine the frequency of the adverse events of antiepileptic drugs ( AEDs ) , in particular carbamazepine ( CBZ ) and oxcarbazepine ( OXC ) in patients with neuralgiform pain using the psychometrically tested Liverpool Adverse Events Profile ( AEP ) and provide clinicians with guidance as to when to change management . Methods The study was conducted as a clinical prospect i ve observational exploratory survey of 161 patients with idiopathic trigeminal neuralgia and its variants of whom 79 were on montherapy who attended a specialist clinic in a London teaching hospital over a period of 2 years . At each consultation they completed the AEP question naire which provides scores of 19–76 with toxic levels being considered as scores > 45 . Results The most common significant side effects were : tiredness 31.3 % , sleepiness 18.2 % , memory problems 22.7 % , disturbed sleep 14.1 % , difficulty concentrating and unsteadiness 11.6 % . Females reported significantly more side effects than males . Potential toxic dose for females is approximately 1200 mg of OXC and 800 mg of CBZ and 1800 mg of OXC and 1200 mg of CBZ for males . Conclusions CBZ and OXC are associated with cognitive impairment . Pharmacokinetic and pharmacodynamic differences are likely to be the reason for gender differences in reporting side effects . Potentially , females need to be prescribed lower dosages in view of their tendency to reach toxic levels at lower dosages . Side effects associated with AED could be a major reason for changing drugs or to consider a referral for surgical management The impact of gender , use of oral contraceptive steroids ( OCS ) , coffee consumption and of smoking on the metabolism of sparteine , caffeine , and paracetamol was studied in 194 r and omly selected subjects ( 98 male and 95 female ) . Thirty-eight of the male volunteers were cigarette smokers , 40 of the female subjects were smokers and /or users of OCS . The metabolic ratio of sparteine oxidation ( MRs ) showed a trimodal distribution . 7.7 % of the subjects had a MRs > 20 and thus were poor metabolizers ( PMs ) . Within the extensive metabolizer ( EM ) subjects , a distinct subgroup accounting for 11 % was observed with 20 > MRs > 1.2 . Six of the 15 phenotypical PMs were heterozygous EMs by genotyping . This indicates the existence of one or several CYP2D6 mutations which can not be identified by the currently employed genotyping methods . In each subgroup , i.e. smokers/OCS and non-smokers/non-OCS , the cumulative frequency distribution of the heterozygous ( wt/B ) phenotype caused a shift to higher MRs compared with the wild-type homozygotes ( wt/wt ) . Thus , for the in vivo activity of CYP2D6 , genetic determinants prevail over environmental factors . Smoking , use of oral contraceptive steroids , caffeine consumption , or gender had no influence on sparteine metabolism . The distribution of the paracetamol glucuronide/paracetamol metabolic ratio appeared to be unimodal although skewed . Glucuronidation capacity was clearly affected by gender , OCS use and smoking . It was higher in male than in female subjects . Male smokers had the highest , and female non-smokers/non-OCS users the lowest metabolic ratio . CYP1A2 activity , as determined by a caffeine metabolic ratio ( ( AFMU + 1X + 1U)/1 , 7U ) , was multimodally distributed and was clearly increased in smokers . It was significantly correlated to paracetamol glucoronidation in male heavy smokers ( r=0.85 ) , suggesting an element of co-regulation of CYP1A2 and of paracetamol conjugating UDP-glucuronosyltransferase isozymes , including UGTI.6 BACKGROUND Amiodarone use was associated with an increased need for pacemaker insertion in a retrospective study of patients with atrial fibrillation ( AF ) and prior myocardial infa rct ion . The aims of this study were to determine prospect ively whether amiodarone increases the need for pacemakers in a general population of patients with AF and whether this effect is modified by sex . METHODS The study included 1005 patients with new-onset AF who were enrolled in the Fibrillation Registry Assessing Costs , Therapies , Adverse events , and Lifestyle ( FRACTAL ) . Multivariable Cox regression models , including time-dependent covariates accounting for medication exposure , were used to evaluate the risk of pacemaker insertion associated with amiodarone use . RESULTS Amiodarone use was associated with an increased risk of pacemaker insertion ( hazard ratio [ HR ] , 2.01 ; 95 % confidence interval [ CI ] , 1.08 - 3.76 ) after adjustment for age , sex , atrial flutter , coronary artery disease , heart failure , and hypertension . The effect of amiodarone use was modified by sex , with a significant risk in women but not in men ( HR , 4.69 ; 95 % CI , 1.99 - 11.05 vs HR , 1.05 ; 95 % CI , 0.42 - 2.58 [ P = .02 ] ) . This interaction remained significant after adjustment for weight , body mass index , weight-adjusted amiodarone dose , and use of other antiarrhythmic or rate control drugs . CONCLUSION The risk of bradyarrhythmia requiring pacemaker insertion associated with amiodarone use for AF is significantly greater in women than in men , independent of weight or body mass index Purpose Data from two clinical studies ( hyperCholesterolaemia in cHildren and Adolescents taking Rosuvastatin OpeN label [ CHARON ; NCT01078675 ] and Study 4522IL/0086 ) were used to describe rosuvastatin pharmacokinetics in patients with heterozygous familial hypercholesterolemia aged ≥6 to < 18 years . Methods Rosuvastatin concentration – time data were analyzed via non-linear mixed-effects modeling ( NONMEM ) , with clearance ( CL/F ) as the pre-defined key pharmacokinetic parameter of interest . In addition , descriptive comparisons between pediatric patients and adults ( healthy and dyslipidemic ) were performed . The data set included 214 pediatric patients , with 2,029 rosuvastatin concentrations . Results A linear two-compartment model with first-order absorption and elimination processes adequately described the combined data set . Weight and gender were significant covariates for CL/F , with moderate between-patient variability remaining ( coefficient of variation ( CV ) 40 % ): CL/F in female children was approximately 30 % lower than in male children , and there was a twofold mean difference in CL/F across the observed weight range . Age was not a significant covariate after accounting for weight and gender differences . However , weight and gender only reduced between-patient variability from 45 ( without covariates ) to 40 % and are considered unlikely to be clinical ly relevant . Conclusions Rosuvastatin pharmacokinetics appeared generally predictable with respect to dose , and time ( study duration ) and the exposure ( dose-normalized area under the plasma concentration – time curve at steady state ( AUCss ) ) in children and adolescents appeared to be similar or lower than adult patients with dyslipidemia PURPOSE Encenicline ( EVP-6124 ) is a selective α7 nicotinic acetylcholine receptor partial agonist being developed for cognitive impairment in Alzheimer 's disease and schizophrenia . We report on 2 single-dose studies to assess the relative bioavailability , pharmacokinetic profile , tolerability , and cognitive effects of encenicline in healthy volunteers . METHODS A single ascending-dose study assessed the safety , tolerability , pharmacokinetic , and pharmacodynamic profiles of encenicline in healthy male volunteers . Subjects received a single 1- , 3.5- , 7- , 20- , 60- , or 180-mg oral solution dose of encenicline or placebo . A second single-dose , r and omized , open-label , 3-period , crossover study in healthy male and female subjects compared the relative bioavailability of a 1-mg oral capsule versus a 1-mg oral solution dose of encenicline and evaluated the effects of food and sex on encenicline pharmacokinetic profile . FINDINGS In the first study , encenicline was well tolerated and dose-proportional increases in C(max ) ( mean range 0.59 - 100 ng/mL ) and AUC0-∞ ( mean range 45.6 - 8890 ng·h/mL ) were observed over a 1- to 180-mg dose range . Procognitive effects on the Digit Symbol Substitution Test were maximal at the 20-mg dose . In the second study , encenicline 1-mg oral capsules and oral solution were bioequivalent and there was no observed food effect on encenicline pharmacokinetic profile with the 90 % confidence intervals of the treatment ratios for both comparisons ( ie , capsule to solution and fed to fasted ) for Cmax and AUC being within 80 % to 125 % . A 30 % to 40 % higher encenicline exposure in female subjects than respective values in male subjects was consistent with a 33 % higher weight of the male subjects . No clinical ly relevant safety profile or tolerability effects of encenicline were observed . IMPLICATION S Encenicline was well tolerated at single doses up to 180 mg , and doses as low as 1 mg had dose- and time-dependent pharmacodynamic effects on the central nervous system . Oral capsule and solution were bioequivalent and were not affected by food . Although a sex effect on pharmacokinetic profile was observed , it was attributable to weight differences . Clinical Trial Registration at EudraCT : 2006 - 005623 - 42 and EudracT : 2008 - 000029 - 20 STUDY OBJECTIVES To compare the steady-state pharmacokinetics and safety of saquinavir soft-gelatin capsules ( SGC ) plus low-dose ritonavir administered once/day in antiretroviral-naive adult patients infected with the human immunodeficiency virus type 1 ( HIV-1 ) and to evaluate any sex-related differences . DESIGN Single-center , open-label , pharmacokinetic study . SETTING University-affiliated outpatient HIV clinic . PATIENTS Six men and seven women with HIV-1 . INTERVENTION Each patient received saquinavir SGC 1600 mg and ritonavir 100 mg for a 14-day course of therapy . Nine serial blood sample s during 24 hours were collected on day 14 of therapy MEASUREMENTS AND MAIN RESULTS Plasma saquinavir and ritonavir concentrations were measured by high-performance liquid chromatography . St and ard noncompartmental methods were used to calculate the pharmacokinetic parameters . The unpaired Student t test was used for the statistical comparison of pharmacokinetic parameters between male and female patients . Once-daily saquinavir SGC plus ritonavir was generally well tolerated . Pharmacokinetic data from five men and five women were evaluable . The median saquinavir area under the concentration-time curve from 0 - 24 hours ( AUC0 - 24 ) in the female patients ( 82,300 ng x hr/ml ) was significantly ( p=0.036 ) higher than that in the male patients ( 47,400 ng x hr/ml ) . This relationship remained significant for weight-adjusted saquinavir AUC0 - 24 values . Ritonavir 's apparent oral clearance in the women was significantly ( p=0.023 ) lower than that in the men . CONCLUSION Significantly higher plasma concentrations of saquinavir were achieved in female compared with male HIV-infected patients receiving once-daily saquinavir SGC 1600 mg plus ritonavir 100 mg STUDY OBJECTIVE To examine the comparative pharmacokinetics of long-term methylprednisolone therapy in black and white renal transplant recipients . DESIGN Comprehensive pharmacokinetic evaluations of patients who participated in our glucocorticoid-monitoring program . SETTING University-based renal transplantation clinic . PATIENTS Six white renal transplant recipients with stable renal function , sex- and ( approximate ) age-matched with six preselected black patients . INTERVENTIONS The daily oral methylprednisolone dose for each patient was administered intravenously , and serial plasma sample s were obtained over 24 hours . MEASUREMENTS AND MAIN RESULTS Methylprednisolone was analyzed by high-performance liquid chromatography . The drug 's pharmacokinetics in black and white patients , respectively , were as follows : mean clearance 234 + /- 124 and 472 + /- 180 ml/hr/kg ( p < 0.05 ) ; volume of distribution 0.3 - 2.0 and 0.8 - 2.0 L/kg ; and elimination
Output:
| We observed that female generally has a lower the gastric emptying time , gastric PH , lean body mass , and higher plasma volume , BMI , body fat , as well as reduce hepatic clearance , difference in activity of Cytochrome P450 enzyme , and metabolize drugs at different rate compared with male .
However , these differences can lead to adverse effects in female especially for the pregnant , post-menopausal , and elderly women .
Conclusion This systematic review provides an evidence for the effectiveness of dosage difference to ensure safety and efficient treatment . |
MS212363 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To test whether overfeeding isoenergetic doses protein , carbohydrate and fat would differentially influence appetite on the same day , and the subsequent day 's food intake . DESIGN Six men were each studied three times on a 5-day protocol . On days 1 and 2 they were fed a medium fat ( MF ) maintenance diet ( comprising 40:47:13 % fat , CHO and protein by energy ) calculated at 1.6 x RMR . Subjects entered the calorimeter at 08.00 on day 3 for 48 h. On day 3 ( manipulation day ) , they ate a MF diet at 1.5 x RMR with an additional 0.6 x RMR as protein ( HP ) , carbohydrate ( HC ) or fat ( HF ) . On days 4 and 5 , ( outcome days ) , subjects had ad libitum access to isoenergetically dense MF ( 40:47:13 ) foods ( 550kJ/100 g ) . Subjective hunger and satiety were tracked hourly during waking hours throughout days 1 - 5 . RESULTS Throughout day 3 subjects felt significantly more full and less hungry on the high protein diet relative to the other two diets ( P = 0.002 ) . Also by the end of day 3 each overfed nutrient led to a significant increase in its own balance of the other two diets ( P < 0.01 ) . These effects did not influence the subsequent day 's energy intake . The alterations in nutrient balance by the end of day 3 were partially buffered by increases in the oxidative disposal of each overfed macronutrient throughout day 4 ( which was proportionately greater for protein ( P < 0.001 ) than carbohydrate ( P = 0.07 ) or fat ( P = 0.1 ) ) . CONCLUSIONS HP diets were more satiating that isoenergetically-dense HC or HF diets on the day they are eaten . The HC diet was transiently more satiating than the HF diet after each meal . This study supports previous work which suggests that relatively large changes in nutrient balance produced on one day appear to be poorly compensated by changes in energy intake on a subsequent day in men OBJECTIVE To investigate whether protein intake influences the decline in energy expenditure during energy restriction . DESIGN Cross-over study of three diets of 4.2 MJ/d for 7 days : one diet with 36 % energy as protein and two with 15 % energy as protein , one high in carbohydrate and the other high in fat . SUBJECTS Two men and six women aged 31 - 57 y. BMI 27.B-34.1 kg/m2 . MEASUREMENTS 24-h energy expenditure ( 24-h EE ) , sleeping metabolic rate ( SMR ) and body weight on days 0 and 7 of each diet ; 24-h urinary nitrogen excretion ( 24-h UN ) on days 0 - 7 of each diet . RESULTS 24-h EE and SMR declined on all three diets but the decrease was significantly less on the high protein diet than on the two low protein diets . Weight loss was similar on all three diets . 24-h UN was less than N intake on the high protein diet but greater than N intake on the two low protein diets . CONCLUSIONS Maintaining protein intake reduces the decrease in energy expenditure during energy restriction 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 . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed BACKGROUND : A relatively high percentage of energy intake as protein has been shown to increase satiety and decrease energy efficiency during overfeeding . AIM : To investigate whether addition of protein may improve weight maintenance by preventing or limiting weight regain after weight loss of 5–10 % in moderately obese subjects . DESIGN OF THE STUDY : In a r and omized parallel design , 148 male and female subjects ( age 44.2±10.1 y ; body mass index ( BMI ) 29.5±2.5 kg/m2 ; body fat 37.2±5.0 % ) followed a very low-energy diet ( 2.1 MJ/day ) during 4 weeks . For subsequent 3 months weight-maintenance assessment , they were stratified according to age , BMI , body weight , restrained eating , and resting energy expenditure ( REE ) , and r and omized over two groups . Both groups visited the University with the same frequency , receiving the same counseling on dem and by the dietitian . One group ( n=73 ) received 48.2 g/day additional protein to their diet . Measurements at baseline , after weight loss , and after 3 months weight maintenance were body weight , body composition , metabolic measurements , appetite profile , eating attitude , and relevant blood parameters . RESULTS : Changes in body mass , waist circumference , REE , respiratory quotient ( RQ ) , total energy expenditure ( TEE ) , dietary restraint , fasting blood-glucose , insulin , triacylglycerol , leptin , β-hydroxybutyrate , glycerol , and free fatty acids were significant during weight loss and did not differ between groups . During weight maintenance , the ‘ additional-protein group ’ showed in comparison to the nonadditional-protein group 18 vs 15 en% protein intake , a 50 % lower body weight regain only consisting of fat-free mass , a 50 % decreased energy efficiency , increased satiety while energy intake did not differ , and a lower increase in triacylglycerol and in leptin ; REE , RQ , TEE , and increases in other blood parameters measured did not differ . CONCLUSION : A 20 % higher protein intake , that is , 18 % of energy vs 15 % of energy during weight maintenance after weight loss , result ed in a 50 % lower body weight regain , only consisting of fat-free mass , and related to increased satiety and decreased energy efficiency OBJECTIVE To compare the effect of isoenergetically-dense , high-protein ( HP ) , high-fat ( HF ) or high-carbohydrate ( HC ) breakfasts ( at 08.30 ) on subjective hunger , fullness and appetite ( measured hourly on a 100 mm visual analogue scale ) , macronutrient balance and ad libitum energy intake ( EI ) , at a test meal ( 13.30 ) and throughout the rest of the day ( until 23.00 ) . DESIGN Six men each spent 24 h in a whole-body indirect calorimeter on three separate occasions during which they received breakfasts design ed to match 75 % of BMR and that comprised , on average 3.1 MJ of protein ( HP ) , carbohydrate ( HC ) or fat ( HF ) , respectively , the remainder being split between the other two macronutrients . Every item of the ad libitum diet comprised 13 % protein , 40 % fat and 47 % carbohydrate by energy , with an energy density of 550 kJ/100 g. RESULTS Subjectively-rated pleasantness did not differ between the breakfasts , or any of the subsequent ad libitum meals . Subjective hunger was significantly greater during the hours between breakfast and lunch after the HF ( 26 ) treatment relative to the HP ( 18 ) or HC ( 18 mm ) meals ( P < 0.001 ) , although the HP treatment suppressed hunger to a greater extent than the other two treatments over 24 h. However , mean ad libitum lunch intakes were similar at 5.38 , 5.30 and 5.18 MJ ( NS ) on the HP , HC and HF treatments , respectively . After-lunch intakes were also very similar at 6.14 , 6.18 and 5.83 MJ ( NS ) . Mean 24-h energy expenditure amounted to 11.12 , 11.14 and 10.93 MJ , respectively , producing energy balances of 5.71 , 5.83 and 5.04 MJ ( NS ) , respectively . The HP , HF and HC breakfasts led to enhanced P , F and C oxidation , respectively ( P < 0.003 ) . CONCLUSIONS Large HP , HC or HF breakfasts led to detectable changes in hunger that were not of sufficient magnitude to influence lunch-time intake 5 h later , or EI for the rest of the day . A single positive balance of each macronutrient can be buffered by oxidation and storage capacity , without leading to changes in meal-to-meal EI , when subjects feed ad libitum on unfamiliar diets of fixed composition The aim of this study was to investigate whether a high protein meal has a different effect on short-term satiety in preschool children than a high carbohydrate meal by measuring their intake of a subsequent meal . Subjects were 35 normal preschool children of both genders aged 5 to 6 years . All children were healthy and r and omly chosen from those who were attending to a day-care center where they received feeding at three meal times : breakfast , lunch and teatime . Children were weighed with light clothes following st and ard recommendations . They were normal according to the weight for height index , using the NCHS st and ards . Two meals with different levels of protein and carbohydrate and equal energy contents were assayed at lunch . The lunches were cooked dishes made from common ingredients . The high carbohydrate meal was consumed in greater amount than the high protein meal ( P < 0.01 ) and a significantly greater energy intake was observed ( P < 0.01 ) . Food and energy intakes at teatime were greater with the high carbohydrate meal , but only the energy intake was significant ( P < 0.05 ) . When subjects consumed the high protein meal during lunch , they ate a significantly lower amount of protein in the subsequent meal , but the carbohydrate intake was similar . The long-term effects of a high protein diet remain to be investigated before recommending of a high protein for obese children The purpose of this investigation was to learn whether the thermogenic effect in man of sucrose and glucose was similar and whether normal weight and overweight subjects responded in a similar manner . Dietary-induced thermogenesis was calculated for the period 15 to 180 min after ingestion of sucrose or glucose in six normal weight and five obese subjects . The metabolic rate was calculated from the oxygen consumption and carbon dioxide output utilizing the ventilated hood technique . In normal weight subjects , the total dietary-induced thermogenesis was significantly greater after sucrose than after glucose ( p less than 0.005 ) but the difference was much less marked in the obese subjects The rates of energy expenditure and wholebody protein turnover were determined during a 9-h period in a group of seven men while they received hourly isocaloric meals of high-protein ( HP ) or high-carbohydrate ( HC ) content . Their responses to feeding were compared with those to a short period of fasting ( 15 - 24 h ) . The 9-h thermic response to the repeated feeding of HP meals was found to be greater than that to the HC meals ( 9.6 + /- 0.6 % vs 5.7 + /- 0.4 % of the energy intake , respectively , means + /- SEM , p less than 0.01 ) . The rate of whole-body nitrogen turnover over 9 h increased from 17.6 + /- 2.2 g on the fasting day to 27.4 + /- 1.4 g during HC feeding ( NS ) and there was a
Output:
| There is convincing evidence that a higher protein intake increases thermogenesis and satiety compared to diets of lower protein content .
The weight of evidence also suggests that high protein meals lead to a reduced subsequent energy intake .
Some evidence suggests that diets higher in protein result in an increased weight loss and fat loss as compared to diets lower in protein , but findings have not been consistent . |
MS212364 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Acute hepatic encephalopathy in 70 cirrhotic patients was monitored during parenteral administration of amino acids between January 1979 and January 1984 . The diagnosis of cirrhosis was confirmed by needle biopsy , and HE by conventional clinical and EEG parameters . The infusion of AA solutions was initiated 48 h after admission and during a 5-day period : 34 patients received a control aminoacid solution , a commercially available AA mixture ( Azonutril ) , and 36 patients a modified solution enriched in BAA prepared from crystallized AA dissolved in distilled water . The calorie intake for both groups was 1600 calories per day from glucose and lipid emulsion . No significant difference was noted based on clinical evolution , even though the plasma AAA/BAA ratio was corrected using the modified AA solution . Of the 34 patients in Group 1 : 10 improved , 14 were unchanged , 10 deteriorated and 7 died . Of the 36 patients in Group 2 : 12 improved , 14 were unchanged , 10 deteriorated and 7 died . EEG tracing evolved in parallel fashion . The authors conclude that modified AA solutions are ineffective in the treatment of acute hepatic encephalopathy in cirrhotic patients The influence of intravenous infusion of branched-chain amino acids ( BCAAs ) on brain function in patients with liver cirrhosis and acute hepatic encephalopathy was examined using a double-blind , r and omized study design . Five medical centers in France and Sweden participated , and 50 patients were studied . The patients received either BCAAs ( 40 gm per day ) in 5 % glucose or 5 % glucose alone ( placebo ) for 5 days or until " wake up " . Nutritional support was provided with equal proportions of carbohydrate and fat . During BCAA administration , plasma concentrations of aromatic amino acids and methionine fell ( 20 to 40 % , p less than 0.05 to 0.01 ) , and the ratio of BCAAs to aromatic amino acid concentrations increased significantly . Clinical improvement was seen in 14 of 25 BCAA-treated patients and in 12 of 25 patients receiving placebo ( N.S. ) . EEG responses were similar in the two groups during treatment . In the BCAA group , 10 of 25 patients died in the course of the study , compared to 5 of 25 in the placebo group ( N.S. ) ; six patients died from encephalopathy in the BCAA group as compared to three among placebo-treated patients . It is concluded that BCAA administration , in the dose and composition employed in the present study , reduces the concentrations of aromatic amino acids but neither improves cerebral function nor decreases mortality in patients with hepatic encephalopathy In a double blind r and omized study , branched-chain amino acids and placebo ( casein ) were compared as a treatment for chronic hepatic encephalopathy in cirrhosis . After a 15-day run-in period with controlled diet ( 45 - 65 g protein ) , the patients were administered , in addition to their diet , branched-chain amino acids ( 0.24 g/kg , 30 patients ) or an equinitrogenous amount of casein ( 34 patients ) . One patient on branched-chain amino acids and two on casein were lost to the study . After 3 months , the index of portal-systemic encephalopathy significantly improved in patients on active treatment ( from 40 [ S.D. 14]% to 21 [ 17 ] ) , but was not in subjects receiving casein ( from 37 [13]% to 36 [ 12 ] ) . Two or more parameters of the index improved in 24 patients treated with amino acids ( 80 % ; confidence limits , 61 - 92 % ) , and only in 12 receiving casein ( 35 % ; confidence limits , 20 - 54 % ; p less than 0.001 ) . Patients who did not improve were given an alternative treatment for 3 more months . Casein-treated patients given branched-chain amino acids rapidly improved . The changes in neuropsychologic function were associated with an improvement in semiquantitative nitrogen balance , which became consistently positive in amino acid-treated subjects ; there was also a mild improvement in nutritional parameters and in liver function tests . The supplementation of oral branched-chain amino acids to the diet is superior to casein as a treatment for providing adequate nitrogen supply and improving the mental state of cirrhotic patients with chronic encephalopathy This trial was undertaken to assess the safety and efficacy of long-term oral supplementation with branched-chain amino acids as an adjunct to conventional therapy in patients with stable cirrhosis and latent encephalopathy . Latent encephalopathy was diagnosed by psychometric testing , used to assess automobile driving capacity . Seventeen patients with impaired driving capacity received either branched-chain amino acids or placebo for 8 weeks before being crossed over to the other regimen for an equal period . Branched-chain amino acids but not placebo significantly improved psychomotor disturbances ( p < 0.01 ) and driving capacity ( p < 0.002 ) . No adverse reactions were observed . We conclude that long-term branched-chain amino acid supplementation is well tolerated and effective in the treatment of impaired automobile driving capacity associated with latent portosystemic encephalopathy We studied the effects of infusion of a branched chain enriched amino acid mixture versus glucose on acute hepatic encephalopathy in patients with cirrhosis . Sixty-five patients were r and omly treated with 1 g/kg per day of an amino acid mixture with 40 % branched chain contents ( 32 patients ) , or isocaloric glucose ( 33 patients ) for a maximum of 16 days . The regimens further included glucose infusion to a total of 26.5 kcal/kg per day and lactulose . The patients took part in the study for 5 - 6 days . In each group 17 patients woke up . In the amino acid group eleven died and four developed renal failure . In the glucose group ten died , three developed renal and two respiratory failure , and one remained encephalopathic . The coma score worsened in three of the patients who died in the amino acid group , but in all patients who died in the glucose group . The negative nitrogen balance on entry reversed in the amino acid group , but not in the glucose group . Thus , the branched chain enriched amino acid supplement did not change the prognosis for wake-up , but had other effects on the cerebral state and on nitrogen homeostasis BACKGROUND & AIMS The role of oral supplementation with branched-chain amino acids ( BCAA ) in advanced cirrhosis is far from settled . A nutritional approach might prevent progressive liver failure and improve nutritional parameters and quality of life . METHODS A multicenter , r and omized study comparing 1-year nutritional supplementation with BCAA against lactoalbumin or maltodextrins was performed in 174 patients with advanced cirrhosis . Primary outcomes were the prevention of a combined end point ( death and deterioration to exclusion criteria ) , the need for hospital admission , and the duration of hospital stay . Secondary outcomes were nutritional parameters , laboratory data and Child-Pugh score , anorexia , health-related quality of life , and need for therapy . RESULTS Treatment with BCAA significantly reduced the combined event rates compared with lactoalbumin ( odds ratio , 0.43 ; 95 % confidence interval , 0.19 - 0.96 ; P = 0.039 ) and nonsignificantly compared with maltodextrins ( odds ratio , 0.51 ; 95 % confidence interval , 0.23 - 1.17 ; P = 0.108 ) . The average hospital admission rate was lower in the BCAA arm compared with control treatments ( P = 0.006 and P = 0.003 , respectively ) . In patients who remained in the study , nutritional parameters and liver function tests were , on average , stable or improved during treatment with BCAA and the Child-Pugh score decreased ( P = 0.013 ) . Also , anorexia and health-related quality of life ( SF-36 question naire ) improved . Long-term compliance with BCAA was poor . CONCLUSIONS In advanced cirrhosis , long-term nutritional supplementation with oral BCAA is useful to prevent progressive hepatic failure and to improve surrogate markers and perceived health status . New formulas are needed to increase compliance BACKGROUND / AIMS The value of paper-pencil tests and West-Haven- criteria for assessment of low- grade hepatic encephalopathy under conditions of a r and omized , double-blind , placebo-controlled , clinical trial was evaluated in a cohort of 217 cirrhotics . METHODS Patients were grade d at least twice clinical ly for severity of hepatic encephalopathy and tested concomitantly with a recommended psychometric test battery . RESULTS Re-evaluation of the study documentation showed that at study entry 33 % and during the study even 50 % of the patients were wrongly allocated to minimal or overt hepatic encephalopathy . Despite the participating physicians ' training , 31 % of the number-connection-tests-A , 20 % of the number-connection-tests-B and 28 % of the line-tracing-test were in retrospect considered invalid by an independent psychologist . Neither the Portosystemic-Encephalopathy-Syndrome ( PSE ) test nor the Psychometric-Hepatic-Encephalopathy-Sum (PHES)-score reliably picked up clinical improvement in the individual patient . Although these test scores could statistically differentiate between patients with minimal and overt hepatic encephalopathy , the clinical classification of individual patients into one of the groups will have a high rate of error . The PHES-Score was less balanced than the score derived from the PSE-Syndrome-Test . CONCLUSIONS Inaccuracies in conducting paper-pencil tests together with the subjectivity and incorrectness of clinical HE-grading question the usefulness of West-Haven- criteria and paper-pencil tests including related scores for quantification of low- grade HE at least in multicenter approaches 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 This multicenter study compared the effects of branched-chain amino acid granules ( Livact((R ) ) Granules , LIV ) and an enteral nutrient for chronic hepatic failure ( Aminoleban((R ) ) EN , EN ) on serum albumin in patients with decompensated liver cirrhosis . This study enrolled " patients with decompensated liver cirrhosis associated with hepatic encephalopathy who were suffering from hypoalbuminemia in spite of adequate food intake , " a condition for which both drugs are indicated . Enrolled patients were r and omized to the two groups according to the central registration method . This study continued for 24 weeks . Selected foods were supplied to each patient in principle so that caloric and protein intakes were st and ardized between the two groups . A total of 281 patients were enrolled . LIV was not inferior to EN concerning the primary efficacy endpoint changes in serum albumin OBJECTIVES : Protein intake impacts on nutritional status and may determine the recurrence of hepatic encephalopathy ( HE ) . A low-protein diet has been considered the st and ard treatment after an episode of HE , while branched-chain amino acids ( BCAA ) have been shown to improve minimal HE . We performed a study to investigate the long-term effects of supplementing a protein-controlled diet with BCAA . METHODS : A r and omized , double-blind , multicenter study that included 116 patients with cirrhosis and a previous episode of HE was conducted in four tertiary care hospitals . All patients received a st and ard diet of 35 kcal/kg per day and 0.7 g of proteins/kg per day and a supplement of 30 g of BCAA ( BCAA group ) or m
Output:
| We found no beneficial or detrimental effects of BCAA on nausea or vomiting in a r and om-effects meta- analysis or on quality of life or nutritional parameters . |
MS212365 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Introduction : The incidence of lung cancer in women living in China is among the highest in the world but it does not appear that tobacco smoking is a major risk factor for lung cancer . As tobacco smoking is highly prevalent in Chinese men , exposure to environmental tobacco smoke ( ETS ) may play an important role in the development of lung cancer in Chinese women who never smoked . We conducted the present investigation because previous studies did not account for dietary habits or indoor air pollution from Chinese-style cooking and they did not assess the effect of occupational exposure to ETS . Methods : A population -based , case – control study was conducted to evaluate the relationship between lung cancer and exposure to ETS among nonsmoking women living in Shanghai , China . Five-hundred and four women diagnosed with incident , primary lung cancer between February 1992 and January 1994 were identified through the population -based Shanghai Cancer Registry . A control group of 601 nonsmoking women was selected r and omly from the Shanghai Residential Registry , and was approximately frequency-matched to the age distribution of the lung cancer cases . Information on lifetime domestic and occupational exposure to ETS was obtained through face-to-face interviews . Adjusted odds ratios ( OR ) and 95 % confidence intervals ( CI ) were estimated by unconditional logistic regression . Results : The OR for ever exposed to ETS from spouses was 1.1 ( 95 % CI : 0.8–1.5 ) , and the OR for ever exposed to ETS at work was 1.7 ( 95 % CI : 1.3–2.3 ) . Furthermore , the OR increased with increasing number of hours of daily exposure to ETS in the workplace and with increasing number of smoking co-workers . No associations were found for exposure to ETS during childhood . Conclusions : The main findings of the present study are that long-term occupational exposure to ETS , both alone or in combination with exposures at home , conferred an increased risk of lung cancer among women who never smoked . The inconsistency of the results regarding exposure to ETS at home and at work may have been due to lower exposures at home Objective : To investigate whether the Irish smoking ban has had an impact on secondh and smoke ( SHS ) exposures for hospitality workers . Design , setting , and participants : Before and after the smoking ban a cohort of workers ( n = 35 ) from a sample of city hotels ( n = 15 ) were tested for saliva cotinine concentrations and completed question naires . Additionally , a r and om sample ( n = 20 ) of city centre bars stratified by size ( range 400–5000 square feet ) , were tested for air nicotine concentrations using passive sample rs before and after the ban . Main outcome measures : Salivary cotinine concentrations ( ng/ml ) , duration of self reported exposures to secondh and smoke , air nicotine ( μg/cubic metre ) . Results : Cotinine concentrations reduced by 69 % , from 1.6 ng/ml to 0.5 ng/ml median ( SD 1.29 ; p < 0.005 ) . Overall 74 % of subjects experienced decreases ( range 16–99 % ) , with 60 % showing a halving of exposure levels at follow up . Self reported exposure to SHS at work showed a significant reduction from a median 30 hours a week to zero ( p < 0.001 ) . There was an 83 % reduction in air nicotine concentrations from median 35.5 µg/m3 to 5.95 µg/m3 ( p < 0.001 ) . At baseline , three bars ( 16 % ) were below the 6.8 μg/m3 air nicotine significant risk level for lung cancer alone ; at follow up this increased to 10 ( 53 % ) . Conclusions : Passive smoking and associated risks were significantly reduced but not totally eliminated . Exposure to SHS is still possible for those working where smoking is still allowed and those working where smoke may migrate from outdoor areas . Further research is required to assess the true extent and magnitude of these exposures Background Profile regression is a Bayesian statistical approach design ed for investigating the joint effect of multiple risk factors . It reduces dimensionality by using as its main unit of inference the exposure profiles of the subjects that is , the sequence of covariate values that correspond to each subject . Objectives We applied profile regression to a case – control study of lung cancer in nonsmokers , nested within the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) cohort , to estimate the combined effect of environmental carcinogens and to explore possible gene – environment interactions . Methods We tailored and extended the profile regression approach to the analysis of case – control studies , allowing for the analysis of ordinal data and the computation of posterior odds ratios . We compared and contrasted our results with those obtained using st and ard logistic regression and classification tree methods , including multifactor dimensionality reduction . Results Profile regression strengthened previous observations in other study population s on the role of air pollutants , particularly particulate matter ≤ 10 μm in aerodynamic diameter ( PM10 ) , in lung cancer for nonsmokers . Covariates including living on a main road , exposure to PM10 and nitrogen dioxide , and carrying out manual work characterized high-risk subject profiles . Such combinations of risk factors were consistent with a priori expectations . In contrast , other methods gave less interpretable results . Conclusions We conclude that profile regression is a powerful tool for identifying risk profiles that express the joint effect of etiologically relevant variables in multifactorial diseases Biomass is widely used for fuel in developing countries . Particles and gases of biomass burning may cause changes in the lung . In this prospect i ve study we investigated histopathological changes in the lungs of 42 non-smoking women [ mean age ( 59±10 ) years ] caused by biomass smoke . We valuated exposure to biomass smoke , case histories , and the fi ndings of physical examination , radiology , bronchoscopy , and lung histopathology . Mean exposure to biomass smoke was ( 28±9 ) hour-year ( 1 hour-year equals 365 hours of exposure per year with average exposure of 1 hour a day ) . The radiological fi ndings were mass ( 42 % ) , reticulonodular opacities ( 31 % ) , mediastinal lymphadenopathy ( 26 % ) , pleuro-parenchymal fi brotic b and ing ( 19 % ) , widening of the pulmonary artery ( 14 % ) , ground glass ( 11 % ) , mosaic perfusion ( 9 % ) , consolidation ( 9 % ) , segmental or subsegmental atelectasis ( 7 % ) , and bronchiectasis ( 7 % ) . The patients were diagnosed with lung cancer ( 35 % ) , interstitial lung disease ( 31 % ) , sarcoidosis ( 9 % ) , tuberculosis ( 9 % ) , chronic obstructive pulmonary disease ( 4 % ) , chronic bronchitis ( 9 % ) , and metastasis ( 4 % ) . Bronchoscopy showed pilies , oedema , erythema , bronchus narrowing , endobronchial tumour , mucosal irregularity , increased vascularisation , blue-black anthracotic plaques , mucosal oedema , and purulent secretion . Transbronchial biopsies revealed neutrophil and lymphocyte leucocytes in the perivascular , peribronchiolar , and interalveolar septa , slightly enlarged connective tissue , thickening of the basal membrane , thickening of interalveolar septa , intimal and medial thickening of the vascular wall and vascular lumen narrowing , anthracosis between the cells and in the bronchiole epithelium . These fi ndings confi rm that biomass smoke has important toxic effects on the lung parenchyma , interstitium , and pulmonary vessels that may result in malignancies The aim of this study was to estimate the effect of exposure to secondh and tobacco smoke on the incidence of lung adenocarcinoma in situ/minimally invasive adenocarcinoma ( AIS/MIA ) . Data from seven case – control studies participating in the International Lung Cancer Consortium ( ILCCO ) were pooled , result ing in 625 cases of AIS/MIA and 7,403 controls , of whom 170 cases and 3,035 controls were never smokers . Unconditional logistic regression was used to estimate adjusted ORs ( ORadj ) and 95 % confidence intervals ( CI ) , controlling for age , sex , race , smoking status ( ever/never ) , and pack-years of smoking . Study center was included in the models as a r and om-effects intercept term . Ever versus never exposure to secondh and tobacco smoke was positively associated with AIS/MIA incidence in all subjects ( ORadj = 1.48 ; 95 % CI , 1.14–1.93 ) and in never smokers ( ORadj = 1.45 ; 95 % CI , 1.00–2.12 ) . There was , however , appreciable heterogeneity of ORadj across studies ( P = 0.01 ) , and the pooled estimates were largely influenced by one large study ( 40 % of all cases and 30 % of all controls ) . These findings provide weak evidence for an effect of secondh and tobacco smoke exposure on AIS/MIA incidence . Further studies are needed to assess the impact of secondh and tobacco smoke exposure using the newly recommended classification of subtypes of lung adenocarcinoma . Cancer Epidemiol Biomarkers Prev ; 24(12 ) ; 1902–6 . © 2015 AACR Background : Several countries are discussing new legislation regarding the ban on smoking in public places , based on the growing evidence of the hazards of secondh and smoke ( SHS ) exposure . The objective of the present study is to quantitatively assess the relationship between smoking , SHS , and serum cotinine levels in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) cohort . Methods : From a study on lung cancer in the EPIC cohort , question naire information on smoking was collected at enrolment , and cotinine was measured in serum . Three statistical models were applied by using sample s available in a cross-section design : ( i ) cotinine levels by categories combining smoking and SHS ( n = 859 ) ; ( ii ) the effect of hours of passive smoking exposure in nonsmokers only ( n = 107 ) ; ( iii ) the effect of the number of cigarettes consumed per day in current smokers only ( n = 832 ) . All models were adjusted for country , sex , age , and body mass index . Results : Among nonsmokers , passive smokers presented significant differences in cotinine compared with nonexposed , with a marked ( but not significant ) difference among former-smokers . A one hour per day increment of SHS gave rise to a significant 2.58 nmol/L ( 0.45 ng/mL ) increase in mean serum cotinine ( P < 0.001 ) . In current smokers , a one cigarette per day increment gave rise to a significant 22.44 nmol/L ( 3.95 ng/mL ) increase in cotinine mean ( P < 0.001 ) . Conclusions : There is clear evidence that not only tobacco smoking but also involuntary exposure increases cotinine levels . Impact : This study strengthens the evidence for the benefits of a smoking ban in public places . Cancer Epidemiol Biomarkers Prev ; 20(5 ) ; 869–75 . © 2011 AACR Abstract Objectives To investigate the association between environmental tobacco smoke , plasma cotinine concentration , and respiratory cancer or death . Design Nested case-control study within the European prospect i ve investigation into cancer and nutrition ( EPIC ) . Participants 303 020 people from the EPIC cohort ( total 500 000 ) who had never smoked or who had stopped smoking for at least 10 years , 123 479 of whom provided information on exposure to environmental tobacco smoke . Cases were people who developed respiratory cancers or died from respiratory conditions . Controls were matched for sex , age ( plus or minus 5 years ) , smoking status , country of recruitment , and time elapsed since recruitment . Main outcome measures Newly diagnosed cancer of lung , pharynx , and larynx ; deaths from chronic obstructive pulmonary disease or emphysema . Plasma cotinine concentration was measured in 1574 people . Results Over seven years of follow up , 97 people had newly diagnosed lung cancer , 20 had upper respiratory cancers ( pharynx , larynx ) , and 14 died from chronic obstructive pulmonary disease or emphysema . In the whole cohort exposure to environmental tobacco smoke was associated with increased risks ( hazard ratio 1.30 , 95 % confidence interval 0.87 to 1.95 , for all respiratory diseases ; 1.34 , 0.85 to 2.13 , for lung cancer alone ) . Higher results were found in the nested case-control study ( odds ratio 1.70 , 1.02 to 2.82 , for respiratory diseases ; 1.76 , 0.96 to 3.23 , for lung cancer alone ) . Odds ratios were consistently higher in former smokers than in those who had never smoked ; the association was limited to exposure related to work . Cotinine concentration was clearly associated with self reported exposure ( 3.30 , 2.07 to 5.23 , for detectable/non-detectable cotinine ) , but it was not associated with the risk of respiratory diseases or lung cancer . Frequent exposure to environmental tobacco smoke during childhood was associated with lung cancer in adulthood ( hazard ratio 3.63 , 1.19 to 11.11 , for daily exposure for many hours )
Output:
| Based on the results of this study , ETS might be an important risk factor of female lung cancer in non-smokers |
MS212366 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 : Chronic periodontitis ( CP ) is associated with increased levels of blood reactive oxygen species ( ROS ) . So , treatment of CP may lead to decrease in blood ROS . However , not much literature is available comparing the effect of surgical and non-surgical periodontal treatment on blood ROS levels . Reactive oxygen metabolites ( ROMs ) are a useful measure of blood ROS . The aim of this study was to investigate the effect of periodontal treatment on plasma ROM levels in CP patients . Material s and Methods : Thirty CP patients and 15 controls were monitored . Plasma sample s were collected at baseline and the clinical parameters were recorded . The CP patients were r and omly divided into two groups : Scaling and root planing ( Group II ) and periodontal flap surgery ( Group III ) . Both groups were re-evaluated 1 and 2 months after therapy . Clinical parameters were review ed , plasma sample s collected , and ROM levels were determined using a spectrophotometric technique . Results : At baseline , the ROM levels for Group II and Group III were 519.8 ± 62.4 and 513.4 ± 74.7 CARR U , respectively , which were higher than Group I value ( 282.9 ± 23.9 , P < 0.001 ) . Periodontal treatment in CP patients result ed in improvement of clinical parameters and a highly significant reduction in plasma ROM level ( P < 0.001 ) after 2 months . Also , there was a more significant reduction in plasma ROM levels in Group III as compared to Group II ( P < 0.05 ) . Conclusions : In CP patients , surgical periodontal treatment was more effective in lowering the plasma ROM levels than when non-surgical periodontal treatment was performed alone and , therefore , may be more beneficial in reducing systemic oxidative stress 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 : Plasma glutathione peroxidase ( eGPx ) is an important selenium containing antioxidant in human defense against oxidative stress . While crevicular fluid ( GCF ) eGPx levels and its association with periodontal disease is well documented , there is no data on correlation of GCF and serum eGPx levels in chronic periodontitis . Hence this study was undertaken to further probe into the role of oxidative stress in periodontal diseases and effect of nonsurgical periodontal therapy ( NSPT ) by correlating GCF and serum levels of eGPx . Material s and methods : Thirty subjects ( 16-Males and 14-Females ; age : 30–38 years ) participated in the study . The subjects were divided , based on gingival index , probing pocket depth and clinical attachment level into : Healthy ( group-1 , n=10 ) , Gingivitis ( group-2 , n=10 ) and Periodontitis ( group-3 , n=10 ) . Chronic periodontitis patients after NSPT constituted group 4 . GCF and serum sample s collected from each subject were quantified for eGPx levels using Enzyme linked Immunosorbent Assay . Results : The mean eGPx concentrations increased from health ( 14.01 ng/μl and 78.26 ng/ml ) to gingivitis ( 22.86 ng/μl and 90.44 ng/ml ) and then to periodontitis ( 29.89 ng/μl and 103.43 ng/ml ) , in GCF and serum respectively . After NSPT , there was statistically significant reduction in eGPx concentration in GCF and serum ( 19.41 ng/μl and 85.21 ng/ml ) . Further , all the GCF eGPx values showed a positive correlation to that of serum eGPx level . Conclusion : Thus , increased eGPx concentration in GCF can be considered as an indicator of local increase in oxidative stress . While , increase in serum eGPx levels indicates that periodontal disease can also lead to increased oxidative stress at the systemic level Aim The purpose of this study was to investigate the effects of non-surgical periodontal treatment on hemoglobinA1c ( HbA1c ) levels , oxidative stress balance and quality of life ( QOL ) in patients with type 2 diabetes mellitus ( T2DM ) compared to no periodontal treatment ( simple oral hygiene instructions only ) . Methods The design was a 6-month , single-masked , single center , r and omized clinical trial . Patients had both T2DM and chronic periodontitis . Forty participants were enrolled between April 2014 and March 2016 at the Nephrology , Diabetology and Endocrinology Department of Okayama University Hospital . The periodontal treatment group ( n = 20 ) received non-surgical periodontal therapy , including scaling and root planing plus oral hygiene instructions , and consecutive supportive periodontal therapy at 3 and 6 months . The control group ( n = 17 ) received only oral hygiene instructions without treatment during the experimental period . The primary study outcome was the change in HbA1c levels from baseline to 3 months . Secondary outcomes included changes in oxidative stress balance ( Oxidative-INDEX ) , the Diabetes Therapy-Related QOL and clinical periodontal parameters from baseline to 3 months and baseline to 6 months . Results Changes in HbA1c in the periodontal treatment group were not significantly different with those in the control group at 3 and 6 months . Systemic oxidative stress balance and QOL significantly improved in the periodontal treatment group compared to the control group at 3 months . In the subgroup analysis ( moderately poor control of diabetes ) , the decrease in HbA1c levels in the periodontal treatment group was greater than that in the control group at 3 months but not significant . Conclusions In T2DM patients , non-surgical periodontal treatment improved systemic oxidative stress balance and QOL , but did not decrease HbA1c levels at 3 months follow-up . Trial registration Current Controlled Trials UMIN-ICDR UMIN 000013278 ( Registered April 1 , 2014 ) BACKGROUND This study investigates the levels of superoxide dismutase ( SOD ) activity in serum and saliva of patients with chronic periodontitis ( CP ) . In addition , the outcome of scaling and root planing ( SRP ) with and without vitamin E supplementation is evaluated in terms of changes in periodontal parameters and SOD activity in patients with CP . METHODS Serum and salivary SOD activity in 38 patients with CP were compared with those of 22 systemically and periodontally healthy individuals ( control group ) . At periodontal examination , serum and saliva sample s were obtained . Patients with CP were r and omly divided into treatment groups 1 ( TG-1 ) and 2 ( TG-2 ) . SRP was performed for both groups , and TG-2 also received 200 mg ( 300 IU ) vitamin E every other day . Periodontal parameters and SOD activity were evaluated after 3 months . SOD activity was determined using an SOD assay and enzyme-linked immunosorbent assay reader at 450 nm . RESULTS SOD activity in both serum ( P < 0.05 ) and saliva ( P < 0.001 ) was lower in patients with CP compared with controls . After 3 months of follow-up , SOD activity improved in both treatment groups ; however , the improvement in TG-2 was higher than in TG-1 , along with more improvement in periodontal parameters . Serum SOD levels in TG-2 increased even above the level of the control group . CONCLUSIONS Systemic and local SOD levels are lowered in CP . Adjunctive vitamin E supplementation improves periodontal healing as well as antioxidant defense
Output:
| The most common OxS biomarkers used were 8-hydroxydeoxiguanosine ( 8-OHdG ) , total oxidant status ( TOS ) , and total antioxidant status ( TAS ) .
After treatment , most of the studies reported a decrease in 8-OHdG concentration in the gingival crevicular fluid ( GCF ) and saliva .
In addition , the salivary concentration of this biomarker was similar to periodontally healthy patients .
Periodontal therapy was effective in reducing TOS in GCF , saliva , and serum in most studies .
TAS , however , responded inconsistently to the periodontal intervention .
Periodontal therapy reduces the levels of OxS biomarkers , even to values similar to those found in periodontally healthy individuals . |
MS212367 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background and Purpose — Patients are classically at risk of delayed cerebral ischemia ( DCI ) after aneurysmal subarachnoid hemorrhage . We vali date d a grading scale — the VASO GRADE —for prediction of DCI . Methods — We used data of 3 phase II r and omized clinical trials and a single hospital series to assess the relationship between the VASO GRADE and DCI . The VASO GRADE derived from previously published risk charts and consists of 3 categories : VASO GRADE -Green ( modified Fisher scale 1 or 2 and World Federation of Neurosurgical Societies scale [ WFNS ] 1 or 2 ) ; VASO GRADE -Yellow ( modified Fisher 3 or 4 and WFNS 1–3 ) ; and VASO GRADE -Red ( WFNS 4 or 5 , irrespective of modified Fisher grade ) . The relation between the VASO GRADE and DCI was assessed by logistic regression models . The predictive accuracy of the VASO GRADE was assessed by receiver operating characteristics curve and calibration plots . Results — In a cohort of 746 patients , the VASO GRADE significantly predicted DCI ( P<0.001 ) . The VASO GRADE -Yellow had a tendency for increased risk for DCI ( odds ratio [ OR ] , 1.31 ; 95 % CI , 0.77–2.23 ) when compared with VASO GRADE -Green ; those with VASO GRADE -Red had a 3-fold higher risk of DCI ( OR , 3.19 ; 95 % CI , 2.07–4.50 ) . Studies were not a significant confounding factor between the VASO GRADE and DCI . The VASO GRADE had an adequate discrimination for prediction of DCI ( area under the receiver operating characteristics curve=0.63 ) and good calibration . Conclusions — The VASO GRADE results vali date d previously published risk charts in a large and diverse sample of subarachnoid hemorrhage patients , which allows DCI risk stratification on presentation after subarachnoid hemorrhage . It could help to select patients at high risk of DCI , as well as st and ardize treatment protocol s and research studies Using logistic regression , we analyzed the predictive value of a number of entry variables with respect to the outcome variables delayed cerebral ischemia , rebleeding , and poor outcome ( death or severe disability ) in patients with aneurysmal subarachnoid hemorrhage . The entry variables were clinical condition on admission ( grade s on the Glasgow Coma Scale , Hunt and Hess system ) , the amount of subarachnoid and intraventricular blood and the presence of hydrocephalus on the admission computed tomogram , and antifibrinolytic treatment with tranexamic acid . We used data from a prospect ively studied population of 176 patients admitted within 72 hours after subarachnoid hemorrhage . The risk of delayed cerebral ischemia was best predicted by the amount of subarachnoid blood , intraventricular blood , and antifibrinolytic treatment irrespective of clinical condition and hydrocephalus . The site of delayed cerebral ischemia was not related to the location of the subarachnoid hemorrhage . Antifibrinolytic treatment was the only entry variable ( negatively ) predicting the risk of rebleeding . Death or severe disability after 3 months was best predicted by the amount of subarachnoid blood and the initial clinical condition reflected by the grade on the Glasgow Coma Scale Introduction Subarachnoid hemorrhage ( SAH ) can trigger immune activation sufficient to induce the systemic inflammatory response syndrome ( SIRS ) . This may promote both extra-cerebral organ dysfunction and delayed cerebral ischemia , contributing to worse outcome . We ascertained the frequency and predictors of SIRS after spontaneous SAH , and determined whether degree of early systemic inflammation predicted the occurrence of vasospasm and clinical outcome . Methods Retrospective analysis of prospect ively collected data on 276 consecutive patients admitted to a neurosciences intensive care unit with acute , non-traumatic SAH between 2002 and 2005 . A daily SIRS score was derived by summing the number of variables meeting st and ard criteria ( HR > 90 , RR > 20 , Temperature > 38 ° C , or < 36 ° C , WBC count < 4,000 or > 12,000 ) . SIRS was considered present if two or more criteria were met , while SIRS burden over the first four days was calculated by averaging daily scores . Regression modeling was used to determine the relationship among SIRS burden ( after controlling for confounders including infection , surgery , and corticosteroid use ) , symptomatic vasospasm , and outcome , determined by hospital disposition . Results SIRS was present in over half the patients on admission and developed in 85 % within the first four days . Factors associated with SIRS included poor clinical grade , thick cisternal blood , larger aneurysm size , higher admission blood pressure , and surgery for aneurysm clipping . Higher SIRS burden was independently associated with death or discharge to nursing home ( OR 2.20/point , 95 % CI 1.27–3.81 ) . All of those developing clinical vasospasm had evidence of SIRS , with greater SIRS burden predicting increased risk for delayed ischemic neurological deficits ( OR 1.77/point , 95 % CI 1.12–2.80 ) . Conclusions Systemic inflammatory activation is common after SAH even in the absence of infection ; it is more frequent in those with more severe hemorrhage and in those who undergo surgical clipping . Higher burden of SIRS in the initial four days independently predicts symptomatic vasospasm and is associated with worse outcome OBJECTIVE The aim of this study was to investigate prospect ively in an unselected series of patients with an aneurysmal subarachnoid haemorrhage what at present the complications are , what the outcome is , how many of these patients have “ modern treatment”—that is , early obliteration of the aneurysm and treatment with calcium antagonists — what factors cause a delay in surgical or endovascular treatment , and what the estimated effect on outcome will be of improved treatment . METHODS A prospect i ve , observational cohort study of all patients with aneurysmal subarachnoid haemorrhage in the hospitals of a specified region in The Netherl and s. The condition on admission , diagnostic procedures , and treatments were recorded . If a patient had a clinical deterioration , the change in Glasgow coma score ( GCS ) , the presence of focal neurological signs , the results of additional investigations , and the final diagnosed cause of the deterioration were recorded . Clinical outcome was assessed with the Glasgow outcome scale ( GOS ) at 3 month follow up . In patients with poor outcome at follow up , the cause was diagnosed . RESULTS Of the 110 patients , 47 ( 43 % ) had a poor outcome . Cerebral ischaemia , 31 patients ( 28 % ) , was the most often occurring complication . Major causes of poor outcome were the effects of the initial haemorrhage and rebleeding in 34 % and 30 % of the patients with poor outcome respectively . Of all patients 102 ( 93 % ) were treated with calcium antagonists and 45 ( 41 % ) patients had early treatment to obliterate the aneurysm . The major causes of delay of treatment were a poor condition on admission or deterioration shortly after admission , in 31 % and 23 % respectively . CONCLUSIONS In two thirds of the patients with poor outcome the causes of poor outcome are the effects of the initial bleeding and rebleeding . Improved treatment of delayed or postoperative ischaemia will have only minor effects on the outcome of patients with subarachnoid haemorrhage Background The risk of delayed cerebral ischemia ( DCI ) after subarachnoid hemorrhage ( SAH ) is associated with large cerebral artery vasospasm , but vasospasm is not a strong predictor for DCI . Assessment of cerebral autoregulation with transcranial Doppler ( TCD ) may improve the prediction of DCI . The aim of this prospect i ve study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI . Methods We included consecutive patients with low- grade aneurysmal SAH within 4 days of aneurysm rupture . Cerebral autoregulation was evaluated using the moving correlation coefficient Mx calculated from spontaneous fluctuations of cerebral blood flow velocities and arterial blood pressure . Transcranial color-coded sonography was performed to assess large artery vasospasm . Results Thirty patients ( 19 women and 11 men ; mean age ± SD 44.7 ± 12.1 years ) were included . Twenty ( 66.7 % ) patients had vasospasm . DCI occurred in six ( 20 % ) patients after a median delay of 10 days ( range 8–13 days ) . Cerebral autoregulation was impaired at baseline and at day 7 and then returned to normal at day 14 . Neither cerebral autoregulation impairment nor large artery vasospasm alone was associated with DCI . In contrast , the combination of large artery vasospasm with worsening impairment of cerebral autoregulation from baseline to day 7 was significantly correlated to subsequent DCI ( p = 0.007 ) . Conclusions Early deterioration of cerebral autoregulation was strongly predictive of DCI in patients with large artery vasospasm after low- grade SAH . Our results suggest that consideration to both cerebral blood flow velocities and cerebral autoregulation may improve the prediction of DCI UNLABELLED The Fisher revised scale ( FRS ) presents an alternative for evaluating patients with subarachnoid hemorrhage ( SAH ) . In this study , we compared the prognosis of patients with SAH and vasospasms ( VSP ) . METHOD This was a prospect i ve study on patients with a diagnosis of aneurysmal SAH , 72 hours after the initial event . Sequential neurological examinations and Hunt and Hess ( HaH ) score were performed on the 1(st ) , 7(th ) and 14(th ) days . Transcranial Doppler was used to assess vasospasms . RESULTS Out of the 24 patients studied , ten ( 41.66 % ) presented a delayed neurological deficit , such as diminished consciousness , decreased HaH score or death . The single patient classified as FS-1 did not have any delayed neurological deficit , while such deficits evolved in one patient out of five with FS-2 ( 20 % ) ; two out of seven with FS-3 ( 28.57 % ) and seven out of 11 with FS-4 ( 63.63 % ) . CONCLUSION Level three of the FS and FRS seemed to be compatible with regard to predicting the likelihood of progression to severe VSP Background and Purpose — A single-center prospect i ve r and omized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome . Methods — Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grade s 2 , 3 , 4 , and 3 + 4 were r and omized to either the study group of st and ard therapy plus insertion of a lumbar drain or the control group of st and ard therapy alone . The primary outcome measure was the prevalence of delayed ischemic neurological deficit . Results — Two hundred ten patients with aneurysmal subarachnoid hemorrhage ( 166 female , 44 male ; median age , 54 years ; interquartile range , 45–62 years ) were recruited into the control ( n=105 ) and study ( n=105 ) groups of the trial . World Federation of Neurological Surgeons grade was : 1 ( n=139 ) , 2 ( n=60 ) , and 3 ( n=11 ) ; Fisher grade was : 2 ( n=87 ) , 3 ( n=85 ) , and 4 ( n=38 ) . The prevalence of delayed ischemic neurological deficit was 35.2 % and 21.0 % in the control and study groups , respectively ( P=0.021 ) . The prevalence of a modified Rankin Scale score of 4 , 5 , or 6 at Day 10 and 6 months , respectively , was 62.5 % and 18.6 % in the control group and 44.8 % and 19.8 % in the study group ( P=0.009 and 0.83 , respectively ) . Conclusions — Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage . Clinical Trial Registration — URL : www . clinical trials.gov . Unique identifier : NCT00842049 OBJECTIVE We developed a modification of the Fisher computed tomographic rating scale and compared it with the original Fisher scale to determine which scale best predicts symptomatic vasospasm after subarachnoid hemorrhage . METHODS We analyzed data from 1355 subarachnoid hemorrhage patients in the placebo arm of four r and omized , double-blind , placebo-controlled studies of tirilazad . Modified Fisher computed tomographic grade s were calculated on the basis of the presence of cis
Output:
| Conclusion The Fisher scale , modified Fisher scale , and Hijdra sum score are all associated with clinical DCI .
The risk of DCI , however , does not increase with increasing Fisher grade as opposed to the modified Fisher scale . |
MS212368 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Subjects ( N = 139 ) were assigned to intensive behavioral or to low-contact smoking treatment and to 2-mg nicotine gum or to placebo gum in a 2 X 2 factorial design . The 2-mg gum produced higher abstinence rates than did the placebo . Subjects receiving the low-contact condition plus the 2-mg nicotine gum had excellent abstinence rates at both 26 weeks ( 56 % abstainers ) and 52 weeks ( 50 % abstainers ) . Smokers who scored at the median on a measure of physical dependence to nicotine were more likely to benefit by nicotine gum treatment than subjects who scored either higher or lower , but this relation was nonsignificant . The results of this study are compared with an earlier nonblind trial While sex differences in the nicotine withdrawal ( NW ) symptoms and craving ( NC ) have been extensively described in adult cigarette smokers , few studies have investigated these phenomena in adolescents . We investigated the effect of gender and hormonal contraception ( HC ) on NW and NC during the first 14 days of cessation in adolescent smokers using data from a r and omized , placebo-controlled , double-blind trial of the transdermal nicotine replacement therapy for smoking cessation . Analyses showed similar levels of NW severity in males and females , regardless of HC use . However , significantly higher NC was observed in females compared to males , ( 2.22+/-0.12 vs. 1.65+/-1.14 ; p=0.003 ) . Further , females not using HC reported the highest level of NC ( 2.38+/-0.16 ) followed by females using HC ( 2.08+/-0.25 ) and males ( 1.71+/-0.16 ; p=0.007 ) . The current findings suggest that adolescent females experience similar NW severity to males , but have stronger NC . Further , the use of hormonal contraceptives may impact the severity of craving . Addressing these different symptoms in adolescents may be useful in increasing smoking cessation rates in this special population of smokers BACKGROUND This study was conducted to determine the efficacy of the nicotine patch in smoking cessation when combined with self-help material s , three brief visits , and telephone counseling . METHODS One hundred fifty-nine healthy volunteers who smoked at least one pack of cigarettes per day and desired to quit smoking were enrolled in a double-blind trial with 6-week treatment and 6-month follow-up periods . After review of self-help material s , subjects were r and omly assigned to regimens of nicotine or placebo patches . Subjects wore two patches per day for 4 weeks ( 25 mg of nicotine per 24 hours ) , then one patch per day for 2 weeks . Return visits were at the ends of weeks 4 and 6 . Telephone counseling was given during weeks 1 , 2 , 3 , and 5 . Abstinence at 6 weeks was defined as zero cigarettes smoked for the previous 28 days , verified by exhaled carbon monoxide less than 8 ppm at 4 weeks and 6 weeks . Abstinence at 3 and 6 months was defined as self-report of zero cigarettes since the previous contact , verified by carbon monoxide value at 6 months . RESULTS Abstinence rates at 6 weeks , 3 months , and 6 months were 29.5 % , 21.8 % , and 20.5 % in the active group , and 8.8 % , 3.8 % , and 2.5 % in the placebo group ( P < or = .001 for each comparison ) , respectively . Skin irritation was the main side effect , causing 1.3 % to drop out . CONCLUSION The nicotine patch is efficacious in smoking cessation over a 6-month period , when combined with only self-help material s , three brief visits , and telephone counseling The use of nicotine chewing gum combined with psychological support improves the success rate in stopping smoking . We studied the safety and efficacy of a transdermal nicotine patch in stopping smoking . We conducted a double-blind r and omized study comparing the effect of a 16-hour nicotine patch ( 15 + /- 3.5 mg of nicotine in 16 hours ) with those of a placebo patch . Of the 289 smokers ( 207 women and 82 men ) enrolled in the study , 145 were treated with nicotine patches and 144 with placebo patches for 16 weeks . The rates of sustained abstinence were significantly better with active treatment than with the placebo : 53 , 41 , 24 and 17 % of those in the nicotine-patch group were abstinent after 6 , 12 , 26 , and 52 weeks , respectively , as compared with 17 , 10 , 5 and 4 % of those in the placebo-patch group ( p less than 0.0001 ) . Only two subjects with the nicotine patch and one with the placebo patch withdrew from the study because of side effects . The nicotine skin patch proved to be safe and effective , as demonstrated by a higher rate of abstinence than with the placebo AIMS Of six established nicotine replacement therapy ( NRT ) formulations , only the gum and patch have been tested without specialist clinic support in placebo-controlled trials . We aim ed to broaden the evidence base by examining if the nicotine nasal spray ( NNS ) could be effective with only brief support in general practice . DESIGN R and omized placebo-controlled trial . SETTING Twenty-seven English general practice s. PARTICIPANTS A total of 761 heavy smokers received brief support and 12 weeks of treatment with NNS ( 506 ) or placebo ( 255 ) . MEASUREMENTS The primary outcome was biochemically verified complete abstinence from smoking throughout weeks 3 - 12 . FINDINGS NNS compared with placebo more than doubled the number who successfully stopped smoking [ 15.4 % versus 6.7 % , odds ratio ( OR ) = 2.6 , 95 % confidence interval ( CI ) = 1.5 - 4.4 ] . Many participants reported minor irritant adverse symptoms . NNS was particularly effective among those who were more highly dependent on nicotine ( OR = 6.17 , 95 % CI = 2.13 - 17.9 ) . Of those who failed to stop during the first week ( 417 , 54.8 % ) , only one ( 0.2 % ) achieved later success . CONCLUSIONS NNS is effective when given in primary care . The benefit was lower than in a specialist clinic but similar to that with the nicotine patch in primary care . Unlike most other NRT formulations , bupropion or varenicline , NNS was especially helpful for more dependent smokers . Continuing treatment of those initially failing was not beneficial . An initial 1-week prescription to those more dependent on nicotine is likely to be the most cost-effective NNS treatment protocol . These results should offer support to the effectiveness of the other NRT formulations untested in this setting In a r and omized smoking cessation study 211 , 203 and 82 persons were supported with nicotine , silver acetate and ordinary chewing gum , respectively . After 26 weeks there was no overall difference in number of abstainers between treatments . Participants were divided into subsets with low and high weighted packyears consumption ( WPY ) which modifies tobacco consumption by nicotine content . Abstainer rates in the total population controlled for treatment decreased with increasing WPY ( P<0.005 ) . In participants with low WPY abstainer rate was higher in the silver acetate group compared to the nicotine ( P<0.0005 ) and ordinary ( P<0.05 ) chewing gum groups . Nicotine chewing gum was more effective than silver acetate ( P<0.05 ) and ordinary ( P<0.05 ) chewing gum in smokers with high WPY . Ratings on some inconveniences experienced during earlier attempts to quit smoking influenced the ability to break the habit but had no influence on chewing gum effects . This study indicated that through consideration of smoking history it should be possible to individualize pharmacological support to smokers wanting to quit , with silver acetate chewing gum most effective for smokers with a low WPY and nicotine chewing gum most effective for smokers with a high WPY BACKGROUND Substantial concerns have been raised about the neuropsychiatric safety of the smoking cessation medications varenicline and bupropion . Their efficacy relative to nicotine patch largely relies on indirect comparisons , and there is limited information on safety and efficacy in smokers with psychiatric disorders . We compared the relative neuropsychiatric safety risk and efficacy of varenicline and bupropion with nicotine patch and placebo in smokers with and without psychiatric disorders . METHODS We did a r and omised , double-blind , triple-dummy , placebo-controlled and active-controlled ( nicotine patch ; 21 mg per day with taper ) trial of varenicline ( 1 mg twice a day ) and bupropion ( 150 mg twice a day ) for 12 weeks with 12-week non-treatment follow-up done at 140 centres ( clinical trial centres , academic centres , and outpatient clinics ) in 16 countries between Nov 30 , 2011 , and Jan 13 , 2015 . Participants were motivated-to-quit smokers with and without psychiatric disorders who received brief cessation counselling at each visit . R and omisation was computer generated ( 1:1:1:1 ratio ) . Participants , investigators , and research personnel were masked to treatment assignments . The primary endpoint was the incidence of a composite measure of moderate and severe neuropsychiatric adverse events . The main efficacy endpoint was biochemically confirmed continuous abstinence for weeks 9 - 12 . All participants r and omly assigned were included in the efficacy analysis and those who received treatment were included in the safety analysis . The trial is registered at Clinical Trials.gov ( number NCT01456936 ) and is now closed . FINDINGS 8144 participants were r and omly assigned , 4116 to the psychiatric cohort ( 4074 included in the safety analysis ) and 4028 to the non-psychiatric cohort ( 3984 included in the safety analysis ) . In the non-psychiatric cohort , 13 ( 1·3 % ) of 990 participants reported moderate and severe neuropsychiatric adverse events in the varenicline group , 22 ( 2·2 % ) of 989 in the bupropion group , 25 ( 2·5 % ) of 1006 in the nicotine patch group , and 24 ( 2·4 % ) of 999 in the placebo group . The varenicline-placebo and bupropion-placebo risk differences ( RDs ) for moderate and severe neuropsychiatric adverse events were -1·28 ( 95 % CI -2·40 to -0·15 ) and -0·08 ( -1·37 to 1·21 ) , respectively ; the RDs for comparisons with nicotine patch were -1·07 ( -2·21 to 0·08 ) and 0·13 ( -1·19 to 1·45 ) , respectively . In the psychiatric cohort , moderate and severe neuropsychiatric adverse events were reported in 67 ( 6·5 % ) of 1026 participants in the varenicline group , 68 ( 6·7 % ) of 1017 in the bupropion group , 53 ( 5·2 % ) of 1016 in the nicotine patch group , and 50 ( 4·9 % ) of 1015 in the placebo group . The varenicline-placebo and bupropion-placebo RDs were 1·59 ( 95 % CI -0·42 to 3·59 ) and 1·78 ( -0·24 to 3·81 ) , respectively ; the RDs versus nicotine patch were 1·22 ( -0·81 to 3·25 ) and 1·42 ( -0·63 to 3·46 ) , respectively . Varenicline-treated participants achieved higher abstinence rates than those on placebo ( odds ratio [ OR ] 3·61 , 95 % CI 3·07 to 4·24 ) , nicotine patch ( 1·68 , 1·46 to 1·93 ) , and bupropion ( 1·75 , 1·52 to 2·01 ) . Those on bupropion and nicotine patch achieved higher abstinence rates than those on placebo ( OR 2·07 [ 1·75 to 2·45 ] and 2·15 [ 1·82 to 2·54 ] , respectively ) . Across cohorts , the most frequent adverse events by treatment group were nausea ( varenicline , 25 % [ 511 of 2016 participants ] ) , insomnia ( bupropion , 12 % [ 245 of 2006 participants ] ) , abnormal dreams ( nicotine patch , 12 % [ 251 of 2022 participants ] ) , and headache ( placebo , 10 % [ 199 of 2014 participants ] ) . Efficacy treatment comparison did not differ by cohort . INTERPRETATION The study did not show a significant increase in neuropsychiatric adverse events attributable to varenicline or bupropion relative to nicotine patch or placebo . Varenicline was
Output:
| There is high- quality evidence that all of the licensed forms of NRT ( gum , transdermal patch , nasal spray , inhalator and sublingual tablets/lozenges ) can help people who make a quit attempt to increase their chances of successfully stopping smoking .
NRTs increase the rate of quitting by 50 % to 60 % , regardless of setting , and further research is very unlikely to change our confidence in the estimate of the effect .
The relative effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual .
Provision of more intense levels of support , although beneficial in facilitating the likelihood of quitting , is not essential to the success of NRT .
NRT often causes minor irritation of the site through which it is administered , and in rare cases can cause non-ischaemic chest pain and palpitations |
MS212369 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Acquired immunodeficiency syndrome ( AIDS ) continues to be a significant concern for adolescents , especially in minority population s. There is a scarcity of knowledge of the cultural context of sexual behavior in this age group and the influences that lead to early initiation of sex and unsafe sex . Few efforts targeting young adolescents have been community based , although there has been an increased awareness of the need for such research and intervention programs . Four key processes have been defined in gaining community participation in health education programs : ( a ) defining the community and reaching the community ; ( b ) recognizing tensions among service , research , and community participation ; ( c ) involving community residents ; and ( d ) considering cultural differences in a community . These processes are used to describe the " Focus on Kids " project , a human immunodeficiency virus ( HIV ) risk reduction intervention that result ed in significant increases in condom use demonstrated by a r and omized controlled trial 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 To test the efficacy of a prevention intervention to reduce sexual risk behavior among Latino adolescents . DESIGN R and omized controlled trial from April 2000 through March 2003 , with data collection before and after intervention and at 3 , 6 , and 12 months . SETTING Northeast Philadelphia schools . PARTICIPANTS Latinos aged 13 through 18 years ( 249 males and 304 females ) ; 81.6 % retained at 12-month follow-up . INTERVENTIONS The HIV and health-promotion control interventions consisted of six 50-minute modules delivered by adult facilitators to small , mixed-gender groups in English or Spanish . Main Outcome Measure Self-reported sexual behavior . RESULTS Analyses using generalized estimation equations over the follow-up period revealed that adolescents in the HIV intervention were less likely to report sexual intercourse ( odds ratio , 0.66 ; 95 % confidence interval [ CI ] , 0.46 - 0.96 ) , multiple partners ( odds ratio , 0.53 ; 95 % CI , 0.31 - 0.90 ) , and days of unprotected intercourse ( relative risk , 0.47 ; 95 % CI , 0.26 - 0.84 ) and more likely to report using condoms consistently ( odds ratio , 1.91 ; 95 % CI , 1.24 - 2.93 ) . Baseline sexual experience and language use moderated intervention efficacy . Adolescents assigned to the HIV intervention who were sexually inexperienced at baseline reported fewer days of unprotected sex ( relative risk , 0.22 ; 95 % CI , 0.08 - 0.63 ) ; Spanish speakers were more likely to have used a condom at last intercourse ( odds ratio , 4.73 ; 95 % CI , 1.72 - 12.97 ) and had a greater proportion of protected sex ( mean difference , 0.35 ; P<.01 ) compared with similar adolescents in the health-promotion intervention . CONCLUSION Results provide evidence for the efficacy of HIV intervention in decreasing sexual activity and increasing condom use among Latino adolescents The aim of this project was to conduct an initial evaluation among sexually transmitted disease ( STD ) patients of the psychometric properties of two instruments : the National Institute of Mental Health ( NIMH ) multisite condom use self-efficacy scale and the NIMH multisite condom use outcome expectancy scale . The condom use self-efficacy scale was design ed to measure one 's degree of confidence in various aspects of condom use , whereas the outcome expectancy scale was design ed to measure one 's belief about the consequences of using condoms . Using a sample of 641 patients from five geographically diverse STD clinics in the eastern United States , initial reliability coefficients were computed . The alpha coefficient for the self-efficacy scale was .91 and for the outcome expectancy scale .88 , indicating high internal consistency for both scales . Both scales were analyzed using common factor analytic procedures . Five factors emerged from the analysis of the self-efficacy scale and six factors from the analysis of the outcome expectancy scale . Reliability coefficients for the individual factors ranged from .76 to .86 . Construct validity of each scale was assessed by hypothesis testing . As predicted , participants with higher levels of self-efficacy and more positive outcome expectancies were more likely to use condoms A series of interactive videodisc programs design ed to reduce HIV/STD risk behaviors was developed and evaluated . Separate programs were developed for each of three race/ethnicities ( African American , Hispanic , and Caucasian ) at each of two age levels ( middle school and high school ) using extensive formative procedures . Each program uses scenarios with extensive branching story lines to teach decision-making skills and socially appropriate responses to potentially risky sexual situations . In a r and omized experiment with 827 students , significant changes were observed at posttest for the four constructs assessed : ( 1 ) belief that sex occurs as a result of decisions ( vs. " it just happens " ) , ( 2 ) belief that even a single incident of unprotected sex can result in an STD or pregnancy , ( 3 ) intentions and attitudes toward use of condoms , and ( 4 ) self-efficacy in remaining abstinent ( i.e. , avoiding sex ) . At 30-day follow-up , three of the four measures remained significant OBJECTIVE To determine whether the addition of a parental monitoring intervention ( Informed Parents and Children Together [ ImPACT ] ) alone or with " boosters " could enhance ( either broaden or sustain or both ) the effect of a small group , face-to-face adolescent risk reduction intervention Focus on Kids ( FOK ) . METHODS A longitudinal , r and omized , community-based cohort study was conducted of 35 low-income , community-based , in-town setting s. A total of 817 black youths aged 12 to 16 years at baseline were studied . After completion of baseline measures , youths were r and omized to receive a face-to-face intervention alone ( FOK only ) , a face-to-face intervention and a parental monitoring intervention ( FOK plus ImPACT ) , or both of the above plus boosters ( FOK plus ImPACT plus boosters ) . Risk and protective behaviors were assessed at 6 and 12 months after intervention . RESULTS At 6 months ' follow-up , youths in families that were assigned to FOK plus ImPACT reported significantly lower rates of sexual intercourse , sex without a condom , alcohol use , and cigarette use and marginally lower rates of " risky sexual behavior " compared with youths in families that were assigned to FOK only . At 12 months after intervention , rates of alcohol and marijuana use were significantly lower and cigarette use and overall risk intention were marginally lower among FOK plus ImPACT youths compared with FOK only youths . With regard to the boosters delivered at 7 and 10 months , 2 risk behaviors -- use of crack/cocaine and drug selling -- were significantly lower among the youths who were assigned to receive the additional boosters compared with youths without the boosters . The rates of the other risk behaviors and intentions did not differ significantly . CONCLUSIONS The results of this r and omized , controlled trial indicate that the inclusion of a parental monitoring intervention affords additional protection from involvement in adolescent risk behaviors 6 and 12 months later compared with the provision of an intervention that targets adolescents only . At the same time , the results of the present study do not provide sufficient evidence that booster sessions further improve targeted behaviors enough to include them in a combined parent and youth intervention Few studies have tested schoolwide interventions to reduce sexual risk behavior , and none have demonstrated significant schoolwide effects . This study evaluates the schoolwide effects of Safer Choices , a multicomponent , behavioral theory – based HIV , STD , and pregnancy prevention program , on risk behavior , school climate , and psychosocial variables . Twenty urban high schools were r and omized , and cross-sectional sample s of classes were surveyed at baseline , the end of intervention ( 19 months after baseline ) , and 31 months after baseline . At 19 months , the program had a positive effect on the frequency of sex without a condom . At 31 months , students in Safer Choices schools reported having sexual intercourse without a condom with fewer partners . The program positively affected psychosocial variables and school climate for HIV/STD and pregnancy prevention . The program did not influence the prevalence of recent sexual intercourse . Schoolwide changes in condom use demonstrated that a school-based program can reduce the sexual risk behavior of adolescents BACKGROUND Although numerous interventions have been demonstrated to reduce targeted adolescent risk behaviors for brief periods , sustained behavior changes covering multiple risk behaviors have been elusive . OBJECTIVE To determine whether a parental monitoring intervention ( Informed Parents and Children Together [ ImPACT ] ) with and without boosters can further reduce adolescent truancy , substance abuse , and sexual risk behaviors and can alter related perceptions 24 months after intervention among youth who have all received an adolescent risk-reduction intervention , Focus on Kids ( FOK ) . DESIGN R and omized , controlled , 3-celled longitudinal trial . SETTING Thirty-five low-income , urban community sites . PARTICIPANTS Eight hundred seventeen African American youth aged 13 to 16 at baseline . Intervention All youth participated in FOK , an 8-session , theory-based , small group , face-to-face risk-reduction intervention , 496 youth and parents received the 1-session ImPACT intervention ( a videotape and discussion ) , 238 of the ImPACT youth also received four 90-minute FOK boosters delivered in small groups . MAIN OUTCOME MEASURES Responses at baseline and 24 months after intervention to a question naire assessing risk and protective behaviors and perceptions . Analyses used General Linear Modeling , intraclass correlation coefficient , analysis of covariance , and multiple comparisons with least significant difference test adjustment . RESULTS After adjusting for the intraclass correlation coefficient , 6 of 16 risk behaviors were significantly reduced ( P < or = .05 ) among youth receiving ImPACT compared with youth who only received FOK ( respectively , mean number of days suspended , 0.65 vs 1.17 ; carry a bat as a weapon , 4.1 % vs 9.6 % ; smoked cigarettes , 12.5 % vs 22.7 % ; used marijuana , 18.3 % vs 26.8 % ; used other illicit drugs , 1.4 % vs 5.6 % ; and , asked sexual partner if condom always used , 77.9 % vs 64.9 % ) . Four of the 7 theory-based subscales reflected significant protective changes among youth who received ImPACT . ImPACT did not produce any significant adverse effects on behaviors or perceptions . CONCLUSION A parent monitoring intervention can significantly broaden and sustain protection beyond that conferred through an adolescent risk-reduction intervention PURPOSE To identify correlates of sexual risk variations among African-American adolescents , and to examine the influence of prior sexual experience on response to a HIV risk-reduction intervention . METHODS Eight hundred seventeen African-American youth aged 13 to 16 years living in and around urban public housing in Baltimore were recruited to participate in a HIV risk-reduction intervention targeting multiple risk behaviors . An instrument design ed to measure three levels of sexual risk ( " abstinent , " " protected sex " [ having sex with a condom ] , and " unprotected sex " [ having sex without a condom ] ) was administered at baseline , 6 months and 12 months postintervention . Multiple regression analyses were conducted to identify predictors of the degree of sexual risk using longitudinal data . Repeated measure analyses were conducted to assess behavioral changes over time among the three groups . RESULTS Data confirmed the co-variation of sexual risk behavior and other problem behaviors among adolescents , cross-sectionally and longitudinally . After exposure to an 8-session risk-reduction intervention , youth engaging in the highest degree of sexual risk demonstrated the greatest reduction in both sexual risk and other risks . These improvements were seen at both 6 months and 12 months postintervention . Youth who were abstinent at baseline maintained the lowest levels in risk involvement throughout the study period when compared with sexually active youth . However , abstinent youth risk involvement significantly increased at 6 months and 12 months after baseline . Youth engaging in protected sex at baseline demonstrated a significant increase in non-condom use and a significant decrease in multiple risk involvement over time . CONCLUSIONS Results support HIV risk-reduction intervention efforts that target multiple risk behaviors . Response of adolescents to the intervention is directly related to the sexual risk behavior at baseline . These data may suggest that the response to risk behavior intervention depends in part on the risk behavior profile of the population to which it is being applied The effect
Output:
| Results showed no evidence that abstinence-plus programs can affect self-reported sexually transmitted infection ( STI ) incidence , and limited evidence that programs can reduce self-reported pregnancy incidence .
Consistently favorable program effects were found for HIV knowledge .
No adverse effects were observed .
Many abstinence-plus programs appear to reduce short-term and long-term HIV risk behavior among youth in high-income countries .
Evidence for program effects on biological measures is limited .
Evaluations consistently show no adverse program effects for any outcomes , including the incidence and frequency of sexual activity . |
MS212370 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: This study examined the role of a Medication Event Monitoring System ( MEMS ) to assess pill-taking behavior and enhance compliance within a r and omized trial of bupropion-SR for smoking cessation . Female participants ( N = 97 ) received MEMS bottles containing bupropion-SR 150 mg or placebo , to be taken twice daily . A r and omly selected “ feedback ” group of participants was told about the recording device in the bottle cap and received weekly graphic feedback showing their pill-taking behavior with specific instructions for improving compliance . A “ no-feedback ” group was not informed about the MEMS bottles , and did not receive further instruction or feedback beyond the st and ard dosing instructions . Compliance outcomes were the total doses taken and number of doses taken within the prescribed time interval . Results indicated significantly higher compliance over time for the feedback group . Participation in the feedback group predicted higher compliance beyond demographic , smoking , and health belief variables , suggesting significant benefit in providing brief feedback and instruction throughout the medication regimen Medication noncompliance with smoking cessation pharmacotherapies is a significant problem in both research and clinical setting s. This r and omized , controlled , single-blind study compared three single-session psychological interventions to increase use of nicotine gum during a 15-day treatment period . A total of 97 adult smokers were r and omized to receive st and ard treatment ( ST , n = 31 ) , brief feedback ( BF , n = 32 ) plus ST , or contingency management ( CM ; i.e. , payment for chewing at least 12 pieces/day on 10 of 15 intervention days , n = 34 ) plus ST and BF . Only the CM condition led to significantly greater average daily gum use ( pieces/day : ST , 6.17 ; BF , 7.81 ; CM , 10.17 [ p values < .05 ] ) and higher rates of compliance ( ST , 13.6 % ; BF , 25.2 % ; CM , 65.6 % [ p values < .001 ] ) . No differences were observed in smoking abstinence , nicotine withdrawal , or urinary cotinine as a function of treatment . Implication s of the present findings are discussed , including application to clinical trials and extension to real-world use of nicotine gum INTRODUCTION Varenicline , a first-line non-nicotine medication , has not been evaluated in Black smokers , and limited attention has been paid to pharmacotherapy adherence in smoking cessation trials . This pilot study estimated quit rates for Black smokers treated with varenicline and tested a behavioral intervention to aid varenicline adherence . METHODS Seventy-two Black smokers ( > 10 cigarettes per day ; cpd ) were r and omly assigned to adherence support ( AS ; n = 36 ) or st and ard care ( n = 36 ) . All participants received 3 months of varenicline and a single counseling session focused on making a quit plan . AS participants received 5 additional counseling sessions to encourage medication use . Outcome measures included salivary cotinine , and carbon monoxide confirmed smoking abstinence , reductions in self-reported cpd , and pill counts of varenicline adherence at Months 1 , 2 , and 3 . RESULTS Sixty-one participants ( 84.7 % ) completed follow-up at Month 3 . Participants were female ( 62.5 % ) , 46.8 years of age , and smoked 16.3 cpd . No treatment group differences were found on the smoking or adherence outcome measures ( p > .05 ) . Collapsing across treatment , varenicline adherence was adequate ( 86.1 % ) , yet despite a reduction of 12.2 ( 6.5 ) cpd from baseline to Month 3 ( p < 0.001 ) , only 23.6 % were confirmed quit at Month 3 . Participants who were quit at Month 3 had higher varenicline adherence rates ( 95.8 % ) than those who continued to smoke ( 80.8 % , p ≤ .05 ) . CONCLUSIONS Studies are needed to examine the efficacy of varenicline among Black smokers . Interventions to facilitate adherence to pharmacotherapy warrant further attention as adherence is linked to improved tobacco abstinence Nicotine replacement therapy is an effective intervention for smoking cessation , but adherence tends to be low . This article presents results from a pilot evaluation of a brief smoking cessation treatment to improve adherence to the nicotine patch among Latino smokers living with HIV/AIDS . Forty smokers were r and omized to receive either a st and ard 5 As counseling session and 8-week treatment of nicotine patch , or a similar intervention that added a 10-min module to the 5 As counseling that focused on improving adherence to the nicotine patch . Smoking outcomes ( breath carbon monoxide monitoring verified 7-day point prevalence and continuous abstinence ) were evaluated through a 3-month follow-up . Patch usage during the follow-up period was also assessed . Intention to treat analyses indicated that abstinence rates were 2 to 3 times higher in the adherence condition compared with the st and ard condition ( 7-day point prevalence abstinence : 35.0 % vs. 15.0 % ; continuous abstinence : 30.0 % vs. 10.0 % ) . Nicotine patch compliance over an 8-week period was also higher in the adherence condition than in the st and ard condition ( 44 % vs. 25 % ) . Although this small pilot was conducted to estimate effect sizes and was not powered to detect group differences , results are promising and suggest that adding a 10-min module focused on nicotine patch adherence to a st and ard 5 As protocol can increase abstinence rates . Given that this smoking cessation treatment was not specifically tailored to either HIV-positive smokers or Latino smokers , future research should examine whether it may be a promising approach for improving nicotine patch adherence in the general population of smokers Smoking represents an important health risk for people living with HIV ( PLHIV ) . Low adherence to smoking cessation pharmacotherapy may limit treatment effectiveness . In this study , 158 participants recruited from three HIV care centers in New York City were r and omized to receive 12-weeks of varenicline ( Chantix ) either alone as st and ard care ( SC ) or in combination with text message ( TM ) support or TM plus cell phone-delivered adherence-focused motivational and behavioral therapy ( ABT ) . Generalized linear mixed-effect models found a significant decline in varenicline adherence from week 1–12 across treatment groups . At 12-weeks , the probability of smoking abstinence was significantly higher in SC+TM+ABT than in SC . The study demonstrates the feasibility of delivering adherence-focused interventions to PLHIV who smoke . Findings suggest intensive behavioral support is an important component of an effective smoking cessation intervention for this population , and a focus on improving adherence self-efficacy may lead to more consistent adherence and higher smoking abstinence AIMS To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention . DESIGN Two-arm r and omized control trial ( RCT ) . Setting World Wide Web ( WWW ) study based in Norway . PARTICIPANTS Subjects ( n = 396 ) were recruited via internet advertisements and assigned r and omly to conditions . Inclusion criteria were willingness to quit smoking and being aged 18 years or older . INTERVENTION The treatment group received the internet- and cell-phone-based Happy Ending intervention . The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail , web-pages , interactive voice response ( IVR ) and short message service ( SMS ) technology . The control group received a self-help booklet . Additionally , both groups were offered free nicotine replacement therapy ( NRT ) . MEASUREMENTS Abstinence was defined as ' not even a puff of smoke , for the last 7 days ' , and assessed by means of internet surveys or telephone interviews . The main outcome was repeated point abstinence at 1 , 3 , 6 and 12 months following cessation . FINDINGS Participants in the treatment group reported clinical ly and statistically significantly higher repeated point abstinence rates than control participants [ 22.3 % versus 13.1 % ; odds ratio ( OR ) = 1.91 , 95 % confidence interval ( CI ) : 1.12 - 3.26 , P = 0.02 ; intent-to-treat ) . Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group . CONCLUSIONS As the first RCT documenting the long-term treatment effects of such an intervention , this study adds to the promise of digital media in supporting behaviour change Background The behavioural impact of pharmacogenomics is untested ; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication . The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy ( NRT ) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis . Hypotheses to be tested are as follows : IAdherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA ( genotype ) , compared to one tailored to nicotine dependence question naire score (phenotype).II Amongst smokers who fail to quit at six months , motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype . Methods / Design An open label , parallel groups r and omised trial in which 630 adult smokers ( smoking 10 or more cigarettes daily ) using National Health Service ( NHS ) stop smoking services in primary care are r and omly allocated to one of two groups : i . NRT oral dose tailored by DNA analysis ( OPRM1 gene ) ( genotype ) , orii . NRT oral dose tailored by nicotine dependence question naire score (phenotype)The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt , with the secondary outcome being motivation to make another quit attempt , amongst smokers not abstinent at six months . Other outcomes include adherence to NRT in the first seven days and biochemically vali date d smoking abstinence at six months . The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5 % difference in mean proportion of NRT consumed using a two-tailed test at the 5 % level of significance between groups . The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent sample s t-test and by estimating the 95 % confidence interval for observed between-arm difference in mean NRT consumption ( Hypothesis I ) . Motivation to make another quit attempt will be compared between arms in those failing to quit by six months ( Hypothesis II ) . Discussion This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information . Specific issues regarding the choice of design for trials of interventions of this kind are discussed . Trial detailsFunder : Medical Research Council (MRC)Grant number : G0500274IS RCT N : 14352545 Date trial stated : June 2007Expected end date : December 2009Expected reporting date : December INTRODUCTION Nicotine replacement therapy ( NRT ) medications have been shown to be effective in increasing smoking cessation rates . There is , however , a lack of good evidence describing how individuals in primary care use these medications and which factors are likely to affect this . The study objectives are to describe adherence and consumption , examine key factors that may determine use , and examine the relationship between consumption of NRT and abstinence from smoking . METHODS Secondary analysis of data from a r and omized controlled trial conducted in smoking cessation services in primary care . Adult smokers ( n = 633 ) starting a quit attempt within smoking cessation clinics were followed for 6 months , with NRT use closely monitored for an initial treatment period of 4 weeks . The main outcomes were 4-week adherence to prescribed NRT , mean daily consumption of NRT over the 4-week period , and abstinence from smoking at 4 weeks . RESULTS Levels of adherence to prescribed NRT were high : more than 94 % in participants who completed the treatment period . After controlling for possible confounders , prescribing higher doses of patch and oral NRT was associated with higher mean daily consumption of NRT . Using an inhalator to deliver oral NRT was associated with both higher adherence and higher consumption . The amount of NRT consumed predicted future abstinence when reverse causation was accounted for . CONCLUSIONS Most individuals within a clinical trial in primary care who persisted with a quit attempt adhered closely to their prescription . Prescribing higher doses of NRT led to higher consumption and higher consumption to higher abstinence INTRODUCTION There is increasing evidence that response to pharmacological treatment for nicotine dependence may be moderated by genetic polymorphisms . However , the feasibility , acceptability , and impact of genetically tailoring treatment in real-world clinical setting s are unknown . METHODS We conducted a multiphased , mixed- methods feasibility study with current smokers to develop and evaluate a patient-centered , theoretically grounded personalized medicine treatment protocol . The initial research phase included formative work to develop intervention material s. The second phase included a r and omized pilot trial to evaluate the intervention . Trial participants ( n = 36 ) were genotyped for ANKK1 rs180
Output:
| There was evidence that adherence interventions led to modest improvements in rates of cessation .
There was no evidence that interventions to increase adherence to medication led to any adverse events .
There is some evidence that such interventions improve the chances of achieving abstinence but again the evidence for this is relatively weak |
MS212371 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: INTRODUCTION AND OBJECTIVES It has been clearly demonstrated that abciximab is useful in percutaneous coronary interventions . However , it is not known if intracoronary administration of the initial abciximab bolus improves outcome . Moreover , there may be safety concerns . METHODS The study was a single-center prospect i ve r and omized trial that included all patients undergoing coronary angioplasty involving the use of abciximab . Patients were r and omized to either intracoronary or intravenous administration of the abciximab bolus . The primary endpoint was the incidence of major adverse cardiac events ( i.e. , death , myocardial infa rct ion , or the need for revascularization ) ; secondary endpoints were hemorrhagic complications and the troponin-I level . RESULTS The study included 137 patients ; 72 received an intracoronary abciximab bolus and 65 , an intravenous bolus . Clinical characteristics and baseline angiographic findings were similar in the two groups . All patients underwent coronary stent implantation . No difference was observed between the intracoronary bolus group and the intravenous bolus group in type of stent used ( drug eluting stent 47.2 % vs 50.8 % , respectively ) , total stent length , or final TIMI flow grade ( 3 vs 2.97 , respectively ) . The intervention success rates were also similar ( 98.5 % vs. 99 % , respectively ) . No complication associated with the administration route was reported . However , the level of the myocardial injury marker troponin I increased significantly in the intravenous bolus group . Clinical follow-up at 1 year did not reveal any difference in the incidence of major adverse cardiac events : 8.5 % in the intracoronary bolus group versus 6.2 % in the intravenous bolus group . CONCLUSIONS Intracoronary administration of an abciximab bolus did not appear to be less safe or effective than intravenous administration . Less post-procedural myocardial damage was observed in the intracoronary bolus group Background — Abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infa rct ion undergoing primary percutaneous coronary intervention ( PCI ) . Intracoronary abciximab bolus application results in high local drug concentrations and may be more effective than a st and ard intravenous bolus . Methods and Results — Patients undergoing primary PCI were r and omized to either intracoronary ( n=77 ) or intravenous ( n=77 ) bolus abciximab administration with subsequent 12-hour intravenous infusion . The primary end point was infa rct size and extent of microvascular obstruction as assessed by delayed enhancement magnetic resonance . Secondary end points were ST-segment resolution at 90 minutes , Thrombolysis in Myocardial Infa rct ion flow and perfusion grade s after PCI , and the occurrence of major adverse cardiac events within 30 days . The median infa rct size was 15.1 % ( interquartile range , 6.1 % to 25.2 % ) in the intracoronary versus 23.4 % ( interquartile range , 13.6 % to 33.2 % ) in the intravenous group ( P=0.01 ) . Similarly , the extent of microvascular obstruction was significantly smaller in intracoronary compared with intravenous abciximab patients ( P=0.01 ) . Myocardial perfusion measured as early ST-segment resolution was significantly improved in intracoronary patients with an absolute ST-segment resolution of 77.8 % ( interquartile range , 66.7 % to 100.0 % ) versus 70.0 % ( interquartile range , 45.2 % to 83.5 % ; P=0.006 ) . The Thrombolysis in Myocardial Infa rct ion flow after PCI was not different between treatment groups ( P=0.51 ) , but there was a trend toward an improved perfusion grade ( P=0.09 ) . There also was a trend toward a lower major adverse cardiac event rate after intracoronary versus intravenous abciximab application ( 5.2 % versus 15.6 % ; P=0.06 ; relative risk , 0.33 ; 95 % CI , 0.09 to 1.05 ) . Conclusions — Intracoronary bolus administration of abciximab in primary PCI is superior to st and ard intravenous treatment with respect to infa rct size , extent of microvascular obstruction , and perfusion Background —In patients with acute myocardial infa rct ion or unstable angina undergoing coronary angioplasty , abciximab reduces major adverse cardiac events ( MACE ) . Clinical trials have studied intravenous administration only . Intracoronary bolus application of abciximab causes very high local drug concentrations and may be more effective . We studied whether intracoronary bolus administration of abciximab is associated with a reduced MACE rate compared with the st and ard intravenous bolus application . Methods and Results —We stratified 403 consecutive patients with acute myocardial infa rct ion or unstable angina undergoing coronary angioplasty according to the type of application of abciximab . A 20-mg bolus of abciximab was given intravenously in 109 patients and intracoronarily in 294 patients . There were no differences between the groups with regard to diabetes mellitus , cardiogenic shock , successful intervention , or preprocedural and postprocedural TIMI flow . At 30 days , the incidence of MACE ( death , myocardial infa rct ion , urgent revascularization ) was significantly lower in the patients with intracoronary compared with intravenous administration of abciximab ( 10.2 % versus 20.2%;P < 0.008 ) , which was independent from stenting in multivariate analysis . The effect was most pronounced in patients with preprocedural TIMI 0/1 flow ( MACE : intracoronary 11.8 % versus intravenous 27.5 % , P < 0.002 ; n=273 ) . Conclusions —In patients with acute myocardial infa rct ion or unstable angina undergoing emergency coronary angioplasty , intracoronary bolus application of abciximab is associated with a reduction of MACE compared with the st and ard intravenous bolus application of abciximab . Prospect i ve , r and omized trials are warranted to further assess intracoronary application of abciximab BACKGROUND Thrombosis has been implicated as central to the clinical complications of coronary angioplasty ( PTCA ) . Chimeric monoclonal 7E3 Fab ( c7E3 Fab ) is the first of a new class of antiplatelet drugs directed at the platelet glycoprotein IIb/IIIa integrin . This study was performed to determine the pharmacodynamics of c7E3 Fab administration during PTCA and to gain an initial clinical experience with this novel agent . METHODS AND RESULTS The study was a multicenter , open-label , dose-escalation study conducted in two stages . Enrollment included 56 patients scheduled for elective PTCA who were estimated to be at moderate to high risk of sustaining ischemic complications . All patients were given aspirin and heparin . The study drug was given at least 10 minutes before PTCA . In stage 1 , increasing bolus doses of c7E3 Fab were given to 15 patients ; a bolus dose of 0.25 mg/kg was found to result in blockade of > 80 % of the receptors and reduce platelet aggregation to < 20 % compared with baseline , establishing this dose as that necessary to sufficiently suppress platelet activity . In stage 2 , additional c7E3 Fab was administered by continuous infusion to 32 patients for progressively longer periods of time ( up to 24 hours ) to confirm that platelet inhibition could be maintained with prolonged drug infusion . Also , 9 patients otherwise meeting entry criteria were given placebo . There were no thrombotic events among patients receiving c7E3 Fab . Overall procedural and clinical success and complication rates as well as rates of bleeding were statistically similar among groups . However , minor bleeding was more frequent with administration of the active drug . CONCLUSIONS The novel antiplatelet agent c7E3 Fab can be administered during PTCA in combination with aspirin and heparin . Suppression of platelet activity is dose dependent and can be maintained for up to 24 hours . Further evaluation will be required to determine the extent of improvement in ischemic complication and restenosis rates and to provide additional insight into the safety profile of this potent monoclonal platelet antibody Background —Trials of platelet glycoprotein IIb/IIIa inhibitors as adjuncts to primary percutaneous coronary intervention for acute myocardial infa rct ion ( MI ) have shown improved early clinical and angiographic outcomes with treatment . However , variations in trial design s , modest sample sizes , and limited long-term follow-up have precluded these studies from being definitive . Methods and Results —As a prespecified secondary analysis of the CADILLAC trial , we compared early and late outcomes by abciximab assignment among 2082 patients r and omized in an open-label , 2 × 2 factorial- design trial of primary stenting versus angioplasty and abciximab treatment ( n=1052 ) versus no abciximab treatment ( n=1030 ) . Baseline characteristics were balanced between groups . Abciximab treatment was associated with a significant reduction in the composite end point of death , MI , ischemia-driven target-vessel revascularization ( TVR ) , or disabling stroke at 30 days ( 4.6 % versus 7.0 % ; relative risk , 0.65 ; 95 % CI , 0.46 to 0.93 ; P = 0.01 ) . Subacute thrombosis also was significantly reduced with abciximab treatment . At 12 months , however , rates of the composite end point did not differ significantly ( 18.4 % for controls versus 16.9 % for abciximab-treated patients ; relative risk , 0.92 ; 95 % CI , 0.76 to 1.10 ; P = 0.29 ) , reflecting a decrease in the relative difference in TVR rates ( ie , no effect of abciximab on reducing restenosis ) . In an angiographic sub study ( n=656 ) , myocardial salvage , restenosis , and infa rct -artery reocclusion at 7 months were unaffected by abciximab treatment . There was no significant interaction between stenting and abciximab treatment . Conclusions —Adjunctive abciximab treatment during primary percutaneous coronary intervention significantly enhanced 30-day event-free survival , predominantly by reducing ischemia-driven TVR . Abciximab treatment did not affect the composite end point at 1 year , reflecting a lack of effect on restenosis Background —Diabetic patients are at increased risk of adverse outcomes after percutaneous coronary interventions . Although subset analyses suggest particular benefit from the administration of abciximab in diabetic patients , no dedicated large r and omized trials have been performed in diabetic patients undergoing percutaneous coronary intervention , and certainly not after pretreatment with a high loading dose of clopidogrel . Methods and Results —This study ( Intracoronary Stenting and Antithrombotic Regimen : Is Abciximab a Superior Way to Eliminate Elevated Thrombotic Risk in Diabetics [ ISAR-SWEET ] Study ) enrolled 701 diabetic patients with coronary artery disease who underwent an elective percutaneous coronary intervention after pretreatment with a 600-mg dose of clopidogrel > 2 hours before the procedure : 351 patients were r and omly assigned to abciximab and 350 patients to placebo . The primary end point of the trial was the composite incidence of death and myocardial infa rct ion at 1 year . The frequency of angiographic restenosis ( diameter stenosis ≥50 % ) was the secondary end point . The incidence of death or myocardial infa rct ion was 8.3 % in the abciximab group and 8.6 % in the placebo group ( P=0.91 ) , with a relative risk of 0.97 ( 95 % CI , 0.58 to 1.62 ) . The incidence of angiographic restenosis was 28.9 % in the abciximab group and 37.8 % in the placebo group ( P=0.01 ) , with a relative risk of 0.76 ( 95 % CI , 0.62 to 0.94 ) . The incidence of target lesion revascularization was 23.2 % in the abciximab group and 30.4 % in the placebo group ( P=0.03 ) . Conclusions —The findings of this study do not support a significant impact of abciximab on the risk of death and myocardial infa rct ion in diabetic patients undergoing percutaneous coronary interventions after pretreatment with a 600-mg loading dose of clopidogrel at least 2 hours before the procedure . The present findings suggest , however , that abciximab reduces the risk of restenosis in diabetic patients receiving coronary bare metal stents BACKGROUND In the EASY trial , we have shown the clinical equivalence between abciximab bolus-only and abciximab bolus followed by 12-h infusion in a wide spectrum of patients after percutaneous coronary intervention ( PCI ) . Some reports have suggested better outcomes following intracoronary ( IC ) abciximab
Output:
| No difference in bleeding complications was observed between IC and IV regimens .
An accumulating body of evidence suggests the superiority of IC over IV abciximab administration in STEMI patients . |
MS212372 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Purpose Abemaciclib , a cyclin-dependent kinase 4 and 6 inhibitor , demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive , human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy . Methods MONARCH 3 is a double-blind , r and omized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive , HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting . Patients received abemaciclib or placebo ( 150 mg twice daily continuous schedule ) plus either 1 mg anastrozole or 2.5 mg letrozole , daily . The primary objective was investigator-assessed progression-free survival . Secondary objectives included response evaluation and safety . A planned interim analysis occurred after 189 events . Results Median progression-free survival was significantly prolonged in the abemaciclib arm ( hazard ratio , 0.54 ; 95 % CI , 0.41 to 0.72 ; P = .000021 ; median : not reached in the abemaciclib arm , 14.7 months in the placebo arm ) . In patients with measurable disease , the objective response rate was 59 % in the abemaciclib arm and 44 % in the placebo arm ( P = .004 ) . In the abemaciclib arm , diarrhea was the most frequent adverse effect ( 81.3 % ) but was mainly grade 1 ( 44.6 % ) . Comparing abemaciclib and placebo , the most frequent grade 3 or 4 adverse events were neutropenia ( 21.1 % v 1.2 % ) , diarrhea ( 9.5 % v 1.2 % ) , and leukopenia ( 7.6 % v 0.6 % ) . Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy , significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive , HER2-negative advanced breast cancer PURPOSE To compare the efficacy and tolerability of tamoxifen with that of letrozole , an oral aromatase inhibitor , with tamoxifen as first-line therapy in postmenopausal women with advanced breast cancer . PATIENTS AND METHODS Nine hundred seven patients were r and omly assigned letrozole 2.5 mg once daily ( 453 patients ) or tamoxifen 20 mg once daily ( 454 patients ) . Patients had estrogen receptor- and /or progesterone receptor-positive tumors , or both receptors were unknown . Recurrence during adjuvant antiestrogen therapy or within the following 12 months or prior endocrine therapy for advanced disease precluded enrollment . One prior chemotherapy regimen for metastatic disease was allowed . The primary end point was time to progression ( TTP ) . Secondary end points included overall objective response rate ( ORR ) , its duration , rate and duration of clinical benefit , time to treatment failure ( TTF ) , overall survival , and tolerability . RESULTS TTP was significantly longer for letrozole than for tamoxifen ( median , 41 v 26 weeks ) . Treatment with letrozole reduced the risk of progression by 30 % ( hazards ratio , 0.70 ; 95 % confidence interval , 0.60 to 0.82 , P = .0001 ) . TTP was significantly longer for letrozole irrespective of dominant site of disease , receptor status , or prior adjuvant antiestrogen therapy . Similarly , TTF was significantly longer for letrozole ( median , 40 v 25 weeks ) . ORR was higher for letrozole ( 30 % v 20 % ; P = .0006 ) , as was the rate of clinical benefit ( 49 % v 38 % ; P = .001 ) . Survival data are currently immature and not reported here . Both treatments were well tolerated . CONCLUSION Letrozole was significantly superior to tamoxifen in TTP , TTF , ORR , and clinical benefit rate . Our results support its use as first-line endocrine therapy in postmenopausal women with advanced breast cancer PURPOSE The efficacy and tolerability of anastrozole ( Arimidex ; AstraZeneca , Wilmington , DE , and Macclesfield , United Kingdom ) and tamoxifen were compared as first-line therapy for advanced breast cancer in 353 postmenopausal women . PATIENTS AND METHODS The r and omized , double-blind , multicenter study was design ed to evaluate anastrozole 1 mg once daily relative to tamoxifen 20 mg once daily in patients with hormone receptor-positive tumors or tumors of unknown receptor status who were eligible for endocrine therapy . Primary end points were objective response ( OR ) , defined as complete ( CR ) or partial ( PR ) response , time to progression ( TTP ) , and tolerability . RESULTS Anastrozole was as effective as tamoxifen in terms of OR ( 21 % v 17 % of patients , respectively ) , with clinical benefit ( CR + PR + stabilization > or = 24 weeks ) observed in 59 % of patients on anastrozole and 46 % on tamoxifen ( two-sided P = .0098 , retrospective analysis ) . Anastrozole had a significant advantage over tamoxifen in terms of TTP ( median TTP of 11.1 and 5.6 months for anastrozole and tamoxifen , respectively ; two-sided P = .005 ) . The tamoxifen : anastrozole hazards ratio was 1.44 ( lower one-sided 95 % confidence limit , 1.16 ) . Both treatments were well tolerated . However , thromboembolic events and vaginal bleeding were reported in fewer patients who received anastrozole compared with those who received tamoxifen ( 4.1 % v 8.2 % [ thromboembolic events ] and 1.2 % v 3.8 % [ vaginal bleeding ] , respectively ) . CONCLUSION Anastrozole satisfied the predefined criteria for equivalence to tamoxifen . Furthermore , we observed both a significant increase in TTP and a lower incidence of thromboembolic events and vaginal bleeding with anastrozole . These findings indicate that anastrozole should be considered as first-line therapy for postmenopausal women with advanced breast cancer This paper is an overview of the new response evaluation criteria in solid tumours : revised RECIST guideline ( version 1 . 1 ) , with a focus on up date d contents BACKGROUND A phase 2 study showed that progression-free survival was longer with palbociclib plus letrozole than with letrozole alone in the initial treatment of postmenopausal women with estrogen-receptor (ER)-positive , human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer . We performed a phase 3 study that was design ed to confirm and exp and the efficacy and safety data for palbociclib plus letrozole for this indication . METHODS In this double-blind study , we r and omly assigned , in a 2:1 ratio , 666 postmenopausal women with ER-positive , HER2-negative breast cancer , who had not had prior treatment for advanced disease , to receive palbociclib plus letrozole or placebo plus letrozole . The primary end point was progression-free survival , as assessed by the investigators ; secondary end points were overall survival , objective response , clinical benefit response , patient-reported outcomes , pharmacokinetic effects , and safety . RESULTS The median progression-free survival was 24.8 months ( 95 % confidence interval [ CI ] , 22.1 to not estimable ) in the palbociclib-letrozole group , as compared with 14.5 months ( 95 % CI , 12.9 to 17.1 ) in the placebo-letrozole group ( hazard ratio for disease progression or death , 0.58 ; 95 % CI , 0.46 to 0.72 ; P<0.001 ) . The most common grade 3 or 4 adverse events were neutropenia ( occurring in 66.4 % of the patients in the palbociclib-letrozole group vs. 1.4 % in the placebo-letrozole group ) , leukopenia ( 24.8 % vs. 0 % ) , anemia ( 5.4 % vs. 1.8 % ) , and fatigue ( 1.8 % vs. 0.5 % ) . Febrile neutropenia was reported in 1.8 % of patients in the palbociclib-letrozole group and in none of the patients in the placebo-letrozole group . Permanent discontinuation of any study treatment as a result of adverse events occurred in 43 patients ( 9.7 % ) in the palbociclib-letrozole group and in 13 patients ( 5.9 % ) in the placebo-letrozole group . CONCLUSIONS Among patients with previously untreated ER-positive , HER2-negative advanced breast cancer , palbociclib combined with letrozole result ed in significantly longer progression-free survival than that with letrozole alone , although the rates of myelotoxic effects were higher with palbociclib-letrozole . ( Funded by Pfizer ; PALOMA-2 Clinical Trials.gov number , NCT01740427 . ) PURPOSE To compare the clinical activity of the pure antiestrogen fulvestrant at 500 mg/mo ( double the approved dose ) with the aromatase inhibitor anastrozole as first-line endocrine therapy for advanced hormone receptor-positive breast cancer in postmenopausal women . PATIENTS AND METHODS FIRST ( Fulvestrant First-Line Study Comparing Endocrine Treatments ) is a phase II , r and omized , open-label , multicenter study of a fulvestrant high-dose ( HD ) regimen ( 500 mg/mo plus 500 mg on day 14 of month 1 ) versus anastrozole ( 1 mg/d ) . The primary efficacy end point was clinical benefit rate ( CBR ) , defined as the proportion of patients experiencing an objective response ( OR ) or stable disease for > or = 24 weeks . The primary analysis was performed 6 months after the last patient was r and omly assigned . RESULTS CBR was similar for fulvestrant HD ( n = 102 ) and anastrozole ( n = 103 ) , 72.5 % v 67.0 % , respectively ( odds ratio , 1.30 ; 95 % CI , 0.72 to 2.38 ; P = .386 ) . Objective response rate ( ORR ) was also similar between treatments : fulvestrant HD , 36.0 % ; anastrozole , 35.5 % . Time to progression ( TTP ) was significantly longer for fulvestrant versus anastrozole ( median TTP not reached for fulvestrant HD v 12.5 months for anastrozole ; hazard ratio , 0.63 ; 95 % CI , 0.39 to 1.00 ; P = .0496 ) . Duration of OR and CB also numerically favored fulvestrant HD . Both treatments were well tolerated , with no significant differences in the incidence of prespecified adverse events . CONCLUSION First-line fulvestrant HD was at least as effective as anastrozole for CBR and ORR and was associated with significantly longer TTP . Fulvestrant HD was generally well tolerated , with a safety profile similar to that of anastrozole
Output:
| Similarly , overall response rate and clinical benefit rate were higher for patients who received the combination therapy than for patients allocated to AI alone .
Conclusion The addition of CDK 4/6 inhibitors ( either abemaciclib , palbociclib , or ribociclib ) to an AI ( anastrozole or letrozole ) significantly improved PFS , overall response rate , and clinical benefit rate in comparison with a nonsteroidal AI alone |
MS212373 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 effects of the powdered rhizome of Zingiber officinale on the symptoms of motion sickness were compared with those of dimenhydrinate and placebo in 36 undergraduate men and women who reported very high susceptibility to motion sickness . Motion sickness was induced by placing the blindfolded subject in a tilted rotating chair . Measurements of perceived degree of gastrointestinal distress were reported every 15 s for up to 6 minutes by means of psychophysical methods . Z. officinale was superior to dimenhydrinate in reducing motion sickness Objective Ginger has been reported to improve upper gastrointestinal symptoms . Little information about the effects of ginger on gastric motor function , exists , however . Our aim was to investigate the effects of ginger on gastric emptying , antral motility , proximal gastric dimensions , and postpr and ial symptoms . Methods Twenty-four healthy volunteers were studied twice in a r and omized double-blind manner . After an 8 h fast , the volunteers ingested three ginger capsules ( total 1200 mg ) or placebo , followed after 1 h by 500 ml low-nutrient soup . Antral area , fundus area and diameter , and the frequency of antral contractions were measured using ultrasound at frequent intervals over 90 min , and the gastric half-emptying time was calculated from the change in antral area . Gastrointestinal sensations and appetite were scored using visual analog question naires . Data are expressed in terms of mean±st and ard error . Results Antral area decreased more rapidly ( P<0.001 ) and the gastric half-emptying time was less after ginger than placebo ingestion ( 13.1±1.1 vs. 26.7±3.1 min , P<0.01 ) , whereas the frequency of antral contractions was greater ( P<0.005 ) . Fundus dimensions did not differ , and there was no significant difference in any gastrointestinal symptoms . Conclusion Ginger accelerates gastric emptying and stimulates antral contractions in healthy volunteers . These effects could potentially be beneficial in symptomatic patient groups Background : Nausea and vomiting are common and unpleasant complications in pregnancy . Although many alternative therapists support the use of ginger for nausea and vomiting of pregnancy , there is currently insufficient clinical evidence to support its use in this condition Objectives : The present study was performed to assess the effectiveness of ginger in the treatment of nausea and vomiting in pregnancy . Patients and Methods : This seven-day clinical trial was performed on 120 eligible pregnant women with symptoms of mild to moderate nausea and vomiting before 16 weeks gestation . They were divided into ; ginger , placebo and control groups , by block r and omization . Women were asked to record their nausea and vomiting for three days , and then participants received either ginger capsules , or a placebo for four days . No intervention was done with the control group . Data measure was self-recorded symptoms according to the Rhodes Index . Data were analyzed by ANOVA , ANCOVA , Kruskal-Wallis , Chi-square , and Fisher ’s exact test , for the quantitative and qualitative variables . Results : There were no statistical differences in the baseline demographics between the three groups apart from age of marriage and wanted or unwanted pregnancy . An ANCOVA test ( covariance test ) showed significant differences in mean scores after the intervention in the three groups ( P < 0.001 ) . Conclusions : Ginger was effective for the relief of mild to moderate nausea and vomiting in pregnant women at less than 16 weeks gestation In a placebo-controlled study the effect of ginger and fenugreek was examined on blood lipids , blood sugar , platelet aggregation , fibrinogen and fibrinolytic activity . The subjects included in this study were healthy individuals , patients with coronary artery disease ( CAD ) , and patients with non-insulin-dependent diabetes mellitus ( NIDDM ) who either had CAD or were without CAD . In patients with CAD powdered ginger administered in a dose of 4 g daily for 3 months did not affect ADP- and epinephrine-induced platelet aggregation . Also , no change in the fibrinolytic activity and fibrinogen level was observed . However , a single dose of 10 g powdered ginger administered to CAD patients produced a significant reduction in platelet aggregation induced by the two agonists . Ginger did not affect the blood lipids and blood sugar . Fenugreek given in a dose of 2.5 g twice daily for 3 months to healthy individuals did not affect the blood lipids and blood sugar ( fasting and post pr and ial ) . However , administered in the same daily dose for the same duration to CAD patients also with NIDDM , fenugreek decreased significantly the blood lipids ( total cholesterol and triglycerides ) without affecting the HDL-c . When administered in the same daily dose to NIDDM ( non-CAD ) patients ( mild cases ) , fenugreek reduced significantly the blood sugar ( fasting and post pr and ial ) . In severe NIDDM cases , blood sugar ( both fasting and post pr and ial ) was only slightly reduced . The changes were not significant . Fenugreek administration did not affect platelet aggregation , fibrinolytic activity and fibrinogen ♦ Background : In peritoneal dialysis ( PD ) patients , one of the major risk factors for cardiovascular disease is lipid abnormalities . This study was design ed to investigate the effects of ginger supplementation on serum lipids and lipoproteins in PD patients . ♦ Methods : In this r and omized , double-blind , placebo-controlled trial , 36 PD patients were r and omly assigned to either the ginger or the placebo group . The patients in the ginger group received 1,000 mg ginger daily for 10 weeks , while the placebo group received corresponding placebos . At baseline and at the end of week 10 , 7 mL of blood were obtained from each patient after a 12- to 14-hour fast , and serum concentrations of triglyceride , total cholesterol , low density lipoprotein-cholesterol ( LDL-C ) , high density lipoprotein-cholesterol ( HDL-C ) , and lipoprotein ( a ) [ Lp ( a ) ] were measured . ♦ Results : Serum triglyceride concentration decreased significantly up to 15 % in the ginger group at the end of week 10 compared with baseline ( p < 0.01 ) , and the reduction was significant in comparison with the placebo group ( p < 0.05 ) . There were no significant differences between the 2 groups in mean changes of serum total cholesterol , LDL-C , HDL-C , and Lp ( a ) . ♦ Conclusion : This study indicates that daily administration of 1,000 mg ginger reduces serum triglyceride concentration , which is a risk factor for cardiovascular disease , in PD patients Background The activity of ginger in the management of chemotherapy-induced nausea and vomiting ( CINV ) has been suggested , but design inadequacies , heterogeneity of the population , small numbers and poor quality of tested products limit the possibility to offer generalizable results . Patients and methods We conducted a r and omized , double-blind , placebo-controlled , multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose ( > 50 mg/m2 ) cisplatin . Patients received ginger 160 mg/day ( with st and ardized dose of bioactive compounds ) or placebo in addition to the st and ard antiemetic prophylaxis for CINV , starting from the day after cisplatin administration . CINV was assessed through daily visual-analogue scale and Functional Living Index Emesis question naires . The main objective was protection from delayed nausea ; secondary end points included intercycle nausea and nausea anticipatory symptoms . Results In total , 121 patients received ginger and 123 placebo . Lung ( 49 % ) and head and neck cancer ( HNC ; 35 % ) were the most represented tumors . No differences were reported in terms of safety profile or compliance . The incidence of delayed , intercycle and anticipatory nausea did not differ between the two arms in the first cycle and second cycle . A benefit of ginger over placebo in Functional Living Index Emesis nausea score differences ( day 6-day 1 ) was identified for females ( P = 0.048 ) and HNC patients ( P = 0.038 ) . Conclusions In patients treated with high-dose cisplatin , the daily addition of ginger , even if safe , did not result in a protective effect on CINV . The favorable effect observed on nausea in subgroups at particular risk of nausea ( females ; HNC ) deserves specific investigation Chilli peppers have been shown to enhance diet-induced thermogenesis ( DIT ) and reduce energy intake ( EI ) in some studies , but there are few data on other pungent spices . The primary aim of the present study was to test the acute effects of black pepper ( pepper ) , ginger , horseradish and mustard in a meal on 4 h postpr and ial DIT . The secondary aim was to examine the effects on subjective appetite measures , ad libitum EI and energy balance . In a five-way placebo-controlled , single-blind , cross-over trial , twenty-two young ( age 24·9 ( SD 4·6 ) years ) , normal-weight ( BMI 21·8 ( SD 2·1 ) kg/m² ) males were r and omly assigned to receive a brunch meal with either pepper ( 1·3 g ) , ginger ( 20 g ) , horseradish ( 8·3 g ) , mustard ( 21 g ) or no spices ( placebo ) . The amounts of spices were chosen from pre-testing to make the meal spicy but palatable . No significant treatment effects were observed on DIT , but mustard produced DIT , which tended to be larger than that of placebo ( 14 % , 59 ( SE 3 ) v. 52 ( SE 2 ) kJ/h , respectively , P=0·08 ) . No other spice induced thermogenic effects approaching statistical significance . Subjective measures of appetite ( P>0·85 ) , ad libitum EI ( P=0·63 ) and energy balance ( P=0·67 ) also did not differ between the treatments . Finally , horseradish decreased heart rate ( P=0·048 ) and increased diastolic blood pressure ( P= 0·049 ) compared with placebo . In conclusion , no reliable treatment effects on appetite , EI or energy balance were observed , although mustard tended to be thermogenic at this dose . Further studies should explore the possible strength and mechanisms of the potential thermogenic effect of mustard actives , and potential enhancement by , for example , combinations with other food components Abstract 6-Gingerol is a natural compound extracted from ginger . Pre clinical studies demonstrated that 6-gingerol has an anti-emetic activity by inhibiting neurokinin-1 , serotonin , and dopamine receptors . Several clinical trials examined crude ginger powder for preventing chemotherapy-induced nausea and vomiting ( CINV ) , but none of them was conducted with a st and ardized bioactive compound . Patients who received moderately to highly emetogenic adjuvant chemotherapy were r and omized to receive 6-gingerol 10 mg or placebo orally twice daily for 12 weeks . Ondansetron , metoclopramide , and dexamethasone were given to all patients . The primary endpoint was complete response ( CR ) rate defined as no emesis or rescue treatment at any time . Eighty-eight patients were r and omized to receive 6-gingerol ( N = 42 ) or placebo ( N = 46 ) . Most patients received highly emetogenic chemotherapy ( 93 % ) . Overall CR rate was significantly higher in 6-gingerol group as compared with that of the placebo ( 77 vs. 32 % ; P < 0.001 ) . The difference in means of appetite score was significant ( P = 0.001 ) and more noticeable over time . Mean FACT-G score indicating quality of life was significantly higher ( 86.21 ) in 6-gingerol group at 64 days as compared with that of placebo group ( 72.36 ) ( P < 0.001 ) . No toxicity related to 6-gingerol was observed . Patients treated with 6-gingerol reported significantly less grade 3 fatigue ( 2 vs. 20 % ; P = 0.020 ) . 6-Gingerol significantly improved overall CR rate in CINV , appetite and quality of life in cancer patients receiving adjuvant chemotherapy . A phase III r and omized study of 6-gingerol is warranted to confirm these results Purpose The aim of the study was to compare the effect of mefenamic acid and ginger on pain management in primary dysmenorrhea . Methods One hundred and twenty-two female students with moderate to severe primary dysmenorrhea were r and omly allocated to the ginger and mefenamic groups in a r and omized clinical trial . The mefenamic group received 250 mg capsules every 8 h , and the ginger group received 250 mg capsules ( zintoma ) every 6 h from the onset of menstruation until pain relief lasted 2 cycles . The intensity of pain was assessed by the visual analog scale . Data were analyzed by descriptive statistics , t test , Chi-square , Fisher exact test and repeated measurement . Results The pain intensity in the mefenamic and ginger group was 39.01 ± 17.77 and 43.49 ± 19.99 , respectively , in the first month , and 33.75 ± 17.71 and 38.19 ± 20.47 , respectively , in the second month ( p >
Output:
| The included studies that examined the improvement of nausea and vomiting in pregnancy , inflammation , metabolic syndromes , digestive function , and colorectal cancer ’s markers were consistently supported , whereas other expected functions were relatively controversial .
In addition to the quality assessment result , small population s and unst and ardized evaluation systems were the observed shortcomings in ginger clinical trials .
Further studies with adequate design s are warranted to vali date the reported clinical functions of ginger |
MS212374 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 provide a practical quantitative tool for appraising the quality of cost-effectiveness ( CE ) studies . Methods .A committee comprised of health economists selected a set of criteria for the instrument from an item pool . Data collected with a conjoint analysis survey on 120 international health economists were used to estimate weights for each criterion with a r and om effects regression model . To vali date the grading system , a survey was sent to 60 individuals with health economics expertise . Participants first rated the quality of three CE studies on a visual analogue scale , and then evaluated each study using the grading system . Spearman rho and Wilcoxon tests were used to detect convergent validity and analysis of covariance ( ANCOVA ) for discriminant validity . Agreement between the global rating by experts and the grading system was also examined . Results .Sixteen criteria were selected . Their coefficient estimates ranged from 1.2 to 8.9 , with a sum of 93.5 on a 100-point scale . The only insignificant criterion was “ use of subgroup analyses . ” Both convergent validity and discriminant validity of the grading system were shown by the results of the Spearman rho ( correlation coefficient = 0.78 , P < 0.0001 ) , Wilcoxon test ( P = 0.53 ) , and ANCOVA ( F3,146 = 5.97 , P = 0.001 ) . The grading system had good agreement with global rating by experts . Conclusions . The instrument appears to be simple , internally consistent , and valid for measuring the perceived quality of CE studies . Applicability for use in clinical and re source allocation decision-making deserves further study Abstract Objective : To assess the economic impact of two polychemotherapy regimens for patients with advanced ovarian cancer from the perspective of the Belgian health insurance and financing system . Design : An economic evaluation was integrated in an intergroup r and omised controlled trial ( EORTC 55931 ) in which patients were r and omised to receive the new treatment of paclitaxel and cisplatin or the st and ard therapy of cyclophosphamide and cisplatin . Data on the use of medical re sources were collected prospect ively for the 231 European Organization for Research and Treatment of Cancer ( EORTC ) patients in the trial and costs were valued by using unit prices . The outcome for the economic evaluation was mean survival time as determined by the so-called restricted means method , with the time point of restriction fixed by statistical criteria . A correction of censoring of the cost data collected in the trial was also performed . Main outcome measures and results : The paclitaxel and cisplatin group experienced a statistically significant improvement in mean survival time of 4 months , which was associated with an increase in the average total cost per patient of 6795 euros ( EUR ; 1998 values ) , when costs were assessed over the same period as the gain in mean survival time . This corresponds to a point estimate of the incremental cost-effectiveness ratio of EUR20 385 per life-year gained . The impact of uncertainty was assessed by using a bias-corrected and accelerated bootstrap method with 5000 re sample s , and the final results of the analysis are expressed in terms of a cost-effectiveness acceptability curve . Conclusions : The present economic evaluation has shown that the substitution of paclitaxel for cyclophosphamide in the chemotherapy regimen for women with advanced ovarian cancer leads to a significant improvement in patient survival , which is associated with an increase in costs for the Belgian health insurance system PURPOSE To determine the side effects and feasibility of cisplatin and carboplatin each in combination with paclitaxel as front-line therapy in advanced epithelial ovarian cancer . PATIENTS AND METHODS Patients were r and omly allocated to receive paclitaxel 175 mg/m(2 ) intravenously as a 3-hour infusion followed by either cisplatin 75 mg/m(2 ) or carboplatin ( area under the plasma concentration-time curve of 5 ) , both on day 1 . The schedule was repeated every 3 weeks for at least six cycles . Women allocated to paclitaxel-cisplatin were admitted to the hospital , whereas the carboplatin regimen was administered to out patients . RESULTS A total of 208 eligible patients were r and omized . Both regimens could be delivered in an optimal dose and without significant delay . Paclitaxel-carboplatin produced significantly less nausea and vomiting ( P : < .01 ) and less peripheral neurotoxicity ( P : = .04 ) but more granulocytopenia and thrombocytopenia ( P : < .01 ) . The overall response rate in 132 patients with measurable disease was 64 % ( 84 of 132 patients ) , and in patients with elevated CA 125 levels at start , it was 74 % ( 132 of 178 patients ) . With a median follow-up time of 37 months , the median progression-free survival time of all patients was 16 months and the median overall survival time was 31 months . The small number of patients entered onto the study caused wide confidence intervals ( CIs ) around the hazards ratio for progression-free survival of paclitaxel-carboplatin compared with paclitaxel-cisplatin ( hazards ratio , 1.07 ; 95 % CI , 0.78 to 1.48 ) and did not allow conclusions about efficacy . CONCLUSION Paclitaxel-carboplatin is a feasible regimen for out patients with ovarian cancer and has a better toxicity profile than paclitaxel-cisplatin BACKGROUND Despite considerable improvement in the treatment of advanced ovarian cancer , the optimization of efficacy and tolerability remains an important issue . Therefore , we performed a r and omized , phase III non-inferiority trial comparing paclitaxel plus cisplatin ( PT ) with paclitaxel plus carboplatin ( TC ) in patients with advanced ovarian cancer . METHODS A total of 798 patients with International Federation of Gynecology and Obstetrics stage IIB-IV were r and omly assigned to receive six courses of either PT or TC at 3-week intervals . The primary endpoint was the proportion of patients without progression at 2 years . Secondary endpoints included toxicity , response to treatment , quality of life , and overall and progression-free survival time . Quality of life was evaluated using the European Organization for Research and Treatment of Cancer quality -of-life question naire (QLQ)-C30 , version 2.0 . Survival curves were calculated using the Kaplan-Meier method , and hazard ratios were estimated using the Cox proportional hazards model . RESULTS The proportion of patients without progression at 2 years was not statistically significantly different between the two treatment arms ( 40.0 % for PT versus 37.5 % for TC , difference = 2.5 % , one-sided 95 % confidence interval [ CI ] = - infinity to 8.2 % ) . Median progression-free survival time in the TC arm ( 17.2 months , 95 % CI = 15.2 to 19.3 months ) and the PT arm ( 19.1 months , 95 % CI = 16.7 to 21.5 months ) were also not statistically significantly different ; the same was true of median overall survival time ( 43.3 months , 95 % CI = 37.2 to 47.8 months versus 44.1 months , 95 % CI = 40.2 to 49.4 months , for the TC and PT arms , respectively ) . The TC regimen was associated with a higher frequency of hematologic toxicity , but a lower frequency of gastrointestinal and neurologic toxicity , than the PT regimen . Mean global quality -of-life scores at the end of treatment were statistically significantly better in the TC arm than in the PT arm ( 65.25 versus 51.97 , respectively ; difference = -13.28 , 95 % CI = -18.88 to -7.68 ) . CONCLUSION The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life , and should , therefore , be considered as an important alternative for st and ard first-line chemotherapy in patients with advanced ovarian cancer OBJECTIVE Compared with every-3-week paclitaxel ( q3 T ) plus carboplatin , dose-dense weekly paclitaxel ( ddT ) plus carboplatin improved the survival of ovarian cancer patients . We performed a cost analysis comparing these two regimens . METHODS Using a Markov decision model , an acceptable incremental cost-effectiveness ratio ( ICER ) per progression-free life-year saved ( PFLYS ) was estimated . Cost of drugs , growth colony-stimulating factors , and transfusions were derived from Medicare reimbursement data . Survival and rates of complications were estimated based on the clinical trial . RESULTS Using a body weight and surface area of an average woman age 63 , the estimated cost per cycle of ddT was $ 107 vs. $ 80 for q3 T . The costs per cycle of combination chemotherapy including treatment administration were $ 873 for ddT and $ 535 for q3 T . With a median progression-free survival ( PFS ) of 28 months with ddT vs. 17.2 months with q3 T , the ICER was $ 5809 per PFLYS for ddT compared with q3 T arm . Using a maximum ICER of $ 100,000 per LYS as cost-effective threshold , the ddT regimen was cost-effective . The ICER was most sensitive to the hazard rate for difference in PFS between the two regimens . A 4-month difference in PFS result ed in a $ 1200 change of ICER per PFLYS . The ICER was also sensitive to overall survival difference , rate of hematological toxicity , and rate of discontinuation . CONCLUSIONS In this economic model , dose-dense weekly paclitaxel is a cost-effective treatment option for advanced ovarian cancer PURPOSE In r and omized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer . Although in nonr and omized trials , carboplatin and paclitaxel was a less toxic and highly active combination regimen , there remained concern regarding its efficacy in patients with small-volume , resected , stage III disease . Thus , we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population . PATIENTS AND METHODS Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were r and omly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 ( arm I ) , or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours ( arm II ) . RESULTS Seven hundred ninety-two eligible patients were enrolled onto the study . Prognostic factors were similar in the two treatment groups . Gastrointestinal , renal , and metabolic toxicity , as well as grade 4 leukopenia , were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II . Neurologic toxicity was similar in both regimens . Median progression-free survival and overall survival were 19.4 and 48.7 months , respectively , for arm I compared with 20.7 and 57.4 months , respectively , for arm II . The relative risk ( RR ) of progression for the carboplatin plus paclitaxel group was 0.88 ( 95 % confidence interval [ CI ] , 0.75 to 1.03 ) and the RR of death was 0.84 ( 95 % CI , 0.70 to 1.02 ) . CONCLUSION In patients with advanced ovarian cancer , a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity , is easier to administer , and is not inferior , when compared with cisplatin plus paclitaxel INTRODUCTION Paclitaxel plus cisplatin is considered to be the st and ard first-line therapy for advanced ovarian cancer . Previous to this study , economic data on this combination result ed from r and omised clinical trials ( RCTs ) . Therefore , the objective of this study was to compare the clinical and economic outcomes associated with paclitaxel-cisplatin ( PC ) and cyclophosphamide-cisplatin ( CC ) regimens using a pragmatic perspective based on daily clinical practice in a French university hospital . METHOD A retrospective cost-effectiveness analysis , from the hospital-payer perspective , was carried out as a before-after case study in fifty-nine consecutive women with verified International Federation of Gynaecology and Obstetrics ( FIGO ) stage II , III or IV ovarian cancer treated between 1995 and 2000 . Median overall survival ( OS ) was used as the primary endpoint . The quality -adjusted time was assessed by the quality -adjusted time without symptoms or toxicity ( Q-TWiST ) method . Direct medical costs were collected for each patient . Monetary values for French prices in the year 2000 were used and converted to US dollars using an exchange rate of USD 1 = 7 French francs . Several univariate sensitivity analyses were carried out varying unit costs , medical practice s and administration of paclitaxel . RESULTS The incremental cost of the PC regimen was USD 10,716 per patient . OS and quality -adjusted time were improved by 10.8 and 9.3 months with the PC regimen . The cost per life-year gained and per added QALY were USD 11,907 and US
Output:
| For second-line treatment , the use of platinum – paclitaxel combination or platinum monotherapy was cost-effective compared with platinum monotherapy or best supportive care , respectively , in women with recurrent platinum-sensitive disease .
Conclusions Despite varying method ological approaches and multiple sources for cost and effectiveness inputs , this systematic review demonstrated that st and ard platinum – taxane combination chemotherapy for first-line treatment was most cost-effective .
There was unanimous agreement that bevacizumab was not a cost-effective front-line therapy compared with platinum – taxane combination for the overall ovarian cancer population , though its use in the high-use population may yield better value .
For second-line treatment , platinum-based chemotherapy remained cost-effective among patients with recurrent platinum-sensitive disease , while there was limited evidence to conclude the most valuable treatment alternative among patients with recurrent platinum-resistant disease . |
MS212375 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 examine the effect of a mail-mediated intervention , based on self-determination theory , on adults ' exercise behavior . Methods . The study was a r and omized control trial conducted over a 2-month period . Of the initial 185 volunteer participants , 126 ( 68.1 % ) completed question naires at baseline , 1 month , and 2 months . Participants in intervention-only and intervention-plus-booster groups received a mail-delivered packet containing strategies design ed to promote perceptions of autonomy , competence , and relatedness regarding exercise . Those in a control group received an American Heart Association physical-activity facts packet . After 1 month , those in the intervention-plus-booster group received a booster postcard , reiterating the main points of the initial intervention packet . Exercise behavior was the primary outcome variable . Perceptions of autonomy , competence , and relatedness were evaluated as mediating variables . Results . Separate 3 ( group ) × 3 ( time ) repeated measures analyses of variance conducted for men and women revealed that for women , all three groups significantly increased exercise levels over the 2-month period . No significant interactions were found regarding the influence of the intervention on the mediating variables . A process evaluation indicated a lack of compliance regarding completing intervention-packet worksheets . Discussion . Findings suggested that more intensive interventions and greater fidelity of treatment may be needed to evidence change in exercise behavior Background Research on the motivational model proposed by Self-Determination Theory ( SDT ) provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors , and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation . Although obesity is notoriously difficult to reverse and its recidivism is high , adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term . The purpose s of this study are twofold : i ) to describe a 3-year r and omized controlled trial ( RCT ) aim ed at testing a novel obesity treatment program based on SDT , and ii ) to present the rationale behind SDT 's utility in facilitating and explaining health behavior change , especially physical activity/exercise , during obesity treatment . Methods Study design , recruitment , inclusion criteria , measurements , and a detailed description of the intervention ( general format , goals for the participants , intervention curriculum , and main SDT strategies ) are presented . The intervention consists of a 1-year group behavioral program for overweight and moderately obese women , aged 25 to 50 ( and pre-menopausal ) , recruited from the community at large through media advertisement . Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team ( 30 2 h sessions in total ) , and go through a program covering most topics considered critical for successful weight control . These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines . Comparison group receive a general health education curriculum . After the program , all subjects are follow-up for a period of 2 years . Discussion Results from this RCT will contribute to a better underst and ing of how motivational characteristics , particularly those related to physical activity/exercise behavioral self-regulation , influence treatment success , while exploring the utility of Self-Determination Theory for promoting health behavior change in the context of obesity . Trial Registration Clinical Trials Gov. Identifier This study was set out to test if autonomous motivation mediated the relationship between self-efficacy and 12-month physical activity ( PA ) in adults with type 2 diabetes involved in a r and omized exercise trial . Participants ( n = 234 ) completed question naires measuring barrier self-efficacy at 3 months , autonomous motivation at 6 months , and PA at 12 months . A mediational analysis of longitudinal data revealed that autonomous motivation mediated the relationship between barrier-self-efficacy and PA . High barrier self-efficacy can therefore help predict 12-month PA in adults with type 2 diabetes , although this effect is attenuated by autonomous motivation . Hence , participating in PA for autonomous reasons such as by choice and /or for fun further explains PA at 12 months in this population . Results of this study extend our underst and ing of the motivational constructs involved in PA in the maintenance phase . This study has important theoretical implication s in that it helps to organize and consoli date well-known correlates of PA by proposing a temporal relationship between them that could be tailored in interventions PURPOSE This study evaluated exercise-related predictors of successful long-term weight control in women by analyzing the extent to which sustained exercise participation and self-determination theory (SDT)-based exercise motivation variables mediated the impact of a behavioral weight control intervention on 3-yr weight change . METHODS Longitudinal r and omized controlled trial consisting of a 1-yr SDT-based intervention and a 2-yr follow-up with 221 female participants ( means ± SD : age = 37.6 ± 7 yr , body mass index = 31.6 ± 4.1 kg·m(-2 ) ) . The tested model incorporated experimentally manipulated perceived need support , motivational regulations , and 2-yr exercise adherence as mediators of the intervention 's impact on 3-yr weight change . Paths were tested using partial least squares analysis . Where there were significant intervening paths , tests of mediation were conducted . RESULTS Treatment had significant effects on 1- and 2-yr autonomous regulations , 2-yr physical activity , and 3-yr weight change , fully mediated by the tested paths ( effect ratio = 0.10 - 0.61 ) . Moderate and vigorous exercise at 2 yr had a significant effect ( P < 0.001 ) on weight loss success at 3 yr and partially mediated the effect of treatment on weight change . The 2-yr autonomous regulation effects on follow-up weight change were only partially mediated by physical activity ( effect ratio = 0.42 ) . CONCLUSIONS This application of SDT to physical activity and weight management showed that not all types of motivation predict long-term behavioral outcomes and that sustained moderate and vigorous exercise mediated long-term weight change . It provides strong evidence for a link between experimentally increased autonomous motivation and exercise and long-term weight loss maintenance . Results highlight the importance of interventions targeting the internalization of exercise behavioral regulation and making exercise and physical activity positive and meaningful experiences rather than simply focusing on immediate behavior change in overweight/obese women Background The National Institute of Clinical Excellence in the UK has recommended that the effectiveness of ongoing exercise referral schemes to promote physical activity should be examined in research trials . Recent empirical evidence in health care and physical activity promotion context s provides a foundation for testing the utility of a Self Determination Theory (SDT)-based exercise referral consultation . Methods / Design Design : An exploratory cluster r and omised controlled trial comparing st and ard provision exercise on prescription with a Self Determination Theory-based ( SDT ) exercise on prescription intervention . Participants : 347 people referred to the Birmingham Exercise on Prescription scheme between November 2007 and July 2008 . The 13 exercise on prescription sites in Birmingham were r and omised to current practice ( n = 7 ) or to the SDT-based intervention ( n = 6 ) . Outcomes measured at 3 and 6-months : Minutes of moderate or vigorous physical activity per week assessed using the 7-day Physical Activity Recall ; physical health : blood pressure and weight ; health status measured using the Dartmouth CO-OP charts ; anxiety and depression measured by the Hospital Anxiety and Depression Scale and vitality measured by the subjective vitality score ; motivation and processes of change : perceptions of autonomy support from the advisor , satisfaction of the needs for competence , autonomy , and relatedness via physical activity , and motivational regulations for exercise . Discussion This trial will determine whether an exercise referral programme based on Self Determination Theory increases physical activity and other health outcomes compared to a st and ard programme and will test the underlying SDT-based process model ( perceived autonomy support , need satisfaction , motivation regulations , outcomes ) via structural equation modelling . Trial registration The trial is registered as Current Controlled trials IS RCT N07682833 BACKGROUND Regular physical activity can help to prevent cardiovascular disease in women . Underst and ing midlife women 's exercise goals could offer insight into their motivational facilitators and barriers , and assist in the development of better primary prevention strategies for this population . OBJECTIVES We sought to investigate the relationship between midlife women 's physical activity goals and their physical activity participation over time . METHODS A r and om sample of healthy , midlife women ( 40 - 60 years of age ) was selected to participate in a longitudinal study ( n = 156 ) . This study fit a linear mixed model to the data to investigate the fixed effects of physical activity goals on physical activity participation , controlling for Body Mass Index ( BMI ) and Social Support . Mediational analyses were conducted to investigate whether commitment and planning mediated these results . RESULTS There were significant differences between participants with distinct types of goals on physical activity participation over time ( i.e. , baseline , 1 month , and 1 year postbaseline ) , controlling for the effects of BMI and Social Support . Participants with Weight Loss and Health Benefits goals participated in significantly less physical activity than those with Sense of Well-being and Stress Reduction goals . Commitment and Planning each mediated the relationship between participant goals and their physical activity participation . CONCLUSIONS These data suggest having physical activity goals that aim to decrease weight or benefit health may not bode well for healthy midlife women who desire to sustain physically active lives . Instead , health care providers and health promotion specialists might better facilitate long-term participation among healthy women if they emphasize physical activity as a means to enhance their quality of life Assessment of habitual physical activity in epidemiologic and health education studies has been difficult . A seven-day physical activity recall interview was developed and administered in a community health survey , a r and omized clinical trial , and two worksite health promotion programs during 1979 - 1982 . These studies were conducted in several population s in California , Texas , Pennsylvania , and New Jersey . Energy expenditure estimates from the physical activity recall conformed to expected age- and sex-specific values in the cross-sectional community survey . Estimates of energy expenditure were also congruent with other questions on physical activity and job classification . In a r and omized , one-year exercise trial , the physical activity recall detected increases in energy expenditure in the treated group and was positively associated with miles run during training ( p less than 0.05 ) . Changes in energy expenditure were associated with changes in maximal oxygen uptake ( VO2max ( r = 0.33 , p less than 0.05 ) and body fatness ( r = -0.50 , p less than 0.01 ) at six months , and in high density lipoprotein-cholesterol ( r = 0.31 , p less than 0.05 ) and triglyceride ( r = -0.41 , p less than 0.01 ) at one year . The physical activity recall detected significant ( p less than 0.01 ) increases in energy expenditure in treatment groups in two worksite health promotion projects . These data suggest that the physical activity recall provides useful estimates of habitual physical activity for research in epidemiologic and health education studies The purpose of this study was to propose and test a motivational model of high school dropout . The model posits that teachers , parents , and the school administration 's behaviors towards students influence students ' perceptions of competence and autonomy . The less autonomy supportive the social agents ' behaviors are , the less positive the students ' perceptions of competence and autonomy . In turn , the less positive students ' perceptions are , the lower their level of self-determined school motivation are . Finally , low levels of self-determined motivation lead students to develop intentions to drop out of high school , which are later implemented , leading to actual dropout behavior . This model was tested with high school students ( N = 4,537 ) by means of a prospect i ve design . Results from analyses of variance and a structural equation modeling analysis ( with LISREL ) were found to support the model for all participants and for each gender separately The assertion that both the content of goals and the motives behind goals affect psychological well-being has been controversial . Three studies examined this issue directly , showing that both what goals people pursue ( i.e. , whether they strive for extrinsic vs. intrinsic goal contents ) and why people pursue them ( i.e. , whether they strive for autonomous vs. controlled motives ) make significant independent contributions to psychological well-being . The pattern emerged in between-person and within-person studies of cross-sectional well-being and also emerged in a year-long study of prospect i ve change in well-being . Implication s for prescriptive theories of happiness are discussed OBJECTIVE Using self-determination theory ( SDT ) , we examined relationships between cardiac rehabilitation ( CR ) participants ' perceived autonomy support , motivation for exercise , and exercise behavior . RESEARCH METHOD / DESIGN Male CR out patients ( N = 53 ; M age = 62.83 + /- 10.78 years ) . The design was correlational ( cross-sectional and prospect i ve ) , examining relationships between perceived autonomy support and motivation for exercise at Week 4 of CR participation as well as motivation and CR attendance and other indicators of exercise behavior ( frequency , duration , total exercise time ) at a 1-week follow-up , 10 weeks later . RESULTS Perceived autonomy support was correlated with self-determined motivation , r(53 ) = .32 , p < .05 . Self-determined motivation predicted total exercise volume at follow-up , r(53 ) = .34 , p < .05 , as well as length of exercise session duration ( R(2 ) = .27 ; beta = .52 , p < .001 ) . CONCLUSION Results support SDT and the potential for autonomy support from interventionists to affect self-determined motivation and exercise behavior of participants involved in CR Aims : We examined whether autonomy supportive and self-efficacy
Output:
| Results The results show consistent support for a positive relation between more autonomous forms of motivation and exercise , with a trend towards identified regulation predicting initial/short-term adoption more strongly than intrinsic motivation , and intrinsic motivation being more predictive of long-term exercise adherence .
The literature is also consistent in that competence satisfaction and more intrinsic motives positively predict exercise participation across a range of sample s and setting s. Mixed evidence was found concerning the role of other types of motives ( e.g. , health/fitness and body-related ) , and also the specific nature and consequences of introjected regulation .
The majority of studies have employed descriptive ( i.e. , non-experimental ) design s but similar results are found across cross-sectional , prospect i ve , and experimental design s. Conclusion Overall , the literature provides good evidence for the value of SDT in underst and ing exercise behavior , demonstrating the importance of autonomous ( identified and intrinsic ) regulations in fostering physical activity .
Nevertheless , there remain some inconsistencies and mixed evidence with regard to the relations between specific SDT constructs and exercise . |
MS212376 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 — Aortic stiffness is a marker of cardiovascular disease and an independent predictor of cardiovascular risk . Although an association between inflammatory markers and increased arterial stiffness has been suggested , the causative relationship between inflammation and arterial stiffness has not been investigated . Methods and Results — One hundred healthy individuals were studied according to a r and omized , double-blind , sham procedure-controlled design . Each sub study consisted of 2 treatment arms , 1 with Salmonella typhi vaccination and 1 with sham vaccination . Vaccination produced a significant ( P<0.01 ) increase in pulse wave velocity ( at 8 hours by 0.43 m/s ) , denoting an increase in aortic stiffness . Wave reflections were reduced significantly ( P<0.01 ) by vaccination ( decrease in augmentation index of 5.0 % at 8 hours and 2.5 % at 32 hours ) as a result of peripheral vasodilatation . These effects were associated with significant increases in inflammatory markers such as high-sensitivity C-reactive protein ( P<0.001 ) , high-sensitivity interleukin-6 ( P<0.001 ) , and matrix metalloproteinase-9 ( P<0.01 ) . With aspirin pretreatment ( 1200 mg PO ) , neither pulse wave velocity nor augmentation index changed significantly after vaccination ( increase of 0.11 m/s and 0.4 % , respectively ; P = NS for both ) . Conclusions — This is the first study to show through a cause- and -effect relationship that acute systemic inflammation leads to deterioration of large-artery stiffness and to a decrease in wave reflections . These findings have important implication s , given the importance of aortic stiffness for cardiovascular function and risk and the potential of therapeutic interventions with antiinflammatory properties Background New 2007 European Society of Hypertension guidelines recommend measuring arterial stiffness in patients with arterial hypertension , suggesting a carotid – femoral pulse wave velocity over 12 m/s as an estimate of sub clinical organ damage . Considering this cutoff point , it is worth exploring whether or not there are significant differences in results obtained using various techniques for measuring aortic pulse wave velocity . The aim of the study was to compare aortic pulse wave velocity measurements using Complior , SphygmoCor , and Arteriograph devices , and to assess the effect of pulse wave transit time and traveled distance on pulse wave velocity values . Methods Aortic pulse wave velocity was measured on a single visit , using these devices , in r and omized order , in a group of 64 patients with grade 1 or 2 arterial hypertension . Results Aortic pulse wave velocity measured using Complior ( 10.1 ± 1.7 m/s ) was significantly higher than that obtained using SphygmoCor ( 8.1 ± 1.1 m/s ) or Arteriograph ( 8.6 ± 1.3 m/s ) . No differences were noted between pulse wave velocity measurements using SphygmoCor and Arteriograph . Between- method comparison revealed that differences in traveled distance were significant : Complior versus Arteriograph [ 0.09 m , Confidence interval ( CI ) : 0.08–0.12 m , P < 0.05 ] , Complior versus SphygmoCor ( 0.15 m , CI : 0.13–0.16 m , P < 0.05 ) , Arteriograph versus SphygmoCor ( 0.05 m , CI : 0.03–0.07 m , P < 0.05 ) . No between- method differences were found for transit times . Conclusion Differences in pulse wave velocity obtained by compared devices result ed primarily from using various methods for measuring traveled distance . It appears reasonable to establish uniform principles for the measurement of traveled distance . Because a large number of prognosis/survival studies used direct distance between carotid and femoral sites of pulse wave recording , this distance should be mostly recommended Background — Rheumatoid arthritis ( RA ) is associated with increased cardiovascular risk , which is not explained by traditional cardiovascular risk factors but may be due in part to increased aortic stiffness , an independent predictor of cardiovascular mortality . In the present study , our aim was to establish whether aortic stiffness is increased in RA and to investigate the relationship between inflammation and aortic stiffness . In addition , we tested the hypothesis that aortic stiffness could be reduced with anti – tumor necrosis factor-&agr ; ( TNF-&agr ; ) therapy . Methods and Results — Aortic pulse-wave velocity ( PWV ) , augmentation index , and blood pressure were measured in 77 patients with RA and in 142 healthy individuals . Both acute and chronic inflammatory measures and disease activity were determined . The effect of anti-TNF-&agr ; therapy on PWV and endothelial function was measured in 9 RA patients at 0 , 4 , and 12 weeks . Median ( interquartile range ) aortic PWV was significantly higher in subjects with RA than in control subjects ( 8.35 [ 7.14 to 10.24 ] versus 7.52 [ 6.56 to 9.18 ] m/s , respectively ; P=0.005 ) . In multiple regression analyses , aortic PWV correlated independently with age , mean arterial pressure , and log-transformed C-reactive protein ( R2=0.701 ; P<0.0001 ) . Aortic PWV was reduced significantly by anti-TNF-&agr ; therapy ( 8.82±2.04 versus 7.94±1.86 versus 7.68±1.56 m/s at weeks 0 , 4 , and 12 , respectively ; P<0.001 ) ; concomitantly , endothelial function improved . Conclusions — RA is associated with increased aortic stiffness , which correlates with current but not historical measures of inflammation , suggesting that increased aortic stiffness may be reversible . Indeed , anti-TNF-&agr ; therapy reduced aortic stiffness to a level comparable to that of healthy individuals . Therefore , effective control of inflammation may be of benefit in reducing cardiovascular risk in patients with RA Arterial stiffness , estimated by pulse wave velocity ( PWV ) , is an independent predictor of cardiovascular mortality and morbidity . However , the clinical applicability of these measurements and the elaboration of reference PWV values are difficult due to differences between the various devices used . In a population of 50 subjects aged 20–84 years , we compared PWV measurements with three frequently used devices : the Complior and the PulsePen , both of which determine aortic PWV as the delay between carotid and femoral pressure wave and the PulseTrace , which estimates the Stiffness Index ( SI ) by analyzing photoplethysmographic waves acquired on the fingertip . PWV was measured twice by each device . Coefficient of variation of PWV was 12.3 , 12.4 and 14.5 % for PulsePen , Complior and PulseTrace , respectively . These measurements were compared with the reference method , that is , a simultaneous acquisition of pressure waves using two tonometers . High correlation coefficients with the reference method were observed for PulsePen ( r=0.99 ) and Complior ( r=0.83 ) , whereas for PulseTrace correlation with the reference method was much lower ( r=0.55 ) . Upon Bl and –Altman analysis , mean differences of values±2s.d . versus the reference method were −0.15±0.62 m/s , 2.09±2.68 m/s and −1.12±4.92 m/s , for PulsePen , Complior and PulseTrace , respectively . This study confirms the reliability of Complior and PulsePen devices in estimating PWV , while the SI determined by the PulseTrace device was found to be inappropriate as a surrogate of PWV . The present results indicate the urgent need for evaluation and comparison of the different devices to st and ardize PWV measurements and establish reference values BACKGROUND Premature arterial stiffening and atherosclerosis are increased in patients with inflammatory arthropathies such as rheumatoid arthritis ( RA ) , ankylosing spondylitis ( AS ) and psoriatic arthritis ( PsA ) . The proinflammatory protein calprotectin is associated with inflammatory arthropathies , vascular pathology , and acute coronary events . We examined the long-term effects of treatment with tumor necrosis factor (TNF)-α antagonists on aortic stiffness and carotid intima media thickness ( CIMT ) in patients with inflammatory arthropathies , and the relationships to the levels of calprotectin . METHODS Fifty-five patients with RA , AS , or PsA and a clinical indication for anti-TNF-α therapy were included and followed with regular examinations for 1 year . Thirty-six patients starting with anti-TNF-α therapy were compared with a nontreatment group of 19 patients . Examinations included assessment s of aortic stiffness ( aortic pulse wave velocity , aPWV ) , CIMT , and plasma calprotectin . RESULTS After 1 year , aPWV ( mean ( s.d . ) ) was improved in the treatment group , but not in the control group ( -0.54 [ 0.79 ] m/s vs. 0.06 [ 0.61 ] m/s , respectively ; P = 0.004 ) , and CIMT progression ( median ( quartile cut-points , 25th and 75th percentiles ) ) was reduced in the treatment group compared to the control group ( -0.002 [ -0.038 , 0.030 ] mm vs. 0.030 [ 0.011 , 0.043 ] mm , respectively ; P = 0.01 ) . In multivariable analyses , anti-TNF-α therapy over time was associated with improved aPWV ( P = 0.02 ) and reduced CIMT progression ( P = 0.04 ) , and calprotectin was longitudinally associated with aPWV ( P = 0.02 ) . CONCLUSIONS Long-term anti-TNF-α therapy improved aortic stiffness and CIMT progression in patients with inflammatory arthropathies . Calprotectin may be a soluble biomarker reflecting aortic stiffening in these patients
Output:
| CONCLUSION cf-PWV is increased in both ulcerative colitis and Crohn 's disease patients |
MS212377 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Lowering the price of fruit and vegetables is a promising strategy in stimulating the purchase of those foods . However , the true effects of this strategy are not well studied and it is unclear how the money saved is spent . The aim of this study is to examine the effects of a 25 % discount on fruits and vegetables on food purchases in a supermarket environment . Methods A r and omized controlled trial with two research conditions was conducted : a control condition with regular prices ( n = 52 ) and an experimental condition with a 25 % discount on fruits and vegetables ( n = 63 ) . The experiment was carried out using a three-dimensional web-based supermarket , which is a software application in the image of a real supermarket . Data were collected in 2010 in the Netherl and s. Participants received a fixed budget and were asked to buy weekly household groceries at the web-based supermarket . Differences in fruit and vegetable purchases , differences in expenditures in other food categories and differences in total calories were analyzed using independent sample s t-tests and multiple linear regression models accounting for potential effect modifiers and confounders . Results The purchased amount of fruit plus vegetables was significantly higher in the experimental condition compared to the control condition ( Δ984 g per household per week , p = .03 ) after appropriate adjustments . This corresponds to a 25 % difference compared to the control group . Both groups had similar expenditures in unhealthier food categories , including desserts , soda , crisps , c and y and chocolate . Furthermore , both groups purchased an equal number of food items and an equal amount of calories , indicating that participants in the discount condition did not spend the money they saved from the discounts on other foods than fruits and vegetables . Conclusion A 25 % discount on fruits and vegetables was effective in stimulating purchases of those products and did neither lead to higher expenditures in unhealthier food categories nor to higher total calories purchased . Future studies in real supermarkets need to confirm these findings The role of dietary fat in the regulation of energy intake was assessed by manipulating a conventional diet and measuring spontaneous food consumption . Twenty-four women each consumed a sequence of three 2-wk dietary treatments in which 15 - 20 % , 30 - 35 % , or 45 - 50 % of the energy was derived from fat . These diets consisted of foods that were similar in appearance and palatability but differed in the amount of high-fat ingredients used . Relative to their energy consumption on the medium-fat diet , the subjects spontaneously consumed an 11.3 % deficit on the low-fat diet and a 15.4 % surfeit on the high-fat diet ( p less than 0.0001 ) , result ing in significant changes in body weight ( p less than 0.001 ) . A small amount of caloric compensation did occur ( p less than 0.02 ) , which was greatest in the leanest subjects ( p less than 0.03 ) . These results suggest that habitual , unrestricted consumption of low-fat diets may be an effective approach to weight control The purpose of this study was to evaluate the impact of adopting a Mediterranean diet on dietary cost and energy density in free-living conditions . The 12-wk nutritional intervention consisted of 2 group courses and 7 individual sessions with a dietician in a sample of 73 healthy women . To evaluate the dietary response to the nutritional intervention , a registered dietician administered a FFQ at 0 , 6 , 12 , and 24 wk . Total daily dietary cost was calculated using a price list including all items from the FFQ . Our findings indicated that daily energy cost evaluated at wk 12 vs. wk 0 [ 1046 + /- 217 vs. 967 + /- 192 kJ/Canadian dollars ( CAN$ ) , respectively , P = 0.18 ] and total daily dietary cost ( 8.61 + /- 2.13 vs. 8.75 + /- 2.50 CAN$/d per participant , respectively , P = 0.58 ) did not change . Total daily energy density at wk 12 decreased compared with wk 0 ( 2.56 + /- 0.76 vs. 2.20 + /- 0.67 kJ/g ; P < 0.0001 ) . Adherence to the Mediterranean diet led to increased cost related to vegetables , fruits , legumes , nuts and seeds , canola/olive oil , whole grains , poultry , and fish ( P < or = 0.01 ) and to reduced dietary cost for red meat , refined grains , desserts and sweets , and fast food ( P < or = 0.008 ) . In conclusion , these data suggest that adherence to a nutritional intervention program promoting the Mediterranean food pattern is not associated with increased daily dietary cost or energy cost but led to a reduction in energy density . Consequently , increased cost should not be considered a barrier to the promotion and adoption of a Mediterranean diet PURPOSE Degrees of nutrient intake and food groups have been linked to differential chronic disease risk . However , intakes of specific nutrients may also be associated with differential diet costs and unobserved differences in socioeconomic status ( SES ) . The present study examined degrees of nutrient intake , for every key nutrient in the diet , in relation to diet cost and SES . METHODS Socio-demographic data for a stratified r and om sample of adult respondents in the Seattle Obesity Study were obtained through telephone survey . Dietary intakes were assessed using food frequency question naire ( FFQ ) ( n = 1,266 ) . Following st and ard procedures , nutrient intakes were energy-adjusted using the residual method and converted into quintiles . Diet cost for each respondent was estimated using Seattle supermarket retail prices for 384 FFQ component foods . RESULTS Higher intakes of dietary fiber , vitamins A , C , D , E , and B12 , beta carotene , folate , iron , calcium , potassium , and magnesium were associated with higher diet costs . The cost gradient was most pronounced for vitamin C , beta carotene , potassium , and magnesium . Higher intakes of saturated fats , trans fats and added sugars were associated with lower diet costs . Lower cost lower quality diets were more likely to be consumed by lower SES . CONCLUSION Nutrients commonly associated with a lower risk of chronic disease were associated with higher diet costs . By contrast , nutrients associated with higher disease risk were associated with lower diet costs . The cost variable may help somewhat explain why lower income groups fail to comply with dietary guidelines and have highest rates of diet related chronic disease BACKGROUND The inverse relation between energy density ( kcal/g ) and energy cost ( price/kcal ) has been interpreted to suggest that produce ( fruit , vegetables ) is more expensive than snacks ( cookies , chips ) . OBJECTIVE The objective of this study was to show the method ologic weakness of comparing energy density with energy cost . DESIGN The relation between energy density and energy cost was replicated in a r and om-number data set . Additionally , observational data were collected for produce and snacks from an online supermarket . Variables included total energy ( kcal ) , total weight ( g ) , total number of servings , serving size ( g/serving ) , and energy density ( kcal/g ) . Price measures included energy cost ( $ /kcal ) , total price ( $ ) , unit price ( $ /g ) , and serving price ( $ /serving ) . Two-tailed t tests were used to compare price measures by food category . Relations between energy density and price measures within food categories were examined with the use of Spearman rank correlation analysis . RESULTS The relation between energy density and energy cost was shown to be driven by the algebraic properties of these variables . Food category was strongly correlated with both energy density and food price measures . Energy cost was higher for produce than for snacks . However , total price and unit price were lower for produce . Serving price and serving size were greater for produce than for snacks . Within food categories , energy density was uncorrelated with most measures of food price , except for a weak positive correlation with serving price within the produce category . CONCLUSION The findings suggest the relation between energy density and food price is confounded by food category and depends on which measure of price is used OBJECTIVE To examine the effectiveness of two methods of increasing fruit and fruit juice intake in pregnancy : midwives ' advice and vouchers exchangeable for juice . DESIGN Pregnant women were r and omly allocated to three groups : a control group , who received usual care ; an advice group , given advice and leaflets promoting fruit and fruit juice consumption ; and a voucher group , given vouchers exchangeable for fruit juice from a milk delivery firm . Dietary question naires were administered at ~16 , 20 and 32 weeks of pregnancy . Serum beta-carotene was measured at 16 and 32 weeks . SETTING An antenatal clinic in a deprived area . SUBJECTS Pregnant women aged 17 years and over . RESULTS The study comprised 190 women . Frequency of fruit consumption declined during pregnancy in all groups , but that of fruit juice increased substantially in the voucher group . Serum beta-carotene concentration increased in the voucher group , from 106.2 to 141.8 micromol l(-1 ) in women with measurements on both occasions ( P = 0.003 ) , decreased from 120.0 to 99.8 micromol l(-1 ) in the control group ( P = 0.005 ) , and was unchanged in the advice group . CONCLUSIONS Pregnant women drink more fruit juice if they receive vouchers exchangeable for juice supplied by the milk delivery service . Midwives ' advice to eat more fruit has no great effect . Providing vouchers for fruit juice is a simple method of increasing its intake in a deprived population and may be useful for other sections of the community Here , we describe the measurement characteristics of a 13-item dietary screener used in the Prostate Cancer Prevention Trial . We used data from 10,913 men who completed the 13-item dietary screener , a food frequency question naire ( FFQ ) , and question naires on demographic and health-related characteristics and from 146 men who also completed multiple 24-h dietary recalls in a sub study . The analyses in this report focused on percentage energy from fat and saturated fat and used the mean estimates from the dietary recalls as the criterion measures . Absolute nutrient estimates from the screener were about one-third of the estimates from the recalls and the FFQ . Validity was defined as the Pearson correlation of the criterion measures of fat with the corresponding measures from the FFQ and the screener . The FFQ was a statistically significantly more precise measure of percentage energy from fat ( r = 0.71 ) and saturated fat ( r = 0.72 ) than was the screener ( r = 0.50 and 0.53 , respectively ) . There were also statistically significant differences in how well these instruments could detect variation in dietary fat across various participant characteristics , suggesting that the screener may not perform as well as the FFQ across demographic strata such as education ( P < 0.001 ) . The results from this study suggest that the use of short dietary screeners as the sole assessment instrument may result in a serious loss of information regarding important exposures ( e.g. , fat intake ) and lost opportunities to enhance our knowledge regarding dietary factors and cancer risk The Dietary Approaches to Stop Hypertension ( DASH ) diet is perhaps the best example of how a nutrient dense dietary pattern can prevent chronic disease . In r and omized trials , DASH dietary patterns lowered blood pressure in hypertensive individuals.1 Subsequent trials and observational studies have consistently found that DASH-type diets reduced cardiovascular and metabolic BACKGROUND Reducing fruit and vegetable ( F&V ) prices is a frequently considered policy to improve dietary habits in the context of health promotion . However , evidence on the effectiveness of this intervention is limited . OBJECTIVE The objective was to examine the effects of a 50 % price discount on F&Vs or nutrition education or a combination of both on supermarket purchases . DESIGN A 6-mo r and omized controlled trial within Dutch supermarkets was conducted . Regular supermarket shoppers were r and omly assigned to 1 of 4 conditions : 50 % price discounts on F&Vs , nutrition education , 50 % price discounts plus nutrition education , or no intervention . A total of 199 participants provided baseline data ; 151 ( 76 % ) were included in the final analysis . F&V purchases were measured by using supermarket register receipts at baseline , at 1 mo after the start of the intervention , at 3 mo , at 6 mo ( end of the intervention period ) , and 3 mo after the intervention ended ( 9 mo ) . RESULTS Adjusted multilevel models showed significantly higher F&V purchases ( per household/2 wk ) as a result of the price discount ( + 3.9 kg ; 95 % CI : 1.5 , 6.3 kg ) and the discount plus education intervention ( + 5.6 kg ; 95 % CI : 3.2 , 7.9 kg ) at 6 mo compared with control . Moreover , the percentage of participants who consumed recommended amounts of F&Vs ( ≥400 g/d ) increased from 42.5 % at baseline to 61.3 % at 6 mo in both discount groups ( P = 0.03 ) . Education alone had no significant effect . CONCLUSIONS Discounting F&Vs is a promising intervention strategy because it result ed in substantially higher F&V purchases , and no adverse effects were observed . Therefore , pricing strategies form an important focus for future interventions or policy . However , the long-term effects and the ultimate health outcomes require further investigation . This trial was registered at the IS RCT N Trial Register as number IS RCT N56596945
Output:
| Data Synthesis : Foods of lower nutritional value and lower- quality diets generally cost less per calorie and tended to be selected by groups of lower socioeconomic status .
A number of nutrient-dense foods were available at low cost but were not always palatable or culturally acceptable to the low-income consumer .
Acceptable healthier diets were uniformly associated with higher costs .
Food budgets in poverty were insufficient to ensure optimum diets .
Conclusions : Socioeconomic disparities in diet quality may be explained by the higher cost of healthy diets . |
MS212378 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The objective of this study was to assess the evidence for or against the effectiveness of cupping as a treatment option for pain . Fourteen data bases were search ed . R and omized clinical trials ( RCTs ) testing cupping in patients with pain of any origin were considered . Trials using cupping with or without drawing blood were included , while trials comparing cupping with other treatments of unproven efficacy were excluded . Trials with cupping as concomitant treatment together with other treatments of unproven efficacy were excluded . Trials were also excluded if pain was not a central symptom of the condition . The selection of studies , data extraction and validation were performed independently by three review ers . Seven RCTs met all the inclusion criteria . Two RCTs suggested significant pain reduction for cupping in low back pain compared with usual care ( P < .01 ) and analgesia ( P < .001 ) . Another two RCTs also showed positive effects of cupping in cancer pain ( P < .05 ) and trigeminal neuralgia ( P < .01 ) compared with anticancer drugs and analgesics , respectively . Two RCTs reported favorable effects of cupping on pain in brachialgia compared with usual care ( P = .03 ) or heat pad ( P < .001 ) . The other RCT failed to show superior effects of cupping on pain in herpes zoster compared with anti-viral medication ( P = .065 ) . Currently there are few RCTs testing the effectiveness of cupping in the management of pain . Most of the existing trials are of poor quality . Therefore , more rigorous studies are required before the effectiveness of cupping for the treatment of pain can be determined Women diagnosed with breast cancer received massage therapy or practice d progressive muscle relaxation ( PMR ) for 30-min sessions 3 times a week for 5 weeks or received st and ard treatment . The massage therapy and relaxation groups reported less depressed mood , anxiety , and pain immediately after their first and last sessions . By the end of the study , however , only the massage therapy group reported being less depressed and less angry and having more vigor . Dopamine levels , Natural Killer cells , and lymphocytes also increased from the first to the last day of the study for the massage therapy group . These findings highlight the benefit of these complementary therapies , most particularly massage therapy , for women with breast cancer 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 Evaluating the effectiveness of nursing interventions in decreasing pain is a top priority for clinical research . Unfortunately , most of the research on cancer pain relief has been limited to treatment studies involving the administration of analgesics . Research is needed to determine which nonanalgesic methods of pain control are effective and under what conditions . Consequently , an experimental study was design ed to test the effectiveness of massage as an intervention for cancer pain . Twenty-eight patients were r and omly assigned to a massage or control group . The patients in the massage group were given a 10 minute massage to the back ; the patients in the control group were visited for 10 minutes . For males , there was a significant decrease in pain level immediately after the massage . For females , there was not a significant decrease in pain level immediately after the massage . There were no significant differences between pain 1 hour and 2 hours after the massage in comparison with the initial pain for males or females . Massage was shown to be an effective short-term nursing intervention for pain in males in this sample Complementary therapies are increasingly used to reduce side effects of cancer treatment , without evidence for their effectiveness . In a r and omized , prospect i ve , 2-period , crossover intervention study , the authors tested the effects of therapeutic massage ( MT ) and healing touch ( HT ) , in comparison to presence alone or st and ard care , in inducing relaxation and reducing symptoms in 230 subjects . MT and HT lowered blood pressure , respiratory rate ( RR ) , and heart rate ( HR ) . MT lowered anxiety and HT lowered fatigue , and both lowered totalmooddisturbance . Pain ratings were lower after MT and HT , with 4-week nonsteroidal antiinflammatory drug use less during MT . There were no effects on nausea . Presence reduced RR and HR but did not differ from st and ard care on any measure of pain , nausea , mood states , anxiety , or fatigue . MT and HT are more effective than presence alone or st and ard care in reducing pain , mood disturbance , and fatigue in patients receiving cancer chemotherapy BACKGROUND To investigate the method ological quality of r and omized controlled trials in three areas of complementary medicine . METHODS The method ological quality of 207 r and omized trials collected for five previously published systematic review s on homeopathy , herbal medicine ( Hypericum for depression , Echinacea for common cold ) , and acupuncture ( for asthma and chronic headache ) was assessed using a vali date d scale ( the Jadad scale ) and single quality items . RESULTS While the method ological quality of the trials was highly variable , the majority had important shortcomings in reporting and /or methodology . Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals . There were relevant differences in single quality components between the different complementary therapies : For example , acupuncture trials reported adequate allocation concealment less often ( 6 % versus 32 % of homeopathy and 26 % of herb trials ) , and trials on herbal extracts had better summary scores ( mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials ) . Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria . CONCLUSION Trials of complementary therapies often have relevant method ological weaknesses . The type of weaknesses varies considerably across interventions Goal of workBreast cancer survivors have limited options for the treatment of hot flashes and related symptoms . Further , therapies widely used to prevent recurrence in survivors , such as tamoxifen , tend to induce or exacerbate menopausal symptoms . The aim of this preliminary , r and omized controlled trial was to evaluate the effects of a yoga intervention on menopausal symptoms in a sample of survivors of early-stage breast cancer ( stages IA – IIB ) . Material s and methods Thirty-seven disease-free women experiencing hot flashes were r and omized to the 8-week Yoga of Awareness program ( gentle yoga poses , meditation , and breathing exercises ) or to wait-list control . The primary outcome was daily reports of hot flashes collected at baseline , posttreatment , and 3 months after treatment via an interactive telephone system . Data were analyzed by intention to treat . Main results At posttreatment , women who received the yoga program showed significantly greater improvements relative to the control condition in hot-flash frequency , severity , and total scores and in levels of joint pain , fatigue , sleep disturbance , symptom-related bother , and vigor . At 3 months follow-up , patients maintained their treatment gains in hot flashes , joint pain , fatigue , symptom-related bother , and vigor and showed additional significant gains in negative mood , relaxation , and acceptance . Conclusions This pilot study provides promising support for the beneficial effects of a comprehensive yoga program for hot flashes and other menopausal symptoms in early-stage breast cancer survivors Context Some patients nearing death seek pain relief with massage , but little is known about the effectiveness of massage in managing pain in palliative care setting s. Contribution In this r and omized trial in 380 patients with advanced cancer , improvement in pain and mood immediately after treatment was greater with massage than with simple touch . Unfortunately , there were no sustained differences in pain , quality of life , or analgesic use during 3 weeks . Adverse effects were infrequent and similar in both groups . Implication Massage may offer some immediate relief for patients with advanced cancer , but the absence of sustained effects demonstrates the need for more effective strategies to manage pain at the end of life . The Editors Symptom relief is central to end-of-life care ; however , many terminally ill individuals experience serious pain and other physical and emotional symptoms ( 14 ) . Studies examining the efficacy of therapies that may mediate these symptoms deserve the highest priority . The Institute of Medicine and the National Institutes of Health recommend research directed at improving end-of-life care ( 5 , 6 ) . Pain associated with advanced cancer can cause physical and emotional distress , leading to decreased functional ability and quality of life . Massage may interrupt the cycle of distress through the therapist 's intention ( presence , communication , and desire to produce a therapeutic response ) , induction of a relaxation response , increased blood and lymphatic circulation , potentiation of analgesic effects , decreased inflammation and edema , manual release of muscle spasms , increased endogenous endorphin release , and competing sensory stimuli that override pain signals ( 711 ) . Despite theoretical bases supporting the use and growing acceptance of massage therapy , few r and omized clinical trials have assessed its efficacy . Large trials have been difficult to design and carry out ; challenges include frailty of patients with late-stage cancer and reluctance of health care providers to refer patients because of the possibility of r and omization to nonmassage therapy control ( 12 ) . Therapeutic massage can reduce pain and improve symptom distress and quality of life for patients with cancer at the end of life . The purpose of the REST ( Reducing End-of-Life Symptoms with Touch ) study was to evaluate the efficacy of massage compared with an exposure controlling for time , attention , and touch . We hypothesized that massage would decrease pain and explored effects on quality of life , physical and emotional symptom distress , and analgesic medicine use . Methods Design Overview We conducted this prospect i ve , 2-group , r and omized , single-blind trial between November 2003 and October 2006 . After we evaluated patients for inclusion and exclusion criteria , patients provided written informed consent . Then we r and omly assigned patients to a treatment group ( massage ) or control exposure ( simple touch ) . Figure 1 depicts the timing of the study procedures for a hypothetical participant . We collected individual characteristics , disease , pain characteristics , symptom distress , quality of life , functional status ( Karnofsky Performance Scale score ) ( 13 ) , expected helpfulness of massage for pain , and concurrent interventions ( pharmacologic and nonpharmacologic ) at baseline ( within 72 hours of study enrollment ) and at 3 subsequent weekly visits over the 3 to 4 weeks of participation ( sustained outcomes ) . Final data collection occurred approximately 1 week after the final treatment . Data collectors were blinded to treatment assignment . Participants received up to six 30-minute treatments over 2 weeks , with at least 24 hours between treatment sessions . The initial treatment session occurred within 48 hours of baseline data collection . The treatment provider and patient determined the scheduling of treatment sessions . Treatment providers who were not blinded to treatment assignment obtained the immediate outcomes just before and after every treatment session . All participants received routine care in addition to the specified interventions . The Colorado Multiple Institutional Review Board and , where applicable , site-specific institutional review boards approved the study . Figure 1 . Study overview : timing of study procedures . Setting and Participants Study sites included 15 U.S. hospices that are members of the Population -based Palliative Care Research Network ( PoPCRN ) ( 14 ) and the University of Colorado Cancer Center , Aurora , Colorado . Eligible participants were English-speaking adults with advanced cancer ( stage III or IV , all cancer types , any care setting ) who had at least moderate pain ( score 4 on a 0- to 10-point scale ) in the week before enrollment , an anticipated life expectancy of at least 3 weeks , and the ability to consent . Exclusion criteria included receipt of professional massage within 1 month of enrollment , anticoagulant therapy , known platelet count less than 10109 cells/L , or known unstable spine . R and omization and Interventions Verification of eligibility was forwarded by a study coordinator from each study site to the University of Colorado research ers . Two design ated investigators r and omly assigned patients ; assignments were transmitted back to the requesting site . All study personnel other than the on-site study
Output:
| Based on available evidence , we could find that psychoeducational interventions , music interventions , acupuncture plus drug therapy , Chinese herbal medicine plus cancer therapy , compound kushen injection , reflexology , lycopene , TENS , qigong , cupping , cannabis , Reiki , homeopathy ( Traumeel ) , and creative arts therapies might have beneficial effects on adult cancer pain .
No benefits were found for acupuncture ( versus drug therapy or shame acupuncture ) , and the results were inconsistent for massage therapy , transcutaneous electric nerve stimulation ( TENS ) , and Viscum album L plus cancer treatment .
Conclusion . |
MS212379 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Interventions design ed to narrow the gap between research findings and clinical practice may be effective , but also costly . Economic evaluations are necessary to judge whether such interventions are worth the effort . We have evaluated the economic effects of a tailored intervention to support the implementation of guidelines for the use of antihypertensive and cholesterol-lowering drugs . The tailored intervention was evaluated in a r and omized trial , and was shown to significantly increase the use of thiazides for patients started on antihypertensive medication , but had little or no impact on other outcomes . The increased use of thiazides was not expected to have an impact on health outcomes . Methods and Findings We performed cost-minimization and cost-effectiveness analyses on data from a r and omized trial involving 146 general practice s from two geographical areas in Norway . Each practice was r and omized to either the tailored intervention ( 70 practice s ; 257 physicians ) or control group ( 69 practice s ; 244 physicians ) . Only patients that were being started on antihypertensive medication were included in the analyses . A multifaceted intervention was tailored to address identified barriers to change . Key components were an educational outreach visit with audit and feedback , and computerized reminders . Pharmacists conducted the visits . A cost-minimization framework was adopted , where the costs of intervention were set against the reduced treatment costs ( principally due to increased use of thiazides rather than more expensive medication ) . The cost-effectiveness of the intervention was estimated as the cost per additional patient being started on thiazides . The net annual cost ( cost minimization ) in our study population was US$ 53,395 , corresponding to US$ 763 per practice . The cost per additional patient started on thiazides ( cost-effectiveness ) was US$ 454 . The net annual savings in a national program was modeled to be US$ 761,998 , or US$ 540 per practice after 2 y. In this scenario the savings exceeded the costs in all but two of the sensitivity analyses we conducted , and the cost-effectiveness was estimated to be US$ 183 . Conclusions We found a significant shift in prescribing of antihypertensive drugs towards the use of thiazides in our trial . A major reason to promote the use of thiazides is their lower price compared to other drugs . The cost of the intervention was more than twice the savings within the time frame of our study . However , we predict modest savings over a 2-y period OBJECTIVE Computerized medical decision support tools have been shown to improve the quality of care and have been cited by the Institute of Medicine as one method to reduce pharmaceutical errors . We evaluated the impact of an antiinfective decision support tool in a pediatric intensive care unit ( PICU ) . METHODS We enhanced an existing adult antiinfective management tool by adding and changing medical logic to make it appropriate for pediatric patients . Process and outcomes measures were monitored prospect ively during a 6-month control and a 6-month intervention period . M and atory use of the decision support tool was initiated for all antiinfective orders in a 26-bed PICU during the intervention period . Clinician opinions of the decision support tool were surveyed via question naire . RESULTS The rate of pharmacy interventions for erroneous drug doses declined by 59 % . The rate of anti-infective subtherapeutic patient days decreased by 36 % , and the rate of excessive-dose days declined by 28 % . The number of orders placed per antiinfective course decreased 11.5 % , and the robust estimate of the antiinfective costs per patient decreased 9 % . The type of anti-infectives ordered and the number of antiinfective doses per patient remained similar , as did the rates of adverse drug events and antibiotic-bacterial susceptibility mismatches . The surveyed clinicians reported that use of the program improved their antiinfective agent choices as well as their awareness of impairments in renal function and reduced the likelihood of adverse drug events . CONCLUSIONS Use of the pediatric antiinfective decision support tool in a PICU was considered beneficial to patient care by the clinicians and reduced the rates of erroneous drug orders , improved therapeutic dosage targets , and was associated with a decreased robust estimate of antiinfective costs per patient . antiinfective agents , decision support systems , drug therapy , medication errors , child , infant OBJECTIVE Many hospitals utilize antimicrobial management teams ( AMTs ) to improve patient care . However , most function with minimal computer support . We evaluated the effectiveness and cost-effectiveness of a computerized clinical decision support system for the management of antimicrobial utilization . DESIGN A r and omized controlled trial in adult in patients between May 10 and August 3 , 2004 . Antimicrobial utilization was managed by an existing AMT using the system in the intervention arm and without the system in the control arm . The system was developed to alert the AMT of potentially inadequate antimicrobial therapy . MEASUREMENTS Outcomes assessed were hospital antimicrobial expenditures , mortality , length of hospitalization , and time spent managing antimicrobial utilization . RESULTS The AMT intervened on 359 ( 16 % ) of 2,237 patients in the intervention arm and 180 ( 8 % ) of 2,270 in the control arm , while spending approximately one hour less each day on the intervention arm . Hospital antimicrobial expenditures were $ 285,812 in the intervention arm and $ 370,006 in the control arm , for a savings of $ 84,194 ( 23 % ) , or $ 37.64 per patient . No significant difference was observed in mortality ( 3.26 % vs. 2.95 % , p = 0.55 ) or length of hospitalization ( 3.84 vs. 3.99 days , p = 0.38 ) . CONCLUSION Use of the system facilitated the management of antimicrobial utilization by allowing the AMT to intervene on more patients receiving inadequate antimicrobial therapy and to achieve substantial time and cost savings for the hospital . This is the first study that demonstrates in a patient-r and omized controlled trial that computerized clinical decision support systems can improve existing antimicrobial management programs BACKGROUND The Institute of Medicine has urged the adoption of electronic prescribing systems in all health-care organizations by 2010 . Accordingly , computerized physician order entry ( CPOE ) warrants detailed evaluation . Mixed results have been reported about the benefit of this system . No review of its application in surgical patients has been reported to date . We present the implementation of CPOE in the management of surgical patients within an academic multispecialty practice . STUDY DESIGN Retrospective and prospect i ve analyses of patient-safety measures were done pre- and post-CPOE institution , respectively . Other metrics evaluated included medication errors , order-implementation times , efficiencies , personnel requirements , and physician time . Sampling of time span for the order placement process was assessed with direct hidden observation of the provider . RESULTS A total of 15 ( 0.22 % ) medication errors were discovered in 6,815 surgical procedures performed during the 6 months before CPOE use . After implementation , 10 medication errors were found ( 5,963 surgical procedures [ 0.16 % ] ) in the initial 6 months and 13 ( 0.21 % ) in the second 6 months ( 6,106 surgical procedures ) ( p = NS ) . Mean total time from placement of order to nurse receipt before implementation was 41.2 minutes per order ( 2.05 minutes finding chart , 0.72 minutes writing order , 38.4 minutes for unit secretary transcription ) compared with 27 seconds per order using CPOE ( p < 0.01 ) . Four additional informational technology specialists were temporarily required for assistance in implementing CPOE . After CPOE adoption , 11 of 56 ( 19.6 % ) ancillary personnel positions were eliminated related to order-entry efficiencies . CONCLUSIONS Present CPOE technology can allow major efficiency gains , but refinements will be required for improvements in patient safety OBJECTIVE To assess the effects on health care re source utilization of a network of microcomputer workstations for writing all inpatient orders . DESIGN R and omized controlled clinical trial . SETTING Inpatient internal medicine service of an urban public hospital . SUBJECTS A total of 5219 internal medicine patients and the 68 teams of house officers , medical students , and faculty internists who cared for them . INTERVENTION Microcomputer workstations , linked to a comprehensive electronic medical record system , for writing all inpatient orders . MAIN OUTCOME MEASURES Total inpatient charges for each admission and charges for specific categories of orders . A time-motion study of selected interns assessed the ordering system 's time consumption . RESULTS Intervention teams generated charges that were $ 887 ( 12.7 % ) lower per admission than did control teams ( P = .02 ) . Significant reductions ( P < .05 ) were demonstrated separately for bed charges , diagnostic test charges , and drug charges . Reductions of similar proportion and statistical significance were found for hospital costs . The mean length of stay was 0.89 day shorter for intervention resident teams ( P = .11 ) . Interns in the intervention group spent an average of 33 minutes longer ( 5.5 minutes per patient ) during a 10-hour observation period writing orders than did interns in the control group ( P < .0001 ) . CONCLUSIONS A network of microcomputer workstations for writing all inpatient orders significantly lowered patient charges and hospital costs . This would amount to savings of more than $ 3 million in charges annually for this hospital 's medicine service and potentially tens of billions of dollars nationwide . However , the system required more physician time than did the paper charts . Research at other sites and system advances to reduce time requirements are warranted BACKGROUND Physicians frequently need to start antibiotic therapy before the results of bacterial cultures and antibiotic susceptibility tests are available . We developed and evaluated a computerized antibiotic consultant to assist physicians in the selection of appropriate empiric antibiotics . METHODS We used a two-stage r and om- selection study to compare antibiotics suggested by the antibiotic consultant with 482 associated antibiotic susceptibility results and the concurrent antibiotics ordered by physicians . The antibiotics ordered by r and omized physicians were then compared between crossover periods of antibiotic consultant use . RESULTS The antibiotic consultant suggested an antibiotic regimen to which all isolated pathogens were shown to be susceptible for 453 ( 94 % ) of 482 culture results , while physicians ordered an antibiotic regimen to which all isolated pathogens were susceptible for 369 culture results ( 77 % ) ( P < .001 ) . The physicians who prescribed antibiotics to which all pathogens were susceptible did so a mean of 21 hours after the culture specimens were collected . Physicians ordered appropriate antibiotics within 12 hours of the culture collection significantly more often when they had use of the antibiotic consultant than during the period before use ( P < .035 ) . Moreover , 88 % of the physicians stated they would recommend the program to other physicians , 85 % said the program improved their antibiotic selection , and 81 % said they felt use of the program improved patient care . CONCLUSIONS Information from computer-based medical records can be used to help improve physicians ' selection of empiric antibiotics for infections ABSTRACT Studies have shown benefits to patients from improved interventions involving antimicrobial therapy . The purpose of the present study was to evaluate prospect ively the impact of improved interventions by ( i ) the use of TheraTrac 2 , a computer software program which electronically links susceptibility testing results immediately to the pharmacy and alerts pharmacists of potential interventions , and ( ii ) the education of pharmacists involving microbiologic topics . The study group had the new intervention program . The control group had interventions performed the way that they had previously been done by manually review ing hard copies of susceptibility testing data . In a 5-month period , all in patients whose last names began with A to K were the study group ; in patients whose last names began with L to Z were controls . Three analyses were done ; one analysis ( analysis A ) involved only patients with interventions , one analysis ( analysis B ) involved all patients for whom antimicrobial testing was done and who were matched for diagnosis-related groups ( DRGs ) , regardless of whether an intervention occurred , and one analysis ( analysis C ) involved these DRG-matched patients by using severity-adjusted data . In analysis A , the study group had a 4.8 % decreased rate of mortality , an average of a 16.5-day decreased length of stay per patient , and $ 20,886 decreased variable direct costs per patient . None of these differences was statistically significant . In analysis B , the study patients had a 1.2 % higher mortality rate ( P = 0.741 ) , an average of a 2.7-day decreased length of stay per patient ( P = 0.035 ) , and $ 2,626 decreased variable direct costs per patient ( P = 0.008 ) . In analysis C , the study patients had a 1.4 % lower mortality rate , a 1.2-day decreased length of stay per patient , and $ 1,466 decreased variable direct costs per patient . In conclusion , the institution of this program caused substantial cost savings OBJECTIVE Although computerized physician order entry ( CPOE ) may decrease errors and improve quality , hospital adoption has been slow . The high costs and limited data on financial benefits of CPOE systems are a major barrier to adoption . The authors assessed the costs and financial benefits of the CPOE system at Brigham and Women 's Hospital over ten years . DESIGN Cost and benefit estimates of a hospital CPOE system at Brigham and Women 's Hospital ( BWH ) , a 720-ad
Output:
| A few studies found that HIT may offer cost advantages despite their increased acquisition costs .
Sophisticated concurrent prospect i ve economic evaluations need to be conducted to address whether HIT interventions in the medication management process are cost-effective |
MS212380 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7 PURPOSE To examine the effect of weekly completion of a patient-held quality -of-life ( QOL ) diary in routine oncology practice for palliative care patients . PATIENTS AND METHODS In a pragmatic r and omized controlled trial , 115 patients with inoperable lung cancer were r and omly assigned to receive either st and ard care or a structured QOL diary ( European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 and the related lung cancer module LC13 ) that they completed at home each week for 16 weeks . Patients were encouraged to share the QOL information with health professionals involved in their care . Changes in QOL over time ( measured by the Functional Assessment of Cancer Therapy-Lung question naire and the Palliative Care Quality of Life Index ) , discussion of patient problems , and satisfaction with communication and general care were assessed at baseline and at 2 and 4 months after baseline . RESULTS Analysis of QOL indicated a small but consistent difference between patients in the diary group and the st and ard care group . The diary group had a poorer QOL in many domains . Two different QOL summary scores ( total and overall QOL ) indicated a statistically significant between-group difference . No effects were found in relation to satisfaction with care , communication , or the discussion of patient problems . CONCLUSION The regular completion of a QOL question naire without appropriate feedback to health care professionals and without the provision of appropriate support may have a negative impact on inoperable lung cancer patients . Further research should focus on identifying features such as feedback loops that are required for the successful and meaningful use of QOL question naires in routine patient care PURPOSE Radiation Therapy Oncology Group trial 0525 tested whether dose-intensifying temozolomide versus st and ard chemoradiotherapy improves overall survival ( OS ) or progression-free survival ( PFS ) in newly diagnosed glioblastoma . Tests of neurocognitive function ( NCF ) and symptoms ( using the MD And erson Symptom Inventory-Brain Tumor module ; MDASI-BT ) and of quality of life ( European Organisation for the Research and Treatment of Cancer Quality of Life Question naire [ EORTC QLQ ] -C30/BN20 ) examined the net clinical benefit ( NCB ) of therapy . PATIENTS AND METHODS NCF tests ( Hopkins Verbal Learning Test-Revised , Trail Making Test , and Controlled Oral Word Association ) , MDASI-BT , and EORTC QLQ-C30/BN20 were completed in a subset of patients . Multivariate Cox proportional hazard regression modeling determined the prognostic value of baseline and early change from baseline to cycle 1 for OS and PFS . Two- sample proportional test statistic was used to evaluate differences between treatments ( dose-dense v st and ard-dose ) on NCB measures from baseline to cycle 4 in stable patients . RESULTS Overall , 182 patients participated in the study . Baseline NCF tests and the physical functioning quality of life scale were associated with OS and PFS . Baseline to cycle 1 in all NCB components were associated with OS and PFS . There was greater deterioration in the dose-dense arm from baseline to cycle 4 in the Global Health and Motor Function subscales ( EORTC QLQ-C30/BN20 ) as well as in overall symptom burden , overall symptom interference , and activity-related symptom interference subscales ( MDASI-BT ) . There were no between-arm differences in NCF . CONCLUSION Longitudinal collection of NCB measures is feasible in cooperative group studies and provides an added dimension to st and ard outcome measures . Greater adverse symptom burden and functional interference , as well as decreased global health and motor function were observed in patients r and omly assigned to the dose-dense arm . Baseline and early change in NCB measures were associated with decreased rates of survival PURPOSE Although patient-reported cancer symptoms and quality -of-life issues ( SQLIs ) have been promoted as essential to a comprehensive assessment , efficient and efficacious methods have not been widely tested in clinical setting s. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment -Cancer ( ESRA-C ) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits . Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians . PATIENTS AND METHODS This r and omized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center . Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit ( n = 327 ) ; in the control group , no summary was provided ( n = 333 ) . SQLIs were scored for level of severity or distress . One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI . We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians . RESULTS The likelihood of SQLIs being discussed differed by r and omized group and depended on whether an SQLI was first reported as problematic ( P = .032 ) . Clinic visits were similar with regard to duration between groups , and clinicians reported the summary as useful . CONCLUSION The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US r and omized clinical trial This is one of the few studies that have explored the value of baseline symptoms and health-related quality of life ( HRQOL ) in predicting survival in brain cancer patients . Baseline HRQOL scores ( from the EORTC QLQ-C30 and the Brain Cancer Module ( BN 20 ) ) were examined in 490 newly diagnosed glioblastoma cancer patients for the relationship with overall survival by using Cox proportional hazards regression models . Refined techniques as the bootstrap re-sampling procedure and the computation of C-indexes and R2-coefficients were used to try and vali date the model . Classical analysis controlled for major clinical prognostic factors selected cognitive functioning ( P=0.0001 ) , global health status ( P=0.0055 ) and social functioning ( P<0.0001 ) as statistically significant prognostic factors of survival . However , several issues question the validity of these findings . C-indexes and R2-coefficients , which are measures of the predictive ability of the models , did not exhibit major improvements when adding selected or all HRQOL scores to clinical factors . While classical techniques lead to positive results , more refined analyses suggest that baseline HRQOL scores add relatively little to clinical factors to predict survival . These results may have implication s for future use of HRQOL as a prognostic factor in cancer patients PURPOSE This study aim ed to determine whether feeding back patient-reported outcomes ( PROs ) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life ( HRQoL ) . PATIENTS AND METHODS This study was a parallel , multicentered pilot r and omized controlled trial . At most once per week , children age ≥ 2 years old with advanced cancer or their parent completed the computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) survey consisting of age- and respondent-adapted versions of the Memorial Symptom Assessment Scale ( MSAS ) , Pediatric Quality of Life Inventory 4.0 Generic Core Scales ( PedsQL4.0 ) , and an overall Sickness question . In the intervention group ( n = 51 ) , oncologists and families received printed reports summarizing PROs ; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded . No feedback was provided in the control group ( n = 53 ) . Primary outcomes included linear trends of MSAS , PedsQL4.0 total and subscale scores , and Sickness scores during 20 weeks of follow-up , along with child , parent , and provider satisfaction with PediQUEST feedback . RESULTS Feedback did not significantly affect average MSAS , PedsQL4.0 , or Sickness score trends . Post hoc subgroup analyses among children age ≥ 8 years who survived 20 weeks showed that feedback improved PedsQL4.0 emotional ( + 8.1 ; 95 % CI , 1.8 to 14.4 ) and Sickness ( -8.2 ; 95 % CI , -14.2 to -2.2 ) scores . PediQUEST reports were valued by children , parents , and providers and contributed at least sometimes to physician initiation of a psychosocial consult ( 56 % ) . CONCLUSION Although routine feedback of PROs did not significantly affect the child 's symptoms or HRQoL , changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging . Importantly , children , parents , and providers value PRO feedback The potential benefits of health-related quality of life ( HRQL ) assessment in oncology clinical practice include better detection of problems , enhanced disease and treatment monitoring and improved care . However , few empirical studies have investigated the effects of incorporating such assessment s into routine clinical care . Recent r and omized studies have reported improved detection of and communication about patients ' concerns , but few have found effects on patient HRQL or satisfaction . This study examined whether offering interpretive assistance of HRQL results would improve these patient outcomes . Two hundred and thirteen participants with metastatic breast , lung or colorectal cancer were r and omly assigned to one of three conditions : usual care ; HRQL assessment or HRQL assessment followed by a structured interview and discussion . Interviews about patients ' assessment responses were conducted by a research nurse , who then presented HRQL information to the treating nurse . HRQL and treatment satisfaction outcomes were assessed at 3 and 6 months . No significant differences were found between study conditions in HRQL or satisfaction . Results suggest that routine HRQL assessment , even with description of results , is insufficient to improve patient HRQL and satisfaction . It is suggested that positive effects may require supplementing assessment results with specific suggestions for clinical management changes It is well recognized that oncologists should consider patients ' quality of life and functioning when planning and delivering anticancer treatment , but a comprehensive assessment of how a patient feels requires a thorough inquiry . A st and ardized measurement of patients ' quality of life may support clinicians in identifying important problems for discussion during the limited time of the medical consultations . The aim of this study was to assess the feasibility of computer-administered individual quality of life measurements in oncology clinics with immediate feedback of results to clinicians and to examine the impact of the information on consultations . The study employed a prospect i ve non-r and omized design with pre-test post-test within subjects comparisons and involved three medical oncologists and 28 cancer patients receiving chemotherapy . The intervention consisted of completion of quality of life question naires before the consultations and informing clinicians of the results . The main outcome measures were patients ' perceptions of the content of baseline and intervention consultations and satisfaction with communication . A qualitative analysis of clinicians ' interviews was performed . When clinicians had the quality of life results they enquired more often about daily activities ( Z=−2.71 , P=0.007 ) , emotional problems ( Z=−2.11 , P=0.035 ) and work related issues ( Z=−1.89 , P=0.058 ) . There was an increase in the number of issues discussed during the intervention consultation ( Z=−1.89 , P=0.059 ) . Patients were highly satisfied with both consultations . The computer measurement was well accepted by patients who felt that the question naires were a useful tool to tell the doctors about their problems . The clinicians perceived that the quality of life data broadened the range of
Output:
| The evidence on the effectiveness of using QoL tools was inconsistent for patient management , but somewhat more consistent in favour of improving patient – physician communication .
Interviews identified unharnessed potential and growing interest in QoL tool use and associated challenges to address . |
MS212381 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Somatic mutations in EGFR and K-RAS may predict for sensitivity and resistance to EGFR tyrosine kinase inhibitors ( TKIs ) . Whether EGFR and K-RAS mutations could also predict clinical outcome of non-small cell lung cancer ( NSCLC ) patients following front-line chemotherapy has not yet been established . PATIENTS AND METHODS One hundred and sixty-two chemotherapy-naïve patients with locally advanced/metastatic NSCLC who received front-line chemotherapy were included in this retrospective study and their clinical outcome data was analyzed according to EGFR and K-RAS mutation status of their tumors . RESULTS Classical activating EGFR and K-RAS mutations were found in 8.2 and 22.6 % of patients respectively and were not associated with patients ' clinicopathological characteristics . Patients with classical EGFR mutations had a higher probability of response to front-line chemotherapy as compared to those with wild type EGFR ( p=0.023 ) . Multivariate analysis showed that the presence of activating EGFR mutations was an independent factor associated with response to front-line chemotherapy ( HR=4.85 ; 95 % CI : 1.13 - 20.83 , p=0.034 ) . K-RAS mutation status was not associated with response to front-line chemotherapy . The presence of activating EGFR but not of K-RAS mutations was associated with a significantly higher overall survival compared to patients without mutations treated with platinum-based front-line chemotherapy ( p=0.043 ) . CONCLUSIONS The data indicate that EGFR mutation status could be predictive for response to cytotoxic front-line chemotherapy in patients with NSCLC . Additional prospect i ve studies are needed in order to vali date this observation and to define whether these patients should be preferentially treated with front-line TKIs or chemotherapy PURPOSE The phase III , r and omized , placebo-controlled Sequential Tarceva in Unresectable NSCLC ( SATURN ; BO18192 ) study found that erlotinib maintenance therapy extended progression-free survival ( PFS ) and overall survival in patients with advanced non-small-cell lung cancer ( NSCLC ) who had nonprogressive disease following first-line platinum-doublet chemotherapy . This study included prospect i ve analysis of the prognostic and predictive value of several biomarkers . PATIENTS AND METHODS M and atory diagnostic tumor specimens were collected before initiating first-line chemotherapy and were tested for epidermal growth factor receptor ( EGFR ) protein expression by using immunohistochemistry ( IHC ) , EGFR gene copy number by using fluorescent in situ hybridization ( FISH ) , and EGFR and KRAS mutations by using DNA sequencing . An EGFR CA simple sequence repeat in intron 1 ( CA-SSR1 ) polymorphism was evaluated in blood . RESULTS All 889 r and omly assigned patients provided tumor sample s. EGFR IHC , EGFR FISH , KRAS mutation , and EGFR CA-SSR1 repeat length status were not predictive for erlotinib efficacy . A profound predictive effect on PFS of erlotinib relative to placebo was observed in the EGFR mutation-positive subgroup ( hazard ratio [ HR ] , 0.10 ; P < .001 ) . Significant PFS benefits were also observed with erlotinib in the wild-type EGFR subgroup ( HR , 0.78 ; P = .0185 ) . KRAS mutation status was a significant negative prognostic factor for PFS . CONCLUSION This large prospect i ve biomarker study found that patients with activating EGFR mutations derive the greatest PFS benefit from erlotinib maintenance therapy . No other biomarkers were predictive for outcomes with erlotinib , although the study was not powered for clinical outcomes in biomarker subgroups other than EGFR IHC-positive [ corrected ] . KRAS mutations were prognostic for reduced PFS . The study demonstrated the feasibility of prospect i ve tissue collection for biomarker analyses in NSCLC BACKGROUND Because there is no clear consensus as to the predictive value of K-ras gene mutation for survival in patients with lung cancer , we examined the occurrence of K-ras mutations in a large , prospect i ve case series of non-small-cell lung cancer ( NSCLC ) . Our goals were to define the patient characteristics associated with K-ras mutation and to determine whether mutation of this gene might be a biomarker of patient prognosis . METHODS Consecutive , newly diagnosed patients with lung cancer treated with potentially curative resection over a 4-year period were recruited for study . The mutation status of K-ras codon 12 in each patient 's tumor DNA was determined by means of polymerase chain reaction-restriction fragment length polymorphism analysis of archived pathology specimens . Analyses were restricted to adenocarcinoma . RESULTS There was a statistically significant association between female sex and K-ras mutation after adjustment for carcinogen exposures ( odds ratio = 3.3 ; 95 % confidence interval [ CI ] = 1.3 - 7.9 ) ; mutations were found only in smokers . Comparison of Kaplan-Meier curves indicated a strong association between K-ras mutation and decreased patient survival ( two-sided P = .009 ) ; analysis stratified by pathologic staging groups revealed that this association was statistically significant only for stage I tumors ( two-sided P = .002 ) . Cox proportional hazards modeling indicated that K-ras codon 12 mutation was a statistically significant predictor of patient survival , after adjustment for the effects of age , sex , and stage ( risk ratio = 1.8 ; 95 % CI = 1.1 - 3.1 ) . CONCLUSIONS After adjustment for environmental exposures , non-small-cell lung tumors in women appear to be more likely than those in men to harbor K-ras mutations , suggesting a possible role of estrogen exposure in either the initiation or the selection of K-ras mutant clones in adenocarcinoma . In addition , our data suggest that K-ras codon 12 mutation is a marker of aggressive NSCLC , as evidence d by its association with decreased patient survival , particularly for early-stage disease Background . The main attention regarding prognostic and predictive markers in NSCLC directs towards the EGFR-targeted pathway , where the most studied genetic alterations include EGFR mutations , EGFR copy number , and KRAS mutations . We wanted to explore the prognostic impact of mutated KRAS in the stage III setting treated with high-dose radiochemotherapy . Methods . Sample s were obtained from patients participating in two prospect i ve studies of locally advanced NSCLC receiving combined radiochemotherapy : the RAKET study , a r and omized phase II study where patients were treated with induction chemotherapy ( carboplatin/paclitaxel ) followed by concurrent radiochemotherapy , and the Satellite trial , a phase II study with induction chemotherapy ( cisplatin/docetaxel ) followed by radiotherapy concurrent cetuximab . The sample s were analysed regarding KRAS mutations , EGFR mutations , and EGFR FISH positivity . Results . Patients with mutated KRAS had a significantly inferior survival , which maintained its significance in a multivariate analysis when other possible prognostic factors were taken into account . The prevalence of KRAS mutations , EGFR mutations , and EGFR FISH positivity were 28.8 % , 7.5 % , and 19.7 % , respectively . Conclusion . Mutated KRAS is an independent negative prognostic factor for survival in NSCLC stage III disease treated with combined radiochemotherapy . The prevalence of KRAS mutations and EGFR mutations are as expected in this Sc and inavian population Introduction : Relationships between clinical outcomes and epidermal growth factor receptor (EGFR)-related tumor markers were investigated in patients with advanced non-small cell lung cancer . Methods : Patients with stage IIIB/IV non-small cell lung cancer ( 0–2 prior regimens ) received erlotinib ( 150 mg PO per day ) . Response and survival were evaluated , and tumor sample s were assessed by immunohistochemistry ( EGFR , phosphorylated mitogen-activated protein kinase , and phosphorylated AKT protein expression ) , fluorescence in situ hybridization ( FISH ; EGFR gene copy number ) , and DNA sequencing ( EGFR , KRAS gene mutations ) . Results : Among 311 patients , 8 % had a complete/partial response ; the disease control rate was 66 % . Median Overall survival ( OS ) was 6.1 months ; 1-year survival rate was 27.2 % . Two of 4 patients with EGFR mutations had tumor responses , versus 2/68 with wild-type EGFR ( p = 0.014 ) . Progression-free survival ( PFS ) ( HR = 0.31 ) and OS ( HR = 0.33 ) were significantly prolonged in patients with EGFR mutations . Response rate was significantly higher in patients with EGFR FISH-positive ( 17 % ) than FISH-negative tumors ( 6 % ) , and both PFS ( HR = 0.58 ) and OS ( HR = 0.63 ) significantly favored patients with EGFR FISH-positive tumors ; median OS was 8.6 months in the EGFR FISH-positive group . None of 17 patients with a KRAS mutation had a tumor response , but the impact of KRAS mutation status on survival outcomes was of borderline statistical significance . Neither phosphorylated mitogen-activated protein kinase nor phosphorylated AKT immunohistochemistry status had a significant effect on PFS and OS with erlotinib . Conclusions : The presence of EGFR mutations and EGFR FISH-positive tumors may predispose patients to achieving better outcomes on erlotinib , but may have a beneficial impact on prognosis ( irrespective of treatment ) . Prospect i ve , placebo-controlled studies are needed to determine the predictive value of the putative biomarkers A prospect i ve study was performed in patients with non-small cell lung cancer ( NSCLC ) to evaluate the prognostic importance of multiple molecular marker ( p53 , c-Ki-ras , c-erbB-2 ) testing . 103 patients with potentially curative resections ( RO resection ) for NSCLC in histopathological stages I – IIIA were included . SSCP analysis and DNA sequencing for p53 and c-Ki-ras genes were performed on paired tumour and normal lung tissue sample s and immunohistochemistry ( c-erbB-2 ) was done on frozen tissue sections with a specific anti-c-erbB-2 monoclonal antibody . 46/103 ( 44.6 % ) NSCLC showed p53 mutations and 17/103 ( 16.5 % ) c-Ki-ras mutations including 12/37 ( 32.4 % ) adenocarcinomas . Overexpression of c-erbB-2 ( p185 ) was detected in 56/103 ( 54.4 % ) tumours . 24/103 ( 23.3 % ) NSCLC were negative for alterations in all 3 parameters ( c-Ki-ras , p53 and p185 ) whereas 79/103 ( 76.7 % ) were positive for at least one of the 3 parameters . In a regression model including a multiple molecular marker parameter ( negative for all 3 markers versus positive for at least one marker ) , histopathological stage ( P < 0.00001 ) , respectively the pT ( P < 0.01 ) and pN ( P < 0.00001 ) categories and the multiple molecular marker parameter ( P < 0.01 ) were of significant prognostic importance . This study demonstrates that testing 3 molecular markers ( c-Ki-ras , p53 and c-erbB-2 ) improves estimation of prognosis compared to single marker testing and appears to define low ( 82.6 % ± 7.9 % 5-year survival ) and high risk ( 40.2 % ± 5.5 % 5-year survival ) groups for treatment failure in potentially curative ( RO ) resected NSCLC . © 2000 Cancer Research Introduction : Although mutation of the epidermal growth factor receptor ( EGFR ) gene is predictive for the response to EGFR-tyrosine kinase inhibitor , its prognostic impact for patients without EGFR-tyrosine kinase inhibitor treatment remains controversial . We examined for EGFR , KRAS or TP53 mutations in a consecutive large cohort of patients with lung adenocarcinoma , and evaluated their prognostic impact . Methods : We analyzed 397 patients with lung adenocarcinoma who underwent potentially curative pulmonary resection . Total ribonucleic acid was extracted and direct sequencing of each gene was performed after reverse transcription-polymerase chain reaction . Results : We found that 196 patients ( 49 % ) had EGFR mutations . Of these , 83 were exon 19 deletions ( 42 % ) and 92 were L858R ( 47 % ) . Univariate analysis showed that patients with EGFR mutations survived for a longer period than those without mutations ( p = 0.0046 ) . However , there was no difference in overall survival between the patients with exon 19 deletion and those with L858R ( p = 0.4144 ) . Patients with KRAS mutations or TP53 mutations tended to survive for a shorter period ( p = 0.2183 and 0.0230 , respectively ) . Multivariate analysis using the Cox proportional hazards model revealed that smoking status ( p =
Output:
| In conclusion , this meta- analysis suggests that K-RAS mutations are associated with a worse overall survival in patients with NSCLC , especially in patients with adenocarcinoma and early stage |
MS212382 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 was to determine the effects of 6 months of whole-body resistive training ( RT ) on total and regional bone mineral density ( BMD ) and bone mineral content ( BMC ) by age and gender in young and older men and women . METHODS Younger men ( n=10 ) and women ( n=7 ) aged 20 - 29 years ( 25+/-1 years ) and older men ( n=10 ) and women ( n=10 ) aged 65 - 74 years ( 69+/-1 years ) participated in 6 months of progressive whole-body RT . Upper- and lower-body strength was assessed by the one repetition maximum ( 1RM ) test , and total body fat , lean tissue mass , femoral neck BMD , Ward 's triangle BMD , greater trochanter BMD , total-body BMD , and L2-L4 spine BMD were determined by dual-energy X-ray absorptiometry before and after 6 months of RT . RESULTS Percent body fat decreased only in the young men ( P<0.05 ) . Lean tissue mass increased after training in young men and women and older men ( P<0.05 ) but did not change significantly in older women . Upper- and lower-body 1RM strength increased in all groups ( P<0.01 ) . Overall , there was a significant increase in BMD at the femoral neck , ward 's triangle and greater trochanter BMD , as well as total body BMC and leg BMC ( P<0.05 ) . Total-body BMD and L2-L4 spine BMD did not change with RT . There were no gender differences in the training response between men and women for any of the BMD regions and no age differences in the training response , except for a trend between young and older subjects for femoral neck ( P<0.08 ) . CONCLUSION A 6-month RT program increases muscle mass and improves BMD of the femoral region in young and healthy older men and women as a group , with a trend for this to be greater in young subjects STUDY OBJECTIVE To assess the effect of weight-bearing exercise training and subsequent detraining on lumbar bone mineral content in postmenopausal women . DESIGN Non-r and omized , controlled , short-term ( 9 months ) trial and long-term ( 22 months ) exercise training and detraining ( 13 months ) . SETTING Section of applied physiology at a university school of medicine . PATIENTS Thirty-five healthy , sedentary postmenopausal women , 55 to 70 years old . All women completed the study . There was 90 % compliance with exercise training . INTERVENTIONS All women were given calcium , 1500 mg daily . The exercise group did weight-bearing exercise ( walking , jogging , stair climbing ) at 70 % to 90 % of maximal oxygen uptake capacity for 50 to 60 min , 3 times weekly . MEASUREMENTS AND MAIN RESULTS Bone mineral content increased 5.2 % ( 95 % confidence interval [ CI ] , 2.0 % to 8.4 % ; P = 0.0037 ) above baseline after short-term training whereas there was no change ( -1.4 % ) in the control group . After 22 months of exercise , bone mineral content was 6.1 % ( 95 % CI , 3.9 % to 8.3 % above baseline ; P = 0.0001 ) in the long-term training group . After 13 months of decreased activity , bone mass was 1.1 % above baseline in the detraining group . CONCLUSIONS Weight-bearing exercise led to significant increases above baseline in bone mineral content which were maintained with continued training in older , postmenopausal women . With reduced weight-bearing exercise , bone mass reverted to baseline levels . Further studies are needed to determine the threshold exercise prescription that will produce significant increases in bone mass Abstract . There is evidence that high intensity resistance training promotes bone maintenance in older women , however , the effect of high intensity free weight training has not been investigated in older men or women . Furthermore , little is known about the chronic effect of weight training on serum insulin growth factor-I ( IGF-I ) in this population . We compared the effects of a moderate intensity seated resistance-training program with a high intensity st and ing free weight exercise program on bone mass and serum levels of IGF-I and IGFBP3 in healthy older men and women . Twenty-eight men ( 54.6 ± 3.2 years ) and 26 nonestrogen-replaced women ( 52.8 ± 3.3 years ) served as their own controls for 12 weeks , then were r and omly assigned to a moderate or high intensity training group and trained three times/week for 24 weeks . Prior to and after the control period and at the end of training , bone mass and body composition were assessed by dual energy X-ray absorptiometry ( DXA ) , muscle strength by isokinetic dynamometry , muscular power by Wingate Anaerobic Power Test , and IGF-I by radioimmunoassay ( RIA ) . A repeated measures analysis of covariance ( ANCOVA ) revealed that high intensity training result ed in a gain in spine BMD in men ( 1.9 % ) , P < 0.05 , but not in women , whereas moderate intensity training produced no changes in either gender at this site . Increases were observed at the greater trochanter , P < 0.03 , in men regardless of training intensity , but not in women at any hip site . However , when compared with zero , both men and women in the high intensity group demonstrated significant increases in trochanteric BMD ( 1.3 % and 2.0 % , respectively ) and a decrease in femoral BMD ( −1.8 % ) . Neither circulating serum IGF-I nor IGFBP3 were altered by either training regimen , but both training programs result ed in improvements in total body strength ( 37.62 % ) and lean mass ( males 4.1 % , females 3.1 % ) . We conclude that although resistance training of moderate to high intensity produced similar muscle changes in older adults , a higher magnitude is necessary to stimulate osteogenesis at the spine . However , at the spine , intensity was not sufficient to offset low levels of estrogen in early postmenopausal women . Furthermore , bone changes were not accompanied by changes in circulating serum levels of IGF-I or IGFBP3 The effects of weighted vest walking and strength-training exercises on bone mineral density ( BMD ) , balance , strength , and self-efficacy were tested in older women . Eighteen women , age 69.2 ± 3.5 years , were r and omly assigned to an exercise group ( EG ) ( n = 9 ) , or a sedentary control group ( CG ) ( n = 9 ) . The EG participated in 32 weeks ( three 1-h sessions/week ) of supervised strength training and walking , stair climbing , and balance exercises while wearing weighted vests . The CG did not exercise . All women took Ca²+ and vitamin D during the study period . Measures included 1 ) BMD of the hip and lumbar spine measured by dual-energy X-ray absorptiometry , 2 ) strength , 3 ) balance , and 4 ) scores on a self-efficacy instrument . The EG had significant improvements in bone density of the femoral neck and balance and a significant weight loss ( P < 0.05 ) . There were no changes in self-efficacy in either group The purpose of this study was to determine the effects of 12 months of weight bearing and resistance exercise on bone mineral density ( BMD ) and bone remodeling ( bone formation and bone resorption ) in 2 groups of postmenopausal women either with or without hormone replacement therapy ( HRT ) . Secondary aims were to characterize the changes in insulin-like growth factors-1 and -2 ( IGF-1 and -2 ) and IGF binding protein 3 ( IGFBP3 ) in response to exercise training . Women who were 3–10 years postmenopausal ( aged 40–65 years ) were included in the study . Women in the HRT and no HRT groups were r and omized into the exercise intervention , result ing in four groups : ( 1 ) women not taking HRT , not exercising ; ( 2 ) those taking HRT , not exercising ; ( 3 ) those exercising , not taking HRT ; and ( 4 ) women exercising , taking HRT . The number of subjects per group after 1 year was 27 , 21 , 25 , and 17 , respectively . HRT increased BMD at most sites whereas the combination of exercise and HRT produced increases in BMD greater than either treatment alone . Exercise training alone result ed in modest site-specific increases in BMD . Bone remodeling was suppressed in the groups taking HRT regardless of exercise status . The bone remodeling response to exercise training in women not taking HRT was not significantly different from those not exercising . However , the direction of change suggests an elevation in bone remodeling in response to exercise training , a phenomenon usually associated with bone loss . No training-induced differences in IGF-1 , IGF-2 , IGF-l : IGF-2 ( IGF-1 : IGF-2 ) , and IGFBP3 were detected This study compared the effects of two exercise training programs , 11 months in duration , on bone mineral density ( BMD ) in older , sedentary women . Thirty-nine women , aged 60 - 74 years , were assigned to the following groups : ( a ) a group that performed exercises that introduced stress to the skeleton through ground-reaction forces ( GRF ) ( i.e. , walking , jogging , stairs ) ; ( b ) a group that performed exercises that introduced stress to the skeleton through joint-reaction forces ( JRF ) ( i.e. , weight lifting , rowing ) ; or ( c ) a no-exercise control group . BMD of the whole body , lumbar spine , proximal femur , and distal forearm was assessed five times at approximately 3-month intervals . The GRF and JRF exercise programs result ed in significant and similar increases in BMD of the whole body ( 2.0 + /- 0.8 % and 1.6 + /- 0.4 % , respectively ) , lumbar spine ( 1.8 + /- 0.7 % and 1.5 + /- 0.5 % , respectively ) , and Ward 's triangle region of the proximal femur ( 6.1 + /- 1.5 % and 5.1 + /- 2.1 % , respectively ) . There was a significant in BMD of the femoral neck only in response to the GRF exercise program ( GRF , 3.5 + /- 0.8 % ; JRF , -0.2 + /- 0.7 % ) . There were no significant changes in BMD in control subjects . Among all exercisers , there was a significant inverse ( r = -0.52 , p < 0.01 ) relationship between increases in whole body BMD and reductions in fat mass , suggesting a dose response effect of exercise on bone mass . Although femoral neck BMD was responsive only to the GRF exercise program , some adaptations ( i.e. , increase in lean body mass and strength ) that were specific to the JRF exercise program may be important in preventing osteoporotic fractures by reducing the risk for falls . It remains to be determined whether all of these benefits can be gained through a training program that combines the different types of exercises employed in this study PURPOSE The purpose of this study was to compare the effects of a high-load ( 80 % , 1-repetition maximum ( RM ) , 8 reps ) and a high-repetition ( 40 % , 1-RM , 16 reps ) resistance training protocol on muscular strength and bone mineral density ( BMD ) in early postmenopausal , estrogen-deficient women . The 6-month programs were matched initially for training volume ( 3 sets , 3 d x wk(-1 ) ) for 12 exercises selected to specifically load the spine and hip . METHODS Subjects included 25 women ( 41 - 60 yr ) who were matched by spine BMD then r and omly assigned to either the high-load ( HL , N = 10 ) , high-repetition ( HR , N = 7 ) , or control ( C , N = 8) groups . Dietary calcium intakes were supplemented to approximately 1500 mg x d(-1 ) . Total body , spine , and hip BMD ( DXA , Lunar Model DPX-IQ ) , upper and lower body muscular strength , and biochemical markers of bone turnover were measured at baseline and after 6 months of training . RESULTS There were no group differences in the baseline measures . Both training groups showed similar increases in biceps ( 20 % ) and rectus femoris ( 28 - 33 % ) cross-sectional areas , in lower body strength ( approximately 30 % ) and in hip strength ( 37 - 40 % ) . HL showed greater improvements in upper body strength ( HL 25 % , HR 16 % ) . Neither training group experienced significant increases in spine or hip BMD , although the HL total body BMD tended to decrease ( -1.1%+/-0.4 , P = 0.054 ) after training . Osteocalcin tended to increase ( P = 0.08 ) in all groups after training , and the % change in osteocalcin was positively related to % changes in the total hip ( r = 0.41 , P = 0.048 ) and the trochanter ( r = 0.42 , P = 0.04 ) BMD . CONCLUSION The high-load and high-repetition resistance training protocol s were both effective in improving muscular strength and size in postmenopausal women , indicating low-intensity resistance training can be beneficial for the muscular fitness in women for whom high-intensity exercise is contraindicated Osteoporosis is a bone disease associated with reduced bone mineral density result ing in debilitating bone fractures . According to the National Institutes
Output:
| RESULTS The review revealed evidence to support the effectiveness of weight training exercises to increase BMD in postmenopausal women .
Weighted exercises can help in maintaining BMD in postmenopausal women and increasing BMD of the spine and hip in women with osteopenia and osteoporosis . |
MS212383 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION Healthcare quality is usually evaluated through analysing medical outcomes including neonatal readmission and patient and family satisfaction . Parental involvement in neonatal care is considered as one of the most important factors , which directly affects these outcomes . The aim of the present study was to determine the effect of family-centered care including maternal participation , presence , and information about neonatal care , on maternal satisfaction and neonatal readmission ; the care services were provided by the primiparous mothers of preterm infants . MATERIAL S AND METHODS One hundred and ten primiparous mothers with preterm infants participated in this clinical trial . All sample s were r and omly divided into family-centered care ( FCC ) and control groups , through simple r and om sampling . The FCC program , which consisted of information about neonatal care , maternal presence , and participation in the care process , was implemented in the FCC group , while the control group was provided with routine care . Data were obtained using demographic and satisfaction question naires and readmission checklist . RESULTS In the FCC group , the mean score of satisfaction increased after the implementation of the program ( 22.36 and 59.28 before and after the program , respectively ) ( p<0.001 ) ; however , this increase in the control group was not significant . The obtained results regarding the different aspects of satisfaction indicated that mothers in the FCC group were more satisfied with maternal presence in the neonatal intensive care unit ( NICU ) , compared with aspects of information and participation . In addition , the number of neonatal readmission was less in the FCC group compared with the control group , and the mean duration of hospitalization was 6.96 and 12.96 days in the FCC and control groups , respectively ( p<0.001 ) . CONCLUSION FCC program seems to be effective in increasing maternal satisfaction and decreasing neonatal readmission . Therefore , it seems necessary that healthcare authorities of the departments of obstetrics and gynecology in Iran provide the opportunity for the implementation of such programs in clinical environments , which follow the policy of parental absence and participation in the intensive care units Objective : With neonatal intensive care units ( NICUs ) evolving from multipatient wards toward family-friendly , single-family room units , the study objective was to compare satisfaction levels of families and health-care staff across these differing NICU facility design s. Study Design : This prospect i ve study documented , by means of institutional review board-approved question naire survey protocol s , the perceptions of parents and staff from two contrasting NICU environments . Result : Findings showed that demographic subgroups of parents and staff perceived the advantages and disadvantages of the two facility design s differently . Staff perceptions varied with previous experience , acclimation time and employment position , whereas parental perceptions revealed a naiveté bias through surveys of transitional parents with experience in both NICU facilities . Conclusion : Use of transitional parent surveys showed a subject naiveté bias inherent in perceptions of inexperienced parents . Grouping all survey participants demographically provided more informative interpretations of data , and revealed staff perceptions to vary with position , previous training and hospital experience Objective : To compare , in a large representative sample of European neonatal intensive care units , the policies and practice s regarding parental involvement and holding babies in the kangaroo care position as well as differences in the tasks mothers and fathers are allowed to carry out . Design : Prospect i ve multicenter survey . Setting : Neonatal intensive care units in eight European countries ( Belgium , Denmark , France , Italy , The Netherl and s , Spain , Sweden , and the United Kingdom ) . Patients : Patients were not involved in this study . Interventions : None . Measurements and Main Results : A structured question naire was mailed to 362 units ( response rate 78 % ) ; only units with ≥50 very-low-birth-weight annual admissions were considered for this study . Facilities for parents such as reclining chairs near the babies ’ cots , beds , and a dedicated room were common , but less so in Italy and Spain . All units in Sweden , Denmark , the United Kingdom , and Belgium reported encouraging parental participation in the care of the babies , whereas policies were more restrictive in Italy ( 80 % of units ) , France ( 73 % ) , and Spain ( 41 % ) . Holding babies in the kangaroo care position was widespread . However , in the United Kingdom , France , Italy , and Spain , many units applied restrictions regarding its frequency ( sometimes or on parents request only , rather than routinely ) , method ( conventional rather than skin-to-skin ) , and clinical conditions ( especially mechanical ventilation and presence of umbilical lines ) that would prevent its practice . In these countries , fathers were routinely offered kangaroo care less frequently than mothers ( p < .001 ) and less often it was skin-to-skin ( p < .0001 ) . Conclusions : This study showed that , although the majority of units in all countries reported a policy of encouraging both parents to take part in the care of their babies , the intensity and ways of involvement as well as the role played by mothers and fathers varied within and between countries OBJECTIVE To evaluate the impact of individualized , developmentally supportive family-centered care on infant physiological variables , growth , behavioral stress cues , return to sleep state , medical and developmental progress , complications , re source utilization , parental perception of the neonatal intensive-care unit experience , and overall parental satisfaction . DESIGN Quasi-experimental , repeated measures design . SETTING Developmental and a control nursery in a 78-bed , level II/III neonatal intensive-care unit . PARTICIPANTS A convenience sample of 114 premature infants and their parents . INTERVENTIONS Control group infants received the routine neonatal intensive-care unit st and ard of care . Experimental infants received routine care plus the addition of individualized , developmentally supportive family-centered interventions . MAIN OUTCOME MEASURES Between groups , there were no statistically significant differences in demographic factors , days to medical or developmental milestones , length of stay , or direct cost/case . Repeated measures analysis of variance determined that at every point of data collection , the average number of baseline , activity , and postactivity stress cues were lower in the developmentally supportive group . Infants in the developmental group had 8 % less sedatives/narcotics and 15 % less vasopressors costs than the control group . There were no differences in complication rates , parental perceptions of the neonatal intensive-care unit experience , or parental satisfaction between groups . CONCLUSIONS Preterm infants who received developmentally supportive family-centered care demonstrated fewer behavioral stress cues and comparable short-term outcomes and re source utilization than infants who received routine care Objective : Family-centered care is becoming a st and ard of care in neonatal intensive care units ( NICUs ) . The purpose of this study was to evaluate the impact of a national program design ed to promote family-centered care in NICUs and to provide information and comfort to families during the NICU hospitalization of their newborn . Study Design : A quasi-experimental , post-only design was utilized , examining eight March of Dimes NICU Family Support ® ( NFS ) sites . Data were gathered via telephone interviews with NICU administrators and surveys of both NICU staff and NICU families . Result : NICU administrators interviewed identified benefits of NFS , including culture change and additional support to families . Surveys of NICU staff showed that NFS enhances the overall quality of NICU care result ing in less stressed , more informed and confident parents . Surveys of NICU families showed that NFS both reduced their stress and made them feel more confident as their baby 's parent . Conclusion : March of Dimes NFS has had a positive impact on the stress level , comfort level and parenting confidence of NICU families . In addition , it has enhanced the receptivity of staff to the presence and benefits of family-centered care BACKGROUND Family-centred care ( FCC ) is a state-of-the-art practice in neonatal intensive care units ( NICU ) based on its shown benefits on the well-being of both infants and parents . However , there is no systematic knowledge about how FCC is implemented in different European context s. OBJECTIVES To describe parents ' presence and the quality of FCC from the perspectives of mothers , fathers and nurses in 11 European NICUs . METHODS A prospect i ve survey was conducted in Finl and , Sweden , Norway , Estonia , Spain and Italy . The perceived quality of FCC was measured using 8 text-message questions sent to the parents ' mobile phones , one question each day , during the infant 's hospital stay . Nurses answered corresponding questions through a Web question naire during a 3-month period . The responses were rated on a 7-point Likert scale . Parents who were not present in the unit during the day used a " 0 " response . RESULTS A total of 262 families of preterm infants born before 35 gestational weeks participated in the study . Mothers gave 5045 responses , fathers gave 3971 responses and nurses gave 11,132 answers . The mothers were present during 92.7 % and the fathers during 77.9 % of the study days . The mothers rated the quality of FCC slightly higher than the fathers did ( 5.8 [ 95 % CI 5.7 - 5.9 ] vs. 5.7 [ 95 % CI 5.6 - 5.8 ] , mean difference of 0.12 [ 95 % CI 0.05 - 0.2 ] , p<0.001 ) . There was wide variation in the parents ' presence and the quality of FCC between the units . The weakest aspects of FCC were emotional support , parents ' participation in decision-making and fathers ' participation in infant care . The perceived quality of FCC between the nurses and parents were comparable . CONCLUSIONS This study showed a high perceived quality of FCC in 11 European units , as indicated by both parents and nurses . The innovative data - collection method and instrument successfully quantified each unit 's FCC profile for further quality improvement and should be trialled in other NICUs and countries
Output:
| We evaluated 11 studies published from January 2006 to March 2016 : two studies vali date d a parent satisfaction question naire , and nine developed or modified previous question naires to use as outcome measures in their local setting s. Most instruments were not tested on reliability and validity . |
MS212384 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose A few recent epidemiological observations suggest that anticoagulant medications may protect against prostate cancer development . Most studies have been small or subjected to method ological issues , including potential confounding . We provide here new evidence on this association in the context of a population -based case – control study of prostate cancer conducted in Montreal , Canada . Methods Cases were 1,588 men with incident prostate cancer , aged ≤75 years , diagnosed across French hospitals in the Montreal area between 2005 and 2009 . Concurrently , 1,618 population controls from the same residential area and age distribution ( ±5 years ) were r and omly selected from the electoral list of French-speaking men . In-person interviews elicited information on socio-demographic , lifestyle and environmental factors , along with a detailed medical history . Unconditional logistic regression was used to assess the association between lifetime use of anticoagulants and prostate cancer risk . Results 102 subjects ( 2.6 % of cases and 3.7 % of controls ) reported a history of oral anticoagulant therapy . After controlling for age , ancestry , education , family history of prostate cancer , prostate cancer screening frequency , diabetes , body mass index and statin use , ever use of oral anticoagulants showed a weak inverse , non-statistically significant association with prostate cancer ( odds ratio 0.76 , 95 % confidence interval 0.50–1.16 ) . Similar results were observed in analyses considering duration of use or indication for use , restricted to subjects recently screened or stratified by cancer aggressiveness . Conclusions Our findings provide weak support for a protective effect of oral anticoagulant therapy against prostate cancer . Further confirmation is required , especially in light of potential bleeding complications associated with anticoagulants BACKGROUND The influence of the duration of anticoagulant therapy after venous thromboembolism ( VTE ) on the long-term morbidity and mortality is unclear . AIM To investigate the long-term sequelae of VTE in patients r and omized to different duration of secondary prophylaxis . METHODS In a multicenter trial comparing secondary prophylaxis with vitamin K antagonists for 6 weeks or 6 months , we extended the originally planned 2 years follow-up to 10 years . The patients had annual visits and at the last visit clinical assessment of the post-thrombotic syndrome ( PTS ) was performed . Recurrent thromboembolism was adjudicated by a radiologist , blinded to treatment allocation . Causes of death were obtained from the Swedish Death Registry . RESULTS Of the 897 patients r and omized , 545 could be evaluated at the 10 years follow-up . The probability of developing severe PTS was 6 % and any sign of PTS was seen in 56.3 % of the evaluated patients . In multivariate analysis , old age and signs of impaired circulation at discharge from the hospital were independent risk factors at baseline for development of PTS after 10 years . Recurrent thromboembolism occurred in 29.1 % of the patients with a higher rate among males , older patients , those with permanent triggering risk factor - especially with venous insufficiency at baseline - signs of impaired venous circulation at discharge , proximal deep vein thrombosis , or pulmonary embolism . Death occurred in 28.5 % , which was a higher mortality than expected with a st and ardized incidence ratio ( SIR ) of 1.43 ( 95 % CI 1.28 - 1.58 ) , mainly because of a higher mortality than expected from cancer ( SIR 1.83 ; 95 % CI 1.44 - 2.23 ) or from myocardial infa rct ion or stroke ( SIR 1.28 ; 95 % CI 1.00 - 1.56 ) . The duration of anticoagulation did not have a statistically significant effect on any of the long-term outcomes . CONCLUSION The morbidity and mortality during 10 years after the first episode of VTE is high and not reduced by extension of secondary prophylaxis from 6 weeks to 6 months . A strategy to reduce recurrence of VTE as well as mortality from arterial disease is needed Purpose Recent evidence suggests that warfarin use may be associated with a reduced risk of prostate cancer . We aim ed to determine whether exposure to warfarin is also associated with a reduced risk of prostate cancer death . Methods A nested case – control study was conducted within a population -based cohort of 10,012 men aged ≥50 years with newly diagnosed prostate cancer between 1985 and 2002 and with no history of cancer since 1970 using the linked records of Saskatchewan Health and Saskatchewan Cancer Agency registry . We identified 2,309 cases who died of prostate cancer during follow-up . For each case , one control alive at the time of the case ’s death and matched for length of follow-up ( ±6 months ) was r and omly selected . Prescription counts were used to define warfarin exposure . Multivariate conditional logistic regression analysis was used to calculate the adjusted incidence rates of prostate cancer death in relation to warfarin use while adjusting for confounding by age , year of prostate cancer diagnosis , clinical stage and grade of cancer at diagnosis , Chronic Disease Score , and use of warfarin before diagnosis . Results Ever use of warfarin following a diagnosis of prostate cancer was associated with an adjusted rate ratio of 1.44 ( 95 % confidence interval ( CI ) 1.33–1.84 ) for prostate cancer death . The adjusted rate ratio with one-year use of warfarin was 1.77 ( 95 % CI 1.25–2.50 ) compared to never use . The unadjusted rate ratio with five-year use of warfarin was 0.64 ( 95 % CI 0.40–1.00 ) and remained unchanged in the adjusted analysis ( 0.65 , 95 % CI 0.37–1.13 ) , although no longer statistically significant . Conclusion Our study does not provide conclusive evidence for a protective effect of long-term warfarin on prostate cancer-specific mortality . Moreover , short-term warfarin use may be associated with an increased risk of prostate cancer death BACKGROUND The length of time after an episode of venous thromboembolism during which the risk of newly diagnosed cancer is increased is not known , and whether vitamin K antagonists have an antineoplastic effect is controversial . METHODS In a prospect i ve , r and omized study of the duration of oral anticoagulation ( six weeks or six months ) after a first episode of venous thromboembolism , patients were question ed annually about any newly diagnosed cancer . After a mean follow-up of 8.1 years , we used the Swedish Cancer Registry to identify all diagnoses of cancer and causes of death in the study population . The observed numbers of cases of cancer were compared with expected numbers based on national incidence rates , and the st and ardized incidence ratios were calculated . RESULTS A first cancer was diagnosed in 111 of 854 patients ( 13.0 percent ) during follow-up . The st and ardized incidence ratio for newly diagnosed cancer was 3.4 ( 95 percent confidence interval , 2.2 to 4.6 ) during the first year after the thromboembolic event and remained between 1.3 and 2.2 for the following five years . Cancer was diagnosed in 66 of 419 patients ( 15.8 percent ) who were treated for six weeks with oral anticoagulants , as compared with 45 of 435 patients ( 10.3 percent ) who were treated for six months ( odds ratio , 1.6 ; 95 percent confidence interval , 1.1 to 2.4 ) . The difference was mainly due to the occurrence of new urogenital cancers , of which there were 28 cases in the six-week group ( 6.7 percent ) and 12 cases in the six-month group ( 2.8 percent ) ( odds ratio , 2.5 ; 95 percent confidence interval , 1.3 to 5.0 ) . The difference in the incidence of cancer between the treatment groups became evident only after two years of follow-up , and it remained significant after adjustment for sex , age , and whether the thromboembolism was idiopathic or nonidiopathic . Older age at the time of the venous thrombosis and an idiopathic thromboembolism were also independent risk factors for a diagnosis of cancer . No difference in the incidence of cancer-related deaths was detected . CONCLUSIONS The risk of newly diagnosed cancer after a first episode of venous thromboembolism is elevated during at least the following two years . Subsequently , the risk seems to be lower among patients treated with oral anticoagulants for six months than among those treated for six weeks BACKGROUND Indirect evidence suggests that prolonged treatment with warfarin might be associated with a decreased incidence of urogenital cancer . We aim ed to assess this association in a large population -based study . METHODS Beneficiaries of Saskatchewan Health who were eligible for prescription drug benefits and aged 50 years or over with no history of cancer since 1967 were enrolled into a nested , matched case-control study . 19 412 new cases of urogenital cancer diagnosed between Jan 1 , 1981 , and Dec 31 , 2002 , were identified by use of information from the Saskatchewan Cancer Agency registry . For each case , six controls , totalling 116 470 , who were matched for age , sex , and time of diagnosis were selected r and omly . Conditional logistic regression analysis was used to calculate adjusted incidence rates of urogenital cancer in relation to warfarin use . FINDINGS Compared with men who never used warfarin , men with 4 years of warfarin use had an adjusted incidence rate of 0.80 ( 95 % CI [ 0.65 - 0.99 ] ) . For warfarin use 76 - 100 % of the time , the adjusted rate ratios were 0.80 ( 0.66 - 0.96 ) during year 2 preceding diagnosis of prostate cancer , 0.76 ( 0.62 - 0.94 ) during year 3 , and 0.67 ( 0.53 - 0.86 ) during year 4 . No significant association was found between warfarin and risk of other urogenital cancers . INTERPRETATION Our results suggest that warfarin has an antitumour effect that is specific to prostate cancer . Further investigation , with more complete assessment of confounders and that addresses the effect of warfarin on mortality of prostate cancer , is warranted IMPORTANCE A substantial proportion of patients with atrial fibrillation ( AF ) die of noncardiovascular causes , and recent studies suggest a link between AF and cancer . OBJECTIVE To evaluate the associations between AF and cancer in a large , long-term prospect i ve cohort study . DESIGN , SETTING , AND PARTICIPANTS In this cohort study , a total of 34 691 women 45 years or older and free of AF , cardiovascular disease , and cancer at baseline were prospect ively followed up between 1993 and 2013 , for incident AF and malignant cancer within the Women 's Health Study , a r and omized clinical trial of aspirin and vitamin E for the prevention of cardiovascular disease and cancer . Cox proportional hazards models using time-up date d covariates were constructed to assess the association of new-onset AF with subsequent cancer and to adjust for potential confounders . Data analysis was performed from December 2014 to May 2015 . EXPOSURE New-onset AF . MAIN OUTCOMES AND MEASURES Incident malignant cancer confirmed by an end point committee . RESULTS During a median follow-up of 19.1 years of 34 691 study participants ( interquartile range [ IQR ] , 17.6 - 19.7 years ) , new-onset AF and malignant cancer were confirmed among 1467 ( 4.2 % ) and 5130 ( 14.8 % ) participants , respectively . Median age at baseline among participants with new-onset AF and new-onset cancer during follow-up was 58 years ( IQR , 52 - 64 years ) and 55 years ( IQR , 50 - 61 years ) , respectively . Atrial fibrillation was a significant risk factor for incident cancer in age-adjusted ( hazard ratio [ HR ] , 1.58 ; 95 % CI , 1.34 - 1.87 ; P < .001 ) and multivariable-adjusted ( HR , 1.48 ; 95 % CI , 1.25 - 1.75 ; P < .001 ) models . The relative risk of cancer was highest in the first 3 months after new-onset AF ( HR , 3.54 ; 95 % CI , 2.05 - 6.10 ; P < .001 ) but remained significant beyond 1 year after new-onset AF ( adjusted HR , 1.42 ; 95 % CI , 1.18 - 1.71 ; P < .001 ) , and a trend toward an increased cancer mortality was observed ( adjusted HR , 1.32 ; 95 % CI , 0.98 - 1.79 ; P = .07 ) . In contrast , among women with new-onset cancer , the relative risk of AF was increased only within the first 3 months ( HR , 4.67 ; 95 % CI , 2.85 - 7.64 ; P < .001 ) but not thereafter ( HR , 1.15 ; 95 % CI , 0.95 - 1.39 ; P = .15 ) . CONCLUSIONS AND RELEVANCE In this large , initially healthy cohort , women with new-onset AF had an elevated cancer
Output:
| Conclusions : The use of long-term VKAs , for any indication , is associated with lower cancer incidence . |
MS212385 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE --To evaluate the long term efficacy of diets in lowering serum cholesterol concentration . DESIGN --Descriptive overview of 16 published controlled trials of six months ' duration or longer . SETTING --Trials had been conducted in hospital clinics ( 6 ) , industry ( 3 ) , mental hospitals or institutions ( 3 ) , and in general population s ( 4 ) . PATIENTS --Trials had been conducted in high risk subjects ( 5 ) , in unselected healthy subjects ( 6 ) , or for secondary prevention in patients with coronary heart disease ( 5 ) . Women were included in only four trials . INTERVENTIONS --Diets equivalent to the step 1 diet were employed in eight trials , with individual intervention by dietitians ( 3 ) or occupational physicians ( 2 ) or with population advice ( 3 ) . Intensive diets which were more rigorous than the step 2 diet were employed in eight trials . MAIN OUTCOME MEASURES --Net change in serum total cholesterol concentration in subjects receiving treatment with diet compared with values in control subjects after six months to 10 years . RESULTS --In five trials with the step 1 diet as individual intervention the net reduction in serum cholesterol concentration ranged from 0 % to 4.0 % over six months to six years . In trials with population education reductions in cholesterol concentrations were 0.6 - 2.0 % over five to 10 years . When population and individual dietary advice were combined changes in cholesterol concentration ranged from a fall of 2.1 % to a rise of 1.0 % over four to 10 years . Diets more intensive than the step 2 diet reduced serum cholesterol concentration by 13 % over five years in selected high risk men in the population ; by 6.5 - 15.1 % over two to five years in hospital out patients ; and by 12.8 - 15.5 % over one to four and a half years in patients in institutions . CONCLUSIONS --The response to a step 1 diet is too small to have any value in the clinical management of adults with serum cholesterol concentrations above 6.5 mmol/l . Current guidelines recommend screening of serum cholesterol concentration in healthy subjects , followed by treatment with a step 1 diet . The guidelines should be review ed to provide a more realistic estimate of the effect of a step 1 diet and of the likely need for lipid lowering drugs Diet is an important factor in the causation of cancer . Previous systematic review s of one-to-one interventions to encourage dietary change have found that such interventions can achieve modest improvements in diet . However , such interventions are re source intensive and unlikely to be good value for money at a population level . Interventions that address groups , communities or whole population s may be less re source intensive and effect change in a wider population . We report a systematic review of such interventions . We set wide inclusion criteria , including before- and -after studies and studies with a non-r and omized comparison group as well as r and omized trials . We found eighteen studies based in the community , seventeen based on worksites , five based in churches and one based in a supermarket . Interventions which targeted fruit and vegetable intake were most likely to be successful , particularly in worksites and churches . There was also evidence of small positive effects on reducing fat intake in worksites and churches . Overall the community-based interventions showed little effect . The studies included in the present review were generally poorly reported . Dietary changes are reported in the relatively short-term studies review ed here but may not be sustained in the long term . The effects that we have identified are small but the reach is potentially very wide , in some cases as wide as a whole country . The cost effectiveness of such strategies remains to be evaluated A controlled intervention trial , with the purpose of testing the hypothesis that the incidence of coronary heart disease ( CHD ) could be decreased by the use of serum-cholesterol-lowering ( SCL ) diet , was carried out in 2 mental hospitals near Helsinki in 1959 - -71 . The subjects were hospitalized middle-aged men . One of the hospitals received the SCL diet , i.e. a diet low in saturated fats and cholesterol and relatively high in polyunsaturated fats , while the other served as the control with a normal hospital diet . Six years later the diets were reversed , and the trial was continued another 6 years . The use of the SCL diet was associated with markedly lowered serum-cholesterol values . The incidence of CHD , as measured by the appearance of certain electrocardiographic patterns and by the occurrence of coronary deaths , was in both hospitals during the SCL-diet periods about half that during the normal-diet periods . An examination of a number of potential confounding variables indicated that the changes in them were small and failed to account for the considerable reduction in the incidence of CHD . It is concluded that the use of the serum-cholesterol-lowering diet exerted a substantial preventive effect on CHD
Output:
| Dietary advice appears to be effective in bringing about modest beneficial changes in diet and cardiovascular risk factors over approximately 12 months , but longer-term effects are not known |
MS212386 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: An interactive CD-ROM program design ed to reduce adolescent substance use was developed and evaluated . The program uses video vignettes to teach refusal skills and socially acceptable responses to substance use situations , specifically offers of marijuana . In a r and omized pretest-to-posttest experiment with 74 public school students from six classes in three high schools , significant changes were observed at posttest on ( 1 ) the adolescent 's personal efficacy to refuse the offer of marijuana , ( 2 ) the adolescent 's intention to refuse marijuana if offered , and ( 3 ) the adolescent 's perceptions of the social norms associated with substance use and the importance of respecting another 's decision to refuse a drug offer . In addition , adolescents in the treatment condition were able to recall approximately 50 % of the portrayed refusal strategies . Findings are discussed with regard to the potential benefits of an interactive multimedia approach for conducting substance use interventions This article review s major risk factors for cigarette smoking , alcohol , and other drug abuse and promising community-based approaches to primary prevention . In a longitudinal experimental study , 8 representative Kansas City communities were assigned r and omly to program ( school , parent , mass media , and community organization ) and control ( mass media and community organization only ) conditions . Programs were delivered at either 6th or 7th grade , and panels were followed through Grade 9 or 10 . The primary findings were ( a ) significant reductions at 3 years in tobacco and marijuana use and ( b ) equivalent reductions for youth at different levels of risk . This study provides evidence that a comprehensive community program-based approach can prevent the onset of substance abuse and that the benefits are experienced equally by youth at high and low risk The authors evaluated the efficacy of a brief image-based prevention intervention and assessed current drug use as a moderator of intervention effects . In a clinical trial , 416 high school-age adolescents were r and omized to either the brief intervention or usual care control , with data collected at baseline and 3-month follow-up . The brief intervention consisted of a tailored in-person communication and a series of parent/guardian print material s based on the behavior-image model . Health behavior goal setting increased for participants receiving the brief intervention , with an effect size in the small range ( d = 0.33 ) . Overall effect sizes for cigarette smoking frequency and quantity and alcohol use frequency and quantity were small ( ds = 0.16 - 0.21 ) and in favor of the brief intervention . However , adolescents reporting current substance use who received the brief intervention reduced their frequency and heavy use of alcohol , frequency and quantity of cigarette smoking , and reported fewer alcohol/drug problems , with larger effects ranging from small to approaching medium in size ( ds = 0.32 - 0.43 , ps < .01 ) . This study suggests that brief image-based messages may increase health behavior goal setting and reduce substance use , particularly among drug-using older adolescents Effects of anti-tobacco and anti-marijuana TV advertisements on explicit ( i.e. , semantic differential ratings ) and implicit ( i.e. Implicit Association Test , IAT ) attitudes toward tobacco and marijuana were compared . Two hundred twenty nine , 18- to 19-year-old U.S. college students were r and omly assigned to anti-tobacco or anti-marijuana PSA viewing conditions . Participants completed a short survey on attitudes to tobacco and marijuana . Afterwards they watched 15 PSAs embedded in a 15-min science program . At the end , all participants completed IAT for marijuana , IAT for tobacco and the assessment of explicit attitudes . Results of ANCOVA revealed a significant interaction between type of TV PSAs watched and implicit attitudes , F(1,223)=7.12 , p<0.01 when controlling for preexisting attitudes to both substances ; the implicit attitudes were more negative toward the substance that corresponded to the content of advertisements watched ( i.e. , anti-tobacco or anti-marijuana ) . However , analogical analysis on explicit measures showed that attitudes to marijuana became less negative among students that watched anti-marijuana ads than the group with anti-tobacco ads , F(1,222)=5.79 , p<0.02 . The discussion focused on the practical and theoretical implication s of the observed dissociation between implicit and explicit attitudes to marijuana after the exposure to anti-marijuana PSAs OBJECTIVES This study examined the relative perceived effectiveness of 30 antidrug public service announcements ( PSAs ) and assessed the extent to which judgments of effectiveness are related to judgments of realism , amount learned , and positive and negative emotional responses . METHODS Data were obtained from 3608 students in grade s 5 through 12 in 10 schools . The ethnically diverse sample was 50.8 % male . Students in 5 experimental conditions viewed sets of 6 antidrug PSAs and filled out a brief evaluation question naire following each PSA . Those in the control condition viewed a non-drug-related television program . RESULTS The relative perceived effectiveness of the 30 PSAs varied considerably . Sixteen were rated as significantly more effective , and 6 as significantly less effective , than the control program . Relative rated effectiveness was highly related to realism ( r = .87 ) , amount learned ( r = .88 ) , negative emotion ( r = .87 ) , and positive emotion ( r = -.35 ) . CONCLUSIONS Evaluative research is necessary to prevent broadcast of PSAs that could have a negative impact . PSAs should point out the negative consequences of drug use behavior rather than telling adolescents to " just say no. BACKGROUND Despite the availability of an increasing array of empirically vali date d adolescent drug abuse prevention programs , program material s and evaluation findings are poorly disseminated . CD-ROM and the Internet hold promise for disseminating this information to schools and agencies that directly serve youth , and to policy-making bodies that exercise control over funds to support adolescent drug abuse prevention programming . However , data on the relative efficacy of these newer technologies over conventional print means of dissemination are lacking . METHODS Recruited through schools , community agencies , and policy-making bodies , 188 professionals were r and omized to receive prevention program material s via pamphlets ( 55 participants ) , CD-ROM ( 64 participants ) , and the Internet ( 69 participants ) . Participants completed pretest , posttest , and 6-month follow-up measures that assessed their access to prevention program material s ; self-efficacy for identifying , obtaining , and recommending these programs ; and their likelihood of requesting , implementing , and recommending prevention programs to their constituents . RESULTS Participants exposed to dissemination via CD-ROM and the Internet evidence d the greatest short- and long-term gains on accessibility , self-efficacy , and behavioral intention variables . CONCLUSIONS CD-ROM and the Internet are viable means for disseminating adolescent drug abuse prevention programs to schools , community agencies , and policy-making bodies , and should be increasingly used for dissemination purpose Despite clear need , brief web-based interventions for marijuana-using college students have not been evaluated in the literature . The current study was design ed to evaluate a brief , web-based personalized feedback intervention for at-risk marijuana users transitioning to college . All entering first-year students were invited to complete a brief question naire . Participants meeting criteria completed a baseline assessment ( N = 341 ) and were r and omly assigned to web-based personalized feedback or assessment -only control conditions . Participants completed 3-month ( 95.0 % ) and 6-month ( 94.4 % ) follow-up assessment s. Results indicated that although there was no overall intervention effect , moderator analyses found promising effects for those with a family history of drug problems and , to a smaller extent , students who were higher in contemplation of changing marijuana use at baseline . Implication s of these findings for selective intervention of college marijuana use and web-based interventions in general are discussed Two media-based interventions design ed to reduce adolescent marijuana use ran concurrently from 2005 to 2009 . Both interventions used similar message strategies , emphasizing marijuana ’s inconsistency with personal aspirations and autonomy . “ Be Under Your Own Influence ” was a r and omized community and school trial replicating and extending a successful earlier intervention of the same name ( Slater et al. Health Education Research 21:157–167 , 2006 ) . “ Above the Influence ” is a continuing national television , radio , and print campaign sponsored by the Office of National Drug Control Policy ( ONDCP ) . This study assessed the simultaneous impact of the interventions in the 20 U.S. communities . Results indicate that earlier effects of the “ Be Under Your Own Influence ” intervention replicated only in part and that the most plausible explanation of the weaker effects is high exposure to the similar but more extensive ONDCP “ Above the Influence ” national campaign . Self-reported exposure to the ONDCP campaign predicted reduced marijuana use , and analyses partially support indirect effects of the two campaigns via aspirations and autonomy Successful anti-marijuana messages can be hypothesized to have two types of effects , namely persuasion effects , that is , a change in people 's beliefs about using marijuana , and priming effects , that is , a strengthened correlation between beliefs and associated variables such as attitude and intention . This study examined different sets of anti-drug advertisements for persuasion and priming effects . The ads targeted the belief that marijuana is a gateway to stronger drugs , a belief that is often endorsed by campaign planning officials and health educators . A sample of 418 middle and high school students was r and omly assigned to a control video or one of three series of ads , two of which included the gateway message in either an explicit or implicit way . Results did not support the use of the gateway belief in anti-marijuana interventions . Whereas no clear persuasion or priming effects were found for any of the ad sequences , there is some possibility that an explicit gateway argument may actually boomerang . In comparison to the control condition , adolescents in the explicit gateway condition tended to agree less with the gateway message and displayed weaker correlations between anti-marijuana beliefs and their attitude toward marijuana use . The results suggest that the gateway message should not be used in anti-drug interventions OBJECTIVES The authors describe computer services design ed to make patients better informed and more motivated to participate in treatment . Patients use these services through their touch-tone telephone ; access to a home computer or a modem is not needed . METHODS The authors tested the impact of these computer services on the management of 179 pregnant women who had used cocaine during pregnancy or 1 month before pregnancy ( as reported by the woman ) . Patients were r and omly assigned to control and experimental groups ; only the experimental group had access to the computer services . Patients were enrolled during the prenatal period and followed for 6 months after the birth of a live child . Self-reported data on the subjects ' participation in drug treatment programs , health status ( using the SF-36 ) , and addiction severity ( using the addiction severity index ) were collected . The computer collected data on the frequency of the use of the service . The dependent variables were participation in formal treatment during the course of the project , and drug and alcohol use at exit interview . Multiple and logistic regressions were used to identify the effects of the intervention after controlling for demographic and baseline variables . RESULTS Data showed that poor , pregnant , undereducated clients who use drugs and lived in multiple residences could use the services ; about one-third of clients used the services more than three times a week . Access to the service did not lead to significant change in patients ' health status , drug use , or utilization of services . Use of the services did lead to significant changes in participation in drug treatment : subjects who used the service more than three times a week were 1.5 times more likely to participate in formal drug treatment than subjects who used the service less often . Participation in formal drug treatment , however , was not effective in reducing the drug or the alcohol use . CONCLUSIONS Almost all patients used the computer services to some extent , but there seems to be a threshold after which the use of the services had a more positive impact This study investigates an approach for reducing inhalant initiation among younger adolescents : altering Socio-Personal Expectations ( SPEs ) , a term referring to perceived linkages between behavior and personally relevant social outcomes . The study focuses specifically on SPEs regarding outcomes associated with increased social status and popularity . An anti-inhalant message was embedded within a short anti-bullying education video . Young adolescents ( N = 893 ) were assigned r and omly to receive a message focused on the physical or the social harms of inhalant use . The objectives of this study were to test : ( 1 ) the malleability of SPEs , ( 2 ) SPEs ’ predictive validity for future inhalant use , and ( 3 ) whether being exposed to a socio-personal threat , rather than a physical threat , led to different variables affecting drug-relevant decision-making processes . Analysis of variance suggested the malleability of SPEs ( p < .001 ) . Multiple regression analysis revealed that SPEs were predictive of future inhalant use . SPEs accounted for a significant portion of variance in future intentions over and above demographic variables , prior use , psychosocial variables , and perceived physical harm ( R2 = .26 , p < .01 ) . Moreover , being exposed to a social , rather than a physical threat , message result ed in different variables being predictive of future intentions to use inhalants AIMS Continued progress in etiological research and prevention science requires more precise information concerning the specific stages at which socio-demographic variables are implicated most strongly in transition from initial substance use to dependence . The present study examines prospect i ve associations between socio-demographic variables and the subsequent onset of alcohol and drug dependence using data from the National Comorbidity Survey ( NCS ) and the NCS Follow-up survey ( NCS-2 ) . DESIGN The NCS was a nationally representative survey of the prevalence and correlates of DSM-III-R mental and substance disorders in the United States carried out in 1990 - 2002 . The
Output:
| Overall the available evidence does not allow conclusions about the effect of media campaigns on illicit drug use among young people . |
MS212387 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Transcatheter aortic valve replacement ( TAVR ) is an option in certain high-risk surgical patients with severe aortic valve stenosis . It is unknown whether TAVR can be safely introduced to lower-risk patients . OBJECTIVES The NOTION ( Nordic Aortic Valve Intervention Trial ) r and omized clinical trial compared TAVR with surgical aortic valve replacement ( SAVR ) in an all-comers patient cohort . METHODS Patients ≥ 70 years old with severe aortic valve stenosis and no significant coronary artery disease were r and omized 1:1 to TAVR using a self-exp and ing bioprosthesis versus SAVR . The primary outcome was the composite rate of death from any cause , stroke , or myocardial infa rct ion ( MI ) at 1 year . RESULTS A total of 280 patients were r and omized at 3 Nordic centers . Mean age was 79.1 years , and 81.8 % were considered low-risk patients . In the intention-to-treat population , no significant difference in the primary endpoint was found ( 13.1 % vs. 16.3 % ; p = 0.43 for superiority ) . The result did not change in the as-treated population . No difference in the rate of cardiovascular death or prosthesis reintervention was found . Compared with SAVR-treated patients , TAVR-treated patients had more conduction abnormalities requiring pacemaker implantation , larger improvement in effective orifice area , more total aortic valve regurgitation , and higher New York Heart Association functional class at 1 year . SAVR-treated patients had more major or life-threatening bleeding , cardiogenic shock , acute kidney injury ( stage II or III ) , and new-onset or worsening atrial fibrillation at 30 days than did TAVR-treated patients . CONCLUSIONS In the NOTION trial , no significant difference between TAVR and SAVR was found for the composite rate of death from any cause , stroke , or MI after 1 year . ( Nordic Aortic Valve Intervention Trial [ NOTION ] ; NCT01057173 ) Context Whether female sex is associated with an increased risk for adverse events among patients having transcatheter aortic valve replacement ( TAVR ) is unclear . Contribution In this secondary analysis of data from the Placement of Aortic Transcatheter Valves trial , women who had TAVR had more postprocedural major bleeding and vascular complications and improved 1-year survival than men . Caution Other factors , such as paravalvular leak or patientprosthesis mismatch , may have confounded the results . Implication The sex-specific risk associated with TAVR is the reverse of that for surgical aortic valve replacement , for which female sex is associated with an increased risk for adverse events . During the past 50 years , the st and ard of care for patients with severe , symptomatic aortic stenosis ( AS ) has been surgical aortic valve replacement ( SAVR ) , which has been shown to prolong survival and alleviate symptoms compared with medical therapy alone ( 1 , 2 ) . However , at least one third of patients with AS are deemed to be high-risk or inoperable for SAVR due to comorbidities or unfavorable anatomy ( 3 ) . For these patients , transcatheter aortic valve replacement ( TAVR ) has emerged as an alternative ( 1 , 2 , 411 ) . The PARTNER ( Placement of Aortic Transcatheter Valves ) trial was the first to show the safety and efficacy of TAVR compared with accepted st and ard therapies in high-risk and inoperable patients with AS ( 49 ) . The results of this trial ultimately led to the approval of the SAPIEN transcatheter valve ( Edwards Lifesciences ) by the U.S. Food and Drug Administration . Since the PARTNER trial , many other trials and international registries have shown the benefits of TAVR in higher-risk patients ( 1012 ) . Female sex has been shown to be associated with increased risk for adverse events after SAVR ( 1317 ) but has been shown to be a potentially favorable characteristic for patients having TAVR ( 1823 ) . However , prior trials examining sex-based differences in patients having TAVR have been limited in size or have involved only single- or dual-center experiences . Furthermore , not all studies agree that TAVR may be more beneficial in women , with some finding no difference in outcomes or increased adverse events in women ( 2428 ) . Given the conflicting data in the literature , we sought to perform a comprehensive analysis of sex-based differences in patients having TAVR by using the clinical trial structure of the PARTNER experience ( encompassing all TAVR patients treated in not only the r and omized PARTNER trials but also the r and omized and nonr and omized continued access registries ) . We report the baseline demographic characteristics and core laboratoryassessed echocardiographic parameters of women and men treated with TAVR , as well as adjudicated 30-day and 1-year outcomes stratified by sex . Methods Study Design and Patients The PARTNER trial incorporated 2 parallel prospect i ve , multicenter , r and omized , active treatmentcontrolled clinical trials . Patients were divided into 2 cohorts . Cohort A comprised patients who were considered to be high-risk c and i date s for surgery , as defined by a Society of Thoracic Surgeons Predicted Risk of Mortality ( STS-PROM ) score of at least 8 % ( on a scale of 0 % to 100 % , with higher scores indicating greater risk for death within 30 days after surgery ) ( 13 ) and /or by the presence of coexisting conditions associated with a 15 % or greater risk for death at 30 days . Cohort B comprised those who were not considered to be suitable c and i date s for surgery because they had coexisting conditions associated with a 50 % or greater probability of death or serious irreversible morbidity after surgery based on a multidisciplinary heart team assessment . In cohort A , patients were r and omly assigned to TAVR or SAVR ; in cohort B , patients were r and omly assigned to TAVR or medical therapy . Patients in cohort A were enrolled from 11 May 2007 to 28 August 2009 , and those in cohort B were enrolled from 11 May 2007 to 16 March 2009 . After enrollment in the r and omized PARTNER trial , sites were able to continue to consecutively enroll patients in a continued access registry using the same inclusion and exclusion criteria . The purpose of the continued access registry was to accumulate greater real-world experience with regard to the safety and efficacy of TAVR while approval by the U.S. Food and Drug Administration was pending . At the time of initiation of the registry , TAVR could not be performed in the United States unless the patient was formally enrolled in the registry or a comparable clinical trial . Because enrollment in the inoperable trial ( cohort B ) was completed 6 months before enrollment in the high-risk trial ( cohort A ) was completed , investigators decided to extend r and omization of cohort B into the continued access registry to prevent enrollment bias in the ongoing high-risk trial . Once enrollment in the high-risk trial was completed , both cohorts were enrolled in a nonr and omized continued access registry . Enrollment in this registry concluded on 9 January 2012 . The same data collection procedures and follow-up used for the r and omized PARTNER trial were used for the continued access registry . The same clinical events committee , adjudication process , and core laboratory interpretation of echocardiographic data were also used for both the r and omized and continued access portions of the PARTNER trial . The institutional review board at each site approved the study , and all patients provided written informed consent . End Points The 30-day and 1-year frequencies of all-cause mortality , cardiovascular mortality , rehospitalization , stroke , major vascular complications , major bleeding , myocardial infa rct ion , acute kidney injury , and need for a permanent pacemaker were recorded per the PARTNER trial protocol ( 4 , 5 ) . Major vascular complications were defined as any thoracic aortic dissection ; access site or access-related vascular injury leading to death , need for significant blood transfusions , or unplanned percutaneous or surgical intervention ; or distal embolization from a vascular source . Major bleeding was defined as a bleeding event that caused death or permanent disability , caused or prolonged a hospitalization , or required an open or endovascular procedure or a transfusion . All adverse events were fully adjudicated by an independent clinical events committee . Echocardiograms were obtained at baseline ; at discharge or 7 days , whichever came first ; and at 30 days , 6 months , and 1 year after the procedure . All echocardiograms were analyzed at an independent core laboratory that followed the American Society of Echocardiography st and ards for echocardiography core laboratories ( 29 ) . Statistical Analysis The current analysis was an as-treated analysis , which included all TAVR patients from cohort A , cohort B , and the continued access registry . Patients were stratified on the basis of sex . Continuous variables are presented as means and SDs and were compared using the t test ; categorical variables were compared by using the chi-square test or the Fisher exact test , as appropriate . KaplanMeier techniques were used for outcomes that contained all-cause death . All nonmortality outcomes were modeled by using a proportional subdistribution hazards regression to account for the competing risk for death ; the corresponding hazard ratios ( HRs ) and P values are reported from this model . For each sex , the cumulative incidence for 30-day and 1-year outcomes is summarized in the presence of all-cause death . A 2-sided level of 0.05 was used to indicate statistical significance . To assess the association between sex and all-cause mortality at 1 year , Cox multivariable regression analyses were performed . The multivariable model was created by forcing sex into a stepwise model selection procedure with clinical ly relevant c and i date variables using an entry/stay criterion of a P value less than 0.10 . Variables of clinical interest were included if the variable was significant ( P < 0.10 ) in the univariate Cox model . A supplemental model included moderate or severe paravalvular regurgitation at discharge and any major vascular complication as a time-dependent covariate along with variables selected in the final model . Using the same variables as those selected for the multivariable model for mortality , we tested for an association between sex and rehospitalization while accounting for the competing risk for death . We also tested for an interaction between sex and treatment approach ( transfemoral vs. transapical TAVR ) on 1-year all-cause mortality . Analyses were done using the FREQ , TTEST , UNIVARIATE , PHREG , and LIFETEST procedures in SAS , version 9.2 ( SAS Institute ) . Clinical Trial Registration The PARTNER trial was registered at Clinical Trials.gov on 14 September 2007 , slightly more than 4 months after the first patient was enrolled on 11 May 2007 . Only 41 ( 1.3 % ) of the 3216 total patients were enrolled before registration of the trial , and no interval analysis was conducted between enrollment of the first patient and registration of the trial . Role of the Funding Source The PARTNER trial was funded by Edwards Lifesciences , and the protocol was developed collaboratively by the sponsor and the steering committee . The funding source had no involvement in the design , analysis , or interpretation of this sub study or the decision to publish the manuscript . Results Baseline Characteristics All 2559 patients who had TAVR in the PARTNER trial were analyzed on the basis of their sex ( Table 1 ) . Of these , 2000 were in the nonr and omized continued access registry , 40 were in the r and omized continued access registry , and 519 were in the r and omized trial . Five patients in cohort A , 1 in cohort B , and none in the continued access registries were lost to follow-up . A total of 47.7 % of all patients were women , and 52.3 % were men . Table 1 . Study Population The baseline presenting characteristics varied between sexes in terms of demographic variables and AIMS In a prospect i ve r and omised trial we aim ed to compare transapical transcatheter aortic valve implantation ( a-TAVI ) with surgical aortic valve replacement ( SAVR ) in operable elderly patients . METHODS AND RESULTS The study was design ed as a r and omised controlled trial of a-TAVI ( Edwards SAPIEN heart valve system ; Edwards Lifesciences , Irvine , CA , USA ) vs. SAVR . Operable patients with isolated aortic valve stenosis and an age ≥75 years were included . The primary endpoint was the composite of all-cause mortality , cerebral stroke and /or renal failure requiring haemodialysis at 30 days . After advice from the Data Safety Monitoring Board , the study was prematurely terminated after the inclusion of 70 patients because of an excess of events in the a-TAVI group . The primary endpoint was met in five a-TAVI patients ( two deaths , two strokes , and one case of renal failure requiring dialysis ) vs. one stroke in the SAVR group ( p=0.07 ) . In the a-TAVI group , one patient was converted to SAVR because of an abnormally positioned heart , and four patients were re-operated with open heart surgery because of annulus rupture ( n=1 ) , severe paravalvular leakage ( n=2 ) , and blockage of the left coronary artery ( n=1 ) . In the SAVR group , one patient was converted to TAVI because of a large intra-thoracic goitre . CONCLUSIONS Given the limitations of a small
Output:
| Secondary outcomes of kidney injury , new-onset atrial fibrillation , and major bleeding favoured TAVI , while major vascular complications , incidence of permanent pacemaker implantation , and paravalvular regurgitation favoured SAVR .
CONCLUSION Compared with SAVR , TAVI is associated with a significant survival benefit throughout 2 years of follow-up .
Importantly , this superiority is observed irrespective of the TAVI device across the spectrum of intermediate and high-risk patients , and is particularly pronounced among patients undergoing transfemoral TAVI and in females |
MS212388 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND : This study was undertaken to test the hypothesis that early enteral nutrition might reduce the incidence of serious complications after major abdominal surgery . METHODS : In a r and omised double blind prospect i ve trial 30 patients received Nutri-drink and 30 patients received placebo through a nasoduodenal feeding tube . On the day of operation the patients were given median 600 ml of either nutrition or placebo , 60 ml per hour . On the first postoperative day the patients received either 1000 ml ( median ) of nutrition or placebo , on day 2 1200 ml ( median ) nutrition , 1400 ml placebo , on day 3 1000 ml ( median ) nutrition , 1150 ml placebo , and on day 4 1000 ml ( median ) nutrition , 800 ml placebo . All patients were followed up for 30 days by the same investigator . RESULTS : The two groups were similar with regard to nutritional status and type of operation . The rate of postoperative infectious complications was significantly lower in the nutrition group , two of 30 compared with 14 of 30 in the placebo group ( p = 0.0009 ) . CONCLUSION : Early enteral nutrition given to patients after major abdominal surgery results in an important reduction in infectious complications BACKGROUND & AIM The immunomodulating nutrition was supposed to reduce the incidence of complications in surgical patients , but many authors have question ed its value recently . The aim of the study was to assess the impact of enteral immunonutrition in postoperative period . METHODS Between January 2003 and December 2009 , 305 malnourished patients ( 123 F , 182 M , m. age 60.8 ) undergoing resection for pancreatic or gastric cancer , after preoperative 14 days of parenteral feeding , were r and omized in double-blind manner to receive either postoperative immunomodulating enteral diet ( IMEN ) or st and ard oligopeptide diet ( SEN ) . Outcome measures of the intend-to-treat analysis were : number and type of complications , length of hospitalization , mortality , and vital organ function . RESULTS Median postoperative hospital stay was 17.1 days in SEN and 13.1 days in IMEN group ( p = 0.006 ) . Infectious complications were observed in 60 patients ( 39.2 % ) in SEN and 43 ( 28.3 % ) in IMEN group ( p = 0.04 ) . Differences were also observed in overall morbidity ( 47.1 vs 33.5 % , p = 0.01 ) and mortality ( 5.9 vs 1.3 % , p = 0.03 ) , but the ratio of surgical complications , organ function , and treatment tolerance did not differ . CONCLUSIONS The study proved that postoperative immunomodulating enteral nutrition should be the treatment of choice in malnourished surgical cancer patients . The Clinical Trials Data base registry number : NCT00576940 Postoperative oral nutritional supplementation has been shown to be of clinical benefit . This study examined the clinical effects and cost of administration of oral supplements both before and after surgery Background / Aim Perioperative administration of immunoenriched diets attenuates the perioperative inflammatory response and reduces postoperative infection complications . However , many questions still remain unresolved in this area , such as the length of diet administration , diet composition , and the mechanisms involved . We performed an open , r and omized , triple-arm study comparing the effect of two perioperative feeding regimens with a postoperative one . Methods 46 c and i date s for major elective surgery for malignancy in the upper gastrointestinal tract were r and omized to drink preoperatively either 1 L of an immunoenriched formula ( Impact ) for 5 days ( IEF group ) or 1 L of Impact plus ( Impact enriched with glycine ) for 2 days ( IEF plus group ) . The same product as the patient received preoperatively was given to both groups for 7 days postoperatively . In the control group ( CON group ) , patients only received Impact for 7 days postoperatively ; there was no preoperative treatment . The main outcome measures were postoperative C-reactive protein ( CRP ) serum levels . Results In the two preoperatively supplemented groups ( treatment groups ) , perioperative endotoxin levels , CRP ( postoperative day 7 ) , and TNF-α ( postoperative days 1 and 3 ) levels were significantly lower compared to the CON group ( p < .01 ) . Furthermore , the length of postoperative IMU/ICU stay ( Impact 1.9 ± 1.3 days ; Impact plus 2.2 ± 1.1 days ; control group 5.9 ± 0.8 days ) and length of hospital stay ( Impact 19.7 ± 2.3 days ; Impact plus 20.1 ± 1.3 days ; control group 29.1 ± 3.6 days ) were both reduced in the treatment groups compared to the control group . Infectious complications ( Impact 2/14 ( 14 % ) ; Impact plus 5/17 ( 29 % ) ; control group 10/15 ( 67 % ) ) also showed a trend toward reduction in the treatment groups . Conclusions Perioperative administration of an immunoenriched diet significantly reduces systemic perioperative inflammation and postoperative complications in patients undergoing major abdominal cancer surgery , when compared with postoperative diet administration alone . A shortened preoperative feeding regimen of 2 days with Impact enriched with glycine ( Impact plus ) was as effective as Impact administered for 5 days preoperatively Castrostomy feeding has been a well established form of nutritional support for patients presenting with total dysphgia for carcinoma of the oesophagus . More recently , total parenteral nutrition has proved to be efficient and safe , offering an alternative to gastrostomy feeding . Twenty‐four patients were r and omly selected into two groups to compare the efficacy of total parenteral nutrition and gastrostomy feeding with respect to nitrogen balance and weight gain BACKGROUND Although current opinion favours the use of enteral over parenteral nutrition , the clinical benefits of early postoperative nutrition in patients undergoing elective surgery have never been clearly shown . We aim ed to test the hypothesis that postoperative enteral nutrition is better ( fewer postoperative complications ) than parenteral nutrition containing similar energy and nitrogen amounts ( 112 kJ kg(-1 ) day(-1 ) and 1.4 g aminoacid kg(-1 ) day(-1 ) ) . METHODS We did a r and omised multicentre clinical trial in patients with gastrointestinal cancer who were malnourished and c and i date s for major elective surgery . 159 patients were assigned to enteral nutrition and 158 to parenteral nutrition . The primary endpoint was the occurrence of postoperative complications , and secondary endpoints were length of postoperative hospital stay , adverse effects , and treatment crossover . Analysis was by intention to treat . FINDINGS Postoperative complications occurred in 54 ( 34 % ) patients fed enterally versus 78 ( 49 % ) fed parenterally ( relative risk 0.69 , 95 % CI 0.53 - 0.90 , p=0.005 ) . Length of postoperative stay was 13.4 days and 15.0 days in the enteral nutrition and parenteral nutrition groups , respectively ( p=0.009 ) . Adverse effects occurred in 56 ( 35 % ) patients fed enterally versus 22 ( 14 % ) patients fed parenterally ( 2.50 , 1.61 - 3.86 , p<0.0001 ) . 14 ( 9 % ) patients on enteral nutrition had to switch to parenteral nutrition , whereas none of those fed parenterally crossed over to enteral feeding . INTERPRETATION We conclude that early enteral nutrition significantly reduces the complication rate and duration of postoperative stay compared with parenteral nutrition , although parenteral nutrition is better tolerated than enteral nutrition In a comparative clinical trial to examine the influence of 10 days of preoperative parenteral nutrition ( PPN ) on the postoperative complication rate for gastrointestinal carcinoma 59 patients ( controls ) received the regular hospital diet and 66 received PPN . The two groups were similar in nutritional status and in distribution of site and stage of tumour and type of operation . The rates of postoperative wound infection , pneumonia , major complications , and mortality were generally lower in the PPN group , but the differences were significant only for major complications and mortality . The clinical results can be explained by the improvement in various indices of humoral and cellular immunocompetence and the protein status in the PPN group and their deterioration in the control group during the preoperative course HYPOTHESIS Perioperatively administered enteral immunonutrition will improve early postoperative morbidity and cost-effectiveness after gastrointestinal tract surgery . DESIGN A prospect i ve , r and omized , double-blind , multicenter clinical trial . SETTING Surgical departments in German university and teaching hospitals . PATIENTS One hundred fifty-four patients with upper gastrointestinal tract malignant neoplasms who were eligible for analysis . INTERVENTION Preoperatively , patients received 5 days of oral immunonutrition ( an arginine- , RNA- , and omega3 fatty acid-supplemented diet ) or an isoenergetic control diet ( 1 L/d ) . Early postoperative enteral feeding with immunonutrition or an isoenergetic , isonitrogenous control diet using a catheter jejunostomy was performed for 10 days . MAIN OUTCOME MEASURES Postoperative infectious complications , their treatment costs , and cost-effectiveness of immunonutrition were analyzed . Plasma levels of the fatty acids eicosapentaenoic acid and docosahexaenoic acid were measured . RESULTS In the immunonutrition group , significantly fewer infectious complication events occurred ( 14 vs 27 ; P = .05 ) . The number of patients with complications was significantly lower in the supplemented diet group after postoperative day 3 ( 7 vs 16 ; P = .04 ) . The treatment costs of complications in the supplemented diet group were suggestively lower than in the control diet group ( DM 75172 vs DM 204273 ) . Cost-effectiveness was DM 1503 in the experimental group vs DM 3587 in the control group , where DM denotes deutsche mark ( German currency ) . CONCLUSION The perioperative administration of an enteral immunonutrition significantly ( P = .05 ) decreased the early occurrence of postoperative infections and reduced substantially the treatment costs of the complications after major upper gastrointestinal tract surgery BACKGROUND & AIMS Malnutrition is a recognized risk factor for perioperative morbidity , but there is currently no st and ardized definition of malnutrition . The Nutrition Risk Screening 2002 score was recently proposed to identify patients at nutritional risk who may benefit from nutritional support therapy , and has been officially adopted by the European Society of Parenteral and Enteral Nutrition . The aim of this study was to assess the value of the Nutrition Risk Screening 2002 score in predicting the incidence and severity of postoperative complications in gastrointestinal surgery . METHODS We prospect ively evaluated 608 patients admitted for elective gastrointestinal surgery . Nutritional risk was defined by the Nutrition Risk Screening 2002 score and correlated to the incidence and severity of postoperative complications . Complications were classified using an established surgical complication classification . RESULTS The overall incidence of nutritional risk was 14 % . We observed a significantly higher complication rate of 40 % ( 35 out of 87 ) in patients at nutritional risk , compared to 15 % ( 81 out of 521 ) in patients with a normal score ( p<0.001 ) . The incidence of severe complications was significantly higher in patients at nutritional risk ( 54 % versus 15 % ; p<0.001 ) . The odds ratio to develop a complication was 2.8 in patients at risk ( p=0.001 ) , and 3.0 in patients with malignant disease ( p<0.001 ) . The median length of stay in nutritional risk patients was significantly longer ( 10 versus 4 days , p<0.001 ) . CONCLUSION The prevalence of nutritional risk patients in gastrointestinal surgery is high . We showed that nutritional risk screening using the NRS 2002 strongly predicts the incidence and severity of complications Objectives The purpose of this study was to evaluate the effect of preoperative immunonutrition pharmaceutics ( IMPACT ) diet versus st and ard enteral nutrition ( EN ) on the nutritional status and immunity of patients with colorectal or gastrointestinal ( GI ) cancer and to evaluate whether it influences the incidence of postoperative complication . Methods Sixty patients with GI cancer were r and omly divided into 2 groups , immunonutrition ( IM ) and control diet ( CT ) , each of which was fed with IMPACT and conventional diet , respectively , for 7 days before surgical procedures . Variables of nutritional status and immunity , postoperative complications , infections , and the days of postoperative hospitalization were measured . Results There were no significant differences in the immunological
Output:
| Some unwanted effects have also been reported with components of IE nutrition in critical care patients and it is unknown whether there would be detrimental effects by administering IE nutrition to patients who could require critical care support after their surgery . |
MS212389 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Objective To assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) for neovascular age-related macular degeneration ( nAMD ) from a UK National Health Service ( NHS ) perspective . Design A within-trial cost-utility analysis with a 2-year time horizon , based on a multicentre factorial , non-inferiority r and omised controlled trial . Setting 23 hospital ophthalmology clinics . Participants 610 patients aged ≥50 years with untreated nAMD in the study eye . Interventions 0.5 mg ranibizumab or 1.25 mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for 2 years . Main outcome measures Quality -adjusted life-years ( QALYs ) . Results Total 2-year costs ranged from £ 3002/patient ( $ 4700 ; 95 % CI £ 2601 to £ 3403 ) for discontinuous bevacizumab to £ 18 590/patient ( $ 29 106 ; 95 % CI £ 18 258 to £ 18 922 ) for continuous ranibizumab . Ranibizumab was significantly more costly than bevacizumab for both continuous ( + £ 14 989/patient ( $ 23 468 ) ; 95 % CI £ 14 522 to £ 15 456 ; p<0.001 ) and discontinuous treatment ( + £ 8498 ( $ 13 305 ) ; 95 % CI £ 7700 to £ 9295 ; p<0.001 ) , with negligible difference in QALYs . Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay £ 3.5 million ( $ 5.5 million ) per additional QALY gained . Patients receiving continuous bevacizumab accrued higher total costs ( + £ 599 ( $ 938 ) ; 95 % CI £ 91 to £ 1107 ; p=0.021 ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more QALYs ( + 0.020 ; 95 % CI −0.032 to 0.071 ; p=0.452 ) . Continuous bevacizumab therefore cost £ 30 220 ( $ 47 316 ) per QALY gained versus discontinuous bevacizumab . However , bootstrapping demonstrated that if the NHS is willing to pay £ 20 000/QALY gained , there is a 37 % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab . Conclusions Ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no QALY gain . Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial , although there is a 37 % chance that continuous bevacizumab is cost-effective . Trial registration number IS RCT N92166560 BACKGROUND Bevacizumab has been suggested to have similar effectiveness to ranibizumab for treatment of neovascular age-related macular degeneration . The Inhibition of VEGF in Age-related choroidal Neovascularisation ( IVAN ) trial was design ed to compare these drugs and different regimens . Here , we report the findings at the prespecified 2-year timepoint . METHODS In a multicentre , 2 × 2 factorial , non-inferiority r and omised trial , we enrolled adults aged at least 50 years with active , previously untreated neovascular age-related macular degeneration and a best corrected distance visual acuity ( BCVA ) of at least 25 letters from 23 hospitals in the UK . Participants were r and omly assigned ( 1:1:1:1 ) to intravitreal injections of ranibizumab ( 0·5 mg ) or bevacizumab ( 1·25 mg ) in continuous ( every month ) or discontinuous ( as needed ) regimens , with monthly review . Study participants and clinical assessors were masked to drug allocation . Allocation to continuous or discontinuous treatment was masked up to 3 months , at which point investigators and participants were unmasked . The primary outcome was BCVA at 2 years , with a prespecified non-inferiority limit of 3·5 letters . The primary safety outcome was arterial thrombotic event or hospital admission for heart failure . Analyses were by modified intention to treat . This trial is registered , number IS RCT N92166560 . FINDINGS Between March 27 , 2008 , and Oct 15 , 2010 , 628 patients underwent r and omisation . 18 were withdrawn ; 610 received study drugs ( 314 ranibizumab ; 296 bevacizumab ) and were included in analyses . 525 participants reached the visit at 2 years : 134 ranibizumab in continuous regimen , 137 ranibizumab in discontinuous regimen , 127 bevacizumab in continuous regimen , and 127 bevacizumab in discontinuous regimen . For BCVA , bevacizumab was neither non-inferior nor inferior to ranibizumab ( mean difference -1·37 letters , 95 % CI -3·75 to 1·01 ; p=0·26 ) . Discontinuous treatment was neither non-inferior nor inferior to continuous treatment ( -1·63 letters , -4·01 to 0·75 ; p=0·18 ) . Frequency of arterial thrombotic events or hospital admission for heart failure did not differ between groups given ranibizumab ( 20 [ 6 % ] of 314 participants ) and bevacizumab ( 12 [ 4 % ] of 296 ; odds ratio [ OR ] 1·69 , 95 % CI 0·80 - 3·57 ; p=0·16 ) , or those given continuous ( 12 [ 4 % ] of 308 ) and discontinuous treatment ( 20 [ 7 % ] of 302 ; 0·56 , 0·27 - 1·19 ; p=0·13 ) . Mortality was lower with continuous than discontinuous treatment ( OR 0·47 , 95 % CI 0·22 - 1·03 ; p=0·05 ) , but did not differ by drug group ( 0·96 , 0·46 - 2·02 ; p=0·91 ) . INTERPRETATION Ranibizumab and bevacizumab have similar efficacy . Reduction in the frequency of retreatment result ed in a small loss of efficacy irrespective of drug . Safety was worse when treatment was administered discontinuously . These findings highlight that the choice of anti-VEGF treatment strategy is less straightforward than previously thought . FUNDING UK National Institute for Health Research Health Technology Assessment programme Background The effectiveness of ranibizumab in the treatment of diabetic macular edema has been proven with large clinical trials . For bevacizumab only two clinical trials have been published and a head-to-head comparison is lacking to date . However , if proved non-inferior to ranibizumab , use of the off-label bevacizumab could reduce costs enormously without a loss in visual acuity . A cost-effectiveness study has been design ed to substantiate this hypothesis . Aim To compare the effectiveness and costs of 1.25 mg of bevacizumab to 0.5 mg ranibizumab given as monthly intravitreal injections during 6 months in patients with diabetic macular edema . It is hypothesized that bevacizumab is non-inferior to ranibizumab regarding its effectiveness . Design This is a r and omized , controlled , double masked , clinical trial in 246 patients in seven academic trial centres in The Netherl and s. Outcomes The primary outcome measure is the change in best-corrected visual acuity ( BCVA ) in the study eye from baseline to month 6 . Secondary outcomes are the proportions of patients with a gain or loss of 15 letters or more or a BCVA of 20/40 or more at 6 months , the change in leakage on fluorescein angiography and the change in foveal thickness by optical coherence tomography at 6 months , the number of adverse events in 6 months , and the costs per quality adjusted life-year of the two treatments BACKGROUND Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration ( AMD ) . In addition , bevacizumab is used off-label to treat AMD , despite the absence of similar supporting data . METHODS In a multicenter , single-blind , noninferiority trial , we r and omly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation . The primary outcome was the mean change in visual acuity at 1 year , with a noninferiority limit of 5 letters on the eye chart . RESULTS Bevacizumab administered monthly was equivalent to ranibizumab administered monthly , with 8.0 and 8.5 letters gained , respectively . Bevacizumab administered as needed was equivalent to ranibizumab as needed , with 5.9 and 6.8 letters gained , respectively . Ranibizumab as needed was equivalent to monthly ranibizumab , although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive . The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group ( 196 μm ) than in the other groups ( 152 to 168 μm , P=0.03 by analysis of variance ) . Rates of death , myocardial infa rct ion , and stroke were similar for patients receiving either bevacizumab or ranibizumab ( P>0.20 ) . The proportion of patients with serious systemic adverse events ( primarily hospitalizations ) was higher with bevacizumab than with ranibizumab ( 24.1 % vs. 19.0 % ; risk ratio , 1.29 ; 95 % confidence interval , 1.01 to 1.66 ) , with excess events broadly distributed in disease categories not identified in previous studies as areas of concern . CONCLUSIONS At 1 year , bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule . Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly . Differences in rates of serious adverse events require further study . ( Funded by the National Eye Institute ; Clinical Trials.gov number , NCT00593450 . ) PURPOSE To assess long-term outcomes 7 to 8 years after initiation of intensive ranibizumab therapy in exudative age-related macular degeneration ( AMD ) patients . DESIGN Multicenter , noninterventional cohort study . PARTICIPANTS Sixty-five AMD patients originally treated with ranibizumab in the phase 3 Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in AMD ( ANCHOR ) trial , Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular AMD ( MARINA ) trial , and Open-Label Extension Trial of Ranibizumab for Choroidal Neovascularization Secondary to Age-Related Macular Degeneration ( HORIZON ) . METHODS Fourteen clinical trial sites recruited their original subjects for a return evaluation . Individual subject comparisons were obtained from the ANCHOR , MARINA , and HORIZON data bases . MAIN OUTCOME MEASURES The primary end point was percentage with best-corrected visual acuity ( BCVA ) of 20/70 or better ; secondary outcomes included mean change in letter score compared with previous time points and anatomic results on fluorescein angiography , spectral-domain ocular coherence tomography ( OCT ) , and fundus autofluorescence ( FAF ) . RESULTS At a mean of 7.3 years ( range , 6.3 - 8.5 years ) after entry into ANCHOR or MARINA , 37 % of study eyes met the primary end point of 20/70 or better BCVA , with 23 % achieving a BCVA of 20/40 or better . Thirty-seven percent of study eyes had BCVA of 20/200 or worse . Forty-three percent of study eyes had a stable or improved letter score ( ≥0-letter gain ) compared with ANCHOR or MARINA baseline measurements , whereas 34 % declined by 15 letters or more , with overall a mean decline of 8.6 letters ( P<0.005 ) . Since exit from the HORIZON study , study eyes had received a mean of 6.8 anti-vascular endothelial growth factor ( VEGF ) injections during the mean 3.4-year interval ; a subgroup of patients who received 11 or more anti-VEGF injections had a significantly better mean gain in letter score since HORIZON exit ( P
Output:
| A third drug , bevacizumab ( Avastin ) , is only licensed for colorectal cancer , and therefore , use in the eye is ‘ off label’.1 Yet , all three are effective . |
MS212390 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background . Comprehensive economic evaluations have not been conducted on telemedicine consultations to children in rural emergency departments ( EDs ) . Objective . We conducted an economic evaluation to estimate the cost , effectiveness , and return on investment ( ROI ) of telemedicine consultations provided to health care providers of acutely ill and injured children in rural EDs compared with telephone consultations from a health care payer prospect i ve . Methods . We built a decision model with parameters from primary programmatic data , national data , and the literature . We performed a base-case cost-effectiveness analysis ( CEA ) , a probabilistic CEA with Monte Carlo simulation , and ROI estimation when CEA suggested cost-saving . The CEA was based on program effectiveness , derived from transfer decisions following telemedicine and telephone consultations . Results . The average cost for a telemedicine consultation was $ 3641 per child/ED/year in 2013 US dollars . Telemedicine consultations result ed in 31 % fewer patient transfers compared with telephone consultations and a cost reduction of $ 4662 per child/ED/year . Our probabilistic CEA demonstrated telemedicine consultations were less costly than telephone consultations in 57 % of simulation iterations . The ROI was calculated to be 1.28 ( $ 4662/$3641 ) from the base-case analysis and estimated to be 1.96 from the probabilistic analysis , suggesting a $ 1.96 return for each dollar invested in telemedicine . Treating 10 acutely ill and injured children at each rural ED with telemedicine result ed in an annual cost-savings of $ 46,620 per ED . Limitations . Telephone and telemedicine consultations were not r and omly assigned , potentially result ing in biased results . Conclusions . From a health care payer perspective , telemedicine consultations to health care providers of acutely ill and injured children presenting to rural EDs are cost-saving ( base-case and more than half of Monte Carlo simulation iterations ) or cost-effective compared with telephone consultations Background Increasing use of teledermatology should be based on demonstration of favourable accuracy and cost – benefit analysis for the different methods of use of this technique Telehospice ( TH ) utilizes telemedicine technology to provide care at the end of life . A bistate project was launched in 1998 to study the use of home-based telemedicine for routine hospice care . Videophones were deployed for telenursing visits and evaluations by social workers . In order to determine what proportion of home hospice visits could be performed using currently available telemedicine technology , we review ed clinical records retrospectively for hospice nurse home visits . Clinical notes documenting home nursing visits were obtained from two large hospices , one based in Kansas , and the other in Michigan . Records were r and omly selected for patients who received hospice nurse visits during the month of January 2000 . The charts were review ed for patient demographic information , patient assessment s , teaching activities , and interventions . Five hundred ninety-seven nursing notes were analyzed using an 85-item coding instrument . After careful review of the records , the coders also made a subjective observation regarding the suitability of each visit for telemedicine . As part of this analysis , we found that 64.5 % of home hospice nursing visits could be performed by telemedicine . Using TH , it is possible to reduce the number of in-person visits , thereby significantly decreasing the cost of providing hospice care PURPOSE The purpose of this study was to assess the accuracy of a virtual consultation ( VC ) process in determining treatment strategy for patients with malignant epidural spinal cord compression ( MESCC ) . METHODS AND MATERIAL S A prospect i ve clinical data base was maintained for patients with MESCC . A virtual consultation process ( involving exchange of key predetermined clinical information and diagnostic imaging ) facilitated rapid decision-making between oncologists and spinal surgeons . Diagnostic imaging was review ed retrospectively ( by R.R. ) for surgical opinions in all patients . The primary outcome was the accuracy of virtual consultation opinion in predicting the final treatment recommendation . RESULTS After excluding 20 patients who were referred directly to the spinal surgeon , 125 patients were eligible for virtual consultation . Of the 46 patients who had a VC , surgery was recommended in 28 patients and actually given to 23 . A retrospective review revealed that 5/79 patients who did not have a VC would have been considered surgical c and i date s. The overall accuracy of the virtual consultation process was estimated at 92 % . CONCLUSION The VC process for MESCC patients provides a reliable means of arriving at a multidisciplinary opinion while minimizing patient transfer . This can potentially shorten treatment decision time and enhance clinical outcomes A r and omized controlled trial was carried out to measure the cost-effectiveness of realtime teledermatology compared with conventional outpatient dermatology care for patients from urban and rural areas . One urban and one rural health centre were linked to a regional hospital in Northern Irel and by ISDN at 128 kbit/s . Over two years , 274 patients required a hospital outpatient dermatology referral - 126 patients ( 46 % ) were r and omized to a telemedicine consultation and 148 ( 54 % ) to a conventional hospital outpatient consultation . Of those seen by telemedicine , 61 % were registered with an urban practice , compared with 71 % of those seen conventionally . The clinical outcomes of the two types of consultation were similar - almost half the patients were managed after a single consultation with the dermatologist . The observed marginal cost per patient of the initial realtime teledermatology consultation was 52.85 for those in urban areas and 59.93 per patient for those from rural areas . The observed marginal cost of the initial conventional consultation was 47.13 for urban patients and 48.77 for rural patients . The total observed costs of teledermatology were higher than the costs of conventional care in both urban and rural areas , mainly because of the fixed equipment costs . Sensitivity analysis using a real-world scenario showed that in urban areas the average costs of the telemedicine and conventional consultations were about equal , while in rural areas the average cost of the telemedicine consultation was less than that of the conventional consultation We are conducting a three-year study of telehealth in 11 home care offices that serve rural clients in Alberta . Three hundred and twenty palliative home care clients are being recruited to participate in a r and omized controlled trial ( RCT ) to answer three questions about the use of video-phones and their effect on symptom management , quality of life and cost , as well as readiness to use the technology . Both successes and challenges have been identified in three main areas : technology , people/organizational issues and study design . Maintaining study integrity has been the key factor in decision making , as adjustments from the original proposal are made . It is already clear that field-based RCTs are feasible , but require commitment and flexibility on the part of research ers and community partners to work through the study implementation Videotelephony ( real-time audio-visual communication ) has been used successfully in adult palliative home care . This paper describes two attempts to complete an RCT ( both of which were ab and oned following difficulties with family recruitment ) , design ed to investigate the use of videotelephony with families receiving palliative care from a tertiary paediatric oncology service in Brisbane , Australia . To investigate whether providing videotelephone-based support was acceptable to these families , a 12-month non-r and omised acceptability trial was completed . Seventeen palliative care families were offered access to a videotelephone support service in addition to the 24 hours ‘ on-call ’ service already offered . A 92 % participation rate in this study provided some reassurance that the use of videotelephones themselves was not a factor in poor RCT participation rates . The next phase of research is to investigate the integration of videotelephone-based support from the time of diagnosis , through outpatient care and support , and for palliative care rather than for palliative care in isolation . Trial registration ACTRN The clinical effectiveness of realtime teledermatology , store- and -forward teledermatology and conventional outpatient dermatological care were evaluated in a r and omized control trial . A total of 204 patients took part – 102 patients were r and omized to the realtime teledermatology consultation , 96 of whose cases were also referred using a store- and -forward technique , and 102 to the conventional outpatient consultation . There were no differences in the reported clinical outcomes of realtime teledermatology and conventional dermatology . Of those r and omized to the realtime teledermatology consultation , 46 % required at least one subsequent hospital appointment compared with 45 % of those r and omized to the conventional outpatient consultation . In contrast , the dermatologist requested a subsequent hospital appointment for 69 % of those seen by store- and -forward teledermatology . An analysis of costs showed that realtime teledermatology was clinical ly feasible but more expensive than conventional care , while the store- and -forward teledermatology consultation was less expensive but its clinical usefulness was limited . Sensitivity analysis indicated that realtime teledermatology was as economical as conventional care when less artificial assumptions were made about equipment utilization , costs and travel distances to hospital
Output:
| Studies on teledermatology and teleradiology indicated a favorable level of economic efficiency .
Overall , telemedicine programs in Japan were indicated to have a favorable level of economic efficiency . |
MS212391 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: STUDY OBJECTIVE To investigate the effects of peritoneal exposure to carbon dioxide ( CO2 ) on peritoneal microcirculation and free radical scavenger ( FRS ) metabolism , and its role in potential adhesion formation after operative laparoscopy . DESIGN R and omized , controlled study ( Canadian Task Force classification I ) . SETTING University-affiliated hospital . PATIENTS Twenty-eight women undergoing operative laparoscopy for adnexal masses . INTERVENTION For each patient , a 1 x 1-cm sidewall peritoneal flap was excised at the end of laparoscopy and numbered r and omly . Similar flaps obtained from 24 women immediately after entering the abdomen during laparotomy served as controls . MEASUREMENTS AND MAIN RESULTS Changes in glutathione peroxidase ( GSH-Px ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , and glutathione ( GSH ) levels were studied in homogenized peritoneal tissues . The duration of CO2 exposure and amount of CO2 used were correlated with levels of free radical scavengers and compared with controls . Mean CO2 exposure , amount of CO2 used , and CO2 pressure ( 15 mm Hg ) was similar between low irrigation and irrigated laparoscopy ( 118.3 + /- 25 and 39.2 + /- 8.81 min and 125 + /- 20 and 44.5 + /- 6.81 min , respectively ) . The change in FRS levels was significantly correlated with duration and amount of CO2 exposure ( r = -0.92 ) . Levels of GSH-Px , SOD , CAT , and GSH were significantly lower in the CO2 exposure group than in controls ( 0.57 micro mol , 1.8 ng , 48.5 micro mol , 1.5 nmol vs 0.8 micro mol , 2.6 + /- 0.4 ng , 79 micro mol , 3.6 nmol , respectively ) . CONCLUSION Exposure to CO2 has adverse effects on peritoneal microcirculation and cell-protective systems , which are proposed mechanisms in adhesion formation . Avoiding long CO2 exposure and copiously irrigating the abdominal cavity throughout surgery may lessen these effects . The potential role of the peritoneal FRS system on postoperative adhesion formation and its relation to estrogen status m and ates further studies Three groups of 11 New Zeal and women each received , for 32 wk , yeast tablets with no added selenium ( placebo ) or 200 micrograms Se/d in tablets either as selenate or as selenium-enriched yeast ( SeMet ) in a double-blind selenium trial . Plasma and erythrocyte ( RBC ) sample s were collected bimonthly . Gel filtration of plasma from women taking SeMet revealed two major selenium-containing peaks with most of the selenium in the second peak . In contrast , the first peak contained most of the selenium in plasma from women taking selenate . Chromatography of RBC lysates indicated that the majority of the selenium was with hemoglobin ( Hb ) in women taking SeMet but was about equally distributed between glutathione peroxidase ( GSH-Px ) and Hb in women taking selenate . The percentage of selenium associated with GSH-Px was found to be greater in RBCs and plasma of women taking selenate than of those taking SeMet In this prospect i ve study the free radical mediated reactions , the changes of endogenous antioxidant defense mechanism and activation of leukocytes were measured from the blood of patients undergoing elective cholecystectomy because of symptomatic cholecystolithiasis . The patients were r and omised into two groups . Group one contained 21 patients treated by open cholecystectomy(OC ) . Group two consisted of 21 patients treated by laparoscopic cholecystectomy ( LC ) . Both groups had similar patient characteristics . Patients with acute cholecystitis , pancreatitis , choledocholithiasis or other disease were excluded . Values from patients in both groups were compared . The measured biochemical parameters are the following : malondialdehyde ( MDA ) as a marker of the free radical induced lipid peroxidations , reduced and oxidised glutathione ( GSH-GSSG ) , as endogenous scavengers as well as markers of oxidative stress and myeloperoxidase activity ( MPO ) of leukocytes . The results showed significantly lower values of postoperatively measured MDA , GSH-GSSG , and MPO activity of leukocytes in patients with laparoscopic cholecystectomy , indicating a lesser stress response and tissue trauma in this group of patients . The results correspond to the favourable results of most other trials evaluating clinical aspect of LC The patient ’s position during laparoscopic surgery can have a clinical ly relevant effect on lower limb and splanchnic circulation ; this factor has not yet been investigated with respect to oxidative stress markers . In order to assess this effect , a prospect i ve clinical trial was design ed wherein 2 groups of patients were studied . In group A , 15 patients underwent upper abdominal nonhepatobiliary operations ( 13 modified Nissen fundoplications and 2 Taylor vagotomies ) in the head-up position . In group B , 15 patients underwent lower abdominal operations ( 10 laparoscopic colectomies and 5 inguinal hernia repairs ) in the head-down position . The pneumoperitoneum was maintained at 14 mm Hg in all cases . Plasma concentrations of thiobarbituric-acid reactive substances ( TBARS ) , a marker of lipid peroxidation , plasma total antioxidant status ( TAS ) , and serum uric acid concentrations were measured preoperatively , 5 minutes after deflation of the pneumoperitoneum , and 24 hours postoperatively . Aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) serum activities were measured preoperatively and 24 hours postoperatively . In group A , there was a significant increase in TBARS levels ( p<0.005 ) immediately after deflation of the pneumoperitoneum and a significant decrease in TAS and uric acid levels ( p<0.005 ) in the first postoperative day . There was also a significant postoperative elevation in both ALT and AST activities ( p<0.001 ) . In group B , no significant increase was found in postoperative TBARS or transaminase levels . TAS and uric acid levels decreased significantly in the first postoperative day ( p<0.05 ) and ( p<0.005 , respectively ) . In conclusion , these results show that a combination of pneumoperitoneum and the head-up position causes significant increase in lipid peroxidation , decrease in plasma TAS , and increase in transaminases . The mechanism responsible for these events could be the low-flow ischemia-reperfusion syndrome induced by the pneumoperitoneum and aggravated by the head-up position Background and objective : To compare the effects of sevoflurane and desflurane anaesthesia on lipid peroxidation . Methods : We studied 40 healthy patients undergoing elective laparoscopic cholecystectomy . Patients were r and omly allocated to be anaesthetized either with sevoflurane ( n = 20 ) or desflurane ( n = 20 ) . Anaesthesia was maintained with inspiratory concentrations of sevoflurane 1 - 1.5 MAC ( n = 20 ) or desflurane ( n = 20 ) . Sample s were taken for plasma malondialdehyde and superoxide dismutase assays before induction of anaesthesia , before skin incision and at the end of surgery . Alveolar cell sample s were obtained from the lungs using the technique of protective blind bronchoalveolar lavage , after induction of anaesthesia and at the end of surgery for malondialdehyde and superoxide dismutase concentrations . Results : Plasma malondialdehyde increased more after the administration of desflurane than after sevoflurane : after induction 5.9 ± 0.6 nmol mL−1 for desflurane vs. 3.8 ± 0.5 nmol L−1 for sevoflurane ( P < 0.001 ) ; at the end of the surgery : 6.7 ± 0.4 nmol mL−1 for desflurane vs. 4.2 ± 0.3 nmol mL−1 for sevoflurane ( P < 0.001 ) . There was a small but significant increase in plasma superoxide dismutase concentration after desflurane - from 24.2 ± 1.2 to 24.9 ± 0.9 U mL−1 after induction and 25 ± 1 U mL−1 at the end of the surgery ( P < 0.01 ) - but no increase with sevoflurane . Malondialdehyde concentrations increased significantly in the cells obtained by protective blind bronchoalveolar lavage at the end of surgery in the desflurane group ( from 0.3 ± 0.1 to 1.7 ± 0.2 nmol mL−1 ( P < 0.001 ) ) , but not in the sevoflurane group . There were no significant differences between the two anaesthetics in the amounts of superoxide dismutase in the sample s obtained by protective blind bronchoalveolar lavage . Conclusions : Desflurane may cause more systemic and regional lipid peroxidation than sevoflurane during laparoscopic cholecystectomy in healthy human beings BACKGROUND The aim of this work was to determine and compare plasma levels of proinflammatory cytokines ( IL-1beta , IL-6 and TNF-alpha ) , C-reactive protein ( CRP ) and lipoperoxides in patients su bmi tted to laparoscopic cholecystectomy under general anesthesia or regional anesthesia . METHODS Two groups of 15 patients of both sexes were su bmi tted to laparoscopic cholecystectomy either with general or regional anesthesia . In all cases we obtained three sample s of plasma . The first sample was collected immediately before surgery , whereas the other sample s were collected 60 min and 24 h after the cholecystectomy . Using commercial kits , plasma levels of IL-1beta , IL-6 and TNF-alpha were quantified by ELISA , whereas lipoperoxides were determined by a colorimetric method . The ultrasensitive CRP was determined in the hospital by the Prestige 24I automated method . RESULTS In all determinations , proinflammatory cytokines increased 24 h after surgery except plasma levels of IL-1beta in the regional anesthesia group . Comparison of the two different groups showed that the general anesthesia group had a similar or higher quantity of proinflammatory cytokines and oxidative stress when compared to the regional anesthesia group ( p < 0.05 ) . In contrast , plasma levels of CRP were lower in the general anesthesia group ( p < 0.005 ) . CONCLUSIONS The type of anesthesia influences in a different manner the secretion of soluble mediators of inflammation . These observations may have important clinical repercussions BACKGROUND Surgical injury is associated with oxidative stress , often due to ischemia/reperfusion injury . During laparoscopy , increased intra-abdominal pressure caused by pneumoperitoneum may cause splanchnic ischemia followed by reperfusion due to deflation . We measured several markers of oxidative stress in patients undergoing laparoscopic cholecystectomy ( LC ) versus open cholecystectomy ( OC ) to find if these surgical procedures result in different patterns of oxidative stress . METHODS This prospect i ve study enrolled 43 patients with symptomatic cholelithiasis , of whom 21 underwent open , and 22 laparoscopic , cholecystectomy . Twenty healthy adults comprised the control group . Total antioxidant status ( TAS ) , superoxide dismutase ( SOD ) , endogenous peroxide level ( POX ) , oxidized low density lipoprotein ( oLDL ) autoantibodies ( oLAb ) , and neopterin were measured preoperatively and on postoperative days 1 , 3 , and 7 . RESULTS POX values decreased significantly on postoperative day 1 in the OC ( P<0.01 ) , but not in the LC , group . On postoperative day 7 , POX values were higher than preoperatively in both groups ( P<0.01 ) with no difference between the LC and OC groups . Significant postoperative elevations of oLAb and neopterin levels were observed only on postoperative day 7 in the OC group . There were no changes of oLAb and neopterin levels in the LC group . TAS and SOD levels did not change after either LC or OC . CONCLUSION Cholecystectomy , either open or laparoscopic , caused only moderate oxidative stress . Open cholecystectomy caused changes of oLAb and neopterin , suggesting more severe oxidative stress , and a possible role of reactive oxygen species in the healing of the laparotomic wound Background : Although it has been been shown that the elevation of abdominal pressure causes splanchnic ischemia , the pathophysiological changes that occur during laparoscopic cholecystectomy are still under investigation . Our aim was to evaluate the changes in nitric oxide ( NO ) , malondialdehyde ( MDA ) , and gastric intramucosal pH ( pHi ) during laparoscopic surgery to verify whether splanchn
Output:
| However , results were highly discordant with some studies suggesting less pronounced OS after laparoscopic surgery , other studies suggesting potentiation of OS after laparoscopic surgery and some studies demonstrating no difference in OS between open and laparoscopic surgery |
MS212392 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: BACKGROUND We have previously demonstrated that vincristine , liposomal doxorubicin and dexamethasone ( VAD-doxil ) is equally effective with VAD-bolus yielding objective response rates of 61 % as first-line treatment in multiple myeloma ( MM ) . In a phase II study , the addition of thalidomide to VAD-doxil ( TVAD-doxil ) proved feasible and increased response rate to 74 % . The aim of the present multicenter prospect i ve r and omized clinical trial was to compare the efficacy and toxicity of VAD-doxil and TVAD-doxil in previously untreated MM patients . PATIENTS AND METHODS We enrolled 232 newly diagnosed MM patients aged < 75 years , 115 r and omized to VAD-doxil ( arm A ) and 117 to TVAD-doxil ( arm B ) . Patients in arm A received vincristine 2 mg i.v . and liposomal doxorubicin 40 mg/m(2 ) i.v . , on day 1 and dexamethasone 40 mg p.o . daily on days 1 - 4 , 9 - 12 and 17 - 20 for the first cycle and on days 1 - 4 for the next three cycles . Patients in arm B received additionally thalidomide 200 mg p.o . daily , at bedtime . Treatment was administered every 28 days . RESULTS On an intention-to-treat basis , at least partial response was observed , in 62.6 % and in 81.2 % of patients r and omized to arms A and B , respectively ( P = 0.003 ) . Progression-free survival ( PFS ) at 2 years was 44.8 % in arm A and 58.9 % in arm B ( P = 0.013 ) . Overall survival ( OS ) at 2 years was 64.6 % and 77 % , in arms A and B , respectively ( P = 0.037 ) . Considering overall toxicity , constipation , peripheral neuropathy , dizziness/somnolence , skin rash and edema were significantly higher in arm B compared with arm A ( P < 0.01 ) , but grade 3 - 4 toxicities were low and similar in both arms . CONCLUSIONS The addition of thalidomide to VAD-doxil increases response and PFS rates and probably OS in previously untreated myeloma patients . The superiority of efficacy counterbalances the higher overall toxicity of TVAD-doxil Newer chemotherapeutic protocol s as well as high-dose chemotherapy have increased the response rate in myeloma . However , these treatments are not curative . Effective maintenance strategies are now required to prolong the duration of response . We conducted a r and omized trial of maintenance treatment with thalidomide and pamidronate . Two months after high-dose therapy , 597 patients younger than age 65 years were r and omly assigned to receive no maintenance ( arm A ) , pamidronate ( arm B ) , or pamidronate plus thalidomide ( arm C ) . A complete or very good partial response was achieved by 55 % of patients in arm A , 57 % in arm B , and 67 % in arm C ( P = .03 ) . The 3-year postr and omization probability of event-free survival was 36 % in arm A , 37 % in arm B , and 52 % in arm C ( P < .009 ) . The 4-year postdiagnosis probability of survival was 77 % in arm A , 74 % in arm B , and 87 % in arm C ( P < .04 ) . The proportion of patients who had skeletal events was 24 % in arm A , 21 % in arm B , and 18 % in arm C ( P = .4 ) . Thalidomide is an effective maintenance therapy in patients with multiple myeloma . Maintenance treatment with pamidronate does not decrease the incidence of bone events BACKGROUND In multiple myeloma , combination chemotherapy with melphalan plus prednisone is still regarded as the st and ard of care in elderly patients . We assessed whether the addition of thalidomide to this combination , or reduced-intensity stem cell transplantation , would improve survival . METHODS Between May 22 , 2000 , and Aug 8 , 2005 , 447 previously untreated patients with multiple myeloma , who were aged between 65 and 75 years , were r and omly assigned to receive either melphalan and prednisone ( MP ; n=196 ) , melphalan and prednisone plus thalidomide ( MPT ; n=125 ) , or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 ( MEL100 ; n=126 ) . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00367185 . FINDINGS After a median follow-up of 51.5 months ( IQR 34.4 - 63.2 ) , median overall survival times were 33.2 months ( 13.8 - 54.8 ) for MP , 51.6 months ( 26.6-not reached ) for MPT , and 38.3 months ( 13.0 - 61.6 ) for MEL100 . The MPT regimen was associated with a significantly better overall survival than was the MP regimen ( hazard ratio 0.59 , 95 % CI 0.46 - 0.81 , p=0.0006 ) or MEL100 regimen ( 0.69 , 0.49 - 0.96 , p=0.027 ) . No difference was seen for MEL100 versus MP ( 0.86 , 0.65 - 1.15 , p=0.32 ) . INTERPRETATION The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should , at present , be the reference treatment for previously untreated elderly patients with multiple myeloma BACKGROUND Since 1960 , oral melphalan and prednisone ( MP ) has been regarded as the st and ard of care in elderly multiple myeloma patients . This multicentre r and omised trial compared oral MP plus thalidomide ( MPT ) with MP alone in patients aged 60 - 85 years . METHODS Patients with newly diagnosed multiple myeloma were r and omly assigned to receive oral MP for six 4-week cycles plus thalidomide ( n=129 ; 100 mg per day continuously until any sign of relapse or progressive disease ) or MP alone ( n=126 ) . Analysis was intention-to-treat . This study is registered at , number NCT00232934 . RESULTS Patients treated with thalidomide had higher response rates and longer event-free survival ( primary endpoints ) than patients who were not . Combined complete or partial response rates were 76.0 % for MPT and 47.6 % for MP alone ( absolute difference 28.3 % , 95 % CI 16.5 - 39.1 ) , and the near-complete or complete response rates were 27.9 % and 7.2 % , respectively . 2-year event-free survival rates were 54 % for MPT and 27 % for MP ( hazard ratio [ HR ] for MPT 0.51 , 95 % CI 0.35 - 0.75 , p=0.0006 ) . 3-year survival rates were 80 % for MPT and 64 % for MP ( HR for MPT 0.68 , 95 % CI 0.38 - 1.22 , p=0.19 ) . Rates of grade 3 or 4 adverse events were 48 % in MPT patients and 25 % in MP patients ( p=0.0002 ) . Introduction of enoxaparin prophylaxis reduced rate of thromboembolism from 20 % to 3 % ( p=0.005 ) . CONCLUSION Oral MPT is an effective first-line treatment for elderly patients with multiple myeloma . Anticoagulant prophylaxis reduces frequency of thrombosis . Longer follow-up is needed to assess effect on overall survival PURPOSE To determine if thalidomide plus dexamethasone yields superior response rates compared with dexamethasone alone as induction therapy for newly diagnosed multiple myeloma . PATIENTS AND METHODS Patients were r and omly assigned to receive thalidomide plus dexamethasone or dexamethasone alone . Patients in arm A received thalidomide 200 mg orally for 4 weeks ; dexamethasone was administered at a dose of 40 mg orally on days 1 to 4 , 9 to 12 , and 17 to 20 . Cycles were repeated every 4 weeks . Patients in arm B received dexamethasone alone at the same schedule as in arm A. RESULTS Two hundred seven patients were enrolled : 103 were r and omly assigned to thalidomide plus dexamethasone and 104 were r and omly assigned to dexamethasone alone ; eight patients were ineligible . The response rate with thalidomide plus dexamethasone was significantly higher than with dexamethasone alone ( 63 % v 41 % , respectively ; P = .0017 ) . The response rate allowing for use of serum monoclonal protein levels when a measurable urine monoclonal protein was unavailable at follow-up was 72 % v 50 % , respectively . The incidence rates of grade 3 or higher deep vein thrombosis ( DVT ) , rash , bradycardia , neuropathy , and any grade 4 to 5 toxicity in the first 4 months were significantly higher with thalidomide plus dexamethasone compared with dexamethasone alone ( 45 % v 21 % , respectively ; P < .001 ) . DVT was more frequent in arm A than in arm B ( 17 % v 3 % ) ; grade 3 or higher peripheral neuropathy was also more frequent ( 7 % v 4 % , respectively ) . CONCLUSION Thalidomide plus dexamethasone demonstrates significantly superior response rates in newly diagnosed myeloma compared with dexamethasone alone . However , this must be balanced against the greater toxicity seen with the combination PURPOSE To determine whether interferon maintenance therapy improves overall survival and response duration in patients with multiple myeloma who have responded to induction therapy with melphalan and prednisone . PATIENTS AND METHODS In a multicenter trial , patients with symptomatic clinical stage I and stage II and III multiple myeloma were registered at diagnosis and those who responded to melphalan-prednisone ( MP ) were r and omized either to receive interferon ( 2 mU/m2 ) subcutaneously three times per week or no maintenance . MP was discontinued in both groups once a stable response plateau of the monoclonal protein was reached . Interferon was continued until relapse , and then was restarted on subsequent response to MP . Interferon toxicity was recorded using a self-report diary . Survival and response duration were calculated using life-table methods , and were adjusted in the analysis for imbalances in baseline prognostic factors . RESULTS Four hundred two patients were registered and 176 responders were r and omized ( 85 to interferon and 91 to control ) . At a median follow-up time of 43 months , the median survival duration was 43 months for interferon and 35 months for control ( P = .16 ) , but when adjusted for chance imbalances in baseline prognostic factors ( mainly performance status ) , the median survival duration was 44 months and 33 months for interferon and control , respectively ( P = .049 ) . Progression-free survival from r and omization to first relapse also favored interferon ( unadjusted P < .002 ; adjusted P < .003 ) . Interferon toxicity caused 58 % of patients to reduce their dose , of which 84 % were able to return to the initial dose ; 14 % had to discontinue interferon treatment . CONCLUSION Interferon maintenance therapy improves progression-free and overall survival of patients with multiple myeloma who respond to melphalan and prednisone . Toxicity is substantial and must be weighed by patients against the potential benefits in response duration and survival BACKGROUND High-dose therapy with supporting autologous stem-cell transplantation remains a controversial treatment for cancer . In multiple myeloma , first-line regimens incorporating high-dose therapy yield higher remission rates than do conventional-dose treatments , but evidence that this translates into improved survival is limited . METHODS In this multicenter study , the Medical Research Council Myeloma VII Trial , we r and omly assigned 407 patients with previously untreated multiple myeloma who were younger than 65 years of age to receive either st and ard conventional-dose combination chemotherapy or high-dose therapy and an autologous stem-cell transplant . RESULTS Among the 401 patients who could be evaluated , the rates of complete response were higher in the intensive-therapy group than in the st and ard-therapy group ( 44 percent vs. 8 percent , P<0.001 ) . The rates of partial response were similar ( 42 percent and 40 percent , respectively ; P=0.72 ) , and the rates of minimal response were lower in the intensive-therapy group than in the st and ard-therapy group ( 3 percent vs. 18 percent , P<0.00
Output:
| In summary , thalidomide appears to improve the overall survival of patients with newly diagnosed myeloma both when it is added to st and ard , non-transplantation therapy , and when it is given as maintenance therapy following ASCT .
However , thalidomide is associated with toxicity , particularly a significantly increased risk of VTE |
MS212393 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Eighteen consecutive patients satisfying predefined clinical criteria for embolic strokes were prospect ively studied by sequential computerized tomography ( CT ) . Their findings were compared to CT scans obtained from patients presumed to have suffered thrombotic strokes . Our data reveal that the CT appearance of hemorrhagic infa rct ion is likely to occur twice as frequently ( 22 % ) in CT scans of strokes presumed embolic than in those presumed thrombotic , where hemorrhagic infa rct ion appeared at some time in 10 % of the patients . No patient deteriorated with anticoagulation regardless of the CT appearance . In patients showing hemorrhagic infa rct ion before anticoagulants , follow-up scans obtained after the administration of anticoagulants revealed resolution of the hemorrhagic aspect Background and Purpose — We sought to investigate the apparently high risk of early death after an ischemic stroke among patients with atrial fibrillation ( AF ) , identify the main factors associated with early death , and assess the effect of treatment with different doses of subcutaneous unfractionated heparin ( UFH ) given within 48 hours . Methods — We studied the occurrence of major clinical events within 14 days among 18 451 patients from the International Stroke Trial , first for all treatment groups combined . Then , among patients with AF , we examined the effects of treatment with subcutaneous UFH started within 48 hours and continued until 14 days after stroke onset . Results — A total of 3169 patients ( 17 % ) had AF . Seven hundred eighty-four patients were allocated to UFH 12 500 IU SC BID , 773 to UFH 5000 IU SC BID , and 1612 to no heparin . Within each of these groups , half of the patients were r and omly assigned to aspirin 300 mg once daily . Compared with patients without AF , patients with AF were more likely to be female ( 56 % versus 45 % ) , to be old ( mean age , 78 versus 71 years ) , to have an infa rct on prer and omization CT ( 57 % versus 47 % ) , and to have impaired consciousness ( 37 % versus 20 % ) . The initial ischemic stroke type was more often a large-artery infa rct ( 36 % versus 21 % ) . A lacunar stroke syndrome was less common ( 13 % versus 26 % ) . Death within 14 days was more common in patients with AF ( 17 % versus 8 % ) and more often attributed to neurological damage from the initial stroke ( 10 % versus 4 % ) . The frequency of recurrent ischemic or undefined stroke was not significantly different ( 3.9 % versus 3.3 % ) . The proportion of AF patients with further events within 14 days allocated to UFH 12 500 IU ( n=784 ) , UFH 5000 IU ( n=773 ) , and to no-heparin ( n=1612 ) groups were as follows : ischemic stroke , 2.3 % , 3.4 % , 4.9 % ( P = 0.001 ) ; hemorrhagic stroke , 2.8 % , 1.3 % , 0.4 % ( P < 0.0001 ) ; and any stroke or death , 18.8 % , 19.4 % and 20.7 % ( P = 0.3 ) , respectively . No effect of heparin on the proportion of patients dead or dependent at 6 months was apparent . Conclusions — Acute ischemic stroke patients with AF have a higher risk of early death , which can be explained by older age and larger infa rcts but not by a higher risk of early recurrent ischemic stroke , although slightly more patients with AF died from a fatal recurrent stroke of ischemic or unknown type ( 1.3 % versus 0.9 % ) . In patients with AF the absolute risk of early recurrent stroke is low , and there is no net advantage to treatment with heparin . These data do not support the widespread use of intensive heparin regimens in the acute phase of ischemic stroke associated with AF In a group of 60 patients in the acute phase of an ischemic stroke the assumption that low-molecular-weight heparin Kabi 2165 in the dose of 2 X 2,500 anti-Xa units s.c . could prevent thromboembolic complications was tested using a double-blind , placebo-controlled , r and omized trial design . Thirty patients were allocated to each group . Both treatment groups were comparable with regard to neurological status and general condition . In the Kabi 2165 group there were 6 cases of deep venous thrombosis ( DVT ) compared to 15 in the placebo group ( p = 0.05 ) . In the placebo group there were 4 deaths during the trial versus 9 in the Kabi-2165-treated group ( NS ) . Cerebral bleeding complicated 2 cases in the placebo group versus 4 in the Kabi 2165 group ( NS ) . These results indicate that in ischemic stroke patients Kabi 2165 2 X 2,500 anti-Xa units s.c./24 h reduces the frequency of DVT . Because of the small number of patients it is impossible to evaluate the safety IN A PREVIOUS issue of this journa1,l the details of our national cooperative ControIled study of long-term anticoagulant therapy in cerebral ischemia and cerebral infa rct ion were presented along with an interim report covering some eighteen months . At that time , longterm anticoagulation did not appear to reduce the mortality and there was an added risk due to hemorrhagic complications . The study , embracing 7 clinical centers and extending over a period of forty-two months , was brought to an end in August 1961 , and this is a report of our findings and final conclusions . The important aspects of the study , including selection and classification of cases and method of anticoagulation , were fully covered previously and will not be repeated here . A total of 443 patients were enrolled in the study , each patient being assigned to the anticoagulant or nonanticoagulant therapeutic groups on a statistically r and om basis by means of sealed envelopes . All the patients in the study were divided into 5 diagnostic categories : ( 1 ) transient ischemic attacks , ( 2 ) thrombosis-in-evolution , ( 3 ) thrombosis-completed stroke , ( 4 ) thorem ( thrombosis or embolism ) , and ( 5 ) cerebral embolism . Analysis of the control and treated groups showed that they were remarkably comparable in most respects ( table 1 ) . The number of cases involving the internal carotidmiddle cerebral and vertebral-basilar systems varied from category to category ; in the whole series there were 328 in the carotid and 102 in the vertebral-basilar . In regard to blood pressure , 59.6 per cent of the entire group had an elevated blood pressure . To determine the effect of anticoagulant therapy , the cases were analyzed as to the incidence of ( 1 ) deaths , ( 2 ) progression of cerebral infa rct ion due to either extension of the infa rct ed area or a new infa rct ion , ( 3 ) the advent of extracerebral thrombotic episodes ( ECTE ) , including myocardial infa rct ion , pulmonary embolism , thrombophlebitis , and so forth , and ( 4 ) hemorrhagic complications . Patients whose anticoagulants were stopped within two weeks of death when the patient 's condition was deteriorating were reckoned as deaths while on anticoagulants The clinical features of 49 patients who had sustained small strokes in the internal carotid artery territory , who were normotensive , free from cardiac or other relevant disease , and who each had a normal appropriate single vessel angiogram are presented . These were r and omized into two groups : group A , 25 patients , who received only supportive treatment ; group B , 24 patients who were treated with anticoagulants for an average period of 18 months . There was a reduced incidence of neurological episodes during the administration of anticoagulant therapy but , after treatment was discontinued , there was no significant difference between the two groups . In view of the relatively benign prognosis for this syndrome , unless special facilities exist for the personal control of anticoagulant treatment , the dangers may outweigh the benefits In a non‐r and omized controlled study carried out on 238 hospitalized patients with cerebral infa rct ion , anticoagulant treatment ( AC ) was compared with the natural course in the prevention of transient ischemic attacks ( TIA ) , cerebral infa rct ion , stroke , stroke or death . 137 patients were allocated to AC , mean follow‐up 30.5 months , and 101 patients were allocated to the controls ( untreated group ) , mean follow‐up 25.2 months In a double-blind , placebo-controlled trial , 225 patients with acute partial stable thrombotic stroke were r and omly assigned to receive continuous intravenous heparin therapy or placebo for 7 days for the prevention of stroke progression or death . No statistically significant difference between the two groups was found in degree of neurologic change ; incidence of stroke progression after 7 days ; or functional activity level of survivors at 7 days , 3 months and at 1 year after treatment . Compared with controls , a statistically significant greater number of patients in the group receiving heparin died in the year after the stroke . These deaths occurred 3 to 12 months after the initial stroke and probably were not related to treatment . Results of this study do not support the use of intravenous heparin to treat patients who have had acute partial stroke Deep vein thrombosis ( DVT ) and subsequent pulmonary embolism ( PE ) is a major source of mortality and morbidity in stroke patients . This study was design ed to determine the effectiveness of different prophylactic treatments in the prevention of DVT after a stroke in patients undergoing rehabilitation . An additional objective was the identification of risk factors for DVT in stroke in patients during rehabilitation . Three hundred and sixty patients , over a 3-year period , were r and omly assigned to one of four groups : adjusted dose heparin , intermittent pneumatic compression ( IPC ) , functional electrical stimulation ( FES ) , or control . There was no significant difference in the development of DVT by treatment group . Patients with DVT on admission ( prevalent , n = 61 ) were compared with the study patients ( n = 360 ) . Time interval ( from stroke to admission ) and lactic dehydrogenase ( LDH ) concentration were significant risk factors , as well as predictors , for development of DVT ( p < .000 ) . These results suggest that the longer a patient remains without DVT prophylaxis after a stroke , the greater the risk of developing DVT and this supports early prophylaxis before rehabilitation Venous thrombo-embolism is a major and often unrecognized cause of morbidity and mortality in patients after acute strokes . Three hundred and five elderly patients were r and omly allocated to either control ( 161 ) or treatment ( 144 ) with 5000 units calcium heparin subcutaneously 8-hourly for two weeks . A reduction in deep-vein thrombosis rate from 72.7 % in the control group to 22.2 % in treatment patients was achieved . In patients who died ( 84 ) , post-mortem examination to look for pulmonary emboli was performed in 71 . Comparison between treated and untreated patients showed significantly fewer deaths and pulmonary emboli in the treated group . Most of the beneficial effect on mortality was seen in patients with lighter strokes . When patients with pulmonary emboli at post-mortem were excluded , there was no significant difference in the death rate in treatment ( 17 ) and control ( 14 ) groups . At post-mortem , 9.9 % of the strokes were haemorrhagic ( 4 in the treatment and 3 in the control group ) . Low-dose calcium heparin given subcutaneously following acute stroke reduced the number of deep-vein thromboses , pulmonary emboli and deaths without increasing the number of haemorrhagic strokes in this study We studied the effect of argatroban , a new selective thrombin inhibitor , on the haemostatic system in seven patients with acute ischaemic stroke ( the argatroban group ) . Argatroban was infused continuously at 2.5 mg/h for the first 48 h , and then 10 mg of argatroban was infused over 3 h twice a day on days 3 - 7 . The placebo group consisted of six acute ischaemic stroke patients . As a combination therapy , intravenous administration of glycerol was also performed at the same time in five of the seven patients in the argatroban group and in four of the six patients in the placebo group . D-dimer levels were measured by a latex photometric immunoassay that allowed immediate quantitative assessment . The D-dimer levels of our 13 patients with acute ischaemic stroke were raised at the time of admission ( day 1 ) and 69 % of the values were above the 97th percentile ( > 500 ng/ml ) in healthy subjects . D-dimer levels were significantly reduced in the argatroban group on days 2 and 7 after admission when compared with the placebo group ( day 2 : P = 0.032 ; day 7 : P = 0.046 ) . Thus , haemostatic activation occurred in acute ischaemic stroke was effectively blocked by argatroban A r and omized trial of immediate versus delayed anticoagulation of patients with cardiogenic embolic brain infa rct ion was carried out in a multi-centered study . Patients who were within 48 hours of onset of deficit and who had no evidence of hemorrhage on computed tomography ( CT ) were r and om
Output:
| Sensitivity analyses did not identify a particular type of anticoagulant regimen or patient characteristic associated with net benefit .
REVIEW ER 'S CONCLUSIONS Immediate anticoagulant therapy in patients with acute ischaemic stroke is not associated with net short- or long-term benefit .
The data from this review do not support the routine use of any type of anticoagulant in acute ischaemic stroke |
MS212394 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The influence of the source of dietary fat on postpr and ial thermogenesis and substrate oxidation rates , was examined in twelve postmenopausal women aged 57 - 73 years , with BMI 21.9 - 38.3 kg/m(2 ) . A single blind , r and omised , paired comparison of two high-fat , isoenergetic , mixed test meals was conducted . The major source of fat was either cream ( CREAM ) or extra virgin olive oil ( EVOO ) . RMR , diet-induced thermogenesis ( DIT ) and substrate oxidation rates over 5 h were measured by indirect calorimetry . There were no differences in body weight , RMR , fasting carbohydrate or fat oxidation rates between the two occasions . DIT ( EVOO 97 ( SD 46 ) v. CREAM 76 ( SD 69 ) kJ/5 h and EVOO 5.2 ( SD 2.5 ) v. CREAM 4.1 ( SD 3.7)% energy ) did not differ between the two test meals . The postpr and ial increase in carbohydrate oxidation rates , relative to their respective fasting values ( DeltaCOX ) , was significantly lower following the EVOO meal ( EVOO 10.6 ( SD 8.3 ) v. CREAM 17.5 ( SD 10 ) g/5 h ; paired t test , P=0.023 ) , while postpr and ial fat oxidation rates ( DeltaFOX ) were significantly higher ( EVOO 0.0 ( SD 4.4 ) v. CREAM -3.6 ( sd 4.0 ) g/5 h ; P=0.028 ) . In the eight obese subjects , however , DIT was significantly higher following the EVOO meal ( EVOO 5.1 ( SD 2.0 ) v. CREAM 2.5 ( sd 2.9 ) % ; P=0.01 ) . This was accompanied by a significantly lower DeltaCOX ( EVOO 10.9 ( SD 9.9 ) v. CREAM 17.3 ( SD 10.5 ) g/5 h ; P=0.03 ) and significantly higher DeltaFOX ( EVOO 0.11 ( SD 4.4 ) v. CREAM -4.1 ( SD 4.5 ) g/5 h , P=0.034 ) . The present study showed that olive oil significantly promoted postpr and ial fat oxidation and stimulated DIT in abdominally obese postmenopausal women The aim of this dynamic prospect i ve follow-up study was to assess the association between olive oil consumption and the likelihood of weight gain or the incidence of overweight or obesity in a large Mediterranean cohort of 7,368 male and female Spanish university graduates ( the SUN Project ) who were followed for a median period of 28.5 mon . A vali date d Food Frequency Question naire was administered at baseline , and respondents also completed a follow-up question naire after 28.5 mon . Changes in participants ' consumption of olive oil and their weight were assessed during follow-up . A higher baseline consumption of olive oil was associated with a lower likelihood of weight gain , although the differences were not statistically significant . The adjusted difference in weight gain ( kg ) was −0.16 [ 95 % confidence interval ( C1 ) : −0.42 to + 0.11 ] for participants in the upper quintile of olive oil consumption ( median : 46 g/d ) compared with those in the lowest quintile ( median : 6 g/d ) . For participants with a high baseline consumption of olive oil whose olive oil consumption also increased during follow-up , we found a slightly increased but nonsignificant risk of incidence of over-weight or obesity ( adjusted odds ratio=1.19 , 95 % C1 : 0.73 to 1.95 ) . Our study , carried out in a sample of free-living people , shows that a high amount of olive oil consumption is not associated with higher weight gain or a significantly higher risk of developing overweight or obesity in the context of the Mediterranean food pattern BACKGROUND The effect of dietary fat and carbohydrate on glucose metabolism has been debated for decades . OBJECTIVE The objective was to compare the effect of 3 ad libitum diets , different in type and amount of fat and carbohydrate , on insulin resistance and glucose tolerance subsequent to weight loss . DESIGN Forty-six nondiabetic , obese [ mean ( + /-SEM ) body mass index ( in kg/m(2 ) ) : 31.2 + /- 0.3 ] men ( n = 20 ) and premenopausal women ( n = 26 ) aged 28.0 + /- 0.7 y were r and omly assigned to 1 of 3 diets after > or = 8 % weight loss : 1 ) MUFA diet ( n = 16 ) : moderate in fat ( 35 - 45 % of energy ) and high in monounsaturated fatty acids ( > 20 % of energy ) ; 2 ) LF diet ( n = 18 ) : low-fat diet ( 20 - 30 % of energy ) , and 3 ) control diet ( n = 12 ) : 35 % of energy as fat ( > 15 % of energy as saturated fatty acids ) . Protein accounted for 15 % of energy in all 3 diets . A 2-h oral-glucose-tolerance test ( OGTT ) was performed before and after the 6-mo dietary intervention . All foods were provided by a purpose -built supermarket . RESULTS After 6 mo , the MUFA diet reduced fasting glucose ( -3.0 % ) , insulin ( -9.4 % ) , and the homeostasis model assessment of insulin resistance score ( -12.1 % ) . Compared with the MUFA diet , the control diet increased these variables [ 1.4 % ( P = 0.014 ) , 21.2 % ( P = 0.030 ) , and 22.8 % ( P = 0.015 ) , respectively ] , as did the LF diet [ 1.4 % ( P = 0.090 ) , 13.1 % ( P = 0.078 ) , and 15.5 % ( P = 0.095 ) , respectively ] . No significant group differences were detected in glucose or insulin concentrations during the OGTT , in the Matsudas index , in body weight , or in body composition . CONCLUSION A diet high in monounsaturated fat has a more favorable effect on glucose homeostasis than does the typical Western diet in the short term and may also be more beneficial than the official recommended low-fat diet during a period of weight regain subsequent to weight loss BACKGROUND Adherence to a Mediterranean diet has been reported to increase longevity , but concerns have been expressed that such a diet may promote overweight and obesity . OBJECTIVE The objective was to investigate whether adherence to the traditional Mediterranean diet , as operationalized in a Mediterranean diet score , is associated with body mass index ( BMI ) and waist-to-hip ratio ( WHR ) . DESIGN In a general population sample of 23,597 adult men and women participating in the Greek European Prospect i ve Investigation into Cancer and Nutrition Study , a vali date d food-frequency question naire was interviewer-administered , and anthropometric , sociodemographic , physical activity , and other lifestyle characteristics were recorded . BMI and WHR were regressed on a score that reflects adherence to the traditional Mediterranean diet and potentially confounding variables . RESULTS In models in which total energy intake was included , adherence to the Mediterranean diet was unrelated to BMI in both sexes and was weakly related to WHR only in women . When energy intake was not controlled for , a 2-point increase in the score was found to correspond to increases of approximately 650 and 150 g in the weight of an average-height man and woman , respectively , whereas the WHR was found to increase by approximately 0.001 units in men and 0.004 units in women . CONCLUSIONS Adherence to a Mediterranean diet was essentially unrelated to BMI , with small differences depending on model choice and having no practical consequences . Overweight is a genuine problem in Greece and perhaps other Mediterranean countries , but it is likely to be related to limited physical activity in conjunction with excessive positive energy balance Few studies have prospect ively examined dietary patterns and adult weight change , and results to date are inconsistent . This study examines whether a Mediterranean diet ( MD ) pattern is associated with reduced 3-y incidence of obesity using data from the Spanish cohort of the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC-Spain ) . The sample included 17,238 women and 10,589 men not obese and aged 29 - 65 y at baseline ( 1992 - 96 ) . Height and weight were measured at baseline ; weight was self-reported in a follow-up survey a mean of 3.3 y later . Detailed dietary history data , collected using a vali date d method , were used to construct a MD score . Logistic regression models were used to estimate odds of becoming overweight or obese . Among initially overweight subjects , 7.9 % of women and 6.9 % of men became obese , whereas 13.8 % of normal weight men and 23.0 % women became overweight . High MD adherence was associated with significantly lower likelihood of becoming obese among overweight subjects , with stronger associations after adjusting for underreporting of dietary data . Associations ( odds ratios with 95 % CI ) were similar in women ( 0.69 , 0.54 - 0.89 ) and men ( 0.68 , 0.53 - 0.89 ) . Adjusting for the plausibility of reported dietary intakes increased the magnitude of these associations , which were approximately 0.8 without this adjustment . MD adherence was not associated with incidence of overweight in initially normal-weight subjects . Nonetheless , results suggest that promoting eating habits consistent with MD patterns may be a useful part of efforts to combat obesity A r and omised crossover study of eight overweight or obese men ( aged 24 - 49 years , BMI 25.5 - 31.3 kg/m(2 ) ) , who followed two diets for 4 weeks each , was performed to determine whether substitution of saturated fat with monounsaturated fat affects body weight and composition . Subjects were provided with all food and beverages as modules ( selected ad libitum ) of constant macronutrient composition , but differing energy content . The % total energy from saturated fat , monounsaturated fat and polyunsaturated fat was 24 , 13 and 3 % respectively on the saturated fatty acid (SFA)-rich diet and 11 , 22 and 7 % respectively on the monounsaturated fatty acid (MUFA)-rich diet . MUFA accounted for about 80 % of the unsaturated fats consumed on both diets . Body composition , blood pressure , energy expenditure ( resting and postpr and ial metabolic rates , substrate oxidation rate , physical activity ) , serum lipids , the fatty acid profile of serum cholesteryl esters and plasma glucose and insulin concentrations were measured before and after each diet period . Significant ( P < or = 0.05 ) differences in total cholesterol and the fatty acid composition of serum cholesteryl esters provided evidence of dietary adherence . The men had a lower weight ( -2.1 ( SE 0.4 ) kg , P=0.0015 ) and fat mass ( -2.6 ( SE 0.6 ) kg , P=0.0034 ) at the end of the MUFA-rich diet as compared with values at the end of the SFA-rich diet . No significant differences were detected in energy or fat intake , energy expenditure , substrate oxidation rates or self-reported physical activity . Substituting dietary saturated with unsaturated fat , predominantly MUFA , can induce a small but significant loss of body weight and fat mass without a significant change in total energy or fat intake Context Some experts attribute a low incidence of heart disease in Mediterranean countries to dietary habits . Contribution In this multicenter , 3-group trial , investigators r and omly assigned 772 adults at high risk for cardiovascular disease to a low-fat diet or to a Mediterranean diet supplemented with either virgin olive oil ( 1 L per week ) or nuts ( 30 g per day ) . After 3 months , the Mediterranean diet groups had lower mean plasma glucose level , systolic blood pressure , and total cholesterolhigh-density lipoprotein cholesterol ratio than the low-fat diet group . Caution s The Mediterranean diet groups received more nutritional education than the low-fat diet group . Implication s Mediterranean diets supplemented with olive oil or nuts may improve cardiovascular risk factors . The Editors Cardiovascular disease is the main cause of death in industrialized countries , but incidence rates have marked geographic differences . The low incidence of coronary heart disease ( CHD ) in Mediterranean countries has been partly ascribed to dietary habits ( 1 - 3 ) . Recent findings from large European cohort studies ( 4 - 6 ) suggest that a high degree of adherence to the Mediterranean diet is associated with a reduction in mortality . In small clinical studies , the Mediterranean diet or some of its components have reduced blood pressure ( 7 ) and have improved lipid profiles ( 8 , 9 ) and endothelial function ( 10 ) . Moreover , a recent cross-sectional study ( 11 ) and a 2-year feeding trial ( 12 ) have shown
Output:
| Although the results are inconsistent , the evidence points towards a possible role of the Mediterranean diet in preventing overweight/obesity , and physiological mechanisms can explain this protective effect . |
MS212395 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study , 2 ) short- and long-term changes in diet and exercise behavior , and 3 ) effect of the intervention on glucose and lipid metabolism . RESEARCH DESIGN AND METHODS There were 522 middle-aged , overweight subjects with impaired glucose tolerance who were r and omized to either a usual care control group or an intensive lifestyle intervention group . The control group received general dietary and exercise advice at baseline and had an annual physician 's examination . The subjects in the intervention group received additional individualized dietary counseling from a nutritionist . They were also offered circuit-type resistance training sessions and advised to increase overall physical activity . The intervention was the most intensive during the first year , followed by a maintenance period . The intervention goals were to reduce body weight , reduce dietary and saturated fat , and increase physical activity and dietary fiber . RESULTS The intervention group showed significantly greater improvement in each intervention goal . After 1 and 3 years , weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group , respectively . Measures of glycemia and lipemia improved more in the intervention group . CONCLUSIONS The intensive lifestyle intervention produced long-term beneficial changes in diet , physical activity , and clinical and biochemical parameters and reduced diabetes risk . This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system Context A previous Markov modelbased analysis estimated that use of the Diabetes Prevention Program diet and exercise intervention to forestall diabetes in high-risk people would be cost-effective from a societal perspective . Contribution Using a vali date d model design ed to be more complete and realistic than previous models , the authors estimated that the intervention would cost society about $ 62600 per quality -adjusted life-year saved . It would be cost-saving if the annual cost of the intervention decreased from $ 672 to $ 100 . Implication s This model suggests that the Diabetes Prevention Program intervention costs more per quality -adjusted life-year saved than previously estimated , and health plans and insurers may consider it too expensive to cover . The Editors Recent r and omized , controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs ( 1 , 2 ) or glucose-lowering drugs ( 2 - 4 ) . For example , in the Diabetes Prevention Program ( DPP ) , the relative reductions in the 2.8-year incidence of diabetes were 58 % in the lifestyle modification group and 31 % in the metformin group ( 2 ) . This raises hopes of substantially reducing the morbidity , mortality , and cost of this important disease . However , the trial was too short to observe the effects on microvascular or macrovascular outcomes , and the programs cost several hundred dollars a year ( 5 ) . These findings generate obvious questions : What are the long-term effects of trying to prevent diabetes in high-risk people ? Does lifestyle modification truly prevent or just postpone diabetes ? Is such a prevention program cost-effective ? What is the best strategy ? A previous analysis has suggested that lifestyle modification would be cost-effective over 75 years from a societal perspective ( 6 ) . We used a more thorough , clinical ly realistic , and independently vali date d model to estimate the short- and intermediate-term health and economic effects of different prevention programs for high-risk individuals and health plans , as well as for society . Methods We conducted the analysis by using the Archimedes model , which has been described elsewhere ( 7 - 9 ) . Briefly , it is a simulation model written at a relatively high level of anatomic , physiologic , clinical , and administrative detail . It uses object-oriented programming to create in the model objects that correspond to objects in reality , one-to-one . Among the hundreds of objects are people , pancreases , cells , plasma glucose levels , coronary arteries , plaque , chest pain , emergency departments , electrocardiograms , aspirin , and angioplasties . Helpful analogies might be a flight simulator ( in which the objects include the plane and its wings , airports , runways , buildings , and the wind ) , or the SimCity computer game . In the Archimedes model , each individual is simulated down to the level of hepatic glucose production , insulin resistance , -cell fatigue , and similar biological variables . The core of the model is a set of differential equations that represent the anatomy and physiology pertinent to diseases and their complications . Currently , the model includes diabetes , congestive heart failure , coronary artery disease , stroke , hypertension , and asthma in a single integrated model . The structure and equations of the model pertinent to diabetes and its complications are described elsewhere ( 8 , 9 ) . The Appendix and a technical report available through our Web site ( 10 ) describe additional aspects of the model and its validations that are pertinent to this analysis . Calculations are performed by using a distributed computing network . Clinical Events The model includes the biological variables and outcomes relevant to diabetes and its complications . Examples are basal hepatic glucose production ; insulin amount ; insulin resistance ; fasting plasma glucose ; hemoglobin A1c ( HbA1c ) ; 2-hour oral glucose tolerance ; high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , and total cholesterol ; triglycerides ; systolic and diastolic blood pressures and their determinants ( for example , cardiac output , arterial compliance , peripheral resistance ) ; weight and body mass index ( BMI ) ; stenosis of coronary arteries ; retinopathy ( assessed by the Early Treatment of Diabetic Retinopathy scale ) ; urine protein ; creatinine ; peripheral neuropathy ; foot ulcers of varying degrees of severity ; and amputations . The use of differential equations preserves the continuous nature of biological variables as well as the interactions between them . Clinical outcomes are defined in terms of the underlying variables , as occurs in reality . For example , a person is said to have diabetes if his or her fasting plasma glucose level exceeds 6.9375 mmol/L ( 125 mg/dL ) or results on a 2-hour oral glucose tolerance test exceed 11.0445 mmol/L ( 199 mg/dL ) . This enables the model to incorporate different definitions and changes in definitions . The model is continuous : Biological variables are changing and interacting continuously , the natural histories and severity of conditions progress smoothly , any clinical event can occur at any time , and the timing of events is as condensed or drawn out as occurs in reality . The model also includes a detailed representation of the processes and logistics of clinical care and their related costs . Interventions , both to prevent diabetes and to manage it when it occurs , are modeled at the level of the underlying biology . Pertinent to this analysis is that in the model , diet and exercise reduce weight ( 2 ) ; reduce blood pressure ( 11 ) ; improve LDL cholesterol , HDL cholesterol , and total cholesterol levels ( 12 ) ; and decrease fasting plasma glucose levels ( 2 ) . The effects of metformin in the model are to reduce fasting plasma glucose and 2-hour oral glucose tolerance test results ( 2 ) ( by reducing basal hepatic glucose production ) , decrease LDL cholesterol and triglyceride levels ( 13 ) , and retard weight gain . Data used to build the model were derived from basic physiologic studies , surveys , epidemiologic studies , and clinical trials using methods described in the technical report ( 10 ) . Every variable in the model is estimated from at least 1 empirical source ; no variables are simply assumed . We identified specific sources by search ing MEDLINE from 1970 to 28 February 2005 and by consulting textbooks and clinical experts . Because the model includes scores of continuously valued , interacting variables , it does not have simplified states , transitions , or events at discrete time intervals that can be tabulated , as is commonly done for a Markov-type model . The equations themselves are in the technical report ( 10 ) . For nonmathematical readers , we have calculated annualized rates of change of representative biological variables and annualized rates of occurrence of representative clinical events , and compared them with rates for comparable events observed in epidemiologic studies and clinical trials . The Appendix reports those results . Costs The DPP measured the direct medical costs of delivering the lifestyle and metformin interventions ( for example , personnel , health education material s , medications , and laboratory tests ) . Compared with the placebo group 's costs , costs in the lifestyle group were $ 1356 more per person in the first year , with approximately $ 672 in annual costs thereafter ; for the metformin group , costs were $ 977 in the first year and averaged $ 742 per year thereafter ( 5 ) . Following the completion of the DPP , metformin became generic . When this is considered , the cost of the metformin program is reduced to about $ 780 for 3 years , or about $ 260 a year . In the DPP study , costs apply to the year 2000 . To calculate the routine costs of providing health care to high-risk people before they develop diabetes , as well as to people with diabetes and its complications , the model includes a detailed mathematical representation of a health care system , including such elements as facilities , personnel , tests and treatments , protocol s , and provider behaviors . For the base-case analysis , we obtained itemized costs from Kaiser Permanente , a nonprofit , group- practice , integrated managed care organization that provides comprehensive care ( with no deductibles or copayments ) . The facilities , personnel , protocol s , and costs in the model are based on that organization 's records , at the level of detail at which actual accounts are kept ( for example , 37 different kinds of office visits ) . The model calculates costs by keeping track of the occurrence of every event that has cost implication s and adding them up . The costs assigned to any event or item were calculated by Kaiser Permanente 's cost-accounting department using micro-costing methods ( 14 ) , and they represent the real costs to the organization , not charges , reimbursements , or diagnosis-related groups . Because costs vary from setting to setting , the implication s of different cost structures are examined in the sensitivity analysis . Calculation of costs applies to the year 2000 . Indirect costs , such as lost time from work and decreased productivity , are included in the cost-effectiveness analysis through the Quality of Well-Being Index ( 14 ) . We calculated the effects of lifestyle and metformin interventions on quality of life . For people who do not yet have diabetes , we used utility weights reported for the participants of the DPP study ( 15 ) . For people who have diabetes and its complications , we used the results of a published survey by Coffey and colleagues ( 16 ) . Both surveys used the Quality of Well-Being Index . The decrements in quality of life were assumed to be additive for people who have 2 or more complications , with a limit that quality of life could not be less than 0 . Use of an additive rule biases the calculation of cost/ quality -adjusted life-year ( QALY ) in favor of a prevention program , making the program appear more cost-effective than would occur if a multiplicative model were used . We discuss the OBJECTIVES The Finnish Diabetes Prevention Study ( DPS ) was a r and omized intervention program that evaluated the effect of intensive lifestyle modification on the development of diabetes mellitus type 2 in patients with impaired glucose tolerance . As such , a program is dem and ing in terms of re sources ; it is necessary to assess whether it would be money well spent . This determination was the purpose of this study . METHODS We developed a simulation model to assess the economic consequences of an intervention like the one studied in DPS in a Swedish setting . The model used data from the trial itself to assess the effect of intervention on the risk of diabetes and on risk factors for cardiovascular disease . Results from the United Kingdom Prospect i ve Diabetes Study were used to estimate the risk of cardiovascular disease and stroke . Cost data were derived from Swedish studies . The intervention was assumed to be applied to eligible patients from a population -based screening program of 60-year-olds in the County of Stockholm from which the baseline characteristics of the patients was used . RESULTS The model predicted that implementing the program would be cost-saving from the healthcare payers ' perspective . Furthermore , it was associated with an increase in estimated survival of .18 years . Taking into consideration the increased consumption by patients due to their longer survival , the predicted cost-effectiveness ratio was 2,363 euro per quality -adjusted life-year gained . CONCLUSIONS Lifestyle intervention directed toward high-risk subjects would be cost-saving for the healthcare payer and highly cost-effective for society as a whole Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5
Output:
| R and omized clinical trials around the world have shown that combined diet and physical activity promotion programs could prevent or delay progression to type 2 diabetes among persons at increased risk ( 58 ) .
Studies have also demonstrated the feasibility and effectiveness of such programs when they are implemented in primary care or community setting s ( 9 ) .
In 2014 , a systematic review done for the Community Preventive Services Task Force found that programs implemented in health care or community setting s effectively reduced the risk for diabetes in persons at increased risk ; increased the likelihood of reversion to normoglycemia ; and reduced weight and other risk factors for cardiovascular disease , such as elevated blood pressure and lipid levels ( 10 ) . |
MS212396 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Physical fitness is inversely related to mortality in the general population and in subjects with type 2 diabetes . Here , we present data concerning the relationship between changes in physical fitness and modifiable cardiovascular risk factors in subjects with type 2 diabetes from the Italian Diabetes and Exercise Study . RESEARCH DESIGN AND METHODS Sedentary patients with type 2 diabetes ( n = 606 ) were enrolled in 22 outpatient diabetes clinics and r and omized to twice-a-week supervised aerobic and resistance training plus exercise counseling versus counseling alone for 12 months . Baseline to end-of- study changes in cardiorespiratory fitness , strength , and flexibility , as assessed by Vo2max estimation , a 5–8 maximal repetition test , and a hip/trunk flexibility test , respectively , were calculated in the whole cohort , and multiple regression analyses were applied to assess the relationship with cardiovascular risk factors . RESULTS Changes in Vo2max , upper and lower body strength , and flexibility were significantly associated with the variation in the volume of physical activity , HbA1c , BMI , waist circumference , high-sensitivity C-reactive protein ( hs-CRP ) , coronary heart disease ( CHD ) risk score , and inversely , HDL cholesterol . Changes in fitness predicted improvements in HbA1c , waist circumference , HDL cholesterol , hs-CRP , and CHD risk score , independent of study arm , BMI , and in case of strength , also waist circumference . CONCLUSIONS Physical activity/exercise-induced increases in fitness , particularly muscular , predict improvements in cardiovascular risk factors in subjects with type 2 diabetes independently of weight loss , thus indicating the need for targeting fitness in these individuals , particularly in subjects who struggle to lose weight Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies 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 Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P < 0.001 ] , observers 1 and 3 ( ICC = 0.96 , 95 % CI 0.89–0.98 , P < 0.001 ) and observers 2 and 3 ( ICC = 0.91 , 95 % CI 0.75–0.96 , P < 0.001 ) . Conclusions : The TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials OBJECTIVE Nonalcoholic fatty liver disease ( NAFLD ) and its association with insulin resistance are increasingly recognized as major health burdens . The main objectives of this study were to assess the relation between liver lipid content and serum lipids , markers of liver function and inflammation in healthy overweight subjects , and to determine whether caloric restriction ( CR ) ( which improves insulin resistance ) reduces liver lipids in association with these same measures . METHODS AND PROCEDURES Forty-six white and black overweight men and women ( BMI = 24.7 - 31.3 kg/m(2 ) ) were r and omized to " control ( CO ) " = 100 % energy requirements ; " CR " = 25 % ; " caloric restriction and increased structured exercise (CR+EX)"= 12.5 % CR + 12.5 % increase in energy expenditure through exercise ; or " low-calorie diet ( LCD ) " = 15 % weight loss by liquid diet followed by weight-maintenance , for 6 months . Liver lipid content was assessed by magnetic resonance spectroscopy ( MRS ) and computed tomography ( CT ) . Lipid concentrations , markers of liver function ( alanine aminotransferase ( ALT ) , alkaline phosphatase ( ALK ) ) , and whole-body inflammation ( tumor necrosis factor-alpha ( TNF-alpha ) , interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hsCRP ) ) were measured in fasting blood . RESULTS At baseline , increased liver lipid content ( by MRS ) correlated ( P < 0.05 ) with elevated fasting triglyceride ( r = 0.52 ) , ALT ( r = 0.42 ) , and hsCRP ( r = 0.33 ) concentrations after adjusting for sex , race , and alcohol consumption . With CR , liver lipid content was significantly lowered by CR , CR+EX , and LCD ( detected by MRS only ) . The reduction in liver lipid content , however , was not significantly correlated with the reduction in triglycerides ( r = 0.26 ; P = 0.11 ) or with the changes in ALT , high-density lipoprotein (HDL)-cholesterol , or markers of whole-body inflammation . DISCUSSION CR may be beneficial for reducing liver lipid and lowering triglycerides in overweight subjects without known NAFLD Background : To investigate the effects of varied therapeutic lifestyle programs on patients with ultrasound‐diagnosed nonalcoholic fatty liver disease ( NAFLD ) . Methods : A prospect i ve , case‐controlled study was conducted . A total of 54 subjects with NAFLD were subdivided into 3 groups : ( 1 ) diet plus exercise group ( DPE group , n = 16 ) ; ( 2 ) exercise group ( E group , n = 23 ) ; and ( 3 ) control group ( C group , n = 15 ) . The DPE group received a low‐calorie balanced diet and regular high‐intensity stationary bicycle exercise program for 10 weeks , while the E group received the same exercise protocol as the DPE group but without any changes in diet . Anthropometric indices , biochemical data , physical fitness data and liver ultrasound findings were recorded . A generalized estimating equation method was used to determine the differences among groups . Results : Compared with the C group , the DPE group demonstrated significant improvements in anthropometric indices , total cholesterol , insulin sensitivity , liver biochemistry , ultrasound finding and physical fitness , while the E group showed significant improvements in anthropometric indices , insulin sensitivity status , ultrasound finding and physical fitness but not liver biochemistry . Compared with the E group , the DPE group showed greater reduction in anthropometric indices ( body mass index , body weight , abdominal circumference , hip circumference ) , total cholesterol , alanine aminotransferase , and γ‐glutamyltransferase . Conclusion : Our data suggest that both 10‐week diet‐plus‐exercise and exercise‐only therapeutic lifestyle programs are effective for improving anthropometric indices , insulin sensitivity , ultrasound findings and physical fitness in ultrasound‐diagnosed NAFLD patients . However , the range of improvement in patients on the diet‐plus‐exercise program is more obvious than that in patients on the exercise‐only program . Moreover , the diet‐plus‐exercise program result ed in significant improvement in liver biochemistry , but the exercise‐only program did not . In summary , diet plus exercise is more efficacious than exercise alone in the lifestyle modification treatment of NAFLD BACKGROUND & AIMS Aerobic exercise reduces liver fat and visceral adipose tissue ( VAT ) . However , there is limited data from r and omized trials to inform exercise programming recommendations . This study examined the efficacy of commonly prescribed exercise doses for reducing liver fat and VAT using a r and omized placebo-controlled design . METHODS Inactive and overweight/obese adults received 8 weeks of either ; i ) low to moderate intensity , high volume aerobic exercise ( LO : HI , 50 % VO 2peak , 60 min , 4d/week ) ; ii ) high intensity , low volume aerobic exercise ( HI : LO , 70 % VO 2peak , 45 min , 3d/week ) ; iii ) low to moderate intensity , low volume aerobic exercise ( LO : LO , 50 % VO 2peak , 45 min , 3d/week ) ; or iv ) placebo ( PLA ) . Liver fat ( spectroscopy ) and VAT ( magnetic resonance imaging ) were measured before and after intervention . RESULTS Forty-seven of the 48 ( n = 12 in each group ) participants completed the trial . There were no serious adverse events . There was a significant change in group × time interaction in liver fat , which reduced in HI : LO by 2.38 ± 0.73 % , in LO : HI by 2.62 ± 1.00 % , and in LO : LO by 0.84 ± 0.47 % but not in PLA ( increase of 1.10 ± 0.62 % ) ( p = 0.04 ) . There was a significant reduction in VAT in HI : LO ( -258.38 ± 87.78 cm(3 ) ) , in LO : HI ( -386.80 ± 119.5 cm(3 ) ) , and in LO : LO ( -212.96 ± 105.54 cm(3 ) ) , but
Output:
| The liver enzymes , alanine aminotransferase , aspartate aminotransferase and & ggr;-glutamyl transpeptidase , were not significantly altered with exercise .
Conclusions Exercise training reduces intrahepatic fat and FFAs while increasing cardiorespiratory fitness .
An aggregate exercise programme energy expenditure ( > 10 000 kcal ) may be required to promote reductions in intrahepatic fat |
MS212397 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Introduction Curcumin is a polyphenolic compound derived from the plant Curcuma Long Lin that has been demonstrated to have antioxidant and anti-inflammatory effects as well as effects on reducing beta-amyloid aggregation . It reduces pathology in transgenic models of Alzheimer 's disease ( AD ) and is a promising c and i date for treating human AD . The purpose of the current study is to generate tolerability and preliminary clinical and biomarker efficacy data on curcumin in persons with AD . Methods We performed a 24-week r and omized , double blind , placebo-controlled study of Curcumin C3 Complex ® with an open-label extension to 48 weeks . Thirty-six persons with mild-to-moderate AD were r and omized to receive placebo , 2 grams/day , or 4 grams/day of oral curcumin for 24 weeks . For weeks 24 through 48 , subjects that were receiving curcumin continued with the same dose , while subjects previously receiving placebo were r and omized in a 1:1 ratio to 2 grams/day or 4 grams/day . The primary outcome measures were incidence of adverse events , changes in clinical laboratory tests and the Alzheimer 's Disease Assessment Scale - Cognitive Subscale ( ADAS-Cog ) at 24 weeks in those completing the study . Secondary outcome measures included the Neuropsychiatric Inventory ( NPI ) , the Alzheimer 's Disease Cooperative Study - Activities of Daily Living ( ADCS-ADL ) scale , levels of Aβ1 - 40 and Aβ1 - 42 in plasma and levels of Aβ1 - 42 , t-tau , p-tau181 and F2-isoprostanes in cerebrospinal fluid . Plasma levels of curcumin and its metabolites up to four hours after drug administration were also measured . Results Mean age of completers ( n = 30 ) was 73.5 years and mean Mini-Mental Status Examination ( MMSE ) score was 22.5 . One subject withdrew in the placebo ( 8 % , worsened memory ) and 5/24 subjects withdrew in the curcumin group ( 21 % , 3 due to gastrointestinal symptoms ) . Curcumin C3 Complex ® was associated with lowered hematocrit and increased glucose levels that were clinical ly insignificant . There were no differences between treatment groups in clinical or biomarker efficacy measures . The levels of native curcumin measured in plasma were low ( 7.32 ng/mL ) . Conclusions Curcumin was generally well-tolerated although three subjects on curcumin withdrew due to gastrointestinal symptoms . We were unable to demonstrate clinical or biochemical evidence of efficacy of Curcumin C3 Complex ® in AD in this 24-week placebo-controlled trial although preliminary data suggest limited bioavailability of this compound . Trial registration Clinical Trials.gov Identifier : NCT00099710 OBJECTIVE Because curcumin 's anti-inflammatory properties may protect the brain from neurodegeneration , we studied its effect on memory in non-demented adults and explored its impact on brain amyloid and tau accumulation using 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile positron emission tomography ( FDDNP-PET ) . METHODS Forty subjects ( age 51 - 84 years ) were r and omized to a bioavailable form of curcumin ( Theracurmin ® containing 90 mg of curcumin twice daily [ N = 21 ] ) or placebo ( N = 19 ) for 18 months . Primary outcomes were verbal ( Buschke Selective Reminding Test [ SRT ] ) and visual ( Brief Visual Memory Test-Revised [ BVMT-R ] ) memory , and attention ( Trail Making A ) was a secondary outcome . FDDNP-PET signals ( 15 curcumin , 15 placebo ) were determined in amygdala , hypothalamus , medial and lateral temporal , posterior cingulate , parietal , frontal , and motor ( reference ) regions . Mixed effects general linear models controlling for age and education , and effect sizes ( ES ; Cohen 's d ) were estimated . RESULTS SRT Consistent Long-Term Retrieval improved with curcumin ( ES = 0.63 , p = 0.002 ) but not with placebo ( ES = 0.06 , p = 0.8 ; between-group : ES = 0.68 , p = 0.05 ) . Curcumin also improved SRT Total ( ES = 0.53 , p = 0.002 ) , visual memory ( BVMT-R Recall : ES = 0.50 , p = 0.01 ; BVMT-R Delay : ES = 0.51 , p = 0.006 ) , and attention ( ES = 0.96 , p < 0.0001 ) compared with placebo ( ES = 0.28 , p = 0.1 ; between-group : ES = 0.67 , p = 0.04 ) . FDDNP binding decreased significantly in the amygdala with curcumin ( ES = -0.41 , p = 0.04 ) compared with placebo ( ES = 0.08 , p = 0.6 ; between-group : ES = 0.48 , p = 0.07 ) . In the hypothalamus , FDDNP binding did not change with curcumin ( ES = -0.30 , p = 0.2 ) , but increased with placebo ( ES = 0.26 , p = 0.05 ; between-group : ES = 0.55 , p = 0.02 ) . CONCLUSIONS Daily oral Theracurmin may lead to improved memory and attention in non-demented adults . The FDDNP-PET findings suggest that symptom benefits are associated with decreases in amyloid and tau accumulation in brain regions modulating mood and memory Curcumin therapy in animals has produced positive cognitive and behavioural outcomes ; results of human trials , however , have been inconsistent . In this study , we report the results of a 12-month , r and omised , placebo-controlled , double-blind study that investigated the ability of a curcumin formulation to prevent cognitive decline in a population of community-dwelling older adults . Individuals ( n 96 ) ingested either placebo or 1500 mg/d BiocurcumaxTM for 12 months . A battery of clinical and cognitive measures was administered at baseline and at the 6-month and 12-month follow-up assessment s. A significant time × treatment group interaction was observed for the Montreal Cognitive Assessment ( repeated- measures analysis ; time × treatment ; F=3·85 , P<0·05 ) . Subsequent analysis revealed that this association was driven by a decline in function of the placebo group at 6 months that was not observed in the curcumin treatment group . No differences were observed between the groups for all other clinical and cognitive measures . Our findings suggest that further longitudinal assessment is required to investigate changes in cognitive outcome measures , ideally in conjunction with biological markers of neurodegeneration Factors that modify onset of Alzheimer 's disease ( AD ) may be revealed by comparing environmental exposures in affected and unaffected members of discordant twin pairs or sibships . Among siblings at high risk of AD , sustained use of nonsteroidal anti-inflammatory drugs ( NSAIDs ) was associated with delayed onset and reduced risk of AD . After adjustment for use of NSAIDs , there was minimal effect on onset with reported history of any of three common illnesses ( arthritis , diabetes , or acid-peptic disease ) . However , independent of exposure to NSAIDs , onset was unexpectedly delayed in those reporting extended use of histamine H2 blocking drugs . R and omized clinical trials will be needed to affirm the utility of these drugs for prevention , but the present findings may have implication s for pathogenesis : because NSAIDs block the calcium-dependent postsynaptic cascade that induces excitotoxic cell death in NMDA-reactive neurons , and because histamine potentiates such events , excitotoxicity may deserve additional investigation in AD SCOPE Curcumin revealed various health-beneficial properties in numerous studies . However its bioavailability is low due to its limited intestinal uptake and rapid metabolism . The aim of our project was to develop novel curcumin formulations with improved oral bioavailability and to study their safety as well as potential sex-differences . METHODS AND RESULTS In this crossover study , healthy subjects ( 13 women , 10 men ) took , in r and om order , a single oral dose of 500 mg curcuminoids as native powder , micronized powder , or liquid micelles . Blood and urine sample s were collected for 24 h and total curcuminoids and safety parameters were quantified . Based on the area under the plasma concentration-time curve ( AUC ) , the micronized curcumin was 14- , 5- , and 9-fold and micellar curcumin 277- , 114- , and 185-fold better bioavailable than native curcumin in women , men , and all subjects , respectively . Thus , women absorbed curcumin more efficiently than men . All safety parameters remained within the reference ranges following the consumption of all formulations . CONCLUSION Both , the micronized powder and in particular the liquid micellar formulation of curcumin significantly improved its oral bioavailability without altering safety parameters and may thus be ideally suited to deliver curcumin in human intervention trials . The observed sex differences in curcumin absorption warrant further investigation The senescence-accelerated mouse prone 8 ( SAMP8 mice ) is known as a neurodegenerative model and may show age-related deficits of cognition . Curcumin , a major active component of spic turmeric , could increase the capacity of learning and memory in the aged rat . However , it is not known whether curcumin could improve cognitive deficits in SAMP8 mice . The present study was undertaken to evaluate the effect of curcumin on the learning and memory of SAMP8 mice and its possible mechanisms . Subjects were r and omly divided into four groups : SAMR1 mice , SAMP8 mice and two SAMP8 mice groups treated , intragastrically , with curcumin at the dose of 20 and 50mg/kg per day , respectively . After 25days , spatial memory , superoxide dismutase ( SOD ) activity , malondialdehyde ( MDA ) content , p-calcium/calmodulin-dependent kinase II ( p-CaMKII ) and p-N-methyl-d-aspartate receptor subunit 1 ( p-NMDAR1 ) expression in the hippocampus of mice were examined by using the Morris water maze , biochemical analysis , immunohistochemistry and Western blot . Compared with SAMR1 mice , SAMP8 mice had longer escape latency , higher MDA content , lower SOD activity in the hippocampus , and lower intensity of p-CaMKII in the stratum lucidum of hippocampal CA3 and p-NMDAR1 expression in the hippocampal membrane fraction . Both 20 and 50mg/kg curcumin administration significantly shortened the escape latencies and decreased the hippocampal MDA content in the SAMP8 mice . 50mg/kg curcumin administration significantly ameliorated the hippocampal SOD activity , and increased the intensity of p-CaMKII in the stratum lucidum of hippocampal CA3 and p-NMDAR1 expression in the hippocampal membrane fraction of the SAMP8 mice . The present study demonstrated that curcumin treatment could attenuate cognitive deficits of SAMP8 mice in a dose-dependent manner by decreasing the oxidative stress and improving the expression of p-CaMKII and p-NMDAR1 in the hippocampus . Thus treatment with curcumin may have a potential therapeutic agent for aging-related cognitive dysfunctions Background More and more pre clinical studies support the idea that curcumin , a plant-derived natural polyphenol , could be a promising anticancer drug . However , poor bioavailability has limited its efficacy in clinical trials , and plasma curcumin levels remain low despite patients taking gram doses of curcumin . Methods This study aim ed to evaluate the safety and pharmacokinetics of newly developed nanoparticle curcumin with increased water solubility ( named THERACURMIN ) . Six healthy human volunteers were recruited and received THERACURMIN at a single oral dose of 150 mg . After an interval of 2 weeks , the same subjects then received THERACURMIN at a single dose of 210 mg . Plasma curcumin levels were measured at 0 , 1 , 2 , 4 , 6 , and 24 h after THERACURMIN intake using high-performance liquid chromatography ( HPLC ) . Results One subject reported grade 1 diarrhea after intake of 150 mg THERACURMIN . No other toxicities were observed in this study . Cmax for THERACURMIN at 150 and 210 mg was 189 ± 48 and 275 ± 67 ng/ml ( mean ± SEM ) , respectively , and the area under the curve for 24 h was estimated to be 2,649 ± 350 and 3,649 ± 430 ng/ml × h ( mean ± SEM ) , respectively . The t1/2 was estimated to be 9.7 ± 2.1 h for 150 mg and 13.0 ± 3.3 h for 210 mg . Conclusion THERACURMIN can safely increase plasma cur
Output:
| Overall , animal research has shown very promising results in potentiating cognition , both physiologically and behaviourally .
Taking into account measurements of important inflammatory and antioxidant biomarkers , optimal dosages of curcumin , food interactions , and duration of treatment would increase our underst and ing on curcumin 's promising effects on cognition . |
MS212398 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To assess if low-dose hCG is similar to hMG and to rFSH in the late follicular phase . STUDY DESIGN In a prospect i ve r and omized controlled trial , 51 patients undergoing controlled ovarian stimulation received ovarian priming with rFSH and then received hCG ( 200 IU/day ) ( hCG group , n=17 ) , hMG ( 225 IU/day ) ( hMG group , n=17 ) or rFSH ( 200 IU/day ) ( FSH group , n=17 ) in the late stage of follicular development . Parameters of follicular response and serum estradiol , progesterone and testosterone levels were assessed . RESULTS Pre-ovulatory ovarian follicle occurrence and length of treatment were similar among the three treatment groups . Serum progesterone level on the day of pre-ovulatory hCG was significantly higher in the hCG group than in the hMG or rFSH group . Clinical pregnancy rates were similar for all groups . The total cost of treatment was significantly lower for the hCG group than for the groups supplemented with hMG or rFSH . CONCLUSIONS LH in the form of low-dose hCG during the late follicular phase induced the same follicular pattern as hMG and rFSH after ovulation induction . The procedure using hCG produced pregnancy rates similar to those obtained using hMG and rFSH , even though the patients showed higher serum progesterone levels on the hCG day The advent of recombinant DNA technology will soon produce for the market a product that has pure follicle-stimulating hormone ( pFSH ) but no luteinizing hormone . A prospect i ve r and omized study was performed to see if pFSH ( Metrodin ) was able to stimulate the same in vitro fertilization parameters as human menopausal gonadotropin when preceded by gonadotropin suppression by leuprolide acetate . The results showed similar parameters between the two drugs , i.e. , number of oocytes , number of embryos , endometrial thickness at time of human chorionic gonadotropin , fertilization rates and pregnancy rates in a protocol purpose ly design ed to stimulate as many follicles as safely as possible because of a shared oocyte and successful cryopreservation program BACKGROUND To test the effects of progressively decreasing dosages of exogenous LH we combined various amounts of HMG , containing FSH , LH and HCG , and highly purified ( HP ) FSH to treat 120 GnRH agonist-suppressed infertile female patients as c and i date s for controlled ovarian stimulation ( COS ) . METHODS Subjects were r and omly assigned to four treatment groups that received the following daily i.m . gonadotrophin regimens : A , FSH 150 IU only ; B , FSH 150 IU and LH activity 37.5 IU ; C , FSH 150 IU and LH activity 75 IU ; D , FSH 150 IU and LH activity 150 IU . FSH dose adjustments were allowed only after the 14th treatment day . Monitoring included transvaginal ultrasound at 2-day intervals and daily determinations of LH , FSH , estradiol ( E(2 ) ) , progesterone , testosterone and HCG . RESULTS Duration of COS was significantly shortened in patients receiving at least 75 IU daily of LH activity . Small ( < 10 mm diameter ) pre-ovulatory ovarian follicle occurrence was inversely correlated with LH activity dose administered ( r = -0.648 , P < 0.0001 ) and serum HCG levels ( r = -0.272 , P < 0.01 ) but not to serum LH levels . Serum testosterone levels were positively correlated to the LH activity dose administered ( r = 0.313 , P < 0.001 ) , while serum progesterone levels were positively correlated to the FSH dose administered ( r = 0.447 , P < 0.00001 ) but not to the LH activity dose administered . CONCLUSIONS Firstly , HCG content considerably contributes to HMG activity ; secondly , menotrophin LH activity content can reduce in a dose-dependent manner the occurrence of small pre-ovulatory follicles ; and finally , contrary to common belief , enhanced FSH stimulation rather than LH activity appears to cause premature follicle luteinization during COS Although FSH is essential to stimulate ovarian folliculogenesis , increasing physiological and clinical evidence suggests that moderate LH stimulation may also be critical for optimal follicle and oocyte development . Conversely , a clinical trend exists toward conducting controlled ovarian hyperstimulation ( COH ) in a LH-depleted environment , as recently developed gonadotropin preparations are devoid of LH activity , and endogenous LH is suppressed with GnRH analogs in most COH cycles . To investigate the role of LH activity during COH we supplemented highly purified ( HP ) FSH with low dose hCG in GnRH agonist-suppressed women . Twenty normoovulatory women were pretreated with a GnRH agonist and after 2 weeks were r and omly assigned to receive HP FSH ( 150 IU/day ) alone ( group A ; 10 patients ) or combined with hCG ( 50 IU/day ; group B ; 10 patients ) . The HP FSH dose was increased after 14 days only in cases of inadequate response . Treatment was monitored with pelvic ultrasound and daily hormone determinations . None of the patients of group B and 8 of group A required more than 14 days of treatment and increments of the FSH dose . Folliculogenesis and 17beta-estradiol ( E2 ) secretion progressed more rapidly and evenly in group B. Although preovulatory follicle number and E2 concentrations were comparable , patients in group B required a shorter stimulation time ( 12.5+/-0.6 vs. 17.3+/-0.7 days in group A ; P < 0.0001 ) and a lower HP FSH dose ( 1725+/-84 vs. 2670+/-164 IU in group A ; P < 0.0001 ) . Serum levels of LH , E2 , progesterone , and testosterone did not differ between the 2 groups ; serum FSH was higher in group A. We conclude that LH activity promotes folliculogenesis in synergy with FSH in the mid- to late follicular phase and that low dose hCG coadministration optimizes COH by 1 ) enhancing FSH action , 2 ) accelerating ovarian follicle development , 3 ) shortening COH duration , 4 ) lowering HP FSH requirements , and 5 ) reducing COH cost . Thus , moderate LH activity in the follicular phase plays a positive physiological and clinical role in folliculogenesis and ovulation induction OBJECTIVES To clarify the endocrine mechanisms underlying the outcome of different ovulation induction regimens with gonadotropins and GnRH agonists ( GnRH-a ) . DESIGN Prospect i ve study . SETTING Reproductive Endocrinology Center , University of Bologna . PATIENTS Forty eumenorrheic women r and omly assigned to four groups of 10 subjects each . INTERVENTIONS Ovulation induction regimens : group A , purified FSH only ; group B , purified FSH and flare-up GnRH-a ; group C , purified FSH and long GnRH-a ; and group D , hMG and long GnRH-a . MAIN OUTCOME MEASURES Pelvic ultrasound and hormone levels in daily serum sample s and in follicular fluid drawn immediately before hCG administration . RESULTS Exogenous gonadotropin dose did not differ among groups . Group B had fewer preovulatory follicles than group C. Group B had higher serum LH , FSH , E2 , P , T , and follicular fluid LH , E2 , T , and alpha-inhibin than groups C and /or D. Groups C and D did not differ . CONCLUSIONS Long GnRH-a regimens improved follicle yield and the endocrine milieu in spite of comparable exogenous gonadotropin dose and lower serum FSH and thus appear to be preferable in assisted reproduction . Reduced folliculogenesis found in flare-up GnRH-a regimens could be mediated by the atretic effects of high intraovarian and rogens . Efficacy of purified FSH and hMG was comparable BACKGROUND LH activity may influence treatment response and outcome in IVF cycles . METHODS A r and omized , assessor-blind , multinational trial compared ongoing pregnancy rates ( primary end-point ) in 731 women undergoing IVF after stimulation with highly purified menotrophin ( HP-hMG ) ( n = 363 ) or recombinant FSH ( rFSH ) ( n = 368 ) following a long GnRH agonist protocol . Patients received identical pre- and post-r and omization interventions . One or two embryos were transferred on day 3 . RESULTS More oocytes were retrieved ( P < 0.001 ) after rFSH treatment ( 11.8 ) compared with HP-hMG treatment ( 10.0 ) , but a higher proportion developed into top- quality embryos ( P = 0.044 ) with HP-hMG ( 11.3 % ) than with rFSH ( 9.0 % ) . At the end of stimulation , lower estradiol ( E(2 ) ) ( P = 0.031 ) and higher progesterone ( P < 0.001 ) levels were found with rFSH , even after adjusting for follicular response . The distribution of hypo- , iso- and hyper-echogenic endometrium showed a significant ( P = 0.023 ) shift towards the hyperechogenic pattern after rFSH treatment . The ongoing pregnancy rate per cycle was 27 % with HP-hMG and 22 % with rFSH [ odds ratio ( 95 % confidence interval ) : 1.25 ( 0.89 - 1.75 ) ] . CONCLUSION Superiority of HP-hMG over rFSH in ongoing pregnancy rate could not be concluded from this study , but non-inferiority was established . Pharmacodynamic differences in follicular development , oocyte/embryo quality , endocrine response and endometrial echogenicity exist between HP-hMG and rFSH preparations , which may be relevant for treatment outcome The effects of treatment of patients with gonadotrophin-releasing hormone analogue ( GnRHa ) combined with purified follicle stimulating hormone ( FSH ) for in-vitro fertilization ( IVF ) were investigated in detail to determine the influences of different administration routes and the degree of suppression of luteinizing hormone ( LH ) . Responses to exogenous gonadotrophins were studied in infertile women ( n = 60 ) with normal menstrual rhythm whose endogenous gonadotrophin activity was suppressed using a GnRHa in a long protocol . They were r and omized to receive i.m . administration of human menopausal gonadotrophins ( HMGim , Pergonal ) or purified follicle stimulating hormone ( FSH , Metrodin High Purity ) administered either i.m . ( MHPim ) or s.c . ( MHPsc ) . Responses were assessed by measuring plasma FSH , LH , oestradiol , testosterone and progesterone . After stimulation day 4 , the MHPsc group showed significantly higher circulating concentrations of FSH than either the MHPim or HMGim group . However , the HMG group showed significantly higher oestradiol concentrations after stimulation day 5 than either MHP group . The differences in circulating oestradiol concentrations in the MHP-treated patients appeared to be strongly influenced by the mean circulating concentrations of LH in the follicular phase . The patients who showed mean follicular phase LH concentrations of < 1 IU/l showed longer follicular phases , lower circulating oestradiol and testosterone concentrations and also lower follicular fluid concentrations of oestradiol and testosterone , indicating a reduction in the normal follicular metabolism of progesterone to and rogens and oestrogens under these conditions . This group of patients also showed longer follicular phases , which may have consequences for future clinical management BACKGROUND Elevated serum progesterone levels at the end of the follicular phase in controlled ovarian stimulation ( COS ) leads to a poorer ongoing pregnancy rate in IVF cycles due to reduced endometrial receptivity . The objective of this study was to use microarray technology to compare endometrial gene expression profiles at the window of implantation according to the levels of circulating progesterone . METHODS For this prospect i ve cohort study , microarray data were obtained from endometrial biopsies from 12 young healthy oocyte donors undergoing COS with pituitary suppression by either gonadotrophin-releasing hormone ( GnRH ) agonists or antagonists , and recombinant FSH . On the day of recombinant chorionic gonadotrophin ( rCG ) administration , six women had serum progesterone levels ( P ) > 1.5 ng/ml ( study group ) and six had serum P levels < 1.5 ng/ml ( control group ) . Endometrial sample s were collected using a Pipelle catheter 7 days after the rCG injection . RESULTS Using the parametric test , we identified 140 genes significantly dysregulated ( 64 up- and
Output:
| Analysis of confounding factors showed that the intensity of ovarian stimulation is the most important determining factor to explain serum progesterone elevation at the time of hCG administration , CONCLUSIONS This systematic review shows that providing LH activity supplementation in combination with FSH during ovarian stimulation does not have a consistent effect on serum progesterone concentrations at the time of hCG administration .
However , these data also suggest that , in accordance with physiological concept , the timing of LH activity administration could influence the impact on serum progesterone changes |
MS212399 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The mechanisms of correcting immune disorders in patients with pancreatic cancer requiring major surgery procedures by introducing perioperative immune-enhancing diet ( immunonutrition ) are still unclear . The purpose of our study was to investigate the effect of pancreatic cancer , extensive surgery and immunonutrition versus enteral st and ard nutrition on the apoptotic signaling pathways . The r and omized studies were performed in 72 patients before and after pancreatic cancer resection with preoperative st and ard ( Group I ) or enteral immunonutrition ( Group II ) . The expressions of Bcl-2 , Bax , caspases-3 , -9 , NF-κB , PARP-1/89 kDa , TNFR1/CD120a and Fas/CD95 in peripheral blood lymphocytes were assessed by western blot analysis and flow cytometry before and on day 1 , 3 and 7 after surgery . In malnourished patients before and after surgery , the expression of Bcl-2 , Bax , NF-κB , PARP-1 was significantly lower , whereas the expression of caspases , as well as the percentage of cells with death receptors were significantly higher when compared with the control group . There was no difference in Bcl-2 , Bax and PARP-1 expression between the control group and the patients with normal nutritional status ( Group III ) before surgery . In comparison to the st and ard nutrition , the preoperative immunonutrition increased the Bcl-2 and Bax expression inconsiderably but significantly increased the percentage of CD95- and CD120a-positive lymphocytes after surgery . In malnourished patients with pancreatic cancer , the overwhelming expression of caspases and the decrease expression of anti-apoptotic proteins may lead to inappropriate lymphocyte apoptosis and higher cell depletion . The preoperative enteral immunonutrition prevents the postoperative decrease in lymphocyte subsets , but a higher level of lymphocyte susceptibility to undergo accelerated apoptosis can also be considered Introduction Septic shock remains a major health care problem worldwide . Sepsis-induced immune alterations are thought to play a major role in patients ' mortality and susceptibility to nosocomial infections . Programmed death-1 ( PD-1 ) receptor system constitutes a newly described immunoregulatory pathway that negatively controls immune responses . It has recently been shown that PD-1 knock-out mice exhibited a lower mortality in response to experimental sepsis . The objective of the present study was to investigate PD-1-related molecule expressions in septic shock patients . Methods This prospect i ve and observational study included 64 septic shock patients , 13 trauma patients and 49 healthy individuals . PD-1-related-molecule expressions were measured by flow cytometry on circulating leukocytes . Plasmatic interleukin (IL)-10 concentration as well as ex vivo mitogen-induced lymphocyte proliferation were assessed . Results We observed that septic shock patients displayed increased PD-1 , PD-Lig and 1 ( PD-L1 ) and PD-L2 monocyte expressions and enhanced PD-1 and PD-L1 CD4 + T lymphocyte expressions at day 1 - 2 and 3 - 5 after the onset of shock in comparison with patients with trauma and healthy volunteers . Importantly , increased expressions were associated with increased occurrence of secondary nosocomial infections and mortality after septic shock as well as with decreased mitogen-induced lymphocyte proliferation and increased circulating IL-10 concentration . Conclusions These findings indicate that PD-1-related molecules may constitute a novel immunoregulatory system involved in sepsis-induced immune alterations . Results should be confirmed in a larger cohort of patients . This may offer innovative therapeutic perspectives on the treatment of this hitherto deadly disease The objective of this study was to refine the APACHE ( Acute Physiology , Age , Chronic Health Evaluation ) methodology in order to more accurately predict hospital mortality risk for critically ill hospitalized adults . We prospect ively collected data on 17,440 unselected adult medical/surgical intensive care unit ( ICU ) admissions at 40 US hospitals ( 14 volunteer tertiary-care institutions and 26 hospitals r and omly chosen to represent intensive care services nationwide ) . We analyzed the relationship between the patient 's likelihood of surviving to hospital discharge and the following predictive variables : major medical and surgical disease categories , acute physiologic abnormalities , age , preexisting functional limitations , major comorbidities , and treatment location immediately prior to ICU admission . The APACHE III prognostic system consists of two options : ( 1 ) an APACHE III score , which can provide initial risk stratification for severely ill hospitalized patients within independently defined patient groups ; and ( 2 ) an APACHE III predictive equation , which uses APACHE III score and reference data on major disease categories and treatment location immediately prior to ICU admission to provide risk estimates for hospital mortality for individual ICU patients . A five-point increase in APACHE III score ( range , 0 to 299 ) is independently associated with a statistically significant increase in the relative risk of hospital death ( odds ratio , 1.10 to 1.78 ) within each of 78 major medical and surgical disease categories . The overall predictive accuracy of the first-day APACHE III equation was such that , within 24 h of ICU admission , 95 percent of ICU admissions could be given a risk estimate for hospital death that was within 3 percent of that actually observed ( r2 = 0.41 ; receiver operating characteristic = 0.90 ) . Recording changes in the APACHE III score on each subsequent day of ICU therapy provided daily up date s in these risk estimates . When applied across the individual ICUs , the first-day APACHE III equation accounted for the majority of variation in observed death rates ( r2 = 0.90 , p less than 0.0001 ) Introduction Studies on the role of programmed death-1(PD-1 ) and its main lig and ( PD-L1 ) during experimental models of sepsis have shown that the PD-1/PD-L1 pathway plays a pathologic role in altering microbial clearance , the innate inflammatory response and accelerated apoptosis in sepsis . However , the expression of PD-1 and PD-L1 and their role during the development of immune suppression in septic patients have not been eluci date d. The present study was design ed to determine whether the expression of PD-1 and PD-L1 is upregulated in septic shock patients and to explore the role of this pathway in sepsis-induced immunosuppression . Methods Nineteen septic shock patients and 22 sex-matched and age-matched healthy controls were prospect ively enrolled . Apoptosis in lymphocyte sub population s and PD-1/PD-L1 expression on peripheral T cells , B cells and monocytes were measured using flow cytometry . Apoptosis of T cells induced by TNFα or T-cell receptor ligation in vitro and effects of anti-PD-L1 antibody administration were measured by flow cytometry . CD14 + monocytes of septic shock patients were purified and incubated with either lipopolysaccharide , anti-PD-L1 antibody , isotype antibody , or a combination of lipopolysaccharide and anti-PD-L1 antibody or isotype antibody . Supernatants were harvested to examine production of cytokines by ELISA . Results Compared with healthy controls , septic shock induced a marked increase in apoptosis as detected by the annexin-V binding and active caspase-3 on CD4 + T cells , CD8 + T cells and CD19 + B cells . Expression of PD-1 on T cells and of PD-L1 on monocytes was dramatically upregulated in septic shock patients . PD-1/PD-L1 pathway blockade in vitro with anti-PD-L1 antibody decreased apoptosis of T cells induced by TNFα or T-cell receptor ligation . Meanwhile , this blockade potentiated the lipopolysaccharide-induced TNFα and IL-6 production and decreased IL-10 production by monocytes in vitro . Conclusions The expression of PD-1 on T cells and PD-L1 on monocytes was upregulated in septic shock patients . The PD-1/PD-L1 pathway might play an essential role in sepsis-induced immunosuppression Patients with sepsis have impaired host defenses that contribute to the lethality of the disorder . Recent work implicates lymphocyte apoptosis as a potential factor in the immunosuppression of sepsis . If lymphocyte apoptosis is an important mechanism , specific subsets of lymphocytes may be more vulnerable . A prospect i ve study of lymphocyte cell typing and apoptosis was conducted in spleens from 27 patients with sepsis and 25 patients with trauma . Spleens from 16 critically ill nonseptic ( 3 prospect i ve and 13 retrospective ) patients were also evaluated . Immunohistochemical staining showed a caspase-9-mediated profound progressive loss of B and CD4 T helper cells in sepsis . Interestingly , sepsis did not decrease CD8 T or NK cells . Although there was no overall effect on lymphocytes from critically ill nonseptic patients ( considered as a group ) , certain individual patients did exhibit significant loss of B and CD4 T cells . The loss of B and CD4 T cells in sepsis is especially significant because it occurs during life-threatening infection , a state in which massive lymphocyte clonal expansion should exist . Mitochondria-dependent lymphocyte apoptosis may contribute to the immunosuppression in sepsis by decreasing the number of immune effector cells . Similar loss of lymphocytes may be occurring in critically ill patients with other disorders Introduction Although major changes of the immune system have been described in sepsis , it has never been studied whether these may differ in relation to the type of underlying infection or not . This was studied for the first time . Methods The statuses of the innate and adaptive immune systems were prospect ively compared in 505 patients . Whole blood was sample d within less than 24 hours of advent of sepsis ; white blood cells were stained with monoclonal antibodies and analyzed though a flow cytometer . Results Expression of HLA-DR was significantly decreased among patients with severe sepsis/shock due to acute pyelonephritis and intraabdominal infections compared with sepsis . The rate of apoptosis of natural killer ( NK ) cells differed significantly among patients with severe sepsis/shock due to ventilator-associated pneumonia ( VAP ) and hospital-acquired pneumonia ( HAP ) compared with sepsis . The rate of apoptosis of NKT cells differed significantly among patients with severe sepsis/shock due to acute pyelonephritis , primary bacteremia and VAP/HAP compared with sepsis . Regarding adaptive immunity , absolute counts of CD4-lymphocytes were significantly decreased among patients with severe sepsis/shock due to community-acquired pneumonia ( CAP ) and intraabdominal infections compared with sepsis . Absolute counts of B-lymphocytes were significantly decreased among patients with severe sepsis/shock due to CAP compared with sepsis . Conclusions Major differences of the early statuses of the innate and adaptive immune systems exist between sepsis and severe sepsis/shock in relation to the underlying type of infection . These results may have a major impact on therapeutics Introduction The impact of gender on outcome in critically ill patients is unclear . Weinvestigated the influence of gender on the epidemiology of severe sepsis and associated morbidity and mortality in a large cohort of ICU patients in the regionof Piedmont in Italy . Methods This was a post-hoc analysis of data from a prospect i ve , multicenter , observational study in which all patients admitted to one of 24 participatingmedical and /or surgical ICUs between 3 April 2006 and 29 September 2006 wereincluded . Results Of the 3,902 patients included in the study , 63.5 % were male . Female patients weresignificantly older than male patients ( 66 ± 16 years vs. 63 ± 16 years , P < 0.001 ) . Female patients were less likely to have severe sepsis and septic shock on admission to the ICU and to develop these syndromes during theICU stay . ICU mortality was similar in men and women in the whole cohort ( 20.1%vs . 19.8 % , P = 0.834 ) , but in patients with severe sepsis wassignificantly greater in women than in men ( 63.5 % vs. 46.4 % , P = 0.007).In multivariate logistic regression analysis with ICU outcome as the dependentvariable , female gender was independently associated with a higher risk of ICUdeath in patients with severe sepsis ( odds ratio = 2.33 , 95 % confidence interval = 1.23 to 4.39 , P = 0.009 ) but not in the whole cohort ( odds ratio = 1.07,95 % confidence interval = 0.87 to 1.34 ) . Conclusion In this large regional Italian cohort of ICU patients , there were more male thanfemale admissions . The prevalence of severe sepsis was lower in women than in men , but female gender was independently associated with a higher risk of death in theICU for patients with severe sepsis Although salutary effects of female sex steroids have been demonstrated not only in proestrus females but also in male animals treated with estradiol in different models of trauma , it remains unknown whether sex hormones influence post-traumatic immune response in humans . We therefore investigated the effect of sex and age on organ dysfunction and clinical course in patients with multiple injuries . Polytraumatized patients (
Output:
| Major elective surgery overcame many of these method ological limitations . |
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