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MS212600 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Although beta-adrenoreceptor antagonists appear to be beneficial in chronic heart failure there is little information on their effects on autonomic and baroreceptor function which may have important prognostic implication s. We sought to determine first whether beta-adrenoreceptor blockade will improve baroreceptor function and vagal tone in chronic heart failure , and second whether there were any differences between st and ard therapy with metoprolol and the second-generation vasodilating beta-blocker celiprolol . In this double-blind r and omized placebo-controlled study 50 patients with stable chronic heart failure received either celiprolol 200 mg daily , metoprolol 50 mg twice daily or placebo for 12 weeks after a 4-week dose titration period . Thirty-five healthy normal subjects were also studied . Baroreceptor gain was assessed non-invasively by cross-spectral analysis of R-R and systolic blood pressure low- and high-frequency components ( the alpha angle ) during controlled respiration . High-frequency power was used as a measure of vagal modulation . Satisfactory recordings for analysis were obtained in 31 patients with heart failure . The results showed that at baseline baroreceptor gain ( alphaHF ) was significantly depressed in patients with heart failure compared with the normal control group ( 4.95+/-0 . 55 versus 11.73+/-1.32 ms/mmHg , P<0.0001 ) . After 12 weeks of treatment with metoprolol baroreceptor gain improved significantly whether measured while supine ( P=0.03 ) or st and ing ( P=0.009 ) , and this was associated with a significant increase in R-R HF power ( P=0 . 008 ) . There were no significant changes after treatment with celiprolol or placebo . We conclude that metoprolol but not celiprolol therapy restores baroreceptor gain towards normal and increases vagal tone in chronic heart failure . The ancillary properties of celiprolol do not appear to provide any advantages over metoprolol for the restoration of autonomic and baroreceptor function in heart failure CONTEXT Observational studies have shown that psychosocial factors are associated with increased risk for cardiovascular morbidity and mortality , but the effects of behavioral interventions on psychosocial and medical end points remain uncertain . OBJECTIVE To determine the effect of 2 behavioral programs , aerobic exercise training and stress management training , with routine medical care on psychosocial functioning and markers of cardiovascular risk . DESIGN , SETTING , AND PATIENTS R and omized controlled trial of 134 patients ( 92 male and 42 female ; aged 40 - 84 years ) with stable ischemic heart disease ( IHD ) and exercise-induced myocardial ischemia . Conducted from January 1999 to February 2003 . INTERVENTIONS Routine medical care ( usual care ) ; usual care plus supervised aerobic exercise training for 35 minutes 3 times per week for 16 weeks ; usual care plus weekly 1.5-hour stress management training for 16 weeks . MAIN OUTCOME MEASURES Self-reported measures of general distress ( General Health Question naire [ GHQ ] ) and depression ( Beck Depression Inventory [ BDI ] ) ; left ventricular ejection fraction ( LVEF ) and wall motion abnormalities ( WMA ) ; flow-mediated dilation ; and cardiac autonomic control ( heart rate variability during deep breathing and baroreflex sensitivity ) . RESULTS Patients in the exercise and stress management groups had lower mean ( SE ) BDI scores ( exercise : 8.2 [ 0.6 ] ; stress management : 8.2 [ 0.6 ] ) vs usual care ( 10.1 [ 0.6 ] ; P = .02 ) ; reduced distress by GHQ scores ( exercise : 56.3 [ 0.9 ] ; stress management : 56.8 [ 0.9 ] ) vs usual care ( 53.6 [ 0.9 ] ; P = .02 ) ; and smaller reductions in LVEF during mental stress testing ( exercise : -0.54 % [ 0.44 % ] ; stress management : -0.34 % [ 0.45 % ] ) vs usual care ( -1.69 % [ 0.46 % ] ; P = .03 ) . Exercise and stress management were associated with lower mean ( SE ) WMA rating scores ( exercise : 0.20 [ 0.07 ] ; stress management : 0.10 [ 0.07 ] ) in a subset of patients with significant stress-induced WMA at baseline vs usual care ( 0.36 [ 0.07 ] ; P = .02 ) . Patients in the exercise and stress management groups had greater mean ( SE ) improvements in flow-mediated dilation ( exercise : mean [ SD ] , 5.6 % [ 0.45 % ] ; stress management : 5.2 % [ 0.47 % ] ) vs usual care patients ( 4.1 % [ 0.48 % ] ; P = .03 ) . In a subgroup , those receiving stress management showed improved mean ( SE ) baroreflex sensitivity ( 8.2 [ 0.8 ] ms/mm Hg ) vs usual care ( 5.1 [ 0.9 ] ms/mm Hg ; P = .02 ) and significant increases in heart rate variability ( 193.7 [ 19.6 ] ms ) vs usual care ( 132.1 [ 21.5 ] ms ; P = .04 ) . CONCLUSION For patients with stable IHD , exercise and stress management training reduced emotional distress and improved markers of cardiovascular risk more than usual medical care alone AIMS Reduced heart rate variability is associated with an unfavourable prognosis in patients with ischaemic heart disease . Whether physical training can modify this risk factor is not definitely proven . Our hypothesis was that training might increase both physical capacity and heart rate variability in elderly patients recovering from an acute coronary event , i.e. acute myocardial infa rct ion ( n=38 ) or an episode of unstable angina ( n=27 ) . METHODS AND RESULTS 24 h ambulatory ECG recordings were obtained from 65 patients r and omized to either a 3 months supervised outpatient group training programme 50 min three times a week ( n=29 ) or to a control group ( n=36 ) . The two groups were well balanced as regards demographic data and pharmacological treatment at the time of r and omization . Body mass index and pharmacological therapy remained unchanged during the study . Heart rate variability was analysed in the time and frequency domains . At the 3 month follow-up , exercise tolerance had increased from 103 to 120 W in the training group ( P<0.001 ) , and from 102 to 106 W in the control group ( ns ) . The time-domain heart rate variability measures SDNN ( st and ard deviation of all filtered RR intervals over the analysed time period ) and SDANN ( st and ard deviation of the means of all filtered RR intervals for all 5 min epochs of the analysed time period ) increased significantly during the daytime in the training group ( P<0.01 and P<0.05 , respectively ) , but not in the control group . A significant improvement in night-time heart rate variability was observed among controls . There was a statistically significant correlation ( P<0.05 ) between changes in 24 h overall power ( frequency domain measure ) and changes in maximal exercise capacity in the training group . CONCLUSION A regular aerobic group training programme after an acute coronary event can significantly improve exercise capacity and modify heart rate variability in a prognostically favourable direction in elderly low-to-intermediate risk patients , recovering from an acute coronary event BACKGROUND AND PURPOSE Cardiac autonomic dysfunction is associated with risk of restenosis and cardiovascular mortality in patients after percutaneous transluminal coronary angioplasty ( PTCA ) . Analysis of heart rate variability ( HRV ) is an important , widely used method for assessing cardiac autonomic regulation . The purpose of this study was to investigate the effect of exercise training on HRV in subjects after PTCA . SUBJECTS AND METHODS A total of 84 subjects who had undergone PTCA were recruited for this study . The subjects ( age [mean+/-SD]=57.0+/-9.3 years ) were r and omly assigned to either an exercise group to undergo an 8-week outpatient exercise program or a control group to undergo usual care . Heart rate variability was measured for 5 minutes in the supine resting position at baseline and at the end of 8 weeks . RESULTS The parasympathetically modulated HRV of the subjects in the exercise group increased significantly compared with the HRV of subjects in the control group . The effects of training on HRV were independent of angioplasty type ( balloon or stent ) and were unrelated to whether the subjects had received previous PTCA . DISCUSSION AND CONCLUSION Exercise training can increase parasympathetic modulation of cardiac function in people after they have undergone successful PTCA . Our results suggest that analysis of HRV can be extended to assess the effect of exercise training on cardiac autonomic dysfunction in people after coronary angioplasty To investigate the effects of carteolol , which is a nonselective beta-adrenergic agent with intrinsic sympathomimetic activity , on silent myocardial ischemia , exercise-induced myocardial ischemia , indexes of heart rate variability , and pain-modulating system , 20 patients ( mean 60 + /- 9 years ) with chronic stable angina underwent exercise treadmill testing and 24-hour ambulatory electrocardiographic monitoring during 2 weeks of carteolol administration ( 15 mg/day ) in a double-blind , placebo-controlled design . Plasma levels of beta-endorphin and bradykinin and electrical pain stimulation to the skin were measured at rest and peak exercise . Indexes of heart rate variability of both time-domain and frequency-domain analysis were derived from 24-hour ambulatory electrocardiographic monitoring . Carteolol decreased maximal heart rate responses to daily activities during ambulatory monitoring and significantly reduced the median frequency and duration of silent myocardial ischemic episodes ( from 1.0 to 0.0 events/24 hr and from 16 to 0 min/24 hr , respectively ) . Carteolol significantly decreased the rate-pressure product at rest and during exercise with improving maximal ST segment depression , suggesting amelioration of exercise-induced myocardial ischemia . Carteolol did not significantly affect plasma levels of beta-endorphin and bradykinin or pain threshold . It significantly decreased some indexes ( st and ard deviation of all normal sinus R-R intervals in the entire 24-hour recording and st and ard deviation of the mean of all 5-minute segments of normal R-R intervals of a 24-hour recording ) of heart rate variability . These results suggest that carteolol may reduce total myocardial ischemic burden by the reduction of cardiac oxygen dem and during daily activities and exercise stress , while not affecting plasma levels of beta-endorphin , bradykinin , and pain threshold . Because carteolol tended to decrease indexes of heart rate variability , significant caution might be necessary in prescribing the beta-blocking agents with intrinsic sympathomimetic activity like carteolol to patients with potential serious arrhythmia Background It is unclear how much of the reduction in cardiac mortality in coronary heart disease ( CHD ) patients with exercise training is the result of direct effects on the heart and coronary vasculature , or to indirect effects , via primary risk factors . Objective The aim of this article was to quantify the cardiac mortality benefits of exercise-based rehabilitation attributable to risk factor reductions versus the direct effects on the heart and vasculature . Methods The IMPACT coronary heart disease model was used to examine the reduction in cardiac mortality attributable to changes in risk factors from a meta- analysis of cardiac rehabilitation r and omized , controlled trials . Patients were receiving rehabilitation following an acute myocardial infa rct ion , angina pectoris or revascularization . Outcomes considered were primary risk factors ( total cholesterol , systolic blood pressure and smoking behaviour ) and cardiac mortality . Results Nineteen exercise-only cardiac rehabilitation trials ( including 2984 patients ) were identified . Across these trials , exercise training reduced pooled cardiac mortality by 28 % ( relative risk , 0.72 , 95 % confidence interval 0.55–0.95 ) , with 30 fewer deaths than in the control group . Applying the CHD model , approximately 17 ( 58 % ) of these 30 fewer deaths were attributable to reductions in major cardiovascular risk factors : 7.1 deaths ( minimum estimate 6.2 , maximum estimate 9.5 ) attributable to an 18 % reduction in smoking prevalence ; 5.9 deaths ( minimum −0.6 , maximum 12.6 ) to a 0.11 mmol/l reduction in cholesterol , and 4.4 deaths ( −1.0 minimum , 6.7 maximum ) to a 2.0 mmHg reduction in systolic blood pressure . Conclusions Approximately half of the 28 % reduction in cardiac mortality achieved with exercise-based cardiac rehabilitation may be attributed to reductions in major risk factors , particularly smoking . Eur J Cardiovasc Prev Rehabil 13:369–374 © 2006 The European Society of To investigate the effects of physical training on neurovegetative profile of patients with previous anterior myocardial infa rct ion ( MI ) , we studied 38 patients out of the EAMI study at 4 to 6 weeks after anterior MI ( test 1 ) , who were then assigned r and omly to a training group ( n = 22 ) or to a control group ( n = 16 ) and studied again 6 months later ( test 2 ) . Neurovegetative function was assessed by analyzing the heart rate variability ( HRV ) of 24 h , from ambulatory ECG recording , both in time domain , as st and ard deviation
Output:
| Conclusion Pharmacologic , biobehavioral and exercise strategies for secondary prevention of CAD significantly increase HRV . |
MS212601 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 AIMS There is currently no proven chemotherapy regimen for hepatocellular carcinoma ( HCC ) . The principal chemotherapeutic approach in most cases is infusion therapy into the hepatic arteries feeding the tumors . However , the clinical effects of chemotherapy are extremely poor . Therefore , in the present study , we conducted a prospect i ve r and omized trial of the efficacy of oral administration of enteric-coated tegafur/uracil for advanced HCC . METHODS From 1994 to 1999 , a total of 56 consecutive patients with unresectable stage IV-A HCC were studied prospect ively to examine the efficacy of enteric-coated tegafur/uracil in HCC and to determine the significant prognostic factors . Twenty-eight patients were treated only with enteric-coated tegafur/uracil without other anticancer treatment . Another 20 patients were given conservative management only . The remaining eight patients withdrew from the study . RESULTS In the group treated only with enteric-coated tegafur/uracil , the median survival time and 1 and 2 year survival rates were 12.13 months and 55.3 and 36.9 % , respectively . In the control group , the median survival time and 1 year survival rate were 6.20 months and 5.5 % , respectively . By both univariate analysis and multivariate analysis using Cox 's proportional hazards model , treatment with enteric-coated tegafur/uracil was shown to be the factor most significantly favoring a better prognosis . CONCLUSIONS Although the prognosis of most patients with stage IV-A HCC is poor , administration of enteric-coated tegafur/uracil induces long-term survival and is an effective treatment for stage IV-A HCC We conducted a prospect i ve r and omized trial to evaluate the efficacy of Lipiodol in intrahepatic arterial infusion chemotherapy for patients with hepatocellular carcinoma ( HCC ) . A total of 38 patients with unresectable HCCs and underlying cirrhosis were entered in this trial , and 36 of them were evaluable . Every 4 weeks , 17 patients received 70 mg of 4′-epidoxorubicin ( epirubicin ) alone ( group A ) , whereas 19 patients received a Lipiodol emulsion containing the same dose of epirubicin ( group B ) through the hepatic artery . A tumor response ( CR+PR ) was observed in 12 % of group A patients and in 42 % of group B patients . The group B patients showed a significantly higher response rate than the group A patients . There was a tendency for an increased duration of survival ( P=0.09 ) in the group B patients . These results suggested that the infusion of the Lipiodol emulsion with epirubicin was more effective than epirubicin alone for the treatment of these patients with HCC Variant liver oestrogen receptor transcripts in hepatocellular carcinoma are associated with aggressive clinical course and unresponsiveness to tamoxifen . To evaluate the impact on survival and on tumour growth of megestrol ( progestin drug acting at post-receptorial level ) we enrolled 45 patients with HCC characterized by variant liver oestrogen receptors in a prospect i ve , r and omized study with megestrol vs. placebo . Presence of variant oestrogen receptors was determined by RT/PCR . 24 patients were r and omized to no treatment and 21 to therapy with megestrol 160 mg day–1 . Results were analysed by Kaplan-Meier and Cox methods . Survival of hepatocellular carcinoma characterized by variant oestrogen receptors was extremely poor ( median survival 7 months ) ; megestrol significantly improved survival ( 18 months ) ( P = 0.0090 ) . Tumour growth at one year was significantly slowed down in megestrol-treated patients ( P = 0.0212 ) . Bilirubin levels , presence of portal thrombosis , HBV aetiology and treatment were identified at univariate analysis as factors significantly associated with survival ; at multivariate analysis , only megestrol therapy ( P = 0.0003 ) , presence of HBV infection ( P = 0.0009 ) and presence of portal vein thrombosis ( P = 0.0051 ) were factors independently related with survival . ( 1 ) Megestrol slows down the aggressive tumour growth of patients with hepatocellular carcinoma characterized by variant estrogen receptors and ( 2 ) is also able to favourably influence the course of disease , more than doubling median survival . © 2001 Cancer Research One hundred ninety‐two patients with unresectable primary liver cancer studied by members of the Eastern Cooperative Oncology Group ( ECOG ) were evaluable in a prospect ively r and omized clinical trial . Patient discriminants such as performance status were carefully evaluated to assess their influence on prognosis and to evaluate the importance of patient status on response and survival . Patients who were totally bedridden or with signs of overt liver failure were not entered on study . The median survival time for all evaluable previously untreated patients was 17 weeks ( 19 weeks for North American and European , and 10 weeks for South African black patients ) . Among the South African patients , however , there was a significantly larger proportion with an initially poor performance status . Prognostic variables ( performance status , jaundice , and reduced appetite ) dominate any differences among the treatments studied . Among North American and European patients on intravenous ( IV ) 5‐fluorouracil ( 5‐FU ) + Methyl‐CCNU ( MeCCNU ) + Adriamycin ( ADM , doxorubicin ) , the 19 % response rate is offset by 63 % with severe toxicity and a median survival time of only 17 weeks , making this treatment unacceptable clinical ly . The median survival time of North American and European patients treated with IV 5‐FU + MeCCNU was 28 weeks in contrast to a median survival time of 12 weeks with ADM ( P ≤ 0.01 ) . EST 2273 was the ECOG study of patients with primary liver cancer . The results of the first part of the trial were published in 1978 . This report up date s those findings and reports the results of patients entered subsequently on the second part of that study after it was amended in 1979 . With more than 300 evaluable patients in EST 2273 , this duet of studies is the largest ever conducted in patients with primary liver cancer , and draws a new baseline from which to measure the disease and its response to treatment A r and omized controlled trial of tamoxifen ( 60 mg/die ) versus placebo was performed in patients with cirrhosis and advanced inoperable hepatocellular carcinoma . Twenty-two patients were matched and coupled for sex , age , Child-Pugh class and tumour mass and then r and omized to tamoxifen or placebo . Median survival was 74 weeks in the tamoxifen group ( range 27 to 144 weeks ) and 52 weeks in the placebo group ( range 4 to 112 weeks ) . The survival of patients treated with tamoxifen improved significantly compared to the controls ( Logrank-test , p = 0.04 ) . These findings suggest that the effect of the antiestrogen tamoxifen is both statistically and clinical ly significant in increasing survival in patients with advanced hepatocellular carcinoma OBJECTIVES : A prospect i ve r and omized study was performed to test the hypothesis that tamoxifen might improve the survival of patients with advanced hepatocellular carcinoma ( HCC ) and to correlate the response of treatment with the expression of hormone receptors . METHODS : One hundred nineteen patients with advanced and otherwise untreatable HCC were included in a placebo-controlled , single-blind trial . The patients were r and omized to tamoxifen group ( 61 patients ) and control group ( 58 patients ) and were prescribed with a daily dose of 30 mg of tamoxifen and placebo , respectively . Immunohistochemical tests for estrogen and progesterone receptors were performed on the tumor tissues obtained from 66 patients . All patients were closely monitored and the survival outcome of the two groups of patients was compared and stratified according to the hormonal receptor status . RESULTS : There was no difference in the 1-month mortality rates ( 32.8 % vs 43.1 % , p = 0.246 ) and the median survival ( 44 days vs 41 days , p = 0.703 ) between the tamoxifen group and the control group . Furthermore , the expression of hormone receptors in the tumors did not affect the survival outcome of the patients treated with tamoxifen . None of the patients who survived longer than 3 months had tumor that had partial response to tamoxifen treatment on follow-up imaging study . CONCLUSIONS : Tamoxifen has no efficacy in the treatment of patients with advanced HCC and response to treatment was not affected by the expression of hormone receptors Lipiodol injected into the hepatic artery is selectively retained in hepatomas so has been used as a vehicle for cytotoxic drugs . This study compared treatment with 5-epidoxorubicin emulsified in lipiodol and infused into the hepatic artery with symptomatic treatment alone in a r and omised trial . Of 136 patients with hepatoma 78 ( 57 % ) were not eligible , eight ( 6 % ) refused to take part , and 50 entered the trial ( chemotherapy : n = 25 , symptomatic treatment : n = 25 ) . The two groups had similar prognostic indices . Seven of 25 patients allocated to chemotherapy were unable to receive it . The slight survival disadvantage associated with chemotherapy was not significant ( median survival 48 days compared with 51 days , log rank chi 2 = 0.07 , p > 0.05 ) . Patients given chemotherapy spent significantly longer in hospital , however ( median three days compared with one , p = 0.0008 ) . Changes in symptoms and indices of tumour growth did not differ significantly between the two groups . It is concluded that infusion of 5-epidoxorubicin emulsified in lipiodol for hepatoma increased morbidity but did not affect survival . In addition , most patients were unsuitable for this treatment because of advanced disease . The patients in the trial had a short median survival time so the conclusions may not be valid for other patients with hepatoma Thirty-six consecutive patients with advanced hepatocellular carcinoma and chronic liver disease were r and omly allocated to two groups : group I included 20 patients who were treated with 10 mg bid . tamoxifen and group II with 16 non-treated patients . The two groups were homogeneous according to clinical and analytical data . Survival curves in the tamoxifen-treated patients improved significantly when compared with the non-treated group ( p = 0.01 ) . Cumulative survival at the end of the first year was 48.5 % in the treated patients and 9.1 % in controls . Median survival was 261 days in the treated group vs. 172 in the non-treated group ( p < 0.05 ) . Complications of cirrhosis and worsening of the performance status test occurred less in the treated patients than in the controls , but not significantly so . Tamoxifen was well tolerated and no marked side effects were observed . In this series , tamoxifen improved survival in patients with advanced hepatocellular carcinoma BACKGROUND / AIMS Lipiodol chemoembolization is a widely used method of treatment in patients with unresectable hepatocellular carcinoma , but its efficacy is still debated . The aim of our study was to assess the efficacy of lipiodol chemoembolization in patients with unresectable hepatocellular carcinoma . METHODS Seventy-three patients with unresectable hepatocellular carcinoma , but without severe liver disease or portal vein occlusion , were r and omly assigned to receive either repeated lipiodol chemoembolization ( lipiodol , cisplatin ( 2 mg/kg ) , lecithin , and gelatin sponge injected into the hepatic artery ) plus tamoxifen ( 40 mg ) or tamoxifen alone . The main end-point was survival . RESULTS The 37 patients in the lipiodol chemoembolization group received 104 courses ( median 3 per patient ) . By 1 September 1996 , 58 patients had died : 30 in the lipiodol chemoembolization group and 28 in the tamoxifen group . There was no difference in survival between the two groups ( p=0.77 ) . The relative risk of death in the lipiodol chemoembolization plus tamoxifen group as compared to the tamoxifen group was 0.92 ( 95 % confidence interval 0.55 to 1.56 ) . At 1 year , survival was 51 % and 55 % , respectively . An objective tumoral response was more frequently observed in the lipiodol chemoembolization group than in the tamoxifen group ( 24 versus 5.5 % , respectively , p=0.046 ) . Lipiodol chemoembolization caused two deaths and induced signs of liver failure in 51 % of the patients assigned to this treatment . CONCLUSION In our r and omized study , lipiodol chemoembolization did not improve the survival of patients with unresectable hepatocellular carcinoma treated with tamoxifen A r and omized trial of hepatic arterial chemoembolization was conducted in 42 patients with unresectable hepatocellular carcinoma . These patients represented 41 % of patients with hepatocellular carcinoma seen during the inclusion period . In the remaining 59 % , 9 % had resectable tumours and 50 % had unresectable tumours with contraindication
Output:
| In conclusion , chemoembolization improves survival of patients with unresectable HCC and may become the st and ard treatment .
Treatment with tamoxifen does not modify the survival of patients with advanced disease |
MS212602 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 : Emergency department ( ED ) patients show high smoking rates . The effects of ED-initiated tobacco control ( ETC ) on 7-day abstinence at 12 months were investigated . Methods : A r and omised controlled intention-to-treat trial ( trials registry no. : IS RCT N41527831 ) was conducted with 1044 patients in an urban ED . ETC consisted of on-site counselling plus up to four telephone booster sessions . Controls received usual care . Analysis was by logistic regression . Results : In all , 630 ( 60.7 % ) participants were males , the median age was 30 years ( range 18–81 ) and the median smoking intensity was 15 ( range 1–60 ) cigarettes per day . Overall , 580 study participants ( 55.6 % ) were unmotivated , 331 ( 31.7 % ) were ambivalent and 133 ( 12.7 % ) were motivated smokers . ETC ( median time 30 ( range 1–99 ) min ) was administered to 472 ( 91.7 % out of 515 ) r and omised study participants . At follow-up , 685 study participants ( 65.6 % of 1044 ) could be contacted . In the ETC group , 73 out of 515 ( 14.2 % ) in the ETC group were abstinent , whereas 60 out of 529 ( 11.3 % ) controls were abstinent ( OR adjusted for age and gender = 1.31 ( 95 % CI 0.91 to 1.89 , p = 0.15 ) . Stratified for motivation to change behaviour , the adjusted ORs for ETC versus usual care were OR = 1.00 ( 95 % CI 0.57 to 1.76 ) in unmotivated smokers , respectively OR = 1.37 ( 95 % CI 0.73 to 2.58 ) in ambivalent smokers and OR = 2.19 ( 95 % CI 0.98 to 4.89 ) in motivated smokers , p for trend = 0.29 . Conclusions : ETC , in the form of on-site counselling with up to four telephone booster sessions , showed no overall effect on tobacco abstinence after 12 months . A non-significant trend for a better performance of ETC in more motivated smokers was observed Background Emergency departments ( EDs ) have strong potential to initiate tobacco interventions with economically disadvantaged population s. Purpose We piloted three ED-initiated tobacco interventions and derived parameter estimates for future trials . Methods The study enrolled adult patients being treated in an urban ED who were daily smokers . Exclusion criteria included severe illness or pain , isolation ( for contagion ) , altered mental status , an insurmountable language barrier , temporary residence , and lack of telephone access . Subjects in the Bedside + Booster group received motivational counseling by a trained counselor at the bedside , up to three telephone sessions post-visit , and a self-help guide . Subjects in the Faxed Referral group had their personal contact information faxed to the hospital ’s tobacco dependence clinic , whereupon they received identical treatment as the Bedside + Booster group , but all sessions occurred over the telephone ( i.e. , no bedside counseling ) . The St and ard Referral group received the self-help guide and a referral to the hospital ’s tobacco dependence clinic . We used a 2:2:1 r and omization schedule to maximize our experience with the motivational interventions . Outcomes were assessed at 1 and 3 months . Results We enrolled 90 subjects . Of the 36 subjects assigned to the Bedside + Booster condition , 31 ( 87 % ) completed bedside counseling and at least one booster session , while 22 ( 61 % ) completed the maximum four sessions . Of the 37 subjects assigned to the Faxed Referral group , 28 ( 76 % ) completed at least one telephone session , while 19 ( 51 % ) completed the maximum four sessions . Quit attempts over the 3 months ranged from 18 % ( St and ard Referral ) to 57 % ( Faxed Referral ) . Seven-day abstinence was attained by 8 % ( Bedside + Booster ) , 14 % ( Faxed Referral ) , and 6 % ( St and ard Referral ) at 3 months . Conclusions Motivational cessation counseling can be feasibly initiated during the ED encounter with minimal medical staff involvement . Adequately powered trials are needed to study ED-initiated interventions that include post-visit follow-up Introduction Motivational interviewing techniques have been minimally research ed as a function of a teenage smoking intervention . The present study examined the efficacy of a theory-based motivational tobacco intervention ( MTI ) . Methods A r and omized two-group design was used to compare 6-month post-baseline quit and reduction rates among teenagers who received the MTI with those who received brief advice or care as usual . Participants were smokers aged 14 to 19 years ( N = 75 ) who presented for treatment in a university-affiliated hospital emergency department ( ED ) . Motivational interviewing techniques were used by trained providers to facilitate individual change ; stage-based take-home material s also were provided . Results Similar to past clinic-based studies of motivational interviewing with teenage smokers , our study found negative results in terms of intervention efficacy for cessation . Six-month follow-up cessation rates were nonsignificant — two teenagers quit smoking . Among teenagers who were available at follow-up , a medium effect size ( Cohen 's h = .38 ) was found for reduction and a large effect size ( Cohen 's h = .69 ) was found for percentage reduction , although these results also were not statistically significant . Conclusion Although the major findings of this study were not significant , the reductions in tobacco use suggest that motivational interviewing may be a clinical ly relevant counseling model for use in teenage smoking interventions . However , many questions remain , and the current literature lacks studies on trials with significant outcomes using motivational interviewing in smoking cessation . Additionally , more research is needed to examine the suitability of the ED for MTI-type interventions OBJECTIVE To assess the effect of physician counseling and referral on smoking cessation rates and attendance at a smoking cessation program . METHODS This was a prospect i ve , r and omized clinical trial set in a suburban , community teaching hospital emergency department ( ED ) . During study hours , dedicated research associates enrolled consecutive , stable , oriented patients who were smokers . Eligible , consenting patients were r and omized to one of two intervention groups . The control group received a two-page " Stop Smoking " pamphlet from the American Heart Association ( AHA ) . Patients in the intervention group were given the AHA pamphlet along with pharmacologic information and st and ardized counseling by the attending emergency physician , including written and oral referral to a smoking cessation program . The primary outcome measures were telephone contact/attendance at the smoking cessation program by the intervention group and the rate of smoking cessation in both study groups at three months post-ED visit . Categorical data were analyzed by chi-square and Fisher 's exact tests . Rank data were analyzed by Mann-Whitney tests and continuous data by t-tests . All tests were two-tailed with alpha set at 0.05 . RESULTS One hundred fifty-two patients were enrolled ; 78 were r and omized to the intervention group . Nearly 70 % of patients ( 103 ) were available for telephone follow-up . The study groups were statistically similar with regard to baseline demographic characteristics and the prevalence of moderate or severe nicotine addiction . None of the patients ( 0 % ) in the intervention group contacted or attended the smoking cessation program during the study period ( 95 % CI = 0 - 4 % ) . The percentages of patients who stopped smoking after three months were similar in the two groups [ 10.4 % ( 5/48 ) control vs 10.9 % ( 6/55 ) intervention ; p = 1 ] . CONCLUSION The authors found no difference in the smoking cessation rates between ED patients who received written material and those who were counseled by emergency physicians . Referral of patients who smoked to a cessation program was unsuccessful BACKGROUND Many people rely on EDs for routine health care . Often , however , screening and counseling for health risks are not provided . OBJECTIVE To determine prevalence rates of chronic disease and injury risk factors and access to routine health care in a r and om sample of ED patients in 3 cities . METHODS A prospect i ve survey was conducted at 3 hospital EDs in Akron , OH , Boston , MA , and Denver , CO . A modified version of the national Behavioral Risk Factor Surveillance Survey was administered by trained research ers to a convenience sample of non-critically ill patients during r and omly selected shifts . RESULTS Of 1,143 eligible patients , 923 ( 81 % ) agreed to participate . Their mean age was 39 ( range = 17 - 96 ) years . Most were female ( 58 % ) , white ( 60 % ) , and unmarried ( 68 % ) . Thirty-eight percent had no access to primary care . Injury-prone behaviors were prevalent : 53 % of the respondents did not wear seat belts regularly ; 15 % had no working smoke detector ; 3 % kept loaded , unlocked h and guns in their homes ; 11 % had attempted suicide ; 23 % had a positive CAGE screen for alcoholism ; 3 % had operated a motor vehicle in the preceding month while alcohol-intoxicated ; and 11 % had ridden in an automobile with an intoxicated driver . Cancer and chronic disease risks were also common : 48 % smoked ; 16 % had not received a blood pressure check in the preceding year ; and 4 % reported unsafe sexual practice s. Among women aged > 50 years , 42 % had not received a Pap test in the prior 2 years and 14 % had never had mammography . Many prevalence rates and access to care varied among the 3 sites . However , for most risk factors , prevalence rates did not differ in patients with and without access to primary health care . CONCLUSIONS ED patients have high rates of injury and chronic disease risks , and many have no other source of routine health care . Research is needed to determine whether ED-based programs , design ed to reduce injury and chronic disease risks , are feasible and cost-effective OBJECTIVE To define the prevalence of smokers and nicotine-addicted patients in a suburban , community ED . METHODS This was a prospect i ve survey of consecutive ED patients seen in a suburban ED with an annual patient census of 48,000 . Medically stable patients aged 18 years or older were eligible for inclusion . Patients were excluded if they had predominantly psychiatric complaints or were critically ill . Patients were queried about their smoking habits by a closed- question survey , which included the previously vali date d Fagerstrom Test for Nicotine Dependence . The study was conducted during a six-week period , only at times when there were dedicated research associates available to ensure consecutive patient entry . Continuous variables were analyzed by Student 's t-tests . Clinical variables were analyzed by chi-square tests . All tests were two-tailed with alpha at 0.05 . RESULTS 1,515 patients comprised the study group . The mean age ( + /-SD ) was 45.6 ( + /-18.9 ) years ; 52 % were female , 25 % were nonwhite , and 47 % were college graduates . There were 317 ( 21 % ) smokers . Patients having private physicians were less likely to smoke ( 18 % vs 29 % , p = 0.001 ) . Of all smokers , 46 % were moderately to severely nicotine-dependent , 69 % wanted to quit , and 30 % expressed an interest in joining a smoking cessation program . CONCLUSION A substantial percentage of ED patients smoke , many of them are nicotine-addicted , and the majority would like to quit . R and omized , controlled trials are needed to determine whether interventions by physicians in the ED can have an impact on the smoking habits of these patients This study examines the efficacy of a smoking cessation intervention on abstinence rates and motivation to quit smoking . Participants were adult smokers ( N = 543 ) who presented to the emergency department with chest pain and who were admitted to an observation unit for 24-hour observation to rule out myocardial infa rct ion . Participants were r and omly assigned to either usual care or a tailored intervention employing motivational interviewing and telephone follow-up . All individuals choosing to quit were offered nicotine patch therapy . Follow-up assessment s were conducted at 1 , 3 and 6 months . Abstinence ( 7-day point prevalence ) rates were significantly greater among participants receiving the tailored intervention compared with those given usual care ( OR = 1.62 , 95 % CI [ 1.05 - 2.50 ] ) . The largest difference occurred at 1 month : 16.8 % of usual care and 27.3 % of the tailored intervention group were abstinent , with differences decreasing over time . One-third of participants who were quit at month 6 were late quitters whose initial abstinence began after the 1-month follow up . In addition to treatment assignment , psychosocial variables including motivation to quit , confidence , reduced temptation to smoke in response to negative affect , and the perception that their chest pain was related to their smoking , were significant predictors of cessation . Tailored interventions are effective in promoting initial quit attempts for emergency chest pain patients admitted to an observation unit . Additional
Output:
| Findings indicate that ED visits in combination with ED-initiated tobacco cessation interventions are correlated with higher cessation rates than those reported in the National Health Interview Survey . |
MS212603 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 red grape constituent resveratrol possesses cancer chemopreventive properties in rodents . The hypothesis was tested that , in healthy humans , p.o . administration of resveratrol is safe and results in measurable plasma levels of resveratrol . A phase I study of oral resveratrol ( single doses of 0.5 , 1 , 2.5 , or 5 g ) was conducted in 10 healthy volunteers per dose level . Resveratrol and its metabolites were identified in plasma and urine by high-performance liquid chromatography-t and em mass spectrometry and quantitated by high-performance liquid chromatography-UV . Consumption of resveratrol did not cause serious adverse events . Resveratrol and six metabolites were recovered from plasma and urine . Peak plasma levels of resveratrol at the highest dose were 539 ± 384 ng/mL ( 2.4 μmol/L , mean ± SD ; n = 10 ) , which occurred 1.5 h post-dose . Peak levels of two monoglucuronides and resveratrol-3-sulfate were 3- to 8-fold higher . The area under the plasma concentration curve ( AUC ) values for resveratrol-3-sulfate and resveratrol monoglucuronides were up to 23 times greater than those of resveratrol . Urinary excretion of resveratrol and its metabolites was rapid , with 77 % of all urinary agent-derived species excreted within 4 h after the lowest dose . Cancer chemopreventive effects of resveratrol in cells in vitro require levels of at least 5 μmol/L. The results presented here intimate that consumption of high-dose resveratrol might be insufficient to elicit systemic levels commensurate with cancer chemopreventive efficacy . However , the high systemic levels of resveratrol conjugate metabolites suggest that their cancer chemopreventive properties warrant investigation . ( Cancer Epidemiol Biomarkers Prev 2007;16(6):1246–52 Despite extensive research , the cardiovascular effects of coffee consumption in humans remain controversial . Our aim was to investigate the excretion of coffee phenols and the effects of filtered coffee consumption on oxidative stress and plasma homocysteine ( tHcy ) concentration in humans . The study consisted of a multiple-dose clinical supplementation trial and a single-dose study . In the long-term trial , 43 healthy nonsmoking men optionally consumed daily either no coffee , 3 cups ( 450 mL ) , or 6 cups ( 900 mL ) of filtered coffee for 3 weeks , while in the short-term study 35 subjects consumed a single dose of 0 , 1 ( 150 mL ) , or 2 cups ( 300 mL ) of coffee . Long-term consumption of coffee increased the urinary excretion of caffeic and ferulic acid . The change in the total excretion of phenolic acids in 3 and 6 cups groups represented 3.8 and 2.5 % of the amount ingested daily . Plasma tHcy concentrations increased nonsignificantly , but the consumption of coffee had neither short-nor long-term effects on lipid peroxidation or the activity of measured antioxidant enzymes . In conclusion , the consumption of filtered coffee does not have any detectable effects on lipid peroxidation in healthy nonsmoking men . The effect of coffee consumption on tHcy concentrations needs further investigation Subjects of this study consisted of 333 women ( aged 45 - 75 years ) drawn from a large United Kingdom prospect i ve study of diet and cancer , the European Prospect i ve Investigation of Cancer and Nutrition-Norfolk study . Using newly developed gas chromatography/mass spectrometry and liquid chromatography/mass spectrometry methods incorporating triply (13)C-labeled st and ards , seven phytoestrogens ( daidzein , genistein , glycitein , O-desmethylangolensin , equol , enterodiol , and enterolactone ) were measured in 114 spot urines and 97 available serum sample s from women who later developed breast cancer . Results were compared with those from 219 urines and 187 serum sample s from healthy controls matched by age and date of recruitment . Dietary levels were low , but even so , mean serum levels of phytoestrogens were up to 600 times greater than postmenopausal estradiol levels . Phytoestrogen concentrations in spot urine ( adjusted for urinary creatinine ) correlated strongly with that in serum , with Pearson correlation coefficients > 0.8 . There were significant relationships ( P < 0.02 ) between both urinary and serum concentrations of isoflavones across increasing tertiles of dietary intakes . Urinary enterodiol and enterolactone and serum enterolactone were significantly correlated with dietary fiber intake ( r = 0.13 - 0.29 ) . Exposure to all isoflavones was associated with increased breast cancer risk , significantly so for equol and daidzein . For a doubling of levels , odds ratios increased by 20 - 45 % [ log(2 ) odds ratio = 1.34 ( 1.06 - 1.70 ; P = 0.013 ) for urine equol , 1.46 ( 1.05 - 2.02 ; P = 0.024 ) for serum equol , and 1.22 ( 1.01 - 1.48 ; P = 0.044 ) for serum daidzein ] . These estimates of risk are similar to those established for estrogens and and rogens in postmenopausal breast cancer but need confirmation in larger studies Soya isoflavones , genistein and daidzein , are the focus of numerous studies investigating their potential effects on health and results remain controversial . Bioavailability is clearly a crucial factor influencing their bioefficacy and could explain these discrepancies . This study aim ed at assessing : ( 1 ) the isoflavone content of sixty-nine European soya-derivative products sold on the French market ; ( 2 ) the bioavailability of isoflavones comparing supplement with food . Twelve healthy volunteers were recruited in a r and omized two-way crossover trial and received 35 mg isoflavones equivalent aglycone either through supplements or through cheese , both containing different patterns of isoflavone conjugates and different daidzein : genistein ratios . A specific ELISA method was used to assess the plasma and urinary concentrations of isoflavones and thus the pharmacokinetic parameters , which were then normalized to mg of each isoflavone ingested . Results showed that the normalized Cmax of daidzein ( P = 0.002 ) and similarly the normalized AUC0 -- > infinity and Cmax of genistein ( P = 0.002 ) from soya-based capsules were higher than that from soya-based cheese . In conclusion , this work completes studies on isoflavone bioavailability and presents new data regarding isoflavone concentrations in soya-derivative products . Assuming that isoflavone conjugation patterns do not influence isoflavone bioavailability , this study shows that isoflavones contained in capsules are more bioavailable than those contained in soya-based cheese . Although the supplement is more bioavailable , the relative importance of this is difficult to interpret as there is little evidence that supplements are biologically active in human subjects to date and further studies will be necessary for this specific supplement to prove its efficacy Green tea has been shown to exhibit cancer-preventive activities in pre clinical studies . Its principal active components include epigallocatechin gallate ( EGCG ) , epigallocatechin ( EGC ) , epicatechin ( EC ) , and epicatechin gallate , of which EGCG is the most abundant and possesses the most potent antioxidative activity . We performed a Phase I pharmacokinetic study to determine the systemic availability of green tea catechins after single oral dose administration of EGCG and Polyphenon E ( decaffeinated green tea catechin mixture ) . Twenty healthy subjects ( five subjects/dose level ) were r and omly assigned to one of the dose levels ( 200 , 400 , 600 , and 800 mg based on EGCG content ) . All subjects were r and omly crossed-over to receive the two catechin formulations at the same dose level . Blood and urine sample s were collected for up to 24 h after oral administration of the study medication . Tea catechin concentrations in plasma and urine sample s were determined using high-performance liquid chromatography with the coulometric electrode array detection system . After EGCG versus Polyphenon E administration , the mean area under the plasma concentration-time curves ( AUC ) of unchanged EGCG were 22.5 versus 21.9 , 35.4 versus 52.2 , 101.9 versus 79.7 , and 167.1 versus 161.4 min x microg/ml at the 200- , 400- , 600- , and 800-mg dose levels , respectively . EGC and EC were not detected in plasma after EGCG administration and were present at low/undetectable levels after Polyphenon E administration . High concentrations of EGC and EC glucuronide/sulfate conjugates were found in plasma and urine sample s after Polyphenon E administration . There were no significant differences in the pharmacokinetic characteristics of EGCG between the two study medications . The AUC and maximum plasma concentration ( Cmax ) of EGCG after the 800-mg dose of EGCG were found to be significantly higher than those after the 200- and 400-mg dose . The AUC and Cmax of EGCG after the 800-mg dose of Polyphenon E were significantly higher than those after the three lower doses . We conclude that the two catechin formulations result ed in similar plasma EGCG levels . EGC and EC were present in the body after the Polyphenon E administration ; however , they were present predominantly in conjugated forms . The systemic availability of EGCG increased at higher doses , possibly due to saturable presystemic elimination of orally administered green tea polyphenols Dietary estrogens , such as lignans , are similar in structure to endogenous sex steroid hormones and may act in vivo to alter hormone metabolism and subsequent cancer risk . The objective of this study was to examine the effect of dietary intake of a lignan-rich plant food ( flaxseed ) on urinary lignan excretion in postmenopausal women . This r and omized , cross-over trial consisted of three 7-week feeding periods during which 31 healthy postmenopausal women , ages 52 - 82 years , consumed their habitual diets plus 0 , 5 , or 10 grams of ground flaxseed per day . Urine sample s collected for 2 consecutive days during the last week of each feeding period were analyzed for lignan content ( enterodiol , enterolactone , and matairesinol ) by isotope dilution gas chromatography/mass spectrometry . Compared with the 0-gram flaxseed diet , consumption of 5 or 10 grams of flaxseed significantly increased excretion of enterodiol by 1,009 and 2,867 nmol/day , respectively ; significantly increased excretion of enterolactone by 21,242 and 52,826 nmol/day , respectively ; and significantly increased excretion of total lignans ( enterodiol + enterolactone + matairesinol ) by 24,333 and 60,640 nmol/day , respectively . Excretion of matairesinol was not significantly altered by flaxseed consumption . Consumption of flax , a significant source of dietary estrogens , in addition to their habitual diets increased excretion of enterodiol and enterolactone , but not matairesinol , in a dose-dependent manner in this group of postmenopausal women . Urinary excretion of lignan metabolites is a dose-dependent biomarker of flaxseed intake within the context of a habitual diet Estimation of dietary intake of polyphenols is difficult , due to limited availability of food composition data and bias inherent to dietary assessment methods . The aim of the present study was to evaluate the associations between the intake of polyphenol-rich foods and the urinary excretion of several phenolic compounds and therefore explore whether these phenolic compounds could be used as a biomarker of intake . Fifty-three participants of the SU.VI.MAX study ( a r and omised primary -prevention trial evaluating the effect of daily antioxidant supplementation on chronic diseases ) collected a 24 h urine and a spot urine sample and filled a dietary record during a 2 d period . Thirteen polyphenols and metabolites , chlorogenic acid , caffeic acid , m-coumaric acid , gallic acid , 4-O-methylgallic acid , quercetin , isorhamnetin , kaempferol , hesperetin , naringenin , phloretin , enterolactone and enterodiol , were measured using HPLC-electrospray ionisation-MS-MS . In spot sample s apple consumption was positively correlated to phloretin , grapefruit consumption to naringenin , orange to hesperetin , citrus fruit consumption to both naringenin and hesperetin , with r coefficients ranging from 0.31 to 0.57 ( P < 0.05 ) . The combination of fruits and /or fruit juices was positively correlated to gallic acid and 4-O-methylgallic acid , isorhamnetin , kaempferol , hesperetin , naringenin and phloretin ( r 0.24 - 0
Output:
| These data confirm the value of certain urinary polyphenols as biomarkers of intake . |
MS212604 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Chronic non-A , non-B hepatitis occurs in 50 % of Saudi patients with end-stage renal failure and requires long-term hemodialysis since it is a contraindication to renal transplantation . Thirteen patients with biochemical and histological documented chronic non-A , non-B hepatitis ( 11 with HCV antibodies ) entered a double-blind placebo controlled cross-over study , in which Roferon A 3 MU or placebo were administered subcutaneously 3 times weekly after hemodialysis for 6 months . The mean ALT fell significantly from pretreatment levels of 74.7 ( 95 % confidence interval ( CI ) 54.7 , 92.5 ) ( 13 patients in the 6-month run-in period ) and 66.8 ( CI 47.7 , 85.8 ) ( 7 patients in the run-in period + 6 patients in the placebo period ) ( difference NS ) to 37.6 ( CI 21.0 , 54.2 ) during interferon treatment ( P < 0.005 ) . In 10/13 patients ( 77 % ) ALT levels became normal . In the 6-month follow-up period immediately after therapy , the mean ALT was 45.2 ( CI 28.0 , 62.0 ) . Although this change was not significant ( P = 0.49 ) , only 7 of these 10 patients sustained biochemical remission in the 6-month follow-up period . The corresponding total Histological Activity Index improved from 8.9 ( CI 7.5 , 10.3 ) , 8.9 ( CI 7.2 , 10.7 ) ( difference NS ) to 6.2 ( CI 3.9 , 8.5 ) ( P < 0.05 ; P = 0.052 , respectively ) . Intralobular inflammation and periportal inflammation showed the most significant changes . Five of 13 ( 39 % ) and 2/13 patients ( 15 % ) had complete resolution of piecemeal necrosis and intralobular inflammation , respectively . Toxic effects of interferon were mild , early and self-limiting . ( ABSTRACT TRUNCATED AT 250 WORDS R and omized clinical trials ( RCTs ) provide the most reliable therapeutic information available . Unfortunately , there are no systemic listing of RCTs . We compared a MEDLARS search of 3686 biomedical journals for RCTs with a manual search of the medical literature for the period 1966 - 1982 . For the former search we used subject headings ( 1 ) liver disease or ( 2 ) biliary tract disease and subheadings ( 1 ) drug therapy , ( 2 ) surgery , ( 3 ) radiotherapy , or ( 4 ) therapy , and check tags ( 1 ) comparative study or ( 2 ) clinical research . For the manual search , the contents of 34 arbitrarily selected , gastroenterologic , hepatologic , surgical , or general journals were perused . The MEDLARS search identified 160 RCTs and 29 others were found in the references of the 160 . One hundred fifty-four RCTs were identified by both methods . The manual search identified 208 RCTs and an additional 34 were found in the references of the 208 . The MEDLARS search identified only 107 of 208 RCTs found in the references of the 208 . The MEDLARS search identified only 107 of 208 RCTs found manually in the 36 journals , an efficiency rate of 51 % . We estimate that 330 hepatobiliary RCTs had been published during this 17-year period . Sixty percent of the RCTs found by MEDLARS used the key word " r and omized , " " double blind , " or " controlled " in the title , compared to 36 % in those found by the manual search . In order to retrieve RCTs , it is essential that editors require that RCTs be identified in their titles or key words by specific terms such as " controlled , " " r and omized , " and " double blind , " that papers be so catalogued and indexed , and that search ers be instructed in appropriate search strategies BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences Mortality rates among hemodialysis patients vary greatly across regions . Representative data bases containing extensive profiles of patient characteristics and outcomes are lacking . The Dialysis Outcomes and Practice Patterns Study ( DOPPS ) is a prospect i ve , observational study of representative sample s of hemodialysis patients in France , Germany , Italy , Japan , Spain , the United Kingdom , and the United States ( US ) that captures extensive data relating to patient characteristics , prescriptions , laboratory values , practice patterns , and outcomes . This report describes the case-mix features and mortality among 16,720 patients followed up to 5 yr . The crude 1-yr mortality rates were 6.6 % in Japan , 15.6 % in Europe , and 21.7 % in the US . After adjusting for age , gender , race , and 25 comorbid conditions , the relative risk ( RR ) of mortality was 2.84 ( P < 0.0001 ) for Europe compared with Japan ( reference group ) and was 3.78 ( P < 0.0001 ) for the US compared with Japan . The adjusted RR of mortality for the US versus Europe was 1.33 ( P < 0.0001 ) . For most comorbid diseases , prevalence was highest in the US , where the mean age ( 60.5 + /- 15.5 yr ) was also highest . Older age and comorbidities were associated with increased risk of death ( except for hypertension , which carried a multivariate RR of mortality of 0.74 [ P < 0.0001 ] ) . Variability in demographic and comorbid conditions ( as identified by dialysis facilities ) explains only part of the differences in mortality between dialysis centers , both for comparisons made across continents and within the US . Adjustments for the observed variability will allow study of association between practice patterns and outcomes BACKGROUND AND AIM Hepatitis C virus ( HCV ) is prevalent in hemodialysis ( HD ) patients . These patients experience more side-effects with antiviral treatment . The aim of the present study was to evaluate the efficacy and tolerability of pegylated interferon ( PEG-IFN ) alpha-2a in chronic hemodialysis patients with chronic hepatitis C. METHODS Twenty-five patients were included into the study . All of the patients were interferon naive , anti-HCV antibodies positive and polymerase chain reaction HCV-RNA positive . Twelve of the patients received PEG-IFN alpha-2a at a dose of 135 microg weekly for 48 weeks ( Group 1 ) . The remaining 13 patients who received no specific treatment were used as controls ( Group 2 ) . The patients were prospect ively followed up for a period of 18 months . Biochemical and virological responses were evaluated at the end of the study period ( end-of-treatment response ) and 6 months after the completion of therapy ( sustained response ) . RESULTS Virological end-of-treatment response was observed in 10 patients ( 83.4 % ) in Group 1 and one patient ( 7.7 % ) in Group 2 ( P < 0.001 ) . Sustained virological response was observed in nine patients ( 75 % ) in Group 1 and one patient ( 7.7 % ) in Group 2 ( P < 0.001 ) . Alanine aminotransferase ( ALT ) levels were initially increased in seven patients in Group 1 and normalized in five of these patients at the end of the treatment and sustained biochemical response was 71.4 % . In contrast , ALT levels in Group 2 were initially high in five patients and normalized in two of them ( 40 % ) at the end of the 48 weeks . Even if most of the patients experienced several side-effects ( anemia 75 % , fatigue 58.3 % , thrombocytopenia 33.3 % and leukopenia 33.3 % ) , they did not impose the discontinuation of the treatment . CONCLUSION The present study showed that PEG-IFN alpha-2a for 48 weeks is efficacious and well tolerated in hemodialysis patients with HCV BACKGROUND Hepatitis C virus ( HCV ) infection represents an important problem for the dialysis population due to its high prevalence and the long-term development of chronic liver disease , particularly following renal transplantation . METHODS In order to assess the efficacy and tolerance of interferon ( IFN ) in the treatment of chronic hepatitis C in haemodialysis ( HD ) patients and their clinical course following renal transplantation , a multicentre , r and omized , open-label study was conducted to compare IFN therapy vs a control group . RESULTS Nineteen HCV RNA-positive patients received 3 x 10(6 ) U of IFN s.c . , three times a week ( post-HD ) , and 17 HCV RNA-positive patients were assigned to the control group . Tolerance to IFN therapy was good in nine patients , while treatment was discontinued in the other 10 due to the occurrence of side effects . HCV RNA was negative at the end of treatment in 14 out of 19 patients ( 74 % ) receiving IFN and in one patient ( 5 % ) in the control group . Six out of the 14 patients who initially responded to IFN therapy had a virological relapse ( 43 % ) . Eight patients ( 42 % ) remained HCV RNA-negative , three of them until the day that renal transplantation ( RT ) was performed ( 7 , 12 and 27 months , respectively ) , as did five patients on HD during the follow-up ( 27+/-5 months ) . Eight out of the nine patients ( 89 % ) who completed therapy were HCV RNA-negative at the end of treatment , and seven of them ( 78 % ) remained HCV RNA-negative during the follow-up on dialysis ( 21+/-8 months ) . Mean transaminase ( ALT ) values were significantly decreased following IFN therapy , while no changes were observed during the follow-up period in the control group . Fifteen patients ( 10 in the treatment group and five in the control group ) underwent RT . Three patients in the treatment group were HCV RNA-negative at RT , and one of them had a virological relapse 20 months after RT , while the other two remained HCV RNA-negative at 3 months and 24 months after RT , respectively . In contrast to the control group , transaminase ( ALT ) remained within normal limits in all patients in the treatment group . Finally , during the post-RT follow-up , the transaminase mean values were significantly lower in treated patients vs patients in the control group ( P<0.05 ) . CONCLUSIONS It is concluded that the biochemical and virological response to IFN therapy is good in HD patients . In addition , IFN therapy appears to exert a beneficial effect on the course of liver disease following RT , regardless of the virological response . Despite the fact that IFN therapy was discontinued in 10 out of the 19 patients due to the occurrence of side effects , these disappeared following discontinuation of therapy . Therefore , IFN therapy is advisable for HCV-infected dialysis patients who are c and i date s for RT Twenty‐eight prospect i ve r and omized controlled clinical trials evaluating the use of total parenteral nutrition ( TPN ) in cancer patients were identified through a search of major indexing sources . The data were pooled across studies to increase the ability to detect therapeutic effects . The impact of publication bias and the quality of reporting each trial were used to critically assess the conclusions drawn from the pooled analysis . The authors conclude that TPN may be useful when used preoperatively in patients with gastrointestinal tract cancer . It appears to be beneficial in reducing major surgical complications ( pooled P = 0.01 ) and operative mortality ( pooled P = 0.02 ) . No statistically significant benefit from TPN could be demonstrated in survival , treatment tolerance , treatment toxicity , or tumor response in patients receiving chemotherapy or radiotherapy . An increase in the risk of developing an infection in chemotherapy patients given TPN ( pooled P > 0.0001 ) underscores the importance of demonstrating significant benefits in r and omized trials before TPN is used routinely in these patients In this prospect
Output:
| Our meta- analysis showed that the viral response was greater in patients with chronic kidney disease who received antiviral therapy than controls .
No difference in the drop-out rate between study and control patients occurred in the subgroup of dialysis patients on IFN monotherapy .
These results support IFN-based therapy for hepatitis C in patients on maintenance dialysis |
MS212605 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Return to work ( RTW ) of employees on sick leave for common mental disorders may require a multidisciplinary approach . This article aims to assess time to RTW after a psychiatric consultation providing treatment advice to the occupational physician ( OP ) for employees on sick leave for common mental disorders in the occupational health ( OH ) setting , compared to care as usual ( CAU ) . Methods Cluster r and omized clinical trial evaluating patients of 12 OPs receiving consultation by a psychiatrist , compared to CAU delivered by 12 OPs in the control group . 60 patients suffering from common mental disorders and ≥ six weeks sicklisted were included . Follow up three and six months after inclusion . Primary outcome measure was time to RTW . Intention- to-treat multilevel analysis and a survival analysis were performed to evaluate time to RTW in both groups . Results In CAU , referral was the main intervention . Both groups improved in terms of symptom severity and quality of life , but time to RTW was significantly shorter in the psychiatric consultation group . At three months follow up , 58 % of the psychiatric consultation group had full RTW versus 44 % of the control group , a significant finding ( P = 0.0093 ) . Survival analysis showed 68 days earlier RTW after intervention in the psychiatric consultation group ( P = 0.078 ) compared to CAU . Conclusion Psychiatric consultation for employees on sick leave in the OH setting improves time to RTW in patients with common mental disorders as compared to CAU . In further research , focus should be on early intervention in patients with common mental disorders on short sick leave duration . Psychiatric consultation might be particularly promising for improvement of RTW in those patients . Trial registration number IS RCT N : Background In the present study the effect of a workplace-oriented intervention for persons on long-term sick leave for clinical burnout , aim ed at facilitating return to work ( RTW ) by job-person match through patient-supervisor communication , was evaluated . We hypothesised that the intervention group would show a more successful RTW than a control group . Methods In a prospect i ve controlled study , subjects were identified by the regional social insurance office 2 - 6 months after the first day on sick leave . The intervention group ( n = 74 ) was compared to a control group who had declined participation , being matched by length of sick leave ( n = 74 ) . The RTW was followed up , using sick-listing register data , until 1.5 years after the time of intervention . Results There was a linear increase of RTW in the intervention group during the 1.5-year follow-up period , and 89 % of subjects had returned to work to some extent at the end of the follow-up period . The increase in RTW in the control group came to a halt after six months , and only 73 % had returned to work to some extent at the end of the 1.5-year follow-up . Conclusions We conclude that the present study demonstrated an improvement of long-term RTW after a workplace-oriented intervention for patients on long-term sick leave due to burnout . Trial registration Current Controlled Trials NCT01039168 Background Stress-related disorders are widespread and responsible for high societal costs e.g. sick leave payment and reduced productivity . The aim of this study was to evaluate the effect of an intervention program on return to work or labour market . Methods In a controlled interventional study design we compared 72 emotionally distressed patients , who received support during 2006 , with 89 control individuals who had also been sick listed for emotional distress . Intervention was provided by trained psychologists and social workers who were in continuous dialog with the patients , providing counselling e.g. on decisions concerning resumption of work , support to families , participation in meetings with the workplace . Basically , the controls and the intervention group share the same access to welfare benefits . The main outcome was time to return to labour market ( TTR ) . Results The baseline characteristics were similar in the two groups . There were no differences in the rate of resuming work between the two groups . About 80 % in both groups had returned to the labour market after one year . Conclusion An intervention program with psychological stress management and case management did not improve work capability compared to usual care . Work resumption as a single outcome probably is an insensitive parameter of intervention management quality , and should be supplemented by other data on different aspects of treatment BACKGROUND Sickness absence due to mental health problems ( MHPs ) is increasing in several European countries . However , little is known about return to work ( RTW ) for employees with MHPs . This prospect i ve study aim ed to identify predictors for RTW in employees sick-listed with MHPs . METHODS Employees were recruited when applying for sickness benefit due to MHPs from the Municipality of Copenhagen ( n = 644 ) . Information about age , gender , occupation , self-reported RTW expectancy , self-reported reason for absence and prior absence with MHPs was retrieved from application forms for sickness benefit . Each participant was followed-up in the National Register for Social Transfer Payments for a maximum period of 52 weeks to estimate time to RTW . Hazard ratios for RTW with 95 % confidence intervals were calculated using Cox proportional regression analyses . RESULTS Employees sick-listed with self-reported stress/burnout returned to work faster than those with self-reported depression ( HR = 0.76 ) , and other MHPs ( HR = 0.56 ) . A positive RTW expectancy of the sick-listed person ( HR = 1.27 ) and no prior absence with MHPs ( HR = 1.29 ) were associated with a shorter time to RTW . CONCLUSION Sickness absence due to self-reported stress/burnout , a positive RTW expectancy and no prior absence with MHPs predicted a shorter time to RTW among Danish employees sick listed with MHPs . Findings could help social insurance officers and other rehabilitation professionals to identify groups at high risk for prolonged absence Background In recent years an increasing number of patients have been referred to the medical sector with stress symptoms . Moreover , these conditions imply increased sickness absence . This indicates a need for treatment programmes in general medical practice . The aim of this study was to test the effect of a multidisciplinary stress treatment programme on the return to work ( RTW ) rate in persons with work-related stress and establish predictive factors for this outcome . Methods During a two-year period 63 out of 73 referrals to the Stress Clinic ( a section of a Clinic of Occupational Medicine ) completed a stress treatment programme consisted of the following:1 ) Identification of relevant stressors . 2 . Changing the coping strategies of the participants . 3 . Evaluating/changes in participant workload and tasks . 4 . Relaxation techniques . 5 . Physical exercise . 6 . Psychiatric evaluation when indicated by depression test score . On average each patient attended six one-hour sessions over the course of four months . A group of 34 employees referred to the Clinic of Occupational Medicine by their general practitioners served as a control group . Each participant had a one-hour consultation at baseline and after four months . A specialist in occupational medicine carried out all sessions . Return To Work ( RTW ) , defined as having a job and not being on sick leave at the census , was used as outcome measure four months after baseline , and after one and two years . Results The level of sick leave in the stress treatment group dropped from 52 % to 16 % during the first four months of follow-up and remained stable . In the control group , the reduction in sick leave was significantly smaller , ranging from 48 % at baseline to 27 % after four months and 24 % after one year . No statistically significant difference between the two groups was observed after one and two years . Age below 50 years and being a manager increased the odds ratio for RTW after one and two years , while gender and depression had no predictive value . Conclusions The stress treatment programme showed a significant effect on the return to work rate . The stress treatment programme seems feasible for general practitioners . Trial Registration IS RCT Background The aim of the present study was to conduct subgroup-analyses in a prospect i ve cohort of workers on long-term sickness absence to investigate whether associations between perceived work attitude , self-efficacy and perceived social support and time to RTW differ across different health conditions . Methods The study was based on a sample of 926 workers on sickness absence ( 6–12 weeks ) . The participants filled out a baseline question naire and were subsequently followed until the tenth month after listing sick . Perceived work attitude was measured with a Dutch language version of the Work Involvement Scale . Perceived social support was measured with a self-constructed st and ardized scale reflecting a person ’s perception of social support regarding RTW . Self-efficacy was measured with the st and ardised Dutch version of the General self-efficacy scale , assessing the subjects ’ expectations of their general capacities . The sample was divided into three subgroups : musculoskeletal health conditions , other physical health conditions and mental health conditions . Anova analyses and Cox proportional hazards regression analyses were used to identify differences in association between the three factors and the time to RTW between different subgroups . Results The associations between the perceived work attitude , self-efficacy and perceived social support and the time to RTW vary across different health condition subgroups , not only with regard to the strength of the association but also for the type of factor . In the multivariate model , hazard ratios ( HRs ) of 1.33 ( 95 % CI 1.01–1.75 ) in the musculoskeletal subgroup , and 1.26 ( 95 % CI 0.89–1.78 ) in the other physical subgroup were found in perceived work attitude . With regard to perceived social support HRs of 1.39 ( 95 % CI 1.12–1.99 ) respectively 1.51 ( 1.05–2.17 ) in the same subgroups were found . Only self-efficacy remained in the multivariate model in all subgroups with HRs of 1.49 ( 95 % CI 1.12–1.99 ) in the musculoskeletal subgroup , 1.53 ( 95 % CI 1.07–2.18 ) in the other physical subgroup and 1.60 ( 1.07–2.40 ) in the mental subgroup . Conclusions The results of this study show that perceived work attitude , self-efficacy and perceived social support are relevant predictors with regard to the time to RTW in all types of health conditions , but that important differences are observed in type of factor and strengths of the relationships between physical and mental health conditions The aim of this study was to compare the effectiveness of two individual-level psychotherapy interventions : ( a ) treatment as usual consisting of cognitive-behavioral therapy ( CBT ) and ( b ) work-focused CBT ( W-CBT ) that integrated work aspects early into the treatment . Both interventions were carried out by psychotherapists with employees on sick leave because of common mental disorders ( depression , anxiety , or adjustment disorder ) . In a quasi-experimental design , 12-month follow-up data of 168 employees were collected . The CBT group consisted of 79 clients , the W-CBT group of 89 . Outcome measures were duration until return to work ( RTW ) , mental health problems , and costs to the employer . We found significant effects on duration until RTW in favor of the W-CBT group : full RTW occurred 65 days earlier . Partial RTW occurred 12 days earlier . A significant decrease in mental health problems was equally present in both conditions . The average financial advantage for the employer of an employee in the W-CBT group was estimated at $ 5,275 U.S. dollars compared with the CBT group . These results show that through focusing more and earlier on work-related aspects and RTW , functional recovery in work can be substantially speeded up within a regular psychotherapeutic setting . This result was achieved without negative side effects on psychological complaints over the course of 1 year . Integrating work-related aspects into CBT is , therefore , a fruitful approach with benefits for employees and employers alike OBJECTIVE The aim of this study was to explore what characterizes patients receiving clinical interventions vs combined clinical and work-related interventions in a cohort of sick-listed subjects with musculoskeletal or mental disorders . Factors associated with return-to-work were also analysed . DESIGN A prospect i ve cohort study . METHODS A total of 699 newly sick-listed patients responded to a question naire on sociodemographics , measures of health , functioning , work ability , self-efficacy , social support , work conditions , and expectations . The 3-month follow-up question naire included patients ' self-reported measures of return-to-work , work ability and type of interventions . The most frequent International Classification of Diseases-10 diagnoses for patients ' musculoskeletal disorders were dorsopathies ( M50 - 54 ) and soft tissue disorders ( M70 - 79 ) , and for patients with mental disorders , depression ( F32 - 39 ) and stress reactions ( F43 ) . RESULTS Patients with mental disorders who received combined interventions returned to work to a higher degree than those who received only clinical intervention . The prevalence of work-related interventions was higher for those who were younger and more highly educated . For patients with musculoskeletal disorders better health , work ability and positive expectations of return-to-work were associated with return-to-work . However , combined interventions did not affect return-to-work in this group . CONCLUSION Receiving combined interventions increased the probability of return-to-work for patients with mental disorders , but not for patients with musculoskeletal disorders . Better health , positive expectations of return-to-work and better work ability were associated with return-to-work for patients with musculoskeletal disorders Objectives To describe gender differences in work modifications and changed job characteristics during return-to-work after sickness absence . Methods A 13 month prospect i ve cohort study was performed among 119 employees ( 54 women and 65 men ) who had reported sick for more than 1 month due to mental or musculoskeletal disorders . Men and women were of comparable ages and educational levels , worked in similar sectors , at corresponding functional levels , and were
Output:
| RESULTS Self efficacy perception , work motivation , a lower age and a better socioeconomic status were identified as worker-related return to work facilitators .
Among work environment facilitators , good communication practice s , supervisor support , a good assessment and modification of work load , adjustment of expectations , a good relationship between employers and employees and positive work experiences were identified .
Treatment may improve return to work using a multidisciplinary approach , reducing stress and identifying psychosocial determinants of mental problems rather than symptoms and providing a timely health care . |
MS212606 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Anemia is a major health problem worldwide . Because of health and socioeconomic problems , the prevalence of anemia is higher in developing countries . Children and pregnant women are the most vulnerable groups to anemia . The aim of the present study was to determine the magnitude of anemia among school children . Methods A cross-sectional household survey was conducted in January 2011 on 423 children , aged 6–14 years , selected through systematic r and om sampling method . Sociodemographic and anthropometric data were collected using a pre-tested question naire . Capillary blood was taken from the fingertip of each child and hemoglobin was measured using HaemoCue digital photometer . All the necessary safety measures were taken during blood collection . Anthropometric indicators were measured using WHO ’s guideline . Data analysis was made using SPSS Version 16.0 for Windows . The association between predictors and outcome variables were measured by a stepwise logistic regression model . Ethical permission was obtained ; consent of the parents/guardian was taken and confidentiality was maintained . Result A total of 404 children were studied . The mean age was 10.21(SD ± 1.89 ) years . The proportion of females was 217(53.7 % ) . The mean hemoglobin level for both sexes was 11.59(SD ± 1.97 g/dl ) . The current prevalence of anemia was 152(37.6 % ) , out of which , 73(18.1 % ) had mild while 79(19.6 % ) of them had moderate anemia . The prevalence of anemia among the age group of 6–11 years was 118(40.5 % ) while the prevalence among the group of 12–14 years old children was 34(30.1 % ) . Among the selected variables in the logistic regression analysis , low family income [ OR = 4.925 , 95 % CI(1.063,22.820 ) ] , mothers ’ education [ OR = 4.621 , 95 % CI(1.383,15.439 ) ] , intake of plant food [ OR = 3.847 , 95 % CI(2.068 , 7.157 ) ] and intake of animal food [ OR = 2.37 , 95 % CI(1.040,5.402 ) ] were significantly and independently associated with anemia . Conclusion Anemia is a moderate public health problem in the study area . Family income , educational status of parents and inadequate plant and animal food intake are the predictors of anemia . Improving the economic status of the family , women education and health education about balanced animal and plant food consumption are recommended strategies to reduce the burden of anemia Background Causes of child undernutrition are diverse and change in space and time . Investigating current determinants of undernutrition remains vital to design an effective intervention strategy . The study assessed prevalence of undernutrition and its associated factors among children living in Addis Ababa , Ethiopia . Methods A community based cross-sectional study was conducted in 459 school age children and their parents or caregivers living in Lideta sub-city , Addis Ababa , Ethiopia . Participants were selected using a multi-stage simple r and om sampling technique . Height and weight of children was measured and their parents or care givers were interviewed for factors associated with undernutrition . Results About 31 % ( n = 141 ) of the children were undernourished ( 19.6 % stunted , 15.9 % underweight ) . Being male , higher birth order ( > 2 ) , larger family size ( 6–8 ) , low meal frequency ( ≤3 times ) in a day prior to the survey and mud floor house were significantly associated with undernutrition . Similarly , the risk of underweight increased significantly with an increase in age , birth order , family size and also the absence of h and washing facilities . The odds of undernutrition was lower in children born to 20–30 years old mothers compared to those born to mothers younger than 20 years . Conclusions Undernutrition is prevalent among school age children living in Lideta sub city , Addis Ababa . Policy makers should consider school age children in their nutrition policy documents and implement screening program and intervention strategy Background The interaction between malaria and under-nutrition is not well eluci date d in Ethiopia . The objective of this study was to assess the magnitude of under-nutrition and its correlation with malaria among under-five children in south-west Ethiopia . Methods This cross-sectional study was undertaken during March – February , 2009 as part of the baseline assessment of a cluster r and omized trial around Gilgel Gibe Hydroelectric dam , south-west Ethiopia . A total of 2410 under-five children were included for anthropometric measurement and blood investigation for the diagnosis of malaria and anemia . The nutritional status of children was determined using the International Reference Population defined by the U.S National Center for Health Statistics ( NCHS ) . Blood film was used to identify malaria parasite and haemoglobin concentration was determined by Hemo Cue analyzer ( HemoCue Hb 301 , Sweden ) . Results Significant proportion ( 40.4 % ) of under-five children were stunted ( height-for-age<−2SD ) . The prevalence of under-weight was 34.2 % . One third and one tenth of the children had anemia and malaria parasite respectively . Older children were more likely to have under-nutrition . There was no association between malaria and under-nutrition . Children who had malaria parasite were 1.5 times more likely to become anaemic compare to children who had no malaria parasite , [ OR = 1.5 , ( 95 % CI : 1.1–2.0 ) ] . Conclusion In this study , there is no association between malaria and under-nutrition . Children who have malaria are more likely to be anaemic . Malaria prevention and control program should consider nutrition interventions particularly anemia Background Anemia during childhood impairs physical growth , cognitive development and school performance . Identifying the causes of anemia in specific context s can help efforts to prevent negative consequences of anemia among children . The objective of this study was to assess prevalence and identify correlates of anemia among school children in Eastern Ethiopia . Methods A cross sectional study was conducted from January 2012 to February 2012 in Kersa , Eastern Ethiopia . The study included r and omly selected primary school students . Hemoglobin concentration was measured using a Hemocue haemoglobinometer . A child was identified as anemic if the hemoglobin concentration was < 11.5 g/dl for children ( 5–11 yrs ) and < 12 g/dl for child older than 12 years age . Poisson regression model with robust variance was used to calculate prevalence ratios . Result The overall prevalence of anemia was 27.1 % ( 95 % CI : 24.98 , 29.14 ) : 13.8 % had mild , 10.8 % moderate , and 2.3 % severe anemia . Children with in the age group of 5 - 9 years ( APR , 1.083 ; 95 % CI , 1.044- 1.124 ) were at higher risk for anemia . Paternal education ( Illiterate , 1.109 ; 1.044 - 1.178 ) was positively associated with anemia . Children who had irregular legume consumption ( APR , 1.069 ; 95 % CI , 1.022 -1.118 ) were at higher risk for anemia . Conclusion About a quarter of school children suffer from anemia and their educational potential is likely to be affected especially for those with moderate and severe anemia . Child age , irregular legume consumption , and low paternal schooling were associated with anemia . Intervention programmes aim ed to reduce anemia among school children are crucial to ensure proper growth and development of children Background Child malnutrition during the first 1,000 days , commencing at conception , can have lifetime consequences . This study assesses the prevalence of anemia and undernutrition among children aged 6–23 months in midl and and lowl and agroecological zones of rural Ethiopia . Methods Cross-sectional data examining sociodemographic , anthropometry , hemoglobin levels , and meal frequency indicators were collected from 216 children aged 6–23 months and their mothers r and omly selected from eight rural kebele ( villages ) . Results Of 216 children , 53.7 % were anemic , and 39.8 % , 26.9 % , and 11.6 % were stunted , underweight , and wasted , respectively . The prevalence of anemia was higher in the lowl and agroecological zone ( 59.5 % ) than the midl and ( 47.6 % ) . Among those children who were stunted , underweight , and wasted , 63.5 % , 66.7 % , and 68.0 % were anemic , respectively . Child anemia was significantly associated with the child not achieving minimum meal frequency , sickness during the last 2 weeks before the survey , stunting and low body mass index , and with maternal hemoglobin and h and washing behavior . The prevalence of stunting was higher in the lowl and agroecological zone ( 42.3 % ) than the midl and ( 36.2 % ) . The predictors of stunting were age and sex of the child , not achieving MMF , maternal body mass index , and age . As maternal height increases , the length for age of the children increases ( P=0.003 ) . Conclusion The overall prevalence of anemia and undernutrition among children aged 6–23 months in these study areas is very high . The prevalence was higher in the lowl and agro-ecological zone . Health information strategies focusing on both maternal and children nutrition could be sensible approaches to minimize stunting and anemia Introduction . The aim of this study was to determine the prevalence of anemia and determinant factors among children aged 6–59 months living in Kilte Awulaelo Woreda , eastern zone . Method . A community based cross-sectional study was conducted during February 2013 among 6 tabias of Kilte Awulaelo Woreda , northern Ethiopia . A total of 568 children were selected by systematic r and om sampling method . Anthropometric data and blood sample were collected . Bivariate and multivariate logistic regression analyses were performed to identify factors related to anemia . Result . The mean hemoglobin level was 11.48 g/dl and about 37.3 % of children were anemic . Children who were aged 6–23 months [ AOR = 1.89 : 95 % CI ( 1.3 , 2.8 ) ] , underweight [ AOR = 2.05 : 95 % CI ( 1.3 , 3.3 ) ] , having MUAC less than 12 cm [ AOR = 3.35 : 95 % CI ( 2.1 , 5.3 ) ] , and from households with annual income below 10,000 Ethiopian birr [ AOR = 4.86 : 95 % CI ( 3.2 , 7.3 ) ] were more likely to become anemic . Conclusion . The prevalence of anemia among the children is found to be high . It was associated with annual household income , age , and nutritional status of the child . So , improving family income and increasing awareness of the mother/caregiver were important intervention Background . Globally , about 47.4 % of children under five are suffering from anemia . In Ethiopia , 60.9 % of children under two years are suffering from anemia . Anemia during infancy and young childhood period is associated with poor health and impaired cognitive development , leading to reduced academic achievement and earnings potential in their adulthood life . However , there is scarcity of information showing the magnitude of iron deficiency anemia among young children in Ethiopia . Therefore , this study aim ed at assessing prevalence and associated factors of iron deficiency anemia among children under two ( 6–23 months ) . Methods . Institution based cross-sectional study was carried out from March to May , 2014 , at Tsitsika Health Center in Wag-Himra Zone , Northeast Ethiopia . Systematic r and om sampling technique was employed . Automated hemoglobin machine was used to determine the hemoglobin level . Socioeconomic and demographic data were collected by using a pretested and structured question naire . Binary logistic regression analysis was used to identify associated factors and odds ratio with 95 % CI was computed to assess the strength of association . Results . Total of 347 children participated in this study . The overall prevalence of anemia was 66.6 % . In multivariate logistic regression analysis , male sex ( AOR = 3.1 ( 95 % CI : 1.60–5.81 ) ) , 9–11 months of age ( AOR = 9.6 ( 95 % CI : 3.61–25.47 ) ) , poor dietary diversity ( AOR = 3.2 ( 95 % CI : 1.35–7.38 ) ) , stunting ( AOR = 2.7 ( 95 % CI : 1.20–6.05 ) ) , diarrhea ( AOR = 4.9 ( 1.63–14.59 ) ) , no formal education ( AOR = 2.6 ( 95 % CI : 1.26–5.27 ) ) , early initiation of complementary food ( AOR = 11.1 ( 95 % CI : 4.08–30.31 ) ) , and lowest wealth quintile ( AOR = 3.0 ( 95 % CI : 1.01–8.88 ) ) were significantly associated with anemia . Conclusion . The overall prevalence of anemia among children who aged 6–23 months has sever public health importance in the study area . Integrated efforts need to be prioritized to improve health as well as appropriate
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| Conclusion The pooled prevalence of anemia among children was high , indicating that it had been continuing to be a public health problem . |
MS212607 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
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Input: BACKGROUND In the CALYPSO trial , carboplatin-pegylated liposomal doxorubicin ( CD ) demonstrated superior therapeutic index versus carboplatin-paclitaxel ( CP ) in patients with recurrent ovarian cancer . This paper reports the health-related quality of life ( HRQoL ) findings . MATERIAL S AND METHODS HRQoL was measured with the EORTC QoL-QC30 question naire and OV28 ovarian cancer module . Mean change scores from baseline in HRQoL subscales ( five functional scales and global health status ) in each arm and the proportion of patients improved or worsened were calculated every 3 months until 12 months . RESULTS Compliance was 90 % at baseline and 76 % , 64 % , 57 % at 3 , 6 , and 9 months , respectively . Baseline HRQoL showed already impaired global scores ( mean 62/100 ) and considerable symptom burden ( 90 % of patients reporting nonzero scores ) . Global QoL and abdominal symptom scores improved over time in both arms ; at 6 months , 36 % of patients met criteria for improved symptoms . Treatment with CD result ed in less peripheral neuropathy ( 9.8 versus 24.2 ) , fewer other chemotherapy side-effects ( 9.5 versus 16.2 ) , and less impact on body image ( 3.8 versus 10.4 ) versus CP ( all P<0.02 ) at 6 months . CONCLUSIONS These patient-reported outcomes confirm the overall lower toxicity of CD versus CP . The improved disease-related outcomes achieved with CD were not at the expense of Summary Background In the UK , chemotherapy is the st and ard treatment for inoperable , locally advanced , non-metastatic pancreatic cancer . Chemoradiotherapy is also an acceptable treatment option , for which gemcitabine , fluorouracil , or capecitabine can be used as concurrent chemotherapy agents . We aim ed to assess the activity , safety , and feasibility of both gemcitabine-based and capecitabine-based chemoradiotherapy after induction chemotherapy for patients with locally advanced pancreatic cancer . Methods In this open-label , r and omised , two-arm , phase 2 trial , patients aged 18 years or older with histologically proven , locally advanced pancreatic cancer ( with a tumour diameter of 7 cm or less ) were recruited from 28 UK centres between Dec 24 , 2009 and Oct 25 , 2011 . After 12 weeks of induction gemcitabine and capecitabine chemotherapy ( three cycles of gemcitabine [ 1000 mg/m2 on days 1 , 8 , 15 of a 28-day cycle ] and capecitabine [ 830 mg/m2 twice daily on days 1–21 of a 28-day cycle ] ) , patients with stable or responding disease , tumour diameter of 6 cm or less , and WHO performance status 0–1 were r and omly assigned to receive a further cycle of gemcitabine and capecitabine chemotherapy followed by either gemcitabine ( 300 mg/m2 once per week ) or capecitabine ( 830 mg/m2 twice daily , Monday to Friday only ) , both in combination with radiation ( 50·4 Gy in 28 fractions ) . R and omisation ( 1:1 ) was done via a central computerised system and used stratified minimisation . The primary endpoint was 9-month progression-free survival , analysed by intention to treat including only those patients with valid CT assessment s. This trial is registered with IS RCT N , number 96169987 . Findings 114 patients were registered and 74 were r and omly allocated ( 38 to the gemcitabine group and 36 to the capecitabine group ) . After 9 months , 22 of 35 assessable patients ( 62·9 % , 80 % CI 50·6–73·9 ) in the capecitabine group and 18 of 35 assessable patients ( 51·4 % , 39·4–63·4 ) in the gemcitabine group had not progressed . Median overall survival was 15·2 months ( 95 % CI 13·9–19·2 ) in the capecitabine group and 13·4 months ( 95 % CI 11·0–15·7 ) in the gemcitabine group ( adjusted hazard ratio [ HR ] 0·39 , 95 % CI 0·18–0·81 ; p=0·012 ) . 12-month overall survival was 79·2 % ( 95 % CI 61·1–89·5 ) in the capecitabine group and 64·2 ( 95 % CI 46·4–77·5 ) in the gemcitabine group . Median progression-free survival was 12·0 months ( 95 % CI 10·2–14·6 ) in the capecitabine group and 10·4 months ( 95 % CI 8·9–12·5 ) in the gemcitabine group ( adjusted HR 0·60 , 95 % CI 0·32–1·12 ; p=0·11 ) . Eight patients in the capecitabine group had an objective response at 26 weeks , as did seven in the gemcitabine group . More patients in the gemcitabine group than in the capecitabine group had grade 3–4 haematological toxic effects ( seven [ 18 % ] vs none , p=0·008 ) and non-haematological toxic effects ( ten [ 26 % ] vs four [ 12 % ] , p=0·12 ) during chemoradiation treatment ; the most frequent events were leucopenia , neutropenia , and fatigue . Two patients in the capecitabine group progressed during the fourth cycle of induction chemotherapy . Of the 34 patients in the capecitabine group who received chemoradiotherapy , 25 ( 74 % ) received the full protocol dose of radiotherapy , compared with 26 ( 68 % ) of 38 patients in the gemcitabine group . Quality -of-life scores were not significantly different between the treatment groups . Interpretation Our results suggest that a capecitabine-based regimen might be preferable to a gemcitabine-based regimen in the context of consolidation chemoradiotherapy after a course of induction chemotherapy for locally advanced pancreatic cancer . However , these findings should be interpreted with caution because the difference in the primary endpoint was non-significant and the number of patients in the trial was small . Funding Cancer Research UK PURPOSE This r and omized , multicenter , phase III noninferiority trial was design ed to test the efficacy and safety of the combination of pegylated liposomal doxorubicin ( PLD ) with carboplatin ( CD ) compared with st and ard carboplatin and paclitaxel ( CP ) in patients with platinum-sensitive relapsed/recurrent ovarian cancer ( ROC ) . PATIENTS AND METHODS Patients with histologically proven ovarian cancer with recurrence more than 6 months after first- or second-line platinum and taxane-based therapies were r and omly assigned by stratified blocks to CD ( carboplatin area under the curve [ AUC ] 5 plus PLD 30 mg/m(2 ) ) every 4 weeks or CP ( carboplatin AUC 5 plus paclitaxel 175 mg/m(2 ) ) every 3 weeks for at least 6 cycles . Primary end point was progression-free survival ( PFS ) ; secondary end points were toxicity , quality of life , and overall survival . RESULTS Overall 976 patients were recruited . With median follow-up of 22 months , PFS for the CD arm was statistically superior to the CP arm ( hazard ratio , 0.821 ; 95 % CI , 0.72 to 0.94 ; P = .005 ) ; median PFS was 11.3 versus 9.4 months , respectively . Although overall survival data are immature for final analysis , we report here a total of 334 deaths . Overall severe nonhematologic toxicity ( 36.8 % v 28.4 % ; P < .01 ) leading to early discontinuation ( 15 % v 6 % ; P < .001 ) occurred more frequently in the CP arm . More frequent grade 2 or greater alopecia ( 83.6 % v 7 % ) , hypersensitivity reactions ( 18.8 % v 5.6 % ) , and sensory neuropathy ( 26.9 % v 4.9 % ) were observed in the CP arm ; more h and -foot syndrome ( grade 2 to 3 , 12.0 % v 2.2 % ) , nausea ( 35.2 % v 24.2 % ) , and mucositis ( grade 2 - 3 , 13.9 % v 7 % ) in the CD arm . CONCLUSION To our knowledge , this trial is the largest in recurrent ovarian cancer and has demonstrated superiority in PFS and better therapeutic index of CD over st and ard CP BACKGROUND GOG 240 was a practice -changing r and omised phase 3 trial that concluded that chemotherapy plus bevacizumab for advanced cervical cancer significantly improves overall and progression-free survival , and the proportion of patients achieving an overall objective response , compared with chemotherapy alone . In this study , we aim ed to analyse patient-reported outcomes in GOG 240 . METHODS Eligible adult participants ( aged ≥18 years ) had primary stage IVB or recurrent or persistent carcinoma of the cervix with measurable disease and GOG performance status of 0 - 1 . Participants were r and omly assigned by web-based permuted block r and omisation ( block size 4 ) in a 1:1:1:1 ratio to the four treatment groups : cisplatin ( 50 mg/m(2 ) intravenously on day 1 or 2 of the treatment cycle ) and paclitaxel ( 135 mg/m(2 ) intravenously over 24 h or 175 mg/m(2 ) intravenously over 3 h on day 1 ) , with or without bevacizumab ( 15 mg/kg intravenously on day 1 or 2 ) , or paclitaxel ( 175 mg/m(2 ) over 3 h on day 1 ) and topotecan ( 0·75 mg/m(2 ) for 30 min on days 1 - 3 ) with or without bevacizumab ( 15 mg/kg intravenously on day 1 ) . Treatment assignment was concealed at r and omisation ( everyone was masked to treatment assignment , achieved by the use of a computer encrypted numbering system at the National Cancer Institute ) and became open-label when each patient was registered to the trial . Treatment cycles were repeated every 21 days until disease progression or unacceptable toxicity , whichever occurred first . The co primary endpoints of the trial were overall survival and safety ; the primary quality -of-life endpoint was the score on the Functional Assessment of Cancer Therapy-Cervix Trial Outcome Index ( FACT-Cx TOI ) . For our analysis of patient-reported outcomes , participants were assessed before treatment cycles 1 , 2 , and 5 , and at 6 and 9 months after the start of cycle 1 , with the FACT-Cx TOI , items from the FACT-GOG-Neurotoxicity subscale , and a worst pain item from the Brief Pain Inventory . All patients who completed baseline quality -of-life assessment s and at least one further follow-up assessment were evaluable for quality -of-life outcomes . This study is registered with Clinical Trials.gov , number NCT00803062 . FINDINGS Between April 6 , 2009 , and Jan 3 , 2012 , a total of 452 patients were enrolled in the trial , of whom 390 completed baseline quality -of-life assessment and at least one further assessment and were therefore evaluable for quality -of-life outcomes . In these patients , patient-reported outcome completion declined from 426 ( 94 % ) of 452 ( at baseline ) to 193 ( 63 % ) of 307 ( 9 months post-cycle 1 ) , but completion rates did not differ significantly between treatment regimens ( p=0·78 ) . The baseline FACT-Cx TOI scores did not differ significantly between patients who received bevacizumab versus those who did not ( p=0·27 ) . Compared with patients who received chemotherapy alone , patients who received chemotherapy plus bevacizumab reported FACT-Cx TOI scores that were an average of 1·2 points lower ( 98·75 % CI -4·1 to 1·7 ; p=0·30 ) . INTERPRETATION Improvements in overall survival and progression-free survival attributed to the incorporation of bevacizumab into the treatment of advanced cervical cancer were not accompanied by any significant deterioration in health-related quality of life . Patients responding to anti-angiogenesis therapy who maintain an acceptable quality of life could be suitable at progression for treatment with other novel therapies that might confer additional benefit . FUNDING National Institutes of Health The purpose of our study was to compare progression-free survival and quality of life ( QOL ) after cisplatin – gemcitabine ( CG ) or epirubicin – gemcitabine ( EG ) in chemotherapy-naive patients with unresectable non-small-cell lung cancer . Patients ( n=240 ) were r and omised to receive gemcitabine 1125 mg
Output:
| Conclusions and Relevance We failed to find a significant association between PFS and HRQoL in cancer clinical trials .
These findings raise questions regarding the assumption that interventions prolonging PFS also improve HRQoL in patients with cancer . |
MS212608 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Abstract Objective To compare the effect on prevalence of diarrhoea and mortality of household based treatment of drinking water with flocculant-disinfectant , sodium hypochlorite , and st and ard practice s in areas with turbid water source in Africa . Design Cluster r and omised controlled trial over 20 weeks . Setting Family compounds , each containing several houses , in rural western Kenya . Participants 6650 people in 605 family compounds . Intervention Water treatment : flocculant-disinfectant , sodium hypochlorite , and usual practice ( control ) . Main outcome measures Prevalence of diarrhoea and all cause mortality . Escherichia coli concentration , free residual chlorine concentration , and turbidity in household drinking water as surrogates for effectiveness of water treatment . Results In children < 2 years old , compared with those in the control compounds , the absolute difference in prevalence of diarrhoea was –25 % in the flocculant-disinfectant arm ( 95 % confidence interval –40 to –5 ) and –17 % in the sodium hypochlorite arm ( –34 to 4 ) . In all age groups compared with control , the absolute difference in prevalence was –19 % in the flocculant-disinfectant arm ( –34 to –2 ) and –26 % in the sodium hypochlorite arm ( –39 to –9 ) . There were significantly fewer deaths in the intervention compounds than in the control compounds ( relative risk of death 0.58 , P = 0.036 ) . Fourteen per cent of water sample s from control compounds had E coli concentrations < 1 CFU/100 ml compared with 82 % in flocculant-disinfectant and 78 % in sodium hypochlorite compounds . The mean turbidity of drinking water was 8 nephelometric turbidity units ( NTU ) in flocculant-disinfectant households , compared with 55 NTU in the two other compounds ( P < 0.001 ) . Conclusions In areas of turbid water , flocculant-disinfectant was associated with a significant reduction in diarrhoea among children < 2 years . This health benefit , combined with a significant reduction in turbidity , suggests that the flocculant-disinfectant is well suited to areas with highly contaminated and turbid water Reports of cluster r and omised trials require additional information to allow readers to interpret them accurately The effective reporting of r and omised controlled trials has received useful attention in recent years . Many journals now require that reports conform to the guidelines in the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement , first published in 1996 and revised in 2001 . The statement includes a checklist of items that should be included in the trial report . These items are evidence based whenever possible and are regularly review ed . The statement also recommends including a flow diagram to show the flow of participants from group assignment through to the final analysis . The CONSORT statement focused on reporting parallel group r and omised trials in which individual participants are r and omly assigned to study groups . However , in some situations it is preferable to r and omly assign groups of individuals ( such as families or medical practice s ) rather than individuals . Reasons include the threat of contamination of some interventions ( such as dietary interventions ) if individual r and omisation is used . 5 Also , in certain setting s r and omisation by group may be the only feasible method of conducting a trial . Trials with this design are variously known as field trials , community based trials , place based trials , or ( as in this paper ) cluster r and omised trials . In an earlier discussion paper we considered the implication s of the CONSORT statement for the reporting of cluster r and omised trials . Here we present up date d guidance , based on the 2001 revision of the CONSORT statement Background Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement . However , there is limited experimental evidence on the benefits of school-based malaria prevention or how health interventions interact with other efforts to improve education quality . This study aims to evaluate the impact of school-based malaria prevention and enhanced literacy instruction on the health and educational achievement of school children in Kenya . Design A factorial , cluster r and omised trial is being implemented in 101 government primary schools on the coast of Kenya . The interventions are ( i ) intermittent screening and treatment of malaria in schools by public health workers and ( ii ) training workshops and support for teachers to promote explicit and systematic literacy instruction . Schools are r and omised to one of four groups : receiving either ( i ) the malaria intervention alone ; ( ii ) the literacy intervention alone ; ( iii ) both interventions combined ; or ( iv ) control group where neither intervention is implemented . Children from classes 1 and 5 are r and omly selected and followed up for 24 months . The primary outcomes are educational achievement and anaemia , the hypothesised mediating variables through which education is affected . Secondary outcomes include malaria parasitaemia , school attendance and school performance . A nested process evaluation , using semi-structured interviews , focus group discussion and a stakeholder analysis will investigate the community acceptability , feasibility and cost-effectiveness of the interventions . Discussion Across Africa , governments are committed to improve health and education of school-aged children , but seek clear policy and technical guidance as to the optimal approach to address malaria and improved literacy . This evaluation will be one of the first to simultaneously evaluate the impact of health and education interventions in the improvement of educational achievement . Reflection is made on the practical issues encountered in conducting research in schools in Africa . Trial Registration National Institutes of Health Abstract The cluster r and omized trial ( CRT ) is used increasingly in knowledge translation research , quality improvement research , community based intervention studies , public health research , and research in developing countries . However , cluster trials raise difficult ethical issues that challenge research ers , research ethics committees , regulators , and sponsors as they seek to fulfill responsibly their respective roles . Our project will provide a systematic analysis of the ethics of cluster trials . Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation:1.Who is a research subject?2.From whom , how , and when must informed consent be obtained?3.Does clinical equipoise apply to CRTs?4.How do we determine if the benefits outweigh the risks of CRTs?5.How ought vulnerable groups be protected in CRTs?6.Who are gatekeepers and what are their responsibilities ? Subsequent papers in this series will address each of these areas , clarifying the ethical issues at stake and , where possible , arguing for a preferred solution . Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster r and omized trials A group-r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) was conducted in an area of high perennial malaria transmission in western Kenya to test the effect of ITNs on all-cause mortality in children 1 - 59 months of age . Child deaths were monitored over a two-year period by biannual household census in Asembo ( 1997 - 1998 ) and in Gem ( 1998 - 1999 ) . Overall , 1,722 deaths occurred in children 1 - 59 months followed for 35,932 child-years . Crude mortality rates/1,000 child-years were 51.9 versus 43.9 in control and ITN villages in children 1 - 59 months old . The protective efficacy ( PE ) ( 95 % confidence interval ) adjusted for age , study year , study site , and season was 16 % ( 6 - 25 % ) . Corresponding figures in 1 - 11- and 12 - 59-month-old children in control and ITN villages were 133.3 versus 102.3 , PE = 23 % ( 11 - 34 % ) and 31.1 versus 28.7 , PE = 7 % ( -6 - 19 % ) . The numbers of lives saved/1,000 child-years were 8 , 31 , and 2 for the groups 1 - 59 , 1 - 11 , and 12 - 59 months old , respectively . Stratified analysis by time to insecticide re-treatment showed that the PE of ITNs re-treated per study protocol ( every six months ) was 20 % ( 10 - 29 % ) , overall and 26 % ( 12 - 37 % ) and 14 % ( -1 - 26 % ) in 1 - 11- and 12 - 59-month-old children , respectively . ITNs prevent approximately one in four infant deaths in areas of intense perennial malaria transmission , but their efficacy is compromised if re-treatment is delayed beyond six months Background There are few reports of interventions to reduce the common but irrational use of antibiotics for acute non-bloody diarrhoea amongst hospitalised children in low-income setting s. We undertook a secondary analysis of data from an intervention comprising training of health workers , facilitation , supervision and face-to-face feedback , to assess whether it reduced inappropriate use of antibiotics in children with non-bloody diarrhoea and no co-morbidities requiring antibiotics , compared to a partial intervention comprising didactic training and written feedback only . This outcome was not a pre-specified end-point of the main trial . Methods Repeated cross-sectional survey data from a cluster-r and omised controlled trial of an intervention to improve management of common childhood illnesses in Kenya were used to describe the prevalence of inappropriate antibiotic use in a 7-day period in children aged 2 - 59 months with acute non-bloody diarrhoea . Logistic regression models with r and om effects for hospital were then used to identify patient and clinician level factors associated with inappropriate antibiotic use and to assess the effect of the intervention . Results 9 , 459 admission records of children were review ed for this outcome . Of these , 4 , 232 ( 44.7 % ) were diagnosed with diarrhoea , with 130 of these being bloody ( dysentery ) therefore requiring antibiotics . 1 , 160 children had non-bloody diarrhoea and no co-morbidities requiring antibiotics-these were the focus of the analysis . 750 ( 64.7 % ) of them received antibiotics inappropriately , 313 of these being in the intervention hospitals vs. 437 in the controls . The adjusted logistic regression model showed the baseline-adjusted odds of inappropriate antibiotic prescription to children admitted to the intervention hospitals was 0.30 times that in the control hospitals ( 95%CI 0.09 - 1.02 ) . Conclusion We found some evidence that the multi-faceted , sustained intervention described in this paper led to a reduction in the inappropriate use of antibiotics in treating children with non-bloody diarrhoea . Trial registration International St and ard R and omised Controlled Trial Number Register IS RCT A recent meta- analysis of 14 clinical trials indicated that daily compared with intermittent iron supplementation result ed in significantly greater hematological improvement in pregnant women . No such definitive beneficial effect was demonstrated in preschool children . We compared the efficacy of daily and twice weekly iron supplementation for 6 wk under supervised and unsupervised conditions in the treatment of mild and moderate anemia [ hemoglobin ( Hb ) 50 - 109 g/L ] in children aged 2 - 59 mo living in a malaria-endemic area of western Kenya . The study was a cluster-r and omized trial using a factorial design ; participants were aware of the treatment assigned . All children ( n = 1049 ) were administered a single dose of sulfadoxine-pyrimethamine at enrollment followed by 6 wk of daily supervised iron supplementation [ 3 - 6 mg/(kg.d ) ] , twice weekly supervised iron supplementation [ 6 - 12 mg/(kg.wk ) ] , daily unsupervised iron supplementation , or twice weekly unsupervised iron supplementation . In the supervised groups , Hb concentrations at 6 and 12 wk ( 6 wk postsupplementation ) were significantly higher in children given iron daily rather than twice weekly [ mean ( 95 % CI ) difference at 6-wk : 4.2 g/L ( 2.1 , 6.4 ) ; 12-wk : 4.4 g/L ( 1.8 , 7.0 ) ] . Among the unsupervised groups , Hb concentrations were not different at 6 wk [ mean ( 95 % CI ) difference : 0.86 g/L ( -1.4 , 3.1 ) ] , but significantly higher at 12 wk for those assigned daily iron [ mean ( 95 % CI ) difference : 3.4 g/L ( 0.79 , 6.0 ) , P = 0.02 ] . In this malarious area and after initial antimalarial treatment , 6 wk of daily iron supplementation results in better hematological responses than twice weekly iron supplementation in the treatment of anemia in preschool children , regardless of whether adherence can be ensured OBJECTIVE To examine changes in energy intake along with markers of dietary quality ( animal- source energy and protein intakes ) among household members in the presence of supplementary school feeding in rural Kenya . DESIGN A 2-year , longitudinal , r and omized controlled feeding intervention study . SETTING Kyeni South Division , Embu District , Kenya . SUBJECTS A total of 182 schoolchildren and selected household members . RESULTS There was no evidence that schoolchildren who received supplementary snacks at school experienced reduced intakes at home or that intakes by other family members were increased at the expense of the schoolchild 's intake . CONCLUSIONS This analysis highlights a
Output:
| The applicants challenged a government decision to offer Nevirapine in a few pilot sites when evidence showed Nevirapine significantly reduced HIV transmission rates and despite donor offers of a free supply . |
MS212609 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study evaluated differences in sitting habits in the classroom between the project " Moving school " and a traditional school in 8-year-old children . Twenty-two children , since 1.5 years involved in the project were compared to 25 children in a traditional school . Making use of the Portable Ergonomic Observation ( PEO ) method , it was observed that children from a traditional school spend an average of 97 % of the lesson time sitting statically , from which one-third with the trunk bend over 45 degrees . In the " Moving school " this posture was replaced by dynamic sitting ( 53 % ) , st and ing ( 31 % ) and walking around ( 10 % ) , while trunk flexion over 45 degrees was nearly not observed . Children from the " Moving school " also showed significantly less neck and trunk rotation . Additionally , accelerometric data showed significantly more physical activity in lessons of the " Moving school " . Rates of self-reported back or neck pain did not differ significantly between both study groups . Results show that sitting habits are more favourable in a " Moving school " . Further research is needed to study the impact of implementing " Moving school " concepts in traditional schools on sitting habits OBJECTIVE To study the relation between neck pain and work related neck flexion , neck rotation , and sitting . METHODS A prospect i ve cohort study was performed with a follow up of 3 years among 1334 workers from 34 companies . Work related physical load was assessed by analysing objective ly measured exposure data ( video recordings ) of neck flexion , neck rotation , and sitting posture . Neck pain was assessed by a question naire . Adjustments were made for various physical factors that were related or not related to work , psychosocial factors , and individual characteristics . RESULTS A significant positive relation was found between the percentage of the working time in a sitting position and neck pain , implying an increased risk of neck pain for workers who were sitting for more than 95 % of the working time ( crude relative risk ( RR ) 2.01 , 95 % confidence interval ( 95 % CI ) 1.04 to 3.88 ; adjusted RR 2.34 , 95 % CI 1.05 to 5.21 ) . A trend for a positive relation between neck flexion and neck pain was found , suggesting an increased risk of neck pain for people working with the neck at a minimum of 20 ° of flexion for more than 70 % of the working time ( crude RR 2.01 , 95 % CI 0.98 to 4.11 ; adjusted RR 1.63 , 95 % CI 0.70 to 3.82 ) . No clear relation was found between neck rotation and neck pain . CONCLUSION Sitting at work for more than 95 % of the working time seems to be a risk factor for neck pain and there is a trend for a positive relation between neck flexion and neck pain . No clear relation was found between neck rotation and neck pain & NA ; Little is known about the epidemiology of widespread pain ( WSP ) in children and adolescents . This study aims to estimate the new‐onset and prognosis of WSP in schoolchildren and investigate factors predicting its development . A prospect i ve study was conducted among 1756 schoolchildren ( age 10–12 years ) in Southern Finl and . At baseline , information was collected on WSP , regional musculoskeletal pain symptoms , depressiveness , fatigue , sleep problems , physical activity and joint hypermobility . These children were contacted again 1 year and 4 years later to determine the outcome and the new‐onset of WSP . A total of 1282 children ( 73 % ) of the baseline study population were found at both follow‐ups . Of the children who had WSP at baseline , 31 % and 30 % reported persistence/recurrence of symptoms at 1‐ and 4‐year follow‐up , respectively . However , only 10 % of these children reported WSP at both 1 and 4 years . Of the children who were free of WSP at baseline , 18 % reported new‐onset WSP at 1‐year follow‐up and 3 % reported these symptoms at both follow‐up times . The independent baseline risk factors of WSP were older age ( OR 1.3 95 % CI 1.0–1.8 ) , female gender ( OR 1.4 , 1.1–1.9 ) , depressiveness ( OR 1.5 , 1.1–2.2 ) and regional back pain symptoms ( Neck pain : OR 1.7 , 1.1–2.4 ; Upper back pain : OR 2.1 , 1.1–4.1 ; Lower back pain : OR 3.0 , 1.6–5.7 ) . Both psychological factors and somatic pain symptoms predict future development of WSP in adolescents & NA ; The aim of this longitudinal study was to assess changes with age regarding prevalence of pain and perceived health in a student population , as well as change over time at grade level . Pain included frequency of headache , abdominal , and musculoskeletal pain and perceived health included problems sleeping and /or if they often felt tired , lonely , and sad . If gender , age ( grade level ) , stress , physically activity were related to pain and health complaints were tested with multivariate logistic regression analysis . The students ( n = 1908 ) came from r and omly selected schools throughout Sweden and attended grade s 3 , 6 and 9 ( ages 9 , 12 and 15 at the onset of the year ) in 2001 . Three years later , 67 % ( n = 1276 ) of the same students answered a question naire that was constructed for the purpose of the studies . The responses given by the same students showed that girls ’ complaints of pain and perceived health increased with age and boys decreased . Over half ( 56 % ) of the girls and two‐thirds ( 67 % ) of the boys reported no frequent complaints either year . At grade level most variables were rated the same as three years earlier by the same age group . Stress was significantly related to pain and health complaints for girls and the risk of complaints , as calculated with odds ratio , was most evident for students who were characterized as being physically inactive in 2001 and remained inactive three years later . Jointly , significant predictors , such as stress , being physically inactive , gender and grade level , explained 8–20 % of the frequent complaints Study Design . This is a 3-year prospect i ve study of juvenile low back pain ( LBP ) . Objectives . To investigate persistence and change in LBP . Summary of Background Data . Earlier episodes of LBP are a strong risk factor for LBP in adults , while the persistence of LBP through adolescence is not known . Methods . The material comprised all pupils in eighth and ninth grade s ( N = 105 , mean age 14.7 years ) , living within two geographic areas in Eastern Norway in January 1997 . The analyses included 88 adolescents at baseline , and 85 at follow-up . The question naire , which identified LBP as pain or ache in the low back during the preceding year , was answered at baseline in the classroom and at follow-up by post . Results . LBP was reported by 58 % at baseline and by 39 % at follow-up , and LBP provoked by manual work by 40 % at baseline and 26 % at follow-up . Thirty-one percent reported LBP at both occasions . LBP more than 7 days was reported by 32 % at baseline , by 26 % at follow-up , and by 18 % at both occasions . Twenty-two percent of those reporting LBP at baseline rejected ever LBP at follow-up . Baseline reports of LBP predicted corresponding reports of LBP at follow-up : Odds ratio was 4.7 ( 95 % confidence interval 1.7–12.7 ) for LBP generally , 9.1 ( 3.0–27.2 ) for LBP more than 7 days , 9.2 ( 2.9–28.8 ) for LBP provoked by manual work , and 3.8 ( 1.3–11.3 ) for LBP provoked by sitting at school . Conclusion . The findings indicate a persistent , but changeable , trend in LBP from midadolescence until late adolescence . The consistency and the high rates of reports of LBP provoked by manual work and sitting imply needs for more research on the persistence of LBP , and on relevant interventions during school age BACKGROUND School workstations are often inappropriate in not offering an optimal sitting posture . The aim of this study was to investigate the effects of individually adjustable saddle-type chairs with wheels and desks with comfort curve and arm support on schoolchildren 's working postures compared to conventional workstations . METHODS Ninety-seven participants aged 12 - 16 years were followed for 1 year , 47 at an intervention school and 50 at a control school . Anthropometrics and workstation dimensions were measured and working postures analyzed for a part of each group ( n = 21 , both groups ) by means of video recording at baseline , before new workstations were introduced , and during follow-up . RESULTS There was a significant increase in upright back ( p= .012 ) and neck ( p= .019 ) postures in the intervention group compared to controls during follow-up . The saddle-type chairs allowed significantly greater trunk-thigh angles ( p < .001 ) among participants than conventional chairs . CONCLUSIONS In schoolchildren , using individually adjustable saddle-type chairs and desks with comfort curve , a better match between workstations and anthropometric dimensions and improved working postures are obtained than using conventional workstations Study Design . A longitudinal study . Objectives . To estimate the prevalence and incidence of neck and shoulder pain in young adults and to identify the associated and predictive factors of neck and shoulder pain based on 7-year follow-up . Summary of Background Data . Several work-related , psychosocial , and sociodemographic factors have been verified as being related to neck and shoulder pain in adult population s , but far fewer longitudinal studies concerning the topic have been carried out in young population s. Methods . A r and om sample of 826 high school students was investigated when they were 15 to 18 years old and again at 22 to 25 years of age . Altogether , 394 ( 48 % ) patients participated in both surveys . The outcome variable was weekly neck and shoulder pain during the past 6 months in adulthood , and the explanatory variables included some sociodemographic factors , leisure time activities , self-assessed physical condition , psychosomatic stress symptoms , and symptoms of fatigue and sleep difficulties . Results . In 7 years , the prevalence of weekly neck and shoulder pain increased from 17 % to 28 % . Among those who were asymptomatic at baseline , 6-month incidence of occasional or weekly neck and shoulder pain was 59 % 7 years later . In an adjusted model , psychosomatic symptoms remained an associated factor for prevalent neck and shoulder pain 7 years later for both females and males . In females , neck and shoulder pain in adolescence was associated with prevalent neck and shoulder pain in adulthood , and sports loading dynamically in the upper extremities was an associated factor for a low prevalence of neck and shoulder pain 7 years later . In separate analyses of incident neck and shoulder pain , psychosomatic stress symptoms predicted neck and shoulder pain in adulthood . Conclusions . In young adults , the incidence of neck and shoulder pain is high , and the associated factors ofneck and shoulder pain are already multifactorial in a young population Prolonged sitting and psychosocial factors have been associated with musculoskeletal symptoms among adolescents . However , the impact of prolonged static sitting on musculoskeletal pain among South African high school students is uncertain . A prospect i ve observational study was performed to determine whether sitting postural alignment and psychosocial factors contribute to the development of upper quadrant musculoskeletal pain ( UQMP ) in grade ten high school students working on desktop computers . The sitting postural alignment , depression , anxiety and computer use of 104 asymptomatic students were measured at baseline . At three and six months post baseline , the prevalence of UQMP was determined . Twenty-seven students developed UQMP due to seated or computer-related activities . An extreme cervical angle ( < 34.75 degrees or > 43.95 degrees ; OR 2.8 ; 95 % CI : 1.1 - 7.3 ) and a combination of extreme cervical and thoracic angles ( < 63.1 degrees or > 71.1 degrees ; OR 2.2 ; 95 % CI : 1.1 - 5.6 ) were significant postural risk factors for the development of UQMP . Boys with any extreme angle were more likely to suffer pain compared with boys with all middle range angles ( OR 4.9 ; 95 % CI : 1.0 - 24.5 ) . No similar effect was found for girls . There was no strong relationship between depression , anxiety , computer exposure and UQMP among South African high school students
Output:
| CONCLUSION There is unequivocal evidence that sitting and UQMP are related in children and adolescents . |
MS212610 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Between August 1986 and December 1987 , 88 patients received either RATG or OKT3 for immunoprophylaxis before heart transplantation . By the end of the first month after transplantation , 25 % of the patients who received RATG had experienced a rejection episode compared with 43 % of those receiving OKT3 . This difference was persistent as many as 4 months after transplantation . While 50 % of the OKT3 patients had a second episode of rejection , only 35 % of the RATG patients did so . R and omization of these agents was complicated by severe cardiopulmonary side effects attributed to the first dose of OKT3 . Five hours after the first dose of OKT3 , a 25 % drop in mean arterial pressure , accompanied by significant hypoxia , was seen in a majority of patients . There was no difference in the incidence of infection between the two groups We compared an equine antithymocyte globulin (ATGAM)-based protocol with a Minnesota antilymphocyte globulin (MALG)-based protocol and a murine monoclonal CD-3 (OKT-)-based protocol in 3 groups of heart transplant ( HT ) recipients . Thirty-four recipients received a four-day course of ATGAM . Thirty HT recipients received a 14-day course of OKT3 . Fifteen HT recipients received MALG for an average of 10 days . The ATGAM group received cyclosporine beginning preoperatively , while the OKT3 and MALG groups received CyA beginning on post-transplant day 4 . All three groups received identical azathioprine and similar steroid therapy . The 3 groups were similar in age , donor/recipient HLA mismatches , and donor/recipient gender mismatches . The MALG and OKT3 groups had 20 % and 17 % females , respectively , while the ATG group had 41 % ( p < 0.05 ) . Average follow-up exceeded 14 months for each group . The ATGAM group received a higher dose of CyA during " induction " therapy than the OKT3 and MALG groups , and experienced a greater rise in post-transplant serum creatinine levels . We found no difference between the 3 groups in : preoperative creatinine levels , one-year post-transplant creatinine levels , number of patients who could be successfully " weaned " from steroids , or one-year survival . Other data are tabulated as episodes/patient : [ table : see text ] We conclude that ATG plus preoperative CyA is superior for rejection prophylaxis following heart transplantation when compared with either MALG plus postoperative CyA or OKT3 plus postoperative OKT3 is often used routinely for induction immunotherapy or selectively to avoid acute cyclosporine nephrotoxicity in heart transplant recipients at high risk for immediate postoperative kidney failure . It has not been shown in a r and omized trial to be useful in patients at low risk for early kidney failure . We r and omized 30 patients with a serum creatinine level of less than 1.4 mg/dl before heart transplantation to be treated with triple-drug immunotherapy with cyclosporine , which was started before surgery , ( group 1 ) or to be treated with OKT3 for 4 to 6 days after surgery with oral cyclosporine , which was started between days 2 and 4 , after renal function had stabilized ( group 2 ) . Follow-up for 6 months revealed no significant differences in the total number of rejection episodes , total number of infections , or in the serum creatinine level . Four patients in group 1 and five patients in group 2 have had no rejection . OKT3 showed a trend to delay time to first rejection ( p = 0.10 ) , as has been reported for the 14-day induction course of OKT3 . A short course of OKT3 induction in heart transplant recipients at low risk for immediate postoperative kidney failure prolongs the time to first rejection for most patients but does not appear to reduce the total incidence of rejection in the first 6 months after heart transplantation The aim of this study was to compare the efficacy and toxicity of prophylactic OKT3 and equine antithymo-cyte globulin when each drug was administered for a similar duration after heart transplantation . Forty-one patients ( 35 males , 6 females ; mean age 46±2 years ) were r and omized to receive either OKT3 for 10 days ( 20 patients ) commencing within 24–48 hr of transplantation or ATGAM for 8 days ( 21 patients ) commencing on the day of transplantation . All patients were maintained on triple-agent immunosuppression with prednisolone , azathioprine , and cyclosporine . The two groups were well matched with respect to age , sex distribution , pretransplant cardiac diagnosis , and donor heart ischemic time . Mean duration of follow-up was 14 months ( range 9–19 months ) : Actuarial survival at 12 months was 83±9 in the OKT3 group and 81±9 in the ATG group ( P = NS ) . Mean time to first cardiac rejection was 33±8 days in the OKT3 group compared with 27± 5 days in the ATG group ( P = NS ) . Linearized rejection rate did not differ between the two groups at any time point up to 12 months posttransplant . Viral infections were significantly more common in the OKT3 group : 1.6±0.3 vs. 0.8±0.2 infections per patient ( P<0.05 ) . Adverse reactions were more common in patients who received OKT3 prophylaxis and included three patients who developed acute respiratory distress , two of whom required assisted ventilation . In conclusion , prophylactic OKT3 and ATGAM result in comparable rejection rates and survival when administered for a similar duration after cardiac transplantation . OKT3 , however , is associated with increased morbidity due to a higher incidence of adverse reactions and of viral infections Thirty-nine heart transplant recipients were r and omized prospect ively to receive OKT3 or antilymphoblast globulin ( ALG ) for 7 days , having otherwise identical protocol s ( group 1 : OKT3 , n = 20 patients ; group 2 : ALG , n = 19 patients ) . No preoperative immunosuppression was given . The protocol consisted of methylprednisolone , 500 mg intraoperatively , followed by 1 mg/kg/day , intravenously or orally , tapering to 0.2 mg/kg/day at 1 month ; oral cyclosporine starting 3 to 5 days after transplantation ; selective use of azathioprine , 1 to 4 mg/kg/day ; and either OKT3 , 5 mg/day for 7 days , or ALG , 15 mg/kg/day for 7 days . Of the 39 patients in the study , 34 are alive 6 months to 2 years after transplantation . The actuarial survival at 2 years for the OKT3 and ALG groups was 92 % ( + /- 0.07 % ) and 83 % ( + /- 0.09 % ) , respectively ( not significant [ NS ] ) . The time to first rejection for group 1 was 5.6 weeks and for group 2 was 5.3 weeks ( NS ) . The mean number of rejections for group 1 and group 2 was 2.1 episodes per patient and 1.4 per patient , respectively ( NS ) . Three patients in each group were free of rejection at 6 months . The total number of infections at 6 months was 1.05 per patient in group 1 , 0.74 per patient in group 2 ( NS ) , with 35 % of patients receiving OKT3 and 52 % of patients receiving ALG actuarially free of infection by 6 months after surgery ( NS ) . During the first 24 hours after surgery , no significant differences were noted in mean blood pressure , central venous pressure , or Po2 between the groups . ( ABSTRACT TRUNCATED AT 250 WORDS To compare monoclonal anti-T3-receptor antibody ( OKT3 ) and horse antithymocyte globulin ( HATG ) immunoprophylaxis , 23 heart transplant recipients were r and omized to OKT3 ( N = 12 ) 5 mg IV x 14 days of HATG ( N = 11 ) 5 mg/kg IV x 10 days and followed up for 216 + /- 137 days receiving triple immunosuppression . Recipient groups were demographically and clinical ly similar . First rejection occurred later in OKT3 recipients vs HATG recipients ( 31.7 + /- 18.3 vs 15.1 + /- 2.3 days ; p less than 0.01 ) , but the first rejection necessitating intensified immunosuppression occurred at similar times ( 30.9 + /- 14.6 vs 21.9 + /- 10.2 days ; NS ) . Phenotypic characterization of peripheral blood lymphocytes by flow cytometry revealed that OKT3 and HATG recipients had similar decreases in total T lymphocytes and lymphocyte sub population s. During the follow-up period rejection rates in the OKT3- and in the HATG-treated patients were 3.4 + /- 2.7 and 5.9 + /- 4.7 , respectively ( NS ) . The number of rejection episodes per recipient treated with intensified immunosuppression was 1.4 + /- 1.2 in the OKT3- and 2.0 + /- 3.1 in the HATG-treated patients ( NS ) . Infection rates were 4.9 + /- 5.2 in the OKT3- and 2.7 + /- 1.7 in the HATG-treated patients ( NS ) . The number of infection episodes that necessitated intravenous antimicrobial therapy was 2.7 + /- 2.3 in the OKT3- and 1.6 + /- 1.3 in the HATG-treated recipients ( NS ) . The number and length of hospitalizations were similar in patients given OKT3-based or HATG-based immunoprophylaxis . We conclude that immunosuppressive prophylaxis with OKT3 vs HATG in heart transplant recipients is associated with a slightly lower incidence and severity of rejection and slightly higher infection rates The value of immunoprophylaxis with monoclonal anti-CD3 antibodies ( OKT3 ) was evaluated in 44 consecutive , nonr and omized heart transplant patients . The control group ( n = 22 ) was treated with polyclonal rabbit antithymocyte globulin ( RATG ) for 5 days . The study group ( n = 22 ) was treated with OKT3 for 14 days . All patients had identical perioperative immunosuppressive therapy and similar maintenance therapy , with cyclosporine , azathioprine , and low-dose prednisone ( starting prednisone : OKT3 group immediately , RATG group 3 weeks [ n = 11 ] or greater than 3 months [ n = 11 ] after transplantation ) . The mean histologic rejection grade ( Texas classification ) in the RATG and the OKT3 groups was 2.5 + /- 1.9 and 0.6 + /- 0.8 ( p less than 0.005 ) after 1 week and 4.3 + /- 1.6 and 2.0 + /- 1.5 ( p less than 0.001 ) after 2 weeks , but there was no difference in the first year . The linearized rejection rate ( rejections per 100 patient days ) was higher in the RATG group in the first 2 weeks ( 2.6 vs 0 , p less than 0.05 respectively , 7.8 vs 0.7 , p less than 0.001 ) and higher in the OKT3 group in the second month ( 1.4 vs 2.8 , p less than 0.01 ) . In the RATG group the rejection rate fell continuously , to 0.1 at the end of the first year , whereas in the OKT3 group it remained 0.4 ( NS ) . The cumulative first-year incidence was similar for persistent rejections ( RATG 0.38 + /- 0.29 vs OKT3 0.48 + /- 1.13 , NS ) and insignificantly higher for severe rejections in the OKT3 group ( RATG 0.21 + /- 0.32 vs OKT3 0.49 + /- 1.10 ) . Rejection-related mortality in the first year was 0 % ( RATG ) and 9 % ( OKT3 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Recent studies comparing the effects of induction therapy with polyclonal antilymphocyte globulins ( ALG ) or with monoclonal T-cell-specific antibodies are not unanimous . Therefore , 55 heart recipients were allocated to either 7-day courses of polyclonal ALG ( n = 28 ) or of monoclonal OKT3 ( n = 27 ) . Additionally , azathioprine and low dose steroids were given . There were no severe side effects after OKT3 ; the course of ALG , however , had to be discontinued in 20 patients because of extensive flares . No differences between the two groups were found in freedom from rejection or in the incidence of infection . The 1- and 2-year survival was 96 % in both groups . Although monoclonal and polyclonal induction therapies are equally effective for rejection prophylaxis , OKT3 may be preferred because of a lack of important side effects . However , the fact that a shorter course of ALG is equally effective may be in favour of ALG A r and omized trial of RATG ( polyclonal ) vs. OKT3 ( monoclonal ) antibody prophylaxis was carried out in 82 cardiac transplant recipients
Output:
| A greater number of drug related side-effects was observed , however , in the monoclonal group , including episodes of acute pulmonary edema and hypotension .
The increased rate of side-effects with monoclonal antibodies might suggest a superiority of polyclonal over monoclonal antibodies |
MS212611 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A prospect i ve study on 16 patients with advanced ( stage III and IV ) prostate cancer was carried out . TNM stage , general clinical status , serum PSA level , the histological type and Gleason ’s grade of the tumor were registered . Total and rogen blockade or single-drug therapy ( flutamide ) was performed . On average , 4.81 months after the start of therapy rebiopsy , serum PSA determination and general clinical examination were performed . Histologic examination before and after treatment of HE-stained slides , as well as apop-tag reaction to show apoptotic cells , p53 , bcl2 , and Ki-67 immunostaining . Clinical improvement manifested by regression or lack of progression was observed in 10 patients . Increase of the apoptotic index and decrease of the mitotic index was detected in these cases . Serum PSA level decreased in all patients except in 3 fatal cases . The 6 clinical ly nonresponders who died after the second biopsy did not show an increased apoptotic or decreased mitotic index . Ki-67 positivity correlated well with the mitotic activity . Mutant p53 expression was higher in patients in whom anti and rogen therapy was ineffective . The bcl2 expression was a characteristic of the tumors of patients who later died . These results show that the degree of induction of apoptosis in prostate carcinoma by hormonal therapy varies from case to case . A given prostate cancer patient ’s response to therapy may be predicted by following apoptotic and mitotic activity , as well as Ki-67 and p53 expression in repeated biopsies Prostate cancer is a leading cause of cancer-related death in males and is second only to lung cancer . Although effective surgical and radiation treatments exist for clinical ly localized prostate cancer , metastatic prostate cancer remains essentially incurable . Here we show , through gene expression profiling , that the polycomb group protein enhancer of zeste homolog 2 ( EZH2 ) is overexpressed in hormone-refractory , metastatic prostate cancer . Small interfering RNA ( siRNA ) duplexes targeted against EZH2 reduce the amounts of EZH2 protein present in prostate cells and also inhibit cell proliferation in vitro . Ectopic expression of EZH2 in prostate cells induces transcriptional repression of a specific cohort of genes . Gene silencing mediated by EZH2 requires the SET domain and is attenuated by inhibiting histone deacetylase activity . Amounts of both EZH2 messenger RNA and EZH2 protein are increased in metastatic prostate cancer ; in addition , clinical ly localized prostate cancers that express higher concentrations of EZH2 show a poorer prognosis . Thus , dysregulated expression of EZH2 may be involved in the progression of prostate cancer , as well as being a marker that distinguishes indolent prostate cancer from those at risk of lethal progression BACKGROUND Expression of intrinsic markers of tumour hypoxia and angiogenesis are important predictors of radiotherapeutic , and possibly surgical , outcome in several cancers . Extent of tumour hypoxia in localised prostate cancer is comparable to that in other cancers , but few data exist on the association of extent of tumour hypoxia with treatment outcome . We aim ed to study the predictive value of intrinsic markers of tumour hypoxia and angiogenesis in localised prostate cancer , both in patients treated with radiotherapy and in those treated surgically . METHODS We applied a new , needle biopsy tissue microarray ( TMA ) technique to study diagnostic sample s from men with localised , previously untreated prostate cancer treated in two r and omised controlled trials of radiotherapy-dose escalation . Multivariate analysis by Cox proportional hazards was done to assess the association between clinical outcome , in terms of biochemical control , and immunohistochemical staining of hypoxia inducible factor-1 alpha ( HIF-1 alpha ) , vascular endothelial growth factor ( VEGF ) , and osteopontin expression . The analysis was repeated on an independent series of men with localised , previously untreated prostate cancer treated by radical prostatectomy . The main outcome was time to biochemical ( ie , prostate-specific antigen [ PSA ] ) failure . FINDINGS Between Oct 12 , 1995 , and Feb 5 , 2002 , 308 patients were identified from two prospect i ve , r and omised trials at the Royal Marsden Hospital , London and Sutton , UK , for the radiotherapy cohort and diagnostic biopsies were available for 201 of these patients . Between June 6 , 1995 , and Nov 4 , 2005 , 329 patients were identified from the Aarhus University Hospital , Skejby , Denmark , for the prostatectomy cohort ; of these , 40 patients were excluded because the tumour was too small to sample ( 19 patients ) , because the paraffin block was too thin ( 19 patients ) , or because the blocks were missing ( two patients ) , leaving 289 patients for analysis . For patients treated with radiotherapy , increased staining for VEGF ( p=0.008 ) and HIF-1 alpha ( p=0.02 ) expression , but not increased osteopontin expression ( p=0.978 ) , were significant predictors of a shorter time to biochemical failure on multivariate analysis , independent of clinical tumour stage , Gleason score , serum PSA concentration , and dose of radiotherapy . For patients treated with surgery , increased staining for VEGF ( p<0.0001 ) and HIF-1 alpha ( p<0.0001 ) expression , and increased osteopontin expression ( p=0.0005 ) were each significantly associated with a shorter time to biochemical failure on multivariate analysis , independent of pathological tumour stage , Gleason score , serum PSA concentration , and margin status . INTERPRETATION To our knowledge , this is the largest study of intrinsic markers of hypoxia and angiogenesis in relation to the outcome of radical treatment of localised prostate cancer . Increased expression of VEGF , HIF-1 alpha , and , for patients treated with surgery , osteopontin , identifies patients at high risk of biochemical failure who would be suitable for enrolment into trials of treatment intensification Accurate prognostic parameters in prostate biopsies are needed to better counsel individual patients with prostate cancer . We evaluated the prognostic impact of morphologic and immunohistochemical parameters in preoperative prostate cancer biopsies . A consecutive series of prostate biopsies of 279 men ( 72 % with clinical stage T1c and 23 % with T2 ) who subsequently underwent radical prostatectomy was prospect ively analysed for Gleason score , number and percentage of positive cores ( NPC , PPC ) , total percentage of biopsy tissue with tumour ( TPT ) , maximum tumour percentage per core ( MTP ) , and expression of Ki67 , Bcl‐2 and p53 . All biopsy features were significantly associated with at least one feature of the radical prostatectomy specimen . pT stage was independently predicted by PSA , seminal vesicle invasion by Ki67 LI , positive margins by PSA and MTP , large tumour diameter by PSA and PPC , and Gleason score by biopsy Gleason score , MTP , and Ki67 LI , respectively . Biopsy Gleason score , NPC ( 1 vs. > 1 ) , TPT ( < 7 vs. ≥7 % ) , and Ki67 LI ( < 10 vs. ≥10 % ) were significant predictors of biochemical recurrence after radical prostatectomy ( p < 0.01 , each ) . KI67 LI was the only independent prognostic factor in case of a low TPT ( < 7 % ) or low Gleason score ( < 7 ) , the hazard ratio being 6.76 and 6.44 , respectively . In summary , preoperative Gleason score , NPC , TPT and Ki67 LI significantly predict the risk of recurrence after radical prostatectomy , and Ki67 is an independent prognosticator in biopsies with low‐volume or low‐ grade prostate cancer . Analysis of Ki67 LI in these biopsies may help to better identify patients with clinical ly insignificant prostate cancer . © 2008 Wiley‐Liss , Purpose : We previously reported that protein kinase A type I ( PKARIα ) overexpression was predictive of outcome in prostate cancer patients treated with radiotherapy ( RT ) ± short-term and rogen deprivation ( STAD ) on Radiation Therapy Oncology Group ( RTOG ) protocol 86 - 10 . Here , we attempt to verify our prior findings and test the hypothesis that the relationship of the length of AD to patient outcome is affected by PKARIα overexpression . Experimental Design : There were 313 cases in the RTOG 92 - 02 study cohort with available tissue and suitable staining by immunohistochemistry . Median follow-up was 10.1 years . The intensity of PKARIα staining intensity was quantified manually and by image analysis . Multivariate analyses were done for overall mortality using Cox proportional hazards models and for local failure , biochemical failure , distant metastasis , and cause-specific mortality using Fine and Gray 's regression models . Results : The expression levels of PKARIα , determined by manual and image analysis , were strongly correlated ( P < 0.0001 ) . In the multivariate analyses , manual-quantified and image analysis –quantified PKARIα staining intensities were independent predictors of distant metastasis ( P < 0.01 ) , local failure ( P < 0.05 ) , and biochemical failure ( P ≤ 0.01 ) . Furthermore , the benefit of long-term AD over STAD was much less when PKARIα expression was high . Conclusions : PKARIα overexpression has been shown in two RTOG trials to be associated with an increased risk of failure after AD + RT . In this series of contemporary high-risk patients , PKARIα overexpression was associated with diminished response to LTAD + RT relative to STAD + RT , suggesting that such patients would be ideal for a PKARIα knockdown strategy . ( Clin Cancer Res 2009;15(17):5478–84 PURPOSE Conventional pathological variables in prostate cancer may not provide optimal prediction of patient outcome . Pathological findings and p53 immunostaining were measured prospect ively in radical prostatectomy specimens to determine the incremental improvement in prediction of patient outcome over clinical findings . MATERIAL S AND METHODS From a previous prospect i ve study of 392 consecutive patients with prostate cancer who did not receive preoperative therapy and were treated with radical prostatectomy 25 had pathological stage pT3aN0M0 , 24 had pT3bN0M0 , 2 had pT2bN1M0 , 7 had pT3aN1M0 and 14 had pT3bN1 prostate cancer . These locally advanced stage cases comprise the current study population and further analysis was done with p53 immunostaining . All prostate specimens were totally embedded , serially sectioned and whole mounted . We examined pathological , clinical and laboratory findings as well as p53 immunostaining . RESULTS Median followup was 5.4 years ( range 0.5 to 6.4 ) . Univariate analysis revealed that pathological stage , 10 % or greater immunostaining for p53 , area and length of extraprostatic cancer extension , and cancer volume ( all p < /=0.03 ) were associated with biochemical ( prostate specific antigen ) or clinical failure . When all variables were considered in stepwise multivariate analysis none attained statistical significance after p53 status entered the model ( p < 0.01 , risk ratio 2.9 for 10 % or greater versus less than 10 % , 95 % confidence interval 1.4 - 6.2 ) . The concordance index analysis for the predictive ability of prostate specific antigen , stage , grade and ploidy ( c = 0.66 ) was inferior to the predictive ability of a statistical model also including p53 status ( c = 0.71 ) . CONCLUSIONS In cases of locally advanced stage cancer p53 immunoreactivity after radical prostatectomy improves outcome prediction . Addition of this variable to those routinely determined may identify a subset of patients who would benefit from more intensive postoperative surveillance and adjuvant therapy OBJECTIVES Locally advanced prostate cancer is frequently treated with radiotherapy and and rogen deprivation because of the greater rate of extracapsular disease and the concern that radical prostatectomy ( RP ) may not be curative in most cases . A case for surgery for locally advanced disease may be made on the basis of a lower rate of local recurrence compared with radiotherapy in our comparative data base , data suggesting a survival advantage with pelvic lymph node dissection in those with positive nodes , and the observation of improved survival in those with metastatic disease treated by RP compared with radiotherapy . We report on the feasibility of RP as a primary treatment modality for locally advanced disease . METHODS A total of 281 consecutive patients treated by RP between January 1998 and June 2004 were review ed . Locally advanced disease was defined as clinical Stage T2b or worse , prostate-specific antigen level greater than 15 ng/mL , and /or a Gleason score of 8 or greater . Data on the pathologic characteristics , operative complications , and follow-up were obtained from a prospect ively maintained institutional review board-approved data base . RESULTS Pathologic examination demonstrated organ-confined disease in 11.7 % , extracapsular extension in 56.9 % , seminal vesicle involvement in 23.1 % , and positive lymph nodes in 8.9 % . The overall complication rate was 9.7 % compared with 6.9 % for all patients undergoing RP . At a mean follow-up of 34 months ( range 1 to 78 ) , 198 ( 70.4 % ) of 281 patients had an undetectable prostate
Output:
| p16 showed potential for treatment stratification between surgery and radiotherapy but needs further validation in independent studies .
Conclusions Despite years of research , very few tissue biomarkers retain predictive value in independent validation across therapy context .
Currently , none have conclusive ability to help treatment selection . |
MS212612 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain Acetaminophen , ibuprofen , and aspirin are the most commonly used drugs in the United States . Although the frequency of their use has been associated with hypertension , prospect i ve data examining the dose of these drugs and risk of hypertension are lacking . Furthermore , whether certain indications for analgesic use , particularly headache , mediate the association is unclear . We conducted 2 prospect i ve cohort studies among older women 51 to 77 years of age ( n=1903 ) from the Nurses ’ Health Study I and younger women 34 to 53 years of age ( n=3220 ) from the Nurses ’ Health Study II who completed detailed supplemental question naires pertaining to their analgesic use and who did not have hypertension at baseline . We analyzed incident hypertension according to categories of average daily dose of acetaminophen , nonsteroidal anti-inflammatory drugs , and aspirin . Information on indications for analgesic use as well as relevant confounders was also gathered prospect ively . Compared with women who did not use acetaminophen , the multivariable adjusted relative risk for those who took > 500 mg per day was 1.93 ( 1.30 to 2.88 ) among older women and 1.99 ( 1.39 to 2.85 ) among younger women . For nonsteroidal anti-inflammatory drugs , similar comparisons yielded multivariable relative risks of 1.78 ( 1.21 to 2.61 ) among older women and 1.60 ( 1.10 to 2.32 ) among younger women . These associations remained significant among women who did not report headache . Aspirin dose was not significantly associated with hypertension . Higher daily doses of acetaminophen and nonsteroidal anti-inflammatory drugs independently increase the risk of hypertension in women . Because acetaminophen and nonsteroidal anti-inflammatory drugs are commonly used , they may contribute to the high prevalence of hypertension in the United States Background — Although r and omized trials of cyclooxygenase-2 ( COX-2 ) inhibitors have shown increased cardiovascular risk , studies of nonselective , nonsteroidal antiinflammatory drugs ( NSAIDs ) and acetaminophen have been inconsistent . Methods and Results — We examined the influence of NSAIDs and acetaminophen on the risk of major cardiovascular events ( nonfatal myocardial infa rct ion , fatal coronary heart disease , nonfatal and fatal stroke ) in a prospect i ve cohort of 70 971 women , aged 44 to 69 years at baseline , free of known cardiovascular disease or cancer , who provided medication data biennially since 1990 . During 12 years of follow-up , we confirmed 2041 major cardiovascular events . Women who reported occasional ( 1 to 21 d/mo ) use of NSAIDs or acetaminophen did not experience a significant increase in the risk of cardiovascular events . However , after adjustment for cardiovascular risk factors , women who frequently ( ≥22 d/mo ) used NSAIDs had a relative risk ( RR ) for a cardiovascular event of 1.44 ( 95 % CI , 1.27 to 1.65 ) compared with nonusers , whereas those who frequently consumed acetaminophen had a RR of 1.35 ( 95 % CI , 1.14 to 1.59 ) . The elevated risk associated with frequent NSAID use was particularly evident among current smokers ( RR=1.82 ; 95 % CI , 1.38 to 2.42 ) and was absent among never smokers ( Pinteraction=0.02 ) . Moreover , we observed significant dose-response relations : Compared with nonusers , the RRs for a cardiovascular event among women who used ≥15 tablets per week were 1.86 ( 95 % CI , 1.27 to 2.73 ) for NSAIDs and 1.68 ( 95 % CI , 1.10 to 2.58 ) for acetaminophen . Conclusions — Use of NSAIDs or acetaminophen at high frequency or dose is associated with a significantly increased risk for major cardiovascular events , although more moderate use did not confer substantial risk Purpose Treatment of patients with chronic low back pain ( CLBP ) aims to reduce disability , improve functional capacity , and participation . Time contingent prescription of analgesics is a treatment modality in CLBP . The impact of analgesics on functional capacity is unknown . Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation , and self-reported disability in patients with CLBP . Methods Explorative R and omized Placebo-Controlled Clinical Trial was performed in an outpatient pain rehabilitation setting on patients waiting for rehabilitation . Included patients had low back pain lasting > 3 months , visual analogue scale worst pain ≥4.0 cm , and age > 18 years . Outcome measures before ( T0 ) and after treatment ( T1 ) : functional capacity , pain intensity , Rol and Morris Disability Question naire . T1 : global perceived pain relief . Patient characteristics and psychological question naires were assessed . Fifty patients were included in this study and were r and omly assigned to 2 weeks treatment or placebo . Treatment : acetaminophen/tramadol 325 mg/37.5 mg per capsule . Dose : maximum acetaminophen 1,950 mg and tramadol 225 mg per day ; treatment and placebo titrated identically . Compliance and side-effects were monitored . Treatment effects between groups over time were compared . Results One patient ( treatment group ) was lost to follow-up . Forty-nine patients remained in the study . Treatment effects in primary outcomes did not differ significantly between groups . A subgroup of 10 ( 42 % ) patients ( treatment group ) reported global pain relief ( responders ) who reduced self-reported disability ( p < 0.05 ) . Responders had significantly lower catastrophizing scores . Conclusion Overall treatment effects were small and non-significant . A subgroup , however , reported improved functioning as a result of treatment . Responders had lower catastrophizing scores Stopping r and omized trials early because of an apparent benefit is a growing phenomenon . A recent systematic review found that the number of r and omized trials stopped early for benefit has more than doubled since 1990 ( 1 ) . To protect and promote the interests of trial participants , investigators may feel ethically obligated to stop a trial early because of the unexpected harm or apparent benefit of a study treatment . If a study treatment 's benefit far outweighs its adverse effects , is it not unethical to continue enrolling patients in a trial in which , as is typically the case , patients have a 50 % chance of receiving a placebo or an inferior treatment ? In this article , we argue that stopping a r and omized trial early for apparent benefit is often unethical and can be justified only under restricted circumstances . If the scientific community were to accept our arguments , then the approach that investigators , institutional review boards , and data monitoring committees take to the practice of stopping trials early for apparent benefit would substantially change . Ethical Considerations Emanuel and colleagues ( 2 ) describe a framework of 7 requirements for determining whether clinical research is ethical . We use this framework to identify and assess the ethical issues raised by stopping trials early because of apparent benefit ( Table ) . Table . Ethical Violations Result ing from Stopping a Trial Early for Apparent Benefit Scientific Validity The purpose of a trial of alternative interventions is to generate an estimate of treatment effect that closely approximates the true effect and is not misleading . This requires application of scientific procedures that yield valid and reliable data and thus minimize both systematic and r and om error . A systematic review of r and omized trials stopped early for apparent benefit ( 1 ) found that many of the trials yielded implausibly large treatment effects ; the median relative risk was 0.53 . Apparent large treatment effects occurred much more frequently when trials accrued only a small number of events . The odds of a treatment effect larger than the overall median relative risk of 0.53 was 28 times greater ( 95 % CI , 11 to 73 ) among trials in which fewer than the median of 66 events accrued than among trials in which more events accrued . These results , which are consistent with predictions from statistical theory ( 3 ) , suggest that stopping trials early for apparent benefit will systematic ally overestimate treatment effects . The scientific validity of trials that are stopped early is further compromised when trials yield inconclusive data about outcomes that did not influence trial truncation but are nonetheless important to patients , such as disease-free survival , symptom control , quality of life , and adverse effects of treatment . For example , a trial of vitamin E supplementation in premature newborns that was stopped early because of an apparent reduction in intracranial hemorrhage ( 4 ) failed to detect the increase in sepsis associated with vitamin E supplementation that subsequent trials identified ( 5 ) . Social or Scientific Value and Favorable RiskBenefit Ratio It is underst and able that investigators focus their ethical obligations on research participants . Such focus , however , risks neglecting obligations to society . The tendency of truncated trials to overestimate the effect of a treatment on the end point that result ed in trial truncation and to yield insufficient data about other important outcomes endangers the wider community to whom the results will be applied ( 6 ) . On review ing the results of a truncated trial , astute clinicians might appropriately conclude that the benefits of the intervention remain uncertain . However , less skeptical clinicians might assume that the results are true and inappropriately expose patients to the intervention and its unknown harms . Consider the results of a trial in which the investigators continued to enroll patients even though prespecified criteria for early stopping were met . Two interim analyses of a r and omized trial of 5 versus 4 courses of chemotherapy in patients with acute myeloid leukemia ( 7 ) found apparent large benefits to the 5-course regimen ( relative odds reduction of 53 % [ CI , 23 % to 71 % ; P= 0.003 ] in the first analysis and 45 % [ CI , 20 % to 62 % ; P= 0.0002 ] in the second analysis ) . Finding these results too good to be true , the data monitoring committee recommended continuing the trial , which ultimately showed a trend in favor of the 4-course regimen . Had the investigators terminated the trial in accordance with their stopping rule , subsequent patients with leukemia may have experienced the toxicity of an additional course of chemotherapy without benefit . Harm result ing from the misleading findings of truncated trials can be compounded if the findings influence the recommendations of clinical practice guideline panels . Investigators conducting a trial that involved patients undergoing vascular surgery ( 8) stopped the trial early when 2 of 53 patients r and omly assigned to receive the -blocker bisoprolol and 18 of 59 control patients had major cardiovascular events ( relative risk reduction , 90 % [ CI , 59 % to 98 % ] ) . These results contributed to recommendations by the American Heart Association and the American College of Cardiology favoring administration of -blockers to patients with cardiac risk
Output:
| There is high- quality evidence that paracetamol has no effect on quality of life , function , global impression of recovery , and sleep quality for all included time periods .
There were also no significant differences between paracetamol and placebo for adverse events , patient adherence , or use of rescue medication .
For chronic LBP , there is very low- quality evidence ( based on a trial that has been retracted ) for no effect of paracetamol ( 1 g single intravenous dose ) on immediate pain reduction .
AUTHORS ' CONCLUSIONS We found that paracetamol does not produce better outcomes than placebo for people with acute LBP , and it is uncertain if it has any effect on chronic LBP |
MS212613 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Technology may improve self-monitoring adherence and dietary changes in weight loss treatment . Our study aim ed to investigate whether using a personal digital assistant ( PDA ) with dietary and exercise software , with and without a feedback message , compared to using a paper diary/record ( PR ) , results in greater weight loss and improved self-monitoring adherence . Healthy adults ( N = 210 ) with a mean BMI of 34.01 kg/m(2 ) were r and omized to one of three self-monitoring approaches : PR ( n = 72 ) , PDA with self-monitoring software ( n = 68 ) , or PDA with self-monitoring software and daily feedback messages ( PDA+FB , n = 70 ) . All participants received st and ard behavioral treatment . Self-monitoring adherence and change in body weight , waist circumference , and diet were assessed at 6 months ; retention was 91 % . All participants had a significant weight loss ( P < 0.01 ) but weight loss did not differ among groups . A higher proportion of PDA+FB participants ( 63 % ) achieved ≥ 5 % weight loss in comparison to the PR group ( 46 % ) ( P < 0.05 ) and PDA group ( 49 % ) ( P = 0.09 ) . Median percent self-monitoring adherence over the 6 months was higher in the PDA groups ( PDA 80 % ; PDA+FB 90 % ) than in the PR group ( 55 % ) ( P < 0.01 ) . Waist circumference decreased more in the PDA groups than the PR group ( P = 0.02 ) . Similarly , the PDA groups reduced energy and saturated fat intake more than the PR group ( P < 0.05 ) . Self-monitoring adherence was greater in the PDA groups with the greatest weight change observed in the PDA+FB group PURPOSE The present study evaluated whether an intervention using a short message service ( SMS ) by cellular phone and Internet would improve blood pressure , weight control , and serum lipids of obese patients with hypertension during 8 weeks . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the family medicine outpatient department of tertiary care hospital located in an urban city of South Korea . Twenty-eight patients were assigned to an intervention group and 21 to a control group . The goal of intervention was to bring blood pressure , body weight , and serum lipids levels close to normal ranges . Patients in the intervention group were requested to record their blood pressure and body weight in a weekly web based diary through the Internet or by cellular phones . The research ers sent optimal recommendations as an intervention to each patient , by both cellular phone and Internet weekly . The intervention was applied for 8 weeks . RESULTS Systolic ( SBP ) and diastolic blood pressures ( DBP ) significantly decreased by 9.1 and 7.2 mmHg respectively at 8 weeks from the baseline in the intervention group ( p<0.05 ) . However , after 8 weeks from the baseline both SBP and DBP in the control group had not changed significantly . Yet , There were significant mean decreases in body weight and waist circumference by 1.6 kg ( p<0.05 ) and 2.8 cm ( p<0.05 ) in the intervention group , respectively . In the control group increases in body weight and waist circumference ( p<0.05 ) mean changes were also significant . High density lipoprotein cholesterol ( HDL-C ) significantly increased , with a mean change of 3.7 mg/dl at 8 weeks from baseline in the intervention group ( p<0.05 ) . The mean change of HDL-C in the control group was , however , not significant . CONCLUSION During 8 weeks using this web-based intervention by way of cellular phone and Internet SMS improved blood pressure , body weight , waist circumference , and HDL-C in patients with obese hypertension Background For most individuals , long-term maintenance of weight loss requires long-term , supportive intervention . Internet-based weight loss maintenance programs offer considerable potential for meeting this need . Careful design processes are required to maximize adherence and minimize attrition . Objective This paper describes the development , implementation and use of a Web-based intervention program design ed to help those who have recently lost weight sustain their weight loss over 1 year . Methods The weight loss maintenance website was developed over a 1-year period by an interdisciplinary team of public health research ers , behavior change intervention experts , applications developers , and interface design ers . Key interactive features of the final site include social support , self-monitoring , written guidelines for diet and physical activity , links to appropriate websites , supportive tools for behavior change , check-in accountability , tailored reinforcement messages , and problem solving and relapse prevention training . The weight loss maintenance program included a reminder system ( automated email and telephone messages ) that prompted participants to return to the website if they missed their check-in date . If there was no log-in response to the email and telephone automated prompts , a staff member called the participant . We tracked the proportion of participants with at least one log-in per month , and analyzed log-ins as a result of automated prompts . Results The mean age of the 348 participants enrolled in an ongoing r and omized trial and assigned to use the website was 56 years ; 63 % were female , and 38 % were African American . While weight loss data will not be available until mid-2008 , website use remained high during the first year with over 80 % of the participants still using the website during month 12 . During the first 52 weeks , participants averaged 35 weeks with at least one log-in . Email and telephone prompts appear to be very effective at helping participants sustain ongoing website use . Conclusions Developing interactive websites is expensive , complex , and time consuming . We found that extensive paper prototyping well in advance of programming and a versatile product manager who could work with project staff at all levels of detail were essential to keeping the development process efficient . Trial Registration clinical trials.gov OBJECTIVE To develop and evaluate a pictorial , web-based version of the NCI diet history question naire ( Web-PDHQ ) . DESIGN The Web-PDHQ and paper version of the DHQ ( Paper-DHQ ) were administered 4 weeks apart with 218 participants r and omised to order . Dietary data from the Web-PDHQ and Paper-DHQ were vali date d using a r and omly selected 4 d food record recording period ( including a weekend day ) and two r and omly selected 24 h dietary recalls during the 4 weeks intervening between these two diet history administrations . SETTING Research office in Reston , VA , USA . PARTICIPANTS Computer-literate men and women recruited through newspaper advertisements . RESULTS Mean correlation of energy and the twenty-five examined nutrients between the Web-PDHQ and Paper-DHQ was 0.71 and 0.51 , unadjusted and energy-adjusted by the residual method , respectively . Moderate mean correlations ( unadjusted 0.41 and 0.38 ; energy-adjusted 0.41 and 0.34 ) were obtained between both the Web-PDHQ and Paper-DHQ with the 4 d food record on energy and nutrients , but the correlations between the Web-PDHQ and Paper-DHQ with the 24 h recalls were modest ( unadjusted 0.31 and 0.29 ; energy-adjusted 0.37 and 0.26 ) . A subset of participants ( n 48 ) completing the Web-PDHQ at the initial visit performed a retest on the same question naire 1 week later to determine repeatability , and the unadjusted mean correlation was 0.82 . CONCLUSIONS These data indicate that the Web-PDHQ has comparable repeatability and validity to the Paper-DHQ but did not improve the relationship of the DHQ to other food intake measures ( e.g. food records , 24 h recall ) PURPOSE The present study evaluated whether an intervention using the SMS by personal cellular phone and internet would improve the levels of plasma glucose of obese type 2 diabetes at 3 , 6 , 9 , and 12 months . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the endocrinology outpatient department of tertiary care hospital located in an urban city of South Korea . Eighteen patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to decrease body weight and keep blood glucose concentrations close to the normal range . Patients were requested to record their blood glucose level in a weekly diary on the website by personal cellular phones or computer internet . The research er sent optimal recommendations to each patient , by both the cellular phone and the Internet weekly . The intervention was applied for 1 year . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.22 percentage points at 3 months , 1.09 percentage points at 6 months , 1.47 percentage points at 9 months , and 1.49 percentage points at 12 months compared with baseline in the intervention group ( all time points , p<0.05 ) . The percentage change in the control group was , however , not significant . Patients in the intervention group had a decrease of 2-h post-pr and ial test ( 2HPPT ) of 120.1mg/dl at 3 months , 58.9 mg/dl at 6 months , 62.0mg/dl at 9 months , and 102.9 mg/dl at 12 months compared with baseline ( all time points , p<0.05 ) . The mean change in the control group was , however , not significant . CONCLUSION This web-based intervention using SMS of personal cellular phone and Internet improved HbA(1)c and 2HPPT at 3 , 6 , 9 , and 12 months in patients with obese type 2 diabetes OBJECTIVE To determine the characteristics and behaviors associated with adherence to dietary protein interventions among participants with chronic renal disease in the Modification of Diet in Renal Disease ( MDRD ) Study . DESIGN Participants were categorized as consistent adherers or nonadherers on the basis of urinary urea nitrogen excretion and dietary protein intake data from self-reports . Psychosocial and behavioral factors were compared between groups . SUBJECTS Subgroups of consistently adherent and non-adherent participants in the MDRD Study . SETTING 15 clinical centers in the United States . INTERVENTION In the nutrition intervention program , participants were assigned r and omly to a usual- , low- , or very-low-protein diet group . Each eating pattern also specified a phosphorus goal . STATISTICAL ANALYSIS Analysis of variance . RESULT Psychosocial factors significantly related to adherence included participant knowledge , attitude , support , satisfaction , and self-perception of success . Behavioral strategies including participant self-monitoring of protein intake and the provision of feedback by the dietitian were also significantly related to adherence . APPLICATION Nutrition interventions for patients with renal disease should focus on psychosocial factors and behavioral approaches . Such approaches can be successfully incorporated into treatment programs and will assist the dietitian in promoting adherence to usual- , low- , and very-low-protein eating patterns Objective : To evaluate the capability of DietMatePro , a PDA-based dietary assessment program , to monitor dietary intake and to improve adherence to a dietary regimen . Design : R and omized controlled trial . Subjects . Overweight and obese ( Body Mass Index ( BMI ) 25–40 ) participants without dietary restrictions . Intervention : Participants ( n = 174 ) were r and omized to record usual dietary intake using either DietMatePro or a paper food diary for one week to compare concordance with 24-hr recall . At the week 1 visit , participants were individually counseled to follow the diet recommendations of the Ornish Prevention Diet for three weeks and continue monitoring food intake using the assigned method to estimate adherence to the intervention by monitoring condition . Outcome Measures : Spearman correlations between week 1 24-hr recall and the assigned recording method were compared to assess validity . Mean pre-post changes in intake measured by 24-hr recall were compared according to monitoring condition to measure adherence to the Ornish diet . Results : Correlations of energy and nutrient values reported on the food label ranged from 0.41 to 0.71 for the DietMatePro condition versus 0.63 to 0.83 for the paper-based diary . Diet adherence was higher among DietMatePro ( 43 % ) compared to the paper diary ( 28 % ) group ( p = 0.039 ) . Conclusions /Applications : DietMatePro does not appear to produce more valid data than paper-based approaches . DietMatePro may improve adherence to dietary regimens compared to paper-based methods
Output:
| The tested web applications offered similar functionalities for recording food intake .
The systems studied provided some degree of personalization : users can access some systems via PCs or mobile phones and they can choose among various types of data input content for recording food intake .
Many functions , such as search in a food data base , reports , graphical presentation , listing of favorite foods , and overview of the user 's own meals , are optimized to simplify the recording process and save time .
Data sharing and reports are common features of the review ed systems .
However , none use the user 's recorded food history to make suggestions on new nutritional intake , during the food recording process . |
MS212614 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive and rogen-independent prostate cancer . We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic , hormone-independent prostate cancer . METHODS We r and omly assigned 770 men to one of two treatments , each given in 21-day cycles : 280 mg of estramustine three times daily on days 1 through 5 , 60 mg of docetaxel per square meter of body-surface area on day 2 , and 60 mg of dexamethasone in three divided doses before docetaxel , or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily . The primary end point was overall survival ; secondary end points were progression-free survival , objective response rates , and post-treatment declines of at least 50 percent in serum prostate-specific antigen ( PSA ) levels . RESULTS Of 674 eligible patients , 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone . In an intention-to-treat analysis , the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone ( 17.5 months vs. 15.6 months , P=0.02 by the log-rank test ) , and the corresponding hazard ratio for death was 0.80 ( 95 percent confidence interval , 0.67 to 0.97 ) . The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone ( P<0.001 by the log-rank test ) . PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients , respectively ( P<0.001 ) , and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease , respectively ( P=0.30 ) . Grade 3 or 4 neutropenic fevers ( P=0.01 ) , nausea and vomiting ( P<0.001 ) , and cardiovascular events ( P=0.001 ) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone . Pain relief was similar in both groups . CONCLUSIONS The improvement in median survival of nearly two months with docetaxel and estramustine , as compared with mitoxantrone and prednisone , provides support for this approach in men with metastatic , and rogen-independent prostate cancer This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . " Quality " as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence PURPOSE Abiraterone acetate is a prodrug of abiraterone , a selective inhibitor of CYP17 , the enzyme catalyst for two essential steps in and rogen bio synthesis . In castration-resistant prostate cancers ( CRPCs ) , extragonadal and rogen sources may sustain tumor growth despite a castrate environment . This phase I dose-escalation study of abiraterone acetate evaluated safety , pharmacokinetics , and effects on steroidogenesis and prostate-specific antigen ( PSA ) levels in men with CPRC with or without prior ketoconazole therapy . PATIENTS AND METHODS Thirty-three men with chemotherapy-naïve progressive CRPC were enrolled . Nineteen patients ( 58 % ) had previously received ketoconazole for CRPC . Bone metastases were present in 70 % of patients , and visceral involvement was present in 18 % . Three patients ( 9 % ) had locally advanced disease without distant metastases . Fasted or fed cohorts received abiraterone acetate doses of 250 , 500 , 750 , or 1,000 mg daily . Single-dose pharmacokinetic analyses were performed before continuous daily dosing . RESULTS Adverse events were predominantly grade 1 or 2 . No dose-limiting toxicities were observed . Hypertension ( grade 3 , 12 % ) and hypokalemia ( grade 3 , 6 % ; grade 4 , 3 % ) were the most frequent serious toxicities and responded to medical management . Confirmed > or = 50 % PSA declines at week 12 were seen in 18 ( 55 % ) of 33 patients , including nine ( 47 % ) of 19 patients with prior ketoconazole therapy and nine ( 64 % ) of 14 patients without prior ketoconazole therapy . Substantial declines in circulating and rogens and increases in mineralocorticoids were seen with all doses . CONCLUSION Abiraterone acetate was well tolerated and demonstrated activity in CRPC , including in patients previously treated with ketoconazole . Continued clinical study is warranted PURPOSE It has been postulated that castration-resistant prostate cancer ( CRPC ) commonly remains hormone dependent . Abiraterone acetate is a potent , selective , and orally available inhibitor of CYP17 , the key enzyme in and rogen and estrogen bio synthesis . PATIENTS AND METHODS This was a phase I/II study of abiraterone acetate in castrate , chemotherapy-naive CRPC patients ( n = 54 ) with phase II expansion at 1,000 mg ( n = 42 ) using a two-stage design to reject the null hypothesis if more than seven patients had a prostate-specific antigen ( PSA ) decline of > or = 50 % ( null hypothesis = 0.1 ; alternative hypothesis = 0.3 ; alpha = .05 ; beta = .14 ) . Computed tomography scans every 12 weeks and circulating tumor cell ( CTC ) enumeration were performed . Prospect i ve reversal of resistance at progression by adding dexamethasone 0.5 mg/d to suppress adrenocorticotropic hormone and upstream steroids was pursued . RESULTS A decline in PSA of > or = 50 % was observed in 28 ( 67 % ) of 42 phase II patients , and declines of > or = 90 % were observed in eight ( 19 % ) of 42 patients . Independent radiologic evaluation reported partial responses ( Response Evaluation Criteria in Solid Tumors ) in nine ( 37.5 % ) of 24 phase II patients with measurable disease . Decreases in CTC counts were also documented . The median time to PSA progression ( TTPP ) on abiraterone acetate alone for all phase II patients was 225 days ( 95 % CI , 162 to 287 days ) . Exploratory analyses were performed on all 54 phase I/II patients ; the addition of dexamethasone at disease progression reversed resistance in 33 % of patients regardless of prior treatment with dexamethasone , and pretreatment serum and rogen and estradiol levels were associated with a probability of > or = 50 % PSA decline and TTPP on abiraterone acetate and dexamethasone . CONCLUSION CYP17 blockade by abiraterone acetate results in declines in PSA and CTC counts and radiologic responses , confirming that CRPC commonly remains hormone driven PURPOSE The principal objective of this trial was to evaluate the antitumor activity of abiraterone acetate , an oral , specific , irreversible inhibitor of CYP17 in docetaxel-treated patients with castration-resistant prostate cancer ( CRPC ) . PATIENTS AND METHODS In this multicenter , two-stage , phase II study , abiraterone acetate 1,000 mg was administered once daily continuously . The primary end point was achievement of a prostate-specific antigen ( PSA ) decline of > or = 50 % in at least seven of 35 patients . Per an attained phase II design , more than 35 patients could be enrolled if the primary end point was met . Secondary objectives included : PSA declines of > or = 30 % and > or = 90 % ; rate of RECIST ( Response Evaluation Criteria in Solid Tumors ) responses and duration on study ; time to PSA progression ; safety and tolerability ; and circulating tumor cell ( CTC ) enumeration . RESULTS Docetaxel-treated patients with CRPC ( N = 47 ) were enrolled . PSA declines of > or = 30 % , > or = 50 % and > or = 90 % were seen in 68 % ( 32 of 47 ) , 51 % ( 24 of 47 ) , and 15 % ( seven of 47 ) of patients , respectively . Partial responses ( by RECIST ) were reported in eight ( 27 % ) of 30 patients with measurable disease . Median time to PSA progression was 169 days ( 95 % CI , 113 to 281 days ) . The median number of weeks on study was 24 , and 12 ( 25.5 % ) of 47 patients remained on study > or = 48 weeks . CTCs were enumerated in 34 patients ; 27 ( 79 % ) of 34 patients had at least five CTCs at baseline . Eleven ( 41 % ) of 27 patients had a decline from at least five to less than 5 CTCs , and 18 ( 67 % ) of 27 had a > or = 30 % decline in CTCs after starting treatment with abiraterone acetate . Abiraterone acetate was well tolerated . CONCLUSION Abiraterone acetate has significant antitumor activity in post-docetaxel patients with CRPC . R and omized , phase III trials of abiraterone acetate are underway to define the future role of this agent PURPOSE Studies indicate that castration-resistant prostate cancer ( CRPC ) remains driven by lig and -dependent and rogen receptor ( AR ) signaling . To evaluate this , a trial of abiraterone acetate-a potent , selective , small-molecule inhibitor of cytochrome P ( CYP ) 17 , a key enzyme in and rogen synthesis -was pursued . PATIENTS AND METHODS Chemotherapy-naïve men ( n = 21 ) who had prostate cancer that was resistant to multiple hormonal therapies were treated in this phase I study of once-daily , continuous abiraterone acetate , which escalated through five doses ( 250 to 2,000 mg ) in three-patient cohorts . RESULTS Abiraterone acetate was well tolerated . The anticipated toxicities attributable to a syndrome of secondary mineralocorticoid excess-namely hypertension , hypokalemia , and lower-limb edema-were successfully managed with a mineralocorticoid receptor antagonist . Antitumor activity was observed at all doses ; however , because of a plateau in pharmacodynamic effect , 1,000 mg was selected for cohort expansion ( n = 9 ) . Abiraterone acetate administration was associated with increased levels of adrenocorticotropic hormone and steroids upstream of CYP17 and with suppression of serum testosterone , downstream and rogenic steroids , and estradiol in all patients . Declines in prostate-specific antigen > or= 30 % , 50 % , and 90 % were observed in 14 ( 66 % ) , 12 ( 57 % ) , and 6 ( 29 % ) patients , respectively , and lasted between 69 to > or= 578 days . Radiologic regression , normalization of lactate dehydrogenase , and improved symptoms with a reduction in analgesic use were documented . CONCLUSION CYP17 blockade by abiraterone acetate is safe and has significant antitumor activity in CRPC . These data confirm that CRPC commonly remains dependent on lig and -activated AR signaling To test the hypothesis that maximal and rogen blockade improves the effectiveness of the treatment of prostatic cancer , we conducted a r and omized , double-blind trial in patients with disseminated , previously untreated prostate cancer ( stage D2 ) . All 603 men received leuprolide , an analogue of gonadotropin-releasing hormone that inhibits the release of gonadotropins , in combination with either placebo or flutamide , a nonsteroidal anti and rogen that inhibits the binding of and rogens to the cell nucleus . As compared with the 300 patients receiving leuprolide and placebo , the 303 patients r and omly assigned to receive leuprolide and flutamide had a longer progression-free survival ( 16.5 vs. 13.9 months ;
Output:
| This meta- analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled .
CONCLUTIOS : Abiraterone significantly prolonged OS , RPFS and time to progression patients with mCRPC , regardless of prior chemotherapy or whether chemotherapy-naive , and no unexpected toxicity was evident .
Abiraterone can serve as a new st and ard therapy for mCRPC |
MS212615 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background —There is no disease specific , reliable , and valid clinical measure of Achilles tendinopathy . Objective —To develop and test a question naire based instrument that would serve as an index of severity of Achilles tendinopathy . Methods —Item generation , item reduction , item scaling , and pretesting were used to develop a question naire to assess the severity of Achilles tendinopathy . The final version consisted of eight questions that measured the domains of pain , function in daily living , and sporting activity . Results range from 0 to 100 , where 100 represents the perfect score . Its validity and reliability were then tested in a population of non-surgical patients with Achilles tendinopathy ( n = 45 ) , presurgical patients with Achilles tendinopathy ( n = 14 ) , and two normal control population s ( total n = 87 ) . Results —The VISA-A question naire had good test-retest ( r = 0.93 ) , intrarater ( three tests , r = 0.90 ) , and interrater ( r = 0.90 ) reliability as well as good stability when compared one week apart ( r = 0.81 ) . The mean ( 95 % confidence interval ) VISA-A score in the non-surgical patients was 64 ( 59–69 ) , in presurgical patients 44 ( 28–60 ) , and in control subjects it exceeded 96 ( 94–99 ) . Thus the VISA-A score was higher in non-surgical than presurgical patients ( p = 0.02 ) and higher in control subjects than in both patient population s ( p<0.001 ) . Conclusions —The VISA-A question naire is reliable and displayed construct validity when means were compared in patients with a range of severity of Achilles tendinopathy and control subjects . The continuous numerical result of the VISA-A question naire has the potential to provide utility in both the clinical setting and research . The test is not design ed to be diagnostic . Further studies are needed to determine whether the VISA-A score predicts prognosis Background The common regime of eccentric exercise in use for Achilles tendinopathy is somewhat arduous and compliance issues can arise . This is the first study to investigate the effectiveness of a regime of fewer exercise sessions combined with photobiomodulation for the treatment of Achilles tendinopathy . Methods A double blind r and omized controlled trial and intention-to-treat analysis were performed . Eighty participants , 18–65 years with Achilles tendinopathy and symptoms for longer than 3 months , were included in the trial . Participants r and omized into one of four groups ; 1 ( Placebo + Ex Regime 1 ) or 2 ( Laser + Ex Regime 1 ) or 3 ( Placebo + Ex Regime 2 ) or 4 ( Laser + Ex Regime 2 ) . The primary outcome measure was the Victorian Institute of Sports Assessment -Achilles ( VISA-A ) question naire . Outcomes were collected at baseline , week 4 and week 12 . Results Sixteen participants were lost to follow-up at 12 weeks , 4 of which due to adverse reactions . As per intention to treat , missing data were imputed , 80 participants were included in the final analysis . For VISA-A at 12 weeks , group 4 achieved significant gains over the other 3 groups : group 1 ( 18.5 [ 9.1 , 27.9 ] ) , group 2 ( 10.4 [ 1.5 , 19.2 ] ) , group 3 ( 11.3 [ 3.0 , 19.6 ] ) . There was a moderate effect size in favour of exercise twice per week ( 7.2 [ −1.8 , 16.2 ] , ES .7 ) . Conclusions Twice-daily exercise sessions are not necessary as equivalent results can be obtained with two exercise sessions per week . The addition of photobiomodulation as adjunct to exercise can bring added benefit Objective The study examined whether the addition of a night splint to eccentric exercises is beneficial for functional outcome in chronic midportion Achilles tendinopathy . Design One-year follow-up of a r and omised controlled single blinded clinical trial . Setting Sports medicine department in a general hospital . Patients 58 patients ( 70 tendons ) were included . Interventions All patients completed a 12-week heavy load eccentric training programme . One group received a night splint in addition to eccentric exercises . Main outcome measurements Outcome scores were : Victorian Institute of Sport Assessment —Achilles ( VISAA ) score , subjective patient satisfaction and neovascularisation score measured with power Doppler ultrasonography ( PDU ) . Results For both groups the VISA-A score increased significantly ( from 50 to 76 ( p<0.01 ) in the eccentric group and from 49 to 78 ( p<0.01 ) in the night splint group ) . No significant differences in the VISA-A score were found between the groups from baseline to one year ( p = 0.32 ) . The presence of neovessels at baseline did not predict a change in the VISA-A score after one year in the whole group ( p = 0.71 ) . Conclusion Eccentric exercises with or without a night splint improved functional outcome at one year follow-up . At follow-up there was no significant difference in clinical outcome when a night splint was used in addition to an eccentric exercise programme . Between 3 months and one year follow-up , a continuing increase in the VISA-A score was found . Assessment of the neovascularisation score with PDU at baseline has no prognostic value on long-term clinical outcome AIM Prognosis and treatment of Achilles tendon pain ( achillodynia ) has been insufficiently studied . The purpose of the present study was to examine the long-term effect of eccentric exercises compared with stretching exercises on patients with achillodynia . METHODS Patients with achillodynia for at least 3 months were r and omly allocated to one of two exercise regimens . Exercise was performed daily for a 3-month period . Symptom severity was evaluated by tendon tenderness , ultrasonography , a question naire on pain and other symptoms , and a global assessment of improvement . Follow-up was performed at time points 3 , 6 , 9 , 12 weeks and 1 year . RESULTS Of 53 patients with achillodynia 45 patients were r and omized to either eccentric exercises or stretching exercises . Symptoms gradually improved during the 1-year follow-up period and were significantly better assessed by pain and symptoms after 3 weeks and all later visits . However , no significant differences could be observed between the two groups . Women and patients with symptoms from the distal part of the tendon had significantly less improvement . CONCLUSIONS Marked improvement in symptoms and findings could be gradually observed in both groups during the 1-year follow-up period . To that extent this is due to effect of both regimens or the spontaneous improvement is unsettled Aim To evaluate the effectiveness of customised foot orthoses in chronic mid-portion Achilles tendinopathy . Methods This was a participant-blinded , parallel-group r and omised controlled trial at a single centre ( La Trobe University , Melbourne , Australia ) . One hundred and forty participants aged 18–55 years with mid-portion Achilles tendinopathy were r and omised to receive eccentric calf muscle exercises with either customised foot orthoses ( intervention group ) or sham foot orthoses ( control group ) . Allocation to intervention was concealed . The Victorian Institute of Sports Assessment -Achilles ( VISA-A ) question naire was completed at baseline , then at 1 , 3 , 6 and 12 months , with 3 months being the primary end point . Differences between groups were analysed using intention to treat with analysis of covariance . Results After r and omisation into the customised foot orthoses group ( n=67 ) or sham foot orthoses group ( n=73 ) , there was 70.7 % follow-up of participants at 3 months . There were no significant differences between groups at any time point . At 3 months , the mean ( SD ) VISA-A score was 82.1 ( 16.3 ) and 79.2 ( 20.0 ) points for the customised and sham foot orthosis groups , respectively ( adjusted mean difference ( 95 % CI)=2.6 ( −2.9 to 8.0 ) , p=0.353 ) . There were no clinical ly meaningful differences between groups in any of the secondary outcome measures . Conclusions Customised foot orthoses , prescribed according to the protocol in this study , are no more effective than sham foot orthoses for reducing symptoms and improving function in people with mid-portion Achilles tendinopathy undergoing an eccentric calf muscle exercise programme . Trial Registration Number Australian New Zeal and Clinical Trials Registry : number ACTRN12609000829213 Achilles tendinopathy is common and treatment with eccentric exercises seems promising . We design ed a prospect i ve r and omized clinical trial to test the hypothesis that eccentric calf muscle exercises reduce pain and improve function in patients with Achilles tendinopathy . Forty-four patients were recruited from primary care ( mean age : 45 years ; 23 women ; 65 % active in sports ) and r and omized to three treatment groups for 12 weeks : eccentric exercises , a night splint or a combination of both treatments . Pain and function were evaluated at 6 , 12 , 26 and 52 weeks by the Foot and Ankle Outcome Score . At 6 weeks , the eccentric group reported a significant pain reduction ( 27 % compared with baseline , P = 0.007 ) which lasted for 1 year ( 42 % , P = 0.001 ) . The two groups treated with a night splint also reported significant but less pain reduction than the eccentric group . Differences between all the three groups were not significant . At 12 weeks , the eccentric group reported significantly less pain than the splint-only group ( P = 0.04 ) . More patients in the eccentric group than in the splint group returned to sport after 12 weeks . We conclude that eccentric exercises seem to reduce pain and improve function in patients with Achilles tendinopathy . Our results are in line with previous studies and strengthen the recommendation that patients should undergo an eccentric exercise program prior to considering other treatments such as surgery Background Achilles tendinopathy is a common condition that can cause marked pain and disability . Numerous non-surgical treatments have been proposed for the treatment of this condition , but many of these treatments have a poor or non-existent evidence base . The exception to this is eccentric calf muscle exercises , which have become a st and ard non-surgical intervention for Achilles tendinopathy . Foot orthoses have also been advocated as a treatment for Achilles tendinopathy , but the long-term efficacy of foot orthoses for this condition is unknown . This manuscript describes the design of a r and omised trial to evaluate the efficacy of customised foot orthoses to reduce pain and improve function in people with Achilles tendinopathy . Methods One hundred and forty community-dwelling men and women aged 18 to 55 years with Achilles tendinopathy ( who satisfy inclusion and exclusion criteria ) will be recruited . Participants will be r and omised , using a computer-generated r and om number sequence , to either a control group ( sham foot orthoses made from compressible ethylene vinyl acetate foam ) or an experimental group ( customised foot orthoses made from semi-rigid polypropylene ) . Both groups will be prescribed a calf muscle eccentric exercise program , however , the primary difference between the groups will be that the experimental group receive customised foot orthoses , while the control group receive sham foot orthoses . The participants will be instructed to perform eccentric exercises 2 times per day , 7 days per week , for 12 weeks . The primary outcome measure will be the total score of the Victorian Institute of Sport Assessment - Achilles ( VISA-A ) question naire . The secondary outcome measures will be participant perception of treatment effect , comfort of the foot orthoses , use of co- interventions , frequency and severity of adverse events , level of physical activity and health-related quality of life ( assessed using the Short-Form-36 question naire - Version two ) . Data will be collected at baseline , then at 1 , 3 , 6 and 12 months . Data will be analysed using the intention to treat principle . Discussion This study is the first r and omised trial to evaluate the long-term efficacy of customised foot orthoses for the treatment of Achilles tendinopathy . The study has been pragmatically design ed to ensure that the study findings are generalisable to clinical practice .Trial registration Australian New Zeal and Clinical Trials Registry Number : ACTRN12609000829213 In a previous uncontrolled pilot study we demonstrated very good clinical results with eccentric calf muscle training on patients with painful chronic Achilles tendinosis located at the 2–6 cm level in the tendon . In the present prospect i ve multicenter study ( Sundsvall and Umeå ) patients with painful chronic Achilles tendinosis at the 2–6 cm level in the tendon were r and omized to treatment with either an eccentric or a concentric training regimen for the calf muscles . The study included 44 patients , with 22 patients ( 12 men , 10 women ; mean age 48 years ) in each treatment group . The amount of pain during activity ( jogging or walking ) was recorded by the patients on a visual analogue scale , and patient satisfaction was assessed before and after treatment . The patients were instructed to perform their eccentric or concentric training regimen on a daily basis for 12 weeks . In both types of treatment regimen the patients were told to do their exercises despite experiencing pain or discomfort in the tendon during exercise . The results showed that after the eccentric training regimen 82 % of the patients ( 18/22 ) were satisfied and had resumed their previous activity level
Output:
| Moderate level evidence favoured eccentric exercise over control for improving pain and function in mid-portion tendinopathy .
Moderate level evidence favoured eccentric exercise over concentric exercise for reducing pain .
There was moderate level evidence of no significant difference in pain or function between eccentric exercise and heavy slow resistance exercise .
There was low level evidence that eccentric exercise was not superior to stretching for pain or QoL. There was moderate level evidence that a combined exercise protocol was not superior to a lower dosage protocol for improving functional performance .
Eccentric exercise was not superior to splinting for pain ( moderate evidence ) or function ( low level evidence ) .
Summary We conditionally recommend exercise for improving pain and function in mid-portion Achilles tendinopathy .
The balance of evidence did not support recommendation of one type of exercise programme over another .
We conditionally recommend against the addition of a splint to an eccentric exercise protocol and we do not recommend the use of orthoses to improve pain and function in Achilles tendinopathy |
MS212616 | ***TASK*** the task is to summarize an input biomedical literature in 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 Pre clinical and preliminary clinical data indicate that ch14.18 , a monoclonal antibody against the tumor-associated disialoganglioside GD2 , has activity against neuroblastoma and that such activity is enhanced when ch14.18 is combined with granulocyte-macrophage colony-stimulating factor ( GM-CSF ) or interleukin-2 . We conducted a study to determine whether adding ch14.18 , GM-CSF , and interleukin-2 to st and ard isotretinoin therapy after intensive multimodal therapy would improve outcomes in high-risk neuroblastoma . METHODS Patients with high-risk neuroblastoma who had a response to induction therapy and stem-cell transplantation were r and omly assigned , in a 1:1 ratio , to receive st and ard therapy ( six cycles of isotretinoin ) or immunotherapy ( six cycles of isotretinoin and five concomitant cycles of ch14.18 in combination with alternating GM-CSF and interleukin-2 ) . Event-free survival and overall survival were compared between the immunotherapy group and the st and ard-therapy group , on an intention-to-treat basis . RESULTS A total of 226 eligible patients were r and omly assigned to a treatment group . In the immunotherapy group , a total of 52 % of patients had pain of grade 3 , 4 , or 5 , and 23 % and 25 % of patients had capillary leak syndrome and hypersensitivity reactions , respectively . With 61 % of the number of expected events observed , the study met the criteria for early stopping owing to efficacy . The median duration of follow-up was 2.1 years . Immunotherapy was superior to st and ard therapy with regard to rates of event-free survival ( 66±5 % vs. 46±5 % at 2 years , P=0.01 ) and overall survival ( 86±4 % vs. 75±5 % at 2 years , P=0.02 without adjustment for interim analyses ) . CONCLUSIONS Immunotherapy with ch14.18 , GM-CSF , and interleukin-2 was associated with a significantly improved outcome as compared with st and ard therapy in patients with high-risk neuroblastoma . ( Funded by the National Institutes of Health and the Food and Drug Administration ; Clinical Trials.gov number , NCT00026312 . Variation in genes contributing to the host immune response may mediate the relationship between inflammation and prostate carcinogenesis . RNASEL at chromosome 1q25 encodes ribonuclease L , part of the interferon-mediated immune response to viral infection . We therefore investigated the association between variation in RNASEL and prostate cancer risk and progression in a study of 1286 cases and 1264 controls nested within the prospect i ve Physicians ' Health Study . Eleven single-nucleotide polymorphisms ( SNPs ) were selected using the web-based ' Tagger ' in the HapMap CEPH panel ( Utah residents of Northern and Western European Ancestry ) . Unconditional logistic regression models assessed the relationship between each SNP and incident advanced stage ( T(3)/T(4 ) , T(0)-T(4)/M(1 ) and lethal disease ) and high Gleason grade ( > /=7 ) prostate cancer . Further analyses were stratified by calendar year of diagnosis . Cox proportional hazards models examined the relationship between genotype and prostate cancer-specific survival . We also explored associations between genotype and serum inflammatory biomarkers interleukin-6 ( IL-6 ) , C-reactive protein ( CRP ) and tumor necrosis factor-alpha receptor 2 using linear regression . Individuals homozygous for the variant allele of rs12757998 had an increased risk of prostate cancer [ AA versus GG ; odds ratio ( OR ) : 1.63 , 95 % confidence interval ( CI ) : 1.18 - 2.25 ) , and more specifically , high- grade tumors ( OR : 1.90 , 95 % CI : 1.25 - 2.89 ) . The same genotype was associated with increased CRP ( P = 0.02 ) and IL-6 ( P = 0.05 ) levels . Missense mutations R462Q and D541E were associated with an increased risk of advanced stage disease only in the pre-prostate-specific antigen era . There were no significant associations with survival . The results of this study support a link between RNASEL and prostate cancer and suggest that the association may be mediated through inflammation . These novel findings warrant replication in future studies BACKGROUND This first-in-human phase I/IIA study was design ed to evaluate the safety and pharmacokinetics ( PKs ) of AGS-PSCA a fully human monoclonal antibody directed to prostate stem cell antigen ( PSCA ) in progressive castration-resistant prostate cancer . PATIENTS AND METHODS Twenty-nine patients were administered infusions of AGS-PSCA ( 1 - 40 mg/kg ) every 3 weeks for 12 weeks ; 18 final patients received a 40-mg/kg loading dose followed by 20-mg/kg repeat doses . Primary end points were safety and PK . Immunogenicity , antitumor activity and circulating tumor cells were also evaluated . RESULTS No drug-related serious adverse events were noted . Dose escalation stopped before reaching the maximum tolerated dose as target concentrations were achieved . Drug levels accumulated linearly with dose and the mean terminal half-life was 2 - 3 weeks across dose levels . The 40-mg/kg loading dose followed by repeated 20-mg/kg doses yielded serum drug concentrations above the projected minimum therapeutic threshold after two to three doses without excessive drug accumulation or toxicity . Significant antitumor effects were not seen . CONCLUSIONS A 40-mg/kg loading dose followed by 20-mg/kg infusions every 3 weeks is the recommended phase II dose of AGS-PSCA . PSCA is a promising drug target and studies in prostate and other relevant solid tumors are planned PURPOSE To determine the maximum tolerated dose ( MTD ) , toxicity , human anti-J591 response , pharmacokinetics ( PK ) , organ dosimetry , targeting , and biologic activity of (177)Lutetium-labeled anti-prostate-specific membrane antigen ( PSMA ) monoclonal antibody J591 ( (177)Lu-J591 ) in patients with and rogen-independent prostate cancer ( PC ) . PATIENTS AND METHODS Thirty-five patients with progressing and rogen-independent PC received (177)Lu-J591 . All patients underwent (177)Lu-J591 imaging , PK , and biodistribution determinations . Patients were eligible for up to three retreatments . RESULTS Thirty-five patients received (177)Lu-J591 , of whom 16 received up to three doses . Myelosuppression was dose limiting at 75 mCi/m(2 ) , and the 70-mCi/m(2 ) dose level was determined to be the single-dose MTD . Repeat dosing at 45 to 60 mCi/m(2 ) was associated with dose-limiting myelosuppression ; however , up to three doses of 30 mCi/m(2 ) could be safely administered . Nonhematologic toxicity was not dose limiting . Targeting of all known sites of bone and soft tissue metastases was seen in all 30 patients with positive bone , computed tomography , or magnetic resonance images . No patient developed a human anti-J591 antibody response to deimmunized J591 regardless of number of doses . Biologic activity was seen with four patients experiencing > or= 50 % declines in prostate-specific antigen ( PSA ) levels lasting from 3 + to 8 months . An additional 16 patients ( 46 % ) experienced PSA stabilization for a median of 60 days ( range , 1 to 21 + months ) . CONCLUSION The MTD of (177)Lu-J591 is 70 mCi/m(2 ) . Multiple doses of 30 mCi/m(2 ) are well tolerated . Acceptable toxicity , excellent targeting of known sites of PC metastases , and biologic activity in patients with and rogen-independent PC warrant further investigation PURPOSE To compare single-agent gemtuzumab ozogamicin ( GO ) with best supportive care ( BSC ) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for intensive chemotherapy . PATIENTS AND METHODS In this trial , patients at least 61 years old were central ly r and omized ( 1:1 ) to receive either a single induction course of GO ( 6 mg/m(2 ) on day 1 and 3 mg/m(2 ) on day 8) or BSC . Patients who did not progress after GO induction could receive up to eight monthly infusions of the immunoconjugate at 2 mg/m(2 ) . R and omization was stratified by age , WHO performance score , CD33 expression status , and center . The primary end point was overall survival ( OS ) by intention-to-treat analysis . RESULTS A total of 237 patients were r and omly assigned ( 118 to GO and 119 to BSC ) . The median OS was 4.9 months ( 95 % CI , 4.2 to 6.8 months ) in the GO group and 3.6 months ( 95 % CI , 2.6 to 4.2 months ) in the BSC group ( hazard ratio , 0.69 ; 95 % CI , 0.53 to 0.90 ; P = .005 ) ; the 1-year OS rate was 24.3 % with GO and 9.7 % with BSC . The OS benefit with GO was consistent across most subgroups , and was especially apparent in patients with high CD33 expression status , in those with favorable/intermediate cytogenetic risk profile , and in women . Overall , complete remission ( CR [ complete remission ] + CRi [ CR with incomplete recovery of peripheral blood counts ] ) occurred in 30 of 111 ( 27 % ) GO recipients . The rates of serious adverse events ( AEs ) were similar in the two groups , and no excess mortality from AEs was observed with GO . CONCLUSION First-line monotherapy with low-dose GO , as compared with BSC , significantly improved OS in older patients with acute myeloid leukemia who were ineligible for intensive chemotherapy . No unexpected AEs were identified and toxicity was manageable BACKGROUND Sipuleucel-T , an autologous active cellular immunotherapy , has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer . METHODS In this double-blind , placebo-controlled , multicenter phase 3 trial , we r and omly assigned 512 patients in a 2:1 ratio to receive either sipuleucel-T ( 341 patients ) or placebo ( 171 patients ) administered intravenously every 2 weeks , for a total of three infusions . The primary end point was overall survival , analyzed by means of a stratified Cox regression model adjusted for baseline levels of serum prostate-specific antigen ( PSA ) and lactate dehydrogenase . RESULTS In the sipuleucel-T group , there was a relative reduction of 22 % in the risk of death as compared with the placebo group ( hazard ratio , 0.78 ; 95 % confidence interval [ CI ] , 0.61 to 0.98 ; P=0.03 ) . This reduction represented a 4.1-month improvement in median survival ( 25.8 months in the sipuleucel-T group vs. 21.7 months in the placebo group ) . The 36-month survival probability was 31.7 % in the sipuleucel-T group versus 23.0 % in the placebo group . The treatment effect was also observed with the use of an unadjusted Cox model and a log-rank test ( hazard ratio , 0.77 ; 95 % CI , 0.61 to 0.97 ; P=0.02 ) and after adjustment for use of docetaxel after the study therapy ( hazard ratio , 0.78 ; 95 % CI , 0.62 to 0.98 ; P=0.03 ) . The time to objective disease progression was similar in the two study groups . Immune responses to the immunizing antigen were observed in patients who received sipuleucel-T. Adverse events that were more frequently reported in the sipuleucel-T group than in the placebo group included chills , fever , and headache . CONCLUSIONS The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer . No effect on the time to disease progression was observed . ( Funded by Dendreon ; Clinical Trials.gov number , NCT00065442 . PURPOSE To determine the maximum-tolerated dose ( MTD ) , toxicity , human antihuman antibody ( HAHA ) response , pharmacokinetics , organ dosimetry , targeting , and preliminary efficacy of yttrium-90-labeled anti-prostate-specific membrane antigen monoclonal antibody J591 ( (90)Y-J591 ) in patients with and rogen-independent prostate cancer (
Output:
| In general , results of this systematic review show promising advances in the treatment of prostate cancer patients with monoclonal antibodies against prostate-specific antigens with regard to PSA/disease response .
Conclusion Currently , the role of immunotherapy in the treatment of advanced prostate cancer still remains debated . |
MS212617 | ***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: A controlled trial was conducted to evaluate a prevention program aim ed at reducing depressive and anxious symptoms in rural school children . Seventh- grade children with elevated depression were selected . Nine primary schools ( n = 90 ) were r and omly assigned to receive the program , and 9 control schools ( n = 99 ) received their usual health education classes . Children completed question naires on depression , anxiety , explanatory style , and social skills . Parents completed the Child Behavior Checklist ( T. M. Achenbach , 1991 ) . No intervention effects were found for depression . Intervention group children reported less anxiety than the control group after the program and at 6-month follow-up and more optimistic explanations at postintervention . Intervention group parents reported fewer child internalizing and externalizing symptoms at postintervention only OBJECTIVE To conduct a placebo-controlled study of the effectiveness of a universal school-based depression prevention program . METHOD Three hundred ninety-two students age 13 to 15 from two schools were r and omized to intervention ( RAP-Kiwi ) and placebo programs run by teachers . RAP-Kiwi was an 11-session manual-based program derived from cognitive-behavioral therapy . The placebo was similar but with cognitive components removed . Outcomes were self-rated depression scales , the Reynolds Adolescent Depression Scale ( RADS ) , and the Beck Depression Inventory II ( BDI-II ) . Follow-up was to 18 months . Analysis was done on an intent-to-treat basis . RESULTS Immediately after the intervention , depression scores were reduced significantly more by RAP-Kiwi than by placebo , with a mean difference in change from baseline between groups of 1.5 on BDI-II ( CI > 0.38 , p = .01 ) and 2.24 on RADS ( CI > 0.22 , p = .04 ) . Categorical analysis confirmed significant clinical benefit with an absolute risk reduction of 3 % ( 95 % CI , 1 - 11 % , McNemar chi , p = .03 ) , with the " number needed to treat " for short-term benefit of 33 . Group differences in depression scores averaged across time to 18 months were significant on RADS but not on BDI-II . Retention rates were 91 % at 6 months and 72 % at 18 months . CONCLUSIONS The RAP-Kiwi program is a potentially effective public health measure . Confirmation of effectiveness measuring episodes of depressive illness and broader measures of adjustment is warranted The authors investigated the effectiveness and specificity of the Penn Resiliency Program ( PRP ; J. E. Gillham , L. H. Jaycox , K. J. Reivich , M. E. P. Seligman , & T. Silver , 1990 ) , a cognitive-behavioral depression prevention program . Children ( N = 697 ) from 3 middle schools were r and omly assigned to PRP , Control ( CON ) , or the Penn Enhancement Program ( PEP ; K. J. Reivich , 1996 ; A. J. Shatté , 1997 ) , an alternate intervention that controls for nonspecific intervention ingredients . Children 's depressive symptoms were assessed through 3 years of follow-up . There was no intervention effect on average levels of depressive symptoms in the full sample . Findings varied by school . In 2 schools , PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP . In the 3rd school , PRP did not prevent depressive symptoms . The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs This paper describes the development and preliminary efficacy of a program design ed to prevent depressive symptoms in at-risk 10 - 13 year-olds , and relates the findings to the current underst and ing of childhood depression . The treatment targets depressive symptoms and related difficulties such as conduct problems , low academic achievement , low social competence , and poor peer relations , by proactively teaching cognitive techniques . Children were identified as ' at-risk ' based on depressive symptoms and their reports of parental conflict . Sixty-nine children participated in treatment groups and were compared to 73 children in control groups . Depressive symptoms were significantly reduced and classroom behavior was significantly improved in the treatment group as compared to controls at post-test . Six-month follow-up showed continued reduction in depressive symptoms , as well as significantly fewer externalizing conduct problems , as compared to controls . The reduction in symptoms was most pronounced in the children who were most at risk This study evaluated the Penn Resiliency Program 's effectiveness in preventing depression when delivered by therapists in a primary care setting . Two-hundred and seventy-one 11- and 12-year-olds , with elevated depressive symptoms , were r and omized to PRP or usual care . Over the 2-year follow-up , PRP improved explanatory style for positive events . PRP 's effects on depressive symptoms and explanatory style for negative events were moderated by sex , with girls benefiting more than boys . Stronger effects were seen in high-fidelity groups than low-fidelity groups . PRP did not significantly prevent depressive disorders but significantly prevented depression , anxiety , and adjustment disorders ( when combined ) among high-symptom participants . Findings are discussed in relation to previous PRP studies and research on the dissemination of psychological interventions BACKGROUND Depressive disorders in adolescents are a widespread and increasing problem . Prevention seems a promising and feasible approach . METHODS We design ed a cognitive-behavioral school-based universal primary prevention program and followed 347 eighth- grade students participating in a r and omized controlled trial for three months . RESULTS In line with our hypothesis , participants in the prevention program remained on a low level of depressive symptoms , having strong social networks . The control group showed increasing depressive symptoms and a reduced social network . Contrary to our expectations , students low in self-efficacy benefited more from the program than high self-efficient students . Social network did not mediate the relationship between participation in the prevention program and changes in depressive symptoms . CONCLUSIONS Our results show that the prevention program had favorable effects . Further research is needed to explore the impact of self-efficacy on the effects of prevention programs
Output:
| Results and conclusion Limited evidence was found to indicate that CBT , regardless of its content ( i.e. with or without hopeful elements ) , is effective at preventing the onset of clinical levels of depression in young people on a sustained basis . |
MS212618 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The value of azithromycin for treatment of acute bronchitis is unknown , even though this drug is commonly prescribed . We have investigated this question in a r and omised , double-blind , controlled trial . METHODS Adults diagnosed with acute bronchitis , without evidence of underlying lung disease , were r and omly assigned azithromycin ( n=112 ) or vitamin C ( n=108 ) for 5 days ( total dose for each 1.5 g ) . All individuals were also given liquid dextromethorphan and albuterol inhaler with a spacer . The primary outcome was improvement in health-related quality of life at 7 days ; an important difference was defined as 0.5 or greater . Analysis was by intention to treat . FINDINGS The study was stopped by the data -monitoring and safety committee when 220 patients had been recruited . On day 7 , the adjusted difference in health-related quality of life was small and not significant ( difference 0.03 [ 95 % CI -0.20 to 0.26 ] , p=0.8 ) . 86 ( 89 % ) of 97 patients in the azithromycin group and 82 ( 89 % ) of 92 in the vitamin C group had returned to their usual activities by day 7 ( difference 0.5 % [ -10 % to 9 % ] , p>0.9 ) . There were no differences in the frequency of adverse effects ; three patients in the vitamin C group discontinued the study medicine because of perceived adverse effects , compared with none in the azithromycin group . Most patients ( 81 % ) reported benefit from the albuterol inhaler . INTERPRETATION Azithromycin is no better than low-dose vitamin C for acute bronchitis . Further studies are needed to identify the best treatment for this disorder BACKGROUND Influenza causes lower respiratory tract complications ( LRTCs ) , particularly bronchitis and pneumonia , in both otherwise healthy adults and those with underlying conditions . The aim of this study was to assess the effect of oseltamivir treatment on the incidence of LRTCs leading to antibiotic treatment and hospitalizations following influenza illness . METHODS We analyzed prospect ively collected data on LRTCs and antibiotic use from 3564 subjects ( age range , 13 - 97 years ) with influenzalike illness enrolled in 10 placebo-controlled , double-blind trials of oseltamivir treatment . RESULTS In adults and adolescents with a proven influenza illness , oseltamivir treatment reduced overall antibiotic use for any reason by 26.7 % ( 14.0 % vs 19.1 % with placebo ; P<.001 ) and the incidence of influenza-related LRTCs result ing in antibiotic therapy by 55 % ( 4.6 % vs 10.3 % with placebo ; P<.001 ) . In those subjects considered at increased risk of complications , 74 ( 18.5 % ) of 401 placebo recipients developed an LRTC leading to antibiotic use compared with 45 ( 12.2 % ) of 368 oseltamivir recipients ( 34.0 % reduction ; P = .02 ) . Hospitalization for any cause occurred in 18 ( 1.7 % ) of 1063 placebo recipients compared with 9 ( 0.7 % ) of 1350 oseltamivir-treated patients ( 59 % reduction ; P = .02 ) . In contrast , among subjects with an influenzalike illness but without a confirmed influenza infection , the incidence of LRTCs ( 6.7 % vs 5.3 % ) , overall antibiotic use ( 19.7 % vs 19.3 % ) , or hospitalizations ( 1.7 % vs 1.9 % ) was similar between placebo and oseltamivir recipients , respectively . CONCLUSION Oseltamivir treatment of influenza illness reduces LRTCs , antibiotic use , and hospitalization in both healthy and " at-risk " adults OBJECTIVE To evaluate the efficacy and safety of oseltamivir phosphate as treatment for naturally acquired influenza infection . METHODS This study was conducted as a double-blind , r and omized , placebo-controlled , multicenter trial during the influenza epidemic season from January to April 2001 at 7 centers in China . A total of 478 adults without other medical history , aged 18 to 65 years , were enrolled into the study . All subjects demonstrated febrile respiratory illness of no more than 36 hours ' duration with a temperature of 37.8 degrees C or more plus at least two of the following symptoms : coryza/nasal congestion , sore throat , cough , myalgia/muscles aches and pain , fatigue , headache or chills/sweats . Individuals were r and omized into either the oseltamivir phosphate or placebo group with identical-looking capsules . Either oral oseltamivir phosphate , 75 mg twice daily , or placebo was administered to the subjects for 5 days . RESULTS A total of 451 individuals were analyzed for efficacy as the intent-to-treat population ( ITT ) ( 216 oseltamivir and 235 placebo ) and 273 individuals were identified as influenza-infected through laboratory test , who were then defined as the intent-to-treat infected population ( ITTI ) ( 134 oseltamivir and 139 placebo ) . Four hundred and fifty nine individuals were included in the safety analysis . In the ITTI population , the cumulative alleviation proportion of oseltamivir group was significantly higher than that of the placebo group ( P = 0.0466 ) ) . The median duration of illness was 91.6 h [ 95 % confidence interval ( CI ) = 80.2 - 101.3 h ] in the oseltamivir group and 95 h ( 95 % CI = 84.5 - 105.3 h ) in the placebo group . The median area under the curve of decreased total score was significantly higher in the oseltamivir group than in the placebo group , 1382.9 and 1236.7 score-hours , respectively ( P = 0.0196 ) . For the ITT population , similar results were observed . Adverse events ( AE ) were similarly reported in both the oseltamivir group and the placebo group . The main adverse events following test drug were gastrointestinal symptoms , neurological symptoms and rashes . CONCLUSION Oseltamivir was effective and well tolerated as treatment of early naturally acquired influenza We conducted the placebo-controlled double-blind multicenter Phase III trial of newly developed selective oral neuraminidase inhibitor , oseltamivir phosphate ( Ro64 - 0796 ) , in order to evaluate the efficacy and safety , when Ro64 - 0796 was administered orally to both type A and type B influenzavirus infected patients . Patients were r and omly assigned to either Ro64 - 0796 75 mg twice daily group or matching placebo group for five days . A total of 316 patients ( Ro64 - 0796 group ; 154 and placebo group ; 162 ) were recruited , and intent-to-treat infected population , which was defined as the patients that study drug was administered one or more and laboratory-confirmed influenzavirus infection was demonstrated , were 122 and 130 , respectively . Ro64 - 0796 decreased significantly median viral titers after 72 hours ( p = 0.0009 . Analysis of covariance ) , indicating the rapid inhibition of virus replication , and duration of illness which was primary variable of efficacy , was reduced statistically significant by one day ( 23.3 hours ) ( p = 0.0216 , generalized Wilcoxon test ) . Ro64 - 0796 treatment also result ed in the reduction of the fever duration and severity of clinical symptoms . Concerning the safety evaluation , the main accompanied symptoms with Ro64 - 0796 application were gastrointestinal disorders such as bellyache , nausea and vomiting . Most of these events were mild and allowable for the clinical use . There was no abnormal change attributable to Ro64 - 0796 application in the clinical laboratory tests as well as the physiological tests . Our data suggests that Ro64 - 0796 is useful in treating the acute influenzavirus infection In this guideline , evidence is presented and specific recommendations are made about how clinicians can differentiate between bacterial and viral causes of acute bronchitis and about when the use of antibiotics in acute bronchitis is beneficial . The numbers in square brackets are cross-references to the numbered sections in the accompanying background paper , Principles of Appropriate Antibiotic Use for Treatment of Acute Bronchitis in Adults : Background , which is part 2 of this guideline ( see pages 521 - 529 ) . Acute Bronchitis Acute bronchitis is a clinical diagnosis , usually referring to an acute respiratory tract infection in which cough , with or without phlegm , is a predominant feature . The American College of Chest Physicians defines acute cough illness , in contrast to chronic or persistent cough , as lasting less than 3 weeks . As one might expect , there is frequent overlap in how clinicians assign each diagnosis . For example , some clinicians diagnose acute bronchitis only when productive cough is present ; others insist on the presence of purulent sputum [ 1.1 ] . Acute upper respiratory tract infection accounted for approximately 70 % of primary diagnoses in adults presenting for an ambulatory office visit with a chief symptom of cough . Asthma and pneumonia were the next most common diagnoses , assigned to 6 % and 5 % of patients , respectively . Previously undiagnosed asthma is a consideration in patients presenting with an acute cough illness . However , in the setting of acute cough ( < 2 to 3 weeks ' duration ) , the diagnosis of asthma is difficult to establish because of transient bronchial hyperresponsiveness ( and abnormal results on spirometry ) , which many patients with uncomplicated acute bronchitis will have . Since pneumonia is the third most common cause of acute cough illness and potentially the most serious , the primary diagnostic objective should be to exclude the presence of pneumonia [ 1.11.3 ] . Diagnosis An evidence - and quality -based review of four prospect i ve studies evaluating the accuracy of history and physical examination in diagnosing radiographic pneumonia concluded that absence of abnormalities in vital signs ( heart rate 100 beats/min , respiratory rate 24 breaths/min , or oral temperature 38 C ) and chest examination ( focal consolidationfor example , rales , egophony , and fremitus ) sufficiently reduces the likelihood of pneumonia to the point where further diagnostic testing is usually not necessary . Cough lasting longer than 3 weeks exceeds the case definition for acute bronchitis ; such patients should be considered to have persistent cough or chronic cough illness . Irwin and colleagues have developed a well-defined approach to the adult with persistent cough that begins with chest radiography ( 1 ) [ 1.3 , 1.4 ] . As in community-acquired pneumonia , microbiological studies of uncomplicated acute bronchitis identify a pathogen in the minority of cases , ranging from 16 % to 40 % . This variability is most likely due to the epidemic nature of agents that produce uncomplicated acute bronchitis and to limitations in viral and bacterial identification techniques . In epidemiologic studies , respiratory viruses , particularly influenza , appear to cause the majority of cases of uncomplicated acute bronchitis when an agent is sought by culture , antibody serology , or polymerase chain reaction . Specific viruses most frequently associated with acute bronchitis include those that produce primarily lower respiratory tract disease ( influenza B , influenza A , parainfluenza 3 , and respiratory syncytial virus ) , as well as viruses that more commonly produce upper respiratory tract symptoms ( corona virus , adenovirus , and rhinoviruses ) [ 2.1 ] . Unless bacterial superinfection is present ( defined as pneumonia with an infiltrate on chest radiography ) , antibiotic treatment does not affect the clinical course of viral respiratory infection . To date , only Bordetella pertussis , Mycoplasma pneumoniae , and Chlamydia pneumoniae ( TWAR ) have been established as nonviral causes of uncomplicated acute bronchitis in adults . As a group , these agents are associated with 5 % to 10 % of total cases of uncomplicated acute bronchitis in adults . No evidence indicates that Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis produce acute bronchitis in adults without underlying lung disease . Since Gram stain and culture of sputum do not reliably detect M. pneumoniae , C. pneumoniae , or B. pertussis , these tests are not recommended in the evaluation of patients with uncomplicated acute bronchitis [ 2.2 ] . Treatment On the basis of the microbiology of acute bronchitis , it should not be surprising that r and omized , placebo-controlled trials have failed to support a role for antibiotic treatment . By the mid-1990s , published review s of r and omized , placebo-controlled trials had concluded that routine antibiotic treatment of acute bronchitis does not have a consistent impact on duration or severity of illness or on potential complications , such as development of pneumonia . Consistent with these conclusions , the U.S. Food and Drug Administration removed uncomplicated acute bronchitis ( and secondary bacterial infections of acute bronchitis ) as an indication for r
Output:
| There is no evidence that oseltamivir reduces the likelihood of hospitalization , pneumonia or the combined outcome of pneumonia , otitis media and sinusitis in the ITT population |
MS212619 | ***TASK*** the task is to summarize an input biomedical literature 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: Regulatory T cells ( T(reg ) ) inhibit the generation of host-versus-tumor immunity via suppression of tumor-specific effector T-cell responses and development of immune tolerance to neoplastic cells . The transcription factor forkhead box P3 ( FOXP3 ) is an intracellular key molecule for T(reg ) development and function and is considered to represent the most specific T(reg ) cell marker . The aim of this study was to analyze the frequency and prognostic impact of tumor-infiltrating FOXP3(+ ) T(reg ) in colorectal cancer ( CRC ) stratified by mismatch-repair ( MMR ) status . Using the tissue microarray technique , 1,420 tumor sample s were immunohistochemically stained for FOXP3 and stratified into 1,197 MMR-proficient and 223 MMR-deficient CRCs . Additionally , the 1,197 MMR-proficient CRCs were r and omized into 2 subgroups ( Test Groups 1 and 2 ; n = 613 and 584 , respectively ) . In both MMR-proficient CRC subgroups high frequency tumor-infiltrating FOXP3(+ ) T(reg ) was associated with early T stage ( p = 0.001 and < 0.001 ) , tumor location ( p = 0.01 and 0.045 ) and increased 5-year survival rate ( p = 0.004 and < 0.001 ) , whereas in MMR-deficient CRCs an association between FOXP3(+ ) T(reg ) and absence of lymph node involvement ( p = 0.023 ) , absence of vascular invasion ( p = 0.023 ) and improved 5-year survival rate ( p = 0.029 ) could be detected . In a multivariable analysis including age , gender , T stage , N stage , tumor grade , vascular invasion , and tumor border configuration , a high FOXP3(+ ) T(reg ) frequency was an independent prognostic factor in both MMR-proficient CRC subsets ( p = 0.019 and p = 0.007 ) , but not in the MMR-deficient CRCs ( p = 0.13 ) . Therefore , high frequency of tumor-infiltrating FOXP3(+ ) T(reg ) is associated with early T stage and independently predicts improved disease-specific survival in MMR-proficient CRC patients Breast carcinomas are often infiltrated by inflammatory cells , particularly macrophages and T lymphocytes , but the significance of these cells remains unclear . One possible role of these inflammatory cells is that they represent a cell-mediated immune response against the carcinoma . CD8(+ ) lymphocytes are a known crucial component of cell-mediated immunity . The purpose of this study was to explore the prognostic value of tumor-infiltrating CD8(+ ) cytotoxic lymphocytes in breast cancer . Tumor-infiltrating CD8(+ ) lymphocytes were assessed by immunohistochemical staining of tissue microarray cores from 1,334 unselected breast tumors from patients with long-term follow-up . The number of CD8(+ ) T cells was counted in tumor nests ( intratumoral ) , in stroma adjacent to tumor cells , and in stroma distant to tumor cells , and their relationship with clinical outcome was determined . The total number of CD8(+ ) cells was positively correlated with tumor grade ( r(s ) = 0.20 ; P < .001 ) and inversely correlated with patient 's age at diagnosis , estrogen receptor-alpha ( ER-α ) , and progesterone receptor ( PgR ) expression ( Mann-Whitney U test , P < .001 ) . The total patient cohort was r and omly divided into two separate training and validation sets before performing univariate survival analysis . Total number and distant stromal CD8(+ ) lymphocytes were associated with better patient survival ( P = .041 and P < .001 , respectively ) in the training set . In multivariate analysis , total CD8(+ ) T-cell count was an independent prognostic factor in both training and validation sets . These results suggest that tumor-infiltrating CD8(+ ) T lymphocytes have antitumor activity as judged by their favorable effect on patients ' survival and could potentially be exploited in the treatment of breast cancer Antitumor immune response and chemotherapy-induced immunomodulation in colon cancer patients represented the rationale to design new strategies , like GOLFIG chemoimmunotherapy ( gemcitabine , oxaliplatin , 5-fluorouracil/folinic acid , granulocyte macrophage colony-stimulating factor , and aldesleukine ) , that result ed a safe and very active regimen . Antitumor activity and immunity feedback to GOLFIG were strictly correlated with the best outcome observed in patients with autoimmunity signs , increase of central memory T cells , and decrease of regulatory T cells ( Treg ) in the peripheral blood . We thus investigated a potential correlation between the Treg tumor infiltration at diagnosis and the clinical outcome in a current r and omized phase 3 trial aim ed to compare the GOLFIG regimen with the st and ard FOLFOX chemotherapy ( GOLFIG-2 ) . An immunohistochemistry study was carried out to quantify the infiltration of Treg/FoxP3 + T lymphocytes in tumor sample s of 57 patients enrolled in the GOLFIG-2 trial . Treg tumor infiltration scores were correlated with overall survival , treatment-relative survival , and progression-free survival ( PFS ) . Higher Treg tumor infiltration scores were associated with a better prognosis in the whole series ( Treg high score vs. low score : overall survival = mean 43.2 mo vs. 28.6 mo , P=0.0005 ) and a better outcome after treatment ( Treg high score vs. low score : PFS = mean 15.8 mo vs. 8.8 mo , P=0.0009 ; treatment-relative survival = mean 23.1 mo vs. 18.2 mo , P=0.004 ) . PFS was significantly longer in GOLFIG high versus all other subgroups ( mean 18.1 mo vs. 9.9 mo , P=0.01 ) . Our results suggest that a higher FoxP3 + T-lymphocyte tumor infiltration score is a favorable prognostic factor in colon cancer patients undergoing chemo or chemoimmunotherapy Overall peritumoural inflammatory cell infiltration is a prognostic variable in solid tumours , but the survival-related impact of the individual cell types within the infiltrate has still not been fully evaluated and compared with the conventional disease classification . In the present study , the prognostic value of individual white cell counts in the peritumoural inflammatory infiltrate in colorectal cancer was assessed . Intra-operative tumour tissue sample s from 584 patients undergoing elective surgery for colorectal cancer were included . None of the patients received pre- or post-operative adjuvant chemotherapy . Tissue blocks were cut from the periphery of the tumours and embedded in paraffin . All blocks included both tumour tissue and normal bowel tissue . Serial sections of 4 microm were analysed for tumour tissue inflammatory cell infiltration using a computer- and video-assisted microscope , which allowed semi-automated quantification of cells within a fixed area . Total white cells and individual counts of eosinophils , neutrophils , mast cells , lymphocytes , and plasma cells were evaluated in every tumour specimen . Stratification into four groups with similar numbers of events was used to dichotomize the cell counts with respect to survival . The median observation period was 61 ( 49 - 75 ) months . In a multivariate analysis including Dukes ' stage , gender , age , peri-operative blood transfusion , tumour location , and counts of specific inflammatory cells , only advanced Dukes ' stage ( p < 0.0001 ) , high age ( p=0.0003 ) , and tumour location in the rectum predicted poor survival , while high counts of eosinophils ( p=0.006 ) and mast cells ( p=0.02 ) predicted good survival . Tumour-associated eosinophilia and mastocytosis appear to be independent prognostic variables in colorectal cancer . Future studies should investigate the potential biological role of tumour tissue eosinophils and mast cells in the modulation of tumour growth Purpose : An efficient adaptive immunity is critical for a longer survival in cancer . We investigated the prognostic value of tumor infiltration by CD8 + T cells expressing the chemokine-receptor-7 ( Tccr7 ) and the correlation between tumor infiltration by Tccr7 and regulatory CD4+FoxP3 + T cells ( Treg ) in 76 metastatic colorectal cancer ( mCRC ) patients enrolled in a phase III trial . Experimental Design : Tccr7 and Treg cell infiltration in tumor sample s was quantified by immunohistochemistry . The correlation among Tccr7 , Treg tumor infiltration , and patients ' outcome was evaluated . Results : High Tccr7 tumor infiltration was predictive of prolonged OS [ high vs. low Tccr7 score : median 38 months ( 95 % CI : 24.5–51.4 ) vs. 20 months ( 95 % CI : 11.4–28.5 ) ; HR = 0.48 ( 95 % CI : 0.24–0.96 ) ; P = 0.03 ] and prolonged progression-free survival [ PFS ; high vs. low Tccr7 score : median 12 months ( 95 % CI : 7.7–16.2 ) vs. 7 months ( 95 % CI : 5.2–8.7 ) ; HR = 0.54 ( 95 % CI : 0.28–1.01 ) ; P = 0.01 ] after front-line chemotherapy . Regression analysis did not show correlation between Tccr7 and Treg infiltration levels . However , the cluster of patients showing concomitant high infiltration by both Tccr7 and Treg disclosed a favorable outcome [ double high vs. double low tumor infiltration score : median OS = 35 months ( 95 % CI : 20.8–49.1 ) vs. 17 months ( 95 % CI : 4.6–29.3 ) ; HR = 0.32 ( 95 % CI : 0.12–0.87 ) ; P = 0.02 and median PFS = 11 months ( 95 % CI : 9.4–12.5 ) vs. 5 months ( 95 % CI : 2.2–7.7 ) ; HR = 0.43 ( 95 % CI : 0.17–1.06 ) ; P = 0.01 ] . Conclusions : High Tccr7 tumor infiltration score is a favorable prognostic factor for mCRC . Our findings underline the relevance of microenvironment-related immunologic events for patient outcome . Clin Cancer Res ; 18(3 ) ; 850–7 . © 2011 AACR Purpose : Host immune response to tumor may be an important prognostic factor for colon cancer patients . However , little is known on prognostic significance of histopathologic lymphoid reaction to tumor , independent of the number of lymph nodes examined and tumoral molecular alterations , including microsatellite instability ( MSI ) and the CpG isl and methylator phenotype ( CIMP ) , both of which are associated with lymphocytic reaction and clinical outcome . Experimental Design : Using 843 colorectal cancer patients in two independent prospect i ve cohorts , we examined patient prognosis in relation to four components of lymphocytic reaction ( i.e. , Crohn's-like reaction , peritumoral reaction , intratumoral perigl and ular reaction , and tumor-infiltrating lymphocytes ) and overall lymphocytic score ( 0 - 12 ) . CIMP was determined using eight markers including CACNA1 G , CDKN2A ( p16 ) , CRABP1 , IGF2 , MLH1 , NEUROG1 , RUNX3 , and SOCS1 . Cox proportional hazard models computed hazard ratio for mortality , adjusted for covariates including tumor stage , body mass index , lymph node count , KRAS , BRAF , p53 , cyclooxygenase-2 ( PTGS2 ) , MSI , CIMP , and LINE-1 methylation . Results : Increasing overall lymphocytic reaction score including tumor-infiltrating lymphocytes was associated with a significant improvement in colorectal cancer – specific and overall survival ( log-rank P < 0.003 ) . These findings remained significant ( adjusted hazard ratio estimates , 0.49 - 0.71 ; Ptrend < 0.009 ) in multivariate models that adjusted for covariates , including body mass index , MSI , CIMP , LINE-1 hypomethylation , and cyclooxygenase-2 . The beneficial effect of tumoral lymphocytic reaction was consistent across strata of clinical , pathologic , and molecular characteristics . Conclusions : Lymphocytic reactions to tumor were associated with improved prognosis among colorectal cancer patients , independent of lymph node count and other clinical , pathologic , and molecular characteristics . ( Clin Cancer Res 2009;15(20):6412–20 PURPOSE To
Output:
| Stratification by location and T lymphocyte subset indicated that in the tumour centre , CD3 + , CD8 + and FoxP3 + infiltrates were not statistically significant prognostic markers for OS or CS .
In the tumour stroma , high CD8 + , but not CD3 + or FoxP3 + cell infiltrates indicated increased OS .
Furthermore , high CD3 + cell infiltrate was detected at the invasive tumour margin in patients with good OS and DFS ; and high CCR7 + infiltrate was also indicated increased OS .
Conclusion : Overall , high generalised tumour inflammatory infiltrate could be a good prognostic marker for CRC . |
MS212620 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Studies with pertuzumab , a novel anti-HER2 antibody , show improved efficacy when combined with the established HER2-directed antibody trastuzumab in breast cancer therapy . We investigated the combination of pertuzumab or trastuzumab , or both , with docetaxel and the combination of pertuzumab and trastuzumab without chemotherapy in the neoadjuvant setting . METHODS In this multicentre , open-label , phase 2 study , treatment-naive women with HER2-positive breast cancer were r and omly assigned ( 1:1:1:1 ) central ly and stratified by operable , locally advanced , and inflammatory breast cancer , and by hormone receptor expression to receive four neoadjuvant cycles of : trastuzumab ( 8 mg/kg loading dose , followed by 6 mg/kg every 3 weeks ) plus docetaxel ( 75 mg/m(2 ) , escalating , if tolerated , to 100 mg/m(2 ) every 3 weeks ; group A ) or pertuzumab ( loading dose 840 mg , followed by 420 mg every 3 weeks ) and trastuzumab plus docetaxel ( group B ) or pertuzumab and trastuzumab ( group C ) or pertuzumab plus docetaxel ( group D ) . The primary endpoint , examined in the intention-to-treat population , was pathological complete response in the breast . Neither patients nor investigators were masked to treatment . This study is registered with Clinical Trials.gov , number NCT00545688 . FINDINGS Of 417 eligible patients , 107 were r and omly assigned to group A , 107 to group B , 107 to group C , and 96 to group D. Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate ( 49 of 107 patients ; 45·8 % [ 95 % CI 36·1 - 55·7 ] ) compared with those given trastuzumab plus docetaxel ( group A ; 31 of 107 ; 29·0 % [ 20·6 - 38·5 ] ; p=0·0141 ) . 23 of 96 ( 24·0 % [ 15·8 - 33·7 ] ) women given pertuzumab plus docetaxel ( group D ) had a pathological complete response , as did 18 of 107 ( 16·8 % [ 10·3 - 25·3 ] ) given pertuzumab and trastuzumab ( group C ) . The most common adverse events of grade 3 or higher were neutropenia ( 61 of 107 women in group A , 48 of 107 in group B , one of 108 in group C , and 52 of 94 in group D ) , febrile neutropenia ( eight , nine , none , and seven , respectively ) , and leucopenia ( 13 , five , none , and seven , respectively ) . The number of serious adverse events was similar in groups A , B , and D ( 15 - 20 serious adverse events per group in 10 - 17 % of patients ) but lower in group C ( four serious adverse events in 4 % of patients ) . INTERPRETATION Patients given pertuzumab and trastuzumab plus docetaxel ( group B ) had a significantly improved pathological complete response rate compared with those given trastuzumab plus docetaxel , without substantial differences in tolerability . Pertuzumab and trastuzumab without chemotherapy eradicated tumours in a proportion of women and showed a favourable safety profile . These findings justify further exploration in adjuvant trials and support the neoadjuvant approach for accelerating drug assessment in early breast cancer . FUNDING F Hoffmann-La Roche BACKGROUND We studied the effect on tumour response to neoadjuvant therapy of the substitution of lapatinib for trastuzumab in combination with weekly paclitaxel after doxorubicin plus cyclophosphamide treatment , and of the addition of lapatinib and trastuzumab combined after doxorubicin plus cyclophosphamide treatment in patients with HER2-positive operable breast cancer to determine whether there would be a benefit of dual HER2 blockade in these patients . METHODS For this open-label , r and omised phase 3 trial we recruited women aged 18 years or older with an ECOG performance status of 0 or 1 with operable HER2-positive breast cancer . Each received four cycles of st and ard doxorubicin 60 mg/m(2 ) and cyclophosphamide 600 mg/m(2 ) intravenously on day 1 every 3 weeks followed by four cycles of weekly paclitaxel ( 80 mg/m(2 ) ) intravenously on days 1 , 8 , and 15 , every 4 weeks . Concurrently with weekly paclitaxel , patients received either trastuzumab ( 4 mg/kg load , then 2 mg/kg intravenously ) weekly until surgery , lapatinib ( 1250 mg orally ) daily until surgery , or weekly trastuzumab plus lapatinib ( 750 mg orally ) daily until surgery . After surgery , all patients received trastuzumab to complete 52 weeks of HER2-targeted therapy . R and omisation ( ratio 1:1:1 ) was done central ly with stratification by clinical tumour size , clinical nodal status , hormone-receptor status , and age . The primary endpoint was the pathological complete response in the breast , and analysis was performed on an intention-to-treat population . FINDINGS Patient accrual started on July 16 , 2007 , and was completed on June 30 , 2011 ; 529 women were enrolled in the trial . 519 patients had their pathological response determined . Breast pathological complete response was noted in 93 ( 52·5 % , 95 % CI 44·9 - 59·5 ) of 177 patients in the trastuzumab group , 91 ( 53·2 % , 45·4 - 60·3 ) of 171 patients in the lapatinib group ( p=0·9852 ) ; and 106 ( 62·0 % , 54·3 - 68·8 ) of 171 patients in the combination group ( p=0·095 ) . The most common grade 3 and 4 toxic effects were neutropenia ( 29 [ 16 % ] patients in the trastuzumab group [ grade 4 in five patients ( 3 % ) , 28 [ 16 % ] in the lapatinib group [ grade 4 in eight patients ( 5 % ) ] , and 29 [ 17 % ] in the combination group [ grade 4 in nine patients ( 5 % ) ] ) and grade 3 diarrhoea ( four [ 2 % ] patients in the trastuzumab group , 35 [ 20 % ] in the lapatinib group , and 46 [ 27 % ] in the combination group ; p<0·0001 ) . Symptomatic congestive heart failure defined as New York Heart Association Class III or IV events occurred in seven ( 4 % ) patients in the trastuzumab group , seven ( 4 % ) in the lapatinib group , and one ( < 1 % ) in the combination group ; p=0·185 ) . INTERPRETATION Substitution of lapatinib for trastuzumab in combination with chemotherapy result ed in similar high percentages of pathological complete response . Combined HER2-targeted therapy produced a numerically but insignificantly higher pathological complete response percentage than single-agent HER2-directed therapy ; these findings are consistent with results from other studies . Trials are being undertaken to further assess these findings in the adjuvant setting Overexpression of human epidermal growth factor receptor-2 ( HER2 ) in metastatic breast cancer ( MBC ) is associated with poor prognosis . This single-arm open-label trial ( EGF109491 ; NCT00508274 ) was design ed to confirm the efficacy and safety of lapatinib in combination with capecitabine in 52 heavily pretreated Chinese patients with HER2-positive MBC . The primary endpoint was clinical benefit rate ( CBR ) . Secondary endpoints included progression-free survival ( PFS ) , time to response ( TTR ) , duration of response ( DoR ) , central nervous system ( CNS ) as first site of relapse , and safety . The results showed that there were 23 patients with partial responses and 7 patients with stable disease , result ing in a CBR of 57.7 % . The median PFS was 6.34 months ( 95 % confidence interval , 4.93–9.82 months ) . The median TTR and DoR were 4.07 months ( range , 0.03–14.78 months ) and 6.93 months ( range , 1.45–9.72 months ) , respectively . Thirteen ( 25.0 % ) patients had new lesions as disease progression . Among them , 2 ( 3.8 % ) patients had CNS disease reported as the first relapse . The most common toxicities were palmar-plantar erythrodysesthesia ( 59.6 % ) , diarrhea ( 48.1 % ) , rash ( 48.1 % ) , hyperbilirubinemia ( 34.6 % ) , and fatigue ( 30.8 % ) . Exploratory analyses of oncogenic mutations of PIK3CA suggested that of 38 patients providing a tumor sample , baseline PIK3CA mutation status was not associated with CBR ( P = 0.639 ) or PFS ( P = 0.989 ) . These data confirm that the lapatinib plus capecitabine combination is an effective and well-tolerated treatment option for Chinese women with heavily pretreated MBC , irrespective of PIK3CA status BACKGROUND The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic antitumour activity in models of HER2-overexpressing breast cancer . We argue that the two anti-HER2 agents given together would be better than single-agent therapy . METHODS In this parallel groups , r and omised , open-label , phase 3 study undertaken between Jan 5 , 2008 , and May 27 , 2010 , women from 23 countries with HER2-positive primary breast cancer with tumours greater than 2 cm in diameter were r and omly assigned to oral lapatinib ( 1500 mg ) , intravenous trastuzumab ( loading dose 4 mg/kg [ DOSAGE ERROR CORRECTED ] , subsequent doses 2 mg/kg ) , or lapatinib ( 1000 mg ) plus trastuzumab . Treatment allocation was by stratified , permuted blocks r and omisation , with four stratification factors . Anti-HER2 therapy alone was given for the first 6 weeks ; weekly paclitaxel ( 80 mg/m(2 ) ) was then added to the regimen for a further 12 weeks , before definitive surgery was undertaken . After surgery , patients received adjuvant chemotherapy followed by the same targeted therapy as in the neoadjuvant phase to 52 weeks . The primary endpoint was the rate of pathological complete response ( pCR ) , analysed by intention to treat . This trial is registered with Clinical Trials.gov , NCT00553358 . FINDINGS 154 patients received lapatinib , 149 trastuzumab , and 152 the combination . pCR rate was significantly higher in the group given lapatinib and trastuzumab ( 78 of 152 patients [ 51·3 % ; 95 % CI 43·1 - 59·5 ] ) than in the group given trastuzumab alone ( 44 of 149 patients [ 29·5 % ; 22·4 - 37·5 ] ; difference 21·1 % , 9·1 - 34·2 , p=0·0001 ) . We recorded no significant difference in pCR between the lapatinib ( 38 of 154 patients [ 24·7 % , 18·1 - 32·3 ] ) and the trastuzumab ( difference -4·8 % , -17·6 to 8·2 , p=0·34 ) groups . No major cardiac dysfunctions occurred . Frequency of grade 3 diarrhoea was higher with lapatinib ( 36 patients [ 23·4 % ] ) and lapatinib plus trastuzumab ( 32 [ 21·1 % ] ) than with trastuzumab ( three [ 2·0 % ] ) . Similarly , grade 3 liver-enzyme alterations were more frequent with lapatinib ( 27 [ 17·5 % ] ) and lapatinib plus trastuzumab ( 15 [ 9·9 % ] ) than with trastuzumab ( 11 [ 7·4 % ] ) . INTERPRETATION Dual inhibition of HER2 might be a valid approach to treatment of HER2-positive breast cancer in the neoadjuvant setting . FUNDING GlaxoSmithKline PURPOSE This is a noncomparative , r and omized , phase II trial of preoperative taxane-anthracycline in combination with trastuzumab , lapatinib , or combined trastuzumab plus lapatinib in patients with human epidermal growth factor receptor 2 ( HER2 ) -positive , stage II to IIIA operable breast cancer . The primary aim was to estimate the percentage of pathologic
Output:
| Subgroup analyses indicated that the addition of chemotherapy to dual anti-HER2 therapy could greatly improve pCR in the neoadjuvant setting s. However , in the metastatic setting , similar PFS and OS were found in patients receiving dual anti-HER2 therapy with or without chemotherapy .
Dual anti-HER2 therapy was associated with more frequent adverse events than monotherapy , but no statistical differences were observed in cardiac toxicity .
Conclusions This systematic review provides a summary of all the data currently available , and confirms the benefits and risks of dual anti-HER2 therapy for HER2-positive breast cancer |
MS212621 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 drug-related events are common in the elderly , and inappropriate prescribing is a preventable risk factor . Our objective was to determine whether inappropriate prescribing could be reduced when primary care physicians had computer-based access to information on all prescriptions dispensed and automated alerts for potential prescribing problems . METHODS We r and omly assigned 107 primary care physicians with at least 100 patients aged 66 years and older ( total 12 560 ) to a group receiving computerized decision-making support ( CDS ) or a control group . Physicians in the CDS group had access to information on current and past prescriptions through a dedicated computer link to the provincial seniors ' drug-insurance program . When any of 159 clinical ly relevant prescribing problems were identified by the CDS software , the physician received an alert that identified the nature of the problem , possible consequences and alternative therapy . The rate of initiation and discontinuation of potentially inappropriate prescriptions was assessed over a 13-month period . RESULTS In the 2 months before the study , 31.8 % of the patients in the CDS group and 33.3 % of those in the control group had at least 1 potentially inappropriate prescription . During the study the number of new potentially inappropriate prescriptions per 1000 visits was significantly lower ( 18 % ) in the CDS group than in the control group ( relative rate [ RR ] 0.82 , 95 % confidence interval [ CI ] 0.69 - 0.98 ) , but differences between the groups in the rate of discontinuation of potentially inappropriate prescriptions were significant only for therapeutic duplication by the study physician and another physician ( RR 1.66 , 95 % CI 0.99 - 2.79 ) and drug interactions caused by prescriptions written by the study physician ( RR 2.15 , 95 % CI 0.98 - 4.70 ) . INTERPRETATION Computer-based access to complete drug profiles and alerts about potential prescribing problems reduces the rate of initiation of potentially inappropriate prescriptions but has a more selective effect on the discontinuation of such prescriptions Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners Although absolute risk of death associated with raised blood pressure increases with age , the benefits of treatment are greater in elderly patients . Despite this , the ' rule of halves ' particularly applies to this group . We conducted a r and omised controlled trial to evaluate different levels of feedback design ed to improve identification , treatment and control of elderly hypertensives . Fifty-two general practice s were r and omly allocated to either : Control ( n=19 ) , Audit only feedback ( n=16 ) or Audit plus Strategic feedback , prioritising patients by absolute risk ( n=17 ) . Feedback was based on electronic data , annually extracted from practice computer systems . Data were collected for 265,572 patients , 30,345 aged 65 - 79 . The proportion of known hypertensives in each group with BP recorded increased over the study period and the numbers of untreated and uncontrolled patients reduced . There was a significant difference in mean systolic pressure between the Audit plus Strategic and Audit only groups and significantly greater control in the Audit plus Strategic group . Providing patient-specific practice feedback can impact on identification and management of hypertension in the elderly and produce a significant increase in control Abstract Objectives : To investigate the effect of a computer based clinical decision support system and a risk chart on absolute cardiovascular risk , blood pressure , and prescribing of cardiovascular drugs in hypertensive patients . Design : Cluster r and omised controlled trial . Setting : 27 general practice s in Avon . Participants : 614 patients aged between 60 and 79 years with high blood pressure . Interventions : Patients were r and omised to computer based clinical decision support system plus cardiovascular risk chart ; cardiovascular risk chart alone ; or usual care . Main outcome measures : Percentage of patients in each group with a five year cardiovascular risk≥10 % , systolic blood pressure , diastolic blood pressure , prescribing of cardiovascular drugs . Results : Patients in the computer based clinical decision support system and chart only groups were no more likely to have cardiovascular risk reduced to below 10 % than patients receiving usual care . Patients in the computer based clinical decision support group were more likely to have a cardiovascular risk≥10 % than chart only patients , odds ratio 2.3 ( 95 % confidence interval 1.1 to 4.8 ) . The chart only group had significantly lower systolic blood pressure compared with the usual care group ( difference in means−4.6 mm Hg ( 95 % confidence interval−8.4 to−0.8 ) . Reduction of diastolic blood pressure did not differ between the three groups . The chart only group were twice as likely to be prescribed two classes of cardiovascular drugs and over three times as likely to be prescribed three or more classes of drugs compared with the other groups . Conclusions : The computer based clinical decision support system did not confer any benefit in absolute risk reduction or blood pressure control and requires further development and evaluation before use in clinical care can be recommended . Use of chart guidelines are associated with a potentially important reduction in systolic blood pressure OBJECTIVE To review all r and omized clinical trials addressing the efficacy of clinical information systems and to determine the clinical setting s , types of interventions , and effects studied . DATA SOURCES Extensive and systematic MEDLINE search es were conducted using a combination of medical subject headings ( MeSH ) and textword terms to collect trial reports . Manual search es of books and monographs as well as informal contacts were also used . STUDY SELECTION The eligibility criteria were ( 1 ) r and omized controlled clinical trial , ( 2 ) computerized information intervention in the study group , and ( 3 ) effect measured on the process or outcome of care . DATA EXTRACTION Two research assistants independently abstract ed from the selected reports the following structured information : trial sites , computerized interventions , effect variables , and outcomes . Three investigators evaluated the combined list of trial features for setting , intervention , and effect . The statistical analysis included an evaluation of agreement in developing classifications and an analysis of the ratio of positive trial outcomes . DATA SYNTHESIS Most information services were tested in outpatient care ( 82 % ) , particularly in primary care ( 66 % ) . The information intervention targeted the provider in 64 % of the trials . The effect was primarily measured for the process of care ( 76 % ) . Provider prompt/reminder , computer-assisted treatment planner , interactive patient education/therapy , and patient prompt/reminder were significantly successful interventions ( sign test , P < .05 ) . CONCLUSIONS R and omized clinical trials confirm that four generic information interventions are active ingredients of computer systems and can make a significant difference in family medicine ( physician and patient reminders , treatment planner , and patient education ) . To manage care and improve quality , primary care computer systems should incorporate these effective information services OBJECTIVE To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners ( GPs ) . RESEARCH DESIGN AND METHODS A r and omized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Data base . Among these , 150 GPs ( intervention group ) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor ( " high risk " ) , whereas the other 150 GPs ( control group ) received only the letter . The electronic reminder , integrated into a st and ard software system for the management of the daily clinical practice , was displayed when every participating GP opened the medical record of diabetic patients aged > or = 30 years . Only high-risk diabetic patients were included in the analysis . Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up . RESULTS We selected 15,343 high-risk diabetic patients , 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group . Overall , 1,672 patients ( 22.9 % ) of the control group and 1,886 ( 23.5 % ) patients of the intervention group received antiplatelet drugs at baseline ( P = N.S. ) . At the end of the follow-up , the number of treated patients was significantly increased in the intervention group ( odds ratio 1.99 , 95 % CI 1.79 - 2.22 ) versus the control group . The effect of the electronic reminder was more relevant among those patients with one or more cardiovascular risk factors but without previous cardiovascular diseases ( CVDs ) , compared with those with CVDs . CONCLUSIONS These findings provide evidence for the effect of an electronic reminder in affecting the prescriptive behavior of GPs The majority of general practitioners in the Netherl and s have replaced traditional paper-based patient records with computer-based records ; physicians enter patient data themselves in the computer during patient encounters ( 1 ) . The use of electronic patient records creates new opportunities to influence physician behavior through implementation of decision support systems ( 2 - 7 ) . In recent years , research ers have documented various computer-based decision support systems that have influenced physician behavior ( 8 - 17 ) . Other investigators , however , have reported that computer-based decision support has not affected patient care ( 18 ) . To resolve the issue , investigators have compared the results of studies that were conducted in different setting s , used different methods , and involved different population s ( 19 ) . Studies comparing different methods of providing computer-based decision support in r and omized trials are not available . In the Netherl and s , 3 % to 4 % of patient encounters with general practitioners in primary care result in the ordering of blood tests ( 20 ) . However , ordering of blood tests is not always appropriate ( 21 - 29 ) . Research ers argue that excessive ordering of tests causes physicians to pursue evaluation of false-positive results , which in turn leads to additional unnecessary diagnostic examinations ( 30 - 35 ) . Two methods have proven effective in reducing the number of tests ordered by Dutch general practitioners . The first method is based on restricting the number of tests that are listed on an order form . Zaat and colleagues ( 36 , 37 ) developed a restricted paper order form that replaced the existing form . The second method involves introduction of indication-oriented order forms that are based on clinical practice guidelines ( 38 - 40 ) . We hypothesized that an indication-oriented order form based on guidelines , which would provide an optimally restricted list of tests that are relevant for a specific indication , would be more effective in decreasing the number of tests ordered compared with an order form that provides an initially limited list of tests . We therefore conducted a r and omized trial to compare the effect of two versions of BloodLink , a computer-based clinical decision support system , on blood test ordering among Dutch general practitioners . Methods Participants In August and September 1995 , all 64 practice s ( 94 general practitioners ) in the region of Delft , the Netherl and s , were invited to participate in the study . Only practice s that had replaced their paper-based patient records with electronic records and were using the computer during patient encounters were eligible . A total of 46 practice s ( 62 general practitioners ) agreed to participate . R and omization To avoid contamination , we performed r and om allocation at the level of the practice ( 41 , 42 ) . The practice s were first stratified by type : solo practice s or group practice s ( two or more general practitioners in the same practice ) . Each practice was subsequently assigned by simple r and om allocation to use BloodLink-Restricted or BloodLink- Guideline for the full study period . A research er who was not involved in the study and was blinded to the identity of the practice s performed the r and omization by using a r and om-numbers table . After r and omization , 22 practice s involving 30 general practitioners were assigned to use BloodLink-Restricted and 24 practice s involving 32 general practitioners were assigned to use BloodLink- Guideline . Intervention We developed two versions of BloodLink , a computer-based decision support system . BloodLink-Restricted initially displays a reduced list of tests ,
Output:
| Conclusions Currently there is limited positive EMR impact in the physician office . |
MS212622 | ***TASK*** the task is to summarize an input biomedical literature 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 In this study , we examined whether cyclosporine was effective when combined with everolimus in clinical heart transplantation ( HT ) . PATIENTS AND METHODS From August 2004 to July 2007 , 108 adult patients underwent primary HT . The main exclusion criteria were : donors > 60 years ; cold ischemia times > 6 hours ; recipients of multiorgan transplantation or a previous transplantation ; and panel-reactive antibodies > or = 25 % . The cyclosporine plus everolimus regimen ( group CE , n = 32 ) was suggested first ; upon refusal or if the recipient or donor was positive for hepatitis B surface antigen or PCR + hepatitis C infection , then patient was r and omly assigned to success cyclosporine plus mycophenolate mofetil ( MMF ; group CM , n = 24 ) or tacrolimus plus MMF ( group TM , n = 25 ) . All patients underwent similar operative procedures and postoperative care with protocol endomyocardial biopsies . RESULTS No 30-day mortality was noted in any group . The efficacy failure rates were 3 % , 25 % , and 16 % in groups CE , CM , and TM , respectively ( P = .04 between groups CE and CM ) . The 1-year survivals were 96.7 % + /- 18.1 % , 89.7 % + /- 29.8 % , and 81.0 % + /- 35.5 % for groups CE , CM , and TM , respectively ( P = .04 between groups CE and TM ) . The 3-year survival rates were 91.9 % + /- 28.3 % , 79.8 % + /- 46.0 % , and 81.0 % + /- 35.5 % in groups CE , CM , and TM , respectively . CONCLUSIONS The 3 immunosuppressive regimens offered good efficacy after HT . The cyclosporine plus everolimus regimen showed a significantly better result with less efficacy failure ( compared with cyclosporine plus MMF : 3 % vs 25 % ) and better 1-year survival compared with tacrolimus plus MMF : 96.7 % vs 81.0 % Reduction of allograft rejections remains a primary goal for patients after orthotopic heart transplantation . In an open , multicentre , prospect ively r and omised , parallel group study , patients with primary orthotopic heart transplantation under oral immunosuppressive treatments with tacrolimus ( FK506 ) or cyclosporine ( s and immun ) were compared with respect to medical outcome data . As health-related quality -of-life ( HRQOL ) is also supposed to be an important outcome parameter , it was assessed as a secondary variable in these two patient groups . Patients ' self-rated generic HRQOL was assessed 6 weeks , 3 months , 6 months and 12 months after surgery with the SF-36 question naire , a generic HRQOL instrument . For 70 patients ( 46 under tacrolimus , 24 under cyclosporine ) , intent-to-treat analyses were carried out . The tacrolimus group showed improvements in the different HRQOL subscales of the SF-36 compared to the cyclosporine group . Especially the SF-36 subscales ' vitality ' and ' mental health ' showed statistically higher scores for the tacrolimus group . Aggregating psychological and cognitive subscales in the ' mental component score ' , patients treated with tacrolimus showed a statistically significant improvement compared to the cyclosporine group . The assessment of HRQOL variables in the evaluation of treatment effects proved to be an outcome parameter in this study . The results demonstrate the benefit of tacrolimus with respect to the HRQOL of patients , especially in the psychological dimension BACKGROUND Tacrolimus-based immunosuppression seems safe and effective in liver and kidney transplantation . To assess the safety and efficacy of tacrolimus (TAC)-based immunosuppression after cardiac transplantation as well as the relative impact of tacrolimus on immunosuppression-related side effects such as hypertension and hyperlipidemia , we conducted a prospect i ve , r and omized , open-label , multicenter study of otherwise identical tacrolimus- and cyclosporine-based immunosuppressive regimens in adult patients undergoing cardiac transplantation . METHODS Eighty-five adult patients ( pts ) at six United States cardiac transplant centers , undergoing their first cardiac transplant procedure , were prospect ively r and omized to receive either TAC-based ( n = 39 ) or cyclosporine (CYA)-based ( n = 46 ) immunosuppression . All pts received a triple-drug protocol with 15 pts ( 18 % ) receiving peri-operative OKT3 to delay TAC/CYA due to pre-transplant renal dysfunction . Endomyocardial biopsies were performed at Weeks 1 , 2 , 3 , 4 , 6 , 8 , 10 , 12 , 24 , and 52 . The study duration was 12 months . RESULTS Patients were mostly male ( 87 % ) Caucasian ( 90 % ) with a mean age of 54 years and primary diagnoses of coronary artery disease ( 55 % ) and idiopathic dilated cardiomyopathy ( 41 % ) . There were no significant demographic differences between groups . Patient and allograft survival were not different in the two groups . The probability and overall incidence of each grade of rejection , whether treated or not , and the types of treatment required did not differ between the groups . At baseline and through 12 months of follow-up , chemistry and hematology values were similar between the groups except serum cholesterol was higher in the CYA group at 3 , 6 , and 12 months ( 239 vs 205 mg/dL , 246 vs 191 mg/dL , 212 vs 186 mg/dL , respectively , p < 0.001 ) . Likewise , LDL-cholesterol , HDL-cholesterol and triglycerides were significantly higher in the CYA group . More CYA patients received therapy for hypercholesterolemia ( 71 % vs 41 % at 12 months , p = 0.01 ) . There were no significant differences in renal function , hyperglycemia , hypomagnesemia , or hyperkalemia during the first 12 months . More CYA patients developed new-onset hypertension requiring pharmacologic treatment ( 71 % vs 48 % , p = 0.05 ) . The incidence of infection was the same for the two groups ( 2.6 episodes/pt/12 month follow-up ) . CONCLUSION Tacrolimus-based immunosuppression seems effective for rejection prophylaxis during the first year after cardiac transplantation and is associated with less hypertension and hyperlipidemia and no difference in renal function , hyperglycemia or infection incidence when compared to cyclosporine-based immunosuppression UNLABELLED This study compares the pharmacokinetics of tacrolimus ( TAC ) and cyclosporine Neoral ( CsA ) in cardiac transplant recipients . METHODS Twenty-six de novo cardiac recipients were prospect ively and r and omly assigned to receive oral TAC- or CsA-based regimens after 5 to 6 days of rabbit antithymocyte globulin induction . Blood sample s were collected at 0 ( before the dose ) and 0.5 , 1 , 2 , 3 , 4 , 6 , 8 , 10 , as well as 12 hours after drug administration . The pharmacokinetics of the first dose ( PK-1 ) and at steady state ( PK-S , 1 month after transplantation ) were analyzed . RESULTS Comparing the AUC per milligram dose , there was no significant difference between PK-1 and PK-S among TAC ( 46.0 + /- 24.3 ng x h/mg x mL versus 69.0 + /- 43.9 ng x h/mg x mL , P = .15 by paired t-test ) , but a significant difference in CsA ( 25.2 + /- 11.4 ng x h/mg x mL versus 45.4 + /- 12.9 ng x h/mg x mL , P = .0005 by paired t-test ) . This means better TAC absorption in the early post-heart transplant period . Using a single-point blood level to predict AUC , TAC showed a significantly higher correlation than CsA at all corresponding sampling times . Besides , C12 in both PK-1 and PK-S of TAC displayed good correlations to the AUC ( r2 = .895 , P = .00 in PK-1 and r2 = .81 , P = .00 in PK-S ) . The TAC trough level was accurate enough to predict the AUC . CONCLUSION The pharmacokinetic profile of TAC is more reliable than that of CsA in the early post-heart transplant period . A high correlation of trough blood levels with AUC omits the requirement for a multiple sampling strategy to more accurately measure AUC as is needed with INTRODUCTION This study compared the efficacy and safety of a tacrolimus (TAC)-based with a cyclosporine (CsA)microemulsion-based immunosuppressive regimen in primary cardiac transplantation . METHODS Heart recipients were r and omly assigned to receive either TAC or CsA regimen after sequential induction with rabbit anti-thymoglobulin . Endomyocardial biopsies were performed at weeks 1 , 2 , 3 , and 4 and months 2 , 3 , and 6 . RESULTS Among 21 adult patients ( TAC , 11 ; CsA , 10 ) in this study , patient survival rates were 100 % in both groups at the end of 6 months . One patient ( 9 % ) in the TAC group experienced acute rejection ( ISHLT > or = 1B ) versus 6 patients ( 60 % ) in the CsA group ( P = .02 ) . The effects on hematology , biochemistry , cytomegalovirus infection , and hemodynamics were similar in both groups except for better lipid profiles in the TAC group . There were no significant differences in severe adverse events . CONCLUSION The TAC-based regimen had a lower risk of acute rejection compared with CsA in heart transplant recipients . The safety profiles were similar in both groups . Therefore , TAC is an alternative to CsA as a primary maintenance immunosuppressant in heart transplantation BACKGROUND To compare the efficacy and safety of tacrolimus and cyclosporine in heart transplantation , this single-center , prospect i ve , r and omized , open-label clinical trial was undertaken . METHODS Seventy-three adult patients were r and omly assigned at the time of transplantation to receive either tacrolimus ( n=43 ) or cyclosporine ( n=30 ) as the primary immunosuppressant . Ten of the 43 patients in the tacrolimus group received the drug intravenously in the perioperative period ; all other patients received only oral tacrolimus . RESULTS With a mean follow-up of 27 months , patient survival rates ( tacrolimus 83 % , cyclosporine 81 % ) were similar . Fewer patients experienced acute rejection in the tacrolimus group ( 79 % ) than in the cyclosporine group ( 100 % ) , but the difference was not statistically significant . The number of infections and dialysis and insulin requirements were similar for the 2 treatment groups , but the proportion of patients requiring multidrug antihypertensive regimens was lower in the tacrolimus group ( 12.5 % vs 50.0 % at month 6 ; p=.025 ) . The interpatient variance in pharmacokinetic parameters in a subset of 10 patients was much higher after the first oral dose of tacrolimus than at steady-state ( eg , first-dose time at which maximal concentration is reached ( t(max ) ) : 3.5+/-2.5h , steady-state t(max ) : 2.0+/-0.7h ) , and patients treated with intravenous tacrolimus ( n=13 ) rather than oral tacrolimus ( n=30 ) reached target concentrations faster and with less interpatient variability ( eg , at day 0 : 9.72+/-10.9 ng/mL intravenously vs 3.31+/-8.1 orally ) . CONCLUSIONS Tacrolimus was associated with similar efficacy and safety profiles compared with cyclosporine . The higher interpatient variance in absorption associated with oral tacrolimus during the first few days after transplantation would suggest that intravenous tacrolimus should be used during the perioperative period The most advantageous combination of immunosuppressive agents for cardiac transplant recipients has not yet been established . Between November 2001 and June 2003 , 343 de novo cardiac transplant recipients were r and omized to receive steroids and either tacrolimus ( TAC ) + sirolimus ( SRL ) , TAC + mycophenolate mofetil ( MMF ) or cyclosporine ( CYA ) + MMF . Antilymphocyte induction therapy was allowed for up to 5 days . The primary endpoint of ≥3A rejection or hemodynamic compromise rejection requiring treatment showed no significant difference at 6 months ( TAC/MMF 22.4 % , TAC/SRL 24.3 % , CYA/MMF 31.6 % , p = 0.271 ) and 1 year ( p = 0.056 ) , but it
Output:
| No significant differences between the two calcineurin inhibitors were found with regard to acute rejections causing haemodynamic instability , diabetes , renal dysfunction , infection , malignancy , or neurotoxicity .
Conclusion Tacrolimus seems to be superior to cyclosporine in heart transplant patients with regard to hypertension , hyperlipidaemia , gingival hyperplasia and hirsutism .
In addition , tacrolimus seems to be superior to microemulsion cyclosporine in heart transplant patients with regard to a number of outcomes , including death . |
MS212623 | ***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: PURPOSE To examine the extent to which increasingly plainer packaging might increase recall of health warnings . DESIGN A 4 ( pack ID levels ) x 2 ( smoking status : smokers and non-smokers ) between-subjects design in which participants were r and omly assigned to view one package . SAMPLE Two hundred and twenty students from three universities in Nova Scotia , Canada , participated in the survey . MEASURES Participants were asked to recall the health warning on their package . ANALYSIS A sequential binary logistic regression test to examine whether plain packaging and /or smoking status affects health warning recall . RESULTS The odds of recalling the correct health warnings were significantly higher for the two plainest packages relative to the original package . The odds of recalling the correct health warning were also higher for non-smokers relative to smokers . CONCLUSIONS The results provide compelling evidence that health warnings on plain packages can be more easily recalled Objectives To compare adolescents ’ responses to three different styles of cigarette packaging : novelty ( br and ed packs design ed with a distinctive shape , opening style or bright colour ) , regular ( br and ed pack with no special design features ) and plain ( brown pack with a st and ard shape and opening and all br and ing removed , aside from br and name ) . Design Cross-sectional in-home survey . Setting UK . Participants R and om location quota sample of 1025 never smokers aged 11–16 years . Main outcome measures Susceptibility to smoking and composite measures of pack appraisal and pack receptivity derived from 11 survey items . Results Mean responses to the three pack types were negative for all survey items . However , ‘ novelty ’ packs were rated significantly less negatively than the ‘ regular ’ pack on most items , and the novelty and regular packs were rated less negatively than the ‘ plain ’ pack . For the novelty packs , logistic regressions , controlling for factors known to influence youth smoking , showed that susceptibility was associated with positive appraisal and also receptivity . For example , those receptive to the innovative Silk Cut Superslims pack were more than four times as likely to be susceptible to smoking than those not receptive to this pack ( AOR=4.42 , 95 % CI 2.50 to 7.81 , p<0.001 ) . For the regular pack , an association was found between positive appraisal and susceptibility but not with receptivity and susceptibility . There was no association with pack appraisal or receptivity for the plain pack . Conclusions Pack structure ( shape and opening style ) and colour are independently associated , not just with appreciation of and receptivity to the pack , but also with susceptibility to smoke . In other words , those who think most highly of novelty cigarette packaging are also the ones who indicate that they are most likely to go on to smoke . Plain packaging , in contrast , was found to directly reduce the appeal of smoking to adolescents Background This study sought to examine the impact of cigarette packaging on young women , including the impact of ‘ plain ’ packaging . Methods Participants were r and omised to view eight cigarette packs design ed according to one of four experimental conditions : fully-br and ed female br and s ; the same br and s without descriptors ( eg , ‘ slims ’ ) ; the same br and s without br and imagery or descriptors ( ie , ‘ plain ’ packs ) ; and fully br and ed non-female br and s as a control condition . Participants rated packs on perceived appeal , taste , tar , health risks and smoker ‘ traits ’ . Results Fully-br and ed female packs were rated as significantly more appealing than ‘ no descriptor ’ packs , ‘ plain ’ packs and non-female br and ed packs . Female br and ed packs were associated with a greater number of positive attributes including glamour , slimness and attractiveness , compared to br and s without descriptors and ‘ plain ’ packs . Women who viewed plain packs were less likely to believe that smoking helps people control their appetite — an important predictor of smoking among young women — compared to women who viewed br and ed female packs . Conclusions ‘ Plain ’ packaging — removing colours and design elements— and removing descriptors such as ‘ slims ’ from packs may reduce br and appeal and thereby susceptibility to smoking among young women INTRODUCTION Cigarette packaging is among the most prominent forms of tobacco marketing . This study examined the impact of cigarette pack design among young women in the United States . METHOD A national sample of 18- to 19-year-old females in the United States completed an online survey in February 2010 . Participants were r and omized to view eight cigarette packs design ed according to one of four experimental conditions : fully br and ed female packs , same packs without descriptors ( e.g. , " slims " ) , same packs without br and imagery or descriptors ( " plain " packs ) , and br and ed non-female br and s. Participants rated packs on measures of appeal and health risk and completed a behavioral pack selection task . RESULTS Fully br and ed female packs were rated significantly more appealing than the same packs without descriptors , " plain " packs , and non-female-br and ed packs . Female-br and ed packs were associated with a greater number of positive attributes including glamour , slimness , and attractiveness and were more likely to be perceived as less harmful . Approximately 40 % of smokers and nonsmokers requested a pack at the end of the study ; female-br and ed packs were 3 times more likely to be selected than plain packs . CONCLUSION Plain packaging and removing descriptors such as " slims " from cigarette packs may reduce smoking susceptibility among young women Objective To examine the effect of br and ing , as indicated by br and name , on evaluation of the cigarette smoking experience . Design Between-subjects and within-subjects experimental study . Participants were r and omly allocated to smoke a cigarette from a pack featuring a premium br and name and a cigarette from a pack featuring a value br and name . Within each condition , participants unknowingly smoked two identical cigarettes ( either two premium or two value cigarettes ) . Setting Australia , October 2014 , 2 years after tobacco plain packaging implementation . Participants 81 current cigarette smokers aged 19–39 years . From apparently premium and value br and -name packs , 40 smokers were allocated to smoke the same actual premium cigarettes and 41 were allocated to smoke the same actual value cigarettes . Primary outcome measures Experienced taste ( flavour , satisfaction , enjoyment , quality , liking , mouthfeel and aftertaste ) , harshness , dryness , staleness , harm/strength measures ( strength , tar , lightness , volume of smoke ) , draw effort and purchase intent . Results Cigarettes given a premium br and name were rated as having a better taste , were less harsh and less dry than identical cigarettes given a value br and name . This pattern was observed irrespective of whether the two packs actually contained premium or value cigarettes . These effects were specific : the br and name did not influence ratings of cigarette variant attributes ( strength , tar , volume of smoke , lightness and draw effort ) . Conclusions Despite the belief that br and names represent genuine differences between cigarette products , the results suggest that at least some of this perceived sensory difference is attributable to br and image Objective To investigate whether st and ardised cigarette packaging increases the time spent looking at health warnings , regardless of the format of those warnings . Study design A factorial ( two pack styles x three warning types ) within-subject experiment , with participants r and omised to different orders of conditions , completed at a university in London , UK . Methods Mock-ups of cigarette packets were presented to participants with their br and ed portion in either st and ardised ( plain ) or manufacturer- design ed ( br and ed ) format . Health warnings were present on all packets , representing all three types currently in use in the UK : black & white text , colour text , or colour images with accompanying text . Gaze position was recorded using a specialised eye tracker , providing the main outcome measure , which was the mean proportion of a five-second viewing period spent gazing at the warning-label region of the packet . Results An opportunity sample of 30 ( six male , mean age = 23 ) young adults met the following inclusion criteria : 1 ) not currently a smoker ; 2 ) < 100 lifetime cigarettes smoked ; 3 ) gaze position successfully tracked for > 50 % viewing time . These participants spent a greater proportion of the available time gazing at the warning-label region when the br and ed section of the pack was st and ardised ( following current Australian guidelines ) rather than containing the manufacturer 's preferred design ( mean difference in proportions = 0.078 , 95 % confidence interval 0.049 to 0.106 , p < 0.001 ) . There was no evidence that this effect varied based on the type of warning label ( black & white text vs. colour text vs. colour image & text ; interaction p = 0.295 ) . Conclusions During incidental viewing of cigarette packets , young adult never-smokers are likely to spend more time looking at health warnings if manufacturers are compelled to use st and ardised packaging , regardless of the warning design Objectives To investigate the impact of Australia 's plain tobacco packaging policy on two stated purpose s of the legislation — increasing the impact of health warnings and decreasing the promotional appeal of packaging — among adult smokers . Design Serial cross-sectional study with weekly telephone surveys ( April 2006–May 2013 ) . Interrupted time-series analyses using ARIMA modelling and linear regression models were used to investigate intervention effects . Participants 15 745 adult smokers ( aged 18 years and above ) in New South Wales ( NSW ) , Australia . R and om selection of participants involved recruiting households using r and om digit dialling and selecting the nth oldest smoker for interview . Intervention The introduction of the legislation on 1 October 2012 . Outcomes Salience of tobacco pack health warnings , cognitive and emotional responses to warnings , avoidance of warnings , perceptions regarding one 's cigarette pack . Results Adjusting for background trends , seasonality , antismoking advertising activity and cigarette costliness , results from ARIMA modelling showed that , 2–3 months after the introduction of the new packs , there was a significant increase in the absolute proportion of smokers having strong cognitive ( 9.8 % increase , p=0.005 ) , emotional ( 8.6 % increase , p=0.01 ) and avoidant ( 9.8 % increase , p=0.0005 ) responses to on-pack health warnings . Similarly , there was a significant increase in the proportion of smokers strongly disagreeing that the look of their cigarette pack is attractive ( 57.5 % increase , p<0.0001 ) , says something good about them ( 54.5 % increase , p<0.0001 ) , influences the br and they buy ( 40.6 % increase , p<0.0001 ) , makes their pack st and out ( 55.6 % increase , p<0.0001 ) , is fashionable ( 44.7 % increase , p<0.0001 ) and matches their style ( 48.1 % increase , p<0.0001 ) . Changes in these outcomes were maintained 6 months postintervention . Conclusions The introductory effects of the plain packaging legislation among adult smokers are consistent with the specific objectives of the legislation in regard to reducing promotional appeal and increasing effectiveness of health warnings Objectives This study aim ed to test the potential impact of plain packaging for cigarettes on br and appeal among highly socioeconomically disadvantaged smokers using the new design for cigarettes implemented in Australia , which combines plain packaging with larger health warning labels . Design A 2 × 2 factorial design trial embedded within a cross-sectional computer touchscreen survey . Data were collected between March and December 2012 . Setting Socially disadvantaged welfare aid recipients were recruited through a large Social and Community Service Organisation in New South Wales , Australia . Participants N=354 smokers . The majority of the sample had not completed high school ( 64 % ) , earned less than $ A300/week ( 55 % ) and received their income from Government payments ( 95 % ) . Interventions Participants were r and omised to one of the four different pack conditions determined by br and name : Winfield versus Benson & Hedges , and packaging type : br and ed versus plain . Participants were required to rate their assigned pack on measures of br and appeal and purchase intentions . Results Plain packaging was associated with significantly reduced smoker ratings of ‘ positive pack characteristics ’ ( p<0.001 ) , ‘ positive smoker characteristics ’ ( p=0.003 ) and ‘ positive taste characteristics ’ ( p=0.033 ) in the Winfield br and name condition only . Across the four pack conditions , no main differences were found for ‘ negative smoker characteristics ’ ( p=0.427 ) or ‘ negative harm characteristics ’ ( p=0.411 ) . In comparison to plain packaging , the presentation of br and ed packaging was associated with higher odds of smokers ’ purchase intentions ( OR=2.18 , 95 % CI 1.34 to 3.54 ; p=0.002 ) . Conclusions Plain packs stripped of br and ing elements , featuring larger health warning labels , were associated with reduced positive cigarette br and image and purchase intentions among highly socioeconomically disadvantaged smokers Background : Cigarette packaging is a key marketing strategy for promoting br and image . Plain packaging has been proposed to limit br and image , but tobacco companies would resist removal of br and ing design elements . Method : A 3 ( br and types ) × 4 ( degree of plain packaging ) between-subject experimental design was used , using an internet online method , to expose 813 adult Australian smokers to one r and omly selected cigarette pack , after which respondents completed ratings of the pack . Results : Compared with current cigarette packs with full br and ing , cigarette packs that displayed progressively fewer br and ing design elements were perceived increasingly unfavourably in terms of smokers ’ appraisal s of the packs , the
Output:
| Studies of other behavioural outcomes found evidence of increased avoidance behaviours when using st and ardised packs , reduced dem and for st and ardised packs and reduced craving .
Corroborative evidence for the latter finding came from studies assessing non-behavioural outcomes , which in general found greater warning salience when viewing st and ardised , than br and ed packs .
There was mixed evidence for quitting cognitions , whereas findings with youth generally pointed towards st and ardised packs being less likely to motivate smoking initiation than br and ed packs .
We found the most consistent evidence for appeal , with st and ardised packs rating lower than br and ed packs .
Tobacco in st and ardised packs was also generally perceived as worse-tasting and lower quality than tobacco in br and ed packs .
St and ardised packaging also appeared to reduce misperceptions that some cigarettes are less harmful than others , but only when dark colours were used for the uniform colour of the pack .
The available evidence suggests that st and ardised packaging may reduce smoking prevalence .
A reduction in smoking behaviour is supported by routinely collected data by the Australian government .
Data on the effects of st and ardised packaging on non-behavioural outcomes ( e.g. appeal ) are clearer and provide plausible mechanisms of effect consistent with the observed decline in prevalence .
We did not find any evidence suggesting st and ardised packaging may increase tobacco use |
MS212624 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background : The use of administrative data bases to perform epidemiological studies in asthma has increased in recent years . The absence of clinical parameters to measure the level of asthma severity and control is a major limitation of data base studies . A study was undertaken to develop and vali date two data base indexes to measure the control and severity of asthma . Methods : Data base indexes of asthma severity and control were derived from definitions in the Canadian Asthma Consensus Guidelines based on dispensed prescriptions and on medical services recorded in two large administrative data bases from the Canadian province of Québec ( Régie de l’Assurance Maladie du Québec ( RAMQ ) and MED-ECHO ) over 12 months . The data base indexes of asthma severity and control were vali date d against the pulmonary function test results of 71 patients with asthma r and omly selected from two asthma clinics , and they were also applied to a cohort of patients with asthma followed up for 139 283 person-years selected from the RAMQ and MED-ECHO data bases between 1 January 1997 and 31 December 2004 . Results : According to the data base indexes , 49.3 % , 29.6 % and 21.1 % of patients recruited at the asthma clinics were found to have mild , moderate and severe asthma , respectively , while 53.5 % were found to have controlled asthma . The mean predicted value of the forced expiratory volume in 1 s ( FEV1 ) ranged from 89.8 % for mild asthma to 61.5 % for severe asthma ( p<0.001 ) , whereas the range from controlled to uncontrolled asthma was 89.5 % to 67.3 % ( p<0.001 ) . The ratio of the FEV1 to the forced vital capacity ( FEV1/FVC ratio ) measured in 56 patients ranged from 75.8 % for mild asthma to 61.8 % for severe asthma ( p = 0.030 ) , whereas the range from controlled to uncontrolled asthma was 75.3 % to 65.7 % ( p<0.001 ) . Conclusion : In the absence of clinical data , these data base indexes could be used in epidemiological studies to assess the severity and control of asthma BACKGROUND Isl and and mainl and Puerto Rican children have the highest rates of asthma and asthma morbidity of any ethnic group in the United States . OBJECTIVE We evaluated the effectiveness of a culturally adapted family asthma management intervention called CALMA ( an acronym of the Spanish for " Take Control , Empower Yourself and Achieve Management of Asthma " ) in reducing asthma morbidity in poor Puerto Rican children with asthma . METHODS Low-income children with persistent asthma were selected from a national health plan insurance cl aims data base by using a computerized algorithm . After baseline , families were r and omly assigned to either the intervention or a control group . RESULTS No significant differences between control and intervention group were found for the primary outcome of symptom-free days . However , children in the CALMA intervention group had 6.5 % more symptom-free nights , were 3 times more likely to have their asthma under control , and were less likely to visit the emergency department and be hospitalized as compared to the control group . Caregivers receiving CALMA were significantly less likely to feel helpless , frustrated , or upset because of their child 's asthma and more likely to feel confident to manage their child 's asthma . CONCLUSION A home-based asthma intervention program tailored to the cultural needs of low income Puerto Rican families is a promising intervention for reducing asthma morbidity Our objective was to vali date the Council of State and Territorial Epidemiologists ( CSTE ) definition of " probable " asthma and the Health Plan Employer Data and Information Set ( HEDIS ) definition of persistent asthma for diagnosis of pediatric asthma , and examine modifications that improve case recognition . CSTE and HEDIS criteria were applied to a cross-sectional study of 3,905 Medicaid children with physician-confirmed diagnosis of asthma/no asthma using a vali date d survey instrument based upon National Asthma Education and Prevention Program ( NAEPP ) Guidelines . Modified criteria were applied to another group of 1,458 non-Medicaid children from a managed care organization ( MCO ) . Of 1,852 Medicaid children with physician-confirmed asthma , 906 had persistent asthma . CSTE identified 61 % of children with " probable " asthma ; HEDIS identified 44 % of children with persistent asthma . Correct identification increased with greater disease severity . A modified CSTE increased sensitivity from 0.61 to 0.90 , while maintaining high specificity . Three new HEDIS algorithms increased sensitivity from 0.44 to > 0.84 , with specificity > 0.89 . When applied prospect ively to MCO children , these new algorithms demonstrated improved sensitivity . In conclusion , studies using current CSTE or HEDIS algorithms for case recognition underestimate asthma prevalence and overestimate asthma severity in children . Modified algorithms improve the identification of " probable " and persistent asthma OBJECTIVE To assess the practice -level effects of ( 1 ) a physician peer leader intervention and ( 2 ) peer leaders in combination with the introduction of asthma education nurses to facilitate care improvement . And , to compare findings with previously reported patient-level outcomes of trial enrollees . STUDY SETTING Data were included on children 5 - 17 years old with asthma in 40 primary care practice s , affiliated with managed health care plans enrolled in the Pediatric Asthma Care Patient Outcomes Research Team ( PORT ) r and omized trial . STUDY DESIGN Primary care practice s were r and omly assigned to one of two care improvement arms or to usual care . Automated cl aims data were analyzed for 12-month periods using a repeated cross-sectional design . The primary outcome was evidence of at least one controller medication dispensed among patients with persistent asthma . Secondary outcomes included controller dispensing among all identified asthmatics , evidence of chronic controller use , and the dispensing of oral steroids . Health service utilization outcomes included numbers of ambulatory visits and hospital-based events . PRINCIPAL FINDINGS The proportion of children with persistent asthma prescribed controllers increased in all study arms . No effect of the interventions on the proportion receiving controllers was detected ( peer leader intervention effect 0.01 , 95 percent confidence interval [ CI ] : -0.07 , 0.08 ; planned care intervention effect -0.03 , 95 percent CI : -0.09 , 0.02 ) . A statistical trend was seen toward an increased number of oral corticosteroid bursts dispensed in intervention practice s. Significant adjusted increases in ambulatory visits of 0.08 - 0.10 visits per child per year were seen in the first intervention year , but only a statistical trend in these outcomes persisted into the second year of follow-up . No differences in hospital-based events were detected . CONCLUSIONS This analysis showed a slight increase in ambulatory asthma visits as a result of asthma care improvement interventions , using automated data . The absence of detectable impact on medication use at the practice level differs from the positive intervention effect observed in patient self-reported data from trial enrollees . Analysis of automated data on nonenrollees adds information about practice -level impact of care improvement strategies . Benefits of practice -level interventions may accrue disproportionately to the subgroup of trial enrollees . The effect of such interventions may be less apparent at the level of practice s or health plans Objective . Although the Health Plan Employer Data Information Set ( HEDIS ) is a common method for evaluating the quality of asthma care , its accuracy in characterizing persistent asthma in children is unknown . The objective of this study was to compare the assessment of asthma severity ( persistent vs nonpersistent asthma ) using the HEDIS criteria versus clinical criteria using National Heart , Lung , and Blood Institute ( NHLBI ) guidelines . Methods . In a cross-sectional study , we analyzed baseline data from interviews with the parents of 896 children who had asthma and participated in a r and omized controlled trial . Patients had an active clinical diagnosis of asthma , were between 2 and 12 years of age , and had no other pulmonary diseases . Patients had persistent asthma by parent report according to the HEDIS criteria when , within the last year , they had 1 asthma inpatient admission or emergency department visit or 4 asthma medication dispensing events , or 4 outpatient asthma visits and at least 2 asthma medication dispensing events . Patients had persistent asthma by parent report according to the NHLBI criteria when , within the last 2 months , they had nighttime asthma symptoms > 2 nights/mo or daytime asthma symptoms > 2 days/wk . We calculated the sensitivity of each HEDIS criterion , separately and then combined , using the NHLBI criteria as a gold st and ard . Results . On the basis of HEDIS criteria , 656 ( 73 % ) patients had persistent asthma , compared with 338 ( 38 % ) using NHLBI criteria . Although the HEDIS criteria for persistent asthma were fairly sensitive ( 0.89 ) , they were not very specific ( 0.70 ) . For children without daily controller medications ( n = 346 ) , the sensitivity was even lower ( 0.45 ) , but the specificity was similar ( 0.68 ) . We found that the test characteristics were fairly consistent across different age group strata ( 2–4 , 5–9 , and 10–12 years of age ) . Conclusions . HEDIS criteria used to determine the quality of asthma care should be interpreted with caution . Although the criteria for persistent disease — used to determine which children require daily controller medications — are fairly sensitive , they are not very specific and include children who may not require such medications Introduction Asthma is associated with a substantial economic burden on the German Statutory Health Insurance . Aims and objectives To determine costs and re source utilization associated with asthma and to analyze the impact of disease severity on subgroups based on age and gender . Methods A cl aims data base analysis from the statutory health insurance perspective was conducted . Patients with an ICD-10-GM code of asthma were extracted from a 10 % sample of a large German sickness fund . Five controls for each asthma patient matched by age and gender were r and omly selected from the same data base . Costs and re source utilization were calculated for each individual in the asthma and control group . Incremental asthma-related costs were calculated as the mean cost difference . Based on prescribed asthma medication , patients were classified as intermittent or persistent . In addition , age groups of ≤5 , 6–18 , and > 18 years were analyzed separately and gender differences were investigated . Results Overall , 49,668 individuals were included in the asthma group . On average , total annual costs per patient were € 753 higher ( p = 0.000 ) compared to the control group ( € 2,168 vs. € 1,415 ) . Asthma patients had significantly higher ( p = 0.000 ) outpatient ( € 217 ) , inpatient ( € 176 ) , and pharmacy costs ( € 259 ) . Incremental asthma-related total costs were higher for patients with persistent asthma compared to patients with intermittent asthma ( € 1,091 vs. € 408 ) . Women aged > 18 years with persistent asthma had the highest difference in costs compared to their controls ( € 1,207 ; p < 0.0001 ) . Corresponding healthcare re source utilization was significantly higher in the asthma group ( p = 0.000 ) . Conclusions The treatment of asthma is associated with an increased level of healthcare re source utilization and significantly higher healthcare costs . Asthma imposes a substantial economic burden on sickness funds BACKGROUND The risk of invasive pneumococcal disease among persons with asthma is unknown . METHODS We conducted a nested case-control study to examine the association between asthma and invasive pneumococcal disease . The study population included persons 2 to 49 years of age who were enrolled in Tennessee 's Medicaid program ( TennCare ) for more than one year during the study period ( 1995 through 2002 ) and who resided in counties participating in a prospect i ve laboratory-based program of surveillance for invasive pneumococcal disease . For each subject with invasive pneumococcal disease , 10 age-matched controls without invasive pneumococcal disease were r and omly selected from the same population . TennCare files were queried to identify the presence of coexisting conditions that confer a high risk of pneumococcal disease . For the purpose of our study , asthma was defined by documentation of one or more inpatient or emergency-department diagnoses of asthma , two outpatient diagnoses , or the use of asthma-related medications . High-risk asthma was defined as asthma requiring admission to a hospital or a visit to an emergency department , the use of rescue therapy or long-term use of oral corticosteroids , or the dispensing of three or more prescriptions for beta-agonists within the year before enrollment in the study . RESULTS A total of 635 persons with invasive pneumococcal disease and 6350 controls were identified , of whom 114 ( 18.0 percent ) and 516 ( 8.1 percent ) , respectively , had asthma . Persons with asthma had an increased risk of invasive pneumococcal disease ( adjusted odds ratio , 2.4 ; 95 percent confidence interval , 1.9 to 3.1 ) as compared with controls . Among those without coexisting conditions , the annual incidence of invasive pneumococ
Output:
| Conclusion There is no best practice method for the categorisation of asthma severity with cl aims data .
Rather , a combination of algorithms seems to be a pragmatic approach . |
MS212625 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Because universal psychoeducational eating disorder prevention programs have had little success , we developed and evaluated two interventions for high-risk population s : a healthy weight control intervention and a dissonance-based intervention . METHOD Adolescent girls ( N = 148 ) with body image concerns were r and omized to one of these interventions or to a waitlist control group . Participants completed baseline , termination , and 1 , 3 , and 6-month follow-up surveys . RESULTS Participants in both interventions reported decreased thin-ideal internalization , negative affect , and bulimic symptoms at termination and follow-up relative to controls . However , no effects were observed for body dissatisfaction or dieting and effects diminished over time . DISCUSSION Results provide evidence that both interventions effectively reduce bulimic pathology and risk factors for eating disturbances A population -based , r and omized universal classroom intervention trial for the prevention of disruptive behavior ( i.e. , attention-deficit/hyperactivity problems , oppositional defiant problems , and conduct problems ) is described . Impact on developmental trajectories in young elementary schoolchildren was studied . Three trajectories were identified in children with high , intermediate , or low levels of problems on all 3 disruptive behaviors at baseline . The intervention had a positive impact on the development of all disruptive behavior problems in children with intermediate levels of these problems at baseline . Effect sizes of mean difference at outcome were medium or small . In children with the highest levels of disruptive behavior at baseline , a positive impact of the intervention was found for conduct problems BACKGROUND The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems . Because of the shared risk factors for obesity and eating disorders , a targeted prevention of both conditions is a priority . OBJECTIVE We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders . DESIGN A parallel-group , r and omized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital . The study included 113 adolescent ( 12 - 17-y-old ) girls deemed at high risk of adult obesity and eating disorders because of a body mass index ( BMI ) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating . Girls were r and omly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions . Follow-up assessment s occurred immediately after group programs and at 6 and 12 mo . RESULTS Participation in both conditions was associated with decreases in expected BMI gain , age-adjusted BMI metrics , the percentage of fat by using dual-energy X-ray absorptiometry , symptoms of depression and anxiety , and the frequency of loss-of-control eating over 12 mo of follow-up ( Ps < 0.001 ) with no group difference . In follow-up analyses , interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up ( P < 0.05 ) . CONCLUSIONS The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating . Additional research is needed to eluci date the mechanisms by which physical and psychological improvements were observed . This trial was registered at clinical trials.gov as NCT00680979 OBJECTIVE Body dissatisfaction in females is common and a risk factor for the development of an eating disorder . This study tested whether body dissatisfaction could be improved using a brief conditioning intervention in which photographs of participants ' bodies were selectively paired with positive social stimuli ( smiling faces ) and photographs of other bodies were paired with neutral or negative social stimuli ( neutral and frowning faces ) . METHOD 39 women ( mean age = 22.46 ; 64.1 % Caucasian ) with high body dissatisfaction were r and omized to either the evaluative conditioning intervention ( n = 22 ) or to a delayed waitlist control condition ( n = 17 ) . Body dissatisfaction ( specifically , shape and weight concern ) , restraint , eating concern , and self-esteem were assessed at baseline , post treatment and again after four and 12 weeks . RESULTS Compared to women in the delayed waitlist control condition , women in the treatment condition demonstrated a significant decrease in shape and weight concern , and a significant increase in self-esteem . Similar trends were found for the control condition after they completed the intervention . Changes at post treatment related to body dissatisfaction were maintained at 12-week follow-up . CONCLUSIONS Repeatedly pairing photographs of an individual 's body with positive social feedback may lead to improved body image and self-esteem OBJECTIVE A group dissonance-based eating disorder prevention program , in which young women critique the thin ideal , reduces eating disorder risk factors and symptoms , but it can be difficult to identify school clinicians with the time and expertise to deliver the intervention . Thus , we developed a prototype Internet version of this program and evaluated it in a preliminary trial . METHOD Female college students with body dissatisfaction ( N = 107 ; M age = 21.6 years , SD = 6.6 ) were r and omized to the Internet intervention , group intervention , educational video condition , or educational brochure condition . RESULTS Internet and group participants showed greater pre-post reductions in eating disorder risk factors and symptoms than video controls ( M ds = 0.47 and 0.54 , respectively ) and brochure controls ( M ds = 0.75 and 0.72 , respectively ) , with many effects reaching significance . Effects did not differ significantly for Internet versus group participants ( M ds = -0.13 ) or for video versus brochure controls ( M d = 0.25 ) . Effect sizes for the Internet intervention were similar to those previously observed for group versions of this intervention . CONCLUSIONS Results suggest that this prototype Internet intervention is as efficacious as the group intervention , implying that there would be merit in completing this intervention and evaluating it in a fully powered trial Oral healthcare providers have a clinical opportunity for early detection of disordered eating behaviors because they are often the first health professionals to observe overt oral and physical signs . Curricula regarding early recognition of this oral/systemic medical condition are limited in oral health educational programs . Web-based learning can supplement and reinforce traditional learning and has the potential to develop skills . The study purpose was to determine the efficacy of a theory-driven Web-based training program to increase the capacity of oral health students to perform behaviors related to the secondary prevention of disordered eating behaviors . Using the Reach , Effectiveness , Adoption , Implementation and Maintenance evaluation framework , a longitudinal group-r and omized controlled trial involving 27 oral health classes from 12 oral health education programs in the United States was implemented to assess the efficacy of the Web-based training on attitudes , knowledge , self-efficacy and skills related to the secondary prevention of disordered eating behaviors . Mixed-model analysis of covariance indicated substantial improvements among students in the intervention group ( effect sizes : 0.51 - 0.83 ) on all six outcomes of interest . Results suggest that the Web-based training program may increase the capacity of oral healthcare providers to deliver secondary prevention of disordered eating behaviors . Implication s and value of using the Reach , Effectiveness , Adoption , Implementation and Maintenance framework are discussed This study evaluated a targeted intervention design ed to alleviate body image and eating problems in adolescent girls that was delivered over the internet so as to increase access to the program . The program consisted of six , 90-minute weekly small group , synchronous on-line sessions and was facilitated by a therapist and manual . Participants were 73 girls ( mean age=14.4 years , SD=1.48 ) who self-identified as having body image or eating problems and were r and omly assigned to an intervention group ( n=36 ) ( assessed at baseline , post-intervention and at 2- and 6-months follow-up ) or a delayed treatment control group ( n=37 ) ( assessed at baseline and 6–7 weeks later ) . Clinical ly significant improvements in body dissatisfaction , disordered eating , and depression were observed at post-intervention and maintained at follow-up . Internet delivery was enthusiastically endorsed . The program offers a promising approach to improve body image and eating problems that also addresses geographic access problems Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity BACKGROUND Body image dissatisfaction during adolescence is common but not benign . School-based interventions have the potential for wide reach , but scalability of previous programmes is limited by a reliance on external facilitators . AIMS To assess the acceptability , feasibility and efficacy of a teacher-delivered body image intervention . METHOD A pilot clustered r and omised controlled trial in which 16 classes of adolescent girls were allocated to a 6-session body image programme ( n = 261 ) , or usual curriculum control ( n = 187 ) ( registration : IS RCT N42594993 ) . RESULTS Students in the intervention group had significantly improved body esteem and self-esteem and reduced thin-ideal internalisation . Effects for body esteem and thin-ideal internalisation were maintained for 3 months . There were no group differences for eating pathology , peer factors or depression . Acceptability , feasibility and efficacy varied between schools . CONCLUSIONS Teacher-delivered body image lessons have promise but further work is needed to increase efficacy and make interventions suitable across a range of schools OBJECTIVE Lifestyle interventions that promote physical activity and healthy dietary habits may reduce binge eating symptoms and be more feasible and sustainable among ethnic minority women , who are less likely to seek clinical treatment for eating disorders . The purpose of this study was to investigate ( 1 ) whether participating in a lifestyle intervention is a feasible way to decrease binge eating symptoms ( BES ) and ( 2 ) whether changes in BES differed by intervention ( physical activity vs. dietary habits ) and binge eating status at baseline ( binger eater vs. non-binge eater ) in African American and Hispanic women . METHOD Health Is Power ( HIP ) was a longitudinal r and omized controlled trial to promote physical activity and improve dietary habits . Women ( N = 180 ) who completed anthropometric measures and question naires assessing fruit and vegetable and dietary fat intake , BES and demographics at baseline and post-intervention six months later were included in the current study . RESULTS Over one-fourth ( 27.8 % ) of participants were categorized as binge-eaters . Repeated measures ANOVA demonstrated significant two- and three-way interactions . Decreases in BES over time were greater in binge eaters than in non-binge eaters ( F(1,164 ) = 33.253 , p < .001 ) , and women classified as binge eaters who participated in the physical activity intervention reported greater decreases in BES than non-binge eaters in the dietary habits intervention ( F(1,157 ) = 5.170 , p = .024 ) . DISCUSSION Findings suggest behavioral interventions to increase physical activity may lead to reductions in BES among ethnic minority women and ultimately reduce the prevalence of binge eating disorder and health disparities in this population OBJECTIVE This study examined the outcome of a body image and disordered eating intervention for midlife women . The intervention was specifically design ed to address risk factors that are pertinent in midlife . METHOD Participants were 61 women aged 30 to 60 years ( M = 43.92 , SD = 8.22 ) r and omly assigned to intervention ( n = 32 ) or ( delayed treatment ) control ( n = 29 ) groups . Following an 8-session facilitated group cognitive behavioral therapy-based intervention , outcomes from the Body Shape Question naire ; Eating Disorder Examination Question naire ; Body Image Avoidance Question naire ; Physical Appearance Comparison Scale ; Sociocultural Attitudes Towards Appearance Scale , Internalization subscale ; measures of appearance importance , cognitive re appraisal , and self-care ; Dutch Eating Behavior Question naire ; and Kessler Psychological Distress Scale were compared for statistical and clinical significance from baseline to posttest and 6-month follow-up . RES
Output:
| RESULTS Media literacy had the most support for universal prevention .
Most universal approaches showed significant modest effects on risk factors .
Dissonance-based was the best supported approach for selective prevention .
Cognitive-behavior therapy ( CBT ) , a healthy weight program , media literacy , and psychoeducation , were also effective for selective prevention and effects were maintained at follow-up .
CBT was supported for indicated prevention and effects were maintained at follow-up .
DISCUSSION The modest effects for universal prevention were likely due to floor effects . |
MS212626 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Twenty-six patients were recruited for a study of the safety and efficacy of immunotherapy with IPG . They were r and omly assigned to two groups based on skin test titrations to grass allergens . One group was treated in a double-blind fashion before the 1982 grass season with 12 weekly injections totaling approximately 48,000 PNU , and the other group was treated with 12 weekly injections of caramelized glucose histamine placebo . Daily symptom and medication score sheets were completed by all patients each day of the grass season . Blocking antibody rose ninefold in the IPG group ( p less than 0.007 ) but was unchanged in the placebo group . There was no significant change in IgE against rye grass group I in either the IPG or the placebo group . Symptom-score mean in the IPG group was 217 + /- 71 ( S.E.M. ) , statistically lower ( p less than 0.02 ) than the mean in the placebo group 496 + /- 117 ( S.E.M. ) . There were no systemic reactions and only minor local reactions . There was no change in routine laboratory tests in either group . Although two prior studies with grass allergen immunotherapy reported efficacy , these studies did not use symptom-score analysis . This is the first double-blind , histamine placebo-controlled study of grass immunotherapy that demonstrates efficacy by symptom-score index evaluation . IPG is a safe , clinical ly effective , and potentially cost-effective therapy for grass pollinosis BACKGROUND Sublingual immunotherapy with liquid extracts provides an appealing alternative to subcutaneous immunotherapy for the treatment of allergic rhinoconjunctivitis ( ARC ) , but a lack of robust evidence has deterred its use in North America . OBJECTIVE To determine the efficacy and tolerability of st and ardized glycerinated short ragweed sublingual allergen immunotherapy liquid ( RW-SAIL ) extract in subjects with ragweed-related ARC . METHODS This phase 3 , r and omized , placebo-controlled trial was conducted in North America . Subjects ( age range , 18 - 55 years ) with or without asthma were selected based on ARC symptom severity and erythema skin prick reaction to short ragweed . Subjects self-administered the maximum tolerated dose of RW-SAIL ( n = 218 ) or placebo ( n = 211 ) daily beginning approximately 8 to 16 weeks before and through the end of the ragweed pollen season . The primary end point was subject-assessed total combined daily rhinoconjunctivitis symptom and medication scores ( TCS ) . RESULTS During the entire season , there was a 43 % decrease in TCS in subjects treated with RW-SAIL compared with placebo . Similar decreases were observed in TCS between the 2 groups during peak season ( 42 % ) and in daily symptom scores during the entire ( 42 % ) and peak ( 41 % ) seasons . The occurrence of adverse events was similar between the treatment groups ; most were mild in severity . Treatment-related oromucosal local application site reactions occurred early and were transient and self-limited . No anaphylaxis occurred . CONCLUSIONS This is the first successful North American confirmatory phase 3 clinical trial to demonstrate the safety and efficacy of a sublingual st and ardized ragweed allergen immunotherapy liquid extract for the treatment of ARC Background : The clinical efficacy and safety of a six‐grass pollen allergoid has been studied . The advent of more exacting clinical guidelines and a better appreciation of the possible mechanisms of treatment prompted this re appraisal Immunotherapy with polymerized ragweed ( PRW ) has been demonstrated to be safe and effective when compared with monomeric ragweed or untreated controls . To further establish the efficacy of PRW , a trial was conducted comparing PRW , placebo , and no treatment in ragweed-sensitive individuals . In a double-blind manner , 21 patients were treated before the 1981 ragweed season with 15 weekly injections of PRW totaling about 50,000 PNU and 1200 microgram antigen E , while 19 patients were treated with 15 weekly injections of a caramelized glucose and histamine placebo . An additional control group received no injections . Blood was drawn for IgE against ragweed antigen E ( IgE-a-AgE ) and for blocking antibody against AgE before treatment , after treatment ( before season ) , and after season . In the untreated patients , blood was drawn before season and after season . Daily symptom score sheets were completed by patients each day of the ragweed season . Blocking antibody rose more than 40-fold with treatment ( p = 0.0001 ) in the PRW group but was unchanged in the placebo group with treatment . IgE-a-AgE rose with PRW therapy . Clinical efficacy of PRW was again confirmed in this study . Symptom score mean in the PRW group was statistically lower than the mean in the placebo group ( p = 0.022 ) and in the untreated group ( p = 0.018 ) . There were no systemic reactions and only minor local reactions during treatment . In summary , PRW is an improved form of immunotherapy BACKGROUND There have been no data on sublingual immunotherapy ( SLIT ) in Brazilian patients sensitized to house dust mites . This study aim ed to evaluate the mucosal/systemic antibody response changes and clinical efficacy after SLIT using Dermatophagoides pteronyssinus ( Dpt ) allergens with or without bacterial extracts in mite-allergic Brazilian children . METHODS Patients with allergic rhinitis and asthma were selected for a double-blind , placebo-controlled trial r and omized to three groups : DPT ( Dpt extract , n = 34 ) , DPT+MRB ( Dpt plus mixed respiratory bacterial extracts , n = 36 ) , and Placebo ( n = 32 ) . Total symptom and medication scores for rhinitis/asthma , skin prick test ( SPT ) to Dpt , and measurements of Dpt- , Der p 1- , Der p 2-specific serum IgE , IgG4 , IgG1 , and specific salivary IgA were evaluated at baseline and after 12 and 18 months of treatment . RESULTS A significant long-term decline in total symptom/medication scores was observed only in active groups ( DTP and DPT+MRB ) . There was no significant change in SPT results in all groups . SLIT using Dpt allergen alone induced increased levels of serum IgG4 to Dpt , Der p 1 , and Der p 2 , serum IgG1 and salivary IgA to Dpt and Der p 1 . SLIT with Dpt plus bacterial extracts was able to decrease IgE levels , particularly to Der p 2 , to increase salivary IgA levels to Der p 1 , but had no changes on specific IgG4 and IgG1 levels . CONCLUSIONS All children undergoing SLIT showed clinical improvement , but a long-term reduction in symptom/medication scores with modulation of mucosal/systemic antibody responses were seen only in active groups ( DPT and DPT+MRB ) BACKGROUND The efficacy and safety of the 300-index of reactivity ( IR ) dose of 5-grass-pollen sublingual immunotherapy ( SLIT ) tablets ( Stallergènes , Antony , France ) have been demonstrated for the treatment of hay fever in adults . OBJECTIVE We sought to assess the efficacy and safety of this tablet in children and adolescents with grass pollen-related allergic rhinitis . METHODS In this multinational , r and omized , double-blind , placebo-controlled study , 278 children ( 5 - 17 years of age ) with grass pollen-related rhinoconjunctivitis ( confirmed by means of a positive grass pollen skin prick test response and serum-specific IgE measurement ) received once-daily SLIT tablets or placebo . Treatment was initiated 4 months before the estimated pollen season and continued throughout the season . The primary outcome was the rhinoconjunctivitis total symptom score ( RTSS ) , a sum of 6 individual symptom scores : sneezing , runny nose , itchy nose , nasal congestion , watery eyes , and itchy eyes . Secondary end points included rescue medication intake , individual scores , and safety . RESULTS The intent-to-treat population included 266 children ( mean age , 10.9 + /- 3.22 years ) . The RTSS for the 300-IR group was highly significantly different from that of the placebo group ( P = .001 ) . The 300-IR group showed a mean improvement for the RTSS of 28.0 % over that seen with placebo and a median improvement of 39.3 % . Significant differences between the 300-IR and placebo groups were also observed regarding rescue medication score and proportion of days using rescue medication during the pollen season ( P = .0064 and P = .0146 , respectively ) . Adverse events were generally mild or moderate in intensity and expected . No serious side effects were reported . CONCLUSION Five-grass-pollen SLIT tablets ( 300 IR ) reduce both symptom scores and rescue medication use in children and adolescents with grass pollen-related rhinoconjunctivitis This work presents a double-blind , placebo-controlled study of 27 patients with allergic rhinitis to ragweed who received preseasonal desensitization immunotherapy [ IT ] with alum-precipitated aqueous ragweed extracts . We reassessed the following parameters in relation to clinical responses : clinical scores , nasal reactivity to a provocative dose of ragweed causing a 75 % fall in airflow rate ( PD75 ) , ragweed IgE and IgG , and ragweed-induced basophil histamine release ( BHR ) . First , the nasal PD75 correlated with the severity of nasal symptoms ( p less than 0.05 ) . Second , we confirmed a significant symptomatic improvement in the IT-treated group either by clinical scores ( p less than 0.05 ) or the prevention of the seasonal fall of the PD75 ( p less than 0.005 ) . Also , IT reduced the seasonal rise of IgE ( p less than 0.02 ) and induced an increase in IgG ( p less than 0.01 ) and a decrease in BHR ( p less than 0.03 ) . There was a significant correlation between IgE and BHR ( r = 0.80 ; p less than 0.01 ) . After selecting out the effects of IgE , the BHR was still higher in the placebo-treated group than in the IT-treated group ( p less than 0.02 ) , suggesting the involvement of other modulating factors . Symptomatic improvement after IT correlated only with the summation of both IgE and BHR ( PD75 ; r = 0.64 ; p less than 0.005 ) . This observation suggests that the severity of clinical symptoms is determined by several interacting factors and not by the antibody response alone Background : Data supporting a carry‐over effect with sublingual immunotherapy ( SLIT ) are scarce . This r and omized , double‐blind , placebo‐controlled study evaluated the efficacy , carry‐over effect and safety of grass pollen SLIT using co‐seasonal treatment The present work reports the results of a double‐blind clinical trial , comparing the effects of hyposensitization treatment versus placebo in 33 patients with allergic rhinitis , sensitive to a crude extract of the pollen of four different grasses ( Dactylis glamerata , Lolium perenne , Secale cereale , and Phlewn pratense ) . The distribution of these patients in the two groups was done r and omly and gave two comparable groups , as far as clinical and biological features are concerned . The treatment course included five low doses of the aqueous extract followed by 12 injections of Al(OH)3‐adsorbed aliquots of the same extract . Evaluation of the clinical scores was based on diary cards on which symptoms and medications were recorded . A reevaluation of the significance of the symptom and medication scores is presented and the link between both scores is studied . Particular attention is given to the method ological and statistical problems raised during this study . The non‐parametric tests reveal a significant difference ( P < 0.03 ) in the total clinical score between the treated and the placebo groups for the second half of the observation period , when the pathology was most intense BACKGROUND The safety and efficacy of specific immunotherapy for mold allergy are not known in children and adolescents . OBJECTIVE We evaluated the efficacy and safety of specific immunotherapy with a st and ardized allergen extract in a r and omized , double-blind , placebo-controlled , 3-year prospect i ve study of patients who were allergic to only Alternaria alternata . METHODS Fifty children and adolescents ( 25 girls ; 5 - 18 years of age ) with A alternata-induced seasonal allergic rhinoconjunctivitis and /or bronchial asthma were r and omly assigned to groups given treatment ( Novo-Helisen Depot , A alternata 100 % ) or placebo . The primary end point was the combined symptom medication score . Secondary end points included safety , quality of life , and sensitivity to allergen-specific nasal challenge . RESULTS Forty-five children completed the 3-year study . Although there was no significant change in year 1 , the combined symptom medication score decreased in years 2 and 3 of the study ( by 38.7 % and 63.5 % , respectively ; P < .001 for each ) . The reduction in symptoms was associated with a significant improvement in quality of life ( P < .05 ) and decrease in sensitivity after allergen-specific nasal challenge . Side effects were observed in 7 patients ; the most common ( edema at the
Output:
| There was in comparison a more modest body of evidence on effectiveness post-discontinuation of AIT , suggesting a benefit in relation to symptom scores .
AIT is effective in improving symptom , medication , and combined symptom and medication scores in patients with allergic rhinoconjunctivitis while on treatment , and there is some evidence suggesting that these benefits are maintained in relation to symptom scores after discontinuation of therapy |
MS212627 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: New psychiatric out- patients with depressive , phobic , and anxiety neurosis were r and omly allocated to out-patient care or to one of two types of day hospital treatment , one specialising in psychotherapy and the other offering all forms of day care . Of 106 patients who entered the study , 78 had assessment s of psychiatric symptomatology and social adjustment both before treatment and after 4 , 8 and 24 months . There was no significant difference in outcome between depressive , phobic , and anxiety neurosis , and no overall difference in response to treatment between the three types of care . Suicidal symptoms were significantly less common in out- patients . In many respects , neurotic disorder can be regarded as a single syndrome Schizophrenic patients referred for day treatment at the time of discharge from ten hospitals were r and omly assigned to receive day treatment plus drugs or to receive drugs alone . They were tested before assignment and at 6 , 12 , 18 , and 24 months on social functioning , symptoms , and attitudes . Community tenure and costs were also measured . The ten day centers were described on process variables every six months for the four years of the study . Some centers were found to be effective in treating chronic schizophrenic patients and others were not . All centers improved the patients ' social functioning . Six of the centers were found to significantly delay relapse , reduce sumptoms , and change some attitudes . Costs for patients in these centers were not significantly different from the group receiving only drugs . More professional staff hours , group therapy , and a high patient turnover treatment philosophy were associated with poor- result centers . More occupational therapy and a sustained nonthreatening environment were more characteristic of successful outcome centers Day treatment remains a core component in many community mental health programs for persons with severe mental disorders throughout the United States . Many other mental health centers are moving away from day treatment toward psychosocial and vocational rehabilitation programs . Empirical research directly comparing these two systems of organizing outpatient services is needed . In this study the authors compared a rehabilitative day treatment program in one small city with a similar program in a nearby city that changed from day treatment to a supported employment model . Clients who were enrolled in community support services during a baseline year prior to the change and during a follow-up year after the change ( 71 in the program that changed and 112 in the other ) were evaluated during both intervals . In the program that changed , competitive employment improved from 25.4 % to 39.4 % for all clients , and from 33.3 % to 55.6 % for those clients who had been regular attenders of day treatment during the baseline . Hours worked and wages earned similarly improved after the program change . For all work variables , clients who had not worked during the baseline year accounted for the improvements in outcome . Meanwhile , employment remained stable in the day treatment program . No negative outcomes were detected . These results indicate that eliminating day treatment and replacing it with a supported employment program can improve integration into competitive jobs in the community A one-year cohort of patients from a defined catchment area with acute functional disorders were allocated at r and om to brief care ( experimental group ) or st and ard care ( control group ) in hospital to examine the effect of shortening hospital stay on the clinical and social functioning of patients and the distress abnormal functioning caused to others . A total of 127 patients were interviewed on entry to the study , and 106 were followed up . The brief care group had significantly shorter mean and median lengths of stay than the control group , but there was no difference between the groups in the number of days spent in hospital during subsequent admissions . The groups were well matched for clinical and social variables . Rates of improvement over 13 weeks were essentially the same by all measures of outcome , including the Present State Examination and Patient 's Behaviour Assessment Scale , which was developed for the study to measure deterioration in behaviour and social functioning and adverse effects and distress on others . There was no difference between the two groups in burden to the community supporting services , social security requirements , or GP attendances . Improvement rates were nearly identical on all measures within and across diagnostic subgroups . Brief care result ed in a 33 % reduction in average length of stay compared with the year before but was associated with a corresponding increase in day hospital use . The short-stay policy continued the year after the study finished . The findings confirm the value of shortening hospital stay and improving day care facilities for most localities OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The effects of day care therapy for a period of 6 months upon patients with schizophrenia were studied through comparison with schizophrenia out patients at four facilities in Japan . The clinical features of the 31 day care patients and 30 out patients were evaluated by the hospital staff using the Positive and Negative Syndrome Scale ( PANSS ) and Global Assessment Scale ( GAS ) , and by the patients ' close relatives using the Katz Adjustment Scale ( KAS ) before and after 6 months of treatment . Day care patients showed a significant decrease in the general pathological score of PANSS and GAS , but out patients did not show any comparable improvement . As for KAS scores , similar improvement was observed for both the day care patients and out patients After 6 months , 43 % of the day care patients improved on the post-/pre- PANSS total scores ratio , as against only 13 % of the out patients . In addition , 13 % of the out patients were readmitted due to an exacerbation of their symptoms , whereas all day care patients were able to remain at home for 6 months . This study clearly demonstrated that day care therapy for patients with schizophrenia was more effective than the usual out patients treatment setting . Further therapeutic efforts ( e.g. psycho-education ) in day care therapy are needed in order to improve family member 's evaluation of the patient Ninety-one patients admitted as emergencies , suffering from neurosis , personality disorder , or adjustment reaction , were r and omly allocated to day hospital or to continued in-patient care . Follow-up was for up to one year . Clinical outcome was similar in the day care and in-patient groups , but patient satisfaction was significantly greater in day patients . Day hospital care was only about two-thirds of the cost of the cheaper of the two in-patient regimes , even though contact with it was on average twice as long as for in- patients Emerging models of cognitive-behavioral treatment ( CBT ) offer promising new intervention strategies in the psychotherapy of schizophrenia . These models , however , have not been integrated into community support programs and evaluated in comparison to st and ard community treatments . This study examined differences in outcomes of clients who received long-term day treatment program services ( DTP ) compared to clients who received individual CBT that was included as part of their DTP treatment . Twenty-four clients were r and omly assigned to DTP treatment or CBT/DTP treatment . Data on st and ardized measures of psychosocial functioning , symptomatology and rehospitalizations were collected over the course of three years of treatment . Analysis of variance with repeated measures was conducted to evaluate the effects of type of treatment ( CBT/DTP and DTP ) and time ( dependent variable scores taken at the end of treatment years one , two and three ) on the three outcome variables . Results indicate significant improvement for the CBT/DTP group compared to the DTP group in the patterns of change over time for psychosocial functioning and symptomology . In addition to this significant group/time interaction the time factor was also significant for both variables . For rehospitalizations the time factor was significant and the group/time factor was nonsignificant . Implication s for service delivery to persons with schizophrenia and suggestions for future research are discussed BACKGROUND Postnatal depression affects one in ten women within 6 months of childbirth . The most effective treatment strategy for postnatal depression is not clear . METHODS This prospect i ve , naturalistic study of the treatment of postnatal depression compared 30 women treated at a specialised psychiatric day hospital with 30 women treated using routine primary care ( RPC ) . Clinical , marital and social adjustment were assessed on three occasions over 6 months using : the Edinburgh Postnatal Depression Question naire ( EPDS ) ; the Clinical Interview schedule ( CIS ) ; the Anxiety Subscale of the Hospital Anxiety and Depression Scale ; the Dyadic Adjustment Scale ( DAS ) ; and the Work Leisure and Family Life Question naire-Modified ( WLFLQ-M ) . RESULTS There were no significant differences between the two groups at baseline . However , there were significant differences in outcome at 3 and 6 months follow-up for all outcome measures except the DAS . At 6 month follow-up 21 of the PBDU group were no longer depressed compared with 7 of the RPC group . CONCLUSIONS A specialised day hospital is a more effective treatment setting for postnatal depression than routine primary care . LIMITATIONS OF THE STUDY The study is not an RCT , so systematic bias is possible . The sample size is relatively small and the duration of follow-up relatively short The authors r and omly assigned 79 in patients with nonchronic schizophrenia or affective disorder to either an intensive experimental day program called " transitional treatment " or a control treatment -- weekly clinical ly believed to require intensive posthospital treatment to make the transition to the community . Although initially there was a significantly higher dropout rate from the control condition , at the point of discharge from the two programs as well as at 6- and 12-month follow-up there was no difference in outcome . Direct costs for the transitional treatment , however , were much higher BACKGROUND Data on effectiveness of acute day hospital treatment for psychiatric illness are inconsistent . AIMS To establish the effectiveness and costs of care in a day hospital providing acute treatment exclusively . METHOD In a r and omised controlled trial , 206 voluntarily admitted patients were allocated to either day hospital treatment or conventional wards . Psychopathology , treatment satisfaction and subjective quality of life at discharge , 3 months and 12 months after discharge , readmissions to acute psychiatric treatment within 3 and 12 months , and costs in the index treatment period were taken as outcome criteria . RESULTS Day hospital patients showed significantly more favourable changes in psychopathology at discharge but not at follow-up . They also reported higher treatment satisfaction at discharge and after 3 months , but not after 12 months . There were no significant differences in subjective quality of life or in readmissions during follow-up . Mean total support costs were higher for the day hospital group . CONCLUSIONS Day hospital treatment for voluntary psychiatric patients in an inner-city area appears more effective in terms of reducing psychopathology in the shortterm and generates greater patient satisfaction than conventional in-patient care , but may be more costly A prospect i ve r and omized comparative study on the effectiveness of psychiatric day treatment and inpatient treatment is described . The target population consisted of patients who would normally have been admitted to an open inpatient unit . Outcome indicators were psychopathology , social functioning , interpersonal functioning , social network and social support . No differences in effectiveness were found between the two forms of treatment , although more patients accepted and completed day treatment , and day patients were more satisfied . Although a uniform treatment programme for both departments was established , distinct differences did arise in the actual treatment programme offered to the patients . The duration of treatment for the day patients was considerably longer , and the intensity of treatment was more low‐key . No striking differences in the amount of medication prescribed and in the occurrence of crisis situations ( including suicide ) were found . Day treatment turns out to be a realistic alternative for 33 % of all patients admitted for inpatient treatment . It was not possible to predict which type of patient in particular is suitable for day treatment The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05
Output:
| Caring for people in acute day hospitals is as effective as inpatient care in treating acutely ill psychiatric patients . |
MS212628 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Therapeutic hypothermia holds promise as a rescue neuroprotective strategy for hypoxic-ischemic injury , but the incidence of severe neurologic sequelae with hypothermia is unknown in encephalopathic neonates who present shortly after birth . This study reports a multicenter , r and omized , controlled , pilot trial of moderate systemic hypothermia ( 33 degrees C ) vs normothermia ( 37 degrees C ) for 48 hours in neonates initiated within 6 hours of birth or hypoxic-ischemic event . The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers , and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vinel and tests between normothermic and hypothermic groups . Thirty-two hypothermic and 33 normothermic neonates were enrolled . The entry criteria selected a severely affected group of neonates , with 77 % Sarnat stage III . Ten hypothermia ( 10/32 , 31 % ) and 14 normothermia ( 14/33 , 42 % ) patients expired . Controlling for treatment group , outborn infants were significantly more likely to die than hypoxic-ischemic infants born in participating tertiary care centers ( odds ratio 10.7 , 95 % confidence interval 1.3 - 90 ) . Severely abnormal motor scores ( Psychomotor Development Index < 70 ) were recorded in 64 % of normothermia patients and in 24 % of hypothermia patients . The combined outcome of death or severe motor scores yielded fewer bad outcomes in the hypothermia group ( 52 % ) than the normothermia group ( 84 % ) ( P = 0.019 ) . Although these results need to be vali date d in a large clinical trial , this pilot trial provides important data for clinical trial design of hypothermia treatment in neonatal hypoxic-ischemic injury Abstract Background There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function . However , the greatest burden of perinatal asphyxia falls in low and mid-re source setting s where it is unclear whether therapeutic hypothermia is safe and effective . Aims Under the UCL Ug and a Women 's Health Initiative , a pilot r and omized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital , a large public hospital with ~20,000 births in Kampala , Ug and a to determine : (i)The feasibility of achieving consent , neurological assessment , r and omization and whole body cooling to a core temperature 33 - 34 ° C using water bottles(ii)The temperature profile of encephalopathic infants with st and ard care(iii)The pattern , severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome (iv)The feasibility of neurodevelopmental follow-up at 18 - 22 months of age Methods / Design Ethical approval was obtained from Makerere Univer sity and Mulago Hospital . All infants were in-born . Parental consent for entry into the trial was obtained . Thirty-six infants were r and omized either to st and ard care plus cooling ( target rectal temperature of 33 - 34 ° C for 72 hrs , started within 3 h of birth ) or st and ard care alone . All other aspects of management were the same . Cooling was performed using water bottles filled with tepid tap water ( 25 ° C ) . Rectal , axillary , ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1 - 4 , a structured , scorable neurological examination and head circumference were performed on days 7 and 17 . Cranial ultrasound was performed on days 1 , 3 and 7 and scored . Griffiths developmental quotient , head circumference , neurological examination and assessment of gross motor function were obtained at 18 - 22 months . Discussion We will highlight differences in neonatal care and infrastructure that need to be taken into account when considering a large safety and efficacy RCT of therapeutic hypothermia in low and mid re source setting s in the future . Trial registration Current controlled trials IS RCT OBJECTIVE To assess the safety of selective head cooling in birth-asphyxiated term newborn infants while maintaining the rectal temperature at 35.0 degrees C or 34.5 degrees C. METHODS Twenty-six term infants with Apgar < or=6 at 5 minutes or cord/first arterial pH < 7.1 , plus evidence of encephalopathy , were studied . After parental consent had been obtained , 13 infants received selective head cooling with the rectal temperature maintained at 35.0 degrees C in 6 infants and at 34.5 degrees C in 7 infants . The remaining 13 infants were normothermic . Cooling was achieved by circulating water at 10 degrees C through a cap placed around the head . Rectal , fontanelle , and nasopharyngeal temperatures were monitored . RESULTS One cooled infant died 2 days after rewarming , and 3 control infants died . Seizures occurred in 9 (69%)of 13 cooled infants and 5 ( 38 % ) of 13 control infants . Respiratory support within the first 72 hours of life was required in 10 of 13 infants in both the cooled and control groups . Three cooled infants and 1 control infant received nitric oxide for persistent pulmonary hypertension . During the same interval , 6 of the cooled infants and 4 of the control infants had episodes in which their blood pressure fell to < 40 mm Hg ; in 2 infants in each group , the lowest blood pressure was below 35 mm Hg . No requirement for volume expansion or increased inotropic support was seen in any infant during stepwise rewarming . All of the cooled infants demonstrated a fall in heart rate during cooling , but the rate was < 80/min in only 2 cases and no infant had a rate < 70/min . No infant demonstrated an abnormal rhythm or was clinical ly compromised by the change in heart rate . One infant cooled to a rectal temperature of 34.5 degrees C had a prolonged QT interval of 570 ms associated with a heart rate of 85/min on electrocardiogram aged 34 hours . This returned to normal after rewarming . Platelet counts below 150 x 10(9)/L , hypoglycemia below 2.6 mmol/L , and highest creatinine were not statistically different between cooled and control infants . Positive precooling blood cultures were found in 1 cooled and 1 control infant . The mean cap water input temperature used during cooling was 10 + /- 1 degrees C. During active cooling , the mean difference between rectal and nasopharyngeal temperature was 1.4 degrees C in the infants who were not receiving respiratory support , but this gradient could not be measured in those who were receiving respiratory support that involved delivery of warmed gases to the nasopharynx . CONCLUSIONS This study suggests that selective head cooling combined with mild systemic hypothermia of 34.4 degrees C or 35.0 degrees C is a stable , well-tolerated method of reducing cerebral temperature in term newborn infants after perinatal asphyxia Hypoxic-ischemic encephalopathy ( HIE ) remains one of the most important neurologic complications in the newborn . Several experimental and clinical studies have shown that hypothermia is the most effective means known for protecting the brain against hypoxic-ischemic brain damage . Furthermore , recent data have suggested that platelet-activating factor ( PAF ) could play a pathophysiologically important role in the progression of hypoxic-ischemic brain injury . The aim of the present study was to investigate the role of head cooling combined with minimal hypothermia in short-term outcome of infants with perinatal asphyxia . In addition , we have examined the effect of head cooling combined with minimal hypothermia on PAF concentrations in cerebrospinal fluid ( CSF ) after hypoxic-ischemic brain injury . The group of asphyxiated infants ( Group 1 ) consisted of 21 full-term ( gestational age > 37 weeks ) . These infants were r and omized and divided into either a st and ard therapy group ( Group 1a ; n=10 ) or cooling group ( Group 1b ; n=11 ) . Head cooling combined with minimal hypothermia ( rectal temperature 36.5 - 36 degrees C ) was started as soon as practicable after birth . The infants were cooled for 72h and then were rewarmed at 0.5 degrees C/h . The control group ( Group 2 ) consisted of seven full-term infants and none of these infants showed any sign of asphyxia . To measure PAF concentration in CSF , CSF with lumbar puncture was collected into tubes immediately before the cooling ( 1 - 3h after birth ) and again after 36h . We had no evidence of severe adverse events related to hypothermia . In Group 1a , two infants died after 72h of life ; however , all newborn infants in Group 1b survived . Convulsion required treatment in three infants of st and ard therapy group ( 1a ) ; none of the infants in Group 1b had clinical seizure activity . Abnormal EEG patterns were found in four infants of Group 1a ; no EEG abnormalities were noted in Group 1b ( P<0.05 ) . On admission ( before cooling ) , PAF concentration in CSF of asphyxiated infants was found to be significantly higher when compared with that of control ( P<0.001 ) . Mean PAF concentration before initiation of the study was similar in the two asphyxiated groups ( Group 1a vs. 1b ) ( P>0.05 ) . Obtained PAF level in CSF after 36h , showed a profound decline in cooling group of infants compared to Group 1a infants ( P<0.01 ) . In conclusion , the present study suggests that cerebral cooling with minimal hypothermia started soon after birth has no severe adverse effects during 72-h cooling period and that short-term outcome of infants are encouraging . Our results also support the hypothesis PAF an important mediator in hypoxic-ischemic brain injury and demonstrate that head cooling combined with minimal hypothermia reduces the normal increase in PAF following hypoxic-ischemic brain injury in full-term infants In intensive care setting s in the developed world , therapeutic hypothermia is established as a therapy for term infants with moderate to severe neonatal encephalopathy due to perinatal asphyxia . Several pre clinical , pilot and clinical trials conducted in such setting s over the last decade have demonstrated that this therapy is safe and effective . The greatest burden of birth asphyxia falls , however , in low- and middle-income countries ; it is still unclear whether therapeutic hypothermia is safe and effective in this context . In this paper , the issues around treatments that may be proven safe and effective in the developed world and the caution needed in translating these into different setting s and population s are explored . It is argued that there are strong scientific and ethical reasons supporting the conduct of rigorous , r and omised controlled trials of therapeutic hypothermia in middle-income setting s. There also needs to be substantial and sustainable improvements in all facets of antenatal care and in the basic level of newborn resuscitation in low income countries . This will reduce the burden of disease and allow health workers to determine rapidly which infants are most eligible for potential neuroprotection Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a re source poor country with limited access to healthcare . Design Prospect i ve , cluster r and omised and controlled effectiveness study . Setting Lufwanyama , an agrarian , poorly developed district located in the Copperbelt province , Zambia . All births carried out by study birth attendants occurred at mothers ’ homes , in rural village setting s. Participants 127 traditional birth attendants and mothers and their newborns ( 3559 infants delivered regardless of vital status ) from Lufwanyama district . Interventions Using an unblinded design , birth attendants were cluster r and omised to intervention or control groups . The intervention had two components : training in a modified version of the neonatal resuscitation protocol , and single dose amoxicillin coupled with facilitated referral of infants to a health centre . Control birth attendants continued their existing st and ard of care ( basic obstetric skills and use of clean delivery kits ) . Main outcome measures The primary outcome was the proportion of liveborn infants who died by day 28 after birth , with rate ratios statistically adjusted for clustering . Secondary outcomes were mortality at different time points ; and comparison of causes of death based on verbal autopsy data . Results Among 3497 deliveries with reliable information , mortality at day 28 after birth was 45 % lower among liveborn infants delivered by intervention birth attendants than control birth attendants ( rate ratio 0.55 , 95 % confidence interval 0.33 to 0.90 ) . The greatest reductions in mortality were in the first 24 hours after birth : 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants ( 0.40 , 0.19 to 0.83 ) . Deaths due to birth asphyxia were reduced by 63 % among infants delivered by intervention birth attendants ( 0.37 , 0.17 to 0.81 ) and by 81 % within the first two days after birth ( 0.19 , 0.0
Output:
| Meta-regression revealed that hypothermia efficacy does not increase as the gross domestic product per capita rises .
There is enough evidence to support hypothermia as the st and ard care for hypoxic-ischemic encephalopathy .
Evidence from low-re source setting s is limited , but hypothermia efficacy was not shown to be associated with better re sources countries |
MS212629 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Achieving primary implant stability in areas with poor bone density is often challenging to the clinician . Previous research has suggested that modified surgical protocol s might be beneficial in such situations . The objective of the present clinical study was to evaluate the survival rate of implants placed using undersized implant site preparation in areas with poor bone density . MATERIAL S AND METHODS A total of 52 implants were placed in 29 patients . Of the 52 implants , 26 were surgically placed according to the st and ard drilling protocol ( control group ) and 26 were placed in low-density bone using an adapted bone drilling method ( test group ) . The maximum insertion torque values and resonance frequency analysis measurements were also recorded . All implants were examined clinical ly and radiographically at follow-up visits during the study period . Oral hygiene status , bleeding on probing , peri-implant probing depth , and implant survival rate were assessed . RESULTS According to the survival criteria used in the present study , no failure was recorded , and the overall survival rate was 100 % for both groups after 12 months . The mean probing depth was 2.75 ± 0.75 mm in the test group and 2.87 ± 0.79 mm in the control group . The mean insertion torque value was 35.19 ± 4.79 Ncm in the test group and 34.62 ± 5.82 Ncm in the control group . The resonance frequency analysis value was 68.58 ± 4.81 implant stability quotient and 66.69 ± 5.41 implant stability quotient in the test and control groups , respectively . The observed differences were not statistically significant ( P > .05 ) . CONCLUSIONS The results of the present study suggest that placement of implants by an adapted drilling technique in sites with poor bone density is beneficial in enhancing primary implant stability and improving the implant survival rate PURPOSE This study evaluated the survival parameters of single-tooth implants through clinical and radiographic analysis . MATERIAL S AND METHODS Implants were restored within a 24-hour period with a provisional crown design ed to receive an occlusal masticatory load . This approach was compared to implants restored after a healing period ( the control group ) . Forty-six implants were placed in 23 patients who were each treated with 2 Frialit-2 implants placed in sites between the second premolar in the maxilla or m and ible . The manufacturer 's recommended formal surgical procedure was followed , and primary stability was st and ardized with a minimum insertion torque of 20 Ncm . The sites were r and omly selected , and the clinical and radiographic parameters were st and ardized with individual templates . RESULTS Data were collected at 24 h , and at 1 , 3 , 6 , 12 , 18 , and 24 months . The experimental group included 10 failed implants ; 9 of the failed implants had been placed with an insertion torque of 20 Ncm . One implant from the control group failed during the 24-month follow-up period . The survival rate was independent of implant length , site position , and bone quality and quantity . Relative risk for implant failure was associated with insertion torque ( relative risk 0.79 [ CI : 0.66 - 0.930 ] ; Cox regression ) ( P < or = .007 ) , in the experimental group but was not significant for those in the control group ( ie , implants placed after a healing period ; relative risk 0.78 [ CI : 0.34 - 1.78 ] ; Cox regression ) ( P < or = .057 ) . To achieve osseointegration , it was found that an insertion torque above 32 Ncm was necessary ( chi2= 15.68 ; P < or = .004 ) . DISCUSSION A careful evaluation is necessary for a better underst and ing of the survival rates of immediately loaded implants . In this study , insertion torque was associated with the potential for risk , which can be decreased by 20 % per 9.8 Ncm added . CONCLUSION Given these results , and considering the number of patients treated , immediate provisional crowns should only be proposed with early loading if an appropriate initial insertion torque has been applied
Output:
| A literature review was done , following which it was seen that the use of versah drills for bone OD result ed in undersized osteotomy compared to conventional drills .
It also result ed in improved bone density and increase in percentage bone volume and bone-to-implant contact , thereby improving implant stability |
MS212630 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Venous leg ulcers constitute a chronic recurring complaint that affects 1.0–1.3 % of the adult population at some time in life , and which corresponds to approximately 75 % of all chronic ulcers of the leg . Multilayer compression b and aging is , at present , the only treatment that has been proved to be effective in treating this type of ulcer . There is no consensus , however , about the dressings that may be applied , beneath the compression , to promote the healing of this type of ulcer , as there does not seem to be any added benefit from using special dressings rather than simple , low-adherence ones . As well as analgesia , acupuncture provokes peripheral vasodilation , in skin and muscles – which has been demonstrated both experimentally and in clinical practice – probably due to the axon reflex , among other mechanisms . The aim of the present study is to measure the effectiveness and cost of compression treatment for venous leg ulcers combined with special dressings , in comparison with low-adherence ones and acupuncture . Methods / design Cluster-r and omized open-labeled trial , at 15 primary healthcare clinics in the Sevilla-Sur Healthcare District , with a control group treated with compression b and aging and low-adherence dressings ; the experiment will consist , on the one h and , of the compression treatment applied in combination with special dressings ( Treatment 1 ) , and on the other , the compression treatment applied in association with low-adherence dressings , together with acupuncture ( Treatment 2 ) . Discussion The results will be measured and recorded in terms of the median time elapsed until complete healing of the ulcer , and the rate of complete healing at 3 months after beginning the treatment . An economic analysis will also be made . This study , carried out in the context of real clinical practice , will provide information for decision-taking concerning the effectiveness of special dressings . Moreover , for the first time a high- quality study will evaluate the effectiveness of acupuncture in the process of healing venous leg ulcers . Trial registration Current Controlled Trials IS RCT N26438275 The present r and omised clinical trial was aim ed at comparing three minimally invasive restorative treatment approaches for managing dental caries in occlusal surfaces using a non-gamma-2 amalgam and a low-viscosity glass-ionomer as the restorative material . The treatment approaches tested in parallel groups were : conventional in a university setting , modified-conventional and ultraconservative ( Atraumatic Restorative Treatment , ART ) approaches in a field setting . A split-mouth design was used in which the two restorative material s were r and omly placed in 430 matched contralateral pairs of permanent molar teeth . A total of 152 children from five primary schools were recruited and treated by a dental therapist . The restorations were evaluated after 6 years by 2 calibrated independent examiners . The 6-year successes for all occlusal amalgam and glass-ionomer restorations were 72.6 and 72.3 % , respectively . There were no statistically significant differences observed between the successes for both amalgam and glass-ionomer restorations placed either by the ART ( 68.6 % , with 95 % CI = 61–76 % ) approach or by the conventional ( 74.5 % , with 95 % CI = 65–82 % ) and the modified-conventional ( 75.8 % , with 95 % CI = 67–83 % ) approaches after 6 years . There was also no statistically significant difference observed between the successes of occlusal ART restorations with glass-ionomer ( 67.1 % , with 95 % CI = 56–77 % ) and occlusal conventional restorations with amalgam ( 74 % , with 95 % CI = 61–85 % ) after 6 years . ‘ Restoration fracture/marginal defects ’ and ‘ loss of material ’ were the most common causes for failure . The former was more often recorded in amalgam restorations and the latter in glass-ionomer restorations . Secondary caries was observed for 2 % of glass-ionomer and for 10 % of amalgam restorations . This difference was statistically significant ( p = 0.001 ) . The ART approach using glass-ionomer performed equally well as conventional restorative approaches using electrically driven equipment and amalgam for treating dentinal lesions in occlusal surfaces after 6 years OBJECTIVE To compare the survival of glass ionomer cement ( GIC ) restorations placed in a dental clinic setting using both the atraumatic restorative treatment ( ART ) approach with h and instruments , and conventional cavity preparation with rotary instruments . METHOD AND MATERIAL S Two encapsulated high-strength conventional GICs ( Fuji IX GP , Ketac-Molar Aplicap ) were placed in 82 Class I and 53 Class II preparations and one encapsulated non-gamma 2 amalgam alloy ( GK-amalgam ) was placed in 32 Class I preparations , in the primary molars of 60 Chinese children with a mean age of 7.40 + /- 1.24 ( SD ) years . Thus , 9 treatment groups were formed . RESULTS After two years , there were no significant survival differences found among 7 of the 9 treatment groups ( p = 0.99 ) . However , two groups comprising Fuji IX GP and Ketac-Molar Aplicap placed in Class II cavities prepared using the ART approach showed significantly lower restoration survivals ( p < 0.001 ) . Only 3 of the 72 initially sealed fissures adjacent to the restorations appeared to retain any GIC material . CONCLUSIONS In a clinic setting , both the ART h and instrument and conventional rotary instrument methods were equally suitable for high Class I restoration survival , but not for Class II restoration survival where the conventional cavity preparation method was preferable The purpose of this study was to evaluate the clinical performance of glass ionomer cement ( GIC ) restorations comparing two minimally invasive methods in permanent teeth after 12 months . Fifty pregnant women ( second trimester of pregnancy ) , mean age 22 ± 5.30 years , were treated by two previously trained operators . The treatment approaches tested were : chemomechanical method ( CarisolvTM ; MediTeam ) and atraumatic restorative treatment ( ART ) . A split-mouth study design was used in which the two treatments were r and omly placed in 50 matched pairs of permanent teeth . The chemomechanical method ( CM ) was the test group and the ART was the control group . The treatments were performed in Public Health Centers . The tested restorative material was a high-strength GIC ( Ketac Molar ; 3M/ESPE ) . The restorations were placed according to the ART guidelines . Two calibrated independent examiners evaluated the restorations in accordance with ART criteria . The interexaminer kappa was 0.97 . Data were analyzed using 95 % confidence interval on the binomial distribution and Fisher 's exact test at 5 % significance level . In a 12-month follow-up , 86 % of the restorations were evaluated . In the test group ( CM ) , 100 % ( CI=93.3 - 100 % ) of the restorations were considered successful . In the control group ( ART ) 97.6 % ( CI=87.4 - 99.9 % ) of the restorations were considered successful and 2.4 % unsuccessful ( marginal defect > 0.5 mm ) . There was no statistically significant difference between the 12-mounth success rate for both groups ( Fisher 's exact test : P=0.49 ) and between the two operators ( Fisher 's exact test : P=1.00 ) . Both minimally invasive methods , chemomechanical method and ART , showed a similar clinical performance after 12 months of follow up OBJECTIVE To compare the level of pain among children treated according to the Atraumatic Restorative Treatment ( ART ) and the Conventional Restorative Treatment ( CRT ) . STUDY DESIGN Forty children of both genders , 4- to 7-years old , presenting Class I cavitated dentin lesions in primary molars were r and omly allocated to 2 groups . One group ( CRT ) received conventional restorative treatment using rotary instruments , while in the other one ( ART ) h and instruments were used to perform the restorations . All children were treated by the same operator A high-viscosity glass-ionomer cement ( Fuji IX ) was used to restore the teeth in both groups . Children 's pain was measured at the end of the first restorative treatment session using the Wong-Baker FACES Pain Rating Scale ( dependent variable ) . Age , gender , treatment time and treatment group were independent variables . ANOVA and ANCOVA tests were used to analyze the data . RESULTS The CRT procedure took longer than the ART procedure ( p < 0.001 ) . Children from the ART group reported less pain than those from the CRT group ( p = 0.0037 ) . Four year olds reported more pain than 5- to 7-year olds ( p < 0.0001 ) in both groups . CONCLUSIONS Restorations placed using ART were less time consuming , children felt less pain when the ART approach was used , and younger children ( 4-years ) reported more pain than the older ones for both restorative treatments Successful use of atraumatic restorative treatment ( ART ) in children has been reported , but little information is available regarding its use in older adults . The hypothesis of this study was that survival rates of root restorations placed by both ART and the conventional technique were similar . Root-surface caries lesions in 103 institutionalized elders in Hong Kong were treated r and omly by either : ( 1 ) the conventional approach — caries removed by dental burs , and the cavity filled with light-cured resin-modified glass ionomer ; or ( 2 ) the ART approach — caries removed by h and instruments , and the cavity filled with chemically cured high-strength glass ionomer . In total , 84 conventional and 78 ART restorations were placed . After 12 months , 63 conventional and 59 ART restorations were review ed , and the respective 12-month survival rates were 91.7 % and 87.0 % ( p > 0.05 ) . It is concluded that the survival rates of both types of root restorations were high and similar AIMS To provide information on the frequency and distribution patterns of sealants in the Public Dental Health Service for Children ( PDHSC ) in Denmark . A further aim was to determine whether there was a correlation between DMF-S and sealants . DESIGN A cross sectional survey using data from 15-year-old Danes in 2003 . SAMPLE AND SUBJECTS : The sample consisted of 50 r and omly selected municipalities from the 204 municipalities with public clinics . Thirty-nine municipalities ( 78 % ) forwarded useful data . A total number of 3,184 15-year-olds were involved in the study . RESULTS The mean DMF-S was 2.97 ( SD = 1.40 ) and 42 % had a DMF-S = 0 . The mean number of sealants was 3.06 ( SD = 1.60 ) . Two-thirds of all participants had one or more sealed surfaces . At the individual level the correlation coefficient ( rs ) between sealants and DMF-S was -0.05 ( p < 0.01 ) . The mean number of sealants in one municipality was 0.26 , in another 6.00 . The surfaces most often sealed , were the occlusal surfaces on permanent second molars ( 35 % ) , closely followed by the occlusal surfaces on permanent first molars ( 32 % ) . Sealants on premolars were rare ( 1.5 % ) . At the municipality level there was no significant correlation between mean DMF-S , % 15-year-olds with a DMF-S = 0 and mean number of sealants ( rs = 0.02 ( p = 0.90 ) and rs = 0.06 ( p = 0.73 ) , respectively ) . CONCLUSION The data indicate a high use of sealants on molar teeth , a very large inter-municipality variation , no correlation between sealants and DMF-S. These findings suggest that there are no clear guidelines for use of sealants in the PDHSC in Denmark BACKGROUND The authors undertook a study to evaluate the effect of two cavity preparation methods on the initial survival of two more-viscous glass ionomer cements , or GICs , placed in the occlusal surfaces of permanent molar teeth . METHODS Three dentists placed 149 restorations in 68 adult patients in a hospital clinic . They used either atraumatic restorative treatment , or ART , or conventional cavity preparation methods to place two encapsulated esthetic conventional GICs : Fuji IX GP ( GC International Corp. , Tokyo ) and Ketac-Molar Aplicap ( 3 M ESPE , Seefeld , Germany ) . For comparison , they used high-copper-content GK Amalgam Alloy ( Advanced Technology & Material s Co. Ltd. , Beijing ) in conventional preparations . They evaluated the restorations using both direct and indirect observation methods . RESULTS Cavity preparations for which the authors used ART h and instruments took approximately twice as long to complete as did those for which they used conventional rotary instruments . After 12 months , no restorations had failed , but restorations comprising both GICs showed early losses of adjacent sealant material . Both GICs also showed relatively high restoration wear . At 12 months , the mean cumulative net occlusal wear for Fuji IX GP was 77 + /- 47 micrometers , and for Ketac-Molar 83 + /- 51 microm , without statistical significance ( P > .05 ) . Color matching improved significantly with time ( P < .001 ) , without significant differences in color between the two GICs by 12 months ( P = .09 ) . The amalgam alloy had minor surface tarnishing and marginal discrepan
Output:
| AUTHORS ' CONCLUSIONS Low- quality evidence suggests that ART using H-GIC may have a higher risk of restoration failure than conventional treatment for caries lesions in primary teeth . |
MS212631 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Targeting glutamatergic dysfunction provides an exciting opportunity to improve cognitive impairment in schizophrenia . One treatment approach has targeted inadequate antioxidant defenses at glutamatergic synapses . Animal and human data suggest NMDA antagonists worsen executive cognitive controls -- e.g . increase perseverative responses and impair set-shifting . We conducted a preliminary study to test the hypothesis that L-carnosine , an antioxidant and anti-glycation agent which is co-localized and released with glutamate would improve executive dysfunction , a cognitive domain associated with glutamate . METHODS Seventy-five symptomatically stable adults with chronic schizophrenia were r and omly assigned to L-carnosine as adjunctive treatment ( 2 g/day ) or a matched placebo in a double-blind manner for 3 months . Cognitive domains ( executive dysfunction , memory , attention and motor speed ) were assessed using a computerized battery at baseline , 4 and 12 weeks , along with psychopathology ratings and safety parameters . RESULTS The L-carnosine group performed significantly faster on non-reversal condition trials of the set-shifting test compared with placebo but reversal reaction times and errors were not significantly different between treatments . On the strategic target detection test , the L-carnosine group displayed significantly improved strategic efficiency and made fewer perseverative errors compared with placebo . Other cognitive tests showed no significant differences between treatments . Psychopathology scores remained stable . The carnosine group reported more adverse events ( 30 % ) compared with the placebo group ( 14 % ) . Laboratory indices remained within acceptable ranges . CONCLUSIONS These preliminary findings suggest that L-carnosine merits further consideration as adjunctive treatment to improve executive dysfunction in persons with schizophrenia Background Fatigue is a common symptom in modern society . There has been a recent resurgence of interest in traditional remedies for fatigue . Chicken essence , which is rich in anserine and carnosine , has been widely taken in Asian countries as a traditional remedy with various aims , including attenuation of physical and mental fatigue . However , the evidence for its efficacy specifically for mental fatigue remains unclear . We examined the effect of essence of chicken on mental fatigue in humans , using our established fatigue-inducing task and evaluation methods . Material / Methods In this placebo-controlled crossover study , 20 healthy male volunteers were r and omized to receive daily oral administration of essence of chicken or placebo drink provided by Cerebos Pacific Ltd. via Suntory holdings Ltd. for 4 weeks . The participants performed 2-back test trials as a fatigue-inducing mental task and then had a rest session . Just before and after each session , they completed cognitive task trials focusing on selective attention to evaluate the level of mental fatigue . Results After essence of chicken intake for 1 and 4 weeks , the reaction times on the cognitive task trials after the rest session were significantly shorter than those at baseline , and significant changes were not observed with placebo intake . The reaction times before and after the fatigue-inducing session were not altered by either essence of chicken or placebo intake . Conclusions We showed that daily intake of essence of chicken could be effective for the recovery from mental fatigue and is a promising c and i date for use as an anti-fatigue food Background It has long been postulated that the relative abundance of specific nutrients can affect cognitive processes and emotions . Newly described influences of dietary factors on neuronal function and synaptic plasticity have revealed some of the vital mechanisms that could be responsible for the action of diet on brain health and cognitive function . Here , through a double-blind , r and omized , placebo-controlled trial , we asked if the newly discovered chicken meat ingredient-168 ( CMI-168 ) could be beneficial to the cognitive function in healthy adults . Methods Normal , healthy subjects were supplemented with either placebo or CMI-168 for 6 weeks . The subjects were given a series of cognitive tests to examine their levels of cognitive functioning at the beginning and end of supplementation , as well as two weeks after termination of supplementation . The combination of these tests , namely Digit Span Backwards , Letter-Number Sequencing , and the Rey Auditory Verbal Learning Test ( RAVLT ) , was used to assess the subjects ’ attention and working memory . For all comparisons , the probability level of p < 0.05 was taken as statistically significant using repeated measure 2-way ANOVA followed by Bonferroni post-hoc test . Results Overall , subjects supplemented with CMI-168 showed significantly ( p < 0.01 ) better performance in all cognitive tests after 6 weeks ’ supplementation compared to control and such superior performance was maintained even 2 weeks after termination of supplementation . Conclusions The present study reveals the cognition-enhancing properties of a recently developed chicken meat ingredient , likely arising from the promotion of attention and prefrontal cortex functions Stress is a common phenomenon . Every individual experiences it . There are many ways of combating stress . Stress is necessary for preparation against challenging situations and danger . It is necessary to have stress before a test so that we are prepared . For instance , stress actually motivates students to prepare for examination but excessive stress can lead to poor performance . This study evaluates the effect of a commercial essence of chicken ( CEC ) on the various parameters related to stress and cognition of human volunteers . CEC is produced by a hot-water extraction process from chicken meat under high pressure condition . It contains concentrated amounts of proteins , amino acids and peptides such as carnosine compared to homemade traditional chicken soup . Due to the unique extraction process , it has been postulated that readily absorbed amino acids and bioactive peptides are present in CEC . In this experiment , we evaluated the effect of CEC in comparison with a placebo and carageenan on a group of stressed medical students before their examinations . Students were divided into three groups at r and om and given either CEC , placebo or a carageenan drink daily for two weeks . Before and after the two weeks , the students were given a series of tests to assess their mental and physical well-being as well as attention and memory . The tests were the general health question naire ( GHQ ) , SF36 , digit span , construction of figures , 3-min memory test , comprehension and mental arithmetic . The students who ingested essence of chicken fared significantly better than the other two groups of students . The ability of essence of chicken to control anxiety by distraction and promoting attention and memory is discussed About 25 % of 1990 - 1991 Persian Gulf War veterans experience disabling fatigue , widespread pain , and cognitive dysfunction termed Gulf War illness ( GWI ) or Chronic Multisymptom Illness ( CMI ) . A leading theory proposes that wartime exposures initiated prolonged production of reactive oxygen species ( ROS ) and central nervous system injury . The endogenous antioxidant L-carnosine ( β-alanyl-L-histidine ) is a potential treatment since it is a free radical scavenger in nervous tissue . To determine if nutritional supplementation with L-carnosine would significantly improve pain , cognition and fatigue in GWI , a r and omized double blind placebo controlled 12 week dose escalation study involving 25 GWI subjects was employed . L-carnosine was given as 500 , 1000 , and 1500 mg increasing at 4 week intervals . Outcomes included subjective fatigue , pain and psychosocial question naires , and instantaneous fatigue and activity levels recorded by ActiWatch Score devices . Cognitive function was evaluated by WAIS-R digit symbol substitution test . Carnosine had 2 potentially beneficial effects : WAIS-R scores increased significantly , and there was a decrease in diarrhea associated with irritable bowel syndrome . No other significant incremental changes were found . Therefore , 12 weeks of carnosine ( 1500 mg ) may have beneficial cognitive effects in GWI . Fatigue , pain , hyperalgesia , activity and other outcomes were resistant to treatment Folk wisdom suggests that chicken extract is useful for recovery from physical and mental fatigue . To explore this question , the physiological effect of Br and 's Essence of Chicken ( BEC ) , a popular chicken extract used as a traditional remedy , was assessed during recovering from mental stress . We quantitated the blood levels of stress-related substances , and examined the task performance and subjects ' mood states during mental workloads . Subjects were 20 , healthy male students who have never tasted BEC . They took two bottles of BEC or a placebo ( 70 ml/bottle ) daily in the morning for 7 days . On the final experimental day , two mental workload tests were performed : ( A ) a mental arithmetic test ( MAT ; 1600 trials of two or three figure-addition or subtraction for 40 min ) . ( B ) a short-term memory test ( SMT ; 20 trials of memorizing 9 digit numbers ) . Blood was collected before and after each workload task . After the mental workload , the recovery of mean cortisol level of subjects who consumed BEC was significantly faster than that for those consuming the placebo . The task performance of subjects performing the MAT and SMT was also improved with BEC consumption compared with placebo . According to the profile of mood state question naire , subjects felt more active and less fatigued during the workload when they took BEC regularly . We conclude that the extract of chicken has the potential to metabolize stress-related substance in blood and to promote recovery from mental fatigue
Output:
| Currently , there is a lack of convincing evidence to show a cognitive enhancing effect of CE |
MS212632 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 compare 90 ° , 180 ° , and 360 ° selective laser trabeculoplasty ( SLT , 532 nm Nd : YAG laser ) with latanoprost 0.005 % for the control of intraocular pressure ( IOP ) in ocular hypertension ( OHT ) and open angle glaucoma ( OAG ) . Methods : A prospect i ve , r and omised clinical trial in the Department of Ophthalmology , St Thomas ’s Hospital , London , and Clayton Eye Centre , Wakefield , West Yorkshire . 167 patients ( 167 eyes ) with either OHT or OAG were r and omised to receive 90 ° , 180 ° , and 360 ° SLT or latanoprost 0.005 % at night and were evaluated at 1 hour , 1 day , 1 week and 1 , 3 , 6 , and 12 months . Results : The mean follow up was 10.3 months ( range 1–12 months ) . Early , transient , complications such as postoperative ocular pain , uveitis , and 1 hour IOP spike occurred in a number of eyes after SLT , with pain being reported more frequently after 360 ° than 90 ° treatments ( p>0.001 ) . Success rates defined in terms of both a 20 % or more and a 30 % or more IOP reduction from baseline measurements with no additional antiglaucomatous interventions were better with latanoprost than 90 ° ( p<0.001 ) and 180 ° SLT ( p<0.02 ) treatments . Differences in success rates between latanoprost and 360 ° SLT did not reach statistical significance ( p<0.5 ) . Success rates were greater with 180 ° and 360 ° compared to 90 ° SLT ( p<0.05 ) . With 360 ° SLT , 82 % of eyes achieved a > 20 % IOP reduction and 59 % a > 30 % reduction from baseline . Although success rates were better with 360 ° than 180 ° SLT treatments , differences did not reach statistical significance . There were no differences with regard to age , sex , race , pretreatment IOP , OHT versus OAG , laser power setting s , and total laser energy delivered between eyes which responded , in terms of a > 20 % and a > 30 % IOP reduction , and those that did not respond with 180 ° and 360 ° SLT treatments . Conclusions : Success rates were higher with latanoprost 0.005 % at night than with 90 ° and 180 ° SLT treatments . 90 ° SLT is generally not effective . 360 ° SLT appears to be an effective treatment with approximately 60 % of eyes achieving an IOP reduction of 30 % or more . Transient anterior uveitis with associated ocular discomfort is not unusual in the first few days after SLT . Late complications causing ocular morbidity after SLT were not encountered Purpose To compare the efficacy of selective laser trabeculoplasty ( SLT ) to argon laser trabeculoplasty ( ALT ) as treatment and retreatment to lower intraocular pressure ( IOP ) in patients with uncontrolled open-angle glaucoma ( OAG ) on maximally tolerated medication therapy with a follow-up of 12 months . Methods A total of 120 eyes of 120 patients with uncontrolled OAG were enrolled in the study . Group A included patients with IOP > 22 mmHg on maximal medical therapy . A total of 43 eyes underwent SLT treatment and 41 eyes underwent ALT treatment . At the end of the follow-up IOP was < 18 mmHg . Group B included patients with IOP > 20 mmHg at 3 months follow-up after SLT or ALT treatment . These patients were retreated r and omly , 18 with SLT and 18 with ALT . Results In Group A at the end of the follow-up there was no statistically significant difference in IOP lowering between SLT ( 6.01 mmHg ) and ALT ( 6.12 ) ( p=0.794 ) . In Group B at the end of the follow-up patients undergoing SLT presented IOP lowering statistically significant to ALT treatment ( 6.24 mmHg and 4.65 mmHg , respectively , p<0.01 ) . Discussion SLT is effective as treatment for patients with OAG and appears to be equivalent to ALT in IOP lowering at 12 months only in patients without a prior treatment . In case of retreatment SLT appears to be better than ALT in IOP lowering Purpose : To study the effectiveness and safety of selective laser trabeculoplasty ( SLT ) on primary open‐angle glaucoma and ocular hypertension in Chinese eyes INTRODUCTION The falling success rate of ALT ( Argon Laser Trabeculoplasty ) has raised the interest in some new laser techniques , such as q-switched Nd : YAG laser trabeculoplasty ( Coherent Selecta 7000 ) . The " selective " laser trabeculoplasty destroys melanosomes of pigmented trabecular meshwork cells , sparing adjacent non-pigmented cells and tissues . AIM Our goal was to establish the IOP lowering effect of selective laser trabeculoplasty ( SLT -- Selecta Laser Trabeculoplasty ) in comparison with ALT . MATERIAL AND METHODS We have examined 27 patients ( 10 men , 17 women ) aged 35 - 82 , with open angle glaucoma and visual field deterioration despite maximal tolerated topical therapy ( 21 patients --POAG , 3 - -NPG , 1 - -pigmentary glaucoma , 1 - -pseudoexfoliative glaucoma , 1 - -juvenile glaucoma ) . One eye of each patient was r and omly chosen for SLT , the other eye underwent ALT . In each method 50 burns were applied in 180 degrees angle with power setting s of 600 - 1000 mW for ALT and energy setting s of 0.5 - 1.4 mJ for SLT . The IOP was measured 1 hour before laser treatment and 1 , 2 , 24 hours and 3 months after treatment . RESULTS The mean initial IOP in eyes selected for SLT was significantly higher ( 21.26 + /- 4.82 mm Hg ) than in eyes selected for ALT ( 20.26 + /- 4.01 mm Hg ) , t-test : p = 0.037 . However , there was no statistically significant difference in the IOP lowering effect between eyes treated with SLT and eyes treated with ALT . The mean IOP drop from the pre-treatment values was -2.85 + /- 4.62 mm Hg after SLT and -2.63 + /- 3.60 mm Hg after ALT ( t-test , p = 0.84 ) . All values : 2 , 24-hours and 3 months after treatment were significantly lower than pre-treatment values in both groups ( t-test , p < 0.03 ) . Only in the 1st hour after SLT the IOP drop was not significant . There was a significant correlation between the amount of pigment on the trabecular meshwork and the IOP fall ( U Mann-Whitney test ) . In SLT group 6 patients ( 21 % ) developed mild iritis during 1st day after laser treatment , which disappeared after fluorometholon drop therapy . CONCLUSION Both methods --SLT and ALT -- have equivalent IOP lowering effect in short time observation ( 3 months ) . Due to entirely novel mode of Selecta laser action , long term results may show significant differences AIMS To compare the effectiveness of selective laser trabeculoplasty ( SLT , a 532 nm Nd : YAG laser ) with argon laser trabeculoplasty ( ALT ) in lowering the intraocular pressure ( IOP ) in patients with medically uncontrolled open angle glaucoma . METHODS A prospect i ve r and omised clinical trial was design ed . Patients were r and omised to treatment with either SLT or ALT and were evaluated at 1 hour , 1 week , 1 , 3 , and 6 months post-laser . RESULTS There were 18 eyes in each group . Baseline characteristics were similar in both groups . In the SLT group the mean IOP at baseline , 1 , 3 , and 6 months was 22.8 ( SD 3.0 ) , 20.1 ( 4.6 ) , 19.3 ( 6.0 ) , and 17.8 ( 4.8 ) mm Hg , respectively . In the ALT group , the mean IOP at baseline , 1 , 3 , and 6 months was 22.5 ( 3.6 ) , 19.5 ( 4.7 ) , 19.6 ( 5.6 ) , and 17.7 ( 3.3 ) mm Hg , respectively . There was a greater anterior chamber reaction , 1 hour after SLT v ALT ( p < 0.01 ) . Patients with previous failed ALT had a better reduction in IOP with SLT than with repeat ALT ( 6.8 ( 2.4 ) v 3.6 ( 1.8 ) mm Hg ; p = 0.01 ) . CONCLUSION SLT appears to be equivalent to ALT in lowering IOP during the first 6 months after treatment . There is a slightly greater anterior chamber reaction 1 hour after SLT . Patients with previous failed ALT had a significantly greater drop in IOP when treated with SLT vALT . These results need to be confirmed with a larger sample size Objective To compare the effectiveness of argon laser trabeculoplasty ( ALT ) and selective laser trabeculoplasty ( SLT ) in lowering intraocular pressure ( IOP ) in younger patients ( age 60 or less ) . Methods This was a prospect i ve r and omized control trial . Forty-two young patients ( age 29 to 60 y ) had 1 eye r and omized to ALT ( n=22 ) or SLT ( n=20 ) . IOP was measured before laser and 1 hour , 1 day , 6 weeks , 3 months , every 3 months until 2 years , and then yearly postlaser . Chi-square analysis and Student t test were used to determine statistical significance . Results The mean IOP before treatment was 21.9 mm Hg for ALT and 19.1 mm Hg for SLT with no statistical difference between the groups ( P>0.05 ) . At 2 years , 86.4 % of ALT and 75.0 % of SLT eyes required no further surgical intervention ( laser trabeculoplasty or trabeculectomy ) . During the same time period , there was a statistically significant IOP decrease of 11.1 % after ALT ( P=0.01 ) and 7.7 % after SLT ( P=0.01 ) with no statistical difference between the lasers ( P>0.05 ) . Conclusions In younger patients , both ALT and SLT have a significant ocular hypotensive effect 2 years after treatment , with no differences in outcome identified between the laser modalities BACKGROUND Argon laser trabeculoplasty ( ALT ) and selective laser trabeculoplasty ( SLT ) are treatments for open-angle glaucoma . Many patients have previously received ALT but could benefit from further treatment . The purpose of this study was to examine whether SLT provided clinical benefit for patients who had previously received complete argon treatment . METHODS This was a prospect i ve , partially r and omized , comparison study . The study compared the effect after 1 year of SLT in patients with open-angle glaucoma ( primary , pigmentary , or pseudoexfoliation ) who had previously received 360 degrees of ALT with the effect of laser treatment ( ALT or SLT ) given for the first time in patients with this condition . Ninety-six subjects were given 180 degrees of laser trabeculoplasty . When both eyes qualified for treatment , the first eye treated was included in the analysis . Twenty-seven subjects were treated with SLT after previously receiving 360 degrees of ALT therapy ; the remainder were given their first laser treatment , 30 being r and omly assigned by coin toss to receive SLT and 39 to receive ALT . RESULTS The mean intraocular pressure ( IOP ) before treatment was 21.5 mm Hg ( SLT after ALT ) , 22.9 mm Hg ( SLT ) , and 22.0 mm Hg ( ALT ) , with no statistical difference among the groups ( p > 0.05 ) . The mean IOP at 1 year was 16.7 mm Hg ( SLT after ALT ) , 17.1 mm Hg ( SLT ) , and 16.4 mm Hg ( ALT ) . The IOP for all 3 groups was statistically significantly lower than at baseline ( p < 0.001 ) , but there were no differences among the groups in this respect ( p > 0.05 ) . At 1 year , the percentage IOP reductions from baseline were 23 % ( SLT ) , 19.3 % ( SLT after ALT ) , and 24 % ( ALT ) . There were no differences among the groups in the number of medications used before the laser , although there was a small but statistically significant decrease in the number of medications used before or after the laser treatment in both the SLT and the SLT after ALT group , but not the ALT group . INTERPRETATION SLT retreatment can produce a clinical ly useful decrease in IOP at 1 year , similar to that obtained by ALT , in patients who have had prior argon laser treatment . SLT may be a useful adjunctive therapy when 360 degrees of ALT has already been performed Introduction : This study evaluated and compared the efficacy of selective laser trabeculoplasty ( SLT ) and argon laser trabeculoplasty ( ALT ) in terms
Output:
| Conclusion In terms of the IOP lowering effect , there is no difference between SLT and ALT .
It is inconclusive whether 90 ° is less efficacious than 180 ° SLT . |
MS212633 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 double-blind r and om selection comparison was made of the therapeutic effects in acute herpes zoster of 40 % idoxuridine ( IDU ) dissolved in dimethyl sulphoxide ( DMSO ) compared with DMSO and saline flavoured with garlic . Thoracic ( 80 patients ) and trigeminal ( 42 patients ) zoster were investigated separately . The patients were evaluated daily until skin healing and then at 1 , 3 and 6 months by registering pain , paraesthesia and sensitivity disturbances as well as by clinical and photographic evaluation of the skin lesions . Duration of pain was positively correlated to age , to delayed healing and to elevated temperature in the acute phase of zoster . The period of pain before skin eruption was considerably longer in thoracic than in trigeminal zoster , while the latter was associated with a more severe inflammatory reaction , more neurologic sequelae , but also by a faster healing of the skin lesions . IDU was highly effective in shortening the period of pain and improving skin healing in trigeminal zoster , while no effect of IDU was observed in thoracic zoster . The reason for this difference is presently not understood The antiviral effect of 5 % idoxuridine in dimethyl sulphoxide intermittently applied and of 40 % idoxuridine in dimethyl sulphoxide continuously applied for four days to the lesions in patients with zoster of recent onset was studied in two double-blind controlled trials . Most , but not all , of the patients receiving intermittent active treatment had pain for a short period only . The effect of continuous treatment was striking : pain had disappeared within nine days in all the patients and healing was accelerated . The results were statistically significant A double-blind , r and om selection comparison was made of the therapeutic effects in acute herpes zoster of ( A ) 40 % idoxuridine ( IDU ) dissolved in dimethyl sulphoxide ( DMSO ) , or one of the following ointments : ( B ) a basis of polyethylene glycol , ( C ) a basis with 60 % DMSO , ( D ) a basis with 5 % IDU and 60 % DMSO , and ( E ) a basis with 40 % IDU and 60 % DMSO . Each group comprised 20 patients . The patients were evaluated daily until skin healing and then at 1,3 , and 6 months by registering 4 neurological signs , 5 clinical evaluations of skin pathology and 4 photographic evaluations of the skin lesions . A ' profile ' of the effect of each treatment was computed by calculating normalized means for each of the 13 variables . A non-r and om distribution of the clinical and photographic variables indicated a statistically significant , but small therapeutic effect of treatment A on skin healing , whereas no convincing effect on pain or sensitivity disturbances was established . Treatments B-E were without positive effects . The information given by the highly interdependent variables were computed for each variable and for groups of variables after appropriate scoring . It was found that the photographic evaluation contributed evidence independent of the clinical evaluation of skin pathology . A multiple correlation analysis revealed that age was positively correlated to the duration of pain and to delayed healing , that rapid healing was intimately connected to no or short-lived pain , and surprisingly that zoster in the trigeminal area healed faster than in other locations without being correlated to less pain . Treatment A must necessarily be reevaluated taking into account proper controls as well as age and affected dermatomes Oral acyclovir , 800 mg five times per day for seven days , was compared with placebo in a r and omized , double-blind trial conducted at three centers in the United Kingdom . The study group consisted of 364 elderly immunocompetent patients with herpes zoster who were entered within 72 hours of the onset of rash . Acyclovir significantly reduced the times to last new lesion formation ( p less than 0.01 ) , loss of vesicles ( p less than 0.01 ) , and full crusting ( p = 0.03 ) . No significant hastening of rash healing was seen in those who started therapy later than 48 hours after the onset of rash . There was also a significant reduction pain during treatment with acyclovir ( p = 0.02 ) . Acyclovir produced no effects on the frequency or severity of post-herpetic neuralgia . No clinical ly important adverse effects of acyclovir were reported In a double-blind r and omised trial , 38 elderly patients with acute herpes zoster received either isoprinosine ( IP ) or placebo . IP neither shortened the acute phase of herpes zoster nor prevented postherpetic neuralgia . Transient asymptomatic hyperuricaemia affected one third of IP treated patients . Shortcomings in study design and misleading interpretation of results are common in previously published clinical trials of herpes zoster and postherpetic neuralgia . Guidelines for future studies are proposed Oral acyclovir therapy for herpes zoster has been studied in double-blind , placebo-controlled trials of two dosages , 400 mg and 800 mg five times per day for 10 days . Compared with placebo recipients , recipients of the high-dosage acyclovir experienced a significantly shortened period of viral shedding , significantly accelerated time to 50 percent scabbing , significantly accelerated time to 50 percent healing , and after two days of therapy , significantly less frequent formation of new lesions . The duration and severity of acute pain were less in acyclovir recipients , with differences in pain severity achieving statistical significance ( p = 0.03 ) between Days 3 and 10 and correlating with the treatment differences in new lesion formation . In studies of the 400 mg five times per day dose schedule , differences between acyclovir and placebo recipients were not significant . In a six-month follow-up of recipients in the higher dosage study , the acyclovir recipients experienced less post-zoster pain than placebo recipients ; differences in the prevalence of pain were most significant for the presence of a persistent pain in the first three months of follow-up . Oral acyclovir at these dosages appears to be free of adverse reactions . In summary , oral acyclovir at a dosage of 800 mg five times per day for 10 days for treatment of acute herpes zoster is superior to 400 mg five times per day and favorably alters the course of the disease Healthy patients with early painful herpes zoster were treated with corticosteroid orally or lactose tablets in a double-blind fashion . The duration of postherpetic neuralgia was shortened by treatment with the corticosteroid . Corticosteroid therapy did not affect pain during the first two weeks or the rate of skin healing . The duration of postherpetic neuralgia could not be predicted by the healing rate of the skin . Control patients less than 60 years old had rapid resolution of their neuralgia while those more than 60 years old had slower resolution of the pain . Corticosteroid therapy did not cause generalization of the eruption Zoster is a common disease that may be associated with severe and protracted pain . Antiviral therapy with acyclovir intravenously has been shown to modify the course of the disease and reduce pain during the acute phase . The results of two studies using doses of 400 mg and 800 mg of acyclovir orally are outlined . The data suggest a significant benefit of the higher dose treatment on the course of the illness and the pain A double-blind , r and omised trial evaluated the efficacy of oral acyclovir , 800 mg 5 times daily for 7 days , in acute herpes zoster and postherpetic neuralgia . Forty patients aged 16 years or over , presenting to their general practitioners within 3 days of rash onset , received acyclovir , while 43 patients received placebo . Acyclovir reduced the extent and duration of the rash , the spread of the rash to adjacent dermatomes and the incidence of disseminated lesions . It shortened the period of new lesion formation and reduced the incidence of ulceration . The weekly prevalence of pain was reduced on acyclovir by the fourth week , with a reduction in the monthly prevalence of chronic pain in the second and third months and a reduction in associated local neurological symptoms between months 3 - 6 . Total analgesic use in the first 4 weeks was reduced by acyclovir , but during follow up there was no difference in the prevalence of analgesic use between groups . There were slightly fewer medical events on acyclovir in the second week , but the frequency was the same in each group for the rest of the 6 months . Biochemical and haematological tests showed no adverse effects of treatment In a r and omised , double-blind , controlled study of the effect of prednisolone on the development of post-herpetic neuralgia 78 patients with herpes zoster whose pain and exanthema had been present for less than 96 h were given 800 mg acyclovir five times daily for 7 days and prednisolone in a total dose of 575 mg , starting with 40 mg daily in the first week and tapering off over the next 2 weeks . 18 ( 23 % ) of the patients had post-herpetic neuralgia at 6 months after the acute zoster , 9 ( 24.3 % ) having received prednisolone and 9 ( 22.5 % ) placebo . The 95 % CI for the difference between the placebo and prednisolone groups in the proportion of patients having pain at 6 months was minus 17 % to plus 20 % . Prednisolone , however , relieved pain for the first 3 days . The 1 - 2 week interval between admission and reappearance of pain and development of triggered pain seems to be the time needed to establish neuralgia . Once established , the type and intensity of pain remained largely unaltered Sixty-four patients with herpes zoster were entered into a r and omised double-masked , placebo-controlled trial of 5 % acyclovir cream applied five times daily for 5 days . Of these patients , 56 were included in the final analysis ( 26 acyclovir , 30 placebo ) . Significant and objective differences in either progression of the rash , severity of acute pain or incidence of post-herpetic neuralgia were not observed . Although significantly more rashes involuted in the acyclovir group , this isolated finding can not be explained . Twenty-two patients ( 12 acyclovir , 10 placebo ) experienced erythema or desquamation or both during treatment with the cream . The similar incidence of skin reactions in both groups suggests that they were related to the cream base rather than the acyclovir Seventy-one nonimmunocompromised patients with herpes zoster ophthalmicus , presenting within seven days of onset of characteristic skin eruption , were enrolled in a prospect i ve , longitudinal , r and omized , double-masked , placebo-controlled trial with oral acyclovir . In a previous interim report we noted more prompt resolution of dermatomal signs and symptoms with acyclovir treatment . There was also a reduction of viral shedding in acyclovir-treated patients coupled with a trend to greater rate of microdissemination of the virus in placebo-treated patients ( Cobo LM , et al. Ophthalmology 1985 ; 92:1574 - 83 ) . While further substantiating these findings , we report that a ten-day course of treatment with oral acyclovir ( 600 mg , five times a day ) is well-tolerated and significantly reduces the incidence and severity of the most common complications of herpes zoster ophthalmicus : dendritiform keratopathy , stromal keratitis , and uveitis . While this acyclovir treatment regimen reduces the zoster-related pain during the acute phase of the disease , especially in patients treated within 72 hours of onset of skin lesions , it has no evident effect on either incidence , severity , or duration of post-herpetic neuralgia in the patients studied In an uncontrolled open assessment of one patient , cimetidine relieved the pain and shortened the course of herpes zoster . A subsequent uncontrolled trial of cimetidine in 21 patients with herpes zoster produced encouraging results in all but three patients . More recently , Mavligit and Talpaz[3 ] reported that cimetidine 300 mg q.d.s . for seven days produced a rapid improvement in the pain and pruritus of herpes zoster in four cancer patients whose immune systems were profoundly suppressed . Herpes zoster is thought to be associated with a state of depressed cellular immune function[4 ] . It is theoretically possible for H2 receptor antagonists such as cimetidine to modify cell-mediated immune responses since thymus dependent T-lymphocytes have been shown to possess H2 receptors[5 - 7 ] . In addition to a possible direct anti-viral effect[2 ] , cimetidine may augment the immune defences of the body which produce early control of the herpes zoster virus Sixty immunocompetent patients with herpes zoster of various dermatomes were treated 5 times a day for 5 days with either acyclovir at a dose of 400 mg or placebo A double-blind , placebo-controlled trial of amantadine hydrochloride ( Symmetrel ) in acute herpes zoster ( shingles ) was carried out in 100 patients in general practice . The cases were serologically proved . There was no difference in duration of pain between the drug and placebo groups when pain disappeared during the 28 days ' observation period . However , pain lasted more than 28 days in a significantly greater proportion of patients receiving placebo than of those on amantadine . Patients with pain after the 28-day observation period were significantly older than those whose pain disappeared during the study . The drug had no effect on rate of healing or appearance of new lesions Forty-seven out patients with herpes zoster , seen within five days of onset of the eruption , received ten days ' administration of oral levodopa and benserazide or placebo in a double-blind controlled study . Both the total patient group and high-risk group ,
Output:
| Firm recommendations for clinical practice are not possible because existing evidence neither confirms nor refutes the hypothesis that treatment during the acute phase of herpes zoster reduces pain later |
MS212634 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 effects of meal size and frequency on thermic effect of food ( TEF ) were examined in seven healthy normal-weight young women . Each volunteer consumed in r and om order one of two identical meals [ 3138 kJ ( 750 kcal ) , 54.5 % carbohydrate , 14.0 % protein , 31.5 % fat ] . One meal was taken over 10 min [ large meal ( LM ) ] whereas the other was taken in six equal portions of 523 kJ ( 125 kcal ) at 30-min intervals over a 3-h period [ small meals ( SM ) ] . Metabolic rate was measured for 1 h before and every 30 min after the meal started for 5 h. When expressed as either kJ/min ( kcal/min ) or kJ/5h ( kcal/5h ) , TEF was significantly higher in the LM day than in the SM day ( P less than 0.05 ) . We conclude that the temporal pattern in which a mixed caloric load is eaten affects the thermogenic response and may be an important determinant of energy balance after a meal Fifty-two moderately obese adult women were stratified according to their baseline breakfast-eating habits and r and omly assigned a weight-loss program . The no-breakfast group ate two meals per day and the breakfast group ate three meals per day . The energy content of the two weight-loss programs was identical . After the 12-wk treatment , baseline breakfast eaters lost 8.9 kg in the no-breakfast treatment and 6.2 kg in the breakfast treatment . Baseline breakfast skippers lost 7.7 kg in the breakfast treatment and 6.0 kg in the no-breakfast treatment . This treatment-by-strata-by-time interaction effect ( P less than 0.06 ) suggests that those who had to make the most substantial changes in eating habits to comply with the program achieved better results . Analyses of behavioral data suggested that eating breakfast helped reduce dietary fat and minimize impulsive snacking and therefore may be an important part of a weight-reduction program BACKGROUND Different dietary fats are metabolized differently in humans and may influence energy expenditure , substrate oxidation , appetite regulation , and body weight regulation . OBJECTIVE We examined the short-term effects of 4 triacylglycerols ( test fats ) on subjective appetite , ad libitum energy intake , meal-induced thermogenesis , and postpr and ial substrate oxidation . DESIGN Eleven healthy , normal-weight men ( mean age : 25.1 + /- 0.5 y ) consumed 4 different test fats [ conventional fat ( rapeseed oil ) and 3 modified fats ( lipase-structured fat , chemically structured fat , and physically mixed fat ) ] in a r and omized , double-blind , crossover design . RESULTS No significant differences in appetite sensations or ad libitum energy intakes were observed between the 4 test fats . Overall , the 4 fats exerted different effects on energy expenditure ( meal effect : P < 0.01 ) and substrate oxidation ( interaction between meal and time : P < 0.05 ) . In post hoc tests , the 3 modified fats result ed in significantly higher postpr and ial energy expenditure and fat oxidation than did the conventional fat ( P < 0.008 , Bonferroni adjusted ) ; no significant differences were observed between the 3 modified fats . CONCLUSIONS Structured fats do not change short-term postpr and ial appetite sensations or ad libitum energy intakes but do result in higher postpr and ial energy expenditure and fat oxidation than do conventional fats and hence promote negative energy and fat balance . In humans , a physically mixed fat ( trioctanoate + rapeseed oil ) is metabolized as quickly as are structured fats . The position of medium-chain fatty acids on the glycerol backbone of triacylglycerols does not seem to affect energy expenditure or appetite Background : Popular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health , the causal nature of which remains to be explored under real-life conditions . Objective : The aim was to conduct a r and omized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans . Design : The Bath Breakfast Project is a r and omized controlled trial with repeated- measures at baseline and follow-up in a cohort in southwest Engl and aged 21–60 y with dual-energy X-ray absorptiometry – derived fat mass indexes ≤11 kg/m2 in women ( n = 21 ) and ≤7.5 kg/m2 in men ( n = 12 ) . Components of energy balance ( resting metabolic rate , physical activity thermogenesis , energy intake ) and 24-h glycemic responses were measured under free-living conditions with r and om allocation to daily breakfast ( ≥700 kcal before 1100 ) or extended fasting ( 0 kcal until 1200 ) for 6 wk , with baseline and follow-up measures of health markers ( eg , hematology/biopsies ) . Results : Contrary to popular belief , there was no metabolic adaptation to breakfast ( eg , resting metabolic rate stable within 11 kcal/d ) , with limited subsequent suppression of appetite ( energy intake remained 539 kcal/d greater than after fasting ; 95 % CI : 157 , 920 kcal/d ) . Rather , physical activity thermogenesis was markedly higher with breakfast than with fasting ( 442 kcal/d ; 95 % CI : 34 , 851 kcal/d ) . Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health . Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention ( CV : 3.9 % ; 95 % CI : 0.1 % , 7.8 % ) . Conclusions : Daily breakfast is causally linked to higher physical activity thermogenesis in lean adults , with greater overall dietary energy intake but no change in resting metabolism . Cardiovascular health indexes were unaffected by either of the treatments , but breakfast maintained more stable afternoon and evening glycemia than did fasting . This trial was registered at www.is rct n.org as IS RCT N31521726 OBJECTIVE : To study the effect of diet composition on diet-induced thermogenesis ( DIT ) over 24 h in a respiration chamber . SUBJECTS : Eight healthy female volunteers ( age 27±3 y ; body mass index , BMI 23±3 kg/m2).DIETS : A high protein and carbohydrate ( HP/C ) ( 60:10:30 ; percentage energy (E%)carbohydrate , fat and protein , respectively ) and high fat ( HF ) ( 30:60:10 respectively ) diet , both isoenergetic , isovolumetric , composed of normal food items and matched for organoleptic properties ( taste , smell , appearance ) . DESIGN : Subjects spent two 36 h periods each in a respiration chamber consuming both test diets in r and om order . Components of 24 h energy expenditure ( 24 h EE ) : sleeping metabolic rate , DIT and activity induced energy expenditure were measured . RESULTS : DIT was higher in all subjects while on the HP/C diet ( 1295 kJ/d vs 931 kJ/d ; 14.6 % vs 10.5 % of energy intake ; P<0.02 ) . There was no significant difference in other components or total 24 h EE , although there was a trend towards higher EE on the HP/C diet . CONCLUSION : A high protein and carbohydrate diet induces a greater thermic response in healthy individuals when compared to a high fat diet BACKGROUND & AIMS To compare the acute effects of three fatty meals with different fat quality on postpr and ial thermogenesis , substrate oxidation and satiety . METHODS Twenty-nine healthy men aged between 18 and 30 years participated in a r and omised crossover trial comparing the thermogenic effects of three isocaloric meals : high in polyunsaturated fatty acids from walnuts , high in monounsaturated fatty acids from olive oil , and high in saturated fatty acids from fat-rich dairy products . Indirect calorimetry was used to determine resting metabolic rate , respiratory quotient , 5-h postpr and ial energy expenditure and substrate oxidation . Satiety was estimated by using visual analogue scales and measuring caloric intake in a subsequent ad libitum meal . RESULTS Five-h postpr and ial thermogenesis was higher by 28 % after the high-polyunsaturated meal ( p=0.039 ) and by 23 % higher after the high-monounsaturated meal ( p=0.035 ) compared with the high-saturated meal . Fat oxidation rates increased nonsignificantly after the two meals rich in unsaturated fatty acids and decreased nonsignificantly after the high-saturated fatty acid meal . Postpr and ial respiratory quotient , protein and carbohydrate oxidation , and satiety measures were similar among meals . CONCLUSIONS Fat quality determined the thermogenic response to a fatty meal but had no clear effects on substrate oxidation or satiety We investigated the effects of food palatability on the thermic effect of feeding ( TEF ) , substrate oxidation and circulating glucose and insulin . Healthy young men ( 23.4+/-1.0 , SD , years , n=10 ) and older men ( 69.4+/-1.3 , years , n=9 ) were resident in a metabolic unit for two 2-day study periods . On the second day of each period , they consumed in r and om order either a palatable test meal containing 2.93 MJ or a nonpalatable control meal containing the same foods in identical amounts but blended and freeze-dried into biscuit form . TEF and respiratory quotient ( RQ ) were measured over 6 h and blood sample s were taken for measurement of glucose and insulin . Age group had no effect on TEF , RQ or circulating glucose other than to delay the time of peak TEF ( P<0.002 for both meals ) . There was no significant effect of meal type on TEF , but RQ and circulating glucose were higher following consumption of the palatable meal ( P<0.001 for both parameters ) . These results suggest that over 6 h postpr and ial , consumption of palatable foods does not increase TEF , but is instead associated with increased glycemic response and increased carbohydrate oxidation . These changes , combined with previous work on the glycemic index , predict an accelerated return of hunger and increased energy intake at subsequent meals following consumption of palatable vs. control foods . Further studies are needed to examine the possible mechanism for this previously suggested " second meal " effect of diet palatability on energy intake OBJECTIVE To determine whether medium-chain triglycerides , in low-to-moderate amounts consumed with meals ( at breakfast , lunch and dinner ) , can increase daily energy expenditure ( EE ) and 24-h urinary excretion of catecholamines in humans . DESIGN Dose-response study conducted under double-blind r and omised design . SETTING Respiratory chamber at the Faculty of Medicine , University of Geneva . SUBJECTS Eight healthy young men were recruited from the student population by advertisement in our Faculty . METHODS 24-h EE and urinary catecholamines were measured in each subject during stay in a respiratory chamber on four separate occasions . These were r and omised between four different combinations of medium-chain triglycerides ( MCT ) and long-chain triglycerides ( LCT ) , a total 30g/day , which was consumed with their habitual diet in three equal parts ( 10 g each ) at breakfast , lunch , and dinner in the following ratio of MCT : LCT ( g/g ) 0:30 , 5:25 , 15:15 and 30:0 . RESULTS 24-h EE increased significantly with increasing MCT : LCT ratio ( ANOVA , P < 0.001 ) , with the diet providing a total of 15 - 30 g MCT per day stimulating 24-h EE by 5 % : this corresponds to a mean absolute increase in daily EE of approximately 500kJ , with individual values varying between 268 kJ and 756 kJ. No significant differences were observed in respiratory quotient nor in urinary nitrogen losses across diets , but 24-h urinary noradrenaline was significantly increased ( ANOVA , P < 0.025 ) , whereas adrenaline and dopamine were unaltered . CONCLUSIONS This study suggests that relatively low-to-moderate intake of MCT ( 15 - 30 g per day ) as part of habitual diet may play a role in the control of human body composition by enhancing daily EE , and that this effect is mediated at least in part through activation of the sympathetic nervous system Objective : To compare postpr and ial whole-body fat oxidation rates in humans , following high-fat ( 43 % of total energy ) mixed breakfast meals , of fixed energy and macronutrient composition , rich in either monounsaturated fat ( MUFA ) from extra virgin olive oil or saturated fat ( SFA ) from cream . Design : Paired comparison of resting metabolic rate ( RMR ) , thermic effect of a meal and substrate oxidation rates following consumption of isocaloric breakfast meals ,
Output:
| Meals with a high protein or carbohydrate content had a higher DIT than high fat , although this effect was not always significant .
Unclear or inconsistent findings were found by comparing the consumption of meals quickly or slowly , and palatability was not significantly associated with DIT .
These findings indicate that the magnitude of the increase in DIT is influenced by the energy intake , macronutrient composition , and eating pattern of the meal |
MS212635 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECT Implantation of cerebrospinal fluid ( CSF ) shunting devices is associated with a 5 - 15 % risk of infection as cited in contemporary pediatric neurosurgical literature . Shunt infections typically require complete removal of the device and prolonged antibiotic treatment followed by shunt replacement . Moreover , shunt infections are commonly associated with prolonged hospital stays , potential comorbidity , and the increased risk of neurological compromise due to ventriculitis or surgical complications . The authors prospect ively evaluated the incidence of CSF shunt infection following shunt procedures performed using either antimicrobial suture ( AMS ) or conventional suture . METHODS In a single-center , prospect i ve , double-blinded , r and omized controlled trial , the authors enrolled 61 patients , among whom 84 CSF shunt procedures were performed over 21 months . R and omization to the study ( AMS ) or control ( placebo ) group was stratified to minimize the effect of known shunt infection risk factors on the findings . Antibacterial shunt components were not used . The primary outcome measure was the incidence of shunt infection within 6 months of surgery . RESULTS The shunt infection rate in the study group was 2 ( 4.3 % ) of 46 procedures and 8 ( 21 % ) of 38 procedures in the control group ( p = 0.038 ) . There were no statistically significant differences in shunt infection risk factors between the groups ( procedure type and time , age < 6 months , weight < 4 kg , recent history of shunt infection ) . No suture-related adverse events were reported in either group . CONCLUSIONS These results support the suggestion that the use of AMS for CSF shunt surgery wound closure is safe , effective , and may be associated with a reduced risk of postoperative shunt infection . A larger r and omized controlled trial is needed to confirm this association Surgery and other invasive therapies are complex interventions , the assessment of which is challenged by factors that depend on operator , team , and setting , such as learning curves , quality variations , and perception of equipoise . We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process . We also encourage the widespread use of prospect i ve data bases and registries . Reports of new techniques should be registered as a professional duty , anonymously if necessary when outcomes are adverse . Case series studies should be replaced by prospect i ve development studies for early technical modifications and by prospect i ve research data bases for later pre-trial evaluation . Protocol s for these studies should be registered publicly . Statistical process control techniques can be useful in both early and late assessment . R and omised trials should be used whenever possible to investigate efficacy , but adequate pre-trial data are essential to allow power calculations , clarify the definition and indications of the intervention , and develop quality measures . Difficulties in doing r and omised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems . Alternative prospect i ve design s , such as interrupted time series studies , should be used when r and omised trials are not feasible . Established procedures should be monitored with prospect i ve data bases to analyse outcome variations and to identify late and rare events . Achievement of improved design , conduct , and reporting of surgical research will need concerted action by editors , funders of health care and research , regulatory bodies , and professional societies OBJECTIVE To evaluate the efficacy and safety of new antibacterial suture ( Vicryl Plus ) compared with a traditional braided suture ( Vicryl ) in a clinical study . The primary goal was to study effectiveness on reduced surgical site infection in an appendectomy operation . The authors ' secondary goal was to analyze the safety and physical properties of Vicryl plus . MATERIAL AND METHOD This was a prospect i ve , r and omized , controlled , double blind , comparative , single-center study . After appendectomy was done , the patients were r and omized in two groups : Vicryl Plus and Vicryl to selected suture for suturing the abdominal sheath . The surgical site infection was evaluated for 30 days , 6 months , and 1 year . The surgeons and attending doctor were blind to the type of suture . This is the primary report of the first 100 patients . RESULTS There was no difference in demographic and preoperative clinical in both groups . Although there was no statistical difference in the surgical site infection of Vicryl and Vicryl Plus ( 8 and 10 % , p = 0.05 ) , one case of deep surgical site infection was detected in the Vicryl group . No complications and no difference in related suture material s were detected . CONCLUSION Coated polyglactin 910 with tricosan ( Vicryl Plus ) is safe and satisfactory in surgical practice . Surgical site infection of appendectomy seemed too to be comparable between coated polyglactin 910 with tricosan ( Vicryl Plus ) and traditional polyglactin 910 ( Vicryl ) group BACKGROUND Coated polyglactin 910 suture with triclosan was developed recently in order to imbue the parent suture , coated polyglactin 910 , with antibacterial activity against the most common organisms that cause surgical site infections ( SSI ) . Because such alterations could alter the physical properties of the suture , this study sought to compare the intraoperative h and ling and wound healing characteristics of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture in pediatric patients undergoing various general surgical procedures . METHODS This was a prospect i ve , r and omized , controlled , open-label , comparative , single-center study . Pediatric patients ( age 1 - 18 years ) undergoing various surgical procedures were r and omized in a 2:1 ratio to treatment with either coated polyglactin 910 suture with triclosan or coated polyglactin 910 suture . The primary endpoint was the surgeon 's assessment of the overall intraoperative h and ling of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture without triclosan . The secondary endpoints included specific intraoperative suture h and ling measures and wound healing assessment s. The suture h and ling measures were ( 1 ) ease of passage through tissue ; ( 2 ) first-throw knot holding ; ( 3 ) knot tie-down smoothness ; ( 4 ) knot security ; ( 5 ) surgical h and ling ; ( 6 ) surgical h and ; ( 7 ) memory ; and ( 8) suture fraying . Assessment of wound healing included the following : Healing progress , infection , edema , erythema , skin temperature , seroma , suture sinus , and pain . Adverse events were recorded . RESULTS Scores for intraoperative h and ling were favorable and not significantly different for both sutures , although coated polyglactin 910 suture with triclosan received more " excellent " scores ( 71 % vs. 59 % ) . Wound healing characteristics were comparable for both sutures except for pain on postoperative day 1 . Significantly fewer patients treated with polyglactin 910 suture with triclosan reported pain on day 1 than patients who received the other suture ( 68 % vs. 89 % , p = 0.01 ) . The overall incidence of adverse events was 18 % ; none was devicerelated . CONCLUSIONS Coated polyglactin 910 suture with triclosan performed as well or better than traditional coated polyglactin 910 suture in pediatric patients undergoing general surgical procedures . The incidence of postoperative pain was significantly less in patients treated with coated polyglactin 910 suture with triclosan than the traditional suture . We speculate that polyglactin 910 suture with triclosan , by inhibiting bacterial colonization of the suture , reduced pain that can be an indicator of " sub clinical " infection . Coated polyglactin 910 suture with triclosan may be a useful alternative in patients at increased risk of developing SSI BACKGROUND Wound infection and dehiscence are both major contributors to postoperative morbidity . One potential cause or co-factor is the use of suture material . A recently introduced subcutaneous suture is coated with triclosan ( TC ) , an antiseptic drug . It is suggested to reduce wound complications . METHODS To investigate the effect of TC on wound healing a double blind prospect i ve pilot study in women undergoing a breast reduction was performed . Each patient was her own control . After r and omisation the TC-coated sutures were used either on the left or right side . The contralateral side was used as the control . The incidence of dehiscence was studied . RESULTS Twenty-six patients were included . In the TC breasts there was a wound dehiscence in 16 cases , whereas in the control breasts in seven cases a dehiscence was observed ( P=0.023 ) . CONCLUSION These results suggest that TC-coated sutures should be used with caution . These sutures have already been introduced on to the market without good clinical studies and might have potential adverse effects as shown by these data OBJECTIVES To describe the results of the first year of the Dutch national surveillance of surgical-site infections ( SSIs ) and risk factors , which aims to implement a st and ardized surveillance system in a network of Dutch hospitals , to collect comparable data on SSIs to serve as a reference , and to provide a basic infrastructure for further intervention research . DESIGN Prospect i ve multicenter cohort study . SETTING Acute-care hospitals in The Netherl and s from June 1996 to May 1997 . RESULTS 38 hospitals participated , with a slight over-representation of larger hospitals . Following a total of 18,063 operations , 562 SSIs occurred , of which 198 were deep . Multivariate analysis of pooled procedures shows that age , preoperative length of stay , wound contamination class , anesthesia score , and duration of surgery were independent risk factors for SSI . When analyzed by procedure , the relative importance of these risk factors changed . Bacteriological documentation was available for 56 % of the SSIs ; 35 % of all isolates were Staphylococcus aureus . Multiple regression analysis computed the mean extra postoperative length of stay associated with SSI to be 8.2 days . CONCLUSION The first year of national surveillance has shown that it is feasible to collect comparable data on SSI , which are already used for education , policy , and decision making in the network of participating hospitals . This gives room to effectuate the next aim , namely to use the network as an infrastructure for intervention research . Multivariate analysis shows that feedback on a procedure-specific level is important Research on surgical interventions is associated with several method ological and practical challenges of which few , if any , apply only to surgery . However , surgical evaluation is especially dem and ing because many of these challenges coincide . In this report , the second of three on surgical innovation and evaluation , we discuss obstacles related to the study design of r and omised controlled trials and non-r and omised studies assessing surgical interventions . We also describe the issues related to the nature of surgical procedures -for example , their complexity , surgeon-related factors , and the range of outcomes . Although difficult , surgical evaluation is achievable and necessary . Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential
Output:
| There was no difference in the rates of wound breakdown between the 2 groups ( OR = 1.07 ; 95 % CI : 0.21 - 5.43 ; P = 0.93 ; I = 44 % ) CONCLUSIONS Triclosan-impregnated sutures do not decrease the rate of SSIs or decrease the rate of wound breakdown . |
MS212636 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Laparoscopy-assisted colectomy istechnically feasible , but objective evidence of its benefits remainsscarce . This study was done to evaluate the outcomes and operativestress of laparoscopy-assisted colectomy versus the traditional open method in the management of sigmoid complex polyps that can not besafely or adequately removed by colonofibroscopy . Between January 1997 and December 1999 , a total of 42 patients were equally r and omizedto the laparoscopy group and the laparotomy group by the blockedr and omization method . Three patients r and omized to the laparoscopygroup did not complete the trial ; therefore 18 patients treated bylaparoscopy-assisted sigmoidectomy and the other 21 treated by the open method were prospect ively evaluated . These two groups of patients werewell matched in age , gender , symptoms , tumor location , localization method , tumor size , morphology , histopathology , and the accuracy of the clinical diagnosis . Two st and ardized surgical strategies , thelateral-to-medial and medial-to-lateral dissection sequences , wereperformed in 14 and 4 patients of the laparoscopy group , respectively , according to whether their tumors were located above or below 20 cmabove the anal verge . After evaluating the surgical outcomes , we foundthat the laparoscopy group was significantly better than the laparotomygroup in regard to parameters that included severity of postoperativepain , wound size , postoperative complication rate , and the duration ofpostoperative ileus , hospitalization , and disability . There was nosignificant difference in the operating times for these two groups . However , the costs of the laparoscopy group were significantly higher . To evaluate the surgical stress , we measured the serum C-reactiveprotein ( CRP ) level , erythrocyte sedimentation rate ( ESR ) , totallymphocyte count , and CD4+/CD8 + ratio 24 hoursbefore and after surgery . We found that the postoperative serum CRPlevel and the ESR were significantly less elevated and the totallymphocyte counts and CD4+/CD8 + ratio weresignificantly less depressed in the laparoscopy group than in thelaparotomy group . We thus concluded that laparoscopy-assistedsigmoidectomy can be safely performed with shorter convalescence and less operative stress but at a higher cost . We strongly recommended theuse of this technique in the management of sigmoid complex polyps ifthe patient 's economic status permits Background and aims : Reduced fibrinolytic activity of the peritoneum seems to be the main cause of postoperative adhesions . This prospect i ve r and omized trial compared the peritoneal fibrinolytic activity between laparoscopic and conventional colorectal resection . Methods : Parietal peritoneal biopsy specimens were taken in st and ardized elective laparoscopic ( n=14 ) and conventional ( n=16 ) colorectal resections at the beginning and at the end of surgery . Activities and concentrations of tissue-plasminogen activator ( tPA ) , plasminogen activator ( PAI ) type 1 , and tPA/PAI complex were determined by ELISA kits . Results : There was no difference in age , sex , or body mass index between the two groups . Perioperative tPA activity decreased in both groups without differences between the groups . Concentrations and activities of tPA , PAI-1 , and tPA/PAI complex did not differ between the groups at any time . Conclusion : Peritoneal concentrations and activities of tPA , PAI-1 , and tPA/PAI complex are similar during laparoscopic and conventional colorectal resections . A capnoperitoneum of 12 mmHg over 3 h did not affect the peritoneal fibrinolytic BACKGROUND Adjuvant chemotherapy ( 5-fluorouracil , levamisole ) is now st and ard practice in the treatment of Dukes ' B and C coloretal carcinoma ( CRC ) , and this has increased the financial burden on health care systems world-wide . PATIENTS AND METHODS Between 1993 and 1996 , 95 patients in northern Norway were included in a national r and omised CRC study , and assigned to surgery plus adjuvant chemotherapy or surgery alone . In April 1996 , 94 of the patients were evaluable and 82 were still alive . The total treatment costs ( hospital stay , surgery , chemotherapy , administrative and travelling costs ) were calculated . A question naire was mailed to all survivors for assessment of the quality of their lives ( QoL ) ( EuroQol question naire , a simple QoL-scale , global QoL-measure of the EORTC QLQ-C30 ) , and 62 of them ( 76 % ) responded . RESULTS Adjuvant chemotherapy in Dukes ' B and C CRC raised the total treatment costs by 3,369 pounds . The median QoL was 0.83 ( 0 - 1 scale ) in both arms . Employing a 5 % discount rate and an improved survival of adjuvant therapy ranging from 5 % to 15 % , we calculated the cost of one gained quality -adjusted life-year ( QALY ) to be between 4,800 pounds and 16,800 pounds . CONCLUSION Using a cut-off point level of 20,000 pounds per QALY , adjuvant chemotherapy in CRC appears to be cost-effective only when the improvement in 5-year survival is > or = 5 % . Adjuvant chemotherapy does not affect short-term PURPOSE : Traumatic manipulation of cancer specimens during laparoscopic colectomy may increase exfoliation of malignant cells into the peritoneal cavity , causing an early occurrence of peritoneal carcinomatosis or port-sites recurrence . Because of this concern , the routine use of intraperitoneal chemotherapy after laparoscopic colectomy for cancer was suggested recently . We assessed if laparoscopicvs . conventional surgery increases exfoliated malignant cells in the peritoneal cavity during resection of colorectal cancer . METHODS : In a prospect i ve , r and omized fashion , 38 colorectal cancer patients undergoing an elective , curative operation were assigned to either a conventional or laparoscopic procedure between June 1996 and May 1997 . In either group ( n=19 ) , after the abdominal cavity was entered , saline was instilled into the peritoneal cavity , and the fluid was collected ( Specimen 1 ) . During surgery , all irrigating fluids were collected ( Specimen 2 ) . Both specimens were assessed for malignancy using four techniques : filtration process ( ThinPrep ® ) , smear , cell block , and immunochemistry using Ber-EP4 . The change in the amount of tumor cells in both specimens was compared between surgical groups . A pilot study was performed to vali date the proposed cytologic method . RESULTS : In the pilot study of 20 consecutive patients with colorectal cancer , postresectional peritoneal cytology was positive in six patients , including two Stage II ( T3,N0,M0 ) patients . The pilot study also vali date d that our semiquantitative scoring system can be reliably used to assess the amount of free peritoneal cancer cells . In the main study , 16 right colectomies , 3 extended right colectomies , 17 proctosigmoidectomies , and 1 left colectomy were performed . The T and N stages were T1 ( n=13 ) , T2 ( n=5 ) , T3 ( n=8 ) , T4 ( n=11 ) ; N0 ( n=22 ) , N1 ( n=8 ) , N2 ( n=7 ) . Malignant cells were not detected in any Specimens 1 or , more importantly , in Specimens 2 in either surgical group . CONCLUSION : When performed according to strict oncologic surgical principles , laparoscopic techniques in curative colorectal cancer surgery did not have an increased risk of intraperitoneal cancer cell spillage , compared with conventional techniques . We hope that these results can decrease some of the concerns about tumors cell spillage and seeding during laparoscopy BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable . The multicentre COLOR ( COlon cancer Laparoscopic or Open Resection ) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon . METHODS 627 patients were r and omly assigned to laparoscopic surgery and 621 patients to open surgery . The primary endpoint was cancer-free survival 3 years after surgery . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , metastasis , overall survival , and blood loss during surgery . Analysis was by intention to treat . Here , clinical characteristics , operative findings , and postoperative outcome are reported . FINDINGS Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection ( median 100 mL [ range 0 - 2700 ] vs 175 mL [ 0 - 2000 ] , p<0.0001 ) , although laparoscopic surgery lasted 30 min longer than did open surgery ( p<0.0001 ) . Conversion to open surgery was needed for 91 ( 17 % ) patients undergoing the laparoscopic procedure . Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups . Laparoscopic colectomy was associated with earlier recovery of bowel function ( p<0.0001 ) , need for fewer analgesics , and with a shorter hospital stay ( p<0.0001 ) compared with open colectomy . Morbidity and mortality 28 days after colectomy did not differ between groups . INTERPRETATION Laparoscopic surgery can be used for safe and radical resection of cancer in the right , left , and sigmoid colon Laparoscopic surgery is believed to produce an attenuated metabolic stress response and to have a less dampening effect on the immune response than open surgery . To date , the effect has not been studied in a r and omized clinical trial of colorectal cancer Background : We compared the perioperative parameters and outcomes achieved with h and -assisted laparoscopic colectomy ( HALC ) vs open colectomy ( OC ) for the management of benign and malignant colorectal disease , including cancer patients treated with curative intent . Methods : Sixty eligible patients were r and omized to either HALC ( n = 30 ) or OC ( n = 30 ) treatment groups . We used Pearson ’s chi-square and two- sample t-tests to compare the differences in demographics and perioperative parameters . Results : There were no significant differences in age , gender distribution , disease pattern , operative procedure , comorbidity , or history of abdominal surgery . The HALC patients had significantly shorter hospital stays and incision lengths , faster recovery of gastrointestinal function , less analgesic use and blood loss , and lower pain scores on postoperative days 1 , 3 , and 14 . There were no significant differences in operative time , complications , or time to return to normal activity . Conclusion : H and -assisted laparoscopic colectomy ( HALC ) is safe and produces better therapeutic results in terms of perioperative parameters than OC BACKGROUND Laparotomy causes a significant reduction of pulmonary function , and atelectasis and pneumonia occur after elective conventional colorectal resections . OBJECTIVE To evaluate the hypothesis that pulmonary function is less restricted after laparoscopic than after conventional colorectal resection . DESIGN A r and omized clinical trial . SETTING The surgical department of an academic medical center . PATIENTS Sixty patients underwent laparoscopic ( n = 30 ) or conventional ( n = 30 ) resection of colorectal tumors . The 2 groups did not differ significantly in age , sex , localization or stage of tumor , or preoperative pulmonary function . MAIN OUTCOME MEASURES Forced vital capacity , forced expiratory volume in 1 second , peak expiratory flow , mid-expiratory phase of forced expiratory flow , and oxygen saturation of arterial blood . RESULTS The forced vital capacity ( mean + /- SD values : conventional resection group , 1.73+/-0.60 L ; laparoscopic surgery group , 2.59+/-1.11 L ; P<.01 ) and the forced expiratory volume in 1 second ( conventional resection group , 1.19+/-0.51 L/s ; laparoscopic surgery group , 1.80+/-0.80 L/s ; P<.01 ) were more profoundly suppressed in the patients having conventional resection than in those having laparoscopic surgery . Similar results were found for the peak expiratory flow ( conventional resection group , 2.51+/-1.37 L/s ; laparoscopic resection group , 3.60+/-2.22 L/s ; P<.05 ) and the midexpiratory phase of forced expiratory flow ( conventional resection group , 1.87+/-1.12 L/s ; laparoscopic surgery group , 2.67+/-1.76 L/s ; P<.05 ) . The oxygen saturation of arterial blood , measured while the patients were breathing room air , was lower after conventional than after laparoscopic resections ( P<.01 ) . The recovery of the forced vital capacity and forced expiratory volume in 1 second to 80 % of the preoperative value took longer in patients having conventional resection than in
Output:
| However , the data they provided on effectiveness was poorer than the evidence from the review of effectiveness .
In terms of incremental cost per life-year , laparoscopic surgery was found to be more costly and no more effective than open surgery .
Laparoscopic resection is associated with a quicker recovery ( shorter time to return to usual activities and length of hospitalisation ) and no evidence of a difference in mortality or disease-free survival up to 3 years following surgery .
However , operation times are longer and a significant number of procedures initiated laparoscopically may need to be converted to open surgery .
The rate of conversion may be dependent on experience in terms of both patient selection and performing the technique .
In terms of relative cost-effectiveness , laparoscopic resection is associated with a modest additional cost , short-term benefits associated with more rapid recovery and similar long-term outcomes in terms of survival and cure rates up to 3 years .
Assuming equivalence of long-term outcomes , a judgement is required as to whether the benefits associated with earlier recovery are worth this extra cost . |
MS212637 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives : The purpose of this study was to determine analgesic efficacy of dexmedetomidine used as a continuous infusion without loading dose in postcardiac surgery patients . Setting s and Design : A prospect i ve , r and omized , double-blind clinical study in a single tertiary care hospital on patients posted for elective cardiac surgery under cardiopulmonary bypass . Interventions : Sixty-four patients who underwent elective cardiac surgery under general anesthesia were shifted to intensive care unit ( ICU ) and r and omly divided into two groups . Group A ( n = 32 ) received a 12 h infusion of normal saline and group B ( n = 32 ) received a 12 h infusion of dexmedetomidine 0.4 μg/kg/h . Postoperative pain was managed with bolus intravenous fentanyl . Total fentanyl consumption , hemodynamic monitoring , Visual Analogue Scale ( VAS ) pain ratings , Ramsay Sedation Scale were charted every 6 th hourly for 24 h postoperatively and followed-up till recovery from ICU . Student′s t-test , Chi-square/Fisher′s exact test has been used to find the significance of study parameters between the groups . Results : Dexmedetomidine treated patients had significantly less VAS score at each level ( P < 0.001 ) . Total fentanyl consumption in dexmedetomidine group was 128.13 ± 35.78 μg versus 201.56 ± 36.99 μg in saline group ( P < 0.001 ) . A statistically significant but clinical ly unimportant sedation was noted at 6 and 12 h ( P < 0.001 , and P = 0.046 respectively ) . Incidence of delirium was less in dexmedetomidine group ( P = 0.086 + ) . Hemodynamic parameters were statistically insignificant . Conclusions : Dexmedetomidine infusion even without loading dose provides safe , effective adjunct analgesia , reduces narcotic consumption , and showed a reduced trend of delirium incidence without undesirable hemodynamic effects in the cardiac surgery patients Rationale : Dexmedetomidine is associated with less delirium than benzodiazepines and better sleep architecture than either benzodiazepines or propofol ; its effect on delirium and sleep when administered at night to patients requiring sedation remains unclear . Objectives : To determine if nocturnal dexmedetomidine prevents delirium and improves sleep in critically ill adults . Methods : This two‐center , double‐blind , placebo‐controlled trial r and omized 100 delirium‐free critically ill adults receiving sedatives to receive nocturnal ( 9:30 p.m. to 6:15 a.m. ) intravenous dexmedetomidine ( 0.2 & mgr;g/kg/h , titrated by 0.1 & mgr;g /kg/h every 15 min until a goal Richmond Agitation and Sedation Scale score of −1 or maximum rate of 0.7 & mgr;g/kg/h was reached ) or placebo until ICU discharge . During study infusions , all sedatives were halved ; opioids were unchanged . Delirium was assessed using the Intensive Care Delirium Screening Checklist every 12 hours throughout the ICU admission . Sleep was evaluated each morning by the Leeds Sleep Evaluation Question naire . Measurements and Main Results : Nocturnal dexmedetomidine ( vs. placebo ) was associated with a greater proportion of patients who remained delirium‐free during the ICU stay ( dexmedetomidine [ 40 ( 80 % ) of 50 patients ] vs. placebo [ 27 ( 54 % ) of 50 patients ] ; relative risk , 0.44 ; 95 % confidence interval , 0.23‐0.82 ; P = 0.006 ) . The average Leeds Sleep Evaluation Question naire score was similar ( mean difference , 0.02 ; 95 % confidence interval , 0.42‐1.92 ) between the 34 dexmedetomidine ( average seven assessment s per patient ) and 30 placebo ( six per patient ) group patients able to provide one or more assessment s. Incidence of hypotension , bradycardia , or both did not differ significantly between groups . Conclusions : Nocturnal administration of low‐dose dexmedetomidine in critically ill adults reduces the incidence of delirium during the ICU stay ; patient‐reported sleep quality appears unchanged . Clinical trial registered with www . clinical trials.gov ( NCT01791296 ) Background : Peripheral nerve block is a preferable method for elderly patients receiving hip arthroplasty . Sedation with dexmedetomidine may reduce postoperative delirium ( POD ) . The aim of this study was to investigate whether intraoperative sedation with dexmedetomidine , as a supplementary to peripheral nerve block for elderly patients receiving total hip arthroplasty , can decrease the prevalence of POD . Methods : A prospect i ve , r and omized controlled study was conducted with patients 65 years of age or older who underwent total hip arthroplasty between June 2016 and June 2017 . The patients were r and omly assigned to receive a lumbosacral plexus plus T12 paravertebral block supplemented with propofol or dexmedetomidine for sedation . Incidence of POD was the primary endpoint and was determined with the confusion assessment method , and incidence of postoperative cognitive dysfunction ( POCD ) was assessed with the mini-mental state examination . The time of ambulation , discharge time , and complications over a 30-day postsurgery period were also recorded . Results : A total of 296 patients were r and omly assigned to 2 groups . The patients se date d with dexmedetomidine had lower incidences of POD and POCD and were out of bed and discharged sooner than the patients se date d with propofol . There was no difference in complications between the 2 groups . Conclusions : As a supplementary to peripheral nerve block , intraoperative sedation with dexmedetomidine could be associated with a lower incidence of POD , which may have benefits on reducing the incidence of early POCD and offering a better short-term recovery for elderly patients receiving hip arthroplasty BACKGROUND Delirium is a postoperative complication that occurs frequently in patients older than 65 years , and presages adverse outcomes . We investigated whether prophylactic low-dose dexmedetomidine , a highly selective α2 adrenoceptor agonist , could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery . METHODS We did this r and omised , double-blind , placebo-controlled trial in two tertiary-care hospitals in Beijing , China . We enrolled patients aged 65 years or older , who were admitted to intensive care units after non-cardiac surgery , with informed consent . We used a computer-generated r and omisation sequence ( in a 1:1 ratio ) to r and omly assign patients to receive either intravenous dexmedetomidine ( 0·1 μg/kg per h , from intensive care unit admission on the day of surgery until 0800 h on postoperative day 1 ) , or placebo ( intravenous normal saline ) . Participants , care providers , and investigators were all masked to group assignment . The primary endpoint was the incidence of delirium , assessed twice daily with the Confusion Assessment Method for intensive care units during the first 7 postoperative days . Analyses were done by intention-to-treat and safety population s. This study is registered with Chinese Clinical Trial Registry , www.chictr.org.cn , number ChiCTR-TRC-10000802 . FINDINGS Between Aug 17 , 2011 , and Nov 20 , 2013 , of 2016 patients assessed , 700 were r and omly assigned to receive either placebo ( n=350 ) or dexmedetomidine ( n=350 ) . The incidence of postoperative delirium was significantly lower in the dexmedetomidine group ( 32 [ 9 % ] of 350 patients ) than in the placebo group ( 79 [ 23 % ] of 350 patients ; odds ratio [ OR ] 0·35 , 95 % CI 0·22 - 0·54 ; p<0·0001 ) . Regarding safety , the incidence of hypertension was higher with placebo ( 62 [ 18 % ] of 350 patients ) than with dexmedetomidine ( 34 [ 10 % ] of 350 patients ; 0·50 , 0·32 - 0·78 ; p=0·002 ) . Tachycardia was also higher in patients given placebo ( 48 [ 14 % ] of 350 patients ) than in patients given dexmedetomidine ( 23 [ 7 % ] of 350 patients ; 0·44 , 0·26 - 0·75 ; p=0·002 ) . Occurrence of hypotension and bradycardia did not differ between groups . INTERPRETATION For patients aged over 65 years who are admitted to the intensive care unit after non-cardiac surgery , prophylactic low-dose dexmedetomidine significantly decreases the occurrence of delirium during the first 7 days after surgery . The therapy is safe . FUNDING Braun Anaesthesia Scientific Research Fund and Wu Jieping Medical Foundation , Beijing , China . Study drugs were manufactured and supplied by Jiangsu Hengrui Medicine Co , Ltd , Jiangsu , China Background Delirium is a frequent complication after cardiac surgery and its occurrence is associated with poor outcomes . The purpose of this study was to investigate the impact of perioperative dexmedetomidine administration on the incidence of delirium in elderly patients after cardiac surgery . Methods This r and omized , double-blinded , and placebo-controlled trial was conducted in two tertiary hospitals in Beijing between December 1 , 2014 and July 19 , 2015 . Eligible patients were r and omized into two groups . Dexmedetomidine ( DEX ) was administered during anesthesia and early postoperative period for patients in the DEX group , whereas normal saline was administered in the same rate for the same duration for patients in the control ( CTRL ) group . The primary endpoint was the incidence of delirium during the first five days after surgery . Secondary endpoints included the cognitive function assessed on postoperative days 6 and 30 , the overall incidence of non-delirium complications within 30 days after surgery , and the all-cause 30-day mortality . Results Two hundred eighty-five patients were enrolled and r and omized . Dexmedetomidine did not decrease the incidence of delirium ( 4.9 % [ 7/142 ] in the DEX group vs 7.7 % [ 11/143 ] in the CTRL group ; OR 0.62 , 95 % CI 0.23 to 1.65 , p = 0.341 ) . Secondary endpoints were similar between the two groups ; however , the incidence of pulmonary complications was slightly decreased ( OR 0.51 , 95 % CI 0.26 to 1.00 , p = 0.050 ) and the percentage of early extubation was significantly increased ( OR 3.32 , 95 % CI 1.36 to 8.08 , p = 0.008 ) in the DEX group . Dexmedetomidine decreased the required treatment for intraoperative tachycardia ( 21.1 % [ 30/142 ] in the DEX group vs 33.6 % [ 48/143 ] in the CTRL group , p = 0.019 ) , but increased the required treatment for postoperative hypotension ( 84.5 % [ 120/142 ] in the DEX group vs 69.9 % [ 100/143 ] in the CTRL group , p = 0.003 ) . Conclusions Dexmedetomidine administered during anesthesia and early postoperative period did not decrease the incidence of postoperative delirium in elderly patients undergoing elective cardiac surgery . However , considering the low delirium incidence , the trial might have been underpowered . Trial Registration Clinical Trials.gov PURPOSE To determine whether dexmedetomidine sedation in the postanesthesia care unit ( PACU ) could decrease agitation and delirium after free flap surgery . MATERIAL S AND METHODS Eighty patients were r and omly divided into 2 groups . In the experimental group , dexmedetomidine was given at an hourly infusion rate of 0.5 μg/kg for 1 hour before the operation was completed and continued in the PACU at 0.2 to 0.7 μg/kg continuously until the next morning . In the control group , normal saline was given during the same periods . Patients in the 2 groups received sufentanil and midazolam for sedation and pain relief when necessary . Agitation was monitored with the Riker Sedation-Agitation Scale in the PACU and delirium was monitored with the Confusion Assessment Method for the Intensive Care Unit for 5 days postoperatively . RESULTS The overall incidence of agitation was similar between the 2 groups . However , when the influence of patient shifting was excluded , the incidence of agitation in the dexmedetomidine group was apparently lower than that in the control group ( 10.
Output:
| Use of dexmedetomidine significantly increased the risks of bradycardia and hypotension .
Conclusion Findings suggest that dexmedetomidine reduces incidence and duration of ICU delirium .
Furthermore , our systematic search es show that there is limited evidence if a delirium shall be treated with dexmedetomidine |
MS212638 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity . The study design was a parallel-group r and omized controlled trial . One hundred fifteen 11 - 13-year-old children with overweight and obesity were r and omized into either : A six-week day-camp intervention arm focusing on increased physical activity , and healthy diet followed by a subsequent one-year family-based intervention , or a st and ard intervention arm consisting of one weekly exercise session for six weeks . Body mass index ( BMI ) was the primary outcome . BMI z-score , clustered cardiovascular risk z-score , and body composition were secondary outcomes . All outcomes were measured at baseline , six week- , and 52 week follow-up . After six weeks , children from the day-camp intervention arm had improved their BMI ( -2.2 kg/m2 ( 95 % CI -2.6 to -1.7 , P<0.001 ) ) and all secondary outcomes when compared to the children from the st and ard intervention arm . After 52 weeks , the day-camp intervention arm had a lower BMI ( -1.2 kg/m2 ( 95 % CI -1.8 to -0.5 , P = 0.001 ) ) , and BMI z-score ( -0.20 ( 95 % CI -0.35 to -0.05 , P = 0.008 ) ) , and clustered cardiovascular risk z-score ( -0.23 ( 95 % CI -0.37 to -0.08 , P = 0.002 ) ) compared to the st and ard intervention arm . No group differences were detected in body composition after 52 weeks . This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity . However , the effects seem to be diminishing over time OBJECTIVE The study presents the immediate post-intervention results of Kids and Adults Now - Defeat Obesity ! , a r and omized controlled trial to enhance healthy lifestyle behaviors in mother-preschooler ( 2 - 5 years old ) dyads in North Carolina ( 2007 - 2011 ) . The outcomes include change from baseline in the child 's diet , physical activity and weight , and in the mother 's parenting behaviors , diet , physical activity , and weight . METHOD The intervention targeted parenting through maternal emotion regulation , home environment , feeding practice s , and modeling of healthy behaviors . 400 mother-child dyads were r and omized . RESULTS Mothers in the intervention arm , compared to the control arm , reduced instrumental feeding ( -0.24 vs. 0.01 , p<0.001 ) and TV snacks ( -.069 vs. -0.24 , p=0.001 ) . There were also improvements in emotional feeding ( p=0.03 ) , mother 's sugary beverage ( p=0.03 ) and fruit/vegetable ( p=0.04 ) intake , and dinners eaten in front of TV ( p=0.01 ) ; these differences were not significant after adjustment for multiple comparisons . CONCLUSION KAN-DO , design ed to maximize the capacity of mothers as agents of change , improved several channels of maternal influence . There were no group differences in the primary outcomes , but differences were observed in the parenting and maternal outcomes and there were trends toward improvement in the preschoolers ' diets . Long-term follow-up will address whether these short-term trends ultimately improve weight status OBJECTIVE : To determine whether a 2-year family-based intervention using frequent contact and limited expert involvement was effective in reducing excessive weight compared with usual care . METHODS : Two hundred and six overweight and obese ( BMI ≥85th percentile ) children aged 4 to 8 years were r and omized to usual care ( UC ) or tailored package ( TP ) sessions at university research rooms . UC families received personalized feedback and generalized advice regarding healthy lifestyles at baseline and 6 months . TP families attended a single multidisciplinary session to develop specific goals suitable for each family , then met with a mentor each month for 12 months , and every third month for another 12 months to discuss progress and provide support . Outcome measurements ( anthropometry , question naires , dietary intake , accelerometry ) were obtained at 0 , 12 , and 24 months . RESULTS : BMI at 24 months was significantly lower in TP compared with UC children ( difference , 95 % confidence interval : –0.34 , –0.65 to –0.02 ) , as was BMI z score ( –0.12 , –0.20 to –0.04 ) and waist circumference ( –1.5 , –2.5 to –0.5 cm ) . TP children consumed more fruit and vegetables ( P = .038 ) and fewer noncore foods ( P = .020 ) than UC children , and fewer noncore foods were available in the home ( P = .002 ) . TP children were also more physically active ( P = .035 ) . No differences in parental feeding practice s , parenting , quality of life , child sleep , or behavior were observed . CONCLUSIONS : Frequent , low-dose support was effective for reducing excessive weight in predominantly mild to moderately overweight children over a 2-year period . Such initiatives could feasibly be incorporated into primary care Background Obesity is mainly attributed to environmental factors . In developed countries , the time spent on physical activity tasks is decreasing , whereas sedentary behaviour patterns are increasing . The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention ( Nereu programme ) and compared it to counselling intervention such as a health centre intervention programme for the management of children ’s obesity . Methods / Design The study design is a r and omized controlled multicenter clinical trial using two types of interventions : Nereu and Counselling . The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention . This programme is based on a multidisciplinary intervention consisting of 4 components : physical activity sessions for children , family theoretical and practical sessions for parents , behaviour strategy sessions involving both , parents and children , and lastly , weekend extra activities for all . Counselling is offered to the family in the form of a monthly physical health and eating habits session . Participants will be recruited according the following criteria : 6 to 12 year-old-children , referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile ( less than 2 hours per week of physical activity ) , they must live in or near the municipality of Lleida ( Spain ) and their healthcare paediatric unit must have previously accepted to cooperate with this study . The following variables will be evaluated : a ) cardiovascular risk factors ( anthropometric parameters , blood test and blood pressure ) , b ) sedentary and physical activity behaviour and dietary intake , c ) psychological aspects d ) health related quality of life ( HRQOL ) , e ) cost-effectiveness of the intervention in relation to HRQOL . These variables will be then be evaluated 4 times longitudinally : at baseline , at the end of the intervention ( 8 months later ) , 6 and 12 months after the intervention . We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups . Discussion This trial will provide new evidence for the long-term effects of childhood obesity management , as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres . Trial registration Clinical Trials.gov , Background Childhood obesity has been increasing rapidly worldwide . There is limited evidence for effective lifestyle interventions to prevent childhood obesity worldwide , especially in developing countries like China . The objective of this study was to assess the effectiveness of a school-based multi-component lifestyle childhood obesity prevention program ( the CLICK-Obesity study ) in Mainl and China . Methods A cluster r and omized controlled trial was developed among grade 4 students from 8 urban primary schools ( 638 students in intervention , 544 as control ) in Nanjing City , China . Students were r and omly allocated to the control or intervention group at school-level . A one-year multi-component intervention program ( classroom curriculum , school environment support , family involvement and fun programs/events ) together with routine health education was provided to the intervention group , while the control group received routine health education only . The main outcome variables assessed were changes in body mass index , obesity occurrence , obesity-related lifestyle behaviors and knowledge . Results Overall , 1108 ( 93.7 % ) of the 1182 enrolled students completed the intervention study . The intervention group had a larger marginal reduction than did the control group in overall mean BMI value ( -0.32±1.36 vs. -0.29±1.40 , p = 0.09 ) , although this was not significant . Compared with the control group , the intervention group was more likely to decrease their BMI ( OR = 1.44 , 95%CI = 1.10 , 1.87 ) by 0.5 kg/m2 or above , increase the frequency of jogging/running ( OR = 1.55 , 95%CI = 1.18 , 2.02 ) , decrease the frequency of TV/computer use ( OR = 1.41 , 95%CI = 1.09 , 1.84 ) and of red meat consumption ( OR = 1.50 , 95%CI = 1.15 , 1.95 ) , change commuting mode to/from school from sedentary to active mode ( OR = 2.24 , 95%CI = 1.47 , 3.40 ) , and be aware of the harm of selected obesity risk factors . Conclusions The school-based lifestyle intervention program was practical and effective in improving health behaviors and obesity-related knowledge for children in China . This study provides important policy implication s on school-based intervention programs for modifications of obesity-related lifestyles . Trial Registration Chinese Clinical Trial Registry BACKGROUND Few successful treatment modalities exist to address childhood obesity . Given Latinos ' strong identity with family , a family-focused intervention may be able to control Latino childhood obesity . PURPOSE To assess the feasibility and effectiveness of a family-centered , primary care-based approach to control childhood obesity through lifestyle choices . DESIGN R and omized waitlist controlled trial in which control participants received the intervention 6 months after the intervention group . SETTING / PARTICIPANTS Forty-one Latino children with BMI > 85 % , aged 9 - 12 years , and their caregivers were recruited from an urban community health center located in a predominantly low-income community . INTERVENTION Children and their caregivers received 6 weeks of interactive group classes followed by 6 months of culturally sensitive monthly in-person or phone coaching to empower families to incorporate learned lifestyles and to address both family and social barriers to making changes . MAIN OUTCOMES MEASURES Caregiver report on child and child self-reported health-related quality of life ( HRQoL ) ; metabolic markers of obesity ; BMI ; and accelerometer-based physical activity were measured July 2010-November 2011 and compared with post-intervention assessment s conducted at 6 months and as a function of condition assignment . Data were analyzed in 2012 . RESULTS Average attendance rate to each group class was 79 % . Socio-environmental and family factors , along with knowledge , were cited as barriers to changing lifestyles to control obesity . Caregiver proxy and child self-reported HRQoL improved for both groups with a larger but not nonsignificant difference among intervention vs control group children ( p=0.33 ) . No differences were found between intervention and control children for metabolic markers of obesity , BMI , or physical activity . CONCLUSIONS Latino families are willing to participate in group classes and health coaching to control childhood obesity . It may be necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner . TRIAL REGISTRATION This study is registered at Clinical trials.partners.org 2009P001721 Background : The best outcomes for treating childhood obesity have come from comprehensive family-based programmes . However there are questions over their generalizability . Objective : To examine the acceptability and effectiveness of ‘ family-based behavioural treatment ’ ( FBBT ) for childhood obesity in an ethnically and socially diverse sample of families in a UK National Health Service ( NHS ) setting . Methods : In this parallel group , r and omized controlled trial , 72 obese children were r and omized to FBBT or a waiting-list control . Primary outcomes were body mass index ( BMI ) and BMI s.d . scores ( SDSs ) . Secondary outcomes were weight , weight SDSs , height , height SDSs , waist , waist SDSs , FM index , FFM index , blood pressure ( BP ) and psychosocial measures . The outcomes were assessed at baseline and after treatment , with analyses of 6-month data performed on an intent-to-treat ( ITT ) basis . Follow-up anthropometric data were collected at 12 months for the treatment group . Results : ITT analyses included all children with baseline data ( n=60 ) . There were significant BMI SDS changes ( P<0.01 ) for the treatment and control groups of −0.11 ( 0.16 ) and −0.10 ( 1.6 ) . The treatment group showed a significant reduction in systolic BP ( −0.24 ( 0.7 ) , P<0.05 ) and improvements in quality of life and eating attitudes ( P<0.05 ) , with no significant changes for the control group
Output:
| The home-based intervention positively reduced BMI . |
MS212639 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size Summary The pharmacokinetics of aspirin ( ASA ) in acute migraine attacks , and the influence of metoclopramide on ASA disposition , were studied in 32 attacks in 30 patients . An intergroup comparison was made between normal volunteers , and the migraineurs , who were assigned at r and om to one of three treatment groups : a ) oral ASA only ( 900 mg ) ; b ) 10 mg oral metoclopramide + oral ASA 900 mg ; c ) 10 mg i. m. metoclopramide + oral ASA 900 mg . Plasma ASA and SA levels were measured serially over 2 h , and the result ant data evaluated pharmacokinetically . Metoclopramide plasma levels were also determined over 2 h , and the results compared with a second group of normal volunteers . The rates of oral ASA absorption and elimination were unaffected by migraine . Mean absorption rate constants of 14.15±9.48 h−1 ( normals ) , 7.91±3.42 h−1 ( ASA only ) , 6.74±3.26 h−1 ( ASA + oral metoclopramide ) and 8.12±2.82 h−1 ( ASA + i. m. metoclopramide ) were calculated . Mean elimination rate constants ranged from 2.56 h−1 to 3.37 h−1 , and did not differ significantly between controls and migrainous patients . Values for absorption lag time , however , were higher in migraine patients treated with ASA alone than in any other group . The amount of ASA absorbed unhydrolysed was also lower in this group . SA levels appeared unaffected either by the migraine attack , or by metoclopramide administration , over the period of study . Metoclopramide plasma levels were significantly lower during migraine attacks , and the amount of drug absorbed up to 2 h from dosing was also reduced , as compared with non-migrainous subjects . It was concluded that acute migraine caused a delay in orally administered ASA reaching its absorption sites , probably as a result of gastric stasis , and may have decreased the amount of ASA absorbed . The prior administration of metoclopramide , either orally or intramuscularly , reduced the absorption lag time , and thus promoted the early absorption of ASA , probably by restoring alimentary tract motility Objective : To estimate the 1-year prevalences of primary headache disorders and identify their principal risk factors in the general population of Russia . Methods : A countrywide population -based r and om sample of 2725 biologically unrelated adults in 35 cities and nine rural areas were interviewed in a door-to-door survey using a previously vali date d diagnostic question naire . Results : Of the 2725 eligible adults contacted , 2025 ( 74.3 % ) responded ( females 52.6 % , mean age 39.5 ± 13.4 years ) . Of these , 1273 ( 62.9 % ) reported headache ‘ not related to flu , hangover , cold , head injury ’ occurring at least once in the previous year . The gender- and age-st and ardized 1-year prevalence of migraine was 20.8 % . Female gender ( odds ratio ( OR ) = 3.8 ; 95 % confidence interval ( CI ) 2.8–5.1 ) and obesity ( OR = 1.5 ; 1.1–2.1 ) were positively associated with this type of headache . The gender- and age-st and ardized 1-year prevalence of tension-type headache ( TTH ) was 30.8 % . TTH was more prevalent in urban than in rural areas ( OR = 1.6 ; 1.3–2.0 ) . Headache on ≥15 days/month was reported by 213 ( 10.5 % ) respondents ( gender- and age-st and ardized prevalence 10.4 % ) , and associated with low socioeconomic status ( OR = 3.4 ; 2.4–4.9 ) , obesity ( OR = 3.0 ; 2.1–4.3 ) , female gender ( OR = 2.9 ; 2.1–4.1 ) and age over 40 years ( OR = 2.6 ; 1.9–3.6 ) . The majority of these respondents ( 68.1 % ) overused acute headache medications . Conclusion : The study demonstrated a high prevalence of migraine and a very high prevalence of headache on ≥15 days/month , and revealed unmet health-care needs of people with headache in Russia 1 The absorption of effervescent aspirin was studied in two groups of patients during attacks of migraine . The first group received effervescent aspirin alone whilst the second group received intramuscular metoclopramide before effervescent aspirin . 2 After effervescent aspirin alone there was significant impairment in the rate of aspirin absorption during migraine attacks compared with the rate of aspirin absorption in normal volunteers and in the same patients when headache-free . 3 When metoclopramide was given before effervescent aspirin the rate of aspirin absorption during migraine attacks was not significantly different from that obtained in normal volunteers given effervescent aspirin alone or from that obtained in the patients themselves when given both metoclopramide and effervescent aspirin when headache-free . 4 It is concluded that the impairment of absorption of effervescent aspirin during migraine attacks is related to impaired gastro-intestinal motility with delayed gastric emptying and that this impaired motility can be overcome by parenteral metoclopramide & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale
Output:
| Aspirin 1000 mg is an effective treatment for acute migraine headaches , similar to sumatriptan 50 mg or 100 mg .
Addition of metoclopramide 10 mg improves relief of nausea and vomiting .
Adverse events were mainly mild and transient , and were slightly more common with aspirin than placebo , but less common than with sumatriptan 100 mg |
MS212640 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Medical Research Council has for some years encouraged collaborative clinical trials in leukaemia and other cancers , reporting the results in the medical literature . One unreported result which deserves such publication is the development of the expertise to design and analyse such trials . This report was prepared by a group of British and American statisticians , but it is intended for people without any statistical expertise . Part I , which appears in this issue , discusses the design of such trials ; Part II , which will appear separately in the January 1977 issue of the Journal , gives full instructions for the statistical analysis of such trials by means of life tables and the logrank test , including a worked example , and discusses the interpretation of trial results , including brief reports of 2 particular trials . Both parts of this report are relevant to all clinical trials which study time to death , and wound be equally relevant to clinical trials which study time to other particular classes of untoward event : first stroke , perhaps , or first relapse , metastasis , disease recurrence , thrombosis , transplant rejection , or death from a particular cause . Part I , in this issue , collects together ideas that have mostly already appeared in the medical literature , but Part II , next month , is the first simple account yet published for non-statistical physicians of how to analyse efficiently data from clinical trials of survival duration . Such trials include the majority of all clinical trials of cancer therapy ; in cancer trials , however , it may be preferable to use these statistical methods to study time to local recurrence of tumour , or to study time to detectable metastatic spread , in addition to study ing total survival . Solid tumours can be staged at diagnosis ; if this , or any other available information in some other disease is an important determinant of outcome , it can be used to make the overall logrank test for the whole heterogeneous trial population more sensitive , and more intuitively satisfactory , for it will then only be necessary to compare like with like , and not , by chance , Stage I with Stage III Preliminary studies in man of benorylate , 4-(acetamido)phenyl-2-acetoxy-benzoate , have shown that it has antipyretic actions ( Weill , Gaillon , Rendu , and Lejeune , 1968 ; Alex and er , Flahaut , Raveschot , Drykonigen , 1970 ) and an analgesic action significantly superior to placebo and in some instances superior to aspirin ( Vialatel and Gaillon , 1968 ; Hart and Nicholson , 1971 ) . In rheumatoid arthritis , Bain and Burt ( 1970 ) and Cardoe ( 1970 ) have shown that the drug is well tolerated and effective , although the results suggested that their initial dose of 4 g . was inadequate . The pharmacology of benorylate has been reported by Rosner , Malhie , and Mottot ( 1968 ) and the pharmacodynamics of the drug have been described by Robertson ( 1971 ) . Benorylate is well absorbed when taken orally and unlike aspirin its absorption is not influenced by pH. After absorption the molecule undergoes hydrolysis to provide salicylic acid ( SA ) and n-acetyl paraminophenol ( NAPA ) . When compared with aspirin and paracetamol , the peak plasma concentrations ofSA and NAPA are achieved later and more smoothly after benorylate administration . The plateau levels of SA and NAPA obtained after continuous medication are very similar with the three drugs . Excretion of metabolites occurs through the kidney ( 85 per cent . and faeces ( 15 per cent ) . These findings , and the preliminary clinical results , suggested that benorylate merited further assessment in the treatment of rheumatoid arthritis The effectiveness of dothiepin ( a tricyclic anti-depressant ) at a dose of 75 mg given orally at night was compared with placebo for 4 weeks in alleviating pain in 60 patients with classical or definite active rheumatoid arthritis . Patients were classified as either ‘ depressed ’ or ‘ not depressed ’ . The week before , during and 2 weeks after the study , 600 mg ibuprofen was given orally three times daily to all patients . Compared with placebo , dothiepin produced a significant reduction in daytime pain by the end of the treatment period . The Hamilton rating scale in ‘ depressed ’ patients was significantly improved in patients given dothiepin . The Cassano – Castrogiovanni self-evaluation rating scale in both ‘ depressed ’ and ‘ not depressed ’ patients showed a tendency ( not significant ) to be improved following dothiepin treatment compared with placebo . These results suggest that patients with rheumatoid arthritis may experience an increase in pain symptoms due to an alteration of mood . Therapy with tricyclic anti-depressants , such as dothiepin , therefore , may determine an improvement of pain indexes besides having an anti-depressant effect The authors describe a simple non-crossover-blind test for the evaluation of subjective indices . A table for recording pains during the 14 days ' study is described . The patient 's satisfaction with the treatment and the number of days until withdrawal from the trial are recorded . The statistical procedure takes into consideration differences between the treatment groups and makes possible a valuable comparison with drugs tested in other clinical trials . The three dose schedules of antirheumatic treatment were tested on 122 patients and the results compared with those of 342 patients treated with the 6 other antirheumatic drugs ( enteric-coated aspirin , paracetamol , indomethacin , flurbiprofen , mefenamic acid , and prednisolone ) and those of 41 patients who received placebos . The results show that Safapryn ( 3,6 g aspirin + 3.0 g paracetamol daily ) compared with 3.9 g enteric coated aspirin does not offer any advantage in its analgesic effect , although it gives rise to fewer side effects . Phenylbutazone ( 3000 mg ) was almost as effective as 15 mg prednisolone daily . Between the effects of this dosage of phenylbutazone and other non-steroidal antirheumatic drugs , however , no significant difference could be detected . 50 mg phenylbutazone daily and placebo treatment could not be distinguished . The authors thank the Arthritis and Rheumatism Council for Research in Great Britain for its financial support . One of the authors ( PL ) was a Merck , Sharp , and Dohme Research Fellow and another one ( PMB ) received a Robins research scholarship Previous studies of combinations of nonsteroidal drugs used in the treatment of rheumatoid arthritis ( RA ) have yielded conflicting results . We used st and ard methods to measure disease activity and high pressure liquid chromatography to measure plasma drug concentrations . We used doses of choline magnesium trisalicylate , adjusted to achieve therapeutic serum salicylate concentrations , and naproxen in a r and omized , double-blind , placebo-controlled cross-over study of full dose trisalicylate ( CMT ) , full dose naproxen ( N ) , full dose of both ( CMT-N ) , and half dose of both ( cmt-n ) to examine their relative efficacy and toxicity in treating RA . CMT-N was statistically superior to all other treatments in only 1 of 12 efficacy variables , but was equal to N and better than CMT or cmt-n for 7 variables . There were minimal differences among treatments for the other 4 efficacy variables . The mean percentage difference for the efficacy variables between CMT-N and N was 3 % , between CMT-N and CMT was 10.6 % , and between CMT-N and cmt-n was 10.5 % . Thirteen percent of patients manifested toxic reactions during the initial open dose-adjustment salicylate run-in phase . During the double-blind phases of the study , CMT-N was more toxic than N , CMT , or cmt-n ( 7.5 % versus 3.4 % , 1.8 % , and 3.7 % , respectively ) . Tinnitus was more common when full-dose CMT was used ; N ( N or CMT-N ) was associated with increased skin toxicity . Gastrointestinal complaints were equally common with all regimens . CMT-N , although sometimes statistically superior to CMT , N , or cmt-n , showed no clinical ly important additive or synergistic effect versus N or CMT alone Twelve rheumatic patients were given 2.0 and 4.5 g acetylsalicylic acid daily in two 3-week periods . On days 13 and 20 of each period the patients took a suppository containing either placebo or 50 mg of indomethacin . The study was performed double-blind . Indomethacin had a significant additive effect during ASA therapy with 2 g daily as estimated by articular index and subjective ratings of pain and morning stiffness . On the 4.5 g ASA dose there was a significant improvement only for articular index . The patients experienced less pain during maintenance therapy with 4.5 g of ASA compared with 2.0 g daily . Both ASA doses induced complete inhibition of prostagl and in PGF2 alpha release from platelets . Thus the suppression of PGF2 alpha release does not reflect the therapeutic response of these drugs . Side effects observed comprised tinnitus , dizziness and gastritis . In 2 of the patients the aminotransferase levels increased , indicating hepatotoxicity . The protein binding of salicylate decreased with increasing salicylate concentration . As the dose was increased from 2.0 to 4.5 g/day the unbound concentration increased 5 to 24 times . This reflects the combined effect of capacity-limited metabolism and capacity-limited protein binding of salicylate Actions on performance of dextropropoxyphene ( DXP ) alone and in combination with amitriptyline ( AMI ) , indomethacin ( IN ) , and placebo were compared in 15 patients with rheumatoid arthritis . The patients were on their prescribed maintenance regimen excluding analgesics . In four r and omized test sessions at two-week intervals , they received double blind and crossover single oral doses of DXP 130 mg , IN 50 mg , DXP 65 mg + AMI 25 mg or placebo , each after two days ' pretreatment with the same drug . Objective and subjective effects were measured at baseline and 2 and 4 hours after drug administration . DXP impaired critical flicker discrimination , symbol copying and body balance without modifying tracking , choice reactions or attention . It rendered the subjects elated , muzzy , mentally slow and calm . Actions of AMI + DXP were about the same . IN impaired body balance and critical flicker recognition . Plasma concentrations of DXP were moderate to high whilst those of IN and AMI were fairly low . We conclude that therapeutic doses of DXP and IN are relatively safe in regard to driving skills . Small doses of AMI may not enhance the mild psychomotor effects of DXP . Earlier single dose studies carried out with healthy volunteers might have overestimated the decremental effects of analgesics on psychomotor performance In a double-blind between-patient study of aspirin and benorylate carried out in 72 out patients with rheumatoid arthritis , benorylate 4 g twice daily was shown to be an effective analgesic and anti-inflammatory drug , its effects being indistinguishable from those of aspirin 1·2 g four times daily . Compared with the pretreatment values both drugs produced a statistically significant improvement ( P < 0·01 ) in functional grade , overall pain , articular index , and grip strength at the end of the first and second weeks . The overall incidence of side effects was less with benorylate , though this difference was not significant at the 5 % level & NA ; R and omized , double‐blind , placebo‐controlled trials on neuropathic pain treatment are accumulating , so an up date d review of the available evidence is needed . Studies were identified using MEDLINE and EMBASE search es . Numbers needed to treat ( NNT ) and numbers needed to harm ( NNH ) values were used to compare the efficacy and safety of different treatments for a number of neuropathic pain conditions . One hundred and seventy‐four studies were included , representing a 66 % increase in published r and omized , placebo‐controlled trials in the last 5 years . Painful poly‐neuropathy ( most often due to diabetes ) was examined in 69 studies , postherpetic neuralgia in 23 , while peripheral nerve injury , central pain , HIV neuropathy , and trigeminal neuralgia were less often studied . Tricyclic antidepressants , serotonin noradrenaline reuptake inhibitors , the anticonvulsants gabapentin and pregabalin , and opioids are the drug classes for which there is the best evidence for a clinical relevant effect . Despite a 66 % increase in published trials only a limited improvement of neuropathic pain treatment has been obtained . A large proportion of neuropathic pain patients are left with insufficient pain relief . This fact calls for other treatment options to target chronic neuropathic pain . Large‐scale drug trials that aim to identify possible subgroups of patients who are likely to respond to specific drugs are needed to test the hypothesis that a mechanism‐based classification may help improve treatment of the individual patients The therapeutic and adverse effects of 2 weeks of treatment with high-dose indomethacin ( 150 mg/day ) were compared with those of low-dose indomethacin ( 50 mg/day ) combined with paracetamol ( 4 g/day ) in a double-blind , double-dummy , cross-over study in 17 patients with active rheumatoid arthritis . Grip strength , Ritchie 's index , joint circumference , joint pain , and patient 's and physician 's global assessment s were estimated , and conventional laboratory parameters were followed . In addition , the time-concentration profiles of indomethacin and paracetamol were assessed during steady state
Output:
| In general , there were no differences in safety and withdrawals due to inadequate analgesia between combination and monotherapy .
Based on 23 trials , all at high risk of bias , there is insufficient evidence to establish the value of combination therapy over monotherapy for pain management in IA . |
MS212641 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 United Kingdom 's pharmacy regulator contemplated using continuing professional development ( CPD ) in pharmacy revalidation in 2009 , simultaneously asking pharmacy professionals to demonstrate the value of their CPD by showing its relevance and impact . The idea of linking new CPD requirements with revalidation was yet to be explored . Our aim was to develop and vali date a framework to guide pharmacy professionals to select CPD activities that are relevant to their work and to produce a score sheet that would make it possible to quantify the impact and relevance of CPD . Methods : We adapted an existing risk matrix , producing a CPD framework consisting of relevance and impact matrices . Concepts underpinning the framework were refined through feedback from 5 pharmacist teacher‐practitioners . We then asked 7 pharmacists to rate the relevance of the framework 's individual elements on a 4‐point scale to determine content validity . We explored views about the framework through focus groups with 6 participants and interviews with 17 participants who had used it formally in a study . Results : The framework 's content validity index was 0.91 . Feedback about the framework related to 3 themes of penetrability of the framework , usefulness to completion of CPD , and advancement of CPD records for the purpose of revalidation . Discussion : The framework can help professionals better select CPD activities prospect ively , and makes assessment of CPD more objective by allowing quantification , which could be helpful for revalidation . We believe the framework could potentially help other health professionals with better management of their CPD irrespective of their field of practice BACKGROUND Continuing professional development ( CPD ) continues to gain acceptance as a model for health care professionals to engage in lifelong learning . Little is known about how CPD participants use the experience to develop learning plans and implement new knowledge into practice . OBJECTIVE The primary objective of this study was to evaluate the effectiveness of instruments design ed to guide the pharmacist through a CPD process to plan and participate in continuing professional education activities at a national meeting . METHODS The study was a case-control study of pharmacists r and omized from the participants of the 2010 American Pharmacists Association Annual Meeting . The test group ( n=47 ) was instructed to complete CPD planning worksheets design ed to facilitate planning of their continuing pharmacy education activities before the meeting . The control group ( n=58 ) did not have instructions beyond the meeting program . Both groups completed 3 surveys assessing components of the CPD processes : 1 before and 2 after the meeting . The surveys focused on confidence in abilities to identify , plan , and evaluate learning as well as implementation of practice change . RESULTS Nearly all the test groups reported successful application of learning ( 95 % ) and achieving their design ed learning plan ( 87 % ) . Practice changes were implemented in more than half ( 60 % ) of the test groups after using a CPD process to plan their learning activities . There were no significant differences among groups regarding the outcome measures . CONCLUSIONS Participants successfully used a CPD approach to meet their learning plans and achieve meaningful learning outcomes . Integration of CPD components into educational activities may help to promote practice change Objective . To determine whether a structured educational intervention would support pharmacists ' utilization of a continuing professional development ( CPD ) model compared to pharmacist control subjects . Methods . A prospect i ve , r and omized , observational case-control study of CPD was conducted in which pharmacists participated in several educational interventions , and study and control groups completed pre study and post study survey instruments . Results . Survey data from 57 pharmacists ( n = 28 study , n = 29 control ) were analyzed and significant outcomes from the CPD stages of reflect , plan , act , evaluate , and record were found between matched study subjects and study and control group comparisons . Conclusions . With appropriate training and support , pharmacists can utilize a CPD approach to their lifelong learning and professional development Background : The Institute of Medicine states that the new vision for continuing education ( CE ) for health-care professionals will be based on continuing professional development ( CPD ) ; however , information on the utility of CPD is lacking . Objective : To assess the effect of CPD , compared with that of traditional continuing pharmacy education ( CPE ) , on perceptions of factors related to pharmacy practice . Methods : This 10-month , nonblinded , r and omized controlled study recruited licensed pharmacists employed at a health maintenance organization ( HMO ) . After completing a basic CPD course , participants were r and omized to the intervention or control group . The control group was instructed to continue with traditional CPE . The intervention group participants completed 3 CPD workshops and were instructed to utilize the CPD approach for their learning needs . At baseline and follow-up , all participants completed a study question naire on perceptions of their pharmacy practice s. The outcome measures were comparisons on follow-up and changes from baseline to follow-up in responses to the study question naire . Results : One hundred pharmacists were enrolled . The intervention ( n = 44 , 7 lost to follow-up ) and control ( n = 47 , 2 lost to follow-up ) groups were similar at baseline . At follow-up , a higher percentage of intervention participants reported that they had better interactions with other health-care providers ( always/frequently 32 % vs 6 % , respectively ) and initiated practice /work changes ( always/frequently 21 % vs 0 % , respectively ) ( both p < 0.01 ) as a result of their education activities . Compared with control participants at follow-up , intervention participants reported that their education activities improved patient care changes ( 46 % vs 23 % ) , professional knowledge ( 34 % vs 6 % ) , skills ( 48 % vs 17 % ) , and attitudes/values ( 43 % to 11 % ) ( all p < 0.05 ) . However , intervention participants reported more often that time was a barrier to completing education activities ( 75 % vs 32 % , p < 0.001 ) . Conclusions : Pharmacists who participated in CPD reported more often that their perceptions of various aspects of their pharmacy practice improved as a result of their education activities compared with pharmacists who participated in traditional CPE OBJECTIVES To explore factors associated with Scottish pharmacists ' views and attitudes to continuing professional development ( CPD ) . METHODS A retrospective principal component analysis of 552 ( 22.8 % ) question naires returned from a sample of 2420 Scottish pharmacists r and omly selected from the 4300 pharmacists registered with the Royal Pharmaceutical Society of Great Britain and with a Scottish address . KEY FINDINGS Principal component analysis of question naire items ( n = 19 ) revealed four factors associated with Scottish pharmacists ' views and attitudes to CPD : having positive support in the workplace , having access to re sources and meeting learning needs , having confidence in the CPD process and motivation to participate in the CPD process . Community pharmacists were identified as the subgroup of pharmacists that needed most support for CPD regarding all four factors , while pharmacists working in primary care felt that they had most support in the workplace in comparison to other sectors ( P < 0.05 ) and better access to re sources and meeting learning needs when compared to community ( P < 0.001 ) and hospital ( P = 0.008 ) colleagues . Pharmacists working in primary care also felt more motivated to participate in the CPD process than those in the community ( P < 0.001 ) , and hospital pharmacists reported having more confidence in the CPD process compared to community pharmacists ( P < 0.05 ) . CONCLUSION Using principal component analysis has identified four factors associated with Scottish pharmacists ' views and attitudes to CPD . This may provide an approach to facilitate comparison of CPD views and attitudes with intra and inter professional groupings . Further study may allow identification of good practice and solutions to common CPD issues Background Contemporary pharmaceutical care requires sustained pharmacist competency through maintenance and improvement of knowledge , skills , and performance . Existing continuing education ( CE ) models reflect a wide spectrum of international approaches to life-long learning . Objective The objective of this study was to determine CE preferences of pharmacists in Egypt before implementing a plan for compulsory annual CE activities and events for licensure renewal . Setting A question naire containing questions about continuing education needs and preferences of Egyptian pharmacists was distributed to 400 pharmacies in Cairo . The sample was drawn r and omly from the address list in yellow pages . The survey was conducted by personal interview . Method The question naire was design ed and vali date d. Questions were divided into specific domains of interest including pharmacist demographics ; access to internet re sources ; frequency and characteristics of past CE activities ; preferences for delivery and content ; motivation to participation ; and plans for future CE activities . All data analyses were conducted using SPSS for Windows version 18.0 . All statistical tests were 2-tailed and based on a significance level of p value ≤ 0.05 . Results During the six months of question naire distribution , 400 pharmacists ( one from each r and omly selected pharmacies ) were asked to complete the question naire . The response rate was 359 out of 400 pharmacists ( 89.75 % ) . Twenty three percent of respondents had held their highest pharmacy degree to practice for less than 5 years and 19 % had obtained their initial degree more than 15 years ago . More than half of the respondents were female ( 53.3 % ) . Topics related to therapeutics were of highest interest to 85.3 % , closely followed by clinical skills topics . Pharmacists working in community pharmacies had attended less CE events ( 15 vs. 28 % , p = 0.034 within the past 2 years ) when compared to their hospital-based counterparts . Conversely , hospital pharmacists generally reported less satisfaction with current CE ( 21 vs. 33 % , p = 0.021 ) . Conclusion Respondents of the survey expressed enthusiasm towards CE activity , but cited common barriers to participation , as well , such as employer- and technology-based obstacles . These results confirm that features of a successful CE program must be flexible to meet preferences and perceived needs of Egyptian pharmacists
Output:
| Due to the variety of formats and no consistent model , no perfect model or activity has been identified .
However , CPD showed increased practice outcomes versus CE .
Although an increasing amount of technology is being utilized , face-to-face learning is still preferred . |
MS212642 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE This study evaluates the effectiveness of a multi-component oral health intervention in preschool children in a non-r and omized intervention study with a complementary baseline control . METHODS Participants in the main study were 2137 children born between October 2003 and July 2004 in Fl and ers , Belgium . In the intervention group ( 50.5 % of participants ) , an oral health education program was added to a st and ard preventive care program during the first 3 years of life . Oral health examinations were performed by trained dentists when the children were 3 ( 2007 ) and 5 ( 2009 ) years old . Data on dietary habits , oral hygiene habits and dental attendance were obtained through structured question naires . Regression analyses were applied to compare the results of the intervention and control group with baseline measurements obtained before the intervention ( 2003 ) in other cohorts of 3- ( N = 1291 ) and 5-year-olds ( N = 1325 ) living in the same regions . RESULTS The prevalence of caries experience was generally lower in the main study compared with the baseline cohorts , with little differences between the intervention and control group . For the oral health-related behaviours , the control group scored mostly better . Nevertheless , compared with baseline , limited differences were observed in dental attendance , tooth brushing , helping with tooth brushing and consuming in-between drinks ( P < 0.05 ) . CONCLUSION The study illustrates that a multi-component , theory-based intervention at community level had only a limited and temporary effect on oral health-related behaviours in the community under study . Further research is needed to determine how oral health in young children can be improved in the long term OBJECTIVE To assess the impact of oral health promotion integrated with a health promoting school ( HPS ) initiative on the oral health outcomes of secondary school students . MATERIAL S AND METHOD Using an urban-rural stratified cluster r and omized approach , the intervention was applied to secondary school students in Arusha , Tanzania . In the urban , three control ( n = 315 ) and two intervention ( n = 214 ) schools performed oral clinical examination and question naires at baseline . In rural the corresponding figures at baseline were two ( n = 188 ) and three ( n = 360 ) schools . After 2 years , 374 and 358 students remained in the intervention and control arms . RESULTS Mean number of decayed teeth ( DT ) increased in the intervention ( mean score 1.0 vs 1.7 , p < 0.001 ) and control schools ( mean score 1.2 vs 1.7 , p < 0.001 ) . Mean number of teeth with plaque decreased significantly in intervention and control schools . No significant difference in caries increment and plaque decline scores was observed between groups . Mean number of teeth with bleeding decreased ( 0.5 vs 0.3 , p < 0.05 ) in intervention schools , whereas no change was observed in the control schools ( 0.4 vs 0.5 , p = 0.051 ) . Increment in mean number of DT between baseline and follow-up was largest and smallest in students who , respectively , deteriorated and improved their plaque and bleeding scores . CONCLUSION The intervention activities did not show any effect with respect to dental caries , calculus and plaque status among the students investigated . Compared with the control group , more favorable changes in the intervention group occurred with respect to bleeding on probing , suggesting a weak but positive effect on students ' oral hygiene status Background School based oral health education through traditional lecturing has been found successful only in improving oral health knowledge , while has low effectiveness in oral hygiene and gingival health . The aim of this study was to evaluate the effectiveness of experiential learning ( EL ) oral health education to traditional lecturing ( TL ) , on enhancing oral health knowledge , attitude and behavior as well as oral hygiene , gingival health and caries of 10-year-old children . Methods Eighty-four children were recruited for the EL and 100 for the TL group from 3 locations in Greece . Data regarding oral health knowledge , attitude and behavior were collected via question naires . Data regarding dental plaque , gingivitis and caries were collected by clinical examination . The evaluation using question naires and clinical examination was assessed at baseline and 6 and 18 months afterwards . Two calibrated pediatric dentists examined the students using a periodontal probe and artificial light . Modified hygiene index ( HI ) was used for dental plaque recording , the simplified gingival index ( GI-S ) was used for gingivitis and DMFT , based on BASCD criteria , for dental caries . Based on a dedicated manual , the teacher applied in the classroom the oral health educational program using EL . Results EL group had statistically significant better hygiene than the TL at 6 months ( p < 0.05 ) . Within the same group , both groups had enhanced oral health knowledge at 6 and 18 months ( p < 0.05 ) and improved oral health behavior ( p > 0.05 ) and attitude ( p > 0.05 ) at 6 months in comparison to baseline . Conclusion EL program was found more successful than TL in oral hygiene improvement . Both oral health education programs improved the oral health knowledge , attitude and behavior of children . Trial registration Clinical Trials.gov ( NCT02320162 ) Even though there is no “ gold st and ard ” for determining caries lesion activity , it is nonetheless possible to evaluate the validity of such diagnostic measures . The aim of this study was to estimate the construct and predictive validity of caries lesion activity assessment s by means of their ability to reflect known effects of fluoride on caries . A three-year trial of the effect of daily supervised brushing with fluoride toothpaste was carried out among 273 12-year-old children . All children were examined clinical ly according to diagnostic criteria for activity assessment . The relative risk ( fluoride vs. control ) for caries lesion transitions among diagnostic categories was calculated . Fluoride inhibited progression of caries at all stages of lesion formation while at the same time enhancing lesion regression . The effects were most pronounced for active non-cavitated lesions . It is concluded that the clinical diagnostic criteria have construct and predictive validity for the assessment of caries lesion activity The effect of reducing the abrasivity of toothpaste on dental caries was observed in a 3-year clinical trial involving 1106 11 - 13-year-old Berkshire schoolchildren were divided into three groups ; Group 1 were allocated a low abrasivity paste containing 0.8 % sodium monofluorophosphate , Group 2 a paste of conventional abrasivity also containing 0.8 % sodium monofluorophosphate and Group 3 a low abrasivity non-fluoride paste . After 3 years the net DMFS increments ( clinical and radiographic scores combined ) were 4.22 in Group 1 , 4.72 in Group 2 and 6.43 in Group 3 . The differences between Groups 1 and 3 and between Groups 2 and 3 were highly significant ( P less than 0.001 ) . The mean increment in Group 1 was lower than in Group 2 but did not reach statistical significance . Reducing the abrasivity of the toothpaste had no meaningful effect on the st and ard of oral hygiene and prevalence of gingivitis as measured by the Gingival and Plaque Indices BACKGROUND Prophylaxis efforts for the maintenance of tooth health led to a distinctive decrease in caries frequency with children and young persons . Because the toothbrush can still be described as the most important oral hygiene aid , possible differences between the effectivity of electric and manual toothbrushes should be tested in the present study . Elementary school children had been instructed -- within a special prophylaxis program -- over a period of three years to clean their teeth partly with electric partly with manual toothbrushes . MATERIAL AND METHODS In two parallel classes ( 1st class ) of the same elementary school ( Private Martinusschule Mainz-Gonsenheim ) the A-class ( n = 24 children ) was instructed to clean their teeth with a manual toothbrush suitable for children ( Oral-B , Power Tip , Braun AG , Kronberg , Germany ) whereas the B-class ( n = 26 ) received electric toothbrushes ( Oral-B-7 EB 5 K , Braun AG , Kronberg , Germany ) . Every three months the children were instructed in group-preventive methods in school , followed by cleaning instructions , remotivations and the distribution of new electric respectively manual toothbrushes . In order to record the influence of the intensive quarterly oral hygiene instruction , elementary school children ( 1st class ) of the same school type were looked after and examined within the yearly group prophylaxis ( n = 40 ) . The yearly dental examinations included the recording of carious frequency ( DMF-T , dmf-t ) , approximal plaque accumulation ( API ) , and the evaluation of the gingival state ( GI-Index ) as well as the present dental restorative material s. RESULTS After an investigation period of three years no essential differences regarding caries frequency , proportion of dentitions of natural state of health and plaque involvement were found with the children of the respective classes . Children using electric toothbrushes showed after 3 years 27 % of healthy-natured dentitions on average ( 46 % of the children had got API-values of up to 30 % ) and the children who used manual toothbrushes showed 22 % of nature-healthy dentitions ( 52 % of the children had got API-values of up to 30 % ) and in 33 % of the control children who received instructions only once a year healthy-natured dentitions were found after 3 years ( 75 % of the children had got API-values of up to 35 % ) . CONCLUSIONS With regard to caries and gingivitis prevalence modern electric toothbrushes for children can be considered equally efficient like conventional manual toothbrushes for children with children of normal caries risk The clinical effects of different preventive regimens provided for young people in their early and middle teens were studied during a 2-year period . The regimens studied during the 1st year of the trial were professional tooth-cleaning plus fluoride mouth-rinsing every 3rd week versus fluoride varnish treatment every 6 months . During the 2nd year , the preventive measures were given in accordance with the estimated needs of each individual . The results were related to the individuals ' previous experience with dental prevention to determine whether this had a significant influence . The results showed that fairly good or excellent effects on the individuals ' oral hygiene and gingival status were readily achieved and maintained with a professional tooth-cleaning plus fluoride mouth-rinsing regimen . The study failed to demonstrate any superior caries-preventive effect of the fluoride varnish treatments . Subsequent individualized prevention produced similar average end results in all groups . Differences in the results in accordance with the individuals ' previous experience with dental prevention indicate a superior and prolonged influence on dental health of professional tooth-cleaning plus fluoride mouth-rinsing in comparison with a fluoride-based program alone Abstract The effect of a dental prophylactic program based on systematic plaque control has been tested during a 3-year period on youths aged 16–19 years . During their last year at comprehensive school they received professional tooth cleaning every third week by specially trained dental hygiene nurses . At the end of this first experimental year the subjects were offered continued prophylaxis of the same type against caries and gingivitis during 2 more years . Interested subjects were divided equally at r and om into test groups A and B. In the second year group A received professional tooth cleaning once a month and in the third year once each 6 months . Group B was offered , both in the second and third years , only two prophylactic sessions each year according to this model . Test group C comprised the subjects who expressed no interest in continued professional tooth cleaning . A control group , group D , consisted of pupils of the same ages from a neighboring school area . These received in the first experimental year a prophylactic program based on mouthrinsing each second week with 0.2 % sodium fluoride solution . After this first year neither test group C nor the control group D participated in any organized dental health care program . After the first year there were significant differences among the groups , the plaque and gingival indices in the control group D being significantly higher than in test groups A , B and C. At the end of the third year significant improvements in these indices had taken place in groups A and B. The corresponding values in groups C and D did not differ significantly at the three recordings . Significant correlations existed between the plaque and gingivitis scores at the end of the experimental period within the respective groups . Significantly more dental caries ( new DPS ) developed in the control group D than in test groups A and B during the period of the experiment : on average 3.3 versus 1.0 and 1.2 new DFS , respectively . The figure for caries increment in group C was 2.0 . Regardless of grouping , individuals with caries increment during the experimental period had a significantly higher number of risk factors , here defined as the total of upper or lower quartile values for lactobacillus counts , secretion rate and buffering capacity of the saliva , than individuals without caries increment The preset study was performed to assess the effect on caries and gingivitis of plaque control measures such as oral hygiene instruction , toothcleaning practice and professional toothcleaning . 104 children , 13 - 14 years old , participated in the trial . Prior to the start of the preventive treatment all children were examined regarding oral hygiene , gingivitis and caries . The caries examintion was limited to the proximal surfaces of molars and premolars . Following this baseline examination the children were r and omly divided into two treatment groups A , and B. Both groups of children were recalled for professional toothcleaning once every 2 weeks during an 18-month period . In each child the professional toothcleaning was restricted to either the right or the left jaws by r and om selection . In addition , the children of Group A at each recall
Output:
| Mechanical plaque control procedures are effective in reducing plaque and gingivitis .
The addition of fluoride to mechanical plaque control is significant for caries management .
Chlorhexidine rinse has a positive effect on gingivitis and inconclusive role in caries |
MS212643 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 22q13 deletion syndrome ( Phelan – McDermid syndrome ) is characterised by a global developmental delay , absent or delayed speech , generalised hypotonia , autistic behaviour and characteristic phenotypic features . Intranasal insulin has been shown to improve declarative memory in healthy adult subjects and in patients with Alzheimer disease . Aims : To assess if intranasal insulin is also able to improve the developmental delay in children with 22q13 deletion syndrome . Methods : We performed exploratory clinical trials in six children with 22q13 deletion syndrome who received intranasal insulin over a period of 1 year . Short-term ( during the first 6 weeks ) and long-term effects ( after 12 months of treatment ) on motor skills , cognitive functions , or autonomous functions , speech and communication , emotional state , social behaviour , behavioural disorders , independence in daily living and education were assessed . Results : The children showed marked short-term improvements in gross and fine motor activities , cognitive functions and educational level . Positive long-term effects were found for fine and gross motor activities , nonverbal communication , cognitive functions and autonomy . Possible side effects were found in one patient who displayed changes in balance , extreme sensitivity to touch and general loss of interest . One patient complained of intermittent nose bleeding . Conclusions : We conclude that long-term administration of intranasal insulin may benefit motor development , cognitive functions and spontaneous activity in children with 22q13 deletion syndrome Summary Dementia and non-insulin-dependent diabetes mellitus ( NIDDM ) are highly prevalent disorders in the elderly . Diabetes has repeatedly been reported to affect cognition , but its relation with dementia is uncertain . We therefore studied the association between diabetes and dementia in the Rotterdam Study , a large population -based study in the elderly . Of 6330 participants , aged 55 to 99 years old , complete information on diabetes and presence of dementia was available . Diabetes was diagnosed as use of anti-diabetes medication or r and om or post-load serum glucose over 11 mmol/l . Dementia was diagnosed through a stepped approach , including a sensitive screening of all participants and a comprehensive diagnostic work-up . Diabetes was present in 724 ( 11.4 % ) subjects . Of the 265 dementia patients 59 ( 22.3 % ) had diabetes . Multiple logistic regression analyses , adjusting for age and sex differences , revealed a positive association between diabetes and dementia ( odds ratio : 1.3 , 95 % confidence interval : 1.0–1.9 ) . In particular , strong associations were found between dementia and diabetes treated with insulin ( odds ratio : 3.2 , 95 % confidence interval : 1.4–7.5 ) . The relation was strongest with vascular dementia , but was also observed with Alzheimer 's disease . These associations were independent of educational attainment , smoking , body mass index , atherosclerosis , blood pressure and antihypertensive drug treatment , and could not be explained by clinical cerebral infa rct ions . The results suggest that NIDDM is associated with dementia . Alzheimer 's disease may be more frequent in elderly diabetic patients treated with insulin . [ Diabetologia ( 1996 ) 39 : 1392–1397 Previous studies have suggested an acutely improving effect of insulin on memory function . To study changes in memory associated with a prolonged increase in brain insulin activity in humans , here we used the intranasal route of insulin administration known to provide direct access of the substance to the cerebrospinal fluid compartment . Based on previous results indicating a prevalence of insulin receptors in limbic and hippocampal regions as well as improvements in memory with systemic insulin administration , we expected that intranasal administration of insulin improves primarily hippocampus dependent declaration memory function . Also , improvements in mood were expected . We investigated the effects of 8 weeks of intranasal administration of insulin ( human regular insulin 4 x 40 IU/d ) on declarative memory ( immediate and delayed recall of word lists ) , attention ( Stroop test ) , and mood in 38 healthy subjects ( 24 males ) in a double blind , between-subject comparison . Blood glucose and plasma insulin levels did not differ between the placebo and insulin conditions . Delayed recall of words significantly improved after 8 weeks of intranasal insulin administration ( words recalled , Placebo 2.92 + /- 1.00 , Insulin 6.20 + /- 1.03 , p < 0.05 ) . Moreover , subjects after insulin reported signs of enhanced mood , such as reduced anger ( p < 0.02 ) and enhanced self-confidence ( p < 0.03 ) . Results indicate a direct action of prolonged intranasal administration of insulin on brain functions , improving memory and mood in the absence of systemic side effects . These findings could be of relevance for the treatment of patients with memory disorders like in Alzheimer 's disease Raising insulin acutely in the periphery and in brain improves verbal memory . Intranasal insulin administration , which raises insulin acutely in the CNS without raising plasma insulin levels , provides an opportunity to determine whether these effects are mediated by central insulin or peripheral processes . Based on prior research with intravenous insulin , we predicted that the treatment response would differ between subjects with ( epsilon4 + ) and without ( epsilon4- ) the APOE-epsilon4 allele . On separate mornings , 26 memory-impaired subjects ( 13 with early Alzheimer 's disease and 13 with amnestic mild cognitive impairment ) and 35 normal controls each underwent three intranasal treatment conditions consisting of saline ( placebo ) or insulin ( 20 or 40 IU ) . Cognition was tested 15 min post-treatment , and blood was acquired at baseline and 45 min after treatment . Intranasal insulin treatment did not change plasma insulin or glucose levels . Insulin treatment facilitated recall on two measures of verbal memory in memory-impaired epsilon4- adults . These effects were stronger for memory-impaired epsilon4- subjects than for memory-impaired epsilon4 + subjects and normal adults . Unexpectedly , memory-impaired epsilon4 + subjects showed poorer recall following insulin administration on one test of memory . These findings suggest that intranasal insulin administration may have therapeutic benefit without the risk of peripheral hypoglycemia and provide further evidence for apolipoprotein E ( APOE ) related differences in insulin metabolism Insulin receptors have been detected in several structures of the brain , yet the biological significance of insulin acting on the brain remains rather unclear . In humans , direct central nervous effects of insulin are difficult to distinguish from alterations in neuronal functions because of insulin-induced decrease in blood glucose levels . Since several intranasally administered viruses , peptides , and hormones have been shown to penetrate directly from the nose to the brain , we tested whether insulin after intranasal administration likewise has access to the brain . After a 60-min baseline period , insulin ( 20 IU H-Insulin 100 Hoechst ) or vehicle ( 2.7 mg/ml m-Cresol ) was intranasally administered every 15 min to 18 healthy subjects according to a double-blind within-subject crossover design . Auditory-evoked potentials ( AEP ) indexing cortical sensory processing were recorded while the subjects performed a vigilance task ( oddball paradigm ) during the baseline phase and after 60 min of intranasal treatment with insulin or placebo . Blood glucose and serum insulin levels were not affected by intranasal insulin . Compared with placebo , intranasal administration of insulin reduced amplitudes of the N1 ( P < 0.005 ) and P3 ( P < 0.02 ) components of the AEP and increased P3 latency ( P < 0.05 ) . The reduction in P3 amplitude was most pronounced over the frontal recording site ( 2.42 + /- 1.00 vs. 4.92 + /- 0.79 microV , P < 0.0005 ) . At this site , after insulin administration , a broad negative shift developed in the AEP between 280 and 500 ms poststimulus ( area under the curve -166.0 + /- 183.8 vs. 270.8 + /- 138.7 microV x ms after placebo , P < 0.01 ) . The results suggest that after intranasal administration , insulin directly enters the brain and exerts distinct influences on central nervous functions in humans The crucial role of the medial temporal lobe ( MTL ) in episodic memory is well established . Although there is little doubt that its anatomical subregions-the hippocampus , peri- , entorhinal and parahippocampal cortex (PHC)-contribute differentially to mnemonic processes , their specific functions in episodic memory are under debate . Data from animal , human lesion , and neuroimaging studies suggest somewhat contradictory perspectives on this functional specialization : a general participation in declarative memory , an exclusive involvement in associative mnemonic processes , and a specific contribution to spatial memory are reported for the hippocampus , adjacent cortices , and the PHC . A functional lateralization in humans dependent on the verbalizability of the material is also discussed herein . To further eluci date the differential contributions of the various MTL subregions to encoding , we employed an object-location association memory paradigm . The memory for each of the studied associations was tested twice : by the object , and by the location serving as retrieval cue . The memory accuracy in response to both cue types was also assessed parametrically . Brain activity during encoding which leads to different degrees of subsequent memory accuracy under the two retrieval conditions was compared . We found the bilateral posterior PHC to participate in encoding of both the object associated with a location and the location associated with an object . In contrast , activity in an area in the left anterior PHC and the right anterior MTL was only correlated with the memory for the location associated with an object
Output:
| The current limited clinical experience suggests potential beneficial cognitive effects of intranasal insulin .
Analyses provide clinical considerations for future research aim ed at elucidating whether intranasal insulin may be used to improve cognitive functions |
MS212644 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 comparative outcome with GreenLight ( GL ) photoselective vaporisation of the prostate and transurethral resection of the prostate ( TURP ) in men with lower urinary tract symptoms due to benign prostatic obstruction ( BPO ) has been question ed . OBJECTIVE The primary objective of the GOLIATH study was to evaluate the noninferiority of 180-W GL XPS ( XPS ) to TURP for International Prostate Symptom Score ( IPSS ) and maximum flow rate ( Qmax ) at 6 mo and the proportion of patients who were complication free . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve r and omised controlled trial at 29 centres in 9 European countries involving 281 patients with BPO . INTERVENTION 180-W GL XPS system or TURP . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Measurements used were IPSS , Qmax , prostate volume ( PV ) , postvoid residual ( PVR ) and complications , perioperative parameters , and reintervention rates . Noninferiority was evaluated using one-sided tests at the 2.5 % level of significance . The statistical significance of other comparisons was assessed at the ( two-sided ) 5 % level . RESULTS AND LIMITATIONS The study demonstrated the noninferiority of XPS to TURP for IPSS , Qmax , and complication-free proportion . PV and PVR were comparable between groups . Time until stable health status , length of catheterisation , and length of hospital stay were superior with XPS ( p<0.001 ) . Early reintervention rate within 30 d was three times higher after TURP ( p=0.025 ) ; however , the overall postoperative reintervention rates were not significantly different between treatment arms . A limitation was the short follow-up . CONCLUSIONS XPS was shown to be noninferior ( comparable ) to TURP in terms of IPSS , Qmax , and proportion of patients free of complications . XPS results in a lower rate of early re interventions but has a similar rate after 6 mo . TRIAL REGISTRATION Clinical Trials.gov , identifier NCT01218672 PURPOSE To our knowledge we report the first single center , prospect i ve , r and omized study comparing holmium laser enucleation and high performance GreenLight ™ prostate photoselective vaporization as surgical treatment of prostatic adenomas greater than 60 ml . MATERIAL S AND METHODS A total of 80 patients with a large prostatic adenoma were r and omly assigned to surgical treatment with holmium laser enucleation or photoselective vaporization . International Prostate Symptom Score , International Index of Erectile Function-15 , maximum flow rate , post-void residual urine , serum prostate specific antigen and transrectal ultrasound volume were recorded . RESULTS Patient baseline characteristics were similar for holmium laser enucleation and photoselective vaporization . Operative time and catheter removal time were almost equal in the 2 groups ( p = 0.7 and 0.2 , respectively ) . Eight vaporization cases were converted to transurethral prostate resection or holmium laser enucleation intraoperatively due to bleeding . A significantly higher maximum flow rate and lower post-void residual urine were noted in holmium laser cases during the entire followup ( at 1 year each p = 0.02 ) . However , no significant difference in International Prostate Symptom Score , quality of life or International Index of Erectile Function-15 was detected . Prostate volume and serum PSA decreased 78 % and 88 % in the holmium laser group , and 52 % and 60 % in the vaporization group , respectively . CONCLUSIONS Holmium laser enucleation and photoselective vaporization are effective for lower urinary tract symptoms due to a large prostatic adenoma . Early subjective functional results ( maximum flow rate and post-void residual urine ) of holmium laser enucleation appear to be superior to those of photoselective vaporization . In our h and s cases intended to be treated with photoselective vaporization were at 22 % risk of conversion to another modality . This could reflect our determination to vaporize to the capsule in all vaporization cases BACKGROUND Plasmakinetic enucleation of the prostate ( PKEP ) has recently been proved a safe and technically feasible procedure for benign prostatic hyperplasia ( BPH ) . However , its long-term safety , efficacy , and durability in comparison with the gold-st and ard transurethral resection of the prostate ( TURP ) have not yet been reported . OBJECTIVE To report the 3-yr follow-up results of a prospect i ve , r and omised clinical trial comparing PKEP with st and ard TURP for symptomatic BPH . DESIGN , SETTING , AND PARTICIPANTS A total of 204 patients with bladder outflow obstruction ( BOO ) secondary to BPH were prospect ively r and omised 1:1 into either the PKEP group or the TURP group . INTERVENTION The patients in each group underwent the procedure accordingly . MEASUREMENTS All patients were assessed perioperatively and followed at 1 , 3 , 6 , 12 , 18 , 24 , and 36 mo postoperatively . The preoperative and postoperative parameters included International Prostate Symptom Score ( IPSS ) , quality of life ( QoL ) scores , the International Index of Erectile Function ( IIEF ) question naire , maximum urinary flow rates ( Q(max ) ) , transrectal ultrasound (TRUS)-assessed prostate volume , postvoid residual urine ( PVRU ) volume , and serum prostate-specific antigen ( PSA ) level . Patient baseline characteristics , perioperative data , and postoperative outcomes were compared . All complications were recorded . RESULTS AND LIMITATIONS PKEP was significantly superior to TURP in terms of the drop in haemoglobin ( 0.74±0.33 g/dl vs 1.88±1.06 g/dl ; p<0.001 ) , intraoperative irrigation volume ( 11.7±4.5 l vs 15.4±6.2 l ; p<0.001 ) , postoperative irrigation volume and time ( 18.5±7.6 l vs. 30.0±11.4 l and 16.6±5.2 h vs 25.3±8.5 h ; all p<0.001 ) , recovery room stay ( 67.3±11.1 min vs 82.0±16.4 min ; p<0.001 ) , catheterisation time ( 51.7±26.3 h vs 80.5±31.6 h ; p<0.001 ) , hospital stay ( 98.4±20.4 h vs 134.2±31.5 h ; p<0.001 ) , and resected tissue ( 56.4±12.8 g vs 43.8±15.5 g ; p<0.001 ) . There were no statistical differences in operation time and sexual function between the two groups . At 36 mo postoperatively , the PKEP group had a maintained and statistically significant improvement in IPSS ( 2.4±2.2 vs 4.3±2.9 ; p<0.001 ) , QoL ( 0.6±0.5 vs 1.6±1.4 ; p<0.001 ) , Q(max ) ( 28.8±10.1 ml/s vs 25.1±8.0 ml/s ; p=0.017 ) , and TRUS volume ( 21.0±7.3 ml vs 26.4±6.8 ml ; p<0.001 ) , with urodynamically proven deobstruction ( Schäfer grade 0.2±0.02 vs 0.8±0.1 ; p<0.001 ) . More extensive clinical trials are required to vali date these results . CONCLUSIONS PKEP is a safe and highly effective technique for relieving BOO . At 3-yr follow-up , the clinical efficacy of PKEP is durable and compares favourably with TURP OBJECTIVE Prospect ively evaluate perioperative outcomes and 2-yr follow-up after holmium laser enucleation ( HoLEP ) and st and ard open prostatectomy ( OP ) for treating benign prostatic hyperplasia-related obstructed voiding symptoms , with prostates > 70 g. METHODS From March 2003 to December 2004 , 80 consecutive patients were r and omised for surgical treatment with HoLEP ( n=41 ) or st and ard OP ( n=39 ) . All patients were preoperatively assessed with International Prostate Symptom Score and International Index of Erectile Function question naires and complete urodynamic evaluation . Intraoperative and perioperative parameters such as blood loss , catheter removal , and hospital stays were assessed . Early and late complications were recorded . Patients were evaluated at 1- , 3- , 12- , and 24-mo follow-ups with the same tests . RESULTS Operating room time was significantly shorter for the OP group ( 72.09+/-21.22 min vs. 58.31+/-11.95 min , p<0.0001 ) ; catheter removal ( 1.5+/-1.07 d and 4.1+/-0.5 d , p<0.001 ) and hospital stay ( 2.7+/-1.1 d vs. 5.4+/-1.05 d , p<0.001 ) were shorter in the HoLEP group . Blood loss was less and blood transfusions fewer in the HoLEP group ( p<0.001 ) . In both groups urodynamic and uroflowmetry findings improved from baseline , were still evident at the 24-mo follow-up , and were comparable between the two groups . Late complications were also comparable . CONCLUSIONS HoLEP is a feasible technique for treating large prostates . Functional results are similar to OP at the 2-yr follow-up . Reduced catheterisation , hospital stay , and blood loss make HoLEP an attractive option for the treatment of large prostates OBJECTIVES To compare the effectiveness and the safety of photoselective vaporization of the prostate ( PVP ) to open prostatectomy ( OP ) for the surgical treatment of large prostatic adenomas . METHODS A total of 125 patients with prostate gl and s > 80ml were r and omly allocated to PVP ( n=65 ) or OP ( n=60 ) and prospect ively evaluated at 1 , 3 , 6 , and 12 mo postoperatively . International Prostate Symptom Score ( IPSS ) and peak urinary flow rate ( Q(max ) ) were chosen as primary treatment-related end points . RESULTS The patients who underwent PVP experienced a longer length of operation time , shorter time of catheterization , and shorter hospital stay . Adverse events were minor and of similar profiles in both groups , although patients who underwent OP showed a higher transfusion rate . All functional parameters improved significantly compared to baseline values in both groups . The IPSS did not differ between the two groups at 3 , 6 , and 12 mo postoperatively . Patients who underwent OP scored better in the IPSS quality of life score at 6 and 12 mo postoperatively . No significant differences between the two groups in the Q(max ) , postvoid residual urine volume , and International Index for Erectile Function-5 question naire were detected . At 3 mo prostate volume was significantly lower in the OP group compared to the PVP group ( median value 10ml vs. 50ml ; p<0.001 ) and remained as such throughout follow-up , whereas prostate-specific antigen values reached statistical difference at 6 mo ( median value 2ng/ml vs. 2.4ng/ml ; p=0.028 ) . CONCLUSIONS Our results indicate that for a 12-mo period PVP is a highly acceptable treatment alternative to OP OBJECTIVE To perform a prospect i ve , r and omized , long-term comparison between bipolar plasma vaporization of the prostate ( BPVP ) , bipolar transurethral resection in saline ( TURis ) , and monopolar transurethral resection of the prostate ( TURP ) concerning the perioperative and follow-up parameters . METHODS A total of 510 patients with benign prostatic hyperplasia ( BPH ) , Q(max ) < 10 mL/s , International Prostate Symptom Score ( IPSS ) > 19 , and prostate volume between 30 and 80 mL were enrolled in the trial . All cases were evaluated preoperatively and at 1 , 3 , 6 , 12 , and 18 months after surgery by IPSS , quality of life , Q(max ) , and ultrasonography . RESULT Each study arm including 170 cases emphasized similar preoperative parameters . The capsular perforation and intraoperative bleeding rates as well as the mean hemoglobin drop were significantly decreased for BPVP by comparison with TURis and TURP . The postoperative hematuria , blood transfusion , and clot retention rates were significantly higher in the TURP group . The operation time was significantly shorter only for BPVP patients , whereas the catheterization period and hospital stay were significantly reduced for BPVP , followed by TURis . The rates of irritative symptoms and urethral strictures were similar in the 3 series . The recatheterization , bladder neck sclerosis , and retreatment rates were significantly lower in the BPVP group . During the 1 , 3 , 6 , 12 , and 18 months ' follow-up , the BPVP series emphasized significantly superior parameters in terms of IPSS and Q(max ) . CONCLUSION BPVP represents a valuable end
Output:
| No significant difference was found in terms of short-term efficacy between bipolar transurethral resection of the prostate ( B-TURP ) and monopolar transurethral resection of the prostate ( M-TURP ) .
However , B-TURP was associated with a lower rate of perioperative complications .
Better short-term efficacy outcomes , fewer immediate complications , and a shorter hospital stay were found after holmium laser enucleation of the prostate ( HoLEP ) compared with M-TURP .
Compared with M-TURP , GreenLight photoselective vaporization of the prostate ( PVP ) was associated with a shorter hospital stay and fewer complications but no different short-term efficacy outcomes .
This meta- analysis shows that HoLEP is associated with more favorable outcomes than M-TURP in published RCTs .
B-TURP and PVP have result ed in better perioperative outcomes without significant differences regarding efficacy parameters after short-term follow-up compared with M-TURP .
PATIENT SUMMARY Bipolar transurethral resection of the prostate , photovaporization of the prostate , and holmium laser enucleation of the prostate have shown efficacy outcomes comparable with conventional techniques yet reduce the complication rate . |
MS212645 | ***TASK*** the task is to summarize an input biomedical literature 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 double-blind , parallel trial of 40 patients with chronic shoulder pain was carried out to compare alleviation of pain and improvement in mobility after treatment with 20 mg piroxicam each morning or 250 mg naproxen twice daily . During the 3-week study , patients also underwent conservative treatment of therapeutic exercise . Piroxicam was better than naproxen at relieving pain at night , but time , rather than a drug effect , seemed responsible for the improvement in shoulder abduction . No difference between the drugs was demonstrated regarding their effect on pain on active movement of the shoulder and external rotation Objectives : To evaluate the short-term symptomatic efficacy of rofecoxib and diclofenac versus placebo in acute episodes of shoulder pain . Design : R and omized controlled trial of 7 days . Setting : Rheumatologists and /or general practitioners totaling 47 . Participants : Acute shoulder pain . Interventions : Rofecoxib 50 mg once daily , diclofenac 50 mg three times daily , and placebo . Outcome measures : Pain , functional impairment , patient 's global assessment of his/her disease activity , and local steroid injection requirement for persistent pain . The primary variable was the Kaplan-Meier estimates of the percentage of patients at day 7 fulfilling the definition of success ( improvement in pain intensity and a low pain level sustained to the end of the 7 days of the study ; log-rank test ) . Results : There was no difference in the baseline characteristics between the three groups ( rofecoxib n = 88 , placebo n = 94 , and diclofenac n = 89 ) . At day 7 , the Kaplan-Meier estimates of successful patients was higher in the treatment groups than in the placebo ( 54 % , 56 % , and 38 % in the diclofenac , rofecoxib , and placebo groups respectively , p = 0.0070 and p = 0.0239 for placebo versus rofecoxib and diclofenac , respectively ) . During the 7 days of the study , there was a statistically significant difference between placebo and both active arms ( rofecoxib and diclofenac ) in all the evaluated outcome measures A local steroid injection had to be performed in 33 ( 35 % ) and 19 ( 22 % ) patients in the placebo and rofecoxib group respectively . Number needed to treat to avoid such rescue therapy was 7 patients ( 95 % confidence interval 5–15 ) . Conclusion : This study highlights the method ological aspects of clinical trials , e.g. , eligibility criteria and outcome measures , in acute painful conditions . The data also establish that diclofenac and rofecoxib are effective therapies for the management of acute painful shoulder and that they reduce the requirement for local steroid injection OBJECTIVE Shoulder tendinitis and subacromial bursitis are acute , painful inflammatory musculoskeletal conditions that may recur as a result of overuse . We investigated the efficacy of celecoxib in managing patients with acute shoulder tendinitis/bursitis . METHODS In this double blind , placebo controlled , parallel group study , patients with acute onset shoulder tendinitis and /or subacromial bursitis were r and omized to receive one of : celecoxib 400 mg followed by 200 mg bid , naproxen 500 mg bid , or placebo bid for 14 days . The primary measure of efficacy was the mean reduction in Maximum Pain Intensity at Rest , measured using a 100 mm visual analog scale , from baseline to Days 7 and 14 . RESULTS Of the 306 patients r and omized to treatment , 254 completed the study . On Day 7 , the mean reduction from baseline in Maximum Pain Intensity at Rest was significantly greater in the celecoxib group compared with the placebo group ( -27.7 + /- 2.75 mm vs -18.4 + /- 2.63 mm , respectively ; p < 0.05 ) . Similarly , on Day 14 , the mean reduction from baseline in Maximum Pain Intensity at Rest was greater in the celecoxib group compared with placebo ( -35.0 + /- 3.06 mm vs -25.0 + /- 3.05 mm ; p < 0.05 ) . The mean reduction from baseline in Maximum Pain Intensity at Rest was also greater in the naproxen group compared with the placebo group at Day 7 ( -26.4 + /- 2.70 mm vs -18.4 + /- 2.63 mm ; p < 0.05 ) , but not on Day 14 . Secondary measures of efficacy also showed treatment with celecoxib to be significantly better than placebo treatment and similar to treatment with naproxen . In addition , celecoxib was well tolerated in these patients . CONCLUSION Celecoxib showed comparable efficacy to naproxen in relieving the pain of patients with acute shoulder tendinitis and /or subacromial bursitis Using a prospect i ve , double blind , double dummy protocol , we compared the efficacy of subacromial injection of 40 mg of triamcinalone acetonide versus oral indomethacin , 100 mg/day , in 40 patients with acute rotator cuff tendinitis . Repeat injection and refill of medication was given after 3 weeks , if necessary . At 6 weeks , there was no significant difference between the 2 groups with respect to the percentage of patients who improved ( 60 vs 66 % ) or the magnitude of the change of pain and motion variables . This study suggests that there is essentially no difference in the short term efficacy of oral nonsteroidal therapy compared to local corticosteroid injection(s ) in the treatment of rotator cuff tendinitis Background Tendon injuries that occur at the osteotendinous junction are commonly seen in clinical practice and range from acute strain to rupture . Nonsteroidal anti-inflammatory drugs are often prescribed in the treatment of these conditions , but the effect that these agents may have on the healing response at the bone-tendon junction is unclear . Hypothesis In response to an acute injury at the osteotendinous junction , the healing patellar tendon will have inferior biomechanical properties with administration of anti-inflammatory drugs as compared with acetaminophen and control . Study Design Controlled laboratory study . Methods A total of 215 Sprague-Dawley rats underwent transection of the patellar tendon at the inferior pole of the patella , which was subsequently stabilized with a cerclage suture . The animals were then r and omized into 7 groups and administered 1 of the following analgesics for 14 days ibuprofen , acetaminophen , naproxen , piroxicam , celecoxib , valdecoxib , or control . At 14 days , all animals were sacrificed , and the extensor mechanism was isolated and loaded to failure . Biochemical analysis of the repair site tissue was performed . Animal activity throughout the study was monitored using a photoelectric sensor system . Results The control group demonstrated greater maximum load compared with the celecoxib , valdecoxib , and piroxicam groups ( P < .05 ) . The acetaminophen and ibuprofen groups were also significantly stronger than the celecoxib group ( P < .05 ) but not statistically different than the control group . A total of 23 specimens had failure of the cerclage suture with the following distribution control ( 0/23 ) , ibuprofen ( 0/23 ) , acetaminophen ( 0/24 ) , naproxen ( 3/24 ) , piroxicam ( 4/24 ) , celecoxib ( 6/22 ) , and valdecoxib ( 10/24 ) . The difference in distribution of the failures was significant ( P < .001 ) . Conclusions Anti-inflammatory drugs , with the exception of ibuprofen , had a detrimental effect on healing strength at the bone-tendon junction as demonstrated by decreased failure loads and increased failures of the cerclage suture . Acetaminophen had no effect on healing strength . The biomechanical properties paralleled closely with the total collagen content at the injury site , suggesting that these agents may alter healing strength by decreasing collagen content . Clinical Relevance Selective and nonselective cyclooxygenase ( COX ) inhibitors should be used judiciously in the acute period after injury or surgical repair at the bone-tendon junction This study compared the analgesic efficacy and safety of the cyclo-oxygenase-2 specific inhibitor celecoxib with the non-specific non-steroidal anti-inflammatory drug , naproxen , in patients with acute shoulder pain . Adult patients with shoulder pain , onset within the previous 14 days and shoulder pain of ≥ 40 mm on a 100 mm visual analogue scale ( VAS ) , were treated with oral doses of celecoxib or naproxen for 14 days and followed by a visit at day 42 in a double-blind , r and omized study . The primary efficacy assessment was change in maximum pain at rest on a 100 mm VAS at day 14 compared with baseline . In addition , secondary efficacy pain and functional assessment s were analysed at baseline , day 14 and day 42 . A total of 202 patients were included in the trial ( 99 celecoxib 400 mg/day ; 103 naproxen 1 g/day ) . The difference in change from baseline at day 14 in maximum pain at rest was not statistically significant between the two treatment groups , but was numerically higher for celecoxib than for naproxen ( −47.9 ± 2.5 versus −42.3 ± 2.5 , respectively ) . According to the limits of the 95 % confidence interval of the difference between groups ( −12.52 ; 1.38 ) , celecoxib appeared to be at least as effective as naproxen . All secondary efficacy measures followed the same pattern , showing similarity between the two treatments with a trend in favour of celecoxib . The incidences of adverse events were similar for both groups . Fewer patients experienced epigastric pain with celecoxib ( seven patients versus 14 with naproxen ) . This adverse event led to discontinuation in two patients receiving celecoxib and five receiving naproxen . Celecoxib 400 mg/day was at least as effective as naproxen 1 g/day in managing pain in this condition 30 patients with supraspinatus or bicipital tendonitis were r and omly allocated to active infrared laser therapy at 904 nm three times weekly for 2 weeks , dummy laser or drug treatment for 2 weeks . Objective ly maximum active extension , flexion and abduction of the shoulder , and subjectively pain stiffness movement and function were measured at 0 and 2 weeks . Significant improvement of active over dummy laser was noted for all seven assessment s. Active laser therapy produced significant improvement over drug therapy for all three objective measures and pain . Naproxen sodium significantly improved only movement and function compared to dummy laser . These results demonstrate the effectiveness of laser therapy in tendonitis of the shoulder Summary This was a double-blind study design ed to compare the efficacy and tolerability of diclofenac/misoprostol and diclofenac in patients with acute tendinitis/bursitis of the shoulder . Diclofenac 50mg/misoprostol 200μg ( n=185 ) or diclofenac 50 mg ( n=187 ) was administered twice or 3 times daily for 14 days . Various physician ’s and patient ’s assessment s performed during and at the end of treatment showed similar improvements with both treatments . Abdominal pain , nausea and vomiting occurred somewhat more frequently with diclofenac/misoprostol , but patient withdrawals due to adverse events did not differ markedly between the groups . Thus , in the short term treatment of acute tendinitis/bursitis of the shoulder diclofenac/misoprostol possesses efficacy similar to that with diclofenac alone and provides the gastroprotective benefit of misoprostol . Previous studies in Osteoarthritis and rheumatoid arthritis have established diclofenac/misoprostol to be as effective as diclofenac but with significantly less gastrointestinal damage ( Verdickt et al. 1992 The effect of triamcinolone subacromial bursa injection versus naproxen therapy was compared in a r and omized , double-blind , placebo-controlled study of 100 patients who had painful shoulders . Outcome was compared using degree of active abduction , pain , limitation of function , and a clinical index that combined equally weighted measures of all of these . In a time-adjusted analysis , triamcinolone was superior to placebo in all clinical variables . Naproxen was superior to placebo in all variables except pain . Triamcinolone was superior to naproxen in the relief of pain ( P = 0.04 ) and the clinical index ( P = 0.04 ) . Multiple linear regression analysis showed that naproxen and triamcinolone treatment accounted for only 16 % of the variation in outcome , compared with 44 % accounted for by the clinical index prior to treatment . Thus , patients with a poor pretreatment clinical index ( those with the most room for improvement ) were least likely to improve . We conclude that both triamcinolone ( P = 0.00005 ) and naproxen ( P = 0.02 ) are superior to placebo in the treatment of the painful shoulder Summary In order to compare the efficacy and tolerance of two drug formulations of ibuuprofen , conventional tablets 600 mg QID ( CI ) and sustained-release tablets 1200 mg BID ( SRI ) , a total of 147 patients in 7 centres in Denmark with nontraumatic shoulder pain were included in a double-blind dummy study . Initially
Output:
| Low to moderate grade evidence exists regarding the efficacy of non-steroidal anti-inflammatory drugs for rotator cuff tendinopathy .
Oral anti-inflammatory drugs are effective in reducing short-term pain but not function .
In terms of pain and function , oral anti-inflammatory drugs in the short term are as effective as corticosteroid injections |
MS212646 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Context As life expectancy improves among Human Immunodeficiency Virus ( HIV ) patients , renal and cardiovascular diseases are increasingly prevalent in this population . Renal and cardiovascular disease are mutual risk factors and are characterized by albuminuria . Underst and ing the interactions between HIV , cardiovascular risk factors and renal disease is the first step in tackling this new therapeutic frontier in HIV . Methods In a rural primary health care centre , 903 HIV-infected adult patients were r and omly selected and data on HIV-infection and cardiovascular risk factors were collected . Glomerular filtration rate ( eGFR ) was estimated . Albuminuria was defined as an Albumin-Creatinine-Ratio above 30 mg/g . Multivariate logistic regression analysis was used to analyse albuminuria and demographic , clinical and HIV-associated variables . Results The study population consisted of 903 HIV-infected patients , with a median age of 40 years ( Inter-Quartile Range ( IQR ) 34–48 years ) , and included 625 ( 69 % ) women . The median duration since HIV diagnosis was 26 months ( IQR 12–58 months ) and 787 ( 87 % ) received antiretroviral therapy . Thirty-six ( 4 % ) of the subjects were shown to have diabetes and 205 ( 23 % ) hypertension . In the cohort , 21 % had albuminuria and 2 % an eGFR < 60 mL/min/1.73m2 . Albuminuria was associated with hypertension ( adjusted odds ratio ( aOR ) 1.59 ; 95 % confidence interval ( CI ) 1.05–2.41 ; p<0.05 ) , total cholesterol ( aOR 1.31 ; 95 % CI 1.11–1.54 ; p<0.05 ) , eGFR ( aOR 0.98 ; 95 % CI 0.97–0.99 ; p<0.001 ) and detectable viral load ( aOR 2.74 ; 95 % CI 1.56–4.79 ; p<0.001 ) . Hypertension was undertreated : 78 % were not receiving treatment , while another 11 % were inadequately treated . No patients were receiving lipid-lowering medication . Conclusion Glomerular filtration rate was well conserved , while albuminuria was common amongst HIV-infected patients in rural South Africa . Both cardiovascular and HIV-specific variables were associated with albuminuria . Improved cardiovascular risk prevention as well as adequate virus suppression might be the key to escape the vicious circle of renal failure and cardiovascular disease and improve the long-term prognosis of HIV-infected patients Aim : To identify whether the more recently developed equation for estimated glomerular filtration rate ( eGFR ) [ Chronic Kidney Disease Epidemiology Collaboration ( CKD-EPI ) ] is more closely associated with end-organ changes than previous equations in a group of black African descent . Methods : In 1221 r and omly recruited participants of black African ancestry in South Africa , we evaluated serum creatinine concentrations , echocardiographic left ventricular mass index ( n = 833 ) , carotid-femoral ( aortic ) pulse wave velocity ( PWV ) ( n = 1053 ) and carotid intima – media thickness ( n = 633 ) . We calculated eGFR from the Jelliffe , five Cockcroft – Gault , Salazar – Corcoran , Modification of Diet in Renal Disease ( MDRD ) and CKD-EPI equations . Results : After multivariate adjustments , eGFR calculated from all formulae was inversely associated with left ventricular mass index ( P < 0.0001 ) and PWV ( P < 0.05 to < 0.001 ) , but not with carotid intima – media thickness ( P > 0.08 ) . However , although eGFR determined from all equations except Cockcroft – Gault lean body weight or adjusted body weight was independently associated with left ventricular hypertrophy ( n = 390 of 833 ) , CKD-EPI-derived eGFR , but not eGFR determined from alternative equations , was independently associated with an increased PWV ( n = 88 of 1053 ) . eGFR derived from the CKD-EPI and MDRD equations showed a better performance ( area under the receiver operator characteristic curve ) for the detection of left ventricular hypertrophy ( P < 0.0005 ) than eGFR determined from alternative equations . Conclusions : In black Africans , eGFR derived from the CKD-EPI equation is better at detecting end-organ measures than eGFR derived from either the MDRD or alternative equations . To enhance risk prediction in black African communities , eGFR calculated from the CKD-EPI equation may be preferred to other equations Background and Objectives There have been few large population -based studies of the association between rheumatoid arthritis ( RA ) and chronic kidney disease ( CKD ) and glomerulonephritis . This nationwide cohort study investigated the risks of developing CKD and glomerulonephritis in patients with RA , and the associated risks for cardiovascular complications . Methods From the Taiwan National Health Insurance Research Data base , we identified a study cohort of 12,579 patients with RA and r and omly selected 37,737 subjects without RA as a control cohort . Each subject was individually followed for up for 5 years , and the risk of CKD was analyzed using Cox proportional hazards regression models . Results During the follow-up period , after adjusting for traditional cardiovascular risk factors RA was independently associated with a significantly increased risk of CKD ( adjusted hazard ratio [ aHR ] 1.31 ; 95 % confidence interval [ CI ] 1.23–1.40 ) and glomerulonephritis ( aHR 1.55 ; 95 % CI 1.37–1.76 ) . Increased risk of CKD was also associated with the use of non-steroidal anti-inflammatory drugs , cyclosporine , glucocorticoids , mycophenolate mofetil , and cyclophosphamide . Patients with comorbidities had even greater increased risk of CKD . Moreover , RA patients with concurrent CKD had significantly higher likelihood of developing ischemic heart disease and stroke . Conclusions RA patients had higher risk of developing CKD and glomerulonephritis , independent of traditional cardiovascular risk factors . Their increased risk of CKD may be attributed to glomerulonephritis , chronic inflammation , comorbidities , and renal toxicity of antirheumatic drugs . Careful monitoring of renal function in RA patients and tight control of their comorbid diseases and cardiovascular risk factors are warranted Background In the United States , HIV-related kidney disease disproportionately affects individuals of African descent ; however , there are few estimates of kidney disease prevalence in Africa . We evaluated the prevalence of kidney disease among HIV-infected and uninfected Rw and an women . Methods The Rw and an Women 's Interassociation Study and Assessment prospect ively enrolled 936 women . Associations with estimated glomerular filtration rate (eGFR)<60 mL/min/1.73 m2 and proteinuria were assessed in separate logistic regression models . Results Among 891 non-pregnant women with available data , 2.4 % had an eGFR<60 mL/min/1.73 m2 ( calculated by the Modification of Diet in Renal Disease equation , MDRD eGFR ) and 8.7 % had proteinuria ≥1 + . The prevalence of decreased eGFR varied markedly depending on the estimating method used , with the highest prevalence by Cockcroft-Gault . Regardless of the method used to estimate GFR , the proportion with decreased eGFR or proteinuria did not differ significantly between HIV-infected and -uninfected women in unadjusted analysis . After adjusting for age and blood pressure , HIV infection was associated with significantly higher odds of decreased MDRD eGFR but not proteinuria . Conclusion In a well-characterized cohort of Rw and an women , HIV infection was associated with decreased MDRD eGFR . The prevalence of decreased eGFR among HIV-infected women in our study was lower than that previously reported in African-Americans and in other Central and East African HIV population s , although there was substantial variability depending on the equation used to estimate GFR . Future studies are needed to optimize GFR estimates and to determine the impact of antiretroviral therapy on kidney disease in this population The objective is to investigate the accrual rate and risk factors of chronic kidney disease ( CKD ) in an inception cohort of patients with systemic lupus erythematosus ( SLE ) followed at a single tertiary center . A prospect ively collected data base of 256 consecutive patients with SLE followed over a 25-year period was systematic ally interrogated for demographic , disease manifestations , co-morbidities , and outcome . St and ardized SLE activity and damage scores were determined for the first and last study visits , and estimated glomerular filtration rate ( eGFR ; MDRD formula ) was calculated at the time of diagnosis and at each year of the follow-up . CKD was defined as eGFR < 60 ml/min/1.73 m2 . Results were analyzed with univariate and multivariate models and Kaplan-Meier curves , as appropriate . The cohort was predominantly female ( 90 % ) and Jewish ( 91.1 % ) . Mean age at diagnosis was 38 ± 15.5 years , mean SLE activity score 6.4 ± 3.8 , mean disease duration 8.8 ± 6.6 years , and mean damage score 0.2 ± 0.6 . Seventy-five patients ( 30.8 % ) were diagnosed with American College of Rheumatology (ACR)-defined lupus renal disease during the study period . There was a progressive decrease in eGFR over time . The prevalence of CKD was 46.7 % in patients with ACR-defined renal lupus disease and 16.4 % in those without . The hazards ratio for CKD was significantly higher in patients with lupus nephritis ( LN ) than without ( p < 0.001 ) . Earlier CKD was positively associated with hypertension ( p = 0.01 ) , older age at diagnosis ( p = 0.01 ) , and LN ( p < 0.001 ) , and negatively associated with hydroxychloroquine treatment ( p < 0.001 ) . The prevalence of CKD increases cumulatively in patients with SLE , also in those without overt lupus renal disease . Lupus renal disease poses a significant hazard for earlier development of CKD , and hypertension is a major risk factor for patients with and without nephritis . Antimalarial treatment is associated with renal preservation only in patients with lupus nephritis BACKGROUND We sought to investigate renal function in previously untreated symptomatic human immunodeficiency virus (HIV)-infected adults with CD4(+ ) cell counts of < 200 cells/mm(3 ) who were undergoing antiretroviral therapy ( ART ) in Africa . METHODS The study was an observational analysis within a r and omized trial of ART management strategies that included 3316 participants with baseline serum creatinine levels of < or = 360 micromol/L. Creatinine levels were measured before ART initiation , at weeks 4 and 12 of therapy , and every 12 weeks thereafter . We calculated estimated glomerular filtration rate ( eGFR ) using the Cockcroft-Gault formula . We analyzed the incidence of severely decreased eGFR ( < 30 mL/min/1.73 m(2 ) ) and changes in eGFR to 96 weeks , considering demographic data , type of ART , and baseline biochemical and hematological characteristics as predictors , using r and om-effects models . RESULTS Sixty-five percent of the participants were women . Median values at baseline were as follows : age , 37 years ; weight , 57 kg ; CD4(+ ) cell count , 86 cells/mm(3 ) ; and eGFR , 89 mL/min/1.73 m(2 ) . Of the participants , 1492 ( 45 % ) had mild ( > or = 60 but < 90 mL/min/1.73 m(2 ) ) and 237 ( 7 % ) had moderate ( > or = 30 but < 60 mL/min/1.73 m(2 ) ) impairments in eGFR . First-line ART regimens included zidovudine-lamivudine plus tenofovir disoproxil fumarate ( for 74 % of patients ) , nevirapine ( 16 % ) , and abacavir ( 9 % ) ( mostly nonr and omized allocation ) . After ART initiation , the median eGFR was 89 - 91 mL/min/1.73 m(2 ) for the period from week 4 through week 96 . Fifty-two participants ( 1.6 % ) developed severe reductions in eGFR by week 96 ; there was no statistically significant difference between these patients and others with respect to first-line ART regimen received ( P = .94 ) . Lower baseline eGFR or hemoglobin level , lower body mass index , younger age , higher baseline CD4(+ ) cell count , and female sex were associated with greater increases in eGFR over baseline , with small but statistically significant differences between regimens ( P <
Output:
| Conclusion In Africa , CKD is a public health problem , mainly attributed to high-risk conditions as hypertension and diabetes . |
MS212647 | ***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: Summary The FREEDOM study and its Extension provide long-term information about the effects of denosumab for the treatment of postmenopausal osteoporosis . Treatment for up to 8 years was associated with persistent reduction of bone turnover , continued increases in bone mineral density , low fracture incidence , and a favorable benefit/risk profile . Introduction This study aims to report the results through year 5 of the FREEDOM Extension study , representing up to 8 years of continued denosumab treatment in postmenopausal women with osteoporosis . Methods Women who completed the 3-year FREEDOM study were eligible to enter the 7-year open-label FREEDOM Extension in which all participants are scheduled to receive denosumab , since placebo assignment was discontinued for ethical reasons . A total of 4550 women enrolled in the Extension ( 2343 long-term ; 2207 cross-over ) . In this analysis , women in the long-term and cross-over groups received denosumab for up to 8 and 5 years , respectively . Results Throughout the Extension , sustained reduction of bone turnover markers ( BTMs ) was observed in both groups . In the long-term group , mean bone mineral density ( BMD ) continued to increase significantly at each time point measured , for cumulative 8-year gains of 18.4 and 8.3 % at the lumbar spine and total hip , respectively . In the cross-over group , mean BMD increased significantly from the Extension baseline for 5-year cumulative gains of 13.1 and 6.2 % at the lumbar spine and total hip , respectively . The yearly incidence of new vertebral and nonvertebral fractures remained low in both groups . The incidence of adverse and serious adverse events did not increase over time . Through Extension year 5 , eight events of osteonecrosis of the jaw and two events of atypical femoral fracture were confirmed . Conclusions Denosumab treatment for up to 8 years was associated with persistent reductions of BTMs , continued BMD gains , low fracture incidence , and a consistent safety profile Study Design . Retrospective case-control study . Objective . To determine the association of Hounsfield unit ( HU ) measurements with adjacent segment fractures after spinal fusion . Summary of Background Data . Adjacent segment fracture is a potentially devastating complication after spinal fusion surgery in osteoporotic patient . Recently , a technique for assessing bone mineral density using HU measurements from computed tomography was described and correlated with both dual-energy x-ray absorptiometry – assessed bone mineral density and compressive strength in an osseous model . Methods . Patients with adjacent segment fractures after spinal fusion were identified from a prospect ively collected patient data base and matched 1:1 with nonfracture controls on the basis of age , sex , and fusion construct . Minimum follow-up was 6 months . Patients with metabolic bone disease other than osteoporosis or those taking medications known to negatively alter bone strength were excluded . HU assessment was done according to the previously published protocol using the preoperative computed tomography . Results . Twenty patients had complete imaging data and could be matched to nonfracture controls . The groups were well matched with respect to age , sex , body mass index , and number of levels fused . Following the index surgical procedure , the fracture group had more positive sagittal balance than the control group ( 10.7 cm vs. 9.1 cm ) . Analysis of HU values at the fracture level showed a significantly lower value in the fracture group than in the controls ( 145.6 vs. 199.4 , P = 0.006 ) . Similarly , global assessment of HU across the thoracic and lumbar spines was significantly lower in the fracture group ( 139.9 vs. 170.1 , P = 0.032 ) . Conclusion . HU was significantly lower both locally and globally in the fracture cohort . Because computed tomographic scans are frequently part of preoperative planning for spinal fusion , this information should be incorporated in preoperative planning . Studies to prospect ively vali date HU as a predictor of adjacent segment fracture risk and to assess the effect of increasing HU preoperatively with medications for osteoporosis are needed . Level of Evidence : Osteoporosis is a major global health problem , with over 10 million people currently diagnosed with the disease . Although 80 % of osteoporotic patients are women , a considerable number of men are also affected . Also , due to increasing life expectancy , the number of elderly patients with osteoporosis affected by degenerative and traumatic spinal diseases will increase further . Osteoporosis reduces bone quality through negative bone remodelling . Low bone quality can reduce the pull-out strength of pedicle screw , and negative bone remodelling can cause delayed bone fusion . However , pedicle screw instrumentation of the osteoporotic spine carries an increased risk of screw loosening , pull-out , and fixation failure . Our preliminary study aims to investigate the efficiency of exp and able pedicle screws ( OsseoScrew-Spinal Fixation System , Alphatec Spine Inc. , Carlsbad , CA ) in osteoporotic spinal patients . All osteoporotic patients with degenerative and traumatic spinal diseases admitted in our department underwent a pre-operative spinal x-Ray and MRI or CT . Pre-operative clinical assesment of patients was based on the visual analog scale ( VAS ) and Owestry Disability ( ODI ) question naire-a disease-specific outcome measure . Ten osteoporotic patients were treated with exp and able pedicle screws ( OsseoScrew ) . Post-operative clinical assessment of patients was based on the VAS and ODI question naire at 3 months and 1 year of follow-up . Post-operative radiologic follow-up was performed after 3 days ( CT , x-ray ) ; 3 months ( x-ray ) ; 6 months ( spinal CT ) ; and 1 year ( spinal CT ) . Exp and able pedicle screws improved pull-out strength as compared to st and ard pedicle screws in osteoporotic patients with degenerative and traumatic spinal diseases Purpose The LLIF procedure is a useful st and -alone and adjunct surgical approach for many spinal conditions . One complication of LLIF is subsidence of the interbody graft into the vertebral bodies , result ing in severe pain , impaired arthrodesis and potentially fracture of the body . Low bone density , as measured by T score on DEXA scanning , has also been postulated to increase the risk of subsidence . Methods A retrospective review of prospect ively collected data was performed on all patients who underwent LLIF at this institution consisting of 712 levels in 335 patients . Patients with subsidence following LLIF were recorded . We utilized the T score obtained from the femoral neck DEXA scans , which is used to determine overall fracture risk . The T score of patients with subsidence was compared to those without subsidence . Results 20 of 57 ( 35 % ) patients without subsidence had a DEXA T score between −1.0 and −2.4 consistent osteopenia , one patient ( 1.8 % ) exhibited a T score less than −2.5 , consistent with osteoporosis . 13 patients of 23 ( 57 % ) with subsidence exhibited a T score between −1.0 and −2.4 , consistent with osteopenia , five ( 22 % ) exhibited a T score of −2.5 or less , consistent with osteoporosis . The mean DEXA T score in patients with subsidence was −1.65 ( SD 1.04 ) compared to −0.45 ( SD 0.97 ) in patients without subsidence ( p < 0.01 ) . The area under the receiver operating characteristic curve for patients with a T score of −1.0 or less was 80.1 % . Conclusions Patients with DEXA T scores less than −1.0 who undergo st and -alone LLIF are at a much higher risk of developing graft subsidence . Further , they are at an increased risk of requiring additional surgery . In patients with poor bone quality , consideration could be made to supplement the LLIF cage with posterior instrumentation Study Design . Prospect i ve trial . Objective . To examine the clinical efficacy of teriparatide for bone union after instrumented lumbar posterolateral fusion using local bone grafting in women with postmenopausal osteoporosis . Summary of Background Data . Intermittent parathyroid hormone ( PTH ) treatment increases bone mass and reduces the risk for osteoporotic vertebral fractures . Recombinant human PTH ( 1–34 ) has already been approved as a treatment for severe osteoporosis . Pre clinical data support the efficacy of PTH for lumbar spinal fusion . However , clinical results of PTH for spinal fusion have not yet been reported . Methods . Fifty-seven women with osteoporosis diagnosed with degenerative spondylolisthesis were divided into 2 treatment groups , a teriparatide group ( n = 29 ; daily subcutaneous injection of 20 & mgr;g of teriparatide ) and a bisphosphonate group ( n = 28 ; weekly oral administration of 17.5 mg of risedronate ) . All patients underwent decompression and 1- or 2-level instrumented posterolateral fusion with a local bone graft . Fusion rate , duration of bone union , and pain scores were evaluated 1 year after surgery . Results . Pain scores improved after surgery ; however , no significant difference was noted between the groups after surgery . The rate of bone union was 82 % in the teriparatide group and 68 % in the bisphosphonate group . Average duration of bone union was 8 months in the teriparatide group and 10 months in the bisphosphonate group . The rate of bone union and average of duration of bone union in the teriparatide group patients were significantly superior to those in the bisphosphonate group . Conclusion . Daily subcutaneous injection of teriparatide for bone union using local bone grafting after instrumented lumbar posterolateral fusion in women with postmenopausal osteoporosis was more effective than oral administration of bisphosphonate Type of study A 2 to 4-year clinical and radiologic prospect i ve study was conducted for 39 patients over the age of 65 treated by lumbar arthrodesis . Objectives Evaluate the quality of lumbar arthrodesis results in elderly patients , in which the bone osteoporosis ( poor quality of the spine 's anatomic components ) and general factors ( frequent comorbidity ) are likely to make this surgery difficult if not dangerous and evaluate a dedicated instrumentation for osteoporotic bone . Material s and Methods Thirty-nine patients over 65 years of age ( average 73 y ) underwent arthrodesis surgery in 2001 and 2002 and were followed for at least 2 years . The instrumentation used ( Equation , Medtronic , Memphis , USA ) was selected for its mechanical properties adapted for bone of poor mechanical quality . The clinical analysis was based on Oswestry , Visual Analog Scale , and Japanese Orthopaedic Association scores . Radiologic results were evaluated on st and ard anteroposterior , lateral , and 3/4 radiographs , and computed tomography scans if necessary . Results All the patients were followed for 2 to 4 years . Clinical analysis confirmed a very satisfactory progression of the clinical parameters such as lumbar and radicular pain , and the results were maintained between the first and second years and at last follow-up . No serious general complication or need for reoperation was seen in this series . On x-rays , 35 grafts appear to have fused . The anchors did not come out nor did the instrumentation come apart . On the other h and , 2-year radiographs revealed that 2 screws and 2 rods had failed , but this did not affect correction in the 4 completely asymptomatic patients . These 4 cases are considered stable at last follow-up . Conclusions Arthrodesis for elderly patients will undoubtedly increase in the coming years . The conditions for this surgery are different than those for younger patients and it is desirable to try to provide reliable surgical techniques and solutions regarding options for instrumentation and overall perioperative care for these fragile patients . Dedicated instrumentation for osteoporotic bone seems to allow good clinical outcomes BACKGROUND CONTEXT Pedicle screw fixation in osteoporotic bone and in revision of previous pedicle screw fixation cases presents a significant challenge to spine surgeons . Biomechanical tests have shown that a pedicle screw that exp and s within the vertebrae body can substantially improve fixation in the presence of compromised bone . PURPOSE To review the clinical and radiographic results with the use of exp and able pedicle screws . STUDY DESIGN One hundred forty-five patients received one or more exp and able pedicle screws from the Omega21 spinal fixation system ( EBI , L.P. , Parsippany , NJ ) to obtain thorocolumbar or lumbosacral stabilization . PATIENT SAMPLE The indications for use of the exp and able screws were osteoporosis ( 21 cases ) , reoperation of previous pedicle instrumentation ( 27 cases ) , intraoperative screw relocation ( 17 cases ) , construct reinforcement ( 23 cases ) , and sacral anchoring to avoid the necessity of anterior penetration of the sacral cortex ( 57 cases ) . OUTCOME MEASURES The presence of radiographic fusion and complications arising from the instrumentation were review ed at a mean follow-up period of 35 months ( range , 24 - 72 months ) . METHODS A retrospective clinical and radiographic review was performed . Fusion was evaluated based on anterior-posterior and lateral radiographs as well as dynamic radiographs in flexion and extension . RESULTS Radiographic evidence of fusion was obtained in 125 of the 145 cases ( 86 % ) . Eighty-six
Output:
| The strongest evidence was for perioperative teriparatide .
Conclusion : There are 15 articles evaluating osteoporosis in patients undergoing lumbar fusion and the highest level of evidence is for perioperative use of teriparatide |
MS212648 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To examine the 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 The efficacy and safety of darbepoetin alpha ( DA ) for treating patients with active cancer and anemia not receiving or planning to receive cytotoxic chemotherapy or myelosuppressive radiotherapy was evaluated . PATIENTS AND METHODS Patients with active cancer and anemia not receiving or planning to receive chemotherapy or radiotherapy were enrolled onto a phase III , multicenter , r and omized , placebo-controlled study and administered placebo or DA 6.75 microg/kg every 4 weeks ( Q4W ) for up to 16 weeks with a 2-year follow-up for survival . Patients who completed 16 weeks of treatment could receive the same treatment as r and omized Q4W for an additional 16 weeks . The primary end point was all occurrences of transfusions from weeks 5 through 17 ; safety end points included incidence of adverse events and survival . RESULTS The incidence of transfusions between weeks 5 and 17 was lower in the DA group but was not statistically significantly different from that of placebo . DA was associated with an increased incidence of cardiovascular and thromboembolic events and more deaths during the initial 16-week treatment period . Long-term survival data demonstrated statistically significantly poorer survival in patients treated with DA versus placebo ( P = .022 ) . This effect varied by baseline covariates including , sex , tumor type , and geographic region ; statistical significance diminished ( P = .12 ) when the analysis was adjusted for baseline imbalances or known prognostic factors . CONCLUSION DA was not associated with a statistically significant reduction in transfusions . Shorter survival was observed in the DA arm ; thus , this study does not support the use of erythropoiesis-stimulating agents in this subset of patients with anemia of cancer 6007 Background : The study aim ed to evaluate if correction of low hemoglobin ( Hb ) levels by means of the erythropoietin stimulating agent : darbepoetin alpha ( Aranesp ) during radiotherapy ( RT ) improves outcome in patients with HNSCC . Following a planned interim analysis which showed inferiority of the experimental treatment , the trial was stopped in November 2006 . METHODS Pts with HNSCC eligible for primary RT alone and with Hb values below 14.0 g/dl were r and omized to receive Aranesp together with accelerated fractionated RT . Pts . were stratified according to gender , T and N staging , tumor site , and institution . Aranesp was given subcutaneously in a dose of 150 micrograms weekly during RT , or stopped earlier if the Hb exceeded 15.5 g/dl . RESULTS In total , 522 patients ( of a planned intake of 600 ) were included at the time of the interim analysis . Of these 514 pts were eligible for analysis ( 255 pts treated with Aranesp and 259 pts in the control group ) with a median follow up of 49 months . Among these , 201 developed a loco-regional failure ( primary endpoint ) . There have been 238 deaths of which 176 are due to HNSCC . The patients were evenly distributed according to the stratification parameters ( gender , T and N staging , tumor site , institution).Aranesp result ed in the expected increase in Hb in more than 81 % of the patients . The compliance to Aranesp was good with no significant difference in serious ( cardiovascular ) adverse events ( 3 % vs. 1 % ) . Overall , the results showed a poorer outcome in 5-year loco-regional control ( 59 % vs. 68 % ( p = 0.04 , RR : 1.47 [ 1.14 - 1.94 ] ) for the Aranesp vs. control arm . This was also seen for the endpoint of disease-free survival ( 37 % vs. 47 % , p = 0.02 , RR : 1.32 [ 1.04 - 1.68 ] ) , whereas there was no significant difference in overall survival ( 40 % vs. 51 % , p = 0.16 , RR : 1.20 [ 0.93 - 1.55 ] ) . There were no differences in radiation related morbidity . All univariate analyses were confirmed in a multivariate setting . CONCLUSIONS Correction of the Hb level with Aranesp in patients with HNSCC result ed in a significantly poorer tumor control after radiotherapy . The treatment principle was ab and oned and the difference in outcome is being subjected to further examination . No significant financial relationships to disclose BACKGROUND Anemia is common in cancer and has been associated with fatigue and reduced health-related quality of life ( HRQOL ) . We report the association between hemoglobin and fatigue and the impact of reducing fatigue on several domains of HRQOL . PATIENTS AND METHODS These analyses were based on five r and omized trials . Patients completed the Functional Assessment of Cancer Therapy ( FACT ) Anemia scales and numeric rating scales of Energy , Activity and Overall Health at baseline and after the 12-week treatment period . t-tests and linear regression models were used to evaluate associations . Analyses were stratified into three groups : solid tumor chemotherapy patients , lymphoproliferative malignancy chemotherapy patients and non-chemotherapy patients . RESULTS Adjusted mean differences ( 95 % CI ) in FACT Fatigue change scores between hemoglobin responders ( > or = 2 g/dl increase ) and non-responders were 3.0 ( 1.2 , 4.7 ) , 2.8 ( 0.6 , 5.0 ) and 5.8 ( 2.2 , 9.5 ) among the solid tumor , lymphoproliferative malignancy and non-chemotherapy groups , respectively . Significantly greater improvements ( P < 0.01 ) were observed in the FACT well-being scales for patients with meaningful improvement in fatigue ( FACT Fatigue change score > or =3 points ) . After controlling for other factors , patients whose fatigue improved reported substantially greater improvements in energy , ability to perform usual activities and overall health ( P < 0.0001 ) . CONCLUSIONS Across five trials of cancer patients on and off chemotherapy , hemoglobin response was associated with meaningful improvements in fatigue , which , in turn , was associated with improved physical , functional , emotional and overall well-being A recent study in dogs suggested that erythropoietin ( EPO ) not only promotes the synthesis of increased numbers of reticulated platelets but that these newly produced platelets are hyperreactive compared with controls . Because of the increasing use of EPO in the perioperative setting , we characterized the effects of EPO on platelet reactivity in healthy human volunteers . In a r and omized , controlled trial , we studied the effects of EPO on platelet reactivity , thrombopoiesis , and endothelial activation in circumstances similar to those of autologous blood donation . Thirty healthy male volunteers received placebo or EPO ( 100 or 500 U/kg of body weight given intravenously ) three times a week for 2 weeks and underwent phlebotomy on days 8 and 15 . Thrombin receptor-activating peptide induced expression of P-selectin , and CD63 increased 2- to 3-fold during EPO treatment . The enhanced platelet reactivity was also reflected by a 50 % increase in soluble P-selectin in plasma . Plasma E-selectin levels increased in a dose-dependent fashion by more than 100 % during EPO treatment , indicating substantial activation of endothelial cells . A 10 % to 20 % increase in platelet counts was observed in both EPO groups on day 5 . In the placebo group , platelets increased only several days after the first phlebotomy . The increase in platelet counts was not reflected by changes in the amounts of reticulated platelets or circulating progenitor cells . In summary , we found that EPO markedly enhances endothelial activation and platelet reactivity , which may adversely affect patients at cardiovascular risk . However , the increased platelet reactivity could be exploited in patients with platelet dysfunction . ( Blood . 2000;95:2983 - 2989 BACKGROUND AND OBJECTIVES Continuous erythropoietin receptor activator ( C.E.R.A. ) is an innovative agent with unique erythropoietin receptor activity and a prolonged half-life , which has the potential for administration at extended dosing intervals . The objectives of this dose-finding study were to evaluate the hemoglobin ( Hb ) dose-response , pharmacokinetics , and safety of repeated doses of C.E.R.A. given once every 3 weeks to anemic patients with multiple myeloma ( MM ) receiving chemotherapy . DESIGN AND METHODS This was an exploratory two-stage , open-label , parallel-group , multicenter study . Patients received C.E.R.A. doses of 1.0 , 2.0 , 3.5 , 4.2 , 5.0 , 6.5 , or 8.0 mg/kg once every 3 weeks by subcutaneous injection initially for 6 weeks , followed by a 12-week optional extension period . The primary outcome measures were the average Hb level and its change from baseline over the initial 6-week period , based on values of the slope of the linear regression analysis and the area under the curve . Rates of Hb response ( defined as an increase in Hb of > or = 2 g/dL without transfusion ) and blood transfusion were also evaluated . RESULTS Sixty-four patients entered the study . Dose-related increases in Hb levels were observed during the initial 6-week treatment period for C.E.R.A. doses of 1.0 - 4.2 mg/kg , with a similar response observed at higher doses . At least 70 % of patients receiving 2.0 - 8.0 mg/kg of C.E.R.A. had Hb responses during the 18-week study . The elimination half-life of C.E.R.A. was found to be long ( 6.3 - 9.7 days [ 151.2 - 232.8 hours ] ) . All doses were generally well tolerated . INTERPRETATION AND CONCLUSIONS Based on its unique , long elimination half-life , C.E.R.A. has been demonstrated to be an effective and well-tolerated treatment of anemia given once every 3 weeks to patients with multiple myeloma receiving chemotherapy PURPOSE To determine the effect of darbepoetin alfa ( DA ) on progression-free survival ( PFS ) and overall survival ( OS ) in patients with chemotherapy-induced anemia ( CIA ) . PATIENTS AND METHODS Two 16-week r and omized , double-blind , placebo-controlled phase III studies of weekly DA in anemic patients with lung cancer ( n = 314 ) or lymphoproliferative malignancies ( LPMs ; n = 344 ) undergoing chemotherapy were analyzed with prospect ively defined long-term PFS and OS end points . Short-term effects of DA on PFS and OS were analyzed by including two additional 16-week dose-finding , double-blind , placebo-controlled studies in anemic patients with multiple tumor types ( n = 405 ) and LPMs ( n = 66 ) . RESULTS Median follow-up is 15.8 months ( lung cancer ) and 32.6 months ( L
Output:
| In addition , there is strong evidence that cancer patients receiving ESAs have an increased risk of thromboembolic and cardiovascular events . |
MS212649 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Plasma levels of insulin-like growth factor-I ( IGF-I ) have been associated with the risk of prostate cancer . However , the association of IGF-I with specific tumor stage and grade at diagnosis , which correlate with risk of recurrence and mortality , has not been studied rigorously . To determine whether plasma levels of IGF-I and its main circulating binding protein , IGF binding protein-3 ( IGFBP-3 ) , predict more aggressive forms of prostate cancer , we investigated the association between plasma levels of each and specific stages and grade s of prostate cancer . METHODS We examined 530 case patients and 534 control subjects in a nested case-control study in the prospect i ve Physicians ' Health Study . Patients with prostate cancer diagnosed from 1982 through 1995 were matched to control subjects by age and smoking status . IGF-I and IGFBP-3 were measured in prospect ively collected plasma sample s. Conditional logistic regression models were used to estimate the relative risks ( RRs ) for prostate cancer associated with IGF-I and IGFBP-3 , stratified on grade ( Gleason score > or = 7 versus < 7 ) and stage ( early = stage A or B prostate cancer versus advanced = stage C or D prostate cancer ) . All statistical tests were two-sided . RESULTS Plasma levels of IGF-I and IGFBP-3 were predictors of advanced-stage prostate cancer ( RR = 5.1 , 95 % confidence interval [ CI ] = 2.0 to 13.2 for highest versus lowest quartiles of IGF-I ; RR = 0.2 , 95 % CI = 0.1 to 0.6 for highest versus lowest quartiles of IGFBP-3 ) but not of early-stage prostate cancer . Neither was differentially associated with Gleason score . Men with high IGF-I levels and low IGFBP-3 levels had an RR for advanced-stage prostate cancer of 9.5 ( 95 % CI = 1.9 to 48.4 ) compared with men with low levels of both . Combining IGF-I and IGFPB-3 measurements with a st and ard prostate-specific antigen ( PSA ) measurement for prostate cancer screening increased the specificity ( from 91 % to 93 % ) but decreased sensitivity ( from 40 % to 36 % ) compared with measurement of PSA alone . CONCLUSIONS Circulating levels of IGF-I and IGFBP-3 may predict the risk of developing advanced-stage prostate cancer , but their utility for screening patients with incident prostate cancer may be limited Recent studies have suggested that IGF-I and IGF-binding protein (IGFBP)-3 , in combination with prostate-specific antigen ( PSA ) , may enhance prostate cancer detection . In this study , we sought to determine the effect on the prediction of future prostate cancer occurrence by incorporating ratios of total and free PSA , IGF-I , IGFBP-3 into PSA testing . Within a population -based prospect i ve cohort study , we investigated the validity ( sensitivity and specificity ) of plasma concentrations of total and free PSA , IGF-I , and IGFBP-3 and combinations thereof , in 114 cases and 97 controls , in the range of 1.75 - 13.5 microg/l for PSA , as used by Khosravi et al. ( See Ref . 7 ) . Validity estimated by the area under the curve in receiver operator characteristics analysis ( with 95 % confidence interval ) for total PSA was 0.78 ( range , 0.71 - 0.84 ) ; total/free PSA , 0.69 ( range , 0.62 - 0.76 ) ; total PSA/IGF-I , 0.72 ( range , 0.65 - 0.79 ) ; free PSA/IGF-I , 0.55 ( range , 0.48 - 0.63 ) ; total PSA/IGFBP-3 , 0.74 ( range , 0.68 - 0.81 ) ; and free PSA/IGFBP-3 , 0.57 ( range , 0.49 - 0.64 ) . Analysis of ratios of IGF-I , IGFBP-3 , and free and total PSA did not improve validity of PSA testing in the prediction of future occurrence of prostate cancer . It is unlikely that these combinations will improve prostate cancer detection Background : The acid-labile subunit ( ALS ) acts in the insulin-like growth ( IGF ) system by binding circulating IGF-I in a ternary complex with binding protein (IGFBP)-3 to prevent IGF-I from crossing the endothelial barrier . Given the role of the IGF system in prostate cancer , ALS may influence carcinogenesis by modulating IGF-I levels or bioavailability . Methods : We undertook a prospect i ve study nested in the Physicians ' Health Study to examine ALS , free IGF-I , and prostate cancer . We assayed circulating levels of ALS and IGF components among 545 incident cases and 545 matched controls . We calculated relative risks ( RR ) and 95 % confidence intervals ( 95 % CI ) adjusted for life-style factors , total IGF-I , and IGFBP3 . Results : ALS was positively correlated with total IGF-I ( r = 0.58 ) , IGFBP3 ( r = 0.68 ) , and free IGF-I ( r = 0.36 ) . Comparing highest versus lowest quartiles , we found no association between free IGF-I and prostate cancer risk ( RR , 0.9 ; 95 % CI , 0.6 - 1.3 ) . In contrast , ALS was positively associated with risk among men in the 2nd ( RR , 1.5 ; 94 % CI , 1.0 - 2.3 ) , 3rd ( RR , 1.6 ; 94 % CI , 1.1 - 2.5 ) , and 4th quartiles ( RR , 1.4 ; 94 % CI , 0.9 - 2.1 ) compared with lowest quartile . The association was stronger for advanced stage tumors ( RR , 2.0 ; 94 % CI , 0.8 - 4.6 ) . There was a suggestion of an interaction between ALS and total IGF-I , whereby high circulating IGF-I was associated with an increased risk of advanced prostate cancer among men with low but not higher ALS levels . Discussion : Plasma ALS is positively associated with prostate cancer risk , and may interact biologically with IGF-I to affect carcinogenesis . These data provide further support for the role of the IGF axis in prostate cancer . Cancer Epidemiol Biomarkers Prev ; 19(2 ) ; A major problem in review ing the published results of different epidemiologic studies of the relation between a quantitative variable and the risk of disease is that the results are presented in many different ways . The purpose of this paper is to exemplify methods by which results expressed either as risks ( or rates ) according to quantlle groups of the quantitative variable or as results derived from a logistic regression analysis can be reexpressed in a uniform manner , as a mean difference in the quantitative variable between the cases of disease and the other subjects in the study . An important assumption of the methods is that the quantitative variable has an approximately normal distribution , and a way of investigating the appropriateness of this assumption is given . The methods can be applied to both prospect i ve and case-control studies and are exemplified by a number of studies of serum albumin concentrations and mortality . In some applications , these methods can be used as a precursor to formal meta- analysis , for example , when differential control of potential confounding factors is not a problem . At the least , the methods can be useful either in quantitatively review ing published studies before undertaking new research or in putting the results of a new study into the context of previously published ones Several epidemiologic studies have examined with diverging results the relationships between circulating levels of insulin-like growth factors ( IGF ) and of IGF-binding proteins ( IGFBP ) and prostate cancer risk . We assessed the association of prediagnostic plasma levels of IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 and subsequent occurrence of prostate cancer in a case-control study nested in the SU.VI.MAX trial . The SU.VI.MAX study was a primary prevention trial testing a daily supplementation with low-dose antioxidant vitamins and minerals in male and female middle-aged volunteers in France . One hundred prostate cancer cases were diagnosed among 4,855 SU.VI.MAX participants over a 9-year follow-up period . For each case , four age-matched controls were selected r and omly . Frozen baseline plasma sample s were used to measure IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 . Conditional logistic regression was used to assess the association between these four biochemical markers and prostate cancer risk . After controlling for the intervention group in the trial and the other IGF axis variables , the odds ratios and 95 % confidence interval ( 95 % CI ) comparing the upper quartile to the baseline quartile were 1.83 ( 95 % CI , 0.85 - 3.95 ) , 1.05 ( 95 % CI , 0.35 - 3.18 ) , 0.79 ( 95 % CI , 0.39 - 1.58 ) , and 0.42 ( 95 % CI , 0.12 - 1.52 ) for IGF-I , IGF-II , IGFBP-2 , and IGFBP-3 , respectively . More suggestive associations for IGF-I and IGFBP-3 were observed with advanced and aggressive cancers . Our results are consistent with those of some previous prospect i ve studies and suggest that IGF axis variables are not long-term predictors of the occurrence of prostate cancer Circulating concentrations of insulin-like growth factor I ( IGF-I ) and IGF binding proteins ( IGFBP ) have been associated with the risk of several types of cancer . Dietary correlates of IGF-I and IGFBPs are not yet well established . The objective of this study was to assess the association between dietary intake and serum concentrations of IGF-I , IGFBP-1 , IGFBP-2 , and IGFBP-3 in a cross-sectional analysis of 4,731 men and women taking part in the European Prospect i ve Investigation into Cancer and Nutrition . Diet was assessed using country-specific vali date d dietary question naires . Serum concentrations of IGF-I , IGFBP-1 , IGFBP-2 and IGFBP-3 were measured , and the associations between diet and IGF-I and IGFBPs were assessed using multiple linear regression adjusting for sex , age , body mass index , smoking status , and alcohol and energy intake . Each 1 SD increment increase in total and dairy protein and calcium intake was associated with an increase in IGF-I concentration of 2.5 % , 2.4 % , and 3.3 % , respectively ( P for trend < 0.001 for all ) and a decrease in IGFBP-2 of 3.5 % , 3.5 % , and 5.4 % ( P for trend < 0.001 for all ) , respectively . There were no significant associations between the intake of protein or calcium from nondairy sources and IGF-I. The results from this large cross-sectional analysis show that either the intake of dairy protein or calcium is an important dietary determinant of IGF-I and IGFBP-2 concentrations ; however , we suggest that it is more likely to be protein from dairy products . ( Cancer Epidemiol Biomarkers Prev 2009;18(5):1333–40 OBJECTIVE To quantify the level of insulin-like growth factor ( IGF-1 ) in serum and investigate its role in the diagnosis of prostate cancer . METHODS IGF-1 immunoradiometric assay ( IRMA ) was set up and used to determine serum IGF-1 level in patients with prostate cancer ( n = 81 ) , benign prostate hyperplasia ( BPH , n = 55 ) , uroepithelial tumor ( n = 32 ) and healthy male controls ( n = 84 ) . Furthermore , the levels of IGF-1 and prostate-specific antigen ( PSA ) in 38 patients with BPH were determined every three months for one year . RESULTS Linearity was well demonstrated for IGF-1 in the range of 8 - 1000 ng ( r = 0.98 ) , the lowest limit for detecting IGF-1 being 2 mg/L and the mean recovery for detecting IGF-1 being 94.5 % . The within-replicate coefficient of variance ( CV ) of IGF-1 detection was 7.2 % for a higher level ( 382.4 mg/L ) and 4.2 % for a low level ( 32.5 mg/L ) of IGF-1 . Insulin , growth factor or IGF-2 did not interfere with the detection of IGF-1 ( < 3 ml/L ) . There was high level of IGF-1 in patients with prostate cancer than in healthy controls , patients with BPH and uroepithelial tumor ( P < 0.05 ) ; the odds ratio and its 95 % confidence intervals were 2.86 and 1.38 - 5.34 , respectively ; the specificity and sensitivity of IGF-1 determination were 0.68 and 0.58 , respectively ; furthermore , the level of IGF-1 was increased during the development of prostate cancer . CONCLUSIONS These findings demonstrate that IGF-1 may serve prospect ively as an important tumor marker in the diagnosis and prediction of prostate
Output:
| No strong associations were observed for IGF-II , IGFBP-1 or IGFBP-2 with either milk intake or prostate cancer risk .
There was additional evidence to suggest that the suppression of IGF-II can reduce tumor size , and contradictory evidence with regards to the effect of IGFBP-3 suppression on tumor progression .
Conclusion IGF-I is a potential mechanism underlying the observed associations between milk intake and prostate cancer risk |
MS212650 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 prospect i ve r and omized controlled trial was performed to determine whether stents may be eliminated after uncomplicated ureteroscopic lithotripsy for ureteral stones . MATERIAL S AND METHODS A total of 58 patients underwent uncomplicated ureteroscopic intracorporeal lithotripsy . After stone fragmentation patients were r and omized to a nonstented ( 29 ) or a stented ( 29 ) treatment group . Intracorporeal lithotripsy was performed with the holmium laser in 57 cases and by electrohydraulic lithotripsy in 1 without balloon dilation or the extraction of stone fragments . Patients were followed 1 , 6 and 12 weeks postoperatively . In stented cases the stent was removed at 1 week . Outcome measures included postoperative symptoms assessed with a visual analog scale , postoperative analgesic requirements , complications and the stone-free rate . RESULTS At 1 week the symptoms of flank pain , abdominal pain , dysuria and frequency were significantly greater in the stented group ( p < 0.005 ) . There were no differences in symptoms in the groups at subsequent followup visits . There was no difference in treatment groups in terms of the amount of analgesic required in the recovery room or during 1 week after ureteroscopy . Similarly there was no difference in the number of patients requiring antiemetics . One patient in the stented group required hospitalization for genitourinary sepsis and 1 patient in the nonstented group visited the emergency room for postoperative vomiting . The stone-free rate was 100 % in each group . CONCLUSIONS These results demonstrate that after ureteroscopic intracorporeal lithotripsy with the holmium laser patients with a stent have significantly greater irritative and painful symptoms than those without a stent in the early postoperative period . There was no difference in nonstented and stented ureteroscopy with respect to complications or stone-free status . Therefore , we believe that routine stenting after ureteroscopic intracorporeal lithotripsy with the holmium laser is not required as long as the procedure is uncomplicated and performed without balloon dilation of the ureteral orifice Retro grade calculus migration during ureteroscopic lithotripsy remains a problem in 5–40 % of cases . We assessed the safety and efficacy of the Stone Cone device , in comparison with the st and ard flat wire basket . A total of 56 consecutive patients with ureteral calculi , suitable for ureteroscopic extraction and /or lithotripsy , where included in this prospect i ve study . Patients were r and omly allocated into two groups . In group A ( 30 patients ) , we used the Stone Cone , while in group B ( 26 patients ) we used the st and ard flat wire basket . The Stone Cone was placed through a cystoscope under fluoroscopic guidance , or when necessary under direct ureteroscopic control . Whenever necessary , intracorporeal electrohydraulic lithotripsy took place in both groups . Statistical significance was assessed by the paired t-test . The mean operative time was 48.5 min in group A , and 42.4 min in group B. Intact calculus extraction was possible in 16.6 % in group A , and in 7.6 % in group B ( P<0.01 ) . Retro grade stone migration was revealed in 23 % in group B only ( P<0.001 ) . Also , residual fragments > 3 mm were recorded in 30.7 % in group B only ( P<0.001 ) . None of the patients in group A required auxiliary procedures , in contrary to 23 % in group B ( P<0.001 ) . No major complications were recorded in group A , while in group B a case of major ureteral mucosal abrasion was recorded . The Stone Cone is safe and efficient in preventing retro grade stone migration and in minimizing residual fragments during ureteroscopic lithotripsy in comparison with the flat wire basket PURPOSE We present the first r and omized clinical study using BackStop , a novel reverse thermosensitive water-soluble polymer that is dispensed above the stone(s ) and temporarily occludes the ureter to prevent retropulsion of stone fragments during ureteroscopic lithotripsy . After fragmentation is completed and concretions are extracted , conventional irrigation with saline dissolves the polymer , which is then flushed out . MATERIAL S AND METHODS A total of 68 subjects with a single stone in the proximal ureter and an indication for ureteroscopic lithotripsy were enrolled in this prospect i ve , r and omized , single-blind , controlled , multisite clinical study . Each subject was r and omly assigned to the BackStop group ( 34 ) or the control group ( 34 with no antiretropulsion device ) . For subjects in the experimental group BackStop was dispensed into the ureter above the stone using a 3Fr or 5Fr catheter . Ureteroscopic lithotripsy was performed in all subjects using pneumatic or laser energy . Measured end points included the retropulsion rate , the need for subsequent procedures , the stone-free rate at followup , the occurrence of adverse events and ureteral occlusion , if any , and post-stone fragmentation and extraction . RESULTS Subjects r and omized to the BackStop group experienced a statistically significant ( p = 0.0002 ) lower rate of retropulsion ( 8.8 % , 3 of 34 ) vs the control group ( 52.9 % , 18/34 ) . There were no adverse events in the BackStop group and BackStop was successfully dissolved in every subject , result ing in a patent ureter . CONCLUSIONS BackStop appears to be a novel , safe and effective means of preventing stone fragment retropulsion during ureteroscopic lithotripsy for the management of ureteral stones OBJECTIVES To evaluate our experience in treating 155 patients with upper urinary tract calculi ureteroscopically . The treatment of urinary calculi has remained the most frequent application of ureteroscopy . Miniaturization of semirigid and flexible ureteroscopes has permitted easier access to calculi throughout the urinary tract . METHODS Ureteroscopic stone treatment was attempted in 155 patients with upper urinary tract calculi between November 1995 and March 1997 . Fifty-nine ( 38.1 % ) patients had renal calculi , 82 ( 52.9 % ) ureteral , and 14 ( 9 % ) had both renal and ureteral calculi . Both semirigid and flexible ureteroscopes were used for treatment ( rigid alone in 21 [ 13.5 % ] , flexible in 64 [ 41.3 % ] , and both rigid and flexible in 70 [ 45.2 % ] patients ) . Lithotripsy was required in 122 ( 79 % ) of the patients . The holmium : yttrium-aluminum-garnet laser was used in 113 ( 92.6 % ) of these patients . RESULTS All patients with ureteral calculi ( 29 proximal , 19 mid , and 34 distal ) were successfully cleared after one endoscopic procedure except for 1 patient with a proximal ureteral calculus who had a 4-mm residual fragment in the kidney . Of the 59 patients with renal calculi , 47 ( 79.7 % ) were totally clear of stones 1 month after treatment . The remaining 12 ( 20.3 % ) patients had evidence of residual calculi 3 to 4 mm or less in diameter . In patients with combined renal and ureteral calculi , 1 1 of 14 ( 78.6 % ) were rendered stone free . The remaining 3 ( 21.4 % ) patients had evidence of residual calculi 4 mm in diameter . Overall , 95 % of the patients were treated in an outpatient setting . Morbidity was low , with no evidence of stricture . CONCLUSIONS Ureteroscopy and laser lithotripsy in experienced h and s are a safe and reliable method for the treatment of ureteral and even intrarenal calculi OBJECTIVE A series of experiments were conducted to test the hypothesis that the mechanism of holmium : YAG lithotripsy is photothermal . METHODS AND RESULTS To show that holmium : YAG lithotripsy requires direct absorption of optical energy , stone loss was compared for 150 J Ho : YAG lithotripsy of calcium oxalate monohydrate ( COM ) stones for hydrated stones irradiated in water ( 17+/-3 mg ) and hydrated stones irradiated in air ( 25+/-9 mg ) v dehydrated stones irradiated in air ( 40+/-12 mg ) ( P < 0.001 ) . To show that Ho : YAG lithotripsy occurs prior to vapor bubble collapse , the dynamics of lithotripsy in water and vapor bubble formation were documented with video flash photography . Holmium : YAG lithotripsy began at 60 microsec , prior to vapor bubble collapse . To show that Ho : YAG lithotripsy is fundamentally related to stone temperature , cystine , and COM mass loss was compared for stones initially at room temperature ( approximately 23 degrees C ) v frozen stones ablated within 2 minutes after removal from the freezer . Cystine and COM mass losses were greater for stones starting at room temperature than cold ( P < or = 0.05 ) . To show that Ho : YAG lithotripsy involves a thermochemical reaction , composition analysis was done before and after lithotripsy . Postlithotripsy , COM yielded calcium carbonate ; cystine yielded cysteine and free sulfur ; calcium hydrogen phosphate dihydrate yielded calcium pyrophosphate ; magnesium ammonium phosphate yielded ammonium carbonate and magnesium carbonate ; and uric acid yielded cyanide . To show that Ho : YAG lithotripsy does not create significant shockwaves , pressure transients were measured during lithotripsy using needle hydrophones . Peak pressures were < 2 bars . CONCLUSION The primary mechanism of Ho : YAG lithotripsy is photothermal . There are no significant photoacoustic effects 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 We performed a prospect i ve , non-r and omised study to determine the appropriate first-line treatment modality for distal ureteral stones . Between 2003 and 2004 , a total of 124 patients with distal ureteral calculi were entered into the study ( mean age 48 years , 35 women and 99 men ) . Sixty-two patients were treated with shock wave lithotripsy ( SWL ) and 62 patients with ureteroscopy ( URS ) . The average stone size was 6.9 mm ( 3–33 mm ) for SWL and 7.2 mm ( 3–30 mm ) for URS . The treatment decision depended on the patients ’ preference and clinical parameters ( i.e. contraindications for anaesthesia ) . URS was performed under general anaesthesia , using semirigid 8 Fr instruments . SWL was performed under analgo-sedation using a Modulith SLX . Of patients treated with SWL , 84 % had a treatment success within 7 days , 98 % after URS . These results show a significant success ( P=0.005 ) in favour of URS . The average in-patient stay after SWL was 3 days and for URS 4 days ( not significant ) . The results show a high efficacy and a low complication rate for both modalities . The attained stone-free rate shows a significant advantage for primary URS INTRODUCTION The aim of this study was to investigate and compare the success and complication rates of extracorporeal shockwave lithotripsy ( SWL ) in three cohorts of patients older than 60 years . PATIENTS AND METHODS Our study included 444 patients older than 60 years who were treated with SWL between May 2001 and May 2008 at the Croatian Referential Center for Urolythiasis in Osijek . Three groups were formed : group
Output:
| EVIDENCE SYNTHESIS For stones that do not pass spontaneously or with MET , shock wave lithotripsy ( SWL ) and ureteroscopy ( URS ) are the most common and efficient treatment modalities .
Both techniques have obvious advantages and disadvantages as well as different patterns of complications .
For select cases or patients , other modalities may be useful .
Ureteral stones of up to 10 mm and eligible for observation may be offered MET . |
MS212651 | ***TASK*** the task is to summarize an input biomedical literature 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 establish whether an interactive booklet on respiratory tract infections in children reduces reconsultation for the same illness episode , reduces antibiotic use , and affects future consulting intentions , while maintaining parental satisfaction with care . Design Pragmatic cluster r and omised controlled trial . Setting 61 general practice s in Wales and Engl and . Participants 558 children ( 6 months to 14 years ) presenting to primary care with an acute respiratory tract infection ( 7 days or less ) . Children with suspected pneumonia , asthma or a serious concomitant illness , or needing immediate hospital admission were excluded . Three withdrew and 27 were lost to follow-up , leaving 528 ( 94.6 % ) with main outcome data . Interventions Clinicians in the intervention group were trained in the use of an interactive booklet on respiratory tract infections and asked to use the booklet during consultations with recruited patients ( and provide it as a take home re source ) . Clinicians in the control group conducted their consultations as usual . Main outcome measures The proportion of children who attended a face-to-face consultation about the same illness during the two week follow-up period . Secondary outcomes included antibiotic prescribing , antibiotic consumption , future consulting intentions , and parental satisfaction , reassurance , and enablement . Results Reconsultation occurred in 12.9 % of children in the intervention group and 16.2 % in the control group ( absolute risk reduction 3.3 % , 95 % confidence interval −2.7 % to 9.3 % , P=0.29 ) . Using multilevel modelling ( at the practice and individual level ) to account for clustering , no significant difference in reconsulting was noted ( odds ratio 0.75 ; 0.41 to 1.38 ) . Antibiotics were prescribed at the index consultation to 19.5 % of children in the intervention group and 40.8 % of children in the control group ( absolute risk reduction 21.3 % , 95 % confidence interval 13.7 to 28.9 ) , P<0.001 ) . A significant difference was still present after adjusting for clustering ( odds ratio 0.29 ; 0.14 to 0.60 ) . There was also a significant difference in the proportion of parents who said they would consult in the future if their child developed a similar illness ( odds ratio 0.34 ; 0.20 to 0.57 ) . Satisfaction , reassurance , and parental enablement scores were not significantly different between the two groups . Conclusions Use of a booklet on respiratory tract infections in children within primary care consultations led to important reductions in antibiotic prescribing and reduced intention to consult without reducing satisfaction with care . Trial registration Current Controlled Trials IS RCT Background To explore ways to reduce the overuse of antibiotics for acute respiratory infections ( ARIs ) , we conducted a pilot clustered r and omized controlled trial ( RCT ) to evaluate DECISION+ , a training program in shared decision making ( SDM ) for family physicians ( FPs ) . This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician . Consequently , the objective of this study is to evaluate , in patients consulting for ARIs , if exposure of physicians to a modified version of DECISION+ , DECISION+2 , would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician . Methods / design The study is a multi-center , two-arm , parallel clustered RCT . The 12 family practice teaching units ( FPTUs ) in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be r and omized to a DECISION+2 intervention group ( experimental group ) or to a no-intervention control group . These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study . There will be two data collection periods : pre-intervention ( baseline ) including 175 patients with ARIs in each study arm , and post-intervention including 175 patients with ARIs in each study arm ( total n = 700 ) . The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician . Secondary outcome measures include : 1 ) physicians and patients ' decisional conflict ; 2 ) the agreement between the parties ' decisional conflict scores ; and 3 ) perception of patients and physicians that SDM occurred . Also in patients , at 2 weeks follow-up , adherence to the decision , consultation for the same reason , decisional regret , and quality of life will be assessed . Finally , in both patients and physicians , intention to engage in SDM in future clinical encounters will be assessed . Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration . Discussion DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed , value-based decisions . Trial Registration Clinical Trials.gov : OBJECTIVES . To determine whether we could increase adherence to the Centers for Disease Control and Prevention ( CDC ) recommendations with well-accepted approaches to improving quality of care and adherence to the CDC recommendations result ed in improved outcomes for acute otitis media ( AOM ) . METHODS . A cluster r and omization study was conducted in 12 pediatric practice s ( 6 intervention and 6 control sites ) . The main outcome measures were adherence to the CDC recommendations ( modified to include 2 additional antimicrobial agents ) and a subsequent antibiotic prescription for AOM within 30 days after diagnosis . RESULTS . Of 3152 patients referred to research assistants , 2584 ( 82 % ) were eligible . Of those eligible , 1368 ( 99 % ) of 1382 at the intervention sites and 1138 ( 99 % ) of 1146 at the control sites consented to participate . Rates of adherence to the CDC recommendations were not significantly higher at the intervention sites than at the control sites , for initial enrollment episodes ( 78.2 % vs 70.6 % ) or second episodes ( 62.6 % vs 59.9 % ) . After controlling for clustering according to site and covariates , children who were not treated in adherence to the CDC recommendations for both episodes had 1.60 times the odds of a subsequent prescription within 12 days , compared with those treated in adherence at both episodes . CONCLUSIONS . Despite using evidence -based approaches that are known to influence physician behavior , we were unable to increase adherence to the CDC recommendations for treatment of AOM . However , we did establish that prescription of antimicrobial therapy consistent with the CDC recommendations for a second episode of AOM was associated with improved outcomes , measured as the need for subsequent antibiotic prescription . Because of the selection of resistant otopathogens , adherence to the CDC recommendations is likely more important in subsequent episodes of AOM than in the initial episode Abstract Objective : To assess the medicalising effect of prescribing antibiotics for sore throat . Setting : 11 general practice s in Engl and . Design : R and omised trial of three approaches to sore throat : a 10 day prescription of antibiotics , no antibiotics , or a delayed prescription if the sore throat had not started to settle after three days . Patients : 716 patients aged 4 and over with sore throat and an abnormal physical sign : 84 % had tonsillitis or pharyngitis . Outcome measures : Number and rate of patients making a first return with sore throat , pharyngitis , or tonsillitis . Early returns ( within two weeks ) and complications ( otitis media , sinusitis , quinsy ) . Outcomes were documented in 675 subjects ( 94 % ) . Results : Mean follow up time was similar ( antibiotic group 1.07 years , other two groups 1.03 years ) . More of those initially prescribed antibiotics initially returned to the surgery with sore throat ( 38 % v 27 % , adjusted hazard ratio for return 1.39 , 95 % confidence interval 1.03 to 1.89 ) . Antibiotics prescribed for sore throat during the previous year had an additional effect ( hazard ratio 1.69 , 1.20 to 2.37 ) . Longer duration of illness ( > 5 days ) was associated with increased return within six weeks ( hazard ratio 2.90 , 1.70 to 4.92 ) . Prior attendance with upper respiratory conditions was also associated with increased reattendance . There was no difference between groups in early return ( 13/238 ( 5.5 % ) v 27/437 ( 6 % ) ) , or complications ( 2/236 ( 0.8 % ) v3/434 ( 0.7 % ) ) . Conclusions : Complications and early return result ing from no or delayed prescribing of antibiotics for sore throat are rare . Both current and previous prescribing for sore throat increase reattendance . To avoid medicalising a self limiting illness doctors should avoid antibiotics or offer a delayed prescription for most patients with sore throat . Key messages Sore throat is one of the commonest presentations of upper respiratory illness in primary care and attendence is increasing Complications are rare with no , or delayed , antibiotic prescription Prescribing antibiotics increases reattendance for future episodes Unless patients are very ill general practitioners should consider exploring concerns , explain the natural history , and avoid or delay prescribing CONTEXT Prescribing practice s for otitis media are not consistent with current evidence -based recommendations . OBJECTIVE To determine whether point-of-care evidence delivery regarding the use and duration of antibiotics for otitis media decreases the duration of therapy from 10 days and decreases the frequency of prescriptions written . DESIGN R and omized , controlled trial . SETTING Primary care pediatric clinic affiliated with university training program . Intervention . A point-of-care evidence -based message system presenting real time evidence to providers based on their prescribing practice for otitis media . MAIN OUTCOME MEASURES Proportion of prescriptions for otitis media that were for < 10 days and frequency with which antibiotics were prescribed . RESULTS Intervention providers had a 34 % greater reduction in the proportion of time they prescribed antibiotics for < 10 days . Intervention providers were less likely to prescribe antibiotics than were control providers . CONCLUSIONS A point-of-care information system integrated into outpatient pediatric care can significantly influence provider behavior for a common condition A r and omised controlled trial involving 54 general practitioners ( GPs ) was conducted in Canberra , Australian Capital Territory from September 1997 to November 1999 . In the first year of the study , 24 GPs , who constituted the active arm of the intervention group , were involved in the consideration of evidence and the development and implementation of a set of clinical guidelines for the treatment of acute respiratory infections . These guidelines were then endorsed in a meeting together with specialist colleagues . In the second year of the study the group of GPs who had been acting as controls , received a moderate intervention consisting of a brief educational event and distribution of the locally developed guidelines . We obtained data from January 1997 to December 1999 from the Health Insurance Commission on prescribing rates for 40 of the doctors in the study . The rate of prescribing was calculated as the number of antibiotic prescriptions per 100 Medicare services . The average yearly prescribing decreased significantly in the intensive intervention group and increased in the moderate intervention group , ( p=0.026 ) . A mixed effects longitudinal time series model was fitted to the data to account for seasonal variation of antibiotic prescribing and trends over time . The intensive intervention group significantly reduced their antibiotic prescribing over time compared to the moderate intervention group , ( p<0.001 ) . This study has shown that an intensive intervention in which general practitioners were actively engaged in development and consideration of the evidence base for the guidelines result ed in a significant fall in general antibiotic prescribing Objective To assess the effect of general practitioner testing for C reactive protein ( disease approach ) and receiving training in enhanced communication skills ( illness approach ) on antibiotic prescribing for lower respiratory tract infection . Design Pragmatic , 2 × 2 factorial , cluster r and omised controlled trial . Setting 20 general practice s in the Netherl and s. Participants 40 general practitioners from 20 practice s recruited 431 patients with lower respiratory tract infection . Main outcome measures The primary outcome was antibiotic prescribing at the index consultation . Secondary outcomes were antibiotic prescribing during 28 days ’ follow-up , reconsultation , clinical recovery , and patients ’ satisfaction and enablement . Interventions General practitioners ’ use of C reactive protein point of care testing and training in enhanced communication skills separately and combined , and usual care . Results General practitioners in the C reactive protein test group prescribed antibiotics to 31 % of patients compared with 53 % in the no test group ( P=0.02 ) . General practitioners trained in enhanced communication skills prescribed antibiotics to 27 % of patients compared with 54 % in the no training group ( P<0.01 ) . Both interventions showed a statistically significant effect on antibiotic prescribing at any point during the 28 days ’ follow-up . Clinicians in the combined intervention group prescribed antibiotics to 23 % of patients ( interaction term was non-significant ) . Patients ’ recovery and satisfaction were similar in all study groups . Conclusion Both general practitioners ’ use of point of care testing for C reactive protein and training in enhanced communication skills significantly reduced antibiotic prescribing for lower respiratory tract infection without compromising patients ’ recovery and satisfaction with
Output:
| Interventions that combined parent education with clinician behaviour change decreased antibiotic prescribing rates by between 6 - 21 % ; structuring the parent-clinician interaction during the consultation may further increase the effectiveness of these interventions .
Automatic computerised prescribing prompts increased prescribing appropriateness , while passive information , in the form of waiting room educational material s , yielded no benefit .
Conflicting evidence from the included studies found that interventions directed towards parents and /or clinicians can reduce rates of antibiotic prescribing .
The most effective interventions target both parents and clinicians during consultations , provide automatic prescribing prompts , and promote clinician leadership in the intervention design |
MS212652 | ***TASK*** the task is to summarize an input biomedical literature 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 key issue in the analysis of outcome trials is the adjustment for baseline covariates that influence the primary outcome . Imbalance of an important covariate between treatment groups at baseline is of considerable concern if one treatment group is favored over another with respect to the hypothesis testing outcome . With the use of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan ( RENAAL ) study data base as an example , the influence of baseline proteinuria on the primary composite endpoint , ESRD , and ESRD or death after adjusting for baseline proteinuria as a continuous covariate was examined . Increasing baseline proteinuria was associated with increased risk for renal events , confirming that proteinuria is an important covariate for renal outcomes . When the r and omization was stratified according proteinuria < 2000 mg/g or > /=2000 mg/g , within the higher proteinuria stratum ( > /=2000 mg/g ) , patients in the losartan group had a higher baseline mean proteinuria value . When the imbalance was adjusted , an increase in the magnitude and the significance of the risk reduction with losartan for each outcome was observed . No apparent interaction between treatment effect and baseline proteinuria was found , and there was no heterogeneity in the treatment response in patients with different baseline proteinuria levels . After proteinuria was adjusted as a continuous variable , greater treatment effects were observed in the RENAAL study . This effect was due solely to the imbalance in baseline proteinuria . Considering the importance of proteinuria as a risk factor , adjustment for baseline proteinuria as a continuous covariate should be prespecified in the design and analysis of clinical trials involving renal outcomes , even when patients are stratified on the basis of level of proteinuria BACKGROUND It is unknown whether either the angiotensin-II-receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure . METHODS We r and omly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan ( 300 mg daily ) , amlodipine ( 10 mg daily ) , or placebo . The target blood pressure was 135/85 mm Hg or less in all groups . We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration , the development of end-stage renal disease , or death from any cause . We also compared them with regard to the time to a secondary , cardiovascular composite end point . RESULTS The mean duration of follow-up was 2.6 years . Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group ( P=0.02 ) and 23 percent lower than that in the amlodipine group ( P=0.006 ) . The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group ( P=0.003 ) and 37 percent lower in the irbesartan group than in the amlodipine group ( P<0.001 ) . Treatment with irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups ( P=0.07 for both comparisons ) . These differences were not explained by differences in the blood pressures that were achieved . The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group ( P=0.008 ) and 21 percent more slowly than in the amlodipine group ( P=0.02 ) . There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point . CONCLUSIONS The angiotensin-II-receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes . This protection is independent of the reduction in blood pressure it causes BACKGROUND Chronic allograft nephropathy ( CAN ) is the leading cause of late allograft failure , with only limited treatment options . Blockade of the renin-angiotensin system ( RAS ) decreases progression in diabetic and non-diabetic renal disease , but the effect on CAN is as yet unclear . Therefore , we have studied retrospectively the effect of RAS blockade on renal survival in patients with biopsy-proven CAN . METHODS The medical records of 72 patients with biopsy-proven CAN were evaluated with regard to time course of graft function , proteinuria , blood pressure , and antihypertensive and immunosuppressive treatment . Cox 's proportional hazards model was used for analysing renal graft survival after the index biopsy . RESULTS On univariate analysis , histological determinants influencing renal survival were the chronic interstitial and chronic tubular score , and clinical parameters were the serum creatinine level at the time of the biopsy , the relative change in serum creatinine level between 12 months post-transplantation and at the time of the biopsy , mean systolic and diastolic blood pressure after the biopsy , and RAS blockade by angiotensin-converting enzyme inhibitor or angiotensin receptor blocker . On multivariate analysis , graft outcome was influenced by the relative change in serum creatinine level between 12 months post-transplantation and the time of the index biopsy , the urinary protein excretion , the mean diastolic blood pressure after the index biopsy , and RAS blockade . Renal graft survival after treatment with RAS blockade was 6.3 ( 0.9 - 10.9 ) years as opposed to 1.8 ( 0.1 - 6.7 ) years in untreated patients ( P = 0.003 ) . CONCLUSION RAS blockade increases graft survival in CAN . In view of the limited treatment options for CAN , this finding is of importance and needs confirmation by a prospect i ve r and omized trial A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The checklist is similarly flexible . This iterative process makes the CONSORT statement a continually evolving instrument . While participants in the CONSORT group and their degree of involvement vary over time , members meet regularly to review the need to refine CONSORT . At the 1999 meeting , the participants decided to revise the original statement . This report reflects changes determined by consensus of the CONSORT group , partly in response to emerging evidence on the importance of various elements of RCTs . Revision of the CONSORT Statement Thirteen members of the CONSORT group met in May 1999 with the primary objective of revising the original CONSORT checklist and flow diagram , as needed . The group discussed the merits of including each item in the light of current evidence . As in developing the original CONSORT statement , our intention was to keep only those items deemed fundamental to reporting st and ards for an RCT . Some items not considered essential may well be highly desirable and should still be included in an RCT report even though they are not included in CONSORT . Such items include approval of an institutional ethical review board , sources of funding for the trial , and a trial registry number ( as , for example , the International St and ard R and omized Controlled Trial Number [ IS RCT N ] used to register an RCT at its inception [ 17 ] ) . Shortly after the meeting , a revised version of the checklist was circulated to the group for additional comments and feedback . Revisions to the flow diagram were similarly made . All these changes were discussed when CONSORT participants met in May 2000 , and the revised statement was finalized shortly afterward . The revised CONSORT statement includes a 22-item checklist ( Table ) and a flow diagram ( Figure ) . Its primary aim is to help authors improve the quality of reports of simple two-group , parallel RCTs . However , the basic philosophy underlying the development of the statement can be applied to any design . In this regard , additional statements for other design s will be forthcoming from the group ( 13 ) . CONSORT can also be used by peer review ers and editors to identify reports with inadequate description of trials and those with potentially biased results ( 1 , 2 ) . Table . Checklist of Items To Include When Reporting a R and omized Trial Figure . Flow diagram of the progress through the phases of a r and omized trial ( enrollment , intervention allocation , follow-up , and data analysis ) . During the 1999 meeting , the group also discussed the benefits of developing an explanatory document to enhance the use and dissemination of CONSORT . The document is patterned on reporting of statistical aspects of clinical research ( 18 ) , which was developed to help facilitate the recommendations of the ICMJE 's Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals . Three members of the CONSORT group , with assistance from members on some checklist items , drafted an explanation and elaboration document . That document ( 19 ) was circulated to the group for additions and revisions and was last revised after review at the latest CONSORT group meeting . Changes to CONSORT 1 . In the revised checklist , a new column for Paper Section and Topic integrates information from the Subheading column that was contained in the original statement . 2 . The Was It Reported ? column has been integrated into a Reported on Page Number column , as requested by some journals . 3 . Each item of the checklist is now numbered , and the syntax and order have been revised to improve the flow of information . 4 . Title and Abstract are now combined in the first item . 5 . While the content of the revised checklist is similar to that of the original one , some items that previously were combined are now separate . For example , authors had been asked to describe primary and secondary outcome ( s ) measure(s ) and the minimum important difference(s ) , and indicate how the target sample size was projected . In the new version , issues pertaining to outcomes ( item 6 ) and sample size ( item 7 ) are separate , enabling authors to be more explicit about each . Moreover , some items request additional information . For example , for outcomes ( item 6 ) authors are asked to report any methods used to enhance the quality of measurements , such as multiple observations . 6 . The item asking for the unit of r and omization ( for example , cluster ) has been dropped because specific checklists have been developed for reporting cluster RCTs ( 20 ) and other design types ( 13 ) since publication of the original checklist . 7 . Whenever possible , new evidence is incorporated into the revised checklist . For example , authors are asked to be explicit about whether the analysis reported is by intention to treat ( item 16 ) . This request is based in part on the observations ( 21 ) that authors do not adequately describe and apply intention-to-treat analysis and that reports not providing this information are less likely to provide other relevant information , such as losses to follow-up ( 22 ) . 8 . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow-up , and
Output:
| Proteinuria decreased significantly in group A patients only .
Lisinopril also significantly reduced radiolabeled aprotinin uptake and metabolism , plasma aldosterone , and ammonia excretion .
Patients with more than or equal to 30 % reduction in proteinuria had a significant association with rs699 polymorphism in the angiotensinogen gene .
The rate of decline of renal graft function in patients with chronic allograft nephropathy was not adversely affected by lisinopril therapy given for 1 year .
Lisinopril significantly reduced proteinuria , renal proximal tubular polypeptide catabolism , plasma aldosterone , and ammonia excretion suggesting relative preservation of graft function .
Treating metabolic acidosis allowed safe and prolonged use of angiotensinogen-converting enzyme inhibitors |
MS212653 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The open tension-free mesh-plug hernia technique , transabdominal preperitoneal ( TAPP ) technique , and totally extraperitoneal ( TEP ) laparoscopic technique all are common surgical procedures for primary unilateral inguinal hernia repair . However , the choice of the right surgical procedure still is controversial in China . This study aim ed to compare open tension-free hernioplasty with two laparoscopic hernia repairs . Methods In this study , 164 male patients with primary unilateral inguinal hernia were r and omized to undergo an open operation with mesh-plug and patch , TAPP , or TEP . Results Completion of the study required 3 years , from February 2006 to February 2009 . Of the 164 patients , 62 underwent open repair , 50 had TAPP , and 52 had TEP . The patients then were followed up for 15.6 ± 8.5 months . The average operating time for the open repair group was significantly shorter than for the other two groups ( p < 0.001 ) . The cost for the open repair group also was significantly less than for the other two groups ( p < 0.001 ) . By contrast , the pain scores in the open mesh group were significantly higher than in the other two groups ( p < 0.001 ) . The hospital stay and the recovery time both were significantly longer in open repair group than in the other two groups ( p < 0.001 ) . No major complications or recurrence was found in any of the groups . Conclusions The findings show that open tension-free mesh-plug hernia repair , TAPP , and TEP are safe and effective for patients with primary unilateral inguinal hernia . Both TAPP and TEP are superior to open repair in terms of less postoperative pain and faster recovery time . The authors therefore recommend laparoscopic repair techniques as the preferable choice of surgical procedure . However , they think open repair will remain a practical solution in China because of its lower cost , short learning period , and need for no special equipment Background Data are insufficient to compare transabdominal preperitoneal repair ( TAPP ) and total extraperitoneal ( TEP ) techniques of laparoscopic inguinal hernia repair . There is very scant data comparing the two techniques in terms of long-term outcomes , which include chronic groin pain , quality of life , and time to return to normal activity . This prospect i ve , r and omized , controlled trial compared TEP versus TAPP techniques of laparoscopic inguinal hernia repair in terms of these long-term outcomes . Methods This study was conducted from May 1 , 2007 to March 30 , 2012 . Patients with uncomplicated groin hernia were r and omized to transabdominal preperitoneal ( TAPP ) or totally extraperitoneal ( TEP ) techniques . A total of 160 patients were r and omized to group I ( TEP ) and 154 patients to group II ( TAPP ) . Pain was assessed with Visual Analogue Scale ( VAS ) preoperatively and postoperatively at 24 h , 1 week , 6 weeks , 3 , 6 , and 12 months , and yearly thereafter . Quality of life was assessed with Short Form–36 version 2 ( SF 36v2 ) preoperatively and postoperatively at 3 months follow-up . Results Demographic , clinical profiles , intraoperative , and early postoperative parameters were well matched . There was significantly higher acute pain following TAPP repair ; however , the chronic groin pain was comparable in both TEP and TAPP . Preoperative pain and immediate postoperative pain had significant correlation with chronic groin pain . Significant improvement from preoperative to postoperative quality of life was seen in both TEP and TAPP repairs , but there was no difference between TEP and TAPP in postoperative period . Time to return to normal activity also was similar between the two groups . Conclusions The TEP and TAPP techniques of laparoscopic repair of inguinal hernia have comparable long-term outcomes in terms of incidence of chronic groin pain , quality of life , and resumption of normal activities . Chronic groin pain had a significant correlation with preoperative pain and early postoperative pain . However , TAPP was associated with significantly higher incidence of early postoperative pain , longer operative time , and cord edema , whereas TEP was associated with a significant higher incidence of seroma formation . The cost was comparable between the two AIM To compare four approaches in primary repair of inguinal hernia as regards operative and postoperative outcome . METHODS One hundred consecutive patients with primary inguinal hernia Nyhus I-III were r and omized into four groups . Group I had open pro-peritoneal repair , group II had Lichtenstein tension-free mesh repair , group III had Transabdominal pro-peritoneal ( TAPP ) repair while group IV had laparoscopic totally extraperitoneal ( TEP ) hernia repair . RESULTS Operative time ranged from 10.71 to 120.61 min . Laparoscopic operations were significantly longer than open operations ( 54.5 + 13.2 , 34.21 + 23.5 versus 96.12 + 22.5 , 77.4 + 43.21 ; t=3.891 , p<0.001 ) . Open pro-peritoneal approach had significantly longer operative time compared to Lichtenstein approach ( 54.5 + 13.2 versus 34.21 + 23.5 ) . Postoperative pain was significantly higher in patients who had open repairs ( 7.067 + 1.831 , 6.5 + 3.5 versus 5.8 + 1.568 , 4.8 + 2.33 ; t=3.424 , p=0.002 ) . There was one case of conversion in each of the two laparoscopic groups . Laparoscopic operations were associated with significantly faster return to normal domestic activities and to work . CONCLUSION Laparoscopic hernia repair offers less postoperative pain and faster recovery on the expense of longer operative time . TEP and TAPP laparoscopic techniques gave similar results Background There is very scant literature on the impact of inguinal hernia mesh repair on testicular functions and sexual functions following open and laparoscopic repair . The present r and omized study compares TAPP and TEP repairs in terms of testicular functions , sexual functions , quality of life and chronic groin pain . Methods This study was conducted from April 2012 to October 2014 . A total of 160 patients with uncomplicated groin hernia were r and omized to either trans-abdominal pre-peritoneal ( TAPP ) repair or totally extra-peritoneal ( TEP ) repair . Testicular functions were assessed by measuring testicular volume , testicular hormone levels preoperatively and at 3 months postoperatively . Sexual functions were assessed using BMSFI , and quality of life was assessed using WHO-QOL BREF scale preoperatively and at 3 and 6 months postoperatively . Chronic groin pain was evaluated using the VAS scale at 3 months , 6 months and at 1 year . Results The median duration of follow-up was 13 months ( range 6–18 months ) . The mean preoperative pain scores ( p value 0.35 ) as well as the chronic groin pain were similar between TEP and TAPP repairs at 3 months ( p value 0.06 ) and 6 months ( p value 0.86 ) . The testicular resistive index and testicular volume did not show any significant change at follow-up of 3 months ( p value 0.9 ) in the study population . No significant difference was observed in testicular resistive index and testicular volume when comparing TEP and TAPP groups at at follow-up of 3 months ( p value > 0.05 ) . There was a statistically significant improvement in the sexual drive score , erectile function and overall satisfaction over the follow-up period following laparoscopic inguinal hernia repair . However , sexual function improvement was similar in patients undergoing both TEP and TAPP repairs . All the domains of quality of life in the study population showed a significant improvement at a follow-up of 3 and 6 months . Subgroup analysis of all the domains of quality of life in both TAPP and TEP groups showed a similar increment as in the study population ( p value < 0.001 ) ; however , the mean scores of all the domains were comparable between the two subgroups ( p value > 0.05 ) , preoperatively and 3 and 6 months follow-up . Conclusions Laparoscopic groin hernia repair improves the testicular functions , sexual functions and quality of life , but TEP and TAPP repairs are comparable in terms of these long-term outcomes Background The current prospect i ve r and omized controlled clinical study aim ed to assess the short- and long-term results of recurrent inguinal hernia repair , and to compare the results for transabdominal preperitoneal ( TAPP ) and totally extraperitoneal ( TEP ) procedures with those for open tension-free repair . Methods For this study , 82 patients were r and omly assigned to undergo TAPP ( group A , n = 24 ) , TEP ( group B , n = 26 ) , or open Lichtenstein hernioplasty ( group C , n = 32 ) . All the patients with recurrent inguinal hernias had undergone previous repair using conventional open procedures . Physical examination showed Nyhus type II hernia in the vast majority of the patients ( 59 % ) . High-risk patients ( American Society of Anesthesiology [ ASA ] III or IV ) ; coagulation disorders ; previous abdominal or pelvic surgery ; and irreducible , congenital , and massive scrotal or sliding hernias were excluded from the study . Results There was a statistically significant difference ( p = 0.001 ) in operating time favoring the open procedure . The intensity of postoperative pain was greater in the open hernia repair group 24 h , 48 h , and 7 days after surgery ( p = 0.001 ) , with a greater consumption of pain medication among these patients ( p < 0.004 ) . The median time until return to work was 14 days for group A , 13 days for Group g , and 20 days for group C. The comparison was in favor of laparoscopically treated patients . Nine recurrences ( 4 in the laparoscopic groups and 5 in the open group ) were documented within 3 years of follow-up evaluation . Conclusion Laparoscopic inguinal hernia repair ( TAPP or TEP ) is the method of choice for dealing with recurrent inguinal hernia Background The aim of this prospect i ve r and omized multicenter trial was to evaluate the recurrence rates and complications of open versus laparoscopic repairs of inguinal hernias . Methods Patients with primary unilateral inguinal hernias were r and omized to Shouldice repair , Bassini operation , tension-free hernioplasty ( Lichtenstein repair ) , laparoscopic transabdominal extraperitoneal hernioplasty ( TEP ) , or laparoscopic transabdominal preperitoneal hernioplasty ( TAPP ) . The primary outcome parameter was the rate of recurrence at 3 years . The secondary outcome was the rate of intraoperative , perioperative , and long-term complications . Follow-up comprised of clinical examination after 1 , 2 , and 3 years . Results Three hundred and sixty-five patients were r and omly assigned to one of the five procedures . The intention-to-treat analysis showed that the cumulative 3-year recurrence rate was 3.4 % in the Bassini group , 4.7 % in the Shouldice group , 0 % in the Lichtenstein group , 4.7 % in the TAPP group , and 5.9 % in the TEP group ( p = 0.48 ) . Comparing open ( Bassini , Shouldice , Lichtenstein ) versus laparoscopic ( TAPP , TEP ) techniques ( p = 0.29 ) and comparing the use of mesh prostheses ( Lichtenstein , TAPP , TEP ) versus suturing techniques ( Bassini , Shouldice ) ( p = 0.74 ) showed no significance in the rate of recurrence . The rates of intraoperative ( p = 0.15 ) , perioperative ( p = 0.09 ) , and long-term complications ( p = 0.13 ) were without significance between the five groups . Comparing mesh techniques ( Lichtenstein , TAPP , TEP ) versus suturing techniques ( Bassini , Shouldice ) showed no significance in the rate of complications . The per- protocol analysis for the comparison of mesh ( Lichtenstein , TAPP , TEP ) versus suturing ( Bassini , Shouldice ) techniques revealed that recurrences ( p = 0.74 ) , intraoperative ( p = 0.64 ) , perioperative ( p = 0.27 ) , and long-term complications ( p = 0.91 ) were evenly distributed . Conclusions In this multicenter study , no significant difference in the recurrence rate and complications between laparoscopic and open methods of hernia repair was revealed OBJECTIVE To compare the effects of laparoscopic inguinal hernia repair ( LIHR ) and Lichtenstein tension-free inguinal hernia repair and to explore the safety and feasibility of LIHR as well as the advantages and disadvantages of these procedures . SUBJECTS AND METHODS In total , 252 patients with inguinal hernia were equally r and omized into the transabdominal preperitoneal ( TAPP ) repair , totally extraperitoneal ( TEP ) repair , and Lichtenstein tension-free hernia repair groups ( n=84 each ) . Operating time , postoperative pain scores , postoperative scrotal seroma , postoperative local esthesiodermia , postoperative chronic pains , postoperative long-term hernia relapse , and costs of hospitalization were compared among the three groups . RESULTS All laparoscopic operations were performed smoothly without intraoperative conversion to open surgery . The LIHR groups showed significantly better effects on postoperative p
Output:
| Conclusions TEP and TAPP have their own advantages .
TEP repair reduces short-term postoperative pain more effectively than TAPP repair and results in shorter hospital stay of primary cases .
In contrast , TAPP repair is correlated with shorter surgery duration . |
MS212654 | ***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: Comm and hallucinations represent a special problem for the clinical management of psychosis . While compliance with both non-harmful and harmful comm and s can be problematic , sometimes in the extreme , active efforts to resist comm and s may also contribute to their malignancy . Previous research suggests Cognitive Behaviour Therapy ( CBT ) to be a useful treatment for reducing compliance with harmful comm and hallucinations . The purpose of this trial was to evaluate whether CBT augmented with acceptance-based strategies from Acceptance and Commitment Therapy could more broadly reduce the negative impact of comm and hallucinations . Forty-three participants with problematic comm and hallucinations were r and omized to receive 15 sessions of the intervention " TORCH " ( Treatment of Resistant Comm and Hallucinations ) or the control , Befriending , then followed up for 6 months . A sub- sample of 17 participants was r and omized to a waitlist control before being allocated to TORCH or Befriending . Participants engaged equally well with both treatments . Despite TORCH participants subjectively reporting greater improvement in comm and hallucinations compared to Befriending participants , the study found no significant group differences in primary and secondary outcome measures based on blinded assessment data . Within-group analyses and comparisons between the combined treatments and waitlist suggested , however , that both treatments were beneficial with a differential pattern of outcomes observed across the two conditions Background . Psychodynamic psychotherapy is a psychological treatment approach that has a growing empirical base . Research has indicated an association between therapist-facilitated affective experience and outcome in psychodynamic therapy . Affect-phobia therapy ( APT ) , as outlined by McCullough et al. , is a psychodynamic treatment that emphasizes a strong focus on expression and experience of affect . This model has neither been evaluated for depression nor anxiety disorders in a r and omized controlled trial . While Internet-delivered psychodynamic treatments for depression and generalized anxiety disorder exist , they have not been based on APT . The aim of this r and omized controlled trial was to investigate the efficacy of an Internet-based , psychodynamic , guided self-help treatment based on APT for depression and anxiety disorders . Methods . One hundred participants with diagnoses of mood and anxiety disorders participated in a r and omized ( 1:1 ratio ) controlled trial of an active group versus a control condition . The treatment group received a 10-week , psychodynamic , guided self-help treatment based on APT that was delivered through the Internet . The treatment consisted of eight text-based treatment modules and included therapist contact ( 9.5 min per client and week , on average ) in a secure online environment . Participants in the control group also received online therapist support and clinical monitoring of symptoms , but received no treatment modules . Outcome measures were the 9-item Patient Health Question naire Depression Scale ( PHQ-9 ) and the 7-item Generalized Anxiety Disorder Scale ( GAD-7 ) . Process measures were also included . All measures were administered weekly during the treatment period and at a 7-month follow-up . Results . Mixed models analyses using the full intention-to-treat sample revealed significant interaction effects of group and time on all outcome measures , when comparing treatment to the control group . A large between-group effect size of Cohen ’s d = 0.77 ( 95 % CI : 0.37–1.18 ) was found on the PHQ-9 and a moderately large between-group effect size d = 0.48 ( 95 % CI : 0.08–0.87 ) was found on the GAD-7 . The number of patients who recovered ( had no diagnoses of depression and anxiety , and had less than 10 on both the PHQ-9 and the GAD-7 ) were at post-treatment 52 % in the treatment group and 24 % in the control group . This difference was significant , χ2(N = 100 , d f = 1 ) = 8.3 , p < .01 . From post-treatment to follow-up , treatment gains were maintained on the PHQ-9 , and significant improvements were seen on the GAD-7 . Conclusion . This study provides initial support for the efficacy of Internet-delivered psychodynamic therapy based on the affect-phobia model in the treatment of depression and anxiety disorders . The results support the conclusion that psychodynamic treatment approaches may be transferred to the guided self-help format and delivered via the Internet Background Adults with attention deficit hyperactivity disorder ( ADHD ) often present with a lifelong pattern of core symptoms that is associated with impairments of functioning in daily life . This has a substantial personal and economic impact . In clinical practice there is a high need for additional or alternative interventions for existing treatments , usually consisting of pharmacotherapy and /or psycho-education . Although previous studies show preliminary evidence for the effectiveness of mindfulness-based interventions in reducing ADHD symptoms and improving executive functioning , these studies have method ological limitations . This study will take account of these limitations and will examine the effectiveness of Mindfulness Based Cognitive Therapy ( MBCT ) in further detail . Methods / design A multi-centre , parallel-group , r and omised controlled trial will be conducted in N = 120 adults with ADHD . Patients will be r and omised to MBCT in addition to treatment as usual ( TAU ) or TAU alone . Assessment s will take place at baseline and at three , six and nine months after baseline . Primary outcome measure will be severity of ADHD symptoms rated by a blinded clinician . Secondary outcome measures will be self-reported ADHD symptoms , executive functioning , mindfulness skills , self-compassion , positive mental health and general functioning . In addition , a cost-effectiveness analysis will be conducted . Discussion This trial will offer valuable information about the clinical and cost-effectiveness of MBCT in addition to TAU compared to TAU alone in adults swith ADHD.Trial registration Clinical Trials.gov NCT02463396 . Registered 8 June 2015 Objectives Evaluating and comparing the effectiveness of two smartphone-delivered treatments : one based on behavioural activation ( BA ) and other on mindfulness . Design Parallel r and omised controlled , open , trial . Participants were allocated using an online r and omisation tool , h and led by an independent person who was separate from the staff conducting the study . Setting General community , with recruitment nationally through mass media and advertisements . Participants 40 participants diagnosed with major depressive disorder received a BA treatment , and 41 participants received a mindfulness treatment . 9 participants were lost at the post-treatment . Intervention BA : An 8-week long behaviour programme administered via a smartphone application . Mindfulness : An 8-week long mindfulness programme , administered via a smartphone application . Main outcome measures The Beck Depression Inventory-II ( BDI-II ) and the nine-item Patient Health Question naire Depression Scale ( PHQ-9 ) . Results 81 participants were r and omised ( mean age 36.0 years ( SD=10.8 ) ) and analysed . Results showed no significant interaction effects of group and time on any of the outcome measures either from pretreatment to post-treatment or from pretreatment to the 6-month follow-up . Subgroup analyses showed that the BA treatment was more effective than the mindfulness treatment among participants with higher initial severity of depression from pretreatment to the 6-month follow-up ( PHQ-9 : F ( 1 , 362.1)=5.2 , p<0.05 ) . In contrast , the mindfulness treatment worked better than the BA treatment among participants with lower initial severity from pretreatment to the 6-month follow-up ( PHQ-9 : F ( 1 , 69.3)=7.7 , p<0.01 ) ; BDI-II : ( F(1 , 53.60)=6.25 , p<0.05 ) . Conclusions The two interventions did not differ significantly from one another . For participants with higher severity of depression , the treatment based on BA was superior to the treatment based on mindfulness . For participants with lower initial severity , the treatment based on mindfulness worked significantly better than the treatment based on BA . Trial registration Clinical Trials NCT01463020 BACKGROUND There appears to be consensus that patients with only one or two prior depressive episodes do not benefit from treatment with mindfulness-based cognitive therapy ( MBCT ) . AIMS To investigate whether the effect of MBCT on residual depressive symptoms is contingent on the number of previous depressive episodes ( trial number NTR1084 ) . METHOD Currently non-depressed adults with residual depressive symptoms and a history of depression ( ≤2 prior episodes : n = 71 ; ≥3 episodes : n = 59 ) were r and omised to MBCT ( n = 64 ) or a waiting list ( control : n = 66 ) in an open-label , r and omised controlled trial . The main outcome measured was the reduction in residual depressive symptoms ( Hamilton Rating Scale for Depression , HRSD-17 ) . RESULTS Mindfulness-based cognitive therapy was superior to the control condition across subgroups ( β = -0.56 , P<0.001 ) . The interaction between treatment and subgroup was not significant ( β = 0.45 , P = 0.16 ) . CONCLUSIONS Mindfulness-based cognitive therapy reduces residual depressive symptoms irrespective of the number of previous episodes of major depression Depression presents a serious condition for the individual and a major challenge to health care and society . Internet-based cognitive behavior therapy ( ICBT ) is a treatment option supported in several trials , but there is as yet a lack of effective studies of ICBT in “ real world ” primary care setting s. We examined whether ICBT differed from treatment-as-usual ( TAU ) in reducing depressive symptoms after 3 months . TAU comprised of visits to general practitioner , registered nurse , antidepressant drugs , waiting list for , or psychotherapy , or combinations of these alternatives . Patients , aged ≥ 18 years , who tentatively met criteria for mild to moderate depression at 16 primary care centers in the south-western region of Sweden were recruited and then assessed in a diagnostic interview . A total of 90 patients were r and omized to either TAU or ICBT . The ICBT treatment included interactive elements online , a workbook , a CD with mindfulness and acceptance exercises , and minimal therapist contact . The treatment period lasted for 12 weeks after which both groups were assessed . The main outcome measure was Beck Depression Inventory-II ( BDI-II ) . Additional measures were Montgomery Åsberg Depression Rating Scale – self rating version ( MADRS-S ) and Beck Anxiety Inventory ( BAI ) . The analyses revealed no significant difference between the two groups at post treatment , neither on BDI-II , MADRS-S , nor BAI . Twenty patients ( 56 % ) in the ICBT treatment completed all seven modules . Our findings suggest that ICBT may be successfully delivered in primary care and that the effectiveness , after 3 months , is at par with TAU Mindfulness-based cognitive therapy ( MBCT ) showed efficacy for currently depressed patients . However , most of the available studies suffer from important method ological shortcomings , including the lack of adequate control groups . The present study aims to compare MBCT with a psycho-educational control group design ed to be structurally equivalent to the MBCT program but excluding the main putative " active ingredient " of MBCT ( i.e. , mindfulness meditation practice ) for the treatment of patients with major depression ( MD ) who did not achieve remission following at least 8 weeks of antidepressant treatment . Out of 106 screened subjects , 43 were r and omized to receive MBCT or psycho-education and were prospect ively followed for 26 weeks . MD severity was assessed with the Hamilton Rating Scale for Depression ( HAM-D ) and the Beck Depression Inventory-II ( BDI-II ) . Measures of anxiety , mindfulness , and quality of life were also included . All assessment s were performed at baseline , 4 , 8 , 17 and 26-weeks . Both HAM-D and BDI scores , as well as quality of life and mindfulness scores , showed higher improvements , which were particularly evident over the long-term period , in the MBCT group than in the psycho-education group . Although limited by a small sample size , the results of this study suggest the superiority of MBCT over psycho-education for non-remitted MD subjects OBJECTIVES People in the late stage of bipolar disorder ( BD ) experience elevated relapse rates and poorer quality of life ( QoL ) compared with those in the early stages . Existing psychological interventions also appear less effective in this group . To address this need , we developed a new online mindfulness-based intervention targeting quality of life ( QoL ) in late stage BD . Here , we report on an open pilot trial of ORBIT ( online , recovery-focused , bipolar individual therapy ) . METHODS Inclusion criteria were : self-reported primary diagnosis of BD , six or more episodes of BD , under the care of a medical practitioner , access to the internet , proficient in English , 18 - 65 years of age . Primary outcome was change ( baseline - post-treatment ) on the Brief QoL.BD ( Michalak and Murray , 2010 ) . Secondary outcomes were depression , anxiety , and stress measured on the DASS scales ( Lovibond and Lovibond , 1993 ) . RESULTS Twenty-six people consented to participate ( Age M=46.6 years , SD=12.9 , and 75 % female ) . Ten participants were lost to follow-up ( 38.5 % attrition ) . Statistically significant improvement in QoL was found for the completers , t(15)=2.88 , 95 % CI:.89 - 5.98 , p=.011 , ( Cohen׳s dz=.72 , partial η(2)=.36 ) , and the intent
Output:
| Results support the effectiveness of web-based mindfulness interventions in reducing depression and anxiety and in enhancing quality of life and mindfulness skills , particularly in those with clinical anxiety . |
MS212655 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The purpose of the study was to assess the effect of sodium bicarbonate ingestion upon repeated bouts of intensive short duration exercise . Twenty-three subjects participated in the investigation ( 8 females and 15 males , age 21.4 + /- 2.3 , mean + /- sd ) . Subjects completed six trials ; three following the ingestion of sodium bicarbonate ( 300 mg/kg body weight ) and three following the ingestion of a placebo ( 8 g sodium chloride ) . Each trial consisted of ten ten-second sprints on a cycle ergometer with 50 seconds recovery between each sprint . ' Peak power ' and ' average power output ' during each ten second sprint was measured from the flywheel of the ergometer using a light-sensitive monitor ( Cranlea ) linked to a BBC microcomputer . The power outputs recorded during each ten-second sprint of the bicarbonate trials were then compared with those recorded during the corresponding sprint of the placebo trials . The bicarbonate trials produced higher mean ' average power ' outputs in all ten of the ten-second sprints , with the difference in ' average power ' output being statistically significant in eight of these ( p less than 0.05 ) . The results also revealed that the difference in the ' average power ' outputs attained during the bicarbonate and placebo trials increased as the number of sprint repetitions increased ( p less than 0.01 ) . ' Peak power ' output was also greater in the bicarbonate trials with it being significantly higher ( p less than 0.001 ) during the final ten-second sprint . It was concluded that during exercise consisting of repeated , short- duration sprints , power output was enhanced following the ingestion of sodium bicarbonate , ( 300 mg/kg body weight ) ABSTRACT The aim of this study was to investigate the effects of sodium bicarbonate ( NaHCO3 ) on 4 km cycling time trial ( TT ) performance when individualised to a predetermined time to peak blood bicarbonate ( HCO3− ) . Eleven male trained cyclists volunteered for this study ( height 1.82 ± 0.80 m , body mass ( BM ) 86.4 ± 12.9 kg , age 32 ± 9 years , peak power output ( PPO ) 382 ± 22 W ) . Two trials were initially conducted to identify time to peak HCO3− following both 0.2 g.kg−1 BM ( SBC2 ) and 0.3 g.kg−1 BM ( SBC3 ) NaHCO3 . Thereafter , on three separate occasions using a r and omised , double-blind , crossover design , participants completed a 4 km TT following ingestion of either SBC2 , SBC3 , or a taste-matched placebo ( PLA ) containing 0.07 g.kg−1 BM sodium chloride ( NaCl ) at the predetermined individual time to peak HCO3−. Both SBC2 ( −8.3 ± 3.5 s ; p < 0.001 , d = 0.64 ) and SBC3 ( −8.6 ± 5.4 s ; p = 0.003 , d = 0.66 ) reduced the time to complete the 4 km TT , with no difference between SBC conditions ( mean difference = 0.2 ± 0.2 s ; p = 0.87 , d = 0.02 ) . These findings suggest trained cyclists may benefit from individualising NaHCO3 ingestion to time to peak HCO3− to enhance 4 km TT performance Zabala , M , Requena , B , Sánchez-Muñoz , C , González-Badillo , JJ , García , I , Ööpik , V , and Pääsuke , M. Effects of sodium bicarbonate ingestion on performance and perceptual responses in a laboratory-simulated BMX cycling qualification series . J Strength Cond Res 22(5 ) : 1645 - 1653 , 2008-The objective of this study was to examine the effect of sodium bicarbonate ( NaHCO3− ) ingestion on performance and perceptual responses in a laboratory-simulated bicycle motocross ( BMX ) qualification series . Nine elite BMX riders volunteered to participate in this study . After familiarization , subjects undertook two trials involving repeated sprints ( 3 × Wingate tests [ WTs ] separated by 30 minutes of recovery ; WT1 , WT2 , WT3 ) . Ninety minutes before each trial , subjects ingested either NaHCO3− or placebo in a counterbalanced , r and omly assigned , double-blind manner . Each trial was separated by 4 days . Performance variables of peak power , mean power , time to peak power , and fatigue index were calculated for each sprint . Ratings of perceived exertion were obtained after each sprint , and ratings of perceived readiness were obtained before each sprint . No significant differences were observed in performance variables between successive sprints or between trials . For the NaHCO3− trial , peak blood lactate during recovery was greater after WT2 ( p < 0.05 ) and tended to be greater after WT3 ( p = 0.07 ) , and ratings of perceived exertion were not influenced . However , improved ratings of perceived readiness were observed before WT2 and WT3 ( p < 0.05 ) . In conclusion , NaHCO3− ingestion had no effect on performance and RPE during a series of three WT simulating a BMX qualification series , possibly because of the short duration of each effort and the long recovery time used between the three WTs . On the contrary , NaHCO3− ingestion improved perceived readiness before each WT PURPOSE The aim of this study was to determine the effects of sodium bicarbonate ingestion on prolonged intermittent exercise and performance . METHODS Eight healthy male subjects ( mean + /- SD : age 25.4 + /- 6.4 yr , mass 70.9 + /- 5.1 kg , height 179 + /- 7 cm , VO(2max ) 4.21 + /- 0.51 L.min-1 ) volunteered for the study , which had received ethical approval . Subjects undertook two 30-min intermittent cycling trials ( repeated 3-min blocks ; 90 s at 40 % VO(2max ) , 60 s at 60 % VO(2max ) , 14-s maximal sprint , 16-s rest ) after ingestion of either sodium bicarbonate ( NaHCO(3 ) ; 0.3 g.kg-1 ) or sodium chloride ( NaCl ; 0.045 g x kg(-1 ) . Expired air , blood lactate ( BLa ) , bicarbonate ( HCO(3)- ) , and pH were measured at rest , 30 and 60 min postingestion , and during the 40 % VO(2max ) component of exercise ( 4 , 10 , 16 , and 29 min ) . RESULTS After ingestion , pH increased from rest to 7.46 + /- 0.03 and 7.40 + /- 0.01 for NaHCO(3 ) and NaCl , respectively ( main effect for time and trial ; P < 0.05 ) . Values decreased at 15 min of exercise to 7.30 + /- 0.07 and 7.21 + /- 0.06 , respectively , remaining at similar levels until the end of exercise . BLa peaked at 15 min ( 12.03 + /- 4.31 and 10.00 + /- 2.58 mmol . L-1 , for NaHCO(3 ) and NaCl , respectively ; P > 0.05 ) remaining elevated until the end of exercise ( P < 0.05 ) . Peak power expressed relative to sprint 1 demonstrated a significant main effect between trials ( P < 0.05 ) . Sprint 2 increased by 11.5 + /- 5 % and 1.8 + /- 9.5 % for NaHCO(3 ) and NaCl , respectively . During NaHCO(3 ) , sprint 8 remained similar to sprint 1 ( 0.2 + /- 17 % ) , whereas a decrease was observed during NaCl ( -10.0 + /- 16.0 % ) . CONCLUSION The results of this study suggest that ingestion of NaHCO(3 ) improves sprint performance during prolonged intermittent cycling Siegler , JC and Gleadall-Siddall , D0 . Sodium bicarbonate ingestion and repeated swim sprint performance . J Strength Cond Res 24(11 ) : 3105 - 3111 , 2010-The purpose of the present investigation was to observe the ergogenic potential of 0.3 g·kg−1 of sodium bicarbonate ( NaHCO3 ) in competitive , nonelite swimmers using a repeated swim sprint design that eliminated the technical component of turning . Six male ( 181.2 ± 7.2 cm ; 80.3 ± 11.9 kg ; 50.8 ± 5.5 ml·kg−1·min−1 & OV0312;O2max ) and 8 female ( 168.8 ± 5.6 cm ; 75.3 ± 10.1 kg ; 38.8 ± 2.6 ml·kg−1·min−1 & OV0312;O2max ) swimmers completed 2 trial conditions ( NaHCO3 [ BICARB ] and NaCl placebo [ PLAC ] ) implemented in a r and omized ( counterbalanced ) , single blind manner , each separated by 1 week . Swimmers were paired according to ability and completed 8 , 25-m front crawl maximal effort sprints each separated by 5 seconds . Blood acid-base status was assessed preingestion , pre , and postswim via capillary finger sticks , and total swim time was calculated as a performance measure . Total swim time was significantly decreased in the BICARB compared to PLAC condition ( p = 0.04 ) , with the BICARB condition result ing in a 2 % decrease in total swim time compared to the PLAC condition ( 159.4 ± 25.4 vs. 163.2 ± 25.6 seconds ; mean difference = 4.4 seconds ; 95 % confidence interval = 8.7 - 0.1 ) . Blood analysis revealed significantly elevated blood buffering potential preswim ( pH : BICARB = 7.48 ± 0.01 , PLAC = 7.41 ± 0.01 ) along with a significant decrease in extracellular K+ ( BICARB = 4.0 ± 0.1 mmol·L−1 , PLAC = 4.6 ± 0.1 mmol·L−1 ) . The findings suggest that 0.3 g·kg−1 NaHCO3 ingested 2.5 hours before exercise enhances the blood buffering potential and may positively influence swim performance Abstract We have evaluated whether sodium bicarbonate , taken chronically ( 0.5 g · kg−1 body mass ) for a period of 5 days would improve the performance of eight subjects during 60 s of high-intensity exercise on an electrically braked cycle ergometer . The first test was performed prior to chronic supplementation ( pre-ingestion ) while the post-ingestion test took place 6 days later . A control test took place approximately 1 month after the cessation of all testing . Acid-base and metabolite data ( n = 7 ) were measured from arterialised blood both pre- and post-exercise , as well as daily throughout the exercise period . The work completed by the subjects in the control and pre-ingestion test [ 21.1 ( 0.9 ) and 21.1 ( 0.9 ) MJ , respectively ] was less than ( P < 0.05 ) that completed in the post-ingestion test [ 24.1 ( 0.9 ) MJ ; F(2,21 ) = 3.4 , P < 0.05 , power = 0.57 ] . Peak power was higher after the 5-day supplementation period ( P < 0.05 ) . Ingestion of the sodium bicarbonate for a period of 5 days result ed in an increase in pH ( F(5,36 ) = 12.5 , P < 0.0001 , power = 1.0 ) over the 5-day period . The blood bicarbonate levels also rose during the trial ( P < 0.05 ) from a resting level of 22.8 ( 0.4 ) to 28.4 ( 1.1 ) mmol · l−1 after 24 h of ingestion . In conclusion , the addition of sodium bicarbonate to a normal diet proved to be of ergogenic benefit in the performance of short-term , high-intensity work PURPOSE Sodium bicarbonate ( NaHCO3 ) ingestion may prevent exercise-induced perturbations in acid-base balance , thus result ing in performance enhancement . This study aim ed to determine whether different levels of NaHCO3 intake influences acid-base balance and performance during high-intensity exercise after 5 d of supplementation . METHODS Twenty-four men ( 22 + /- 1.7 yr ) were r and omly assigned to one of three groups ( eight subjects per group ) : control ( C , placebo ) , moderate NaHCO3 intake ( MI , 0.3 g x kg(-1 ) x d(-1 ) ) , and high NaHCO3 intake ( HI , 0.5 g x kg(-1 ) x d(-1 ) ) . Arterial pH , HCO3(- ) , PO2 , PCO2 , K+ , Na , base excess ( BE ) , lactate , and mean power ( MP ) were measured before and after a Wingate test pre- and postsupplementation . RESULTS HCO3(- ) increased proportionately to the dosage level . No differences were detected
Output:
| This meta- analysis provides evidence that chronic , but not acute , ingestion of NaHCO3 increases both Wingate test peak and mean power |
MS212656 | ***TASK*** the task is to summarize an input biomedical literature in 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 Occupational low back pain ( OLBP ) is widespread in industrialized societies . We present a model to estimate the net economic costs of investments in ergonomic interventions at the company level to reduce work-related low back pain . METHODS Costs of interventions are defined by incorporating not only the costs of investment of equipment and labor , but also by taking into account the avoided costs of lost work time , medical care costs , and productivity improvements . In the net-cost model , all costs are annualized and are calculated at the level of an individual organization . Three case studies have been performed based on data from three companies in the manufacturing sector of the United States using the above approach . RESULTS The net-cost estimates for the three case studies consistently show that ergonomic interventions applied appropriately can result in substantial cost savings for the companies . CONCLUSIONS Although generalizing on the basis of three case studies is not ideal , our analyses show that it might be in the economic interest of management to play a more active role to prevent back pain . Gathering useful retrospective cost data , even on interventions deemed effective by corporate innovators , proved to be extremely difficult . We conclude that it is essential to incorporate a protocol for collecting cost and effectiveness data in the st and ard operating procedures of ergonomists and companies introducing such innovation . We intend to vali date the net-cost model for the monitoring and reporting of such data through prospect i ve studies in a variety of industrial setting s and in countries at various stages of economic development BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program Study Design . R and omized controlled trial . Objectives . To investigate the effectiveness and costs of a mini-intervention , provided in addition to the usual care , and the incremental effect of a work site visit for patients with subacute disabling low back pain . Summary of Background Data . There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain . Methods . A total of 164 patients with subacute low back pain were r and omized to a mini-intervention group ( A ) , a work site visit group ( B ) , or a usual care group ( C ) . Groups A ( n = 56 ) and B ( n = 51 ) underwent one assessment by a physician plus a physiotherapist . Group B received a work site visit in addition . Group C served as controls ( n = 57 ) and was treated in municipal primary health care . All patients received a leaflet on back pain . Pain , disability , specific and generic health-related quality of life , satisfaction with care , days on sick leave , and use and costs of health care consumption were measured at 3- , 6- , and 12-month follow-ups . Results . During follow-up , fewer subjects had daily pain in Groups A and B than in Group C ( Group A vs. Group C , P = 0.002 ; Group B vs. Group C , P = 0.030 ) . In Group A , pain was less bothersome ( Group A vs. Group C , P = 0.032 ) and interfered less with daily life ( Group A vs. Group C , P = 0.040 ) than among controls . Average days on sick leave were 19 in Group A , 28 in Group B , and 41 in Group C ( Group A vs. Group C , P = 0.019 ) . Treatment satisfaction was better in the intervention groups than among the controls , and costs were lowest in the mini-intervention group . Conclusions . Mini-intervention reduced daily back pain symptoms and sickness absence , improved adaptation to pain and patient satisfaction among patients with subacute low back pain , without increasing health care costs . A work site visit did not increase effectiveness Background : Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders . Methods : This one year , r and omised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company . Participants were r and omised to receive ( 1 ) ergonomics training only , ( 2 ) training plus a trackball , ( 3 ) training plus a forearm support , or ( 4 ) training plus a trackball and forearm support . Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention . Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors , baseline pain levels , and psychosocial job factors . Results : Post-intervention , 63 participants were diagnosed with one or more incident musculoskeletal disorders . Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders ( HR = 0.49 , 95 % CI 0.24 to 0.97 ) after adjusting for baseline pain levels and demographic and psychosocial factors . The armboard also significantly reduced neck/shoulder pain ( p = 0.01 ) and right upper extremity pain ( p = 0.002 ) in comparison to the control group . A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months . Conclusion : Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees Musculoskeletal injuries in the workplace are recognized as a major health and economic problem ; however , little has been done to develop strategies that emphasize both quality and cost control . The purpose of this ten-year perspective investigation was to evaluate the use of quality -based st and ardized diagnostic and treatment protocol s as part of an unbiased injury surveillance system . The program was evaluated in a public utility company with more than 5300 employees , and result ed in a measurable and long-term improvement in all outcome parameters measured : ( 1 ) The number of days lost from work and the number of new injuries reported fell by 55 and 51 % , respectively . ( 2 ) The average time lost per injury dropped by 40 % . ( 3 ) The number of surgeries performed decreased by 67 % , and the operative success rate increased dramatically . ( 4 ) Finally , as an added benefit , there was a 60 % reduction in expenditures for lost time and replacement wages , result ing in a cumulative ten-year savings of more than 4.1 million dollars . The program accomplished the goal of ensuring quality care in a prospect i ve concurrent fashion . As an additional benefit , the program also reduced unjustified lost time and compensation costs through early functional return , efficient use of diagnostic studies , and avoidance of surgery whenever possible . Future emphasis on health-care delivery in the workers ' compensation setting should concentrate on high- quality medical care , which will , in turn , lead to secondary cost savings Study Design . A retrospective and prospect i ve cohort . Objectives . To compare the effectiveness of occupational intervention , early intervention , and st and ard care in the management of Worker ’s Compensation injury cl aims . Summary of Background Data . The current management of occupational back pain and work-related upper extremity disorders with either st and ard care or early intervention appears to be ineffective . Methods . A retrospective cohort compared injury cl aim incidence , duration , and costs between one company with access to st and ard care and another similar company with access to early intervention . A prospect i ve cohort looked at the effect of one company changing from st and ard care to occupational management in comparison with the control group with early intervention . Survival analysis was used to attempt to explain differences in injury cl aim duration . Results . St and ard care result ed in lower injury cl aim incidence , duration , and costs than early intervention , whereas occupational management result ed in lower injury cl aim incidence , duration , and costs than st and ard care . The covariates of physical therapist involvement , chiropractor involvement , injury severity , and relationship between Worker ’s Compensation and the employer were associated with delayed time to cl aim closure in the company with access to early intervention with the most important covariate being physical therapist involvement ( hazard rate ratio 19.88 , 95 % confidence interval 7.95–39.77 ) . Only the covariate of injury severity was associated with delayed time to cl aim closure in the company with access to occupational management ( hazard rate ratio 1.67 , 95 % confidence interval 1.05–27.20 ) . Conclusions . It is recommended that an occupational management approach , in comparison with st and ard care or early intervention , be considered for management of occupational injuries Aims : To test the long term cost-benefit and cost-effectiveness of the Sherbrooke model of management of subacute occupational back pain , combining an occupational and a clinical rehabilitation intervention . Methods : A r and omised trial design with four arms was used : st and ard care , occupational arm , clinical arm , and Sherbrooke model arm ( combined occupational and clinical interventions ) . From the Quebec WCB perspective , a cost-benefit ( amount of consequence of disease costs saved ) and cost-effectiveness analysis ( amount of dollars spent for each saved day on full benefits ) were calculated for each experimental arm of the study , compared to st and ard care . Results : At the mean follow up of 6.4 years , all experimental study arms showed a trend towards cost benefit and cost effectiveness . These results were owing to a small number of very costly cases . The largest number of days saved from benefits was in the Sherbrooke model arm . Conclusions : A fully integrated disability prevention model for occupational back pain appeared to be cost beneficial for the workers ’ compensation board and to save more days on benefits than usual care or partial interventions . A limited number of cases were responsible for most of the long term disability costs , in accordance with occupational back pain epidemiology . However , further studies with larger sample s will be necessary to confirm these results OBJECTIVES To determine the effectiveness and direct of two protective devices-a shielded 3 ml safety syringe ( Safety-Lok ; Becton Dickinson and Co. , Becton Dickinson Division , Franklin Lakes , N.J. ) and the components of a needleless IV system ( InterLink ; Baxter Healthcare Corp. , Deerfield , Ill.)--in preventing needlestick injuries to health care workers . DESIGN Twelve-month prospect i ve , controlled , before- and -after trial with a st and ardized question naire to monitor needlestick injury rates . SETTING Six hospital inpatient units , consisting of three medical units , two surgical units ( all of which were similar in patient census , acuity , and frequency of needlesticks ) , and a surgical-trauma intensive care unit , at a 900-bed urban university medical center . PARTICIPANTS All nursing personnel , including registered nurses , licensed practical nurses , nursing aides , and students , as well as medical teams consisting of an attending physician , resident physician , interns , and medical students on the study units . INTERVENTION After a 6-month prospect i ve surveillance period , the protective devices were r and omly introduced to four of the chosen study units and to the surgical-trauma intensive care unit . RESULTS Forty-seven needlesticks were reported throughout the entire study period , 33 in the 6 months before and 14 in the 6 months after the introduction of the protective devices . Nursing staff members who were using hollow-bore needles and manipulating intravenous lines accounted for the greatest number of needlestick injuries in the pre-intervention period . The overall rate of needlestick injury was reduced by 61 % , from 0.785 to 0.303 needlestick injuries per 1000 health care worker-days after the introduction of the protective devices ( relative risk = 1.958 ; 95 % confidence interval , 1.012 to 3.790 ; p = 0.046 ) . Needlestick injury rates associated with intravenous line manipulation , procedures with 3 ml syringes , and sharps disposal were reduced by 50 % ; however , reductions in these subcategories were not statistically significant . No seroconversions to HIV-1 or hepatitis B virus seropositivity occurred among those with needlestick injuries . The direct cost for each needlestick prevented was $ 789 . CONCLUSIONS Despite an overall reduction in needlestick injury rates , no statistically significant reductions could be directly attributed to the protective devices . These devices are associated with
Output:
| RESULTS We found strong evidence that ergonomic and other musculoskeletal injury prevention interventions in manufacturing and warehousing are worth undertaking in terms of their financial merits .
We also found strong evidence that multisector disability management interventions are worth undertaking .
While the economic evaluation of interventions in this literature warrants further expansion , we found a sufficient number of studies to identify strong , moderate , and limited evidence in certain industry-intervention clusters . |
MS212657 | ***TASK*** the task is to summarize an input biomedical literature in 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: This is an interval analysis of the 2-year prospect i ve multicenter Childrens Cancer Study Group study of 1,141 chronic venous access devices in 1,019 children with cancer . Device type was external catheter ( EC ) 72 % , totally implantable ( TID ) 28 % , and did not differ for diagnosis or age except more double-lumen devices in bone marrow transplant protocol s ( 77 % ) and more TIDs in children less than 1 year old ( 17.7 % ) . Insertion characteristics evaluated in 1,078 ( 95 % ) were : operating room placement 99 % ; general anesthesia 98 % ; cutdown 67 % ; percutaneous 33 % ; atrial position 50 % , caval position 50 % ; and perioperative antibiotics 48 % . Vein entry was the external jugular 33 % , internal jugular 22 % , subclavian 35 % , cephalic 7 % , and saphenous 3 % . Insertion was difficult or very difficult in only 10 % and operative complications occurred in only 0.7 % . Degree of difficulty bore no relationship to device type or patient age . The reasons for removal in 736 devices ( 67 % ) were due to complications in 39 % , of which infections were the most frequent . There was some variance between centers ranging from 8.5 % to 31 % for infection ; 2.8 % to 24 % for dislodgment ; and 0 % to 13 % for occlusion . ECs had a higher risk of dislodgment ; elective removals were more frequent in TIDs ; there was no difference in infection as a cause for removal between ECs and TIDs . Dislodgment was associated with the shortest distance of the cuff to the skin exit ( mean , 4 cm ) : less than or equal to 2 cm , 49 % ; greater than 2 cm , 28 % ( P = .009 ) and occurred most frequently in the younger patient ( 18.9 % , 0 to 1 years ; 0.5 % , greater than 8 years A group of 43 adult patients with acute leukaemia ( AL ) were r and omized to receive a double-lumen totally implantable subcutaneous port system ( PORT , n=19 ) or a double-lumen central venous catheter ( CVC , n=24 ) before induction chemotherapy . Six patients were excluded due to protocol violation ( n=4 , CVC ) and technical difficulties ( n=2 , PORT ) . A st and ardized catheter record form was used for recording of catheter function , local infection and bleeding . The study was prematurely closed due to extensive subcutaneous bleeding after placement in five patients with a PORT . Intention to treat ( n=43 ) or per protocol ( PP ) analysis ( n=37 ) did not reveal a significant difference between the two groups with regard to catheter survival time ( PP PORT , median 113 days , range 2–634 days ; CVC , 55 days , 11–223 days ) . The number of positive blood cultures per 100 central venous access device days was significantly higher in the CVC group ( median 3.6 per 100 days ) than in the PORT group ( 0.9 per 100 days ; P=0.02 ) . In addition , the time to the first blood culture positive for coagulase-negative staphylococcus was shorter in the CVC group ( median 14 days ) than in the PORT group ( 52 days ; P=0.02 ) . Despite fewer infectious complications in the PORT group the use of a double-lumen CVC is advocated in patients with AL undergoing induction treatment due to the risk of extensive local bleeding after placement of the PORT BACKGROUND The incidence of Hickman catheter sepsis is 10 % to 40 % , with result ant catheter loss in one third of infections . Urokinase causes dissolution of colonized intracatheter fibrin thrombi and may improve salvage . STUDY AIMS To evaluate the efficacy of 12-hour-interval slow-push urokinase infusion in addition to st and ard antibiotic therapy in the treatment of catheter sepsis in a pediatric oncology population . METHODS A two-arm r and omized double-blind trial was undertaken , with catheter salvage rate as the end point . Patients with Hickman catheter sepsis were r and omized after culture data confirmed the diagnosis . The study drug was administered by a slow intravenous push and given at 12-hour intervals for a total of four doses . The catheters were aspirated after 1 hour . RESULTS AND CONCLUSIONS The trial was stopped after 41 patients were entered into the study ; 18 patients received a placebo , and 23 received the urokinase . In the placebo group , six catheters were lost ; in the urokinase group , eight were lost . The rate of bacterial clearance was equivalent for both . After administration of the study drug , each group had three episodes of fever and chills ; two of these result ed in hypotension ( one in each group ) . The authors conclude that slow-push urokinase infusion during established Hickman catheter sepsis does not result in improved catheter salvage or bacterial clearance . Slow intravenous push infusions in this setting may provoke hemodynamic instability even after initiation of antibiotics From June 1982 until December 1989 , 93 permanent central venous catheters [ 59 external catheters ( ECs ) and 34 implanted catheters ( ICs ) ] were placed in 69 patients . The median age of these patients at placement was 5.6 years for ECs and 8.8 years for ICs ( P less than 0.05 ) . Follow-up evaluation was possible on 86 catheters ( 58 ECs and 28 ICs ) . The median time of insertion was 236 days and 316 days for ECs and ICs , respectively ( P less than 0.05 ) . The median number of open days was 58 for ECs and 66 for ICs ( not significant ) . 17 catheters ( 6 ECs and 11 ICs ) were transiently obstructed ( P less than 0.005 ) . 30 episodes of bacteraemia were documented in 20 patients . The incidence of catheter sepsis and bacteraemia of unknown source was one in 278 and 283 open days for ECs and ICs , respectively ( not significant ) . In this retrospective study , ECs appeared to be as safe as ICs when infection was correlated with use of the catheter , but this finding should be confirmed in a r and omised design Since 1984 , 316 subcutaneous ports ( SP ) and 339 external venous catheters ( EC ) [ Roko Catheter , The Hospital for Sick Children ( HSC ) ] have been inserted in hematology/ oncology patients at HSC . During a 22-month period ( July 1987 to April 1989 ) , a committed central line nurse ( J.I. ) prospect ively collected clinical and microbiologic data on 144 consecutive SPs and 130 consecutive ECs . Children with the SP had 0.6 infected lines and 0.7 infectious episodes per 1,000 patient days compared to 2.9 infected lines and 4.3 infectious episodes per 1,000 patient days with the EC ( p < 0.001 ) . This lower infectious complication rate with SP was demonstrated in the entire group of unselected patients and in a cohort of children with acute lymphoblastic leukemia ( ALL ) receiving intensive chemotherapy , and it was evident in all age groups . In view of the other advantages of SP – normal activity , absence of the need for home maintenance , improved body image , less expense – these data suggest that SPs are the preferred device in pediatric patients and provide effective venous access with acceptable complication rates PURPOSE To compare the frequency of infectious episodes or other problems occurring with an externalized catheter ( Hickman ) versus a subcutaneously implanted device ( Port-a-Cath , Pharmacia , Piscataway , NJ ) in cancer patients , we performed a prospect i ve , r and omized study in 100 cancer patients ( age range , 5 to 74 years ) . PATIENTS AND METHODS Patients who were chemotherapy c and i date s and required an indwelling catheter were monitored prospect ively and evaluated during the 180 days after the insertion of the catheter and again at time of study closure . The frequency of catheter use , reason for access , and any problems that might have been related to catheter use were noted . All data were collected prospect ively and included the patient 's age , sex , underlying malignancy , temperature , and leukocyte and absolute granulocyte counts at the time of catheter insertion and when complications occurred . The time to and reason for removal of the catheter , as well as any intercurrent infectious or mechanical problems , were also determined . RESULTS Most of the infections that occurred were caused by gram-positive organisms , especially staphylococci or streptococci . A total of 22 complications ( 11 in each group ) result ed in removal of the central line . Only one infection in the Hickman catheter group and four in the Port-a-Cath group led to removal of the central line . All other infectious episodes were successfully treated without removal of the catheters . The mean device life was 230 days for the Hickman catheter and 318 days for the Port-a-Cath ( not significant ) . CONCLUSION There were no differences between the two study groups regarding incidence of documented infections or mechanical or thrombotic complications PURPOSE Infection and thrombosis are serious complications of long-term vascular access devices in children undergoing chemotherapy . Since routine fibrinolytic therapy may decrease these complications , the purpose of this study was to compare the efficacy of an every-2-week administration of urokinase with st and ard heparin flushes in reducing the incidence of device-related infections and occlusions . MATERIAL S AND METHODS This study was a prospect i ve , r and omized phase III multicenter trial conducted by the Children 's Cancer Group , in which patients with implantable ports or tunneled catheters received either urokinase or heparin every 2 weeks for 12 months . Study end points were time to first occlusion or time to first device-related infection . RESULTS Five hundred seventy-seven patients from 29 institutions were enrolled , of whom 51 % had external catheters and 49 % had ports . Urokinase administration result ed in fewer occlusive events than heparin ( 23 % v 31 % ; P = .02 ) , a longer time to first occlusive event ( log-rank analysis , P = .006 ) , and a 1.6-fold difference in the rate of occlusive events ( Poisson regression , P = .003 ) . Similar results were noted when comparing ports and tunneled catheters . The urokinase group also had a 1.4-fold difference in the rate of infection ( Poisson regression , P = .05 ) and longer time to first infection ( log-rank , P = .07 ) , but the difference was significant only in tunneled catheters . CONCLUSION Urokinase administration every 2 weeks significantly affects the rate of occlusive events in ports and tunneled catheters and of infectious events in external catheters compared with heparin administration Long-term therapy of oncology patients has been facilitated by permanent indwelling central venous catheters , but catheter-related infections remain a serious complication of their use . Using a retrospective matched cohort design , we compared the risk of catheter-related infection in 47 adult solid tumor patients with right atrial Hickman catheters and 94 patients with totally implanted port catheters . Patients were matched for primary solid tumor , presence of metastases , age , gender , and date of catheter insertion . Seven of 47 patients with Hickman catheters developed catheter-related infection ( 1.8 infections/1,000 catheter days at risk ) compared with 10 of 94 patients with implanted port catheters ( 0.4/1000 catheter days , P less than 0.0002 ) . Hickman catheters were used more often for terminally ill patients than were port catheters which was a potential source of bias , but results were unchanged after stratifying patients on lifespan . Our study suggests that there are fewer infections in port than in Hickman catheters in adult patients with solid tumors , but prospect i ve r and omized studies are needed One hundred and forty-eight Hickman-Broviac ( HB ) catheters and 299 Port-a-Cath R ( PAC ) were inserted over the past 5 years at the Institut Jules Bordet . The HB catheter was associated with a complication rate of 4.1/1000 days of access , of which infections were the most common , leading to catheter removal in 22 % of patients . The average PAC remained in situ for 232.9 ( range 1 - 1298 ) days ; the complication rate was only 0.45/1000 days of access . The Hickman-Broviac catheter and the totally implanted port Port-a-Cath achieve safe and reliable venous access in cancer patients We prospect ively studied the continuous function and complication rates of 286 central venous catheters consecutively placed in 264 children and young adults at a single institution over a 19-month period ( median follow-up , 376 days ) . Externalized catheters ( 91 Hickman [ H ] , 113 Broviac [ B ] ) and implantable ports ( n = 82 ) were compared for complications , including infection and throm
Output:
| Conclusion The findings of this study showed that totally implantable ports are superior to external catheters in terms of catheter-associated complications . |
MS212658 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The additional effect of anterior cruciate ligament ( ACL ) reconstruction on muscle strength and physical performance after a structured exercise programme is not well understood . Objectives To investigate and compare muscle strength and physical performance test results after a structured exercise programme , in young active adults with acute ACL injury , between those treated with and without ACL reconstruction ( ACLR ) and to evaluate these test results as predictors of clinical outcomes 2 and 5 years after injury . Study design Prospect i ve cohort study . Methods In a treatment r and omised controlled trial of acute ACL injury ( the KANON- study ) , 87/121 young active adults underwent two muscle strength tests and five physical performance tests after a structured exercise programme ( median 37 ( IQR 24 ) weeks after injury ) . Results were presented and compared as limb symmetry indices ( LSI ) ; endpoints in predictive analyses were having a delayed ACLR over the first 5 years and self-reported knee function ( Knee injury and Osteoarthritis Outcome Score ; KOOS4 ) at 2 and 5 years . Results Overall , 74–95 % of patients had LSI≥90 % in the individual tests , with no difference between treatment groups ( p=0.08–0.92 ) . Results of the one-leg rise tests predicted KOOS4 at 2 and 5 years ( R2=0.25 and 0.24 , p=0.001 and 0.002 ) and vertical hop results predicted having a delayed ACLR over a 5-year course after injury ( p=0.048 ) in those starting with exercise alone ( n=21 ) . Conclusions After an acute ACL tear , the majority of young active adults regain physical performance and muscle strength after a structured exercise programme , with or without surgical reconstruction . Poor physical performance at the end of rehabilitation predicted worse patient-reported outcomes at 2 and 5 years regardless of treatment . Registration number : IS RCT N84752559 OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Purpose Several studies compare the short- and long-term results of anterior cruciate ligament ( ACL ) reconstruction using bone-patellar tendon-bone ( BPTB ) graft or double-looped semitendinosus and gracilis ( DLSG ) graft . However , no studies evaluate the long-term results of BPTB grafts fixed with metal interference screws and DLSG grafts fixed with the Bone Mulch Screw and the Washer Loc . This prospect i ve r and omized multicentre study has the null hypothesis that there is no difference in long-term outcome between the two procedures . Methods A total of 114 patients with a symptomatic ACL rupture were r and omized to reconstruction with either a BPTB graft ( N = 58 ) or a DLSG graft ( N = 56 ) . Follow-up was conducted after one , two and seven years . At the seven-year follow-up , 102 of the 114 patients ( 89 % ) were available for evaluation ; however , 16 of these by telephone-interview only . Results Ten patients in the BPTB group and 19 patients in the DLSG group underwent additional knee surgery ( P = 0.048 ) , two and three , respectively , of these were ACL revisions ( n.s . ) . The total flexion work was lower in the DLSG group ( P = 0.001 ) . The mean peak flexion torque and extension work , however , showed no difference between the groups . No significant differences were found between the groups regarding the Tegner activity score , the Lysholm functional score , the Knee injury and osteoarthritis outcome score ( KOOS ) , subjective knee function , anterior knee pain or mobility . There was no significant difference in laxity between the groups on the Lachman test or the KT-1,000 maximum manual force test . Conclusions Both grafts and fixation methods result ed in satisfactory subjective outcome and objective stability . Both these methods can therefore be considered as suitable alternatives for ACL reconstructions . Level of evidence II We investigated the long-term outcome of 100 patients 15 years after having been r and omly allocated to primary repair ( augmented or non-augmented ) or non-surgical treatment of an anterior cruciate ligament ( ACL ) rupture . The subjective outcome was similar between the groups , with no difference regarding activity level and knee-injury and osteoarthritis outcome score but with a slightly lower Lysholm score for the non-surgically treated group . This difference was attributed to more instability symptoms . The radiological osteoarthritis ( OA ) frequency did not differ between surgically or non-surgically treated patients , but if a meniscectomy was performed , two-thirds of the patients showed OA changes regardless of initial treatment of the ACL . There were significantly more meniscus injuries in patients initially treated non-surgically . One-third of the patients in the non-surgically treated group underwent secondary ACL reconstruction due to instability problems . In this study , ACL repair itself could not reduce the risk of OA nor increase the subjective outcome scores . However , one-third of the non-surgical treated patients were later ACL reconstructed due to instability . The status of the menisci was found to be the most important predictor of developing OA . Early ACL repair and also ACL reconstruction can reduce the risk of secondary meniscus tears . Indirectly this supports the hypothesis that early stabilization of the knee after ACL injury is advantageous for the long-term outcome Background There are conflicting results in the literature regarding the association between radiographic knee osteoarthritis ( OA ) and symptoms and function in subjects with previous anterior cruciate ligament ( ACL ) reconstruction . Aim To investigate the associations between radiographic tibiofemoral knee OA and knee pain , symptoms , function and knee-related quality of life ( QOL ) 10–15 years after ACL reconstruction . Study design Cross-sectional study . Material and methods 258 subjects were consecutively included at the time of ACL reconstruction and followed up prospect ively . The authors included the Knee Injury and Osteoarthritis Outcome Score to evaluate knee pain , other symptoms ( symptoms ) , activities of daily living and sport and recreation ( Sport/Rec ) and QOL . The subjects underwent st and ing radiographs 10–15 years after the ACL reconstruction . The radiographs were grade d with the Kellgren and Lawrence ( K&L ) classification ( grade 0–4 ) . Results 210 subjects ( 81 % ) consented to participate in the 10–15-year follow-up . Radiographic knee OA ( K&L ≥ grade 2 ) was detected in 71 % , and 24 % showed moderate or severe radiographic knee OA ( K&L grade s 3 and 4 ) . No significant associations were detected between radiographic knee OA ( K&L grade ≥2 ) and pain , function or QOL , respectively , but subjects with radiographic knee OA showed significantly increased symptoms . Severe radiographic knee OA ( K&L grade 4 ) was significantly associated with more pain , symptoms , impaired Sport/Rec and reduced QOL . Conclusion Subjects with radiographic knee OA showed significantly more symptoms than those without OA , and subjects with severe radiographic knee OA had significantly more pain , impaired function and reduced quality of life than those without radiographic knee OA 10–15 years after ACL reconstruction Background Specific guidelines for operative versus nonoperative management of anterior cruciate ligament injuries do not yet exist . Hypothesis Surgical risk factors can be used to indicate whether reconstruction or conservative management is best for an individual patient . Study Design Prospect i ve nonr and omized controlled clinical trial ; Level of evidence , 2 . Methods Patients were classified as high , moderate , or low risk using preinjury sports participation and knee laxity measurements . Early anterior cruciate ligament reconstruction ( within 3 months of injury ) was recommended to high-risk patients and conservative care to low-risk patients . It was recommended that moderate-risk patients have either early reconstruction or conservative care , according to the day of presentation . Assessment of subjective outcomes , activity , physical measurements , and radiographs was performed at mean follow-up of 6.6 years . Results Early phase conservative management result ed in more late phase meniscus surgery than did early phase reconstruction at all risk levels ( high risk , 25 % vs 6.5 % ; moderate risk , 37 % vs 7.7 % , P = . 01 ; low risk , 16 % vs 0 % ) . Early- and late-reconstruction patients ’ Tegner scores increased from presurgery to follow-up ( P < . 001 ) but did not return to preinjury levels . Early-reconstruction patients had higher rates of degenerative change on radiographs than did nonreconstruction patients ( P < . 05 ) . Conclusions Early phase reconstruction reduced late phase knee laxity , risk of symptomatic instability , and the risk of late meniscus tear and surgery . Moderate- and high-risk patients had similar rates of late phase injury and surgery . Reconstruction did not prevent the appearance of late degenerative changes on radiographs . Relationship between bone contusion on initial magnetic resonance images and the finding of degenerative changes on follow-up radiographs were not detected . The treatment algorithm used in this study was effective in predicting risk of late phase knee surgery Background Anterior cruciate ligament injuries are common in athletes , but there are few studies of long-term outcomes . Hypothesis Long-term knee function of anterior cruciate ligament-injured athletes is inferior to that of their uninjured teammates . Study Design Retrospective cohort study . Methods Thirty-three Division I-A athletes who had sustained an anterior cruciate ligament injury during their college career completed a series of question naires that assessed knee function and quality of life 2 to 14 years after injury . Their responses were compared with those of a matched cohort of their uninjured teammates . Results There were no differences in the mean Tegner scores , modified Lysholm scores , or in the scores of the SF-36 between groups . Sixteen anterior cruciate ligament-injured athletes scored A or B in the subjective portion of the International Knee Documentation Committee score and 17 scored C or D , whereas 24 control subjects scored A or B and 9 scored C or D , a statistically significant difference between groups . Five injured and 14 control athletes had participated at a professional or national team level after college . Conclusions Quality of life of elite collegiate athletes who sustained an anterior cruciate ligament injury was not significantly different from that of their uninjured teammates , but knee function differed between groups PURPOSE The purpose of the study was to quantify the amount of agreement among orthopaedic surgeons regarding the natural history of the anterior cruciate ligament (ACL)-deficient knee , surgery , and rehabilitation , and the treatment of these patients . TYPE OF STUDY Physician mail survey . METHODS Orthopaedic surgeons were r and omly selected from the American Academy of Orthopaedic Surgeons ( AAOS ) directory . Only individuals who treated or referred ACL-insufficient patients for treatment within the past year were asked to complete the 3-page survey . The survey included 25 questions regarding clinical opinion . Clinical agreement was present when 80 % or more of the surgeons agreed on the same response option . RESULTS The total number of surgeons who responded to the survey was 397 ( response rate , 54.8 % ) and the number who had treated or referred ACL-insufficient patients in the past year was 261 . Among surgeons who completed the question naire , the response rates to the individual questions ranged from 92 % to 100 % . The mean response rate for all questions was 97.4 % . The mean age of the surgeons was 48.4 years , and 35.8 % considered their practice to be a subspecialty in sports medicine or knee surgery . For
Output:
| This systematic review found impaired knee-related QOL in ACL-deficient individuals ≥5 years after ACL rupture , compared to population norms .
Meta- analysis revealed similar knee-related QOL in ACL-deficient and ACL-reconstructed groups , and no difference in health-related QOL scores for seven of the eight SF-36 domains |
MS212659 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Aims /hypothesisGait characteristics and balance are altered in diabetic patients . Little is known about possible treatment strategies . This study evaluates the effect of a specific training programme on gait and balance of diabetic patients . Methods This was a r and omised controlled trial ( n = 71 ) with an intervention ( n = 35 ) and control group ( n = 36 ) . The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening ( twice weekly over 12 weeks ) . Controls received no treatment . Individuals were allocated to the groups in a central office . Gait , balance , fear of falls , muscle strength and joint mobility were measured at baseline , after intervention and at 6-month follow-up . Results The trial is closed to recruitment and follow-up . After training , the intervention group increased habitual walking speed by 0.149 m/s ( p < 0.001 ) compared with the control group . Patients in the intervention group also significantly improved their balance ( time to walk over a beam , balance index recorded on Biodex balance system ) , their performance-oriented mobility , their degree of concern about falling , their hip and ankle plantar flexor strength , and their hip flexion mobility compared with the control group . After 6 months , all these variables remained significant except for the Biodex sway index and ankle plantar flexor strength . Two patients developed pain in their Achilles tendon : the progression for two related exercises was slowed down . Conclusions /interpretationSpecific training can improve gait speed , balance , muscle strength and joint mobility in diabetic patients . Further studies are needed to explore the influence of these improvements on the number of reported falls , patients ’ physical activity levels and quality of life . Trial registration : Clinical Trials.gov NCT00637546 Funding : This work was supported by the Swiss National Foundation ( SNF ) : OBJECTIVE To determine the effect of a specific exercise regimen on clinical measures of postural stability and confidence in a population with peripheral neuropathy ( PN ) . DESIGN Prospect i ve , controlled , single blind study . SETTING Outpatient clinic of a university hospital . PARTICIPANTS Twenty subjects with diabetes mellitus and electrodiagnostically confirmed PN . INTERVENTION Ten subjects underwent a 3-week intervention exercise regimen design ed to increase rapidly available distal strength and balance . The other 10 subjects performed a control exercise regimen . MAIN OUTCOME MEASURES Unipedal stance time , functional reach , t and em stance time , and score on the activities-specific balance and confidence ( ABC ) scale . RESULTS The intervention subjects , but not the control subjects , showed significant improvement in all 3 clinical measures of balance and nonsignificant improvement on the ABC scale . CONCLUSION A brief , specific exercise regimen improved clinical measures of balance in patients with diabetic PN . Further studies are needed to determine if this result translates into a lower fall frequency in this high-risk population There is insufficient evidence to support the use of exercise in the management of chronic disablement in people with inflammatory peripheral neuropathy . Therefore , our study aim ed to determine the feasibility and effectiveness of a physiotherapist prescribed community based exercise programme for reducing chronic disablement in patients with stable motor neuropathy . We assessed the effects of a 12 week unsupervised , community based strengthening , aerobic and functional exercise programme on activity limitation and other measures of functioning in 16 people with stable motor neuropathy and 10 healthy control subjects . Fourteen of 16 patients and 8 out of 10 healthy control subjects completed the study and exercised safely in the community with no adverse events . Significant improvements were seen in all measures of activity limitation and in wider measures of health including anxiety , depression and fatigue in the patient group . Improvements were sustained at six months after completion of the exercise programme , except for depression . Ten patients continued to exercise regularly at six months . These findings demonstrate that individually prescribed community based exercise is feasible and acceptable for people with stable motor neuropathy and participation in exercise may be successful in reducing chronic disablement . Future r and omised controlled trials are needed to examine the efficacy of this complex community based intervention BACKGROUND Lymphoma patients undergoing therapy must cope with the side-effects of the disease itself , therapy and associated immobility . Peripheral neuropathy ( PNP ) , loss of balance control and weakness not only diminishes patients ' quality of life ( QOL ) , it can also affect planning and the dosage of therapy . Exercise may enable patients to reverse these declines , improving their performance level and QOL . PATIENTS AND METHODS We carried out a r and omized , controlled trial , assigning 61 lymphoma patients either to a control group ( CG ; N=31 ) or to a 36-week intervention ( IG ; N=30 ) , consisting of sensorimotor- , endurance- and strength training twice a week . Primary end point was QOL ; secondary end points included movement coordination , endurance , strength and therapy-induced side-effects . RESULTS Intergroup comparison revealed improved QOL- ( ΔT1-T0 ; P=0.03 ) and PNP-related deep sensitivity in the IG : 87.5 % were able to reduce the symptom , compared with 0 % in the CG ( P<0.001 ) . Significant differences in the change of balance control could be found between the groups , with the IG improving while the CG steadily declined ( monopedal static ΔT3-T0 ; P=0.03 ; dynamic ΔT3-T0 ; P=0.007 ; perturbed mono-ΔT3-T0 ; P=0.009 and bipedal ΔT3-T0 ; P=0.006 ) , failed attempts ( monopedal static ΔT3-T0 ; P=0.02 , dynamic ΔT3-T0 ; P<0.001 and perturbed ΔT3-T0 ; P=0.006 ) and improved time to regain balance ( ΔT3-T0 ; P=0.04 ) . Moreover , the change in the aerobic performance level ( ΔT3-T0 ; P=0.05 ) and additional amount of exercise carried out per week [ metabolic equivalent ( MET ) ; P=0.02 ] differed significantly across groups . CONCLUSIONS Exercise , especially sensorimotor training , is a feasible and promising method to support cancer patients during therapy . It improves patients QOL , reduces restrictions from side-effects such as PNP and improves patients ' balance control , physical performance level and mobility . GERMAN CLINICAL TRIALS REGISTER NUMBER DRKS00003894 This study was design ed to determine whether a 6-month Tai Chi exercise program can improve self-reported physical functioning limitations among healthy , physically inactive older individuals . Ninety-four community residents ages 65 to 96 ( M age = 72.8 years , SD = 5.1 ) volunteered to participate in the study . Participants were r and omly assigned to either a 6-month experimental ( Tai Chi ) group ( n = 49 ) , which exercised twice per week for 60 min , or a wait-list control group ( n = 45 ) . A 6-item self-report physical functioning scale , assessing the extent of behavioral dysfunction caused by health problems , was used to evaluate change in physical functioning limitations as a result of Tai Chi intervention . Results indicated that compared to the control group , participants in the Tai Chi group experienced significant improvements in all aspects of physical functioning over the course of the 6-month intervention . Overall , the experimental group had 65 % improvement across all 6 functional status measures ranging from daily activities such as walking and lifting to moderate-vigorous activities such as running . It was concluded that the 6-month Tai Chi exercise program was effective for improving functional status in healthy , physically inactive older adults . A self-paced and self-controlled activity such as Tai Chi has the potential to be an effective , low-cost means of improving functional status in older persons OBJECTIVE To assess the efficacy of a balance rehabilitation treatment by using both a powered platform on which subjects st and and specific physical exercises ( EXs ) . DESIGN Crossover trial . SETTING Physical and rehabilitation medicine department in Italy . PARTICIPANTS Patients ( N=33 ) with balance disorders ( 14 vestibular origin , 19 peripheral neuropathy origin ) . INTERVENTIONS Patients underwent powered platform then EX treatment ( n=17 ) ; the other 16 received the same treatments in reverse order . powered platform consisted of balancing on a sinusoidally oscillating powered platform ( in anteroposterior and laterolateral directions in separate trials ) with eyes open and closed . A physical therapist administered Cawthorne-Cooksey EXs for patients with vestibular disorders and modified Frenkel EXs for patients with neuropathy . Treatment lasted 1 hour a day for 10 consecutive days , except for the weekend . MAIN OUTCOME MEASURES Body sway area , subjective score of stability , balance and gait scores , and amplitude of head displacement while balancing on the oscillating powered platform were recorded before , ( t0 ) after the first ( t1 ) , and after the second treatment ( t2 ) , regardless of the powered platform or EX order . RESULTS On average , all participants improved balance regardless of the order of treatments , and more so at t2 than t1 . Improvement was observed by using instrumental evaluations and balance and gait scales . In both patient groups , powered platform treatment proved to be as effective as EX in improving balance . This effect was stronger in patients with vestibular disorders , independently of order of treatment . CONCLUSIONS Balance rehabilitation with either EX or powered platform is effective in patients with balance disorders of vestibular or neuropathic origin . These findings point to the value of either or both physical EXs and powered platform in increasing stability and potentially decrease the risk of falling in patients with neuropathy , for whom few results are documented in the literature BACKGROUND Diabetes is the most important cause of peripheral neuropathy ( DPN ) . No definitive treatment for DPN has been established , and very few data on the role of exercise training on DPN have been reported . AIM OF THE STUDY We sought to examine the effects of long-term exercise training on the development of DPN in both Types 1 and 2 diabetic patients . PARTICIPANTS AND METHODS Seventy-eight diabetic patients without signs and symptoms of peripheral DPN were enrolled , r and omized , and subdivided in two groups : 31 diabetic participants [ 15 f , 16 m ; 49+/-15.5 years old ; body mass index ( BMI ) = 27.9+/-4.7 ] , who performed a prescribed and supervised 4 h/week brisk walking on a treadmill at 50 % to 85 % of the heart rate reserve ( exercise group : EXE ) , and a control group of 47 diabetic participants ( CON ; 24 f , 23 m ; 52.9+/-13.4 years old ; BMI = 30.9+/-8.4 ) . Vibration perception threshold ( VPT ) , nerve distal latency ( DL ) , nerve conduction velocity ( NCV ) , and nerve action potential amplitude ( NAPA ) in the lower limbs were measured . RESULTS We found significant differences on Delta ( delta ) in NCV for both peroneal and sural motor nerve between the EXE and CON groups during the study period ( P<.001 , for both ) . The percentage of diabetic patients that developed motor neuropathy and sensory neuropathy during the 4 years of the study was significantly higher in the CON than the EXE group ( 17 % vs. 0.0 % , P<.05 , and 29.8 % vs. 6.45 % , P<.05 , respectively ) . In addition , the percentage of diabetic patients who developed increased VPT ( 25 V ) during the study was significantly higher in the CON than the EXE group ( 21.3 % vs. 12.9 % , P<.05 ) . Change on Hallux VPT from baseline to the end of the study was significantly different between the EXE and CON groups ( P<.05 ) ; no significant change in Malleolus VPT between the two groups occurred . CONCLUSIONS This study suggests , for the first time , that long-term aerobic exercise training can prevent the onset or modify the natural history of DPN Background : Pain is a common symptom in peripheral neuropathies . The factors determining why some peripheral neuropathies are painful and others are not are incompletely understood . Pro-inflammatory cytokines have been implicated to play a crucial role in the generation of pain . Objective : To investigate whether cytokine profiles differ between patients with painful or painless neuropathy . Methods : In this prospect i ve study , we analyzed blood mRNA and protein levels of the pro-inflammatory cytokines interleukin-2 ( IL-2 ) and tumor necrosis factor-α ( TNF ) and the anti-inflammatory cytokines IL-4 and IL-10 in 32 patients with painful neuropathy , 20 patients with painless neuropathy , and 38 healthy control subjects , using quantitative real-time PCR and ELISA . Results : Patients with a painful neuropathy had about twofold higher IL-2 mRNA ( p = 0.001 ) and TNF mRNA ( p < 0.0001 ) and protein levels ( p = 0.009 ) than healthy control subjects and about twofold higher IL-2 and TNF mRNA ( p = 0.03 ; p = 0.001 ) and protein levels ( p = 0.04 ; p = 0.04 ) than patients with painless neuropathy . In contrast , mRNA levels of the anti-inflammatory cytokine IL-10 were about twofold higher in patients with painless neuropathy than in patients with painful neuropathy ( p = 0.001 ) and controls ( p
Output:
| Current data suggests that exercise is a feasible , safe , and promising supportive measure for neuropathic patients .
This is best documented for patients with diabetic peripheral neuropathy ( DPN ) , suggesting that endurance training has the potential to prevent the onset of and reduce the progression of DPN .
In general , balance exercises showed the highest effect on the motor as well as sensory symptoms in all types of PNP .
Conclusion Overall , balance training appears to be the most effective exercise intervention .
Studies focusing exclusively on strength , or a combination of endurance and strength , appear to have a lower impact .
For metabolically-induced neuropathies , endurance training also plays an important role . |
MS212660 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Three parallel studies on screening for lung cancer , supported by the National Cancer Institute , were carried out by the Mayo Clinic , Johns Hopkins Medical Institutions , and Memorial Sloan-Kettering Center from 1971 to 1982 . No significant mortality improvement was established that could be attributed to cytologic screening examinations . Many stage I lung cancers were detected by radiographic screening , with excellent changes for long-term survival . Patients with stage I cancers who were operated on had significantly better survival rates than those who failed to undergo surgery . Statistical modeling , however , indicates that long-term annual screening of a high-risk population would decrease lung cancer mortality by no more than 18 % Background . Ovarian cancer is the fifth most common cause of cancer‐related death in American women . The median age at diagnosis is about 62 years ; incidence rises rapidly after age 60 . Pelvic examination has been the primary method for detection of ovarian carcinoma . It is insensitive for the detection of early disease , however : most women present with disease beyond the pelvis ( Stages III and IV ) and are not curable with existing techniques . Two new technologies may be useful as screening tools for earlier detection of ovarian cancer . CA 125 is an antigenic determinant expressed on an ovarian cancer cell line . Transvaginal ultrasound ( TVUS ) images the ovaries from within the vagina and can be performed by a technician in about 10 minutes . In small preoperative studies of women with ovarian masses , serum CA 125 levels have been elevated ( typically above 35 U/ml ) in over two‐thirds of cases and in up to 50 % of Stage I cases . The test is not absolutely specific : elevations have been reported with pregnancy , endometriosis , menstruation , benign ovarian tumors , and with cancers of the breast , colon , pancreas , lung , stomach , and liver . Nevertheless , the specificity of CA 125 in postmenopausal women has been reported at about 95 % or more . TVUS provides higher resolving power for ovarian abnormalities than transabdominal ultrasound or physical examination ; however , experience with it is limited . CA 125 and TVUS may be complementary In a controlled investigation the survival prospect s of lung cancer in a population of men aged 40 and over who had been offered six-monthly chest radiographs over a period of three years were compared with lung cancer in a similar population without such x-ray facilities . The five-year survival rate of lung cancer in the study series was 15 % , and in cases discovered by six-monthly examination 23 % , compared with 6 % in the control series . The average expectation of life after diagnosis was 2·5 years for the test cases and 1·2 for the control cases . Survival declined with age . Of resected lung cancer , 32 % survived five years in the test series and 23 % in the control series . The five-year survival rate for squamous carcinoma and adenocarcinoma in the test series was 28 % and 25 % respectively , compared with 15 % and nil in the control series . On the basis of these results it is concluded that through earlier radiological detection a modest improvement in the prognosis of lung cancer can be achieved The Memorial Sloan-Kettering lung cancer screening program was begun in 1974 to evaluate sputum cytology as a supplement to the annual chest x-ray examination for early detection and diagnosis . The 10,040 adult , male cigarette smokers who enrolled were r and omly assigned to receive annual chest x-ray examinations only or a dual screen with annual chest x-ray examination and four monthly sputum cytology evaluation . Over 40 percent of the 288 who developed lung cancer were diagnosed in stage I , and their survival was 76 percent at five years ; overall survival was 35 percent . Nearly one third of the lung cancers detected on first examination on the dual screen , and 14 percent of those on subsequent examinations were found by cytologic examination . The same number of cancers developed in the x-ray screen only group , and were diagnosed at a later date . Despite the delay , survival and mortality were the same , suggesting that the squamous carcinomas detected by cytologic examination alone are very slow growing and tend to remain localized until detectable by x-ray examination BACKGROUND The Mayo Lung Project ( MLP ) was a r and omized , controlled clinical trial of lung cancer screening that was conducted in 9211 male smokers between 1971 and 1983 . The intervention arm was offered chest x-ray and sputum cytology every 4 months for 6 years ; the usual-care arm was advised at trial entry to receive the same tests annually . No lung cancer mortality benefit was evident at the end of the study . We have extended follow-up through 1996 . METHODS A National Death Index-PLUS search was used to assign vital status and date and cause of death for 6523 participants with unknown information . The median survival for lung cancer patients diagnosed before July 1 , 1983 , was calculated by use of Kaplan-Meier estimates . Survival curves were compared with the log-rank test . RESULTS The median follow-up time was 20.5 years . Lung cancer mortality was 4.4 ( 95 % confidence interval [ CI ] = 3.9 - 4.9 ) deaths per 1000 person-years in the intervention arm and 3.9 ( 95 % CI = 3.5 - 4.4 ) in the usual-care arm ( two-sided P : for difference = .09 ) . For participants diagnosed with lung cancer before July 1 , 1983 , survival was better in the intervention arm ( two-sided P : = .0039 ) . The median survival for patients with resected early-stage disease was 16.0 years in the intervention arm versus 5.0 years in the usual-care arm . CONCLUSIONS Extended follow-up of MLP participants did not reveal a lung cancer mortality reduction for the intervention arm . Similar mortality but better survival for individuals in the intervention arm indicates that some lesions with limited clinical relevance may have been identified in the intervention arm The Multiphasic Health Checkup Evaluation Study , a long-term clinical trial , has been completed . A study group of 5156 men and women age 35 - 54 at entry was urged to have annual multiphasic health checkups ( MHCs ) for 16 years . A control group of 5557 comparable subjects was not so urged but was followed up in a comparable fashion . The mean and median number of MHCs per person were 6.8 and 6 , respectively , in the study group and 2.8 and 1 , respectively , in the control group . During 16 years the study group experienced a 30 % reduction ( p less than 0.05 ) in deaths from pre-specified " potentially postponable " causes , largely associated with lower death rates from colorectal cancer and hypertension . This reduction was most pronounced in the early years of the study . The two groups did not differ to a statistically significant degree in mortality from all other causes ( 84 % of total mortality ) or in total mortality . There was no difference in self-reported disability in the overall groups . In the setting of our prepaid health care plan where MHCs were already available on a voluntary basis , a program of urging middle-aged persons to undergo regular MHCs brought about a substantial reduction in mortality from preselected diseases Cigarette‐smoking males ( 6,364 ) , aged 40–64 , were r and omized into an intervention group which received 6‐monthly screening by chest X‐ray and sputum cytology , and a control group which received no asymptomatic investigation . After 3 years , both groups entered a follow‐up period during which they received annual chest X‐rays . Lung cancer cases detected by screening were identified at an earlier stage , more often resectable , and had a significantly better survival than “ interval ” cases diagnosed mainly because of symptoms . Comparison of the 2 groups showed a higher incidence of lung cancer in the intervention group , despite the follow‐up period when both groups received annual examinations . There was no significant difference in mortality between the 2 groups The study was launched in the mid‐1970s to explore the capability of screening by chest X‐ray and sputum cytology to be used as an effective component of the lung cancer control program in the Czech Republic , a Central European country with a high and increasing occurrence of lung cancer in men at that time . A complementary objective of this report is to ascertain whether the cumulative numbers of lung cancer deaths would equalize in the two r and omized groups during a prolonged follow‐up period A prospect i ve and controlled study for early detection of lung cancer in the county of Erfurt with a follow-up of 10 years is presented . A collective of 41,532 males born between 1907 and 1932 was screened by chest fluorography at 6 month intervals and compared with a control group consisting of 102,348 males of the same age , who were screened at intervals of about 18 months . No significant reduction of overall mortality and of lung cancer mortality was achieved . Semi-annual screening brought about a higher detection rate ( 9%/6.5 % ) , an increase in the resection rate ( 28%/19 % ) and higher 5 and 10 year survival rates ( 52 % ; 27%/39 % ; 19 % ) of resected patients than screening in 18 month intervals . Among those patients who refused resection or were surgically untreatable , the difference in survival rates between the two investigation groups lasted only up to the 12 months barrier . This is regarded as the effect of the lead-time bias . Fluorographic screening is effective only in patients with peripheral cancers . Patients resected for central lung cancers did not show differences in the survival rates . In both investigation groups considered together surgical therapy was possible mainly in those patients who had been detected by screening ( resection rate : 48 % ; 5 yr survival rate : 26.9 % ) . The resection rate of all the others amounted to 9 % , the 5 yr survival rate to 1.4 % . Therefore we consider fluorography to time as the only chance for lung cancer control of high risk groups in spite of the absence of reduction of lung cancer mortality The Early Lung Cancer Action Project ( ELCAP ) is design ed to evaluate baseline and annual repeat screening by low radiation dose computed tomography ( low‐dose CT ) in persons at high‐risk for lung cancer . The authors report on the baseline screening experience . For full evaluation of screening , they await the results of annual repeat screening Objectives To examine whether age at entry , history of cigarette smoking , exposure to non-tobacco lung carcinogens , or previous pulmonary illnesses were confounders or effect modifiers of the relation between screening and lung cancer mortality in the Mayo Lung Project . Setting —The Mayo Lung Project was a r and omised , controlled , clinical trial conducted between 1971 and 1986 in 9211 male smokers over the age of 45 in Minnesota ( USA ) . The group screened received chest x ray examination and sputum cytology every four months for six years . The unscreened group were recommended to obtain usual care ( annual chest x ray examination and sputum cytology ) . After follow up , lung cancer mortality was similar in both groups . Methods —Proportional hazard models were used to analyse data . A variable was considered a confounder if its inclusion in a model changed the rate ratio for screening by more than 15 % ; a variable was considered an effect modifier if its stratum-specific rate ratio for screening differed by a factor of two . Results None of the four aforementioned variables changed the rate ratio associated with screening ( 1.07 ) by more than 2 % . The effect of screening may have differed by years smoked ( rate ratio for smoking fewer than 30 years 2.4 ; rate ratio for smoking 30 or more years 1.0 ) , though we suspect that this result occurred by chance . Conclusion Adjustment for or stratification by four established lung cancer risk factors did not alter the original findings of the Mayo Lung Project
Output:
| The current evidence does not support screening for lung cancer with chest radiography or sputum cytological examination .
Frequent chest radiography might be harmful . |
MS212661 | ***TASK*** the task is to summarize an input biomedical literature in 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: Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity Abstract : To examine the risk of mortality following all clinical fractures , we followed 6459 women age 55–81 years participating in the Fracture Intervention Trial for an average of 3.8 years . All fractures and deaths were confirmed by medical record or death certificate . Clinical fractures were fractures that came to medical attention . Fracture status was used as a time-dependent covariate in proportional hazards models . The 907 women who experienced a fracture were older , had lower bone mineral density and were more likely to report a positive fracture history . A total of 122 women died over the course of the study with 23 of these deaths occurring after a clinical fracture . The age-adjusted relative risk ( 95 % confidence intervals ) of dying following a clinical fracture was 2.15 ( 1.36 , 3.42 ) . This primarily reflected the higher mortality following a hip fracture , 6.68 ( 3.08 , 14.52 ) ; and clinical vertebral fracture , 8.64 ( 4.45 , 16.74 ) . Results were similar after adjusting for treatment assignment , health status and specific common comorbidities . There was no increase in mortality following a forearm or other fracture ( non-hip , non-wrist , non-vertebral fracture ) . In conclusion , clinical vertebral fractures and hip fractures are associated with a substantial increase in mortality among a group of relatively healthy older women SUMMARY Objective : To compare the effects of alendronate ( ALN ) 70 mg once weekly ( OW ) and risedronate ( RIS ) 5 mg daily between-meal dosing on biochemical markers of bone turnover and bone mineral density ( BMD ) in postmenopausal women with osteoporosis . Research design and methods : This was a 3-month , r and omised , double-blind , placebo-controlled study with a double-blind extension to 12 months . The study enrolled 549 postmenopausal women ( ALN 219 , RIS 222 and placebo ( PBO ) 108 ) who were > 60 years of age at outpatient centres . Main outcome measures : The primary endpoint was reduction in urine N-telopeptides of type 1 collagen ( NTx ) corrected for creatinine level at 3 months . Secondary parameters included change in BMD at the spine and hip at 6 and 12 months , NTx at 1,6 and 12 months , and serum bone-specific alkaline phosphatase ( BSAP ) at 1 , 3 , 6 and 12 months . Adverse experiences ( AEs ) were recorded throughout the study for an assessment of treatment safety profiles and tolerability . Results : Over 3 months , ALN produced a significantly greater mean reduction in urine NTx than did RIS ( −52 % vs −32 % , p < 0.001 ) , which was maintained at 12 months . ALN produced a significantly greater mean BMD increase than did RIS at 6 months , and it was maintained at 12 months at the lumbar spine ( 4.8 % vs 2.8 % , p < 0.001 ) and total hip ( 2.7 % vs 0.9 % , p < 0.001 ) , as well as at the trochanter and femoral neck . Significant reductions in BSAP with ALN compared to RIS were maintained over the 12 months of treatment . Study size did not allow for meaningful assessment of differences in fracture rates . Tolerability was generally similar between ALN , RIS and PBO , and the incidence of upper GIAEs causing discontinuation and oesophageal AEs was similar in the ALN and RIS groups . Conclusion : In this study , ALN 70 mg OW produced a 50 % greater reduction in bone resorption as measured by urine NTx and significantly greater increases in lumbar spine and hip BMD than did RIS 5 mg daily . The treatments had similar safety profiles and were generally well-tolerated . Additional studies are needed comparing OW ALN with OW RIS , which became available after the commencement of the present study Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction Both raloxifene ( RLX ) and alendronate ( ALN ) can treat and prevent new vertebral fractures , increase bone mineral density ( BMD ) , and decrease biochemical markers of bone turnover in postmenopausal women with osteoporosis . This phase 3 , r and omized , double-blind 1-yr study assessed the effects of combined RLX and ALN in 331 postmenopausal women with osteoporosis ( femoral neck BMD T-score , less than -2 ) . Women ( aged < or = 75 yr ; > or = 2 yr since their last menstrual period ) received placebo , RLX 60 mg/d , ALN 10 mg/d , or RLX 60 mg/d and ALN 10 mg/d combined . At baseline , 6 and 12 months , BMD was measured by dual x-ray absorptiometry . The bone turnover markers serum osteocalcin , bone-specific alkaline phosphatase , and urinary N- and C-telopeptide corrected for creatinine were measured . The effects of RLX and ALN were considered to be independent and additive if the interaction effect was not statistically significant ( P > 0.10 ) in a two-way ANOVA model . All changes in BMD and bone markers at 12 months were different between placebo and each of the active treatment groups , and between the RLX and RLX+ALN groups ( P < 0.05 ) . On average , lumbar spine BMD increased by 2.1 , 4.3 , and 5.3 % from baseline with RLX , ALN , and RLX+ALN , respectively . The increase in femoral neck BMD in the RLX+ALN group ( 3.7 % ) was greater than the 2.7 and 1.7 % increases in the ALN ( P = 0.02 ) and RLX ( P < 0.001 ) groups , respectively . The changes from baseline to 12 months in bone markers ranged from 7.1 to -16.0 % with placebo , -23.8 to -46.5 % with RLX , -42.3 to -74.2 % with ALN , and -54.1 to -81.0 % in the RLX+ALN group . RLX and ALN increased lumbar spine and femoral neck BMD , and decreased osteocalcin and C-telopeptide corrected for creatinine in an additive and independent manner , because the interaction effects were not significant . Although the ALN group had changes in BMD and bone markers that were approximately twice the magnitude as in the RLX group , it is not known how well these changes correlate to the clinical outcome of fracture . RLX+ALN reduced bone turnover more than either drug alone , result ing in greater BMD increment , but whether this difference reflects better fracture risk reduction was not assessed in this study BACKGROUND Up to 3 years of treatment with alendronate , 5 mg/d , prevents postmenopausal bone loss . OBJECTIVE To determine whether the effect of alendronate is sustained at 4 years of treatment and persists after treatment is discontinued . DESIGN R and omized , controlled trial . SETTING United States and Europe . PARTICIPANTS 1609 postmenopausal women 45 to 59 years of age . INTERVENTION Participants were r and omly assigned to receive oral alendronate , 5 mg/d or 2.5 mg/d ; placebo ; or open-label estrogen-progestin . Women in the alendronate groups received alendronate for the first 2 years of the study . Treatment was then continued without change or replaced with placebo for the last 2 years of the study . MEASUREMENTS Annual measurement of bone mineral density . RESULTS By year 4 , the bone mineral density of participants in the placebo group had decreased by 1 % to 6 % ( P < 0.001 ) . Four years of treatment with 5 mg of alendronate per day increased bone mineral density at the spine ( mean change [ + /-SE ] , 3.8%+/-0.3 % ) , hip ( mean , 2.9%+/-0.2 % ) , and total body ( mean , 0.9%+/-0.2 % ) ( P < 0.001 overall ) . By year 4 , bone mineral density at most skeletal sites was greater in participants who switched from alendronate to placebo than in those who continuously received placebo . In years 3 and 4 , bone loss in participants who switched from alendronate to placebo was similar to that seen during years 1 and 2 in those who continuously received placebo . Compared with 5 mg of alendronate per day , estrogen-medroxyprogesterone acetate produced similar increases in bone mineral density and estradiol-norethisterone acetate produced increases that were substantially greater . CONCLUSIONS Four years of treatment with alendronate or estrogen-progestin prevented postmenopausal bone loss . A residual effect was seen 2 years after alendronate therapy was stopped ; however , continuous alendronate treatment was more effective in preventing postmenopausal bone loss than 2 years of alendronate followed by 2 years of placebo OBJECTIVE To investigate whether the incidence of vertebral fractures is related to the magnitude of change in bone mineral density ( BMD ) during alendronate treatment . METHODS Women in this study were age 55 - 81 years ( n = 2,984 ) . While participating in the Fracture Intervention Trial , they received 5 mg/day of alendronate for 2 years followed by 10 mg/day for the remaining 12 - 30 months of the study . Their BMD was measured at baseline and at 12 and 24 months , and spine radiographs were obtained at baseline and again at 36 or 48 months to identify new vertebral fractures . RESULTS After 12 months of alendronate treatment , 35 % of participants had increases of > or =3 % in total hip BMD , and 21 % had either decreased total hip BMD or no change . Women who had larger increases in total hip BMD during the first 12 months had a lower incidence of new vertebral fractures during the entire followup period . Only 3.2 % of women with increases of > or =3 % in total hip BMD experienced new vertebral fractures , whereas twice as many women ( 6.3 % ) whose BMD declined or stayed the same experienced new fractures ( adjusted odds ratio 0.45 , 95 % confidence interval 0.27 - 0.72 ) . Similar patterns were observed for spine BMD at 12 months , and for both sites using change in BMD at 24 months . CONCLUSION Women with increases of > or =3 % in B
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| The clinical implication of these results is that there are important differences in anti-fracture efficacy among currently available agents . |
MS212662 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Clinical studies have shown the usefulness of antimicrobial photodynamic therapy ( aPDT ) as an adjunctive in periodontal therapy . These studies did not utilize indocyanine green ( ICG ) as a recently introduced photosensitizer . The aim of this study was to perform a full-mouth double-blind r and omized controlled clinical study to test the efficacy of adjunctive aPDT with ICG compared with scaling and root planing ( SRP ) alone in chronic periodontitis treatment . MATERIAL S AND METHODS Fifty patients were selected for this study . All patients received SRP . Then , each patient was r and omly assigned to either the test group ( aPDT+SRP ) or the control group ( SRP ) . aPDT was performed with a diode laser ( wavelength : 810 nm , power : 200mW ) and ICG as photosensitizer . The adjunctive procedure was repeated after 7 , 17 and 27 days . The clinical parameters including bleeding on probing ( BOP ) , clinical attachment loss ( CAL ) , plaque index ( PI ) , probing pocket depth ( PPD ) , full mouth plaque score ( FMPS ) and full mouth bleeding score ( FMBS ) were measured at baseline and after 1 and 3 months . RESULTS There were no significant differences between two groups at baseline . BOP , PPD and FMBS showed significant improvements in the test group ( P≤0.001 ) . In terms of PI , FMPS and CAL , no significant differences were observed between both groups ( P≥0.05 ) . CONCLUSION aPDT as an adjunctive approach yielded complete resolution of inflammation and significant reduction in periodontal pocket depth . However , aPDT had no additional advantages in clinical attachment gain and plaque score Background : There are limited clinical experiments addressing the effects of photodynamic therapy ( PDT ) and low-level laser therapy ( LLLT ) as an adjunct to conventional scaling and root planing ( SRP ) alone . Aim : The aim of this clinical trial was to evaluate the clinical effects of adjunctive use of PDT , combination of PDT with LLLT as adjunct to conventional SRP alone in the treatment of chronic periodontitis . Material s and Methods : In a single-centered r and omized and controlled clinical trial , 24 patients ( 15 males and 9 females ) with untreated chronic periodontitis were r and omly assigned in a split-mouth design into three treatment groups which included Group I : SRP only , Group II : SRP and PDT ( 1 % methylene blue [ MB ] solution ) , and Group III : SRP , PDT , and LLLT . Clinical parameters such as plaque index , gingival index , modified sulcular bleeding index , probing depth ( PD ) , and clinical attachment level ( CAL ) were measured at baseline , 1 , 3 , and 6 months after therapy . Results : Within each group , significant improvements ( P < 0.001 ) were found for all variables in 6-month follow-up compared with baseline . The improvement in clinical parameters was significantly greater in Group III compared to Group I and Group II . The mean PD ( mm ) reduction from baseline to 6 months in Group I was 2.50 ± 0.54 , Group II was 2.57 ± 0.53 , and Group III was 3.14 ± 0.50 . The mean CAL ( mm ) gain from baseline to 6 months in Group I was 2.63 ± 0.47 , Group II was 2.55 ± 0.44 , and Group III was 3.07 ± 0.55 . Conclusion : In patients with chronic periodontitis , a combination of a single application of PDT ( using a 980 nm laser and MB ) and LLLT provide additional benefit to SRP in terms of clinical parameters 6 months following the intervention AIM This split-mouth double-masked r and omized controlled clinical study evaluated the effectiveness of photoactivated disinfection ( PAD ) using light-emitting diode ( LED ) as an adjunct in the management of patients affected by moderate to severe chronic periodontitis . MATERIAL S AND METHODS Sixteen patients affected by moderate to severe chronic periodontitis were enrolled . After scaling and root planing ( SRP ) , each quadrant was assigned to one of the following groups : LED group ( 625 - 635 nm , maximum power density : 2000 mW/cm(2 ) ) , photosensitizer group ( tolouidine blue O , 0.1 mg/ml ) , PAD group ( photosensitizer and LED ) and control group ( no adjunctive treatment ) . The adjunctive treatments were repeated after 7 and 14 days . The clinical parameters of bleeding on probing , probing pocket depth and clinical attachment level were measured at baseline and 1 and 3 months after SRP . RESULTS At 1 and 3 months , all groups showed significant improvements with regard to all clinical parameters compared to baseline ( all p : < 0.001 ) . There were no significant differences among groups in terms of changes of clinical parameters in any time interval ( all p > 0.05 ) . CONCLUSION The application of PAD using LED with the current setting did not have additional effects on clinical parameters in patients diagnosed with moderate to severe chronic periodontitis compared with SRP alone OBJECTIVE To compare photodynamic therapy ( PDT ) as an adjunctive treatment of chronic periodontitis with scaling and root planing ( Sc/Rp ) in smokers . METHODS This is a split-mouth , single-masked r and omized controlled clinical trial conducted at the Faculty of Dentistry , King Abdulaziz University , Jeddah , Saudi Arabia between May 2010 and March 2011 . Fifty-four teeth with probing depth of ≥5 mm at one or more periodontal sites in 20 smokers diagnosed with moderate to severe chronic periodontitis were selected . In each patient , at least one tooth was r and omly assigned to Sc/Rp plus PDT ( test group ) and the contra-lateral tooth was assigned to Sc/Rp only ( control ) . Plaque index ( PI ) , bleeding on probing ( BOP ) , probing depth ( PD ) , recession and clinical attachment level ( CAL ) were recorded at baseline and 3 months after the periodontal treatment . Descriptive statistics and Wilcoxon signed ranked test were used for data analysis . RESULTS There was a statistically significant improvement in PD , CAL , BOP , and PI after periodontal treatment in both groups . No statistically significant differences between the 2 groups in any of the periodontal parameters were found at baseline ( p>0.05 ) , but a statistically significant greater reduction in PD ( p=0.028 ) and CAL ( p=0.044 ) in the test compared to the control group was found at the 3-month follow up . CONCLUSION Photodynamic therapy might have an additional benefit to scaling and root planing when treating smokers affected with periodontitis AIM To investigate the effect of photodynamic therapy ( PDT ) as adjunct to mechanical therapy in furcations . MATERIAL S AND METHODS A double-blind , parallel , r and omized controlled clinical trial was conducted in subjects presenting class II furcations . The subjects were r and omly allocated to a test ( PDT ; n = 16 ) or control group ( non-activated laser/only photosensitizer ; n = 21 ) . At baseline , 3 and 6 months , clinical , microbiological and cytokine pattern evaluation was performed . Clinical attachment level was defined as the primary outcome variable . RESULTS Clinical parameters improved after both therapies ( p < 0.05 ) with no differences between groups at any time point ( p > 0.05 ) . At 6 months , real-time PCR evaluation showed a decrease in Porphyromonas gingivalis and Tannerella forsythia only in the PDT group ( p < 0.05 ) with no inter-group differences . Regarding cytokines , IL-4 and IL-10 levels increased in both groups at 6 months . GM-CSF , IL-8 , IL-1β and IL-6 levels decreased only in the PDT group after 3 months ( p < 0.05 ) . At 3 months , inter-group analyses showed that GM-CSF , IFN-γ , IL-6 and IL-8 levels were lower in the PDT group . At 6 months , lower IL-1β levels were also observed in the PDT group ( p < 0.05 ) . CONCLUSION Photodynamic therapy did not promote clinical benefits for class II furcations ; however , advantages in local levels of cytokines and a reduction in periodontopathogens were demonstrated BACKGROUND There is an ongoing controversy on the benefits of treatment protocol s , including dental lasers and photodynamic therapy ( PDT ) . The purpose of this study is to compare the local biologic effects of PDT , diode soft laser ( DSL ) therapy , and conventional deep scaling and root planing ( SRP ) in residual pockets . METHODS Thirty-two individuals were included based on a history of previous treatment for periodontitis and the persistence of sites with probing depths > 4 mm and bleeding on probing . Residual pockets were debrided with an ultrasonic device and then r and omly assigned either to PDT , DSL , or SRP . Gingival crevicular fluid was collected before treatment , after 14 days , and at 2 and 6 months . Levels of 13 cytokines and nine acute-phase proteins were measured using a bead-based multiplexing analysis system . RESULTS Treatment with PDT , DSL , or SRP led to significant changes in several cytokines and acute-phase proteins : Compared with baseline , levels of interleukin-17 , basic fibroblast growth factor , granulocyte colony-stimulating factor , granulocyte macrophage colony-stimulating factor , and macrophage inflammatory protein 1-α were lower 14 days and 2 months after treatment . Except for granulocyte colony-stimulating factor , these differences remained significant throughout the observation period . The levels of five acute-phase proteins ( α-2 macroglobulin , haptoglobin , serum amyloid P , procalcitonin , and tissue plasminogen activator ) were significantly higher at 6 months than at baseline . No significant differences were observed among the three treatment modalities at any time point for any biochemical parameter . CONCLUSIONS Levels of several cytokines and acute-phase proteins significantly changed after treatment regardless of treatment modality . There was no evidence for a specific DSL- or PDT-enhanced expression of inflammatory mediators BACKGROUND AND OBJECTIVE In recent years , there has been a growing interest in the use of dental lasers for treatment of periodontal diseases . The purpose of this short-term clinical trial was to evaluate the effects of a combination of photodynamic therapy with low-level laser therapy as an adjunct to nonsurgical treatment of chronic periodontitis . MATERIAL AND METHODS Twenty-four nonsmoking adults with untreated chronic periodontitis were r and omly assigned in a split-mouth design to receive scaling and root debridement with or without one course of adjunctive photodynamic therapy and low-level laser therapy within 5 d. Plaque , bleeding on probing , probing depth and gingival recession were recorded at baseline , 1 and 3 mo after the treatment . Gingival crevicular fluid was collected for assay of interleukin-1β levels at baseline , 1 wk and 1 mo . RESULTS The test teeth achieved greater reductions in the percentage of sites with bleeding on probing and in mean probing depth at 1 mo compared with the control teeth ( p < 0.05 ) . A significant decrease in gingival crevicular fluid volume was observed in both groups at 1 wk ( p < 0.001 ) , with a further decrease at 1 mo in the test sites ( p < 0.05 ) . The test sites showed a greater reduction of interleukin-1β levels in gingival crevicular fluid at 1 wk than the control sites ( p < 0.05 ) . No significant differences in periodontal parameters were found between the test and control teeth at 3 mo . CONCLUSIONS The present study suggests that a combined course of photodynamic therapy with low-level laser therapy could be a beneficial adjunct to nonsurgical treatment of chronic periodontitis on a short-term basis . Further studies are required to assess the long-term effectiveness of the combination of photodynamic therapy with low-level laser therapy as an adjunct in nonsurgical treatment of periodontitis BACKGROUND The management of aggressive periodontitis ( AgP ) represents a challenge for clinicians because there are no st and ardized protocol s for an efficient control of the disease . This r and omized controlled clinical trial evaluated the effects of repeated applications of antimicrobial photodynamic therapy ( aPDT ) adjunctive to scaling and root planing ( SRP ) in patients with AgP. METHODS Using a split-mouth design , 20 patients with generalized AgP were treated with aPDT + SRP ( test group ) or SRP only ( control group ) . aPDT was applied at four periods . All patients were monitored for 90 days . Clinical , microbiologic , and immunologic parameters were statistically analyzed . RESULTS In deep periodontal pocket analysis ( probing depth [ PD ] ≥ 7 mm at baseline ) , the test group presented a decrease in PD and a clinical attachment gain significantly higher than the control group at 90 days ( P < 0.05 ) . The test group also demonstrated significantly less periodontal pathogens of red and orange complexes and a lower interleukin-1β/interleukin-10 ratio than the control group ( P < 0.05 ) . CONCLUSION The application of four sessions of aPDT , adjunctive to SRP , promotes additional clinical , microbiologic , and immunologic benefits in the treatment of deep periodontal pockets in single-rooted teeth in patients with The aim of this study was to investigate the adjunctive effect of antimicrobial
Output:
| CONCLUSION From the literature review ed the efficacy aPDT as adjunct to SRP in downregulating GCF cytokines remains debatable . |
MS212663 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 / OBJECTIVES To evaluate the success of a multifaceted , hospicewide , nurse-focused pain-management intervention for improving patient pain outcomes . DESIGN Comparative , descriptive . SETTING A large , nonprofit hospice that primarily provides home care . SAMPLE Two sample s were included in the study . One sample ( n = 47 ) was from a study completed in 1995 before the intervention , and one ( n = 255 ) was from a study completed in 1997 after the intervention . All patients had been diagnosed with cancer and were alert and able to self-report . METHODS Secondary analysis of data that were collected as part of two quality -of-life studies . The four-part intervention included intensive pain-management education for the nurses , development and implementation of pain-management policies and procedures , changes in pain assessment and management documentation , and development and use of quality assurance monitors by the nursing staff . MAIN RESEARCH VARIABLES Pain at its worst , pain relief , and quality of life . FINDINGS Adjusted mean pain-relief scores were significantly lower in 1995 ( X = 5.8 ) than in 1997 ( X = 8.4 ) . In 1995 , 43 % of patients reported pain relief at a level of 5 or less ( on a 0 - 10 scale ) . This number dropped to 10 % by 1997 . Adjusted mean pain-at-its-worst scores were significantly lower in 1997 ( X = 6.1 ) than in 1995 ( X = 6.7 ) . Pain relief was found to be positively correlated ( r = 0.41 - 0.51 ) with quality of life in both sample s. CONCLUSIONS The hospicewide pain-management intervention was effective . IMPLICATION S FOR NURSING PRACTICE Through careful study and multifaceted nurse-focused interventions , pain outcomes of hospice patients with cancer can be improved We tested whether computer-based decision support ( CBDS ) could enhance the ability of primary care physicians ( PCPs ) to manage chronic pain . Structured summaries were generated for 50 chronic pain patients referred by PCPs to a pain clinic . A pain specialist used a decision support system to determine appropriate pain therapy and sent letters to the referring physicians outlining these recommendations . Separately , five board-certified PCPs used a CBDS system to “ treat ” the 50 cases . A successful outcome was defined as one in which new or adjusted therapies recommended by the software were acceptable to the PCPs ( i.e. , they would have prescribed it to the patient in actual practice ) . Two pain specialists review ed the PCPs ’ outcomes and assigned medical appropriateness scores ( 0 = totally inappropriate to 10 = totally appropriate ) . One year later , the hospital data base provided information on how the actual patients ’ pain was managed and the number of patients re-referred by their PCP to the pain clinic . On the basis of CBDS recommendations , the PCP subjects “ prescribed ” additional pain therapy in 213 of 250 evaluations ( 85 % ) , with a medical appropriateness score of 5.5 ± 0.1 . Only 25 % of these chronic pain patients were subsequently re-referred to the pain clinic within 1 yr . The use of a CBDS system may improve the ability of PCPs to manage chronic pain and may also facilitate screening of consults to optimize specialist utilization OBJECTIVE Efforts to improve pain assessment and treatment in critically ill patients are poorly studied and represent an opportunity to improve quality of care . We sought to improve pain assessment and treatment in patients in a surgical intensive care unit at an academic medical center . DESIGN We performed a prospect i ve study of pain assessment and treatment in two surgical intensive care units in 2001 . We measured pain assessment as the percentage of 4-h intervals where the patient 's pain was measured using a visual analog scale . We measured pain treatment as the percentage of 4-h intervals where the patient 's pain score on the scale was < or =3 . We then implemented four separate " plan-do- study -act " cycles to improve pain assessment and treatment . MAIN OUTCOME MEASURES We evaluated the percentage of 4-h patient-nursing intervals that were scored numerically pre- and post-intervention . We evaluated the percentage of 4-h patient-nursing intervals where the patients had a pain score of < or =3 pre- and post-intervention . In addition , we monitored naloxone use as a measure of adverse events related to pain treatment . RESULTS Our baseline assessment of pain was 42 % and the baseline treatment was 59 % . After 5 weeks , pain assessment improved to 71 % and pain management improved to 97 % . CONCLUSION Our interventions were associated with significant improvements in pain assessment and treatment without an increase in adverse events related to pain therapy . Our interventions were relatively simple and may be implemented broadly . Our interventions provide insights into the application of complexity theory in improvement efforts The purpose of this study was to vali date the changes in acute pain measurement scales that are most strongly associated with a patient-determined indicator of clinical importance . Measures of pain intensity and pain relief are commonly used outcomes in therapeutic clinical trials . Recent studies of the properties of acute pain measures have provided data defining the cut-off points that are best associated with clinical ly important differences . Validation of these findings in another clinical trial data set is important . Data were obtained from the titration phase of a recently conducted r and omized controlled clinical trial of oral transmucosal fentanyl citrate ( OTFC ) , which compared OTFC to immediate release morphine sulfate ( MSIR ) for the treatment of cancer-related acute breakthrough pain . Changes in pain intensity and pain relief were recorded every 15 minutes for 60 minutes and global medication performance recorded at the end of each study pain episode . At any titration step , if the patient felt that the first dose of the study medication did not provide adequate relief within 30 minutes , an additional rescue medication could be taken . To find the level of each pain scale best associated with this measure of the adequacy of pain relief , the calculated sensitivity , specificity , and accuracy for different cut-off points of the measured pain scales were compared to whether or not the patient needed rescue medication . The overall ability of the pain measures to discriminate episodes for which a rescue was not needed was calculated using area under the receiver operating characteristics ( ROC ) curves . Data were analyzed from 134 OTFC-naive patients who collected data on 1307 episodes of breakthrough pain . Using the criteria of a balanced sensitivity and specificity , the best cut-off points were determined to be : 33 % for the percent pain intensity difference ; > or = 2 for the raw pain intensity difference on a 0 - 10 numeric rating scale ; > or = 2 ( i.e. , moderate or better ) for pain relief ; > or = 33 % for the percent maximum total pain relief ; and > or = 2 ( good or better ) for global medication performance . ROC area under the curve ranged from 0.839 to 0.862 for each of the pain measures listed above , calculated at 60 minutes . These data indicate that the pain scale cut-off points that are best associated with a patient-derived measure of a clinical ly important difference closely approximate those found in an earlier study . ROC analysis provided evidence that the overall pain measures were strongly associated with not requiring an " additional dose of rescue medication . " Thus , the cut-off points determined for these pain scales provide a good surrogate measure of a patient-determined clinical ly important response . This provides support for the usefulness of these values in future clinical trials of pain therapy & NA ; Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments . Perhaps the most important aspect of a pain measure 's validity is its sensitivity , or ability to detect changes in pain over time and due to treatment . Several factors may affect a measure 's sensitivity , including the complexity of the rating task for the measure , the number of pain intensity levels assessed by the measure , the dimension of pain assessed ( e.g. pain intensity vs. pain relief ) , and the number of individual ratings ( e.g. single rating vs. composite score ) used to create the measure . The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two sample s of persons participating in a r and omized controlled trial . One hundred and twenty‐three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery : morphine , ketorolac , or placebo . Two measures of pain intensity ( a visual analog scale ( VAS ) and a 4‐point verbal rating scale ( VRS ) ) were administered at baseline , and these measures plus a 5‐point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery . As predicted , we found variability in the sensitivity of the outcome measures used in these studies , with the 4‐point VRS showing less sensitivity than the VAS or relief ratings . However , contrary to our prediction , a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects . Finally , we found that pain relief ratings were related to , but also distinct from , change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point . These findings have important implication s for the assessment of pain in clinical trials BACKGROUND The Joint Commission on Accreditation of Health Care Organizations declared pain level to be the " fifth vital sign . " This has led to increased efforts to reduce patients ' pain scores . Current postoperative analgesic modalities may not be entirely safe . We prospect ively studied pain and sedation scores to determine whether postoperative patients were reaching sedation levels similar to patients undergoing " conscious sedation " ( eg , colonoscopy cases ) . " Conscious sedation " patients have been shown to achieve states of sedation , which at time result in oxygen desaturation . METHODS Fifty-three patients within three groups were compared in an observational study . Group 1 included " conscious sedation " patients undergoing colonoscopy . Group 2 included postoperative patients using patient-controlled analgesia ( PCA ) . Group 3 included postoperative patients under nurse-controlled analgesia ( NCA ) . Levels of sedation were monitored using the 6-point Ramsay sedation scale . Pain and oxygen saturation were monitored using an 11-point verbal scale and finger pulse oximetry , respectively . Patients were monitored for up to 12 hours in the postoperative period or for the length of their colonoscopy procedure . RESULTS Patients in groups 1 and 2 reached similar sedation levels . CONCLUSIONS Patients may reach dangerous levels of sedation during the first 24 hours postoperatively . Patients using PCA devices warrant close observation during this time period Pain complicates the recovery process after ambulatory surgery . We surveyed 175 ambulatory surgery patients to determine pain severity , analgesic use , relationship of pain to duration of recovery , and the relative importance of various factors to predicting these outcomes . Multivariate regression analysis was used to determine unique contributions of predictor variables to outcome . Surgical procedures included knee arthroscopy ( n = 50 ) , hernia surgery ( n = 25 ) , pelvic laparoscopy ( n = 25 ) , transvaginal uterine surgery ( n = 25 ) , surgery for breast disease ( n = 25 ) , and plastic surgery ( n = 25 ) . Maximum pain ( on a scale of 0–10 ) varied from 2.3 ± 0.5 to 5.1 ± 0.5 ( mean ± se ) , depending on surgical procedure ; 24 % of patients had pain scores of ≥7 , and 24 % were delayed in Phase 1 recovery by pain . Pain scores were lower if local anesthetic or ketorolac was administered intraoperatively ( 22 % and 26 % respectively ) . Fentanyl dose during recovery correlated with maximum pain scores ; fentanyl dose was 42 % less if ketorolac was administered intraoperatively . In females , the recovery fentanyl dose increased in proportion to the intraoperative fentanyl dose . The maximum pain score was predictive of total recovery time ( 135 , 172 , and 212 min of recovery for maximum pain scores of 0–3 , 4–6 , and 7–10 , respectively;P < 0.001 ) . We conclude that improvements in pain therapy are warranted to improve patient comfort and to expedite recovery OBJECTIVES To describe the impact of musculoskeletal pain ( MP ) ; to compare management of MP by the population and by primary care physicians ; and to identify misconceptions about treatment . METHODS 5803 people with MP and 1483 primary care physicians , r and omly selected , in eight European countries were interviewed by telephone . A structured question naire was used to ask about usual management of MP and perceived benefits and risks of treatment . Current health status ( SF-12 ) was also assessed . RESULTS From primary care physicians ' perceptions , MP appears to be well managed . All presenting patients are offered some form of treatment , 90 % or more doctors are trying to improve patients ' quality of life , and most are aware and concerned about the risks of treatment with NSAIDs . From a population perspective , up to 27 % of people with pain do not seek medical help and of those who do , several wait months/years before seeing a doctor . 55 % or fewer patients who have seen a doctor are currently receiving prescription treatment for their pain . Communication between doctors and patients is poor ; few patients are given information about their condition ; and many have misconceptions about treatment . CONCLUSIONS Management of MP is similar across eight European countries , but there is discordance between physician and patient perspectives of care . Some people with pain have never sought medical help despite being in constant/daily pain . Those who do seek help receive little written information or explanation and many have misperceptions about the benefits and risks of treatment that limit their ability to actively participate in decisions about their care CON
Output:
| RESULTS The recommendations specify that all care setting s formulate structured , multilevel systems approaches ( sensitive to the type of pain , population served , and setting of care ) that ensure prompt recognition and treatment of pain , involvement of patients and families in the pain management plan , improved treatment patterns , regular re assessment and adjustment of the pain management plan as needed , and measurement of processes and outcomes of pain management . |
MS212664 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Animal data suggest that a D1 antagonistic component in neuroleptic drugs counteracts development of dopamine supersensitivity and of tolerance to cataleptic effect . This has led to the hypothesis that neuroleptics with D1 antagonistic activity should cause a better suppression of tardive dyskinesia ( TD ) and less rebound aggravation after withdrawal than pure D2 antagonists . In this study the effect of zuclopenthixol ( mixed D1/D2 antagonist ) and haloperidol ( D2 antagonist ) was evaluated in chronic psychotic patients with TD . Fifteen patients completed a r and omized crossover study with blind evaluation of TD and parkinsonism . The test medications , haloperidol and zuclopenthixol , caused a significant suppression of TD and a significant increase of parkinsonism . No significant differences between haloperidol and zuclopenthixol were observed . No TD aggravation was seen . The lack of differences between the mixed D1/D2 antagonist and a D2 antagonist suggest that tolerance and DA supersensitivity play no or a minor role for development of TD 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 Zuclopenthixol acetate — a new injectable formulation with a duration of action of 2–3 days — was compared with conventional intramuscular and oral formulations of haloperidol and zuclopenthixol in the initial treatment of acutely disturbed , psychotic patients . The patients were stratified into 3 diagnostic categories : acute psychoses ( 48 patients ) , mania ( 22 patients ) , and exacerbation of chronic psychoses ( 73 patients ) . The patients were rated on the Brief Psychiatric Rating Scale ( BPRS ) , the Bech‐Rafaelsen Mania Rating Scale ( brmas ) ( only manic patients ) and globally on the Clinical Global Impression ( CGI ) . The study was an open , r and omized multicentre trial with a 6‐day treatment period . The zuclopenthixol acetate patients received 1–4 doses , the haloperidol patients 1–26 and the zuclopenthixol patients 1–22 doses . The assessment s on the CGI showed that all 3 treatments caused a clear reduction of the severity of illness scores in all 3 diagnostic categories , with no differences between treatments . The ratings of the acute and chronic psychotic patients on the BPRS also showed significant reductions in scores with no differences between treatments . All 3 treatments caused a rapid remission of symptoms on the BRMAS . Haloperidol induced hypokinesia in significantly more patients than zuclopenthixol acetate after 24 h. Later there were no significant differences between treatments . Zuclopenthixol acetate fulfils many desires for an amended neuroleptic formulation for the initial treatment of acutely disturbed psychotic patients OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate PURPOSE The aim of this longitudinal study was to determine whether the depot formulation of an antipsychotic reduces violence in out patients with schizophrenia as compared to oral administration of the same antipsychotic . METHODS Forty-six previously violent patients with schizophrenia were r and omised to receive treatment with oral or depot zuclopenthixol for 1 year . Clinicians interviewed patients at baseline and every month thereafter to assess treatment adherence . An interviewer blinded to treatment assignments interviewed an informant about any violent behaviour during the previous month . RESULTS Violence during the follow-up year was inversely proportional to treatment adherence , better compliance , and greater reduction of positive symptoms . Lower frequency of violent acts was observed in the depot group . The level of insight at baseline was not significantly associated with violence recidivism . Regardless of route of administration , treatment non-adherence was the best predictor of violence . CONCLUSIONS Some patients with schizophrenia and prior violent behaviour may benefit from the depot formulation of antipsychotic medication Acutely psychotic patients presenting as psychiatric emergencies with aggression or agitation are often administered conventional antipsychotics intramuscularly . However , patients view intramuscular administration as coercive , and conventional antipsychotics are often associated with adverse events . In this open study , consecutive adult patients presenting with an acute exacerbation of schizophrenia or other psychotic disorder were assigned to oral risperidone 2 - 6 mg/day ( n = 48 ) or oral zuclopenthixol 20 - 50 mg/day ( n = 27 ) for 7 - 14 days . Lorazepam ( either oral or intramuscular ) was administered to both groups as needed . Patients were assessed regularly until day 14 or discharge . Mean Positive And Negative Syndrome Scale ( PANSS ) aggression scores ( sum of item scores on excitement , poor impulse control , hostility and uncooperativeness ) decreased steadily and similarly in both groups ; the mean changes from baseline were statistically significant at days 10 and 14 and at study end-point . The mean decrease at study end-point in the PANSS component score for hostility was statistically significant in the risperidone group , but not in the zuclopenthixol group . Social Dysfunction and Aggression Scale aggression scores and Clinical Global Impression scores decreased significantly and similarly in both groups . Overall , 18.7 % of patients showed minor extrapyramidal symptoms during the study , but only 16.7 % of risperidone-treated patients , compared to 59.3 % of zuclopenthixol-treated patients , received anti-parkinsonian medication ( p < 0.001 ) . Lorazepam was administered to all of the patients assigned to risperidone and to 89 % of those assigned to zuclopenthixol . Oral risperidone plus lorazepam is a convenient , effective and well-tolerated alternative to conventional antipsychotics for the treatment of acute psychosis in emergency psychiatry The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas BACKGROUND Studies on the effects of antipsychotics on cognitive deficits in schizophrenia mostly suggest a superior effect of atypical over typical compounds , although findings are inconsistent and effect sizes small . Several method ological issues , such as heterogeneous patient sample s , incomparable drug doses , effects of prior medication , construct validity , and retest effects on neuropsychological tasks , confound most results and the comparability between studies . Consequently , the conclusion concerning effects of antipsychotics on cognition is still equivocal . OBJECTIVE The present r and omized clinical trial examined the effects on cognition of comparatively low doses of a typical antipsychotic ( zuclopenthixol ) and an atypical antipsychotic ( risperidone ) in a homogeneous group of drug-naive first-episode schizophrenic patients in a longitudinal setting . METHODS First-episode schizophrenic patients who had never previously been exposed to antipsychotic treatment ( N=25 ) were r and omly allocated to treatment with flexible doses of zuclopenthixol or risperidone in an open-label design . Cognitive functions were examined both when patients were drug-naive , and after 13 weeks of treatment . A comprehensive neuropsychological battery was used in order to optimize construct validity , and principal components of cognitive functions were extrapolated in order to reduce type I errors . A healthy control group was tested at baseline and after 13 weeks , in order to examine retest effects . The cognitive domains studied were executive functions , selective attention , and reaction time . RESULTS The patients showed considerable cognitive deficits when drug-naive . There were few differential effects of risperidone and zuclopenthixol on cognitive deficits , except for a differential significance , respectively , tendency towards improved reaction and movement times in the risperidone group , and a lack of such in the zuclopenthixol group . These differences were no longer significant after covarying for extrapyramidal side effects and anticholinergic medication that were more prevalent in the zuclopenthixol group and the increases after medication were comparable with retest effects in controls . CONCLUSION The study underscores the importance of examining impact of factors , such as clinical improvement , extrapyramidal side effects , anticholinergic medication and retest effects in longitudinal efficacy studies . This study does not support efficacy of either risperidone or zuclopenthixol on cognitive functions in drug-naive schizophrenia patients after 3 months of medication , because neither could be distinguished from retest effects of the healthy control group The aim of this study was to evaluate the efficacy and side effects of zuclopenthixol acetate compared with haloperidol in the management of the acutely disturbed schizophrenic patient . Suitable subjects diagnosed as having schizophreniform disorder or acute exacerbation of schizophrenia admitted to the psychiatric wards Hospital Kuala Lumpur were r and omised to receive either zuclopenthixol acetate or haloperidol . They were rated blind for three consecutive days using the Brief Psychiatric Rating Scale ( BPRS ) , Clinical Global Impression ( CGI ) and UKU Side Effects Scale . Apart from repeat injections of the same medication , no other anti-psychotic was given for the duration of the study . 50 subjects entered the study of which 44 completed . 23 were given zuclopenthixol acetate and 21 haloperidol . Both groups significantly reduced BPRS and CGI scores on all 3 days compared to the initial rating ( p < 0.001 ) . There was however no difference between the zuclopenthixol acetate and haloperidol group scores on all days ( p > 0.05 ) . More subjects on haloperidol than
Output:
| Zuclopenthixol dihydrochloride appears to cause more EPSEs than clozapine , risperidone or perphenazine , but there was no difference in EPSEs when compared to placebo or chlorpromazine .
Similar numbers required hypnotics/sedatives when zuclopenthixol dihydrochloride was compared to sulpiride , and similar numbers of reported side-effects were found when its isomers were compared .
The other comparisons did not report adverse-effect data .Reported data indicate zuclopenthixol dihydrochloride demonstrates no difference in mental or global states compared to placebo , chlorpromazine , chlorprothixene , clozapine , haloperidol , perphenazine , sulpiride , thiothixene , trifluoperazine , depot and isomers .
Zuclopenthixol dihydrochloride , when compared with risperidone , is favoured when assessed using the PANSS in the short term , but not in the medium term .
Prescribing practice is unlikely to change based on this meta- analysis .
Recommending any particular course of action about side-effect medication other than monitoring , using rating scales and clinical assessment , and prescriptions on a case-by-case basis , is also not possible . |
MS212665 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background and Purpose — The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown . The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity . Methods — Sub study within a large 3-armed r and omized controlled trial , which compared 3 different models of physiotherapy service delivery , was provided for 4 weeks during subacute , inpatient rehabilitation ( n=283 ) . The duration of all physiotherapy sessions was recorded . In addition , 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 AM and 4:30 PM . At each observation , we recorded physical activity , location , and people present . Results — Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time , respectively , when compared with usual care . Participants were st and ing or walking for a median of 8.2 % of observations . On weekdays , circuit class therapy participants spent more time in therapy-related activity ( 10.2 % of observations ) when compared with usual care participants ( 6.1 % of observations ) . On weekends , 7-day therapy participants spent more time in therapy-related activity ( 4.2 % of observations ) when compared with both usual care and circuit class therapy participants ( 0 % of observations for both groups ) . Activity levels outside of therapy sessions did not differ between groups . Conclusions — A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day . Clinical Trial Registration — URL : http://www.anzctr.org.au/. Unique identifier : ACTRN12610000096055 Background Increased therapy has been linked to improvements in functional ability of people with stroke . Aim To determine the effectiveness of two alternative models of increased physiotherapy service delivery ( seven-day week therapy or group circuit class therapy five days a week ) to usual care . Method Three-armed r and omized controlled trial with blinded assessment of outcome . People admitted with a diagnosis of stroke , previously independently ambulant and with a moderate level of disability were recruited . ‘ Usual care ’ was individual physiotherapy provided five-days a week . Seven-day week therapy was usual care physiotherapy provided seven-days a week . Participants in the circuit class therapy arm of the trial received physiotherapy in group circuit classes in two 90-min sessions , five-days a week . Primary outcome was distance walked on the six-minute walk test at four-weeks post-r and omization . Results Two hundred eighty-three participants were r and omized ; primary outcome data were available for 259 ( 92 % ) . In the seven-day arm participants received an additional three hours of physiotherapy and thosein the circuit class armanadditional 22 h. There were no significant between-group differences at four-weeks in walking distance ( P = 0·72 ) . Length of stay was shorter for seven-day ( mean difference −2·9 days , 95 % confidence interval −17·9 to 12·0 ) and circuit class participants ( mean difference −9·2 days , 95 % confidence interval −24·2 to 5·8 ) compared to usual care , but this was not significant . Conclusions Both seven-day therapy and group circuit class therapy increased physiotherapy time , but walking outcomes were equivalent to usual care Abstract Purpose : This study determined the impact of a pragmatic 6-day physiotherapy service on length of stay , functional independence , gait and balance in people undergoing inpatient rehabilitation , compared to a 5-day service . Method : A prospect i ve cohort study with historical comparison was undertaken in a mixed inpatient rehabilitation unit . Intervention period participants ( 2011 ) meeting inclusion criteria were eligible for a 6-day physiotherapy service . All other participants , including the historical cohort ( 2010 ) received usual care ( 5-day physiotherapy ) . Length of stay , functional independence , gait and balance performance were measured . Results : A total of 536 individuals participated in this study ; 270 in 2011 ( 60 % received 6-day physiotherapy ) and 266 in 2010 . Participants in 2011 showed a trend for reduced length of stay ( 1.7 days , 95%CI −0.53 to 3.92 ) compared to 2010 . Other measures showed no significant differences between cohorts . In 2011 , those receiving 6-day physiotherapy were more dependent , but showed significantly improved functional independence and balance compared to those receiving 5-day physiotherapy ( p < 0.040 ) without impacting length of stay . Conclusion : Implementing a 6-day physiotherapy service in a “ real-world ” rehabilitation setting demonstrated a trend towards reduced length of stay , and improved functional gains . This service could lead to cost-savings for hospitals and improved patient flow . Implication s for Rehabilitation “ Real-world ” implementation of a 6-day physiotherapy service in rehabilitation shows a trend for reducing length of stay . This reduction in length of stay may lead to cost-savings for the hospital system , and improve patient flow into rehabilitation . Patients receiving 6-day physiotherapy made significant gains in balance and functional independence compared to patients receiving 5-day physiotherapy services in the rehabilitation setting Background The cause of adverse weekend clinical outcomes remains unknown . In 2013 , the “ NHS Services , Seven Days a Week ” project was initiated to improve access to services across the seven-day week . Three years on , we sought to analyse the impact of such changes across the English NHS . Methods Aggregated trust-level data on crude mortality rates , Summary Hospital-Level Mortality Indicator ( SHMI ) , mean length of stay ( LOS ) , A&E admission and four-hour breach rates were obtained from national Hospital Episode Statistics and A&E data sets across the English NHS , excluding mental and community health trusts . Trust annual reports were analysed to determine the presence of any seven-day service reorganisation in 2013–2014 . Funnel plots were generated to compare institutional performance and a difference in differences analysis was performed to determine the impact of seven-day changes on clinical outcomes between 2013 and 2014 , 2014–2015 and 2015–2016 . Data was summarised as mean ( SD ) . Results Of 159 NHS trusts , 79 ( 49.7 % ) instituted seven-day changes in 2013–2014 . Crude mortality rates , A&E admission rates and mean LOS remained relatively stable between 2013 and 2016 , whilst A&E four-hour breach rates nearly doubled from 5.3 to 9.7 % . From 2013 to 2014 to 2014–2015 and 2015–2016 , there were no significant differences in the change in crude mortality ( 2014–2015 p = 0.8 , 2015–2016 p = 0.9 ) , SHMI ( 2014–2015 p = 0.5 , 2015–2016 p = 0.5 ) , mean LOS ( 2014–2015 p = 0.5 , 2015–2016 p = 0.4 ) , A&E admission ( 2014–2015 p = 0.6 , 2015–2016 p = 1.0 ) or four-hour breach rates ( 2014–2015 p = 0.06 , 2015–2016 p = 0.6 ) between trusts that had implemented seven-day changes compared to those which had not . Conclusions Adverse weekend clinical outcomes may not be ameliorated by large scale reorganisations aim ed at improving access to health services across the week . Such changes may negatively impact care quality without additional financial investment , as demonstrated by worsening of some outcomes . Detailed prospect i ve research is required to determine whether such reallocation of finite re sources is clinical ly effective Background Providing additional Saturday rehabilitation can improve functional independence and health related quality of life at discharge and it may reduce patient length of stay , yet the economic implication s are not known . The aim of this study was to determine from a health service perspective if the provision of rehabilitation to in patients on a Saturday in addition to Monday to Friday was cost effective compared to Monday to Friday rehabilitation alone . Methods Cost utility and cost effectiveness analyses were undertaken alongside a multi-center , single-blind r and omized controlled trial with a 30-day follow up after discharge . Participants were adults admitted for inpatient rehabilitation in two publicly funded metropolitan rehabilitation facilities . The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus an additional rehabilitation service on Saturday . Incremental cost utility ratio was reported as cost per quality adjusted life year ( QALY ) gained and an incremental cost effectiveness ratio ( ICER ) was reported as cost for a minimal clinical ly important difference ( MCID ) in functional independence . Results 996 patients ( mean age 74 ( st and ard deviation 13 ) years ) were r and omly assigned to the intervention ( n = 496 ) or the control group ( n = 500 ) . Mean difference in cost of AUD$1,673 ( 95 % confidence interval ( CI ) -271 to 3,618 ) was a saving in favor of the intervention group . The incremental cost utility ratio found a saving of AUD$41,825 ( 95 % CI -2,817 to 74,620 ) per QALY gained for the intervention group . The ICER found a saving of AUD$16,003 ( 95 % CI -3,074 to 87,361 ) in achieving a MCID in functional independence for the intervention group . If the willingness to pay per QALY gained or for a MCID in functional independence was zero dollars the probability of the intervention being cost effective was 96 % and 95 % , respectively . A sensitivity analysis removing Saturday penalty rates did not significantly alter the outcome . Conclusions From a health service perspective , the provision of rehabilitation to in patients on a Saturday in addition to Monday to Friday , compared to Monday to Friday rehabilitation alone , is likely to be cost saving per QALY gained and for a MCID in functional independence . Trial registration Australian and New Zeal and Clinical Trials Registry November 2009 Background Disinvestment from inefficient or ineffective health services is a growing priority for health care systems . Provision of allied health services over the weekend is now commonplace despite a relative paucity of evidence supporting their provision . The relatively high cost of providing this service combined with the paucity of evidence supporting its provision makes this a potential c and i date for disinvestment so that re sources consumed can be used in other areas .This study aims to determine the effectiveness , cost-effectiveness and safety of the current model of weekend allied health service and a new stakeholder-driven model of weekend allied health service delivery on acute medical and surgical wards compared to having no weekend allied health service . Methods / Design Two stepped wedge , cluster r and omised trials of weekend allied health services will be conducted in six acute medical/surgical wards across two public metropolitan hospitals in Melbourne ( Australia ) . Wards have been chosen to participate by management teams at each hospital . The allied health services to be investigated will include physiotherapy , occupational therapy , speech therapy , dietetics , social work and allied health assistants . At baseline , all wards will be receiving weekend allied health services . Study 1 intervention will be the sequential disinvestment ( roll-in ) of the current weekend allied health service model from each participating ward in monthly intervals and study 2 will be the roll-out of a new stakeholder-driven model of weekend allied health service delivery . The order in which weekend allied health services will be rolled in and out amongst participating wards will be determined r and omly . This trial will be conducted in each of the two participating hospitals at a different time interval . Primary outcomes will be length of stay , rate of unplanned hospital readmission within 28 days and rate of adverse events . Secondary outcomes will be number of complaints and compliments , staff absenteeism , and patient discharge destination , satisfaction , and functional independence at discharge . Discussion This is the world ’s first application of the recently described non-inferiority ( roll-in ) stepped wedge trial design , and the largest investigation of the effectiveness of weekend allied health services on acute medical surgical wards to date .Trial registration Australian New Zeal and Clinical Trials Registry . Registration number : ACTRN12613001231730 ( first study ) and ACTRN12613001361796 ( second study ) .Was this trial prospect ively registered ? : Yes . Date registered : 8 November 2013 ( first study ) , 12 December 2013 ( second study ) .Anticipated completion : June 2015 . Protocol version : 1.Role of trial sponsor : KP and DL are directly employed by one of the trial sponsors , their roles were : KP assisted with overall development of research design and assisted with overall project management ; DL contributed to project management , administration and communications strategy Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES To identify factors relating to the intensity of rehabilitation services received and to ascertain the relation between injury outcomes , demographics , types of therapy , and the intensity of rehabilitation services provided . DESIGN A multicenter , prospect i ve , nonr and omized study with inpatient rehabilitation data collected between
Output:
| For acute general medical and surgical hospital wards , it was unclear whether the weekend allied health service model provided in the two identified r and omised trials led to significant changes in measured outcomes .
The benefit of providing additional allied health services is clearer in subacute rehabilitation setting s than for acute general medical and surgical wards in hospitals . |
MS212666 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Aims /hypothesisCardiac disease remains the leading cause of mortality in type 2 diabetes , yet few strategies to target cardiac dysfunction have been developed . This r and omised controlled trial aim ed to investigate high intensity intermittent training ( HIIT ) as a potential therapy to improve cardiac structure and function in type 2 diabetes . The impact of HIIT on liver fat and metabolic control was also investigated . Methods Using an online r and om allocation sequence , 28 patients with type 2 diabetes ( metformin and diet controlled ) were r and omised to 12 weeks of HIIT ( n = 14 ) or st and ard care ( n = 14 ) . Cardiac structure and function were measured by 3.0 T MRI and tagging . Liver fat was determined by 1H-magnetic resonance spectroscopy and glucose control by an OGTT . MRI analysis was performed by an observer blinded to group allocation . All study procedures took place in Newcastle upon Tyne , UK . Results Five patients did not complete the study and were therefore excluded from analysis : this left 12 HIIT and 11 control patients for the intention-to-treat analysis . Compared with controls , HIIT improved cardiac structure ( left ventricular wall mass 104 ± 17 g to 116 ± 20 g vs 107 ± 25 g to 105 ± 25 g , p < 0.05 ) and systolic function ( stroke volume 76 ± 16 ml to 87 ± 19 ml vs 79 ± 14 ml to 75 ± 15 ml , p < 0.01 ) . Early diastolic filling rates increased ( 241 ± 84 ml/s to 299 ± 89 ml/s vs 250 ± 44 ml/s to 251 ± 47 ml/s , p < 0.05 ) and peak torsion decreased ( 8.1 ± 1.8 ° to 6.9 ± 1.6 ° vs 7.1 ± 2.2 ° to 7.6 ± 1.9 ° , p < 0.05 ) in the treatment group . Following HIIT , there was a 39 % relative reduction in liver fat ( p < 0.05 ) and a reduction in HbA1c ( 7.1 ± 1.0 % [ 54.5 mmol/mol ] to 6.8 ± 0.9 % [ 51.3 mmol/mol ] vs 7.2 ± 0.5 % [ 54.9 mmol/mol ] to 7.4 ± 0.7 % [ 57.0 mmol/mol ] , p < 0.05 ) . Changes in liver fat correlated with changes in HbA1c ( r = 0.70 , p < 0.000 ) and 2 h glucose ( r = 0.57 , p < 0.004 ) . No adverse events were recorded . Conclusions /interpretationThis is the first study to demonstrate improvements in cardiac structure and function , along with the greatest reduction in liver fat , to be recorded following an exercise intervention in type 2 diabetes . HIIT should be considered by clinical care teams as a therapy to improve cardiometabolic risk in patients with type 2 diabetes . Trial registration : www.is rct n.com 78698481 Funding : Medical Research Council BACKGROUND & AIMS We determined the effects of acute and chronic calorie restriction with either a low-fat , high-carbohydrate ( HC ) diet or a low-carbohydrate ( LC ) diet on hepatic and skeletal muscle insulin sensitivity . METHODS Twenty-two obese subjects ( body mass index , 36.5 + /- 0.8 kg/m2 ) were r and omized to an HC ( > 180 g/day ) or LC ( < 50 g/day ) energy-deficit diet . A euglycemic-hyperinsulinemic clamp , muscle biopsy specimens , and magnetic resonance spectroscopy were used to determine insulin action , cellular insulin signaling , and intrahepatic triglyceride ( IHTG ) content before , after 48 hours , and after approximately 11 weeks ( 7 % weight loss ) of diet therapy . RESULTS At 48 hours , IHTG content decreased more in the LC than the HC diet group ( 29.6 % + /- 4.8 % vs 8.9 % + /- 1.4 % ; P < .05 ) but was similar in both groups after 7 % weight loss ( LC diet , 38.0 % + /- 4.5 % ; HC diet , 44.5 % + /- 13.5 % ) . Basal glucose production rate decreased more in the LC than the HC diet group at 48 hours ( 23.4 % + /- 2.2 % vs 7.2 % + /- 1.4 % ; P < .05 ) and after 7 % weight loss ( 20.0 % + /- 2.4 % vs 7.9 % + /- 1.2 % ; P < .05 ) . Insulin-mediated glucose uptake did not change at 48 hours but increased similarly in both groups after 7 % weight loss ( 48.4 % + /- 14.3 % ; P < .05 ) . In both groups , insulin-stimulated phosphorylation of c-Jun-N-terminal kinase decreased by 29 % + /- 13 % and phosphorylation of Akt and insulin receptor substrate 1 increased by 35 % + /- 9 % and 36 % + /- 9 % , respectively , after 7 % weight loss ( all P < .05 ) . CONCLUSIONS Moderate calorie restriction causes temporal changes in liver and skeletal muscle metabolism ; 48 hours of calorie restriction affects the liver ( IHTG content , hepatic insulin sensitivity , and glucose production ) , whereas moderate weight loss affects muscle ( insulin-mediated glucose uptake and insulin signaling ) IMPORTANCE Nonalcoholic fatty liver disease ( NAFLD ) is a prevalent risk factor for chronic liver disease and cardiovascular disease . OBJECTIVE To compare the effects of moderate and vigorous exercise on intrahepatic triglyceride content and metabolic risk factors among patients with NAFLD . DESIGN , SETTING , AND PARTICIPANTS In this r and omized clinical trial , participants with central obesity and NAFLD were recruited from community-based screening in Xiamen , China , from December 1 , 2011 , through December 25 , 2013 . Data analysis was performed from August 28 , 2015 , through December 15 , 2015 . INTERVENTIONS Participants were r and omly assigned to vigorous-moderate exercise ( jogging 150 minutes per week at 65%-80 % of maximum heart rate for 6 months and brisk walking 150 minutes per week at 45%-55 % of maximum heart rate for another 6 months ) , moderate exercise ( brisk walking 150 minutes per week for 12 months ) , or no exercise . MAIN OUTCOMES AND MEASURES Primary outcome , change in intrahepatic triglyceride content measured by proton magnetic resonance spectroscopy at 6 and 12 months ; secondary outcomes , changes in body weight , waist circumference , body fat , and metabolic risk factors . RESULTS A total of 220 individuals ( mean [ SD ] age , 53.9 [ 7.1 ] years ; 149 woman [ 67.7 % ] ) were r and omly assigned to control ( n = 74 ) , moderate exercise ( n = 73 ) , and vigorous-moderate exercise ( n = 73 ) groups . Of them , 211 ( 95.9 % ) completed the 6-month follow-up visit ; 208 ( 94.5 % ) completed the 12-month follow-up visit . Intrahepatic triglyceride content was reduced by 5.0 % ( 95 % CI , -7.2 % to 2.8 % ; P < .001 ) in the vigorous-moderate exercise group and 4.2 % ( 95 % CI , -6.3 % to -2.0 % ; P < .001 ) in the moderate exercise group compared with the control group at the 6-month assessment . It was reduced by 3.9 % ( 95 % CI , -6.0 % to -1.7 % ; P < .001 ) in the vigorous-moderate exercise group and 3.5 % ( 95 % CI , -5.6 % to -1.3 % ; P = .002 ) in the moderate exercise group compared with the control group at the 12-month assessment . Changes in intrahepatic triglyceride content were not significantly different between vigorous-moderate and moderate exercise at the 6- or 12-month assessment . Body weight , waist circumference , and blood pressure were significantly reduced in the vigorous-moderate exercise group compared with the moderate exercise and control groups at the 6-month assessment and in the vigorous-moderate and moderate exercise groups compared with the control group at the 12-month assessment . In addition , body fat was significantly reduced in the vigorous-moderate exercise group compared with the moderate exercise and control groups at the 12-month assessment . After adjusting for weight loss , the net changes in intrahepatic triglyceride content were diminished and became nonsignificant between the exercise and control groups ( except for the moderate exercise group at the 6-month assessment ) . CONCLUSIONS AND RELEVANCE Vigorous and moderate exercise were equally effective in reducing intrahepatic triglyceride content ; the effect appeared to be largely mediated by weight loss . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01418027 BACKGROUND & AIMS Little is known about how weight loss affects magnetic resonance imaging ( MRI ) of liver fat and volume or liver histology in patients with nonalcoholic steatohepatitis ( NASH ) . We measured changes in liver fat and liver volume associated with weight loss by using an advanced MRI method . METHODS We analyzed data collected from a previous r and omized controlled trial in which 43 adult patients with biopsy-proven NASH underwent clinical evaluation , biochemical tests , and MRI and liver biopsy analyses at the start of the study and after 24 weeks . We compared data between patients who did and did not have at least 5 % decrease in body mass index ( BMI ) during the study period . RESULTS Ten of 43 patients had at least a 5 % decrease in BMI during the study period . These patients had a significant decrease in liver fat , which was based on MRI proton density fat fraction estimates ( 18.3 % ± 7.6 % to 13.6 % ± 13.6 % , P = .03 ) , a relative 25.5 % reduction . They also had a significant decrease in liver volume ( 5.3 % ) . However , no significant changes in levels of alanine aminotransferase or aspartate aminotransferase were observed with weight loss . Thirty-three patients without at least 5 % decrease in BMI had insignificant increases in estimated liver fat fraction and liver volume . CONCLUSIONS A reduction in BMI of at least 5 % is associated with significant decrease in liver fat and volume in patients with biopsy-proven NASH . These data should be considered in assessing effect size in studies of patients with nonalcoholic fatty liver disease or obesity that use MRI-estimated liver fat and volume as end points 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
Output:
| Pooling of six studies ( 94 participants ) suggests that exercise training also improves basal hepatic insulin sensitivity ( mean change in hepatic insulin sensitivity index : 0.13 [ 0.05 to 0.21 ] mg m-2 min-1 per μU mL-1 ) , but available evidence is limited , and the impact of exercise on insulin-stimulated hepatic insulin sensitivity remains unclear |
MS212667 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Behavior Change Communications ( BCC ) play a decisive role in modifying socio-cultural norms affecting the perception and nutritional practice s during pregnancy . Objective To examine the effectiveness of ‘ Trials of Improved Practice s ’ ( TIPs ) on dietary and iron-folate intake during pregnancy . Design Community based quasi experimental study with a control group Setting Four villages of Chiraigaon Community Development Block of Varanasi , India from May 2010 and recruited from August 2010 . End line assessment , after 12 weeks of intervention , was completed in April 2011 . Participants Pregnant women in 13–28 weeks of gestation Intervention TIPs was implemented in addition to ongoing essential obstetric care services in two villages through 3 home ( assessment , negotiation and evaluation ) visits and only assessment and evaluation visits in the other two control villages . Interpersonal communication , endorsing the active participation of family members and home based reminder material s were the TIPs based strategies . The effect of TIPs was assessed by comparing key outcome variables at baseline and after 12 weeks of intervention . Outcome Measures Hemoglobin% , anemia prevalence , weight gain , compliance for iron-folate supplementation and dietary intake of calorie , protein , calcium and iron . Results A total of 86 participants completed the study . At the end , mean hemoglobin levels were 11.5±1.24 g/dl and 10.37±1.38 g/dl in the TIPs and control groups , respectively . The prevalence of anemia reduced by half in TIPs group and increased by 2.4 % in the control group . Weight gain ( grams/week ) was significantly ( p<0.01 ) higher in TIPs group ( 326.9±91.8 vs. 244.6±97.4 ) . More than 85 % of the PW in TIPs group were compliant for Iron-folate and only 38 % were compliant among controls . The mean intake of protein increased by 1.78gm in intervention group and decreased by 1.81 gm in controls ( p<0.05 ) . More than two thirds of PW in TIPs group were taking one extra meal and only one third of controls were doing the same . Conclusion TIPs found to be an effective approach to improve the nutritional status of pregnant women in the study area . TIPs strategy could be further explored on larger sample representing different socio-cultural and geographical areas . Trial Registration Clinical Trial Registry of India BACKGROUND Consistent evidence of an influence of maternal dietary intake during pregnancy on infant body size and composition in human population s is lacking , despite robust evidence in animal models . OBJECTIVE We sought to evaluate the influence of maternal macronutrient intake and balance during pregnancy on neonatal body size and composition , including fat mass and fat-free mass . STUDY DESIGN The analysis was conducted among 1040 mother-offspring pairs enrolled in the prospect i ve prebirth observational cohort : the Healthy Start Study . Diet during pregnancy was collected using repeated 24-hour dietary recalls ( up to 8) . Direct measures of body composition were obtained using air displacement plethysmography . The National Cancer Institute measurement error model was used to estimate usual dietary intake during pregnancy . Multivariable partition ( nonisocaloric ) and nutrient density ( isocaloric ) linear regression models were used to test the associations between maternal dietary intake and neonatal body composition . RESULTS The median macronutrient composition during pregnancy was 32.2 % from fat , 15.0 % from protein , and 47.8 % from carbohydrates . In the partition multivariate regression model , individual macronutrient intake values were not associated with birthweight or fat-free mass , but were associated with fat mass . Respectively , 418 kJ increases in total fat , saturated fat , unsaturated fat , and total carbohydrates were associated with 4.2-g ( P = .03 ) , 11.1-g ( P = .003 ) , 5.9-g ( P = .04 ) , and 2.9-g ( P = .02 ) increases in neonatal fat mass , independent of prepregnancy body mass index . In the nutrient density multivariate regression model , macronutrient balance was not associated with fat mass , fat-free mass , or birthweight after adjustment for prepregnancy body mass index . CONCLUSION Neonatal adiposity , but not birthweight , is independently associated with increased maternal intake of total fat , saturated fat , unsaturated fat , and total carbohydrates , but not protein , suggesting that most forms of increased caloric intake contribute to fetal fat accretion Background Although it is known that lifestyle behaviors of pregnant women are closely related to maternal and fetal health , number of data concerning efficacy of intervention on lifestyle during pregnancy is limited . The purpose of this study is to determine the effect of lifestyle interventions on improving dietary habits and lifestyle behaviors , ensuring gestational weight gain ( GWG ) within recommended levels and limiting postpartum weight retention ( PWR ) . Methods The study was conducted as a r and omized controlled trial in a family health center located in Istanbul , Turkey , between June 2011 and July 2012 . The primary outcomes were GWG , and the proportion of pregnant women whose GWG was within the Institute of Medicine ( IOM ) guidelines . One hundred two pregnant women with gestation ≤12 weeks , age ≥18 years , gravidity ≤2 , and who did not intend to lose weight in prepregnancy period were r and omly included in this study as intervention ( n = 51 ) and control ( n = 51 ) groups . The study was completed with 45 women for each group . The control group received routine antenatal care . The intervention group was received an individualized lifestyle intervention focusing on healthy lifestyle , diet , exercise , and weight monitoring as four sessions at 12–15 , 16–18 , 20–24 , and 37 weeks gestation . Lifestyle behaviors were evaluated with Health-Promoting Lifestyle Profile-II . Dietary habits were assessed by 3-day dietary recalls , and weight was followed from pregnancy until 6 weeks postpartum . Results The lifestyle interventions had a significant effect on improving lifestyle behaviors , protein intake , percentage of energy from protein , calcium , magnesium , iron , zinc , and vegetable intakes when adjusted for confounders ( p < 0.05 ) . The proportion of women who were within the IOM recommendations was higher in the intervention group ( 51.1 % ) than in the control group ( 28.9 % ) The odds ratio for GWG within IOM was statistically significant between the groups ( OR = 0.59 , 95 % CI , 0.45–0.72 ) . There were no difference between groups in terms of the other dietary intakes , total GWG , and PWR ( p > 0.05 ) . Conclusions Lifestyle intervention improves the lifestyle behaviors during pregnancy and increases the appropriate GWG for prepregnancy body mass index ( BMI ) , but it has a limited effect in terms of improving dietary habits and has no effect on PWR BACKGROUND The role played by dairy product intake during pregnancy on neonatal outcomes has raised interest in the last few years . However , studies on this association remain scarce . Thus , the aim of this study was to determine the association between dairy product consumption during pregnancy and neonatal and maternal outcomes . METHODS A prospect i ve study was conducted with 98 pregnant women , aged 18 - 40 , from the city of Porto , Portugal . Socio-demographic and lifestyle characteristics were assessed through a question naire . Dairy product consumption was assessed with a three-day food diary completed during the first and second trimesters . Postpartum medical records were examined for neonatal and maternal outcomes . Multivariate linear regression analyses were performed to assess the association between dairy intake and neonatal and maternal outcomes , adjusting for dietary variables and maternal characteristics . RESULTS Compared to the first trimester pregnant women had higher energy intake and lower calcium , iodine and yogurt intake in the second trimester ( P<0.05 ) . Total dairy and yogurt intake in the first trimester were positively associated with head circumference and placental weight ( respectively β=0.002 , P=0.014 , β=0.333 , P=0.012 ) . Change in total dairy intake between the second and first trimester was negatively associated with maternal weight gain during pregnancy ( β=-0.007 , P=0.020 ) . CONCLUSION The findings of this study suggest that dairy product intake during pregnancy may have an effect on neonatal head circumference , placental weight , and gestational weight gain Previous studies revealed associations of urinary Cd ( U-Cd ) , a chronic Cd exposure biomarker , with blood pressure ( BP ) in non-pregnant adults . However , the evidence regarding trimester-specific blood pressure in pregnancy and U-Cd and effect modification by dietary intake of micronutrients is scarce . We r and omly selected 653 women from the Omega Study cohort . U-Cd was quantified by inductively coupled plasma mass spectrometry . Trimester-specific , systolic ( SBP ) and diastolic blood pressure ( DBP ) were determined employing st and ard protocol s and mean arterial pressure ( MAP ) was also calculated . Associations of SBP , DBP , and MAP with U-Cd tertiles ( ≤0.21 ; 0.22–0.41 ; ≥0.42 μg/g Cr ) were assessed using multivariable linear regression models . We also explored effect modification by pre-pregnancy BMI ( ≤25 or > 25 kg/m2 ) or low/high micronutrients intake . After adjusting confounders in women with elevated ( upper tertile ) as compared with those with low ( lowest tertile ) U-Cd ( ≥0.42 vs. ≤0.21 μg/g Cr , respectively ) had reduced third trimester MAP ( −1.8 ; 95 % confidence interval ( CI ) = −3.1 , −0.5 mmHg ) and second trimester MAP ( −1.1 ; 95 % CI = −2.3 , −0.03 mmHg ) . A significant decrease in third-trimester MAP associated with increased U-Cd was observed only among normal/underweight women ( BMI ≤ 25 kg/m2 ) and women with high dietary intake of micronutrients ( calcium , magnesium , zinc , and selenium ) . Notably , U-Cd concentrations increased with the increased consumption of zinc and non-heme iron food sources . No significant differences in U-Cd concentrations were found in preeclamptic women compared with non-preeclamptic women . Our study provides evidence that dietary intake of micronutrients should be taken into account when assessing the health effects of Cd in pregnant women BACKGROUND Maternal diet during pregnancy has been suggested to influence bone health in later life . OBJECTIVE We assessed the association of maternal first-trimester dietary intake during pregnancy with childhood bone mass . DESIGN In a prospect i ve cohort study in 2819 mothers and their children , we measured first-trimester daily energy , protein , fat , carbohydrate , calcium , phosphorus , and magnesium intakes by using a food-frequency question naire and homocysteine , folate , and vitamin B-12 concentrations in venous blood . We measured childhood total body bone mass by using dual-energy X-ray absorptiometry at the median age of 6.0 y. RESULTS Higher first-trimester maternal protein , calcium , and phosphorus intakes and vitamin B-12 concentrations were associated with higher childhood bone mass , whereas carbohydrate intake and homocysteine concentrations were associated with lower childhood bone mass ( all P-trend < 0.01 ) . Maternal fat , magnesium intake , and folate concentrations were not associated with childhood bone mass . In the fully adjusted regression model that included all dietary factors significantly associated with childhood bone mass , maternal phosphorus intake and homocysteine concentrations most-strongly predicted childhood bone mineral content ( BMC ) [ β = 2.8 ( 95 % CI : 1.1 , 4.5 ) and β = -1.8 ( 95 % CI : -3.6 , 0.1 ) g per SD increase , respectively ] , whereas maternal protein intake and vitamin B-12 concentrations most strongly predicted BMC adjusted for bone area [ β = 2.1 ( 95 % CI : 0.7 , 3.5 ) and β = 1.8 ( 95 % CI : 0.4 , 3.2 ) g per SD increase , respectively ] . CONCLUSION Maternal first-trimester dietary factors are associated with childhood bone mass , suggesting that fetal nutritional exposures may permanently influence bone development Obese pregnant women are the focus of numerous dietary and lifestyle intervention studies , however there is a paucity of literature examining the habitual dietary and lifestyle habits of this population . This paper aims to assess maternal dietary and lifestyle habits in an obese cohort , in order to identify priority areas to be addressed in future studies and in clinical practice . This prospect i ve observational study recruited 100 pregnant women with a body mass index 30.0–39.9 kg/m2 from routine antenatal clinics . Dietary intakes were assessed using a 3-day food diary and a structured lifestyle question
Output:
| Conclusion These results are consistent with a lack of improvement in calcium dietary intake during pregnancy and confirm the gap between HICs and LMICs , with alarmingly low intakes recorded for pregnant women in LMICs . |
MS212668 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Dietary intake of fish and the omega-3 fatty acids have been associated with lower risk of Alzheimer disease and stroke . OBJECTIVE To examine whether intakes of fish and the omega-3 fatty acids protect against age-related cognitive decline . DESIGN Prospect i ve cohort study . SETTING Geographically defined Chicago , Ill , community . PARTICIPANTS Residents , 65 years and older , who participated in the Chicago Health and Aging Project . MAIN OUTCOME MEASURE Change in a global cognitive score estimated from mixed models . The global score was computed by summing scores of 4 st and ardized tests . In-home cognitive assessment s were performed 3 times over 6 years of follow-up . RESULTS Cognitive scores declined on average at a rate of 0.04 st and ardized units per year ( SU/y ) . Fish intake was associated with a slower rate of cognitive decline in mixed models adjusted for age , sex , race , education , cognitive activity , physical activity , alcohol consumption , and total energy intake . Compared with a decline rate in score of -0.100 SU/y among persons who consumed fish less than weekly , the rate was 10 % slower ( -0.090 SU/y ) among persons who consumed 1 fish meal per week and 13 % slower ( -0.088 SU/y ) among persons who consumed 2 or more fish meals per week . The fish association was not accounted for by cardiovascular-related conditions or fruit and vegetable consumption but was modified after adjustment for intakes of saturated , polyunsaturated , and trans fats . There was little evidence that the omega-3 polyunsaturated fatty acids were associated with cognitive change . CONCLUSIONS Fish consumption may be associated with slower cognitive decline with age . Further study is needed to determine whether fat composition is the relevant dietary constituent Background Some studies have suggested an association between omega-3 long-chain polyunsaturated fatty acids ( n-3 LC PUFAs ) and better cognitive outcomes in older adults . To date , only two r and omised , controlled trials have assessed the effect of n-3 LC PUFA supplementation on cognitive function in older cognitively healthy population s. Of these trials only one found a benefit , in the subgroup carrying the ApoE-ε4 allele . The benefits of n-3 LC PUFA supplementation on cognitive function in older normal population s thus still remain unclear . The main objective of the current study was to provide a comprehensive assessment of the potential of n-3 LC PUFAs to slow cognitive decline in normal elderly people , and included ApoE-ε4 allele carriage as a potential moderating factor . The detailed methodology of the trial is reported herein . Methods The study was a parallel , 18-month , r and omised , double-blind , placebo-controlled intervention with assessment at baseline and repeated 6-monthly . Participants ( N = 391 , 53.7 % female ) aged 65 - 90 years , English-speaking and with normal cognitive function , were recruited from metropolitan Adelaide , South Australia . Participants in the intervention arm received capsules containing fish-oil at a daily dosage of 1720 mg of docosahexaenoic acid and 600 mg of eicosapentaenoic acid while the placebo arm received the equivalent amount of olive oil in their capsules . The primary outcome is rate of change in cognitive performance , as measured by latent variables for the cognitive constructs ( encompassing Reasoning , Working Memory , Short-term Memory , Retrieval Fluency , Inhibition , Simple and Choice-Reaction Time , Perceptual Speed , Odd-man-out Reaction Time , Speed of Memory Scanning , and Psychomotor Speed ) and assessed by latent growth curve modeling . Secondary outcomes are change in the Mini-mental State Examination , functional capacity and well-being ( including health status , depression , mood , and self-report cognitive functioning ) , blood pressure , and biomarkers of n-3 LC PUFA status , glucose , lipid metabolism , inflammation , oxidative stress , and DNA damage . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : Given evidence that eicosapentaenoic acid ( EPA ) , docosahexaenoic acid ( DHA ) , and anthocyanin-rich blueberries provide neurocognitive benefit , we investigated long-term supplementation in older adults with cognitive complaints . In a 24-week r and omized , double-blind , placebo-controlled trial , elderly men and women received daily fish oil ( FO ) or blueberry ( BB ) or both . Diet records confirmed that participants reduced background consumption of EPA , DHA , and anthocyanins as prescribed . Erythrocyte EPA + DHA composition increased in the FO groups ( p = 0.0001 ) . Total urinary anthocyanins did not differ between the groups after supplementation but glycoside and native ( food ) forms increased only in the BB-supplemented groups . The FO ( p = 0.03 ) and BB ( p = 0.05 ) groups reported fewer cognitive symptoms , and the BB group showed improved memory discrimination ( p = 0.04 ) , indicating that supplementation improved cognition . Cognitive benefit in the BB group was associated with the presence of urinary anthocyanins reflecting recent BB intake but not with anthocyanin metabolites . However , combined FO + BB treatment was not associated with cognitive enhancement as expected Docosahexaenoic acid ( DHA ) is important for brain function , and higher DHA intake is inversely correlated with relative risk of Alzheimer 's disease . The potential benefits of DHA supplementation in people with mild cognitive impairment ( MCI ) have not been fully examined . Our study aim ed to determine the effect of DHA supplementation on cognitive function and hippocampal atrophy in elderly subjects with MCI . This was a r and omized , double-blind , placebo-controlled trial in Tianjin , China . 240 individuals with MCI aged 65 years and over were recruited and equalized r and omly allocated to the DHA or the placebo group . Participants received 12-month DHA supplementation ( 2 g/day ) or corn oil as placebo . Both global and specific subdomains of cognitive function and hippocampal volume were measured at baseline , 6 months , and 12 months . Both changes were analyzed by repeated-measure analysis of variance ( ANOVA ) . This trial has been registered : ChiCTR-IOR-15006058 . A total of 219 participants ( DHA : 110 , Placebo : 109 ) completed the trial . The change in mean serum DHA levels was greater in the intervention group ( + 3.85 % ) compared to the control group ( + 1.06 % ) . Repeated- measures analyses of covariance showed that , over 12 months , there was a significant difference in the Full-Scale Intelligence Quotient ( ηp2 = 0.084 ; p = 0.039 ) , Information ( ηp2 = 0.439 ; p = 0.000 ) , and Digit Span ( ηp2 = 0.375 ; p = 0.000 ) between DHA-treated versus the placebo group . In addition , there were significant differences in volumes of left hippocampus ( ηp2 = 0.121 , p = 0.016 ) , right hippocampus ( ηp2 = 0.757 , p = 0.008 ) , total hippocampus ( ηp2 = 0.124 , p = 0.023 ) , and global cerebrum ( ηp2 = 0.145 , p = 0.032 ) between the two groups . These findings suggest that DHA supplementation ( 2 g/day ) for 12 months in MCI subjects can significantly improve cognitive function and slow the progression of hippocampal atrophy . Larger , longer-term confirmatory studies are warranted BACKGROUND Plasma fatty acids may affect the risk of cognitive decline in older adults . OBJECTIVES We prospect ively studied the association between plasma fatty acids and cognitive decline in adults aged 50 - 65 y at baseline and conducted a subgroup analysis . DESIGN From 1987 through 1989 , the Atherosclerosis Risk in Communities ( ARIC ) Study analyzed plasma fatty acids in cholesteryl esters and phospholipids in whites residing in Minneapolis , MN . From 1990 through 1992 and from 1996 through 1998 , 3 neuropsychological tests in the domains of delayed word recall , psychomotor speed , and verbal fluency were administered . We selected cutoffs for statistically reliable cognitive decline in each of these domains and a measure of global cognitive change computed by principal-components analysis . Multivariate logistic regression was conducted . Focusing on n-3 highly unsaturated fatty acids ( HUFAs ) , a subgroup analysis assessed differential association across potential effect modifiers implicated in oxidative stress and increased risk of neurodegenerative disease . RESULTS In the 2251 study subjects , the risk of global cognitive decline increased with elevated palmitic acid in both fractions and with high arachidonic acid and low linoleic acid in cholesteryl esters . Higher n-3 HUFAs reduced the risk of decline in verbal fluency , particularly in hypertensive and dyslipidemic subjects . No significant findings were shown for psychomotor speed or delayed word recall . CONCLUSIONS Promoting higher intakes of n-3 HUFAs in the diet of hypertensive and dyslipidemic persons may have substantial benefits in reducing their risk of cognitive decline in the area of verbal fluency . However , clinical trials are needed to confirm this finding BACKGROUND Very-long-chain n-3 polyunsaturated fatty acids ( n-3 PUFAs ) are suggested to be related to cognitive performance in older adults . However , limited data exist on the association between n-3 PUFAs and performance in specific cognitive domains . OBJECTIVE We evaluated the association between plasma n-3 PUFA proportions and cognitive performance in 5 cognitive domains and determined whether plasma n-3 PUFA proportions predict cognitive change over 3 y. DESIGN We used data from the FACIT trial , in which participants received folic acid or placebo capsules for 3 y. Fatty acid proportions in plasma cholesteryl esters at baseline were measured in 807 men and women aged 50 - 70 y. Cognitive performance for memory , sensorimotor speed , complex speed , information-processing speed , and word fluency was assessed at baseline and after 3 y. The cross-sectional analyses were based on all 807 participants ; the longitudinal analyses were based only on 404 participants in the placebo group . RESULTS Higher plasma n-3 PUFA proportions predicted less decline in sensorimotor speed ( multiple linear regression coefficient , z score = 0.31 ; 95 % CI : 0.06 , 0.57 ) and complex speed ( 0.40 ; 95 % CI : 0.10 , 0.70 ) over 3 y. Plasma n-3 PUFA proportions did not predict 3-y changes in memory , information-processing speed , or word fluency . The cross-sectional analyses showed no association between plasma n-3 PUFA proportions and performance in any of the 5 cognitive domains . CONCLUSIONS In this population , plasma n-3 PUFA proportions were associated with less decline in the speed-related cognitive domains over 3 y. These results need to be confirmed in r and omized controlled trials Depressive symptoms may increase the risk of progressing from mild cognitive impairment ( MCI ) to dementia . Consumption of n-3 PUFA may alleviate both cognitive decline and depression . The aim of the present study was to investigate the benefits of supplementing a diet with n-3 PUFA , DHA and EPA , for depressive symptoms , quality of life ( QOL ) and cognition in elderly people with MCI . We conducted a 6-month double-blind , r and omised controlled trial . A total of fifty people aged > 65 years with MCI were allocated to receive a supplement rich in EPA ( 1·67 g EPA + 0·16 g DHA/d ; n 17 ) , DHA ( 1·55 g DHA + 0·40 g EPA/d ; n 18 ) or the n-6 PUFA linoleic acid ( LA ; 2·2 g/d ; n 15 ) . Treatment allocation was by minimisation based on age , sex and depressive symptoms ( Geriatric Depression Scale , GDS ) . Physiological and cognitive assessment s , question naires and fatty acid composition of erythrocytes were obtained at baseline and 6 months ( completers : n 40 ; EPA n 13 , DHA n 16 , LA n 11 ) . Compared with the LA group , GDS scores improved in the EPA ( P=0·04 ) and DHA ( P=0·01 ) groups and verbal fluency ( Initial Letter Fluency ) in the DHA group ( P=0·04 ) . Improved GDS scores were correlated with increased DHA plus EPA ( r 0·39 , P=0·02 ) . Improved self-reported physical health was associated with increased DHA . There were no treatment effects on other cognitive or QOL parameters . Increased intakes of DHA and EPA benefited mental health in older people with MCI . Increasing n-3 PUFA intakes may reduce depressive symptoms and the risk of progressing to dementia . This needs to be investigated in larger , depressed sample s with MCI BACKGROUND Epidemiologic and animal studies have suggested that dietary fish or fish oil rich in omega
Output:
| This Systematic Review concludes that omega-3 supplementation might have a positive effect on cognitive function .
Thus , n-3 LCPUFAs could be used as a preventive or therapeutic tool for cognitive decline in aged or elder adults |
MS212669 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The Fifth Commission on Antiepileptic Drugs of the International League Against Epilepsy was asked to advise the ILAE Executive on the place of new drugs in the treatment of patients with newly diagnosed or chronic epilepsy . With the licensing of a significant number of new antiepileptic drugs ( AEDs ) in the last 5 - 10 years , there is an obvious need for these new treatments to be introduced efficiently and effectively to benefit the care and management of people with epilepsy . Implicit in this will be a determination of the comparative efficacy , tolerability , and overall effectiveness against st and ard ( existing ) AEDs and against other new drugs . Although many of the issues relating to comparative studies were addressed in Guidelines for the Clinical Evaluation of Antiepileptic Drugs , produced by the Fourth Commission , several complex ethical and method ological problems remain that would benefit from further discussion aim ed at the establishment of some form of consensus . Although determination of the relative risks of rare but potentially serious idiosyncratic adverse reactions and teratogenicity can be determined only by adequate postmarketing surveillance , other issues concerning the efficacy , tolerability , and effectiveness of new drugs can best be determined within the context of well- design ed r and omized ( or otherwise controlled ) clinical trials ( RCTs ) . It is the design , structure , and outcomes of such comparative RCTs that dem and further consideration . Many of the difficulties arise because the most meaningful and satisfactory comparative studies will essentially be those that compare monotherapy with a new agent with monotherapy with alternative agents . The Commission recognizes that several different parties have interests in comparative studies . First and foremost patients and their doctors require adequate information to guide daily practice in an “ evidence -based ” way so that patients can make fully informed decisions about their drug treatment . Individual pharmaceutical manufacturers need to know how their drug compares with other products so that a drug can be appropriately positioned in the market . Licensing authorities have traditionally ignored issues of comparative Background The choice of antiepileptic drug for an individual should be based upon the highest quality evidence regarding potential benefits and harms of the available treatments . Systematic review s and meta- analysis of r and omised controlled trials should be a major source of evidence supporting this decision making process . We summarise all available individual patient data evidence from r and omised controlled trials that compared at least two out of eight antiepileptic drugs given as monotherapy . Methods Multiple treatment comparisons from epilepsy monotherapy trials were synthesized in a single stratified Cox regression model adjusted for treatment by epilepsy type interactions and making use of direct and indirect evidence . Primary outcomes were time to treatment failure and time to 12 month remission from seizures . A secondary outcome was time to first seizure . Results Individual patient data for 6418 patients from 20 r and omised trials comparing eight antiepileptic drugs were synthesized . For partial onset seizures ( 4628 ( 72 % ) patients ) , lamotrigine , carbamazepine and oxcarbazepine provide the best combination of seizure control and treatment failure . Lamotrigine is clinical ly superior to all other drugs for treatment failure but estimates suggest a disadvantage compared to carbamazepine for time to 12 month remission [ Hazard Ratio ( 95 % Confidence Interval ) = 0.87(0.73 to 1.04 ) ] and time to first seizure [ 1.29(1.13 to 1.48 ) ] . Phenobarbitone may delay time to first seizure [ 0.77(0.61 to 0.96 ) ] but at the expense of increased treatment failure [ 1.60(1.22 to 2.10 ) ] . For generalized onset tonic clonic seizures ( 1790 ( 28 % ) patients ) estimates suggest valproate or phenytoin may provide the best combination of seizure control and treatment failure but some uncertainty remains about the relative effectiveness of other drugs . Conclusion For patients with partial onset seizures , results favour carbamazepine , oxcarbazepine and lamotrigine . For generalized onset tonic clonic seizures , results favour valproate and phenytoin 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 BACKGROUND The use of phenobarbital for childhood epilepsy is controversial because of reported behavioural side-effects ; however , whether this research can validly be extrapolated to developing countries is not clear . We undertook a r and omised comparison of phenobarbital and phenytoin to assess the acceptability and efficacy of phenobarbital as monotherapy for childhood epilepsy in rural India . METHODS Between August , 1995 , and February , 1996 , 109 unselected children aged 2 - 18 years with partial and generalised tonic-clonic epilepsy were identified by population screening . 15 families declined to take part . 94 children were r and omly allocated treatment with phenobarbital ( 1.5 mg/kg daily for 2 weeks ; maintenance dose 3.0 mg/kg daily ; n = 47 ) or phenytoin ( 2.5 mg/kg daily then 5.0 mg/kg daily ; n = 47 ) . Children were followed up for 12 months . The primary outcome measure was the frequency of behavioural side-effects ; behaviour was assessed by the Conners parent rating scale for children aged 6 years and older , and by the preschool behaviour screening question naire ( BSQ ) for those aged 2 - 5 years , at 12 months or at withdrawal from treatment . Analysis was by intention to treat . FINDINGS The mean log-transformed scores on the behaviour rating scales did not differ significantly between the phenobarbital and phenytoin groups ( Conners 2.64 [ SD 0.71 ] vs 2.65 [ 0.89 ] , p = 0.97 ; n = 32 in each group : BSQ 2.12 [ 1.31 ] vs 2.18 [ 1.02 ] , p = 0.94 ; n = 4 vs 3 ) . The odds ratio for behavioural problems ( phenobarbital vs phenytoin ) was 0.51 ( 95 % CI 0.16 - 1.59 ) . There was no excess in parental reports of side-effects for phenobarbital . We found no difference in efficacy between the study drugs ( adjusted hazard ratio for time to first seizure from r and omisation 0.97 [ 0.28 - 3.30 ] ) . INTERPRETATION This evidence supports the acceptability of phenobarbital as a first-line drug for childhood epilepsy in rural setting s in developing countries PRIMIDONE ( Mysoline ) has been shown to be an effective anticonvulsant drug . 1 - 6 It has been stated that primidone is exceptionally valuable in the control of focal seizures and the " drug of choice " for the treatment of psychomotor seizures . 7 - 9 Previous clinical comparative studies have not contradicted this cl aim . 4,5 One study found that phenobarbital and primidone were equally effective as anticonvulsants with 50 mg of phenobarbital being equivalent to 250 mg of primidone . Another similar study 5 revealed that primidone and phenobarbital are about equally effective as anticonvulsants but more effective than diphenylhydantoin ( Dilantin ) . However , as the authors of that study point out , the five day medication trial was not sufficient for maximal anticonvulsant effect of diphenylhydantoin to occur . Their data revealed a sharp increase in effectiveness of diphenylhydantoin on the fifth treatment day , while primidone and phenobarbital were relatively more effective on the first and second days . Recent studies have shown that most newly diagnosed epileptic patients can be satisfactorily treated with a single antiepileptic drug . We therefore undertook a prospect i ve r and omised pragmatic trial of the comparative efficacy and toxicity of four major antiepileptic drugs , utilised as monotherapy in newly diagnosed epileptic patients . Between 1981 and 1987 243 adult patients aged 16 years or over , newly referred to two district general hospitals with a minimum of two previously untreated tonic-clonic or partial with or without secondary generalised seizures were r and omly allocated to treatment with phenobarbitone , phenytoin , carbamazepine , or sodium valproate . The protocol was design ed to conform with st and ard clinical practice . Efficacy was assessed by time to first seizure after the start of treatment and time to enter one year remission . The overall outcome with all of the four drugs was good with 27 % remaining seizure free and 75 % entering one year of remission by three years of follow up . No significant differences between the four drugs were found for either measure of efficacy at one , two , or three years of follow up . The overall incidence of unacceptable side effects , necessitating withdrawal of the r and omised drug , was 10 % . For the individual drugs phenobarbitone ( 22 % ) was more likely to be withdrawn than phenytoin ( 3 % ) , carbamazepine ( 11 % ) , and sodium valproate ( 5 % ) . In patients with newly diagnosed tonic-clonic or partial with or without secondary generalised seizures , the choice of drug will be more influenced by considerations of toxicity and costs Objective : To assess the relative risk of major congenital malformation ( MCM ) from in utero exposure to antiepileptic drug ( AEDs ) . Methods : Prospect i ve data collected by the UK Epilepsy and Pregnancy Register were analysed . The presence of MCMs recorded within the first three months of life was the main outcome measure . Results : Full outcome data were collected on 3607 cases . The overall MCM rate for all AED exposed cases was 4.2 % ( 95 % confidence interval ( CI ) , 3.6 % to 5.0 % ) . The MCM rate was higher for polytherapy ( 6.0 % ) ( n = 770 ) than for monotherapy ( 3.7 % ) ( n = 2598 ) ( crude odds ratio ( OR ) = 1.63 ( p = 0.010 ) , adjusted OR = 1.83 ( p = 0.002 ) ) . The MCM rate for women with epilepsy who had not taken AEDs during pregnancy ( n = 239 ) was 3.5 % ( 1.8 % to 6.8 % ) . The MCM rate was greater for pregnancies exposed only to valproate ( 6.2 % ( 95 % CI , 4.6 % to 8.2 % ) than only to carbamazepine ( 2.2 % ( 1.4 % to 3.4 % ) ( OR = 2.78 ( p<0.001 ) ; adjusted OR = 2.97 ( p<0.001 ) ) . There were fewer MCMs for pregnancies exposed only to lamotrigine than only to valproate . A positive dose response for MCMs was found for lamotrigine ( p = 0.006 ) . Polytherapy combinations containing valproate carried a higher risk of MCM than combinations not containing valproate ( OR = 2.49 ( 1.31 to 4.70 ) ) . Conclusions : Only 4.2 % of live births to women with epilepsy had an MCM . The MCM rate for polytherapy exposure was greater than for monotherapy exposure . Polyther
Output:
| Several confounding factors , most notably the differences in design of the trials with respect to blinding , were likely to have impacted on the results of the primary outcome ' time to treatment failure ' , and in turn , the treatment failure rates may have impacted on the secondary efficacy outcomes of time to first seizure and time to 12-month and six-month remission .
AUTHORS ' CONCLUSIONS Low-certainty evidence from this review suggests that phenytoin may be a more effective drug than phenobarbitone in terms of treatment retention ( treatment failures due to lack of efficacy or adverse events or both ) .
Moderate-certainty evidence from this review also indicates no differences between the drugs in terms of time to seizure recurrence and seizure remission . |
MS212670 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: STUDY OBJECTIVE To assess the efficacy of 13CO2 laser laparoscopy in treating infertile women with minimal to mild endometriosis according the American Fertility Society classification in terms of pregnancy rates . DESIGN Prospect i ve study . SETTING Medical school-affiliated hospital . PATIENTS One hundred seventy-six women whose infertility was associated with minimal or mild endometriosis diagnosed by laparoscopy . INTERVENTIONS The patients were treated with one of four methods : 49 underwent operative laparoscopy with newly developed 13CO2 laser vaporization and /or resection ; 45 were treated by operative laparoscopy with simple monopolar electrocoagulation ; 43 who had undergone only diagnostic laparoscopy did not receive any treatment ; and 39 received danazol 800 mg/day for 3 months after diagnostic laparoscopy . MEASUREMENTS AND MAIN RESULTS Estimated cumulative pregnancy rates using life table analyses were indicators of treatment of success and compared among the treatments . A subgroup of 111 patients considered to have endometriosis as the only major infertility factor were also evaluated and compared among treatment options . Pregnancy rates in the CO2 laser laparoscopy group were significantly higher than in the other three groups and in endometriosis-only subset . CONCLUSIONS Advanced laparoscopic surgery with the CO2 laser can be more efficient than other modalities in treating infertile women with minimal to mild endometriosis in terms of pregnancy rates . It appears that in experienced h and s , laser laparoscopy has more favorable results than the other treatments OBJECTIVE To determine pregnancy rates ( PR ) after fimbrioplasty and salpingostomy in nonocclusive distal tubal disease . To evaluate the relative impact of various factors using contemporary statistical analysis . DESIGN Prospect i ve cohort . SETTING Tertiary institutional infertility clinic . PATIENTS ( S ) Infertility patients . INTERVENTION(S ) Fimbrioplasty and salpingostomy . MAIN OUTCOME MEASURE(S ) Cumulative PR , monthly fecundity rates , monthly probability of pregnancy , crude PR , and cure rates . RESULTS ( S ) Thirty-five percent of patients conceived with a cure rate of 72.2 % , monthly probability of pregnancy of 3.9 % , and monthly fecundity rate of 3.9 % . Cumulative PRs were 22 % , 35 % , and 58 % at 6 , 12 , and 24 months , respectively . Pairwise comparisons ( unilateral , bilateral , or either ) failed to detect any statistical difference between the salpingostomy and fimbrioplasty groups . Salpingostomy patients initially may have a higher tendency to become pregnant but appear to lose that advantage after the first few months . When patients with tubo-ovarian adhesions are excluded from the analysis , patients who underwent a bilateral salpingostomy as their sole procedure had better outcome compared with those who only underwent bilateral fimbrioplasty . There was no significant association between pregnancy outcome and the presence of endometriosis , other infertility factors , or tubo-ovarian adhesions . The staging of adnexal adhesions and endometriosis did not predict pregnancy outcome . CONCLUSION ( S ) Laparoscopic fimbrioplasty and salpingostomy are clinical ly efficacious for the treatment of nonocclusive distal tubal disease . After accounting for statistical interactions of various factors among them , no particular association with pregnancy outcome could be identified . This illustrates the need for a revision of the classification of patients with distal tubal disease Minor degrees of endometriosis have often been regarded as being of no import and hence remain untreated , but a study of the natural history of endometriosis has demonstrated that 47 % ( 95 % confidence limits , 23–71 % ) of patients ( n=35 ) given placebo in a double‐blind , r and omized controlled trial showed progression of the disease when assessed before and after treatment by laparoscopy . The active agent , the progestogen gestrinone , was given at a dose of 2.5 mg twice weekly and result ed in an improvement of the disease ( p < 0.004 ) . Furthermore , follow‐up over 12 months showed no significant difference between those patients treated with active agent or placebo , and none between those with persistent disease and those in whom it had been obliterated . These data suggest that a diagnosis of mild endometriosis should be followed by treatment to prevent progressive disease , but that the treatment does not influence subsequent fertility . They indicate that expectant treatment has no place and that even if fertility is not an immediate requirement , active treatment should be instituted , and that the new gestogen , gestrinone is efficacious . Other treatments , such as danazol or luteinizing hormone releasing hormone ( LHRH ) agonists , or the older contraceptive or pseudopregnancy regimens , must be set against spontaneous improvement ( in 5 of 17 patients i.e. 29 % ) or elimination ( in 4 of 17 patients i.e. 24 % ) in the placebo group . Infertile patients with mild endometriosis have disorders of follicular and luteal function , and in vitro fertilization suggests a reduced fertilization rate . Nevertheless , these patients require active treatment if these problems are not to be compounded by adhesions , possibly leading to ovarian enclosure , that would further reduce the untreated cumulative conception rate Minimal pelvic endometriosis can be the only pathology found in infertility patients undergoing an infertility work-up . Although the mechanism by which endometriosis causes infertility is not known , it is well established that pregnancy can be attained in many patients when this disease is treated . Three different modes of treatment were used in 167 infertility patients who had minimal pelvic endometriosis without other pelvic pathology . Group I ( danazol ) achieved 48.9 % pregnancy rates ( 23/47 ) , group II ( CO2 laser ) had 44.6 % pregnancy rates ( 37/83 ) , and group III ( CO2 laser and danazol ) achieved 51.4 % pregnancy rates ( 19/37 ) . Although the pregnancy rates in groups I and III were higher , they were not statistically significant when compared with group II Ninety infertility patients with moderate endometriosis were r and omized between laparoscopic electrocautery and 6 months of danazol therapy and studied for 7 months after treatment . Twenty of the 45 patients undergoing electrocautery conceived ( 44 % ) during the follow-up interval . Forty-one of the 45 patients in the danazol group completed the course of therapy , and 16 of those conceived ( 39 % ) during the same follow-up interval . There was no statistical difference between the two groups ( P less than 0.53 ) . No patients in the electrocautery group experienced complications . This demonstrates that electrocautery is safe and effective in the treatment of moderate endometriosis OBJECTIVE To assess the efficacy of laser laparoscopic surgery in the treatment of pain associated with minimal , mild , and moderate endometriosis . DESIGN A prospect i ve , r and omized , double-blind , and controlled clinical study . SETTING Royal Surrey County Hospital , Guildford , United Kingdom , a referral center for the laser laparoscopic treatment of endometriosis . PATIENTS Sixty-three patients with pain ( dysmenorrhoea , pelvic pain , or dyspareunia ) and minimal to moderate endometriosis . INTERVENTIONS The patients were r and omized at the time of laparoscopy to laser ablation of endometriotic deposits and laparoscopic uterine nerve ablation or expectant management . Pain symptoms were recorded subjectively and by visual analogue scale . The women were unaware of the treatment allocated as was the nurse who assessed them at 3 and 6 months after surgery . MAIN OUTCOME MEASURE Improvement or resolution of pain symptoms assessed subjectively and by visual analogue score . RESULTS Laser laparoscopy results in statistically significant pain relief compared with expectant management at 6 months after surgery . Sixty-two and a half percent of the lasered patients reported improvement or resolution of symptoms compared with 22.6 % in the expectant group . Results were poorest for minimal disease and , if patients with mild and moderate disease only are included , 73.7 % of patients achieved pain relief . There were no operative or laser complications . CONCLUSIONS Laser laparoscopy is a safe , simple , and effective treatment in alleviating pain symptoms in women with stages I , II , and III endometriosis OBJECTIVE To determine the efficacy of the endoscopic treatment of complete distal tubal occlusion or moderate to severe tubal phimosis and to analyze outcome using contemporary statistical method ologies . DESIGN Prospect i ve cohort analysis . SETTING Tertiary-care institution . PATIENTS One hundred thirteen consecutive patients undergoing a neosalpingostomy or salpingostomy . INTERVENTIONS KTP/532 laser ( Laserscope , Santa Clara , CA ) laparoscopy . Additional infertility factors were treated postoperatively . MAIN OUTCOME MEASURES Crude pregnancy rate ( PR ) , monthly fecundity rate , monthly probability of pregnancy , cure rate , and cumulative PRs . Outcome was compared on the basis of the surgical procedure performed . The impact of endometriosis as well as other fertility factors was analyzed . RESULTS Twenty-three patients conceived yielding a crude PR of 20.4 % , a monthly fecundity rate of 2.6 % , a monthly probability of pregnancy of 6.4 % , and a cure rate of 52.4 % . There were six ectopic pregnancies ( 5.3 % ) . A significant difference was found among the cumulative pregnancy curves . The cumulative pregnancy curve for unilateral salpingostomy differed significantly from that of unilateral neosalpingostomy . Patients with endometriosis and no other infertility factors had a significantly better cumulative pregnancy curve compared with patients without endometriosis or other factors as well as compared with patients with no endometriosis but with other infertility factors . Patients undergoing bilateral neosalpingostomy had a cure rate of 9.0 % whereas patients undergoing bilateral salpingostomy had a cure rate of 34.2 % . CONCLUSIONS Operative endoscopy yields PRs that are comparable to those reported in the literature for laparotomy . The presence of complete bilateral distal tubal occlusion has a negative impact on outcome In order to analyse the efficacy of resection/ablation of minimal/mild endometriotic lesions for improving fertility , we conducted a r and omized clinical trial . Eligible patients were women aged < /=36 years who were trying to conceive and had a laparoscopically confirmed diagnosis of minimal/mild endometriosis ( stage I or II of the revised American Fertility Society classification ) and otherwise unexplained infertility for > /=2 years . Eligible women were r and omly assigned to resection or ablation of visible endometriosis ( 54 patients ) or diagnostic laparoscopy only ( 47 patients ) . After laparoscopy women tried to conceive spontaneously for 1 year ( follow-up period ) . A total of five women withdrew from the study : three for personal reasons , and two were lost to follow-up . Considering 51 women in the resection/ablation and 45 in the no-treatment group who ended the follow-up period , 12 ( 24 % ) in the resection/ablation group and 13 ( 29 % ) in the no treatment group conceived ; the difference was not significant . Two spontaneous abortions were observed in the resection/ablation group and three in the no-treatment one . Thus the 1 year birth rate was 10 out of 51 women ( 19.6 % ) in the resection/ablation group and 10 out of 45 women ( 22.2 % ) in the no-treatment group . In conclusion , the results of this study do not support the hypothesis that ablation of endometriotic lesions markedly improves fertility rates BACKGROUND Minimal or mild endometriosis is frequently diagnosed in infertile women . It is often treated by resection or ablation of the lesions , but whether this improves fertility has not been established . We carried out a r and omized , controlled trial to determine whether laparoscopic surgery enhanced fecundity in infertile women with minimal or mild endometriosis . METHODS We studied 341 infertile women 20 to 39 years of age with minimal or mild endometriosis . During diagnostic laparoscopy the women were r and omly assigned to undergo resection or ablation of visible endometriosis or diagnostic laparoscopy only . They were followed for 36 weeks after the laparoscopy or , for those who became pregnant during that interval , for up to 20 weeks of pregnancy . RESULTS Among the 172 women who had resection or ablation of endometriosis , 50 became pregnant and had pregnancies that continued for 20 weeks or longer , as compared with 29 of the 169 women in the diagnostic-laparoscopy group ( cumulative probabilities , 30.7 percent and 17.7 percent , respectively ; P=0.006 by the log-rank test ) . The corresponding rates of fecundity were 4.7 and 2.4 per 100 person-months ( rate ratio , 1.9 ; 95 percent confidence interval , 1.2 to 3.1 ) . Fetal losses occurred in 20.6 percent of all the recognized pregnancies in the laparoscopic-surgery group and in 21.6 percent of all those in the diagnostic-laparoscopy group ( P=0.
Output:
| The results still need to be interpreted with caution as Marcoux 1997 reported a large positive effect of surgery whereas Gruppo Italiano reported a small negative effect .
When considering fetal losses , meta- analysis did not demonstrate an effect of laparoscopic surgery when compared to diagnostic laparoscopy only .
The use of laparoscopic surgery in the treatment of subfertility related to minimal and mild endometriosis may improve future fertility |
MS212671 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To evaluate the safety , efficacy and biomarkers of short-course proton beam radiation and capecitabine , followed by pancreaticoduodenectomy in a phase 1/2 study in pancreatic ductal adenocarcinoma ( PDAC ) patients . METHODS AND MATERIAL S Patients with radiographically resectable , biopsy-proven PDAC were treated with neoadjuvant short-course ( 2-week ) proton-based radiation with capecitabine , followed by surgery and adjuvant gemcitabine . The primary objective was to demonstrate a rate of toxicity grade ≥ 3 of < 20 % . Exploratory biomarker studies were performed using surgical specimen tissues and peripheral blood . RESULTS The phase 2 dose was established at 5 daily doses of 5 GyE. Fifty patients were enrolled , of whom 35 patients were treated in the phase 2 portion . There were no grade 4 or 5 toxicities , and only 2 of 35 patients ( 4.1 % ) experienced a grade 3 toxicity event ( chest wall pain grade 1 , colitis grade 1 ) . Of 48 patients eligible for analysis , 37 underwent pancreaticoduodenectomy . Thirty of 37 ( 81 % ) had positive nodes . Locoregional failure occurred in 6 of 37 resected patients ( 16.2 % ) , and distant recurrence occurred in 35 of 48 patients ( 72.9 % ) . With median follow-up of 38 months , the median progression-free survival for the entire group was 10 months , and overall survival was 17 months . Biomarker studies showed significant associations between worse survival outcomes and the KRAS point mutation change from glycine to aspartic acid at position 12 , stromal CXCR7 expression , and circulating biomarkers CEA , CA19 - 9 , and HGF ( all , P<.05 ) . CONCLUSIONS This study met the primary endpoint by showing a rate of 4.1 % grade 3 toxicity for neoadjuvant short-course proton-based chemoradiation . Treatment was associated with favorable local control . In exploratory analyses , KRAS(G12D ) status and high CXCR7 expression and circulating CEA , CA19 - 9 , and HGF levels were associated with poor survival Context . Hadrontherapy is an innovative form of radiotherapy using beams of protons or carbon ions able to destroy some radio-resistant tumours . Because these tumours are highly specific amongst all cancerous tumours , it is impossible to determine the incidence of these diseases from surveillance registries . Goal . To assess , within the Rhône-Alpes region , the incidence of cancers being hadrontherapy indications . Method . Prospect i ve , multicentre continuous data collection during 1 year , by practitioners participating to multidisciplinary tumor board . Tumours are inoperable , radio resistant , at primary stage of development , or locally recurrent , with low metastatic potential . Results . Study involved 27 healthcare centres , 52 groups of specialist practitioners . The estimated incidence of cancers eligible for hadrontherapy in the Rhône-Alpes region in 2010 , that is , for 34 locations in all , is of 8.5/100 000 inhabitants . Appraisal of the low potential of metastatic progression is impeded , because these are rare diseases , whose outcome is unfamiliar to investigators . Conclusion . Future epidemiological studies will need to focus on prognosis and on the metastatic progression rate of these diseases . Indeed , there are few information available on this subject in the literature that could be used to improve preventive measures , medical care , and the surveillance of these rare cancers PURPOSE This study describes the early clinical outcomes of a prospect i ve phase 2 study of consolidative involved-node proton therapy ( INPT ) as a component of combined-mode therapy in patients with stages I to III Hodgkin lymphoma ( HL ) with mediastinal involvement . METHODS AND MATERIAL S Between September 2009 and June 2013 , 15 patients with newly diagnosed HL received INPT after completing chemotherapy in an institutional review board-approved protocol comparing the dosimetric impact of PT with those of three-dimensional conformal radiation therapy ( 3DCRT ) and intensity modulated RT . Based on (18)F-Fluorodeoxyglucose positron emission tomography/computed tomography ( (18)F-FDG PET/CT ) response , 5 children received 15 to 25.5 cobalt Gy equivalent ( CGE ) of INPT after receiving 4 cycles of Adriamycin , Bleomycin , Vincristine , Etoposide , Prednisone , Cyclophosphamide or Vincristine , adriamycin , methotrexate , Prednisone chemotherapy , and 10 adults received 30.6 to 39.6 CGE of INPT after 3 to 6 cycles of Adriamycin , Bleomycine , Vinblastine , Dacarbazine . Patients were routinely evaluated for toxicity during and after treatment , using Common Terminology Criteria for Adverse Events , version 3.0 , and for relapse by physical examination and routine imaging . Relapse-free survival ( RFS ) and event-free survival ( EFS ) rates were calculated using the Kaplan-Meier method from the time of diagnosis . RESULTS The median follow-up was 37 months ( range , 26 - 55 ) . Two events occurred during follow-up : 1 relapse ( inside and outside the targeted field ) and 1 transformation into a primary mediastinal large B cell lymphoma . The 3-year RFS rate was 93 % , and the 3-year EFS rate was 87 % . No acute or late grade 3 nonhematologic toxicities were observed . CONCLUSIONS Although decades of follow-up will be needed to realize the likely benefit of PT in reducing the risk of radiation-induced late effects , PT following chemotherapy in patients with HL is well-tolerated , and disease outcomes were similar to those of conventional photon therapy Background and purpose Radiotherapy for recurrent malignant brain tumors is usually limited because of the dose tolerance of the normal brain tissue . The goal of the study was to evaluate the efficacy and feasibility of reirradiation for patients with recurrent malignant brain tumors . Patients and methods The subjects comprised 26 patients with recurrent malignant brain tumors treated with conventional radiotherapy ( RT , n = 8) , stereotactic radiotherapy ( SRT , n = 10 ) , and proton beam therapy ( PBT , n = 8) at our institute . Fifteen patients had glioblastoma , 6 had WHO grade 3 glioma , and 5 had other tumors . The dose of initial radiotherapy was 34.5–94.4 Gy . Different radiation schedules were compared using the equivalent dose in 2-Gy fractions . Results Reirradiation was completed in all patients without a severe acute reaction . The reirradiation doses were 30–60 Gy ( median , 42.3 Gy ) and the total doses for the initial and second treatments were 64.5–150.4 Gy ( median , 100.0 Gy ) . Currently , 11 patients are alive ( median follow-up period , 19.4 months ) and 15 are dead . The median survival and local control periods after reirradiation of the 26 patients were 18.3 and 9.3 months , respectively . For the 15 patients with glioblastoma , these periods were 13.1 and 11.0 months , respectively . Two patients showed radiation necrosis that was treated by surgery or conservative therapy . Conclusion Reirradiation for recurrent malignant brain tumor using conventional RT , SRT , or PBT was feasible and effective in selected cases . Further investigation is needed for treatment optimization for a given patient and tumor condition . ZusammenfassungHintergrund und ZielsetzungBei bösartigen Hirntumoren ist eine operative Beh and lung schwierig und bei rezidivierenden Tumoren schränkt die Dosistoleranz des normalen Hirngewebes eine Strahlentherapie häufig ein . Ziel der Studie war es , die Durchführbarkeit und Wirksamkeit einer erneuten Bestrahlung ( Rebestrahlung ) bei Patienten mit einem rezidivierenden bösartigen intrakraniellen Tumor zu bewerten . Patienten und Method enBei den Prob and en h and elte es sich um 26 Patienten , die mit konventioneller Strahlentherapie ( RT , n = 8) , stereotaktischer Strahlentherapie ( SRT , n = 10 ) und Protonentherapie ( PBT , n = 8) in unserer Einrichtung beh and elt wurden . Die Beh and lung wurde in Abhängigkeit vom Tumorzust and ausgewählt . Ein Glioblastom hatten 15 Patienten , darunter 6 Patienten mit einem Gliom vom WHO-Grad III . Die Dosis der anfänglichen Strahlentherapie lag bei 34,5–94,4 Gy . Es wurden verschiedene Bestrahlungspläne anh and der Äquivalentdosis in 2-Gy-Fraktionen verglichen . ErgebnisseBei allen Patienten wurde die Rebestrahlung ohne schwere akute Reaktion abgeschlossen . Die Rebestrahlungsdosen betrugen 30–60 Gy ( Median 42,3 Gy ) und die Gesamtdosen der ersten und zweiten Beh and lung 64,5–150,4 Gy ( Median 100,0 Gy ) . Gegenwärtig leben noch 11 Patienten ( medianer Nachuntersuchungszeitraum 19,4 Monate ) , 15 Patienten sind bereits verstorben . Die mediane Überlebenszeit betrug 18,3 Monate und der Zeitraum für die lokale Kontrolle 9,3 Monate bezogen auf alle Patienten sowie 13,1 bzw . 11,0 Monate bezogen auf die Glioblastompatienten . Eine beherrschbare Strahlennekrose hatten 2 der 26 Patienten . SchlussfolgerungenDie Rebestrahlung bei rezidivierendem bösartigem Hirntumor anh and konventioneller RT , SRT oder PBT war durchführbar und wirksam . Weitere Untersuchungen sind notwendig , um die optimale Beh and lung für einzelne Patienten bzw . einen bestimmten Tumorzust and herauszufinden Background While conventionally fractionated radiation therapy alone is an acceptable option for poor prognostic patients with unresectable stage III NSCLC , we hypothesized that accelerated hypofractionated radiotherapy will have similar efficacy without increasing toxicity . Methods This is a retrospective analysis of 300 patients diagnosed with stage III NSCLC treated between 1993 and 2009 . Patients included in the study were medically or surgically inoperable , were free of metastatic disease at initial workup and did not receive concurrent chemotherapy . Patients were categorized into three groups . Group 1 received 45 Gy in 15 fractions over 3 weeks ( Accelerated Radiotherapy ( ACRT ) ) while group 2 received 60 - 63 Gy ( St and ard Radiation Therapy 1 ( STRT1 ) ) and group 3 received > 63 Gy ( St and ard Radiation Therapy ( STRT2 ) ) . Results There were 119 ( 39.7 % ) patients in the ACRT group , 90 ( 30.0 % ) in STRT1 and 91 ( 30.3 % ) in STRT2 . More patients in the ACRT group had KPS ≤ 60 ( p < 0.001 ) , more commonly presented with weight loss > 5 % ( p = 0.002 ) , and had stage 3B disease ( p < 0.001 ) . After adjusting for clinical variables , there were no differences in the radiation groups in terms of the patterns of local or distant tumor control or overall survival . Some benefit in relapse free survival was seen in the STRT1 group as compared to ACRT ( HR = 0.65 , p = 0.011 ) . Acute toxicity profiles in the ACRT were significantly lower for grade ≥ 2 radiation dermatitis ( p = 0.002 ) , nausea/vomiting ( p = 0.022 ) , and weight loss during treatment ( p = 0.020 ) . Conclusions Despite the limitations of a retrospective analysis , our experience of accelerated hypofractionated radiation therapy with 45 Gy in 15 fractions appears to be an acceptable treatment option for poor performance status patients with stage III inoperable tumors . Such a treatment regimen ( or higher doses in 15 fractions ) should be prospect ively evaluated using modern radiation technologies with the addition of sequential high dose chemotherapy in stage III NSCLC PURPOSE Combined-modality treatment is st and ard treatment for patients with clinical stage I/II Hodgkin lymphoma ( HL ) . We hypothesized that an early positron emission tomography ( PET ) scan could be used to adapt treatment . Therefore , we started the r and omized EORTC/LYSA/FIL Intergroup H10 trial evaluating whether involved-node radiotherapy ( IN-RT ) could be omitted without compromising progression-free survival in patients attaining a negative early PET scan after two cycles of ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) as compared with st and ard combined-modality treatment . PATIENTS AND METHODS Patients age 15 to 70 years with untreated clinical stage I/II HL were eligible . Here we report the clinical outcome of the preplanned interim futility analysis scheduled to occur after documentation of 34 events in the early PET-negative group . Because testing for futility in this noninferiority trial corresponds to testing
Output:
| No phase III trial has been published using proton beam therapy in comparison with the best photon therapy , but numerous retrospective and dosimetric studies have revealed an advantage of proton beam therapy compared to photons , above all in tumours next to parallel organs at risk ( thoracic and abdominal tumours ) .
Use of proton beam therapy is growing for common cancers within clinical trials but some indications could be applied sooner since in silico analysis showed major advantages with this technique |
MS212672 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Abstract Background Although the incidence of Clostridium difficile infection ( CDI ) is increasing , available CDI treatment options are limited in terms of sustained response after treatment . This phase 3 trial assessed the efficacy and safety of surotomycin , a novel bactericidal cyclic lipopeptide , versus oral vancomycin in subjects with CDI . Methods In this r and omized , double-blind , active-controlled , multicenter , international trial , subjects with CDI confirmed by a positive toxin result were r and omized to receive surotomycin ( 250 mg twice daily ) or vancomycin ( 125 mg 4 times daily ) orally for 10 days . The primary endpoints were clinical response at end of treatment and evaluation of surotomycin safety . The key secondary endpoints were clinical response over time and sustained clinical response through a 30- to 40-day follow-up period . Clostridium difficile infection recurrence during follow-up and time to diarrhea resolution were also analyzed . Results In total , 570 subjects were r and omized and had confirmed CDI ; 290 subjects received surotomycin and 280 subjects received vancomycin . Surotomycin clinical cure rates at end of treatment ( surotomycin/vancomycin : 79.0%/83.6 % ; difference of −4.6 % ; 95 % confidence interval , −11.0 to 1.9 ] ) , clinical response over time ( stratified log-rank test , P = .832 ) , and sustained clinical response at end of trial ( Day 40–50 ) ( 60.6%/61.4 % ; difference of −0.8 % ; 95 % CI , −8.8 to 7.1 ) in the microbiological modified intent to treat population did not meet noninferiority or superiority criteria versus vancomycin . Both treatments were generally well tolerated . Conclusions Surotomycin failed to meet the criteria for noninferiority versus vancomycin for the primary and key secondary endpoints in this trial Background The available treatment options for Clostridium difficile infection ( CDI ) are limited by high recurrence rates . Surotomycin was a novel bactericidal cyclic lipopeptide in development to treat CDI that demonstrated non-inferiority to vancomycin in a Phase 2 trial . Objectives To assess surotomycin safety and clinical response ( non-inferiority versus vancomycin ) at the end of treatment ( EOT ) of CDI . Additionally , to assess surotomycin response over time and sustained response at 30 - 40 days post-EOT ( superiority versus vancomycin ) . Patients and methods Patients with CDI were r and omized ( 1:1 ) to receive twice-daily oral surotomycin 250 mg alternating with twice-daily placebo or four-times-daily oral vancomycin 125 mg for 10 days in this Phase 3 , double-blind , multicentre , international trial . Clinical response over time and sustained clinical response were monitored until the end of the trial , through a follow-up period of 30 - 40 days . Clinical Trial Registration : NCT01598311 . Results A total of 285 and 292 patients with confirmed CDI were r and omized to receive surotomycin and vancomycin , respectively . Surotomycin-associated clinical response at EOT was non-inferior to vancomycin ( surotomycin/vancomycin : 83.4%/82.1 % ; difference 1.4 % , 95 % CI - 4.9 , 7.6 ) . Following treatment with surotomycin , both clinical response over time ( stratified log-rank test , P = 0.277 ) and sustained clinical response ( 63.3%/59.0 % ; difference 4.3 % , 95 % CI - 3.6 , 12.2 ) did not demonstrate superiority versus vancomycin at end of trial . Both treatments were generally well tolerated . Conclusions Surotomycin demonstrated non-inferiority to vancomycin for CDI clinical response at EOT . Surotomycin did not demonstrate superiority to vancomycin for clinical response over time or sustained clinical response rate IMPORTANCE Clostridium difficile infection ( CDI ) is a major burden in health care and community setting s. CDI recurrence is of particular concern because of limited treatment options and associated clinical and infection control issues . Fecal microbiota transplantation ( FMT ) is a promising , but not readily available , intervention . OBJECTIVE To determine whether frozen- and -thawed ( frozen , experimental ) FMT is noninferior to fresh ( st and ard ) FMT in terms of clinical efficacy among patients with recurrent or refractory CDI and to assess the safety of both types of FMT . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , noninferiority trial enrolling 232 adults with recurrent or refractory CDI , conducted between July 2012 and September 2014 at 6 academic medical centers in Canada . INTERVENTIONS Patients were r and omly allocated to receive frozen ( n = 114 ) or fresh ( n = 118 ) FMT via enema . MAIN OUTCOMES AND MEASURES The primary outcome measures were clinical resolution of diarrhea without relapse at 13 weeks and adverse events . Noninferiority margin was set at 15 % . RESULTS A total of 219 patients ( n = 108 in the frozen FMT group and n = 111 in the fresh FMT group ) were included in the modified intention-to-treat ( mITT ) population and 178 ( frozen FMT : n = 91 , fresh FMT : n = 87 ) in the per- protocol population . In the per- protocol population , the proportion of patients with clinical resolution was 83.5 % for the frozen FMT group and 85.1 % for the fresh FMT group ( difference , -1.6 % [ 95 % CI , -10.5 % to ∞ ] ; P = .01 for noninferiority ) . In the mITT population the clinical resolution was 75.0 % for the frozen FMT group and 70.3 % for the fresh FMT group ( difference , 4.7 % [ 95 % CI , -5.2 % to ∞ ] ; P < .001 for noninferiority ) . There were no differences in the proportion of adverse or serious adverse events between the treatment groups . CONCLUSIONS AND RELEVANCE Among adults with recurrent or refractory CDI , the use of frozen compared with fresh FMT did not result in worse proportion of clinical resolution of diarrhea . Given the potential advantages of providing frozen FMT , its use is a reasonable option in this setting . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01398969 BACKGROUND Clostridium difficile infection is a serious diarrheal illness associated with substantial morbidity and mortality . Patients generally have a response to oral vancomycin or metronidazole ; however , the rate of recurrence is high . This phase 3 clinical trial compared the efficacy and safety of fidaxomicin with those of vancomycin in treating C. difficile infection . METHODS Adults with acute symptoms of C. difficile infection and a positive result on a stool toxin test were eligible for study entry . We r and omly assigned patients to receive fidaxomicin ( 200 mg twice daily ) or vancomycin ( 125 mg four times daily ) orally for 10 days . The primary end point was clinical cure ( resolution of symptoms and no need for further therapy for C. difficile infection as of the second day after the end of the course of therapy ) . The secondary end points were recurrence of C. difficile infection ( diarrhea and a positive result on a stool toxin test within 4 weeks after treatment ) and global cure ( i.e. , cure with no recurrence ) . RESULTS A total of 629 patients were enrolled , of whom 548 ( 87.1 % ) could be evaluated for the per- protocol analysis . The rates of clinical cure with fidaxomicin were noninferior to those with vancomycin in both the modified intention-to-treat analysis ( 88.2 % with fidaxomicin and 85.8 % with vancomycin ) and the per- protocol analysis ( 92.1 % and 89.8 % , respectively ) . Significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence of the infection , in both the modified intention-to-treat analysis ( 15.4 % vs. 25.3 % , P=0.005 ) and the per- protocol analysis ( 13.3 % vs. 24.0 % , P=0.004 ) . The lower rate of recurrence was seen in patients with non – North American Pulsed Field type 1 strains . The adverse-event profile was similar for the two therapies . CONCLUSIONS The rates of clinical cure after treatment with fidaxomicin were noninferior to those after treatment with vancomycin . Fidaxomicin was associated with a significantly lower rate of recurrence of C. difficile infection associated with non – North American Pulsed Field type 1 strains . ( Funded by Optimer Pharmaceuticals ; Clinical Trials.gov number , NCT00314951 . Recurrence of Clostridium difficile infection ( CDI ) occurs in approximately 25 % of successfully treated patients . Two phase 3 r and omized , double-blind trials were conducted at 154 sites in the United States , Canada , and Europe to compare fidaxomicin vs vancomycin in treating CDI . Patients with CDI received fidaxomicin 200 mg twice daily or vancomycin 125 mg 4 times daily for 10 days . The primary end point was clinical cure of CDI at end of treatment , and a secondary end point was recurrence during the 28 days following clinical cure . In all , 1164 subjects were enrolled , of which a subgroup of 128 in the per- protocol population had another recent episode of CDI prior to the CDI diagnosis at study enrollment . In the analysis of this subgroup , initial response to therapy was similar for both drugs ( > 90 % cure ) . However , recurrence within 28 days occurred in 35.5 % of patients treated with vancomycin and 19.7 % of patients treated with fidaxomicin ( −15.8 % difference ; 95 % confidence interval , −30.4 % to −0.3 % ; P = .045 ) . Early recurrence ( within 14 days ) was reported in 27 % of patients treated with vancomycin and 8 % of patients treated with fidaxomicin ( P = .003 ) . In patients with a first recurrence of CDI , fidaxomicin was similar to vancomycin in achieving a clinical response at end of therapy but superior in preventing a second recurrence within 28 days . Clinical Trials Registration . NCT00314951 and NCT00468728 Our study sought to compare the strain types of Clostridium difficile causing initial and recurrent episodes of C. difficile infection ( CDI ) in adult patients with a first episode of CDI or 1 prior episode of CDI within the previous 90 days . Strains originated from patients who had been entered into two phase 3 r and omized clinical trials of fidaxomicin versus vancomycin . Isolates of C. difficile from the initial and recurrent episodes within 28 ( ±2 ) days of cure of CDI were compared using restriction endonuclease analysis ( REA ) typing . Paired isolates were available from 90 of 194 ( 46 % ) patients with recurrent CDI . Patients with isolates available were significantly younger ( P = .008 ) and more likely to be from Canadian sites ( P = .0001 ) , compared with patients without isolates . In 75 of 90 subjects ( 83.3 % ) , the identical REA type strain was identified at recurrence and the initial episode ( putative relapse ) . Early recurrences ( 0–14 days after treatment completion ) were relapses in 86.7 % and a new strain ( reinfection ) in 13.3 % . Later recurrences ( 15–31 days after treatment ) were relapses in 76.7 % and reinfections in 23.3 % . Mean time ( ± st and ard deviation ) to recurrence was 12.2 ( ±6.4 ) days for relapses and 14.7 ( ±6.8 ) days for reinfections ( P = .177 ) . The most common BI/NAP1/027 group and the previous US epidemic REA group J/NAP2/001 had a significantly higher combined rate of recurrence with the same strain ( relapse ) , compared with the other REA groups ( 39 of 42 [ 93 % ] vs 36 of 48 [ 75 % ] , respectively ; P = .023 ) . We found a higher than historic rate of recurrent CDI caused by the same isolate as the original episode , a finding that may be related to the relatively short observation period in this study and the high frequency of isolation of epidemic strains , such as groups BI and J , for which relapse rates may be higher than for other REA groups . Caution in generalizing these observations is required , because the patients studied were younger and more likely to be from Canadian sites than were patients with recurrence who did not provide isolates . Clinical Trials Registration . NCT00314951 and NCT00468728 Background Clostridium difficile infection ( CDI ) is a leading cause of diarrhoea in health care setting s with symptoms ranging from m
Output:
| CONTENT Meta-analyses and systematic review s have shown that CDI and rCDI risk factors are similar .
C. difficile spore germination can be influenced by gut environmental factors result ing from dysbiosis , and spore outgrowth may be affected stage by some antimicrobials ( e.g. fidaxomicin , ramoplanin , oritavancin ) . |
MS212673 | ***TASK*** the task is to summarize an input biomedical literature 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: We report on the outcome of children with Philadelphia positive acute lymphoblastic leukaemia ( Ph+ ALL ) treated on the UK Medical Research Council ( MRC ) trial for childhood ALL , MRC ALL 97 , between January 1997 and June 2002 . Forty‐two ( 2·3 % ) patients were Ph+ . Nineteen ( 45 % ) had < 25 % blasts in bone marrow ( BM ) within the first 2 weeks of treatment and were defined as a good response group ( GRG ) , the others as a poor response group ( PRG ) . Thirty‐six ( 86 % ) achieved first complete remission ( CR1 ) at the end of induction , of which 28 underwent BM transplantation ( BMT ) . The median follow‐up was 42 months ( range , 21–84 ) . The 3‐year event‐free survival ( EFS ; 52 % , 95 % CI , 36–66 % ) was a considerable improvement on the previous MRC UKALL XI trial ( 27 % ) . EFS for the GRG and PRG were 68 % ( 43–84 % ) and 39 % ( 18–59 % ) , respectively ( P = 0·03 ) ; presenting white cell count < 50 × 109/l ( P = 0·02 ) was predictive for overall survival . Changes in the MRC ALL97 trial within the study period result ed in some Ph+ ALL receiving daunorubicin and either prednisolone or dexamethasone during induction . Though the use of daunorubicin during induction was not a prospect i ve study question , EFS was significantly better for those whose induction included this drug ( P = 0·02 ) . Steroid r and omization was not stratified for Ph+ ALL patients and was not predictive for EFS . BMT in CR1 appeared to reduce the risk of a subsequent BM relapse . These results show significant improvement on previous MRC trials ; future therapeutic strategies should include early intensive therapy and BMT in CR1 Despite a widespread belief that glucocorticoid therapy is associated with positive energy balance and excess weight gain there is a dearth of quantitative evidence about its effects and the underlying mechanisms of any effects . The primary aim of the present study was to quantify the effect of dexamethasone and prednisone treatment on energy intake in children treated for childhood acute lymphoblastic leukemia . A secondary aim was to test for differences in excess weight gain between patients treated using the 2 glucocorticoids . We measured energy intake in 26 patients ( mean + /- SD age , 6.3 + /- 2.3 yr ) during a 5-d period " on " steroids and again in the week before steroid treatment . Changes in body mass index from diagnosis to 1 and 2 yr postdiagnosis were expressed as SD scores . Steroid treatment was associated with a significant increase in energy intake of approximately 20 % ( mean paired difference , 1.7 MJ/d ; SD , 2.8 ; 95 % confidence interval , 0.7 - 2.8 MJ/d ) , with no significant difference between the 2 steroids . The mean change in body mass index SD score was + 0.38 ( SD , 1.10 ; P < 0.05 ) to 1 yr and + 0.68 ( SD , 1.38 ; P < 0.05 ) to 2 yr , with no significant difference between the 2 groups of patients . Glucocorticoid treatment in childhood acute lymphoblastic leukemia increases energy intake markedly , and this effect contributes to the excess weight gain and obesity characteristic of patients being treated for acute lymphoblastic leukemia In previous clinical trials of childhood acute lymphoblastic leukemia ( ALL ) , dexamethasone result ed in higher event-free survival rates than prednisone , presumably due to greater central nervous system penetration . Dexamethasone 's association with long-term neurocognitive toxicity is unknown . In this multisite study , we measured neurocognitive functioning in 92 children with st and ard-risk ALL , 1 to 9.99 years at diagnosis , at a mean of 9.8 years after r and omization to prednisone ( n = 41 ) or dexamethasone ( n = 51 ) on Children 's Cancer Group ( CCG ) 1922 . No significant overall differences in mean neurocognitive and academic performance scores were found between the prednisone and dexamethasone groups after adjusting for age , sex , and time since diagnosis . The exception was that patients receiving dexamethasone scored one-third of a st and ard deviation worse on word reading ( 98.8 + /- 1.7 vs 104.9 + /- 1.8 ; P = .02 ) . There were no group differences in the distribution of test scores or the parents ' report of neurologic complications , psychotropic drug use , and special education . Further analyses suggested for the dexamethasone group , older age of diagnosis was associated with worse neurocognitive functioning ; for the prednisone group , younger age at diagnosis was associated with worse functioning . In conclusion , our study did not demonstrate any meaningful differences in long-term cognitive functioning of childhood ALL patients based on corticosteroid r and omization . This study is registered with http://www . clinical trials.gov under NCT00085176 objective Disturbances in body weight regulation are often encountered during glucocorticoid treatment and are associated with increased insulin resistance and truncal fat accumulation . Children were investigated who were receiving glucocorticoid treatment for acute lymphoblastic leukaemia ( ALL ) . They were r and omized to receive either prednisolone or dexamethasone as part of induction of remission . This r and omization process provided a suitable opportunity to compare the effects of these two administered steroid on surrogate markers of adipocyte activity ( leptin ) and hyperinsulinaemia/insulin resistance ( SHBG ) The 1997 acute lymphoblastic leukaemia ( ALL ) trial ( ALL97 ) was a r and omised comparison of prednisolone versus dexamethasone and of 6‐mercaptopurine versus 6‐thioguanine . During the first 2 years of the trial , review of survival data showed the preceding trial , UKALL XI , was no better than its predecessor and that survival for childhood ALL in the UK had not improved in the fashion witnessed by other cooperative treatment groups . The therapy template was therefore altered to an American Children ’s Cancer Group ( CCG ) style regimen , including stratification by age , white cell count and early response to therapy by assessment of the bone marrow . This phase of the trial was design ated ALL97/99 . Comparison of the two phases showed that the event‐free survival ( EFS ) for both ALL97 and ALL97/99 was better than previous UKALL trials , as was overall survival ( OS ) for ALL97/99 . Both EFS and OS were significantly better in ALL97/99 than in ALL97 ( at five years , 80·0 % vs. 74·0 % , P = 0·002 ; and 88·0 % vs. 83·5 % , P = 0·005 , respectively ) . Isolated central nervous system ( CNS ) relapse for patients in ALL97/99 was half that in ALL97 ( 3·0 % vs. 4·9 % ) , P = 0·03 ) and the overall CNS relapse rate was halved in ALL97/99 ( 4·4 % vs. 9·6 % , P < 0·00005 ) . There were no significant differences for non‐CNS relapse , induction deaths or deaths in remission between the two phases of the trial Alterations in hemostasis leading to symptomatic thromboembolism have been observed in patients with acute lymphoblastic leukemia ( ALL ) receiving Escherichia coli asparaginase ( CASP ) combined with steroids . Moreover , hereditary prothrombotic risk factors are associated with an increased risk for venous thromboembolism in pediatric ALL patients treated according to the BFM 90/95 protocol s ( including CASP combined with prednisone during induction therapy ) . To assess whether the thromboembolic risk associated with established prothrombotic risk factors is modified by treatment modalities ( prednisone or dexamethasone ) , the present analysis was performed . Three hundred thirty-six consecutively recruited leukemic children treated according to different BFM protocol s ( PRED group , n = 280 , 60 mg/m(2 ) prednisone ; DEXA group , n = 56 , 10 mg/m(2 ) dexamethasone during induction therapy ) were studied . Study end point was the onset of symptomatic vascular accidents during induction therapy . Cumulative thromboembolism-free survival was significantly reduced in children in the PRED group ( thrombosis frequency , 10.4 % ) compared with children in the DEXA group ( thrombosis frequency , 1.8 % ; P = .028 ) . Although no significant difference was found in the overall prevalence of prothrombotic risk factors , 46.5 % of patients in the PRED group who experienced thromboembolic events were carriers of a prothrombotic risk factor , whereas no carrier in the DEXA group had a thromboembolism . At the time of maximum CASP activity , fibrinogen and activities of antithrombin , plasminogen , and protein S were significantly reduced in the PRED group . No significant correlation could be found between CASP activity and levels of coagulation factors . In conclusion , the use of dexamethasone instead of prednisone , administered with CASP , significantly reduced the onset of venous thromboembolism The Children 's Cancer Group enrolled 13 298 young people age < 21 years on 1 of 16 protocol s between 1983 and 2002 . Outcomes were examined in three time periods , 1983–1988 , 1989–1995 , 1996–2002 . Over the three intervals , 10-year event-free survival ( EFS ) for Rome/National Cancer Institute st and ard risk ( SR ) and higher risk ( HR ) B-precursor patients was 68 and 58 % , 77 and 63 % , and 78 and 67 % , respectively , whereas for SR and HR T-cell patients , EFS was 65 and 56 % , 78 and 68 % , and 70 and 72 % , respectively . Five-year EFS for infants was 36 , 38 , and 43 % , respectively . Seminal r and omized studies led to a number of important findings . Stronger post-induction intensification improved outcome for both SR and HR patients . With improved systemic therapy , additional intrathecal ( IT ) methotrexate effectively replaced cranial radiation . For SR patients receiving three-drug induction , iso-toxic substitution of dexamethasone for prednisone improved EFS . Pegylated asparaginase safely and effectively replaced native asparaginase . Thus , rational therapy modifications yielded better outcomes for both SR and HR patients . These trials provide the platforms for current Children 's Oncology Group trials Conventional therapy for childhood acute lymphoblastic leukemia ( ALL ) includes prednisone and oral 6-mercaptopurine . Prior observations suggested potential advantages for dexamethasone over prednisone and for intravenous ( IV ) over oral 6-mercaptopurine , which remain to be vali date d. We report the results of a r and omized trial of more than 1000 subjects that examined the efficacy of dexamethasone and IV 6-mercaptopurine . Children with National Cancer Institute st and ard-risk ALL were r and omly assigned in a 2 x 2 factorial design to receive dexamethasone ( 6 mg/m(2)/d ) for 28 days in induction , plus taper , compared with prednisone ( 40 mg/m(2)/d ) . The second r and omized assignment was for daily oral or weekly IV 6-mercaptopurine during consolidation . During maintenance , 5 days of the r and omized steroid was given monthly , at the same dose , and all patients received daily oral 6-mercaptopurine . During delayed intensification , all patients received a dexamethasone dosage of 10 mg/m(2)/d for 21 days , with taper . Intrathecal ( IT ) methotrexate was the sole central nervous system-directed therapy . Patients r and omly assigned to receive dexamethasone had a 6-year isolated central nervous system-relapse rate of 3.7 % + /- 0.8 % , compared with 7.1 % + /- 1.1 % for prednisone ( P = .01 ) . There was also a trend toward fewer isolated bone marrow relapses with dexamethasone . The 6-year event-free survival ( EFS ) was 85 % + /- 2 % for dexamethasone and 77 % + /- 2 % for prednisone ( P = .002 ) . EFS was similar with oral or IV 6-mercaptopurine ; however , patients assigned to IV 6-mercaptopurine had decreased survival after relapse PURPOSE To evaluate whether dexamethasone ( DEXA ) yields a better outcome than prednisolone ( PRED ) in a prospect i ve , r and omized , controlled trial for the treatment of childhood acute lymphoblastic leukemia ( ALL ) . PATIENTS AND METHODS Two hundred thirty-one st and ard-risk ( SR ) patients and 128 intermediate-risk ( IR ) non-B-cell ALL patients were registered from March
Output:
| There was no statistically significant difference in the risk of osteonecrosis , sepsis , fungal infection , diabetes or pancreatitis .
DEX in induction therapy for children with ALL is more efficacious than PRED .
However , DEX is also associated with more toxicity , and currently it remains unclear whether short-term superiority of DEX will also result in better overall survival |
MS212674 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background The purpose of this study was to identify predictors of 3-month mortality in critically ill older persons under medical care and to assess the clinical impact of an ICU stay on physical and cognitive dependence and subjective health status in survivors . Methods We conducted a prospect i ve observational cohort study including all older persons 75 years and older consecutively admitted into ICU during a one-year period , except those admitted after cardiac arrest , All patients were followed for 3 months or until death . Comorbidities were assessed using the Charlson index and physical dependence was evaluated using the Katz index of Activity of Daily Living ( ADL ) . Cognitive dependence was determined by a score based on the individual components of the Lawton index of Daily Living and subjective health status was evaluated using the Nottingham Health Profile ( NHP ) score . Results One hundred patients were included in the analysis . The mean age was 79.3 ± 3.4 years . The median Charlson index was 6 [ IQR , 4 to 7 ] and the mean ADL and cognitive scores were 5.4 ± 1.1 and 1.2 ± 1.4 , respectively , corresponding to a population with a high level of comorbidities but low physical and cognitive dependence . Mortality was 61/100 ( 61 % ) at 3 months . In multivariate analysis only comorbidities assessed by the Charlson index [ Adjusted Odds Ratio , 1.6 ; 95 % CI , 1.2 - 2.2 ; p < 0.003 ] and the number of organ failures assessed by the SOFA score [ Adjusted Odds Ratio , 2.5 ; 95 % CI , 1.1 - 5.2 ; p < 0.02 ] were independently associated with 3-month mortality . All 22 patients needing renal support after Day 3 died . Compared with pre-admission , physical ( p = 0.04 ) , and cognitive ( p = 0.62 ) dependence in survivors had changed very little at 3 months . In addition , the mean NHP score was 213.1 ± 132.8 at 3 months , suggesting an acceptable perception of their quality of life . Conclusions In a selected population of non surgical patients 75 years and older , admission into the ICU is associated with a 3-month survival rate of 38 % with little impact on physical and cognitive dependence and subjective health status . Nevertheless , a high comorbidity level ( ie , Charlson index ) , multi-organ failure , and the need for extra-renal support at the early phase of intensive care could be considered as predictors of death Objective : To examine the impact of delirium during intensive care unit stay on long-term health-related quality of life and cognitive function in intensive care unit survivors . Design : Prospect i ve 18-month follow-up study . Setting : Four intensive care units of a university hospital . Patients : A median of 18 months after intensive care discharge , question naires were sent to 1,292 intensive care survivors with ( n = 272 ) and without ( n = 1020 ) delirium during their intensive care stay . Measurements and Main Results : The Short Form-36v1 , checklist individual strength-fatigue , and cognitive failure question naire were used . Covariance analysis was performed to adjust for relevant covariates . Of the 915 responders , 171 patients were delirious during their intensive care stay ( median age 65 [ interquartile range 58–85 ] , Acute Physiology and Chronic Health Evaluation II score 17 [ interquartile range 14–20 ] ) , and 745 patients were not ( median age 65 [ interquartile range 57–72 ] , Acute Physiology and Chronic Health Evaluation II score 13 [ interquartile range 10–16 ] ) . After adjusting for covariates , no differences were found between delirium and nondelirium survivors on the Short Form-36 and checklist individual strength-fatigue . However , survivors who had suffered from delirium reported that they made significantly more social blunders , and their total cognitive failure question naire score was significantly higher , compared to survivors who had not been delirious . Survivors of a hypoactive delirium subtype performed significantly better on the domain mental health than mixed and hyperactive delirium patients . Duration of delirium was significantly correlated to problems with memory and names . Conclusions : Intensive care survivors with delirium during their intensive care unit stay had a similar adjusted health-related quality of life evaluation , but significantly more cognitive problems than those who did not suffer from delirium , even after adjusting for relevant covariates . In addition , the duration of delirium was related to long-term cognitive problems BACKGROUND Infectious , autoimmune , and neurodegenerative diseases are associated with profound psychological disturbances . Studies in animals clearly demonstrate that cytokines mediate illness-associated behavioral changes . However , the mechanisms underlying the respective psychological alterations in humans have not been established yet . Therefore , we investigated the effects of low-dose endotoxemia , a well-established and safe model of host-defense activation , on emotional , cognitive , immunological , and endocrine parameters . METHODS In a double-blind , crossover study , 20 healthy male volunteers completed psychological question naires and neuropsychological tests 1 , 3 , and 9 hours after intravenous injection of Salmonella abortus equi endotoxin ( 0.8 ng/kg ) or saline in 2 experimental sessions . Blood sample s were collected hourly , and rectal temperature and heart rate were monitored continuously . RESULTS Endotoxin had no effects on physical sickness symptoms , blood pressure , or heart rate . Endotoxin caused a mild increase in rectal temperature ( 0.5 degrees C ) , and increased the circulating levels of tumor necrosis factor alpha ( TNF-alpha ) , soluble TNF receptors , interleukin (IL)-6 , IL-1 receptor antagonist , and cortisol . After endotoxin administration , the subjects showed a transient significant increase in the levels of anxiety ( effect size [ ES ] = 0.55 ) and depressed mood ( ES = 0.66 ) . Verbal and nonverbal memory functions were significantly decreased ( ES = 0.55 to 0.64 ) . Significant positive correlations were found between cytokine secretion and endotoxin-induced anxiety ( r = 0.49 to r = 0.60 ) , depressed mood ( r = 0.40 to r = 0.75 ) , and decreases in memory performance ( r = 0.46 to r = 0.68 ) . CONCLUSIONS In humans , a mild stimulation of the primary host defense has negative effects on emotional and memory functions , which are probably caused by cytokine release . Hence , cytokines represent a novel target for neuropsychopharmacological research Objective Recent studies have shown significant cognitive problems some months after critical illness . However there has been no research examining cognitive function within the intensive care unit ( ICU ) in non-delirious patients . Design and setting A prospect i ve study in an ICU . Patients and participants Using the Cambridge Neuropsychological Test Automated Battery ( CANTAB ) , 30 long-stay , tracheal-intubated ICU patients were tested . Prior to testing on ICU the Confusion Assessment Measure ( CAM-ICU ) was administered and only those patients clearly not delirious and off sedation for several days were tested . The CANTAB tests were repeated a week after ICU discharge on the general ward and then again at 2 months . Sixteen patients completed the follow-up . Results While on ICU all 30 patients showed significant problems with strategic thinking and problem solving ; 20 patients had some problems with memory . The degree of difficulty with problem solving on ICU was correlated with length of ICU stay ( p = 0.011 ) , age ( p = 0.036 ) and length of hospital stay post ICU ( p = 0.044 ) . Problems with memory in ICU and on the general ward were correlated with admission APACHE II score ( p = 0.004 and p = 0.005 respectively ) . At the 2-month follow-up 5 of 16 patients ( 31 % ) scored below the 25 percentile for memory and 8 of 16 ( 50 % ) below the 25 percentile for problem solving ( Slater TA , Jones C , Griffiths RD , Wilson S , Benjamin K ( 2004 ) Cognitive impairment during and after intensive care : a pilot study . Intensive Care Med 30 [ Suppl 1]:S199 ) . Conclusions Difficulties with problem solving and poor memory remained a significant issue for 2 months after ICU discharge Objective To examine neuropsychological function , depression , and quality of life 6 months after discharge in patients who received mechanical ventilation in the intensive care unit . Design Prospect i ve cohort study . Setting Tertiary care , medical and coronary intensive care unit of a university-based medical center . Study Population A total of 275 consecutive , mechanically ventilated patients from a medical intensive care unit were prospect ively followed . At 6 months , 157 were alive , of whom 41 ( 26 % ) returned for extensive follow-up testing . Measurement and Main Results Neuropsychological testing and assessment of depression and quality of life were performed at 6-month follow-up . Seven of 41 patients were excluded from further analysis due to preexisting cognitive impairment determined via surrogate interviews using the Modified Blessed Dementia Rating Scale and a review of medical records . On the basis of strict criteria derived from normative data , we found that 11 of 34 patients ( 32 % ) were neuropsychologically impaired . Impairment was generally diffuse but occurred primarily in areas of psychomotor speed , visual and working memory , verbal fluency , and visuo-construction . The rate of neuropsychological deficits in the study population was markedly higher than population norms for mild dementia . Scores on the Geriatric Depression Scale – Short Form were significantly more abnormal in the neuropsychologically impaired group than in the nonimpaired group at hospital discharge ( p = .04 ) and at 6-month follow-up ( p = .02 ) , and clinical ly significant depression was found in 27 % of impaired subjects at hospital discharge and in 36 % at 6-month follow-up . No differences were observed between groups in quality of life as measured with the Short Form Health Survey-12 at discharge or 6-month follow-up . Conclusions Prolonged neuropsychological impairment is common among survivors of the medical intensive care unit and occurs with greater than anticipated frequency when compared with relevant normative data . Future investigations are warranted to eluci date the nature of the association between critical illness , neuropsychological impairment , depression , and decreased quality of life Introduction Long-term outcomes of elderly patients after medical ICU care are little known . The aim of the study was to evaluate functional status and quality of life of elderly patients 12 months after discharge from a medical ICU . Methods We prospect ively studied 112/230 healthy elderly patients ( ≥65 years surviving at least 12 months after ICU discharge ) with full functional autonomy without cognitive impairment prior to ICU entry . The main diagnoses at admission using the Acute Physiology and Chronic Health Evaluation III ( APACHE III ) classification diagnosis and length of ICU stay and ICU scores ( APACHE II , Sepsis-related Organ Failure Assessment ( SOFA ) and OMEGA ) at admission and discharge were collected . Comprehensive geriatric assessment included the presence of the main geriatric syndromes and the application of Lawton , Barthel , and Charlson Indexes and Informant Question naire on Cognitive Decline to evaluate functionality , comorbidity and cognitive status , respectively . The EuroQol-5D assessed quality of life . Data were collected at baseline , during ICU and ward stay and 3 , 6 and 12 months after hospital discharge . Paired or unpaired T-tests compared differences between groups ( continuous variables ) , whereas the chi-square and Fisher exact tests were used for comparing dichotomous variables . For variables significant ( P ≤ 0.1 ) on univariate analysis , a forward multiple regression analysis was performed . Results Only 48.9 % of patients ( mean age : 73.4 ± 5.5 years ) were alive 12 months after discharge showing a significant decrease in functional autonomy ( Lawton and Barthel Indexes ) and quality of life ( EuroQol-5D ) compared to baseline status ( P < 0.001 , all ) . Multivariate analysis showed a higher Barthel Index and EQ-5D vas at hospital discharge to be associated factors of full functional recovery ( P < 0.01 , both ) . Thus , in patients with a Barthel Index ≥ 60 or EQ-5D vas ≥40 at discharge the hazard ratio for full functional recovery was 4.04 ( 95 % CI : 1.58 to 10.33 ; P = 0.005 ) and 6.1 ( 95 % CI : 1.9 to 19.9 ; P < 0.01 ) , respectively . Geriatric syndromes increased after ICU stay and remained significantly increased during follow-up ( P < 0.001 ) . Conclusions The survival rate of elderly medical patients 12 months after discharge from the ICU is low ( 49 % ) , although functional status and quality of life remained similar to baseline in most of the survivors . However , there was a two-fold increase in the prevalence of geriatric syndromes Objective : To test the hypothesis that duration of delirium in the intensive care unit is an independent predictor of long-term cognitive impairment after critical illness requiring mechanical ventilation . Design : Prospect i ve cohort study . Setting : Medical intensive care unit in a large community hospital in the United States .
Output:
| Conclusion The results of most studies of the studies review ed suggest that critical illness and ICU treatment are associated with long-term cognitive impairment . |
MS212675 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Before any new diagnostic test is accepted in clinical practice , such a test should be compared with established diagnostic tools in an appropriately large series of patients encompassing the complete spectrum of challenges to which the test is exposed . The aim of the present study was to assess the relative diagnostic and prognostic accuracies of high-dose dipyridamole echocardiography ( two-dimensional echocardiographic monitoring during dipyridamole infusion up to 0.84 mg/kg over 10 hours ) versus maximal symptom-limited bicycle exercise ECG test in patients with angina . METHODS AND RESULTS We studied 429 consecutive in-hospital patients who met the following inclusion criteria : history of chest pain , off antianginal therapy for at least 2 days ( 1 week for beta-blockers ) , no previous myocardial infa rct ion and /or obvious regional left ventricular dyssynergy of contraction ( akinesis or dyskinesis ) at baseline , and acceptable acoustic window under resting conditions . All patients underwent dipyridamole echocardiography and exercise ECG -- on different days and in r and om order -- within 1 week of coronary angiography ( which was performed independent of test results ) and were followed up for 37.8 + /- 14 months ( range , 1 to 73 months ) . Criteria of positivity were for dipyridamole echocardiography , a transient regional dyssynergy absent in the baseline examination ; for exercise ECG , an ST-segment shift of > or = 0.1 mV from baseline ; and for coronary angiography , a luminal reduction of > or = 75 % in at least one major coronary vessel ( 50 % for left main ) . There were 183 patients without and 246 with coronary artery disease ; 132 had one- , 70 had two- , and 44 had three- and /or left main vessel disease . The specificity was higher for dipyridamole echocardiography than for exercise ECG ( 90 % versus 51 % , P < .001 ) . The overall sensitivity of dipyridamole echocardiography was similar to that of exercise ECG ( 75 % versus 74 % , P = NS ) , with no significant differences in the subset with one- ( 67 % versus 69 % , P = NS ) , two- ( 79 % versus 77 % , P = NS ) , or three- ( 93 % versus 86 % , P = NS ) vessel disease . During the follow-up , there were 20 deaths , 13 nonfatal myocardial infa rct ions , and 126 revascularization procedures . In the univariate analysis , dipyridamole result ed in higher chi 2 values than did exercise stress testing . A Cox forward stepwise survival analysis identified the dipyridamole time as the most powerful prognostic predictor of death ( chi 2 = 19.4 , P < .0001 ) of all invasive and noninvasive parameters . The dipyridamole time also provided independent and additional prognostic information when it was adjusted for age , diabetes , resting ECG , and exercise stress test according to a modified , interactive stepwise procedure . This is true when death only , death and myocardial infa rct ion , and death , myocardial infa rct ion , and revascularization procedures were considered end points . CONCLUSIONS In patients with no previous myocardial infa rct ion and good resting left ventricular function , compared with exercise ECG , dipyridamole echocardiography has a similar sensitivity and a higher specificity for the noninvasive detection of angiographically assessed coronary artery disease . Dipyridamole echocardiography also provides information in addition to that provided by exercise ECG for predicting death , infa rct ion , and all events when the presence as well as the timing , severity , and extension of dipyridamole-induced wall motion abnormalities are considered Because of numerous reports of false positive results with thallium-201 ( Tl-201 ) stress testing in patients with left bundle branch block , the authors decided to evaluate another mode of coronary vasodilatation , dipyridamole , for the diagnosis of coronary atheromatosis . Nine patients were prospect ively studied with stress and dipyridamole Tl-201 scintigraphy ; both tests were performed within three to 79 days of one another . Five of the patients also had coronary angiograms ( four within one year , one five years earlier ) . Four of the patients had normal results with both tests ( two normal angiograms , two not performed ) ; two had reversible septal defects with stress-induced coronary vasodilatation but normal dipyridamole studies ( only one had an angiogram , which was normal ) ; one patient had a fully reversible septal defect with stress and a fixed defect with dipyridamole ( normal angiogram ) ; one had a partially reversible septal stress defect which was fixed with dipyridamole ; and one had a normal stress study but a reversible septal defect with dipyridamole ( an angiogram performed five years earlier showed 30 to 40 % stenosis of the anterior descending artery ) . Because it seems that dipyridamole produces fewer false positive results , it should be used instead of stress testing to induce coronary vasodilatation in patients with left bundle branch block BACKGROUND The prognostic value of tomographic myocardial perfusion imaging with dipyridamole or adenosine in patients with left bundle-branch block has not been established . METHODS AND RESULTS The study group consisted of 245 patients with left bundle-branch block who underwent tomographic ( single photon emission tomography ) myocardial perfusion imaging with thallium-201 ( n=173 ) or technetium-99 m sestamibi ( n=72 ) and either dipyridamole ( n=153 ) or adenosine ( n=92 ) stress . Patients were prospect ively classified into two groups . Patients were classified as " high risk " if they had ( 1 ) a large severe fixed defect ( n=28 ) , ( 2 ) a large reversible defect ( n=36 ) , or ( 3 ) cardiac enlargement and either increased pulmonary uptake ( thallium ) or a decreased resting ejection fraction ( sestamibi ) ( n=20 ) . The remaining 161 patients ( 66 % of the study group ) were at " low risk . " Follow-up was 99 % complete at 3+/-1.4 years . Three-year overall survival was 57 % in the high-risk group compared with 87 % in the low-risk group ( P<.0001 ) . Survival free of cardiac death/nonfatal myocardial infa rct ion/cardiac transplantation was 55 % in the high-risk group and 93 % in the low-risk group ( P<.0001 ) . The presence of a high-risk scan had significant incremental prognostic value after adjustment for age , sex , diabetes , and previous myocardial infa rct ion ( P<.0001 ) . Patients with a low-risk scan had an overall survival that was not significantly different from that of a US age-matched population ( P=.86 ) . CONCLUSIONS Tomographic myocardial perfusion imaging with adenosine or dipyridamole stress provides important prognostic information in patients with left bundle-branch block , which is incremental to clinical assessment This article is the first of two papers about the care of patients with chronic stable angina . The second paper , which deals with the treatment of patients with chronic stable angina , will be published in a future issue . Both articles have been adapted from material s created by the Committee on Guidelines for Chronic Stable Angina sponsored by the American College of Cardiology ( ACC ) , the American Heart Association ( AHA ) , and the American College of PhysiciansAmerican Society of Internal Medicine ( ACPASIM ) ( 1 - 3 ) . The adaptations in these articles are intended to make the information more useful for clinicians who do not specialize in the care of patients with heart disease . The committee created the original material s after review ing published reports identified in part through MEDLINE search es of the English literature from 1975 through 1998 . The weight of the evidence was ranked high and given a grade of A if the data were derived from multiple r and omized clinical trials involving many patients . The weight of the evidence was ranked intermediate and given a grade of B if the data were derived from a few r and omized trials involving small numbers of patients , nonr and omized studies , or observational registries . A lower rank and a grade of C were given when an expert consensus was the primary basis for the recommendation . We used the following classification system for final recommendations . Class I referred to conditions for which there is evidence or general agreement that a given procedure or treatment is useful and effective ; class II referred to conditions for which there is conflicting evidence or a divergence of opinion about the usefulness or efficacy of a procedure or treatment ; class IIa referred to conditions for which the weight of evidence or opinion is in favor of usefulness or efficacy of a procedure or treatment ; class IIb referred to conditions for which usefulness or efficacy of a procedure or treatment is less well established by evidence or opinion ; and class III referred to conditions for which there is evidence or general agreement that the procedure or treatment is not useful or effective and in some cases may be harmful . For the sake of brevity , we have combined some original recommendations and omitted others , especially those that affect fewer patients , are based on weaker evidence , or recommend that interventions not be done . Scope of the Guidelines These recommendations are intended for adult patients with stable chest pain syndromes and known or suspected ischemic heart disease and patients who have ischemic equivalents , such as dyspnea or arm pain with exertion . Also , some recommendations about follow-up apply to patients who become asymptomatic during therapy . These guidelines are not intended for patients with acute ischemic syndromes , patients with chest pain after cardiac transplantation , patients with chest pain within 6 months of revascularization by percutaneous techniques or coronary artery bypass grafting ( CABG ) , patients with coronary artery disease ( CAD ) detected without symptoms , patients with nonanginal chest pain , or pediatric patients . The Initial Evaluation The initial evaluation of patients presenting with chest pain includes a detailed history , a focused physical examination , and performance of a few tests and procedures that are useful for estimating the probability of significant CAD ( Figure 1 ) . Significant CAD is defined as an obstruction of at least one major epicardial artery that occupies at least 70 % of the artery 's cross-sectional diameter or an obstruction of the left main coronary artery that occupies at least 50 % of its diameter . Figure 1 . Diagnosis of chest pain . Comorbid conditions and patient preferences . The history should elicit specific information about chest pain because accurate characterization helps determine whether CAD is the cause of angina . Angina usually occurs in patients with CAD , but it can occur in patients with unobstructed coronary arteries who have myocardial ischemia related to an arterial spasm or endothelial dysfunction . It also can occur in patients with other cardiovascular problems , such as aortic stenosis , hypertrophic cardiomyopathy , or uncontrolled hypertension . Symptoms that mimic angina can also occur in patients with noncardiac conditions involving the chest wall , esophagus , or lung . The following characteristics of chest pain should be determined : quality , location , duration , and the presence of factors that provoke and relieve the pain . Angina is characterized by a substernal pain or discomfort , although it may radiate to the neck , jaw , epigastrium , or arms . Patients often describe the quality of angina with characteristic terms , such as squeezing , grip-like , pressure-like , suffocating , or heavy . Angina usually lasts for minutes . Exertion or emotional stress provokes it , and rest or nitroglycerin relieves it , typically within 30 seconds to several minutes . After the history is obtained , the clinician should classify the chest pain . Typical angina has the following characteristics : 1 ) substernal chest discomfort with a characteristic quality and duration that is 2 ) provoked by exertion or emotional stress and 3 ) relieved by rest or nitroglycerin . Atypical angina has two of the three characteristics of typical angina , while noncardiac chest pain has one or none of the characteristics of typical angina . The term noncardiac chest pain means that the probability of CAD is low . The term nonspecific chest pain more accurately describes this situation , but tradition prevents its use . In patients with angina , the severity of pain should be grade d according to the Canadian Cardiovascular Society ( CCS ) classification system ( Table 1 ) ( 6 ) . Although grading chest pain is less useful for establishing a diagnosis or estimating risk , it is essential for evaluating the effects of therapy . Table 1 . Grading of Angina by the Canadian Cardiovascular Society Classification System In patients with angina , the stability of pain should be assessed . Patients have unstable angina if the pain started recently ; is more easily provoked ; or occurs with increased frequency , severity , or duration ( 7 ) . Some patients with unstable angina have a measurable risk for short-term death ( 8) . Those characterized as high risk have a 1.7 % probability of dying within 30 days , and those characterized as moderate risk have a 1.2 % probability . These patients have pain at rest , nocturnal pain , signs or symptoms of heart failure , or new or ischemic changes on resting electrocardiography ( ECG ) . They should be evaluated in the inpatient setting . However , patients with unstable angina whose pain has been present for at least 2 weeks and who lack any of angina 's more worrisome clinical features , including ECG changes , can be evaluated in an outpatient setting because their probability of death or myocardial infa rct ion within 30 days is indistinguishable from zero . The initial history should also include information about the risk factors for CAD , such as smoking , hyperlipidemia , diabetes , hypertension , and a family
Output:
| Since these cutoff points are not absolute , there is no definite threshold of risk below which no further work-up is warranted .
The probabilities for nonanginal chest pain and atypical angina are larger in primary care practice .
For risk stratification in a patient with chronic stable angina who has a history of documented MI or Q waves on |
MS212676 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: We investigated the prospect i ve relationship between thyroid status and the risk of dementia and Alzheimer 's disease among a r and om sample of 1843 participants , aged 55 years and over , from the population ‐based prospect i ve Rotterdam Study OBJECTIVE Sub clinical thyroid disorders are common in older individuals . Health risks associated with sub clinical hypothyroidism in older adults are unclear . The aim of the study is to evaluate whether thyroid status in elderly subjects correlates with physical and cognitive function at baseline and with 3-year mortality . DESIGN A population -based , prospect i ve cohort of the OCTABAIX study ( 307 inhabitants aged 85 years at baseline ) . METHODS Chronic drug prescription , functional status ( Barthel and Lawton indices ) and cognitive status according to the Spanish version of the Mini-Mental State Examination were recorded . Quality of life was assessed using the visual analogue scale of the quality of life test . Concentrations of TSH and thyroxine were measured . Participants were classified in accordance with clinical categories of thyroid function . RESULTS Twenty ( 6.5 % ) individuals had sub clinical hypothyroidism and five ( 1.6 % ) had sub clinical hyperthyroidism . Compared with euthyroid subjects ( n=280 ; 91.8 % ) , sub clinical hypo- and hyperthyroidism subjects were not significantly associated with poor physical or cognitive function at baseline . Fifty-one ( 15.1 % ) subjects died during the 36 months of follow-up . TSH values and sub clinical hypo- and hyperthyroidism were not associated with an increased overall mortality risk ( hazard ratio ( HR ) 1.086 , 95 % CI 0.987 - 1.196 and HR 0.905 , 95 % CI 0.902 - 1.053 respectively ) . CONCLUSIONS This study does not support the association of TSH or thyroid disorders with physical or cognitive function at baseline or with 3-year mortality in the oldest old subjects OBJECTIVE To what extent endogenous sub clinical thyroid disorders contribute to impaired physical and cognitive function , depression , and mortality in older individuals remains a matter of debate . DESIGN A population -based , prospect i ve cohort of the Longitudinal Aging Study Amsterdam . METHODS TSH and , if necessary , thyroxine and triiodothyronine levels were measured in individuals aged 65 years or older . Participants were classified according to clinical categories of thyroid function . Participants with overt thyroid disease or use of thyroid medication were excluded , leaving 1219 participants for analyses . Outcome measures were physical and cognitive function , depressive symptoms ( cross-sectional ) , and mortality ( longitudinal ) RESULTS Sixty-four ( 5.3 % ) individuals had sub clinical hypothyroidism and 34 ( 2.8 % ) individuals had sub clinical hyperthyroidism . Compared with euthyroidism ( n=1121 ) , sub clinical hypo- , and hyper-thyroidism were not significantly associated with impairment of physical or cognitive function , or depression . On the contrary , participants with sub clinical hypothyroidism did less often report more than one activity limitation ( odds ratio 0.44 , 95 % confidence interval ( CI ) 0.22 - 0.86 ) . After a median follow-up of 10.7 years , 601 participants were deceased . Sub clinical hypo- and hyper-thyroidism were not associated with increased overall mortality risk ( hazard ratio 0.89 , 95 % CI 0.59 - 1.35 and 0.69 , 95 % CI 0.40 - 1.20 respectively ) . CONCLUSIONS This study does not support disadvantageous effects of sub clinical thyroid disorders on physical or cognitive function , depression , or mortality in an older population Background : It is unclear whether in late life serum thyroid-stimulating hormone ( TSH ) predicts risk of developing cognitive impairment . Objective : This study investigated the prospect i ve relationship of serum TSH with the risk of developing mild cognitive impairment ( MCI ) , Alzheimer ’s disease ( AD ) and vascular dementia ( VaD ) in an elderly cohort with a 4-year follow-up . Methods : Data are for 660 subjects aged 65 years and older from an Italian population -based cohort who were cognitively normal at an extensive assessment in 1999/2000 and underwent follow-up assessment in 2003/2004 . Serum TSH was measured at baseline . Multinomial logistic models adjusted for sociodemographic and cardiovascular risk factors were used to investigate the association of serum TSH ( both as a tertile and continuous log-transformed variable ) with risk of incident MCI , AD and VaD diagnosed according to international criteria . Results : Over 3.8 ± 0.7 years of follow-up , there were 149 incident MCI cases ( 77 with impairment of memory and 72 with impairment of nonmemory domains ) and 86 incident dementia cases ( 53 with AD , 28 with VaD ) . No association between baseline TSH and risk of developing any MCI subtype or AD was found . The highest TSH tertile had a threefold higher increased risk of VaD ( OR : 3.25 , 95 % CI : 1.01–10.77 , p = 0.048 ) compared to the lowest tertile . Risk of VaD increased about 60 % for each 1 SD increase in log-transformed TSH ( OR : 1.61 , 95 % CI : 1.06–2.44 , p = 0.025 ) . Conclusions : In this elderly cohort , baseline TSH was not related to the risk of developing MCI or AD , but high TSH was associated with an increased risk of VaD. These results suggest further need for research using larger sample s to examine the role of TSH as a predictor of VaD and the role of thyroid autoimmunity in vascular cognitive impairment Neuroanatomical connections point to possible interactions between areas influencing energy homeostasis and those influencing cognition . We assessed whether serum leptin , thyroxine , and thyroid stimulating hormone ( TSH ) levels are associated with and interact to influence cognitive performance among US adults . Data from the National Health and Nutrition Examination Survey III ( 1988 - 1994 ) were used . Measures included a battery of neuropsychological tests and serum leptin , thyroxine , and TSH levels ( 20 - 59-year-old : n = 1114 - 2665 ; 60 - 90-year-old : n = 1365 - 5519 ) . Among those 20 - 59-year-old , the middle tertile of leptin ( vs. first tertile ) was inversely related to the number of errors on the symbol digits substitution test . Increased thyroxine level was associated with a poorer performance on the serial digits test in the 20 - 59-year-old , but a better performance on the math test in 60 - 90-year-old group . TSH was associated with poor performance on various tests in the 20 - 59-year-old , but better performance in the 60 - 90-year-old group . Significant antagonistic interactions were found in both age groups between thyroxine , TSH , and leptin for a number of tests , including between leptin and thyroxine in the 60 - 90-year-old group in their association with word recall-correct score . We found significant associations of our main exposures with cognitive function among US adults , going in opposite directions between age groups in the cases of thyroid hormonal levels , as well as some interactive effects between exposures . It is important to conduct prospect i ve cohort studies to provide further insight into potential interventions that would assess interactive effects of various hormonal replacement regimens Thyroid dysfunction is associated with cognitive impairment and dementia , including Alzheimer 's disease ( AD ) . It remains unclear whether thyroid dysfunction results from , or contributes to , Alzheimer pathology . We determined whether thyroid function is associated with dementia , specifically AD , and Alzheimer-type neuropathology in a prospect i ve population -based cohort of Japanese-American men . Thyrotropin , total and free thyroxine were available in 665 men aged 71 - 93 years and dementia-free at baseline ( 1991 ) , including 143 men who participated in an autopsy sub- study . During a mean follow-up of 4.7 ( S.D. : 1.8 ) years , 106 men developed dementia of whom 74 had AD . Higher total and free thyroxine levels were associated with an increased risk of dementia and AD ( age and sex adjusted hazard ratio ( 95 % confidence interval ) per S.D. increase in free thyroxine : 1.21 ( 1.04 ; 1.40 ) and 1.31 ( 1.14 ; 1.51 ) , respectively ) . In the autopsied sub- sample , higher total thyroxine was associated with higher number of neocortical neuritic plaques and neurofibrillary tangles . No associations were found for thyrotropin . Our findings suggest that higher thyroxine levels are present with Alzheimer clinical disease and neuropathology Background Sub clinical thyroid dysfunction has been implicated as a risk factor for cognitive decline in old age , but results are inconsistent . We investigated the association between sub clinical thyroid dysfunction and cognitive decline in the PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) . Methods Prospect i ve longitudinal study of men and women aged 70–82 years with pre-existing vascular disease or more than one risk factor to develop this condition ( N = 5,154 ) . Participants taking antithyroid medications , thyroid hormone supplementation and /or amiodarone were excluded . Thyroid function was measured at baseline : sub clinical hyper- and hypothyroidism were defined as thyroid stimulating hormones ( TSH ) < 0.45 mU/L or > 4.50 mU/L respectively , with normal levels of free thyroxine ( FT4 ) . Cognitive performance was tested at baseline and at four subsequent time points during a mean follow-up of 3 years , using five neuropsychological performance tests . Results Sub clinical hyperthyroidism and hypothyroidism were found in 65 and 161 participants , respectively . We found no consistent association of sub clinical hyper- or hypothyroidism with altered cognitive performance compared to euthyroid participants on the individual cognitive tests . Similarly , there was no association with rate of cognitive decline during follow-up . Conclusion We found no consistent evidence that sub clinical hyper- or hypothyroidism contribute to cognitive impairment or decline in old age . Although our data are not in support of treatment of sub clinical thyroid dysfunction to prevent cognitive dysfunction in later life , only large r and omized controlled trials can provide definitive evidence IMPORTANCE An association of clinical and sub clinical hypothyroidism with mild cognitive impairment ( MCI ) has not been established . OBJECTIVE To evaluate the association of clinical and sub clinical hypothyroidism with MCI in a large population -based cohort . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional , population -based study was conducted in Olmsted County , Minnesota . R and omly selected participants were aged 70 to 89 years on October 1 , 2004 , and were without documented prevalent dementia [ CORRECTED ] . A total of 2050 participants were evaluated and underwent in-person interview , neurologic evaluation , and neuropsychological testing to assess performance in memory , attention/executive function , and visuospatial and language domains . Participants were categorized by consensus as being cognitively normal , having MCI , or having dementia according to published criteria . Clinical and sub clinical hypothyroidism were ascertained from a medical records linkage system . MAIN OUTCOMES AND MEASURES Association of clinical and sub clinical hypothyroidism with MCI . RESULTS Among 1904 eligible participants , the frequency of MCI was 16 % in 1450 individuals with normal thyroid function , 17 % in 313 persons with clinical hypothyroidism , and 18 % in 141 individuals with sub clinical hypothyroidism . After adjusting for covariates ( age , educational level , sex , apolipoprotein E ε4 , depression , diabetes mellitus , hypertension , stroke , body mass index , and coronary artery disease ) we found no significant association between clinical or sub clinical hypothyroidism and MCI ( odds ratio [ OR ] , 0.99 [ 95 % CI , 0.66 - 1.48 ] and 0.88 [ 0.38 - 2.03 ] , respectively ) . No effect of sex interaction was seen on these effects . In stratified analysis , the odds of MCI with clinical and sub clinical hypothyroidism among men was 1.02 ( 95 % CI , 0.57 - 1.82 ) and 1.29 ( 0.68 - 2.44 ) and , among women , was 1.04 ( 0.66 - 1.66 ) and 0.86 ( 0.37 - 2.02 ) , respectively . CONCLUSIONS AND RELEVANCE In this population -based cohort of elderly people , neither clinical nor sub clinical hypothyroidism was associated with MCI . Our findings need to be vali date d in a separate setting using the published criteria for MCI and confirmed in a longitudinal study CONTEXT The association between sub clinical hyperthyroidism and the risk of dementia has been vali date d in several
Output:
| This meta- analysis supports that low thyrotropin level is significantly associated with an increased risk of Alzheimer ’s disease in the elderly |
MS212677 | ***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: ABSTRACT . A double blind controlled trial of Becotide ® ( beclomethasone diproprionate ) inhalations was carried out for treating cystic fibrosis patients with chronic P. aeruginosa lung infection to determine its efficacy and safety . The aim of the treatment was to diminish the inflammatory response in the lungs of these patients , a response which is initiated by an allergic type III reaction . Pulmonary inflammation was evaluated by measurements of proteolytic activity , albumin concentration and immune complex activity in the sputum solphase before , during , and after the 16 weeks the trial lasted . 26 cystic fibrosis patients participated ( 13 received Becotide ® and 13 placebo ) and the results showed that local steroids have no effect on the inflammatory response in the lungs of cystic fibrosis patients with chronic P. aeruginosa lung infection . No adverse effects were demonstrated . There was , however , a significant increase in the inflammatory parameters for all 26 cystic fibrosis patients when the trial period was over , compared to the insidious pulmonary destruction which takes place in the lungs of these patients , and it corresponded to a significant decrease ( p<0.05 ) in forced vital capacity which took place at the same time . Therefore , chronic P. aeruginosa lung infection in these patients should be treated as efficiently as possible Long-term treatment with ibuprofen twice daily , at doses that achieve peak plasma concentration ( Cmax ) > 50 μg/ml , slows progression of lung disease in patients with cystic fibrosis ( CF ) . Previous data suggest that Cmax > 50 μg/ml is associated with a reduction in neutrophil ( PMN ) migration into the lung and that lower concentrations are associated with an increase in PMN migration . To estimate the threshold concentration at which ibuprofen is associated with a decrease in PMN migration in vivo , we measured the PMN content of oral mucosal washes in 35 healthy ( age 19 - 40 years ) and 16 CF ( age 18 - 32 years ) subjects who took ibuprofen twice daily for 10 days in doses that achieved Cmax 8 to 90 μg/ml . Cmax > 50 μg/ml was associated with a 31 ± 7 % ( mean ± S.E.M. ) reduction in PMNs in CF ( n = 11 , p < 0.001 ) and 25 ± 6 % reduction in PMNs in healthy subjects ( n = 16 , p < 0.001 ) . Increasing concentrations above 50 μg/ml was not associated with a greater decrease in PMNs . The reduction in PMN migration was consistently present 12 h after a dose , but not after 24 h. Cmax < 50 μg/ml was associated with an increase in PMNs of approximately 40 % . These results suggest that Cmax > 50 μg/ml and twice daily dosing of ibuprofen are required to decrease PMN migration , and reinforce the current recommendation that pharmacokinetics should be performed in CF patients prescribed ibuprofen Abstract A double-blind r and omised cross-over trial of aerosol carbenicillin and gentamicin treatment in young adult cystic-fibrosis patients chronically infected with Pseudomonas aeruginosa has shown that aerosol antibiotic treatment produces both subjective and objective improvement . This treatment therefore appears to be useful in selected patients BACKGROUND Inhaled hypertonic saline acutely increases mucociliary clearance and , in short-term trials , improves lung function in people with cystic fibrosis . We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial . METHODS In this double-blind , parallel-group trial , 164 patients with stable cystic fibrosis who were at least six years old were r and omly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent ( control ) saline twice daily for 48 weeks , with quinine sulfate ( 0.25 mg per milliliter ) added to each solution to mask the taste . A bronchodilator was given before each dose , and other st and ard therapies were continued during the trial . RESULTS The primary outcome measure , the rate of change ( slope ) in lung function ( reflected by the forced vital capacity [ FVC ] , forced expiratory volume in one second [ FEV1 ] , and forced expiratory flow at 25 to 75 percent of FVC [ FEF25 - 75 ] ) during the 48 weeks of treatment , did not differ significantly between groups ( P=0.79 ) . However , the absolute difference in lung function between groups was significant ( P=0.03 ) when averaged across all post-r and omization visits in the 48-week treatment period . As compared with the control group , the hypertonic-saline group had significantly higher FVC ( by 82 ml ; 95 percent confidence interval , 12 to 153 ) and FEV1 ( by 68 ml ; 95 percent confidence interval , 3 to 132 ) values , but similar FEF25 - 75 values . The hypertonic-saline group also had significantly fewer pulmonary exacerbations ( relative reduction , 56 percent ; P=0.02 ) and a significantly higher percentage of patients without exacerbations ( 76 percent , as compared with 62 percent in the control group ; P=0.03 ) . Hypertonic saline was not associated with worsening bacterial infection or inflammation . CONCLUSIONS Hypertonic saline preceded by a bronchodilator is an inexpensive , safe , and effective additional therapy for patients with cystic fibrosis . ( Clinical Trials.gov number , NCT00271310 . A r and omized cross-over study was undertaken to compare nebulized ( 1 ) ceftazidime with ( 2 ) a combination of gentamicin and carbenicillin , and ( 3 ) saline , each given for 4 months , in patients with cystic fibrosis infected with Pseudomonas aeruginosa . Mean peak expiratory flow on ceftazidime , 299 litres/min , and on gentamicin and carbenicillin , 297 litres/min , were greater than on saline , 278 litres/min ( P less than 0.02 and P less than 0.05 respectively ) . Similarly mean forced expiratory volume in 1 second on ceftazidime , 1.70 litres , and on gentamicin and carbenicillin , 1.70 litres , were greater than on saline , 1.48 litres ( P less than 0.02 and P less than 0.01 respectively ) . Mean forced vital capacity on gentamicin and carbenicillin , 2.93 litres , was also greater than on saline ( P less than 0.05 ) . We were unable to demonstrate any difference in efficacy between the antibiotic regimens . The patients were admitted to hospital less frequently during the study year compared with the previous year ( P less than 0.05 ) . Sixty-nine per cent of patients had a clinical ly significant ( 20 % ) increase in forced expiratory volume in 1 second on an antibiotic regimen compared with that on entry to study , but a minority of patients appear not to respond to this form of treatment BACKGROUND Aztreonam lysine for inhalation ( AZLI ) is being developed for treatment of CF patients with Pseudomonas aeruginosa airway infection . METHODS This double-blind , r and omized , placebo-controlled Phase 2 study evaluated the safety , tolerability and efficacy of 75 and 225 mg AZLI administered BID for 14 days using the eFlow Electronic Nebulizer ( Pari Innovative Manufacturers , Inc. , Midlothian , VA ) . Patients were 13 years and older with FEV1>or=40 % predicted , chronic P. aeruginosa infection , and had used no anti-pseudomonal antibiotics for 56 days . RESULTS Of 131 patients screened , 105 received AZLI or placebo . Mean age was 26 years and mean FEV1 percent predicted was 77 % at baseline . There was a statistically significant reduction , compared to placebo , in P. aeruginosa CFU density in each AZLI group at Days 7 and 14 ( P<0.001 ) . The planned primary analysis , percent change in FEV1 at Day 14 , demonstrated no statistically significant difference . Post hoc analysis demonstrated significant increase in FEV1 at Day 7 for the subset of patients with baseline FEV1<75 % predicted in the 225 mg AZLI group . Bronchodilator use was associated with greater improvement in FEV1 , as well as greater reduction in P. aeruginosa bacterial density and higher plasma aztreonam concentrations in the 225 mg AZLI group . Adverse events were similar between placebo and AZLI although there was a trend toward increased respiratory symptoms in the 225 mg AZLI group . CONCLUSION These data support the further development of AZLI and provide information for the design of subsequent studies BACKGROUND Controlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis . OBJECTIVE To assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis . DESIGN Double blind placebo controlled r and omised sequence crossover trial . Fluticasone propionate ( 400 μg/day ) was given as a dry powder inhaler for six weeks with a four week washout period before crossover . OUTCOME MEASURES Sputum inflammatory markers ( interleukin-8 , tumour necrosis factor-α ( TNF-α ) and neutrophil elastase — both free and bound to α1-antiprotease ) , sputum interleukin-10 , lung function , and symptomatology . SUBJECTS Twenty three children from a regional cystic fibrosis centre were enrolled into the study , with mean age 10.3 years ( range 7 to 17 years ) and mean baseline forced expiratory volume in one second ( FEV1 ) of 64 % ( range 21 % to 102 % ) predicted for sex and height . One patient was excluded for non-compliance to the study protocol . RESULTS No significant benefit was shown for the use of fluticasone propionate in any of the outcomes . For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml ( 95 % confidence interval ( CI ) 8 to 2866 pg/ml ) in favour of placebo ; while for maximal expiratory flow at 25 % ( MEF25 % ) remaining forced vital capacity predicted for sex and height there was a 15 percentage points ( pp ) ( 95 % CI 4 to 26 pp ) mean treatment difference in favour of placebo . Sputum interleukin-10 was undetected in any sample s and unaffected by fluticasone propionate . Neither atopic status , baseline FEV1 , nor concomitant DNase therapy had any effect on response to treatment . CONCLUSIONS Lack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways . It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy Background : Macrolides display immunomodulatory effects that may be beneficial in chronic inflammatory pulmonary diseases . The aim of the study was to document whether long term use of azithromycin may be associated with respiratory benefits in young patients with cystic fibrosis . Methods : A multicentre , r and omised , double blind , placebo controlled trial was conducted from October 2001 to June 2003 . The criteria for enrolment were age older than 6 years and forced expiratory volume in 1 second ( FEV1 ) of 40 % or more . The active group received either 250 mg or 500 mg ( body weight < or ⩾40 kg ) of oral azithromycin three times a week for 12 months . The primary end point was change in FEV1 . Results : Eighty two patients of mean ( SD ) age 11.0 ( 3.3 ) years and mean ( SD ) FEV1 85 (22)% predicted were r and omised : 40 in the azithromycin group and 42 in the placebo group . Nineteen patients were infected with Pseudomonas aeruginosa . The relative change in FEV1 at month 12 did not differ significantly between the two groups . The number of pulmonary exacerbations ( count ratio 0.50 ( 95 % CI 0.32 to 0.79 ) , p<0.005 ) , the time elapsed before the first pulmonary exacerbation ( hazard ratio 0.37 ( 95 % CI 0.22 to 0.63 ) , p<0.0001 ) , and the number of additional courses of oral antibiotics were significantly reduced in the azithromycin group regardless of the infectious status ( count ratio 0.55 ( 95 % CI 0.36 to 0.85 ) , p<0.01 ) . No severe adverse events were reported . Conclusion : Long term use of low dose azithromycin in young patients with cystic fibrosis has a beneficial effect on lung disease expression , even before infection with Pseudomonas aeruginosa BACKGROUND Persistent endobronchial inflammation is in part responsible for the attrition of lung function seen in cystic fibrosis . Leukotrienes act as pro-inflammatory mediators . The aim of this study was to assess the efficacy of the leukotriene receptor antagonist zafirlukast as a potential anti-inflammatory agent in the treatment of adult patients with cyst
Output:
| We addressed the questions in one of three ways , based on available evidence : ( 1 ) commissioned systematic review , ( 2 ) modified systematic review , or ( 3 ) summary of existing Cochrane review s. CONCLUSIONS It is hoped that the guidelines provided in this article will facilitate the appropriate application of these treatments to improve and extend the lives of all individuals with cystic fibrosis |
MS212678 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Objective : To evaluate the effect of simultaneous zinc and vitamin A supplementation on diarrhoea and acute lower respiratory infections in children . Study design : R and omised double blind placebo controlled trial . Setting : Urban slums of Dhaka , Bangladesh . Participants and methods : 800 children aged 12 - 35 months were r and omly assigned to one of four intervention groups : 20 mg zinc once daily for 14 days ; 200 000 IU vitamin A , single dose on day 14 ; both zinc and vitamin A ; placebo . The children were followed up once a week for six months , and morbidity information was collected . Results : The incidence and prevalence of diarrhoea were lower in the zinc and vitamin A groups than in the placebo group . Zinc and vitamin A interaction had a rate ratio ( 95 % confidence interval ) of 0.79 ( 0.66 to 0.94 ) for the prevalence of persistent diarrhoea and 0.80 ( 0.67 to 0.95 ) for dysentery . Incidence ( 1.62 ; 1.16 to 2.25 ) and prevalence ( 2.07 ; 1.76 to 2.44 ) of acute lower respiratory infection were significantly higher in the zinc group than in the placebo group . The interaction term had rate ratios of 0.75 ( 0.46 to 1.20 ) for incidence and 0.58 ( 0.46 to 0.73 ) for prevalence of acute lower respiratory infection . Conclusions : Combined zinc and vitamin A synergistically reduced the prevalence of persistent diarrhoea and dysentery . Zinc was associated with a significant increase in acute lower respiratory infection , but this adverse effect was reduced by the interaction between zinc and vitamin A. What is already known on this topic Trials of vitamin A supplementation have failed to show a beneficial effect on morbidity in children Experimental studies have shown that , in the presence of zinc deficiency , vitamin A supplementation fails to reverse vitamin A deficiency Coexistence of deficiencies of zinc and vitamin A could be a reason for the failure of vitamin A supplementation , but data in humans are limited What this paper adds Combined zinc and vitamin A supplementation is more effective in reducing persistent diarrhoea and dysentery than either vitamin A or zinc alone Zinc alone increased respiratory illnesses , but interaction between zinc and vitamin A reduced this adverse Poor micronutrient status is associated with diarrheal illness , but it is not known whether low folate and /or cobalamin status are independent risk factors for diarrhea . We measured the association between plasma folate and cobalamin and subsequent diarrheal morbidity in a prospect i ve cohort study of 2296 children aged 6 - 30 mo in New Delhi , India . Plasma concentrations of folate , cobalamin , total homocysteine ( tHcy ) , and methylmalonic acid were determined at baseline . Whether a child had diarrhea was recorded during weekly visits in a 4-mo zinc supplementation trial . Diarrhea episodes lasting < 7 , ≥7 , and ≥14 d were classified as acute , prolonged , and persistent , respectively . There was a total of 4596 child periods with acute , 633 with prolonged , and 117 with persistent diarrhea during follow-up . Children with plasma folate concentrations in the lowest quartile had higher odds of persistent diarrhea than children in the other quartiles [ adjusted OR = 1.77 ( 95 % CI = 1.14 , 2.75 ) ; P = 0.01 ] . This effect differed between boys [ adjusted OR = 2.51 ( 95 % CI = 1.47 , 4.28 ) ] and girls [ adjusted OR = 1.03 ( 95 % CI = 0.53 , 2.01 ) ; P-interaction = 0.030 ] . We found a small but significant association between high plasma tHcy concentration and acute diarrhea [ adjusted OR = 1.14 ( 95 % CI = 1.04 , 1.24 ) ; P = 0.006 ] . Plasma cobalamin concentration was not a predictor of diarrheal morbidity . In conclusion , poor folate status was an independent predictor of persistent diarrhea in this population Background / Objectives : Zinc is an essential micronutrient and deficiency can lead to an increased risk for infectious diseases and growth retardation among children under 5 years of age . We aim ed to estimate disease-specific and all-cause mortality attributable to zinc deficiency . Subject/ Methods : We estimated the prevalence of zinc deficiency in Latin America , Africa and Asia , where based on zinc availability in the diet and childhood stunting rates , zinc deficiency is widespread . The relative risks of death among zinc-deficient children for diarrhea , malaria and pneumonia were estimated from r and omized controlled trials . We used the comparative risk assessment methods to calculate deaths and burden of disease ( measured in disability-adjusted life years , DALYs ) from each of these three diseases attributable to zinc deficiency in these regions . Results : Zinc deficiency was responsible for 453 207 deaths ( 4.4 % of childhood deaths ) , and 1.2 % of the burden of disease ( 3.8 % among children between 6 months and 5 years ) in these three regions in 2004 . Of these deaths , 260 502 were in Africa , 182 546 in Asia and 10 159 in Latin America . Zinc deficiency accounted for 14.4 % of diarrhea deaths , 10.4 % of malaria deaths and 6.7 % of pneumonia deaths among children between 6 months and 5 years of age . Conclusions : Zinc deficiency contributes to substantial morbidity and mortality , especially from diarrhea . Zinc supplementation provided as an adjunct treatment for diarrhea may be the best way to target children most at risk of deficiency Background Vitamin A and zinc are crucial for normal immune function , and may play a synergistic role for reducing the risk of infection including malaria caused by Plasmodium falciparum . Methods A r and omized , double-blind , placebo-controlled trial of a single dose of 200 000 IU of vitamin A with daily zinc supplementation was done in children of Sourkoudougou village , Burkina Faso . Children aged from 6 to 72 months were r and omized to receive a single dose of 200 000 IU of vitamin A plus 10 mg elemental zinc , six days a week ( n = 74 ) or placebo ( n = 74 ) for a period of six months . Cross-sectional surveys were conducted at the beginning and the end of the study , and children were evaluated daily for fever . Microscopic examination of blood smear was done in the case of fever ( temperature ≥37.5 ° C ) for malaria parasite detection . Results At the end of the study we observed a significant decrease in the prevalence malaria in the supplemented group ( 34 % ) compared to the placebo group ( 3.5 % ) ( p < 0.001 ) . Malaria episodes were lower in the supplemented group ( p = 0.029 ) , with a 30.2 % reduction of malaria cases ( p = 0.025 ) . Time to first malaria episode was longer in the supplemented group ( p = 0.015 ) . The supplemented group also had 22 % fewer fever episodes than the placebo group ( p = 0.030 ) . Conclusion These results suggest that combined vitamin A plus zinc supplementation reduces the risk of fever and clinical malaria episodes among children , and thus may play a key role in malaria control strategies for children in Africa Despite concerns over the neurocognitive effects of micronutrient deficiencies in infancy , few studies have examined the effects of micronutrient supplementation on specific cognitive indicators . This study investigated , in 2002 , the effects of iron-folic acid and /or zinc supplementation on the results of Fagan Test of Infant Intelligence ( FTII ) and the A-not-B Task of executive functioning among 367 Nepali infants living in Sarlahi district . Infants were enrolled in a cluster-r and omized , placebo-controlled clinical trial of daily supplementation with 5 mg of zinc , 6.25 mg of iron with 25 µg of folic acid , or zinc-iron-folic acid , or placebo . These were tested on both the tasks using five indicators of information processing : preference for novelty ( FTII ) , fixation duration ( FTII ) , accelerated performance ( ≥85 % correct ; A-not-B ) , deteriorated performance ( < 75 % correct and > 1 error on repeat-following-correct trails ; A-not-B ) , and the A-not-B error ( A-not-B ) . At 39 and 52 weeks , 247 and 333 infants respectively attempted the cognitive tests ; 213 made an attempt to solve both the tests . The likelihood of females completing the A-not-B Task was lower compared to males when cluster r and omization was controlled [ odds ratio=0.67 ; 95 % confidence interval 0.46 - 0.97 ; p<0.05 ] . All of the five cognitive outcomes were modelled in linear and logistic regression . The results were not consistent across either the testing sessions or the information-processing indicators . Neither the combined nor the individual micronutrient supplements improved the performance on the FTII or the A-not-B Task ( p>0.05 ) . These findings suggest that broader interventions ( both in terms of scope and duration ) are needed for infants who face many biological and social stressors Controversy exists about the effect of zinc on growth and the GH-IGF system . Zinc supplementation has been shown to stimulate linear growth in zinc-deficient children . However the mechanism of this effect has not been well characterized . Furthermore , the effect of zinc supplementation on non-zinc-deficient short children is unknown . We investigated the effect of zinc supplementation on endogenous GH secretion , serum IGF-I and IGFBP-3 concentrations , IGF-I and IGFBP-3 generation in response to exogenous GH , bone formation markers , and linear growth of non-zinc-deficient children with idiopathic short stature . We analyzed prospect ively serum zinc , IGF-I , IGFBP-3 , alkaline phosphatase , osteocalcin , and GH response to clonidine test , and performed a somatomedin generation test before and 6 weeks after zinc supplementation in 22 ( 16 M , 6 F ) prepubertal children with idiopathic short stature . Serum IGF-I increased from 67.4+/-70.6 to 98.2+/-77.3 ng/ml ( p < 0.001 ) , IGFBP-3 from 2326+/-770 to 2758+/-826 ng/ml ( p < 0.001 ) , alkaline phosphatase from 525+/-136 to 666+/-197 U/l ( p < 0.0001 ) , and osteocalcin from 16.8+/-10.6 to 25.8+/-12.8 ng/ml ( p < 0.05 ) after zinc supplementation despite there being no difference in GH response to clonidine after zinc supplementation ( peak GH 11.6+/-6.9 vs 13.4+/-7.8 ng/ml , GH area under the curve during clonidine test 689+/-395 vs 761+/-468 , NS ) . Percent change in IGF-I and IGFBP-3 during the somatomedin generation test was not significantly affected by zinc supplementation ( 118 % vs 136 % and 57 % vs 44 % , respectively ) . There was no significant correlation between percentage increase in zinc levels and percentage increase in parameters tested . Height SDS or weight SDS did not improve significantly in 17 patients who continued on zinc supplementation for at least 6 months ( 6 - 12 months ) ( -2.59 vs -2.53 SDS and -1.80 vs -1.67 SDS , respectively ) . Zinc supplementation increased basal IGF-I , IGFBP-3 , alkaline phosphatase and osteocalcin without changing GH response to clonidine . Zinc supplementation did not affect sensitivity to exogenous GH as tested by IGF-I and IGFBP-3 generation test . These results suggest a direct stimulatory effect of zinc on serum IGF-IGFBP-3 , alkaline phosphatase and osteocalcin . Despite improvements in the above parameters , zinc supplementation to children with idiopathic short stature with normal serum zinc levels did not significantly change height or weight SDS during 6 - 12 months follow-up Summary Background In north India , vitamin A deficiency ( retinol < 0·70 μmol/L ) is common in pre-school children and 2–3 % die at ages 1·0–6·0 years . We aim ed to assess whether periodic vitamin A supplementation could reduce this mortality . Methods Participants in this cluster-r and omised trial were pre-school children in the defined catchment areas of 8338 state-staffed village child
Output:
| There was a medium to large positive effect on zinc status .
We found no clear evidence of benefit or harm of supplementation with regard to haemoglobin or iron status .
Supplementation had a negative effect on copper status .
AUTHORS ' CONCLUSIONS In our opinion , the benefits of preventive zinc supplementation outweigh the harms in areas where the risk of zinc deficiency is relatively high . |
MS212679 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 currently recommended frequency for prostate-specific antigen ( PSA ) screening tests for prostate cancer is 1 year , but the optimal screening interval is not known . Our goal was to determine if a longer interval would compromise the detection of curable prostate cancer . METHODS A cohort of 4491 men aged 55 - 75 years , all participants in the Rotterdam section of the European R and omized Study of ( population -based ) Screening for Prostate Cancer , were invited to participate in an initial PSA screening . Men who received that screening were invited for a second screen 4 years later . Pathology findings from needle biopsy cores were compared for men in both rounds . Statistical tests were two-sided . RESULTS A total of 4133 men were screened in the first round ( the prevalence screen ) , and 2385 were screened in the second round . The median amount of cancer in needle biopsy sets was 7.0 mm ( 95 % confidence interval [ CI ] = 5.4 mm to 8.6 mm ) in the first round and 4.1 mm ( 95 % CI = 2.6 mm to 5.6 mm ) in the second round ( P = .001 ) . Thirty-six percent of the adenocarcinomas detected in the first round but only 16 % of those detected in the second round had a Gleason score of 7 or higher ( mean difference = 20 % [ 95 % CI = 10 % to 30 % ] ; P<.001 ) . Whereas 25 % of the adenocarcinomas detected in the first round had adverse prognostic features , only 6 % of those detected in the second round did ( mean difference = 19 % [ 95 % CI = 11 % to 26 % ] ; P<.001 ) . Baseline PSA values were predictive for the amount of tumor in biopsies in men with cancer in the first round but not for that in the second round . CONCLUSION Most large prostate cancers with high serum PSA levels were effectively detected in a prevalence screen . In this population , a screening interval of 4 years appears to be short enough to constrain the development of large tumors , although it is inconclusive whether this will result in a survival benefit The objective was to investigate how prostate cancer and its treatment affects sexual , urinary and bowel functions and to what extent eventual complications cause distress . A question naire was sent to 431 men aged 50 - 80 years with prostate cancer diagnosed in 1992 in the Stockholm area ( Sweden ) and 435 r and omly selected men with a similar age distribution . Sexual function , as compared with their youth , was diminished in a majority of all men . The prostate cancer patients were , however , more likely to report low frequency and /or intensity in all aspects of sexual function . A majority of the men were distressed by a waning sexual capacity . The proportion of men with prostate cancer who were severely distressed owing to a decline in sexual function was larger than in the reference group . The willingness to trade off an intact sexual function for long-term survival varied considerably among the men in the reference group . Urinary and bowel symptoms were less common than a waning sexual function in both groups , and few appeared to be severely distressed by urinary or bowel symptoms . A decline in sexual functions was the most common cause of disease-specific distress in men with prostate cancer OBJECTIVE To describe the incidence , time to onset and extent of anaemia occurring in patients with prostate cancer receiving combined hormone blockade ( CHB ) and the timing and extent of recovery from anaemia in those patients where CHB was discontinued . PATIENTS AND METHODS Patients with prostate cancer were evaluated prospect ively by physical examination and laboratory tests at baseline and at routine intervals while receiving CHB . Of 142 patients who received CHB , 133 were evaluable for the assessment of anaemia ; CHB was discontinued in 76 patients , of whom 64 were assessable for recovery from their anaemia . RESULTS Haemoglobin levels declined significantly in all patients from a mean baseline of 149 g/L to means of 139 g/L , 132 g/L and 131 g/L at 1 , 2 and 3 months , respectively . Haemoglobin levels continued to decline during CHB to a mean nadir of 123 g/L at a mean of 5.6 months of CHB , representing a mean absolute haemoglobin decline at nadir of 25.4 g/L. In 120 of the 133 ( 90 % ) patients , the relative decline in haemoglobin at nadir was > or = 10 % and was > or = 25 % in 17 ( 13 % ) others , representing a mean absolute haemoglobin decline in this subset of 42.7 g/L. Significant symptoms related to anaemia occurred in 17 patients ( 13 % ) . Anaemia and symptoms in these patients were easily corrected with the subcutaneous administration of recombinant human erythropoietin . CONCLUSIONS The anaemia associated with and rogen deprivation is significant and occurs routinely in men receiving CHB . It is normochromic , normocytic , temporally-related to the initiation of and rogen blockade and usually resolves after CHB is discontinued . We suggest that patients receiving CHB undergo haematological testing at baseline , 1 - 2 months after initiating CHB and periodically thereafter . Patients developing anaemia should be question ed about symptoms reflecting physiological compromise ( e.g. angina , dyspnoea on exertion ) . In the absence of other causes , CHB should be suspected in the development of anaemia in patients receiving this treatment BACKGROUND Most studies that have described the sensitivity and specificity of prostate-specific antigen ( PSA ) as a screening test have been conducted in urology practice setting s or in media-based screening programs . The control patients from these setting s may have a higher prevalence of urologic disorders that increase serum PSA levels than that of the general population in which screening efforts might take place , leading to biased estimates of sensitivity and specificity . OBJECTIVE To determine the sensitivity and specificity of serum PSA levels for the early detection of prostate cancer in a population -based setting . PATIENTS AND METHODS This population -based case-control study was conducted in Olmsted County , Minnesota , where the Rochester Epidemiology Project could identify all incident cases of prostate cancer through passive surveillance of medical care provided to local residents . Case patients were all 177 men ( age range , 50 - 79 years ) who were newly diagnosed as having prostate cancer from 1990 through 1992 and had a prediagnostic serum PSA determination ( 90 % of all incident cases ) . Control patients were r and omly selected from the Olmsted County population and had undergone a clinical examination to exclude prostate cancer . RESULTS The median ( 25th and 75th percentiles ) of serum PSA levels was 9.4 ng/mL ( 5.4 and 18.6 ng/mL , respectively ) for case patients and 1.2 ng/mL ( 0.7 and 2.1 ng/mL , respectively ) for control patients ( P < .001 ) . When sensitivity was plotted against 1-specificity , the area under the receiver operating characteristic curve was 0.94 ( SE , 0.01 ) . The predictive power declined somewhat with age , with areas under the curve of 0.96 , 0.94 , and 0.90 for men in their 50s , 60s , and 70s , respectively . When cases were restricted to the 155 men with clinical ly localized disease , the area under the curve was essentially unchanged ( 0.94 ; SE , 0.01 ) and still much greater than the estimates of 0.75 that were reported from urology practice - and media-based setting s. CONCLUSIONS In a community-based setting , serum PSA levels provide better discrimination between men with and without clinical ly localized prostate cancer than has been observed in studies that were conducted in urologic practice s. These results suggest that previous decision analyses may have underestimated the predictive value of PSA for the detection of prostate cancer in a primary care or community-wide screening program OBJECTIVES To evaluate the effect of immediate and rogen suppression in conjunction with st and ard external beam irradiation ( RT ) versus RT alone on a group of men after prostatectomy who had indications for adjuvant treatment . METHODS A national prospect i ve r and omized trial ( Radiation Therapy Oncology Group [ RTOG ] 85 - 31 ) comparing st and ard external beam RT plus immediate and rogen suppression versus external beam RT alone with delayed hormonal treatment at relapse was initiated for patients with locally advanced adenocarcinoma of the prostate . One hundred thirty-nine of the patients in this trial had indications for adjuvant treatment after prostatectomy ( eg , capsular penetration , seminal vesicle involvement ) . Seventy-one of the patients received RT with immediate and rogen suppression ( luteinizing hormone-releasing hormone [ LHRH ] agonist ) ; 68 patients received RT alone with hormonal manipulation instituted only at the time of relapse . RESULTS With a median follow-up of 5 years , the estimated progression-free survival rate ( failure defined as prostate-specific antigen [ PSA ] greater than 0.5 ng/mL ) was 65 % for the men who received combination therapy and 42 % for those treated by RT alone with hormones reserved for relapse ( P = 0.002 ) . Differences in the rates of freedom from biochemical relapse were observed when failure was defined as PSA of 1.0 to 3.9 ng/mL ( 71 % versus 46 % ; P = 0.008 ) and PSA greater than 4.0 ng/mL ( 76 % versus 55 % ; P = 0.05 ) , respectively . No differences were observed between the groups with respect to the end points of local control , distant failure , and overall survival . The use of immediate and rogen suppression ( ie , LHRH agonists ) and the absence of pathologic nodal involvement were independently associated with prolongation of freedom from biochemical relapse by multivariate analysis . CONCLUSIONS Patients with prostate cancer and indications for postoperative RT should be considered for combined RT and hormonal manipulation . Because statistically significant advantages for this experimental approach could not be defined for all end points studied ( in particular , overall survival ) , efforts should be made to enroll these patients in the recently activated RTOG trial ( 96 - 01 ) comparing RT plus placebo to the combination of RT plus Casodex in the postoperative setting BACKGROUND The utility of digital rectal examination ( DRE ) as a screening test for early detection of prostate cancer has not been established . Therefore , we evaluated the usefulness of DRE as a st and -alone screening test and in conjunction with measured serum prostate-specific antigen ( PSA ) levels of 0 - 3.9 ng/mL and transrectal ultrasonography ( TRUS ) . METHODS Our study population consisted of 10,523 men aged 54 - 76 years who were r and omly assigned to the screening arm of the Rotterdam , The Netherl and s , section of the European R and omized Study of Screening for Prostate Cancer . The underlying prevalence of detectable prostate cancer was estimated by logistic regression analysis and used for calculating the sensitivity of DRE as a test . Pathologic characteristics of 105 radical prostatectomy specimens were used to determine the aggressiveness of the tumors diagnosed ( and missed ) by DRE . RESULTS The overall detection rate for prostate cancer in this population when serum PSA measurement , DRE , and TRUS were used was 4.5 % , and the detection rate with DRE alone was 2.5 % . The positive predictive value of DRE ranged from 4 % to 11 % in men with PSA levels of 0 - 2.9 ng/mL and from 33 % to 83 % in men with PSA levels of 3.0 - 9.9 ng/mL or more . Most tumors detected by DRE in men with PSA levels of less than 4.0 ng/mL were small ( mean volumes = 0.24 - 0.83 mL ) , and most were well differentiated ( Gleason scores of 6 or less ) . Minimal , moderate , and advanced cancers were seen in 42 % , 42 % , and 16 % of men , respectively , with a PSA level of 4.0 ng/mL or less . DRE alone allowed detection of 264 ( 55.8 % ) of 473 cancers ; 82 ( 17.3 % ) of the 473 cancers would have remained undetected by PSA-based screening alone ( i.e. , no follow-up procedures for PSA values of 0 - 3.9 ng/mL ) . CONCLUSIONS For PSA values of 0 - 3.9 ng/mL , the positive predictive value and sensitivity of DRE , tumor volume , and tumor grade were strongly dependent on PSA level . DRE has a poor performance in low PSA ranges It has been noted that the most important evidence for a benefit of early detection of prostate cancer using prostate-specific antigen ( PSA ) testing would be a decline in prostate cancer mortality rates to levels below those existing before diagnostic use of PSA testing . We document a decrease in U.S. prostate cancer mortality rates in white men less than 85 years of age to levels below those existing in 1986 , the year use of PSA testing was approved . In fact , for men 60 - 79 years of age , prostate cancer mortality rates were lower in 1997 than in any year since 1950 . Although it has been argued that the decrease in prostate cancer mortality rates began too soon to be explained by PSA testing , stage-specific survival rates indicate
Output:
| Important trends in prostate cancer incidence and mortality also occurred at that time .
Disease-specific mortality rates paralleled trends in prostate cancer incidence ( 15 , 16 ) .
The argument that the decline in mortality can be attributed to PSA screening would be stronger if it could be shown that the decline was largest in areas with more screening .
Currently available prognostic markers can distinguish a small number of men with excellent prognosis for long-term survival and a small number of men with |
MS212680 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study evaluates a youth subject-directed smoking prevention and cessation program titled Breathe Easy ! The program was delivered at two sites and a control group was recruited from two additional sites . Surveys were administered prior to the program and either 1 month or 6 months after completion at the exposure sites . The same survey administration procedure was used as the control . After controlling for invalid responses and including only those that completed both surveys , 251 exposure subjects and 159 control subjects remained for analysis . At sites with 1-month follow-up , no significant difference was noted between intervention and control groups . At the sites with 6-month follow-up , prevalence dropped from 18.7 % to 8.9 % , which is statistically significant , while at the control site prevalence changed from 14.1 % to 9.4 % , which is not significant . Additional outcomes examined in the exposed group showed trends toward smoking cessation and prevention at higher rates than those of the unexposed group This investigation evaluated the efficacy of expressive writing as a treatment adjunct to a brief office smoking cessation intervention plus nicotine patch therapy in young adults . Participants aged 18 - 24 years were r and omized to a brief office intervention ( n=99 ) or to an expressive writing plus brief office intervention ( n=97 ) . Both conditions received four individual visits plus 6 weeks of nicotine patch therapy , which began on the quit date following the week 2 visit . Participants in the expressive writing plus brief intervention condition wrote for 2 consecutive days before and 3 consecutive days after the quit date . The brief office intervention group completed a control writing assignment . At end of treatment ( week 8) , biochemically confirmed 7-day point-prevalence abstinence for the expressive writing plus brief office intervention condition was significantly greater than for the brief office condition ( 33 % vs. 20 % , p=.043 , OR=2.0 , 95 % CI=1.0 - 3.7 , from a logistic regression adjusting for gender ) . At 24 and 52 weeks , abstinence rates were similar for the brief office intervention versus expressive writing plus brief office intervention ( 12 % vs. 11 % at 24 weeks ; 11 % vs. 11 % at 52 weeks ) . The results suggest that expressive writing has promise as a smoking cessation treatment adjunct for young adults . Lengthier interventions or the use of boosters should be tested to extend treatment effects . However , participants reported a low level of enthusiasm for the expressive writing , which may be a barrier to implementing it over a longer time frame . Therefore , other modes of delivering expressive writing to young adult cigarette smokers should be explored BACKGROUND Community dental clinics are good setting s for smoking intervention . The aim here was to put forward a strategy for preventing adolescent smoking by means of a brief intervention . METHODS A total of 2,586 12-year-olds participated in this follow-up study . They were asked upon arrival for their annual routine dental examination to complete a smoking question naire and were r and omly assigned to either the intervention group or the usual care control group according to the last digit of their date of birth ( odd or even ) . The intervention comprised annually inquiring about smoking , showing photographs of the harmful effects of smoking on the teeth , allowing participants to examine their own mouth with a mirror , and finally counselling them in accordance with their answer to the question on smoking habits . The smoking status reported was not verified by other means . RESULTS The prevalence of smoking at the end of the 2-year follow-up was 18.1 % , in the intervention group and 20.8 % among the controls . However , no statistically significant differences between groups were found . CONCLUSIONS These results reflect the difficulties of achieving successful results with long-term smoking cessation programs with adolescents in unstable conditions During June 2000-May 2001 , the American Cancer Society conducted a r and omized trial of telephone counseling among more than 3,500 current smokers who called to seek assistance in quitting . All eligible callers were r and omized to receive either self-help booklets through the mail or booklets and up to 5 sessions of telephone counseling . Approximately 12 % ( 420/3,522 ) of study participants were 18 - 25 years of age . Using intent to treat analyses , 3- and 6-month quit rates among both younger and older smokers were significantly higher among those who received telephone counseling than among those who received self-help booklets only . Three-month rates were 20 % versus 9 % for 18 - 25 year olds and 15 % versus 10 % for older adults . Results indicate that younger smokers can benefit from telephone counseling Smoking cessation interventions are needed for young adults . Innovative approaches to behavior change for this population should be tested . Formative research and process evaluation of those approaches would result in more effective programs . This paper presents the development process and process evaluation of a web-based smoking cessation program . A description of the stages of development is presented with formative research , development of the web-based intervention , formative evaluation , and process evaluation . The smokers reported high usage of the intervention and satisfaction with the intervention in that it helped to raise their consciousness about quitting , encouraged them to set behavioral goals , provided stages of change feedback , and offered interactivity in presenting information and strategies about quitting . The Internet may be a promising tool for patient education according to the process results Background Happy Ending ( HE ) is an intense 1-year smoking cessation program delivered via the Internet and cell phone . HE consists of more than 400 contacts by email , Web pages , interactive voice response , and short message service technology . HE includes a craving helpline and a relapse prevention system , providing just-in-time therapy . All the components of the program are fully automated . Objective The objectives were to describe the rationale for the design of HE , to assess the 12-month efficacy of HE in a sample of smokers willing to attempt to quit without the use of nicotine replacement therapy , and to explore the potential effect of HE on coping planning and self-efficacy ( prior to quitting ) and whether coping planning and self-efficacy mediate treatment effect . Methods A two-arm r and omized controlled trial was used . Subjects were recruited via Internet advertisements and r and omly assigned to condition . Inclusion criteria were willingness to quit on a prescribed day without using nicotine replacement and being aged 18 years or older . The intervention group received HE , and the control group received a 44-page self-help booklet . Abstinence was defined as “ not even a puff of smoke , for the last seven days ” and was assessed by means of Internet surveys or telephone interviews 1 , 3 , 6 , and 12 months postcessation . The main outcome was repeated point abstinence ( ie , abstinence at all four time points ) . Coping planning and self-efficacy were measured at baseline and at the end of the preparation phase ( ie , after 2 weeks of treatment , but prior to cessation day ) . Results A total of 290 participants received either the HE intervention ( n=144 ) or the control booklet ( n=146 ) . Using intent-to-treat analysis , participants in the intervention group reported clinical ly and statistically significantly higher repeated point abstinence rates than control participants ( 20 % versus 7 % , odds ratio [ OR ] = 3.43 , 95 % CI = 1.60 - 7.34 , P = .002 ) . Although no differences were observed at baseline , by the end of the preparation phase , significantly higher levels of coping planning ( t 261 = 3.07 , P = .002 ) and precessation self-efficacy ( t 261 = 2.63 , P = .01 ) were observed in the intervention group compared with the control group . However , neither coping planning nor self-efficacy mediated long-term treatment effect . For point abstinence 1 month after quitting , however , coping planning and self-efficacy showed a partial mediation of the treatment effect . Conclusions This 12-month trial documents a long-term treatment effect of a fully automated smoking cessation intervention without the use of nicotine replacement therapy . The study adds to the promise of using digital media in supporting behavior change Background Epidemiologic data indicate most adolescents and adults experience multiple , simultaneous risk behaviors . Purpose The purpose of this study is to examine the efficacy of a brief image-based multiple-behavior intervention ( MBI ) for college students . Methods A total of 303 college students were r and omly assigned to : ( 1 ) a brief MBI or ( 2 ) a st and ard care control , with a 3-month postintervention follow-up . Results Omnibus treatment by time multivariate analysis of variance interactions were significant for three of six behavior groupings , with improvements for college students receiving the brief MBI on alcohol consumption behaviors , F(6 , 261 ) = 2.73 , p = 0.01 , marijuana-use behaviors , F(4 , 278 ) = 3.18 , p = 0.01 , and health-related quality of life , F(5 , 277 ) = 2.80 , p = 0.02 , but not cigarette use , exercise , and nutrition behaviors . Participants receiving the brief MBI also got more sleep , F(1 , 281 ) = 9.49 , p = 0.00 , than those in the st and ard care control . Conclusions A brief image-based multiple-behavior intervention may be useful in influencing a number of critical health habits and health-related quality -of-life indicators of college students OBJECTIVES . Nicotine nasal spray has been 1 of the most successful forms of nicotine-replacement therapy in adult population s. The nasal sprayer has not been studied in adolescent smokers . The objective of this pilot study was to determine the feasibility and utility of using nicotine nasal spray for adolescent smokers who wanted to quit smoking . METHODS . Forty adolescent smokers who were between 15 and 18 years of age and smoked ≥5 cigarettes daily for at least 6 months were recruited from several San Francisco Bay area schools from 2005 to 2007 . Using a r and omized , open-label , 12-week trial , adolescent smokers were assigned to receive either weekly counseling alone ( control ) for 8 weeks or 8 weeks of counseling along with 6 weeks of nicotine nasal spray . Self-reported smoking abstinence was verified by both expired-air carbon monoxide and salivary cotinine . RESULTS . There was no difference in cessation rates , the numbers of cigarettes smoked per day , or cotinine levels at 12 weeks . Fifty-seven percent of participants stopped using their spray after only 1 week . The most commonly reported adverse effect was nasal irritation and burning ( 34.8 % ) followed by complaints about the taste and smell ( 13 % ) . CONCLUSIONS . The unpleasant adverse effects , poor adherence , and consequent lack of efficacy observed in our pilot study do not support the use of nicotine nasal spray as an adjunct to counseling for adolescent smokers who wish to quit OBJECTIVE The purpose of this study was to develop a smoking cessation program combined with an Internet-assisted instruction ( IAI ) program to help youth smokers quit smoking , and to evaluate the effectiveness of the program in changing youth 's attitudes toward smoking , smoking behavior , and self-efficacy for smoking cessation . METHODS To achieve this goal , a comparative study of 77 senior high students divided into two groups was conducted . One group , design ated as the experimental group , accepted a 6-week smoking cessation program plus an IAI program and the other group did not receive any intervention as the comparison group . All participants completed question naires before and after the program . RESULTS The results showed that the strategy of combining the smoking cessation program and an IAI program was highly effective in terms of effects upon the youth 's attitude towards smoking , smoking behavior , and self-efficacy . There was a highly positive correlation between the participants ' attitude toward smoking and self-efficacy . In contrast , cigarette consumption was in a strongly negative correlation with self-efficacy . CONCLUSION Most of all participants in the experimental group recognized the effectiveness of the program , and thought the smoking cessation program with an IAI program was helpful and welcomed by youth . This study can serve as reference for future design and implementation of IAI programs for youth smoking cessation The majority of regular adult smokers begin smoking in adolescence and there is a clear need for youth-targeted smoking cessation interventions . The present r and omized , controlled trial tested the effectiveness of motivational enhancement therapy ( MET ) to reduce smoking among 81 adjudicated adolescents . Participants received either MET or an education control . Smoking abstinence , quantity , and frequency were assessed at 1 and 6 months post treatment . Results suggest that although between-group differences on outcome measures were not significant at follow-up , smoking behavior decreased in both groups with approximately 10 % achieving 1-month smoking abstinence at 6-month follow-up . Furthermore , participant response to MET varied by level of alcohol use and impulsivity such that participants with lower levels of alcohol use and impulsivity had significantly greater response to MET . In contrast , participants who endorsed higher rates of alcohol use and impulsivity responded better to the control than the MET condition . Results suggest that MET may be an effective intervention for some adolescent smokers but may be contraindicated for adolescents who have concomitant problems with alcohol use or impulsivity The use of alternative medicine for smoking cessation have been increasing steadily in recent years . A series of clinical group studies was performed to clarify the effect , outcome and success rate of an acupuncture treatment for smoking cessation . This study was conducted for four weeks using 238 smoking
Output:
| Complex approaches show promise , with some persistence of abstinence ( 30 days point prevalence abstinence at six months ) , especially those incorporating elements sensitive to stage of change .
Psycho-social interventions have not so far demonstrated effectiveness , although pooled results for the Not on Tobacco trials suggest that that this approach may yet prove to be effective ; however , their definition of cessation ( one or more smoke-free days ) may not adequately account for the episodic nature of much adolescent smoking . |
MS212681 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 European trial investigating normothermic ex vivo liver perfusion ( NEVLP ) as a preservation technique for liver transplantation ( LT ) uses gelofusine , a non-US Food and Drug Administration-approved , bovine-derived , gelatin-based perfusion solution . We report a safety and feasibility clinical NEVLP trial with human albumin-based Steen solution . Transplant outcomes of 10 human liver grafts that were perfused on the Metra device at 37 ° C with Steen solution , plus 3 units of erythrocytes were compared with a matched historical control group of 30 grafts using cold storage ( CS ) as the preservation technique . Ten liver grafts were perfused for 480 minutes ( 340 - 580 minutes ) . All livers cleared lactate ( final lactate 1.46 mmol/L ; 0.56 - 1.74 mmol/L ) and produced bile ( 61 mL ; 14 - 146 mL ) during perfusion . No technical problems occurred during perfusion , and all NEVLP-preserved grafts functioned well after LT . NEVLP versus CS had lower aspartate aminotransferase and alanine aminotransferase values on postoperative days 1 - 3 without reaching significance . No difference in postoperative graft function between NEVLP and CS grafts was detected as measured by day 7 international normalized ratio ( 1.1 [ 1 - 1.56 ] versus 1.1 [ 1 - 1.3 ] ; P = 0.5 ) and bilirubin ( 1.5 ; 1 - 7.7 mg/dL versus 2.78 ; 0.4 - 15 mg/dL ; P = 0.5 ) . No difference was found in the duration of intensive care unit stay ( median , 1 versus 2 days ; range , 0 - 8 versus 0 - 23 days ; P = 0.5 ) and posttransplant hospital stay ( median , 11 versus 13 days ; range , 8 - 17 versus 7 - 89 days ; P = 0.23 ) . Major complications ( Dindo-Clavien ≥ 3b ) occurred in 1 patient in the NEVLP group ( 10 % ) compared with 7 ( 23 % ) patients in the CS group ( P = 0.5 ) . No graft loss or patient death was observed in either group . Liver preservation with normothermic ex vivo perfusion with the Metra device using Steen solution is safe and results in comparable outcomes to CS after LT . Using US Food and Drug Administration-approved Steen solution will avoid a potential regulatory barrier in North America . Liver Transplantation 22 1501 - 1508 2016 AASLD Experimental studies have suggested that end‐ischaemic dual hypothermic oxygenated machine perfusion ( DHOPE ) may restore hepatocellular energy status and reduce reperfusion injury in donation after circulatory death ( DCD ) liver grafts . The aim of this prospect i ve case – control study was to assess the safety and feasibility of DHOPE in DCD liver transplantation Dual hypothermic oxygenated machine perfusion ( DHOPE ) of the liver has been advocated as a method to reduce ischemia/reperfusion injury ( IRI ) . This study aim ed to determine whether DHOPE reduces IRI of the bile ducts in donation after circulatory death ( DCD ) liver transplantation . In a recently performed phase 1 trial , 10 DCD livers were preserved with DHOPE after static cold storage ( SCS ; http://www.trialregister.nl NTR4493 ) . Bile duct biopsies were obtained at the end of SCS ( before DHOPE ; baseline ) and after graft reperfusion in the recipient . Histological severity of biliary injury was grade d according to an established semiquantitative grading system . Twenty liver transplantations using DCD livers not preserved with DHOPE served as controls . Baseline characteristics and the degree of bile duct injury at baseline ( end of SCS ) were similar between both groups . In controls , the degree of stroma necrosis ( P = 0.002 ) and injury of the deep peribiliary gl and s ( PBG ; P = 0.02 ) increased after reperfusion compared with baseline . In contrast , in DHOPE‐preserved livers , the degree of bile duct injury did not increase after reperfusion . Moreover , there was less injury of deep PBG ( P = 0.04 ) after reperfusion in the DHOPE group compared with controls . In conclusion , this study suggests that DHOPE reduces IRI of bile ducts after DCD liver transplantation . Liver Transplantation 24 655–664 2018 AASLD Liver transplantation is a highly successful treatment , but is severely limited by the shortage in donor organs . However , many potential donor organs can not be used ; this is because sub-optimal livers do not tolerate conventional cold storage and there is no reliable way to assess organ viability preoperatively . Normothermic machine perfusion maintains the liver in a physiological state , avoids cooling and allows recovery and functional testing . Here we show that , in a r and omized trial with 220 liver transplantations , compared to conventional static cold storage , normothermic preservation is associated with a 50 % lower level of graft injury , measured by hepatocellular enzyme release , despite a 50 % lower rate of organ discard and a 54 % longer mean preservation time . There was no significant difference in bile duct complications , graft survival or survival of the patient . If translated to clinical practice , these results would have a major impact on liver transplant outcomes and waiting list mortality . Normothermic machine perfusion of the liver improved early graft function , demonstrated by reduced peak serum aspartate transaminase levels and early allograft dysfunction rates , and improved organ utilization and preservation times , although no differences were seen in graft or patient survival Non‐anastomotic biliary stricture ( NAS ) formation is a major complication of liver transplantation . We prospect ively determined the time to development of responsiveness to treatment , and clinical outcomes following NAS formation . In addition , an extensive analysis of the association of recipient , donor , and clinical variables with NAS formation was performed . A total of 749 consecutive patients was studied in a prospect i ve , protocol ‐based fashion . Seventy‐two patients ( 9.6 % ) developed NAS at a mean of 23.6 ± 34.2 weeks post‐transplantation . Non‐anastomotic biliary stricture formation resolved in only 6 % of affected patients . Although patient survival was not affected , retransplantation and graft loss rates were significantly greater in recipients who developed NAS . In contrast to previous reports , a pretransplant diagnosis of HCV was associated with a low frequency of NAS formation . The incidence of NAS was independently associated with pretransplant diagnoses of PSC and autoimmune hepatitis . Hepatic artery thrombosis , and prolonged warm and cold ischemia times were also independent risk factors for NAS formation . We conclude that NAS developed in ∼10 % of primary liver transplant recipients . A pretransplant diagnosis of autoimmune hepatitis has been identified as a novel independent risk factor for NAS formation . Development of NAS significantly attenuates graft but not patient survival The use of livers from donation after circulatory death ( DCD ) is increasing , but concerns exist regarding outcomes following use of grafts from “ marginal ” donors . To compare outcomes in transplants using DCD and donation after brain death ( DBD ) , propensity score matching was performed for 973 patients with chronic liver disease and /or malignancy who underwent primary whole‐liver transplant between 2004 and 2014 at University Hospitals Birmingham NHS Foundation Trust . Primary end points were overall graft and patient survival . Secondary end points included postoperative , biliary and vascular complications . Over 10 years , 234 transplants were carried out using DCD grafts . Of the 187 matched DCDs , 82.9 % were classified as marginal per British Transplantation Society guidelines . Kaplan – Meier analysis of graft and patient survival found no significant differences for either outcome between the paired DCD and DBD patients ( p = 0.162 and p = 0.519 , respectively ) . Aspartate aminotransferase was significantly higher in DCD recipients until 48 h after transplant ( p < 0.001 ) . The incidences of acute kidney injury and ischemic cholangiopathy were greater in DCD recipients ( 32.6 % vs. 15 % [ p < 0.001 ] and 9.1 % vs. 1.1 % [ p < 0.001 ] , respectively ) . With appropriate recipient selection , the use of DCDs , including those deemed marginal , can be safe and can produce outcomes comparable to those seen using DBD grafts in similar recipients Objective : To assess the incidence and impact of biliary complications in recipients transplanted from donors after cardiac death ( DCD ) at one single large institution . Background : Shortage of available cadaveric organs is a significant limiting factor in liver transplantation ( LT ) . The use of DCD offers the potential to increase the organ pool . However , early results with DCD liver grafts were associated with a greater incidence of ischemic cholangiopathy ( IC ) , leading to several programs to ab and oning this source of organs . Methods : A retrospective analysis of a prospect i ve data base from April 2001 to 2010 focused on 167 consecutive DCD-LT . Each DCD transplant was matched with 2 brain death donors ( DBD ) grafts ( n = 333 ) according to the period of transplantation . Primary outcome measures were biliary complications including the severity of complications , graft survival and patient survival . Minimum follow-up was 3 months . Results : Anastomotic stricture was the most common biliary complication ( DCD = 30 , 19 % vs. DBD = 41 , 13 % ) . Most were treated endocoscopically ( grade IIIa = 72 % ) , whereas hepatico-jejunostomy ( grade IIIb ) was performed in 22 % . Primary IC occurred in 4 ( 2.5 % ) recipients from the DCD group and was absent in the DBD group ( P = 0.005 ) . However , none of these patients required retransplantation . Patient and graft survival at 1 , 3 , and 5 years were similar between DCD and DBD groups ( P = 0.106 , P = 0.138 , P = 0.113 , respectively ) . Conclusions : The encouraging results with DCD-LT are probably due to the selection of DCD grafts and clear definition of warm ischemia The number of donor organs suitable for liver transplantation is restricted by cold preservation and ischemia – reperfusion injury . We present the first patients transplanted using a normothermic machine perfusion ( NMP ) device that transports and stores an organ in a fully functioning state at 37 ° C . In this Phase 1 trial , organs were retrieved using st and ard techniques , attached to the perfusion device at the donor hospital , and transported to the implanting center in a functioning state . NMP livers were matched 1:2 to cold‐stored livers . Twenty patients underwent liver transplantation after NMP . Median NMP time was 9.3 ( 3.5–18.5 ) h versus median cold ischaemia time of 8.9 ( 4.2–11.4 ) h. Thirty‐day graft survival was similar ( 100 % NMP vs. 97.5 % control , p = 1.00 ) . Median peak aspartate aminotransferase in the first 7 days was significantly lower in the NMP group ( 417 IU [ 84–4681 ] ) versus ( 902 IU [ 218–8786 ] , p = 0.03 ) . This first report of liver transplantation using NMP‐preserved livers demonstrates the safety and feasibility of using this technology from retrieval to transplantation , including transportation . NMP may be valuable in increasing the number of donor livers and improving the function of transplantable organs Hypothermic machine perfusion ( HMP ) is widely used to preserve kidneys for transplantation with improved results over cold storage ( CS ) . To date , successful transplantation of livers preserved with HMP has been reported only in animal models . In this , the first prospect i ve liver HMP study , 20 adults received HMP‐preserved livers and were compared to a matched group transplanted with CS livers . HMP was performed for 3–7 h using centrifugal perfusion with Vasosol ® solution at 4–6 ° C . There were no cases of primary nonfunction in either group . Early allograft dysfunction rates were 5 % in the HMP group versus 25 % in controls ( p = 0.08 ) . At 12 months , there were two deaths in each group , all unrelated to preservation or graft function . There were no vascular complications in HMP livers . Two biliary complications were observed in HMP livers compared with four in the CS group . Serum injury markers were significantly lower in the HMP group . Mean hospital stay was shorter in the HMP group ( 10.9 ± 4.7 days vs. 15.3 ± 4.9 days in the CS group , p = 0.006 ) . HMP of donor livers provided safe and reliable preservation in this pilot case‐controlled series . Further multicenter HMP trials are now warranted Introduction The use of marginal or extended criteria donor livers is increasing . These organs carry a greater risk of initial dysfunction and early failure , as well as inferior long-term outcomes . As such , many are rejected due to a perceived risk of use and use varies widely between centres . Ex situ normothermic machine
Output:
| MP techniques which have per se the potential to alleviate ischaemia-reperfusion injury : Such as hypothermic MP and NRP , have also reported lower rates of ITBL .
Other biliary complications , such as biliary leak and anastomotic biliary strictures , are reported with similar incidences with all MP techniques .
There is currently less clinical evidence available to support normothermic MP as a mitigator of biliary complications following liver transplantation .
On the other h and , restoration of organ to full metabolism during normothermic MP allows assessment of hepatobiliary function before transplantation , although universally accepted criteria have yet to be vali date d. CONCLUSION MP of the liver has the potential to have a positive impact on post-transplant biliary complications , specifically ITBL , and exp and extended criteria donor livers utilisation |
MS212682 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE --To assess the efficacy of a single intra-articular injection of triamcinolone hexacetonide ( THA ) in knee osteoarthritis ( OA ) and examine factors which may relate to treatment efficacy . METHODS --Eighty four patients with clinical and radiographic evidence of knee OA were recruited and r and omly allocated to receive either THA ( 20 mg in 1 ml ) or placebo ( 0.9 % normal saline , 1 ml ) . Follow up assessment s evaluated the following outcome variables : patient opinion of overall change in the treated knee , visual analogue pain score ( VAS ) , distance walked in one minute ( WD ) , and Health Assessment Question naire modified for lower limb function ( HAQ ) . RESULTS --Seventy eight percent of THA and 49 % of placebo treated patients reported overall improvement at week 1 ( p < 0.05 ) . At week 6 , improvement was reported in 57 % and 55 % of patient groups , respectively . VAS improved in both groups at week 1 ( THA , p < 0.001 ; placebo , p < 0.05 ) and week 6 ( both p < 0.01 ) . Improvement in VAS was significantly greater among THA treated patients at week 1 only ( p < 0.01 ) . Subgroup analysis of THA treated patients revealed greater improvement in VAS among patients with clinical evidence of an effusion ( p < 0.05 ) , and those who had synovial fluid successfully aspirated at the time of injection ( p < 0.01 ) . WD improved in THA treated patients at week 1 ( p < 0.001 ) , and in both groups at week 6 ( THA , p < 0.001 ; placebo , p < 0.01 ) . Improvements in HAQ were seen in THA patients only at weeks 1 and 6 ( p < 0.05 ) . Regression analysis did not identify any additional clinical , radiographic , or synovial fluid characteristics which influenced the response . CONCLUSIONS --THA provided short term pain relief in knee OA . Increased benefit was associated with both clinical evidence of joint effusion and successful aspiration of synovial fluid at the time of injection We report the results of a double-blind three-centre study , employing a cross-over design , set up to compare the efficacy of intra-articular injections of Myc 2095 ( 20 mg ) , triamcinolone hexacetonide ( Lederspan ) ( 20 mg ) and placebo in 40 patients with synovitis of the knee joint . Each patient included in the study contributed data on 2 of the 3 treatment variables being compared . Seven clinical parameters were assessed every 6 weeks , while the doctor 's and the patient 's assessment s were scored . Intra articular treatment both with Myc 2095 and triamcinolone hexacetonide proved to be effective . Placebo response was also very high . After the first Myc 2095 injection , improvement in " tenderness " , " pain under load " and " swelling and hydrops " was significantly superior to that following placebo treatment . The evaluation of the second injections indicated a marked carry-over effect from the first course . This was also evident from the doctor 's and patient 's assessment s. The importance of including a placebo in the evaluation of anti-phlogistic drugs in clinical trials , emerged from this study BACKGROUND Glucosamine and chondroitin sulfate are used to treat osteoarthritis . The multicenter , double-blind , placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial ( GAIT ) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis . METHODS We r and omly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily , 1200 mg of chondroitin sulfate daily , both glucosamine and chondroitin sulfate , 200 mg of celecoxib daily , or placebo for 24 weeks . Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia . Assignment was stratified according to the severity of knee pain ( mild [ N=1229 ] vs. moderate to severe [ N=354 ] ) . The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24 . RESULTS The mean age of the patients was 59 years , and 64 percent were women . Overall , glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent . As compared with the rate of response to placebo ( 60.1 percent ) , the rate of response to glucosamine was 3.9 percentage points higher ( P=0.30 ) , the rate of response to chondroitin sulfate was 5.3 percentage points higher ( P=0.17 ) , and the rate of response to combined treatment was 6.5 percentage points higher ( P=0.09 ) . The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group ( P=0.008 ) . For patients with moderate-to-severe pain at baseline , the rate of response was significantly higher with combined therapy than with placebo ( 79.2 percent vs. 54.3 percent , P=0.002 ) . Adverse events were mild , infrequent , and evenly distributed among the groups . CONCLUSIONS Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee . Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain . ( Clinical Trials.gov number , NCT00032890 . ) IMPORTANCE Osteoarthritis ( OA ) of the knee is the most frequent form of arthritis and a cause of pain and disability . Combined nonpharmacologic and pharmacologic treatments are recommended as the optimal treatment approach , but no evidence supports the recommendation . OBJECTIVE To assess the clinical benefits of an intra-articular corticosteroid injection given before exercise therapy in patients with OA of the knee . DESIGN , SETTING , AND PARTICIPANTS We performed a r and omized , blinded , placebo-controlled clinical trial evaluating the benefit of intra-articular corticosteroid injection vs placebo injection given before exercise therapy at an OA outpatient clinic from October 1 , 2012 , through April 2 , 2014 . The participants had radiographic confirmation of clinical OA of the knee , clinical signs of localized inflammation in the knee , and knee pain during walking ( score > 4 on a scale of 0 to 10 ) . INTERVENTIONS Participants were r and omly allocated ( 1:1 ) to an intra-articular 1-mL injection of the knee with methylprednisolone acetate ( Depo-Medrol ) , 40 mg/mL , dissolved in 4 mL of lidocaine hydrochloride ( 10 mg/mL ) ( corticosteroid group ) or a 1-mL isotonic saline injection mixed with 4 mL of lidocaine hydrochloride ( 10 mg/mL ) ( placebo group ) . Two weeks after the injections , all participants started a 12-week supervised exercise program . MAIN OUTCOMES AND MEASURES The primary outcome was change in the Pain subscale of the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) question naire ( range , 0 - 100 ; higher scores indicate greater improvement ) at week 14 . Secondary outcomes included the remaining KOOS subscales and objective measures of physical function and inflammation . Outcomes were measured at baseline , week 2 ( exercise start ) , week 14 ( exercise stop ) , and week 26 ( follow-up ) . RESULTS One hundred patients were r and omized to the corticosteroid group ( n = 50 ) or the placebo group ( n = 50 ) ; 45 and 44 patients , respectively , completed the trial . The mean ( SE ) changes in the KOOS Pain subscale score at week 14 were 13.6 ( 1.8 ) and 14.8 ( 1.8 ) points in the corticosteroid and placebo groups , respectively , corresponding to a statistically insignificant mean difference of 1.2 points ( 95 % CI , -3.8 to 6.2 ; P = .64 ) . We found no statistically significant group differences in any of the secondary outcomes at any time point . CONCLUSIONS AND RELEVANCE No additional benefit results from adding an intra-articular injection of 40 mg of corticosteroid before exercise in patients with painful OA of the knee . Further research is needed to establish optimal and potentially synergistic combinations of conservative treatments . TRIAL REGISTRATION clinical trialsregister.eu Identifier : 2012 - 002607 - 18 ; clinical trials.gov Identifier : NCT01945749 Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose OBJECTIVES : To show whether intra-articular steroid injections are effective in osteoarthritis ; to determine factors that predict response ; and to determine whether injection has a beneficial effect on muscle strength . METHODS : Double blind , placebo controlled , crossover study in 59 patients with symptomatic osteoarthritis of the knee . Outcome measure- Primary outcome measure : change in visual analogue score for pain at three weeks . Predictors of response analysed using logistic regression with a 15 % decrease in pain score at three weeks defining response . RESULTS : Intra-articular methyl prednisolone acetate produced a significant reduction in visual analogue pain score at three weeks compared to both baseline ( median change -2.0 mm , interquartile range -16.25 to 4.0 ) and placebo ( median 0.0 mm , interquartile range -9.0 to 6.25 ) . No clinical predictors of response could be identified . Muscle strength was not significantly improved in the short term by intra-articular injection . CONCLUSIONS : Intra-articular corticosteroids are effective for short term relief of pain in osteoarthritis but predicting responders is not possible . There may be a place for their more widespread use Background Studies have evaluated the concomitant use of hyaluronan ( HA ) with steroids , anti-inflammatory drugs and analgesic agents in an attempt to magnify the extent and duration of pain relief due to knee osteoarthritis . To date there has not been an intra-articular combination therapy available for relief of knee osteoarthritis symptoms – one that combines the fast acting onset of symptom relief provided by a corticosteroid with the long-lasting symptom relief provided by HA in a single injection . The objective of this study was to evaluate the safety and preliminary performance of two new HA formulations , Hydros ( hyaluronan-based hydrogel suspended in hyaluronan solution ) and Hydros-TA ( HA plus 10 mg of triamcinolone acetonide [ TA ] ) in subjects with knee osteoarthritis . Methods We conducted a Phase 2 prospect i ve , multicenter , r and omized , double-blind feasibility trial . Participants ( n = 98 ; mean age 60 years ) with knee osteoarthritis ( Kellgren-Lawrence grade 2 or 3 ) were r and omized to three treatment groups : Hydros , Hydros-TA , and Synvisc-One ® ( hylan G-F 20 ) . Participants received one 6 ml intra-articular injection in the treatment knee and were evaluated at 2 , 6 , 13 , and 26 weeks post-treatment . Safety was assessed from adverse events at all study visits . The primary efficacy outcome was the change from baseline on the Western Ontario and McMaster Universities
Output:
| An analysis of multiple time points suggested that effects decrease over time , and our analysis provided no evidence that an effect remains six months after a corticosteroid injection |
MS212683 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 : Bronchopulmonary dysplasia ( BPD ) is the focus of many intervention trials , yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians . Thus , we wished to define BPD by a st and ardized oxygen saturation monitoring at 36 weeks corrected age , and compare this physiologic definition with the st and ard clinical definition of BPD based solely on oxygen administration . METHODOLOGY : A total of 199 consecutive very low birthweight infants ( VLBW , 501 to 1500 g birthweight ) were assessed prospect ively at 36±1 weeks corrected age . Neonates on positive pressure support or receiving > 30 % supplemental oxygen were assigned the outcome BPD . Those receiving ≤30 % oxygen underwent a stepwise 2 % reduction in supplemental oxygen to room air while under continuous observation and oxygen saturation monitoring . Outcomes of the test were “ no BPD ” ( saturations ≥88 % for 60 minutes ) or “ BPD ” ( saturation < 88 % ) . At the conclusion of the test , all infants were returned to their baseline oxygen . Safety ( apnea , bradycardia , increased oxygen use ) , inter-rater reliability , test – retest reliability , and validity of the physiologic definition vs the clinical definition were assessed . RESULTS : A total of 199 VLBW were assessed , of whom 45 ( 36 % ) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age . The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air . The physiologic definition diagnosed BPD in 30 ( 24 % ) of the cohort . All infants were safely studied . The test was highly reliable ( inter-rater reliability , κ=1.0 ; test – retest reliability , κ=0.83 ) and highly correlated with discharge home in oxygen , length of hospital stay , and hospital readmissions in the first year of life . CONCLUSIONS : The physiologic definition of BPD is safe , feasible , reliable , and valid and improves the precision of the diagnosis of BPD . This may be of benefit in future multicenter clinical trials OBJECTIVE To determine whether an earlier observation , that infants fed a casein-hydrolysate formula ( Nutramigen ) have lower neonatal jaundice levels than those fed st and ard formulas , would be repeated in a larger independent group of infants with more frequent measurements and more rigorous statistical analysis . DESIGN Newborn infants were fed human milk , a st and ard whey-predominant formula ( Enfamil ) , or Nutramigen ( n = 20 for each group ) during the first 3 weeks of life . Transcutaneous jaundice index was measured daily for the first week of life and every 2 to 3 days thereafter , using a noninvasive jaundice meter . Linear regression models of the data were constructed , vali date d , and compared statistically . SETTING General community hospital with subsequent home visitation . PARTICIPANTS Healthy , term newborn infants selected by convenience , based on time of birth . INTERVENTION Infants were exclusively fed human milk , Enfamil , or Nutramigen . Formulas were r and omly assigned . MAIN OUTCOME MEASURE Jaundice index , a transcutaneous measurement of jaundice . RESULTS The jaundice index differed significantly among the 3 groups . Paired comparisons showed that the jaundice index of the Nutramigen group was significantly lower than that of the Enfamil group ( on days 6 - 16 ) and the human milk group ( on days 3 - 20 ) . The jaundice index of the Enfamil-fed group was significantly lower than that of the human milk group on days 13 to 19 . CONCLUSIONS Jaundice levels are lower in neonates fed Nutramigen rather than Enfamil and both these groups have lower jaundice levels than breast-fed infants OBJECTIVE To evaluate the effectiveness of fluid supplementation in decreasing the rate of exchange transfusion and the duration of phototherapy in term neonates with severe nonhemolytic hyperbilirubinemia . STUDY DESIGN This was a r and omized controlled trial conducted in a tertiary care referral unit in northern India . Seventy-four term neonates with severe nonhemolytic hyperbilirubinemia ( total serum bilirubin > 18 mg/dL [ 308 micromol/L ] to < 25 mg/dL [ 427 micromol/L ] ) . The subjects were r and omized to an " extra fluids " group ( intravenous fluid supplementation for 8 hours and oral supplementation for the duration of phototherapy ; n = 37 ) or a control group ( n = 37 ) . RESULTS At inclusion , 54 infants ( 73 % ) had high serum osmolality , including 28 ( 75 % ) in the extra fluids group and 26 ( 70 % ) in the control group . The proportion of infants who underwent exchange transfusion was lower in the extra fluids group than in the control group : 6 ( 16 % ) versus 20 (54%)(P = .001 ; relative risk = 0.30 ; 95 % confidence interval = 0.14 to 0.66 ) . The duration of phototherapy was also shorter in the extra fluids group : 52 + /- 18 hours versus 73 + /- 31 hours ( P = .004 ) . CONCLUSION Fluid supplementation in term neonates presenting with severe hyperbilirubinemia decreased the rate of exchange transfusion and duration of phototherapy OBJECTIVE To compare the effectiveness of two methods of vascular access in newborns . DESIGN R and omized controlled trial . SETTING Neonatal intensive care unit in Regional Hospital of Valdivia , Chile . PARTICIPANTS Seventy-four high-risk newborns . INTERVENTIONS Peripherally inserted central catheter and peripheral intravenous catheter . MAIN OUTCOME MEASURES Length of neonatal intensive care unit stay and incidence of sepsis and phlebitis . RESULTS / DATA ANALYSIS : There were no statistically significant differences in the length of the neonatal intensive care unit stay and in the incidence of sepsis between groups . There was a significant higher incidence of phlebitis in the peripheral intravenous catheter group . CONCLUSIONS Although there was not a significant effect of the kind of catheter on length of neonatal intensive care unit stay , the peripherally inserted central catheter is recommended because of the decreased risk of phlebitis and the decreased number of venipuncture attempts and catheters needed to complete intravenous therapy Abstract Background : This study compared the rates of decrease in serum bilirubin levels in severely jaundiced healthy term infants given oral or intravenous fluid supplementation during phototherapy . Methods : A r and omized controlled study was carried out in the neonatal intensive care unit of Zeynep Kamil Maternity and Children Hospital ( Istanbul , Turkey ) over a 4-month period . Two hundred fifty healthy term infants with hyperbilirubinemia were r and omized to receive either solely breastmilk ( n=125 ) or both breastmilk and intravenous fluid ( n=125 ) during phototherapy . Results : There were no significant differences ( p>0.05 ) in the mean birth weight , mean gestastional age , modes of delivery , mean time of admission age , mean serum osmolality , and hematocrit and reticulocyte count between the two groups . Similarly , there was no significant difference ( p>0.05 ) in the mean indirect serum bilirubin level at the time of admission to the neonatal intensive care unit and at 4 , 8 , 12 , 24 , and 48 hours after commencement of phototherapy between the two groups . There was no significant difference ( p>0.05 ) in the mean duration of phototherapy or in the median duration of hospitalization between the two groups . Conclusions : Based on our results , intravenous fluid support has no effect on the rate of decrease in serum bilirubin and decrease in duration of phototherapy in healthy term newborns with no dehydratation . However , using the oral route avoided the need for intravenous cannulae and their attendant complications . Insensible fluid loss is increased during phototherapy , so protection of hydration status with oral feeding is important for newborns OBJECTIVE Our purpose was to evaluate the effect of breast-feeding frequency on serum bilirubin levels in the first 3 days after birth . STUDY DESIGN Two hundred seventy-five infants were r and omly assigned to a frequent or dem and breast-feeding schedule . RESULTS Infants in the frequent group ( n = 131 ) nursed nine ( 7.5 to 10.5 ) times per day ( median and inner 80 % ) , and the dem and group ( n = 143 ) fed 6.5 ( 5.5 to 8.0 ) times per day . The serum bilirubin level was measured in all infants between 48 and 80 hours ( median 53 hours , inner 80 % 48 to 68 hours ) and was 7.4 ( 1.8 to 10.7 ) mg/dl in the frequent group and 8.0 ( 2.9 to 11.2 ) mg/dl in the dem and group ( p = 0.103 ) . There was no correlation between the frequency of breast-feeding and the serum bilirubin level . CONCLUSION Within the range of the frequency of nursing observed in this study , we could not demonstrate a significant effect on serum bilirubin levels in the first 3 days after birth We measured the serum bilirubin concentrations in 2,416 consecutive infants admitted to our well-baby nursery . The maximum serum bilirubin concentration exceeded 12.9 mg/dL ( 221 mumol/L ) in 147 infants ( 6.1 % ) , and these infants were compared with 147 r and omly selected control infants with maximum serum bilirubin levels less than or equal to 12.9 mg/dL. In 66 infants ( 44.9 % ) , we identified an apparent cause for the jaundice , but in 81 ( 55 % ) , no cause was found . Of infants for whom no cause for hyperbilirubinemia was found , 82.7 % were breast-fed v 46.9 % in the control group ( P less than .0001 ) . Breast-feeding was significantly associated with hyperbilirubinemia , even in the first three days of life . The 95th percentile for bottle-fed infants is a serum bilirubin level of 11.4 mg/dL v 14.5 mg/dL for the breast-fed population , and the 97th percentiles are 12.4 and 14.8 mg/dL , respectively . Of the formula-fed infants , 2.24 % had serum bilirubin levels greater than 12.9 mg/dL v 8.97 % of breast-fed infants ( P less than .000001 ) . When compared with previous large studies , the incidence of " readily visible " jaundice ( serum bilirubin level greater than 8 mg/dL ) appears to be increasing . The dramatic increase in breast-feeding in the United States in the last 25 years may explain this observation . There is a strong association between breast-feeding and jaundice in the healthy newborn infant . Investigations for the cause of hyperbilirubinemia in healthy breast-fed infants may not be indicated unless the serum bilirubin level exceeds approximately 15 mg/dL , whereas in the bottle-fed infant , such investigations may be indicated if the serum bilirubin exceeds approximately 12 mg/dL. ( ABSTRACT TRUNCATED AT 250 WORDS Objectives : To determine the incidence of severe hyperbilirubinaemia in the newborn , and to identify associated clinical and demographic variables , and short-term outcomes . Design : Prospect i ve , population -based study . Setting : UK and Republic of Irel and , between 1 May 2003 and 31 May 2005 . Participants : Infants in the first month of life with severe hyperbilirubinaemia ( maximum unconjugated serum bilirubin ⩾510 & mgr;mol/l ) . Results : 108 infants met the case definition , 106 from the UK and 2 from the Republic of Irel and . The UK incidence of severe hyperbilirubinaemia was 7.1/100 000 live births ( 95 % CI 5.8 to 8.6 ) . Only 20 cases presented in hospital ; 88 were admitted with severe jaundice . 64 ( 60.4 % ) cases were male , and 56 ( 51.8 % ) were of ethnic minority origin . 87 ( 80.5 % ) cases were exclusively breast fed . Co-morbidity included haemolysis , dehydration , infection and bruising . 14 infants showed evidence of bilirubin encephalopathy , of whom 3 died . The UK incidence of bilirubin encephalopathy was 0.9/100 000 live births ( 95 % CI 0.46 to 1.5 ) . Conclusions : This is the first large , prospect i ve , population -based study of the incidence of severe hyperbilirubinaemia in the newborn . The clinical and demographic associations , and short-term outcomes identified , are the same as those reported recently in North America and Europe Thirty to 50 % of very low-b
Output:
| Beyond eight hours postintervention , serum bilirubin was similar between the two groups .
AUTHORS ' CONCLUSIONS There is no evidence that IV fluid supplementation affects important clinical outcomes such as bilirubin encephalopathy , kernicterus , or cerebral palsy in healthy , term newborn infants with unconjugated hyperbilirubinaemia requiring phototherapy .
In this review , no infant developed these bilirubin-associated clinical complications .
Low- to moderate- quality evidence shows that there are differences in total serum bilirubin levels between fluid-supplemented and control groups at some time points but not at others , the clinical significance of which is uncertain .
There is no evidence of a difference between the effectiveness of IV and oral fluid supplementations in reducing serum bilirubin .
Similarly , no infant developed adverse events or complications from fluid supplementation such as vomiting or abdominal distension . |
MS212684 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 : Sexually transmitted disease ( STD ) , including AIDS , disproportionately affects African-American and Hispanic women . Goal : To evaluate efficacy of st and ard and enhanced ( addition of optional support groups ) gender- and culture-specific , small-group behavioral interventions , compared to interactive STD counseling , in high risk minority women for two years . Methods : Women with a non-viral STD were treated and enrolled in a r and omized trial . Follow-up screens and interviews occurred at 6 months , 1 year , 18 months ( short interview , optional exam ) and 2 years . The primary outcome was subsequent infection with chlamydia and /or gonorrhea . Secondary outcomes included risky sexual behaviors . We employed logistic regression based on intention-to-treat . Results : Data from 775 women were included ; the retention rate was 91 % . Adjusted infection rates were higher in the controls in Year 1 ( 26.8 % ) , Year 2 ( 23.1 % ) , and cumulatively ( 39.8 % ) than in the enhanced ( 15.4 % , P = 0.004 ; 14.8 % , P < 0.03 ; 23.7 % , P < 0.001 , respectively ) and st and ard ( 15.7 % , P = 0.006 ; 14.7 % , P = 0.03 ; 26.2 % , P < 0.008 , respectively ) intervention arms at these time points . Enhanced-intervention women who opted to attend support groups ( attendees ) had the lowest adjusted infection rates in Year 1 ( 12.0 % ) and cumulatively ( 21.8 % ) . Intervention women in general , but particularly attendees , were significantly less likely than controls to have repeat infections . Multiple partners and unprotected sex with an untreated or incompletely treated partner helped explain group differences in infection . Conclusions : Risk-reduction interventions significantly decreased both single and multiple infective episodes with chlamydia and /or gonorrhea and risky sexual behaviors in the two-year study period . Support-group attendance appeared to contribute additional risk reduction in Year 1 OBJECTIVES We sought to assess the effectiveness of approaches targeting improved sexually transmitted infection ( STI ) sexual partner notification through patient referral . METHODS From January 2002 through December 2004 , 600 patients with Neisseria gonorrhoeae or Chlamydia trachomatis were recruited from STI clinics and r and omly assigned to either a st and ard-of-care group or a group that was counseled at the time of diagnosis and given additional follow-up contact . Participants completed an interview at baseline , 1 month , and 6 months and were checked at 6 months for gonorrhea or chlamydial infection via nucleic acid amplification testing of urine . RESULTS Program participants were more likely to report sexual partner notification at 1 month ( 86 % control , 92 % intervention ; adjusted odds ratio [ AOR ] = 1.8 ; 95 % confidence interval [ CI ] = 1.02 , 3.0 ) and were more likely to report no unprotected sexual intercourse at 6 months ( 38 % control , 48 % intervention ; AOR = 1.5 ; 95 % CI = 1.1 , 2.1 ) . Gonorrhea or chlamydial infection was detected in 6 % of intervention and 11 % of control participants at follow-up ( AOR = 2.2 ; 95 % CI = 1.1 , 4.1 ) , with greatest benefits seen among men ( for gender interaction , P = .03 ) . CONCLUSIONS This patient-based sexual partner notification program can help reduce risks for subsequent STIs among urban , minority patients presenting for care at STI clinics The objective of this study was to determine acceptability and feasibility of patient-based partner referral ( PBPR ) and patient-delivered partner medication ( PDPM ) among female sexually transmitted infection ( STI ) patients in a community-based STI screening study . Women were r and omized to STI screening at home or at a clinic . STI patients could choose between PBPR and PDPM . Six-week follow-up interviews , and in-depth interviews , were conducted . STI prevalence was high . Most of the 106 women with an STI chose PDPM , mainly because partners would not have time or would not want to attend a clinic , and to ensure that partners received treatment . Nearly all partners reportedly took medication ( 94 ; 89 % took it in front of the woman ) or went to a clinic for treatment ( 92 % ) . No adverse events were reported . Good communication emerged as the key to successful partner notification . In conclusion , PDPM could be used as a strategy to improve STI treatment coverage Background : Expedited partner therapy ( EPT ) has been shown to reduce the risk of persistent or recurrent gonorrhea and chlamydial infection in heterosexuals , and to increase the proportion of sex partners receiving treatment . The objective of this analysis was to evaluate the consistency of EPT 's effect across sociodemographic and behavioral subgroups . Methods : Subset analyses from a r and omized controlled trial compared EPT to st and ard partner referral ( SPR ) in sociodemographic and behaviorally defined subgroups . Outcomes included persistent or recurrent infection in study participants and participants ' report that their partners received treatment . Results : Reinfection risk was lower among EPT recipients than nonrecipients in 21 of 22 subgroups , with relative risks ( RRs ) varying from 0.4 to 0.94 . Compared to persons receiving SPR , persons receiving EPT were more likely to report that their partners were very likely to have been treated in 33 of 34 subgroups ( RRs range , 1.03 - 1.36 ) . Although EPT reduced the risk of persistent or recurrent infection somewhat more in men ( RR , 0.56 ; 95 % CI , 0.3 - 1.08 ) than in women ( RR , 0.81 ; 95 % CI , 0.61 - 1.07 ) and more in persons with gonorrhea ( RR , 0.32 ; 95 % CI , 0.13 - 0.78 ) than those with chlamydial infection ( RR , 0.82 ; 95 % CI , 0.63 - 1.07 ) , the RR of partners being treated associated with EPT was similar in men ( RR , 1.21 ; 95 % CI , 1.05 - 1.39 ) and women ( RR , 1.18 ; 95 % CI , 1.10 - 1.27 ) , and also in persons with gonorrhea ( RR , 1.33 ; 95 % CI , 0.80 - 2.23 ) and chlamydial infection ( RR , 1.33 ; 95 % CI , 1.07 - 1.66 ) . Conclusions : In this study , EPT is shown to be superior to SPR across a wide spectrum of sociodemographic and behaviorally defined subgroups Background Repeated infection with Chlamydia trachomatis increases the risk for serious sequelae : pelvic inflammatory disease , ectopic pregnancy , infertility , and chronic pelvic pain . A substantial proportion of women treated for C trachomatis infection are reinfected by an untreated male sex partner in the first several months after treatment . Effective strategies to ensure partner treatment are needed . Goal The goal of the study was to determine whether repeated infections with C trachomatis can be reduced by giving women doses of azithromycin to deliver to male sex partners . Study Design A multicenter r and omized controlled trial was conducted among 1787 women aged 14 to 34 years with uncomplicated C trachomatis genital infection diagnosed at family planning , adolescent , sexually transmitted disease , and primary care clinics or emergency or other hospital departments in five US cities . Women treated for infection were r and omized to one of two groups : patient-delivered partner treatment ( in which they were given a dose of azithromycin to deliver to each sex partner ) or self-referral ( in which they were asked to refer their sex partners for treatment ) . The main outcome measure was C trachomatis DNA detected by urine ligase chain reaction ( LCR ) or polymerase chain reaction ( PCR ) by 4 months after treatment . Results The characteristics of study participants enrolled in each arm were similar except for a small difference in the age distribution . Risk of reinfection was 20 % lower among women in the patient-delivered partner treatment arm ( 87/728 ; 12 % ) than among those in the self-referral arm ( 106/726 ; 15 % ) ; however , this difference was not statistically significant ( odds ratio , 0.80 ; 95 % confidence interval , 0.62–1.05;P = 0.102 ) . Women in the patient-delivered partner treatment arm reported high compliance with the intervention ( 82 % ) . Conclusion Patient-delivered partner treatment for prevention of repeated C trachomatis infection among women is comparable to self-referral and may be an appropriate option for some patients OBJECTIVES To determine the effectiveness of an intervention for pharmacy workers in improving their recognition and management of sexually transmitted disease ( STD ) syndromes . METHODS We r and omly selected 14 districts ( total population nearly 4 million ) from the 24 districts of low socioeconomic status in Lima , Peru . We r and omly assigned paired districts to receive training and support for management and prevention of STDs or a control intervention about management of diarrhoea . The STD intervention included interactive luncheon seminars on recognition and management of four STD syndromes ( urethral discharge , vaginal discharge , genital ulcers , and pelvic inflammatory disease ) and STD/HIV prevention counselling ; monthly pharmacy visits by " prevention salespersons " who distributed material s that included " STD/HIV prevention packets " containing information , condoms , and cards given to patients for referral of their sex partners ; and workshops for physicians on managing patients with STD syndromes referred from pharmacies . St and ardized simulated patients visited pharmacies in intervention and control districts at one , three , and six months after training to assess outcomes . FINDINGS St and ardized simulated patients reported significantly better recognition and management ( appropriate antimicrobial regimens provided for discharge syndromes and referral to specially trained physicians for genital ulcers or pelvic inflammatory disease ) by pharmacy workers of all four STD syndromes . They also reported significantly more frequent recommendations for use of condoms and treatment of partners at pharmacies in intervention districts than in control districts ( by " intention-to-train " analyses , P<0.05 for 47/48 primary outcome comparisons ) . CONCLUSION Training was feasible and effectively improved pharmacy workers ' practice BACKGROUND We sought to compare two methods of notifying sex partners of subjects infected with the human immunodeficiency virus ( HIV ) or persons who had shared needles with them ( needle-sharing partners ) : " patient referral , " in which the responsibility for notifying partners was left to the patient , and " provider referral , " in which providers attempted to notify partners . METHODS Names of sex partners and needle-sharing partners and information on how to locate them were obtained from consenting HIV-infected subjects identified in the HIV-testing programs at three public health departments in North Carolina . The subjects were r and omly assigned to a patient-referral group ( in which patients had the initial responsibility for notifying their partners ) or a provider-referral group ( in which the study counselor notified the partners ) . The success of attempts to notify partners was monitored by means of interviews with counselors conducted both in the field and at the health department . RESULTS Of 534 HIV-positive persons identified at the health departments , 247 ( 46 percent ) did not return for counseling after the test , 8 were counseled outside the study , and 117 ( 22 percent ) were ineligible . Of the 162 invited to participate , 88 ( 54 percent ) declined and 74 ( 46 percent ) agreed . The subjects were mostly male ( 69 percent ) , black ( 87 percent ) , homosexual or bisexual ( 76 percent of the men ) , and had a median age of 30 years . Thirty-nine were assigned to the provider-referral group and 35 to the patient-referral group . In the provider-referral group 78 of 157 partners ( 50 percent ) were successfully notified , whereas in the patient-referral group only 10 of 153 ( 7 percent ) were notified . Of the partners notified by the counselors , 94 percent were not aware that they had been exposed to HIV . Overall , 23 percent of the partners notified and tested were HIV-positive . CONCLUSIONS In this trial , leaving the notification of partners up to the subjects ( patient referral ) was quite ineffective , despite the North Carolina law requiring that partners be notified . Partner notification by public health counselors ( provider referral ) was significantly more effective . Although the effectiveness of notification procedures is constrained by the accuracy of the information provided by HIV-infected patients , counselors who notify the partners of an infected patient can refer them to educational , medical , and support services targeted to persons at high risk for HIV infection and may encourage the adoption of less risky behavior Background : Screening has been recommended to reduce the prevalence and morbidity associated with genital chlamydia infection in the United Kingdom . Methods : We describe the rationale and study design of the Chlamydia Screening Studies ( ClaSS ) , a collaborative project design ed to evaluate screening outside genitourinary medicine clinics . A non-selective , active screening approach in 16–39 year olds r and omly sample d from 27 general practice lists in the Bristol and Birmingham areas formed the
Output:
| contract referral , 4 .
Where measured , there was no statistical evidence of differences in the incidence of adverse effects between PN strategies .
The evidence assessed in this review does not identify a single optimal strategy for PN for any particular STI .
When combining trials of STI causing urethritis or cervicitis , expedited partner therapy was more successful than simple patient referral for preventing re-infection of the index patient but was not superior to enhanced patient referral .
Expedited partner therapy interventions should include all components that were part of the trial intervention package .
There was insufficient evidence to determine the most effective components of an enhanced patient referral strategy . |
MS212685 | ***TASK*** the task is to summarize an input biomedical literature in 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 the clinical efficacy of magnetic resonance imaging ( MRI ) of the knee in acute injuries with indeterminate clinical findings , using arthroscopy as a gold st and ard . Design A prospect i ve double-blind study was performed . All patients underwent MRI on a 1.5 T magnet using dual spin echo pulse sequences . This was followed by arthroscopy . Setting Tertiary care referral center . Patients Twenty-three patients with an average age of 26 years satisfied the study criteria . Patients had to have been seen by one of two orthopaedic surgeons within 6 weeks of sudden trauma to the knee complicated by a hemarthrosis , clinical assessment of which was equivocal . Results The respective sensitivity and specificity for MRI of the knee were 90 % ( 18/20 ) and 67 % ( 2/3 ) for detecting any anterior cruciate ligament injury , 50 % ( 1/2 ) and 86 % ( 18/21 ) for detecting medial meniscal tears , and 88 % ( 7/8 ) and 73 % ( 11/15 ) for detecting lateral meniscal tears . MRI also identified injuries that could not be assessed on arthroscopy , including 14 bone bruises , five posterior cruciate ligament tears , nine medial collateral ligament tears , and one lateral collateral ligament tear . The detection of composite injury requiring surgical intervention yielded a sensitivity of 100 % ( 16/16 ) and a specificity of 71 % ( 5/7 ) . Prospect i ve use of MRI evaluation of the knee could have prevented 22 % ( 5/23 ) of diagnostic arthroscopic procedures . Conclusion Equivocal clinical findings in patients with acute knee injury should lead to use of MRI in an appropriate clinical setting . To our knowledge a prospect i ve study of the efficacy of MRI of the knee in this patient population has not been reported . In the presence of such inclusion criteria , the results of our study support the use of early MRI to guide further surgical management Abstract The results of magnetic resonance imaging ( MRI ) were compared with those of arthroscopy in a prospect i ve series of 244 patients . A dedicated system for MRI of limbs and peripheral joints – the 0,2-T Artoscan ( Esaote , Italy ) – was used for imaging knee joint lesions . T1-weighted spin-echo sagittal images , T2-weighted gradient-echo coronal images , and axial views for lesions of the femoropatellar joint were acquired . Paraxial sagittal and oblique coronal views were obtained for imaging of the cruciate ligaments . This protocol allowed excellent visualization of the cruciate ligaments and medial and lateral meniscus in almost all patients . Compared with arthroscopy performed within 48 h after imaging , the sensitivity , specificity , and accuracy were respectively 93 % , 97 % , and 95 % for tears of the medial meniscus ; 82 % , 96 % , and 93 % for tears of the lateral meniscus ; 100 % , 100 % , and 100 % for tears of the posterior cruciate ligament ; 98 % , 98 % , and 97 % for tears of the anterior cruciate ligament ; and 72 % , 100 % , and 92 % for full-thickness articular cartilage lesions . The examination can be performed within 30–45 min at lower cost than diagnostic arthroscopy . MRI with a 0.2-T magnet is a safe and valuable adjunct to the clinical examination of the knee and an aid to efficient preoperative planning A prospect i ve double-blind study was undertaken to evaluate the usefulness of magnetic resonance imaging in the accurate interpretation of pathological intra-articular changes in the knee . Forty-seven patients who were scheduled to have arthroscopy and three patients who wer to have arthrotomy volunteered for magnetic resonance imaging preoperatively . The radiologists had no clinical or roentgenographic information about the patients before the evaluation of the magnetic resonance images , and the radiologists ' interpretations were unknown to the surgeon before the arthroscopy or arthrotomy was done . Our important observations were limited to the findings in the menisci and in the anterior cruciate ligament . Magnetic resonance imaging had a positive predictive value of 75 per cent , a negative predictive value of 90 per cent , a sensitivity of 83 per cent , and a specificity of 84 per cent for pathological findings in the menisci . For complete tears of the anterior cruciate ligament , the positive predictive value was 74 per cent ; the negative predictive value , 70 per cent ; the sensitivity , 61 per cent ; and the specificity , 82 per cent . We believe that magnetic resonance imaging , when combined with clinical and roentgenographic examination , provides the most accurate non-invasive source of information that is currently available for pathological findings in the menisci and in the anterior cruciate ligament The aim of this study was to detect the accuracy of routine magnetic resonance imaging ( MRI ) done in different centres and its agreement with arthroscopy in meniscal and ligamentous injuries of the knee . We prospect ively examined 70 patients ranging in age between 22 and 59 years . History taking , plain X-ray , clinical examination , routine MRI and arthroscopy were done for all patients . Sensitivity , specificity , accuracy , positive and negative predictive values , P value and kappa agreement measures were calculated . We found a sensitivity of 47 and 100 % , specificity of 95 and 75 % and accuracy of 73 and 78.5 % , respectively , for the medial and lateral meniscus . A sensitivity of 77.8 % , specificity of 100 % and accuracy of 94 % was noted for the anterior cruciate ligament ( ACL ) . We found good kappa agreements ( 0.43 and 0.45 ) for both menisci and excellent agreement ( 0.84 ) for the ACL . MRI shows high accuracy and should be used as the primary diagnostic tool for selection of c and i date s for arthroscopy . Level of evidence : 4.RésuméLe but de cette étude est de détecter un examen de routine l’IRM et la bonne correspondance entre ces constatations et les constatations arthroscopiques des lésions méniscales ou des lésions ligamentaires du genou . Nous avons réalisé une étude prospect i ve de 70 patients âgés de 22 à 59 ans avec analyse de l’histoire clinique , des radiographies , de l’examen clinique , de l’examen IRM et des constatations arthroscopiques . La sensitivité , la spécificité et l’exactitude des constatations ont été évaluées de manière statistique . Nous avons trouvé respectivement une sensitivité de 47 % et 100 % , une spécificité de 95 % et 75 % et une exactitude des constatations de 73 % et 78,5 % , pour les lésions du ménisque interne ou du ménisque latéral . En ce qui concerne les ligaments croisés , la sensitivité est de 77,8 % , la spécificité de 100 % et l’exactitude des constatations de 94 % avec une bonne correspondance Kappa ( 0,43 et 0,45 ) pour les ménisques et 0,84 pour le ligament croisé antérieur . L’IRM peut donc être utilisée comme un élément tout à fait sûr et routinier concernant le diagnostic primaire des lésions miniscales ou des lésions ligamentaires chez les patients devant bénéficier d’une arthroscopie . Niveau d’évidence : 4 Rapidly progressing medical technology sometimes obscures the importance of history and physical examination . This study was design ed to assess the value of MRI and clinical examination in the diagnosis of ligamentous and meniscal knee injuries in comparison with arthroscopic findings . In the year 2003 - 2004 , we conducted a prospect i ve , single blind study to assess ligamentous and meniscal injuries of the knee in patients with acute knee trauma . The mean age was 27.9 years . The sex distribution was 81.4 % male and 18.6 % female ; 42.9 % of injuries affected the right knee and 57.1 % the left knee . All the included patients were ordered a MRI , executed in five separate centres . All patients underwent arthroscopy by the author . Arthroscopic findings were the diagnostic reference . Clinical examination was accurate in 91.4 % , and MRI in 88.5 % of anterior cruciate ligament injuries . For posterior cruciate ligament injuries , clinical accuracy was 100 % and MRI 94.6 % . Clinical examination was accurate in 96.9 % and MRI in 85.9 % of medial meniscal injuries . For lateral meniscus injuries , clinical accuracy was 85.4 % and MRI 73.8 % . MRI findings showed the lowest correlation with arthroscopic findings in lateral meniscus injuries ( r = 0/47 ) . Clinical diagnostic performance was poorest in case of combined cruciate ligament and meniscal injuries . We found an excellent correlation between MRI and clinical findings . However , when MRI is normal , high clinical suspicion and a skilled clinical examination are more reliable This prospect i ve double-blind study was design ed to evaluate the capability of magnetic resonance imaging to serve as a diagnostic tool in patients who have a clinical ly suspected disorder of the meniscus . The imaging studies provided a diagnostic accuracy of 72 per cent , a sensitivity of 88 per cent , and a specificity of 57 per cent . The positive and negative predictive values were 66 and 83 per cent . The diagnostic sensitivity was 94 per cent for lesions of the medial meniscus ; this value differed significantly from that of 78 per cent for lesions of the lateral meniscus ( p less than 0.05 ) . The 37 per cent specificity for lesions of the medial meniscus was extremely low compared with the rate of 69 per cent for lesions of the lateral meniscus ( p less than 0.01 ) . In the intermediate part of the meniscus , the diagnostic sensitivity was 37 per cent on the medial side and 23 per cent on the lateral side ; these values were significantly less than the average of 74 per cent for the other meniscal segments ( p less than 0.001 ) . The imaging studies provided an over-all accuracy of 67 per cent in the detection of degeneration of the meniscus , 78 per cent in the identification of meniscal tears , and 82 per cent in the delineation of postoperative lesions Abstract Purpose Rupture of the anterior cruciate ligament ( ACL ) is a common injury , often presenting with a typical injury pattern . Historically , the literature indicates that the accuracy of diagnosis of ACL ruptures is poor at the initial medical consultation . The aims of this study were to determine : the mechanism of injury ; changes in accuracy of diagnosis of ACL ruptures at initial presentation over the last decade ; and the effect of subsequent delay in diagnosis and definitive treatment . Methods A prospect i ve cohort of one hundred and thirty-two consecutive patients who underwent ACL reconstruction between 2005 and 2009 were analysed . The median age of the patients was 18 years ( 12–57 ) . Sixteen patients were excluded due to chronic ACL injury . Results One hundred and sixteen patients ( 117 ACL ruptures ) were included in the analysis . A typical injury pattern was documented in 87 ( 74.4 % ) of cases . The most common sporting activities associated with an ACL injury were football ( 35.3 % ) , skiing ( 21.6 % ) and rugby ( 10.3 % ) . The majority of patients ( 67.5 % ) sought medical attention within 1 week from time of injury . The correct diagnosis of an ACL rupture was made in 33 cases ( 28.2 % ) at the initial medical consultation . The diagnosis was made following medical consultation in 13 ( 11.1 % ) of cases with the use of magnetic resonance imaging and 6 ( 5.1 % ) cases at arthroscopy . The median time to diagnosis was 6 weeks ( 0–192 ) , and the median time to ACL reconstruction was 24 weeks ( 1–240 ) . A delay in diagnosis of > 6 months was associated with a medial meniscal tear rate of 72.2 % compared to 23.1 % if the diagnosis was made within 4 months of the injury ( p < 0.05 ) . Conclusions Despite a ‘ typical ’ mechanism of injury leading to ACL rupture , the rate of initial diagnosis in the UK still remains poor . This often leads to an unnecessary delay in the diagnosis and subsequent treatment and increases the risk of secondary injury to the knee . A delay in diagnosis of > 6 months was associated with an increased medial meniscal tear rate . Patients who present with a ‘ typical ’ injury pattern should therefore be referred for further assessment by a knee specialist within 6 weeks . Level of evidence IV The results of selective magnetic resonance imaging of the knee were compared with those of arthroscopy in a prospect i ve series of fifty patients . A specifically design ed protocol for imaging , producing T1 sagittal images interleaved at four millimeters while the patient 's foot was in 20 degrees of external rotation , was utilized . This technique , called selective magnetic resonance imaging , yielded excellent visualization of the posterior cruciate ligament , medial meniscus , and lateral meniscus in all patients . However , in only 7
Output:
| Magnetic field strength had no significant effect on accuracy . |
MS212686 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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***EXAMPLES***
Input: OBJECTIVE To assess the effect of more intensive medical therapy on the rate of transcranial Doppler ( TCD ) microemboli and cardiovascular events in patients with asymptomatic carotid stenosis ( ACS ) . DESIGN A prospect i ve study . SETTING A teaching hospital . PATIENTS Four hundred sixty-eight patients with ACS greater than 60 % by Doppler peak velocity . MAIN OUTCOME MEASURES We compared ( 1 ) the proportion of ACS patients who had microemboli on TCD , ( 2 ) cardiovascular events , ( 3 ) rate of carotid plaque progression , and ( 4 ) baseline medical therapy , before and since 2003 . RESULTS Among 468 ACS patients , 199 were enrolled between January 1 , 2000 , and December 31 , 2002 ; and 269 were enrolled between January 1 , 2003 , and July 30 , 2007 . Microemboli were present in 12.6 % before 2003 and 3.7 % since 2003 ( P < .001 ) . The decline in microemboli coincided with better control of plasma lipids and slower progression of carotid total plaque area . Since 2003 , there have been significantly fewer cardiovascular events among patients with ACS : 17.6 % had stroke , death , myocardial infa rct ion , or carotid endarterectomy for symptoms before 2003 , vs 5.6 % since 2003 ( P < .001 ) . The rate of carotid plaque progression in the first year of follow-up has declined from 69 mm(2 ) ( SD , 96 mm(2 ) ) to 23 mm(2 ) ( SD , 86 mm(2 ) ) ( P < .001 ) . CONCLUSIONS Cardiovascular events and microemboli on TCD have markedly declined with more intensive medical therapy . Less than 5 % of patients with ACS now st and to benefit from revascularization ; patients with ACS should receive intensive medical therapy and should only be considered for revascularization if they have microemboli on TCD Background and Purpose — This study aim ed to monitor cognitive performance during a 3-year period in subjects with bilateral asymptomatic severe internal carotid artery stenosis and to explore the role of cerebral hemodynamics and atherosclerotic disease in the development of cognitive dysfunction . Methods — One hundred fifty-nine subjects with bilateral asymptomatic severe internal carotid artery stenosis were included and prospect ively evaluated for a 3-year period . At entry , demographics , vascular risk profile , and pharmacological treatments were defined . Cognitive status was evaluated using the Mini-Mental State Examination at baseline and at follow-up . Cerebral hemodynamics was assessed by transcranial Doppler – based breath-holding index test . As a measure of the extent of systemic atherosclerotic disease , common carotid artery intima-media thickness was measured . A cutoff for pathological values was set at 0.69 for breath-holding index and 1.0 mm for intima-media thickness . Results — The risk of decreasing in Mini-Mental State Examination score increased progressively from patients with bilaterally normal to those with unilaterally abnormal breath-holding index , reaching the highest probability in patients with bilaterally abnormal breath-holding index ( P<0.0001 ) . Pathological values of intima-media thickness did not influence the risk of Mini-Mental State Examination score change . Conclusions — Our findings suggest that patients with asymptomatic bilateral severe internal carotid artery stenosis may be at risk of developing cognitive impairment . The evaluation of the hemodynamic status , besides providing insights about the possible mechanism behind the cognitive dysfunction present in carotid atherosclerotic disease , may be of help for the individuation of subjects deserving earlier and more aggressive treatments Background and Purpose — Progression of asymptomatic carotid stenoses with > 50 % luminal narrowing is associated with an increased risk of stroke . The significance of the progression rate in these patients is unknown . The main aim of this study was to evaluate the rate of change of carotid luminal narrowing over 1 year , as a risk factor for ipsilateral ischemic events , in patients with a > 50 % asymptomatic carotid stenosis . Secondary aims were to establish the incidence of changes in carotid luminal narrowing and establish additional risk factors for ipsilateral neurological events . Methods — A retrospective analysis was conducted of data derived from the deferred endarterectomy arm of the Asymptomatic Carotid Surgery Trial . Patients were followed up for ≥5 years with serial carotid duplex examinations . Data were derived from information obtained at r and omization and annual follow-up visits with carotid duplex examination . Potential risk factors for ipsilateral neurological events were analyzed in Poisson regression models . Results — Data from 1469 patients were included . Two hundred forty-four had ipsilateral events ; 240 had ipsilateral carotid surgery ; 370 died from nonstroke causes ; and 82 had an asymptomatic carotid occlusion . The annual incidence of progression in the cohort as a whole was 5.2 % . Ipsilateral events occurred in 17 % of patients . Diabetes and previous contralateral symptoms showed a significant independent association with ipsilateral neurological events . Ipsilateral events were associated with high rates of progression over 1 year but not with low progression rates or regression . Conclusions — Fast rates of progression of carotid luminal narrowing should be interpreted as a sign of significantly increased risk of future ipsilateral neurological events BACKGROUND Previous clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ( " embolic protection " ) is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications . METHODS In this trial , we compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients 79 years of age or younger who had severe carotid stenosis and were asymptomatic ( i.e. , had not had a stroke , transient ischemic attack , or amaurosis fugax in the 180 days before enrollment ) and were not considered to be at high risk for surgical complications . The trial was design ed to enroll 1658 patients but was halted early , after 1453 patients underwent r and omization , because of slow enrollment . Patients were followed for up to 5 years . The primary composite end point of death , stroke , or myocardial infa rct ion within 30 days after the procedure or ipsilateral stroke within 1 year was tested at a noninferiority margin of 3 percentage points . RESULTS Stenting was noninferior to endarterectomy with regard to the primary composite end point ( event rate , 3.8 % and 3.4 % , respectively ; P=0.01 for noninferiority ) . The rate of stroke or death within 30 days was 2.9 % in the stenting group and 1.7 % in the endarterectomy group ( P=0.33 ) . From 30 days to 5 years after the procedure , the rate of freedom from ipsilateral stroke was 97.8 % in the stenting group and 97.3 % in the endarterectomy group ( P=0.51 ) , and the overall survival rates were 87.1 % and 89.4 % , respectively ( P=0.21 ) . The cumulative 5-year rate of stroke-free survival was 93.1 % in the stenting group and 94.7 % in the endarterectomy group ( P=0.44 ) . CONCLUSIONS In this trial involving asymptomatic patients with severe carotid stenosis who were not at high risk for surgical complications , stenting was noninferior to endarterectomy with regard to the rate of the primary composite end point at 1 year . In analyses that included up to 5 years of follow-up , there were no significant differences between the study groups in the rates of non-procedure-related stroke , all stroke , and survival . ( Funded by Abbott Vascular ; ACT I Clinical Trials.gov number , NCT00106938 . ) BACKGROUND For an asymptomatic patient with severe carotid stenosis the most important question is how to prevent an ischemic stroke . Carotid artery stenosis is the estimated cause of stroke in 8 - 20 % of the cases . Today more than 50 % of procedures for carotid stenosis are done on asymptomatic patients , but few of the r and omized controlled trials comparing carotid endarterectomy and stenting examined specifically these patients . METHODS All patients with severe ( > 70 % ) asymptomatic carotid artery stenosis seen in the Carmel medical center vascular clinic were prospect ively screened and r and omized 1:1 for carotid endarterectomy ( CEA ) or carotid stenting ( CAS ) . Patients eligible for both procedures were enrolled . The primary objectives of the study were : 1 ) periprocedural complications - stroke ( CVA ) , transient ischemic attack ( TIA ) , myocardial infa rct ion ( MI ) , and death ; 2 ) long-term results : mortality , prevention of ipsilateral stroke or TIA , and freedom from restenosis . RESULTS One-hundred and thirty-six patients were treated with mean follow-up of 26 months . There was no difference in short and long term results between the two groups . Thirty day morbidity included : 1 CVA in each group with no MI . Long-term results included 4 deaths in each group ; none from CVA . One TIA was noted after CAS , and 3 cases of restenosis were found in CEA and one in CAS . CONCLUSIONS CAS is a maturing procedure and has improved significantly over the past several years . Future developments of stents and protection devices will achieve better perioperative results . This along with our excellent long term results will promote the use of stenting for suitable patients OBJECTIVES This study determines the risk of ipsilateral ischaemic neurological events in relation to the degree of asymptomatic carotid stenosis and other risk factors . METHODS Patients ( n=1115 ) with asymptomatic internal carotid artery ( ICA ) stenosis greater than 50 % in relation to the bulb diameter were followed up for a period of 6 - 84 ( mean 37.1 ) months . Stenosis was grade d using duplex , and clinical and biochemical risk factors were recorded . RESULTS The relationship between ICA stenosis and event rate is linear when stenosis is expressed by the ECST method , but S-shaped if expressed by the NASCET method . In addition to the ECST grade of stenosis ( RR 1.6 ; 95 % CI 1.21 - 2.15 ) , history of contralateral TIAs ( RR 3.0 ; 95 % CI 1.90 - 4.73 ) and creatinine in excess of 85 micromol/L ( RR 2.1 ; 95 % CI 1.23 - 3.65 ) were independent risk predictors . The combination of these three risk factors can identify a high-risk group ( 7.3 % annual event rate and 4.3 % annual stroke rate ) and a low risk group ( 2.3 % annual event rate and 0.7 % annual stroke rate ) . CONCLUSIONS Linearity between ECST per cent stenosis and risk makes this method for grading stenosis more amenable to risk prediction without any transformation not only in clinical practice but also when multivariable analysis is to be used . Identification of additional risk factors provides a new approach to risk stratification and should help refine the indications for carotid endarterectomy BACKGROUND Because of recent advances in best medical treatment ( BMT ) , it is currently unclear whether any additional surgical or endovascular interventions confer additional benefit , in terms of preventing late ipsilateral carotid territory ischemic stroke in asymptomatic patients with significant carotid stenoses . The aim was to compare the stroke-preventive effects of BMT alone , with that of BMT in combination with carotid endarterectomy ( CEA ) or carotid artery stenting ( CAS ) in patients with high grade asymptomatic extracranial carotid artery stenosis . METHODS SPACE-2 was planned as a three-armed , r and omized controlled trial ( BMT alone vs. CEA plus BMT vs. CAS plus BMT , IS RCT N 78592017 ) . However , because of slow patient recruitment , the three-arm study design was amended ( July 2013 ) to become two parallel r and omized studies ( BMT alone vs. CEA plus BMT , and BMT alone vs. CAS plus BMT ) . RESULTS The change in study design did not lead to any significant increase in patient recruitment , and trial recruitment ceased after recruiting 513 patients over a 5 year period ( CEA vs. BMT ( n = 203 ) ; CAS vs. BMT ( n = 197 ) , and BMT alone ( n = 113 ) ) . The 30 day rate of death/stroke was 1.97 % for patients undergoing CEA , and 2.54 % for patients undergoing CAS . No strokes or deaths occurred in the first 30 days after r and omization in patients r and omized to BMT . There were several potential reasons for the low recruitment rates into SPACE-2 , including the ability for referring doctors to refer their patients directly for CEA or CAS outwith the trial , an inability to convince patients ( who had come " mentally prepared " that an intervention was necessary )
Output:
| A recent review has , however , identified a number of clinical /imaging features that may be associated with higher rates of stroke on medical therapy .
Summary The majority of surgeons/interventionists are unlikely to accept radical changes in practice until new r and omized trials confirm that the risk of stroke on modern medical therapy is significantly lower than that previously accepted . |
MS212687 | ***TASK*** the task is to summarize an input biomedical literature in 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 Bosutinib is an oral Src/Abl tyrosine kinase inhibitor . The phase III Bosutinib Efficacy and Safety in Newly Diagnosed Chronic Myeloid Leukemia ( BELA ) trial compared bosutinib with imatinib in newly diagnosed , chronic-phase chronic myeloid leukemia ( CML ) . PATIENTS AND METHODS A total of 502 patients were r and omly assigned 1:1 to bosutinib 500 mg per day or imatinib 400 mg per day . RESULTS The complete cytogenetic response ( CCyR ) rate at 12 months was not different for bosutinib ( 70 % ; 95 % CI , 64 % to 76 % ) versus imatinib ( 68 % ; 95 % CI , 62 % to 74 % ; two-sided P = .601 ) ; therefore , the study did not achieve its primary end point . The major molecular response ( MMR ) rate at 12 months was higher with bosutinib ( 41 % ; 95 % CI , 35 % to 47 % ) compared with imatinib ( 27 % ; 95 % CI , 22 % to 33 % ; two-sided P < .001 ) . Time to CCyR and MMR was faster with bosutinib compared with imatinib ( two-sided P < .001 for both ) . On-treatment transformation to accelerated/blast phase occurred in four patients ( 2 % ) on bosutinib compared with 10 patients ( 4 % ) on imatinib . A total of three CML-related deaths occurred on the bosutinib arm compared with eight on the imatinib arm . The safety profiles of bosutinib and imatinib were distinct ; GI and liver-related events were more frequent with bosutinib , whereas neutropenia , musculoskeletal disorders , and edema were more frequent with imatinib . CONCLUSION This ongoing trial did not meet its primary end point of CCyR at 12 months , despite the observed higher MMR rate at 12 months , faster times to CCyR and MMR , fewer on-treatment transformations to accelerated/blast phase , and fewer CML-related deaths with bosutinib compared with imatinib . Each drug had a distinct safety profile BACKGROUND Imatinib slows development of chronic myeloid leukemia ( CML ) . However , available information on morbidity and mortality is largely based on sponsored trials , whereas independent long-term field studies are lacking . PATIENTS AND METHODS Consecutive CML patients who started imatinib treatment before 2005 and who were in complete cytogenetic remission ( CCyR ) after 2 years ( ± 3 months ) were eligible for enrollment in the independent multicenter Imatinib Long-Term ( Side ) Effects ( ILTE ) study . Incidence of the first serious and nonserious adverse events and loss of CCyR were estimated according to the Kaplan-Meier method and compared with the st and ard log-rank test . Attainment of negative Philadelphia chromosome hematopoiesis was assessed with cytogenetics and quantitative polymerase chain reaction . Cumulative incidence of death related or unrelated to CML progression was estimated , accounting for competing risks , according to the Kalbleisch-Prentice method . St and ardized incidence ratios were calculated based on population rates specific for sex and age classes . Confidence intervals were calculated by the exact method based on the χ(2 ) distribution . All statistical tests were two-sided . RESULTS A total of 832 patients who were treated for a median of 5.8 years were enrolled . There were 139 recorded serious adverse events , of which 19.4 % were imatinib-related . A total of 830 nonserious adverse events were observed in 53 % of patients ; 560 ( 68 % ) were imatinib-related . The most frequent were muscle cramps , asthenia , edema , skin fragility , diarrhea , tendon , or ligament lesions . Nineteen patients ( 2.3 % ) discontinued imatinib because of drug-related toxic effects . Forty-five patients lost CCyR , at a rate of 1.4 per 100 person-years . Durable ( > 1 year ) negative Philadelphia chromosome hematopoiesis was attained by 179 patients . Twenty deaths were observed , with a 4.8 % mortality incidence rate ( st and ardized incidence ratio = 0.7 ; 95 % confidence interval = 0.40 to 1.10 , P = .08 ) , with only six ( 30 % ) associated with CML progression . CONCLUSIONS In this study , CML-related deaths were uncommon in CML patients who were in CCyR 2 years after starting imatinib , and survival was not statistically significantly different from that of the general population BACKGROUND Imatinib , a selective inhibitor of the BCR-ABL tyrosine kinase , produces high response rates in patients with chronic-phase chronic myeloid leukemia ( CML ) who have had no response to interferon alfa . We compared the efficacy of imatinib with that of interferon alfa combined with low-dose cytarabine in newly diagnosed chronic-phase CML . METHODS We r and omly assigned 1106 patients to receive imatinib ( 553 patients ) or interferon alfa plus low-dose cytarabine ( 553 patients ) . Crossover to the alternative group was allowed if stringent criteria defining treatment failure or intolerance were met . Patients were evaluated for hematologic and cytogenetic responses , toxic effects , and rates of progression . RESULTS After a median follow-up of 19 months , the estimated rate of a major cytogenetic response ( 0 to 35 percent of cells in metaphase positive for the Philadelphia chromosome ) at 18 months was 87.1 percent ( 95 percent confidence interval , 84.1 to 90.0 ) in the imatinib group and 34.7 percent ( 95 percent confidence interval , 29.3 to 40.0 ) in the group given interferon alfa plus cytarabine ( P<0.001 ) . The estimated rates of complete cytogenetic response were 76.2 percent ( 95 percent confidence interval , 72.5 to 79.9 ) and 14.5 percent ( 95 percent confidence interval , 10.5 to 18.5 ) , respectively ( P<0.001 ) . At 18 months , the estimated rate of freedom from progression to accelerated-phase or blast-crisis CML was 96.7 percent in the imatinib group and 91.5 percent in the combination-therapy group ( P<0.001 ) . Imatinib was better tolerated than combination therapy . CONCLUSIONS In terms of hematologic and cytogenetic responses , tolerability , and the likelihood of progression to accelerated-phase or blast-crisis CML , imatinib was superior to interferon alfa plus low-dose cytarabine as first-line therapy in newly diagnosed chronic-phase CML Underst and ing the impact of second-line tyrosine kinase inhibitor therapy on the health-related quality of life ( HRQOL ) of imatinib (IM)-resistant and IM-intolerant chronic phase chronic myeloid leukemia ( CP CML ) patients is important given the increased survival that comes with therapy . As part of a bosutinib single-arm phase 2 trial , 200 IM-resistant and 88 IM-intolerant CP CML patients ' HRQOL was assessed prior to and throughout treatment with the Functional Assessment of Cancer Therapy-Leukemia ( FACT-Leu ) . Little HRQOL impairment was demonstrated at baseline . Over the course of 96 weeks on bosutinib therapy , patients noted statistically significant and /or clinical ly meaningful improvements on several FACT-Leu scales Imatinib ( Gleevec ) , a highly effective specific tyrosine kinase inhibitor , demonstrates a better side effect profile than interferon-alpha ( IFN ) , which impairs patients ' quality of life ( QoL ) . This phase III international study evaluated QoL outcomes in 1,106 newly diagnosed patients with chronic-phase chronic myeloid leukemia ( CML ) who were r and omized to receive either imatinib 400 mg daily or IFN up to 5 MU/m(2)/d with cytarabine ( Ara-C ) 20 mg/m(2)/d added for 10 days every month ( IFN + LDAC ) . Crossover to the other treatment arm was permitted due to a lack of efficacy or treatment intolerance . QoL was assessed with the Functional Assessment of Cancer Therapy-Biologic Response Modifiers ( FACT-BRM ) at baseline , monthly for 6 months and then at months 9 , 12 , and 18 . The Trial Outcome Index ( TOI ; a composite endpoint of physical/functional/treatment-specific subscales ) was the primary endpoint . Secondary endpoints measured were social/family well-being ( SFWB ) and emotional well-being ( EWB ) . QoL was analyzed for the first 18 months of treatment using mixed effects growth curve models . The primary analyses were intention-to-treat ( ITT ) ; secondary analyses incorporated crossover as a time-dependent covariate . A total of 1,049 patients completed at least one QoL assessment . Two hundred sixty-one patients ( 50 % ) crossed over from IFN to imatinib and 11 ( 2 % ) crossed over from imatinib to IFN . There was a significant decline in TOI scores for the IFN treatment arm compared with preservation of baseline TOI scores in the imatinib arm ( P < .001 , ITT ) . Mean social/family and EWB scores were 22.8 and 19.5 , respectively , for imatinib and 21.6 and 17.6 , respectively , for IFN ( P < .001 , ITT ) . After crossing over from IFN to imatinib , patients experienced a significant ( P < .001 ) increase in TOI scores . Imatinib offers clear QoL advantages over IFN as first-line treatment of chronic-phase CML . In addition , patients who crossed over to imatinib reported higher QoL than those who remained on IFN . Semin Hematol 40(suppl 2):31 - 36 PURPOSE Quality of life ( QOL ) outcomes in patients with chronic myeloid leukemia ( CML ) were evaluated in an international phase III study . PATIENTS AND METHODS Newly diagnosed patients with chronic phase CML were r and omly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine ( IFN+LDAC ) . Cross-over to the other treatment was permitted because of intolerance or lack of efficacy . Patients completed cancer-specific QOL ( Functional Assessment of Cancer Therapy-Biologic Response Modifiers ) and utility ( Euro QoL-5D ) question naires at baseline and during treatment ( n = 1,049 ) . The primary QOL end point was the Trial Outcome Index ( TOI ; a measure of physical function and well-being ) . Secondary end points included social and family well-being ( SFWB ) , emotional well-being ( EWB ) , and the utility score . Primary analyses were intention to treat with secondary analyses accounting for cross-over . RESULTS Patients receiving IFN+LDAC experienced a large decline in the TOI , whereas those receiving imatinib maintained their baseline level . Treatment differences at each visit were significant ( P < .001 ) and clinical ly relevant in favor of imatinib . Mean SFWB , EWB , and utility scores were also significantly better for those patients taking imatinib . Patients who crossed over to imatinib experienced a large increase in TOI ; significant ( P < .001 ) differences were observed between patients who did and did not cross over in favor of imatinib . CONCLUSION Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML . In addition , patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC Imatinib mesylate ( IM ) is a first-line treatment of chronic phase-chronic myeloid leukemia ( CP-CML ) . The primary objective of this study was to assess the quality of life ( QOL ) in patients with CP-CML treated with IM . Ninety patients with newly diagnosed CP-CML were assessed for QOL with first-line IM . Patients completed the cancer-specific FACT-BRM question naire ( functional assessment of cancer therapy-biologic response modifiers ) at baseline and at 3 and 6 months . FACT-BRM consists of subscales including physical well-being ( PWB ) , social and family well-being ( SFWB ) , emotional well-being ( EWB ) , functional well-being ( FWB ) , BRM-physical , and BRM-mental . The primary endpoint was the Trial Outcome Index ( TOI ) , created as a measure of physical function and well-being . An increase of ≥5 from baseline was considered to be a clinical ly significant improvement . The mean TOI score increased from 75.5 at baseline to 85.2 ( p<0.0001 ) at 6 months , representing a healthy QOL . When comparing the individual TOI subscales , there was a mean increase of 16.4 in the daily functioning and well-being score , and a mean decrease of 6.2 , 4.9 , and 16.1 was noted in fatigue , emotional/cognitive dysfunction , and side-effects scores at 6 months , respectively . Improvement was not affected by age , sex , or Sokal score . With prolonged treatment , IM results in a higher physical well-
Output:
| The most solid data in this area indicate that CML patients receiving TKIs have a worse HRQOL profile when compared to their peers , without cancer , in the general population and interventions to improve HRQOL outcomes are thus needed .
However , HRQOL assessment in these studies emphasize the unique information provided by the patient 's perspective . |
MS212688 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Delay in follow-up after an abnormal mammogram is associated with advanced disease stage , poorer survival , and increased anxiety . Despite the implementation of many patient navigator programs across the country , there are few published , peer- review ed studies documenting its effectiveness . We tested the effectiveness of a patient navigator in improving timeliness to diagnosis , decreasing anxiety , and increasing satisfaction in urban minority women after an abnormal mammogram . Women with suspicious mammograms were r and omly assigned to usual care ( N = 50 ) or usual care plus intervention with a patient navigator ( N = 55 ) . There were no demographic differences between the two groups . Women in the intervention group had shorter times to diagnostic resolution ( mean 25.0 vs. 42.7 days ; p = .001 ) , with 22 % of women in the control group without a final diagnosis at 60 days vs. 6 % in the intervention group . The intervention group also had lower mean anxiety scores ( decrease of 8.0 in intervention vs. increase of 5.8 in control ; p < .001 ) , and higher mean satisfaction scores ( 4.3 vs. 2.9 ; p < .001 ) . Patient navigation is an effective strategy to improve timely diagnostic resolution , significantly decrease anxiety , and increase patient satisfaction among urban minority women with abnormal mammograms The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . Objectives To assess the long term psychological impact on women who were recalled for further investigation after mammography screening and to find any factors that might predict coping ability in order to identify those subjects who require additional support at an earlier stage . Setting Counties of Västerbotten and Västernorrl and , Sweden . Methods A prospect i ve design was used in which 252 recalled women completed question naires twice — once within a week of having received the all-clear and again at follow up six months later . A group of 1104 r and omly selected , screen negative women were followed up in the same way for comparison . The question naire included the Psychological Consequences Question naire ( PCQ ) and basic sociodemographic data . The main outcome measure was the total score on the PCQ at six months . Results Of the 252 women , 235 ( 93 % ) completed both question naires . In the control group , 987 ( 89.4 % ) women responded . Six months after the all-clear , recalled women were still significantly more anxious ( p<0.001 ) than those who had been screened but not recalled . The strongest predictor of psychological distress at six months was the PCQ score at the first measurement . Other predictors were a low level of education , living in high density urban areas , and having only one child or no children at all . Widows appeared to cope better than other women . Conclusions It is possible to define a group of women with false positive results who are already at risk of coping less effectively at the time of recall . Offering these women counselling or other types of support should be considered The aim was to investigate the psychological consequences of further investigation after breast cancer screening . Study participants include 509 women ( 61 % ) recalled due to suspicious findings on screening mammograms , and a matched control group of 285 women ( 68 % ) with normal mammograms . Psychological distress was prospect ively assessed with the Hospital Anxiety and Depression Scale ( HADS ) . 46 % of the women reported borderline or clinical ly significant anxiety prior to the recall visit . A few days after the visit , anxiety and depression had decreased significantly ( P<0.01 ) in women informed about normal or benign results at the recall clinic , while reported distress remained at relatively high levels in women referred to surgical biopsy . The results demonstrate the adverse short-term effect of a delay in receiving false-positive results , but do not indicate that the recall experience results in long-term anxiety or depression for a majority of women The purpose of this study was to evaluate a woman 's psychological and immunological response to breast biopsy before and after the procedure . Women were enrolled into the study when notified of the need for breast biopsy . Psychological and immunological assessment s were made at enrollment , on the day of breast biopsy , as well as 1 month and 4 months after notification of biopsy results . Psychological assessment s demonstrated that perceived stress , anxiety , and mood disturbance were heightened before biopsy and remained elevated after biopsy regardless of the diagnosis . Immunologically , the women exhibited reduced natural killer cell activity and INF gamma production before biopsy with reductions significant 1 month after the procedure . In contrast , IL-4 , IL-6 , and IL-10 production were increased before and after the procedure with most significant increases prior to the procedure and continuing 1 month after the procedure . These results demonstrate that undergoing biopsy of the breast for cancer diagnosis is an emotional experience , characterized by increased perceived stress , anxiety , and mood disturbance . This emotional distress is accompanied by reduced NK cell activity and cytokine dysregulation . The psychological and immunological impact of breast biopsy is not transient , but persists well beyond the actual experience of the biopsy procedure . Noteworthy is the observation that women with benign or malignant biopsy results experienced similar psycho-immune consequences . Hence , these observations are of relevance not only to women diagnosed with malignancy , who face the challenges of cancer treatment and adaptation to illness , but also to women with benign biopsy findings PURPOSE / OBJECTIVES To investigate distress and its association with immune function among women with suspected breast cancer . DESIGN Prospect i ve , descriptive , correlational study . SETTING An outpatient breast clinic at a tertiary urban hospital . SAMPLE A convenience sample of women who had either a fine needle aspiration or open breast biopsy for a suspicion of breast cancer . Thirty-five women comprised the study sample , 6 with malignant and 29 with benign tumors . METHODS Data were collected at three points in time . The first time ( T1 ) was after the physician visit when the need for breast biopsy was ascertained . The second time ( T2 ) was 7 - 10 days postbiopsy , and the third time ( T3 ) was 7 - 10 days after T2 . At T1 , T2 , and T3 , participants filled out the Brief Symptom Inventory ( a measure of psychological distress ) and the Adapted Symptom Distress Scale ( a measure of symptom distress ) and provided a blood sample . Demographic data also were collected at T1 . Immune function was measured by serum cytokine levels of transforming growth factor beta ( TGF beta ) and tumor necrosis factor alpha ( TNF alpha ) . MAIN RESEARCH VARIABLES Psychological distress , symptom distress , and immune function . FINDINGS Psychological distress scores were moderate to high . Symptom distress was either nonexistent or slight . Significant correlations between psychological distress and symptom distress were found at T2 and T3 . At T2 , significant relationships between psychological distress and TNF alpha and between symptom occurrence and TNF alpha were found . Psychological and symptom distress scores were significantly different between women with malignant versus benign tumors at all three times . No differences in cytokine levels were found between the groups . CONCLUSIONS These results suggest the strong effect that the diagnostic process has on psychological distress and its potential effects on immune functioning . Distress was significantly greater for women with malignant disease ; however , women with benign disease continued to have elevated levels of distress . IMPLICATION S FOR NURSING PRACTICE Nurses should be aware of the extremely stressful nature of the diagnostic phase and should continue to provide support , knowing that this distress continues throughout this phase , particularly for women diagnosed with malignancy The objective of this study was to evaluate and document pain and psychological distress related to imaging-guided core needle biopsy ( CNB ) of the breast . This prospect i ve study of 52 consecutive patients undergoing CNB of the breast assessed anxiety , pain , acute stress disorder , and activities of daily living both preprocedure and at 24 hours , 5 days , and 30 days postprocedure . Survey instruments included the State-Trait Anxiety Inventory ( STAI ) , a visual analog pain scale , the SF-36 Physical Functioning Scale , and DSM IV criteria for acute stress disorder . Preprocedure the mean scores for self-reported levels of state and trait anxiety were 47.11 ( SD = 13.53 ) and 37.71 ( SD = 11.24 ) , respectively . At 24 hours postprocedure , the mean score for self-reported state anxiety was 38.74 ( SD = 17.77 ) , a significant reduction from the preprocedure level reported by patients ( p < 0.005 ) . Further reductions in state anxiety levels were reported at 5 and 30 days postprocedure . The mean scores for state anxiety fell within the normal range at 30 days postprocedure ( mean 32.75 , SD = 10.97 ) . However , at 5 days post-CNB , patients with confirmed malignancies reported significantly more anxiety than patients without malignancies ( p = 0.002 ) . This difference was not present at 30 days post-CNB ( p = 0.17 ) . Patients reported average pain scores of 2.0 ( on a scale of 0 - 10 ) during the biopsy . This decreased to 1.3 at 24 hours , 0.3 at 5 days , and 0.2 at 30 days . Reported symptoms of acute stress related to the procedure significantly increased over the period between the 5-day interview and the 30-day interview . One ( 2 % ) patient reported avoidance of thoughts about CNB 5 days postprocedure and 5 ( 12 % ) patients reported this at 30 days postprocedure ( p < 0.05 ) . Patients undergoing CNB reported significant levels of state anxiety which were greatest at the time of biopsy . A significant decrease was observed at 24 hours postprocedure , despite the fact that biopsy results were not available to the patients . Self-reported levels of anxiety for the group , regardless of biopsy results , fell within the normal range by 30 days . Further research and interventions are recommended to address the management of anxiety for patients undergoing CNB Five community- design ed pilot projects were undertaken to reduce the time to diagnosis following an abnormal mammogram . One thous and five hundred and seventy-eight women with abnormal mammograms completed a self-administered question naire ( 71 % response ) which inquired about experiences and satisfaction with time delay from screening to diagnosis , the information received and support given by health professionals , and measures of anxiety and stress during this time interval . Four of the five pilot project initiatives shortened the time interval from screening to diagnosis , the greatest improvement occurring with facilitated referral from screening to diagnostic breast imaging . There was little difference among the pilot projects and control for most measures of client satisfaction and anxiety . Differences were found between biopsied and nonbiopsied women for several of these measures . Shortening the time to diagnosis positively influenced the client 's perception of unnecessary delay
Output:
| In a small cohort of women , distress levels are heightened to worrying levels that may have long-term implication s. There was strong evidence for relationships among medical history , education and trait anxiety with distress .
There was no substantiation of the association between younger age and increased psychological distress that has been consistently reported with other cancers . |
MS212689 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE This study evaluated the efficacy and safety of risperidone monotherapy in the treatment of acute bipolar mania . METHOD Patients with DSM-IV bipolar I disorder experiencing an acute manic episode ( baseline Young Mania Rating Scale score > /== " BORDER="0">20 ) were r and omly assigned to 3 weeks of treatment with risperidone ( flexible dose : 1 - 6 mg/day ) or placebo . The primary efficacy measure was the mean baseline-to-endpoint change in total score on the Young Mania Rating Scale . Secondary efficacy measures included the Clinical Global Impression ( CGI ) severity rating and scores on the Montgomery-Asberg Depression Rating Scale , Positive and Negative Syndrome Scale , and Global Assessment Scale ( GAS ) . Safety assessment s consisted of monitoring adverse events , vital signs , electrocardiogram and laboratory results , and scores on the Extrapyramidal Symptom Rating Scale . RESULTS Subjects ( N=259 ) received treatment with either risperidone ( N=134 ) or placebo ( N=125 ) . The mean modal dose of risperidone was 4.1 mg/day . Improvement in mean Young Mania Rating Scale total score ( adjusted for covariates ) was significantly greater in the risperidone than in the placebo group at endpoint ( mean change=-10.6 [ SD=9.5 ] versus -4.8 [ SD=9.5 ] , respectively ) , with significant between-group differences seen as early as 3 days after start of treatment ( change with risperidone : mean=-6.8 [ SD=5.8 ] ; change with placebo : mean=-4.0 [ SD=5.8 ] ) and continuing throughout all time points . Improvements in CGI severity ratings and scores on the Montgomery-Asberg Depression Rating Scale , Positive and Negative Syndrome Scale , and GAS were also significantly greater among patients receiving risperidone than those given placebo . The most common adverse event reported among risperidone patients was somnolence . While Extrapyramidal Symptom Rating Scale scores were significantly greater in patients receiving risperidone , mean total and subscale scores were low . CONCLUSIONS Risperidone monotherapy was significantly more efficacious than placebo in the treatment of acute mania and demonstrated a rapid onset of action . Risperidone was well tolerated by patients in this study The pharmacologic profile of the new proton pump inhibitor esomeprazole has demonstrated advantages over omeprazole that suggest clinical benefits for patients with acid‐related disease Background — Clinical trials have demonstrated that , compared with placebo , intensive statin therapy reduces ischemia in patients with acute coronary syndromes and in patients with stable coronary artery disease . However , no studies to date have assessed intensive versus moderate statin therapy in older patients with stable coronary syndromes . Methods and Results — A total of 893 ambulatory coronary artery disease patients ( 30 % women ) 65 to 85 years of age with ≥1 episode of myocardial ischemia that lasted ≥3 minutes during 48-hour ambulatory ECG at screening were r and omized to atorvastatin 80 mg/d or pravastatin 40 mg/d and followed up for 12 months . The primary efficacy parameter ( absolute change from baseline in total duration of ischemia at month 12 ) was significantly reduced in both groups at month 3 and month 12 ( both P<0.001 for each treatment group ) with no significant difference between the treatment groups . Atorvastatin-treated patients experienced greater low-density lipoprotein cholesterol reductions than did pravastatin-treated patients , a trend toward fewer major acute cardiovascular events ( hazard ratio , 0.71 ; 95 % confidence interval , 0.46 , 1.09 ; P=0.114 ) , and a significantly greater reduction in all-cause death ( hazard ratio , 0.33 ; 95 % confidence interval , 0.13 , 0.83 ; P=0.014 ) . Conclusions — Compared with moderate pravastatin therapy , intensive atorvastatin therapy was associated with reductions in cholesterol , major acute cardiovascular events , and death in addition to the reductions in ischemia observed with both therapies . The contrast between the therapies ’ differing efficacy for major acute cardiovascular events and death and their nonsignificant difference in efficacy for reduction of ischemia suggests that low-density lipoprotein cholesterol – lowering thresholds for ischemia and major acute cardiovascular events may differ . The Study Assessing Goals in the Elderly ( SAGE ) demonstrates that older men and women with coronary artery disease benefit from intensive statin therapy BACKGROUND Despite the use of aspirin , there is still a risk of ischaemic events after percutaneous coronary intervention ( PCI ) . We aim ed to find out whether , in addition to aspirin , pretreatment with clopidogrel followed by long-term therapy after PCI is superior to a strategy of no pretreatment and short-term therapy for only 4 weeks after PCI . METHODS 2658 patients with non-ST-elevation acute coronary syndrome undergoing PCI in the CURE study had been r and omly assigned double-blind treatment with clopidogrel ( n=1313 ) or placebo ( n=1345 ) . Patients were pretreated with aspirin and study drug for a median of 6 days before PCI during the initial hospital admission , and for a median of 10 days overall . After PCI , most patients ( > 80 % ) in both groups received open-label thienopyridine for about 4 weeks , after which study drug was restarted for a mean of 8 months . The primary endpoint was a composite of cardiovascular death , myocardial infa rct ion , or urgent target-vessel revascularisation within 30 days of PCI . The main analysis was by intention to treat . FINDINGS There were no drop-outs . 59 ( 4.5 % ) patients in the clopidogrel group had the primary endpoint , compared with 86 ( 6.4 % ) in the placebo group ( relative risk 0.70 [ 95 % CI 0.50 - 0.97 ] , p=0.03 ) . Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death , myocardial infa rct ion , or any revascularisation ( p=0.03 ) , and of cardiovascular death or myocardial infa rct ion ( p=0.047 ) . Overall ( including events before and after PCI ) there was a 31 % reduction cardiovascular death or myocardial infa rct ion ( p=0.002 ) . There was less use of glycoprotein IIb/IIIa inhibitor in the clopidogrel group ( p=0.001 ) . At follow-up , there was no significant difference in major bleeding between the groups ( p=0.64 ) . INTERPRETATION In patients with acute coronary syndrome receiving aspirin , a strategy of clopidogrel pretreatment followed by long-term therapy is beneficial in reducing major cardiovascular events , compared with placebo BACKGROUND The objective of the current study was to examine possible clinical predictors of positive response to lamotrigine or gabapentin monotherapy in treatment-refractory affectively ill patients . METHODS Forty-five patients with treatment refractory bipolar ( n = 35 ) or unipolar ( n = 10 ) affective disorder participated in a clinical study evaluating six weeks of treatment with lamotrigine , gabapentin , or placebo monotherapy given in a double-blind , r and omized fashion with two subsequent cross-overs to the other agents . Patients received daily mood ratings and weekly cross-sectional scales . Much or very much improved on the Clinical Global Impression scale modified for bipolar illness was considered a positive response . Degree of response was correlated with a number of baseline demographic and course of illness variables in a univariate analysis and then by linear regression . RESULTS Response rates to lamotrigine ( 51 % ) exceeded those to gabapentin ( 28 % ) and placebo ( 21 % ) . A positive response to lamotrigine monotherapy was associated with a bipolar diagnosis ; fewer hospitalizations ; fewer prior medication trials ; and male gender ( of which the latter two variables survived logistic regression ) . For gabapentin , degree of response correlated with shorter duration of illness ; younger age ; and lower baseline weight ( with the latter two surviving linear regression ) . CONCLUSIONS In this highly treatment-refractory population , lamotrigine appeared most effective for male patients with fewer prior medication trials . Gabapentin monotherapy , although not better than placebo , appeared most effective in those with younger age and lower baseline weight . These preliminary data in a treatment refractory subgroup may help in the further definition of the range of clinical utility of these widely used anticonvulsants OBJECTIVE To identify factors predicting response to first TNF blocking treatment course in patients with established RA with a special focus on gender differences . METHODS Patients with active RA initiating their first treatment course of TNF-blocking therapy were enrolled . The study period was March 1999 through September 2006 . The prospect i ve protocol included information on demographics , clinical characteristics of patients and response measures . Fulfilment of ACR 50 - 70 % improvement and European League Against Rheumatism ( EULAR ) good response or remission [ 28-joint disease activity score ( DAS28 ) < 2.6 ] at 3 months were chosen as primary outcome measures . Potential predictors of responses were identified using multivariate binary logistic regression models . RESULTS In total , 1565 patients were included in the study . Gender did not influence treatment response . Consistently , concomitant methotrexate ( MTX ) was significantly associated with EULAR remission , EULAR good response , ACR50 response and ACR70 response with odds ratios ( ORs ) 1.97 , 2.13 , 2.10 and 1.75 , respectively . Concurrent treatment with other DMARDs was also significantly associated with EULAR remission , EULAR good response and ACR50 response ( OR : 1.96 , 2.24 and 1.94 , respectively ) . Likewise , low HAQ at baseline consistently predicted good clinical outcome . Disease activity at baseline was directly associated with favourable response when measured by ACR50 and ACR70 ( OR : 1.59 and 1.60 , respectively ) , whereas DAS28 score at baseline was inversely associated with EULAR remission ( OR : 0.78 ) . CONCLUSIONS In this observational study of patients with established RA , gender did not predict response to anti-TNF therapy , whereas treatment with concomitant DMARDs , especially MTX and low disability were associated with good response . Choice of outcome measures may influence the predictive value of baseline features AIM To compare the efficacy , safety and tolerability of a fixed combination glyburide/metformin preparation with those of glyburide or metformin alone in patients with type 2 diabetes inadequately controlled by sulphonylurea , diet and exercise . METHODS In this 16-week , r and omized , double-blind , parallel group study , 639 patients with inadequate glycaemic control on at least half-maximal dose of sulphonylurea were r and omly assigned to : glyburide 10 mg b.i.d . ( n = 164 ) ; metformin 500 mg ( n = 153 ) ; glyburide/metformin 2.5 mg/500 mg ( n = 160 ) ; or glyburide/metformin 5 mg/500 mg ( n = 162 ) . Titration was allowed to maximum doses of 2000 mg for metformin or 10 mg/2000 mg and 20 mg/2000 mg for glyburide/metformin 2.5 mg/500 mg and 5 mg/500 mg respectively . The primary outcome measure was HbA1c level after 16 weeks ; secondary end-points included fasting and 2-h post-pr and ial plasma glucose . Adverse events ( AEs ) were recorded and summarized by treatment group . RESULTS Both strengths of glyburide/metformin equally reduced mean HbA1c by 1.7 % more than did glyburide alone ( p < 0.001 ) , and by 1.9 % more than did metformin alone ( p < 0.001 ) . Final mean fasting plasma glucose concentrations were also lower in both glyburide/metformin groups than in the glyburide ( -2.8 mmol/l , -51.3 mg/dl ; p < 0.001 ) and metformin groups ( -3.6 mmol/l , -64.2 mg/dl ; p < 0.001 ) . Safety and tolerability were similar across all treatment groups , except for a higher incidence of gastrointestinal AEs in the metformin monotherapy group , and more patients reporting mild or moderate symptoms of hypoglycaemia while taking glyburide/metformin . CONCLUSIONS Both glyburide/metformin tablet strengths produced , with equal efficacy , significantly better glycaemic control than monotherapy with either agent . These data also confirm that glycaemic efficacy does not require maximal sulphonylurea doses in combination with metformin AIMS In observational studies , prolonged lower blood total cholesterol levels - down at least to 3 mmol . l-1 - are associated
Output:
| Findings , based on 59 studies and data of more than 250,000 patients suggested that for the majority of drugs no substantial differences in efficacy and safety exist between men and women .
Some clinical ly important exceptions , however , were apparent : women experienced substantially lower response rates with newer antiemetics than men ( 45 % vs. 58 % ; relative risk 1.49 , 95 % confidence interval 1.35 - 1.64 ) ; men had higher rates of sexual dysfunction than women while on paroxetine for major depressive disorder ; women discontinued lovastatin more frequently than men because of adverse events .
Overall , for the majority of drugs sex does not appear to be a factor that has to be taken into consideration when choosing a drug treatment . |
MS212690 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: An interactive , self- study learning system for airway management instruction that utilizes a “ sensorized ” manikin head ( Actronics Inc. , Pittsburgh , PA ) was compared to didactic instruction from anesthesiologists during third-year medical student anesthesia rotations . Before students were allowed to participate in airway management on anesthetized patients , they were r and omly separated into two groups . One group received instruction from the learning system , and the other group was given a lecture with guided practice on a st and ard tracheal intubating manikin . Differences between groups were then assessed using 22 separate variables as all students performed actual airway management on patients undergoing general anesthesia . Anesthesia faculty , residents , and nurse anesthetists , blinded to group , served as assessors . There were 48 and 49 students in the didactic instruction and learning system groups , respectively . Beginning experience level of students with respect to airway management was similar between groups before the anesthesia rotations . There were 185 and 188 evaluation forms completed to assess the didactic instruction and learning system groups , respectively . Demographic data regarding patients were recorded . Patients in the learning system group on whom students performed airway management were older , had a larger average body mass index , and their airways more frequently received higher Mallampati classifications ( glottic structures more difficult to visualize ) . No difference in the quality of airway management efforts or in students ' appraisal of their own performances was seen between groups . Neither group demonstrated more rapid development of psychomotor skills . Students were equally satisfied with both methods of instruction . We conclude that the airway management self- study learning system is as efficacious as didactic instruction for pre clinical airway management instruction during third-year medical student anesthesia rotations Objective : To compare the usefulness for training of a porcine model ( larynx , trachea , and pig skin ) and a manikin model using a Portex cricothyrotomy kit ( PCK ) . Methods : In a prospect i ve r and omised crossover trial , participants in the airway workshop performed crico-thyrotomy using a PCK on the porcine and manikin models ( Tracheostomy Trainer and Case ) . The porcine model was made with larynxes and trachea from freshly slaughtered pigs and covered with a piece of thinned pigskin stapled to a wooden board . Participants were asked to assess the following : reality of skin turgor ; difficulty with skin penetration , l and mark recognition and procedure ; reality of the model ; and preference for each model using a visual analogue scale ( VAS ) of 0–10 cm . The VAS scores for each model were compared . Results : 49 participants were included in the study . Mean ( SD ) VAS scores for the reality of skin turgor , degree of difficulty with skin penetration and l and mark recognition were higher with the porcine model than with the manikin model ( 7.0 ( 2.1 ) vs 4.7 ( 2.0 ) , 6.4 ( 2.4 ) vs 3.6 ( 2.2 ) , 5.1 ( 2.2 ) vs 4.2 ( 2.5 ) , respectively ) . There was no difference between the models in the difficulty of the procedure ( 5.0 ( 2.4 ) vs 4.7 ( 3.2 ) ) . The porcine model had a higher VAS score for overall reality and preference of the model ( 7.1 ( 2.0 ) vs 4.8 ( 2.3 ) and 7.1 ( 2.0 ) vs 4.8 ( 2.2 ) , respectively ) . Conclusion : The porcine model is a more useful training tool than the manikin model for cricothyrotomy with PCK because of its reality and similarity to human anatomy INTRODUCTION The human patient simulator has proved to be an effective educational device for teaching physicians and paramedical personnel . METHODOLOGY To determine whether veterinary medicine students would benefit from similar educational sessions , 90 students each took a turn being the patient 's clinician as real-life scenarios were played out on the simulator . The students induced and maintained anesthesia on their patient and monitored vital signs . Several critical events were presented for the students to diagnose and treat as they occurred . All students su bmi tted a written evaluation of the course upon completion . The last 40 students were r and omly divided into two groups of 20 students each . The students in Group I experienced the simulator before their clerkship examination , and those in Group II took the examination before their simulator experience . RESULTS The students rapidly gained confidence in treating their simulated patient . This carried over to the clinical setting , where they appeared to be more confident when anesthetizing live patients . The simulator experience brought together much of the previous didactic material that they had been exposed to so they could appreciate its clinical relevance . The overwhelming response to the simulator experience was positive . The students in Group I had a significantly higher score on the clerkship examination dealing with concepts review ed by simulation than those in Group II , who engaged in self- study instead of the simulation exercise ( p < 0.001 ) . CONCLUSION We conclude that the human patient simulator was a valuable learning tool for students of veterinary medicine . It was exciting for the students to work with , made them deal with " real-life " scenarios , permitted them to learn without subjecting live patients to complications , enabled them to retrace their steps when their therapy did not correct the simulated patient 's problems , and facilitated correlation of their basic science knowledge with clinical data , thus accelerating their ability to h and le complex clinical problems in healthy and diseased patients Background With increasing pressure to use operating room time efficiently , opportunities for residents to learn fiberoptic orotracheal intubation in the operating room have declined . The purpose of this study was to determine whether fiberoptic orotracheal intubation skills learned outside the operating room on a simple model could be transferred into the clinical setting . Methods First-year anesthesiology residents and first- and second-year internal medicine residents were recruited . Subjects were r and omized to a didactic-teaching-only group ( n = 12 ) or a model-training group ( n = 12 ) . The didactic-teaching group received a detailed lecture from an expert bronchoscopist . The model-training group was guided , by experts , through tasks performed on a simple model design ed to refine fiberoptic manipulation skills . After the training session , subjects performed a fiberoptic orotracheal intubation on healthy , consenting , anesthetized , paralyzed female patients undergoing elective surgery with predicted “ easy ” laryngoscopic intubations . Two blinded anesthesiologists evaluated each subject . Results After the training session , the model group significantly outperformed the didactic group in the operating room when evaluated with a global rating scale ( P < 0.01 ) and checklist ( P < 0.05 ) . Model-trained subjects completed the fiberoptic orotracheal intubation significantly faster than didactic-trained subjects ( P < 0.01 ) . Model-trained subjects were also more successful at achieving tracheal intubation than the didactic group ( P < 0.005 ) . Conclusion Fiberoptic orotracheal intubation skills training on a simple model is more effective than conventional didactic instruction for transfer to the clinical setting . Incorporating an extraoperative model into the training of fiberoptic orotracheal intubation may greatly reduce the time and pressures that accompany teaching this skill in the operating room GOAL Isolate and evaluate the impact of mental imagery on the acquisition of an emergency surgical technique . METHOD We studied 44 first-year medical students performing a cricothyrotomy on a mannequin to determine the impact of teaching using mental imagery ( MI ) and /or kinesiology ( KG ) compared to the st and ard Adv and ec Trauma Life Support ( ATLS ) approach . Students were r and omly assigned to one of three groups : MI and KG , KG alone or control ( ATLS ) . Two weeks after the one-hour teaching session , they were evaluated with an OSCE testing the performance of the different steps of the technique , the time required and its fluidity . RESULTS Total results ( maximum : 25 marks ) are as follows : KG + MI = 20.3 + /- 1.5 ; KG = 19.3 + /- 2.9 ; ATLS = 18.2 + /- 2.5 . The only statistically significant difference for total results was in the use of MI and KG compared to the control group . Kinesiology alone or with mental imagery improved the fluidity of the performance . CONCLUSION Many factors influence the acquisition of a surgical technique . This study showed that acquisition and performance of an emergency procedure ( cricothyrotomy ) was improved when mental imagery and kinesiology were combined to teach it Abstract Simulation-based teaching ( SBT ) is increasingly used in medical education . As an alternative to other teaching methods there is a lack of evidence concerning its efficacy . The aim of this study was to evaluate the potency of SBT in anesthesia in comparison to problem-based discussion ( PBD ) with students in a r and omized controlled setting . Thirty-three fourth-year medical students attending a curricular anesthesiology course were r and omly allocated to either a session of SBT or a session of PBD on an emergency induction method . Ten days later all students underwent examination in a simulator . The performance of each student was evaluated by weighted tasks , established according to a modified Delphi process . Confidence and a multiple-choice question naire were additionally performed pre- and post-intervention . A total of 32 students completed the study . Participants in the SBT group presented with significantly higher self- assessment scores after the intervention than students in the PBD group . However , students in the SBT group achieved only slightly and statistically insignificantly higher scores in the theoretical and simulator examination ( p > 0.05 ) with only a moderate effect size of d = 0.52 . The current study demonstrates that both PBD and SBT lead to comparable short-term outcomes in theoretical knowledge and clinical skills . However , undesirably , SBT students overrated their anticipated clinical abilities and knowledge improvement OBJECTIVE To compare the ' 4-stage ' teaching technique ( demonstration , deconstruction , formulation , performance ) with the traditional ' 2-stage ' teaching technique ( deconstruction , performance ) in laryngeal mask airway ( LMA ) insertion . METHODS Using a prospect i ve r and omised study design , participants were taught LMA insertion on a manikin by either the ' 2-stage ' or ' 4-stage ' teaching method . Subjects were eligible if they had never inserted a LMA . Skill acquisition was assessed immediately following training , and skill retention assessed a number of weeks later . The primary outcome was LMA insertion on a manikin , with successful ventilation within 30 s. Other outcomes included overall time to LMA insertion , and number of errors . Assessors were blinded to the teaching method used for each subject . RESULTS A total of 120 participants were r and omised between the two teaching groups ( 60 subjects in each group ) . Mean time to LMA insertion at acquisition was 39.7 s for 2-stage and 34.7 s for 4-stage ( p>0.05 ) , and proportion completing within 30 s was 41.67 % for 2-stage and 48.33 % for the 4-stage teaching group ( p>0.05 ) . With skill retention assessment , mean time to LMA insertion was 44.3 s for 2-stage and 42.5 s for the 4-stage teaching group ( p>0.05 ) . Proportion completing task within 30 s was 34.0 % for 2-stage and 41.67 % for 4-stage group ( p>0.05 ) . Overall , there was no significant difference found in skill acquisition or in skill retention between the 2 or 4-stage teaching method . CONCLUSION The 2-stage teaching technique is not statistically different to the 4-stage teaching method in efficacy of LMA insertion skill acquisition or retention OBJECTIVES The primary purpose of this study was to determine whether the endotracheal intubation ( ETI ) success rate is different among paramedic students trained on a human patient simulator versus on human subjects in the operating room ( OR ) . METHODS Paramedic students ( n = 36 ) with no prior ETI training received identical didactic and mannequin teaching . After r and omization , students were trained for ten hours on a patient simulator ( SIM ) or with 15 intubations on human subjects in the OR . All students then underwent a formalized test of 15 intubations in the OR . The primary outcome was the rate of successful intubation . Secondary outcomes were the success rate at first attempt and the complication rate . The study was powered to detect a 10 % difference for the overall success rate ( alpha = 0.05 , beta = 0.20 ) . RESULTS The overall intubation success rate was 87.8 % in the SIM group and 84.8 % in the OR group ( difference of 3.0 % [ 95 % confidence interval { CI } = -4.2 % to 10.1 % ; p = 0.42 ] ) . The success rate on the first attempt was 84.4 % in the SIM group and 80.0 % in the OR group ( difference of 4.4 % [ 95 % CI = -3.4 % to 12.3 % ; p = 0.27 ] ) . The complication rate was 6.3 % in the SIM group and 4.4 % in the OR group ( difference of 1.9 % [ 95 % CI = -2.9 % to 6.6 % ; p = 0.44 ] ) . CONCLUSIONS When tested in the OR , paramedic students who were trained in ETI on a simulator are as effective as students who trained on human subjects . The results support using simulators to teach ETI Introduction : Major resuscitation councils endorse the use of the laryngeal mask airway ( LMA ) by paramedics for lifesaving airway interventions . Learning and maintaining adequate skill level is important for patient safety . The aim of this project was to develop a training program that provides student paramedics with initial knowledge and experience in LMA insertion skills
Output:
| Simulation-based airway management curriculum is superior to no intervention and nonsimulation intervention for important education outcomes . |
MS212691 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 Postnatal women ( < 12 months postpartum ) are at increased risk of physical inactivity . Purpose To evaluate the efficacy and feasibility of a theory-based physical activity ( PA ) intervention delivered to postnatal women primarily via mobile telephone short message service ( SMS ) . Methods Eighty-eight women were r and omized to the intervention ( n = 45 ) or minimal contact control ( n = 43 ) condition . The 12-week intervention consisted of a face-to-face PA goal - setting consultation , a goal - setting magnet , three to five personally tailored SMS/week and a nominated support person who received two SMS per week . SMS content targeted constructs of social cognitive theory . Frequency ( days/week ) and duration ( min/week ) of PA participation and walking for exercise were assessed via self-report at baseline , 6 and 13 weeks . Results Intervention participants increased PA frequency by 1.82 days/week ( SE ± 0.18 ) by 13 weeks ( F(2,85 ) = 4.46 , p = 0.038 ) and walking for exercise frequency by 1.08 days/week ( SE ± 0.24 ) by 13 weeks ( F(2,85 ) = 5.38 , p = 0.02 ) . Positive trends were observed for duration ( min/week ) of PA and walking for exercise . Conclusions Intervention exposure result ed in increased frequency of PA and walking for exercise in postnatal women Background Recent studies have shown the potential of Web-based interventions for changing dietary and physical activity ( PA ) behavior . However , the pathways of these changes are not clear . In addition , nonusage poses a threat to these interventions . Little is known of characteristics of participants that predict usage . Objective In this study we investigated the users and effect of the Healthy Weight Assistant ( HWA ) , a Web-based intervention aim ed at healthy dietary and PA behavior . We investigated the value of a proposed framework ( including social and economic factors , condition-related factors , patient-related factors , reasons for use , and satisfaction ) to predict which participants are users and which participants are nonusers . Additionally , we investigated the effectiveness of the HWA on the primary outcomes , self-reported dietary and physical activity behavior . Methods Our design was a two-armed r and omized controlled trial that compared the HWA with a waiting list control condition . A total of 150 participants were allocated to the waiting list group , and 147 participants were allocated to the intervention group . Online question naires were filled out before the intervention period started and after the intervention period of 12 weeks . After the intervention period , respondents in the waiting list group could use the intervention . Objective usage data was obtained from the application itself . Results In the intervention group , 64 % ( 81/147 ) of respondents used the HWA at least once and were categorized as “ users . ” Of these , 49 % ( 40/81 ) used the application only once . Increased age and not having a chronic condition increased the odds of having used the HWA ( age : beta = 0.04 , P = .02 ; chronic condition : beta = 2.24 , P = .003 ) . Within the intervention group , users scored better on dietary behavior and on knowledge about healthy behavior than nonusers ( self-reported diet : χ2 2 = 8.4 , P = .02 ; knowledge : F1,125 = 4.194 , P = .04 ) . Furthermore , users underestimated their behavior more often than nonusers , and nonusers overestimated their behavior more often than users ( insight into dietary behavior : χ2 2 = 8.2 , P = .02 ) . Intention-to-treat analyses showed no meaningful significant effects of the intervention . Exploratory analyses of differences between pretest and posttest scores of users , nonusers , and the control group showed that on dietary behavior only the nonusers significantly improved ( effect size r = −.23 , P = .03 ) , while on physical activity behavior only the users significantly improved ( effect size r = −.17 , P = .03 ) . Conclusions Respondents did not use the application as intended . From the proposed framework , a social and economic factor ( age ) and a condition-related factor ( chronic condition ) predicted usage . Moreover , users were healthier and more knowledgeable about healthy behavior than nonusers . We found no apparent effects of the intervention , although exploratory analyses showed that choosing to use or not to use the intervention led to different outcomes . Combined with the differences between groups at baseline , this seems to imply that these groups are truly different and should be treated as separate entities . Trial registration Trial ID number : IS RCT N42687923 ; http://www.controlled-trials.com/IS RCT N42687923/ ( Archived by WebCite at http://www.webcitation.org/5xnGmvQ9Y The aim of this study was to evaluate dietary changes during and after a dietary treatment shown to result in significant and sustained weight loss among lactating overweight and obese women . This is crucial before clinical implementation . Data were collected from the LEVA ( in Swedish : Livsstil för Effektiv Viktminskning under Amning [ Lifestyle for Effective Weight Loss During Lactation ] ) r and omized controlled factorial trial with a 12-week intervention and a 1-year follow up . At 10 to 14 weeks postpartum , 68 lactating Swedish women with a prepregnancy body mass index ( calculated as kg/m(2 ) ) of 25 to 35 were r and omized to structured dietary treatment , physical exercise treatment , combined treatment , or usual care ( controls ) for a 12-week intervention , with a 1-year follow-up . Dietary intake was assessed with 4-day weighed dietary records . Recruitment took place between 2007 and 2010 . The main outcome measures were changes in macro- and micronutrient intake from baseline to 12 weeks and 1 year . Main and interaction effects of the treatments were analyzed by a 2 × 2 factorial approach using a General Linear Model adjusted for relevant covariates ( baseline intake and estimated underreporting ) . It was found that at baseline , the women had an intake of fat and sucrose above , and an intake of total carbohydrates and fiber below , recommended levels . At 12 weeks and 1 year , the dietary treatment led to reduced intake of energy ( P<0.001 and P=0.005 , respectively ) , fat ( both P values < 0.001 ) , and sucrose ( P<0.001 and P=0.050 ) . At 12 weeks , total carbohydrates were reduced ( P<0.001 ) . A majority of women in all groups reported low intakes of vitamin D , folate , and /or iron . In conclusion , a novel dietary treatment led to reduced intake of fat and carbohydrates . Diet composition changed to decreased proportions of fat and sucrose , and increased proportions of complex carbohydrates , protein and fiber . Weight loss through dietary treatment was achieved with a diet in line with macronutrient recommendations Background Weight gain during the childbearing years and failure to lose pregnancy weight after birth contribute to the development of obesity in postpartum Latinas . Methods Madres para la Salud [ Mothers for Health ] was a 12-month , r and omized controlled trial exploring a social support intervention with moderate-intensity physical activity ( PA ) seeking to effect changes in body fat , fat tissue inflammation , and depression symptoms in sedentary postpartum Latinas . This report describes the efficacy of the Madres intervention . Results The results show that while social support increased during the active intervention delivery , it declined to pre-intervention levels by the end of the intervention . There were significant achievements in aerobic and total steps across the 12 months of the intervention , and declines in body adiposity assessed with bioelectric impedance . Conclusions Social support from family and friends mediated increases in aerobic PA result ing in decrease in percent body fat . Trial registration Clinical Trials.gov Identifier : NCT01908959 OBJECTIVE To examine the feasibility , acceptability , and initial efficacy of a technology-based weight loss intervention for urban , low-income mothers . METHODS Eighteen obese , ethnic minority , socioeconomically disadvantaged mothers in the first year after childbirth were r and omly assigned to either : 1 ) technology-based intervention , which included empirically supported behavior-change strategies , daily skills , and self-monitoring text messages with personalized feedback , biweekly counseling calls from a health coach , and access to a Facebook support group , or 2 ) usual-care control . RESULTS After 14 weeks of treatment , the technology-based intervention participants had significantly greater weight loss ( -2.9 ± 3.6 kg ) than usual care ( 0.5 ± 2.3 kg ; adjusted mean difference : -3.2 kg , 95 % confidence interval -6.2 to -0.1 kg , P = .04 ) . One-third of intervention participants ( 3 of 9 ) and no control participants lost > 5 % of their initial body weight at follow up . CONCLUSIONS AND IMPLICATION S Results suggest the potential for using technology to deliver a postpartum weight loss intervention among low-income racial/ethnic minorities OBJECTIVE Optimizing gestational weight gain ( GWG ) in early pregnancy is of clinical and public health importance , especially in higher risk pregnancies . DESIGN AND METHODS In a robustly design ed , r and omized controlled trial , 228 pregnant women at risk of developing gestational diabetes mellitus ( GDM ) were allocated to either control ( written health information only ) or intervention ( four-session lifestyle program ) . All women received st and ard maternal care . Measures were completed at 12 - 15 and 26 - 28 weeks gestation . Measures included anthropometrics ( weight and height ) , physical activity ( pedometer and International Physical Activity Question naire ) , question naires ( risk perception ) , and GDM screening . RESULTS The mean ( SD ) age [ 31.7 ( 4.5 ) and 32.4 ( 4.7 ) years ] and body mass index [ BMI ; 30.3 ( 5.9 ) and 30.4 ( 5.6 ) kg/m(2 ) ] were similar between control and intervention groups , respectively . By 28 weeks , GWG was significantly different between control and intervention groups [ 6.9 ( 3.3 ) vs. 6.0 ( 2.8 ) kg , P < 0.05 ] . When stratified according to baseline BMI , overweight women in the control group gained significantly more weight compared to overweight women in the intervention group [ 7.8 ( 3.4 ) vs. 6.0 ( 2.2 ) kg , P < 0.05 ] , yet in obese women , GWG was similar in both groups . Physical activity levels declined by 28 weeks gestation overall ( P < 0.01 ) ; however , the intervention group retained a 20 % higher step count compared to controls [ 5,203 ( 3,368 ) vs. 4,140 ( 2,420 ) steps/day , P < 0.05 ] . Overall , GDM prevalence was 22.8 % [ Corrected ] , with a trend toward less cases in the intervention group ( P = 0.1 ) . CONCLUSIONS Results indicate that a low-intensity lifestyle intervention , integrated with antenatal care , optimizes healthy GWG and attenuates physical activity decline in early pregnancy . Efficacy in limiting weight gain was greatest in overweight women and in high-risk ethnically diverse women OBJECTIVE To determine if an interactive , computerized Video Doctor counseling tool improves self-reported diet and exercise in pregnant women . METHODS A r and omized trial comparing a Video Doctor intervention to usual care in ethnically diverse , low-income , English-speaking pregnant women was conducted . Brief messages about diet , exercise , and weight gain were delivered by an actor-portrayed Video Doctor twice during pregnancy . RESULTS In the Video Doctor group ( n=158 ) , there were statistically significant increases from baseline in exercise ( + 28 min ) , intake of fruits and vegetables , whole grains , fish , avocado and nuts , and significant decreases in intake of sugary foods , refined grains , high fat meats , fried foods , solid fats , and fast food . In contrast , there were no changes from baseline for any of these outcomes in the usual care group ( n=163 ) . Nutrition knowledge improved significantly over time in both groups but more so in the Video Doctor group . Clinician-patient discussion s about these topics occurred significantly more frequently in the Video Doctor group . There was no difference in weight gain between groups . CONCLUSION A brief Video Doctor intervention can improve exercise and dietary behaviors in pregnant women . PRACTICE IMPLICATION S The Video Doctor can be integrated into prenatal care to assist clinicians with effective diet and exercise counseling BACKGROUND Behavioural interventions might improve clinical outcomes in pregnant women who are obese . We aim ed to investigate whether a complex intervention addressing diet and physical activity could reduce the incidence of gestational diabetes and large-for-gestational-age infants . METHODS The UK Pregnancies Better Eating and Activity Trial ( UPBEAT ) is a r and omised controlled trial done at antenatal clinics in eight hospitals in multi-ethnic , inner-city locations in the UK . We recruited pregnant women ( 15 - 18 weeks plus 6 days of gestation ) older than 16 years who were obese ( BMI ≥30 kg/m(2 ) ) . We r and omly assigned participants to either a behavioural intervention or st and ard antenatal care with an internet-based , computer-generated , r and omisation procedure , minimising by age , ethnic origin , centre , BMI , and par
Output:
| The meta-analyses demonstrated a significant result for limiting gestational weight gain , losing postnatal weight in 1 - 2 months , increasing self-reported moderate and vigorous physical activity and reducing caloric intake using diet-related software .
Our review shows that an e-based lifestyle intervention is an acceptable approach . |
MS212692 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE This prospect i ve study evaluated the neurosensory recovery pattern of the inferior alveolar nerve following the bilateral sagittal split osteotomy ( BSSO ) . PATIENTS AND METHODS Forty-two consecutive patients undergoing BSSO were studied using five neurosensory tests : 1 ) static light touch , 2 ) moving touch discrimination , 3 ) two-point discrimination , 4 ) nociception , and 5 ) thermoreception . Intraoperative assessment of inferior alveolar nerve damage was made ; other variables recorded included type of fixation , age , concomitant procedures , advancement vs setback , and magnitude of the movement . A subjective question naire was completed by the patient . RESULTS The variables that affected neurosensory function following BSSO were degree of nerve damage and the amount of time elapsed following surgery . Larger myelinated fibers ( A-alpha ) recovered slower and to a lesser degree at all time intervals up to 2 years when compared with small myelinated and unmyelinated nerve fibers . The magnitude of nerve damage directly correlated with early neurosensory deficit , but equalized over time . CONCLUSION The long term ( 6 months and greater ) chance for neurosensory recovery is good despite intraoperative nerve manipulation . Patients seem to adapt and report normal neurosensory function even though objective testing indicates continued neurosensory deficit Three hundred seventeen normal fingers and 612 fingers in 153 h and s with carpal tunnel syndrome were tested for sensibility using the Weinstein Enhanced Sensory Test ( WEST ) with calibrated monofilaments , by static two-point discrimination ( s2PD ) and moving two-point discrimination ( m2PD ) , using the Disk-Criminator , and by Strauch 's ten test . Equivalent Semmes-Weinstein monofilament ( SWM ) test values were also determined as a gold st and ard for comparison . With both the WEST and SWM test values , the norms for interpretation have an unacceptably wide latitude because of the use of an ordinal scale of increasingly unequal intervals . With the WEST and Disk-Criminator tests , some cases of early sensory loss were missed . The SWM test apparatus , although producing relatively reliable values , is not easily portable , and its use is time-consuming in a busy office ; the WEST device is prohibitively expensive . The ten test is rapid , simple , and sensitive in evaluation . It measures sensibility on a continuous analog scale , and allows for multiple points of testing in the h and , with good inter- and intra-examiner reliability . It is accurate in detecting very early loss of sensibility . In addition , the ten test requires no instrumentation Objectives Semmes-Weinstein monofilaments are too long for use in parts of the oral cavity . The present study used shortened Semmes-Weinstein monofilaments to evaluate reliability and spatial differences in the intraoral tactile detection threshold ( TDT ) and the filament-prick pain detection threshold ( FPT ) in healthy volunteers . Methods For practical purpose s , classic Semmes-Weinstein monofilaments with 20 different diameters were cut to half their length ( ie , 19 mm ) and the bending forces were measured . Eighteen men and 18 women ( age range , 20 to 33 y ) were recruited to evaluate the reliability and reproducibility of measurements using half-cut monofilaments . The TDT and the FPT were measured on the labial maxillary gingiva , on the palatal maxillary gingiva , and at the anterior tip of the tongue , using a double r and om staircase method . Results According to the forces needed to bend the half-cut filaments , they were renumbered from 2.55 to 6.86 . There were significant differences of bending force between the half-cut and original monofilaments ( P<0.001 ) , Using half-cut filaments , the following differences could be detected ; the labial maxillary gingiva had a significantly higher TDT threshold compared with the other test sites ( P<0.001 ) . By contrast , the palatal posterior maxillary gingiva had a significantly higher FPT threshold compared with the other test sites ( P<0.001 ) . Discussion s The present study illustrated that in healthy participants , half-cut Semmes-Weinstein monofilaments reliably and easily assess TDT and FPT intraorally . A combined examination of sensory and pain thresholds using these filaments contributes to the clinical examination for orofacial pain The aim of this study was to conduct a prospect i ve clinical trial comparing the neurosensory function of the inferior alveolar nerve ( IAN ) after m and ibular advancement surgery with either bilateral sagittal split osteotomies ( BSSO ) or m and ibular distraction ostoegenesis ( MDO ) . 23 Class II m and ibular hypoplasia patients requiring m and ibular advancement were r and omized into two groups for either BSSO or MDO . Subjective and objective neurosensory evaluations were performed preoperatively and at the following postoperative times : 2 weeks ( TBD1 ) , 6 weeks ( TBD2 ) , 12 weeks ( TBD3 ) , 6 months ( TBD4 ) and 12 months ( TBD5 ) . Subjective evaluation included the use of a visual analogue scale ( VAS ) . Objective evaluation included the use of light touch ( LT ) , two-point discrimination ( 2PD ) and pain detection threshold ( PD ) tests . Intra-operative or postoperative complications were recorded . Using a mixed model , no significant differences were reported in subjective VAS scores and objective LT , 2PD and PD scores between the BSSO and MDO groups over 12 months ( p>0.05 ) . Common postoperative complications included localized wound infection ( BSSO=2 , MDO=6 ) and condylar resorption ( BSSO=1 , MDO=1 ) PURPOSE The purpose of this analysis was to compare the frequency and severity of nerve damage with rigid and wire fixation in patients participating in a prospect i ve , r and omized clinical trial . PATIENTS AND METHODS One hundred twenty-six patients who required a bilateral sagittal split osteotomy and m and ibular advancement were r and omly assigned to receive either rigid or wire fixation . Tactile sensation in the mental nerve region bilaterally was determined presurgically and throughout the subsequent 2 years by using monofilament detection and brush stroke direction . Neurosensory levels were compared between the types of fixation over time . RESULTS Evaluation with monofilament detection showed no significant difference between types of fixation throughout the 2-year follow-up . However , brush stroke determination showed significantly greater hypesthesia with rigid compared with wire fixation from 8 weeks through 2 years postoperatively . CONCLUSION Rigid fixation result ed in more anesthesia in the mental nerve distribution than wire fixation when tested with brush stroke direction . However , increased anesthesia was not present when measured with monofilament determination PURPOSE This study investigated neurosensory disturbances in patients after orthognathic surgery in relation to differences in m and ibular splitting methods and degree of surgical skill . PATIENTS AND METHODS Forty-five patients who had undergone bilateral sagittal split ramus osteotomies ( SSRO ) , and 21 ( group L ) who had undergone intraoral inverted L ramus osteotomies ( ILRO ) , were examined for postsurgical neurosensory disturbances . Twenty-two ( group S1 ) of the SSRO patients were treated by 11 surgeons who had little experience , and the others ( 23 patients ; group S2 ) were treated by 2 skilled surgeons who had considerable experience . One of the 2 skilled surgeons was the only surgeon carrying out the ILRO procedure . The neurosensory tests employed included light touching using a Semmes-Weinstein monofilament tester ( SW tester ) , electrical stimulation , and a question naire to determine changes in subjective sensations , at the time of each sensory evaluation . Neurosensory examinations were carried out bilaterally ( 132 sides ) at 1 , 3 , 6 , and 12 months after surgery . RESULTS More patients showed abnormal thresholds for the 2 measurement techniques in the SSRO group than in the ILRO group , and furthermore there were more such patients in group S1 than in group S2 , at each measurement point . At 6 months after surgery , the number of patients with reduced sensitivity was significantly higher in group S1 than in group L ( P < .05 ) . In the SSRO group at each measurement point , the thresholds for the lower lip and chin were unrelated to the set-back ( or advance ) distance . By contrast , in group L only at the 1-month evaluation point , the thresholds for the lower lip and chin were significantly raised in patients whose setback distances were larger than average ( P < .05 ) . CONCLUSIONS Postsurgical neurosensory disturbances of the lower lip and chin occur more frequently in SSRO patients treated by surgeons having little experience than in those treated by skilled surgeons , although the difference is not significant . Long-term prognosis for resolution of postsurgical neurosensory disturbances is better in ILRO patients than in SSRO patients . Although the width of movement of the split bone fragments has an influence on postsurgical neurosensory disturbances immediately after ILRO , the relationship becomes less obvious with time The criteria and scoring method for a system to evaluate the quality of r and omized control trials ( RCTs ) in dental research based on published reports is presented . This sytem is based on one devised for evaluation of RCTs in medicine . Items assessed in this system include r and omization and blinding procedures , subject selection criteria , treatment protocol s , and statistical analyses . Assessing the quality of RCTs can contribute to improved study design , implementation and reporting by investigators , and evaluation of reports by referees and editors of scientific journals Deficits in the neurosensory function ( NF ) of the inferior alveolar nerve ( IAN ) are often encountered after bilateral sagittal split osteotomy of the m and ible . A prospect i ve follow-up study was performed to examine the long-term effect of especially gentle h and ling of the soft tissues on the medial side of the ascending ramus . After the initial incision , the soft tissues of the ramus were either retracted extremely gently and minimally ( test side ) or , as was the earlier routine , more widely ( contralateral control side ) . NF was tested with 2-point discrimination ( 2-PD ) and vitality scanner tests ( VST ) preoperatively and four times postoperatively up to 1 year . Patients ' subjective sensations were also assessed . The results showed a difference between the sides , which was most distinct at the 6-month follow-up ( P=0.028 ) measured with VST , while 2-PD did not show any statistical differences . Our findings support the earlier intraoperative neurophysiologic reports that dissection trauma to the IAN around the m and ibular foramen may cause NF deficits in the IAN even before the actual splitting of the m and ible . Therefore , minimal distraction of the soft tissues in the ramus is indicated . Higher age is an evident risk factor , and subjective sensation correlates with 2-PD in the lower lip Sensory impairment after bilateral sagittal split osteotomy ( BSSO ) due to inferior alveolar nerve ( IAN ) lesions may be either temporary or permanent and either complete or partial . The aim of this prospect i ve study is to evaluate , by means of objective sensory testing , IAN sensory disturbances development in patients who underwent BSSO.IAN sensory disturbances development at the first week , fourth week , sixth month , and twelfth month of follow-up review in a group of 60 patients who underwent BSSO from January 1 , 1998 , to July 31 , 1999 , at the Maxillofacial Surgery Department of the “ La Sapienza ” University of Rome . The 60 patients were examined in the presurgical period ; the IAN functionality regarding thermal sensibility , nociception , and two-point discrimination , was assessed at follow-up in 120 sides . In our study the highest rate of spontaneous recovery of the entire IAN functionality was observed at the sixth month . This finding witnesses how neuropraxia and axonotmesis give a spontaneous recovery that most frequently occurs within 6 months from surgery , independently from age and sex of the patient . The persistence of anesthesia over 12 months could be a sign of neurotmesis PURPOSE The aim of this prospect i ve study was to objective ly evaluate the inferior alveolar nerve ( IAN ) sensory disturbances in patients who underwent sagittal split ramus osteotomy ( SSRO ) and its spontaneous recovery and to define the incidence of sensibility loss , time , and area at which the recovery occurs . PATIENTS AND METHODS Clinical evaluation of the IAN sensory disturbance was undertaken preoperatively and at the first week , fourth week , 2 months , and 6 months postoperatively in 30 patients who underwent SSRO at the Oral and Maxillofacial Surgery Division of the Araraquara Dental School -- Unesp and at the Plastic Surgery Division of the Medical Sciences School -- Unicamp . The 30 patients were examined at all periods regarding the IAN functionality by Semmes-Weinstein testing . RESULTS The mean age of the patients included in this study was 29.36 years old . All patients showed sensibility loss at the 7-day evaluation time . The comparison between sides , gender , and age did not show any significant difference . In most of the examined zone , the data collected at 6 months were statistically similar to the data collected at the preoperative period . All zones presented significant recovery , starting from 30 days after surgery . Twenty patients had total spontaneous recovery at the final period , in all examined zones . CONCLUSIONS The SSRO presents the disadvantage of temporary paresthesia ; however , spontaneous nerve function recovery does occur . The Semmes-Weinstein test is a reliable , inexpensive , and easy-to-apply tool , which can be used for clinical evaluation on a daily basis at
Output:
| Before surgery , the lowest detectable threshold corresponded to a mean of 0.07 to 0.16 g. At 1 month after surgery , the lowest detectable threshold averaged 6 g , and at 1 year after surgery , the mean value was 0.16 to 0.4 g. CONCLUSIONS After bilateral sagittal split osteotomy , at 1 month after surgery , the sensory threshold increases approximately 35- to 85-fold compared with the presurgery threshold .
Within 1 year , the threshold normally decreases almost to presurgery levels , representing 96 % to 98 % sensory recovery . |
MS212693 | ***TASK*** the task is to summarize an input biomedical literature in 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: To evaluate the maintenance of efficacy of risperidone long‐acting injectable ( RLAI ) in stable patients with schizophrenia or schizoaffective disorders . The prevalence of patients who met st and ardized remission criteria will be also evaluated as well as the predictors factors of remission according to psychopathological , psychosocial and subjective correlates Background A number of recently published r and omized controlled trials conducted in developed countries have reported no advantage for assertive interventions over st and ard care models . One possible explanation could be that so-called " st and ard care " has become more comprehensive in recent years , incorporating some of the salient aspects of assertive models in its modus oper and i. Our study represents the first r and omised controlled trial assessing the effect of a modified assertive treatment service on readmission rates and other measures of outcome in a developing country . Methods High frequency service users were r and omized into an intervention ( n = 34 ) and a control ( n = 26 ) group . The control group received st and ard community care and the active group an assertive intervention based on a modified version of the international model of assertive community treatment . Study visits were conducted at baseline and 12 months with demographic and illness information collected at visit 1 and readmission rates documented at study end . Symptomatology and functioning were measured at both visits using the PANSS , CDSS , ESRS , WHO-QOL and SOFAS . Results At 12 month follow-up subjects receiving the assertive intervention had significantly lower total PANSS ( p = 0.02 ) as well as positive ( p < 0.01 ) and general psychopathology ( p = 0.01 ) subscales ' scores . The mean SOFAS score was also significantly higher ( p = 0.02 ) and the mean number of psychiatric admissions significantly lower ( p < 0.01 ) in the intervention group . Conclusions Our results indicate that assertive interventions in a developing setting where st and ard community mental services are often under re source d can produce significant outcomes . Furthermore , these interventions need not be as expensive and comprehensive as international , first-world models in order to reduce inpatient days , improve psychopathology and overall levels of functioning in patients with severe mental illness BACKGROUND Recently , remission criteria for schizophrenia have been proposed , based on low symptom severity of core symptoms ( severity criterion ) , sustained over minimally 6 months ( time criterion ) . Little is known , however , about the added value of the time criterion in addition to the cross-sectional severity criterion . METHODS In order to evaluate whether remission is a valid concept for daily clinical practice , the cumulative incidence of patients meeting remission criteria was evaluated in a large naturalistic prospect i ve study of patients with schizophrenia or schizoaffective disorder in different treatment setting s in Belgium . The impact of being in remission on global and daily functioning was evaluated . RESULTS Over time , nearly 1 out of 3 patients with a diagnosis of schizophrenia or schizoaffective disorder ( 29 % ) met criteria for remission at study endpoint . Patients in remission had better insight in their disorder , a higher level of global functioning and functioned better with respect to daily living tasks , both compared to patients never meeting remission criteria and to patients only meeting the severity criterion but not the time criterion . Of the patients not meeting remission criteria at baseline , 21 % attained remission at study endpoint . CONCLUSION The remission severity and time criteria appear to combine into a valid concept for daily clinical practice and should be a target for treatment BACKGROUND Recently , the " Remission in Schizophrenia Working Group " proposed remission criteria consisting of a reduction to mild levels on key symptoms for at least 6 months . AIMS This study applied these remission criteria to a large first-episode psychosis sample in order to ( 1 ) determine the rates of remission ; ( 2 ) explore predictors of remission ; and ( 3 ) test the external validity of these criteria . METHODS We analyzed data from 462 subjects with a first-episode of psychosis who participated in a long-term , multinational , r and omized , double-blinded trial of risperidone and haloperidol over 2 to 4 years . RESULTS At some time point in the study 323 ( 70 % ) of the 462 subjects had a reduction to mild levels on the key symptoms as measured by the PANSS although only 109 ( 23.6 % ) maintained this level for at least 6 months thereby meeting remission criteria . The two strongest predictors of remission were shorter duration of untreated psychosis ( p=0.01 ) and treatment response at 6 weeks ( p=0.001 ) . Compared to non-remitted patients , those in remission experienced greater improvement on all PANSS subscales ( p<.0001 ) , CGI-S ( p<.0001 ) , better quality of life ( p=0.006 ) , fewer relapses ( p<.0001 ) , displayed a more favorable attitude towards their medication ( p=.002 ) , had lower EPS levels according to the ESRS ( p=<.0001 ) and received lower doses of antipsychotic medication ( p=0.003 ) . The remission and non-remission groups did not differ significantly regarding composite cognitive scores , suicidality and body mass index . CONCLUSIONS The results suggest that the remission criteria , although based solely on core symptom improvement , can effectively identify patients who have a more favorable overall outcome OBJECTIVE This study examined the treatment response of patients with first-episode schizophrenia and schizoaffective disorder and potential predictors of response . METHOD First-episode patients were assessed on measures of psychopathology , cognition , social functioning , and biological parameters and treated according to a st and ardized algorithm . RESULTS One hundred eighteen patients ( 52 % male , mean age 25.2 years ) entered the study . The cumulative percentage of patients responding by 1 year was 87 % ; the median time to response was 9 weeks . The following variables were significantly associated with less likelihood of response to treatment : male sex , obstetric complications , more severe hallucinations and delusions , poorer attention at baseline , and the development of parkinsonism during antipsychotic treatment . Variables not significantly related to treatment response were diagnosis ( schizophrenia versus schizoaffective disorder ) , premorbid functioning , duration of psychotic symptoms prior to study entry , baseline disorganization , negative and depressive symptoms , baseline motor function , akathisia and dystonia during treatment , growth hormone and homovanillic acid measures , psychotic symptom activation to methylpheni date , and magnetic resonance measures . CONCLUSIONS Patients with first-episode schizophrenia and schizoaffective disorder have high rates of response to antipsychotic treatment ; there are specific clinical and pathobiologic predictors of response OBJECTIVE Switching medications is common in the treatment of schizophrenia . This study examines the effectiveness of olanzapine therapy following a clinical ly warranted switch from risperidone during treatment of patients with schizophrenia . RESEARCH DESIGN AND METHODS This post-hoc analysis used data from the risperidone arm of a r and omized , open-label , 1-year study of patients with schizophrenia . Study protocol permitted antipsychotic switching when clinical ly warranted , and outcomes were assessed with st and ard psychiatric measures . Statistical analyses assessed changes from pre- to post-medication switch and endpoint comparisons between patients switched from risperidone to olanzapine and patients continued on risperidone . RESULTS Most patients who switched from risperidone switched to olanzapine ( 43/60 ; 71.7 % ) . Average duration of risperidone treatment prior to switching was 86 days ( mean modal dose 4.0 mg/day ) . Most switchers ( 86 % ) completed the 1-year study on olanzapine ( average duration 241 days ; mean modal dose 12.0 mg/day ) . Following switch to olanzapine , patients experienced significant improvements on clinical ( Brief Psychiatric Rating Scale ) and social ( Quality of Life Inventory ) parameters , with similar proportions of patients achieving remission status at endpoint compared with risperidone patients not requiring medication switch ( 41.9 vs. 35.5 % ) . Mean weight gain for switchers was approximately 0.4 kg while on risperidone ( average treatment duration < 3 months ) and 2.4 kg on olanzapine ( average treatment duration approximately 8 months ) . CONCLUSIONS This study suggests that olanzapine is an effective treatment option for schizophrenia patients requiring a switch from risperidone . Given the small sample size and lack of a comparative group , one can not determine if other medication options would have been as effective as the switch to olanzapine . Thus , further research is warranted Although the concept of remission has been widely accepted and utilized in depression and anxiety disorders , there has been much less emphasis on defining remission in schizophrenia . Recently , an expert consensus definition of remission in schizophrenia was proposed along specific operational criteria for the attainment of remission focusing on the three core dimensions of psychopathology identified within schizophrenia : psychoticism , disorganization and negative symptoms . To date , the criteria have been applied retrospectively to several clinical studies , and these have demonstrated that the proposed definition of remission correlates significantly with established measures of symptom severity , functioning and quality of life , and appears achievable for a significant proportion of patients receiving at least 3 months of pharmacotherapy . In this article we extend the notion of remission to include an examination of the possible association of several modifiable and unmodifiable factors and co-morbidities on remission status . We also propose an investigation into the likelihood of different patient population s in achieving remission as well as assessing the impact of remission on health care costs and family burden . Since cognitive dysfunction and negative symptoms may be strongly correlated with a lower likelihood of achieving remission , we recommend retrospective and /or prospect i ve studies to determine the relationship between neurocognitive status and the predominance of negative symptoms at treatment start and the probability of achieving remission . Taken together , these studies should help identify key predictors of remission , further define the remitted state , reduce therapeutic pessimism , raise treatment expectations and chart a strategy for further research in this important area PURPOSE Although treatment advances have improved outcomes in schizophrenia , definitions of remission and recovery are still evolving . Recently proposed criteria for remission ( mild or less on multiple core-symptom ratings for at least 6 months ) have been applied to a 1-year study of long-acting risperidone injection . METHODS In a 50-week , open-label trial , stable patients with schizophrenia or schizoaffective disorder who received long-acting risperidone injection every 2 weeks were assessed using the Positive and Negative Syndrome Scale ( PANSS ) . Remission criteria for the PANSS were applied ; global illness severity ( Clinical Global Impressions ) and patient-rated health status ( 36-Item Short-form Health Survey ) were measured . RESULTS Groups were identified by initial remission status ( excluding the time component ) . Although considered clinical ly " stable , " 68.2 % ( 394/578 ) did not meet the symptom-severity component of remission criteria at baseline . Following long-acting , injectable risperidone treatment , 20.8 % ( 82 ) of nonremitted patients achieved symptom remission for at least 6 months , with significant decreases in mean PANSS total and cluster scores ( P < 0.0001 ) and significantly improved patient-rated health status ( P < 0.0001 ) . Percentages rated as not ill , very mild , or mild increased from 39 % to 88 % . Among 31.8 % ( 184/578 ) of patients meeting the symptom-severity component of remission criteria at baseline , 84.8 % ( 156 ) maintained these criteria at endpoint . CONCLUSIONS Among previously " stable , " nonremitted patients , many achieved symptom remission after long-acting , injectable risperidone treatment , with significant improvements in multiple symptom domains and patient-rated health status . These results warrant further study as these remission criteria may represent a meaningful clinical endpoint and an important step towards functional recovery BACKGROUND The goal of these secondary analyses of clinical trial data was to characterize clinical outcomes in patients with schizophrenia who met symptom severity or duration thresholds for two alternative definitions of remission , and to explore their relationships to improvement duration and quality of life outcomes . METHODS Definition 1 used threshold criteria for selected PANSS items sustained over at least 6-months Definition 2 used Brief Psychiatric Rating Scale ( BPRS ) % change , a threshold score for the Clinical Global Improvement-Severity ( CGI-S ) maintained for at least 8 weeks , and threshold scores for selected BPRS items . Positive and Negative Symptom Scale ( PANSS ) and Quality of Life scale ( QLS ) total scores were pooled from 6 clinical trials . The extent to which the alternative severity thresholds from these two definitions and duration of clinical improvement were associated with different clinical and QLS outcomes was explored . Regression analysis also assessed the relative contribution of each of the components of the two definition severity thresholds to improvements in QLS Total score . RESULTS Increases in QLS scores were greater for those patients who met either threshold criteria relative to those who met neither ( p<.0001 ) . Significantly greater improvements in QLS scores were observed for patients who met either threshold criteria at the 8- , 16- and 24-week visits relative to those who met criteria at weeks 16 and 24 , or at week 24 only ( p<0.001 ) , as well as for the subset of patients who met threshold criteria at both 24 and 52 weeks relative to those who met criteria at only one of these 2 time points . Only 31 % to 47 %
Output:
| Patients who were treated with long-acting injectable risperidone showed high maintenance of remission status .
Studies comparing second-generation antipsychotics versus haloperidol showed higher remission rates for the former .
The variables most frequently associated with remission were better premorbid function , milder symptoms at baseline ( especially negative symptoms ) , early response to treatment , and shorter duration of untreated psychosis .
Variability in the length and frequency of follow-ups , as well as differences in dropout rates , could partially explain the differences in reported rates .
Rates of symptomatic remission exceeded reported rates for functional recovery . |
MS212694 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: A r and omized study was performed to compare efficacy and side effects of laser and cryotherapy : 51 patients were treated with laser vaporization and 50 patients with cryotherapy . Success rates for laser and cryotherapy were not significantly different . Success rates were significantly related to lesion size . Grade of CIN , positive endocervical curettage , parity , and age at treatment were not found to be related . Vaginal discharge , both in duration and amount , was significantly less in patients treated with laser vaporization , compared with cryotherapy , but pain and bleeding occurred more often in patients treated with laser vaporization . A brief review of possible sources of bias in comparative studies on laser and cryotherapy is given , indicating the preference for a r and omized study . It is concluded that widespread introduction of laser facilities in smaller centers is not justified , because the success rates are not better than those of cryotherapy , and because the advantages of less discharge are outweighed by the high cost OBJECTIVE To evaluate the usefulness of bipolar electrocautery scissors for cervical conization . METHODS AND MATERIAL S Forty patients with severe dysplasia/in situ carcinoma of the uterine cervix underwent cervical conization : 20 r and omly selected patients were operated on with the unipolar energy scalpel and the other 20 were operated on with bipolar electrocautery scissors . In both groups operating time , number of ligations , blood loss , duration of recovery , perioperative complications and adequacy of the margins of the lesion were assessed . Data were compared by analysis of variance . RESULTS In the bipolar group the average operating time and duration of recovery were significantly reduced ( halved ) , no ligations were needed and the amount of blood loss was significantly reduced . Regarding perioperative complications , in the bipolar group there were no hemorrhages nor need of a second operation or transfusion . Infections did not occur in either group . We found no difference between the two groups regarding adequacy of the margins of the lesion for a good pathologic examination . CONCLUSION Bipolar electrocautery scissors were safe and useful in cervical conization by reducing the operating time and blood loss without increasing postoperative morbidity Fifty‐five patients were r and omized in a double‐blinded manner to large loop excision of the transformation zone ( LLETZ ) ( 29 patients ) or radical cervical diathermy with fulgaration ( RCDF ) ( 26 patients ) for treatment of cervical intraepithelial neoplasia ( CIN ) . Patients completed a 2‐month diary of symptoms and completed a 10‐week postoperative question naire . White vaginal discharge lasted 7.3 ( 4.6 ) days ( SD ) for RCDF compared to 3.4 ( 1.6 ) days ( SD ) for LLETZ . There was no significant difference in any other symptoms on analysis This appears to be the first report clearly assessing the length and severity of postoperative symptoms following LLETZ or RCDF . There is no reason on length and severity of postoperative symptoms to choose 1 of these 2 treatment methods over the other Objective To determine whether loop diathermy excision of the transformation zone and laser vaporisation are equally effective in the treatment of cervical intraepithelial neoplasia The results of laser and cryosurgical treatment in 106 patients with histologically proven carcinoma in situ of the uterine cervix ( CIN III ) are presented . Seventy-one patients were treated with the laser and in 63 of these further follow-up with colposcopy and cytology failed to show any abnormality . This represents an initial success rate of 89 % . In 8 patients ( 11 % ) initial treatment was considered to have failed because of persistent dyskaryotic smears and histological evidence of cervical intraepithelial neoplasia ( CIN II-III ) . Six of these patients were treated successfully with a further laser application and two patients had conization . The overall success rate for the laser was 97 % . Thirty-five patients were treated with cryosurgery and subsequent follow-up was negative in 29 of these patients ( 83 % ) . The 6 treatment failures ( 17 % ) were subsequently successfully treated with local destructive therapy ( 4 with cryosurgery , 1 with laser , and 1 with needle diathermy ) . The overall success rate for cryofreezing was 94.2 % . In cases of CIN III the laser is more likely to achieve eradication of the lesion with a single application than cryofreezing In a r and omized trial concerning 123 women with CIN , 59 were treated with laser conization under colposcope without further hemostatic remedy and 64 with cold knife conization guided by Schiller 's iodine dyeing supported by side sutures , vaginal packing and postoperative oral administration of tranexam acid . Follow‐up with colposcopy and cytology was done 3 and 12 weeks post‐conization and then every 6 months . The average follow‐up period was 36 months ( 28–48 ) . Peroperative bleeding was rather less pronounced in the laser group . Postoperatively , however , bleeding requiring treatment was significantly less common in the laser group ( 5 % ) than in the cold knife group ( 17 % ) BACKGROUND Cervical intraepithelial neoplasia ( CIN ) can be managed by ablative or excisional procedures . We have compared the excision time , effectiveness , and safety of loop diathermy ( loop ) against laser conization . METHODS In a prospect i ve study in two hospital departments 222 women were r and omized to loop or laser conization . Data were collected by question naires after operation and at two follow-up examinations . RESULTS At department A ( 122 women ) , two physicians performed 27 % of the loop and 35 % of the laser excisions ; at department B ( 100 women ) , the corresponding figures were 69 % and 59 % . Loop was quicker than laser conization in both departments ( median 3 - 4 min versus 10 - 20 min ) , while laser conization was more time consuming in department A ( median A/B = 20/10 min ) . Peroperative bleeding dominated during the laser procedure in both departments and complicated the loop procedure more frequently in department A. Postoperative bleeding occurred with equal frequency in the four groups ( 41.8 % , 52.7 % , 59.2 % , 64.7 % ) . At both departments , bleeding for more than two weeks was reported twice as often after laser conization ( A:13.8 % , B:24.2 % ) , when compared to loop excision ( A:7.1 % , B:13.7 % ) . Residual CIN was found in all of three re-conizations and in one of eight hysterectomy specimens . CONCLUSIONS Loop was quicker than laser excision , per- and postoperative bleeding diminished , and the success rates were comparable . Physicians mastered Loop excision after a few attempts . However , the results improved , when performed by a restricted number of physicians . Histological incomplete excision indicates close colposcopic and cytologic follow-up to identify residual CIN OBJECTIVES Loop electrosurgical excision of the transformation zone ( LEETZ ) was recently associated with relatively high failure rates . We evaluated whether the combination of LEETZ with laser vaporization is superior to LEETZ alone in reducing the rates of recurrent abnormal cytology and residual disease . METHODS The study population included 426 women with histologic diagnosis of cervical intraepithelial neoplasia ( CIN ) 2 - 3 , of whom 289 ( study group ) were treated by LEETZ followed by laser vaporization of the crater base and walls and 137 ( control group ) were treated by LEETZ alone . All women were followed scrupulously at regular intervals for recurrent abnormal cytology and residual disease . The mean follow-up periods were 43 and 59 months for the study and control groups , respectively . RESULTS Both groups were derived from the same community and were similar in epidemiologic characteristics and disease severity . Although the incidence of positive surgical margins was similar in both groups ( 10.4 and 9.5 % for the study and control groups , respectively ) , recurrent abnormal cytology ( 10.2 % vs 5.5 % , P = 0.07 ) and histologic residual disease ( 21.4 % vs 0 % , P = 0.05 ) were more frequent among women in the control group . This applied to women with both negative and positive surgical margins . Both study and control women with positive surgical margins , especially at the endocervix , were at higher risk for recurrence . CONCLUSION The addition of laser vaporization to LEETZ may improve outcome of both women with positive margins and women with negative margins . Our results support conservative management for all treated women , regardless of cone margin status We compared the pain of excisional cervical surgery by the laser or loop diathermy ( LLETZ ) in a r and omised controlled clinical trial . Eighty women with CIN III were recruited from a laser colposcopy clinic specifically adapted to run r and omized trials . They were scheduled for excision of their cervical transformation zone and both groups were matched for age , parity , and size of lesion . We measured linear analogue pain scores , subjective pain scores , and operative time . The laser and loop diathermy inflicts similar discomfort and there is no detectable difference between the median pain scores of women in either group ( P = 0.99 ) . However , in the h and s of an experienced surgeon it takes 4 min extra to excise the cervical transformation zone with a laser compared to loop diathermy . The average time from sitting in the chair to the end of the procedure was 13.02 min ( SD 3.65 ) for the group allocated diathermy surgery compared to 17.30 min ( SD 5.33 ) for a laser excision log transformed t(log transformed data ) = 3.7 ( P < 0.001 ) The objective of this r and omized controlled trial was to determine whether the pure cut setting results in less thermal artefact than the traditional blend setting when performing a large loop excision of the transformation zone ( LLETZ ) . Forty-nine consenting women were r and omized to undergo an LLETZ procedure using either the pure cut or the blend setting . Two histopathologists , who were blind to the r and omization , examined the specimens and then grade d and measured the degree of thermal artefact . No significant difference was noted at the epithelial margin . At the deep stromal margins , in the blend group , the mean thickness of thermal artefact was 0.382 mm ( 95 % CI , 0.350–0.414 ) and in the cut group 0.325 mm ( 95 % CI , 0.297–0.353 ) . This was statistically significant . No significant difference was detected in terms of grading of thermal artefact , the presence of dysplasia at the specimen margins , or in positive follow-up smears . Although there was less thermal artefact at the deep stromal margin , cautery at this margin does not generally interfere with pathological assessment of the specimen and the pure cut setting does not produce a clinical ly significant decrease in the degree of thermal artefact Ninety patients with cervical intraepithelial neoplasia ( CIN ) were r and omly assigned to loop excision ( n = 38 ) or cold-knife conization ( n = 52 ) . All specimens were well evaluable at histology . The average width of the lesions at histology was 10.2 and 9.7 mm , respectively ( ns ) . The average weight of the specimens was 2.6 and 5.6 g ( P < 0.01 ) and the average depth was 9.2 and 15.8 mm ( P < 0.01 ) , respectively . The distance between the cervical resection margin and CIN was 14 mm after loop excision and 24 mm after cold-knife conization ( P < 0.06 ) . The margins of the specimen were not clear of disease in 8 patients after loop excision and in 12 patients after conization ( ns ) . Two patients after loop excision and in three patients after cold-knife conization had postoperative bleeding . The results suggest that , compared with cold-knife conization , loop excision removes less healthy tissue without reducing the chances for cure In a r and omized study , 204 patients with exocervical intra‐epithelial neoplasia were allocated to either laser evaporation ( 103 ) or cryocoagulation ( 101 ) . The patients were treated on an outpatient basis without anesthesia . In the case of initial treatment failure the same method was to be used for retreatment . One hundred and eighty‐seven patients were followed‐up for an average of 50 months ( 12‐80 ) . Eighty‐six of 94 laser‐evaporated patients ( 91 % ) and 89 of 93 cryocoagulated patients ( 96 % ) were cured after one treatment . Five of 8 laser failures and 3 of 4 cry0 failures were cured by retreatment . The cure rate after one or two laser evaporations was 97 % ( 91 of 94 patients ) , and after one or two cryo coagulations , 99 % ( 92 of 93 patients ) . Eighty per cent of residual or recurrent neoplasia occurred within 15 months and 96 % within 2 years of treatment . No invasive neoplasia occurred during the follow‐up period and no tendency was seen towards higher grade s of intra‐epithelial neoplasia in the failures compared with the initial diagnoses . It is concluded that laser evaporation and cryocoagulation are equally effective for the treatment of exocervical intra‐epithelial neoplasia The objective of the treatment of cervical intraep
Output:
| No significant differences in treatment failures were demonstrated in terms of persistent disease after treatment .
Large loop excision of the transformation zone appeared to provide the most reliable specimens for histology with the least morbidity .
Morbidity was lower than with laser conisation , although the trials did not provide data for every outcome measure .
There were not enough data to assess the effect on morbidity when compared with laser ablation .
AUTHORS ' CONCLUSIONS The evidence suggests that there is no obvious superior surgical technique for treating cervical intraepithelial neoplasia in terms of treatment failures or operative morbidity |
MS212695 | ***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: Summary Background Cisplatin and fluoropyrimidine ( CF ) are st and ard first- line treatment in advanced gastric cancer , but no second-line treatment has yet been established . We present a phase II study in which we evaluated the efficacy and toxicity of the combination of Sorafenib ( S ) , and Oxaliplatin as second-line therapy . Methods Patients with progressive gastric adenocarcinoma after CF- first-line , ECOG 0–2 , and measurable disease were included . The primary objective was PFS . Treatment doses were Oxaliplatin 130 mg/m2/3 weeks and Sorafenib 800 mg/bid/d . Results We included 40 patients . CR was 2.5 % and SD was 47.2 % . Grade 3–4 toxic effects were neutropenia ( 9.8 % ) , thrombocytopenia ( 7.3 % ) , neurotoxicity ( 4.9 % ) and diarrhea ( 4.9 % ) . Median PFS was 3 months ( 95 % CI : 2.3–4.1 ) and median OS was 6.5 months ( 95 % CI : 5.2–9.6 ) . Time to progression ( TTP ) to first line therapy was a prognosis factor . Median OS was 9.7 months when time-to-progression during first-line chemotherapy was > 6 months and 5.6 m when it was < 6 months ( p = 0.04 ) . Conclusions Time-to-progression under a CF-based first-line therapy determines subgroups of GC patients with different prognosis . The combination of Oxaliplatin-Sorafenib in advanced GC patients previously treated with CF appears safe , but our results do not support the implementation of a phase III trial PURPOSE To evaluate safety and efficacy of combined transarterial chemoembolization ( TACE ) with doxorubicin-eluting beads ( DEB ) and sorafenib in patients with advanced hepatocellular carcinoma ( HCC ) . PATIENTS AND METHODS A prospect i ve single-center phase II study was undertaken involving patients with unresectable HCC . The protocol involved sorafenib 400 mg twice per day combined with DEB-TACE . Safety and response were assessed . Results DEB-TACE in combination with sorafenib was successfully administered in 35 patients : mean age , 63 years ; Child 's A , 89 % ; Barcelona Clinic Liver Cancer stage C , 64 % ; Eastern Cooperative Oncology Group performance status of 0 and 1 , 46 % and 54 % , respectively ; and mean index tumor size , 7.7 cm ( st and ard deviation , ± 4.2 cm ) . Patients underwent 128 cycles of therapy ( sorafenib plus DEB-TACE , 60 cycles ; sorafenib alone , 68 cycles ) . Median number of cycles per patient was two ( range , one to five cycles ) ; median number of days treated with sorafenib was 71 ( range , 4 to 620 days ) . The most common toxicities during cycle one were fatigue ( 94 % ) , anorexia ( 67 % ) , alterations in liver enzymes ( 64 % ) , and dermatologic adverse effects ( 48 % ) . Although most patients experienced at least one grade 3 to 4 toxicity , most toxicities were minor ( grade 1 to 2 , 83 % v grade 3 to 4 , 17 % ) . Toxicity during cycle two was decreased . Over the course of the study , there were 40 sorafenib dose interruptions and 25 sorafenib dose reductions . Sorafenib plus DEB-TACE was associated with a disease control rate of 95 % ( Response Evaluation Criteria in Solid Tumors Group)/100 % ( European Association for the Study of the Liver [ EASL ] ) , with an objective response of 58 % ( EASL ) . CONCLUSION The combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe , with most toxicities related to sorafenib . Toxicity is manageable with dose adjustment of sorafenib . Preliminary efficacy data are promising Summary Background Sorafenib is the sole molecular-targeted agent showing a survival benefit in patients with advanced hepatocellular carcinoma ( HCC ) . We evaluated the tolerability and effectiveness of a combination of S-1 with sorafenib in patients with advanced HCC . Methods S-1 was administered during days 1–14 and sorafenib was administered every day . This treatment was repeated every 21 days . In phase I , we determined the maximum tolerated dose ( MTD ) and dose-limiting toxicities ( DLTs ) . The dose of each drug was planned as follows : cohort 1 : S-1 48 mg/m2/day and sorafenib 400 mg/day , cohort 2a : S-1 48 mg/m2/day and sorafenib 800 mg/day , cohort 2b : S-1 64 mg/m2/day and sorafenib 400 mg/day , cohort 3 : S-1 64 mg/m2/day and sorafenib 800 mg/day , and cohort 4 : S-1 80 mg/m2/day and sorafenib 800 mg/day . In phase II , the patients were treated at the MTD to evaluate safety and efficacy . Results Nineteen patients were enrolled in phase I. One of the six patients in cohort 1 and one of the six patients in cohort 3 experienced DLT . None of the three patients in cohort 2a experienced DLT and three of the four patients in cohort 4 experienced DLT . Therefore , cohort 3 was considered the MTD . Subsequently , 26 patients were enrolled in phase II . The most common grade 3/4 toxicities were an increase of aspartate aminotransferase ( 38.5 % ) , thrombocytopenia ( 23.1 % ) , neutropenia ( 19.2 % ) , hyperbilirubinemia ( 15.4 % ) , an increase of alanine aminotransferase ( 15.4 % ) , hyponatremia ( 11.5 % ) , rash ( 11.5 % ) , and hypophosphatemia ( 11.5 % ) . Sudden death occurred in one patient ( 3.8 % ) . A patient ( 3.8 % ) had a partial response , 15 ( 57.7 % ) had stable disease , and 10 ( 38.5 % ) had progressive disease . The median times to progression and overall survival were 2.4 and 10.5 months , respectively . Conclusion The MTD of S-1 and sorafenib in patients with advanced HCC was 64 mg/m2/day and 800 mg/day , respectively . This dose/regimen demonstrated substantial clinical activity among patients with advanced HCC Background : Gallbladder cancers and cholangiocarcinomas make up a heterogenous group of tumours with a poor prognosis in advanced stages . On the basis of evidence of dysregulation of the epidermal growth factor receptor , vascular endothelial growth factor and mitogen-activated protein kinase pathways in biliary cancers , we performed a phase 2 trial of sorafenib and erlotinib in patients with advanced biliary cancers . Methods : Eligible patients were previously untreated in the advanced setting with adequate hepatic and bone marrow function . Sorafenib and erlotinib were administered continuously at 400 mg BID and 100 mg daily , respectively . Results : Thirty-four eligible patients were recruited . The study was terminated after the first stage of accrual owing to failure to meet the predetermined number of patients who were alive and progression free at 4 months . There were two unconfirmed partial responses ( 6 % , 95 % CI : 1–20 % ) , with a median progression-free survival of 2 months ( 95 % CI : 2–3 ) , and median overall survival of 6 months ( 95 % CI : 3–8 months ) . Grade 3 and 4 adverse events included hypertension , AST/ALT increase , bilirubin increase , diarrhoea , hypokalaemia , hypophosphatemia and rash . Conclusions : Despite compelling pre clinical rationale , the combination of sorafenib and erlotinib does not have promising clinical activity in an unselected population of patients with biliary cancers . Improved patient selection based on tumour biology and molecular markers is critical for future evaluation of targeted therapies in this disease Purpose : This multicenter , phase II study evaluates the efficacy and safety of erlotinib , an epidermal growth factor receptor ( EGFR ) inhibitor , plus sorafenib , a multityrosine kinase inhibitor against vascular endothelial growth factor receptors , in patients with previously untreated advanced non – small cell lung cancer ( NSCLC ) . Experimental Design : Chemotherapy-naïve patients with stage IIIB/IV NSCLC received erlotinib ( 150 mg once a day ) and sorafenib ( 400 mg twice a day ) until disease progression or unacceptable toxicity . The primary end point was the rate of nonprogression at 6 weeks . Secondary end points included objective response rate ( ORR ) , time to progression , overall survival , and adverse events . Exploratory end points included pretreatment EGFR and KRAS mutation status , pharmacokinetics , and cytochrome P450 polymorphisms . Results : Fifty patients initiated therapy . The nonprogression rate at 6 weeks was 74 % : 12 ( 24 % ) partial response and 25 ( 50 % ) stable disease . Ultimately , the ORR was 28 % . Median time to progression was 5.0 months [ 95 % confidence interval ( 95 % CI ) , 3.2 - 6.8 months ] . Median overall survival was 10.9 months ( 95 % CI , 3.8 - 18.1 months ) . Grade 3/4 adverse events included fatigue ( 16 % ) , h and -foot skin reaction ( 16 % ) , rash ( 16 % ) , diarrhea ( 14 % ) , and hypophosphatemia ( 42 % ) . There was one treatment-related fatal pulmonary hemorrhage . Patients with wild-type EGFR had a higher ORR ( 19 % ) than previously reported for single-agent erlotinib/sorafenib . Erlotinib levels were lowered . This was associated with CYP3A4 polymorphism and was possibly due to sorafenib . Conclusion : Despite a possible drug interaction , sorafenib plus erlotinib has promising clinical activity in patients with stage IIIB/IV NSCLC and has an acceptable safety profile . Further evaluation of this combination as potential salvage therapy in EGFR mutation – negative patients and the possible drug interaction is warranted . Clin Cancer Res ; 16(11 ) ; 3078–87 . © 2010 AACR PURPOSE To define the safety , efficacy , and pharmacogenetic and pharmacodynamic effects of sorafenib with gemcitabine-based chemoradiotherapy ( CRT ) in locally advanced pancreatic cancer . METHODS AND MATERIAL S Patients received gemcitabine 1000 mg/m(2 ) intravenously weekly × 3 every 4 weeks per cycle for 1 cycle before CRT and continued for up to 4 cycles after CRT . Weekly gemcitabine 600 mg/m(2 ) intravenously was given during concurrent intensity modulated radiation therapy of 50 Gy to gross tumor volume in 25 fractions . Sorafenib was dosed orally 400 mg twice daily until progression , except during CRT when it was escalated from 200 mg to 400 mg daily , and 400 mg twice daily . The maximum tolerated dose cohort was exp and ed to 15 patients . Correlative studies included dynamic contrast-enhanced MRI and angiogenesis genes polymorphisms ( VEGF-A and VEGF-R2 single nucleotide polymorphisms ) . RESULTS Twenty-seven patients were enrolled . No dose-limiting toxicity occurred during induction gemcitabine/sorafenib followed by concurrent CRT . The most common grade 3/4 toxicities were fatigue , hematologic , and gastrointestinal . The maximum tolerated dose was sorafenib 400 mg twice daily . The median progression-free survival and overall survival for 25 evaluable patients were 10.6 and 12.6 months , respectively . The median overall survival for patients with VEGF-A -2578 AA , -1498 CC , and -1154 AA versus alternate genotypes was 21.6 versus 14.7 months . Dynamic contrast-enhanced MRI demonstrated higher baseline K(trans ) in responding patients . CONCLUSIONS Concurrent sorafenib with CRT had modest clinical activity with increased gastrointestinal toxicity in localized unresectable pancreatic cancer . Select VEGF-A/VEGF-R2 genotypes were associated with favorable survival PURPOSE Despite recent advances in the management of high- grade and recurrent gliomas , survival remains poor . Antiangiogenic therapy has been shown to be efficacious in the treatment of high- grade gliomas both in pre clinical models and in clinical trials . We sought to determine the safety and maximum tolerated dose of sorafenib when combined with both radiation and temozolomide in the primary setting or radiation alone in the recurrent setting . METHODS AND MATERIAL S This was a pre clinical study and an open-label phase I dose escalation trial . Multiple glioma cell lines were analyzed for viability after treatment with radiation , temozolomide , or sorafenib or combinations of them .
Output:
| The clinical utility of sorafenib was established early in development , with low burden on patients and re sources .
However , these early successes were followed by rapid and exhaustive testing against various malignancies and combination regimens , leading to excess patient burden .
Our evaluation of sorafenib development suggests many opportunities for reducing costs and unnecessary patient burden in cancer drug development |
MS212696 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 and compare the effects of Buddhist walking meditation and traditional walking on glycemic control and vascular function in patients with type 2 diabetes mellitus . METHODS Twenty three patients with type 2 diabetes ( 50 - 75 years ) were r and omly allocated into traditional walking exercise ( WE ; n=11 ) or Buddhism-based walking meditation exercise ( WM ; n=12 ) . Both groups performed a 12-week exercise program that consisted of walking on the treadmill at exercise intensity of 50 - 70 % maximum heart rate for 30min/session , 3 times/week . In the WM training program , the participants performed walking on the treadmill while concentrated on foot stepping by voiced " Budd " and " Dha " with each foot step that contacted the floor to practice mindfulness while walking . RESULTS After 12 weeks , maximal oxygen consumption increased and fasting blood glucose level decreased significantly in both groups ( p<0.05 ) . Significant decrease in HbA1c and both systolic and diastolic blood pressure were observed only in the WM group . Flow-mediated dilatation increased significantly ( p<0.05 ) in both exercise groups but arterial stiffness was improved only in the WM group . Blood cortisol level was reduced ( p<0.05 ) only in the WM group . CONCLUSION Buddhist walking meditation exercise produced a multitude of favorable effects , often superior to traditional walking program , in patients with type 2 diabetes Diabetes is the leading cause of major complications , such as end-stage renal disease and lower extremity amputations , and is a significant contributor to ischemic heart disease , stroke , peripheral vascular disease , and vision loss ( 1 ) . There has been increasing acceptance of the importance of individualizing glycemic management and assessment of risk for adverse events , especially hypoglycemia ( 26 ) . This is of great importance for all patients , especially older adults ( aged 65 years ) with comorbid conditions . In 2013 , 12.0 million older adults in the United States had diabetes , comprising 40 % of the 30.2 million persons with the disease ( 7 ) . Older adults account for an estimated 60 % to 70 % of the U.S. Department of Veterans Affairs ( VA ) and U.S. Department of Defense ( DoD ) diabetic population ( largely retirees ) ( VA/DoD. Unpublished data ) . These considerations make safe and effective diabetes management a policy priority for health care providers ( physicians , nurses , dietitians , and pharmacists ) and policymakers in both the VA and the DoD. The 2017 VA/DoD Clinical Practice Guideline ( CPG ) for the Management of Type 2 Diabetes Mellitus in Primary Care offers health care providers an evidence -based framework to evaluate , treat , and manage persons with type 2 diabetes mellitus in the context of their individual needs and preferences ( 8) . The current article is a summary of key CPG recommendations , which was developed with multiple stakeholders to ensure representation by a broad spectrum of clinicians . It provides practice recommendations for the care of patients with diabetes , with an emphasis on shared decision making . Guideline Development and Review Process These recommendations were developed using methods established by the VA/DoD Evidence -Based Practice Work Group ( EBPWG ) ( 9 ) , which are aligned with st and ards for trustworthy guidelines ( 10 ) . The EBPWG and the U.S. Army Medical Comm and selected guideline panel cochairs ( 1 each from the VA and the DoD ) . The cochairs then selected a multidisciplinary panel of practicing clinician stakeholders , including primary care physicians ( family and internal medicine ) , endocrinologists , medical nutritionists , pharmacists , diabetes educators , and nurse practitioners . At the start of the CPG development process and at other key points throughout , all members were required to su bmi t disclosure statements for potential conflicts of interest in the previous 24 months . Verbal affirmations of no conflicts were used during meetings throughout the development process . The project team was also subject to r and om Web-based surveillance ( for example , ProPublica ) . The VA/DoD contracted with The Lewin Group , a third party with expertise in clinical practice guideline development , to facilitate meetings . The guideline panel , in collaboration with the ECRI Institute , developed 9 key questions using the PICOTS ( population , intervention , comparator , outcomes , timing of outcomes measurement , and setting ) format . A systematic search of the peer- review ed literature from January 2009 through March 2016 was conducted to find evidence relevant to the key questions that focused on r and omized trials , systematic review s , and meta-analyses of fair or better quality . One key question was up date d through 14 June 2016 . The search methods and results are detailed in the full guideline ( 8) . The guideline panel rated recommendations by using the GRADE ( Grading of Recommendations Assessment , Development and Evaluation ) method ( 11 ) . The guideline panel focused on developing new and up date d recommendations using the evidence review for the key questions . The panel also considered , without a complete review of the relevant evidence , the current applicability of recommendations that were included in the 2010 CPG . As part of the development process , a patient focus group was also convened to better underst and the perspectives of patients receiving diabetes treatment in the VA and the DoD. Five patients were included , consistent with the requirements of the federal Paperwork Reduction Act . All patients had type 2 diabetes and were veterans receiving care in the VA . The focus group explored knowledge of treatment options , views on the delivery of care , patients ' needs and preferences , and the effect of diabetes on their lives . Important concepts that emerged from the focus group were shared with the panel and informed guideline development . It was acknowledged that this convenience sample may not be representative of all VA and DoD patients receiving treatment for type 2 diabetes . The draft guideline was sent to more than 15 expert review ers inside and outside the federal sector . Comments were review ed and , where appropriate , were incorporated into the final guideline based on panel consensus . The VA/DoD EBPWG approved the final document on 3 April 2017 and released it on 17 April 2017 . Recommendations are presented in the Table , and an algorithm for establishing a personalized glycemic goal and treatment plan is presented in the Figure . Key recommendations are review ed in this article . Table . Summary of Recommendations From the 2017 VA/DoD CPG on the Management of Type 2 Diabetes Mellitus Figure . Algorithmic approach to evaluating glycemic control risk factors , setting a personalized glycemic control target range , providing self-management ( including lifestyle and nutrition ) education , and initiating or reevaluating medication therapy . Recommendations Provide Patient-Centered Care and Incorporate Shared Decision Making The CPG strongly encourages clinicians to incorporate shared decision making and partner with their patients . Shared decision making is the process by which the patient and family , in conjunction with the care provider , reach an agreement about a plan of care and treatment . Key principles include readiness of the patient and family , tools with underst and able information about the benefits and harms of all options , and strategies to identify and incorporate patient preferences . Patients can not effectively participate in care and shared decision making unless they underst and diabetes and how they can be involved in planning and carrying out the jointly developed care plan . Shared decision making reinforces a trusted therapeutic relationship and increases patient satisfaction and treatment buy-in with regard to the methods used to reach a particular goal or treatment plan ( 1214 ) . It should be used not only for patients with stable glycemic control but also to assist those who are not able or willing to make lifestyle changes and decisions that affect their diabetes at any time during the course of treatment . At a minimum , shared decision making should be included at the time of diagnosis , during difficulties with management , and at times of transition or development of complications ( 14 ) . Benefits include greater knowledge of medications ( 13 ) and underst and ing of risks ( 14 ) . In addition , patient-centered care and shared decision making together may decrease patient anxiety , increase trust in clinicians ( 15 ) , and improve treatment adherence ( 16 ) . Family involvement should be considered if appropriate , especially in older adults ( 17 ) . Patient information should be culturally appropriate ; underst and able and actionable by people with limited literacy skills ; and accessible to those with physical , sensory , or learning needs ( 18 ) . As part of the patient-centered care approach to diabetes management , clinicians should explore with the patient the outcomes of previous opportunities for shared decision making , their ability to self-manage , prior efforts to change health behaviors , past treatment experiences ( including reasons for discontinuing treatment ) , and relevant clinical outcomes . In actively sharing decisions , they should involve the patient in prioritizing problems to be addressed and setting specific goals regardless of the setting or level of care . Assess Patient Characteristics and Nonglycemic Factors When Interpreting Results of Hemoglobin A1c , Fructosamine , and Other Glycemic Biomarker Testing Many factors affect measurement of hemoglobin A1c ( HbA1c ) besides the level of glycemia ( 19 ) . Because HbA1c level depends on the duration of erythrocyte exposure to glucose , conditions that alter erythrocyte life span affect the measured level of HbA1c ( 20 , 21 ) . Iron deficiency anemia , which prolongs erythrocyte life span and exposes the cell to glucose for a longer period , is associated with falsely elevated HbA1c levels ( 22 ) . In contrast , conditions that shorten erythrocyte life span ( such as hemolytic anemia ) may result in falsely low HbA1c levels . Various other conditions , such as chronic kidney disease , may alter HbA1c measurement . Hemoglobin variants can result in falsely elevated or falsely lowered HbA1c levels , depending on the assay used ( 2325 ) . In addition , oral hypoglycemic agents ( metformin or sulfonylureas ) may alter the relationship between blood glucose and HbA1c levels , although the clinical significance is unclear ( 26 ) . There are also racial/ethnic differences in HbA1c levels for a given level of glycemia . A previous study found that African Americans with prediabetes ( 27 ) had HbA1c values that were 0.4 % higher than among white persons ; those who were within 3 years of diagnosis ( 28 ) also had higher HbA1c values than white persons for any measure of glycemia . This difference can not be explained by measured differences in glycemia , clinical factors known to affect HbA1c measurement , or sociodemographic factors ( 27 , 28 ) . Therefore , it is recommended that a new diagnosis of diabetes be based on a confirmatory fasting blood glucose level of at least 7.0 mmol/L ( 126 mg/dL ) if the initial HbA1c value is 6.5 % to 6.9 % . How and where the HbA1c level is measured can also affect results because of intralaboratory variation ( variation in test accuracy and precision ) and interlaboratory variation ( variation related to use of different test methods ) . A single HbA1c measurement , even from a
Output:
| Conclusion The Qigong training can improve the blood glucose status of the type 2 DM patients and has positive effects on the management of type 2 DM . |
MS212697 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***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 trial assessed pharmacokinetic interactions between cetuximab and irinotecan . Patients were placed in either in group A ( irinotecan 350 mg/m2/3 weeks and 400 mg/m2 cetuximab at week 2 then 250 mg/m2/week ) or group B ( cetuximab weekly starting week 1 then irinotecan starting week 4 ) . Patient plasma or serum sample s from each treatment arm were analysed using HPLC and ELISA . Among 14 patients , compartmental model showed no significant differences in mean plasma AUC at week 1 versus week 4 for irinotecan ( 44,388 versus 39,800 microg/ml/h ) and cetuximab ( 20,441 versus 23,363 microg/ml/h ) , respectively . Half-lifes ( st and ard deviations ) for irinotecan were 16.02 ( + /-8.41 ) h at week 1 and 13.99 ( + /-2.14 ) h at week 4 , and for cetuximab 106 ( + /-32 ) at week 3 and 111 ( + /-30 ) h at week 4 . Mean concentration-versus-time profiles either alone or in combination were superimposable for cetuximab and irinotecan . From this study , we conclude that there is no evidence of pharmacokinetic interaction between irinotecan and cetuximab BACKGROUND Treatment with cetuximab , a monoclonal antibody directed against the epidermal growth factor receptor , improves overall and progression-free survival and preserves the quality of life in patients with colorectal cancer that has not responded to chemotherapy . The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment-independent prognostic value . METHODS We analyzed tumor sample s , obtained from 394 of 572 patients ( 68.9 % ) with colorectal cancer who were r and omly assigned to receive cetuximab plus best supportive care or best supportive care alone , to look for activating mutations in exon 2 of the K-ras gene . We assessed whether the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups . RESULTS Of the tumors evaluated for K-ras mutations , 42.3 % had at least one mutation in exon 2 of the gene . The effectiveness of cetuximab was significantly associated with K-ras mutation status ( P=0.01 and P<0.001 for the interaction of K-ras mutation status with overall survival and progression-free survival , respectively ) . In patients with wild-type K-ras tumors , treatment with cetuximab as compared with supportive care alone significantly improved overall survival ( median , 9.5 vs. 4.8 months ; hazard ratio for death , 0.55 ; 95 % confidence interval [ CI ] , 0.41 to 0.74 ; P<0.001 ) and progression-free survival ( median , 3.7 months vs. 1.9 months ; hazard ratio for progression or death , 0.40 ; 95 % CI , 0.30 to 0.54 ; P<0.001 ) . Among patients with mutated K-ras tumors , there was no significant difference between those who were treated with cetuximab and those who received supportive care alone with respect to overall survival ( hazard ratio , 0.98 ; P=0.89 ) or progression-free survival ( hazard ratio , 0.99 ; P=0.96 ) . In the group of patients receiving best supportive care alone , the mutation status of the K-ras gene was not significantly associated with overall survival ( hazard ratio for death , 1.01 ; P=0.97 ) . CONCLUSIONS Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab , whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab . The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone . ( Clinical Trials.gov number , NCT00079066 . PURPOSE To evaluate the efficacy of cetuximab plus taxane/carboplatin ( TC ) as first-line treatment of advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This multicenter , open-label , phase III study enrolled 676 chemotherapy-naïve patients with stage IIIB ( pleural effusion ) or IV NSCLC , without restrictions by histology or epidermal growth factor receptor expression . Patients were r and omly assigned to cetuximab/TC or TC . TC consisted of paclitaxel ( 225 mg/m(2 ) ) or docetaxel ( 75 mg/m(2 ) ) , at the investigator 's discretion , and carboplatin ( area under the curve = 6 ) on day 1 every 3 weeks for < or = six cycles ; cetuximab ( 400 mg/m(2 ) on day 1 , 250 mg/m(2 ) weekly ) was administered until progression or unacceptable toxicity . The primary end point was progression-free survival assessed by independent radiologic review committee ( PFS-IRRC ) ; overall response rate ( ORR ) , overall survival ( OS ) , quality of life ( QoL ) , and safety were key secondary end points . PFS and ORR assessed by investigators were also evaluated . Results Median PFS-IRRC was 4.40 months with cetuximab/TC versus 4.24 months with TC ( hazard ratio [ HR ] = 0.902 ; 95 % CI , 0.761 to 1.069 ; P = .236 ) . Median OS was 9.69 months with cetuximab/TC versus 8.38 months with TC ( HR = 0.890 ; 95 % CI , 0.754 to 1.051 ; P = .169 ) . ORR-IRRC was 25.7 % with cetuximab/TC versus 17.2 % with TC ( P = .007 ) . The safety profile of this combination was manageable and consistent with its individual components . CONCLUSION The addition of cetuximab to TC did not significantly improve the primary end point , PFS-IRRC . There was significant improvement in ORR by IRRC . The difference in OS favored cetuximab but did not reach statistical significance BACKGROUND The Lung Cancer Cetuximab Study is an open-label , r and omized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone , in patients with advanced EGFR-expressing , non-small-cell lung cancer ( NSCLC ) . End points of the study are activity , safety and pharmacokinetics . PATIENTS AND METHODS Following r and omization , for a maximum of eight cycles , patients received three-weekly cycles of cisplatin ( 80 mg/m(2 ) , day 1 ) and vinorelbine ( 25 mg/m(2 ) on days 1 and 8) alone or following cetuximab treatment ( initial dose 400 mg/m(2 ) , followed by 250 mg/m(2 ) weekly thereafter ) . RESULTS Eighty-six patients were r and omly allocated to the study ( 43 per arm ) . Confirmed response rates were 28 % in the cisplatin/vinorelbine arm ( A ) and 35 % in the cetuximab plus cisplatin/vinorelbine arm ( B ) . Median progression-free survival ( PFS ) was 4.6 months in arm A and 5.0 months in arm B , with PFS rates at 12 months of 0 % and 15 % , respectively . Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0 % and 16 % , respectively . The cetuximab combination was well tolerated . CONCLUSION In the first-line treatment of advanced NSCLC , the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care ( 287 patients ) or best supportive care alone ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ Clinical Trials.gov ] . ) BACKGROUND This two-part phase Ib/II study investigated the feasibility of administering cetuximab in combination with oxaliplatin and infusional 5-fluorouracil (5-FU)/folinic acid ( FA ) in a weekly schedule ( AIO FUFOX protocol ) as first-line treatment in patients with epidermal growth factor receptor-detectable advanced colorectal cancer . PATIENTS AND METHODS Cetuximab was administered weekly : 400 mg/m(2 ) initial dose , then 250 mg/m(2 ) and FUFOX : oxaliplatin 50 mg/m(2 ) , FA 500 mg/m(2 ) and 5-FU as a 24-h infusion at either 1500 or 2000 mg/m(2 ) administered for 4 weeks followed by a 1-week rest ( one cycle ) . RESULTS Dose-limiting toxicity ( grade 3 diarrhea ) occurred in 3 of 14 assessable patients receiving 5-FU at st and ard 2000 mg/m(2 ) . This dose was administered to a further 25 patients . Cetuximab combined with FUFOX was generally well tolerated with the most common grade 3/4 adverse events being diarrhea ( 27 % ) and paresthesia ( 16 % ) . The confirmed response rate for patients receiving 5-FU at st and ard 2000 mg/m(2 ) ( N = 41 ) was 56 % , with a median duration of 9.3 months . Median progression-free and overall survival times including all 49 patients were 8.1 ( 95 % confidence interval 6.0 - 9.7 ) and 28.2 months , respectively . Cetuximab pharmacokinetics seemed not to be different for combination with FUFOX compared with cetuximab/irinotecan combinations . CONCLUSION This protocol is well tolerated and shows promising efficacy supporting further investigation PURPOSE To determine the efficacy of cetuximab in patients with recurrent or progressive non-small-cell lung cancer ( NSCLC ) after receiving at least one prior chemotherapy regimen . PATIENTS AND METHODS This was an open-label , phase II study of patients with epidermal growth factor receptor ( EGFR ) -positive and EGFR-negative advanced NSCLC with Eastern Cooperative Oncology
Output:
| Addition of cytotoxic chemotherapy to cetuximab significantly increases the risk of high- grade acneiform rash compared with cetuximab monotherapy . |
MS212698 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND It is not known whether short-term and rogen-deprivation therapy ( ADT ) before and during radiotherapy improves cancer control and overall survival among patients with early , localized prostate adenocarcinoma . METHODS From 1994 through 2001 , we r and omly assigned 1979 eligible patients with stage T1b , T1c , T2a , or T2b prostate adenocarcinoma and a prostate-specific antigen ( PSA ) level of 20 ng per milliliter or less to radiotherapy alone ( 992 patients ) or radiotherapy with 4 months of total and rogen suppression starting 2 months before radiotherapy ( radiotherapy plus short-term ADT , 987 patients ) . The primary end point was overall survival . Secondary end points included disease-specific mortality , distant metastases , biochemical failure ( an increasing level of PSA ) , and the rate of positive findings on repeat prostate biopsy at 2 years . RESULTS The median follow-up period was 9.1 years . The 10-year rate of overall survival was 62 % among patients receiving radiotherapy plus short-term ADT ( the combined-therapy group ) , as compared with 57 % among patients receiving radiotherapy alone ( hazard ratio for death with radiotherapy alone , 1.17 ; P=0.03 ) . The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from 8 % to 4 % ( hazard ratio for radiotherapy alone , 1.87 ; P=0.001 ) . Biochemical failure , distant metastases , and the rate of positive findings on repeat prostate biopsy at 2 years were significantly improved with radiotherapy plus short-term ADT . Acute and late radiation-induced toxic effects were similar in the two groups . The incidence of grade 3 or higher hormone-related toxic effects was less than 5 % . Re analysis according to risk showed reductions in overall and disease-specific mortality primarily among intermediate-risk patients , with no significant reductions among low-risk patients . CONCLUSIONS Among patients with stage T1b , T1c , T2a , or T2b prostate adenocarcinoma and a PSA level of 20 ng per milliliter or less , the use of short-term ADT for 4 months before and during radiotherapy was associated with significantly decreased disease-specific mortality and increased overall survival . According to post hoc risk analysis , the benefit was mainly seen in intermediate-risk , but not low-risk , men . ( Funded by the National Cancer Institute ; RTOG 94 - 08 Clinical Trials.gov number , NCT00002597 . ) Purpose : Castration therapy adjuvant to radiotherapy can significantly improve overall survival compared with radiotherapy alone in patients with locally advanced prostate cancer . Although many of the adverse effects of castration therapy are manageable , they can have a detrimental effect on quality of life . Here we evaluate the efficacy and tolerability of the non-castration-based therapy bicalutamide ( ‘ Casodex ’ ) 150 mg adjuvant to radiotherapy in patients with T1 - 4 , M0 , any n prostate cancer . Methods : The subset of patients within the early prostate cancer ( EPC ) program who received radiotherapy with curative intent ( n = 1,370 ) were included in the analysis . These patients were r and omized to receive oral bicalutamide 150 mg once daily ( n = 699 ) or placebo ( n = 671 ) . Results : The median follow-up for patients included in this analysis was 7.2 years . In patients with locally advanced disease ( n = 305 ) , bicalutamide adjuvant to radiotherapy significantly improved : progression-free survival ( PFS ) , reducing the risk of objective progression by 44 % compared with radiotherapy alone [ hazard ratio ( HR ) 0.56 ; 95 % confidence interval ( CI ) 0.40 , 0.78 ; P < 0.001 ) . Prostate-specific antigen (PSA)–PFS , reducing the risk of PSA progression by 59 % compared with radiotherapy alone ( HR 0.41 ; 95 % CI 0.30 , 0.55 ; P < 0.001 ) . Overall survival , reducing the risk of death by 35 % compared with radiotherapy alone ( HR 0.65 ; 95 % CI 0.44 , 0.95 ; P = 0.03 ) . This significant overall survival benefit for bicalutamide was driven by a lower risk of prostate cancer-related deaths ( 16.1 vs 24.3 % , respectively ) . There was no significant difference in PFS or overall survival in patients with localized disease ( n = 1,065 ) . Conclusions : In patients with locally advanced disease , bicalutamide 150 mg adjuvant to radiotherapy demonstrates significant clinical benefits in terms of overall survival , PFS and PSA – PFS compared with radiotherapy alone . The overall survival benefit in these patients is consistent with prior studies evaluating castration-based therapies adjuvant to radiotherapy ( Bolla et al. in Lancet 360:103–108 , 2002 ; Pilepich et al. in Int J Radiat Oncol Biol Phys 61:1285–1290 , 2005 ) . In addition , the clinical benefit of bicalutamide 150 mg in locally advanced patients , but not in those with localized disease , is consistent with the overall results from the EPC program ( McLeod et al. BJU Int 97:247–254 , 2006 ) . Given the quality -of-life advantages of bicalutamide relative to castration , bicalutamide 150 mg adjuvant to radiotherapy is an attractive alternative for men with locally advanced prostate cancer PURPOSE We evaluated the benefits and sequencing of and rogen suppression ( AS ) administered with external beam radiation therapy ( EBRT ) in T2-T3 prostate cancers . MATERIAL S AND METHODS Between 1990 and 1999 , 481 patients were entered in 2 successive , prospect i ve , r and omized studies , including 161 in the study 1 and 325 in study 2 . Eligible patients had clinical stages T2-T3 prostate cancer . In the first study ( L-101 ) subjects were r and omly allocated among EBRT alone ( group 1 ) , EBRT preceded by 3 months of AS ( group 2 ) , and neoadjuvant , concomitant and adjuvant AS for a total of 10 months ( group 3 ) . In the second study ( L-200 ) we analyzed neoadjuvant and concomitant AS ( total 5 months ) vs neoadjuvant , concomitant and short course adjuvant ( total 10 months ) AS with EBRT . In each study we used a total AS ( a luteinizing hormone-releasing hormone agonist plus an anti and rogen ) and a st and ard dose of radiation therapy at that time . Patient characteristics were well balanced in regard to age , stage , prostate specific antigen and Gleason score . No biochemical evidence of disease ( BNED ) was defined as an end point according to the Vancouver rule . RESULTS In the study 1 at a median followup of 5 years 7-year biochemical-free survival rates were 42 % , 66 % and 69 % in groups 1 to 3 , respectively . BNED was significantly different between groups 1 and 2 ( p = 0.009 ) and between groups 1 and 3 ( p = 0.003 ) but not between groups 2 and 3 ( p = 0.6 ) . Multivariate analysis using a Cox proportional hazards model showed an HR of 6.1 for Gleason score ( p = 0.001 ) , 1.4 for PSA ( p = 0.002 ) , 0.5 for group 1 vs group 2 ( p = 0.01 ) and 0.35 for group 1 vs group 3 ( p = 0.008 ) . In study 2 BNED at 4 years was 65 % . There was no significant difference between arms 1 and 2 ( p = 0.55 ) . CONCLUSIONS The analysis of study 1 shows a benefit of using a short course of neoadjuvant AS with EBRT vs EBRT alone for localized T2-T3 prostate cancers . Moreover , in each study adding a short course of adjuvant AS after neoadjuvant 1 provided no more advantage in these patients BACKGROUND We conducted a r and omized , prospect i ve trial comparing external irradiation with external irradiation plus goserelin ( an agonist analogue of gonadotropin-releasing hormone that reduces testosterone secretion ) in patients with locally advanced prostate cancer . METHODS From 1987 to 1995 , 415 patients with locally advanced prostate cancer were r and omly assigned to receive radiotherapy alone or radiotherapy plus immediate treatment with goserelin . The patients had a median age of 71 years ( range , 51 to 80 ) . Patients in both groups received 50 Gy of radiation to the pelvis over a period of five weeks and an additional 20 Gy over an additional two weeks as a prostatic boost . Patients in the combined-treatment group received 3.6 mg of goserelin ( Zoladex ) subcutaneously every four weeks starting on the first day of irradiation and continuing for three years ; those patients also received cyproterone acetate ( 150 mg orally per day ) during the first month of treatment to inhibit the transient rise in testosterone associated with the administration of goserelin . RESULTS Data were available for analysis on 401 patients . The median follow-up was 45 months . Kaplan-Meier estimates of overall survival at five years were 79 percent ( 95 percent confidence interval , 72 to 86 percent ) in the combined-treatment group and 62 percent ( 95 percent confidence interval , 52 to 72 percent ) in the radiotherapy group ( P=0.001 ) . The proportion of surviving patients who were free of disease at five years was 85 percent ( 95 percent confidence interval , 78 to 92 percent ) in the combined-treatment group and 48 percent ( 95 percent confidence interval , 38 to 58 percent ) in the radiotherapy group ( P<0.001 ) . CONCLUSIONS Adjuvant treatment with goserelin , when started simultaneously with external irradiation , improves local control and survival in patients with locally advanced prostate cancer PURPOSE To test the hypothesis that increasing radiation dose delivered to men with early-stage prostate cancer improves clinical outcomes . PATIENTS AND METHODS Men with T1b-T2b prostate cancer and prostate-specific antigen < /= 15 ng/mL were r and omly assigned to a total dose of either 70.2 Gray equivalents ( GyE ; conventional ) or 79.2 GyE ( high ) . No patient received and rogen suppression therapy with radiation . Local failure ( LF ) , biochemical failure ( BF ) , and overall survival ( OS ) were outcomes . Results A total of 393 men were r and omly assigned , and median follow-up was 8.9 years . Men receiving high-dose radiation therapy were significantly less likely to have LF , with a hazard ratio of 0.57 . The 10-year American Society for Therapeutic Radiology and Oncology BF rates were 32.4 % for conventional-dose and 16.7 % for high-dose radiation therapy ( P < .0001 ) . This difference held when only those with low-risk disease ( n = 227 ; 58 % of total ) were examined : 28.2 % for conventional and 7.1 % for high dose ( P < .0001 ) . There was a strong trend in the same direction for the intermediate-risk patients ( n = 144 ; 37 % of total ; 42.1 % v 30.4 % , P = .06 ) . Eleven percent of patients subsequently required and rogen deprivation for recurrence after conventional dose compared with 6 % after high dose ( P = .047 ) . There remains no difference in OS rates between the treatment arms ( 78.4 % v 83.4 % ; P = .41 ) . Two percent of patients in both arms experienced late grade > /= 3 genitourinary toxicity , and 1 % of patients in the high-dose arm experienced late grade > /= 3 GI toxicity . CONCLUSION This r and omized controlled trial shows superior long-term cancer control for men with localized prostate cancer receiving high-dose versus conventional-dose radiation . This was achieved without an increase in grade > /= 3 late urinary or rectal morbidity PURPOSE In a r and omized study we compared the combination of orchiectomy and radiotherapy to radiotherapy alone as treatment for locally advanced prostate cancer . Patients who were treated only with radiotherapy initially underwent castration therapy at clinical progression , providing the opportunity to compare immediate vs deferred endocrine intervention . MATERIAL S AND METHODS In this prospect i ve study 91 patients with locally advanced prostate cancer were r and omized to receive external beam radiotherapy ( 46 ) or combined orchiectomy and radiotherapy ( 45 ) after surgical lymph node staging . Survival rates were calculated . RESULTS During 14 to 19 years of followup 87 % of the patients in the radiotherapy group and 76 % in the combined orchiectomy and radiotherapy group died ( log rank p = 0.03 ) . Prostate cancer mortality was 57 % and 36 % , respectively ( log rank p =
Output:
| There was a statistically significant advantage to the use of and rogen suppression , in terms of both overall survival and disease free survival , when compared to radiotherapy alone .
The use of long-term goserelin ( up to three years ) was the strategy providing the higher magnitude of clinical benefit .
Complete hormonal blockade was not shown to be superior to goserelin monotherapy .
Conclusions Based on the findings of this systematic review , the evidence supports the use of and rogen suppression with goserelin monotherapy as the st and ard treatment for patients with prostate cancer treated with radiotherapy , which are at high risk of recurrence or metastases |
MS212699 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstrac Objective : To test the effect of extra non-directive information about prenatal testing , given individually or in a class . Setting : Antenatal clinics in a district general hospital and a university hospital . Design : R and omised controlled trial ; participants allocated to control group or offer of extra information individually or in class . Subjects : 1691 women booking antenatal care before 15 weeks ' gestation . Interventions : All participants received the usual information about prenatal tests from hospital staff . Individual participants were offered a separate session with a research midwife in which prenatal screening was described in detail . Class participants were offered the same extra information in an early prenatal class . Main outcome measures : Attendance at extra information sessions ; uptake rates of prenatal tests ; levels of anxiety , underst and ing , and satisfaction with decisions . Results : Attendance at classes was lower than at individual sessions ( adjusted odds ratio 0.45 ; 95 % confidence interval 0.35 to 0.58 ) . Ultrasonography was almost universally accepted ( 99 % ) and was not affected by either intervention . Uptake of cystic fibrosis testing , high in controls ( 79 % ) , was lowered in the individual group ( 0.44 ; 0.20 to 0.97 ) and classes ( 0.39 ; 0.18 to 0.86 ) . Uptake of screening for Down 's syndrome , already low ( 34 % ) in controls , was not further depressed by extra information in classes ( 0.99 ; 0.70 to 1.39 ) and was slightly higher in the individual group ( 1.45 ; 1.04 to 2.02 ) . Women offered extra information had improved underst and ing and were more satisfied with information received ; satisfaction with decisions about prenatal testing was unchanged . The offer of individual information reduced anxiety later in pregnancy . Conclusions : Ultrasonography is valued for non-medical reasons and chosen even by fully informed people who eschew prenatal diagnosis . The offer of extra information has no overall adverse effects on anxiety and reduces uptake of blood tests when background uptake rate is high ( but not when it is already low ) . High uptake of prenatal blood tests suggests compliant behaviour and need for more information The purpose of this study was to determine if providing men with information about screening for prostate cancer would enable them to assume a more active role in decision making with their family physician , and lower levels of anxiety and decisional conflict . Men were recruited from one family medical clinic in Winnipeg , Manitoba . One hundred men scheduled for a periodic health examination ( PHE ) were r and omly assigned to receive verbal and written information either prior to the PHE , or following the second interview . Men completed measures of preferred decisional role and anxiety prior to the PHE ; and assumed decisional role , decisional conflict , and anxiety post PHE . Results demonstrated that men who received the information prior to the PHE assumed a significantly more active role in making a screening decision , and had lower levels of decisional conflict post PHE . The two groups did not differ with regard to levels of state anxiety . Providing men with information enables them to make informed screening decisions with their family physicians The purpose of this study was to develop and test a decision support intervention ( DSI ) to assist women to make and act on informed decisions that are consistent with their values in the area of menopause and hormone replacement therapy ( HRT ) . Mode and intensity of intervention were tested in midlife women ( N = 248 ) , r and omly assigned to one of three intervention formats : written information only , guided discussion , or personalized decision exercise . Data were collected over 12 months . Knowledge , decisional conflict , satisfaction with health care provider , and self-efficacy improved following intervention and were maintained for 12 months for all groups . Women 's adherence to their own plans over 12 months was 59 % ( exercise ) , 76 % ( calcium intake ) , and 89 % ( HRT ) . Carefully written information is effective in promoting knowledge , adherence , and satisfaction among well-educated , interested women . It was concluded that women can underst and complex information , including tradeoffs regarding treatment options . Women will adhere to their own plans , suggesting that consumer rather than provider plans may be the more appropriate gold st and ard for measuring adherence Patient satisfaction measures have previously addressed satisfaction with medical care , satisfaction with providers , and satisfaction with outcomes , but not satisfaction with the health care decision itself . As patients become more involved in health care decisions , it is important to underst and specific dynamics of the decision itself The Satisfaction with Decision ( SWD ) scale measures satisfaction with health care decisions . It was developed in the context of postmenopausal hormone-replacement therapy decisions The six-item scale has excellent reliability ( Cronbach 's alpha = 0.86 ) . Discriminant validity , tested by performing principal- components analysis of items pooled from the SWD scale and two conceptually related measures , was good . Correlation of the SWD scale with measures of satisfaction with other aspects of the decision-making process showed the SWD scale was correlated most highly ( 0.64 ) with " decisional confidence , " and least with " desire to participate in health care de cisions " and " satisfaction with provider " The SWD scale predicts decision certainty in this study . Use in an independent study showed that the SWD scale was correlated with the likelihood of patients ' intentions to get a flu shot . Further investigation in relation to other health decisions will establish the utility of the SWD scale as an outcome measure Key words : patient satisfaction ; medical decision making ; decision support ( Med Decis Making 1996;16:58 - 64 OBJECTIVE : To assess the impact of providing an educational videotape , ' Treatment Choices for Ischaemic Heart Disease : a Shared Decision-Making Program Videotape , ' to patients referred for coronary angiography compared with st and ard patient-physician decision making ( usual care ) . STUDY DESIGN : R and omized controlled clinical trial . SETTING : University Hospital and Veterans Affairs Hospital . PATIENTS : A consecutive sample of 217 patients referred for coronary angiography were r and omized to receive ' usual care ' or to receive the videotape in addition to st and ard patient physician decision making ( videotape ) : 109 completed the study ( 50 % completion rate ) . MAIN OUTCOME MEASURES : Knowledge of coronary artery disease , satisfaction , self-reported physical and mental health functioning , and the proportion of patients who were referred for coronary revascularization . RESULTS : Compared with patients who received ' usual care , ' those who received the videotape were more knowledgeable ( mean score 83 vs. 58 % ; P < 0.0001 ) but less satisfied with their treatment ( 79 vs. 88 % ; P = 0.038 ) . There were no significant differences between the videotape and ' usual care ' groups with respect to satisfaction with the decision making process ( mean score 73 vs. 77 % ; P = 0.37 ) , satisfaction with the decision made ( mean score 73 vs. 78 % ; P = 0.28 ) , physical functioning ( 38 vs. 38 % ; P = 0.76 ) , mental health functioning ( 49 vs. 49 % ; P = 0.94 ) , or in referral for coronary revascularization ( OR 0.60 ; 95 % CI 0.22 - 1.65 ; P = 0.33 ) . CONCLUSION : Although the educational videotape increased patients ' knowledge level , it was associated with a decrease in their level of satisfaction with treatment . Before there is wide-spread dissemination of this technology , advocates should demonstrate its effectiveness in everyday practice In early 1983 , all 1,280 faculty and resident physicians at one hospital who were eligible to be vaccinated against hepatitis B were divided r and omly into three groups : Group 1 physicians received general information about the risks and benefits of alternative vaccine decisions ; Group 2 physicians were additionally invited to provide personal information for an individualized decision analysis ( 12.6 percent responded ) ; and Group 3 physicians , who served as controls , were not contacted . In one year 's follow-up , 20 percent of physicians were screened for hepatitis B antibody or vaccinated . More Group 2 physicians whose decision analyses recommended screening or vaccination took these actions ( 39 percent ) than any other group . Group assignment remained significantly associated with vaccine decisions after analyzing results by the " intention to treat " principle , and after adjusting for training status , exposure to blood and blood products , and pre- study intentions about the vaccine . Despite the low overall vaccine acceptance rate , it is concluded that individualized decision analysis can influence the clinical decisions taken by knowledgeable and interested patients Background . This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aim ed at increasing patient participation in these discussion OBJECTIVE : To determine the effect of the Ischemic Heart Disease Shared Decision-Making Program ( IHD SDP ) an interactive videodisc design ed to assist patients in the decision-making process involving treatment choices for ischemic heart disease , on patient decision-making . DESIGN : R and omized , controlled trial . SETTING : The Toronto Hospital , University of Toronto , Toronto , Ontario , Canada . PARTICIPANTS : Two hundred forty ambulatory patients with ischemic heart disease amenable to elective revascularization and ongoing medical therapy . MEASUREMENTS AND MAIN RESULTS : The primary outcome was patient satisfaction with the decision-making process . This was measured using the 12-item Decision-Making Process Question naire that was developed and vali date d in a r and omized trial of the benign prostatic hyperplasia SDP . Secondary outcomes included patient knowledge ( measured using 20 questions about knowledge deemed necessary for an informed treatment decision ) , treatment decision , patient-angiographer agreement on decision , and general health scores . Outcomes were measured at the time of treatment decision and /or at 6 months follow-up . Shared decision-making program scores were similar for the intervention and control group ( 71 % and 70 % , respectively ; 95 % confidence interval [ CI ] for 1 % difference , −3 % to 7 % ) . The intervention group had higher knowledge scores ( 75 % vs 62 % ; 95 % CI for 13 % difference , 8 % to 18 % ) . The intervention group chose to pursue revascularization less often ( 58 % vs 75 % for the controls ; 95 % CI for 17 % difference , 4 % to 31 % ) . At 6 months , 52 % of the intervention group and 66 % of the controls had undergone revascularization ( 95 % CI for 14 % difference , 0 % to 28 % ) . General health and angina scores were not different between the groups at 6 months . Exposure to the IHD SDP result ed in more patient-angiographer disagreement about treatment decisions . CONCLUSIONS : There was no significant difference in satisfaction with decision-making process scores between the IHD SDP and usual practice groups . The IHD SDP patients were more knowledgeable , underwent less revascularization ( interventional therapies ) , and demonstrated increased patient decision-making autonomy without apparent impact on quality of life BACKGROUND In response to the isolation of the BRCA1 gene , a breast-ovarian cancer-susceptibility gene , biotechnology companies are already marketing genetic tests to health care providers and to the public . Initial studies indicate interest in BRCA1 testing in the general public and in population s at high risk . However , the optimal strategies for educating and counseling individuals have yet to be determined . PURPOSE Our goal was to evaluate the impact of alternate strategies for pretest education and counseling on decision-making regarding BRCA1 testing among women at low to moderate risk who have a family history of breast and /or ovarian cancer . METHODS A r and omized trial design was used to evaluate the effects of education only ( educational approach ) and education plus counseling ( counseling approach ) , as compared with a waiting-list ( control ) condition ( n = 400 for all groups combined ) . The educational approach review ed information about personal risk factors , inheritance of cancer susceptibility , the benefits , limitations , and risks of BRCA1 testing , and cancer screening and prevention options . The counseling approach included this information , as well as a personalized discussion of experiences with cancer in the family and the potential psychological and social impact of testing . Data on knowledge of inherited cancer and BRCA1 test characteristics , perceived risk , perceived benefits , limitations and risks of BRCA1 testing , and testing intentions were collected by use of structured telephone interviews at baseline and at 1-month follow-up . Provision of a blood sample for future testing served as a proxy measure of intention to be tested ( in the education and counseling arms of the study ) . The effects of intervention group on study outcomes were evaluated by use of hierarchical linear regression modeling and logistic regression modeling ( for the blood sample outcome ) . All P values are for two-sided tests . RESULTS The educational and counseling approaches both led to significant increases in knowledge , relative to the control condition ( P < .001 for both ) . The counseling approach , but not the educational approach , was superior to the control condition in producing significant increases in perceived limitations and risks of BRCA1 testing ( P < .01 ) and decreases in perceived benefits ( P < .05 ) . However , neither approach produced changes in intentions to have BRCA1 testing . Prior to and following both education only and education plus counseling , approximately one half of the participants stated that they intended to be tested ; after the session , 52 % provided a blood sample . CONCLUSIONS St and ard educational approaches may be equally effective as exp and ed counseling approaches in enhancing knowledge . Since knowledge is a key aspect of medical decision-making , st and ard education may be adequate in situations where genetic testing must be streamlined . On the other h and , it has been argued that optimal decision-making requires not only knowledge , but also a reasoned evaluation of the positive and negative consequences of alternate decisions . Although the counseling approach is more likely to achieve this goal , it may not diminish interest in testing , even among women at low to moderate risk . Future research should focus on
Output:
| In the big picture , use of health decision aids should result in better decisions .
If the choice of a screening or treatment strategy is to be truly informed , patient knowledge about the decision seems a straightforward outcome measure .
Another logical end point for choice of strategy is whether decision aids result in selection s that are more consistent with a patient 's assessed outcome preferences , risk attitudes , and time preferences .
Finally , improved decision making may lead to better health status in some situations , which can be measured by using a host of disease-specific or generic health status measurements . |
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