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Intention-to-treat Analysis (intention-to-treat + analysis)
Selected AbstractsSchool-based alcohol education: results of a cluster-randomized controlled trialADDICTION, Issue 3 2009Matthis Morgenstern ABSTRACT Objective This study aimed to examine the effects of a school-based alcohol education intervention. Design Two-arm three-wave cluster-randomized controlled trial, with schools as the unit for randomization. Surveys were conducted prior to intervention implementation, then 4 and 12 months after baseline. Setting A total of 30 public schools in Schleswig-Holstein, Germany. Participants Baseline data were obtained from 1686 7th graders. The retention rate was 85% over 12 months. Intervention The intervention consisted of four interactive lessons conducted by teachers, booklets for students and booklets for parents. Measures Knowledge, attitudes, life-time alcohol consumption (ever use alcohol without parental knowledge, ever been drunk and ever binge drinking) and past-month alcohol use. Results Intention-to-treat analyses revealed that intervention status was associated with more general knowledge about alcohol and lower levels of life-time binge drinking. No effects were found with respect to students' self-reported attitudes, intentions to drink, life-time alcohol use and past-month alcohol use. Conclusions The results indicate that this brief school-based intervention had a small short-term preventive effect on alcohol misuse. [source] The Impact of a Brief Expectation Survey on Parental Satisfaction in the Pediatric Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 12 2006Christopher D. Spahr MD Abstract Objectives To determine the effect of physician knowledge of parental expectations on satisfaction with emergency department (ED) care. Methods This was a prospective, controlled, interventional trial involving parents of children presenting to a children's hospital ED. Parents completed an expectation survey on arrival, which was either immediately placed back in the enrollment envelope (control) or shown to the physician caring for the child (intervention). The physician was instructed to initial the expectation survey to acknowledge receipt of the survey. Parents then completed a satisfaction survey at discharge. The primary outcomes were differences in satisfaction with physician review of the expectation survey, as measured by 1) parental ratings of overall care and 2) their willingness to recommend the ED to others. A third (baseline) group completed only a satisfaction survey at discharge. Results A total of 614 (66%) of the 930 enrolled parents completed the study. Intention-to-treat analysis did not show a significant increase in parental satisfaction ratings for either overall care or recommend the ED; however, only 42% of the intervention group surveys had documented physician review. When these initialed surveys were compared with the control group in a per-protocol analysis, there was a significant improvement in parental satisfaction. There were no differences between the control and baseline groups, indicating no effect of the expectation survey completion on satisfaction. Conclusions Physician knowledge of written parental expectations may improve parental satisfaction during an ED visit. Further work is needed to overcome the barriers to physician review of the expectation survey to maximize parent satisfaction. [source] Vinpocetine treatment in acute ischaemic stroke: a pilot single-blind randomized clinical trialEUROPEAN JOURNAL OF NEUROLOGY, Issue 1 2001V. L. Feigin The aim of the study was to assess the safety and feasibility of a clinical trial on the effect of vinpocetine, a synthetic ethyl ester of apovincamine, in acute ischaemic stroke. Thirty consecutive patients with computed tomography verified diagnosis of acute ischaemic stroke, who could receive drug treatment within 72 h of stroke onset, were enrolled. The patients were randomly allocated to receive either low-molecular weight dextran alone or in combination with vinpocetine. Poor outcome was defined as being dead or having a Barthel index of <,70 or a Rankin score of 3,5. Intention-to-treat analysis was applied. One-tenth of all hospitalized patients with acute ischaemic stroke were eligible for the trial. Thirty eligible patients were treated with either low-molecular weight dextran alone (mean age 57.9 ± 11.6 years, n = 15) or in combination with vinpocetine (mean age 60.8 ± 6.6 years, n = 15). The two treatment groups were comparable with respect to major prognostic variables. A relative risk (RR) reduction of poor outcome at 3 months follow-up was 30% (RR = 0.7; 95% confidence interval [CI] 0.1,3.4), as defined by the modified Barthel Index, and 60% as defined by the modified Ranking score (RR = 0.4, 95% CI: 0.1,1.7). The National Institute of Health (NIH,NINDS) Stroke Scale score was marginally significantly better in the vinpocetine treated group at 3 months of follow-up (P = 0.05, anova). No significant adverse effects were seen. This pilot study shows that a full-scale randomized double-blind, placebo-controlled trial of vinpocetine treatment in acute ischaemic stroke is feasible and warranted. [source] Rabeprazole- versus Esomeprazole-Based Eradication Regimens for H. pylori InfectionHELICOBACTER, Issue 6 2007I-Chen Wu Abstract Background: Different kinds of proton pump inhibitor-based triple therapies could result in different Helicobacter pylori eradication rates. Aim: The aims of this study were to compare the efficacy and safety of rabeprazole- and esomeprazole-based triple therapy in primary treatment of H. pylori infection in Taiwan. Patients and Methods: From June 2005 to March 2007, 420 H. pylori -infected patients were randomly assigned to receive a 7-day eradication therapy with either esomeprazole 40 mg daily (EAC group, n = 209) or rabeprazole 20 mg b.i.d. (RAC group, n = 211) in combination with amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d.. Follow-up endoscopy with biopsy was done 12,16 weeks after completion of eradication therapy. Those who refused endoscopic exams underwent 13C-urea breath test to assess the treatment response. Results: Intention-to-treat analysis revealed that the eradication rate was 89.4% in the EAC group and 90.5% in RAC groups (p -value = .72). All of the subjects returned for assessment of compliance (100% in EAC group vs. 99.5% in RAC group, p -value = .32) and adverse events (3.83% in EAC group vs. 6.16% in RAC group, p -value = .27). Sixty (28.7%) and 37 (17.6%) patients in EAC and RAC group, respectively, refused endoscopy and underwent a 13C-urea breath test to determine the treatment effect. Conclusion: In conclusion, rabeprazole- and esomeprazole-based primary therapies for H. pylori infection are comparable in efficacy and safety. [source] Effectiveness of hepatitis C treatment with pegylated interferon and ribavirin in urban minority patients,HEPATOLOGY, Issue 4 2010Paul Feuerstadt Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%-63% (efficacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-naïve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with a mean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P = 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naïve, HIV antibody,negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients. (HEPATOLOGY 2010.) [source] Celecoxib as an adjunct in the treatment of depressive or mixed episodes of bipolar disorder: a double-blind, randomized, placebo-controlled study,,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 2 2008Fabiano G. Nery Abstract Objective To investigate whether the cox-2 inhibitor celecoxib has antidepressant effects in bipolar disorder (BD) patients during depressive or mixed phases. Methods We studied 28 DSM-IV BD patients who were experiencing a depressive or mixed episode and were on a stable dose of a mood stabilizer or atypical antipsychotic medication. Subjects were randomized to receive 6 weeks of double-blind placebo or celecoxib (400,mg/day) treatment. Current mood stabilizer or antipsychotic medication remained at the same doses during the trial. Results Intention-to-treat analysis showed that the patients receiving celecoxib had lower Hamilton Depression Rating Scale (HamD) scores after 1 week of treatment compared to the patients receiving placebo, but this difference was not statistically significant (p,=,0.09). The improvement in the first week of treatment was statistically significant when the analysis included only the subjects who completed the full 6-week trial (p,=,0.03). The two groups did not differ significantly on depressive or manic symptoms from the second week until the end of the trial. Celecoxib was well tolerated with the exception of two subjects who dropped out of the study due to rash. Conclusions Our findings suggest that adjunctive treatment with celecoxib may produce a rapid-onset antidepressant effect in BD patients experiencing depressive or mixed episodes. Copyright © 2008 John Wiley & Sons, Ltd. [source] Effect of mesalazine on mucosal immune biomarkers in irritable bowel syndrome: a randomized controlled proof-of-concept studyALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009R. CORINALDESI Summary Background, Intestinal immune infiltration contributes to symptoms in patients with irritable bowel syndrome (IBS). Aim, To assesses the effect of mesalazine (mesalamine) on mucosal immune cells in patients with IBS, through a pilot study. Methods, A randomized, double-blind, placebo-controlled trial in 20 patients with IBS in tertiary care setting. Patients were randomized to receive placebo or 800 mg mesalazine three times daily for 8 weeks. The primary endpoint was a significant reduction in total colonic immune cells on biopsies obtained at the end of treatment compared to baseline. Secondary endpoints included effects on subsets of immune cells, inflammatory mediators and symptom severity. Intention-to-treat analysis was performed. Results, Mesalazine markedly reduced immune cells as compared with placebo (P = 0.0082); this effect was ascribed to a marked inhibition of mast cells (P = 0.0014). Mesalazine significantly increased general well-being (P = 0.038), but had no significant effects on abdominal pain (P = 0.084), bloating (P = 0.177) or bowel habits. No serious drug-related adverse events were reported during the study. Conclusions, Mesalazine is an effective and safe approach to reduce mast cell infiltration and may improve general well-being in patients with IBS. These results support the hypothesis that immune mechanisms represent potential therapeutic targets in IBS. [source] Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegalyCLINICAL ENDOCRINOLOGY, Issue 2 2008Philippe Chanson Summary Background, An essential criterion for control of acromegaly is normalization of IGF-I levels. Somatostatin analogues act to suppress IGF-I and GH levels. Objective, To assess the efficacy and safety of 48 weeks titrated dosing of lanreotide Autogel. Design, Open-label, multicentre, phase III, 48-week trial. Methods, Patients with active acromegaly (IGF-I levels > 1·3 times upper limit of age-adjusted normal range) were recruited. Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels. Intention-to-treat analysis was performed to determine the proportion of patients with normalized age-adjusted IGF-I levels at study end. Secondary evaluations included GH levels, clinical acromegaly signs and safety. Results, Fifty-seven of 63 patients completed the study. Lanreotide Autogel resulted in normalized age-adjusted IGF-I levels in 27 patients (43%, 95% CI 31,55). Mean GH levels decreased from 6·2 to 1·5 µg/l at study end, with 53 of 62 patients (85%) having GH levels , 2·5 µg/l (95% CI 76·7,94·3) and 28 of 62 patients (45%) with levels < 1 µg/l (95% CI 32·8,57·6). Twenty-four (38%) had both normal IGF-I levels and GH levels , 2·5 µg/l. Acromegaly symptoms reduced significantly in most patients throughout the study. The most common adverse events were gastrointestinal, as expected for somatostatin analogues. Conclusions, Using IGF-I as primary end-point, 48 weeks lanreotide Autogel treatment, titrated for optimal hormonal control, controlled IGF-I and GH levels effectively, reduced acromegaly symptoms and was well tolerated. [source] Naltrexone versus acamprosate in the treatment of alcohol dependence: a multi-centre, randomized, double-blind, placebo-controlled trialADDICTION, Issue 10 2006Kirsten C. Morley ABSTRACT Aim To compare the efficacy of acamprosate and naltrexone in the treatment of alcohol dependence., Design A double-blind, placebo-controlled trial., Setting Three treatment centres in Australia., Participants A total of 169 alcohol dependent subjects were given naltrexone (50 mg/day), acamprosate (1998 mg/day) or placebo for 12 weeks. Intervention All subjects were offered manualized compliance therapy, a brief intervention that targets problems that may affect treatment compliance such as ambivalence and misperceptions about medication. Measurements Time to the first drink, time to first relapse, drinks per drinking day and cumulative abstinence. Findings In intention-to-treat analyses, there were no differences between groups on outcome measures of drinking, craving or biochemical markers. Similarly, analyses of the 94 subjects that completed the study in full and demonstrated 80% compliance, revealed no significant treatment effects. Differential treatment effects were identified after stratification according to scores on the Alcohol Dependence Scale (ADS) and Depression Anxiety and Stress Scale (DASS). A significant beneficial treatment effect on time to first relapse was revealed for subjects with ,no depression' allocated to naltrexone (n = 56; P < 0.01). In addition, a significant beneficial treatment effect was revealed in subjects with ,low dependence' allocated to naltrexone (n = 34; P < 0.05). Conclusions The results of this study support the efficacy of naltrexone in the relapse prevention of alcoholism amongst those with low levels of clinical depression and alcohol dependence severity. No effect of acamprosate was found in our sample. [source] The Effect of a High-Intensity Functional Exercise Program on Activities of Daily Living: A Randomized Controlled Trial in Residential Care FacilitiesJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 10 2009Håkan Littbrand PT OBJECTIVES: To evaluate whether a high-intensity functional weight-bearing exercise program reduces dependency in activities of daily living (ADLs) in older people living in residential care facilities, focusing on people with dementia. DESIGN: Randomized, controlled trial. SETTING: Nine residential care facilities. PARTICIPANTS: One hundred ninety-one older people dependent in ADLs and with a Mini-Mental State Examination score of 10 or greater. One hundred (52.4%) of the participants had dementia. INTERVENTION: A high-intensity functional weight-bearing exercise program or a control activity consisting of 29 sessions over 3 months. MEASUREMENTS: The Barthel ADL Index; follow-up at 3 months (directly after the intervention) and 6 months with intention-to-treat analyses. RESULTS: There were no statistically significant differences between the groups regarding overall ADL performance. Analyses for each item revealed that a smaller proportion of participants in the exercise group had deteriorated in indoor mobility at 3 months (exercise 3.5% vs control 16.0%, P=.01) and 6 months (7.7% vs 19.8%, P=.03). For people with dementia, there was a significant difference in overall ADL performance in favor of the exercise group at 3 months (mean difference 1.1, P=.03) but not at 6 months. CONCLUSION: A high-intensity functional weight-bearing exercise program seems to reduce ADL decline related to indoor mobility for older people living in residential care facilities. The program does not appear to have an overall effect on ADLs. In people with dementia, the exercise program may prevent decline in overall ADL performance, but continuous training may be needed to maintain that effect. [source] Meta-analysis: The efficacy and safety of monoclonal antibody targeted to epidermal growth factor receptor in the treatment of patients with metastatic colorectal cancerJOURNAL OF DIGESTIVE DISEASES, Issue 4 2009Fang NIE OBJECTIVE: To evaluate systematically the efficacy and safety of anti-epidermal growth factor receptor (EGFR) monoclonal antibody added to a chemotherapeutic regimen in the treatment of patients with metastatic colorectal cancer (mCRC). METHODS: Eligible articles were identified by searching electronic databases. All randomized trials comparing the arm with an anti-EGFR monoclonal antibody to the arm without an anti-EGFR monoclonal antibody during the treatment of mCRC were included. A statistical analysis was performed with Review Manager 4.2.8. RESULTS: Seven randomized trials (n= 4186) were identified. The pooled response rates were 25.4% and 17.6% by intention-to-treat analyses for patients with or without an anti-EGFR monoclonal antibody, respectively, the OR was 3.36 (95% CI 1.42,7.95); the incidence of grades 3,4 adverse events were 71.2% and 54.3% for two groups, respectively, the OR was 2.23 (95% CI 1.74,2.86). The incidence of diarrhea, skin toxicity, hypomagnesemia was 62.3% versus 55.7%; 79.3% versus 19.7%; 27.2% versus 5.6%; and the summary OR was 1.36 (95% CI 1.03,1.80); 33.47 (95% CI 14.81,75.61); 6.73 (95% CI 3.84,11.82), respectively. CONCLUSION: Our results confirmed that monoclonal antibody targeted to EGFR could be effective in increasing response rates and could be a key therapeutic agent in the optimal treatment of mCRC, despite a moderate increase in grades 3,4 adverse events. [source] Evaluation of a primary care-oriented brief counselling intervention for obesity with and without orlistatJOURNAL OF INTERNAL MEDICINE, Issue 4 2006W. S. C. POSTON Abstract. Objective., There is a significant need for an obesity treatment model suitable for the primary care environment. We examined the effectiveness of a brief counselling intervention alone, in combination with orlistat, and drug-alone in a 12-month randomized-clinical trial at a medical school obesity centre. Methods., Participants (N = 250) with body mass index (BMI) ,27 were randomized. Changes in body weight, lipids, blood pressure and serum glucose were examined. Drug adherence and attendance were also evaluated. Results., Completers analysis was conducted on 136 participants with data at baseline, 6 and 12 months and intention-to-treat analyses (ITT) for the total sample. Amongst completers, participants in the drug only (P = 0.012) and drug + brief counselling (P = 0.001) groups lost more weight (mean ± SD: ,3.8 ± 5.8 kg and ,4.8 ± 4.4 kg, respectively) than participants in the brief counselling only group at 6 months (,1.7 ± 3.3 kg), but there were no significant group differences at 12 months. ITT model results were similar to completers at 6 months and remained significant at 12 months, but the weight losses were more modest (<3 kg) for both groups receiving orlistat. For brief counselling alone, participants gained weight (1.7 ± 4.2 kg). Cardiovascular disease (CVD) parameter changes were negligible. Conclusions., Pharmacotherapy alone or combined with brief counselling resulted in modest weight losses that had minimal impact on cardiovascular parameters, but were greater than brief counselling alone. Whilst brief interventions and primary pharmacotherapy have been suggested as viable treatments for implementation in primary care settings, our study suggests that such minimal interventions provide minimal benefits. [source] Clinical trial: the combination of rifaximin with partially hydrolysed guar gum is more effective than rifaximin alone in eradicating small intestinal bacterial overgrowthALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2010M. Furnari Aliment Pharmacol Ther 2010; 32: 1000,1006 Summary Background, Abnormal intestinal clearance is involved in the pathogenesis of small intestinal bacterial overgrowth (SIBO). It is known that partially hydrolysed guar gum affects intestinal motility. Eradication therapy of SIBO is based on antibiotic treatment: no data are available on the role of fibre supplementation in eradicating SIBO. Aim, To assess whether the combination of partially hydrolysed guar gum and rifaximin is more effective than rifaximin alone in the treatment of SIBO. Methods, A 50 g-glucose breath test was given to 500 consecutive patients. Patients with a positive glucose breath test and predisposing conditions to SIBO entered into the study, and were randomized to receive rifaximin 1200 mg/day or rifaximin 1200 mg/day plus partially hydrolysed guar gum 5 g/day for 10 days. Patients completed a symptom questionnaire and glucose breath test both in basal condition and 1 month after withdrawal of therapy. Results, Seventy-seven patients had SIBO. Eradication rate of SIBO was 62.1% in the rifaximin group (both on per-protocol and intention-to-treat analyses), and 87.1% (per-protocol, P = 0.017) and 85.0% (intention-to-treat, P = 0.036) in the rifaximin-plus-partially hydrolysed guar gum group. Clinical improvement was observed in 86.9% and 91.1% of eradicated cases in rifaximin and rifaximin-plus-partially hydrolysed guar gum groups respectively (P = 0.677). Conclusion, The combination of rifaximin with partially hydrolysed guar gum seems to be more useful in eradicating SIBO compared with rifaximin alone. [source] Meta-analysis: factors affecting placebo response rate in the irritable bowel syndromeALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2010A. C. Ford Aliment Pharmacol Ther 2010; 32: 144,158 Summary Background, Irritable bowel syndrome (IBS) is a functional disorder of the gastrointestinal tract with a significant placebo response. Aim, To conduct a systematic review and meta-analysis examining the magnitude of placebo response rate in treatment trials for IBS. Methods, MEDLINE, EMBASE and the Cochrane central register of controlled trials were searched to identify randomized controlled trials (RCTs) comparing pharmacological therapies with placebo in adult IBS patients. Studies reported either global assessment of IBS symptom cure or improvement or abdominal pain cure or improvement. Data were extracted as intention-to-treat analyses with drop-outs assumed to be treatment failures and pooled using a random-effects model. Proportion of placebo patients experiencing symptom improvement or resolution was reported with a 95% confidence interval (CI). Effect of trial characteristics on magnitude of placebo response was examined. Results, In all, 73 RCTs were eligible, including 8364 patients with IBS allocated to placebo. Pooled placebo response rate across all RCTs was 37.5% (95% CI 34.4,40.6%). Rates were higher in European RCTs, RCTs that used physician-reported outcomes and RCTs using shorter duration of therapy. Conclusions, Placebo response rates across RCTs of pharmacological therapies in IBS were high. Future research should identify patient characteristics predicting placebo response. [source] Endoscopic variceal ligation alone or with pharmacological therapy for recurrent variceal bleeding: the importance of intention-to-treat analysesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2 2010A. Krag No abstract is available for this article. [source] Mobile Crisis Team Intervention to Enhance Linkage of Discharged Suicidal Emergency Department Patients to Outpatient Psychiatric Services: A Randomized Controlled TrialACADEMIC EMERGENCY MEDICINE, Issue 1 2010Glenn W. Currier MD Abstract Objectives:, Many suicidal patients treated and released from emergency departments (ED) fail to follow through with subsequent outpatient psychiatric appointments, often presenting back for repeat ED services. Thus, the authors sought to determine whether a mobile crisis team (MCT) intervention would be more effective than standard referral to a hospital-based clinic as a means of establishing near-term clinical contact after ED discharge. This objective was based on the premise that increased attendance at the first outpatient mental health appointment would initiate an ongoing treatment course, with subsequent differential improvements in psychiatric symptoms and functioning for patients successfully linked to care. Methods:, In a rater-blinded, randomized controlled trial, 120 participants who were evaluated for suicidal thoughts, plans, or behaviors, and who were subsequently discharged from an urban ED, were randomized to follow-up either in the community via a MCT or at an outpatient mental health clinic (OPC). Both MCTs and OPCs offered the same structured array of clinical services and referral options. Results:, Successful first clinical contact after ED discharge (here described as "linkage" to care) occurred in 39 of 56 (69.6%) participants randomized to the MCT versus 19 of 64 (29.6%) to the OPC (relative risk = 2.35, 95% CI = 1.55,3.56, p < 0.001). However, we detected no significant differences between groups using intention-to-treat analyses in symptom or functional outcome measures, at either 2 weeks or 3 months after enrollment. We also found no significant differences in outcomes between participants who did attend their first prescribed appointment via MCT or OPC versus those who did not. However divided (MCT vs. OPC, present at first appointment vs. no show), groups showed significant improvements but maintained clinically significant levels of dysfunction and continued to rely on ED services at a similar rate in the 6 months after study enrollment. Conclusions:, Community-based mobile outreach was a highly effective method of contacting suicidal patients who were discharged from the ED. However, establishing initial postdischarge contact in the community versus the clinic did not prove more effective at enhancing symptomatic or functional outcomes, nor did successful linkage with outpatient psychiatric care. Overall, participants showed some improvement shortly after ED discharge regardless of outpatient clinical contact, but nonetheless remained significantly symptomatic and at risk for repeated ED presentations. ACADEMIC EMERGENCY MEDICINE 2010; 17:36,43 © 2009 by the Society for Academic Emergency Medicine [source] Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up resultsBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2003Helga Gimbel Objective To compare total abdominal hysterectomy and subtotal abdominal hysterectomy performed for benign uterine diseases. Design Randomised, controlled, unblinded trial with central, computer-generated randomisation. Setting Danish trial performed in 11 departments of gynaecology. Population Women referred for benign uterine diseases were randomised to total abdominal hysterectomy (n= 158) or subtotal abdominal hysterectomy (n= 161). One-year follow up questionnaires had a response rate of 87%. Methods Patients were followed by strict data collection procedures, including postal questionnaires. The results after one year of follow up were analysed by intention-to-treat analyses. Main outcome measures (1) Primary: urinary incontinence and (2) secondary: post-operative complications, quality of life (SF-36), constipation, prolapse of the vaginal vault/cervical stump, satisfaction with sexual life, pelvic pain and vaginal bleeding. Results A significantly (P= 0.043) smaller proportion of women had urinary incontinence one year after total abdominal hysterectomy compared with subtotal abdominal hysterectomy [9%vs 18% (OR 2.08, 95% CI 1.01,4.29)]. The lower proportion of incontinent women in the total abdominal hysterectomy group was a result of a higher proportion of symptom relief (total abdominal hysterectomy: 20/140, subtotal abdominal hysterectomy: 14/136) as well as a lower proportion of women with new symptoms (total abdominal hysterectomy: 3/140, subtotal abdominal hysterectomy: 10/137). Twenty-seven women (20%) from the subtotal abdominal hysterectomy group had vaginal bleeding and two of them had to have their cervix removed. No other clinically important differences were found between the two hysterectomy methods. Conclusions A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy one year post-operatively. [source] Effect of exercise on upper extremity pain and dysfunction in head and neck cancer survivorsCANCER, Issue 1 2008A randomized controlled trial Abstract BACKGROUND. Shoulder pain and disability are well recognized complications associated with surgery for head and neck cancer. This study was designed to examine the effects of progressive resistance exercise training (PRET) on upper extremity pain and dysfunction in postsurgical head and neck cancer survivors. METHODS. Fifty-two head and neck cancer survivors were assigned randomly to PRET (n = 27) or a standardized therapeutic exercise protocol (TP) (n = 25) for 12 weeks. The primary endpoint was change in patient-rated shoulder pain and disability from baseline to postintervention. Secondary endpoints were upper extremity strength and endurance, range of motion, fatigue, and quality of life. RESULTS. Follow-up assessment for the primary outcome was 92%, and adherence to the supervised PRET and TP programs were 95% and 87%, respectively. On the basis of intention-to-treat analyses, PRET was superior to TP for improving shoulder pain and disability (,9.6; 95% confidence interval [95% CI], ,16.4 to ,4.5; P = .001), upper extremity strength (+10.8 kg; 95% CI, 5.4,16.2 kg; P < .001), and upper extremity endurance (+194 repetitions × kg; 95% CI, 10,378 repetitions × kg; P = .039). Changes in neck dissection impairment, fatigue, and quality of life favored the PRET group but did not reach statistical significance. CONCLUSIONS. The PRET program significantly reduced shoulder pain and disability and improved upper extremity muscular strength and endurance in head and neck cancer survivors who had shoulder dysfunction because of spinal accessory nerve damage. Clinicians should consider the addition of PRET in the rehabilitation of postsurgical head and neck cancer survivors. Cancer 2008. © 2008 American Cancer Society. [source] Smoking cessation intervention in parents of young children: a randomised controlled trialADDICTION, Issue 11 2005Abu Saleh M. Abdullah ABSTRACT Objective To examine whether telephone counselling based on the stages of change component of Transtheoretical model of behaviour change together with educational materials could help non-motivated smoking parents of young children to cease. Design Randomised controlled trial. Setting Hong Kong Special Administrative Region, PR China. Participants 952 smoker fathers and mothers of Chinese children aged 5 years. Intervention Participants were randomly allocated into two groups: the intervention group received printed self-help materials and three-session telephone-based smoking cessation counselling delivered by trained counsellors; the control group received printed self-help materials only. A structured questionnaire was used for data collection at baseline and at 1, 3 and 6 month follow up. Main outcome measures The main outcome is 7 day point prevalence quit rate at 6 months (defined as not smoking during the 7 days preceding the 6 month follow up) determined by self reports. Other secondary outcomes were self reported 24 h point prevalence quit rate and self-reported continuous quit rate and bio-chemically validated quit rate at 6 months. Results A total of 952 smoker fathers and mothers were randomized to the intervention (n = 467) and control (n = 485) groups. Most were daily smokers (92.4%) and the mean number of cigarettes smoked per day was 14.5 (SD = 8.9). By using intention-to-treat analysis, the 7 day point prevalence quit rate at 6 month follow up was significantly greater in the intervention group (15.3%; 68/444) than the control group (7.4%; 34/459) (P < 0.001). The absolute risk reduction was 7.9% (95% confidence interval: 3.78% to 12.01%). The number needed to treat to get one additional smoker to quit was 13 (95% CI: 8,26). The crude odds ratio of quitting was 2.3(95% CI: 1.5,3.5). The adjusted odds ratio was 2.1 (95% CI: 1.4,3.4) (adjusted for age, number of years smoked, and alcohol dependency). Conclusion Proactive telephone counselling is an effective aid to promote smoking cessation among parents of young children. [source] Double-Dose, New-Generation Proton Pump Inhibitors Do Not Improve Helicobacter pylori Eradication RateHELICOBACTER, Issue 6 2007Hyo Sun Choi Abstract Background: Up to present, omeprazole plus two antibiotics are used for Helicobacter pylori eradication therapy . Few studies have compared double-dose new-generation, proton pump inhibitors (PPI) with omeprazole. Therefore, we conducted a randomized, prospective study to evaluate differences in H. pylori eradication rates by PPI type. Material and Methods: Between January 2006 and December 2006, 576 consecutive patients with proven H. pylori infection were enrolled prospectively. Four different PPIs [omeprazole 20 mg b.i.d. (old generation), or pantoprazole 40 mg b.i.d., rabeprazole 20 mg b.i.d., or esomeprazole 40 mg b.i.d. (new generation)] were added to clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week. Results: By intention-to-treat analysis, no difference was found between the eradication rates of these four PPIs: 64.9% (omeprazole, n = 148), 69.3% (pantoprazole, n = 140), 69.3% (rabeprazole, n = 140), and 72.9% (esomoprazole, n = 148). When eradication rates were analyzed according to whether patients had an ulcer or not on a per-protocol basis, no difference was found between the eradication rates of the four PPIs. However, side-effects were more common in the esomeprazole-based triple therapy group than in the other groups (p < .05). Conclusions: No convincing evidence was obtained that double-dose new-generation PPIs have better H. pylori eradication rates and tolerability than omeprazole. [source] Recent Use of Proton Pump Inhibitor-Based Triple Therapies for the Eradication of H. pylori: A Broad Data ReviewHELICOBACTER, Issue 2 2003Hans-Joachim Ulmer abstract Introduction. For the eradication of Helicobacter pylori a 1-week triple therapy combining proton pump inhibitors with two antibiotics has been recommended as a gold standard therapy. However, a recent broad data review on the efficacy of the different regimens is missing. Therefore, the aim of this study was to systematically review the recent literature. Methods. We undertook a broad data review of the efficacy of nine different 7-day triple therapies consisting of a proton pump inhibitor (lansoprazole, pantoprazole, omeprazole) in its standard dosage and two antibiotics. Relevant original papers on H. pylori eradication in adults, published in English or German between 1995 and 2000, were identified from MEDLINE searches. Studies were reviewed and selected according to predefined criteria. Results. Our predefined criteria were fulfilled by 79 full paper articles including 112 study arms with 8383 patients on intention-to-treat, or 6787 patients on per-protocol basis, respectively. The mean eradication rates unweighted or weighted by the number of patients in the study arm vary from 71.9% to 83.8% for intention-to-treat analysis and from 78.5% to 91.2% for per-protocol analysis. Conclusions. All nine PPI based triple therapy regimens are very effective in H. pylori eradication. The current literature review underlines that the use of either lansoprazole, omeprazole, or pantoprazole combined with two antibiotics yield similar high eradication rates. [source] Excellent outcome following down-staging of hepatocellular carcinoma prior to liver transplantation: An intention-to-treat analysis,,HEPATOLOGY, Issue 3 2008Francis Y. Yao We previously reported encouraging results of down-staging of hepatocellular carcinoma (HCC) to meet conventional T2 criteria (one lesion 2,5 cm or two to three lesions <3 cm) for orthotopic liver transplantation (OLT) in 30 patients as a test of concept. In this ongoing prospective study, we analyzed longer-term outcome data on HCC down-staging in a larger cohort of 61 patients with tumor stage exceeding T2 criteria who were enrolled between June 2002 and January 2007. Eligibility criteria for down-staging included: (1) one lesion >5 cm and up to 8 cm; (2) two to three lesions with at least one lesion >3 cm and not exceeding 5 cm, with total tumor diameter up to 8 cm; or (3) four to five lesions with none >3 cm, with total tumor diameter up to 8 cm. A minimum observation period of 3 months after down-staging was required before OLT. Tumor down-staging was successful in 43 patients (70.5%). Thirty-five patients (57.4%) had received OLT, including two who had undergone live-donor liver transplantation. Treatment failure was observed in 18 patients (29.5%), primarily due to tumor progression. In the explant of 35 patients who underwent OLT, 13 had complete tumor necrosis, 17 met T2 criteria, and five exceeded T2 criteria. The Kaplan-Meier intention-to-treat survival at 1 and 4 years after down-staging were 87.5% and 69.3%, respectively. The 1-year and 4-year posttransplantation survival rates were 96.2% and 92.1%, respectively. No patient had HCC recurrence after a median posttransplantation follow-up of 25 months. The only factor predicting treatment failure was pretreatment alpha-fetoprotein >1,000 ng/mL. Conclusion: Successful down-staging of HCC can be achieved in the majority of carefully selected patients and is associated with excellent posttransplantation outcome. (HEPATOLOGY 2008.) [source] Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C,,HEPATOLOGY, Issue 2 2008Stefan Zeuzem The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting of interferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naïve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFN,)-2a 180 ,g one time per week (qwk), or alb-IFN 900 or 1,200 ,g once every two weeks (q2wk), or 1,200 ,g once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 ,g q2wk, 55.5% (61/110) with 1,200 ,g q2wk, and 50.9% (59/116) with 1,200 ,g q4wk, and 57.9% (66/114) with PEG-IFN,-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 ,g q2wk, 18.2% with 1,200 ,g q2wk and 12.1% with 1,200 ,g q4wk, and 6.1% with PEG-IFN,-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 ,g q2wk versus PEG-IFN,-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFN,-2a. (HEPATOLOGY 2008;48:407,417.) [source] Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response,HEPATOLOGY, Issue 1 2008Olav Dalgard A recent nonrandomized pilot trial showed that hepatitis C virus (HCV) patients with genotype 2/3 and rapid virological response (RVR) had a 90% sustained virological response (SVR) rate after 14 weeks of treatment. We aimed to assess this concept in a randomized controlled trial. In the trial, 428 treatment-naïve HCV RNA,positive patients with genotype 2 or 3 were enrolled. Patients with RVR were randomized to 14 (group A) or 24 (group B) weeks of treatment. Patients were treated with pegylated interferon ,-2b (1.5 ,g/kg) subcutaneously weekly and ribavirin (800-1400 mg) orally daily. The noninferiority margin was set to be 10% between the two groups with a one-sided 2.5% significance level. RVR was obtained in 302 of 428 (71%), and 298 of these were randomized to group A (n = 148) or group B (n = 150). In the intention-to-treat analysis, SVR rates were 120 of 148 (81.1%) in group A and 136 of 150 (90.7%) in group B (difference, 9.6%; 95% confidence interval, 1.7-17.7). Among patients with an HCV RNA test 24 weeks after the end of treatment, 120 of 139 (86.3%) patients in group A achieved SVR compared with 136 of 146 (93.2%) in group B (difference, 6.9%; 95% confidence interval, ,0.1 to +13.9). Conclusion: We cannot formally claim that 14 weeks of treatment is noninferior to 24 weeks of treatment. However, the SVR rate after 14 weeks of treatment is high, and although longer treatment may give slightly better SVR, we believe economical savings and fewer side effects make it rational to treat patients with genotype 2 or 3 and RVR for only 14 weeks. (HEPATOLOGY 2007.) [source] Techniques for liver parenchymal transection: a meta-analysis of randomized controlled trialsHPB, Issue 4 2009Viniyendra Pamecha Abstract Background:, Different techniques of liver parenchymal transection have been described, including the finger fracture, sharp dissection, clamp,crush methods and, more recently, the Cavitron ultrasonic surgical aspirator (CUSA), the hydrojet and the radiofrequency dissection sealer (RFDS). This review assesses the benefits and risks associated with the various techniques. Methods:, Randomized clinical trials were identified from the Cochrane Library Trials Register, MEDLINE, EMBASE, Science Citation Index Expanded and reference lists. Odds ratio (ORs), mean difference (MDs) and standardized mean differences (SMDs) were calculated with 95% confidence intervals based on intention-to-treat analysis or available-case analysis. Results:, We identified seven trials including a total of 556 patients. Blood transfusion requirements were lower with the clamp,crush technique than with the CUSA or hydrojet. The clamp,crush technique was quicker than the CUSA, hydrojet or RFDS. Infective complications and transection blood loss were greater with the RFDS than with the clamp,crush method. There was no significant difference between techniques in mortality, morbidity, liver dysfunction or intensive therapy unit and hospital stay. Conclusions:, The clamp,crush technique is more rapid and is associated with lower rates of blood loss and otherwise similar outcomes when compared with other methods of parenchymal transection. It represents the reference standard against which new methods may be compared. [source] The effects of physical exercise on depressive symptoms among the aged: a systematic reviewINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 5 2006Noora Sjösten Abstract Objective To determine the effects of physical exercise on depression or depressive symptoms among the aged. Method A literature search covering various medical databases was conducted to identify randomised controlled trials (RCT's) about the effects of exercise treatments on depression or depressive symptoms among the aged. The studies were classified according to the baseline depression status of participants and assessed in relation to allocation concealment, blinding at outcome assessment, follow-up and whether intention to treat analysis was used. Studies meeting the inclusion criteria were accepted. Results Exercise was effective in treating depression among those suffering from minor or major depression and in reducing depressive symptoms among those with a high amount of depressive symptoms at baseline. However, both the allocation concealment and the blinding method were adequately described in only four studies. Furthermore, intention-to-treat analysis was conducted in half of the studies and some follow-up information after the intervention has been published for five studies. Conclusions Physical exercise may be efficient in reducing clinical depression and depressive symptoms in the short-term among the aged suffering from depression or a high amount of depressive symptoms. More well controlled studies are needed. Copyright © 2006 John Wiley & Sons, Ltd. [source] Pimecrolimus versus placebo in genital aphthous ulcers of Behcet's disease: a randomized double-blind controlled trialINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 3 2010Cheyda CHAMS-DAVATCHI Abstract Background:, Genital aphthous ulcers of Behcet's disease (BD) are painful and usually resistant to local treatments. Pimecrolimus is an ascomycin macrolactam, used in inflammatory skin diseases. Objective:, To discover if pimecrolimus can accelerate the healing of BD genital aphthous ulcers. Methods:, Ninety patients with genital aphthous ulcers were enrolled. Only patients treated with colchicine alone were selected. All patients signed a written consent form. Patients were randomly assigned to pimecrolimus or placebo cream, applied twice daily for 1 week. The primary outcome was the healing period. Up to 7 days, it was considered as a positive result. Results were compared by chi-square test. The mean healing time was compared by analysis of variance. Analyses were done both by the ,intention-to-treat' and ,treatment-completed' methods. Results:, Both groups were similar at the entry (gender, age, ulcer size, pain intensity and treatment delay). By intention-to-treat analysis, in the pimecrolimus group, 18 patients had positive and 27 negative results. In the control group, four had positive and 41 negative results. The difference was significant (,2 = 10.167, P = 0.001). By treatment-completed analysis, with pimecrolimus, 18 patients had positive and 22 negative results. With placebo, four had positive, and 41 negative results. The difference was significant (,2 = 12.574, P = 0.0004). Comparison of mean healing time in the pimecrolimus versus placebo group, demonstrated a significant acceleration both in intention-to-treat analysis (10.7 vs. 20.7 days, F = 17.466, P < 0.0001) and treatment-completed analysis (8.3 vs. 20.7 days, F = 29.289, P < 0.0001). Conclusion:, Pimecrolimus is safe and efficient in the treatment of BD genital ulcers, by accelerating the healing process. [source] Effect of Antibiotic Guidelines on Outcomes of Hospitalized Patients with Nursing Home,Acquired PneumoniaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2009Ali A. El Solh MD OBJECTIVES: To compare the 2003 community-acquired pneumonia (CAP) guideline and the 2005 healthcare-associated pneumonia (HCAP) guideline on time to clinical stability, length of hospital stay, and mortality in nursing home patients hospitalized for pneumonia. DESIGN: Retrospective study. SETTING: Three tertiary-care hospitals. PARTICIPANTS: Three hundred thirty-four nursing home patients. MEASUREMENTS: Patients were classified according to the antibiotic regimens they received based on the 2003 CAP guideline or the 2005 HCAP guideline. Time to clinical stability, time to switch therapy, and mortality were evaluated in an intention-to-treat analysis. A multivariate survival model using propensity analysis was used to adjust for heterogeneity between the two groups. RESULTS: Of the 334 patients, 258 (77%) were treated according to the 2003 HCAP guideline. Time to clinical stability did not differ between those treated according to the 2003 CAP or the 2005 HCAP guidelines. Only the Pneumonia Severity Index (P=.006) and multilobar involvement (P=.005) were significantly associated with delay in achieving clinical stability. Adjusted in-hospital and 30-day mortality were comparable in both cohorts (odds ratio (OR)=0.87, 95% confidence interval (CI)=0.49,1.34, and OR=0.79, 95% CI=0.42,1.31, respectively), although time to switch therapy and length of stay were longer for those treated according to the 2005 HCAP guideline. CONCLUSION: In hospitalized nursing home patients with pneumonia, treatment with an antibiotic regimen according to the 2003 CAP guideline achieved comparable time to clinical stability and in-hospital and 30-day mortality with a regimen based on the 2005 HCAP guideline. [source] Flu: Effect of Vaccine in Elderly Care Home Residents: A Randomized TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2007Fiona Gaughran MD OBJECTIVES: To determine whether assessing seroprotection after influenza vaccine and administering booster vaccination where not achieved reduces hospitalization and death. To estimate the overall seroprotection rate of influenza vaccine. DESIGN: A two-arm, partially blind, randomized, multicenter, parallel-group, controlled trial. SETTING: Twenty-six care homes in three South London boroughs in fall 2004. PARTICIPANTS: Two hundred seventy-seven elderly permanent care home residents meeting eligibility criteria. INTERVENTION: Postvaccination blood samples were randomized to booster evaluation or no booster evaluation (control). If evaluation revealed inadequate seroprotection, a booster vaccine was administered. MEASUREMENTS: Primary outcome was hospitalization to end April 2005; secondary outcomes were death, antibiotic use, and seroprotection. RESULTS: Sixty percent of the controls and 41% of the booster evaluation group responded to routine vaccination. Booster vaccination where indicated increased seroprotection rates in the booster evaluation group to 66%. Treatment groups did not differ in any outcome measures in the intention-to-treat analysis (hospitalization odds ratio=1.02, 95% confidence interval=0.55,1.87). There was a tendency towards greater differences between groups in the per-protocol analysis than in the intention-to-treat analysis, particularly regarding seroprotection rates. The same effect was observed in the a priori exploratory analysis of residents not seroprotected after routine vaccination alone. CONCLUSION: In a year without circulating influenza, there is no clinical benefit of administering a booster vaccine if routine trivalent vaccination fails to result in seroprotection. Hemagglutination titers rose in two strains postbooster vaccination but fell against the novel strain, Wyoming. The benefit of such a booster strategy when influenza is prevalent thus remains unc ertain. [source] Treatment of Uncorrected Refractive Error Improves Vision-Specific Quality of LifeJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2006Anne L. Coleman MD OBJECTIVES: To evaluate the benefit of eyeglasses and magnifiers in elderly patients with uncorrected refractive errors. DESIGN: A single-center, randomized, prospective, controlled trial (September 2001 to August 2003). SETTING: Los Angeles County, California. PARTICIPANTS: One hundred thirty-one community-dwelling persons aged 65 and older who had habitual distance visual acuity of 20/32 or worse and whose distant visual acuity, near visual acuity, or both could be improved with eyeglasses, a magnifier, or both by two lines of acuity or more. INTERVENTION: Sixty-six were randomized to receive a prescription and voucher for free eyeglasses, a magnifier, or both immediately, and 65 were randomized to receive a prescription and voucher after the 3-month follow-up visit (the control group). MEASUREMENTS: Primary outcome was vision-specific functioning as measured using the 25-item National Eye Institute,Visual Functioning Questionnaire (NEI-VFQ). Secondary outcomes were distance and near visual acuity and overall functioning as measured using the Rosow-Breslau function questionnaire. RESULTS: In the intention-to-treat analysis of 3-month follow-up data, participants who received the eyeglasses prescription and voucher immediately had greater improvement in NEI-VFQ composite scores than the control group (P<.01). They also had greater improvement in perceptions of their general vision (P<.01), distance visual acuity (P=.03), near visual acuity (P=.04), and mental health (P=.02). CONCLUSION: Correction of uncorrected refractive error, one of the leading causes of visual impairment in older people, improved the vision-specific quality of life of community-dwelling older persons. [source] | ||||||||||||||||||||||||||||