Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.

Pulmonary rehabilitation for chronic obstructive pulmonary disease

Abstract: Background The widespread application pulmonary rehabilitation in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function attributable to the programs. This review updates that reported by Lacasse et al Lancet 1996; 748:1115-1119. Objectives To determine the impact of rehabilitation on health-related quality of life (QoL) and exercise capacity in patients with COPD. Search strategy The 14 randomized controlled trials (RCTs) included in the original meta-analysis were included. Additional RCTs were identified from the Cochrane Airways Group's registry of COPD RCTs using the strategy: [exp, lung diseases, obstructive] and [exp, rehabilitation or exp, exercise therapy] and [research design or longitudinal studies or evaluation study or randomized controlled trial]. Abstracts presented at American Thoracic Society 1980-2000, American College of Chest Physicians 1980-2000 and European Respiratory Society 1987-2000 were also searched. Selection criteria RCTs of rehabilitation in patients with COPD in which quality of life (QoL) and/or functional (FEC) or maximal (MEC) exercise capacity were measured. Rehabilitation was defined as exercise training for at least 4 weeks with or without education and/or psychological support. Control groups received conventional community care without rehabilitation. Data collection and analysis Weighted mean differences (WMD) were calculated using a random-effects model. Missing data from the primary study reports were requested from the authors. Main results 23 RCTs met the inclusion criteria. Statistically significant improvements were found for all the outcomes. In three important domains of QoL (Chronic Respiratory Questionnaire scores for Dyspnea, Fatigue and Mastery), the effect was larger than the minimal clinically important difference of 0.5 units using this instrument. For example Dyspnoea score: WMD 0.98 units, 95% Confidence Interval (95% CI) 0.74 - 1.22 units; n=9 trials. For FEC and MEC, the effect was small and a little below the threshold of clinical significance for the 6- minute walking distance: WMD 49 m, 95% CI: 26 - 72 m; n=10 trials. Reviewer's conclusions Rehabilitation relieves dyspnea and fatigue and enhances patients' sense of control over their condition. These improvements are moderately large and clinically significant. The average improvement in exercise capacity was modest. Rehabilitation forms an important component of the management of COPD.

Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.

Abstract: The CONSORT (Consolidated Standards of Reporting Trials) Statement, including a checklist and a flow diagram, was developed to help authors improve their reporting of randomized controlled trials. Its primary focus was on individually randomized trials with 2 parallel groups that assess the possible superiority of one treatment compared with another but is now being extended to other trial designs. Noninferiority and equivalence trials have methodological features that differ from superiority trials and present particular difficulties in design, conduct, analysis, and interpretation. Although the rationale for such trials occurs frequently, those designed and described specifically as noninferiority or equivalence trials appear less commonly in the medical literature. The quality of reporting of those that are published is often inadequate. In this article, we present an adapted CONSORT checklist for reporting noninferiority and equivalence trials and provide illustrative examples and explanations for those items amended from the original CONSORT checklist. The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions.

The care transitions intervention: results of a randomized controlled trial.

Abstract: Background Patients with complex care needs who require care across different health care settings are vulnerable to experiencing serious quality problems. A care transitions intervention designed to encourage patients and their caregivers to assert a more active role during care transitions may reduce rehospitalization rates. Methods Randomized controlled trial. Between September 1, 2002, and August 31, 2003, patients were identified at the time of hospitalization and were randomized to receive the intervention or usual care. The setting was a large integrated delivery system located in Colorado. Subjects (N = 750) included community-dwelling adults 65 years or older admitted to the study hospital with 1 of 11 selected conditions. Intervention patients received (1) tools to promote cross-site communication, (2) encouragement to take a more active role in their care and to assert their pREFERENCES, and (3) continuity across settings and guidance from a “transition coach.” Rates of rehospitalization were measured at 30, 90, and 180 days. Results Intervention patients had lower rehospitalization rates at 30 days (8.3 vs 11.9, P = .048) and at 90 days (16.7 vs 22.5, P = .04) than control subjects. Intervention patients had lower rehospitalization rates for the same condition that precipitated the index hospitalization at 90 days (5.3 vs 9.8, P = .04) and at 180 days (8.6 vs 13.9, P = .046) than controls. The mean hospital costs were lower for intervention patients ($2058) vs controls ($2546) at 180 days (log-transformed P = .049). Conclusion Coaching chronically ill older patients and their caregivers to ensure that their needs are met during care transitions may reduce the rates of subsequent rehospitalization. Trial Registration clinicaltrials.gov Identifier:NCT00244491

Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure

Abstract: Objective. —To evaluate the effect of angiotensin-converting enzyme (ACE) inhibitors on mortality and morbidity in patients with symptomatic congestive heart failure. Data Sources and Study Selection. —Data were obtained for all completed, published or unpublished, randomized, placebo-controlled trials of ACE inhibitors that were at least 8 weeks in duration and had determined total mortality by intention to treat, regardless of sample size. Trials were identified based on literature review and correspondence with investigators and pharmaceutical firms. Data Extraction. —Using standard tables, data were extracted by one author and confirmed where necessary by the other author or the principal investigator of the trial. Unpublished data were obtained by direct correspondence with the principal investigator of each study or pharmaceutical firm. Data Synthesis. —The data for each outcome were combined using the Yusuf-Peto adaptation of the Mantel-Haenszel method. Overall, there was a statistically significant reduction in total mortality (odds ratio [OR], 0.77; 95% confidence interval [CI], 0.67 to 0.88;P Conclusions. —Total mortality and hospitalization for congestive heart failure are significantly reduced by ACE inhibitors with consistent effects in a broad range of patients. (JAMA. 1995;273:1450-1456)

The Finnish Diabetes Prevention Study (DPS) Lifestyle intervention and 3-year results on diet and physical activity

Abstract: OBJECTIVE —To describe the 1 ) lifestyle intervention used in the Finnish Diabetes Prevention Study, 2 ) short- and long-term changes in diet and exercise behavior, and 3 ) effect of the intervention on glucose and lipid metabolism. RESEARCH DESIGN AND METHODS —There were 522 middle-aged, overweight subjects with impaired glucose tolerance who were randomized to either a usual care control group or an intensive lifestyle intervention group. The control group received general dietary and exercise advice at baseline and had an annual physician’s examination. The subjects in the intervention group received additional individualized dietary counseling from a nutritionist. They were also offered circuit-type resistance training sessions and advised to increase overall physical activity. The intervention was the most intensive during the first year, followed by a maintenance period. The intervention goals were to reduce body weight, reduce dietary and saturated fat, and increase physical activity and dietary fiber. RESULTS —The intervention group showed significantly greater improvement in each intervention goal. After 1 and 3 years, weight reductions were 4.5 and 3.5 kg in the intervention group and 1.0 and 0.9 kg in the control group, respectively. Measures of glycemia and lipemia improved more in the intervention group. CONCLUSIONS —The intensive lifestyle intervention produced long-term beneficial changes in diet, physical activity, and clinical and biochemical parameters and reduced diabetes risk. This type of intervention is a feasible option to prevent type 2 diabetes and should be implemented in the primary health care system.