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.

Forced Use of the Upper Extremity in Chronic Stroke Patients: Results From a Single-Blind Randomized Clinical Trial

Abstract: Background and Purpose—Of all stroke survivors, 30% to 66% are unable to use their affected arm in performing activities of daily living. Although forced use therapy appears to improve arm function in chronic stroke patients, there is no conclusive evidence. This study evaluates the effectiveness of forced use therapy. Methods—In an observer-blinded randomized clinical trial, 66 chronic stroke patients were allocated to either forced use therapy (immobilization of the unaffected arm combined with intensive training) or a reference therapy of equally intensive bimanual training, based on Neuro-Developmental Treatment, for a period of 2 weeks. Outcomes were evaluated on the basis of the Rehabilitation Activities Profile (activities), the Action Research Arm (ARA) test (dexterity), the upper extremity section of the Fugl-Meyer Assessment scale, the Motor Activity Log (MAL), and a Problem Score. The minimal clinically important difference (MCID) was determined at the onset of the study. Results—One week after...

A randomized trial comparing radical prostatectomy with watchful waiting in early prostate cancer

Abstract: Background: Radical prostatectomy is widely used in the treatment of early prostate cancer. The possible survival benefit of this treatment, however, is unclear. We conducted a randomized trial to ...

Effect of a Pharmacy Care Program on Medication Adherence and Persistence, Blood Pressure, and Low-Density Lipoprotein Cholesterol: A Randomized Controlled Trial

Abstract: ContextPoor medication adherence diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications, placing them at increased risk for nonadherence.ObjectiveTo test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).Design, Setting, and PatientsA multiphase, prospective study with an observational phase and a randomized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications. The study was conducted from June 2004 to August 2006.InterventionAfter a 2-month run-in phase (measurement of baseline adherence, BP, and LDL-C), patients entered a 6-month intervention phase (standardized medication education, regular follow-up by pharmacists, and medications dispensed in time-specific packs). Following the intervention phase, patients were randomized to continued pharmacy care vs usual care for an additional 6 months.Main Outcome MeasuresPrimary end point of the observation phase was change in the proportion of pills taken vs baseline; secondary end points were the associated changes in BP and LDL-C. Primary end point of the randomization phase was the between-group comparison of medication persistence.ResultsA total of 200 elderly patients (77.1% men; mean [SD] age, 78 [8.3] years), taking a mean (SD) of 9 (3) chronic medications were enrolled. Coronary risk factors included drug-treated hypertension in 184 patients (91.5%) and drug-treated hyperlipidemia in 162 (80.6%). Mean (SD) baseline medication adherence was 61.2% (13.5%). After 6 months of intervention, medication adherence increased to 96.9% (5.2%; P<.001) and was associated with significant improvements in systolic BP (133.2 [14.9] to 129.9 [16.0] mm Hg; P = .02) and LDL-C (91.7 [26.1] to 86.8 [23.4] mg/dL; P = .001). Six months after randomization, the persistence of medication adherence decreased to 69.1% (16.4%) among those patients assigned to usual care, whereas it was sustained at 95.5% (7.7%) in pharmacy care (P<.001). This was associated with significant reductions in systolic BP in the pharmacy care group (−6.9 mm Hg; 95% CI, −10.7 to −3.1 mm Hg) vs the usual care group (−1.0 mm Hg; 95% CI, −5.9 to 3.9 mm Hg; P = .04), but no significant between-group differences in LDL-C levels or reductions.ConclusionsA pharmacy care program led to increases in medication adherence, medication persistence, and clinically meaningful reductions in BP, whereas discontinuation of the program was associated with decreased medication adherence and persistence.Trial Registrationclinicaltrials.gov Identifier: NCT00393419Published online November 13, 2006 (doi:10.1001/jama.296.21.joc60162).

Publication bias in clinical trials due to statistical significance or direction of trial results.

Abstract: Background The tendency for authors to submit, and of journals to accept, manuscripts for publication based on the direction or strength of the study findings has been termed publication bias. Objectives To assess the extent to which publication of a cohort of clinical trials is influenced by the statistical significance, perceived importance, or direction of their results. Search methods We searched the Cochrane Methodology Register (The Cochrane Library [Online] Issue 2, 2007), MEDLINE (1950 to March Week 2 2007), EMBASE (1980 to Week 11 2007) and Ovid MEDLINE In-Process & Other Non-Indexed Citations (March 21 2007). We also searched the Science Citation Index (April 2007), checked reference lists of relevant articles and contacted researchers to identify additional studies. Selection criteria Studies containing analyses of the association between publication and the statistical significance or direction of the results (trial findings), for a cohort of registered clinical trials. Data collection and analysis Two authors independently extracted data. We classified findings as either positive (defined as results classified by the investigators as statistically significant (P < 0.05), or perceived as striking or important, or showing a positive direction of effect) or negative (findings that were not statistically significant (P ≥ 0.05), or perceived as unimportant, or showing a negative or null direction in effect). We extracted information on other potential risk factors for failure to publish, when these data were available. Main results Five studies were included. Trials with positive findings were more likely to be published than trials with negative or null findings (odds ratio 3.90; 95% confidence interval 2.68 to 5.68). This corresponds to a risk ratio of 1.78 (95% CI 1.58 to 1.95), assuming that 41% of negative trials are published (the median among the included studies, range = 11% to 85%). In absolute terms, this means that if 41% of negative trials are published, we would expect that 73% of positive trials would be published. Two studies assessed time to publication and showed that trials with positive findings tended to be published after four to five years compared to those with negative findings, which were published after six to eight years. Three studies found no statistically significant association between sample size and publication. One study found no significant association between either funding mechanism, investigator rank, or sex and publication. Authors' conclusions Trials with positive findings are published more often, and more quickly, than trials with negative findings.