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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.


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Journal ArticleDOI
TL;DR: A systematic review of randomized trials of interventions to alter the interaction between patients and practitioners, develop taxonomies of the interventions and outcomes, and assess the evidence that such interventions improve patients’ health and well-being.
Abstract: PURPOSE We wanted to identify published randomized trials of interventions to alter the interaction between patients and practitioners, develop taxonomies of the interventions and outcomes, and assess the evidence that such interventions improve patients’ health and well-being. METHODS Undertaking a systematic review of randomized trials, we sought trials in primary and secondary care with health-related outcomes, which we found by searching MEDLINE, HealthSTAR, and PsycINFO bibliographic databases through 1999. We also completed one round of manual citation searching. RESULTS Thirty-five trials were included. Most were set in primary care in North America. Trials were heterogeneous in populations, settings, interventions, and measures. Interventions frequently combined several poorly described elements. Explicit theoretical underpinning was rare, and only one study linked intervention through process to outcome measures. Health outcomes were rarely measured objectively (6 of 35), and only 4 trials with health outcomes met predefined quality criteria. Interventions frequently altered the process of interactions (significantly in 73%, 22 of 30 trials). Principal outcomes favored the intervention group in 74% of trials (26 of 35), reaching statistical significance in 14 (40%). Positive effects on health outcomes achieved statistical significance in 44% of trials (11 of 25); negative effects were uncommon (5 of 25, 20%). Simple approaches to increasing the participation of patients in the clinical encounter, such as providing practitioners with a note from patients about their concerns beforehand, showed promise, as did more complex programs providing specific information about disease and attention to emotion. Apparently similar interventions varied in effectiveness across studies. CONCLUSIONS Successful interactions between patients and their practitioners lie at the heart of medicine, yet there are few rigorous trials of well-specified interventions to inform best practice. Trial evidence suggests that a range of approaches can achieve changes in this interaction, and some show promise in improving patients’ health. To advance knowledge further, we need to replicate promising studies using rigorous methods. These should include explicit theoretical frameworks designed to link effects on key communication and interaction characteristics through to effects on health outcomes.

575 citations

Journal ArticleDOI
TL;DR: Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate‐to‐high‐risk ambulatory patients with cancer who were starting chemotherapy.
Abstract: Background Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. Methods We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy. The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days. The main safety outcome was a major bleeding episode. Results Of the 574 patients who underwent randomization, 563 were included in t...

575 citations

Journal ArticleDOI
01 Sep 2003-Stroke
TL;DR: This structured, progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance, balance, and mobility beyond those attributable to spontaneous recovery and usual care.
Abstract: Background and Purpose— Rehabilitation care after stroke is highly variable and increasingly shorter in duration. The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear. The objective of this study was to determine whether a structured, progressive, physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care. Methods— This randomized, controlled, single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions. We included persons with stroke who were living in the community. One hundred patients (mean age, 70 years; mean Orpington score, 3.4) consented and were randomized from a screened sample of 582. Ninety-two subjects completed the trial. Intervention was a structured, progressive, physiologically based, therapist-supervised, in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility, strength, balan...

575 citations

Journal ArticleDOI
TL;DR: CBT is related to short-term effects on depression and anxiety and both short and long term effects on QOL and individual interventions were more effective than group.
Abstract: Objective: The purpose of this meta-analysis was to investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on commonly reported problems (depression, anxiety, pain, physical functioning, and quality of life (QOL)) in adult cancer survivors. Methods: Meta analyses of randomized controlled trials of CBT and PE were conducted. MEDLINE, PSYCHINFO and the Cochrane Database were searched from 1993-2004. The effects of individual versus group interventions and short ( 8 months) term follow up are also reported. Results: Fifteen studies met quality criteria. The sample size was 1,492 adult cancer survivors with an age range of 18-84. 790 were randomly assigned to intervention groups and 702 to control groups. CBT varied in duration from 4 weekly one-hour sessions to 55 weekly two-hour sessions. PE ranged from a single 20-minute session to 6 weekly one-hour sessions. Follow up ranged from 1 week to 14 months. CBT was effective for depression (ES = 1.2; 95% CI = 0.22-2.19), anxiety (ES = 1.99; 95% CI = 0.69-3.31), and QOL

574 citations


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Performance
Metrics
No. of papers in the topic in previous years
YearPapers
20241
202317,032
202234,327
202112,220
202010,774
20199,017