Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate
Abstract
Background: Some people believe that patients who take part in randomised controlled trials (RCTs) face risks that they would not face if they opted for non-trial treatment. Others think that trial participation is beneficial and the best way to ensure access to the most up-to-date physicians and treatments. This is an updated version of the original Cochrane review published in Issue 1, 2005.
Objectives: To assess the effects of patient participation in RCTs ('trial effects') independent both of the effects of the clinical treatments being compared ('treatment effects') and any differences between patients who participated in RCTs and those who did not. We aimed to compare similar patients receiving similar treatment inside and outside of RCTs.
Search strategy: In March 2007, we searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, The Cochrane Methodology Register, SciSearch and PsycINFO for potentially relevant studies. Our search yielded 7586 new references. In addition, we reviewed the reference lists of relevant articles.
Selection criteria: Randomized studies and cohort studies with data on clinical outcomes of RCT participants and similar patients who received similar treatment outside of RCTs.
Data collection and analysis: At least two review authors independently assessed studies for inclusion, assessed study quality and extracted data.
Main results: We identified 30 new non-randomized cohort studies (45 comparisons): no new RCTs…
How strong is the evidence?
Evidence Hub reads this as a meta-analysis, done in people. Its evidence level is 1 of 5 (Highest · pooled evidence). Pooled evidence from several studies sits at the top of the evidence pyramid. Reported size: 86,640 participants or records.
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