Author Affiliations: Department of Obstetrics and Gynecology, University of California, Los Angeles (Dr Pitkin) and Department of Obstetrics and Gynecology, University of Utah, Salt Lake City (Dr Scott).
The randomized controlled trial (RCT), introduced into clinical research
more than 50 years ago, has assumed increasing importance in evaluating medical
interventions. Most studies comparing randomized and nonrandomized trials
addressing the same question have found that RCTs generally yield less favorable
assessments of treatment efficacy than the nonrandomized trials.1 Although
this conclusion is not quite unanimous,2 there
has been increasing recognition of the importance of random assignment in
medical research and the RCT now occupies a prominent position in the hierarchy
of evidence on which to base clinical judgments.3 In
addition to random assignment, allocation concealment and other features of
experimental design are also critical for proper conduct of an RCT.4 Attention to these essential aspects improves study
quality5 and, presumably, the trust clinicians
can place in the findings.
Pitkin RM, Scott JR. Evaluating Gynecological Surgical ProceduresTrials and Tribulations. JAMA. 2004;291(12):1503-1504. doi:10.1001/jama.291.12.1503