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March 24/31, 2004

Evaluating Gynecological Surgical Procedures: Trials and Tribulations

Author Affiliations

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).

JAMA. 2004;291(12):1503-1504. doi:10.1001/jama.291.12.1503

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.