For the last half-century, randomized clinical trials (RCTs) have been the “gold standard” of evaluating the efficacy or effectiveness of clinical interventions. Randomized clinical trials are based on well-recognized principles1 that underlie guidelines, such as the CONSORT (Consolidated Standards of Reporting Trials),2- 4 for reporting such studies. As frequently happens when practices become routine, the underlying logic fades into the background. This increasingly appears to be the case with RCT methodology. Even the best performed RCTs often fail to provide information most crucial to evaluating the treatment under study and thus to improving medical decision making.
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