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Clinical, Research, and Policy Importance

Helena C. Kraemer, PhD; Ellen Frank, PhD; David J. Kupfer, MD

JAMA. 2006;296:1286-1289.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Two concerns stand out: statistical vs clinical significance and the heterogeneity of effect sizes. The first problem is well recognized and can be dealt with by requiring that a clinically interpretable effect size always be reported. Perhaps the most clinically meaningful effect size is . . . [Full Text of this Article]

RCT Methods and Interpretations

Author Affiliations: Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, Calif (Dr Kraemer); Department of Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, Pa (Drs Frank and Kupfer).

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