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Abstract

The large and increasing number of randomized clinical trials in all of medicine has prompted the introduction of guidelines that are intended to improve the quality of the research and of the published papers derived from such investigations. These guidelines for reporting clinical trials, the Consolidated Standards of Reporting Trials (the CONSORT statement) were set forth by a group of journal editors, statisticians, biomedical investigators, and editors. The CONSORT statement has been published in several major medical journals and is likely to have a major impact on editorial policies as well as the design of such investigations. I have invited Dr Kenneth F. Schulz of the Centers for Disease Control and Prevention, a leading investigator in the evaluation of clinical trials and a participant in the design of the CONSORT guidelines, to prepare this brief summary for the Annals. The CONSORT statement is expected to have a substantial effect on the peer review of clinical trials, and it promises to elevate the quality of such investigations. Future submissions to the Annals will be evaluated in the context of these guidelines.