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August 28, 1996

Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement

Author Affiliations

From the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY (Dr Begg); Center for Bioethics, University of Pennsylvania, Philadelphia (Dr Cho); Department of Neurological Surgery, University of California, San Francisco (Ms Eastwood); The Lancet, London, United Kingdom (Dr Horton); Departments of Medicine and Epidemiology and Community Health, University of Ottawa (Ontario) (Mr Moher); Department of Statistics, Stanford (Calif) University (Dr Olkin); Obstetrics and Gynecology, Los Angeles, Calif (Dr Pitkin); JAMA, Chicago, III (Dr Rennie); Centers for Disease Control and Prevention, Atlanta, Ga (Drs Schulz and Stroup); and Center for Health Services Research in Primary Care, Durham (NC) Veterans Affairs Medical Center (Dr Simel).

JAMA. 1996;276(8):637-639. doi:10.1001/jama.1996.03540080059030

THE RANDOMIZED controlled trial (RCT), more than any other methodology, can have a powerful and immediate impact on patient care. Ideally, the report of such an evaluation needs to convey to the reader relevant information concerning the design, conduct, analysis, and generalizability of the trial. This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial. Accurate and complete reporting also benefits editors and reviewers in their deliberations regarding submitted manuscripts. For RCTs to ultimately benefit patients, the published report should be of the highest possible standard.

For editorial comment see p 649.  Evidence produced repeatedly over the last 30 years indicates a wide chasm between what a trial should report and what is actually published in the literature. In a review of 71 RCTs with negative results published between 1960 and 1975, the authors reported that the vast