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August 28, 1996

How to Report Randomized Controlled TrialsThe CONSORT Statement

JAMA. 1996;276(8):649. doi:10.1001/jama.1996.03540080071033

The best evidence on the efficacy of medical interventions comes from well-conducted, randomized controlled trials (RCTs), but unless such trials are reported adequately, it is impossible to assess that information. In response to increasing evidence that reporting of RCTs is imperfect, there has been a concerted effort to set standards for reporting RCTs, the process described by Begg et al1 in this issue of THE Journal.

See also p 637.

In December 1994, JAMA published the Standards of Reporting Trials (SORT) statement.2 We followed this with the publication of a trial using all the SORT headings.3 In an accompanying Editorial,4 I called for the SORT group to agree on common standards with another group that had met in Asilomar.5 Representatives of both groups were brought together by David Moher, MSc, of the University of Ottawa. Their discussions were informed by comments from readers, many of