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A Proposal for Structured Reporting of Randomized Controlled Trials

Erik Andrew, PhD; Aslam Anis, PhD; Tom Chalmers, MD; Mildred Cho, PhD; Mike Clarke, PhD; David Felson, MD; Peter Gøtzsche, MD; Richard Greene, MD, PhD; Alejandro Jadad, MD; Wayne Jonas, MD; Terry Klassen, MD; Paul Knipschild, MD; Andreas Laupacis, MD, MSc; Curtis L. Meinert, PhD; David Moher, MSc; Graham Nichol, MD; Andy Oxman, MD; Marie-France Penman, BScN; Stuart Pocock, PhD; Joan Reisch, PhD; David Sackett, MD; Kenneth Schulz, PhD, MBA; Judy Snider; Peter Tugwell, MD; Jon Tyson, MD; France Varin, PhD; Wikke Walop, PhD; Sharon Walsh, MD; George Wells, PhD
JAMA. 1994;272(24):1926-1931. doi:10.1001/jama.1994.03520240054041.
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A RANDOMIZED controlled trial (RCT) is the most reliable method of assessing the efficacy of health care interventions.1,2 Reports of RCTs should provide readers with adequate information about what went on in the design, execution, analysis, and interpretation of the trial. Such reports will help readers judge the validity of the trial.

There have been several investigations evaluating how RCTs are reported. In an early study, Mahon and Daniel3 reviewed 203 reports of drug trials published between 1956 and 1960 in the Canadian Medical Association Journal. Only 11 reports (5.4%) fulfilled their criteria of a valid report. In a review of 45 trials published during 1985 in three leading general medical journals, Pocock and colleagues4 reported that a statement about sample size was only mentioned in five (11.1%) of the reports, that only six (13.3%) made use of confidence intervals, and that the statistical analyses tended to

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