A Proposal for Structured Reporting of Randomized Controlled Trials

Abstract

A RANDOMIZED controlled trial (RCT) is the most reliable method of assessing the efficacy of health care interventions.^1,2Reports 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 Daniel³reviewed 203 reports of drug trials published between 1956 and 1960 in the<i>Canadian Medical Association Journal</i>. 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 colleagues⁴reported 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