A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group

TLDR

Randomized controlled trials are the gold standard for evaluating healthcare interventions, and clear reporting of design, execution, analysis, and interpretation is essential for readers to assess trial validity, a need highlighted by multiple studies on RCT reporting. Early reviews examined 203 drug trial reports from 1956–1960 and 45 trials from 1985, revealing sparse reporting of key methodological details such as sample size, confidence intervals, and statistical analyses. Only 5.4 % of examined reports met criteria for a valid RCT report.

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