A Proposal for Structured Reporting of Randomized Controlled Trials

Erik Andrew

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Clinical practice guidelines implementation

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 theCanadian 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 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

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References

1989Health Measurement Scales: A Practical Guide to Their Development and Use 1987Measuring Health: A Guide to Rating Scales and Questionnaires 1995Assessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists 1993The Cochrane Collaboration: Preparing, Maintaining, and Disseminating Systematic Reviews of the Effects of Health Care 1990More Informative Abstracts Revisited 1994Assessing the Quality of Randomization From Reports of Controlled Trials Published in Obstetrics and Gynecology Journals 1982Reporting on Methods in Clinical Trials 1989Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis

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2001Action research: a systematic review and guidance for assessment.2001CONSORT Revised—Improving the Reporting of Randomized Trials 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)2001The art of quality assessment of RCTs included in systematic reviews 1998

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