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December 28, 1994

A Proposal for Structured Reporting of Randomized Controlled Trials

Author Affiliations

Nycomed Imaging, Oslo, Norway; Clinical Epidemiology Unit, Ottawa (Ontario) Civic Hospital; New England Medical Center for Health Services Research and Study Design, Boston, Mass; Institute for Health Policy Studies, University of California, San Francisco; Clinical Trial Service Unit, Radcliffe Infirmary, Oxford, England; (member of writing committee), Boston (Mass) University School of Medicine; (member of writing committee), The Nordic Cochrane Centre, Research and Development Secretariat, Copenhagen, Denmark; Agency for Health Care Policy and Research, Rockville, Md; Oxford Regional Pain Relief Unit, Headington, Oxford, England; Medical Research Fellowship, Walter Reed Army Institute of Research, Washington, DC; Division of Emergency Medicine, Children's Hospital of Eastern Ontario, Ottawa; Ryksuniversiteit Limburg, Vakgoep Epidemiologie, Limburg, the Netherlands; (member of writing committee), Clinical Epidemiology Unit, Ottawa (Ontario) Civic Hospital; Department of Epidemiology, The Johns Hopkins University, Baltimore, Md; (chair and member of writing committee), Clinical Epidemiology Unit, Ottawa (Ontario); Civic Hospital; Clinical Epidemiology Unit, Brigham and Women's Hospital, Boston, Mass; Department of Health Services, National Institute of Public Health, Oslo, Norway; Multiple Sclerosis Clinic, Ottawa (Ontario) General Hospital; (member of writing committee), Medical Statistics Unit, London School of Hygiene and Tropical Medicine, University of London, (England); Department of Pediatrics and Medical Computer Science, University of Texas Health Science Center, Dallas; (member of writing committee), Nuffield Department of Clinical Medicine, University of Oxford (England); Division of STD/HIV Prevention, National Center for Prevention Services, Centers for Disease Control and Prevention, Atlanta, Ga; Department of Epidemiology and Community Medicine, University of Ottawa (Ontario); Department of Medicine, University of Ottawa (Ontario); Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas; Faculty of Pharmacy, University of Montreal (Quebec); Biometrics Division, Drugs Directorie, Health Canada, Ottawa, Ontario; Department of Medicine, Ottawa (Ontario) Civic Hospital; (member of writing committee), Clinical Epidemiology Unit, Ottawa (Ontario) Civic Hospital.

JAMA. 1994;272(24):1926-1931. doi:10.1001/jama.1994.03520240054041

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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