McMaster University

McMaster University

Douglas G Altman

Doug AltmanTitle of presentation

"Improving the Reporting of Randomized trials: CONSORT and Beyond"


Recognition of the importance of clear and adequately informative reports of randomised controlled trials (RCTs) became clear only in the mid 1990s. One factor was the rise in the conduct of systematic reviews, which highlighted the fact that the reporting of methods and results of the ‘primary’ studies was often inadequate.

The CONSORT Statement, developed by researchers and editors and first published in 1996, gave a consensus view on those elements of a trial that should always be reported. It comprised a checklist of items to include in a trial report and a diagram to indicate the flow participants through the stages of the trial. The recommendations were evidence-based where possible.

It was recognised that the CONSORT would need to be regularly reviewed and updated to take account of new evidence, and a major update of the Statement was published in 2001, accompanied by a detailed explanatory document. A further major update will appear in March 2010.

This talk will briefly review the history of assessments of and guidelines for the reporting of randomised trials leading up to CONSORT and I will describe various available extensions to CONSORT. I will then describe the 2010 changes to CONSORT and explain their rationale. Lastly, I will consider the impact of reporting guidelines.


Doug Altman is Professor of Statistics in Medicine at the University of Oxford, Director of both the Centre for Statistics in Medicine and the Clinical Trials Research Unit at Oxford, and Director of the Cancer Research UK - Medical Statistics Group. He is a recent co-founder of the EQUATOR Network (Enhancing the QUAlity and Transparency Of Health Research).

Professor Altman has carried out extensive research into the quality of health research methodology and reporting and has contributed significantly to the large body of evidence demonstrating widespread deficiencies in the reporting of health research, including, for example research on inadequate or selective reporting of clinical trials. His professional interests include the use and misuse of statistics in medical research, studies of prognosis, randomised trials, systematic reviews, and regression modelling.

Professor Altman is author of Practical Statistics for Medical Research (1991) and co-editor of Statistics with Confidence (1989 and 2000) and Systematic Reviews in Health Care (1995 and 2001). He is statistical advisor to the Cochrane Collaboration and the BMJ. Professor Altman is an executive member of several groups working on reporting guidelines, including CONSORT for randomised trials, QUOROM / PRISMA for systematic reviews, STROBE for epidemiological studies, and REMARK for tumour marker prognostic studies.

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