Developed from a presentation at a workshop ‘Clinical trials: past, present and future’, Division of Cardiovascular Sciences, NHLBI, Bethesda, MD, USA (Sept 2010).
Special Issue Paper
Improving the reporting of randomised trials: the CONSORT Statement and beyond†
Article first published online: 18 AUG 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Statistics in Medicine
Special Issue: Papers from the 2010 National Heart, Lung and Blood Institute Clinical Trial Workshop
Volume 31, Issue 25, pages 2985–2997, 10 November 2012
How to Cite
Altman, D. G., Moher, D. and Schulz, K. F. (2012), Improving the reporting of randomised trials: the CONSORT Statement and beyond. Statist. Med., 31: 2985–2997. doi: 10.1002/sim.5402
- Issue published online: 11 OCT 2012
- Article first published online: 18 AUG 2012
- Manuscript Accepted: 15 MAR 2012
- Manuscript Received: 14 MAR 2012
An extensive and growing number of reviews of the published literature demonstrate that health research publications have frequent deficiencies. Of particular concern are poor reports of randomised trials, which make it difficult or impossible for readers to assess how the research was conducted, to evaluate the reliability of the findings, or to place them in the context of existing research evidence. As a result, published reports of trials often cannot be used by clinicians to inform patient care or to inform public health policy, and the data cannot be included in systematic reviews. Reporting guidelines are designed to identify the key information that researchers should include in a report of their research. We describe the history of reporting guidelines for randomised trials culminating in the CONSORT Statement in 1996. We detail the subsequent development and extension of CONSORT and consider related initiatives aimed at improving the reliability of the medical research literature. Copyright © 2012 John Wiley & Sons, Ltd.