Download the PDF of the CONSORT publication on Harms


Considerable evidence suggests that reporting of harms-related data from RCTs needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Canada, in May 2003 to address this problem. The result was 10 new recommendations about reporting harms-related issues to add to the main CONSORT checklist, accompanying explanation, and examples to highlight specific aspects of proper reporting.


Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141(10):781-788. Full text PDF.

Improving Patient Care is a special section within Annals supported in part by the U.S. Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ). The opinions expressed in this article are those of the authors and do not represent the position or endorsement of AHRQ or HHS.

Pictured (l-r): John Ioannidis, David Moher, Ken Schulz, and Doug Altman at the CONSORT group meeting in Montebello, Canada in May 2003.


Page last edited: 14 January 2008