The CONSORT extMontebello-Canada-2003ension for reporting harms outcomes extends 10 checklist items of the CONSORT (2001) checklist. Considerable evidence suggests that reporting of harms-related data from RCTs needs improvement.

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




Available Downloads

The main CONSORT flow diagram should be used.

Document Word Format PDF Format
Checklist n/a Download
Statement & Elaboration n/a Download


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. PMID: 15545678