The CONSORT extension 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.
The main CONSORT flow diagram should be used.
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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