John P.A. Ioannidis, MD; Stephen J.W. Evans, MSc; Peter C. Gøtzsche, MD, DrMedSci; Robert T. O'Neill, PhD; Douglas G. Altman, DSc; Kenneth Schulz, PhD; David Moher, PhD; for the CONSORT Group*
For definitions of terms, see Glossary.
Disclaimer: Dr. O'Neill is an employee of the U.S. Food and Drug Administration. The views expressed are those of the author and do not necessarily represent those of the U.S. Food and Drug Administration.
Grant Support: Abbott Laboratories, Children's Hospital of Eastern Ontario Research Institute, Health Canada, The Lancet, and Merck and Co., Inc. provided funding for the Montebello meeting. Dr. Altman is supported by Cancer Research UK.
Potential Financial Conflicts of Interest: None disclosed.
Requests for Single Reprints: David Moher, PhD, Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Ioannidis: Clinical Trials and Evidence-Based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, and Biomedical Research Institute, Foundation for Research and Technology-Hellas, Ioannina 45110, Greece.
Mr. Evans: Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.
Dr. Gøtzsche: The Nordic Cochrane Centre, Rigshospitalet, Department 7112, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.
Dr. O'Neill: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Dr. Altman: Cancer Research UK/NHS Centre for Statistics in Medicine, Old Road Campus, Old Road, Headington, Oxford OX3 7LF, United Kingdom.
Dr. Schultz: Family Health International, PO Box 13950, Research Triangle Park, NC 27709.
Dr. Moher: Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada.
In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety.
Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting.
We hope that this document, in conjunction with other CONSORT-related materials (www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.
*For a list of members of the CONSORT Group, see Appendix 1.
Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits (1).
Table 1. Original CONSORT Checklist
Table 2. Checklist of Items To Include When Reporting Harms in Randomized, Controlled Trials
Table 3. Common Poor Reporting Practices for Harms-Related Data
Appendix Table 1. Adverse Events among Human Immunodeficiency Virus-Infected Patients Whose Aphthous Ulcers Had Healed Previously When Treated with Thalidomide and Who Then Were Treated with Thalidomide or Placebo in a Maintenance-Phase Study
Appendix Table 2. Adverse Events during the First 8 Weeks
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John P.A. Ioannidis, Stephen J.W. Evans, Peter C. Gøtzsche, Robert T. O'Neill, Douglas G. Altman, Kenneth Schulz, et al. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Ann Intern Med. 2004;141:781–788. doi: 10.7326/0003-4819-141-10-200411160-00009
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Published: Ann Intern Med. 2004;141(10):781-788.
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