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Unformatted text preview: Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement 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; and David Moher, PhD, for the CONSORT Group * 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 ( Con solidated S tandards o f R eporting T rials) state- ment, 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 stan- dard 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 doc- ument. Ann Intern Med. 2004;141:781-788. www.annals.org For author affiliations, see end of text. For definitions of terms, see Glossary. *For a list of members of the CONSORT Group, see Appendix 1, available at www.annals.org. Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits (1). T he CONSORT ( Con solidated S tandards o f R eporting T rials) statement, a checklist ( Table 1 ) flow diagram first published in 1996 and revised 5 years later (2, 3), is an effort to standardize, and thereby improve, published re- ports of randomized, controlled trials (RCTs). One of the additions to the 2001 revision was an item about reporting adverse events. This single item did not do full justice to the importance of harms-related issues. The CONSORT Group met in September 2001 to discuss how to correct this deficiency. We aimed to provide evidence-based guid- ance on the reporting of harms in RCTs. First, we searched MEDLINE, EMBASE, Web of Science, and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence. We also communicated with experts and reviewed bibliographies of identified articles to find additional studies. At a meeting in Montebello, Que- bec, Canada, in May 2003, CONSORT Group members, including several journal editors and additional experts in related fields, held a structured discussion of recommenda-...
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This note was uploaded on 12/30/2010 for the course BST 252 taught by Professor Tsodikov during the Winter '06 term at UC Davis.
- Winter '06