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_References_consort - SPECIAL COMMUNICATION The CONSORT...

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SPECIAL COMMUNICATION The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials David Moher, MSc Kenneth F. Schulz, PhD, MBA Douglas Altman, DSc for the CONSORT Group A REPORT OF A RANDOMIZED CON- trolledtrial(RCT)shouldcon- vey to the reader, in a trans- parent manner, why the study was undertaken and how it was con- ductedandanalyzed.Forexample,alack ofadequatelyreportedrandomizationhas been associated with bias in estimating the effectiveness of interventions. 1,2 To assess the strengths and limitations of an RCT, readers need and deserve to know the quality of its methods. Despite sev- eral decades of educational efforts, RCTs still are not being reported adequately. 3-6 For example, a review of 122 recently published RCTs that evaluated the effec- tiveness of selective serotonin reuptake inhibitors as first-line management strat- egy for depression found that only 1 (0.8%) article described randomization adequately. 5 Inadequatereportingmakes the interpretation of RCT results diffi- cult if not impossible. Moreover, inad- equate reporting borders on unethical practice when biased results receive false credibility. HISTORY OF CONSORT In the mid 1990s, 2 independent initia- tives to improve the quality of reports of RCTs led to the publication of the CONSORT (Consolidated Standards of Reporting Trials) statement, 7 which was developed by an international group of clinical trialists, statisticians, epidemi- ologists, and biomedical editors. CONSORT has been supported by a growing number of medical and health care journals 8-11 and editorial groups, in- cluding the International Committee of Medical Journal Editors 12 (ICMJE, also known as the Vancouver Group), the Council of Science Editors (CSE), and Author Affiliations: University of Ottawa, Thomas C. Chalmers Centre for Systematic Reviews, Ottawa, On- tario (Mr Moher); Family Health International and De- partment of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill (Dr Schulz); and ICRF Medical Statistics Group and Cen- tre for Statistics in Medicine, Institute of Health Sci- ences, Oxford, England (Dr Altman). Members of the CONSORT Group are listed at the end of this article. Simultaneous Publication: The revised CONSORT statement also appears in Annals of Internal Medi- cine (2001;134:657-662) and The Lancet (2001;357: 1191-1194). Correspondence and Reprints: Leah Lepage, PhD, Thomas C. Chalmers Centre for Systematic Reviews, Children’s Hospital of Eastern Ontario Research In- stitute, Room R235, 401 Smyth Rd, Ottawa, On- tario, Canada K1H 8L1 (e-mail: llepage@uottawa.ca). To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improve- ment. Investigators and editors developed the original CONSORT (Consoli-
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