Abstract
To comprehend the results of a randomised controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by use of a checklist and flow diagram. The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of a trial (enrolment, intervention allocation, follow- up, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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Acknowledgements
The effort to improve the reporting of randomised trials, from its beginnings with the Standards of Reporting Trials (SORT) group to the current activities of the Consolidated Standards of Reporting Trials (CONSORT) group, has involved many people around the globe. We thank Leah Lepage for keeping everybody all lined up and moving in the same direction.
Financial support to convene meetings of the CONSORT group was provided in part by Abbott Laboratories, American College of Physicians, GlaxoWellcome, The Lancet, Merck, the Canadian Institutes for Health Research, National Library of Medicine, and TAP Pharmaceuticals.
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First published in Lancet (2001) 357:1191–1194
*Members of the CONSORT Group listed at end of paper
The revised CONSORT statement was also published in 2001 in the Journal of the American Medical Association no. 285 pp 1987–1991 and in Annals of Internal Medicine no. 134 pp 657–662.
University of Ottawa, Thomas C Chalmers Centre for Systematic Reviews, Ottawa, Ontario, Canada (D Moher MSc); Family Health International and Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, NC, USA (K F Schulz PhD); and ICRF Medical Statistics Group and Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, UK (D G Altman DSc)
For correspondence, please contact Dr. Leah Lepage at the Thomas C. Chalmers Centre for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Room R235, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada (e-mail: llepage@uottawa.ca)
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Moher, D., Schulz, K.F., Altman, D.G. et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Clin Oral Invest 7, 2–7 (2003). https://doi.org/10.1007/s00784-002-0188-x
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DOI: https://doi.org/10.1007/s00784-002-0188-x