David Moher, MSc; Kenneth F. Schulz, PhD, MBA; Douglas G. Altman, DSc; for the CONSORT Group*
The revised CONSORT statement is also published in JAMA (April 18, 2001) and The Lancet (April 14, 2001). Authors can use any one of these references when citing CONSORT.
Acknowledgments: The effort to improve the reporting of randomized 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. The authors thank Leah Lepage for keeping everybody all lined up and moving in the same direction.
Grant Support: Financial support to convene meetings of the CONSORT group was provided in part by Abbott Laboratories, the American College of Physicians–American Society of Internal Medicine, GlaxoWellcome, The Lancet, Merck & Co., the Canadian Institutes for Health Research, the National Library of Medicine, and TAP Pharmaceuticals.
Requests for Single Reprints: Leah Lepage, PhD, Thomas C. Chalmers Center for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Room R235, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada.
Current Author Addresses: Mr. Moher: Thomas C. Chalmers Center for Systematic Reviews, Children's Hospital of Eastern Ontario Research Institute, Room R2226, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada.
Dr. Schulz: Quantitative Sciences, Family Health International, PO Box 13950, Research Triangle Park, NC 27709.
Dr. Altman: ICRF Medical Statistics Group, Centre for Statistics in Medicine, Institute of Health Sciences, Old Road, Headington, OX3 7LF Oxford, United Kingdom.
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 improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper 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 the 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 (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed 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.
*For a list of contributors to the CONSORT statement, see Appendix.
Table. Checklist of Items To Include When Reporting a Randomized Trial
Flow diagram of the progress through the phases of a randomized trial (enrollment, intervention allocation, follow-up, and data analysis).
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Moher D, Schulz KF, Altman DG, for the CONSORT Group*. The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials. Ann Intern Med. 2001;134:657-662. doi: 10.7326/0003-4819-134-8-200104170-00011
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Published: Ann Intern Med. 2001;134(8):657-662.
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