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The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration

Douglas G. Altman, DSc; Kenneth F. Schulz, PhD; David Moher, MSc; Matthias Egger, MD; Frank Davidoff, MD; Diana Elbourne, PhD; Peter C. Gøtzsche, MD; Thomas Lang, MA, CONSORT Group
[+] Article and Author Information

From ICRF Medical Statistics Group and Centre for Statistics in Medicine, Institute of Health Sciences, Oxford, MRC Health Services Research Collaboration, University of Bristol, Bristol, and London School of Hygiene and Tropical Medicine, London, United Kingdom; Family Health International and The School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Thomas C. Chalmers Centre for Systematic Reviews, Ottawa, Ontario, Canada; American College of Physicians–American Society of Internal Medicine, Philadelphia, Pennsylvania; Nordic Cochrane Centre, Copenhagen, Denmark; and Tom Lang Communications, Lakewood, Ohio.


Acknowledgments: The authors thank Leah Lepage for coordinating the activities of the CONSORT group and Margaret J. Sampson, Louise Roy, and Kaitryn Campbell for creating a database of references.

Grant Support: Financial support to convene meetings of the CONSORT group was provided in part by Abbott Laboratories, American College of Physicians–American Society of Internal Medicine, GlaxoWellcome, The Lancet, Merck, the Canadian Institutes for Health Research, National Library of Medicine, and TAP Pharmaceuticals.

Requests for Single Reprints: Leah Lepage, PhD, 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.

Current Author Addresses: Professor Altman: ICRF Medical Statistics Group, Centre for Statistics in Medicine, Institute of Health Sciences, Old Road, Headington, Oxford OX3 7LF, United Kingdom.

Dr. Schulz: Quantitative Sciences, Family Health International, PO Box 13950, Research Triangle Park, NC 27709.

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. Egger: MRC Health Services Research Collaboration, University of Bristol, Canynge Hall, Whiteladies Road, Bristol B58 2PR, United Kingdom.

Dr. Davidoff: Annals of Internal Medicine, American College of Physicians–American Society of Internal Medicine, 190 N. Independence Mall West, Philadelphia, PA 19106.

Professor Elbourne: Medical Statistics Unit, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom.

Dr. Gøtzsche: Nordic Cochrane Centre, Rigshospitalet, Dept 7112, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark.

Mr. Lang: 13849 Edgewater Drive, Lakewood, OH 44107.


Ann Intern Med. 2001;134(8):663-694. doi:10.7326/0003-4819-134-8-200104170-00012
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Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards.

A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials.

This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included.

The CONSORT statement, this explanatory and elaboration document, and the associated Web site (www.consort-statement.org) should be helpful resources to improve reporting of randomized trials.

Throughout the text, terms marked with an asterisk are defined at end of text.

Figures

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Figure 1.
Revised template of the CONSORT (ConsolidatedStandardsofReportingTrials) diagram showing the flow of participants through each stage of a randomized trial(56-58).
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Figure 2.
Flow diagram of a multicenter trial comparing implantation of heparin-coated stents with percutaneous transluminal angioplasty (PTCA).144

The diagram includes detailed information on the interventions received. CABG = coronary artery bypass grafting. Adapted from reference .

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Figure 3.
Flow diagram of a trial of chiropractic manipulation of the cervical spine for treatment of episodic tension-type headache.145

The diagram includes the number of patients actively followed up at different times during the trial. Adapted from reference .

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Figure 4.
Flow diagram of a trial of the topoisomerase I inhibitor irinotecan in patients with metastatic colorectal cancer in whom fluorouracil chemotherapy had failed.146

The diagram includes the results for the main outcome (overall survival). Adapted from reference .

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Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

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