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17 April 2001 | Volume 134 Issue 8 | Pages 663-694
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 (http://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.
Author and Article 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{at}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. ACADEMIA AND CLINIC
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
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 A. R. Hughes, L. Stewart, J. Chapple, J. H. McColl, M. D. C. Donaldson, C. J. H. Kelnar, M. Zabihollah, F. Ahmed, and J. J. Reilly Randomized, Controlled Trial of a Best-Practice Individualized Behavioral Program for Treatment of Childhood Overweight: Scottish Childhood Overweight Treatment Trial (SCOTT) Pediatrics, March 1, 2008; 121(3): e539 - e546. [Abstract] [Full Text] [PDF]
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I. Boutron, D. Moher, D. G. Altman, K. F. Schulz, P. Ravaud, and for the CONSORT Group Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration Ann Intern Med, February 19, 2008; 148(4): 295 - 309. [Abstract] [Full Text] [PDF]
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I. Boutron, D. Moher, D. G. Altman, K. F. Schulz, P. Ravaud, and for the CONSORT Group Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments Ann Intern Med, February 19, 2008; 148(4): W-60 - W-66. [Abstract] [Full Text] [PDF]
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 M. Marmor, I. Belitskaya-Levy, and A. A. Arslan RE: LETTER TO THE EDITOR ON "BIAS IN CLINICAL INTERVENTION RESEARCH" Am. J. Epidemiol., February 15, 2008; 167(4): 500 - 501. [Full Text] [PDF]
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V. Hertzberg, M. Chimowitz, M. Lynn, C. Chester, W. Asbury, and G. Cotsonis Use of dose modification schedules is effective for blinding trials of warfarin: evidence from the WASID study Clinical Trials, February 1, 2008; 5(1): 23 - 30. [Abstract] [PDF]
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 C. Y. Ko, J. Parikh, and D. Zingmond Secondary Analyses of Large Population-Based Data Sets: Issues of Quality, Standards, and Understanding Ann. Surg. Oncol., February 1, 2008; 15(2): 395 - 396. [Full Text] [PDF]
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S. A. Olivo, L. G. Macedo, I. C. Gadotti, J. Fuentes, T. Stanton, and D. J Magee Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review Physical Therapy, February 1, 2008; 88(2): 156 - 175. [Abstract] [Full Text] [PDF]
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C. P. Belani, S. Ramalingam, M. C. Perry, R. V. LaRocca, D. Rinaldi, P. S. Gable, and W. J. Tester Randomized, Phase III Study of Weekly Paclitaxel in Combination With Carboplatin Versus Standard Every-3-Weeks Administration of Carboplatin and Paclitaxel for Patients With Previously Untreated Advanced Non-Small-Cell Lung Cancer J. Clin. Oncol., January 20, 2008; 26(3): 468 - 473. [Abstract] [Full Text] [PDF]
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A. M. Whelan, T. M. Jurgens, and L. Lord Evaluating the Quality of Randomized Controlled Trials that Examine the Efficacy of Natural Health Products: A Systematic Review of Critical Appraisal Instruments Evid. Based Complement. Altern. Med., January 18, 2008; (2008) nem186v1. [Abstract] [Full Text] [PDF]
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D. W. Kissane Letting Go of the Hope That Psychotherapy Prolongs Cancer Survival J. Clin. Oncol., December 20, 2007; 25(36): 5689 - 5690. [Full Text] [PDF]
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M. Savoye and J. Dziura Efficacy of a Weight Management Program in Overweight Children Reply JAMA, October 24, 2007; 298(16): 1860 - 1861. [Full Text] [PDF]
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C. J M. Lowe, K. L Barker, M. Dewey, and C. M Sackley Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials BMJ, October 20, 2007; 335(7624): 812 - 812. [Abstract] [Full Text] [PDF]
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J. P. Vandenbroucke, E. v. Elm, D. G. Altman, P. C. Gotzsche, C. D. Mulrow, S. J. Pocock, C. Poole, J. J. Schlesselman, M. Egger, and for the STROBE initiative Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration Ann Intern Med, October 16, 2007; 147(8): W-163 - W-194. [Abstract] [Full Text] [PDF]
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 M. Egger, D. G Altman, J. P Vandenbroucke, and of the STROBE group Commentary: Strengthening the reporting of observational epidemiology the STROBE statement Int. J. Epidemiol., October 2, 2007; (2007) dym199v1. [Full Text] [PDF]
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S. Ebrahim and M. Clarke STROBE: new standards for reporting observational epidemiology, a chance to improve Int. J. Epidemiol., October 1, 2007; 36(5): 946 - 948. [Full Text] [PDF]
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