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ACADEMIA AND CLINIC

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

right arrow 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, for the CONSORT Group

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
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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.

 

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Ann OncolHome page
V. Pavone, U. Ricardi, S. Luminari, P. Gobbi, M. Federico, L. Baldini, E. Iannitto, G. Ucci, L. Marcheselli, L. Orsucci, et al.
ABVD plus radiotherapy versus EVE plus radiotherapy in unfavorable stage IA and IIA Hodgkin's lymphoma: results from an Intergruppo Italiano Linfomi randomized study
Ann. Onc., April 1, 2008; 19(4): 763 - 768.
[Abstract] [Full Text] [PDF]


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Fam PractHome page
M Shirazi, A. Zeinaloo, S. Parikh, M Sadeghi, A Taghva, M Arbabi, A S. Kashani, F Alaeddini, K Lonka, and R Wahlstrom
Effects on readiness to change of an educational intervention on depressive disorders for general physicians in primary care based on a modified Prochaska model--a randomized controlled study
Fam. Pract., April 1, 2008; 25(2): 98 - 104.
[Abstract] [Full Text] [PDF]


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ptjournalHome page
A. I. Kottink, H. J Hermens, A. V Nene, M. J Tenniglo, C. G Groothuis-Oudshoorn, and M. J IJzerman
Therapeutic Effect of an Implantable Peroneal Nerve Stimulator in Subjects With Chronic Stroke and Footdrop: A Randomized Controlled Trial
Physical Therapy, April 1, 2008; 88(4): 437 - 448.
[Abstract] [Full Text] [PDF]


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Arch Intern MedHome page
B. Djulbegovic, A. Kumar, H. P. Soares, I. Hozo, G. Bepler, M. Clarke, and C. L. Bennett
Treatment Success in Cancer: New Cancer Treatment Successes Identified in Phase 3 Randomized Controlled Trials Conducted by the National Cancer Institute-Sponsored Cooperative Oncology Groups, 1955 to 2006
Arch Intern Med, March 24, 2008; 168(6): 632 - 642.
[Abstract] [Full Text] [PDF]


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BMJHome page
L. Wood, M. Egger, L. L. Gluud, K. F Schulz, P. Juni, D. G Altman, C. Gluud, R. M Martin, A. J G Wood, and J. A C Sterne
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study
BMJ, March 15, 2008; 336(7644): 601 - 605.
[Abstract] [Full Text] [PDF]


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Schizophr BullHome page
M. Cleary, G. E. Hunt, S. Matheson, N. Siegfried, and G. Walter
Psychosocial Treatment Programs for People With Both Severe Mental Illness and Substance Misuse
Schizophr Bull, March 1, 2008; 34(2): 226 - 228.
[Abstract] [Full Text] [PDF]


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PediatricsHome page
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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ANN INTERN MEDHome page
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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ANN INTERN MEDHome page
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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Am J EpidemiolHome page
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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Clin TrialsHome page
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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Ann. Surg. Oncol.Home page
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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ptjournalHome page
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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JCOHome page
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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Evid Based Complement Alternat MedHome page
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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JCOHome page
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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JAMAHome page
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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BMJHome page
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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ANN INTERN MEDHome page
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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Int J EpidemiolHome page
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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Int J EpidemiolHome page
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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