This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on ISI (230)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in JAMA  Topic Collections  • Journalology/ Peer Review/ Authorship  • Quality of Care, Other  • Statistics and Research Methods  • Randomized Controlled Trial  • Alert me on articles by topic

A Comparative Before-and-After Evaluation

David Moher, MSc; Alison Jones, BA; Leah Lepage, PhD; for the CONSORT Group

JAMA. 2001;285:1992-1995.

Context  The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal.

Objective  To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs.

Design and Setting  Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator).

Main Outcome Measures  Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument.

Results  Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8).

Conclusion  Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.

Author Affiliations: University of Ottawa (Mr Moher) and Thomas C. Chalmers Centre for Systematic Reviews (Mr Moher, Ms Jones, and Dr Lepage), Ottawa, Ontario.

RELATED ARTICLES

The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
David Moher, Kenneth F. Schulz, Douglas Altman, and for the CONSORT Group
JAMA. 2001;285(15):1987-1991.
ABSTRACT | FULL TEXT  

Value of Flow Diagrams in Reports of Randomized Controlled Trials
Matthias Egger, Peter Jüni, Christopher Bartlett, and for the CONSORT Group
JAMA. 2001;285(15):1996-1999.
ABSTRACT | FULL TEXT  

Physician Interpretations and Textbook Definitions of Blinding Terminology in Randomized Controlled Trials
P. J. Devereaux, Braden J. Manns, William A. Ghali, Hude Quan, Christina Lacchetti, Victor M. Montori, Mohit Bhandari, and Gordon H. Guyatt
JAMA. 2001;285(15):2000-2003.
ABSTRACT | FULL TEXT  

CONSORT Revised—Improving the Reporting of Randomized Trials
Drummond Rennie
JAMA. 2001;285(15):2006-2007.
EXTRACT | FULL TEXT  

April 18, 2001
JAMA. 2001;285(15):2023-2024.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

STROBE: A Beacon for Observational Studies
Nijsten et al.
Arch Dermatol 2008;144:1200-1204.
FULL TEXT  

STARD Statement: Still Room for Improvement in the Reporting of Diagnostic Accuracy Studies
Bossuyt
Radiology 2008;248:713-714.
FULL TEXT  

Quality of Reporting of Diagnostic Accuracy Studies: No Change Since STARD Statement Publication--Before-and-after Study
Wilczynski
Radiology 2008;248:817-823.
ABSTRACT | FULL TEXT  

Survival End Point Reporting in Randomized Cancer Clinical Trials: A Review of Major Journals
Mathoulin-Pelissier et al.
JCO 2008;26:3721-3726.
ABSTRACT | FULL TEXT  

Improving the Quality of Abstract Reporting for Phase I Cancer Trials
Strevel et al.
Clin. Cancer Res. 2008;14:1782-1787.
ABSTRACT | FULL TEXT  

Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments
Boutron et al.
ANN INTERN MED 2008;148:W-60-W-66.
ABSTRACT | FULL TEXT  

Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review
Olivo et al.
ptjournal 2008;88:156-175.
ABSTRACT | FULL TEXT  

Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups
Tong et al.
Int J Qual Health Care 2007;19:349-357.
ABSTRACT | FULL TEXT  

STROBE: new standards for reporting observational epidemiology, a chance to improve
Ebrahim and Clarke
Int J Epidemiol 2007;36:946-948.
FULL TEXT  

The Quality of Reporting of Orthopaedic Randomized Trials with Use of a Checklist for Nonpharmacological Therapies
Chan and Bhandari
JBJS 2007;89:1970-1978.
ABSTRACT | FULL TEXT  

Sample size in studies on diagnostic accuracy in ophthalmology: a literature survey
Bochmann et al.
Br. J. Ophthalmol. 2007;91:898-900.
ABSTRACT | FULL TEXT  

The Incidence of "Causal" Statements in Teaching-and-Learning Research Journals
Robinson et al.
Am Educ Res J 2007;44:400-413.
ABSTRACT | FULL TEXT  

Heparin-bonded circuits versus nonheparin-bonded circuits: an evaluation of their effect on clinical outcomes
Mangoush et al.
Eur. J. Cardiothorac. Surg. 2007;31:1058-1069.
ABSTRACT | FULL TEXT  

Issues in the Registration of Clinical Trials
Zarin et al.
JAMA 2007;297:2112-2120.
ABSTRACT | FULL TEXT  

Guidelines and Consensus Statements Regarding the Conduction and Reporting of Clinical Research Studies
Falagas and Pitsouni
Arch Intern Med 2007;167:877-877.
FULL TEXT  

The ORION statement: guidelines for transparent reporting of Outbreak Reports and Intervention studies Of Nosocomial infection
Stone et al.
J Antimicrob Chemother 2007;59:833-840.
ABSTRACT | FULL TEXT  

Reporting Implementation in Randomized Trials: Proposed Additions to the Consolidated Standards of Reporting Trials Statement
Mayo-Wilson
Am. J. Public Health 2007;97:630-633.
ABSTRACT | FULL TEXT  

Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making
Efficace et al.
Ann Oncol 2007;18:775-781.
ABSTRACT | FULL TEXT  

"Surgical research or comic opera" redux.
Sade
Ann. Thorac. Surg. 2006;82:1173-1174.
FULL TEXT  

Evidence of improving quality of reporting of randomized controlled trials in subfertility
Dias et al.
Hum Reprod 2006;21:2617-2627.
ABSTRACT | FULL TEXT  

There is nothing staid about STARD: progress in the reporting of diagnostic accuracy studies.
Johnston and Holloway
Neurology 2006;67:740-741.
FULL TEXT  

The quality of diagnostic accuracy studies since the STARD statement: has it improved?
Smidt et al.
Neurology 2006;67:792-797.
ABSTRACT | FULL TEXT  

Improving the quality of reporting randomized controlled trials in cardiothoracic surgery: The way forward.
Tiruvoipati et al.
J. Thorac. Cardiovasc. Surg. 2006;132:233-240.
ABSTRACT | FULL TEXT  

Believability of clinical trials: A diagnostic testing perspective.
Lauer
J. Thorac. Cardiovasc. Surg. 2006;132:249-251.
FULL TEXT  

Quality of reporting of randomized, controlled trials in cerebral palsy.
Anttila et al.
Pediatrics 2006;117:2222-2230.
ABSTRACT | FULL TEXT  

Reporting of randomized controlled trials in Hodgkin lymphoma in biomedical journals.
Kober et al.
JNCI J Natl Cancer Inst 2006;98:620-625.
ABSTRACT | FULL TEXT  

Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement
Piaggio et al.
JAMA 2006;295:1152-1160.
ABSTRACT | FULL TEXT  

Adding chloroquine to conventional treatment for glioblastoma multiforme: a randomized, double-blind, placebo-controlled trial.
Sotelo et al.
ANN INTERN MED 2006;144:337-343.
ABSTRACT | FULL TEXT  

Reporting Participation in Epidemiologic Studies: A Survey of Practice
Morton et al.
Am J Epidemiol 2006;163:197-203.
ABSTRACT | FULL TEXT  

Endorsement of the CONSORT statement by high impact medical journals: survey of instructions for authors
Altman and for the CONSORT Group
BMJ 2005;330:1056-1057.
FULL TEXT  

Cluster Randomized Trials of Professional and Organizational Behavior Change Interventions in Health Care Settings
Grimshaw et al.
The ANNALS of the American Academy of Political and Social Science 2005;599:71-93.
ABSTRACT  

Methodological quality and reporting of ethical requirements in phase III cancer trials
Tuech et al.
J. Med. Ethics 2005;31:251-255.
ABSTRACT | FULL TEXT  

Quality of Reporting of Diagnostic Accuracy Studies
Smidt et al.
Radiology 2005;235:347-353.
ABSTRACT | FULL TEXT  

The quality of reporting of diagnostic accuracy studies published in ophthalmic journals
Siddiqui et al.
Br. J. Ophthalmol. 2005;89:261-265.
ABSTRACT | FULL TEXT  

Evaluation of New Treatments in Radiation Oncology: Are They Better Than Standard Treatments?
Soares et al.
JAMA 2005;293:970-978.
ABSTRACT | FULL TEXT  

Quality of Reporting of Observational Longitudinal Research
Tooth et al.
Am J Epidemiol 2005;161:280-288.
ABSTRACT | FULL TEXT  

A Review of the True Methodological Quality of Nutritional Support Trials Conducted in the Critically Ill: Time for Improvement
Doig et al.
Anesth. Analg. 2005;100:527-533.
ABSTRACT | FULL TEXT  

Using Benefit Harm Tradeoffs to Estimate Sufficiently Important Difference: The Case of the Common Cold
Barrett et al.
Med Decis Making 2005;25:47-55.
ABSTRACT  

The Consolidated Standards of Reporting Trials (CONSORT): Better Presentation of Surgical Trials in the Journal of Hand Surgery
SAUERLAND and DAVIS
J Hand Surg Eur Vol 2004;29:621-624.
ABSTRACT | FULL TEXT  

Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond
Moher et al.
CMAJ 2004;171:349-350.
FULL TEXT  

Travelling but never arriving: reflections of a retiring editor
Smith
BMJ 2004;329:242-244.
FULL TEXT  

The Classic Caries Clinical Trial: Constraints and Opportunities
Stamm
J. Dent. Res. 2004;83:C6-C14.
FULL TEXT  

Quality of Abstracts Describing Randomized Trials in the Proceedings of American Society of Clinical Oncology Meetings: Guidelines for Improved Reporting
Krzyzanowska et al.
JCO 2004;22:1993-1999.
ABSTRACT | FULL TEXT  

Evaluating Gynecological Surgical Procedures: Trials and Tribulations
Pitkin and Scott
JAMA 2004;291:1503-1504.
FULL TEXT  

CONSORT statement: extension to cluster randomised trials
Campbell et al.
BMJ 2004;328:702-708.
FULL TEXT  

Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement
Des Jarlais et al.
Am. J. Public Health 2004;94:361-366.
ABSTRACT | FULL TEXT  

The Quality of Reporting in Diagnostic Test Research: Getting Better, Still Not Optimal
Bossuyt
Clin. Chem. 2004;50:465-466.
FULL TEXT  

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
Bossuyt et al.
Fam Pract 2004;21:4-10.
ABSTRACT | FULL TEXT  

Bad reporting does not mean bad methods for randomised trials: observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group
Soares et al.
BMJ 2004;328:22-24.
ABSTRACT | FULL TEXT  

Has CONSORT improved the reporting of randomized controlled trials in the palliative care literature? A systematic review
Piggott et al.
Palliat Med 2004;18:32-38.
ABSTRACT  

Clinical trials in orthodontics II: assessment of the quality of reporting of clinical trials published in three orthodontic journals between 1989 and 1998
Harrison
J. Orthod. 2003;30:309-315.
ABSTRACT | FULL TEXT  

Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization
Shiffman et al.
ANN INTERN MED 2003;139:493-498.
ABSTRACT | FULL TEXT  

Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials--Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?
Efficace et al.
JCO 2003;21:3502-3511.
ABSTRACT | FULL TEXT  

Manual versus powered toothbrushes: The Cochrane review
NIEDERMAN
Journal of the American Dental Association 2003;134:1240-1244.
ABSTRACT | FULL TEXT  

Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative
Bossuyt et al.
Am. J. Roentgenol. 2003;181:51-55.
ABSTRACT | FULL TEXT  

International Standards for Clinical Trial Conduct and Reporting
Niederman et al.
J. Dent. Res. 2003;82:415-416.
FULL TEXT  

Analysis and Reporting of Factorial Trials: A Systematic Review
McAlister et al.
JAMA 2003;289:2545-2553.
ABSTRACT | FULL TEXT  

Common statistical errors in the design and analysis of subfertility trials
Vail and Gardener
Hum Reprod 2003;18:1000-1004.
ABSTRACT | FULL TEXT  

Pitfalls in the design and analysis of efficacy trials in subfertility: Associate editor's commentary: on the article 'Common statistical errors in the design and analysis of subfertility trials' by A.Vail and E.Gardner.
Daya
Hum Reprod 2003;18:1005-1009.
FULL TEXT  

Clinical Trials in the Journal of Pediatric Psychology: Applying the CONSORT Statement
Stinson et al.
J Pediatr Psychol 2003;28:159-167.
ABSTRACT | FULL TEXT  

Commentary: The Journal of Pediatric Psychology Should Adopt the CONSORT Statement as a Way of Improving the Evidence Base in Pediatric Psychology
McGrath et al.
J Pediatr Psychol 2003;28:169-171.
FULL TEXT  

Development and validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project
Qual Saf Health Care 2003;12:18-23.
ABSTRACT | FULL TEXT  

Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative
Bossuyt et al.
ANN INTERN MED 2003;138:40-44.
ABSTRACT | FULL TEXT  

Reporting diagnostic tests
Straus
BMJ 2003;326:3-4.
FULL TEXT  

Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
Bossuyt et al.
BMJ 2003;326:41-44.
ABSTRACT | FULL TEXT  

Improving Reports of Studies of Diagnostic Tests: The STARD Initiative
Rennie
JAMA 2003;289:89-90.
FULL TEXT  

Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative
Bossuyt et al.
Clin. Chem. 2003;49:1-6.
ABSTRACT | FULL TEXT  

Towards Complete and Accurate Reporting of Studies of Diagnostic Accuracy: The STARD Initiative
Bossuyt et al.
Radiology 2003;226:24-28.
ABSTRACT | FULL TEXT  

Reflections on Medical Journals
Kassirer
ANN INTERN MED 2002;137:1012-1012.
FULL TEXT  

Reflections on Medical Journals
Moher et al.
ANN INTERN MED 2002;137:1011-1012.
FULL TEXT  

Quality of RCTs in Periodontology-- A Systematic Review
Montenegro et al.
J. Dent. Res. 2002;81:866-870.
ABSTRACT | FULL TEXT  

The "CONSORT" Guidelines for Randomized Controlled Trials in Obstetrics & Gynecology
Grimes
Obstet Gynecol 2002;100:631-632.
FULL TEXT  

Quality of Reporting of Randomized Trials as a Measure of Methodologic Quality
Huwiler-Muntener et al.
JAMA 2002;287:2801-2804.
ABSTRACT | FULL TEXT  

Reporting Number Needed to Treat and Absolute Risk Reduction in Randomized Controlled Trials
Nuovo et al.
JAMA 2002;287:2813-2814.
ABSTRACT | FULL TEXT  

Improving standards of medical and public health research
Colditz
J. Epidemiol. Community Health 2002;56:333-334.
FULL TEXT  

Publication Bias: The Problem and Some Suggestions
Rivara and Cummings
Arch Pediatr Adolesc Med 2002;156:424-425.
FULL TEXT  

Abstracts of Randomized Controlled Trials Presented at the Society for Pediatric Research Meeting: An Example of Publication Bias
Klassen et al.
Arch Pediatr Adolesc Med 2002;156:474-479.
ABSTRACT | FULL TEXT  

A plea to authors: ensure your studies comply with guidelines
Smith
BMJ 2002;324:314-314.
FULL TEXT  

Better standards for better reporting of RCTs
Bossuyt
BMJ 2001;322:1317-1318.
FULL TEXT  

The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
Moher et al.
JAMA 2001;285:1987-1991.
ABSTRACT | FULL TEXT  

Value of Flow Diagrams in Reports of Randomized Controlled Trials
Egger et al.
JAMA 2001;285:1996-1999.
ABSTRACT | FULL TEXT  

CONSORT Revised--Improving the Reporting of Randomized Trials
Rennie
JAMA 2001;285:2006-2007.
FULL TEXT  

The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Altman et al.
ANN INTERN MED 2001;134:663-694.
ABSTRACT | FULL TEXT