Cited by 2,755Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAcademic Publishing and Open Access

The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

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Moher, David, Schulz, Kenneth F, Altman, Douglas G·2001·BMC Medical Research Methodology

Abstract

To comprehend the results of a randomized controlled trial (RCT), readers must understand its design, conduct, analysis and interpretation. That goal can only be achieved 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 biasedestimates of treatment effect or 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, 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.

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  1. Huston P, Hoey J: CMAJ endorses the CONSORT statement. CMAJ 1996, 155:1277-1279
  2. O'Toole LB: MRC uses checklist similar to CONSORTs. BMJ 1997, 314:1127- 26.
  3. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB: Meta-analysis of obser- vational studies in epidemiology: a proposal for reporting. JA- MA. 2000, 283:2008-2012

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Authors
Moher, D., Schulz, K. F., & Altman, D. G.
Affiliations
  • University of Ottawa (CA)
  • University of North Carolina at Chapel Hill (US)
  • University of Oxford (GB)
Corresponding author
  • Moher, David
  • Schulz, Kenneth F
  • Altman, Douglas G
Venue
BMC Medical Research Methodology
Published
2001-04-20
Volume
1
Issue
1
Pages
2-2
ISSN
1471-2288 (ISSN-L)
OpenAlex
W1501619595
Cited by
2,755
References
175
Citations by year
2026: 6 · 2025: 18 · 2024: 38 · 2023: 31 · 2022: 36 · 2021: 78 · 2020: 144 · 2019: 124 · 2018: 102 · 2017: 110 · 2016: 120 · 2015: 146 · 2014: 149 · 2013: 138 · 2012: 152
FWCI
99.38
Type
journal article
Language
en
Open access
Locations
  • BMC Medical Research Methodology (publishedVersion)
  • PubMed Central (publishedVersion, other-oa)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
  • Abbott Laboratories
  • Wellcome Trust
  • U.S. National Library of Medicine
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
Keywords
CONSORT statement, reporting quality, randomized controlled trials, reporting guidelines, reporting checklist, flowcharts, intention-to-treat analysis, clinical trial transparency, bias in treatment effect estimates
MeSH terms
Humans, Publishing, Quality Control, Reproducibility of Results, Randomized Controlled Trials as Topic

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