Cited by 193Meta-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·Journal of the American Podiatric Medical Association

Abstract

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only 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 biased estimates of treatment effect or because 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 trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are 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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  • The randomized controlled trial was conducted in accordance with the CONSORT 2010 Statement and the CONSORT-EHEALTH guidelines.

    “The RCT was conducted in accordance with the CONSORT 2010 Statement [51] and the CONSORT-EHEALTH guidelines [52,53] to study the efficacy of two experimental conditions: 1) In Vivo Exposure and 2) Augmented Reality Exposure (see S1 CONSORT Checklist).”

    From In Vivo versus augmented reality exposure in the treatment of small animal phobia: A randomized controlled trial (2016) · cites this paper as [51]

    The Revision of the CONSORT statement section (page unavailable) describes a CONSORT checklist and flow diagram for reporting randomized trials. But it says this revision was finalized after a May 2000 meeting; the cited paper is not the CONSORT 2010 Statement. Citation [51] is attached to CONSORT 2010, not to the separately cited CONSORT-EHEALTH guidelines. (LLM, conf=0.88)

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  • The study will follow the CONSORT statement and the SPIRIT guidelines.

    “For this protocol, we will follow the CONSORT statement (Consolidated Standards of Reporting Trials, http://www.consort-statement.org) (25, 26) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials (27, 28).”

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Research works printed but not linked: 8

  1. Huston P, Hoey J: CMAJ endorses the CONSORT statement. CMAJ 1996, 155:1277-1279
  2. Moher D, Jones A, Lepage L, : Use of the CONSORT statement and quality of reports of randomized trials: a comparative before and after evaluation? JAMA 2001, 285:1992-1995
  3. Egger M, Jüni P, Bartlett C, : The value of patient flow charts in reports of randomized controlled trials: bibliographic study. JAMA 2001, 285:1996-1999
  4. Chalmers I: Current Controlled Trials: an opportunity to help improve the quality of clinical research. Curr Control Trials Cardi- ovasc Med 2000, 1:3-8
  5. Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T, : The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine. 2001, 134:663-694
  6. O'Toole LB: MRC uses checklist similar to CONSORTs. BMJ 1997, 314:1127- 26.
  7. 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
  8. Neumann PJ, Stone PW, Chapman RH, Sandberg EA, Bell CM: The Quality of Reporting in Published Cost-Utility Analyses, 1976-1997. Ann Intern Med 2000, 132:964-972

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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)
Venue
Journal of the American Podiatric Medical Association
Publisher
MDPI AG
Published
2001-09
Volume
91
Issue
8
Pages
437-442
ISSN
  • 1930-8264 (ISSN-L)
  • 8750-7315
OpenAlex
W2082317966
Cited by
193
References
22
Citations by year
2026: 1 · 2025: 3 · 2024: 7 · 2023: 10 · 2022: 12 · 2021: 7 · 2020: 15 · 2019: 9 · 2018: 13 · 2017: 6 · 2016: 9 · 2015: 8 · 2014: 9 · 2013: 8 · 2012: 6
FWCI
3.76
Type
journal article
Language
en
Open access
Locations
  • Journal of the American Podiatric Medical Association (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Abbott Laboratories
  • 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, reporting checklist, flowcharts, intention-to-treat analysis, bias in treatment effect estimation, clinical trial transparency
MeSH terms
Humans, Publishing, Quality Control, Research Design, Reproducibility of Results, Randomized Controlled Trials as Topic

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