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

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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

DOI 10.1186/1471-2288-1-2PMC PMC32201

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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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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
ORCID: Moher, David
Schulz, Kenneth F
Altman, Douglas G
Venue: BMC Medical Research Methodology
Publisher: Springer Science and Business Media LLC
Published: 2001-04-20
Volume: 1
Issue: 1
Pages: 2-2
ISSN: 1471-2288 (ISSN-L)
DOI: 10.1186/1471-2288-1-2
PMC: PMC32201
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: gold
doi.org
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
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 › Library and Information Sciences › 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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The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

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