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The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
Open accessAbstract
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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“Six criterion were adapted from the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement 42 and the Consolidated Standards of Reporting Trials (CONSORT) statement to assess risk of bias of individual studies.43”
From Domain-Specific Physical Activity and Mental Health: A Meta-analysis (2017) · cites this paper as [43]
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“The study follows the CONSORT statement (Consolidated Standards of Reporting Trials) [54, 55], CONSORT-EHEALTH [56] and SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials) [57, 58].”
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“In accordance with CONSORT guidelines [54], randomisation will occur after participants have completed their baseline measures.”
From Study protocol for a randomised controlled trial of internet-based cognitive-behavioural therapy for obsessive-compulsive disorder (2014) · cites this paper as [54]
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“However, mindfulness and hypnosis appear to help alleviate pain via corticothalamic modulation of ascending nociceptive input.[90][91][92][93]”
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Metadata
- 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)
- 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
- 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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