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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 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 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]
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“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).”
From Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: Study Protocol of a Randomized Control Trial (2022) · cites this paper as [25]
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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)
- 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
- bronze
- doi.org
- 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 › Library and Information Sciences › 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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