CONSORT statement: extension to cluster randomised trials
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Readers may misinterpret the cohort data as sample size if the trial design is not clearly explained.
“Readers may misinterpret the cohort data as sample size if the trial design is not clearly explained”
From Evaluation of reporting quality of abstracts of randomized controlled trials regarding patients with COVID-19 using the CONSORT statement for abstracts (2022) · cites this paper as Campbell et al., 2004
The Comments section says cluster-trial reports need clear design and analysis information so readers can accurately interpret results. The Explanation section also distinguishes the planned sample size from the numbers of participants and clusters contributing to an analysis. Neither passage specifically says readers may mistake cohort data for sample size. (LLM, conf=0.81)
Experimental — accuracy not yet measuredThe trial will be reported using the Consolidated Standards of Reporting Trials checklist and its extension for cluster RCTs.
“The trial will be reported using the Consolidated Standards of Reporting Trials checklist and its extension for cluster RCTs.43”
Other trial designs, such as cluster randomised trials and noninferiority trials, require varying amounts of additional information.
“Other trial designs, such as cluster randomised trials and noninferiority trials, require varying amounts of additional information.”
From CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. (2010) · cites this paper as [11]
The CONSORT group is developing recommendations to help improve the reporting of multiple-arm trials.
“The CONSORT (Consolidated Standards of Reporting Trials) group is developing recommendations to help improve the reporting of multiple-arm trials [22,23].”
From Reporting of analyses from randomized controlled trials with multiple arms: a systematic review (2013) · cites this paper as [22]
For some guidelines, notably some extensions of the CONSORT Statement, explanatory information has been included with the reporting recommendations in a single article.
“For some guidelines, notably some extensions of the CONSORT Statement, the explanatory information has been included with the reporting recommendations in a single article (e.g., CONSORT cluster [49], NPT [18]).”
From Guidance for Developers of Health Research Reporting Guidelines (2010) · cites this paper as [49]
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- Authors
- Campbell, M. K., Elbourne, D. R., & Altman, D. G.
- Affiliations
- University of Aberdeen (GB)
- London School of Hygiene & Tropical Medicine (GB)
- University of Oxford (GB)
- Corresponding author
- Campbell, Marion K
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2004-03-18
- Volume
- 328
- Issue
- 7441
- Pages
- 702-708
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC381234
- OpenAlex
- W4248033032
- Cited by
- 2,557
- References
- 44
- Citations by year
- 2026: 32 · 2025: 41 · 2024: 53 · 2023: 73 · 2022: 60 · 2021: 88 · 2020: 114 · 2019: 84 · 2018: 90 · 2017: 92 · 2016: 102 · 2015: 120 · 2014: 122 · 2013: 152 · 2012: 150
- FWCI
- 132.41
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, other-oa)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Cancer Research UK
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- CONSORT statement, reporting guidelines, trial reporting quality
- MeSH terms
- Publishing, Research Design, Cluster Analysis, Randomized Controlled Trials as Topic, Guidelines as Topic, Guideline Adherence
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