Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000–8
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OBJECTIVE: To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. DESIGN: Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We compared manuscripts published before CONSORT (2000-4) with those published after CONSORT (2005-8). We also investigated differences by journal impact factor, type of journal, and trial setting. DATA SOURCES: A validated Medline search strategy. Eligibility criteria for selecting studies Cluster randomised trials published in English language journals, 2000-8. RESULTS: There were significant improvements in five of 14 reporting criteria: identification as cluster randomised; justification for cluster randomisation; reporting whether outcome assessments were blind; reporting the number of clusters randomised; and reporting the number of clusters lost to follow-up. No significant improvements were found in adherence to methodological criteria. Trials conducted in clinical rather than non-clinical settings and studies published in medical journals with higher impact factor or general medical journals were more likely to adhere to recommended reporting and methodological criteria overall, but there was no evidence that improvements after publication of the CONSORT extension for cluster trials were more likely in trials conducted in clinical settings nor in trials published in either general medical journals or in higher impact factor journals. CONCLUSION: The quality of reporting of cluster randomised trials improved in only a few aspects since the publication of the extension of CONSORT for cluster randomised trials, and no improvements at all were observed in essential methodological features. Overall, the adherence to reporting and methodological guidelines for cluster randomised trials remains suboptimal, and further efforts are needed to improve both reporting and methodology.
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Inconsistent reporting, particularly for study duration, step intervals, and key operational details, limits reproducibility and makes cross-study comparisons more challenging.
“At the same time, inconsistent reporting, particularly for study duration, step intervals, and key operational details, limits reproducibility and makes cross-study comparisons more challenging, echoing concerns that stronger and more consistent reporting standards are needed (116).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [116]
The Results report minimal overall improvement in reporting, and the Discussion (Statement of principal findings; page unavailable) calls for further improvements and possibly more stringent editorial policies. That supports the cited concern about reporting standards. The paper does not identify study duration or step intervals as particular gaps, or establish the claimed effects on reproducibility and cross-study comparisons. (LLM, conf=0.83)
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- Authors
- Ivers, N. M., Taljaard, M., Dixon, S., Bennett, C., McRae, A., Taleban, J., Skea, Z., Brehaut, J. C., Boruch, R. F., Eccles, M. P., Grimshaw, J. M., Weijer, C., Zwarenstein, M., & Donner, A.
- Affiliations
- Women's College Hospital (CA)
- Ottawa Hospital (CA)
- Western University (CA)
- University of Calgary (CA)
- University of Aberdeen (GB)
- University of Pennsylvania (US)
- Newcastle University (GB)
- Institute for Clinical Evaluative Sciences (CA)
- Corresponding author
- Ivers, N. M.
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2011-09-26
- Volume
- 343
- Issue
- sep26 1
- Pages
- d5886-d5886
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC3180203
- OpenAlex
- W2010316693
- Cited by
- 193
- References
- 38
- Citations by year
- 2026: 9 · 2025: 2 · 2024: 11 · 2023: 13 · 2022: 17 · 2021: 15 · 2020: 25 · 2019: 9 · 2018: 16 · 2017: 11 · 2016: 14 · 2015: 12 · 2014: 7 · 2013: 15 · 2012: 17
- FWCI
- 3.05
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion, cc-by-nc)
- Scholarship@Western (Western University) (submittedVersion, cc-by-nc)
- Scholarship@Western (Western University) (submittedVersion)
- Funders
- Canada Research Chairs
- Canadian Institutes of Health Research (MOP89790, MOP85066)
- 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 › Sociology and Political Science › Delphi Technique in Research
- Keywords
- CONSORT extension, reporting quality, methodological quality, reporting guidelines adherence, journal impact factor
- MeSH terms
- Randomized Controlled Trials as Topic, Guidelines as Topic
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