CONSORT 2010 statement: extension to randomised crossover trials
Open accessAbstract
Evidence shows the quality of reporting of randomised controlled trials is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, prevents researchers from extracting information for systematic reviews, and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. The primary focus of the statement was on parallel group trials with two treatment groups. Crossover trials are a particular type of trial for chronic conditions in which participants are randomised to a sequence of interventions. They are a useful and efficient design because participants act as their own control. However, the reporting of crossover trials has been variable and incomplete, which hinders their use in clinical decision making and by future researchers. We present the CONSORT extension to randomised crossover trials, which aims to facilitate better reporting of crossover trials. The CONSORT 2010 checklist is revised for crossover designs, and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT crossover checklist items are provided.
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Extensions to CONSORT have been developed to address methodological issues in reporting different types of trial designs, data, and interventions.
“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [35]
Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.
“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: updated guideline for reporting randomised trials (2025) · cites this paper as [35]
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References 70 · Cited by 785
- Authors
- Dwan, K., Li, T., Altman, D. G., & Elbourne, D.
- Affiliations
- Cochrane Canada (CA)
- Johns Hopkins University (US)
- University of Oxford (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Dwan, Kerry
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2019-07-31
- Volume
- 366
- Pages
- l4378
- ISSN
- 1756-1833 (ISSN-L)
- 0959-8138
- PMC
- PMC6667942
- OpenAlex
- W2955930369
- Cited by
- 785
- References
- 70
- Citations by year
- 2026: 138 · 2025: 158 · 2024: 143 · 2023: 124 · 2022: 79 · 2021: 79 · 2020: 61 · 2019: 2 · 2016: 1
- FWCI
- 36.93
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- BMJ (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- National Eye Institute (UG1EY020522)
- 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
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Keywords
- CONSORT, trial reporting quality, reporting checklist, flowcharts, chronic disease, reporting transparency
- MeSH terms
- Data Interpretation, Statistical, Publishing, Research Design, Randomized Controlled Trials as Topic, Cross-Over Studies
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