Consolidated Standards of Reporting Trials (CONSORT) extensions covered most types of randomized controlled trials, but the potential workload for authors was high
Open accessAbstract
Objectives Our aim was to determine the coverage of randomized controlled trials (RCTs) by the Consolidated Standards of Reporting Trial (CONSORT) Statement and its extensions and to evaluate the potential workload for authors to adhere to the guidelines.Study design and setting We identified CONSORT extensions from the CONSORT Web site. We randomly selected a sample of 1,000 RCTs indexed in PubMed in 2016 and recorded whether they were covered by CONSORT extensions for specific study designs or interventions. We evaluated the potential workload for authors by counting the number of documents and pages they have to consult to have a full understanding of the guidelines.Results We identified 14 extensions. Only one extension was updated concurrently with the main CONSORT in 2010, three were updated after 2-7 years, and three are still based on CONSORT 2001. Overall, 81% of RCTs are covered by relevant CONSORT guidelines; missing extensions for specific study designs were under development at the time of the search (Nov 2018). However, 6 of 10 extensions covered <2% of the trials. A median [Q1-Q3] of 4 [4-5] documents and 67 [57-78] pages should be consulted.Conclusion Most RCTs indexed in PubMed are covered by the CONSORT Statement and extensions, but the potential workload for authors could be high.
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A review of 1000 randomised trials indexed in PubMed in 2016 showed that 85% had a parallel group design, whereas the other main designs were crossover (7%) and cluster (5%).
“A review of 1000 randomised trials indexed in PubMed in 2016 showed that 85% had a parallel group design, whereas the other main designs were crossover (7%) and cluster (5%).”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [191]
Of the 1000 trials, 88% had two groups, 8% had three groups, and 4% had four or more groups.
“Of the 1000 trials, 88% had two groups, 8% had three groups, and 4% had four or more groups.191”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [191]
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- Authors
- Ghosn, L., Boutron, I., & Ravaud, P.
- Affiliations
- Inserm (FR)
- Corresponding author
- Boutron, Isabelle
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2019-09
- Volume
- 113
- Pages
- 168-175
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2947362869
- Cited by
- 24
- References
- 41
- Citations by year
- 2026: 1 · 2025: 12 · 2024: 3 · 2023: 3 · 2022: 3 · 2021: 1 · 2020: 1
- FWCI
- 0.25
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Clinical Epidemiology (acceptedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, cc-by-nc)
- Funders
- Groupe Hospitalier Paris Centre - Assistance Publique Hopitaux de Paris (MERRI-AAP- 2017-010)
- 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 statement, CONSORT extension, reporting guidelines, randomized controlled trials, guideline adherence, trial reporting quality
- MeSH terms
- Humans, Publishing, Research Design, Randomized Controlled Trials as Topic, Workload, Guideline Adherence, Research Report
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