Reporting of participant flow diagrams in published reports of randomized trials
Open accessAbstract
BACKGROUND: Reporting of the flow of participants through each stage of a randomized trial is essential to assess the generalisability and validity of its results. We assessed the type and completeness of information reported in CONSORT (Consolidated Standards of Reporting Trials) flow diagrams published in current reports of randomized trials. METHODS: A cross sectional review of all primary reports of randomized trials which included a CONSORT flow diagram indexed in PubMed core clinical journals (2009). We assessed the proportion of parallel group trial publications reporting specific items recommended by CONSORT for inclusion in a flow diagram. RESULTS: Of 469 primary reports of randomized trials, 263 (56%) included a CONSORT flow diagram of which 89% (237/263) were published in a CONSORT endorsing journal. Reports published in CONSORT endorsing journals were more likely to include a flow diagram (62%; 237/380 versus 29%; 26/89). Ninety percent (236/263) of reports which included a flow diagram had a parallel group design, of which 49% (116/236) evaluated drug interventions, 58% (137/236) were multicentre, and 79% (187/236) compared two study groups, with a median sample size of 213 participants. Eighty-one percent (191/236) reported the overall number of participants assessed for eligibility, 71% (168/236) the number excluded prior to randomization and 98% (231/236) the overall number randomized. Reasons for exclusion prior to randomization were more poorly reported. Ninety-four percent (223/236) reported the number of participants allocated to each arm of the trial. However, only 40% (95/236) reported the number who actually received the allocated intervention, 67% (158/236) the number lost to follow up in each arm of the trial, 61% (145/236) whether participants discontinued the intervention during the trial and 54% (128/236) the number included in the main analysis. CONCLUSIONS: Over half of published reports of randomized trials included a diagram showing the flow of participants through the trial. However, information was often missing from published flow diagrams, even in articles published in CONSORT endorsing journals. If important information is not reported it can be difficult and sometimes impossible to know if the conclusions of that trial are justified by the data presented.
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A review of RCTs published in five leading general and internal medicine journals found that reporting was considerably more thorough in articles that included a diagram of the flow of participants through a trial, as recommended by CONSORT.
“A review of RCTs published in five leading general and internal medicine journals found that reporting was considerably more thorough in articles that included a diagram of the flow of participants through a trial, as recommended by CONSORT.70”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials. (2016) · cites this paper as [70]
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Meyer, H.-G. J., Pandis, N., Seehra, J., & Faggion, C. M. (2023) · Figshare · doi:10.6084/m9.figshare.22715250
Meyer, H.-G. J., Pandis, N., Seehra, J., & Faggion, C. M. (2023) · Figshare · doi:10.6084/m9.figshare.22715256
Meyer, H.-G. J., Pandis, N., Seehra, J., & Faggion, C. M. (2023) · Figshare · doi:10.6084/m9.figshare.22715265
Meyer, H.-G. J., Pandis, N., Seehra, J., & Faggion, C. M. (2023) · Figshare · doi:10.6084/m9.figshare.22715262
Lytras, M. D., Alzahrani, B., Almabadi, R., Abukammas, S., Alsaywid, B. S., & Lytra, C.-C. (. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-27743-6.00008-7
Panthong, K., Pradujprom, P., & Wongupparaj, P. (2026) · Psicologí a Educativa · doi:10.5093/psed2026a17
A Qualitative Study of Screening Logs in Clinical Trials: How Can We Improve Current Practice?Preprint
High, J., Hammond, M., & Stirling, S. (2026) · Research Square · doi:10.21203/rs.3.rs-11350823/v1
- Authors
- Hopewell, S., Hirst, A., Collins, G. S., Mallett, S., Yu, L.-M., & Altman, D. G.
- Affiliations
- University of Oxford (GB)
- Corresponding author
- Hopewell, Sally
- Venue
- Trials
- Published
- 2011-12
- Volume
- 12
- Issue
- 1
- Pages
- 253-253
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3260171
- OpenAlex
- W2154833223
- Cited by
- 84
- References
- 21
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 8 · 2023: 14 · 2022: 3 · 2021: 3 · 2020: 4 · 2019: 6 · 2018: 9 · 2017: 3 · 2016: 5 · 2015: 2 · 2014: 6 · 2013: 4 · 2012: 2
- FWCI
- 4.10
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- Funders
- Université Paris Descartes
- Medical Research Council (MC_qA137931)
- 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 › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- CONSORT, reporting quality, clinical trial registration, participant attrition, loss to follow-up, generalizability of trial results, pharmacological interventions
- MeSH terms
- Cross-Sectional Studies, Humans, Publications, Research Design, Randomized Controlled Trials as Topic
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