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Cited by 216Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAcademic Publishing and Open Access

The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement

Mills, Edward J., Wu, Ping, Gagnier, Joel, Devereaux, P.J.·2005·Contemporary Clinical Trials
DOI 10.1016/j.cct.2005.02.008
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Abstract

If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting Trials (CONSORT) were developed to improve the suboptimal reporting of RCTs. We aimed to determine the extent to which RCTs report key methodological factors included in the revised CONSORT recommendations following publication of these recommendations. We conducted an observational study of RCTs published between July 2002 and June 2003 in 5 leading general medicine journals. We determined the proportion and 95% confidence intervals of RCTs that reported sequence generation, allocation concealment, randomization implementation, blinding status of participants, health care providers, outcome assessors, and data analysts, sample size justification, method of analysis (e.g. intention-to-treat), and a participant flow diagram. We included a total of 253 RCTs. RCTs reported: sequence generation 80% (95% CI 75-80%), allocation concealment 48% (95% CI 42-54%), randomization implementation 55% (95% CI 49-61%), blinding status of participants 40% (34-46%), health care providers 17% (95% CI 13-22%), outcome assessors 47% (95% CI 41-53%), data analysts 15% (10-19%), sample size justification 83% (95% CI 78-87%), method of analysis 87% (95% CI 83-91%)), and participant flow diagrams 86% (95% CI 82-90%). Although reporting of some CONSORT recommendations is high, reporting of several essential recommendations remains suboptimal. Authors need to comply with and journals need to enforce reporting of the revised CONSORT recommendations.

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Authors
Mills, E. J., Wu, P., Gagnier, J., & Devereaux, P. J.
Affiliations
  • McMaster University (CA)
  • London School of Hygiene & Tropical Medicine (GB)
  • University of Toronto (CA)
Corresponding author
Mills, Edward J.
ORCID
Venue
Contemporary Clinical Trials
Publisher
Elsevier BV
Published
2005-08
Volume
26
Issue
4
Pages
480-487
ISSN
1551-7144 (ISSN-L)
DOI
10.1016/j.cct.2005.02.008
OpenAlex
W1971252299
Cited by
216
References
38
Citations by year
2026: 2 · 2025: 1 · 2023: 1 · 2022: 1 · 2021: 3 · 2020: 4 · 2019: 4 · 2018: 7 · 2017: 8 · 2016: 8 · 2015: 13 · 2014: 12 · 2013: 11 · 2012: 57
FWCI
12.64
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Contemporary Clinical Trials (publishedVersion)
  • PubMed (publishedVersion)
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 statement, reporting quality, randomized controlled trials, trial methodology reporting, allocation concealment, blinding, sequence generation, sample size justification, intention-to-treat analysis, medical journals
MeSH terms
Humans, Periodicals as Topic, Publishing, Research Design, Writing, Reproducibility of Results, Randomized Controlled Trials as Topic, Single-Blind Method, Peer Review, Research

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