Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement
Open accessAbstract
OBJECTIVE: The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to improve the quality of randomized controlled trial (RCT) reports. We assessed the quality of current Japanese RCT reports by conducting a cross-sectional study to examine the extent to which they adhere to the CONSORT statement. METHODS: Reports of RCTs conducted in Japan that were published in medical journals between January and March 2004 were sampled from MEDLINE. The proportion of adherence to each item in the CONSORT checklist was evaluated for each report. Additionally, information on ethics reporting and funding sources was collected. RESULTS: A total of 98 RCT reports from Japan were evaluated, and adherence to the CONSORT statement was found to be suboptimal. Only 6 of 29 items in the checklist were described in more than 80% of reports. Adherence to key methodological items of the CONSORT statement was as follows: 23% for sample size determination, 39% for random sequence generation, 17% for allocation concealment, 29% for blinding, 53% for numbers analyzed, and 6% for inclusion of a flow diagram. Adherence to additional items was 82% for ethics committee approval, 92% for receiving informed consent, and 20% for disclosing funding sources. CONCLUSION: Our study on adherence of recent RCT reports from Japan to the CONSORT statement reveals that there is a significant need for improvement. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.
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The rise in CONSORT scores in recent studies is probably connected to authors' growing familiarity with the CONSORT items.
“The rise in scores in recent studies is probably connected to authors'growing familiarity with the CONSORT items. This has led to an increase in the number of studies presenting reports with greater detail (Uetani et al. 2009).”
From Adherence to the CONSORT statement of randomized clinical trials on dentin hypersensitivity treatment using mouthwashes (2025) · cites this paper as Uetani et al. 2009
The Discussion (page unavailable) identifies unfamiliarity with CONSORT as a likely reason for poor reporting and says that reports in journals adopting CONSORT showed greater adherence. This supports a link between familiarity and more complete reporting, but the paper does not establish that CONSORT scores rose in recent studies or that growing familiarity caused such a rise. (LLM, conf=0.83)
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- Authors
- Uetani, K., Nakayama, T., Ikai, H., Yonemoto, N., & Moher, D.
- Affiliations
- Kyoto University (JP)
- University of Ottawa (CA)
- Venue
- Internal Medicine
- Published
- 2009
- Volume
- 48
- Issue
- 5
- Pages
- 307-313
- ISSN
- 0918-2918 (ISSN-L)
- 1349-7235
- OpenAlex
- W1981096172
- Cited by
- 59
- References
- 30
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 4 · 2022: 3 · 2021: 2 · 2020: 4 · 2019: 5 · 2018: 6 · 2017: 2 · 2016: 3 · 2015: 1 · 2014: 5 · 2013: 12 · 2012: 3
- FWCI
- 3.72
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Ottawa
- Ministry of Health, Labour and Welfare
- 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, reporting guidelines adherence, sample size determination, random sequence generation, allocation concealment, blinding, research ethics approval, funding disclosure, flowcharts
- MeSH terms
- Cross-Sectional Studies, Humans, Japan, Quality Control, Randomized Controlled Trials as Topic, Guideline Adherence
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