Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement
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概要
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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.
著者
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MOHER David
Department of Pediatrics and Epidemiology & Community Medicine Faculty of Medicine University of Ott
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IKAI Hiroshi
Department of General Medicine & Clinical Epidemiology, Kyoto University Hospital, Kyoto University
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Nakayama Takeo
Department Of Epidemiology Medical Research Institute Tokyo Medical And Dental University
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Yonemoto Naohiro
Department of Biostatistics, Kyoto University School of Public Health
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Uetani Kae
Department of Health Informatics, Kyoto University School of Public Health
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Moher David
Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, and the Ottawa Health Research Institute
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Ikai Hiroshi
Department of Primary Care and Emergency Medicine, Kyoto University Graduate School of Medicine
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