Uetani Kae, Nakayama Takeo, Ikai Hiroshi, Yonemoto Naohiro, Moher David
Department of Health Informatics, Kyoto University School of Public Health.
Intern Med. 2009;48(5):307-13. doi: 10.2169/internalmedicine.48.1358. Epub 2009 Mar 2.
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.
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.
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.
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.
制定试验报告统一标准（CONSORT）声明旨在提高随机对照试验（RCT）报告的质量。我们通过开展一项横断面研究来评估当前日本RCT报告的质量，以检查它们在多大程度上遵循CONSORT声明。
从MEDLINE中抽取2004年1月至3月在日本进行并发表于医学期刊的RCT报告。对每份报告评估其在CONSORT清单中各项目的遵循比例。此外，收集了关于伦理报告和资金来源的信息。
共评估了98份来自日本的RCT报告，发现对CONSORT声明的遵循情况并不理想。清单中的29个项目中，只有6个项目在超过80%的报告中有所描述。对CONSORT声明关键方法学项目的遵循情况如下：样本量确定为23%，随机序列生成39%，分配隐藏17%，盲法29%，分析人数53%，纳入流程图6%。对其他项目的遵循情况为：伦理委员会批准82%，获得知情同意92%，披露资金来源20%。
我们关于日本近期RCT报告对CONSORT声明遵循情况的研究表明，有很大的改进需求。需要对RCT报告的质量以及提高报告质量的方法进行进一步调查。
