Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement
Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement
复制标题
DOI：
10.2169/internalmedicine.48.1358
复制
发表时间：
2009-01-01
影响因子：
1.2
通讯作者：
Moher, David
中科院分区：
文献类型：
--
作者：
Uetani, Kae;Nakayama, Takeo;Moher, David
目的为提高随机对照试验（RCT）报告质量，制定临床试验报告统一标准（CONSORT）。我们进行了一项横断面研究，以检查在何种程度上，他们坚持CONSORT statement.Methods在日本进行的随机对照试验的报告，发表在医学期刊上的2004年1月至3月的质量进行了评估，从MEDLINE。对每份报告的CONSORT检查表中每个项目的依从性比例进行了评价。此外，道德报告和资金来源的信息被collected.Results共98个RCT报告从日本进行了评估，并坚持CONSORT声明被发现是次优的。在80%以上的报告中，仅描述了检查表中29个项目中的6个。CONSORT声明中关键方法学项目的依从性如下：样本量确定为23%，随机序列生成为39%，分配隐藏为17%，设盲为29%，分析数量为53%，纳入流程图为6%。坚持额外的项目是82%的伦理委员会批准，92%的知情同意书，和20%的披露资金来源。结论我们的研究，坚持最近的RCT报告从日本的CONSORT声明显示，有一个显着的需要改进。需要进一步调查RCT报告的质量和提高报告质量的方法。
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.