Department of Biostatistics, University of Liverpool, Liverpool, UK; Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.
Department of Biostatistics, University of Liverpool, Liverpool, UK.
J Clin Epidemiol. 2019 Nov;115:90-97. doi: 10.1016/j.jclinepi.2019.07.007. Epub 2019 Jul 18.
The objective of this study was to assess the uptake of the rheumatoid arthritis core outcome set (RA-COS) using data from multiple data providers, and to investigate factors that may influence this uptake.
An observational review was carried out on all clinical trials of rheumatoid arthritis that were indexed on the World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP). Various measures of COS uptake were calculated from information presented in the trial registries and trial publications. Logistic regression was conducted to investigate factors thought to be associated with planned COS uptake.
A total of 341 trials were eligible for the evaluation of RA-COS uptake. In the decade leading up to 2019, the assessment of uptake based on published results was maintained at just over 80%. Trials that were not commercially funded were much less likely to plan to measure the RA-COS than those with industry funding (60% vs. 80%; adjusted OR 0.18, 95% CI 0.11 to 0.32; P < 0.001).
This study has demonstrated that the use of the WHO-ICTRP can identify a large and geographically diverse range of trials to include in the evaluation of COS uptake.
本研究旨在评估类风湿关节炎核心结局集（RA-COS）的采用情况，数据来源于多个数据提供者，并探讨可能影响采用的因素。
对世界卫生组织-国际临床试验注册平台（WHO-ICTRP）索引的所有类风湿关节炎临床试验进行了观察性综述。从试验注册处和试验出版物中提供的信息中计算了各种 COS 采用措施。采用逻辑回归分析了与计划采用 COS 相关的因素。
共有 341 项试验符合评估 RA-COS 采用情况的条件。在 2019 年之前的十年中，基于已发表结果评估的采用率保持在 80%以上。没有商业资金支持的试验计划测量 RA-COS 的可能性远低于有行业资金支持的试验（60%比 80%；调整后的 OR 0.18，95%CI 0.11 至 0.32；P<0.001）。
本研究表明，WHO-ICTRP 的使用可以识别大量具有地理多样性的试验，纳入 COS 采用情况的评估。
