Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, No.199, Donggang West Road, Chengguan District, Lanzhou City, Gansu Province, China.
Key Laboratory of Evidence-Based Medicine and Knowledge Translation of Gansu Province, Lanzhou, China.
Trials. 2021 Mar 26;22(1):233. doi: 10.1186/s13063-021-05187-8.
Sjogren's syndrome (SS) is a chronic autoimmune rheumatic disease with an incidence of 0.03 to 0.3%. In recent years, there are an increasing number of randomized controlled trials of traditional Chinese medicine (TCM) for SS. However, there are generally some problems in these published clinical trials: lack of reporting primary or long-term outcomes and the heterogeneous in different clinical trials' outcome. Our study aims to determine the priority outcomes and standard TCM syndromes for all stakeholders and reach agreement on the COS and syndromes to be measured and reported in all future TCM trials in patients with SS.
A phase-wise refinement approach will be used, consisting of three phases, yet complementary, sub-work phases, whereby each phase will inform the next coming phases. The following are the three phases: (I-a) identifying of a long initial list of outcomes through systematic literature review and semi-structured qualitative interviews and (I-b) identifying an initial list of TCM syndromes through (1) systematic literature review, (2) referencing ancient Chinese medical books, and (3) retrospective studies of medical records; (II) prioritization of outcomes using Delphi survey with different stakeholders, such as health professionals and patients; and (III) through consensus meetings with patients and professionals to agree on the final COS and TCM syndromes.
We summarized the actions of COS into three points: direct action, indirect action, and final action. After the final COSs is completed, we will publish this research in a journal to promote communication.
Core Outcome Measures in Effectiveness Trials Initiative (COMET) number 1429 . Registered on 01 December 2019.
干燥综合征（SS）是一种慢性自身免疫性风湿病，发病率为 0.03%至 0.3%。近年来，越来越多的中药治疗 SS 的随机对照试验。然而，这些已发表的临床试验通常存在一些问题：缺乏对主要或长期结局的报告，以及不同临床试验结局的异质性。我们的研究旨在确定所有利益相关者的优先结局和标准中医证候，并就 SS 患者所有未来中药试验中要测量和报告的结局和证候达成共识。
我们将采用分阶段完善的方法，包括三个阶段，但相互补充的分阶段，每个阶段都将为下一个阶段提供信息。以下是三个阶段：（I-a）通过系统文献回顾和半结构化定性访谈确定一个初始的长列表的结局；（I-b）通过（1）系统文献回顾、（2）参考古代中医书籍和（3）病历回顾性研究确定初始的中医证候列表；（II）使用德尔菲调查法对不同利益相关者（如卫生专业人员和患者）进行结局的优先排序；（III）通过患者和专业人员的共识会议，就最终的 COS 和中医证候达成一致。
我们将 COS 的行动总结为三个点：直接行动、间接行动和最终行动。完成最终的 COS 后，我们将在期刊上发表这项研究，以促进交流。
疗效试验核心结局测量倡议（COMET）编号 1429。于 2019 年 12 月 1 日注册。
