Zhang Xuan, Zhang Lin, Wang Juan, Lau Chung Tai, Wang Nana, Zhang Xuanqi, Wang Ping, Li Ji, Han Fei, Bian Zhaoxiang
Teaching and Research Division, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong Special Administrative Region 999077, China.
Department of Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China.
J Integr Med. 2025 Jul 31. doi: 10.1016/j.joim.2025.07.010.
To improve the consistency of outcome documentation and address the potential for outcome reporting bias in clinical trials involving integrative Chinese and Western medicine (ICWM) for ulcerative colitis (UC), we aim to develop a customized core outcome set (COS) that incorporates input from various stakeholders. The study design of this COS has been informed by the COMET Initiative Handbook, with adherence to the guidelines from the Core Outcome Measures in Effectiveness Trials (COS-STAR) statement and COS-STAndards Reporting recommendations (COS-STAP) recommendations. Five groups of stakeholders will be invited to participate in the development of COS for clinical trials with ICWM for UC, including healthcare professionals, patients, COS developers, COS users, and methodologists. The process will involve five stages: (1) conducting a systematic review of outcomes reported in clinical trials and protocols to develop a list of potential outcome domains; (2) conducting semi-structured interviews to obtain important outcomes; (3) choosing the most important outcomes by conducting three-round Delphi surveys; (4) achieving a consensus in a face-to-face meeting to discuss the final COS; and (5) publication, dissemination and implementation of COS. Consequently, this specialized COS will be applicable to clinical trials involving both traditional Chinese medicine (TCM) and ICWM interventions. Please cite this article as: Zhang X, Zhang L, Wang J, Lau CT, Wang NN, Zhang XQ, Wang P, Li J, Han F, Bian ZX. A protocol for developing, disseminating and implementing a core outcome set for clinical trials of integrative Chinese and Western medicine for ulcerative colitis. J Integr Med. 2025; Epub ahead of print.
为提高结局记录的一致性，并解决涉及中西医结合治疗溃疡性结肠炎（UC）的临床试验中结局报告偏倚的可能性，我们旨在制定一个定制的核心结局集（COS），该结局集纳入了来自不同利益相关者的意见。本COS的研究设计参考了COMET计划手册，并遵循有效性试验核心结局指标（COS-STAR）声明和COS标准报告建议（COS-STAP）的指南。将邀请五组利益相关者参与制定中西医结合治疗UC的临床试验COS，包括医疗保健专业人员、患者、COS开发者、COS使用者和方法学家。该过程将包括五个阶段：（1）对临床试验和方案中报告的结局进行系统评价，以制定潜在结局领域列表；（2）进行半结构化访谈以获取重要结局；（3）通过三轮德尔菲调查选择最重要的结局；（4）在面对面会议上达成共识，讨论最终的COS；（5）COS的发表、传播和实施。因此，这个专门的COS将适用于涉及中医和中西医结合干预的临床试验。请引用本文：Zhang X, Zhang L, Wang J, Lau CT, Wang NN, Zhang XQ, Wang P, Li J, Han F, Bian ZX. 一项关于制定、传播和实施中西医结合治疗溃疡性结肠炎临床试验核心结局集的方案。《整合医学杂志》。2025年；印刷前在线发表。
