稳定型心绞痛中医药临床试验核心指标集研制

Core outcome set for stable angina pectoris in traditional Chinese medicine(COS-SAP-TCM)

目的:本研究旨在研制适用于中医治疗稳定型心绞痛(SAP)研究的核心指标集(COS)。方法:研究通过系统评价中医药治疗SAP的文献,并对医生和SAP患者展开定性访谈,产生指标池。邀请利益相关者参加两轮在线德尔菲调查和一场面对面共识会议对指标进行评分。最后通过共识会议产生最终的 COS。结果:指标池纳入了324 个指标,在此基础上遴选出65个指标进入初始清单应用到德尔菲调查中。来自7个利益相关群体的223名参与者参与了德尔菲调查并对指标进行评分,87人完成了第一轮,47 人完成了第二轮。31名参与者参加了共识会议,最终共识包括来自4个指标域 中的6 个指标进入到最终核心指标集,包括心绞痛发作频率、心绞痛发作持续时间、西雅图心绞痛量表平板运动总时间、心血管事件和心电图 QT 间期。结论:本研究研制的COS为今后 SAP 中医临床试验中的测量和报告提供了最少指标集合。通过使用该 COS 可以减少试验间的异质性,促进利益相关者进行循证决策。

Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.