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

Abstract

Abstract 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 evidence-based decision-making for stakeholders.