Exploring methodology for investigating Chinese coronary artery disease patient values and preferences: A methodological study protocol

Background: Coronary artery disease (CAD) remains a leading cause of global mortality and disability. CAD patients face tradeoffs between antithrombotic therapy benefits and bleeding risks, underscoring the need to incorporate patient values and preferences into clinical guidelines. Establishing minimal important differences (MIDs) for patient-important outcomes supports clinical guideline development by determining the smallest change in outcomes that patients consider important. However, directly conducting patient surveys to establish MIDs presents several methodological challenges. Methods: We established a multidisciplinary working group to guide the MID investigation. Using a three-phase process, we identified key outcomes through literature review and discussion. We will develop draft health outcome descriptions by synthesizing evidence from clinical guidelines and qualitative studies, supplemented with patient interviews, and refine the drafts through iterative cognitive interviews. We then designed outcome-specific draft MID questionnaires and will employ cognitive interviews to assess clarity and comprehensibility. Discussion: This study will develop standard materials for surveying patient values and determining MIDs in Chinese CAD patients. The resulting methodology will support future investigations into patient-important outcomes and provide critical evidence for clinical guideline development.