Development of a core outcome set for cardiac rehabilitation in patients with myocardial infarction: a study protocol.

ABSTRACT

INTRODUCTION: Heterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic reviews. Developing a core outcome set (COS) may solve this problem. METHODS AND ANALYSIS: We will first identify a preliminary list of outcomes through a systematic review. Next, we will conduct semistructured interviews with patients to explore additional potential outcomes deemed important by patients. Then, we will engage various stakeholders such as clinicians, researchers and methodologists in two Delphi survey tends to refine and prioritise the identified outcomes. Subsequently, we will gather insights directly from patients with MI by administering plain language patient surveys; patients will be involved in questionnaire development. Finally, we will hold two face-to-face consensus meetings for patients and other stakeholders to develop the final COS for cardiac rehabilitation in MI. ETHICS AND DISSEMINATION The Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine approved this study (2022DZMEC-349). The final COS will be published in a peer-reviewed journal and disseminated in conferences. TRIAL REGISTRATION We registered this study in the Core Outcome Measures in Effectiveness Trials Initiative (COMET) platform. REGISTRATION NUMBER 1725 (http//www.comet-initiative.org/studies/details/1725).