Background: Integrative medicine is commonly used in China. Researchers prefer to report efficacy outcomes rather than safety outcomes in clinical trials; thus, evidence regarding safety in integrative medicine is unclear. Developing a core outcome set (COS) for safety outcomes is necessary.
Objectives: In this study, a representative example of the methodology for developing COS to assess safety outcomes of cardiovascular diseases in clinical trials investigating integrated medicine was developed.
Methods: Safety information will be extracted from package inserts and through systematic reviews of treatments for cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension) to develop an extensive list of safety outcomes, which will then be categorized according to whether subjective or objective outcomes. Patients participated in semi-structured interviews. Questionnaires for clinician-reported safety outcomes and patient reported safety outcomes will be developed. Two rounds of the Delphi survey will then be conducted for different stakeholders (traditional Chinese medicine clinicians and researchers in cardiovascular diseases, Western medicine clinicians and researchers in cardiovascular diseases, integrated medicine clinicians and researchers of cardiovascular diseases, pharmacologists, methodologists of evidence-based medicine, and patients). After round 2 of the Delphi analysis, a face-to-face consensus meeting will be held to determine the final COS for assessing safety outcomes in cardiovascular diseases.
Results: Anaphylaxis, arrhythmia, cardiac arrest, hypotension, mortality, and bleeding are clinician-reported core adverse events for all cardiovascular disease. Cardiopalmus, chest distress, dizziness, and syncope are patient-reported core symptoms for all cardiovascular disease. We also recommend clinician-reported and patient-reported core adverse events for angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension.
Conclusions: The core safety outcomes for cardiovascular disease may improve the consistency of adverse events reporting in future clinical trials.
Patient, public and/or healthcare consumer involvement: Clinicians, researchers, methodologists participated in the design, management, and process of the research. Patients participated in semi-structured interviews and online survey.