Article type
Year
Abstract
Background: Integrative medicine is commonly used in China. Researchers prefer to report efficacy outcomes rather than safety outcomes in clinical trials; thus, evidence regarding harms in integrative medicine is unclear. Developing a core outcome set (COS) for harms is necessary.
Methods: Harms will be extracted from package inserts and through systematic reviews of cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension) to develop a long list of harms, which will then be categorized according to whether subjective or objective harms. 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). Patients were invited to participate in a survey. After round 2 of the Delphi analysis, an online consensus meeting was held to determine the final COS for assessing harms in cardiovascular diseases.
Results: Anaphylaxis, arrhythmia, cardiac arrest, hypotension, mortality, and bleeding are clinician-reported core outcomes for harms reporting in 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 harms for angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension.
Conclusions: The core harms 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.
Methods: Harms will be extracted from package inserts and through systematic reviews of cardiovascular diseases (including angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension) to develop a long list of harms, which will then be categorized according to whether subjective or objective harms. 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). Patients were invited to participate in a survey. After round 2 of the Delphi analysis, an online consensus meeting was held to determine the final COS for assessing harms in cardiovascular diseases.
Results: Anaphylaxis, arrhythmia, cardiac arrest, hypotension, mortality, and bleeding are clinician-reported core outcomes for harms reporting in 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 harms for angina pectoris, myocardial infarction, heart failure, atrial fibrillation, bradyarrhythmia, and hypertension.
Conclusions: The core harms 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.