Patient-Reported Outcomes in Cardiovascular Trials

Patient-reported outcomes (PROs) are reports of a person’s health status that provide a global perspective of patient well-being. PROs can be classified into four primary domains: global, mental, physical, and social health. In this descriptive review, we focus on how PROs can be used in cardiac clinical trials, with an emphasis on cardiac surgical trials for patients with coronary heart disease and heart failure. We also highlight ongoing challenges and provide specific suggestions and novel opportunities to advance the field of cardiac clinical trials. Current challenges include the long-term measurement of PROs in clinical trials beyond one year, inconsistency in the choice of the outcome measures among studies, and the lack of measurement of PROs across multiple domains. Opportunities for advancement include measuring PROs using consumer health informatics tools, including returning information back to participants in formats that they can understand using visualization. Future opportunities include quantifying cohort-specific minimally clinically important differences for PROs.