Patient-Reported Outcomes in Cardiovascular Trials

Abstract

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 4 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 cardiac clinical trials. Current challenges include the long-term measurement of PROs in clinical trials beyond 1 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 minimal clinically important differences for PROs.

Figure 1.

Four patient-reported outcome domains Abbreviations: DASI: Duke Activity Status Index, EQ-5D: Euro-Qol-5D, GADS: Generalized Anxiety Disorder Assessment, HADS: Hospital Anxiety and Depression Scale, MoCA: Montreal Cognitive Assessment, Neuro-QoL: Quality of Life in Neurological Disorders, PHQ-9: Patient Health Questionnaire-9, PROMIS: Patient Reported Outcomes Measurement Information System, SF-12, SF-36: Short Form Health Survey 12-item, 36-item

Figure 2.

Cycle of impaired physical, social, and psychological function

Figure 3.

Example of PRO visual analogy