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 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.

Person-Centered Models for Cardiovascular Care: A Review of the Evidence: A Scientific Statement From the American Heart Association

“…Although many studies in this review used patient-reported outcome measures, the essential contribution of these data was ultimately “for research purposes only” to increase knowledge or to describe patient perspectives, expectations, or experiences. 203,204 A scoping review revealed 34 disease-specific patient-reported outcome measures for use with different cardiac conditions that have not been consistently integrated into clinical care despite the compelling ways in which these data could advance improvements in care. 204 This suggests the need to consider the opportunities for integrating and using these measures beyond research, in clinical care.…”

Peer-support interventions for women with cardiovascular disease: protocol for synthesising the literature using an evidence map

“…Outcomes will include health status, HRQoL and healthcare costs. We will include disease-specific and generic reports and measures of two patient-reported outcomes: health status (ie, worsening of the condition) and HRQoL (ie, perceived well-being measured using the Minnesota Living with Heart Failure, Kansas City Cardiomyopathy Questionnaire, 12-item short form survey (SF-12), EQ 5D value health instrument) 82. Estimating direct and indirect costs of peer support using a cost-effectiveness analysis, incremental cost-effectiveness ratio or quality-adjusted life-years will be included 83…”

“…We will include disease-specific and generic reports and measures of two patient-reported outcomes: health status (ie, worsening of the condition) and HRQoL (ie, perceived well-being measured using the Minnesota Living with Heart Failure, Kansas City Cardiomyopathy Questionnaire, 12-item short form survey (SF-12), EQ 5D value health instrument). 82 Estimating direct and indirect costs of peer support using a costeffectiveness analysis, incremental cost-effectiveness ratio or quality-adjusted life-years will be included. 83 Systematically retrieve, screen and classify the evidence All team members, including women with lived experience, will participate in retrieving, screening and classifying the evidence.…”

Patient-Centered Adult Cardiovascular Care: A Scientific Statement From the American Heart Association

“…When captured rigorously, PRO results can aid in decisionmaking, systematic reviews, meta-analysis, and clinical guideline development and ultimately influence health care policy. 38 On an individual level, PROs provide a holistic picture of the consequences of the treatment or intervention and the impact it has on symptoms and quality of life. The Consensus-Based Standards for the Selection of Health Measurement Instruments checklist recommends using a multidomain approach for the measurement of PROs, including a selection of instruments across multiple domains and generic and disease-specific outcome assessments (Figure 2 and Supplemental Table S1).…”

“…When captured rigorously, PRO results can aid in decision-making, systematic reviews, meta-analysis, and clinical guideline development and ultimately influence health care policy. 38…”