Patient-Reported Outcomes in Cardiovascular Trials.

Area of Science:

• Cardiology
• Clinical Trials
• Patient-Reported Outcomes

Background:

• Patient-reported outcomes (PROs) offer insights into patient well-being across global, mental, physical, and social health domains.
• PROs are crucial for evaluating treatment efficacy and patient experience in clinical research.

Purpose of the Study:

• To review the application of PROs in cardiac clinical trials, particularly for coronary heart disease and heart failure surgical trials.
• To identify current challenges and propose future opportunities for advancing PRO utilization in cardiac research.

Main Methods:

• Descriptive review of literature on PROs in cardiac clinical trials.
• Analysis of challenges and opportunities in PRO measurement and application.

Main Results:

• Key challenges include long-term PRO measurement (beyond 1 year), inconsistent outcome measure selection, and lack of multi-domain PRO assessment.
• Opportunities include leveraging consumer health informatics tools and data visualization for participant feedback.

Conclusions:

• Advancing cardiac clinical trials requires addressing PRO measurement inconsistencies and duration limitations.
• Future research should focus on integrating novel technologies and defining cohort-specific minimal clinically important differences for PROs to enhance patient-centered care.