Association Between a Novel Adult Congenital Heart Disease-Specific Patient-Reported Health Status Metric and...

Area of Science:

• Cardiology
• Patient-Reported Outcomes
• Health Services Research

Background:

• Disease-specific patient-reported outcomes (PROs) are crucial clinical metrics.
• Data on PRO performance in adult congenital heart disease (ACHD) are limited.
• Novel ACHD-specific PRO metrics are needed to assess patient health status.

Purpose of the Study:

• To investigate the association between a novel ACHD-specific PRO metric and clinical variables.
• To validate the Adult Congenital Heart Disease Patient-Reported Outcome Version 1 (ACHD PRO V.1) against gold standard PROs.
• To determine the utility of ACHD PRO V.1 as a clinical outcome in ACHD.

Main Methods:

• Assessed the association between ACHD PRO V.1 summary score and hospital admission in 333 ACHD patients.
• Examined relationships between ACHD PRO V.1 domain scores and clinical variables, Quality of Life (QOL), depression, and anxiety.
• Utilized data from the international APPROACH IS-II cohort.

Main Results:

• Worse ACHD PRO V.1 scores were significantly associated with unplanned hospital admission (adjusted β, -5.7; P=0.007).
• ACHD PRO V.1 domains showed strong associations with relevant clinical variables.
• Moderate correlations were observed between ACHD PRO V.1 domains and gold standard measures for QOL, depression, and anxiety.

Conclusions:

• Lower ACHD PRO V.1 summary scores correlate with a history of unplanned cardiac admissions.
• The ACHD PRO V.1 demonstrates good content validity against clinical conditions and established PROs.
• The ACHD PRO V.1 is supported as a direct and surrogate clinical outcome measure for ACHD.