Validation of the PROMIS-29v2 Health-Related Quality-of-Life Questionnaire in Patients With Coronary Heart Disease Participating in Remote Cardiac Rehabilitation.

Purpose: The aim of this study was to validate the 29-item Patient-Reported Outcomes Measurement Information System version 2.0 (PROMIS-29v2) health-related quality-of-life (HRQL) questionnaire for use in patients with coronary heart disease (CHD) participating in remotely delivered cardiac rehabilitation (CR).

Methods: Patients commencing remote CR across four sites in New South Wales, Australia, answered the PROMIS-29v2 and 12-item Short Form Health Survey version 2.0 (SF-12v2) questionnaires at CR entry and completion (6 wk). The data were analyzed for validity, reliability, and responsiveness to change.

Results: Patients (N = 89) had a mean age of 66.9 ± 9.3 yr; 83% were male and were referred to CR for elective percutaneous coronary intervention (PCI) (42%), myocardial infarction (36%), and coronary artery bypass grafting (22%). Internal consistency reliability was adequate, with the Cronbach α ranging from 0.78-0.98. Convergent validity between the PROMIS-29v2 and SF-12v2 summary scores showed significantly strong correlations for physical ( r = 0.62) and moderate for mental ( r = 0.36) health. Discriminant validity was confirmed for sex (women reported lower physical and mental health) and referral diagnosis (patients who had elective PCI reported better physical health). Effect size (ES) comparisons confirmed responsiveness to change from CR entry to completion in physical health (ES = 0.51) and demonstrated evidence of more responsiveness than SF-12v2 for mental health (ES = 0.70).

Conclusion: The PROMIS-29v2 is reliable, valid, and responsive to changes in patients with CHD attending remotely delivered CR and allows for baseline HRQL assessment, between-diagnosis comparisons, and evaluation of changes over time.