Abstract 101: The Development and Initial Validation of PROMIS-Plus-HF Profile Measure
Circulation: Cardiovascular Quality and Outcomes
Background: Bringing together generic and heart failure (HF)-specific items in a publicly-available, patient-reported outcome measure may facilitate better health status comparisons across groups and within individuals longitudinally in learning health systems and clinical research studies.
Methods and Results: We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF profile measure, a HF-specific instrument based on the generic The Patient-Reported Outcomes Measurement Information System (PROMIS). We conducted eight focus groups with 61 HF patients and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman rho correlations with Kansas City Cardiomyopathy Questionnaire (KCCQ) subscores. In a longitudinal sample, we performed responsiveness testing (paired t-tests) with 75 HF patients receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach’s alpha) coefficients ranged from 0.52-0.96, with alpha≥0.70 in 12/17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with KCCQ subscores supported expected convergent (r/rho>0.60) and divergent validity (r/rho<0.30). In the longitudinal sample, 10/18 domains had improved (P<0.05) scores from baseline to follow-up.
Conclusions: The PROMIS-Plus-HF profile measure—a complete assessment of physical, mental, and social health—exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains, or the entire measure, can be used, depending on the clinical or research purpose.
Center for Cardiovascular Analytics, Research + Data Science (CARDS)
Ahmad, Faraz S.; Kallen, Michael A.; Schifferdecker, Karen E.; Carluzzo, Kathleen L.; Yount, Susan E.; Gelow, Jill M; McCullough, Peter A.; Kimmel, Stephen E.; Fisher, Elliot S.; and Cella, David, "Abstract 101: The Development and Initial Validation of PROMIS-Plus-HF Profile Measure" (2019). Articles, Abstracts, and Reports. 3472.