A Patient-Reported Metric of Social and Physical Function after Left Ventricular Assist Devices: A PROMIS of a Better Assessment

Abstract

<h3>Purpose</h3> To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) generic measures of social and physical function in patients with a left ventricular assist device (LVAD). <h3>Methods</h3> Adult heart failure (HF) patients at 12 U.S. sites in 2016-2020 enrolled in The Mechanical Circulatory Support: Measures of Adjustment and Quality Of Life Study (<i>n</i>=361). Post-LVAD implant, they completed PROMIS Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles and Activities, and Physical Function; and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Social and Physical Limitation measures. PROMIS is standardized to a general population (mean=50; SD=10). KCCQ-12 range is 0-100. Higher scores represent better outcomes. Construct validity was evaluated by Pearson correlations between PROMIS and KCCQ-12 scores. Known-groups validity was evaluated by analysis of variance to distinguish PROMIS means across NYHA and self-reported financial difficulties. <h3>Results</h3> Mean age was 58 years; 80% were male, 70% were Non-Hispanic White, 79% had financial difficulties due to condition/treatment, and 61% were NYHA I-II. Similar numbers enrolled at 3, 6, 12-26, and > 26 months post-implant. Mean scores for PROMIS and KCCQ-12 measures decreased (worsened) as NYHA worsened (<i>p</i><0.0001; Figure), and as financial difficulties increased (<i>p</i><0.001). Nearly all mean PROMIS scores were less than 50. Correlations between PROMIS (generic) and KCCQ-12 (HF-specific) social and physical measures were moderately high (<i>r</i>=0.56 and <i>r</i>=0.59, respectively; <i>p</i><0.0001). <h3>Conclusion</h3> PROMIS measures of social and physical function were associated with well-accepted measures commonly assessed in HF and post-LVAD. Unlike condition-specific measures, PROMIS scores can be compared to the general population or other clinical conditions, thus providing a useful way to interpret social and physical function after LVAD implant.