Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study

Abstract

Generic and heart failure-specific measures do not capture unique aspects of living with a ventricular assist device (VAD). Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist deviceadjustment and health-related quality of life (HRQOL). Patients were recruited from 10/26/16-2/29/20 from 12 U.S. VAD programs. We created a dataset of participants (n=620) enrolled before left (L)VAD implantation, with data at 3- or 6- months post-implantation (group1 [n=154]), and participants enrolled after LVAD implantation, with data at one timepoint (group 2 [n=466]). We constructed 5item banks: 3 modified from existing measures and 2 new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity. Of 620 participants, 56% (n=345) were implanted as destination therapy, 51% (n=316) were <12 months post-implantation, mean age=57.3 years, 78% (n=485) male, 70% (n=433) White, 58% (n=353) married/partnered, and 58% (n=357) with >high school education. We developed 5 new VAD item banks/measures: 6-item VAD Team Communication; 12-item Self-efficacy Regarding VAD Self-care; 11-item Being Bothered by VAD Self-care and Limitations; 7-item Satisfaction with Treatment; and 11-item Stigma. Cronbach's alpha reliability ranged from good (≥0.80) to excellent (≥0.90) for item banks/measures. All measures, except VAD Team Communication, demonstrated at least moderate correlations (≥0.30) with construct validity indicators. These measures meet IRT modeling assumptions and requirements; scores demonstrate reliability and validity. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and guide post-VAD interventions.