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Novel Measures to Assess Ventricular Assist Device Patient-reported Outcomes: Findings from the MCS A-QOL Study.
Novel Measures to Assess Ventricular Assist Device Patient-reported Outcomes: Findings from the MCS A-QOL Study. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation Grady, K. L., Kallen, M. A., Beiser, D. G., Lindenfeld, J., Teuteberg, J., Allen, L. A., McIlvennan, C. K., Rich, J., Yancy, C., Lee, C. S., Denfeld, Q. E., Kiernan, M., Walsh, M. N., Adler, E., Ruo, B., Stehlik, J., Kirklin, J. K., Bedjeti, K., Cella, D., Hahn, E. A. 2023Abstract
BACKGROUND: Generic and heart failure-specific measures do not capture unique aspects of living with a VAD. Using state-of-the-science psychometric measurement methods, we developed a measurement system to assess post-ventricular assist device (VAD) adjustment and HRQOL.METHODS: 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 five item banks: three modified from existing measures and two new measures. Analyses included item response theory (IRT) modeling, differential item functioning tests for systematic measurement bias, and indicators of reliability and validity.RESULTS: 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 five 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.CONCLUSIONS: 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.
View details for DOI 10.1016/j.healun.2023.08.007
View details for PubMedID 37591454