TY - JOUR
T1 - Novel measures to assess ventricular assist device patient-reported outcomes
T2 - Findings from the MCS A-QOL study
AU - Grady, Kathleen L.
AU - Kallen, Michael A.
AU - Beiser, David G.
AU - Lindenfeld, Jo Ann
AU - Teuteberg, Jeffrey
AU - Allen, Larry A.
AU - McIlvennan, Colleen K.
AU - Rich, Jonathan
AU - Yancy, Clyde
AU - Lee, Christopher S.
AU - Denfeld, Quin E.
AU - Kiernan, Michael
AU - Walsh, Mary Norine
AU - Adler, Eric
AU - Ruo, Bernice
AU - Stehlik, Josef
AU - Kirklin, James K.
AU - Bedjeti, Katy
AU - Cella, Dave
AU - Hahn, Elizabeth A.
N1 - Publisher Copyright:
© 2023 International Society for the Heart and Lung Transplantation
PY - 2024/1
Y1 - 2024/1
N2 - Background: 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 device adjustment and health-related quality of life (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 5 item 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. 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 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. 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.
AB - Background: 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 device adjustment and health-related quality of life (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 5 item 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. 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 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. 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.
KW - patient-reported outcomes
KW - satisfaction with treatment
KW - self efficacy
KW - stigma
KW - ventricular assist device
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UR - http://www.scopus.com/inward/citedby.url?scp=85171201022&partnerID=8YFLogxK
U2 - 10.1016/j.healun.2023.08.007
DO - 10.1016/j.healun.2023.08.007
M3 - Article
C2 - 37591454
AN - SCOPUS:85171201022
SN - 1053-2498
VL - 43
SP - 36
EP - 50
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 1
ER -