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

Kathleen L Grady; Michael Anthony Kallen; David G. Beiser; Jo Ann Lindenfeld; Jeffrey Teuteberg; Larry A. Allen; Colleen K. McIlvennan; Jonathan D Rich; Clyde Yancy; Christopher S. Lee; Quin E. Denfeld; Michael Kiernan; Mary Norine Walsh; Eric Adler; Bernice Ruo; Josef Stehlik; James K. Kirklin; Katy Bedjeti; Dave Cella; Elizabeth A Hahn

doi:10.1016/j.healun.2023.08.007

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

Kathleen L Grady^*, Michael Anthony Kallen, David G. Beiser, Jo Ann Lindenfeld, Jeffrey Teuteberg, Larry A. Allen, Colleen K. McIlvennan, Jonathan D Rich, Clyde Yancy, Christopher S. Lee, Quin E. Denfeld, Michael Kiernan, Mary Norine Walsh, Eric Adler, Bernice Ruo, Josef Stehlik, James K. Kirklin, Katy Bedjeti, Dave Cella, Elizabeth A Hahn

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	36-50
Number of pages	15
Journal	Journal of Heart and Lung Transplantation
Volume	43
Issue number	1
DOIs	https://doi.org/10.1016/j.healun.2023.08.007
State	Published - Jan 2024

Funding

This work was sponsored by the National Institutes of Health , National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [ R01HL130502 ], Grady KL and Hahn EA [co-PIs]). Kathleen L. Grady, PhD, RN – NIH (NIA and NHLBI) funding, support for attending conferences (ISHLT, HFSA, STS Intermacs AQO), leadership roles in ISHLT (director Board of Directors, member ISHLT Foundation Board, chair Grants and Awards Committee). Michael A. Kallen, PhD, M PH – none related to this manuscript. David G. Beiser, MD, MS – none related to this manuscript. JoAnn Lindenfeld, MD – consultant to AstraZeneca, Abbott, Alleviant, Boston Scientific, CVRx, Cytokinetics, Edwards Lifesciences, Merck, Medtronic, VWave. Jeffrey Teuteberg, MD – none related to this manuscript. Larry A. Allen, MD – consultant to ACI Clinical, American Heart Association, Boston Scientific, Cytokinetics, Novartis, Quidel, UpToDate. Colleen K. McIlvennan, PhD, DNP, ANP – none related to this manuscript. Jonathan Rich, MD – none related to this manuscript. Clyde Yancy, MD – none related to this manuscript. Christopher S. Lee, PhD, RN – none related to this manuscript. Quin E. Denfeld, PhD, RN – NIH/NINR funding. Michael Kiernan, MD – consultant: Medtronic and Endotronix, Honoraria: Abiomed. Mary Norine Walsh, MD – none related to this manuscript. Eric Adler, MD – consultant Abbott and Medtronic. Bernice Ruo, MD, MAS – none related to this manuscript. Josef Stehlik, MD – consulting: Medtronic, TransMedics, Natera; grant support: Natera, Merck. James K. Kirklin, MD – none related to this manuscript. Katy Bedjeti, MSW – none related to this manuscript. Dave Cella, PhD – President, PROMIS Health Organization (nonprofit organization, unfunded). Elizabeth A. Hahn, MA – none related to this manuscript.

Keywords

patient-reported outcomes
satisfaction with treatment
self efficacy
stigma
ventricular assist device

ASJC Scopus subject areas

Surgery
Pulmonary and Respiratory Medicine
Cardiology and Cardiovascular Medicine
Transplantation

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10.1016/j.healun.2023.08.007

Cite this

Grady, K. L., Kallen, M. A., Beiser, D. G., Lindenfeld, J. A., Teuteberg, J., Allen, L. A., McIlvennan, C. K., Rich, J. D., 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. (2024). Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study. Journal of Heart and Lung Transplantation, 43(1), 36-50. https://doi.org/10.1016/j.healun.2023.08.007

@article{17564bd76070449dac076dc52e451f70,

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

abstract = "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.",

keywords = "patient-reported outcomes, satisfaction with treatment, self efficacy, stigma, ventricular assist device",

author = "Grady, {Kathleen L} and Kallen, {Michael Anthony} and Beiser, {David G.} and Lindenfeld, {Jo Ann} and Jeffrey Teuteberg and Allen, {Larry A.} and McIlvennan, {Colleen K.} and Rich, {Jonathan D} and Clyde Yancy and Lee, {Christopher S.} and Denfeld, {Quin E.} and Michael Kiernan and Walsh, {Mary Norine} and Eric Adler and Bernice Ruo and Josef Stehlik and Kirklin, {James K.} and Katy Bedjeti and Dave Cella and Hahn, {Elizabeth A}",

note = "Funding Information: This work was sponsored by the National Institutes of Health , National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [ R01HL130502 ], Grady KL and Hahn EA [co-PIs]). Funding Information: Kathleen L. Grady, PhD, RN – NIH (NIA and NHLBI) funding, support for attending conferences (ISHLT, HFSA, STS Intermacs AQO), leadership roles in ISHLT (director Board of Directors, member ISHLT Foundation Board, chair Grants and Awards Committee). Michael A. Kallen, PhD, M PH – none related to this manuscript. David G. Beiser, MD, MS – none related to this manuscript. JoAnn Lindenfeld, MD – consultant to AstraZeneca, Abbott, Alleviant, Boston Scientific, CVRx, Cytokinetics, Edwards Lifesciences, Merck, Medtronic, VWave. Jeffrey Teuteberg, MD – none related to this manuscript. Larry A. Allen, MD – consultant to ACI Clinical, American Heart Association, Boston Scientific, Cytokinetics, Novartis, Quidel, UpToDate. Colleen K. McIlvennan, PhD, DNP, ANP – none related to this manuscript. Jonathan Rich, MD – none related to this manuscript. Clyde Yancy, MD – none related to this manuscript. Christopher S. Lee, PhD, RN – none related to this manuscript. Quin E. Denfeld, PhD, RN – NIH/NINR funding. Michael Kiernan, MD – consultant: Medtronic and Endotronix, Honoraria: Abiomed. Mary Norine Walsh, MD – none related to this manuscript. Eric Adler, MD – consultant Abbott and Medtronic. Bernice Ruo, MD, MAS – none related to this manuscript. Josef Stehlik, MD – consulting: Medtronic, TransMedics, Natera; grant support: Natera, Merck. James K. Kirklin, MD – none related to this manuscript. Katy Bedjeti, MSW – none related to this manuscript. Dave Cella, PhD – President, PROMIS Health Organization (nonprofit organization, unfunded). Elizabeth A. Hahn, MA – none related to this manuscript. Publisher Copyright: {\textcopyright} 2023 International Society for the Heart and Lung Transplantation",

year = "2024",

month = jan,

doi = "10.1016/j.healun.2023.08.007",

language = "English (US)",

volume = "43",

pages = "36--50",

journal = "Journal of Heart and Lung Transplantation",

issn = "1053-2498",

publisher = "Elsevier Inc.",

number = "1",

}

Grady, KL, Kallen, MA, Beiser, DG, Lindenfeld, JA, Teuteberg, J, Allen, LA, McIlvennan, CK, Rich, JD , Yancy, C, Lee, CS, Denfeld, QE, Kiernan, M, Walsh, MN, Adler, E, Ruo, B, Stehlik, J, Kirklin, JK, Bedjeti, K, Cella, D & Hahn, EA 2024, 'Novel measures to assess ventricular assist device patient-reported outcomes: Findings from the MCS A-QOL study', Journal of Heart and Lung Transplantation, vol. 43, no. 1, pp. 36-50. https://doi.org/10.1016/j.healun.2023.08.007

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 Anthony

AU - Beiser, David G.

AU - Lindenfeld, Jo Ann

AU - Teuteberg, Jeffrey

AU - Allen, Larry A.

AU - McIlvennan, Colleen K.

AU - Rich, Jonathan D

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 - Funding Information: This work was sponsored by the National Institutes of Health , National Heart Lung and Blood Institute (NHLBI), Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL, [ R01HL130502 ], Grady KL and Hahn EA [co-PIs]). Funding Information: Kathleen L. Grady, PhD, RN – NIH (NIA and NHLBI) funding, support for attending conferences (ISHLT, HFSA, STS Intermacs AQO), leadership roles in ISHLT (director Board of Directors, member ISHLT Foundation Board, chair Grants and Awards Committee). Michael A. Kallen, PhD, M PH – none related to this manuscript. David G. Beiser, MD, MS – none related to this manuscript. JoAnn Lindenfeld, MD – consultant to AstraZeneca, Abbott, Alleviant, Boston Scientific, CVRx, Cytokinetics, Edwards Lifesciences, Merck, Medtronic, VWave. Jeffrey Teuteberg, MD – none related to this manuscript. Larry A. Allen, MD – consultant to ACI Clinical, American Heart Association, Boston Scientific, Cytokinetics, Novartis, Quidel, UpToDate. Colleen K. McIlvennan, PhD, DNP, ANP – none related to this manuscript. Jonathan Rich, MD – none related to this manuscript. Clyde Yancy, MD – none related to this manuscript. Christopher S. Lee, PhD, RN – none related to this manuscript. Quin E. Denfeld, PhD, RN – NIH/NINR funding. Michael Kiernan, MD – consultant: Medtronic and Endotronix, Honoraria: Abiomed. Mary Norine Walsh, MD – none related to this manuscript. Eric Adler, MD – consultant Abbott and Medtronic. Bernice Ruo, MD, MAS – none related to this manuscript. Josef Stehlik, MD – consulting: Medtronic, TransMedics, Natera; grant support: Natera, Merck. James K. Kirklin, MD – none related to this manuscript. Katy Bedjeti, MSW – none related to this manuscript. Dave Cella, PhD – President, PROMIS Health Organization (nonprofit organization, unfunded). Elizabeth A. Hahn, MA – none related to this manuscript. 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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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 -

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

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