Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study

This report evaluated responsiveness validity (sensitivity to change) for five ventricular assist device (VAD)-specific patient-reported outcomes (PROs). Patients at 12 U.S. sites completed PRO measures at months 3 and 6 post-VAD including: Being Bothered by VAD, Self-care and Limitations, Self-effi...

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Main Authors: Elizabeth A. Hahn, MA, Larry A. Allen, MD, MHS, David Cella, PhD, David G. Beiser, MD, MS, Quin E. Denfeld, PhD, RN, James Kirklin, MD, JoAnn Lindenfeld, MD, Colleen K. McIlvennan, PhD, Bernice Ruo, MD, Jeffrey Teuteberg, MD, Michael Kiernan, MD, Liviu Klein, MD, MS, Christopher S. Lee, PhD, RN, Catherine Murks, NP, Jonathan Rich, MD, Josef Stehlik, MD, Mary Norine Walsh, MD, MACC, Katy Bedjeti, MSW, Kathleen L. Grady, PhD
Format: Article
Language:English
Published: Elsevier 2025-08-01
Series:JHLT Open
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Online Access:http://www.sciencedirect.com/science/article/pii/S2950133425000643
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author Elizabeth A. Hahn, MA
Larry A. Allen, MD, MHS
David Cella, PhD
David G. Beiser, MD, MS
Quin E. Denfeld, PhD, RN
James Kirklin, MD
JoAnn Lindenfeld, MD
Colleen K. McIlvennan, PhD
Bernice Ruo, MD
Jeffrey Teuteberg, MD
Michael Kiernan, MD
Liviu Klein, MD, MS
Christopher S. Lee, PhD, RN
Catherine Murks, NP
Jonathan Rich, MD
Josef Stehlik, MD
Mary Norine Walsh, MD, MACC
Katy Bedjeti, MSW
Kathleen L. Grady, PhD
author_facet Elizabeth A. Hahn, MA
Larry A. Allen, MD, MHS
David Cella, PhD
David G. Beiser, MD, MS
Quin E. Denfeld, PhD, RN
James Kirklin, MD
JoAnn Lindenfeld, MD
Colleen K. McIlvennan, PhD
Bernice Ruo, MD
Jeffrey Teuteberg, MD
Michael Kiernan, MD
Liviu Klein, MD, MS
Christopher S. Lee, PhD, RN
Catherine Murks, NP
Jonathan Rich, MD
Josef Stehlik, MD
Mary Norine Walsh, MD, MACC
Katy Bedjeti, MSW
Kathleen L. Grady, PhD
author_sort Elizabeth A. Hahn, MA
collection DOAJ
description This report evaluated responsiveness validity (sensitivity to change) for five ventricular assist device (VAD)-specific patient-reported outcomes (PROs). Patients at 12 U.S. sites completed PRO measures at months 3 and 6 post-VAD including: Being Bothered by VAD, Self-care and Limitations, Self-efficacy Regarding VAD Self-care, Treatment Satisfaction, VAD Team Communication, Stigma, Kansas City Cardiomyopathy Questionnaire (KCCQ-12), EQ-5D-3L, and Intermacs Post-Implant Quality of Life Form. Statistical methods included linear mixed effect models, analysis of variance methods and Pearson correlation coefficients (r). To evaluate sensitivity to change, VAD change scores were mapped to change in indicator variables (better, no change, worse). The VAD-specific PRO measures demonstrated preliminary evidence of responsiveness to change from month 3 to month 6. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and identify areas of concern that may guide interventions to support adjustment to having a VAD and enhance life quality. Clinical Trial Registration: ClinicalTrials.gov ID: NCT03044535.
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spelling doaj-art-aa474db652fa4eb3b939ab6ba1a23a8a2025-08-20T03:37:31ZengElsevierJHLT Open2950-13342025-08-01910026910.1016/j.jhlto.2025.100269Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL studyElizabeth A. Hahn, MA0Larry A. Allen, MD, MHS1David Cella, PhD2David G. Beiser, MD, MS3Quin E. Denfeld, PhD, RN4James Kirklin, MD5JoAnn Lindenfeld, MD6Colleen K. McIlvennan, PhD7Bernice Ruo, MD8Jeffrey Teuteberg, MD9Michael Kiernan, MD10Liviu Klein, MD, MS11Christopher S. Lee, PhD, RN12Catherine Murks, NP13Jonathan Rich, MD14Josef Stehlik, MD15Mary Norine Walsh, MD, MACC16Katy Bedjeti, MSW17Kathleen L. Grady, PhD18Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL; Corresponding author: Elizabeth A. Hahn, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 625 N. Michigan Ave., Suite 2200, Chicago, IL 60611. Telephone: +1 312 503 9804.Medicine, University of Colorado, Aurora, COMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, ILEmergency Medicine, University of Chicago, Chicago, ILNursing, Oregon Health and Science University, Portland, ORKirklin Solutions Inc., Hoover, ALMedicine, Vanderbilt University, Nashville, TNMedicine, University of Colorado, Aurora, COMedicine, University of California-San Diego, La Jolla, CAMedicine, Stanford University, Stanford, CACardiology, Tufts University School of Medicine, Boston, MAMedicine, University of California, San Francisco, CANursing, Boston College, Chestnut Hill, MAEmergency Medicine, University of Chicago, Chicago, ILMedicine, Northwestern University Feinberg School of Medicine, Chicago, ILMedicine, University of Utah, Salt Lake City, UTHeart Failure and Cardiovascular Research Institute, Ascension St Vincent Heart Center, Indianapolis, INMedical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, ILSurgery, Northwestern University Feinberg School of Medicine, Chicago, ILThis report evaluated responsiveness validity (sensitivity to change) for five ventricular assist device (VAD)-specific patient-reported outcomes (PROs). Patients at 12 U.S. sites completed PRO measures at months 3 and 6 post-VAD including: Being Bothered by VAD, Self-care and Limitations, Self-efficacy Regarding VAD Self-care, Treatment Satisfaction, VAD Team Communication, Stigma, Kansas City Cardiomyopathy Questionnaire (KCCQ-12), EQ-5D-3L, and Intermacs Post-Implant Quality of Life Form. Statistical methods included linear mixed effect models, analysis of variance methods and Pearson correlation coefficients (r). To evaluate sensitivity to change, VAD change scores were mapped to change in indicator variables (better, no change, worse). The VAD-specific PRO measures demonstrated preliminary evidence of responsiveness to change from month 3 to month 6. Use of these measures may assist VAD clinicians to inform patients about VADs as a treatment option and identify areas of concern that may guide interventions to support adjustment to having a VAD and enhance life quality. Clinical Trial Registration: ClinicalTrials.gov ID: NCT03044535.http://www.sciencedirect.com/science/article/pii/S2950133425000643Mechanical Circulatory supportVentricular assist devicePatient-reported outcomesResponsiveness validity
spellingShingle Elizabeth A. Hahn, MA
Larry A. Allen, MD, MHS
David Cella, PhD
David G. Beiser, MD, MS
Quin E. Denfeld, PhD, RN
James Kirklin, MD
JoAnn Lindenfeld, MD
Colleen K. McIlvennan, PhD
Bernice Ruo, MD
Jeffrey Teuteberg, MD
Michael Kiernan, MD
Liviu Klein, MD, MS
Christopher S. Lee, PhD, RN
Catherine Murks, NP
Jonathan Rich, MD
Josef Stehlik, MD
Mary Norine Walsh, MD, MACC
Katy Bedjeti, MSW
Kathleen L. Grady, PhD
Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
JHLT Open
Mechanical Circulatory support
Ventricular assist device
Patient-reported outcomes
Responsiveness validity
title Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
title_full Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
title_fullStr Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
title_full_unstemmed Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
title_short Responsiveness validity for measures of adjustment to life with a left ventricular assist device: Findings from the MCS A-QOL study
title_sort responsiveness validity for measures of adjustment to life with a left ventricular assist device findings from the mcs a qol study
topic Mechanical Circulatory support
Ventricular assist device
Patient-reported outcomes
Responsiveness validity
url http://www.sciencedirect.com/science/article/pii/S2950133425000643
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