Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure

Faraz S. Ahmad, Michael A. Kallen, Karen E. Schifferdecker, Kathleen L. Carluzzo, Susan E. Yount, Jill Gelow, Peter A. McCullough, Stephen E. Kimmel, Elliot S. Fisher, David Cella

    Research output: Contribution to journalArticle

    Abstract

    Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.

    Original languageEnglish (US)
    Pages (from-to)e005751
    JournalCirculation. Heart failure
    Volume12
    Issue number6
    DOIs
    StatePublished - Jun 1 2019

    Fingerprint

    Information Systems
    Heart Failure
    Cardiomyopathies
    Health Status
    Patient Reported Outcome Measures
    Patient-Centered Care
    Quality of Health Care
    Focus Groups
    Research
    Psychometrics
    Decision Making
    Mental Health
    Interviews

    Keywords

    • decision-making
    • health status
    • heart failure
    • patient-reported outcome measures
    • quality of life

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine

    Cite this

    Ahmad, F. S., Kallen, M. A., Schifferdecker, K. E., Carluzzo, K. L., Yount, S. E., Gelow, J., ... Cella, D. (2019). Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure. Circulation. Heart failure, 12(6), e005751. https://doi.org/10.1161/CIRCHEARTFAILURE.118.005751

    Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure. / Ahmad, Faraz S.; Kallen, Michael A.; Schifferdecker, Karen E.; Carluzzo, Kathleen L.; Yount, Susan E.; Gelow, Jill; McCullough, Peter A.; Kimmel, Stephen E.; Fisher, Elliot S.; Cella, David.

    In: Circulation. Heart failure, Vol. 12, No. 6, 01.06.2019, p. e005751.

    Research output: Contribution to journalArticle

    Ahmad, FS, Kallen, MA, Schifferdecker, KE, Carluzzo, KL, Yount, SE, Gelow, J, McCullough, PA, Kimmel, SE, Fisher, ES & Cella, D 2019, 'Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure', Circulation. Heart failure, vol. 12, no. 6, pp. e005751. https://doi.org/10.1161/CIRCHEARTFAILURE.118.005751
    Ahmad, Faraz S. ; Kallen, Michael A. ; Schifferdecker, Karen E. ; Carluzzo, Kathleen L. ; Yount, Susan E. ; Gelow, Jill ; McCullough, Peter A. ; Kimmel, Stephen E. ; Fisher, Elliot S. ; Cella, David. / Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure. In: Circulation. Heart failure. 2019 ; Vol. 12, No. 6. pp. e005751.
    @article{38699f93e7914c98943252c1a51a6b05,
    title = "Development and Initial Validation of the PROMIS{\circledR}-Plus-HF Profile Measure",
    abstract = "Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS{\circledR}-Plus-HF (Patient-Reported Outcomes Measurement Information System{\circledR}-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.",
    keywords = "decision-making, health status, heart failure, patient-reported outcome measures, quality of life",
    author = "Ahmad, {Faraz S.} and Kallen, {Michael A.} and Schifferdecker, {Karen E.} and Carluzzo, {Kathleen L.} and Yount, {Susan E.} and Jill Gelow and McCullough, {Peter A.} and Kimmel, {Stephen E.} and Fisher, {Elliot S.} and David Cella",
    year = "2019",
    month = "6",
    day = "1",
    doi = "10.1161/CIRCHEARTFAILURE.118.005751",
    language = "English (US)",
    volume = "12",
    pages = "e005751",
    journal = "Circulation: Heart Failure",
    issn = "1941-3297",
    publisher = "Lippincott Williams and Wilkins",
    number = "6",

    }

    TY - JOUR

    T1 - Development and Initial Validation of the PROMIS®-Plus-HF Profile Measure

    AU - Ahmad, Faraz S.

    AU - Kallen, Michael A.

    AU - Schifferdecker, Karen E.

    AU - Carluzzo, Kathleen L.

    AU - Yount, Susan E.

    AU - Gelow, Jill

    AU - McCullough, Peter A.

    AU - Kimmel, Stephen E.

    AU - Fisher, Elliot S.

    AU - Cella, David

    PY - 2019/6/1

    Y1 - 2019/6/1

    N2 - Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.

    AB - Background Bringing together generic and heart failure (HF)-specific items in a publicly available, patient-reported outcome measure may facilitate routine health status assessment for improving clinical care and shared decision-making, assessing quality of care, evaluating new interventions, and comparing groups with different conditions. Methods and Results We performed a mixed-methods study to develop and validate the PROMIS®-Plus-HF (Patient-Reported Outcomes Measurement Information System®-Plus-Heart Failure) profile measure-a HF-specific instrument based on the generic PROMIS. We conducted 8 focus groups with 61 patients with HF and phone interviews with 10 HF clinicians. The measure was developed via an iterative process of reviewing existing PROMIS items and developing and testing new HF items. In a 600-patient sample, we estimated reliability (internal consistency; test-retest, with n=100 participants). We conducted validity analyses using Pearson r and Spearman ρ correlations with Kansas City Cardiomyopathy Questionnaire subscores. In a longitudinal sample, we performed responsiveness testing (paired t tests) with 75 patients with HF receiving interventions with expected health status improvement. The PROMIS-Plus-HF measure comprises 86 items (64 existing; 22 new) across 18 domains. Internal consistency reliability (Cronbach α) coefficients ranged from 0.52 to 0.96, with α≥0.70 in 12 of 17 domains. Test-retest intraclass correlation coefficients were ≥0.90. Correlations with Kansas City Cardiomyopathy Questionnaire subscores supported expected convergent ( r/ρ>0.60) and divergent validity ( r/ρ<0.30). In the longitudinal sample, 10 of 18 domains had improved ( P<0.05) scores from baseline to follow-up. Conclusions The PROMIS-Plus-HF profile measure-a complete assessment of physical, mental, and social health-exhibited good psychometric characteristics and may facilitate patient-centered care and research. Subsets of domains and items can be used depending on the clinical or research purpose.

    KW - decision-making

    KW - health status

    KW - heart failure

    KW - patient-reported outcome measures

    KW - quality of life

    UR - http://www.scopus.com/inward/record.url?scp=85067453702&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=85067453702&partnerID=8YFLogxK

    U2 - 10.1161/CIRCHEARTFAILURE.118.005751

    DO - 10.1161/CIRCHEARTFAILURE.118.005751

    M3 - Article

    VL - 12

    SP - e005751

    JO - Circulation: Heart Failure

    JF - Circulation: Heart Failure

    SN - 1941-3297

    IS - 6

    ER -