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 M.
AU - McCullough, Peter A.
AU - Kimmel, Stephen E.
AU - Fisher, Elliot S.
AU - Cella, David
N1 - Publisher Copyright:
© 2019 American Heart Association, Inc.
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
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U2 - 10.1161/CIRCHEARTFAILURE.118.005751
DO - 10.1161/CIRCHEARTFAILURE.118.005751
M3 - Article
C2 - 31163985
AN - SCOPUS:85067453702
SN - 1941-3289
VL - 12
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
IS - 6
M1 - e005751
ER -