Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure

Kathryn E. Flynn, Li Lin, Stephen J. Ellis, Stuart D. Russell, John A. Spertus, David J. Whellan, Ileana L. Piña, Lawrence J. Fine, Kevin A. Schulman, Kevin P. Weinfurt

Research output: Contribution to journalArticle

Abstract

Background: Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure. Methods: Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak Vo2, 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions. Results: The KCCQ was correlated with peak Vo2 (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak Vo2 (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo2 (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II. Conclusions: These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

Original languageEnglish (US)
Pages (from-to)S64-S71
JournalAmerican heart journal
Volume158
Issue number4 SUPPL.
DOIs
StatePublished - Oct 1 2009

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Flynn, K. E., Lin, L., Ellis, S. J., Russell, S. D., Spertus, J. A., Whellan, D. J., Piña, I. L., Fine, L. J., Schulman, K. A., & Weinfurt, K. P. (2009). Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. American heart journal, 158(4 SUPPL.), S64-S71. https://doi.org/10.1016/j.ahj.2009.07.010