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. Pina, Lawrence J. Fine, Kevin A. Schulman, Kevin P. Weinfurt

Research output: Contribution to journalArticle

33 Citations (Scopus)

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)
JournalAmerican Heart Journal
Volume158
Issue number4 SUPPL.
DOIs
StatePublished - Oct 2009
Externally publishedYes

Fingerprint

Managed Care Programs
Health Policy
Cardiomyopathies
Visual Analog Scale
Outpatients
Heart Failure
Delivery of Health Care
Surveys and Questionnaires
Patient Reported Outcome Measures
Linear Models
Quality of Life

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Outcomes, health policy, and managed care : Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. / Flynn, Kathryn E.; Lin, Li; Ellis, Stephen J.; Russell, Stuart D.; Spertus, John A.; Whellan, David J.; Pina, Ileana L.; Fine, Lawrence J.; Schulman, Kevin A.; Weinfurt, Kevin P.

In: American Heart Journal, Vol. 158, No. 4 SUPPL., 10.2009.

Research output: Contribution to journalArticle

Flynn, KE, Lin, L, Ellis, SJ, Russell, SD, Spertus, JA, Whellan, DJ, Pina, IL, Fine, LJ, Schulman, KA & Weinfurt, KP 2009, 'Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure', American Heart Journal, vol. 158, no. 4 SUPPL.. https://doi.org/10.1016/j.ahj.2009.07.010
Flynn, Kathryn E. ; Lin, Li ; Ellis, Stephen J. ; Russell, Stuart D. ; Spertus, John A. ; Whellan, David J. ; Pina, Ileana L. ; Fine, Lawrence J. ; Schulman, Kevin A. ; Weinfurt, Kevin P. / Outcomes, health policy, and managed care : Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. In: American Heart Journal. 2009 ; Vol. 158, No. 4 SUPPL.
@article{bb0053a19f6a49718416c273e6395b4a,
title = "Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure",
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.",
author = "Flynn, {Kathryn E.} and Li Lin and Ellis, {Stephen J.} and Russell, {Stuart D.} and Spertus, {John A.} and Whellan, {David J.} and Pina, {Ileana L.} and Fine, {Lawrence J.} and Schulman, {Kevin A.} and Weinfurt, {Kevin P.}",
year = "2009",
month = "10",
doi = "10.1016/j.ahj.2009.07.010",
language = "English (US)",
volume = "158",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "4 SUPPL.",

}

TY - JOUR

T1 - Outcomes, health policy, and managed care

T2 - Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure

AU - Flynn, Kathryn E.

AU - Lin, Li

AU - Ellis, Stephen J.

AU - Russell, Stuart D.

AU - Spertus, John A.

AU - Whellan, David J.

AU - Pina, Ileana L.

AU - Fine, Lawrence J.

AU - Schulman, Kevin A.

AU - Weinfurt, Kevin P.

PY - 2009/10

Y1 - 2009/10

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=70349577645&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70349577645&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2009.07.010

DO - 10.1016/j.ahj.2009.07.010

M3 - Article

C2 - 19782791

AN - SCOPUS:70349577645

VL - 158

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 4 SUPPL.

ER -