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 - Piña, Ileana L.
AU - Fine, Lawrence J.
AU - Schulman, Kevin A.
AU - Weinfurt, Kevin P.
N1 - Funding Information:
This research was supported by National Institutes of Health grants: 5U01HL063747, 5U01HL068973, 5U01HL066501, 5U01HL066482, 5U01HL064250, 5U01HL066494, 5U01HL064257, 5U01HL066497, 5U01HL068980, 5U01HL064265, 5U01HL066491, 5U01HL064264, 5U01HL066461, R37AG18915, and P60AG10484.
Funding Information:
HF-ACTION was a multicenter, randomized controlled trial designed to test the long-term safety and efficacy of aerobic exercise training versus usual care in patients with left ventricular dysfunction and New York Heart Association (NYHA) class II to IV heart failure. 6 Baseline assessments included health-related quality of life and health status measures and prerandomization cardiopulmonary exercise testing to determine aerobic capacity. Enrollment criteria included left ventricular ejection fraction of 35% or less, NYHA class II to IV heart failure, and ability and willingness to undergo exercise training. Patients were excluded if they were unable to exercise, were already exercising regularly, or had experienced a cardiovascular event in the preceding 6 weeks. Additional details have been described previously. 6 The relevant institutional review boards, research ethics boards, and ethics committees of the participating centers and the coordinating center approved the protocol. This work was supported by grants from the National Heart, Lung, and Blood Institute. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents.
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.
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U2 - 10.1016/j.ahj.2009.07.010
DO - 10.1016/j.ahj.2009.07.010
M3 - Article
C2 - 19782791
AN - SCOPUS:70349577645
SN - 0002-8703
VL - 158
SP - S64-S71
JO - American Heart Journal
JF - American Heart Journal
IS - 4 SUPPL.
ER -
