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

Full 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 VO(2), 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 VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (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 information

Author/s: Flynn, Kathryn E (KE); Lin, Li (L); Ellis, Stephen J (SJ); Russell, Stuart D (SD); Spertus, John A (JA); Whellan, David J (DJ); Piña, Ileana L (IL); Fine, Lawrence J (LJ); Schulman, Kevin A (KA); Weinfurt, Kevin P (KP); HF-ACTION Investigators;

Affiliation: Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA. kathryn.flynn(-atsign-)duke.edu

Grants: 5U01HL063747 (Agency:NHLBI NIH HHS) ; 5U01HL064250 (Agency:NHLBI NIH HHS) ; 5U01HL064257 (Agency:NHLBI NIH HHS) ; 5U01HL064264 (Agency:NHLBI NIH HHS) ; 5U01HL064265 (Agency:NHLBI NIH HHS) ; 5U01HL066461 (Agency:NHLBI NIH HHS) ; 5U01HL066482 (Agency:NHLBI NIH HHS) ; 5U01HL066491 (Agency:NHLBI NIH HHS) ; 5U01HL066494, (Agency:NHLBI NIH HHS) ; 5U01HL066497 (Agency:NHLBI NIH HHS) ; 5U01HL066501 (Agency:NHLBI NIH HHS) ; 5U01HL068973 (Agency:NHLBI NIH HHS) ; 5U01HL068980 (Agency:NHLBI NIH HHS) ; P60AG10484 (Agency:NIA NIH HHS) ; R37AG18915 (Agency:NIA NIH HHS)

Journal and publication information

Publication Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural

Journal: American heart journal (Am Heart J), published in United States. (Language: eng)

Reference: 2009-Oct; vol 158 (issue 4 Suppl) : pp S64-71

Dates: Created 2009/09/28; Completed 2009/10/29;

PMID: 19782791, status: MEDLINE (last retrieval date: 10/29/2009, IMS Date: )

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