Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure
Section snippets
Methods
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
Results
HF-ACTION randomly assigned 2331 patients, of whom 2330 (99.9%) completed the KCCQ and 2274 (98%) completed the VAS. Participant characteristics are shown in Table I . Table II shows the distributions of patient-reported and clinical outcome measures. Mean peak Vo2 was 15 mL/kg per minute, mean 6-minute walk distance was 365 m, and nearly two thirds of the patients were NYHA class II. The mean KCCQ score was 66, and the mean VAS score was 66.
Discussion
We used baseline data from HF-ACTION to characterize relationships among important patient-reported health-related quality-of-life and clinical measures and to examine whether the relationships differed among subgroups. As expected, the patient-reported outcome measures (ie, VAS and KCCQ) were moderately correlated with each other, and the heart failure–specific KCCQ had stronger correlations with exercise capacity than the more general VAS. The KCCQ physical limitation subscale, which was
Conclusions
Differences in patient-reported outcome measures (including the KCCQ, its subscales, and the VAS) are associated with differences in clinical measures (including peak Vo2, 6-minute walk distance, and NYHA class). The VAS, a general patient-reported measure, had smaller correlations with exercise capacity than the disease-specific KCCQ. With a few exceptions, these relationships are consistent across different groups of patients with heart failure. While the small size of the correlations
Disclosures
Dr Ellis reports receiving grants from GE Medical. Dr Spertus owns the copyright to the Kansas City Cardiomyopathy Questionnaire. Dr Whellan reports receiving grants or funding from GE Medical and the National Institutes of Health. Dr Piña reports receiving grants or funding from the National Institutes of Health; receiving personal income for consulting from the Food and Drug Administration; and receiving honoraria from AstraZeneca, Innovia, Merck, Novartis, Sanofi-Aventis, and Solvay. Dr
Acknowledgements
We thank Susan Kay Roll, RN, University of Cincinnati, for her role as an author on the abstract and Damon M. Seils, MA, Duke University, for assistance with manuscript preparation. Ms Roll and Mr Seils did not receive compensation for their assistance apart from their employment at institutions where the study was conducted.
References (24)
- et al.
Preferences for quality of life or survival expressed by patients with heart failure
J Heart Lung Transplant
(2001) - et al.
Patient-reported outcomes to support medical product labeling claims: FDA perspective
Value Health
(2007) - et al.
Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale
Am Heart J
(2007) - et al.
Comparison of losartan and captopril on heart failure-related outcomes and symptoms from the losartan heart failure survival study (ELITE II)
Am Heart J
(2005) - et al.
Monitoring clinical changes in patients with heart failure: a comparison of methods
Am Heart J
(2005) - et al.
Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure
J Am Coll Cardiol
(2000) Exercise and the failing heart
Cardiol Clin
(1987)- et al.
Association of functional and health status measures in heart failure
J Card Fail
(2006) - et al.
Age, functional capacity, and health-related quality of life in patients with heart failure
J Card Fail
(2004) - et al.
Health status identifies heart failure outpatients at risk for hospitalization or death
J Am Coll Cardiol
(2006)
The relationship between B-type natriuretic peptide and health status in patients with heart failure
J Card Fail
Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission
N Engl J Med
Cited by (53)
Feasibility of Assessing Adolescent and Young Adult Heart Transplant Recipient Mental Health and Resilience Using Patient-Reported Outcome Measures
2022, Journal of the Academy of Consultation-Liaison PsychiatryImpact of Tafamidis on Health-Related Quality of Life in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial)
2021, American Journal of CardiologyCitation Excerpt :In this context, the reduction in the decline in KCCQ domain scores with tafamidis (compared with placebo) in ATTR-ACT, which ranged from 12 to 16 points, represents a large, clinically meaningful change in patients’ outcomes. Similarly, the 9-point difference in EQ VAS between tafamidis and placebo at month 30 is notably greater than the 3-point difference considered clinically meaningful in patients with heart failure.19 A particularly striking aspect of these data was the observation that a large proportion of patients reported that their QoL (as assessed by the KCCQ-OS and the global PGA) had improved with tafamidis treatment.
Rationale and design of the Study of Dietary Intervention Under 100 MMOL in Heart Failure (SODIUM-HF)
2018, American Heart JournalPalliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial
2017, Journal of the American College of CardiologyCitation Excerpt :The overall summary score is derived from the physical function, symptom, social function, and quality-of-life domains. A 5-point change in the KCCQ overall summary score is considered a clinically meaningful difference (17). The FACIT–Pal is a 46-item measure of self-reported generic quality of life (27 general; 19 palliative care) that assesses quality of life in several domains, including physical well-being, social/family well-being, emotional well-being, functional well-being, and palliative care with a range of 0 to 184.
ClinicalTrials.gov Identifier: NCT00047437.
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.