Patient-reported outcome measures detect clinically meaningful changes in chronic HF
Compared with NYHA class, patient-reported outcome measures were more likely to detect clinically meaningful changes in patients with chronic HF, researchers reported.
“The clinician-interpreted and reported NYHA class has been utilized for decades to quantitate heart failure patient functional status and outcomes in clinical trials and clinical practice. However, the NYHA class does have some notable limitations,” Gregg Fonarow, MD, interim chief in the UCLA division of cardiology, director of the Ahmanson-UCLA Cardiomyopathy Center and co-director at the UCLA Preventive Cardiology Program at the University of California, Los Angeles, told Healio. “In contrast, the use of data directly collected from patients, so-called patient-reported outcome measures, have been increasingly utilized in clinical trials.”
The cohort study, published in JAMA Cardiology, included 2,872 outpatients (median age, 68 years; 30% women) with chronic HF with reduced ejection fraction across 145 U.S. practices from December 2015 to October 2017 who were enrolled in the CHAMP-HF registry. All patients had complete data on NYHA class and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at baseline and at 12 months.
The primary outcome was all-cause mortality, HF hospitalization and mortality/HF hospitalization at 12 months.
Differences in improvement
In the cohort, 10.9% of patients were NYHA class I, 59.5% of patients were class II, 28% of patients were class III and 1.6% of patients were class IV. In contrast, for KCCQ score, 39.4% of patients had the best health status, scoring 75 to 100; 33.7% of patients scored 50 to 74; 21.3% of patients scored 25 to 49; and 5.6% of patients had the worst health status, scoring 0 to 24.
According to the researchers, 34.9% of patients experienced a change in their NYHA class, with 20.9% demonstrating improvement and 14% demonstrating worsening. In addition, 48.3% of patients experienced 5 or more points of improvement for KCCQ score and 26.8% experienced 5 or more points of worsening for KCCQ score.
For NYHA class, the most common trajectory was no change (65.1% of patients), whereas the most common trajectory for KCCQ score was an improvement of at least 10 points (36.5% of patients).
NYHA class improvement was not associated with clinical outcomes, but after adjustments, KCCQ improvement of 5 or more points was independently associated with reduced risk for mortality (adjusted HR = 0.59; 95% CI, 0.44-0.8; P < .001) and mortality/HF hospitalization (aHR = 0.73; 95% CI, 0.59-0.89; P = .002).
According to Fonarow, further studies are required focusing on how to best achieve patient-reported outcome measures in all clinical care settings.
“While we had hypothesized that the patient-reported changes in KCCQ overall score would be more strongly associated with clinical event outcomes, it was surprising to see that NYHA functional class changes had no association among these patients followed in routine clinical practice,” Fonarow said. “The clinical practice implications of this study are that patient-reported outcome measures should be collected, reported and acted on in routine clinical practice in heart failure.”
Reconsider NYHA class use
In an accompanying editorial, Paul A. Heidenreich, MD, MS, professor in the department of medicine at Stanford University School of Medicine and the VA Palo Alto Health Care System, California, noted that this study builds on other studies that suggested patient-reported outcomes were superior to clinician-reported outcomes.
“The implication of the study by Greene et al is that the NYHA class should be reconsidered if it does not match the patient-reported data,” Heidenreich wrote. “When used together, prognosis assessment and treatment decisions will be improved.”
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Gregg Fonarow, MD, can be reached at gfonarow@mednet.ucla.edu.
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