European Journal of Heart Failure | 2021
Current challenges for using the Kansas City Cardiomyopathy Questionnaire to obtain a standardized patient‐reported health status outcome
Abstract
In April 2020, the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved the use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) as a primary endpoint in drug trials for patients with heart failure (HF).1 Noted in the FDA approval is a recommendation to establish thresholds for clinically meaningful within-patient change on KCCQ subscales.1 This approval represents an important step forward for using a patient-reported outcome measure to evaluate clinical services. Given the importance of this development, it is essential to discuss three critical challenges that are evident from recent HF trials (Table 1),2–8 and that need to be resolved as clinicians or patients attempt to use the KCCQ to obtain a standardized evaluation of clinically meaningful change in patient health status.