Background: Heart failure (HF) reduces patient quality of life more than other chronic illnesses. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a patient-reported outcome (PRO) instrument that is completed directly by the patient and is commonly used to address the patient's perspective on HF in clinical trials. The FDA Guidance on using PROs in clinical programs emphasizes the need to use qualitative patient interviews to ensure that a PRO instrument addresses all relevant concepts in a clinical area and that it is easily understood by patients. Objectives: The goal of this project was to assess patient insights regarding HF symptoms, physical limitations, and other impacts and to compare these to the content of the KCCQ, and to see how well patients understand the KCCQ items. Methods: Participants were 28 stable Class II - IV NYHA heart failure patients ages 42 to 90. Fifteen patients were interviewed to elicit patient insights and 13 patients were interviewed to assess patient comprehension of the KCCQ items. Results: The most commonly endorsed HF symptoms and impacts are listed in the table . These concepts are assessed in the KCCQ. The majority of the KCCQ items were rated as highly or somewhat relevant by 66% or more of the patients interviewed; items assessing ability to dress and shower/bathe, need to sleep sitting up, and limitations in visiting friends or family were rated as relevant by less than 50% of patients. Patients generally understood the instructions, items, and response options of the KCCQ with no problems or complications. Conclusions: Qualitative data from this study support the significance of the concepts measured by the KCCQ, such as HF symptoms and physical limitations. Thus, the KCCQ and other measures of these concepts may be useful as endpoints in development programs of novel drugs that may potentially have an impact on the burden of illness of HF in terms of symptoms and physical limitations. Category Examples/patient descriptions Percent of patients endorsing symptom or impact Symptoms Breathing problems Shortness of breath, wheezing 93% Tiredness Drowsy, exhausted 93% Swelling Legs when up and going all day 67% Impacts Physical mobility Get light headed when I bend down 93% Physical limitations Steer away from anything strenuous 93% Emotional effects Anxiety about shortness of breath 87%
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