Abstract 4143004: A Stepwise Approach to Identifying and Assessing the Content Validity of Patient-Reported Outcome (PRO) Measures for Use with Adults with Acute Heart Failure

Different patient-reported outcome (PRO) measures have been used and validated in studies of patients with heart failure (HF), including disease-specific measures like the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ). However, there is limited research available regarding the content validity (i.e., comprehensiveness, relevance, and comprehensibility) of those measures specifically as it relates to patients with acute HF (AHF). This study used a stepwise approach to identify PRO measures used in AHF studies and evaluate their content validity through a landscape analysis, concept mapping, and cognitive debriefing (CD) interviews with US-based patients. A landscape analysis was performed to identify PRO measures used in AHF studies. To assess concept coverage, items in each PRO measure were mapped to concepts (i.e., signs/symptoms and impacts on daily life) from the AHF conceptual model developed by Moshkovich et al. (2020). PRO measures with the most comprehensive and/or appropriate concept coverage were further evaluated through CD interviews with US adults who had been hospitalized for AHF within the last six months. The landscape analysis resulted in the identification of 15 PRO measures for use in AHF; nine were deemed appropriate for concept mapping. Following mapping, four measures were selected for further research based on their comprehensive concept coverage (KCCQ, PROMIS®+HF-27), effectiveness at measuring health utility (EQ-5D-5L), and suitability for measuring shortness of breath (a dyspnea numeric rating scale [NRS]). The KCCQ, in particular, showed good concept coverage, addressing more than half (n=12) of the key concepts in the Moshkovich et al. (2020) model. Twenty adults with AHF, representing NYHA classes I (n=4), II (n=8), and III (n=8), a mean age of 64 years (range: 39-81), and an average of 110 days since hospitalization (range: 26-183), participated in CD interviews. Participants found each measure easy to understand and answer, with items relevant to their experience of AHF. Participants found the recall periods, ranging from 24-hours to 2-weeks, appropriate and easy to use. This study’s stepwise approach allowed for the systematic identification and evaluation of the content validity of four PRO measures—the KCCQ, dyspnea NRS, EQ-5D-5L, and PROMIS®+HF-27—for use with adults with AHF. This research fills a gap in the current published literature regarding measures appropriate for use with adults with AHF.