Content validation of the Angioedema Quality of Life Questionnaire (AE-QoL) in a population of adult and adolescent patients with hereditary angioedema (HAE)

Abstract Background There is a lack of clear evidence pointing to a fit-for-purpose instrument to measure impacts on health-related quality of life (HRQoL) in adult and adolescent patients with hereditary angioedema (HAE). The purpose of this study was to determine whether the Angioedema Quality of Life Questionnaire (AE-QoL) is content valid and appropriate for capturing the impact of HAE attacks on HRQoL in both adults and adolescents with HAE. Methodology This study used one-on-one, audio-recorded, cognitive debriefing interviews employing think-aloud and verbal probing approaches to evaluate the relevance, comprehensibility, and comprehensiveness of the AE-QoL in this patient population. All data were quality checked then coded and analyzed using inductive and deductive approaches. Results This study included 10 adolescents and 12 adults with HAE in the United States. Overall, participants had positive impressions of the AE-QoL, finding the length and recall period appropriate, and the response options clear and easy to understand. Some reported minor concerns with the instructions, but none that prevented them from completing the instrument. Participants found the instrument relevant to their experiences with HAE, noting that items that were not personally relevant were still important to ask. Overall, participants found the AE-QoL comprehensible and comprehensive, although some participants, primarily adolescents, reported being unfamiliar with the word “leisure,” making it difficult to answer the item asking about impact of attacks on “leisure time.” Adolescents also reported that questions about school-related impacts were missing and would be important to ask about specifically. Conclusions This study presents evidence that supports the content validity of the AE-QoL in adult and adolescent patients with HAE. While revisions could be considered prior to using the instrument with samples of adolescent patients with HAE, in general, adolescents and adults with HAE found the measure relevant, comprehensive, and comprehensible.