Background: : Qualitative research can inform the development of asthma patient-reported outcome (PRO) measures and user-friendly technologies through defining measurement constructs, identifying potential limitations in measurement and sources of response error, and evaluating usability.
Objective: : To inform the development of a comprehensive asthma PRO assessment with input from patients and clinical experts.
Methods: : Self-reported adult asthma patients recruited from a 3000-member New England area research panel participated in either one of three focus groups (n = 21) or individual cognitive item debriefing interviews (n = 20) to discuss how asthma impacts their health-related quality of life (HR-QOL), and provide feedback on a preliminary set of asthma impact survey items and prototype patient reports. Focus groups and cognitive interviews were conducted using traditional research principles (e.g. semi-structured interview guide, probing, and think aloud techniques). An expert advisory panel (n = 12) including asthma clinical specialists and measurement professionals was convened to review results from the focus group and cognitive interview studies, and make recommendations for final survey and report development.
Results: : Domains of health impacted by asthma included physical (recreation, play, competitive sports, and exercise), social (activities, family relationships), emotional (anger, upset, frustration, anxiety, worry), sleep, role (recreational/leisure activities, work), and sexual functioning. Most items in the impact survey were easily understood, covered important content, and included relevant response options. Items with contradictory examples and multiple concepts were difficult to comprehend. Suggestions were made to expand survey content by including additional items on physical and sexual functioning, sleep, self-consciousness, stigma, and finances. Reports were considered useful and participants saw value in sharing the results with their doctors. Graphic presentation of scores was not always understood; participants preferred tabular presentation of score levels with associated interpretative text. Display of inverse scores for different measures (higher scores equaling better health on one scale and worse health on another) shown on a single page was confusing. The score history section of the report was seen as helpful for monitoring progress over time, particularly for those recently diagnosed with asthma.Expert panelists agreed that displaying inverse scores in a single summary report could be confusing to patients and providers. They also stressed the importance of comprehensive interpretation guidelines for patients, with an emphasis on what they should do next based on scores. Panelists made recommendations for provider and aggregate-level reports (e.g. 'red flags' to indicate significant score changes or cut points of significance; identification of subgroups that have scored poorly or recently got worse).
Conclusion: : Incorporating input from patients, clinicians, and measurement experts in the early stages of product development should improve the construct validity of this PRO measure and enhance its practical application in healthcare.