162 Validation of a patient-reported outcome measure in adults with morphea

Abstract

Morphea is an inflammatory skin disease resulting in sclerosis of underlying tissues which causes functional limitations and cosmetic sequalae that negatively impact quality of life. Previous health-related quality of life (HRQoL) and patient reported outcome (PRO) studies have focused on children in which a validated measure, the Localized Scleroderma Quality of Life Instrument (LoSQI), has been developed. No validated PRO measure exists for adults with morphea. We aimed to validate the first adult morphea specific PRO using qualitative and quantitative methods. We hypothesize that the adult LoSQI will have support for validity in capturing patient-reported quality of life. Qualitative measures included focus groups to identify key domains affected in adults with morphea and cognitive interviews to validate items selected for the adult LoSQI. Quantitative analysis from field testing are forthcoming. Focus groups revealed items within content domains from the pediatric LoSQI unique to adults including worry about disease prognosis, impact on family planning, and effects on intimate relationships. Adults emphasized the impact of stiffness and limited mobility, rather than itch emphasized by pediatric patients. Feedback from cognitive interviews resulted in the removal of items not resonant with adults, including the feeling of embarrassment from morphea treatment as well as minor changes to instructions. We conclude that adults with morphea experience unique HRQoL impact compared to children and the items selected for the adult LoSQI accurately capture the adult patient’s experience with morphea. The adult LoSQI represents the first morphea-specific PRO measure and an important development for the improvement of clinical trials and improved patient outcomes.