Abstracts

Rationale: Health-related quality of life is an important patient-reported outcome to understand the impact of disease and its treatments on children with chronic conditions. In pediatric epilepsy, several epilepsy-specific measures exist; however, they are lengthy, not clinically feasible, not developed in a heterogeneous sample, and lack developmentally-appropriate parallel parent and child forms. The aim of the present study was to develop the PedsQL™-Epilepsy Module in youth with epilepsy. Methods: Participants were involved in one of two phases of measurement development. The first phase involved participation in focus groups to develop item content for the Epilepsy Module (n=11; M_childage=9.7±4.5; 55% male; 36% localization-related epilepsy). Once content was identified, binning and winnowing was used to select/modify items from a comprehensive item bank drawn from previously published instruments. Novel items were created in the absence of a fitting choice. The second phase involved individual cognitive interviews of a draft version of the module (n=14; M_childage=8.9±4.9; 71% female; 43% localization-related epilepsy). Youth and caregivers completed a demographic questionnaire and PedsQL™-Epilepsy Module. Medical chart reviews were also conducted to obtain seizure and treatment related data. Results: Focus group data revealed content in several different thematic areas, including Physical Restrictions, Seizure Management, Mood/Behavior, Social Functioning, Sleep/Fatigue, Side Effects, and Cognitive/Executive Functioning. Response options were based on the PedsQL™-Generic Core Scales (e.g., Never, Almost Never, Sometimes, Often, Almost Always).  Next, expert feedback (n=11) was elicited to modify/add/remove items. Cognitive interviewing data provided further modifications to the instrument, including wording changes, clarification, deletion of items, and adapting items to be more developmentally appropriate. Conclusions: Development of a new health-related quality of life measure is an iterative process that requires patient/parent input and expert feedback through several phases of development to ensure that the final instrument captures meaningful and relevant information from both personal and professional perspectives. Initial data is quite promising and will result in a final PedsQL™-Epilepsy Module that will be tested in the last phase of development, a national validation study.  The new validated PedsQL™-Epilepsy Module can likely be used for clinical and research purposes in the future. This instrument will help us better understand the impact of epilepsy and its treatment on child quality of life and develop interventions to optimize functioning.