韓国における小児てんかんの臨床共通データ要素の開発と臨床的有用性の検討：実用的な標準化に向けて

This study aimed to develop and evaluate a set of common data elements (CDEs) for pediatric epilepsy tailored to the time-limited clinical setting in Korea, and to examine their feasibility and clinical utility through real-world implementation.

A multicenter development process was undertaken, beginning with a review of existing clinical records, international CDE frameworks, and elements for pediatric epilepsy research. Initial and follow-up CDE templates were drafted through expert discussions across nine tertiary hospitals and retrospectively tested at two academic centers. Revisions were made to enhance feasibility. The finalized CDEs were applied prospectively to all pediatric epilepsy patients at Seoul National University Bundang Hospital in 2024 for feasibility assessments. Their clinical utility was assessed by profiling baseline characteristics, comorbidities, and seizure trajectories, and by comparing patient subgroups.

Template development focused on capturing comprehensive yet feasible data. The initial form captured key baseline variables, while the follow-up form allowed practical longitudinal tracking of seizures, treatments, comorbidities, and outcomes using simplified categorical scales. Applied to 1,096 patients, the templates allowed efficient profiling of the cohort: 33% had developmental delay, 15.4% had febrile seizures, and 30% had drug-resistant epilepsy. Subgroup comparisons revealed distinct clinical patterns, including favorable courses in self-limiting syndromes and more complex profiles in those presenting with status epilepticus. Longitudinal tracking enabled estimation of seizure-active periods, with a median duration of 8.2-9.5 years in SeLECTS patients.

This study shows that pediatric epilepsy CDEs are feasible in time-limited clinics and enable high-quality data collection, improving care and supporting research and collaboration.