ArticleBMJ open2026
Development and psychometric validation of a screening tool of psychosocial risk factors in patients with epilepsy: the ARisE study protocol.
Article in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionEpilepsy is one of the most common neurological chronic diseases worldwide. While medications can control seizures, about one-third of people with epilepsy have drug-resistant epilepsy and continue to experience seizures. Psychosocial burdens are a major concern, as they are linked to seizure worsening and vice versa. Early identification of risk factors for psychosocial burdens could help prevent such deterioration. However, a comprehensive and time-efficient screening tool to detect these risks is lacking. Therefore, this study aims to develop such a screening tool and to test its psychometric properties. METHODS AND ANALYSIS: The three-phase, mixed-methods study runs from January 2025 to December 2027 at the University Medical Center Hamburg-Eppendorf in cooperation with the Epilepsy Center Hamburg. Phase 1 includes identification of psychosocial risk factors and existing measures by (1) conducting semi-structured interviews with people with epilepsy about illness-related influence regarding International Classification of Functioning, Disability and Health (ICF) components (eg, body function and structure, activity and participation, environmental factors) and (2) reviewing national and international epilepsy guidelines for suitable screening tools. Findings will (3) be discussed with an expert advisory board of healthcare professionals and patients. In phase 2, we will (4) develop the screening tool based on identified measures and newly developed items covering all ICF components. The preliminary item pool will be discussed and rated by the expert advisory board. To ensure comprehensibility, (5) the new tool will be tested in at least two rounds of cognitive interviews with people with epilepsy and adjusted accordingly. Phase 3 will include psychometric testing of the new screening tool (eg, item characteristics, construct validity, internal validity) via a cross-sectional online survey. ETHICS AND DISSEMINATION: The study has been approved by the Psychological Ethics Committee of the Center for Psychosocial Medicine at the University Medical Center Hamburg-Eppendorf, Germany (LPEK-0888, LPEK-1091). Study results will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: DRKS00036047).
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