In an effort to bridge the gap in patient-reported outcome measures (PROMs) for epilepsy, researchers have developed the Seizure-Related Impact Assessment Scale (SERIAS). This innovative tool aims to assess the balance between seizures and the adverse effects of treatments on patients’ lives, offering both qualitative and quantitative insights into epilepsy-related disabilities. The study’s results are expected to pave the way for more comprehensive evaluations in clinical trials and everyday practice.
Methodology and Recruitment
The study recruits adults diagnosed with epilepsy from two prominent Australian Epilepsy Centres, excluding those with functional seizures or who cannot complete English-language validated instruments. Upon providing informed consent, participants answer questionnaires at three intervals: baseline, three months, and six months. The SERIAS tool comprises five questions evaluating the monthly impact of seizures and treatment side effects on work, home, school, family, social, and non-work activities. Additionally, a visual analogue scale gauges epilepsy-related disability.
Comprehensive Psychometric Analysis
To ensure robust validation, SERIAS is administered alongside seven internationally recognized instruments that measure treatment-related adverse effects, mood disorders, and quality of life. The target sample size is 100 participants, with over half expected to complete all questionnaires at each time point. The analysis will examine convergent validity through bivariate correlations with relevant measures, while reliability will be assessed using Cronbach’s alpha, McDonald’s omega, and test-retest correlation coefficients.
Inferences for Clinical Application
– SERIAS offers a comprehensive assessment by integrating both qualitative and quantitative measures of epilepsy-related disability.
– This tool can help clinicians better understand the trade-offs between seizure control and treatment side effects, potentially leading to more personalized treatment plans.
– Including SERIAS in clinical trials may provide more detailed patient outcomes, enhancing the evaluation of new epilepsy treatments.
Ethical approval for this multisite study was granted by the Alfred Health Ethics Committee (HREC 17/23). The findings are slated for publication in peer-reviewed journals and will be presented at scientific conferences to ensure wide dissemination within the medical community.
Original Article: BMJ Open. 2024 Jun 11;14(6):e083929. doi: 10.1136/bmjopen-2024-083929.
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