Validation of the Seizure-Related Impact Assessment Scale (SERIAS): a study protocol.

Introduction: This study aims to validate the Seizure-Related Impact Assessment Scale (SERIAS). This novel patient-reported outcome measure (PROM) compares the 'trade-off' between seizures and treatment-related adverse effects, and measures epilepsy disability qualitatively and quantitively. It fills an important gap in PROMs for epilepsy clinical trials and practice.
Methods and Analysis: Adults with epileptologist-confirmed epilepsy from two Australian Epilepsy Centres are being recruited. People with functional seizures, or who are unable to self-complete English-language validated instruments are excluded. Participants providing informed consent are invited to complete questionnaires at baseline, 3 and 6 months later. SERIAS includes five questions that ask about the number of days per month that seizures or treatment-related adverse effects partially or fully impact work/home/school and family/social/non-work activities, as well as a visual analogue scale regarding epilepsy-related disability. SERIAS is completed alongside seven internationally validated instruments measuring treatment-related adverse effects, mood disorders and quality of life. Target recruitment is n=100, ensuring>50 people complete all questionnaires at all timepoints. Comprehensive psychometric analysis will be performed. Convergent validity will be investigated using bivariate correlations with relevant measures. Reliability will be investigated using Cronbach's alpha, McDonald's omega and test-retest correlation coefficients. SERIAS will be a novel PROM for epilepsy clinical trials and practice.
Ethics and Dissemination: Multisite ethics approval was granted by the Alfred Health Ethics Committee (HREC 17/23). Results of this study will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
Trial Registration Number: ACTRN12623000599673.
Competing Interests: Competing interests: EF reports salary support from LivaNova USA for the SERIAS validation study. EF reports grants from Brain Foundation Australia, Royal Australasian College of Physicians Fellows Research Establishment Fellowship, Monash University Early Career Postdoctoral Fellowship, Monash Partners STAR Clinician Fellowship, Sylvia and Charles Viertel Charitable Foundation Clinical Investigator Award, outside the submitted work. AC reports salary support from LivaNova USA for the SERIAS validation study. CE reports no disclosures relating to this study. J-PN reports no disclosures relating to this study. GR reports no disclosures relating to this study. TW-B reports no disclosures relating to this study. TJOB reports NHMRC Programme Grant (#APP1091593), grants from UCB Pharma, grants from Eisai Pharma, grants and personal fees from Zynerba Pharmaceuticals, grants from Biogen, outside the submitted work. PK reports no disclosures relating to this study. His institution has received research grants from Eisai, LivaNova and UCB Pharma outside the submitted work; and he has received consultancy/speaker fees from Angelini, Eisai, LivaNova, SK Life and UCB Pharma outside the submitted work. CM reports salary support from LivaNova USA for the SERIAS validation study. He has also received conference travel support and/or speaker fees from Merck, Novartis and Biogen. He has received research support from the National Health and Medical Research Council, Multiple Sclerosis Research Australia, The University of Melbourne, The Royal Melbourne Hospital Neuroscience Foundation, and Dementia Australia. JAF consults for LivaNova, and is President of the Epilepsy Study Consortium that owns the copyright to SERIAS.
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