Authors :
Presenting Author: Emma Foster, PhD FRACP – Monash University
Alison Conquest, BBiomedSc (Hons.) – Monash University
Chris Ewart, - – Monash University
John-Paul Nicolo, PhD FRACP – The Royal Melbourne Hospital
Genevieve Rayner, PhD, MPsych(ClinNeuro) – The University of Melbourne
Toby Winton-Brown, PhD FRANZCP – Alfred Health
Terence J. O'Brien, MBBS, MD – Alfred Health
Patrick Kwan, MD PhD – Monash University
Charles B. Malpas, PhD, MPsych(ClinNeuro) – Royal Melbourne Hospital
Jacqueline French, MD – New York University Comprehensive Epilepsy Center
Rationale:
Seizures drive much of the burden associated with epilepsy. Appropriately, the primary goal of epilepsy treatment is seizure freedom. Two-thirds of people living with epilepsy may become seizure free with antiseizure medication. The remaining one-third may achieve a substantial reduction in their seizure burden through resective surgery, neuromodulation and dietary therapies. However, treatment frequently exerts serious, often dose limiting, adverse effects, further contributing to the burden of epilepsy.
Self-reported burden of disease is an important outcome measure in clinical research and practice. These data may be collected through patient reported outcome measures (PROMs) which are brief questionnaires completed by patients. There is a clear need for a robust epilepsy-specific PROM that collects both seizure- and treatment-related burden. An ideal epilepsy PROM would provide a sense of ‘trade off’ between seizure- and treatment-burden at that particular point in time. This would allow clinicians to refine treatment regimens at each appointment. Additionally, the PROM would provide reliable data to track progress over time and across treatment regimens to indicate if patients’ disease burden is improving.
In this prospective study, we aimed to create and validate the Seizure-Related Impact Assessment Scale (SERIAS, figure 1) to address this critical gap in epilepsy PROMs. Methods:
Adult epilepsy patients attending Alfred Health’s Comprehensive Epilepsy Centre (Melbourne, Australia) completed SERIAS at baseline, 3- and 6-month timepoints, along with validated instruments: QOLIE-31 (quality of life), SSS-8 (somatic symptoms), NDDI-E (depression), GAD-7 (anxiety) and WSAS (seizure- and treatment-related functional impairment). A subgroup of patients also completed SERIAS twice within two weeks to investigate test-retest reliability. This study has Alfred Health IRB approval 17/23.Results:
99 patients (n=67 females) completed baseline SERIAS. Mean age was 42 years (SD=16, range=18-77). Most patients reported > 0 days of disability (62%, median SERIAS score=3, IQR=0–24.5). Based on quartiles, 37 (37%) patients reported no disability, 14 (14%) low disability, 23 (23%) moderate disability, and 25 (25%) high disability. Greater disability was negatively correlated with QOLIE-31 total score (r =-0.48, p< 0.001), and positively correlated with scores on NDDI-E (r=0.32, p< 0.001), SSS-8 (r=0.39, p< 0.001), WSAS for seizures (r=0.59, p< 0.001), and WSAS for treatment (r=0.58, p< 0.001). Psychometric reliability for SERIAS was high (ɑ=0.87). Test-retest reliability was high (n=38 patients, r=0.83, p< 0.001).