Analysing patient-generated data to understand behaviours and characteristics of women with epilepsy of childbearing years: A prospective cohort study

Background Women with epilepsy (WWE) are vulnerable in pregnancy, with increased risks to mother and baby including teratogenic risks, especially from valproate. The free EpSMon mobile-phone app allows self-monitoring to afford patient-centred feedback on seizure related risks, such as sudden death in epilepsy (SUDEP) to its users. We sought to generate insights into various seizure related risks and its treatments in WWE of childbearing age (16 to 60 years ) using EpSMon. Methods The study utilizes a prospective real-world cohort of 5.5 years. Patient reported data on demographics, medication taken, diagnoses, seizure types and recognised biological, psychological, and social factors of seizure related harm were extracted. Data was stratified according to frequent and infrequent users and those scoring lower and higher risk scores. Multivariate logistic regression and different statistical tests were conducted. Findings Data from 2158 WWE of childbearing age encompassing 4016 self-assessments were analysed. Overall risk awareness was 25.3% for pregnancy and 54.1% for SUDEP. Frequent users were more aware of pregnancy risks but not of SUDEP. Repeated EpSMon use increased SUDEP awareness but not pregnancy risks. Valproate was used by 11% of WWE, ranging from 6.5% of younger to 31.5% of older women. Conclusions The awareness to risks to pregnancy, SUDEP and valproate is low. Valproate is being used by a significant minority. It is imperative risk communication continues for WWE based on their individual situation and need. This is unlikely to be delivered by current clinical models. Digital solutions hold promise but require work done to raise implementation and acceptability.