Title: The impact of COVID-19 on health equality and mortality in people with epilepsy in Wales
Funder: Health and Care Research Wales (Welsh Government)

Abstract: BACKGROUND COVID-19 has had significant health and economic effects in Wales.(1-3) It is important both to know how COVID-19 has affected people with chronic disease, and how chronic disease affects the risk of developing COVID-19 and its complications. Epilepsy is a common neurological disease, affecting 30,000 people in Wales.(4) People with epilepsy face significant physical health, mental health and social problems.(5) The public health burden of epilepsy is recognised by respected international bodies.(6) Scheduled and unscheduled care, comorbidities, and time off work add to the economic burden of epilepsy which could be £100 million per year in Wales.(7) Small, mostly survey-based, studies have reported COVID-19 related problems for people with epilepsy, e.g increased seizures, worsening mental health and difficulties getting medication.(8-12) Population level studies on epilepsy and COVID-19 are limited to two studies on COVID-19 mortality which found a slightly increased risk of COVID-19 death for people with epilepsy.(13, 14) There are no published studies on epilepsy outcomes and COVID-19 or the effects of COVID-19 on epilepsy in Wales. This project addresses this knowledge gap and priority area of assessing the impact of COVID-19 on non-COVID-19 health and care service provision. AIMS We will investigate how COVID-19 has affected outcomes for people with epilepsy in Wales, comparing epilepsy outcomes during the pandemic with background rates, and with rates in a control population. We will investigate whether epilepsy is a risk factor for SARS-CoV-2 infection, COVID-19 hospitalisation, death due to COVID-19 or COVID-19 vaccination uptake when compared with a matched control population. PLAN OF INVESTIGATION We will perform an observational, longitudinal, national cohort study using population-level data within the Secure Anonymised Information Linkage (SAIL) Databank.(15) Data will be analysed within an existing, approved, COVID-19 project.(16) Our study period will be 1/1/2016–30/6/2021. 1/1/2016–29/2/2020 being pre-pandemic and 1/3/2020– 30/6/2021 being the pandemic phase. We will identify people with epilepsy using primary and secondary care diagnosis and medication codes.(17) We will create a control cohort (matched for age, sex and deprivation) recording covariates including comorbidities, ethnicity, health board and smoking status. Epilepsy outcomes will include rates of emergency department attendances, unscheduled hospital admissions, status epilepticus, mortality, anxiety and depression, and epilepsy medication dispensing. COVID-19 outcomes will include rates of SARS-CoV-2 infection, COVID-19 hospitalisation, deaths and vaccination. We will use multivariate regression models and time-to-event analysis to compare pandemic and pre-pandemic epilepsy outcome rates and COVID-19 outcomes in people with epilepsy and controls. We will stratify our results for specific groups including children, older adults and individuals living with intellectual disability, taking into account the effects of deprivation. BENEFITS The power of the detailed, population level data available within SAIL, together with the experience of the project team, will enable us to provide rapid answers to key questions for people with epilepsy. This will guide Welsh policy for healthcare provision and vaccination policy for epilepsy, and other chronic diseases, both during the ongoing COVID-19 pandemic and for the future.

Lay abstract: AIM To study how: a. COVID-19 has affected people with epilepsy in Wales. b. Epilepsy affects the risk of developing COVID-19. OBJECTIVES 1. Measure important outcomes for people with epilepsy in Wales, comparing these before and during the COVID-19 pandemic. The outcomes will include: hospital admissions, emergency department (A+E) attendances, severe epileptic seizures, anxiety and depression, medication dispensing rates and deaths. 2. Measure rates of COVID-19 infection, hospitalisation, death and vaccination in people with epilepsy in Wales. We will compare these rates with those from a similar group of people without epilepsy. 3. We will look for differences in these results in special groups of people with epilepsy: children, older adults, people with intellectual disability and people living in more deprived areas. We will look for any geographical differences in the results. BACKGROUND Coronavirus disease 2019 (COVID-19) has changed the lives of people in Wales. It has caused significant changes in health and social care. It is important to know how these changes have affected the care of people with long-term medical conditions. It is also important to understand how long-term medical conditions affect the risk of developing COVID-19 and its complications. Epilepsy is a common long-term condition affecting around 30,000 people in Wales. People with epilepsy face significant physical health, mental health and social problems.(5) COVID-19 has affected people with epilepsy in Wales in many ways. Small studies have shown that people with epilepsy may have more seizures, worse mental health and trouble getting medication due to COVID 19.(8-12) Two large studies in England and the USA have shown a slightly increased risk of COVID- 19 death in people with epilepsy.(13, 14) So far there have been no studies on the effects of COVID-19 on people with epilepsy in Wales. The SAIL (Secure Anonymised Information Linkage) databank holds a large amount of anonymised health care data for research, for the whole of Wales.(15) SAIL has been important in COVID-19 research in Wales. We are experienced in using SAIL for epilepsy research and using SAIL data will allow us to quickly study almost everybody with epilepsy in Wales. WHAT WE HOPE TO DISCOVER We hope to discover whether COVID-19 has changed the lives of people with epilepsy in Wales and whether having epilepsy is a risk factor for developing COVID-19. PUBLIC INVOLVEMENT We are working with a leading epilepsy charity, Epilepsy Action.(18) We have discussed this project at Epilepsy Action groups throughout Wales. Feedback from these groups has helped develop the project. Epilepsy Action will continue to co-ordinate public involvement throughout the project. They will support patient volunteers to be involved with the project, giving important feedback to the team. DISSEMINATION We will present our results in patient involvement groups and conferences. We will publish a scientific article of our work. We will work with Epilepsy Action to produce a plain English report and video of the results. Epilepsy Action will share this report and video, and the experiences of people involved in the study, using their magazine, website and social media. If our results highlight issues or differences in the care for people with epilepsy in Wales, we will use our professional and patient networks to improve epilepsy services and the lives of people with epilepsy in Wales.

Research activity codes: 2.4 SURVEILLANCE AND DISTRIBUTION
Health categories: NEUROLOGICAL