Title: Developing a preconception care pathway for women with epilepsy in the UK: identifying key interventions and patient-reported outcomes using a mixed-methods Delphi consensus approach
Funder: Department of Health and Social Care

Abstract: Research question For women with epilepsy aged 16-50 years in the UK, what are the essential elements of preconception care that will improve patient-reported outcomes along the preconception care pathway? Background Preconception care supports improvements in the health of women with epilepsy prior to conception and is defined by the WHO as a series of promotive, preventive and curative health interventions to maximize maternal and child healthcare. The need for this study is highlighted by the valproate scandal that hit the international news in 2016 which revealed women of childbearing potential continuing to have prescriptions for a high-risk medication. The most recent iterations of this scandal were highlighted within a public hearing held by the European Medicines Agency and representatives from three UK epilepsy voluntary organizations indicated 1/5 recalled having a conversation with a healthcare professional concerning valproate s risks. Such experiences of women with epilepsy are further highlighted by the finding that the majority of women with epilepsy who die in pregnancy and in the first 12 months after delivery did not receive preconception care [1]. Why women do not receive preconception care is unclear and in the absence of evidence and mixed opinions, we, therefore, need the community and stakeholders to form a consensus achieved through Delphi methods. Aims and Objectives The aim of this mixed-methods Delphi study is to use consensus methods to develop a preconception care pathway for this high-risk group. The study objectives are to: identify the essential preconception care interventions identify the key stages in the care pathway that they should be delivered enable the development of patient-reported outcome measures for women with epilepsy. Methods This Delphi study will build on the findings of a systematic review and PPI consultation completed prior to study commencement. &quot;Key stakeholders&quot; recruitment will ensure representation from the most vulnerable and those with experience of an unplanned pregnancy, in order to reveal potential barriers for the inclusion of meaningful key interventions, and factors influencing care pathway access and patient outcomes of relevance. This four-stage mixed-method Delphi study will: Stage 1: explore through focus group and interviews the preconception care experience of a purposive sample of women with epilepsy their partners, spouse, family, carers and friends; to develop the online Delphi survey. Stage 2 & 3: complete two sequential online surveys by key stakeholders including women, rating items on a 9 point Likert scale for inclusion as key preconception interventions, stages of intervention and outcomes of relevance for patients. Stage 4: invite a representative panel of a key stakeholder in a face-to-face consensus meeting to discuss and agree with predetermined criteria of consensus items of inclusion in the care pathway and patient-reported outcome. Timelines for delivery The 18-month project, with advisory panel to monitor study progress and advise to overcome any barrier e.g. recruitment and retention. Anticipated Impact and Dissemination The outputs of this study will be the identification of key interventions and when to implement them and informing on how to measure the impact in service and in future research.

Lay abstract: Preconception care is advised for women with epilepsy. It involves taking steps to make sure a woman s epilepsy and health are at there best before getting pregnant. This is vital because epilepsy and epilepsy drugs can increase the risk of problems for mother and baby. These include: Risks of worsening seizure control, if a woman stops taking her epilepsy drugs for fear of harm to the baby. This could increase the chance of injury or even death in epilepsy. Risks of birth defects in the baby, if the mother is not taking the best type and dose of an epilepsy drug. This includes valproate (Epilim). Preconception care offers the chance to avoid some of these risks. It is not clear why all women don't have this support. Or, why some, don't plan pregnancy. When it is unclear what is the best way to provide health services, research can help. One such method, called Delphi brings experts together to agree on areas of concern. This study will invite experts to give their views. Feedback from expert groups is shared and discussed over a series of stages until a consensus is agreed. For this study experts are: People with personal experience of living with epilepsy Health professionals with expertise in preconception care, and care of women with epilepsy Results will be used to: &bull; identify essential support (interventions) &bull; develop a pathway of stages for stepping in to support women, and &bull; develop a patient-reported outcome, to measure impact in service and in future research Delphi stage 1 &ndash; the research team will hold a series of focus groups (face-to-face and online) and interviews with experts living with epilepsy. This will help focus the online survey in areas important to people with epilepsy. Delphi stage 2 &ndash; experts are emailed the survey and asked to score which interventions and outcomes they think are most important. Researchers analyse the scores and provide anonymous feedback. Delphi stage 3 &ndash; experts reflect on their previous scoring. Feedback will show the scores of other 'expert' groups (keeping identify private). They can consider changing or sticking with original responses. The survey is repeated. Delphi stage 4 &ndash; a group of experts will be invited to attend a meeting, the results will be discussed and voted on, to agree on essential preconception interventions, stages of support, and outcomes of importance to patients. The study team will publish findings throughout the process and share with all stakeholders. This study has been developed in consultation with patients and the public, through an online survey and a meeting of Epilepsy Action members. Participants unanimously agreed on the need and the acceptability of methods for this study.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES;7.3 MANAGEMENT AND DECISION MAKING;7.1 INDIVIDUAL CARE NEEDS
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH;NEUROLOGICAL