What we will do
EpiSafe Research: Six Interlinked Work Packages
The EpiSafe research programme is organised into six work packages, each aimed at addressing different aspects of epilepsy care during pregnancy and beyond.
Here's an overview.
1. Mapping the evidence and understanding the views of women and healthcare professionals
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Mapping the evidence & views: A systematic review of risk factors for seizures in pregnancy, evaluation of guidelines, and secondary analysis of maternal adherence to anti-epileptic drugs (AEDs).
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Impact of seizures & AED exposure: Investigation into the effects of seizures and AED exposure on mothers and babies through systematic reviews, focusing on various outcomes and experiences.
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Care of pregnant women with epilepsy: Observational and qualitative studies to detail care processes, challenges faced by women, particularly from underrepresented groups, and healthcare professionals' difficulties in providing appropriate care.
2. Co-design and refinement of the EpiSafe bundle for implementation
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Stakeholder engagement: Collaboration with women with epilepsy, healthcare professionals, and policymakers through workshops.
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Co-design & prototyping: Development and refinement of the EpiSafe bundle, including simulations and training.
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Field testing: Real-world evaluations in non-trial sites to identify and address practical challenges.
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Scalability planning: Development of strategies for broader roll-out, ensuring alignment with existing systems and needs.
3. Evaluating the impact of the EpiSafe bundle
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Randomised trial: A trial to test Epi-Safe's effect on care for pregnant women with epilepsy in 30 maternity units.
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Implementation evaluation: Assessment of the EpiSafe's delivery, acceptability, and adoption among women and healthcare professionals.
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Qualitative study: Exploration of views on EpiSafe through focus groups and interviews.
4. Long-term effects of medicines on child neurodevelopment
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Long-Term impact study: Investigating the long-term effects of the anti-epileptic drugs (AEDs) lamotrigine and levetiracetam on child neurodevelopment, focusing on areas like verbal IQ, intelligence, memory, and social functioning.
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Associations and outcomes: Examining the relationship between various non-AED factors and neurodevelopment, comparing neurodevelopmental outcomes based on different AED management, and assessing early neurodevelopmental assessments' predictive value.
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Women's views: Conducting interviews with women to understand their concerns and perceptions about the long-term effects of AEDs on their children, and how these concerns influence their decisions regarding medication management during pregnancy.
5. Economic evaluation and decision-analytic modelling
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Develop models: Create preliminary models for economic evaluation, considering both immediate cost-effectiveness and long-term impacts on infants.
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Evaluate costs and effectiveness: Estimate the costs and effectiveness of the EpiSafe intervention, focusing on major outcomes like preterm birth and seizure-related harms.
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Analyse long-term outcomes: Assess the long-term costs and consequences for infants exposed to AEDs during pregnancy.
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Explore distributional analysis: Investigate the possibility of analysing cost-effectiveness across different population subgroups, considering factors like income and ethnicity.
6. Involving and engaging with women, their family, the people that support them and the public
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Establish partnerships: Create a structured Patient, Public Involvement and Engagement (PPIE) governance model and collaborate with the Epilepsy Research Institute to form an Advisory Group. Develop a map of stakeholders and build long-term relationships with diverse groups for two-way engagement.
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Integrate Advisory Group insight: Involve Advisory Group members directly in Work Packages by having them attend meetings, deepening their understanding of the research for more meaningful involvement and input.
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Measure impact: Report how PPIE contributes to the EpiSafe research and the experiences of those involved.
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Long-Term strategy: Transform the Advisory Group into a specialised interest group for sustained impact and community benefit.