Grant winner 2014

“This research will clarify for the first time the relationship between direct studies and studies using electronic healthcare data. This will provide important information on the accuracy of risk estimates for different AEDs used during pregnancy and insight into how best to study neurodevelopmental effects of AEDs in the future. It is hoped that the findings of this research will be communicated to patients and healthcare professionals within two years to help ensure that women are given reliable information about their treatment options during pregnancy.” Dr Rachel Charlton (pictured)

Grant type: Project

Principal investigator: Dr Rachel Charlton

Institution: University of Bath

Amount: £98,160

Duration: 18 months

Scientific title: Sensitivity of electronic healthcare data to investigate neurodevelopmental outcomes following prenatal exposure to anti-epileptic drugs

Why is this research needed?
For women with epilepsy pregnancy requires very careful planning, because several anti-epileptic drugs (AEDs) have been shown to increase the chance of birth defects in the unborn child. Exposure to certain AEDs before birth can also have effects upon a child’s behaviour and development, but the nature of these is not fully understood and further research is needed.

Traditional methods for evaluating behaviour and development (i.e. face-to-face interviews) require a lot of work and they are very expensive. In recent years, databases that contain routinely collected electronic patient medical records have been increasingly used to study these effects. However, whilst this approach offers many advantages, including lower cost and access to larger numbers of exposed children, it is not clear whether it is a reliable way of detecting developmental problems. This is important to know, because if risks are overestimated, an AED that is in fact safe and effective may not be recommended by doctors; but if they are underestimated, doctors may recommend an AED and inadvertently cause harm.

What are the aims?
The team will investigate whether methods using routinely collected healthcare data are as reliable as direct clinical observation for studying the effects of AEDs on child development.

How will the research be carried out?
During the study, the team will take existing anonymised electronic data from a database of general practice (GP) records, called the Clinical Practice Research Datalink, and they will use it to estimate the risk of neurodevelopmental problems following exposure to different AEDs in the womb. They will then compare their results to those from a previous study led by researchers in Liverpool, which used traditional methods.

What difference will it make?
This project will help doctors to provide women who have epilepsy with the most reliable and accurate information about their treatment options during pregnancy. It will also serve as a guide to researchers who are planning to explore the neurodevelopmental effects of AEDs in the future.