Are new methods as good as traditional ones in assessing the neurodevelopmental outcomes of anti-epileptic drug exposure before birth?

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.

Dr Rachel Charlton, at the University of Bath, and colleagues in Bath, Birmingham, Liverpool, Manchester, Newcastle and Cork, have been awarded £98,160 over 18 months, for a project entitled Sensitivity of electronic healthcare data to investigate neurodevelopmental outcomes following prenatal exposure to antiepileptic drugs, in which they 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. 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.

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.

 

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