One afternoon I was spending the day doing not very much and an email landed in my inbox from Epilepsy Action,
“The EMPIRE team at Queen Mary University of London have recently completed a Delphi survey, Defining core outcomes for clinical trials in pregnant women with epilepsy (E-core). As the next step, they are going to hold a consensus meeting between different stakeholders, to finalise the results before publishing them.
They would like to invite you to attend the meeting as a patient representative, to help them gain more insight from the survey results."
I was very excited by this as the blog has been the reason I had been invited along and is achieving what I have wanted since I started to this, to have an input on helping those with epilepsy in pregnancy. I of course took up their offer.
If you would like to know more about a Delphi survey it can be found here: http://en.wikipedia.org/wiki/Delphi_method
The Consultation meeting was the final stage to the E-core and the aim was to discuss and finalise the results of the Delphi survey. Two participants from each stakeholders group will be minimally present.
At this point I would like to note that all research is not my own and has been taken from the meeting and/or the Epilepsy Action website, opinions expressed are my own.
The Empire study
EMPIRE is a study on the management of anti-epileptic drugs (AEDs) for women with epilepsy who are pregnant.
When a woman with epilepsy is pregnant, it is important that her doctor considers such issues as:
There is very little research on the type of care and treatment that is beneficial to the mother and baby. Therefore, doctors may find it difficult to reliably advise on the best way to treat and manage such patients during this time. Doctors are responsible for reducing the risk of seizure while ensuring that the drugs do not affect the developing baby.
The research team carrying out the study is led by Professor Khalid Khan from Queen Mary University, London. The study is funded by the National Institute for Health Research Health Technology Assessment Programme
The overall aim of the meeting was to develop a consensus between different stakeholders around a minimum set of critical outcomes for studies, reviews and guidelines on management of epilepsy in pregnancy.
Current studies on pregnant mothers with epilepsy are mainly focussed on the short and long term foetal outcomes due to AED exposure, and to some extent on seizure deterioration.
There is wide variation in the reporting of outcomes for other relevant obstetric outcomes such as mode of delivery, preterm birth, and antepartum and postpartum haemorrhage.
There is a need to develop a set of core outcomes for studies involving mothers with epilepsy. Given the rarity of the condition, such a strategy will allow meaningful synthesis of evidence.
In layman’s terms it means that there will be a set of outcomes which each study would have to cover to make sure that any future studies would be comparable.
My first shock of the meeting was that both my Neurologist and Obstetrician were in attendance. It was interesting to see their input into what they considered a core outcome. In all honesty it also gave me a new respect for them both as I sat and listened to them. Both made very valid points in their arguments, and seeing them both there reassured me that they were striving to do the best for pregnant women with epilepsy. I have to admit I also felt a little intimidated sat in the room as I was the only patient representative actually in the room. However it was a chance I could not pass up.
The areas in which consensus had been agreed are as shown below along with their %. The stakeholders included obstetricians and midwives, neurologists and epilepsy nurses, 14 Neonatologists and 25 patient representatives:
The only one I believe was taken out on the day was the ectopic pregnancy, and this was something they consulted myself and the other patient representatives before removing. Drowning was considered the most important of any ‘injury’ as there had been 3 deaths of women with epilepsy in the last year/two years due to this. (The time span may be slightly off as I am writing this two weeks later but was no more than a two year time frame).
Up for discussion
Then we were on to discussing the areas that no consensus had been agreed, and the meeting was to decide which should be included. Overall it was interesting to see what different people wanted for a core set of outcomes from research into epilepsy and pregnancy, there were times patient representatives and medical professionals disagreed. This was obviously to be expected as what they were looking at from a medical point of view was not necessarily important for those with epilepsy on a day to day perspective. Or the core things I would want to know as someone with epilepsy weren’t necessarily of interest to the doctors, for example the % of women it affected driving. As a patient with epilepsy losing your license could affect your whole life on a day to day basis. But is this an area that doctors were interested in? It proved for some healthy debate. There were also some areas that were redefined and re grouped.
It was very interesting to see how much detail the professionals would want to go into in terms of research but how constricted they were by both time and money. I don’t as yet have the final results for the areas where consensus was not agreed so it would be interesting to hear people opinions. There is no right or wrong answer just opinions.
One doctor raised the point –would setting this core list of outcomes mean some studies wouldn’t get funded? Although this shows that research into pregnancy and epilepsy is making moves forward, it showed how badly underfunded that research is. I came away feeling positive about the way things were moving forward, a bit sad at the fact this was coming too late for my baby, very tired but overall happy that I’d had the chance to sit in on this and take part. I have yet to have the final results from the consensus meeting but when I do I shall make sure I update the blog.
I appreciate this is long winded however I put to you as a reader, if you were a pregnant woman with epilepsy, or if this was to affect your children what areas would you want to know about? Having looked at the areas that hadn’t been agreed which do you believe should be included? Of those that consensus had already been agreed are there any that you agree or disagree with?
I would really like to get an overview to feed back to the researchers.
I have tried to condense down a two hour meeting for the blog so if there are any points you would like more information on please get in touch.
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My names Faye, mostly known for being a tea addict and keen runner and swimmer. I'm 32, married and I had my 1st child in June 2015, oh and I also happen to have epilepsy. This is my story of Pregnancy, Motherhood & Epilepsy.