The EMPiRE model could save lives and lead to increased quality of life.
Women with epilepsy are 10 times more likely to die during pregnancy than those who don’t have the condition, with seizures acting as the most likely cause of death.
Many of these deaths could be avoided if there were a prognostic model for assessing a patient’s seizure status. Knowing whether a patient is high-risk would allow practitioners to develop personalized care plans to be carried out before, during and after delivery.
A group of researchers set out to develop and externally validate a predictive model that could assess the risk status of pregnant women who are on anti-epileptic drugs. As detailed in this article recently published in PLOS Medicine, researchers determined the net benefit of implementing the EMPiRE (AntiEpileptic drug Monitoring in PREgnancy) model, using different probability thresholds so that caregivers could make informed decisions when it came to monitoring patients and administering medicine. Results suggested that the EMPiRE model displayed the highest net proportional benefit for predicted probability thresholds from 12% to 99%.
Researchers from Queen Mary University of London Shakila Thangaratinam, Ph.D., John Allottey, M.S., and Javier Zamora, Ph.D., M.S., found that using the model “could reduce the number of women unnecessarily given an intervention from as little as two to as much as 54 for every 100 women seen.”
The study recruited 527 participants from 50 hospitals in the United Kingdom. They were all pregnant women with epilepsy who were taking one of the following anti-epileptic drugs: lamotrigine, carbamazepine, phenytoin or levetiracetam. The patients were recruited at the time of their first antenatal visit and proceeded to record their seizures in diaries designed for this purpose.
Using this data, researchers developed the EMPiRE model, a simple nomogram that relies on eight items to calculate the probability that a patient will have seizures. The model relies on data gathered from predictors, such as age at first seizure and mental health history. It can be implemented during the first antenatal visit.
While current protocol treats all pregnant women with epilepsy as if they will experience seizures, the EMPiRE model’s ability to differentiate promises to reduce the number of women who endure unnecessary treatment, such as taking increased amounts of anti-epileptic drugs. It could also lift unnecessary restrictions on activity — such as driving — and cut the number of women who cease taking anti-epileptic drugs during pregnancy for fear of hurting the fetus.
Researchers believe there may be financial benefits to the EMPiRE model, as well. “There could be a reduction in both actual cost of service to the healthcare provider and improvement of quality of life for the woman,” they told Inside Digital Health™. Being able to accurately estimate the risks could promote a more collaborative approach to treatment for both clinicians and patients, resulting in a shared decision-making process.
While the EMPiRE model is ready for use by healthcare professionals in clinical practice, there are limitations. The model is meant for patients receiving care in high-income settings and researchers caution that, for it to be effective, there should be information available for all predictors in the model.
Moving forward, the researchers also recommend “the model be validated in different settings and populations to fully appreciate its transportability.” To assess its impact in improving health outcomes, they suggest the model be assessed via randomized trials.
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