The National Institutes of Health (NIH) awarded a $3.4 million grant to Cleveland Clinic to develop a tool to predict individual outcomes in epilepsy surgery. The five-year grant, led by Lara Jehi, M.D., supports the creation of an epilepsy surgery nomogram (ESN) using diagnostic technology and predictive modeling.
The project is a five-year collaboration between the Cleveland Clinic Neurological Institute’s Epilepsy Center and the Cleveland Clinic Lerner Research Institute’s Quantitative Health Sciences team with Mayo Clinic and the University of Campinas. The study will incorporate robust patient data into a comprehensive nomogram (risk calculator) to better determine which patients will most benefit from the procedure.
“The typical current path to epilepsy surgery reveals the unquestionable need for process improvements that could be fostered by a tool like the ESN,” said Dr. Jehi, research director of the Cleveland Clinic Epilepsy Center. “Patients now hear the ‘average’ chance of success with this brain surgery, but do not know what their individual chance of success is: ‘How did a patient like me do with this procedure?’ The nomogram will enable us to bring patient counseling into the 21st century and expand it beyond our best ‘educated opinion’ to actual science. It will arm physicians with an advanced statistical tool to better select optimal surgical candidates and estimate the likelihood of seizure freedom after epilepsy surgery.”
Epilepsy currently affects 3 million people in the United States with associated costs of care ranging between $17 billion and $19 billion annually. Epilepsy surgery is the treatment of choice for drug-resistant epilepsy but currently remains underutilized due to multiple factors, including an inability to predict individualized outcomes following surgery. Patients undergo sophisticated testing to determine the area in the brain triggering the seizures, yet the decision to initiate this work-up and the final choice of the surgical procedure to perform are subjective and variable.
The multi-center research team will build upon on their first ESN, which used basic clinical patient characteristics, including age, gender and seizure frequency, to provide an objective, individualized prediction of postoperative seizure outcomes at two and five years after epilepsy surgery. Their nomogram and its initial retrospective validation were recently published in Lancet Neurology.
Through this new grant, the researchers will create an enhanced risk calculator by adding additional clinical, imaging, genetic, electrophysiological and histopathology data. The comprehensive ESN will be developed from a retrospective cohort of 450 patients from Cleveland Clinic, Mayo Clinic and University of Campinas, and prospectively validated in 250 patients from the same centers.
“When completed, this project will generate the first objective, validated, user-friendly epilepsy surgery prediction tool,” said Dr. Jehi. “We will learn from the collective experience of thousands of patients. Instead of each physician working on an island, we can synthesize data and pull it all together to make more strategic predictions using a much more scientific decision-making process. Achieving this goal will improve patient counseling and benefit public health.”
The nomogram concept was pioneered at Cleveland Clinic by Michael Kattan, Ph.D., chair of Quantitative Health Sciences, to better help predict outcomes for patients. His risk calculators, designed to help physicians make informed decisions about patient care, have been applied to many diseases, including coronary artery disease, an array of cancers, type 2 diabetes, and total joint replacements.
“The development of risk prediction calculators like the ESN is vital for improving medical decision-making,” said Dr. Kattan. “Tools like this represent another step toward personalized medicine that will ultimately improve efficiency, outcomes and patient care.”