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."
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 49,000 employees are more than 3,400 full-time salaried physicians and researchers and 14,000 nurses, representing 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a 165-acre main campus near downtown Cleveland, nine community hospitals, more than 150 northern Ohio outpatient locations - including 18 full-service family health centers and three health and wellness centers - and locations in Weston, Fla.; Las Vegas, Nev.; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2015, there were 6.6 million outpatient visits, 164,700 hospital admissions and 208,807 surgical cases throughout the Cleveland Clinic health system. Patients came for treatment from every state and 180 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.
About the Lerner Research Institute
The Lerner Research Institute is home to Cleveland Clinic's laboratory, translational and clinical research. Its mission is to promote human health by investigating in the laboratory and the clinic the causes of disease and discovering novel approaches to prevention and treatments; to train the next generation of biomedical researchers; and to foster productive collaborations with those providing clinical care. Lerner researchers publish more than 1,500 articles in peer-reviewed biomedical journals each year. Lerner's total annual research expenditure was $260 million in 2016 (with $140 million in competitive federal funding, placing Lerner in the top five research institutes in the nation in federal grant funding). Approximately 1,500 people (including approximately 200 principal investigators, 240 research fellows, and about 150 graduate students) in 12 departments work in research programs focusing on heart and vascular, cancer, brain, eye, metabolic, musculoskeletal, inflammatory and fibrotic diseases. The Lerner has more than 700,000 square feet of lab, office and scientific core services space. Lerner faculty oversee the curriculum and teach students enrolled in the Cleveland Clinic Lerner College of Medicine (CCLCM) of Case Western Reserve University - training the next generation of physician-scientists. Institute faculty also participate in multiple doctoral programs, including the Molecular Medicine PhD Program, which integrates traditional graduate training with an emphasis on human diseases. The Lerner is a significant source of commercial property, generating 64 invention disclosures, 15 licenses, 121 patents, and one new spinoff company in 2016. Visit us at http://www.lerner.ccf.org. Follow us on Twitter at http://www.twitter.com/CCLRI.