Human Epilepsy Project (HEP) 1 is a multicenter prospective observational study of newly treated focal epilepsy patients with a goal of identifying biomarkers predictive of patient prognosis. Significant effort was employed to ensure proper enrollment including an adjudication committee.
Subjects were submitted for enrollment if they were deemed to have a >80% likelihood of focal epilepsy and were seen within four months of treatment initiation. If subjects had a normal or no MRI/ EEG, or if eligibility was in question for any other reason, they were adjudicated by 4 expert epileptologists to establish a consensus agreement on the diagnosis. Details of history, MRI and EEG findings at time of enrollment for each group were analyzed, along with reasons for later disqualification.
Using strict enrollment criteria and an expert adjudication panel, only 2.6% (13/489) of those enrolled were later discovered not to have a diagnosis of focal epilepsy. Despite lacking MRI/EEG confirmation of focal epilepsy, those requiring adjudication had a lower rate of misdiagnosis when compared to those who did not require adjudication.