Abstracts

Rationale: Maintaining multiple sites for observational studies is a driver of inefficiency and high cost. The Human Epilepsy Project 2 (HEP2) was initiated as a 13 site prospective, observational study that aimed to better characterize the challenges of living with medication-resistant focal epilepsy. Patients were to be followed over two years to monitor changes in seizure frequencies, treatment course, adverse events, presence of comorbidities like depression and anxiety, healthcare costs, and quality of life. Two years after study initiation, a decision was made to centralize patient follow-up with a single coordinator and eliminate reliance on a local site model. We report on the feasibility of multi-site study centralization.

Methods: All participants were/are over age of 16 and under 65, diagnosed with focal epilepsy, and failed 4 previous trials with anti-seizure medications (ASMs), with at least 2 due to failure of seizure control. Participants were excluded from the study if they had a diagnosis of idiopathic generalized epilepsy or mixed focal and generalized non-epileptic seizures. At the initial visit, participants provided baseline data on demographics, seizure history, history of neurological insult, medical history, family history of epilepsy, EEG and MRI results, and all treatment information. HEP2 participants were recruited from 9 epilepsy centers across the country beginning July 2018. In September 2020, the study (HEP2 extension) was converted to a centralized trial design, with one clinical coordinator re-consenting and collecting participant information at each check-in.

Results: HEP2 enrolled 154 participants, of whom 23 completed all study visits prior to the transition to the HEP2 extension study in December 2020. Of the 131 participants eligible for continuation, 82 (63%) agreed to continue in the HEP2 extension study. The number of participants who were eligible to continue but did not agree to participate varied widely by center (Table 1). Of the remaining 82 patients who agreed to be contacted for the HEP2 extension study, 44 (53.6%) were re-consented to the extended protocol. The transfer rates also varied widely by epilepsy center (Table 1, Figure 1).

Conclusions: To our knowledge, this is the first centralization of a multisite study in the epilepsy space. Patients are continuing to convert from the original study. Conversion rates from eligible to transferred participants range by site from 20% to 70%, indicating that centralization is feasible, but more work is needed with individual sites to ensure patients are properly informed on transfer activities and intent of the study. Study coordinators should ensure patient contact information is kept up to date and take steps to reduce time of transfer to avoid gaps in data collection.

Funding: Please list any funding that was received in support of this abstract.: This study has received funding by UCB, Neurelis, and SK Life Sciences.