Abstracts

Rationale: Seizure freedom is most often regarded as the goal of AED therapy, though other measures may represent favorable outcomes for caregivers. We sought to identify caregiver-defined characteristics of successful epilepsy treatment and to quantify efficacy measures as they relate to the perceived success of antiepileptic drug (AED) use. Methods: A 22-question survey focused on measures of AED efficacy was designed using physician input, patient focus groups, and common clinical trial endpoints. Caregivers of children with epilepsy were administered the survey while attending routine pediatric neurology clinic visits at Emory University. Responses were pooled and frequencies for each question calculated. Responses were further analyzed with regard to seizure type and treatment group, characterized as newly diagnosed/controlled (exposure to 1 AED), adjunctive treatment (exposure to 2 AEDs), or refractory to treatment (exposure to ?3 AEDs). Results: Two hundred ninety-five surveys were completed with 109 (37%) newly diagnosed/controlled, 84 (28%) adjunctive, and 102 (35%) refractory. The majority (86%) were completed by the patients parent. The mean patient age was 9.6 years with 66% treated for > 2 years. Seizure freedom and seizure reduction were reported as the two most important outcome measures, respectively, across all seizure types and treatment groups. Two hundred sixteen (76%) respondents considered their seizures controlled, yet reported a median seizure frequency of 3 per year. Refractory patients tended to accept a higher seizure frequency per year as control versus those newly diagnosed (6/yr vs 2/yr). Amongst patients that reported their seizures as uncontrolled, seizure freedom > 6 months and median seizure reduction > 90% maintained for over one year was regarded as evidence of efficacy. These measures were the same regardless of seizure type or treatment group. Conclusions: While seizure freedom is the most important outcome measure of AED therapy for families and patients, it does not necessarily represent the concept of adequate seizure control. When seizure reduction is the outcome goal, the percent reduction and duration of response representing efficacy is considerably different from outcome measures commonly reported in clinical trials. The goals of treatment and quantification of efficacy measures are similar across all seizure types and treatment groups, suggesting the ultimate goals of treatment do not change for patients as their seizures become refractory to medical treatment. The inclusion of patient-centered outcome goals in clinical trials will likely improve informed decision making and patient expectations when choosing AED treatments.