Abstracts

Rationale: There is a shortage of research volunteers for participation in randomized controlled trials (RCT s) related to Epilepsy Surgery. This has led to the early termination of several large NIH-funded projects and limited the chances of funding for future trials. Focus groups aimed at understanding perceptions of surgery rather than reasons for enrollment have not proven to be helpful (Engel et al., 2010). To this end, we undertook a patient-centered qualitative pilot study specifically focused on barriers and motivations of surgery patients for entering RCTs using a post-surgical study of antiepileptic drug (AED) reduction as an example.Methods: We interviewed 22 subjects (11 pre-surgery; 11 post-surgery) under IRB approval using semi-structured interviews with a mix of open-ended and rank ordered questions. The interviews were audio recorded and summarized. Themes were analyzed using standard qualitative methods with a modified inductive grounded theory (Glaser and Strauss 1967).Results: See demographics Table. Only six of 22 subjects (27%) had been previously offered participation in any type of research trial. Responses to open ended questions about motivations for enrolling in research focused primarily on helping others 16 of 20 (80%). When asked to rank the top three of six provided options for motivations, almost all subjects chose helping to improve science/medicine, researchers/doctors, or people in the future (3 separate responses). 18 of 22 selected one of these responses as their most important reason. Open-ended questions about barriers to enrolling in research focused overwhelmingly (89%) on inconvenience (time/travel/annoyance), followed by worry about health risks in 3 of 18 (17%) respondents. When asked to rank the top three of six provided options for barriers, 14 of 20 (70%) listed inconvenience and 15 of 20 (75%) listed risk as within their top three barriers to entering research. In analyzing verbatim responses underlying subjects choices, the most common responses were health-related concerns (58%). Of note, 60% of pre-surgery participants selected risk as their top ranked barrier while only 2 of 10 (20%) post-surgery participants did so. Conversely, 20% of pre-surgery participants selected inconvenience as their top barrier while 50% post-surgery participants did so. For AED reduction, 63% expressed a willingness to accept an increased risk of having breakthrough seizures from 20% to 30%. The most common verbatim centered on helping others. There was also a cohort (17-50%) who would be willing to reinstate seizure precautions (including driving restrictions).Conclusions: Some surgical patients are willing and motivated to enter research trials that increase risk and place burden of seizure precautions. Optimizing enrollment in surgical RCTs (AED withdrawal in particular) requires: 1. acknowledge shifting priorities between pre and postoperative periods; 2. minimize patient inconvenience (possibly non-traditional data collection); 3. highlight the potential benefit to others.