Abstracts

Rationale: Obtaining valid, useful information about long-term patient outcomes requires strong methodological design from the outset, engagement of patients and families, utilization of appropriate incentives, flexibility with participants needs and preferences, and adaptation to emerging trends and communication technologies. Studies of children also require re-enrollment as participants become adults. The Connecticut Study of Epilepsy (CSE), enrolled children (0-15y) with newly diagnosed epilepsy (1993-97). Multiple strategies were employed over a median 15.5y (max 20) follow-up.Methods: Upon recruitment, parents received Seizures and Epilepsy in Children: A guide for parents (Freeman, Vining, Pilas) which had just been published. They were called every 3-4m and medical records reviewed every 6m. Major study papers were shared with families. When participants reached 18, they were invited to re-enroll as adults and asked to provide a HIPAA waiver. A choice of gift card (coffee shop, bookstore, or movie tickets) was offered. We used an internet search service called Locate Plus to find new contact information for families we could not reach and periodically checked the Social Security Death Index for names of lost-to-follow-up patients. We sent out Thank You cards with a thumb drive containing study articles to actively followed subjects and We Miss You cards with thumb drives to participants that had been out of contact with reply cards to send back indicating best method to contact them in the future. Results: 47 (8%) were lost before 5y (11 deaths, 10 refusals, 26 lost). Another 50 (8%) were lost by 10y (3 deaths, 23 refusals, 24 lost). On turning 18, 317 have re-enrolled as adults, 249 with and 58 without HIPAA authorization. 31 refused further participation. Locate Plus successfully reconnected us with 62 families. Responses to cards and thumb drives yielded another 11 participants. 6 participants have made special requests concerning contact frequency (4 every 6m, 2 every 12m), or for the use of email (41), mailed letters (2), contact via texting (8) or Facebook (1). Participation was 542 (96%) in a 5-y interview for those followed 5 y and 502 (~97%) for those followed 9y. Of those invited to a young adult assessment, 95% agreed to participate. Disproportionate refusals and losses to follow-up (32/135, 24%) occurred between 18-21y. After this age, participation stays steady. Conclusions: Maintaining participation of young study subjects over two decades requires considerable efforts, resources, and flexibility. Trade-offs arise between the detail and intensity of participation versus the resources needed to sustain such a study and willingness of subjects to continue participating. Multiple strategies and flexibility in accommodating participants preferences are required. The transition to young adulthood is an important juncture in healthcare for many with epilepsy. It is also a time when motivation for study participation waivers. Those interested in studying this transition will need to employ a range of strategies. Funding NINDS RO1/R37-31146 1992-2014