Abstracts

The ability to recruit sufficient numbers of participants into genetic research studies is critical for success in identifying genes related to disease. The purpose of this study is to quantify the percentage of patients and family members who agree to participate by signing informed consent (or verbalizing assent), and giving a peripheral blood sample. Also, reasons for refusal to enroll will be reported. These data will help in design of future genetic studies and may increase future participation rates.
This is a retrospective analysis of enrollment rates and reasons for refusal to participate in a study entitled [ldquo]Genetic Influences on Human Epilepsy[rdquo] which is currently in progress. Patient charts were screened to determine if study inclusion criteria were met and the attending physician would introduce the study coordinator at the end of the office visit. Patients and family members then chose whether to participate in the study.
Over an 18 month period, 1,570 neurology outpatient clinical records at the Children[apos]s Hospital of Philadelphia were screened for this project. Ninety-nine patients (ages 3 to 20) met inclusion criteria and were asked to participate. Of those 99 patients, 80 agreed to enroll (81%), and 19 refused (19%). The major reasons cited for patient refusal included fear of blood draw (42%), a sense of being too overwhelmed to consider participation (16%), and none given (42%). All 80 pediatric patients who agreed to enroll have had blood drawn. In addition, 115 family members of patients who agreed to enroll were asked to participate. To date, 111 (96%) have agreed to enroll and 4 (4%) refused participation for unknown reasons.
The rate of participation is 81% for pediatric patients and 96% for family members. Since fear of [ldquo]a needle[rdquo] is a major reason for refusal in this population, an alternative would be to obtain a DNA sample from a buccal swab. Although the DNA is of lesser quality and quantity when isolated this way, it could increase participation rates in this population significantly. Since newer AED[rsquo]s require few blood draws for clinical purposes, this may be an even more important issue in future years. A more detailed analysis of the factors influencing decision to refuse to participate is warranted. Parental age, education, ethnic background and other factors may play a significant role and should be systematically examined in research studies.
[Supported by: NS-R01-400396 to RJB and the Univ. of PA Center for Neurobiology and Behavior.]