Abstracts

RATIONALE: Older adults are faced with significant economic, medical, and social difficulties associated with the aging process. These factors interfere with the mature adults[ssquote] ability to participate in research studies. As an increasing amount of research studies are including this population, careful consideration of these factors should be addressed.
METHODS: This was a retrospective analysis of eligibility criteria from VA Coop Study #428, [dsquote]Treatment of Seizures in the Elderly Population[dsquote]. Eighteen VAMC[ssquote]s are presently participating in a study to evaluate the efficacy and tolerability of gabapentin (GBP), lamotrigine (LTG), and carbamazipine (CBZ) in the treatment of seizures in individuals 60 or older. Screening records were reviewed to determine reason(s) for ineligibility into the trial. Refusal forms were sent to all centers to determine the most common reasons for refusals.
RESULTS: 1,295 patients have been screened. Of these, 594 were enrolled and 701 were excluded. The number excluded is likely to be an underestimate since screening forms were not done on every potential patient. The most common exclusion reasons are no seizures in the last 3 months (24 %), unstable medical disorders (16 %), unable to give consent (15 %), questionable compliance (14.6 %), satisfied with current treatment (14.5%), and refused (10.4%). Other exclusions included treated with study drug (7.7 %), alcohol withdrawal (4%), psychiatric disorder (3.8 %), chronic barbiturates (3.6 %), metabolic seizures (2.6%), street drugs (1.6%), enrolled in other research (1.4%), allergy (1.2 %), acute CNS infection (0.41 %), HIV (0.14%). Reasons for refusals included family member refusal (17%), denial of seizures (15%), too much medication (7%), travel (4.2%), nursing home (4.2%), and guinea pig (3.4%). The effects of age, gender, race, and level of education were not analyzed.
CONCLUSIONS: Elderly patients are more likely to refuse participation in research than younger adults. Approval from family members/caregivers becomes more important in determining participation. Other demographic factors such as age, gender, race, and education may influence an older patient[ssquote]s decision to participate in a study. Cognitive impairment related to aging contributes to the inability of older patients to understand and give consent. Retrospectively, older patients may consider participation in clinical trials, if fewer visits were required. Participation of older adults may increase if the family members are actively included in the recruitment process. More attention should be placed on educating the family about the rationale for good, clinical research in this population of patients. Further scrutiny of the reasons for refusal is needed.
[Supported by: VA Cooperative Study Program]