Objective: Achieving enrollment goals of randomized clinical trials (RCT) within budgets depends on the timely recruitment of sufficient numbers of participants. We report a comparison of recruitment methods and yields of previously deployed veterans into a large RCT.
Study design and setting: A retrospective survey concerning recruitment was administered to staff at 28 sites participating in the VA Cooperative Study #475, "Antibiotic Treatment of Gulf War Veterans' Illnesses" (GWVI).
Results: Twenty-one sites reported identifying 31,407 Gulf War Veterans (GWV). Of these, 13.7% were successfully contacted, 3.5% were enrolled, and 1.2% were randomized. Mass mailings and direct telephone calls to GWV identified from a GWV database accounted for 78% of the GWV contacted. The other 22% were contacted by using referrals from medical staff, veterans' groups, media advertisements, and other methods. Data collected prospectively at the Albany Stratton VAMC were similar to data collected retrospectively from other sites.
Conclusion: These findings demonstrate that in previously deployed GWV with GWVI, 1.2% could be randomized. Although the use of all recruitment methods combined achieved the study recruitment goal, these data demonstrate that mass mailing and direct telephone contacts were effective recruitment methods.