Fitzpatrick Annette L, Fried Linda P, Williamson Jeff, Crowley Patricia, Posey Delilah, Kwong Linly, Bonk Janet, Moyer Roberta, Chabot Joyce, Kidoguchi Lara, Furberg Curt D, DeKosky Steven T
Department of Epidemiology, University of Washington, Seattle, WA 98115, USA.
Contemp Clin Trials. 2006 Dec;27(6):541-53. doi: 10.1016/j.cct.2006.06.007. Epub 2006 Jul 4.
The difficulty involved in recruiting healthy older adults into clinical trials, especially those involving pharmacologic agents, is an important issue in research. The Ginkgo Evaluation of Memory (GEM) Study, a double-blind, placebo-controlled randomized clinical trial evaluating Ginkgo biloba to prevent dementia, successfully recruited 3072 participants age 75 years and older at four U.S. sites from September 2000 through June 2002. Using targeted mailing lists, an estimated 243,400 study brochures were mailed out to potential participants. Subsequent attempts were made to reach 14,603 households by telephone, from which 12,186 (83.4%) successful contacts were made. Overall, telephone or in-person evaluations identified 2149 (17.6%) ineligible persons for cognitive (20.6%), medical (49.4%), or other (30.0%) reasons. A total of 6944 (57.0%) refused participation resulting in 3072 enrolled into the study, a recruitment rate of 25.2% based on telephone contacts made or 1.3% of all mailed brochures. Recruitment rates were stable over the 21-month enrollment period but were higher for the two urban centers than the two rural ones. Recruitment was dependent most on mailing lists available, density of older adults in the catchment areas, and Institutional Review Board restrictions. Men and persons under age 85 were more likely to enroll. Primary reason for refusals involved lack of interest (48.4%) or self-perceived poor health (16.2%). Over 9% were unwilling to give up current Ginkgo supplementation or would not accept assignment to placebo. An additional 7% did not want another medication and almost 4% had care-giving responsibilities which prevented involvement. Mass mailings were the most successful approach for recruitment at all four sites and the method through which the vast majority of interviewees had learned about the study. Information on the experience of the GEM Study recruitment may be helpful to other clinical trials attempting to randomize older adults into prevention trials.
招募健康的老年人参与临床试验，尤其是那些涉及药物制剂的试验，其中存在的困难是研究中的一个重要问题。银杏记忆评估（GEM）研究是一项双盲、安慰剂对照的随机临床试验，旨在评估银杏叶预防痴呆症的效果。该研究于2000年9月至2002年6月期间在美国的四个地点成功招募了3072名75岁及以上的参与者。通过使用目标邮件列表，估计向潜在参与者寄出了243,400份研究宣传册。随后通过电话联系了14,603户家庭，其中成功联系到了12,186户（83.4%）。总体而言，通过电话或面对面评估确定了2149名（17.6%）因认知（20.6%）、医疗（49.4%）或其他（30.0%）原因不符合条件的人。共有6944名（57.0%）拒绝参与，最终有3072人被纳入研究，基于电话联系的招募率为25.2%，占所有寄出宣传册的1.3%。在21个月的招募期内，招募率保持稳定，但两个城市中心的招募率高于两个农村中心。招募主要取决于可用的邮件列表、集水区老年人的密度以及机构审查委员会的限制。男性和85岁以下的人更有可能被纳入。拒绝参与的主要原因包括缺乏兴趣（48.4%）或自我感觉健康状况不佳（16.2%）。超过9%的人不愿意放弃目前服用的银杏补充剂或不接受分配到安慰剂组。另外7%的人不想要另一种药物，近4%的人因有护理责任而无法参与。大规模邮寄是所有四个地点最成功的招募方式，也是绝大多数受访者了解该研究的途径。GEM研究招募经验的信息可能对其他试图将老年人随机纳入预防试验的临床试验有所帮助。
