Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial
Attrition and retention of ethnically diverse subjects in a multicenter randomized controlled research trial
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DOI：
10.1016/s0197-2456(01)00171-4
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发表时间：
2001-12-01
期刊：
影响因子：
--
通讯作者：
Boushey, HA
中科院分区：
文献类型：
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作者：
Janson, SL;Alioto, ME;Boushey, HA
招募和保留受试者对于开展随机临床试验至关重要。当在样本中为招募少数民族成员做出重大努力时，所有受试者亚组的相似保留率至关重要。关于为什么研究对象撤回参与研究的同意书，以及是否受种族或其他因素的影响，我们知之甚少。本研究的目的是确定退出大型多中心随机试验的原因，以及这些原因在种族和性别亚组之间是否存在差异。此外，我们有兴趣比较退出试验的受试者与留在试验中的匹配受试者，以确定哪些因素促使完全完成研究。使用队列调查设计，在研究完成后通过电话采访退出大型多中心随机试验的成人受试者（n = 35）和完成研究的匹配受试者（n = 35）。撤回知情同意的受试者往往是女性和少数民族成员。最常见的问题-撤回知情同意的受试者报告的频率显著高于匹配的保留受试者-是干扰工作、缺乏时间、复杂繁琐的记录保存要求、研究药物治疗方案困难以及由于研究人员缺乏灵活性而难以重新安排预约。只有17%的退出受试者对整体研究经验感到满意，而匹配的保留受试者为52%。在随机对照试验中完成所有要求访视的匹配受试者报告了促进完成的三个原因：报酬、完成承诺和相信研究很重要。(C)Elsevier Science Inc. 2001.
Recruitment and retention of subjects is critically important for the conduct of randomized clinical trials. When significant effort is given toward recruiting members of ethnic minorities in a sample, a similar rate of retention for all subgroups of subjects is essential. Little is known about why research subjects withdraw consent to participate in research and whether attrition is influenced by ethnicity or other factors. The purpose of this study was to determine the reasons for withdrawal from a large, multicenter randomized trial and whether these reasons differed among ethnic and gender subgroups. Additionally, we were interested in comparing withdrawn subjects to matched subjects who stayed in the trial to determine what factors encouraged full study completion. Using a cohort survey design, adult subjects (n = 35) who withdrew from a large, multicenter randomized trial and matched subjects who completed the study (n = 35) were interviewed by telephone after study completion. Subjects who withdrew consent tended to be female and members of ethnic minorities. The most frequent problems-reported significantly more often by subjects who withdrew consent compared to matched retained subjects-were interference with work, lack of time, complicated and cumbersome record-keeping requirements, difficult study medicine regimens, and difficulty rescheduling appointments due to lack of flexibility on the part of study personnel. Only 17% of withdrawn subjects were satisfied with the overall research experience compared to 52% of matched retained subjects. Matched subjects who completed all required visits in the randomized controlled trial reported three reasons that promoted completion: remuneration, commitment to finish, and belief that the study was important. (C) Elsevier Science Inc. 2001.