Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana
Repeated Assessments of Informed Consent Comprehension among HIV-Infected Participants of a Three-Year Clinical Trial in Botswana
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DOI：
10.1371/journal.pone.0022696
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发表时间：
2011-10-27
期刊：
影响因子：
3.7
通讯作者：
Samandari, Taraz
中科院分区：
文献类型：
--
作者：
Chaisson, Lelia H.;Kass, Nancy E.;Samandari, Taraz
背景：知情同意（IC）几十年来一直是临床试验伦理行为的国际标准。然而，研究参与者往往对关键问题的理解不完整，语言障碍或缺乏对研究概念的熟悉加剧了这一问题。很少有研究人员测量参与者的理解IC，而更少的进行中期评估，一旦试验正在进行中。方法和结果：我们评估的理解IC使用20个问题的真/假测验管理在6个月的时间间隔的背景下，安慰剂对照，随机试验，预防结核病感染艾滋病毒的成年人在博茨瓦纳（2004-2009年）。测验用英语和西班牙语进行。要参加结核病试验，参与者必须有>= 16/20的正确回答。我们研究了理解的概念和理解在三年内发生变化的程度。我们分析了来自1,835名参与者的5,555个测验。参与者的最高教育水平是：28%小学，59%中学，9%大学和7%没有正规教育。百分之八十的参与者在第一次尝试时通过了注册测验（Quiz 1），其余的人在第二次尝试时通过了。那些受过小学以上教育的人和那些用英语参加测验的人更有可能在第一次尝试时获得及格分数（调整后的比值比和95%置信区间分别为3.1（2.4-4.0）和1.5（1.2，1.9））。90-100%的参与者理解试验的目的或程序，而44-77%的参与者理解随机化、安慰剂或风险。最初尝试测验1失败的参与者在试验后期测验失败的可能性更大。通过率提高测验重新administration在随后的years.Conclusions：管理的理解测验在招生和随访期间是可行的，在一个大的，国际合作和有效地确定IC理解试验参与者。需要采取策略来提高对安慰剂和随机化等概念的理解。在整个研究过程中的理解评估可以加强关键概念。
Background: Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.Methods and Findings: We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have >= 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Conclusions: Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts.