Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process
Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process
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DOI：
10.1177/1740774513509316
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发表时间：
2014-02-01
期刊：
影响因子：
2.7
通讯作者：
Conde, Marcus B.
中科院分区：
文献类型：
--
作者：
Mexas, Fernanda;Efron, Anne;Conde, Marcus B.
在发展中国家，缺乏对知情同意（IC）过程中试验相关信息的理解水平进行评估的方法。目的通过对在巴西里约热内卢进行的一项新结核病（TB）治疗方案临床试验的参与者使用知情同意评估工具（ICAI），评估IC过程中试验相关信息的理解和保留情况方法ICAI的格式以美国国家癌症研究所的IC理解检查表的语言和结构为基础。ICAI旨在评估RioMAR研究IC过程的要点，该过程涉及巴西监管机构要求的研究伦理原则：自主、有益、无害和公正。（1）患者是否参加临床试验？(2)是否正在评估两种不同的治疗方法？(3)治疗组是否随机选择？(4)是否需要进行HIV检测？(5)是否需要肝功能检查？(6)参与者可以随时离开研究吗？(7)参与本研究的风险和获益是否清楚？(8)孕妇可以参加本研究吗？(9)研究药物之一是否会降低避孕药的有效性？(10)患者参加研究是否付费？ICAI应用于两个时间点：立即在临床试验中招募后，2个月后。结果共61例患者谁参加了RioMAR研究参加了这项研究。在第一次ICAI时，所有问题的正确答案的百分比为82%; 31名参与者（51%）不记得需要进行HIV检测（问题4），43名参与者（70%）不知道他们可以离开研究（问题6）。其他个人问题至少有76%的参与者回答正确。年龄、性别、家庭月收入、居住社区、受教育程度与不正确答案之间无相关性（p > 0.07）。当对第一个和第二个ICAI问题的回答进行比较时，15%或更多的参与者对10个问题中的5个问题的回答相互矛盾。有两个问题只问了女性。最后，只有6的ICAI的当前版本的10个问题适用于大多数trials;其他的是trial specific.Conclusions ICAI可以适应一个单独的trial，并可能被证明是一个有用的工具，同意讨论后，以确定研究参与者不完全理解的问题，从而促使研究人员重新解释的主题，可能在一个更基本的方式。
Background Methods for assessing the level of understanding of trial-related information during the informed consent (IC) process in developing countries are lacking.Purpose To assess the understanding and retention of trial-related information presented in the IC process by administering an informed consent assessment instrument (ICAI) to participants in a clinical trial for a new tuberculosis (TB) regimen being conducted in Rio de Janeiro (Brazil).Methods The format of the ICAI was based on the language and structure of the United States National Cancer Institute's IC comprehension checklist. The ICAI was designed to assess points of the RioMAR study IC process that addressed the principles of research ethics requested by Brazilian Regulatory Authority: autonomy, beneficence, non-maleficence, and justice. Briefly, (1) Is the respondent participating in a clinical trial? (2) Are two different treatments being evaluated? (3) Is the treatment arm chosen by chance? (4) Is an HIV test required? (5) Are liver function tests required? (6) Can participants leave the study at any time? (7) Are the risks and benefits of taking part in the study clear? (8) May pregnant women participate in the study? (9) Can one of the study drugs reduce the effectiveness of contraceptives? (10) Are patients paid to participate in the study? The ICAI was applied at two time points: immediately after enrollment in the clinical trial and 2 months later.Results A total of 61 patients who enrolled in the RioMAR study participated in this study. The percentage of correct answers to all questions was 82% at the time of the first ICAI; 31 participants (51%) did not recall that an HIV test was required (question 4) and 43 (70%) did not know that they could leave the study (question 6). Other individual questions were answered correctly by at least 76% of participants. There was no association between incorrect answers and age, gender, monthly family income, neighborhood, or level of education (p > 0.07). When the responses to the first and the second ICAI questions were compared, 15% or more of participants had conflicting answers to 5 of the 10 questions.Limitations The ICAI uses dichotomous responses, leading to a 50% chance of guessing the correct answers. Two questions were asked only of women. Finally, only 6 of the 10 questions on the current version of the ICAI apply to most trials; others are trial-specific.Conclusions The ICAI may be adapted to an individual trial and may prove to be a useful tool following a consent discussion to identify issues not fully understood by the research participants, thus prompting study staff to re-explain topics, possibly in a more elementary manner.