Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial
Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial
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DOI：
10.1186/1472-6939-11-8
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发表时间：
2010-05-14
影响因子：
2.7
通讯作者：
Kang, Gagandeep
中科院分区：
文献类型：
--
作者：
Sarkar, Rajiv;Sowmyanarayanan, Thuppal V.;Kang, Gagandeep
背景：对补充传统知情同意过程的不同方法的研究产生了相互矛盾的结果。本研究旨在评估在给予知情同意之前接受团体咨询的参与者是否比接受个人咨询的参与者更好地理解研究的关键组成部分和同意书，基于团体咨询将促进潜在参与者之间的讨论并增强他们对知情同意的理解的假设。方法：参与营养补充试验的儿童的父母在给予知情同意之前被随机分配接受团体咨询或个人咨询。为了评估参与者的理解程度，大约 48-72 小时后，采访者对受访者的分配组不知情，进行了结构化问卷调查。 结果：总共招募了 128 名家长，并为其中 118 名（90.2%）的家长进行了随访。所有受访者都知道他们的孩子参与了一项研究以及样本收集的详细信息。然而，他们对研究目的、随机化和退出的理解很差。干预组和对照组对知情同意关键要素的理解没有差异。结论：结果表明团体咨询可能不会影响对知情同意过程的整体理解。需要进一步的研究来设计更好的方法来提高参与者对临床试验中随机化的理解。
Background: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.Methods: Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.Results: A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.Conclusions: The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.