一项旨在改善临床研究中知情同意情况的简单干预措施的试点研究：可行性、方法与结果。
A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.
作者信息
Kass Nancy E, Taylor Holly A, Ali Joseph, Hallez Kristina, Chaisson Lelia
机构信息
Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
出版信息
Clin Trials. 2015 Feb;12(1):54-66. doi: 10.1177/1740774514560831. Epub 2014 Dec 4.
BACKGROUND
Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding.
METHODS
Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding.
RESULTS
144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance.
CONCLUSIONS
Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples.
背景
研究表明，参与者并不总是能充分理解研究内容。虽然一些同意书干预措施能提高理解程度，但在实际试验环境之外研究同意书时，出现了方法学上的挑战。本研究检验了在实际研究中测试两种同意书干预措施的可行性，并衡量了干预措施在提高理解方面的有效性。
方法
纳入八项正在进行的临床试验中的任何一项试验的参与者，被依次分配到三种不同的知情同意策略之一，以参与他们的临床试验。对照组参与者接受其试验的标准同意程序。第一个干预组的参与者收到一份列出要点的情况说明书，总结关键研究信息。第二个干预组的参与者收到列出要点的情况说明书，并参加了一次反馈问答环节。之后，患者回答封闭式和开放式问题，以评估患者的理解程度和读写能力。生成描述性统计数据、Wilcoxon-Mann-Whitney检验和Kruskal-Wallis检验以评估相关性；回归分析确定理解的预测因素。
结果
144名参与者入组。通过回归分析，接受第二种干预措施的参与者在关于理解的开放式问题上的得分比对照组参与者高7.6个百分点（p = .02），尽管未经调整的比较未达到统计学显著性。
结论
我们的研究支持以下假设，即与标准同意书相比，同时收到列出要点的情况说明书和问答环节的患者理解程度更高。情况说明书和简短的结构化对话实施起来快速，且易于在各项研究中复制，应在更大样本中进行测试。
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