A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.
A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.
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DOI：
10.1177/1740774514560831
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发表时间：
2015-02
期刊：
影响因子：
--
通讯作者：
Chaisson L
中科院分区：
文献类型：
--
作者：
Kass NE;Taylor HA;Ali J;Hallez K;Chaisson L
知情同意旨在确保个人了解研究的目的，风险和益处，然后可以自愿决定是否参加研究。然而，研究表明，同意程序并不总是导致充分的参与者理解，可能比必要的时间更长，更复杂。研究还表明，一些知情同意干预措施，包括增强知情同意书和与患者的广泛讨论，增加了理解，但在实际试验环境中研究知情同意时提出了方法学挑战。本研究旨在检查在实际研究中测试两种知情同意干预措施的可行性，并衡量干预措施在提高对试验理解方面的有效性。出于本研究的目的，将入组8项正在进行的临床试验（“合作研究”）中任何一项的参与者按顺序分配至涉及不同知情同意程序的3个研究组之一（1个对照组和2个干预组）。对照组参与者接受标准的知情同意书和流程。第一干预组的受试者收到了一份项目符号情况说明书，除了标准知情同意书外，还提供了所有研究组成部分的简单总结。第二干预组的参与者收到了项目符号说明书和标准知情同意材料，然后还与合作研究人员进行了反馈问答。同意程序后，我们管理封闭式和开放式问题，以评估患者的理解和我们评估的识字水平。生成描述性统计、Wilcoxon-Mann-Whitney和Kruskal-Wallis检验以评估相关性;回归分析确定患者理解的预测因子。144人参加。使用回归分析，接受第二次干预的参与者，包括标准同意书，项目符号事实表和与研究工作人员的结构化问答，开放式问题评分比接受对照组（仅标准同意）的参与者高7.6个百分点（p=.02），尽管未调整的比较没有达到统计学显著性。11名临床试验研究者同意参与，8项试验提供了足够的数据，从而证明了在实际环境中进行知情同意研究的可行性。我们的研究支持这样的假设，即与仅接受标准知情同意书和程序的患者相比，接受项目符号说明书和问答的患者具有更高的理解力。事实说明书和简短的结构化对话可以快速管理，并且易于在研究中复制，并且应该在更大的样本中进行有效性测试。
Informed consent is intended to ensure that individuals understand the purpose, risks, and benefits of research studies, and then can decide, voluntarily, whether to enroll. However, research suggests that consent procedures do not always lead to adequate participant understanding and may be longer and more complex than necessary. Studies also suggest some consent interventions, including enhanced consent forms and extended discussions with patients, increase understanding, yet methodologic challenges have been raised in studying consent in actual trial settings. This study aimed to examine the feasibility of testing two consent interventions in actual studies and also to measure effectiveness of interventions in improving understanding of trials. Participants enrolling in any of eight ongoing clinical trials (“collaborating studies”) were, for the purposes of this study, sequentially assigned to one of three study arms involving different informed consent procedures (one control and two intervention). Control participants received standard consent form and processes. Participants in the 1st intervention arm received a bulleted fact-sheet providing simple summaries of all study components in addition to the standard consent form. Participants in the 2nd intervention arm received the bulleted fact-sheet and standard consent materials and then also engaged with a member of the collaborating study staff in a feedback Q&A session. Following consent procedures, we administered closed and open ended questions to assess patient understanding and we assessed literacy level. Descriptive statistics, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of patient understanding. 144 participants enrolled. Using regression analysis participants receiving the 2nd intervention, which included a standard consent form, bulleted fact sheet and structured question and answer session with a study staff member, had open-ended question scores that were 7.6 percentage points higher (p=.02) than participants who received the control arm (standard consent only), although unadjusted comparisons did not reach statistical significance. Eleven clinical trial investigators agreed to participate and 8 trials provided sufficient data to be included, thereby demonstrating feasibility of consent research in actual settings. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a question and answer session have higher understanding compared to patients receiving standard consent form and procedures alone. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples for effectiveness.
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影响因子：
1.7
作者：
Sengupta S;Lo B;Strauss RP;Eron J;Gifford AL
通讯作者：
Gifford AL
影响因子：
3.7
作者：
Benatar JR;Mortimer J;Stretton M;Stewart RA
通讯作者：
Stewart RA
DOI：
10.2307/3564113
发表时间：
2000-05-01
期刊：
IRB
影响因子：
--
作者：
Daugherty, C K;Banik, D M;Ratain, M J
通讯作者：
Ratain, M J
影响因子：
4.4
作者：
Dresden, GM;Levitt, MA
通讯作者：
Levitt, MA
DOI：
10.1525/jer.2012.7.1.37
发表时间：
2012-02-01
影响因子：
1.3
作者：
Bull, Susan;Farsides, Bobbie;Ayele, Fasil Tekola
通讯作者：
Ayele, Fasil Tekola