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改善研究参与者对知情同意进行研究的理解的干预措施:系统性审查
1Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Md 20892, USA.
JAMA
|October 7, 2004
概括
提高研究参与者的理解是至关重要的. 与研究小组进行一对一的讨论显著提高了在知情同意期间的理解力,而不是多媒体或增强形式.
科学领域:
- 临床研究伦理学
- 在知情同意的过程中,提供知情同意.
- 参与者理解能力
背景情况:
- 潜在的研究参与者经常难以理解知情同意信息.
- 关于提高参与者理解的有效方法的数据有限.
研究的目的:
- 系统地审查旨在提高研究参与者对知情同意信息的理解的干预措施.
- 确定最有效的策略,以改善临床研究环境中的理解.
主要方法:
- 在MEDLINE和其他来源进行了全面的文献搜索,用于评估改善知情同意理解干预措施的试验.
- 包括的研究包括随机对照试验,纵向试验和非随机分配的受控试验.
- 提取的数据包括研究设计,质量,参与者特征,干预措施和与理解,满意度和招生意愿相关的结果.
主要成果:
- 分析了42项涉及各种干预措施的试验.
- 多媒体和增强的同意表格在改善理解方面取得了有限的成功.
- 扩展的一对一讨论显示了参与者理解的显著改善 (所有P<.001).
- 测试/反干预改善了理解,但有可能将记忆与理解混为一谈.
- 较低的教育水平与理解能力的降低有关.
结论:
- 诸如多媒体和增强的同意表格等干预措施在改善研究参与者的理解方面表现出有限的有效性.
- 研究小组成员或中立教育工作者专门为一对一讨论的时间似乎是增强理解的最有效方法.
- 进一步的研究是必要的,以优化知情同意流程,并确保参与者理解.
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