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简化知情同意作为普遍预防措施
Iris Z Feinberg1, Ajeet Gajra2, Lori Hetherington3
1Department of Learning Sciences, College of Education and Human Development, Georgia State University, Atlanta, GA, USA. Ifeinberg2@gsu.edu.
Scientific reports
|June 8, 2024
概括
简化知情同意文件 (ICD) 改善了临床研究中的患者理解. 这种简单的语言方法有利于所有成年人,无论阅读能力如何,有助于参与试验.
科学领域:
- 卫生识字 卫生识字
- 参与临床研究 参与临床研究
- 患者的理解能力
背景情况:
- 低健康素养影响美国五分之一的成年人,阻碍了对知情同意文件 (ICD) 的理解.
- 在ICD中简化语言可以提高对不同研究群体的可理解性和包容性.
- 评估简化的ICD对于加强临床试验参与至关重要.
研究的目的:
- 评估简化的ICD的可理解性.
- 确定阅读技能和工作记忆等因素是否会影响简化ICD的有效性.
主要方法:
- 在格鲁吉亚,对192名年龄在18-77岁之间的成年人进行了在线调查.
- 参与者使用简化的ICD完成了测试.
- 使用统计模型分析理解和潜在的缓解因素.
主要成果:
- 参与者在使用简化的ICD时表现明显更好.
- 个人差异 (年龄,性别,种族,城市化,认知指标) 并没有减轻简化效应.
- 通过包括交互条款,模型匹配没有显著改善.
结论:
- ICD中的简化语言和语法作为一种普遍的预防措施,减少了所有成年人的认知负担.
- 提高ICD的可理解性可能有助于提高临床试验招生目标.
- 健康素养和简单语言的指导方针是有效的,使研究可访问.
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