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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.

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此摘要是机器生成的。

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.

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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.