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改善临床试验中英语和西班牙语使用者的知情同意

Susana Peinado¹, Jessica E Thompson², Leo Plouffe³

¹RTI International, 3040 E. Cornwallis Road, Durham, NC, 27709-2194, USA. speinado@rti.org.

Therapeutic innovation & regulatory science

|October 29, 2025

概括

了解临床试验知情同意至关重要. 这项研究发现,英语和西班牙语的受访者都难以理解医疗术语和复杂的过程,这凸显了需要更清晰,简单的同意表格的需要.

科学领域:

临床试验临床试验
在知情同意的情况下同意.
卫生识字卫生识字
跨文化沟通跨文化沟通

背景情况:

患者在临床试验中对知情同意的理解往往不理想,阻碍了知情决策.
翻译复杂的知情同意文件可能会给非英语使用者带来新的误解.
这项定性研究调查了英语和西班牙语说话者对临床知情同意表格的理解和看法.

研究的目的:

检查英语和西班牙语参与者如何理解和感知复杂的临床知情同意表格.
确定与知情同意文件相关的误解,担忧和偏好领域.
为了比较不同翻译方法对知情同意材料的有效性.

主要方法:

与英语 (n=9) 和西班牙语 (n=9) 的女性进行了18次半结构面试.
测试了妇科药物试验的知情同意表格.
评估了两个西班牙语用户的翻译版本:一个通用版本,一个医学专用版本,使用专题分析.

主要成果:

两种语言群体的共同主题包括难以使用医学术语,不熟悉药物开发和厌恶不确定性.
参与者希望获得可理解的数字信息,并对研究信息产生情感反应.
西班牙语说话者通常更喜欢医学翻译版本而不是一般翻译,尽管不一致.

结论:

预先测试知情同意材料至关重要,以确保可理解性,避免术语,并减轻负面情绪反应,特别是在风险方面.
在可行的情况下,使用翻译方法的组合可以提高理解力.
强化了使用适合观众熟悉的简单语言的价值.

关键词:

了解理解理解理解理解理解经过知情同意的同意.风险沟通风险沟通是什么西班牙语西班牙语西班牙语西班牙语西班牙语西班牙语翻译翻译翻译翻译不确定性不确定性

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