临床试验中的识字障碍允许:回顾性分析
Fatima N Mirza1, Eric Wu2, Hael F Abdulrazeq1
1Brown University, Providence, RI, USA.
EClinicalMedicine
|January 7, 2025
概括
临床试验同意表格写得高于成年人的平均阅读水平,增加了患者退学率. 简化这些表格可能会提高参与者保留和理解.
科学领域:
- 临床研究方法论临床研究方法论
- 医疗素养和患者沟通
- 医学伦理学和知情同意
背景情况:
- 临床试验中的知情同意表格历来超过了患者平均阅读水平.
- 这种可读性差距给获得真正知情同意带来了挑战.
- 对临床试验参与者保留率的影响仍未得到充分研究.
研究的目的:
- 分析临床试验同意表的可读性.
- 为了确定同意表格可读性和参与者退学率之间的关系.
- 探索简化同意表格的方法,以提高可访问性.
主要方法:
- 从798个联邦资助的美国临床试验的同意表的可读性分析完成到2023年1月1日.
- 同意表的可读性 (弗莱什-金凯德分级) 与试验中断率的相关性.
- 使用大型语言模型进行形式子集的探索性简化,并进行医学法律审查.
主要成果:
- 弗莱什-金凯德平均成绩水平为12.0±1.3,明显高于美国8年级成年平均阅读水平.
- 每增加一级的可读性都与16%更高的失业率相关 (IRR,1.16;P < 0.001).
- 形式简化在降低阅读水平,同时保持基本法律内容方面表现有前途.
结论:
- 联邦资助的临床试验中的知情同意表经常超过大多数美国成年人的阅读理解能力.
- 这种可读性障碍可能会对临床试验参与者保留产生负面影响.
- 对LLM和简化工具的进一步研究是有必要的,以解决识字障碍并加强试验参与.
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