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创建以患者为中心的临床试验附录信息化同意表格的初步步骤
Bellinda L King-Kallimanis1, Andrea Ferris1, Lisa Dropkin2
1LUNGevity Foundation, Chicago, Illinois.
JTO clinical and research reports
|October 16, 2023
概括
对知情同意表格 (ICFs) 的简短附录可以改善临床试验参与. 患有肺癌的患者发现总结关键信息的附录很有帮助,建议以患者为中心的方法同意试验.
科学领域:
- 临床试验方法论 临床试验方法论
- 患者的倡导和参与.
- 卫生识字和沟通健康知识
背景情况:
- 信息化同意表格 (ICF) 对于概述临床试验风险和益处至关重要.
- 目前的ICF可能是漫长而复杂的,可能会阻碍患者的理解.
- 提高试验信息的可访问性对于明智决策至关重要.
研究的目的:
- 评估对ICFs进行简洁补充的可行性.
- 确定与潜在临床试验参与者最相关的关键信息.
- 探索患者对改善ICF的看法.
主要方法:
- 审查了20个ICF,以确保可读性和符合美国联邦法规.
- 针对9名肺癌患者进行了重点小组和采访,使用假设的第3期ICF.
- 评估患者在ICF附录中包含信息的偏好.
主要成果:
- 在ICF中,平均21页是10年级的阅读水平,超过了美国8年级的平均水平.
- 患者报告说,长时间的ICF让他们感到"压倒".
- 一个由患者建议的附录,引用详细的ICF部分,受到好评.
结论:
- 在ICF结构和可读性的变化阻碍了患者的知情决策.
- 制定以患者为中心的附录可以提高理解和参与试验.
- 结果为改善ICF提供了一份路线图,超出肺癌试验范围.
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