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重新设计试验以包容学习障碍的人 - 一个实际的例子

Victoria Shepherd¹, Rachel Royston², Vaso Totsika²

¹Centre for Trials Research, Cardiff University, 6th Floor Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. ShepherdVL1@cardiff.ac.uk.

|January 12, 2026

概括

临床试验往往排除学习障碍的人,加剧了健康不平等. 用可访问的材料和更简单的流程重新设计试验可以改善这个服务不足的群体的包容性.

科学领域:

卫生公平研究卫生公平研究
临床试验的设计
残疾人包容性包括在内.

背景情况:

具有学习障碍的人面临临临床试验的重大排斥,导致健康差异和寿命缩短.
一个英国范围内的协作",没有关于我们的研究,没有我们",解决了学习障碍的人参与研究的障碍.
这项研究侧重于实际的重新设计策略,以提高学习障碍患者临床试验的包容性.

研究的目的:

在临床试验中识别学习障碍者纳入临床试验的障碍.
为更具包容性的临床试验提出实际设计修改.
为未来的试验设计和进行提供信息,以实现更好的健康公平.

主要方法:

一个平台试验 (PANORAMIC) 根据预定义的标准被选择进行审查.
为了进行系统分析,使用了INCLUDE受损同意能力框架.
确定了障碍,并提出了替代设计方法,以扩大试验访问.

主要成果:

尽管是COVID-19的高风险群体,但学习障碍者仅占PANORAMIC试验新兵的0.01%.
确定了更多包容性的实际策略,包括早期利益相关者参与和修订的资格标准.
关键建议包括做出合理的调整,例如易读文件和简化研究程序.

结论:

可访问的研究设计和适当的适应措施对于将学习障碍患者纳入临床试验至关重要.
实施实际策略可以提高卫生公平性和为服务不足的人群进行研究的质量.
未来的临床试验应优先考虑包容性设计,以确保代表性并减少健康差异.

关键词:

可访问性可访问性临床试验临床试验是指临床试验的临床试验.包容性包容性是指包容性.智力障碍智力障碍是一种智力障碍.学习障碍学习障碍是什么

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