改善患者参与临床试验:与关键利益相关者一起启动BOAT试验
Henil Upadhyay1, Anna Robinson-Barella2, Andrew Husband3
1School of Pharmacy, Newcastle University, United Kingdom; Adult Bronchiectasis Service, Freeman Hospital, Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
Respiratory medicine
|December 18, 2025
概括
这项研究评估了对非囊性纤维化支气管切除症患者的持续或暂停的阿兹罗密辛预防. 患者和公众参与增强了招聘材料,改善了试验设计和患者参与.
科学领域:
- 肺部病理学 肺部病理学
- 临床试验 临床试验
- 医疗保健服务研究 医疗服务研究
背景情况:
- 非囊性纤维化支气管切除症是一种慢性炎症性肺病.
- 经常出现的恶化严重降低了患者的生活质量.
- 阿齐思罗米预防是管理支气管病的标准护理.
研究的目的:
- 在非囊性纤维化支气管切除症患者中,比较停止阿兹罗米辛预防的临床有效性与持续的阿兹罗米辛预防.
- 评估视频动画作为临床试验环境中的招聘工具的实用性.
- 评估患者和公众参与和参与 (PPIE) 对试验设计和材料的影响.
主要方法:
- 进行了一项双盲,随机的,非劣势性试验 (支气管切除:优化阿兹罗米辛预防治疗 - BOAT试验).
- 试验中的一项研究 (SWAT) 纳入了用于招聘的视频动画.
- 焦点小组和与患者的采访为面向患者的材料和动画的开发提供了信息.
主要成果:
- 患者和公众参与和参与 (PPIE) 显著提高了试验设计和面向患者的文档的适当性和可接受性.
- 视频动画开发的考虑因素包括格式,设备兼容性和网站集成.
- 早期的PPIE参与对于完善招聘材料至关重要.
结论:
- 患者和公众参与和参与 (PPIE) 对于提高临床试验设计和患者招聘材料至关重要.
- 视频动画可以是有效的招聘工具,当开发与患者输入和技术考虑.
- 通过PPIE优化面向患者的材料可以提高试验的可接受性和潜在的招聘效率.
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