开发一个适应性儿科重症监护室平台试验与关键利益相关者:一个定性研究
Tracy Karen Mitchell1, Julie C Menzies2, Padmanabhan Ramnarayan3
1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK Tracy.Mitchell@Liverpool.ac.uk.
BMJ open
|January 8, 2025
概括
这项研究发现,年轻人,家长和儿科重症监护室 (PICU) 工作人员认为拟议的适应性平台试验是可以接受的. 他们的意见将有助于设计一个以家庭为中心的试验,以改善重症儿童的治疗.
科学领域:
- 儿科重症监护室的儿童重症监护室
- 临床试验设计 临床试验设计
- 定性研究是指质量研究.
背景情况:
- 平台试验加速了成年人的治疗发现,正如COVID-19期间所见的那样.
- 适应性平台试验提供了对多种干预措施的高效测试.
- 儿科重症监护 (PICU) 需要创新的试验设计.
研究的目的:
- 为英国在PICU的第一个适应性平台试验的设计提供信息.
- 纳入年轻患者,家长/护理人员和PICU工作人员的观点.
- 确保以家庭为中心和可操作的试验协议.
主要方法:
- 使用半结构焦点小组进行定性研究.
- 对收集的数据进行反思性的专题分析.
- 涉及86名参与者:18名年轻人,15名家长/照顾者,53名PICU工作人员.
主要成果:
- 利益相关者认为拟议的PICU平台试验是可以接受的.
- 关键的设计见解包括广泛的资格,优先考虑儿童的生活质量和生存结果.
- 为治理和克服试验挑战提供建议.
结论:
- 拟议的适应性PICU平台试验对关键利益相关者来说是可以接受的.
- 利益相关者的意见确保了严格而又以家庭为中心的设计.
- 调查结果为一个协议提供了信息,用于为重症儿童生成高质量的证据.
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