在紧急和重症监护研究中使用的同意方法的观点:快速,系统的审查
Niamh Mahon1, Leanne M C Hays1, Eva Coy1
1University College Dublin Clinical Research Centre, St. Vincent's University Hospital, Dublin, Ireland.
Trials
|March 11, 2026
概括
替代性同意模型通常可以接受用于紧急和重症监护研究. 患者和相对参与是关键的,流行病研究强调了对这些方法的需求.
科学领域:
- 紧急医疗 紧急医疗
- 临床护理研究 临床护理研究
- 临床试验 临床试验
背景情况:
- 由于患者病情的严重程度,在紧急和重症监护研究中,知情同意是具有挑战性的.
- 替代性同意方法对于推进实践和优化患者结果至关重要.
- 关于替代性同意存在不同的意见,特别是在服务不足的群体和COVID-19后.
研究的目的:
- 系统地审查和评估关于紧急和重症监护研究中的替代同意方法的各种意见.
- 调查各种同意模式的可接受性,包括为服务不足的人群和在流行病期间.
主要方法:
- 在2024年7月31日之前对定量和质量研究进行了快速系统审查.
- 在多个数据库中进行了搜索 (MEDLINE,EMBASE,PsycINFO,科学网,CENTRAL).
- 通过叙事合成总结了研究结果,重点关注服务不足的群体和流行病环境.
主要成果:
- 包括来自26个国家的145项符合条件的研究,研究了延期,代孕和医疗保健专业人员同意等方法.
- 其他同意模式通常是可以接受的,优先考虑的是患者/相对参与.
- 可接受性根据先前的研究参与,疾病经验和感知风险而有所不同;流行病研究显示需要和准备程度增加.
结论:
- 其他同意模式,包括推迟,亲属/代孕,医生同意,通常可以接受紧急情况,重症监护和流行病研究.
- 在决策中高度强调患者和患者的参与.
- 需要进一步的研究来解决对服务不足群体的共识和适应问题.
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