新生儿重症监护中的父母和从业人员的选择同意:试验中的混合方法研究
Tracy Mitchell1, Izabela Andrzejewska2, Cheryl Battersby3
1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.
Archives of disease in childhood. Fetal and neonatal edition
|September 1, 2025
概括
在低风险新生儿试验中可以接受口头选择退出,但时间至关重要. 父母和工作人员发现neoGASTRIC试验
科学领域:
- 新生儿研究伦理
- 临床试验招募策略
- 经知情同意的流程
背景情况:
- 在新生儿试验中使用口头选择退出,以提高效率和代表性.
- 关于多中心新生儿试验中选择退出同意的操作性和可接受性存在有限的理解.
- 在 neoGASTRIC 试验中,对早产婴儿进行了常规或非常规的胃含量测量.
研究的目的:
- 探索父母和工作人员在neoGASTRIC试验中的口头选择退出同意的观点和经验.
- 在多中心新生儿环境中评估选择退出同意的可接受性和操作性.
- 确定影响新生儿研究中选择退出同意程序有效性的因素.
主要方法:
- 进行了混合方法的过程评估,包括问卷,采访和重点小组.
- 这项研究涉及英国四个新生儿病房的253名参与者 (167名工作人员和86名家长).
- 数据收集集中在参与者对口头选择退出同意过程的体验和看法上.
主要成果:
- 父母和工作人员普遍支持选择退出同意,认为neoGASTRIC干预措施具有低风险和非侵入性.
- 尽管对研究信息横幅/海报的认识很低 (21%),但家长们重视及时的研究讨论.
- 观察到选择退出同意的变化,一些父母在分娩期间或分娩后不久接近时感到压倒;一些工作人员使用了修改后的选择方式.
结论:
- 在较低风险的新生儿试验中,相应时间的口头选择退出同意是可以接受的,也是相称的.
- 在类似的新生儿研究环境中,neoGASTRIC试验的结果为改进同意程序提供了有价值的见解.
- 这项研究强调了在选择退出同意模式中考虑父母能力和信息提供时间的重要性.
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