在时间关键的产科试验中质疑同意的方法:混合方法研究的发现
Elizabeth Deja1, Andrew Weeks2,3, Charlotte Van Netten4
1Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK e.deja@liverpool.ac.uk.
BMJ open
|February 10, 2024
概括
没有事先同意的研究 (RWPC) 适用于紧急产科试验. 大多数妇女和工作人员更喜欢RWPC而不是产前同意进行时间关键的产后出血治疗,理由是减少了恐慌和研究浪费.
科学领域:
- 产科和妇科 产科和妇科
- 临床试验方法论 临床试验方法论
- 知情同意研究研究 信息化同意
背景情况:
- 试验法允许在紧急情况下在没有事先同意的情况下进行研究 (RWPC),但其在时间关键的产科试验中的使用是有限的.
- 了解参与者和工作人员对同意的看法对于伦理和有效的临床研究至关重要.
研究的目的:
- 在紧急产后随机临床试验中探索关于产前招募,同意和RWPC的观点和经验.
- 评估不同同意途径在时间关键的产科环境中的适当性.
主要方法:
- 在COPE试验中进行的一项嵌入式混合方法研究.
- 数据收集包括问卷,录制的招聘讨论,与妇女和分娩伴侣的采访,以及与工作人员的重点小组.
主要成果:
- 参与者希望获得更容易获得的产前研究信息.
- 大多数妇女和工作人员发现产前或早期劳动同意不合适,因为潜在的恐慌和资格问题.
- 有对RWPC的支持,特别是对于低风险的标准干预措施,如COPE试验中的干预措施,以及产后出血的妇女.
结论:
- 对于时间关键的产科干预,RWPC得到了支持.
- 这些发现质疑在这样的背景下日常使用产前同意和口头同意.
- 在紧急产科研究中同意的伦理考虑需要仔细评估.
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