影响参与儿科麻醉临床研究意愿的因素 (FILIPPA):以图片为基础的结构化访谈研究
Clemens Miller1,2, Jan Scholand2, Johannes Wieditz2,3
1Neurosurgical Critical Care Unit, Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.
Paediatric anaesthesia
|May 17, 2024
概括
研究的复杂性显著影响了儿童麻醉试验的父母同意. 更复杂的研究设计,如随机对照试验,显示较低的同意率,突出需要增强的招聘策略.
科学领域:
- 儿科麻醉学 儿科麻醉学
- 临床试验设计 临床试验设计
- 知情同意研究研究 信息化同意
背景情况:
- 在儿科临床试验中,知情同意至关重要.
- 影响儿童麻醉研究同意的因素已知,但研究设计的影响尚不清楚.
研究的目的:
- 量化研究复杂性对父母同意小儿麻醉研究的意愿的影响.
主要方法:
- 一项以图片为基础的采访研究涉及106名父母/监护人.
- 假设研究的复杂性各不相同:观察性,随机对照试验和II期药理学试验.
- 对同意的意愿用5分利克尔特尺度进行了测量.
主要成果:
- 随着研究复杂度的增加,同意的概率下降 (观察: 90.9%,RCT: 48.6%,II期: 32.7%).
- 更高的复杂性与增加的"绝对下降"反应相关.
- 以前的研究暴露,孩子的年龄较大,以及母亲的性别影响了同意决策.
结论:
- 随着研究复杂度的增加,父母同意儿童麻醉研究的意愿下降.
- 需要更多的努力来提高儿科患者在更复杂的研究设计中的入学率.
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