一项基于问卷的研究,探索参与者在围产期人类挑战试验中的观点
James H J Bevan1, Anastasia A Theodosiou2, James Corner3
1From the Faculty of Medicine, University of Southampton, School of Primary Care, Population Science and Medical Education, Southampton, United Kingdom.
The Pediatric infectious disease journal
|July 18, 2023
概括
孕妇可以安全地参与人类挑战研究. 该研究发现,怀孕的志愿者是以利他主义为动机,并认为干预是自然和安全的,超过了对不适的担忧.
科学领域:
- 产科和妇科 产科和妇科
- 传染病研究 传染病研究
- 孕产妇和胎儿医学 孕产妇和胎儿医学
背景情况:
- 从历史上看,孕妇一直被排除在医学研究之外,包括人类挑战研究.
- 在Lactamica 9研究中,研究了孕妇用开始性细菌进行鼻腔注射,以评估新生儿传播.
- 对于涉及孕妇和新生儿的研究,道德和实践方面的考虑是很重要的.
研究的目的:
- 在人类挑战研究中调查孕妇志愿者的动机,担忧和经验.
- 评估怀孕人口中人类挑战研究的可行性和可接受性.
- 了解参与者对研究干预和程序的看法.
主要方法:
- 使用完全匿名的定性和半定量问卷 (参与前和参与后).
- 雇员强制使用利克特尺度,词汇关联和自由文本问题来收集数据.
- 在参与前 (87.1%) 和参与后 (62.5%) 调查问卷中获得高回复率.
主要成果:
- 大多数参与者都是以利他主义为动机,并认为干预是"自然"",保护性"和"安全的".
- 担忧主要与程序不适有关,对自己或婴儿风险的担忧很小 (分别为18.5%和22.2%).
- 参与后,93.3%的人认为程序是可以接受的,对研究团队的互动有积极的反.
结论:
- 在健康的孕妇中进行人类挑战研究被证明是可以接受和可行的.
- 利他主义的动机和对干预作为"自然"的看法是关键因素.
- 乳酸胺9研究为未来涉及孕妇人口的研究提供了一个成功的模型.
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