紧急口头同意产前研究:一个有根据的理论研究研究
Carol Bedwell1, Wendy Taylor2, Caroline Cunningham3
1Centre for Childbirth, Women's and Newborn Health, International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.
BJOG : an international journal of obstetrics and gynaecology
|November 8, 2024
概括
在紧急情况下获得研究的知情同意,特别是产后出血,可以使用口头同意和书面同意. 清晰,及时的信息和足够的临床医师培训对于参与者的信任和接受至关重要.
科学领域:
- 医学伦理 医学伦理
- 临床研究方法论临床研究方法论
- 产科和妇科 产科和妇科
背景情况:
- 临床研究中的知情同意在紧急情况下带来了独特的挑战.
- 产后出血 (PPH) 管理通常需要快速干预,使传统的同意过程复杂化.
- 之前的研究还没有充分探索PPH研究中参与者和临床医生的双重同意方法的经验.
研究的目的:
- 调查妇女,分娩伴侣和医疗保健专业人员关于口头同意的经验,随后是追溯的书面同意.
- 在涉及PPH管理装置的前性队列研究中评估这种同意过程的可接受性和可行性.
- 确定影响决策的因素和在产科紧急情况中获得同意的挑战.
主要方法:
- 采用了定性基础理论方法.
- 针对性和理论抽样招募了51名参与者 (12名女性,12名分娩伴侣,16名产科医生,11名助产士) 在英格兰西北部的一家高等机构.
- 半结构面试进行并使用框架分析进行分析,直到数据和为止.
主要成果:
- 妇女更喜欢在活动时获得足够的,简洁的信息,而不是提前.
- 与产科医生的信任关系是女性参与的关键因素.
- 产科医生认为,在紧急情况下获得同意比常规程序更具挑战性.
结论:
- 妇女,伴侣和临床医生可以接受在PPH紧急情况下进行研究的口头同意,其后是追溯的书面同意.
- 提供适当和及时的信息对于明智的决策至关重要.
- 医疗保健专业人员需要专门的培训,以有效地导航在紧急情况下的同意过程.
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