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Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study
BJOG: An International Journal of Obstetrics & Gynaecology ( IF 4.7 ) Pub Date : 2024-11-08 , DOI: 10.1111/1471-0528.17997
Carol Bedwell, Wendy Taylor, Caroline Cunningham, Andrew D. Weeks, Dame Tina Lavender

ObjectiveTo understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage postpartum haemorrhage (PPH).DesignGrounded Theory.SettingTertiary facility in North‐West England, UK.SampleWe used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives.MethodsSemi‐structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique.ResultsMost women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency.ConclusionsThis is one of the first studies to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and those discussing consent require adequate training (199/200).

中文翻译:


产时研究的紧急口头同意:一项扎根理论研究



目的了解妇女、分娩伴侣和卫生专业人员在一项管理产后出血 (PPH) 装置的前瞻性队列研究中口头后回顾性书面同意的经验。设计接地理论.地点位于英国英格兰西北部的第三家工厂。样本我们使用目的和理论抽样招募了 51 名参与者;12 名妇女、12 名分娩伴侣、16 名产科医生和 11 名助产士。方法进行半结构化访谈,使用主题指南作为重点,直到达到数据饱和。使用框架分析技术分析数据。结果大多数女性希望获得足够的信息,以便在事件发生时做出决定,而不是提前做出决定,并且宁愿不被细节所淹没。决定参加的一个关键因素是与主治产科医生建立积极和信任的关系。产科医生认为,在紧急情况下获得研究同意需要不同的方法,并且比在紧急情况下同意标准程序更具挑战性。结论这是最早探索口头同意的研究之一,随后与女性、临床医生和观察者进行回顾性书面同意过程。这是所有人都能接受的,但是信息需要适当,并且那些讨论同意的人需要足够的培训 (199/200)。
更新日期:2024-11-08
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