新生儿重症监护中气管插管研究中家长对知情同意的看法。
Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care.
作者信息
Tippmann Susanne, Schäfer Janine, Arnold Christine, Winter Julia, Paul Norbert W, Mildenberger Eva, Kidszun André
机构信息
Division of Neonatology, Department of Pediatrics, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Division of Neonatology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
出版信息
Front Pediatr. 2024 Jan 8;11:1324948. doi: 10.3389/fped.2023.1324948. eCollection 2023.
BACKGROUND AND OBJECTIVE
Obtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care.
METHODS
This was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial.
RESULTS
We received responses from 33 mothers and 27 fathers ( = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, = 60) parents felt that the informed consent process was satisfactory. One parent (100%, = 1) approached before birth, 23 parents (82.1%, = 28) approached after birth but before enrolment and 26 (83.9%, = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment.
CONCLUSION
Parents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question.
背景与目的
在新生儿急诊研究中获得知情同意具有挑战性。本研究的目的是评估父母在参与新生儿急诊护理临床试验后的知情同意观念。
方法
这是一项对比较产房和新生儿重症监护病房中视频喉镜和直接喉镜用于新生儿气管插管的随机对照试验的补充分析。在获得临床试验的知情同意后，要求父母回答一系列关于他们对参与临床试验及同意过程看法的自填式问题。知情同意在出生前、出生后但在纳入试验前或纳入试验后给出。
结果
参与研究的63名早产和足月婴儿的父母中，我们收到了33名母亲和27名父亲（n = 60）的回复。53名（89.8%，n = 59）父母同意婴儿应参与临床试验，51名（85%，n = 60）父母同意应征求父母的知情同意。53名（89.8%，n = 59）父母认为他们的婴儿参与该特定试验会有益。52名（86.7%，n = 60）父母认为知情同意过程令人满意。1名在出生前被征求意见的父母（100%，n = 1）、23名在出生后但在入组前被征求意见的父母（82.1%，n = 28）以及26名在入组后被征求意见的父母（83.9%，n = 31）对同意过程的时机感到满意。8名（13.3%，n = 60）父母在提供知情同意时感到有些压力。其中，2名（25%）在入组前被征求意见，6名（75%）在入组后被征求意见。
结论
父母重视他们的婴儿参与新生儿急诊临床试验，并认为征求同意很重要。在本研究中，干预前或干预后获得同意似乎不那么重要。未来的研究可能需要调查对于相关个体研究，哪种同意形式是父母最能接受的。
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