新生儿重症监护中家长和医生选择退出同意的经验:一项试验中的混合方法研究。

IF 3.6 2区 医学 Q1 PEDIATRICS
Tracy Mitchell, Izabela Andrzejewska, Cheryl Battersby, Christina Cole, Zoe Daskalopoulou, Jon Dorling, Chris Gale, Michaela Graham, Marie Hubbard, Pollyanna Hardy, Madeleine Hurd, Andrew Robert King, Brett James Manley, David Murray, Elizabeth Nuthall, Heather O'Connor, Shalini Ojha, Calum T Roberts, Amy Rodriquez, Charles Christoph Roehr, Kayleigh Stanbury, Lyvonne Tume, Lauren Young, Kerry Woolfall
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引用次数: 0

摘要

背景:在新生儿试验中,口头选择退出同意已被用于减轻家庭负担,使招募更有效率和代表性。它包括在随机分配之前通过海报和传单提供信息,父母可以口头“选择退出”他们的孩子被随机分配到试验中。对于选择退出同意在多中心新生儿试验中是如何运作的,以及工作人员和家长对其可接受性的理解有限。目的:探讨新生儿随机试验neoGASTRIC中口头选择退出同意的观点和经验,该试验比较了早产儿常规和非常规胃内容物测量。方法:采用混合方法(问卷调查、访谈和焦点小组)在试验中进行评价。环境:四个英国新生儿病房。参与者:253名参与者;167名工作人员(149份问卷;18份来自两个焦点小组);86名家长(85份问卷;15份访谈;14份同时参与)。结果:家长和工作人员支持neoGASTRIC的选择退出同意,因为干预措施被认为是低风险和无创的。家长们喜欢在适当的时间进行研究谈话;只有21%的人注意到研究信息横幅/海报。选择退出同意的操作在提供信息的时间和随机化时间方面有所不同。在分娩期间或分娩数小时内接近的妇女报告说,她们感到不知所措,缺乏考虑研究的能力。一些工作人员采用了修改后的选择加入办法。结论:在一项低风险试验中,比较不同的可接受的临床非药物实践,在新生儿背景下,适当的时间口头选择退出方法被认为是可接受的。研究结果为neoGASTRIC提供了信息,并将指导这种情况下的同意方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial.

Background: In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally 'opt out' of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.

Objective: To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.

Methods: A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.

Setting: Four UK neonatal units.

Participants: 253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).

Results: Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.

Conclusions: An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.

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来源期刊
CiteScore
9.00
自引率
4.50%
发文量
90
审稿时长
6-12 weeks
期刊介绍: Archives of Disease in Childhood is an international peer review journal that aims to keep paediatricians and others up to date with advances in the diagnosis and treatment of childhood diseases as well as advocacy issues such as child protection. It focuses on all aspects of child health and disease from the perinatal period (in the Fetal and Neonatal edition) through to adolescence. ADC includes original research reports, commentaries, reviews of clinical and policy issues, and evidence reports. Areas covered include: community child health, public health, epidemiology, acute paediatrics, advocacy, and ethics.
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