Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK
Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
BMJ Open. 2024 Jan 2;14(1):e077023. doi: 10.1136/bmjopen-2023-077023.
The Bronchiolitis Endotracheal Surfactant Study (BESS) is a randomised controlled trial to determine the efficacy of endo-tracheal surfactant therapy for critically ill infants with bronchiolitis. To explore acceptability of BESS, including approach to consent within a limited time frame, we explored parent and staff experiences of trial involvement in the first two bronchiolitis seasons to inform subsequent trial conduct.
A mixed-method embedded study involving a site staff survey, questionnaires and interviews with parents approached about BESS.
Fourteen UK paediatric intensive care units.
Of the 179 parents of children approached to take part in BESS, 75 parents (of 69 children) took part in the embedded study. Of these, 55/69 (78%) completed a questionnaire, and 15/69 (21%) were interviewed. Thirty-eight staff completed a questionnaire.
Parents and staff found the trial acceptable. All constructs of the Adapted Theoretical Framework of Acceptability were met. Parents viewed surfactant as being low risk and hoped their child's participation would help others in the future. Although parents supported research without prior consent in studies of time critical interventions, they believed there was sufficient time to consider this trial. Parents recommended that prospective informed consent should continue to be sought for BESS. Many felt that the time between the consent process and intervention being administered took too long and should be 'streamlined' to avoid delays in administration of trial interventions. Staff described how the training and trial processes worked well, yet patients were missed due to lack of staff to deliver the intervention, particularly at weekends.
Parents and staff supported BESS trial and highlighted aspects of the protocol, which should be refined, including a streamlined informed consent process. Findings will be useful to inform proportionate approaches to consent in future paediatric trials where there is a short timeframe for consent discussions.
ISRCTN11746266.
毛细支气管炎气管内表面活性物质研究（BESS）是一项随机对照试验，旨在确定气管内表面活性物质治疗毛细支气管炎危重症婴儿的疗效。为了探索 BESS 的可接受性，包括在有限时间内进行知情同意的方法，我们在头两个毛细支气管炎季节探索了家长和工作人员对试验参与的经验，为后续试验提供信息。
一项混合方法嵌入式研究，包括对参与 BESS 的现场工作人员进行调查、对接受 BESS 评估的家长进行问卷调查和访谈。
英国 14 家儿科重症监护病房。
在 179 名被评估参与 BESS 的儿童家长中，有 75 名家长（69 名儿童中的 69 名）参与了嵌入式研究。其中，55/69（78%）完成了问卷，15/69（21%）接受了访谈。38 名工作人员完成了问卷。
家长和工作人员认为该试验是可以接受的。可接受性的适应理论框架的所有构建都得到了满足。家长认为表面活性物质的风险较低，并希望他们孩子的参与能帮助未来的其他人。尽管家长支持在时间关键干预研究中进行无事先同意的研究，但他们认为有足够的时间来考虑这项试验。家长建议，应继续为 BESS 寻求前瞻性知情同意。许多人认为，从同意过程到干预措施实施之间的时间过长，应该“简化”，以避免干预措施实施的延误。工作人员描述了培训和试验过程是如何顺利进行的，但由于缺乏提供干预措施的工作人员，特别是在周末，有患者被漏诊。
家长和工作人员支持 BESS 试验，并强调了协议的某些方面需要改进，包括简化知情同意程序。这些发现将有助于为未来儿科试验中需要在短时间内进行知情同意讨论的情况提供适当的同意方法。
ISRCTN86176414。
