在儿科围手术期和麻醉环境中招募参与者的障碍和促进因素：从褪黑激素与咪达唑仑在焦虑儿童用药前的试验中获得的经验教训（MAGIC试验）

BJA open Pub Date : 2025-02-04 DOI:10.1016/j.bjao.2024.100375

Marie C. Hyslop , Diana E. Papaioannou , Robert Bolt , Matthew J. Wilson , Michael Bradburn , Janet Clarkson , Esther Herbert , Nicholas Ireland , Jennifer Kettle , Amanda Loban , Amy C. Norrington , Christopher Vernazza , Christopher Deery

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引用次数: 0

摘要

招募不良是随机对照试验过早结束的一个关键原因。儿童全麻前褪黑素治疗焦虑（MAGIC）试验是一项多中心随机对照试验，在手术前，褪黑素与咪达唑仑在焦虑儿童用药前的对比。该试验于2019年至2022年进行，由于招聘无效而提前结束。本文描述了试验中出现的挑战，并为未来围手术期试验的设计提供了建议。方法采用基于案例的方法识别招聘障碍。作为定性子研究的一部分，与当地站点团队、参与者和护理人员的半结构化访谈也探讨了招聘的障碍和推动因素。结果遇到的问题包括在压力环境下的时间敏感性；儿科同意的可行性；研究药房可用性；麻醉师平衡的变化；药物前选择中的多因素决策问题副首席研究员计划无法支持麻醉实习生轮转的试验。未来的儿科围手术期药物试验可以考虑在工作时间以外资助研究药学；就拟在剧院入院单位进行的研究药物进行风险评估；以及量身定制的场地可行性评估设计，以帮助解决实践中的变化。将麻醉学培训生纳入副首席研究员计划结构的可行性仍面临挑战。结论麻醉及围手术期医学儿科临床试验人员招募面临重大挑战。MAGIC试验强调了麻醉实践在个人、地方和地区层面的差异。从MAGIC试验中吸取的经验教训确定了儿科试验注册的具体障碍，提供了解决方案并讨论了正在面临的挑战。临床试验注册：isrctn注册：ISRCTN18296119。

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Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial)

Background

Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. The trial ran between 2019 and 2022, closing early because of recruitment futility. This paper describes the challenges that arose during the trial and offers recommendations for the design of future perioperative trials.

Methods

A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment.

Results

Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure.

Conclusions

There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges.