CAEP 2024学术研讨会:加拿大急诊医学适应性平台试验。

IF 2.4
CJEM Pub Date : 2025-05-01 Epub Date: 2025-04-29 DOI:10.1007/s43678-025-00874-w
Nathalie Germain, Martyne Audet, Lorraine Graves, Srinivas Murthy, Shelley L McLeod, Jaspreet Khangura, Shirin Golchi, Andrew D McRae, Corinne M Hohl, Ivy Cheng, Gabrielle Olivier Chevrier, John C Marshall, Patrick M Archambault
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引用次数: 0

摘要

目的:加拿大急诊医师协会2024适应性平台试验学术研讨会小组探讨了适应性平台试验是否可以在加拿大急诊科(ed)实施。该小组旨在提出并完善根据快速审查结果和专家小组关于在ed中进行适应性平台试验的回应而制定的建议。方法:从2023年11月至2024年5月,对构建急诊医学适应性平台试验的现有后勤和伦理障碍和促进因素进行快速回顾。新出现的主题和想法被收集并用于与关键利益相关者进行个人半结构化访谈,包括急诊医学研究的领导者、专门从事这些设计的方法学家和生物统计学家、患者合作伙伴、研究人员和参与加拿大和国外平台试验的研究人员。结果:从23篇文章和17位专家访谈中,我们确定了加拿大急诊医学适应性平台试验的促进因素和障碍,涉及五个领域:证据强度和质量、相对优势、适应性、复杂性、实施环境和准备程度。研究人员认为,最突出的需求是有目的和临床相关的试验设计、方法学专业知识以及与伦理当局的和谐合作。我们提供了14条建议,跨越4个层面:政策、试验者、地点和患者,以解决急诊医学适应性平台试验的障碍。对于每一项建议,我们都提供了相应的实施策略,这些策略来自于实施变革的专家建议(ERIC)。结论:适应性试验设计非常适合急诊环境,前提是干预措施既易于临床医生实施,又足以改善急诊医学实践。这些设计是专门为解决验证性试验、新出现的疾病和创伤护理而量身定制的,但诸如混乱的急诊科、复杂的统计和方法要求以及监管方面的考虑等障碍仍然存在,需要深思熟虑的实施策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
CAEP 2024 Academic Symposium: adaptive platform trials in emergency medicine in Canada.

Objective: The Canadian Association of Emergency Physicians 2024 Academic Symposium Panel on adaptive platform trials explored whether adaptive platform trials could be implemented in Canadian emergency departments (EDs). This panel aimed to propose and refine recommendations formulated by the results of a rapid review and responses from a panel of experts about conducting adaptive platform trials in EDs.

Methods: From November 2023 to May 2024, a rapid review was conducted on the existing logistical and ethical barriers and facilitators to structuring adaptive platform trials in emergency medicine. The emerging themes and ideas were collected and used to conduct individual semi-structured interviews with key stakeholders, including leaders in emergency medicine research, methodologists and biostatisticians specializing in these designs, patient partners, research personnel, and investigators involved in platform trials across Canada and abroad.

Results: From 23 articles and 17 expert interviews, we identified facilitators and barriers to adaptive platform trials in Canadian emergency medicine spread across five domains: evidence strength and quality, relative advantage, adaptability, complexity, and implementation climate and readiness. The most salient needs according to investigators were purposeful and clinically relevant trial design, methodological expertise, and harmonious collaboration with ethics authorities. We provide 14 recommendations across 4 levels: policy, trialist, site, and patient to address barriers to adaptive platform trials in emergency medicine. For each recommendation, we provided corresponding implementation strategies from the Expert Recommendations for Implementing Change (ERIC).

Conclusions: Adaptive trial designs are well suited for emergency settings provided the interventions are both easy for clinicians to administer and relevant enough to ameliorate the practice of emergency medicine. These designs are particularly tailored to tackle confirmatory trials, emerging diseases, and trauma care, but barriers like a chaotic ED, complex statistical and methodological requirements, and regulatory considerations persist and require thoughtful implementation strategies.

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