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基于救护车服务的脑卒中随机对照试验的系统评价。

A systematic review of ambulance service-based randomised controlled trials in stroke.

机构信息

Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Queens Medical Centre Campus, Nottingham, NG7 2UH, UK.

East Midlands Ambulance Service NHS Trust, Nottingham, UK.

出版信息

Neurol Sci. 2023 Dec;44(12):4363-4378. doi: 10.1007/s10072-023-06910-w. Epub 2023 Jul 5.

Abstract

BACKGROUND

Treatment for stroke is time-dependent, and ambulance services play a vital role in the early recognition, assessment and transportation of stroke patients. Innovations which begin in ambulance services to expedite delivery of treatments for stroke are developing. However, research delivery in ambulance services is novel, developing and not fully understood.

AIMS

To synthesise literature encompassing ambulance service-based randomised controlled interventions for acute stroke with consideration to the characteristics of the type of intervention, consent modality, time intervals and issues unique to research delivery in ambulance services. Online searches of MEDLINE, EMBASE, Web of Science, CENTRAL and WHO IRCTP databases and hand searches identified 15 eligible studies from 538. Articles were heterogeneous in nature and meta-analysis was partially available as 13 studies reported key time intervals, but terminology varied. Randomised interventions were evident across all points of contact with ambulance services: identification of stroke during the call for help, higher dispatch priority assigned to stroke, on-scene assessment and clinical interventions, direct referral to comprehensive stroke centres and definitive care delivery at scene. Consent methods ranged between informed patient, waiver and proxy modalities with country-specific variation. Challenges unique to the prehospital setting comprise the geographical distribution of ambulance resources, low recruitment rates, prolonged recruitment phases, management of investigational medicinal product and incomplete datasets.

CONCLUSION

Research opportunities exist across all points of contact between stroke patients and ambulance services, but randomisation and consent remain novel. Early collaboration and engagement between trialists and ambulance services will alleviate some of the complexities reported.

REGISTRATION NUMBER

PROSPERO 2018CRD42018075803.

摘要

背景

脑卒中的治疗具有时间依赖性,救护车服务在脑卒中患者的早期识别、评估和转运中发挥着至关重要的作用。为了加速脑卒中治疗的实施,救护车服务领域正在开展创新。然而,救护车服务中的研究实施尚属新颖、发展中且尚未被充分理解。

目的

综合评估基于救护车服务的急性脑卒中随机对照干预研究文献,重点考虑干预类型、同意模式、时间间隔以及救护车服务中研究实施所特有的问题等特征。通过在线检索 MEDLINE、EMBASE、Web of Science、CENTRAL 和 WHO IRCTP 数据库以及手工检索,从 538 篇文章中筛选出 15 项符合条件的研究。这些文章在性质上存在异质性,由于仅有 13 项研究报告了关键时间间隔,但术语存在差异,因此部分可进行荟萃分析。随机干预措施可见于与救护车服务的各个接触点:呼救时识别脑卒中、为脑卒中患者分配更高的调度优先级、现场评估和临床干预、直接转至综合脑卒中中心以及现场实施确定性治疗。同意方法包括患者知情同意、豁免和代理同意,存在国家差异。院前环境中特有的挑战包括救护车资源的地理分布、低招募率、延长的招募阶段、试验药物的管理以及不完整的数据组。

结论

脑卒中患者与救护车服务的各个接触点都存在研究机会,但随机化和同意仍然是新颖的。试验人员与救护车服务早期的合作与参与将有助于缓解报告的部分复杂性。

注册号

PROSPERO 2018CRD42018075803。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eaff/10641071/0cfc16f7b4a0/10072_2023_6910_Fig1_HTML.jpg

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