救护车早期强化降压卒中试验的过程评估:设计、原理与反思。

IF 2.2 3区 医学 Q3 CLINICAL NEUROLOGY Cerebrovascular Diseases Pub Date : 2024-09-05 DOI:10.1159/000541322
Ruixue Liu, Chen Chen, Feifeng Liu, Yapeng Lin, Hongling Chu, Hueiming Liu, Craig S Anderson, Jie Yang, Gang Li, Lili Song, Menglu Ouyang
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引用次数: 0

摘要

导言:第四届INTEnsive救护车降压治疗超急性脑卒中试验(INTERACT4)是一项在中国救护车上开展的大规模、多中心、前瞻性、随机、开放标签、盲法终点评估试验,旨在评估院前降压治疗疑似急性脑卒中血压升高患者的有效性和安全性。预设的过程评价旨在探索试验干预的实施情况,为解释试验结果提供支持,并为今后在更广泛的环境中推广干预提出建议:该过程评估采用混合方法设计,遵循规范化过程理论(NPT)和英国医学研究理事会(UK MRC)的指导。将对院前早期强化降压治疗的保真度、覆盖面、可接受性、适宜性、采用率、可持续性以及影响实施的相关环境因素和机制进行分析。对救护车工作人员、病房和急诊科临床医生及护士进行半结构式访谈,探讨他们对干预措施的看法、背景因素以及对未来在实践中实施的潜在建议。还将对观察记录、调查、常规监测数据、现场记录和病例报告表中的数据进行分析,以了解背景护理和环境:INTERACT4的过程评估将为院前早期强化降压干预在不同医疗系统的实施提供启示,并有助于更好地解释试验结果,以便进一步扩大规模。
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Process Evaluation of an Ambulance-Delivered Early Intensive Blood Pressure-Lowering Stroke Trial: Design, Rationale, and Reflection.

Introduction: The fourth INTEnsive ambulance-delivered blood pressure Reduction in hyper-ACute stroke Trial (INTERACT4) is a large-scale, multicenter, prospective, randomized, open-label, blinded endpoint assessment trial, initiated in an ambulance in China, aiming at evaluating the effectiveness and safety of prehospital blood pressure (BP) lowering in patients with suspected acute stroke and elevated BP. A prespecified process evaluation is intended to explore the implementation of the trial intervention, provide support to interpret the trial outcomes and put forward suggestions to scale up the intervention in broader settings in the future.

Methods: This process evaluation is a mixed-methods design, and follows the Normalization Process Theory (NPT) and the UK Medical Research Council (UK MRC) guidance. Fidelity, reach, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting the implementation of prehospital early intensive BP-lowering treatment will be analyzed. Semi-structured interviews with ambulance staff, ward and emergency department clinicians, and nurses are undertaken to explore perceptions of the intervention, contextual factors, and potential suggestions for future implementation in practice. Data from observational records, surveys, conventional monitoring data, on-site records, and case report forms will be analyzed to understand background care and context.

Conclusion: The process evaluation of INTERACT4 will provide insights for the implementation of prehospital early intensive BP-lowering intervention in different health systems and help better explain the trial results for further scale up.

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来源期刊
Cerebrovascular Diseases
Cerebrovascular Diseases 医学-临床神经学
CiteScore
4.50
自引率
0.00%
发文量
90
审稿时长
1 months
期刊介绍: A rapidly-growing field, stroke and cerebrovascular research is unique in that it involves a variety of specialties such as neurology, internal medicine, surgery, radiology, epidemiology, cardiology, hematology, psychology and rehabilitation. ''Cerebrovascular Diseases'' is an international forum which meets the growing need for sophisticated, up-to-date scientific information on clinical data, diagnostic testing, and therapeutic issues, dealing with all aspects of stroke and cerebrovascular diseases. It contains original contributions, reviews of selected topics and clinical investigative studies, recent meeting reports and work-in-progress as well as discussions on controversial issues. All aspects related to clinical advances are considered, while purely experimental work appears if directly relevant to clinical issues.
期刊最新文献
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