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农村院前急性卒中分诊(PAST)试验方案:一项旨在将农村急性卒中患者快速转运至区域卒中中心的对照试验

The rural Prehospital Acute Stroke Triage (PAST) trial protocol: a controlled trial for rapid facilitated transport of rural acute stroke patients to a regional stroke centre.

机构信息

Stroke Program, Centre for Brain & Mental Health Research, John Hunter Hospital, University of Newcastle and Hunter Medical Research Institute, Lookout Road, New Lambton Heights 2305, NSW, Australia.

出版信息

Int J Stroke. 2010 Dec;5(6):506-13. doi: 10.1111/j.1747-4949.2010.00522.x.

DOI:10.1111/j.1747-4949.2010.00522.x
PMID:21050409
Abstract

RATIONALE

Access to intravenous thrombolysis for acute ischaemic stroke is limited worldwide, particularly in regional and rural areas including in Australia. We are testing the effectiveness of a new rural Prehospital Acute Stroke Triage protocol that includes prehospital assessment and rapid transport of patients from a rural catchment to the major stroke centre in Newcastle, NSW, Australia. The local district hospitals within the rural catchment do not have the capability or infrastructure to deliver acute stroke thrombolysis. The trial has relevance to stroke clinicians, health service managers and planners responsible for rural populations.

AIMS

To implement a system of rapid prehospital assessment and facilitated transport that will significantly increase stroke thrombolysis rates to 10% of ischaemic stroke cases in the rural catchment. Validate an eight-point modified National Institutes of Health Stroke Scale for use by paramedics in the prehospital setting to assess patients' potential eligibility for stroke thrombolysis.

DESIGN

The joint project between the John Hunter Hospital Acute Stroke Team and the Ambulance Service of NSW will use a prospective cohort with an historical control group. Tools and protocols have been developed and education undertaken for ambulance field and operations centre personnel. These include a cut-down eight-item National Institutes of Health Stroke Scale (Hunter NIHSS-8) score to be used in the field by paramedics and a transport decision matrix to expedite transport for a suspected stroke patient (road or road plus air transport).

OUTCOMES

The primary outcome measure will be the rate of intravenous tissue plasminogen activator delivery for those who suffer an ischaemic stroke following protocol implementation, in comparison with historical rates over a corresponding period prior to implementation, for residents within the catchment. Sixty cases are required in the postimplementation time epoch to demonstrate a statistically significant absolute increase in thrombolysis rates for ischaemic strokes from <1% to 10%, (power of 80%, α error of 0.05). The major secondary outcome will be inter-rater reliability of the Hunter NIHSS-8.

摘要

背景

全世界范围内,急性缺血性脑卒中患者接受静脉溶栓治疗的机会有限,包括在澳大利亚的一些地区和农村地区。我们正在测试一种新的农村院前急性脑卒中分诊方案的有效性,该方案包括院前评估和将患者从农村流域快速转运到新南威尔士州纽卡斯尔的主要脑卒中中心。农村流域内的当地地区医院没有提供急性脑卒中溶栓治疗的能力或基础设施。该试验与负责农村人群的脑卒中临床医生、卫生服务管理者和规划者有关。

目的

建立一个快速院前评估和便捷转运系统,将农村流域内缺血性脑卒中患者的溶栓治疗率提高到 10%。验证改良的 NIH 脑卒中量表(NIHSS)8 项评分,以评估患者接受脑卒中溶栓治疗的潜在可能性,供护理人员在院前环境中使用。

设计

约翰·亨特医院急性脑卒中治疗小组和新南威尔士州救护车服务机构之间的联合项目将采用前瞻性队列研究和历史对照组。已经为救护车现场和运营中心人员开发了工具和方案,并开展了相关教育。这些工具包括简化的 NIHSS 8 项评分(Hunter NIHSS-8),供护理人员在现场使用,以及一个转运决策矩阵,用于加快疑似脑卒中患者的转运(公路或公路加空运转运)。

结果

主要结局指标是在实施方案后,那些在流域内居住并发生缺血性脑卒中的患者接受静脉组织型纤溶酶原激活物治疗的比率,与实施前相应时间段内的历史比率相比。在实施后时间点需要 60 例病例,以证明缺血性脑卒中溶栓治疗率从<1%提高到 10%具有统计学意义的绝对增加(效能 80%,α误差 0.05)。主要次要结局是 Hunter NIHSS-8 的组内一致性。

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