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菲律宾多中心统一采集短暂性脑缺血发作或脑卒中住院患者数据:菲律宾神经病学协会单数据库-脑卒中(PNA1DB-Stroke)方案。

Multicentre collection of uniform data on patients hospitalised for transient ischaemic attack or stroke in the Philippines: the Philippine Neurological Association One Database-Stroke (PNA1DB-Stroke) protocol.

出版信息

BMJ Open. 2022 May 24;12(5):e055954. doi: 10.1136/bmjopen-2021-055954.

Abstract

INTRODUCTION

For scientific advances to translate into improved patient outcomes, systems of care must be in place to facilitate delivery of care. There is scarce information on quality of care and clinical outcome in our stroke patients. We aim to collect uniform data from patients with first or recurrent transient ischaemic attack (TIA) or ischaemic or haemorrhagic stroke to determine in-patient caseload, patient profile, types of diagnostic and therapeutic procedures, outcomes and overall quality of care among patients hospitalised for acute stroke in the Philippines.

METHODS AND ANALYSIS

This multicentre observational study and standing database will include patients diagnosed with first or recurrent TIA, ischaemic or haemorrhagic stroke or cerebral venous thrombosis, ≥18 years old, and admitted in any of the country's 11 accredited adult neurology residency training institutions. Anonymised data on sociodemographics, medical history, stroke subtype, in-hospital management and discharge outcomes will be collected and entered in a database using a secure online data platform. Outcomes include in-hospital complications, functional, neurological and vital (alive or dead) status at discharge.We intend to capture data from all TIA and stroke cases in participating sites. Based on 2017-2019 census, approximately 10 000 cases each year may be included. Collective data spanning 3 years will be extracted, summarised and analysed every year.

ETHICS AND DISSEMINATION

Approval from ethics committees or institutional review boards (EC/IRB) was obtained from the Single Joint Research Ethics Board and all participating institutions. As this study involves no more than minimal risk to patients, waiver of informed consent was requested. Written information about the study will be provided to patients or legal representative. If site EC/IRB requires written consent, only approved consent forms will be used.To identify areas of improvement and guide public health policies, data on 'real-world' situation are needed. The Philippine Neurological Association One Database-Stroke initiative may become a model that can be implemented in other designated stroke-ready hospitals.

TRIAL REGISTRATION

NCT04972058; ClinicalTrials.gov.

摘要

简介

为了将科学进步转化为改善患者预后,必须建立医疗保健系统以促进医疗服务的提供。我们的中风患者的护理质量和临床结果信息稀缺。我们旨在从首次或复发性短暂性脑缺血发作(TIA)或缺血性或出血性中风患者中收集统一数据,以确定菲律宾因急性中风住院患者的住院患者人数、患者特征、诊断和治疗程序类型、结果以及整体护理质量。

方法和分析

这项多中心观察性研究和常设数据库将包括首次或复发性 TIA、缺血性或出血性中风或脑静脉血栓形成、≥18 岁且在菲律宾 11 个经认证的成人神经病学居住培训机构之一住院的患者。将收集并使用安全的在线数据平台将患者的社会人口统计学、病史、中风亚型、住院管理和出院结果的匿名数据输入数据库。结果包括住院并发症、出院时的功能、神经和生命(存活或死亡)状况。我们打算从参与地点捕获所有 TIA 和中风病例的数据。根据 2017-2019 年的人口普查,每年可能会包括大约 10000 例病例。每年将提取、总结和分析为期 3 年的集体数据。

伦理和传播

单一联合研究伦理委员会和所有参与机构均已获得伦理委员会/机构审查委员会(EC/IRB)的批准。由于这项研究对患者的风险不超过最小风险,因此要求免除知情同意。将向患者或法定代表提供有关该研究的书面信息。如果现场 EC/IRB 需要书面同意,则只能使用经批准的同意书。为了确定改进领域并指导公共卫生政策,需要了解“真实世界”情况的数据。菲律宾神经病学协会一个数据库-中风倡议可能成为可以在其他指定的中风准备就绪的医院实施的模式。

试验注册

NCT04972058;ClinicalTrials.gov。

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