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社区医院急诊科收治患者的呼吸道病毒感染前瞻性队列研究的原理和方案:呼吸道病毒感染对急诊入院的影响(EVERY)研究。

Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study.

机构信息

Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan

Department of Clinical Epidemiology, Hyogo Medical University, Nishinomiya, Japan.

出版信息

BMJ Open. 2024 Apr 15;14(4):e081037. doi: 10.1136/bmjopen-2023-081037.

Abstract

INTRODUCTION

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

METHODS AND ANALYSIS

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients' hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

ETHICS AND DISSEMINATION

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

TRIAL REGISTRATION NUMBER

NCT05913700.

摘要

简介

呼吸道合胞病毒(RSV)是一种引起全球普通感冒的病原体,在高危人群和老年人中可导致住院甚至死亡。然而,RSV 或其他偶发呼吸道感染与潜在疾病急性加重之间的关系尚未得到充分研究。本研究的主要目的是估计 RSV 的流行率、不良结局或住院的危险因素及其对因急性呼吸道症状从急诊科入院的患者的住院过程的影响。此外,我们评估与呼吸道症状相关的其他呼吸道病毒的流行率。

方法和分析

我们正在日本进行一项多中心前瞻性队列研究。我们计划在 2023 年 7 月 1 日至 2024 年 6 月 30 日期间,连续招募 3000 名因急性呼吸道症状或体征从急诊科入院的患者。在入院后 24 小时内采集鼻咽拭子,使用 FilmArray Respiratory 2.1 面板检测 RSV 和其他呼吸道病毒的流行率。从疑似下呼吸道感染的患者中采集配对血清样本,在入院时和 30 天后测量 RSV 抗体。在出院、死亡或入院后 30 天从电子病历中检索患者的住院过程信息。此外,在入院后 180 天收集再次入院和全因死亡率的信息。我们评估 RSV 或其他呼吸道病毒患者与无病毒患者之间的临床结局差异,并根据基线特征进行调整。临床结局包括院内死亡率、住院时间、疾病进展、实验室检查以及呼吸道症状或潜在疾病的管理。

伦理和传播

该研究方案已获得参与医院的机构审查委员会的批准。我们的研究报告将发表在学术期刊和国际会议上。

试验注册编号

NCT05913700。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c82/11029217/736e93b15538/bmjopen-2023-081037f01.jpg

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