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研究方案:了解英格兰养老院居民和工作人员中新型冠状病毒肺炎感染、免疫及其持续时间(VIVALDI)。

Study Protocol: Understanding SARS-Cov-2 infection, immunity and its duration in care home residents and staff in England (VIVALDI).

作者信息

Krutikov Maria, Palmer Tom, Donaldson Alasdair, Lorencatto Fabiana, Forbes Gill, Copas Andrew, Robson James, Hopkins Susan, Moss Paul, Farrar Jeremy, Hayward Andrew, Shallcross Laura

机构信息

Institute of Health Informatics, University College London, London, NW1 2DA, UK.

Institute for Global Health, University College London, London, WC1N 1EH, UK.

出版信息

Wellcome Open Res. 2021 Jan 29;5:232. doi: 10.12688/wellcomeopenres.16193.2. eCollection 2020.

DOI:10.12688/wellcomeopenres.16193.2
PMID:33564722
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7851710/
Abstract

Global infection and mortality rates from severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are disproportionately high in certain populations, including amongst older people. Care home residents are frequently exposed to infection due to contact with staff and other residents, and are highly susceptible to infection due to their age and co-morbidity. In England, official statistics suggest that at least 25% of all deaths in care home residents since the start of pandemic are linked to coronavirus disease 2019 (COVID-19), but limited testing for SARS-CoV-2 early in the pandemic means estimates of the true burden of disease are lacking. Additionally, little is known about patterns of transmission between care homes, the community and hospitals, or the relationship between infection and immunity in care home staff and residents. The VIVALDI study plans to address these questions. VIVALDI is a prospective cohort study aiming to recruit  6,500 staff and 5000 residents from 105 care homes across England. Successive rounds of testing for infection will be performed over a period of 12 months.  Nasopharyngeal swabs will detect evidence of viral RNA and therefore active infection (accompanied by collection of data on symptoms), whereas blood tests will detect antibodies and evidence of cellular immunity to SARS-CoV-2. Whole genome sequencing of viral isolates to investigate pathways of transmission of infection is planned in collaboration with the COVID-19 Genomics UK Consortium. Qualitative interviews with care home staff will investigate the impact of the pandemic on ways of working and how test results influence infection control practices and behaviours. Data from residents and staff will be linked to national datasets on hospital admissions, antibody and PCR test results, mortality and care home characteristics.  Data generated will support national public health efforts to prevent transmission of COVID-19 and protect care home staff and residents from infection. : ISRCTN14447421 05/06/2020.

摘要

严重急性呼吸综合征冠状病毒2(SARS-CoV-2)在某些人群中的全球感染率和死亡率过高,老年人尤为明显。由于与工作人员和其他居民接触,养老院居民经常暴露于感染风险中,且因其年龄和合并症,极易感染。在英国,官方统计数据表明,自大流行开始以来,养老院居民中至少25%的死亡与2019冠状病毒病(COVID-19)有关,但大流行初期对SARS-CoV-2的检测有限,这意味着缺乏对疾病真实负担的估计。此外,对于养老院、社区和医院之间的传播模式,以及养老院工作人员和居民中感染与免疫之间的关系,人们知之甚少。VIVALDI研究计划解决这些问题。VIVALDI是一项前瞻性队列研究,旨在从英国各地的105家养老院招募6500名工作人员和5000名居民。将在12个月内进行连续多轮感染检测。鼻咽拭子将检测病毒RNA证据,从而发现活跃感染(同时收集症状数据),而血液检测将检测抗体以及对SARS-CoV-2的细胞免疫证据。计划与英国COVID-19基因组学联盟合作,对病毒分离株进行全基因组测序,以研究感染传播途径。对养老院工作人员进行定性访谈,将调查大流行对工作方式的影响,以及检测结果如何影响感染控制措施和行为。居民和工作人员的数据将与关于医院入院、抗体和PCR检测结果、死亡率以及养老院特征的国家数据集相链接。所产生的数据将支持国家公共卫生工作,以预防COVID-19传播,并保护养老院工作人员和居民免受感染。:ISRCTN14447421 2020年6月5日

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