Krutikov Maria, Fry Zoe, Azmi Borscha, Lezard Charlotte, Thorn Katie, Patefield Gareth, Childe Graeme, Hudson John, Stirrup Oliver, Jhass Arnoupe, Turner Nicola, Cassell Jackie, Flowers Paul, Hayward Andrew, Copas Andrew, Green Martin, Shallcross Laura
University College London, London, England, WC1E 6BT, UK.
Outstanding Society, Brighton, BN1 2RE, UK.
NIHR Open Res. 2024 Feb 15;4:4. doi: 10.3310/nihropenres.13530.1. eCollection 2024.
Care home residents are vulnerable to severe outcomes from infections such as COVID-19 and influenza. However, measures to control outbreaks, such as care home closures to visitors and new admissions, have a detrimental impact on their quality of life. Many infections and outbreaks could be prevented but the first step is to measure them reliably. This is challenging in care homes due to the lack of data and research infrastructure. During the pandemic, the VIVALDI study measured COVID-19 infections in residents and staff by partnering with care providers and using routinely collected data. This study aims to establish sentinel surveillance and a research database to enable observational and future interventional studies in care homes. The project has been co-produced with care providers, staff, residents, relatives, and researchers. The study (October 2023 to March 2025) will explore the feasibility of establishing a network of 500-1500 care homes for older adults in England that is underpinned by a linked data platform. No data will be collected from staff. The cohort will be created by regularly extracting resident identifiers from Digital Social Care Records (DSCR), followed by pseudonymisation and linkage to routinely collected datasets. Following extensive consultation, we decided not to seek informed consent from residents for data collection, but they can 'opt out' of the study. Our goal is to be inclusive, and it is challenging to give every resident the opportunity to 'opt in' due to cognitive impairment and the requirement for consultees. The project, and all requests to use the data will be overseen by relatives, residents, staff, and care providers. The study has been approved by the Health Research Authority Confidentiality Advisory Group (23/CAG/0134&0135) and the South-West Frenchay Research Ethics Committee (23/SW/0105). It is funded by the UK Health Security Agency.
养老院居民易受新冠病毒和流感等感染导致的严重后果影响。然而，控制疫情爆发的措施，如养老院禁止访客和新入住者进入，会对他们的生活质量产生不利影响。许多感染和疫情爆发是可以预防的，但第一步是要可靠地对其进行监测。由于缺乏数据和研究基础设施，这在养老院中具有挑战性。在疫情期间，VIVALDI研究通过与护理机构合作并使用常规收集的数据来监测居民和工作人员中的新冠病毒感染情况。本研究旨在建立哨点监测和研究数据库，以便在养老院进行观察性研究和未来的干预性研究。该项目是与护理机构、工作人员、居民、亲属和研究人员共同开展的。该研究（2023年10月至2025年3月）将探索在英格兰建立一个由500 - 1500家老年人养老院组成的网络的可行性，该网络以一个关联数据平台为支撑。不会从工作人员那里收集数据。通过定期从数字社会护理记录（DSCR）中提取居民标识符，随后进行假名化处理并与常规收集的数据集进行关联，来创建队列。经过广泛咨询，我们决定不寻求居民对数据收集的知情同意，但他们可以“退出”研究。我们的目标是具有包容性，由于认知障碍和咨询要求，让每个居民都有机会“加入”研究具有挑战性。该项目以及所有使用数据的请求将由亲属、居民、工作人员和护理机构进行监督。该研究已获得健康研究管理局保密咨询小组（23/CAG/0134&0135）和法国西南部弗伦奇研究伦理委员会（23/SW/0105）的批准。它由英国卫生安全局资助。
