The Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Protocol to Develop Extended COVID-19 Surveillance and Trial Platforms
The Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Protocol to Develop Extended COVID-19 Surveillance and Trial Platforms
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DOI：
10.2196/19773
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发表时间：
2020-07-01
影响因子：
8.5
通讯作者：
Hobbs, Richard
中科院分区：
文献类型：
--
作者：
de Lusignan, Simon;Jones, Nicholas;Hobbs, Richard
背景：哨兵网络多年来一直使用常规记录的初级保健数据进行监测。最近，现实世界数据已被用于更广泛的研究项目，以支持快速、廉价的临床试验。由于冠状病毒病 (COVID-19) 大流行导致英国部分国家封锁，导致社区疾病发病率下降，因此需要大量的全科实践来提供有效的 COVID-19 监测并为大流行期间的临床试验做出贡献。 目的：本协议的目的是描述牛津皇家全科医生学院临床信息学数字中心 (ORCHID) 及其前两个平台的快速设计和开发。监视平台将提供扩展的初级保健监测，而试验平台是一个简化的临床试验平台，将整合到常规初级保健实践中。方法：我们将把 FAIR（可查找、可访问、可互操作和可重复使用）元数据原则应用于新的集成数字健康中心，该中心将提取常规收集的一般实践电子健康数据用于临床试验，并提供增强的传染病监测。该中心可通过英国健康数据研究中心和欧洲元数据存储库的会员资格找到。通过在线申请系统的可访问性将提供对研究就绪数据集或开发的定制数据集的访问。通过使用假名数据与其他关键来源（例如医院事件统计数据和国家统计局）的固定链接将促进互操作性。用于分析的所有语义描述符（即本体）和代码将可用于加速分析。我们还将使用通用数据模型提供数据，从美国食品和药物管理局哨兵和观察性医疗结果合作伙伴方法开始，以促进国际研究。根据牛津大学、皇家全科医生学院和英格兰公共卫生部门之间协议的授权，监控平台将提供健康保护和促进工作数据的访问权限。使用试验平台的所有研究都将经过适当的道德和其他监管审批流程。结果：该中心将成为一个自下而上、专业主导的网络，将为会员实践、我们的医疗服务和所服务的人群带来好处。数据将仅用于 SQUIRE（监视、质量改进、研究和教育）目的。我们已经收到了诊所的积极回应，自 2020 年 2 月以来，网络中的诊所数量已增加一倍，达到 1150 多个。COVID-19 监测使病毒学站点数量增加了两倍，达到 293 个（目标 300 个），这有助于收集英国有史以来最大的每周监测拭子总数以及 3000 多个严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 血清学样本。实践正在招募 PRINCIPLE（针对老年人的 COVID-19 干预平台随机试验）试验，这些参与者将通过 ORCHID 进行随访。这些初步成果证明了 ORCHID 提供扩展的国家数字医疗中心的可行性。结论：ORCHID 将通过专业领导的国家初级保健网络和 FAIR 原则的应用，提供大数据的公平和创新使用。安全数据中心将托管定期收集的一般实践数据，这些数据链接到其他关键医疗保健存储库以进行临床试验，并支持增强的现场监测，而无需始终提取大量数据。 ORCHID 将支持快速数据提取、分析和传播，旨在改善未来的一般实践研究和开发，从而对患者护理产生积极影响。
Background: Routinely recorded primary care data have been used for many years by sentinel networks for surveillance. More recently, real world data have been used for a wider range of research projects to support rapid, inexpensive clinical trials. Because the partial national lockdown in the United Kingdom due to the coronavirus disease (COVID-19) pandemic has resulted in decreasing community disease incidence, much larger numbers of general practices are needed to deliver effective COVID-19 surveillance and contribute to in-pandemic clinical trials.Objective: The aim of this protocol is to describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital Hub (ORCHID) and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform is a streamlined clinical trials platform that will be integrated into routine primary care practice.Methods: We will apply the FAIR (Findable, Accessible, Interoperable, and Reusable) metadata principles to a new, integrated digital health hub that will extract routinely collected general practice electronic health data for use in clinical trials and provide enhanced communicable disease surveillance. The hub will be findable through membership in Health Data Research UK and European metadata repositories. Accessibility through an online application system will provide access to study-ready data sets or developed custom data sets. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymized data. All semantic descriptors (ie, ontologies) and code used for analysis will be made available to accelerate analyses. We will also make data available using common data models, starting with the US Food and Drug Administration Sentinel and Observational Medical Outcomes Partnership approaches, to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorized through agreements between Oxford, the Royal College of General Practitioners, and Public Health England. All studies using the Trials Platform will go through appropriate ethical and other regulatory approval processes.Results: The hub will be a bottom-up, professionally led network that will provide benefits for member practices, our health service, and the population served. Data will only be used for SQUIRE (surveillance, quality improvement, research, and education) purposes. We have already received positive responses from practices, and the number of practices in the network has doubled to over 1150 since February 2020. COVID-19 surveillance has resulted in tripling of the number of virology sites to 293 (target 300), which has aided the collection of the largest ever weekly total of surveillance swabs in the United Kingdom as well as over 3000 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology samples. Practices are recruiting to the PRINCIPLE (Platform Randomised trial of INterventions against COVID-19 In older PeopLE) trial, and these participants will be followed up through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national digital health hub.Conclusions: ORCHID will provide equitable and innovative use of big data through a professionally led national primary care network and the application of FAIR principles. The secure data hub will host routinely collected general practice data linked to other key health care repositories for clinical trials and support enhanced in situ surveillance without always requiring large volume data extracts. ORCHID will support rapid data extraction, analysis, and dissemination with the aim of improving future research and development in general practice to positively impact patient care.