Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Rapid innovation to deliver extended COVID-19 surveillance and trial platforms.

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 with the anticipation they could be used to support rapid, lower cost clinical trials. Much larger numbers of general practices are required to deliver effective surveillance and in-pandemic trials, given the partial national lockdown has resulted in falling community disease incidence. OBJECTIVE: To describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital (ORCHID) Hub, and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform will be a streamlined clinical trials platform 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 of Health Data Research UK and European metadata repositories. Accessibility through an online application system will allow study-ready datasets to be accessed or custom datasets developed. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymised data. All semantic descriptors (i.e. 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 FDA Sentinel and OMOP approaches to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorised through agreements between Oxford, the Royal College of General Practitioners and by Public Health England. All studies using the Trials Platform will have gone through appropriate ethical and other regulatory approval. RESULTS: The hub will be a bottom-up, professionally led network ensuring 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. There has already been a positive response from practices and the number in the network has doubled since February 2020 to over 1,150. COVID-19 Surveillance has delivered a trebling of virology sites to 293 (target 300), helping collect the largest ever weekly total of surveillance swabs in the UK as well as over 3,000 SARS-CoV-2 serology samples. Practices are recruiting to the PRINCIPLE trial and follow-up of these participants will take place through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national, digital health hub. CONCLUSIONS: ORCHID will deliver 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 healthcare repositories for clinical trials and support enhanced surveillance in-situ, without always needing 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 upon patient care. CLINICALTRIAL: