Abstract
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.
| Original language | English |
|---|---|
| Article number | e19773 |
| Journal | JMIR Public Health and Surveillance |
| Volume | 6 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2 Jul 2020 |
Bibliographical note
Funding Information: The RCGP RSC is principally funded by Public Health England. The PRINCIPLE trial is funded by UK Research and Innovation and the Department of Health and Social Care through the National Institute for Health Research. SdL is the Director of the Oxford Oxon-RCGP RSC; RB, JS, FF, and EK are partially funded by PHE; and CO and AC are funded by a Wellcome Biomedical resources grant (212763/Z/18/Z). JD and NJ are funded by the Wellcome Trust (216421/Z/19/Z). FDRH is partially funded by the National Institute for Health Research (NIHR) School for Primary Care Research, the NIHR Collaboration for Leadership in Health Research and Care (CLARHC) Oxford, the NIHR Oxford Biomedical Research Centre (BRC), and the NIHR Oxford Medtech and In-Vitro Diagnostics Co-operative (MIC). We acknowledge the contributions of Myer Glickman (ONS), Nick Andrews (PHE), Matthew Swindells (Visiting Professor, University of London), and Ming Tang (NHS England and Improvement).Open Access: This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Public Health and Surveillance, is properly cited. The complete bibliographic information, a link to the original publication on http://publichealth.jmir.org, as well as this copyright and license information must be included.
Publisher Copyright: © Simon de Lusignan, Nicholas Jones, Jienchi Dorward, Rachel Byford, Harshana Liyanage, John Briggs, Filipa Ferreira, Oluwafunmi Akinyemi, Gayatri Amirthalingam, Chris Bates, Jamie Lopez Bernal, Gavin Dabrera, Alex Eavis, Alex J Elliot, Michael Feher, Else Krajenbrink, Uy Hoang, Gary Howsam, Jonathan Leach, Cecilia Okusi, Brian Nicholson, Philip Nieri, Julian Sherlock, Gillian Smith, Mark Thomas, Nicholas Thomas, Manasa Tripathy, William Victor, John Williams, Ian Wood, Maria Zambon, John Parry, Shaun O’Hanlon, Mark Joy, Chris Butler, Martin Marshall, FD Richard Hobbs.
Citation: de Lusignan S, Jones N, Dorward J, Byford R, Liyanage H, Briggs J, Ferreira F, Akinyemi O, Amirthalingam G, Bates C, Lopez Bernal J, Dabrera G, Eavis A, Elliot A, Feher M, Krajenbrink E, Hoang U, Howsam G, Leach J, Okusi C, Nicholson B, Nieri P, Sherlock J, Smith G, Thomas M, Thomas N, Tripathy M, Victor W, Williams J, Wood I, Zambon M, Parry J, O’Hanlon S, Joy M, Butler C, Marshall M, Hobbs F
The Oxford Royal College of General Practitioners Clinical Informatics Digital Hub: Protocol to Develop Extended COVID-19 Surveillance and Trial Platforms
JMIR Public Health Surveill 2020;6(3):e19773 URL: https://publichealth.jmir.org/2020/3/e19773
DOI: DOI: 10.2196/19773
Keywords
- Adaptive clinical trials
- COVID-19
- Clinical trials as a topic
- General practice
- Medical record systems, computerized
- Primary health care
- Public health surveillance
- Sentinel surveillance
- Severe acute respiratory syndrome coronavirus 2
