Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol

Penalvo, J, Mertens, E, Ademović, E, Akgun, S, Baltazar, AM, Buonfrate, D, Čoklo, M, Devleesschauwer, B, Diaz Valencia, PA, Fernandes, JC, Gómez, EJ, Hynds, P, Kabir, Z, Klein, J, Kostoulas, P, Jiménez, LL, Lotrean, LM, Majdan, M, Menasalvas, E, Nguewa, P, Oh, I, O’Sullivan, G, Pereira, DM, Reina Ortiz, M, Riva, Silvia ORCID: https://orcid.org/0000-0003-2153-0169, Soriano, G, Soriano, JB, Spilki, F, Tamang, ME, Trofor, AC, Vaillant, M, Van Iersse, S, Vuković, J and Castellano, JM (2021) Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol. BMJ Open, 11. ISSN 2044-6055 DOI: https://doi.org/10.1136/ bmjopen-2021-055630

Abstract

Introduction unCoVer—Unravelling data for rapid evidence-based response to COVID-19—is a Horizon 2020-funded network of 29 partners from 18 countries capable of collecting and using real-world data (RWD) derived from the response and provision of care to patients with COVID-19 by health systems across Europe and elsewhere. unCoVer aims to exploit the full potential of this information to rapidly address clinical and epidemiological research questions arising from the evolving pandemic. Methods and analysis From the onset of the COVID-19 pandemic, partners are gathering RWD from electronic health records currently including information from over 22 000 hospitalised patients with COVID-19, and national surveillance and screening data, and registries with over 1 900 000 COVID-19 cases across Europe, with continuous updates. These heterogeneous datasets will be described, harmonised and integrated into a multi-user data repository operated through Opal-DataSHIELD, an interoperable open-source server application. Federated data analyses, without sharing or disclosing any individual-level data, will be performed with the objective to reveal patients’ baseline characteristics, biomarkers, determinants of COVID-19 prognosis, safety and effectiveness of treatments, and potential strategies against COVID-19, as well as epidemiological patterns. These analyses will complement evidence from efficacy/safety clinical trials, where vulnerable, more complex/heterogeneous populations and those most at risk of severe COVID-19 are often excluded. Ethics and dissemination After strict ethical considerations, databases will be available through a federated data analysis platform that allows processing of available COVID-19 RWD without disclosing identification information to analysts and limiting output to data aggregates. Dissemination of unCoVer’s activities will be related to the access and use of dissimilar RWD, as well as the results generated by the pooled analyses. Dissemination will include training and educational activities, scientific publications and conference communications.

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Item Type:	Journal Article
Date Deposited:	01 Nov 2022 13:39
URI:	https://research.stmarys.ac.uk/id/eprint/5516
Additional Information:	The unCoVer (Unravelling data for rapid evidence-based response to COVID-19) network includes a sizeable number of partners that will exploit the full potential of real-world data derived from the provision of care to patients with COVID-19 by health systems across Europe and elsewhere. With the availability of international harmonised real-world data provided by the unCoVer network, a large amount of information on patients with COVID-19 will be studied to better understand aspects of pathophysiology, progression and treatment, and the epidemiological patterns of this novel disease, as well as to grasp the less understood, and potentially unearthed, risk factors associated with COVID-19 severity. The development and deployment of a federated data platform for combined analysis meet patients’ data protection principles and comply with ethical standards, including general data protection regulation and national data privacy legislation, while allowing for advanced analytics. Continuous process evaluation will be carried out throughout the project life to identify limitations and barriers to the harmonised use of data, and simultaneously providing advice on improving data systems for rapid response to future public health crises.
Research area:	150 Psychology
School/Department:	Department of Psychology & Pedagogic Science

Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol

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