TY - JOUR
T1 - Unravelling data for rapid evidence-based response to COVID-19: a summary of the unCoVer protocol
AU - UnCoVer Network
AU - Peñalvo, José L
AU - Mertens, Elly
AU - Ademović, Enisa
AU - Akgun, Seval
AU - Baltazar, Ana Lúcia
AU - Buonfrate, Dora
AU - Čoklo, Miran
AU - Devleesschauwer, Brecht
AU - Diaz Valencia, Paula Andrea
AU - Fernandes, João C
AU - Gómez, Enrique Javier
AU - Hynds, Paul
AU - Kabir, Zubair
AU - Klein, Jörn
AU - Kostoulas, Polychronis
AU - Llanos Jiménez, Lucía
AU - Lotrean, Lucia Maria
AU - Majdan, Marek
AU - Menasalvas, Ernestina
AU - Nguewa, Paul
AU - Oh, In-Hwan
AU - O'Sullivan, Georgie
AU - Pereira, David M
AU - Reina Ortiz, Miguel
AU - Riva, Silvia
AU - Soriano, Gloria
AU - Soriano, Joan B
AU - Spilki, Fernando
AU - Tamang, Mary Elizabeth
AU - Trofor, Antigona Carmen
AU - Vaillant, Michel
AU - Van Ierssel, Sabrina
AU - Vuković, Jakov
AU - Castellano, José M
N1 - FTX; DOAJ; (CC BY-NC 4.0) © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - COVID-19
KW - Europe
KW - Humans
KW - Pandemics
KW - SARS-CoV-2
U2 - 10.1136/bmjopen-2021-055630
DO - 10.1136/bmjopen-2021-055630
M3 - A1: Web of Science-article
C2 - 34794999
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e055630
ER -