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. 2021 Nov 18;11(11):e055630.
doi: 10.1136/bmjopen-2021-055630.

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

José L Peñalvo  1 , Elly Mertens  2 , Enisa Ademović  3 , Seval Akgun  4 , Ana Lúcia Baltazar  5 , Dora Buonfrate  6 , Miran Čoklo  7 , Brecht Devleesschauwer  8   9 , Paula Andrea Diaz Valencia  10 , João C Fernandes  11 , Enrique Javier Gómez  12   13   14 , Paul Hynds  15 , Zubair Kabir  16 , Jörn Klein  17 , Polychronis Kostoulas  18 , Lucía Llanos Jiménez  19 , Lucia Maria Lotrean  20 , Marek Majdan  21 , Ernestina Menasalvas  13 , Paul Nguewa  22 , In-Hwan Oh  23 , Georgie O'Sullivan  16 , David M Pereira  24 , Miguel Reina Ortiz  25 , Silvia Riva  26 , Gloria Soriano  2 , Joan B Soriano  27   28   29 , Fernando Spilki  30 , Mary Elizabeth Tamang  31 , Antigona Carmen Trofor  32   33 , Michel Vaillant  34 , Sabrina Van Ierssel  35 , Jakov Vuković  36 , José M Castellano  37   38   39 ; unCoVer network
Collaborators, Affiliations

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

José L Peñalvo et al. BMJ Open. .

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.

Keywords: COVID-19; public health; statistics & research methods.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Geographical distribution of the unCoVer network (Belgium, Bosnia and Herzegovina, Brazil, Colombia, Croatia, Greece, Ireland, Italy, Luxembourg, Norway, Portugal, Romania, Slovakia, South Korea, Spain, Turkey, UK and USA). unCoVer, Unravelling data for rapid evidence-based response to COVID-19.
Figure 2
Figure 2
Management structure of the unCoVer network. unCoVer, Unravelling data for rapid evidence-based response to COVID-19.
Figure 3
Figure 3
Secure multi-party computation of unCoVer data based on Opal-DataSHIELD infrastructure. unCoVer, Unravelling data for rapid evidence-based response to COVID-19.Abbreviation: DB, database.
Figure 4
Figure 4
Data management process of the COVID-19-related data available within the unCoVer network. DPIA, data protection impact assessment; unCoVer, Unravelling data for rapid evidence-based response to COVID-19; WP, work package.
See this image and copyright information in PMC

References

    1. World Health Organization . Expanding our understanding of post COVID-19 condition: report of a who webinar, 2021. [Accessed 09 Feb 2021].
    1. Zhou F, Yu T, Du R, et al. . Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 2020;395:1054–62. 10.1016/S0140-6736(20)30566-3 - DOI - PMC - PubMed
    1. Shi Y, Yu X, Zhao H, et al. . Host susceptibility to severe COVID-19 and establishment of a host risk score: findings of 487 cases outside Wuhan. Crit Care 2020;24:108. 10.1186/s13054-020-2833-7 - DOI - PMC - PubMed
    1. World Health Organization (WHO) . COVID-19 clinical management: living guidance, 2021. Available: https://www.who.int/publications/i/item/WHO-2019-nCoV-clinical-2021-1
    1. Jin Y, Ji W, Yang H, et al. . Endothelial activation and dysfunction in COVID-19: from basic mechanisms to potential therapeutic approaches. Signal Transduct Target Ther 2020;5:293. 10.1038/s41392-020-00454-7 - DOI - PMC - PubMed

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