Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

Gianluigi Li Bassi; Jacky Suen; Adrian Gerard Barnett; Amanda Corley; Jonathan Millar; Jonathon Fanning; India Lye; Sebastiano Colombo; Karin Wildi; Samantha Livingstone; Gabriella Abbate; Samuel Hinton; Benoit Liquet; Sally Shrapnel; Heidi Dalton; John F. Fraser; COVID-19 Critical Care Consortium

doi:10.1136/bmjopen-2020-041417

Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

Gianluigi Li Bassi^*, Jacky Suen, Adrian Gerard Barnett, Amanda Corley, Jonathan Millar, Jonathon Fanning, India Lye, Sebastiano Colombo, Karin Wildi, Samantha Livingstone, Gabriella Abbate, Samuel Hinton, Benoit Liquet, Sally Shrapnel, Heidi Dalton, John F. Fraser, COVID-19 Critical Care Consortium

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

27 Citations (Scopus)

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Abstract

Introduction: There is a paucity of data that can be used to guide the management of critically ill patients with COVID-19. In response, a research and data-sharing collaborative-The COVID-19 Critical Care Consortium-has been assembled to harness the cumulative experience of intensive care units (ICUs) worldwide. The resulting observational study provides a platform to rapidly disseminate detailed data and insights crucial to improving outcomes.

Methods and analysis: This is an international, multicentre, observational study of patients with confirmed or suspected SARS-CoV-2 infection admitted to ICUs. This is an evolving, open-ended study that commenced on 1 January 2020 and currently includes >350 sites in over 48 countries. The study enrols patients at the time of ICU admission and follows them to the time of death, hospital discharge or 28 days post-ICU admission, whichever occurs last. Key data, collected via an electronic case report form devised in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium/Short Period Incidence Study of Severe Acute Respiratory Illness networks, include: patient demographic data and risk factors, clinical features, severity of illness and respiratory failure, need for non-invasive and/or mechanical ventilation and/or extracorporeal membrane oxygenation and associated complications, as well as data on adjunctive therapies.

Ethics and dissemination: Local principal investigators will ensure that the study adheres to all relevant national regulations, and that the necessary approvals are in place before a site may contribute data. In jurisdictions where a waiver of consent is deemed insufficient, prospective, representative or retrospective consent will be obtained, as appropriate. A web-based dashboard has been developed to provide relevant data and descriptive statistics to international collaborators in real-time. It is anticipated that, following study completion, all de-identified data will be made open access.

Trial registration number: ACTRN12620000421932 (http://anzctr.org.au/ACTRN12620000421932.aspx).

Original language	English
Article number	e041417
Pages (from-to)	1-6
Number of pages	6
Journal	BMJ Open
Volume	10
Issue number	12
DOIs	https://doi.org/10.1136/bmjopen-2020-041417
Publication status	Published - 2 Dec 2020
Externally published	Yes

Bibliographical note

Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

epidemiology
intensive & critical care
public health
respiratory infections

Access to Document

10.1136/bmjopen-2020-041417Licence: CC BY-NC

Publisher version (open access)Final published version, 360 KBLicence: CC BY-NC

Cite this

Bassi, G. L., Suen, J., Barnett, A. G., Corley, A., Millar, J., Fanning, J., Lye, I., Colombo, S., Wildi, K., Livingstone, S., Abbate, G., Hinton, S., Liquet, B., Shrapnel, S., Dalton, H., Fraser, J. F., & COVID-19 Critical Care Consortium (2020). Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study. BMJ Open, 10(12), 1-6. Article e041417. https://doi.org/10.1136/bmjopen-2020-041417

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Bassi, GL, Suen, J, Barnett, AG, Corley, A, Millar, J, Fanning, J, Lye, I, Colombo, S, Wildi, K, Livingstone, S, Abbate, G, Hinton, S, Liquet, B, Shrapnel, S, Dalton, H, Fraser, JF & COVID-19 Critical Care Consortium 2020, 'Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study', BMJ Open, vol. 10, no. 12, e041417, pp. 1-6. https://doi.org/10.1136/bmjopen-2020-041417

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T1 - Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

AU - Bassi, Gianluigi Li

AU - Suen, Jacky

AU - Barnett, Adrian Gerard

AU - Corley, Amanda

AU - Millar, Jonathan

AU - Fanning, Jonathon

AU - Lye, India

AU - Colombo, Sebastiano

AU - Wildi, Karin

AU - Livingstone, Samantha

AU - Abbate, Gabriella

AU - Hinton, Samuel

AU - Liquet, Benoit

AU - Shrapnel, Sally

AU - Dalton, Heidi

AU - Fraser, John F.

AU - COVID-19 Critical Care Consortium

N1 - Copyright the Author(s) 2020. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2020/12/2

Y1 - 2020/12/2

N2 - Introduction: There is a paucity of data that can be used to guide the management of critically ill patients with COVID-19. In response, a research and data-sharing collaborative-The COVID-19 Critical Care Consortium-has been assembled to harness the cumulative experience of intensive care units (ICUs) worldwide. The resulting observational study provides a platform to rapidly disseminate detailed data and insights crucial to improving outcomes.Methods and analysis: This is an international, multicentre, observational study of patients with confirmed or suspected SARS-CoV-2 infection admitted to ICUs. This is an evolving, open-ended study that commenced on 1 January 2020 and currently includes >350 sites in over 48 countries. The study enrols patients at the time of ICU admission and follows them to the time of death, hospital discharge or 28 days post-ICU admission, whichever occurs last. Key data, collected via an electronic case report form devised in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium/Short Period Incidence Study of Severe Acute Respiratory Illness networks, include: patient demographic data and risk factors, clinical features, severity of illness and respiratory failure, need for non-invasive and/or mechanical ventilation and/or extracorporeal membrane oxygenation and associated complications, as well as data on adjunctive therapies.Ethics and dissemination: Local principal investigators will ensure that the study adheres to all relevant national regulations, and that the necessary approvals are in place before a site may contribute data. In jurisdictions where a waiver of consent is deemed insufficient, prospective, representative or retrospective consent will be obtained, as appropriate. A web-based dashboard has been developed to provide relevant data and descriptive statistics to international collaborators in real-time. It is anticipated that, following study completion, all de-identified data will be made open access.Trial registration number: ACTRN12620000421932 (http://anzctr.org.au/ACTRN12620000421932.aspx).

AB - Introduction: There is a paucity of data that can be used to guide the management of critically ill patients with COVID-19. In response, a research and data-sharing collaborative-The COVID-19 Critical Care Consortium-has been assembled to harness the cumulative experience of intensive care units (ICUs) worldwide. The resulting observational study provides a platform to rapidly disseminate detailed data and insights crucial to improving outcomes.Methods and analysis: This is an international, multicentre, observational study of patients with confirmed or suspected SARS-CoV-2 infection admitted to ICUs. This is an evolving, open-ended study that commenced on 1 January 2020 and currently includes >350 sites in over 48 countries. The study enrols patients at the time of ICU admission and follows them to the time of death, hospital discharge or 28 days post-ICU admission, whichever occurs last. Key data, collected via an electronic case report form devised in collaboration with the International Severe Acute Respiratory and Emerging Infection Consortium/Short Period Incidence Study of Severe Acute Respiratory Illness networks, include: patient demographic data and risk factors, clinical features, severity of illness and respiratory failure, need for non-invasive and/or mechanical ventilation and/or extracorporeal membrane oxygenation and associated complications, as well as data on adjunctive therapies.Ethics and dissemination: Local principal investigators will ensure that the study adheres to all relevant national regulations, and that the necessary approvals are in place before a site may contribute data. In jurisdictions where a waiver of consent is deemed insufficient, prospective, representative or retrospective consent will be obtained, as appropriate. A web-based dashboard has been developed to provide relevant data and descriptive statistics to international collaborators in real-time. It is anticipated that, following study completion, all de-identified data will be made open access.Trial registration number: ACTRN12620000421932 (http://anzctr.org.au/ACTRN12620000421932.aspx).

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KW - intensive & critical care

KW - public health

KW - respiratory infections

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JF - BMJ Open

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ER -

Design and rationale of the COVID-19 Critical Care Consortium international, multicentre, observational study

Abstract

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Keywords

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