TY - JOUR
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).
KW - epidemiology
KW - intensive & critical care
KW - public health
KW - respiratory infections
UR - http://www.scopus.com/inward/record.url?scp=85097121202&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-041417
DO - 10.1136/bmjopen-2020-041417
M3 - Article
C2 - 33268426
SN - 2044-6055
VL - 10
SP - 1
EP - 6
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e041417
ER -