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

  1. Gianluigi Li Bassi
  2. Jacky Suen
  3. Adrian Gerard Barnett
  4. Amanda Corley
  5. Jonathan Millar
  6. Jonathon Fanning
  7. India Lye
  8. Sebastiano Colombo
  9. Karin Wildi
  10. Samantha Livingstone
  11. Gabriella Abbate
  12. Samuel Hinton
  13. Benoit Liquet
  14. Sally Shrapnel
  15. Heidi Dalton
  16. John F Fraser

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Abstract

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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  1. Version published to 10.1136/bmjopen-2020-041417
  2. ScreenIT

    SciScore for 10.1101/2020.05.29.20115253: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study, using a large collaborative network, attempts to overcome the limitations induced by small patient numbers and geographic restrictions, by providing real-time global data. In a pandemic of an emerging pathogen, high-quality, real-time information is crucial to guide an optimal response. The speed of this response and cumulative experience of ICUs worldwide offer the best framework for determining evidence-based best practices and, therefore, improving outcomes for those requiring critical care. The design of the COVID-19 CCC study has several strengths. First, the care of patients admitted to the ICU, specifically those who are mechanically ventilated, is dependent on regional resources and may vary 20,21. This potential heterogeneity is mitigated by the international composition of the consortium. Second, the study leverages novel data acquisition methods, which may improve and expedite data collection. Third, the registry-based, collaborative, and open-source approach of the study lends itself to the conduct of multiple prospective sub-studies. Fourth, the study incorporates the provision of a web-based dashboard, which provides real-time data in an accessible format. Limitations: Patients will not receive identical treatments and care. While this will limit some aspects of data analysis, it will also give breadth to the scope of the investigation, as data on laboratory and patient characteristics, interventions and adjunct therapies, and outcomes will be availa...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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  3. Version published to 10.1101/2020.05.29.20115253v1 on medRxiv