Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery

Allison Tong; Amanda Baumgart; Nicole Evangelidis; Andrea K Viecelli; Simon A Carter; Luciano Cesar Azevedo; Tess Cooper; Andrew Bersten; Lilia Cervantes; Derek P Chew; See article full text for complete list of authors; Joanne Macdonald

doi:10.1097/CCM.0000000000004817

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Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery

Journal article

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Peer reviewed

Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery

Allison Tong, Amanda Baumgart, Nicole Evangelidis, Andrea K Viecelli, Simon A Carter, Luciano Cesar Azevedo, Tess Cooper, Andrew Bersten, Lilia Cervantes, Derek P Chew, …

Critical Care Medicine, Vol.49(3), pp.503-516

2021

DOI: https://doi.org/10.1097/CCM.0000000000004817

PMID: 33400475

Appears in COVID-19 Research

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Abstract

clinical trial

coronovirus

critical care

infection

patients

sepsis

COVID-19

OBJECTIVES: Respiratory failure, multiple organ failure, shortness of breath, recovery, and mortality have been identified as critically important core outcomes by more than 9300 patients, health professionals, and the public from 111 countries in the global coronavirus disease 2019 core outcome set initiative. The aim of this project was to establish the core outcome measures for these domains for trials in coronavirus disease 2019. DESIGN: Three online consensus workshops were convened to establish outcome measures for the four core domains of respiratory failure, multiple organ failure, shortness of breath, and recovery. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Respiratory failure, assessed by the need for respiratory support based on the World Health Organization Clinical Progression Scale, was considered pragmatic, objective, and with broad applicability to various clinical scenarios. The Sequential Organ Failure Assessment was recommended for multiple organ failure, because it was routinely used in trials and clinical care, well validated, and feasible. The Modified Medical Research Council measure for shortness of breath, with minor adaptations (recall period of 24 hr to capture daily fluctuations and inclusion of activities to ensure relevance and to capture the extreme severity of shortness of breath in people with coronavirus disease 2019), was regarded as fit for purpose for this indication. The recovery measure was developed de novo and defined as the absence of symptoms, resumption of usual daily activities, and return to the previous state of health prior to the illness, using a 5-point Likert scale, and was endorsed. CONCLUSIONS: The coronavirus disease 2019 core outcome set recommended core outcome measures have content validity and are considered the most feasible and acceptable among existing measures. Implementation of the core outcome measures in trials in coronavirus disease 2019 will ensure consistency and relevance of the evidence to inform decision-making and care of patients with coronavirus disease 2019.

Details

Title: Core Outcome Measures for Trials in People With Coronavirus Disease 2019: Respiratory Failure, Multiorgan Failure, Shortness of Breath, and Recovery
Authors: Allison Tong (Author) - The University of Sydney
Amanda Baumgart (Author) - The University of Sydney
Nicole Evangelidis (Author) - The University of Sydney
Andrea K Viecelli (Author) - Princess Alexandra Hospital
Simon A Carter (Author) - The University of Sydney
Luciano Cesar Azevedo (Author)
Tess Cooper (Author) - The University of Sydney
Andrew Bersten (Author) - Flinders University
Lilia Cervantes (Author) - Denver Health Medical Center
Derek P Chew (Author) - Flinders University
See article full text for complete list of authors (Author)
Joanne Macdonald (Group Member) - University of the Sunshine Coast, Queensland, GeneCology Research Centre - Legacy
Contributors: COVID-19-Core Outcomes Set Investigators (Research Group)
Publication details: Critical Care Medicine, Vol.49(3), pp.503-516
Publisher: Lippincott Williams & Wilkins
Date published: 2021
DOI: 10.1097/CCM.0000000000004817
ISSN: 1530-0293; 0090-3493
PMID: 33400475
Copyright note: © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Organisation Unit: School of Science, Technology and Engineering; Centre for Bioinnovation
Language: English
Record Identifier: 99640279202621
Output Type: Journal article

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