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ObjectivesRespiratory 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.DesignThree 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.SettingInternational.PatientsAbout 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops.InterventionsNone.Measurements and main resultsRespiratory 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.ConclusionsThe 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.

Original publication

DOI

10.1097/ccm.0000000000004817

Type

Journal

Critical care medicine

Publication Date

05/01/2021

Volume

Publish Ahead of Print

Addresses

Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. Department of Critical Care Medicine, Hospital Sirio-Libanes, São Paulo, Brazil. College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia. Department of Medicine, Denver Health, Denver, CO. Crowe Associates, Oxon, United Kingdom. Department of Medicine, Pulmonary Sciences and Critical Care, Denver Health, Denver, CO., School of Medicine, University of Colorado Anschutz, Denver, CO. Editorial and Methods Department, Cochrane, London, United Kingdom. Cochrane Australia, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia. Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom. Department of Internal Medicine, School of Medicine, Kyungpook National University, Daegu, South Korea. Department of Internal Medicine, Faculty of Medicine, University of Chile, Santiago, Chile. Department of Surgery, University of Toronto, Toronto, Canada. Department of Critical Care Medicine, University of Toronto, Toronto, Canada. Telethon Kids Institute, Perth, Australia. Department of Medicine, Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. Division of Critical Care and Pulmonology, Department of Medicine, Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa. Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Department of Medicine, University of Cambridge, Cambridge, United Kingdom. School of Medicine, Johns Hopkins University, Baltimore, MD. Critical Care Centre, CHU Lille, Lille University, Lille, France. Nova Medical School, CHRC, New University of Lisbon, Polyvalent Intensive Care Unit, Sao Francisco Xavier Hospital, CHLO, Lisbon, Portugal. Center for Clinical Epidemiology and Research Unit of Clinical Epidemiology, Odense University Hospital, Odense, Denmark. Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany. Department of Respiratory Medicine, Peking University Third Hospital, Beijing, China. Evidence Based Child Health Group, University of Nottingham, Nottingham, United Kingdom. Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom. Sydney Children's Hospital Network, Westmead, NSW, Australia. Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, WA, Australia. Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. Department of Pulmonology Hospital Clinic, University of Barcelona, CIBERESUCICOVID, IDIBAPS, ICREA, Barcelona, Spain. Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom. Section of Infectious Diseases, Department of Medicine, National School of Tropical Medicine, Baylor College of Medicine, Houston, TX. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Keywords

COVID-19-Core Outcomes Set Investigators