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

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. 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. International. About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. None. 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. 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.

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Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and Wolters Kluwer Health, Inc.

Déclaration de conflit d'intérêts

Dr. Tong is supported by The University of Sydney Robinson Fellowship. Dr. Morris is supported by a Clinical Research Career Development Fellowship from the Wellcome Trust (WT 2055214/Z/16/Z). The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article. Dr. Douglas is the principal investigator of clinical and translational research studies of acute respiratory distress syndrome, sepsis, and coronavirus disease 2019 from National Institutes of Health, Roche Pharmaceuticals, and Genentech. Research grants are to his institution, Denver Health Medical Center. Dr. Povoa had received lecture fees from Orion, Pfizer, and Technofage. Dr. Azevedo received funding from Halex Istar and Baxter. Dr. Marshall received funding from AM Pharma, and he disclosed he is Cochair of the World Health Organization Working Group on Clinical Characterization and Management. Dr. Mer received funding from honoraria for serving on speakers bureaus and advisory boards as an invited “key opinion leader,” including from Pfizer, MSD, Astellas, and Sun. Dr. Morris received support from WT/Charity Open Access Fund. Dr. Morris’ institution received funding from WT. Dr. Smyth’s institution received funding from Vertex outside the submitted work; he disclosed having a patent “Alkyl quinolones as biomarkers of Pseudomonas aeruginosa infection and uses thereof”; and he received funding from Teva, Novartis, and Vertex, outside the submitted work. Dr. Simpson disclosed he is a coapplicant on independent grants with Becton Dickinson Biosciences and he is the Director of a National Institute for Health Research In Vitro Diagnostics Co-operative, which works with companies across the diagnostics industry. Dr. Turner’s institution received funding from Burnet Institute and United States Agency for International Development, and she received funding from World Health Organization. The remaining authors have disclosed that they do not have any potential conflicts of interest.