• Chest · Oct 2022

    Review

    Oxygen-Free Days as an Outcome Measure in Clinical Trials of Therapies for COVID-19 and Other Causes of New Onset Hypoxemia.

    • Ari Moskowitz, Matthew S Shotwell, Kevin W Gibbs, Michelle Harkins, Yves Rosenberg, James Troendle, Lisa H Merck, D Clark Files, Marjolein de Wit, Kristin Hudock, B Taylor Thompson, Michelle N Gong, Adit A Ginde, David J Douin, Samuel M Brown, Eileen Rubin, Meghan Morrison Joly, Li Wang, Christopher J Lindsell, Gordon R Bernard, Matthew W Semler, Sean P Collins, Wesley H Self, and Fourth Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Host Tissue Investigators.
    • Department of Medicine, Montefiore Medical Center, The Bronx, NY.
    • Chest. 2022 Oct 1; 162 (4): 804814804-814.

    AbstractMortality historically has been the primary outcome of choice for acute and critical care clinical trials. However, undue reliance on mortality can limit the scope of trials that can be performed. Large sample sizes are usually needed for trials powered for a mortality outcome, and focusing solely on mortality fails to recognize the importance that reducing morbidity can have on patients' lives. The COVID-19 pandemic has highlighted the need for rapid, efficient trials to rigorously evaluate new therapies for hospitalized patients with acute lung injury. Oxygen-free days (OFDs) is a novel outcome for clinical trials that is a composite of mortality and duration of new supplemental oxygen use. It is designed to characterize recovery from acute lung injury in populations with a high prevalence of new hypoxemia and supplemental oxygen use. In these populations, OFDs captures two patient-centered consequences of acute lung injury: mortality and hypoxemic lung dysfunction. Power to detect differences in OFDs typically is greater than that for other clinical trial outcomes, such as mortality and ventilator-free days. OFDs is the primary outcome for the Fourth Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Host Tissue platform, which evaluates novel therapies targeting the host response to COVID-19 among adults hospitalized with COVID-19 and new hypoxemia. This article outlines the rationale for use of OFDs as an outcome for clinical trials, proposes a standardized method for defining and analyzing OFDs, and provides a framework for sample size calculations using the OFD outcome.Copyright © 2022 American College of Chest Physicians. All rights reserved.

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