Evidence map›Paper›PMID 35504307›Full record

ReviewChest2022

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 and 14 more

Open access · greenAbstract readReview
In one paragraph

Review in Chest, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
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  6. Refining normoxemia targets in acute burn care: Reply.The journal of trauma and acute care surgery · 2026
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  19. Response.Chest · 2022
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors at 11 institutions in 1 country.

Ari MoskowitzDepartment of Medicine, Montefiore Medical Center, The Bronx, NY.
Matthew S ShotwellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Kevin W GibbsDepartment of Medicine, Wake Forest University, Winston-Salem, NC.
Michelle HarkinsDepartment of Medicine, University of New Mexico, Albuquerque, NM.
Yves RosenbergNational Heart, Lung, and Blood Institute, Bethesda, MD.
James TroendleNational Heart, Lung, and Blood Institute, Bethesda, MD.
Lisa H MerckDepartment of Emergency Medicine, Virginia Commonwealth University, Richmond, VA.
D Clark FilesDepartment of Medicine, Wake Forest University, Winston-Salem, NC.
Marjolein de WitDepartment of Medicine, Virginia Commonwealth University, Richmond, VA.
Kristin HudockDepartment of Medicine, University of Cincinnati, Cincinnati, OH.
B Taylor ThompsonDepartment of Medicine, Massachusetts General Hospital, Boston, MA.
Michelle N GongDepartment of Medicine, Montefiore Medical Center, The Bronx, NY.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO.
David J DouinDepartment of Anesthesiology, University of Colorado School of Medicine, Aurora, CO.
Samuel M BrownDepartment of Medicine, Intermountain Medical Center, Murray, UT; Office of Research, Intermountain Medical Center, Murray, UT.
Eileen RubinARDS Foundation, Northbrook, IL.
Meghan Morrison JolyVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN.
Li WangDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Christopher J LindsellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.
Gordon R BernardVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.
Matthew W SemlerDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN.
Sean P CollinsVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN; Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), Nashville, TN.
Wesley H SelfVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, TN; Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN. Electronic address: wesley.self@vumc.org.
Fourth Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) Host Tissue Investigators
Vanderbilt University Medical Center · USMontefiore Medical Center · USNational Heart Lung and Blood Institute · USUniversity of Colorado Denver · USVirginia Commonwealth University · USWake Forest University · USGeriatric Research Education and Clinical Center · USIntermountain Medical Center · USMassachusetts General Hospital · USUniversity of Cincinnati · USUniversity of New Mexico · US

Funding

ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating CenterOT2HL156812 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI NOLEN, TRACY L, THOMAS, SONIA M · 2020 to 2024
$1270.7M
Anesthesiology Mentored Research TrainingT32GM135169 · NIGMS · UNIVERSITY OF COLORADO DENVER · PI Susan L Ingram, Vesna Jevtovic-Todorovic · 2021 to 2026
$1.0M
Thiamine as a Renal Protective Agent in Septic ShockK23GM128005 · NIGMS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI MOSKOWITZ, ARI · 2018 to 2021
$761k
NHLBI NIH HHS OT2 HL156812NIGMS NIH HHS K23 GM128005NIGMS NIH HHS T32 GM135169
6 · The paper itself

Abstract

Mortality 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.

Indexed as

Acute Lung InjuryCOVID-19AdultClinical Trials as TopicHumansHypoxiaOutcome Assessment, Health CareOxygenPandemicsOxygenacute lung injuryCOVID-19oxygenrespiratory failure

Identifiers

PMID35504307
PMCPMC9055785
OpenAlexW4225155553

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.