Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov;48(11):1622-1635.
doi: 10.1097/CCM.0000000000004585.

Core Outcomes Set for Trials in People With Coronavirus Disease 2019

Allison Tong  1   2 , Julian H Elliott  3 , Luciano Cesar Azevedo  4 , Amanda Baumgart  1   2 , Andrew Bersten  5 , Lilia Cervantes  6 , Derek P Chew  5 , Yeoungjee Cho  7 , Tess Cooper  1   2 , Sally Crowe  8 , Ivor S Douglas  9 , Nicole Evangelidis  1   2 , Ella Flemyng  10 , Elyssa Hannan  1   2 , Peter Horby  11 , Martin Howell  1   2 , Jaehee Lee  12 , Emma Liu  1   2 , Eduardo Lorca  13 , Deena Lynch  14 , John C Marshall  15 , Andrea Matus Gonzalez  1   2 , Anne McKenzie  16 , Karine E Manera  1   2 , Charlie McLeod  17 , Sangeeta Mehta  18 , Mervyn Mer  19 , Andrew Conway Morris  20 , Saad Nseir  21 , Pedro Povoa  22   23 , Mark Reid  6 , Yasser Sakr  24 , Ning Shen  25 , Alan R Smyth  26 , Tom Snelling  1 , Giovanni Fm Strippoli  1   27 , Armando Teixeira-Pinto  1   2 , Antoni Torres  28 , Tari Turner  3 , Andrea K Viecelli  7 , Steve Webb  3 , Paula R Williamson  29 , Laila Woc-Colburn  30 , Junhua Zhang  31 , Jonathan C Craig  5 ; COVID-19-Core Outcomes Set (COS) Workshop Investigators
Affiliations

Core Outcomes Set for Trials in People With Coronavirus Disease 2019

Allison Tong et al. Crit Care Med. 2020 Nov.

Abstract

Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019.

Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set.

Setting: International.

Subjects: Adults 18 years old and over with confirmed or suspected coronavirus disease 2019, their family members, members of the general public and health professionals (including clinicians, policy makers, regulators, funders, researchers).

Interventions: None.

Measurements: None.

Main results: Six themes were identified. "Responding to the critical and acute health crisis" reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. "Capturing different settings of care" highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. "Encompassing the full trajectory and severity of disease" was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). "Distinguishing overlap, correlation and collinearity" meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). "Recognizing adverse events" refers to the potential harms of new and evolving interventions. "Being cognizant of family and psychosocial wellbeing" reflected the pervasive impacts of coronavirus disease 2019.

Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.

PubMed Disclaimer

Conflict of interest statement

Dr. Tong is supported by The University of Sydney Robinson Fellowship. Dr. Douglas is principal investigator of clinical and translational research studies of acute respiratory distress syndrome, sepsis, and coronavirus disease 2019 from the National Institutes of Health, Roche Pharmaceuticals and Genentech. Research grants are to his institution, Denver Health Medical Center. Dr. Morris is supported by a Clinical Research Career Development Fellowship from the Wellcome Trust (WT 2055214/Z/16/Z). Dr. Povoa had received lecture fees from Orion, Pfizer, and Technofage. Dr. Azevedo received funding from Halex Istar and Pfizer. Dr. Flemyng received funding from Cochrane. Dr. Mer received funding from Pfizer, MSD, Sanofi Aventis, Aspen, and Astellas. Dr. Morris' institution received funding from Wellcome Trust and he received funding from Wellcome Trust/COAF. Dr. Smyth's institution received funding from Vertex; he received funding from Vertex, Teva and Novartis; and he has a patent issued "Alkyl quinolones as biomarkers of Pseudomonas aeruginosa infection and uses thereof." Dr. Turner's institution received funding from Australian Commonwealth Government, Victorian State Government, Australian Stroke Foundation, and she has also provided technical advice to WHO, and the Australian Red Cross Lifeblood service undertaken unrelated consultancies with the Burnet Institute and USAID, and she is an investigator on unrelated living diabetes guidelines funded by several diabetes organizations in Australia. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Figures

Figure 1.
Figure 1.
COVID-19-Core Outcomes Set (COS).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Zhou F, Yu T, Du R, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: A retrospective cohort study. Lancet. 2020; 395:1054–1062 - PMC - PubMed
    1. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet. 2020; 395:507–513 - PMC - PubMed
    1. Bhatraju PK, Ghassemieh BJ, Nichols M, et al. COVID-19 in critically ill patients in the seattle region - case series. N Engl J Med. 2020; 382:2012–2022 - PMC - PubMed
    1. Grasselli G, Zangrillo A, Zanella A, et al. Baseline characteristics and outcomes of 1591 patients infected with SARS-CoV-2 admitted to ICUs of the Lombardy Region, Italy. J Am Med Assoc. 2020; 323:1574–1581 - PMC - PubMed
    1. Chen R, Liang W, Jiang M, et al. Risk factors fo fatal outcome in hospitalized subjected with coronavirus disease 2019 from a nationwide analysis in China. Chest. 2020; 158:97–105 - PMC - PubMed

Publication types

MeSH terms