Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery

Allison Tong; Amanda Baumgart; Nicole Evangelidis; Andrea K. Viecelli; Simon A. Carter; Luciano Azevedo; Tess Cooper; Andrew Bersten; Lilia Cervantes; Derek P. Chew; Sally Crowe; Ivor S. Douglas; Ella Flemyng; Julian H. Elliott; Elyssa Hannan; Peter Horby; Martin Howell; Angela Ju; Jaehee Lee; Eduardo Lorca; Deena Lynch; Karine E. Manera; John C. Marshall; Andrea Matus Gonzalez; Anne McKenzie; Sangeeta Mehta; Mervyn Mer; Andrew Conway Morris; Dale M. Needham; Saad Nseir; Pedro Povoa; Mark Reid; Yasser Sakr; Ning Shen; Alan R. Smyth; A. John Simpson; Thomas Snelling; Giovanni F.M. Strippoli; Armando Teixeira-Pinto; Antoni Torres; Tari Turner; Steve Webb; Paula R. Williamson; Laila Woc-Colburn; Junhua Zhang; Jonathan C. Craig; Aborode Abdullah; Samaya Anumudu; Pedro Arriaga; Luciano Azevedo; COVID-19-Core Outcomes Set Investigators

doi:10.1097/CCM.0000000000004817

Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery

Allison Tong^*, Amanda Baumgart, Nicole Evangelidis, Andrea K. Viecelli, Simon A. Carter, Luciano Azevedo, Tess Cooper, Andrew Bersten, Lilia Cervantes, Derek P. Chew, Sally Crowe, Ivor S. Douglas, Ella Flemyng, Julian H. Elliott, Elyssa Hannan, Peter Horby, Martin Howell, Angela Ju, Jaehee Lee, Eduardo LorcaDeena Lynch, Karine E. Manera, John C. Marshall, Andrea Matus Gonzalez, Anne McKenzie, Sangeeta Mehta, Mervyn Mer, Andrew Conway Morris, Dale M. Needham, Saad Nseir, Pedro Povoa, Mark Reid, Yasser Sakr, Ning Shen, Alan R. Smyth, A. John Simpson, Thomas Snelling, Giovanni F.M. Strippoli, Armando Teixeira-Pinto, Antoni Torres, Tari Turner, Steve Webb, Paula R. Williamson, Laila Woc-Colburn, Junhua Zhang, Jonathan C. Craig, Aborode Abdullah, Samaya Anumudu, Pedro Arriaga, Luciano Azevedo, COVID-19-Core Outcomes Set Investigators

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

46 Citations (Scopus)

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Abstract

OBJECTIVES: 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.

DESIGN: 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.

SETTING: International.

PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops.

INTERVENTIONS: None.

MEASUREMENTS AND MAIN RESULTS: 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.

CONCLUSIONS: 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.

Original language	English
Pages (from-to)	503-516
Number of pages	14
Journal	Critical Care Medicine
Volume	49
Issue number	3
DOIs	https://doi.org/10.1097/CCM.0000000000004817
Publication status	Published - 01 Mar 2021
Externally published	Yes

Bibliographical note

Funding Information:
Supported, in part, by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees), and the Lord Mayor’s Charitable Foundation).

Funding Information:
Dr. Tong is supported by The University of Sydney Robinson Fellowship. Dr. Morris is supported by a Clinical Research

Publisher Copyright:
Copyright © 2021 The Author(s).

Keywords

clinical trial
coronavirus
critical care
infection
patients
sepsis

ASJC Scopus subject areas

Critical Care and Intensive Care Medicine

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10.1097/CCM.0000000000004817Licence: CC BY

Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery
Copyright 2021 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited.
Final published version, 787 KBLicence: CC BY

Cite this

Tong, A., Baumgart, A., Evangelidis, N., Viecelli, A. K., Carter, S. A., Azevedo, L., Cooper, T., Bersten, A., Cervantes, L., Chew, D. P., Crowe, S., Douglas, I. S., Flemyng, E., Elliott, J. H., Hannan, E., Horby, P., Howell, M., Ju, A., Lee, J., ... COVID-19-Core Outcomes Set Investigators (2021). Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery. Critical Care Medicine, 49(3), 503-516. https://doi.org/10.1097/CCM.0000000000004817

@article{f8e02c0767cb4fb5bf71d019d56d6d4a,

title = "Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery",

abstract = "OBJECTIVES: 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. DESIGN: 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. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.",

keywords = "clinical trial, coronavirus, critical care, infection, patients, sepsis",

author = "Allison Tong and Amanda Baumgart and Nicole Evangelidis and Viecelli, {Andrea K.} and Carter, {Simon A.} and Luciano Azevedo and Tess Cooper and Andrew Bersten and Lilia Cervantes and Chew, {Derek P.} and Sally Crowe and Douglas, {Ivor S.} and Ella Flemyng and Elliott, {Julian H.} and Elyssa Hannan and Peter Horby and Martin Howell and Angela Ju and Jaehee Lee and Eduardo Lorca and Deena Lynch and Manera, {Karine E.} and Marshall, {John C.} and Gonzalez, {Andrea Matus} and Anne McKenzie and Sangeeta Mehta and Mervyn Mer and Morris, {Andrew Conway} and Needham, {Dale M.} and Saad Nseir and Pedro Povoa and Mark Reid and Yasser Sakr and Ning Shen and Smyth, {Alan R.} and Simpson, {A. John} and Thomas Snelling and Strippoli, {Giovanni F.M.} and Armando Teixeira-Pinto and Antoni Torres and Tari Turner and Steve Webb and Williamson, {Paula R.} and Laila Woc-Colburn and Junhua Zhang and Craig, {Jonathan C.} and Aborode Abdullah and Samaya Anumudu and Pedro Arriaga and Luciano Azevedo and {COVID-19-Core Outcomes Set Investigators}",

note = "Funding Information: Supported, in part, by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees), and the Lord Mayor{\textquoteright}s Charitable Foundation). Funding Information: Dr. Tong is supported by The University of Sydney Robinson Fellowship. Dr. Morris is supported by a Clinical Research Publisher Copyright: Copyright {\textcopyright} 2021 The Author(s).",

year = "2021",

month = mar,

day = "1",

doi = "10.1097/CCM.0000000000004817",

language = "English",

volume = "49",

pages = "503--516",

journal = "Critical Care Medicine",

issn = "0090-3493",

publisher = "Lippincott Williams and Wilkins",

number = "3",

}

Tong, A, Baumgart, A, Evangelidis, N, Viecelli, AK, Carter, SA, Azevedo, L, Cooper, T, Bersten, A, Cervantes, L, Chew, DP, Crowe, S, Douglas, IS, Flemyng, E, Elliott, JH, Hannan, E, Horby, P, Howell, M, Ju, A, Lee, J, Lorca, E, Lynch, D, Manera, KE, Marshall, JC, Gonzalez, AM, McKenzie, A, Mehta, S, Mer, M, Morris, AC, Needham, DM, Nseir, S, Povoa, P, Reid, M, Sakr, Y, Shen, N, Smyth, AR, Simpson, AJ, Snelling, T, Strippoli, GFM, Teixeira-Pinto, A, Torres, A, Turner, T, Webb, S, Williamson, PR, Woc-Colburn, L, Zhang, J, Craig, JC, Abdullah, A, Anumudu, S, Arriaga, P, Azevedo, L & COVID-19-Core Outcomes Set Investigators 2021, 'Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery', Critical Care Medicine, vol. 49, no. 3, pp. 503-516. https://doi.org/10.1097/CCM.0000000000004817

TY - JOUR

T1 - Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery

AU - Tong, Allison

AU - Baumgart, Amanda

AU - Evangelidis, Nicole

AU - Viecelli, Andrea K.

AU - Carter, Simon A.

AU - Azevedo, Luciano

AU - Cooper, Tess

AU - Bersten, Andrew

AU - Cervantes, Lilia

AU - Chew, Derek P.

AU - Crowe, Sally

AU - Douglas, Ivor S.

AU - Flemyng, Ella

AU - Elliott, Julian H.

AU - Hannan, Elyssa

AU - Horby, Peter

AU - Howell, Martin

AU - Ju, Angela

AU - Lee, Jaehee

AU - Lorca, Eduardo

AU - Lynch, Deena

AU - Manera, Karine E.

AU - Marshall, John C.

AU - Gonzalez, Andrea Matus

AU - McKenzie, Anne

AU - Mehta, Sangeeta

AU - Mer, Mervyn

AU - Morris, Andrew Conway

AU - Needham, Dale M.

AU - Nseir, Saad

AU - Povoa, Pedro

AU - Reid, Mark

AU - Sakr, Yasser

AU - Shen, Ning

AU - Smyth, Alan R.

AU - Simpson, A. John

AU - Snelling, Thomas

AU - Strippoli, Giovanni F.M.

AU - Teixeira-Pinto, Armando

AU - Torres, Antoni

AU - Turner, Tari

AU - Webb, Steve

AU - Williamson, Paula R.

AU - Woc-Colburn, Laila

AU - Zhang, Junhua

AU - Craig, Jonathan C.

AU - Abdullah, Aborode

AU - Anumudu, Samaya

AU - Arriaga, Pedro

AU - Azevedo, Luciano

AU - COVID-19-Core Outcomes Set Investigators

N1 - Funding Information: Supported, in part, by the Flinders University and the National COVID-19 Clinical Evidence Taskforce, convened by the Australian Living Evidence Consortium, hosted by Cochrane Australia, School of Public Health and Preventive Medicine, Monash University supported by the Australian Government, Victorian Department of Health and Human Services, Ian Potter Foundation, Walter Cottman Endowment Fund (managed by Equity Trustees), and the Lord Mayor’s Charitable Foundation). Funding Information: Dr. Tong is supported by The University of Sydney Robinson Fellowship. Dr. Morris is supported by a Clinical Research Publisher Copyright: Copyright © 2021 The Author(s).

PY - 2021/3/1

Y1 - 2021/3/1

N2 - OBJECTIVES: 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. DESIGN: 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. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.

AB - OBJECTIVES: 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. DESIGN: 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. SETTING: International. PATIENTS: About 130 participants (patients, public, and health professionals) from 17 countries attended the three workshops. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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.

KW - clinical trial

KW - coronavirus

KW - critical care

KW - infection

KW - patients

KW - sepsis

U2 - 10.1097/CCM.0000000000004817

DO - 10.1097/CCM.0000000000004817

M3 - Article

C2 - 33400475

AN - SCOPUS:85102214408

SN - 0090-3493

VL - 49

SP - 503

EP - 516

JO - Critical Care Medicine

JF - Critical Care Medicine

IS - 3

ER -

Core outcome measures for trials in people with coronavirus disease 2019: respiratory failure, multiorgan failure, shortness of breath, and recovery

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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