TY - JOUR
T1 - Core Outcome Measures for Trials in People With Coronavirus Disease 2019
T2 - 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 Cesar
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, Tom
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 - COVID-19-Core Outcomes Set Investigators
AU - Anumudu, Samaya
AU - Arriaga, Pedro
AU - Azevedo, Luciano Cesar
AU - Perez, Jairo Barrantes
AU - Baumgart, Amanda
AU - Bozza, Fernando
AU - Carter, Simon
AU - Cervantes, Lilia
AU - Chan, Elaine
AU - Morris, Andrew Conway
AU - Cooper, Tess E.
AU - Crowe, Sally
AU - Cuellar, Fernando
AU - Dheda, Keertan
AU - Douglas, Ivor S.
AU - Elliott, Julian H.
AU - Evangelidis, Nicole
AU - Flemyng, Ella
AU - Hannan, Elyssa
AU - Garner, Paul
AU - Granja, Cristina
AU - Hidalgo, J
AU - Horby, Peter
AU - Howell, Martin
AU - Ju, Angela
AU - Jubb, Alisdair
AU - Kusel, Jeanette
AU - Lee, Jaehee
AU - Lorca, Eduardo
AU - Macdonald, Joanne
AU - Manera, Karine
AU - Marks, Guy B.
AU - Marshall, John C.
AU - González, Andrea Matus
AU - McKenzie, Anne
AU - McLeod, Charlie
AU - Mehta, Sangeeta
AU - Mer, Mervyn
AU - Mesa, Patricia
AU - Needham, Dale
AU - Nseir, Saad
AU - Povoa, Pedro
AU - Ranzani, Otavio
AU - Reid, Mark
AU - Rodriguez-Vega, Gloria
AU - Sakr, Yasser
AU - Sanchez, Carlos
AU - Shankar-Hari, Manu
AU - Shen, Ning
AU - Simpson, A. John
AU - Smyth, Alan R.
AU - Snelling, Tom
AU - Strippoli, Giovanni
AU - Summers, Charlotte
AU - Armando, Teixeira Pinto
AU - Terwee, C. B.
AU - Tong, Allison
AU - Torres, Antoni
AU - Tugwell, Peter
AU - Tunis, S
AU - Turner, Tari
AU - Viecelli, Andrea
AU - Webb, Steve
AU - Williams, David
AU - Williamson, Paula
AU - Woc-Colburn, Laila
AU - Zhang, Junhua
PY - 2021/3
Y1 - 2021/3
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
UR - http://www.scopus.com/inward/record.url?scp=85102214408&partnerID=8YFLogxK
U2 - 10.1097/CCM.0000000000004817
DO - 10.1097/CCM.0000000000004817
M3 - Article
C2 - 33400475
AN - SCOPUS:85102214408
VL - 49
SP - 503
EP - 516
JO - Critical Care Medicine
JF - Critical Care Medicine
SN - 0090-3493
IS - 3
ER -