TY - JOUR
T1 - International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019
AU - COVID-19-Core Outcomes Set (COS) Survey Investigators
AU - Evangelidis, Nicole
AU - Tong, Allison
AU - Howell, Martin
AU - Teixeira-Pinto, Armando
AU - Elliott, Julian H.
AU - Azevedo, Luciano Cesar
AU - Bersten, Andrew
AU - Cervantes, Lilia
AU - Chew, Derek P.
AU - Crowe, Sally
AU - Douglas, Ivor S.
AU - Flemyng, Ella
AU - Horby, Peter
AU - Lee, Jaehee
AU - Lorca, Eduardo
AU - Lynch, Deena
AU - Marshall, John C.
AU - McKenzie, Anne
AU - Mehta, Sangeeta
AU - Mer, Mervyn
AU - Morris, Andrew Conway
AU - Nseir, Saad
AU - Povoa, Pedro
AU - Reid, Mark
AU - Sakr, Yasser
AU - Shen, Ning
AU - Smyth, Alan R.
AU - Snelling, Tom
AU - Strippoli, Giovanni F.M.
AU - Torres, Antoni
AU - Turner, Tari
AU - Webb, Steve
AU - Williamson, Paula R.
AU - Woc-Colburn, Laila
AU - Zhang, Junhua
AU - Baumgart, Amanda
AU - Cabrera, Sebastian
AU - Cho, Yeoungjee
AU - Cooper, Tess
AU - Guha, Chandana
AU - Liu, Emma
AU - Gonzalez, Andrea Matus
AU - McLeod, Charlie
AU - Natale, Patrizia
AU - Saglimbene, Valeria
AU - Viecelli, Andrea K.
AU - Craig, Jonathan C.
PY - 2020/11/1
Y1 - 2020/11/1
N2 - OBJECTIVES: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. DESIGN: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. 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, and researchers).None. MAIN RESULTS: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. CONCLUSIONS: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.
AB - OBJECTIVES: There are over 4,000 trials conducted in people with coronavirus disease 2019. However, the variability of outcomes and the omission of patient-centered outcomes may diminish the impact of these trials on decision-making. The aim of this study was to generate a consensus-based, prioritized list of outcomes for coronavirus disease 2019 trials. DESIGN: In an online survey conducted in English, Chinese, Italian, Portuguese, and Spanish languages, adults with coronavirus disease 2019, their family members, health professionals, and the general public rated the importance of outcomes using a 9-point Likert scale (7-9, critical importance) and completed a Best-Worst Scale to estimate relative importance. Participant comments were analyzed thematically. 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, and researchers).None. MAIN RESULTS: In total, 9,289 participants from 111 countries (776 people with coronavirus disease 2019 or family members, 4,882 health professionals, and 3,631 members of the public) completed the survey. The four outcomes of highest priority for all three groups were: mortality, respiratory failure, pneumonia, and organ failure. Lung function, lung scarring, sepsis, shortness of breath, and oxygen level in the blood were common to the top 10 outcomes across all three groups (mean > 7.5, median ≥ 8, and > 70% of respondents rated the outcome as critically important). Patients/family members rated fatigue, anxiety, chest pain, muscle pain, gastrointestinal problems, and cardiovascular disease higher than health professionals. Four themes underpinned prioritization: fear of life-threatening, debilitating, and permanent consequences; addressing knowledge gaps; enabling preparedness and planning; and tolerable or infrequent outcomes. CONCLUSIONS: Life-threatening respiratory and other organ outcomes were consistently highly prioritized by all stakeholder groups. Patients/family members gave higher priority to many patient-reported outcomes compared with health professionals.
UR - http://www.scopus.com/inward/record.url?scp=85092801529&partnerID=8YFLogxK
U2 - 10.1097/CCM.0000000000004584
DO - 10.1097/CCM.0000000000004584
M3 - Article
C2 - 32804789
AN - SCOPUS:85092801529
SN - 0090-3493
VL - 48
SP - 1612
EP - 1621
JO - Critical Care Medicine
JF - Critical Care Medicine
IS - 11
ER -
