International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019

被引：11

作者：

Evangelidis, Nicole ^{[1
,2
]}

Tong, Allison ^{[1
,2
]}

Howell, Martin ^{[1
,2
]}

Teixeira-Pinto, Armando ^{[1
,2
]}

Elliott, Julian H. ^{[3
]}

Azevedo, Luciano Cesar ^{[4
]}

Bersten, Andrew ^{[5
]}

Cervantes, Lilia ^{[6
]}

Chew, Derek P. ^{[5
]}

Crowe, Sally ^{[7
]}

Douglas, Ivor S. ^{[8
,9
]}

Flemyng, Ella ^{[10
]}

Horby, Peter ^{[11
]}

Lee, Jaehee ^{[12
]}

Lorca, Eduardo ^{[13
]}

Lynch, Deena ^{[14
]}

Marshall, John C. ^{[15
]}

McKenzie, Anne ^{[16
]}

Mehta, Sangeeta ^{[17
,18
]}

Mer, Mervyn ^{[19
,20
]}

Morris, Andrew Conway ^{[21
]}

Nseir, Saad ^{[22
,23
]}

Povoa, Pedro ^{[24
,25
,26
]}

Reid, Mark ^{[6
]}

Sakr, Yasser ^{[27
]}

Shen, Ning ^{[28
]}

Smyth, Alan R. ^{[29
]}

Snelling, Tom ^{[1
]}

Strippoli, Giovanni F. M. ^{[1
,30
]}

Torres, Antoni ^{[31
]}

Turner, Tari ^{[3
]}

Webb, Steve ^{[3
]}

Williamson, Paula R. ^{[32
]}

Woc-Colburn, Laila ^{[33
]}

Zhang, Junhua ^{[34
]}

Baumgart, Amanda ^{[1
,2
]}

Cabrera, Sebastian ^{[1
,2
]}

Cho, Yeoungjee ^{[35
]}

Cooper, Tess ^{[1
,2
]}

Guha, Chandana ^{[1
,2
]}

Liu, Emma ^{[1
,2
]}

Gonzalez, Andrea Matus ^{[1
,2
]}

McLeod, Charlie ^{[36
]}

Natale, Patrizia ^{[1
,30
]}

Saglimbene, Valeria ^{[1
,30
]}

Viecelli, Andrea K. ^{[35
]}

Craig, Jonathan C. ^{[5
]}

机构：

[1] Univ Sydney, Sydney Sch Publ Hlth, Sydney, NSW, Australia

[2] Childrens Hosp Westmead, Ctr Kidney Res, Westmead, NSW, Australia

[3] Monash Univ, Cochrane Australia, Sch Publ Hlth & Prevent Med, Melbourne, Vic, Australia

[4] Hosp Sirio Libanes, Dept Crit Care Med, Sao Paulo, Brazil

[5] Flinders Univ S Australia, Coll Med & Publ Hlth, Adelaide, SA, Australia

[6] Denver Hlth, Dept Med, Denver, CO USA

[7] Crowe Associates Ltd, Thame, Oxon, England

[8] Denver Hlth, Pulm Sci & Crit Care, Dept Med, Denver, CO USA

[9] Univ Colorado Anschutz, Sch Med, Denver, CO USA

[10] Cochrane, Editorial & Methods Dept, London, England

[11] Univ Oxford, Nuffield Dept Med, Oxford, England

[12] Kyungpook Natl Univ, Sch Med, Dept Internal Med, Daegu, South Korea

[13] Univ Chile, Dept Internal Med, Fac Med, Santiago, Chile

[14] Jonze Soc, Brisbane, Qld, Australia

[15] Univ Toronto, Dept Surg, Toronto, ON, Canada

[16] Telethon Kids Inst, Perth, WA, Australia

[17] Univ Toronto, Dept Med, Toronto, ON, Canada

[18] Univ Toronto, Interdept Div Crit Care Med, Toronto, ON, Canada

[19] Univ Witwatersrand, Div Crit Care & Pulmonol, Dept Med, Charlotte Maxeke Johannesburg Acad Hosp, Johannesburg, South Africa

[20] Univ Witwatersrand, Fac Hlth Sci, Johannesburg, South Africa

[21] Univ Cambridge, Dept Med, Cambridge, England

[22] CHU Lille, Crit Care Ctr, F-59000 Lille, France

[23] Lille Univ, F-59000 Lille, France

[24] Univ Nova Lisboa, Sao Francisco Xavier Hosp, Nova Med Sch, CHRC,Polyvalent Intens Care Unit,CHLO, Lisbon, Portugal

[25] OUH Odense Univ Hosp, Ctr Clin Epidemiol, Odense, Denmark

[26] OUH Odense Univ Hosp, Res Unit Clin Epidemiol, Odense, Denmark

[27] Jena Univ Hosp, Dept Anesthesiol & Intens Care, Jena, Germany

[28] Peking Univ Third Hosp, Dept Resp Med, Beijing, Peoples R China

[29] Univ Nottingham, Evidence Based Child Hlth Grp, Nottingham, England

[30] Univ Bari, Dept Emergency & Organ Transplantat, Bari, Italy

[31] Univ Barcelona, Hosp Clin, Dept Pulmonol, CIBERES,IDIBAPS,ICREA, Barcelona, Spain

[32] Univ Liverpool, Dept Biostat, Liverpool, Merseyside, England

[33] Baylor Coll Med, Dept Med, Natl Sch Trop Med, Sect Infect Dis, Houston, TX 77030 USA

[34] Tianjin Univ Tradit Chinese Med, Evidence Based Med Ctr, Tianjin, Peoples R China

[35] Univ Queensland, Fac Med, Brisbane, Qld, Australia

[36] Perth Childrens Hosp, Dept Infect Dis, Perth, WA, Australia

来源：

CRITICAL CARE MEDICINE | 2020年 / 48卷 / 11期

关键词：

clinical trial; coronavirus; critical care; infection; patients; sepsis;

D O I：

10.1097/CCM.0000000000004584

中图分类号：

R4 [临床医学];

学科分类号：

1002 ; 100602 ;

摘要：

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). Interventions: None. Measurements: 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.

引用

页码：1612 / 1621

页数：10

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