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

Nicole Evangelidis 1 Allison Tong 1 Martin Howell 1 Armando Teixeira-Pinto 1 Julian H. Elliott 2 Luciano Cesar Azevedo Andrew Bersten 3 Lilia Cervantes Derek P. Chew 3 Sally Crowe Ivor S. Douglas 4 Ella Flemyng Peter Horby 5 Jaehee Lee 6 Eduardo Lorca 7 Deena Lynch John C. Marshall 8 Anne Mckenzie Sangeeta Mehta 8 Mervyn Mer 9 Andrew Conway Morris 10 Saad Nseir 11, 12 Pedro Povoa 13 Mark Reid Yasser Sakr 14 Ning Shen Alan R. Smyth 15 Tom Snelling 1 Giovanni F. M. Strippoli 16 Antoni Torres 17, 18 Tari Turner 2 Steve Webb 2 Paula R. Williamson 19 Laila Woc-Colburn 20 Junhua Zhang 21 Amanda Baumgart 1 Sebastian Cabrera 7 Yeoungjee Cho 22 Tess Cooper 1 Chandana Guha 1 Emma Liu 1 Andrea Matus Gonzalez 1 Charlie Mcleod Patrizia Natale 16 Valeria Saglimbene 16 Andrea K. Viecelli 22 Jonathan C. Craig 3
Abstract : 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.
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https://hal.univ-lille.fr/hal-03324313
Contributeur : Lilloa Université de Lille <>
Soumis le : lundi 23 août 2021 - 14:57:55
Dernière modification le : jeudi 26 août 2021 - 03:03:02

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Nicole Evangelidis, Allison Tong, Martin Howell, Armando Teixeira-Pinto, Julian H. Elliott, et al.. International Survey to Establish Prioritized Outcomes for Trials in People With Coronavirus Disease 2019. Critical Care Medicine, Lippincott, Williams & Wilkins, 2020, 48 (11), pp.1612-1621. ⟨10.1097/ccm.0000000000004584⟩. ⟨hal-03324313⟩

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