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doi: 10.1097/ccm.0000000000004585 , 10.17863/cam.58188 , 10.60692/5xn7v-54f36 , 10.60692/1y5v6-6z938
pmid: 32804792
pmc: PMC7448717
handle: 11379/541099 , 20.500.12210/40958 , 2123/23337 , 1854/LU-8691275 , 11586/314871
doi: 10.1097/ccm.0000000000004585 , 10.17863/cam.58188 , 10.60692/5xn7v-54f36 , 10.60692/1y5v6-6z938
pmid: 32804792
pmc: PMC7448717
handle: 11379/541099 , 20.500.12210/40958 , 2123/23337 , 1854/LU-8691275 , 11586/314871
Objectives: The outcomes reported in trials in coronavirus disease 2019 are extremely heterogeneous and of uncertain patient relevance, limiting their applicability for clinical decision-making. The aim of this workshop was to establish a core outcomes set for trials in people with suspected or confirmed coronavirus disease 2019. Design: Four international online multistakeholder consensus workshops were convened to discuss proposed core outcomes for trials in people with suspected or confirmed coronavirus disease 2019, informed by a survey involving 9,289 respondents from 111 countries. The transcripts were analyzed thematically. The workshop recommendations were used to finalize the core outcomes set. 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, researchers). Interventions: None. Measurements: None. Main Results: Six themes were identified. “Responding to the critical and acute health crisis” reflected the immediate focus on saving lives and preventing life-threatening complications that underpinned the high prioritization of mortality, respiratory failure, and multiple organ failure. “Capturing different settings of care” highlighted the need to minimize the burden on hospitals and to acknowledge outcomes in community settings. “Encompassing the full trajectory and severity of disease” was addressing longer term impacts and the full spectrum of illness (e.g. shortness of breath and recovery). “Distinguishing overlap, correlation and collinearity” meant recognizing that symptoms such as shortness of breath had distinct value and minimizing overlap (e.g. lung function and pneumonia were on the continuum toward respiratory failure). “Recognizing adverse events” refers to the potential harms of new and evolving interventions. “Being cognizant of family and psychosocial wellbeing” reflected the pervasive impacts of coronavirus disease 2019. Conclusions: Mortality, respiratory failure, multiple organ failure, shortness of breath, and recovery are critically important outcomes to be consistently reported in coronavirus disease 2019 trials.
Male, Clinical trial; Coronavirus; Critical care; Infection; Patients; Sepsis; Adult; Aged; COVID-19; Coronavirus Infections; Female; Health Services Accessibility; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Pandemics; Pneumonia, Viral; Randomized Controlled Trials as Topic; Research Design; SARS-CoV-2; Symptom Assessment; Betacoronavirus, Sociology and Political Science, coronavirus, Social Sciences, Incidence and Management of Hip Fractures, FOS: Health sciences, Critical Care and Intensive Care Medicine, patients, Health Services Accessibility, sepsis, Psychological intervention, Outcome Assessment, Health Care, Medicine and Health Sciences, Disease, Management of Delirium in Critical Care Patients, core outcomes, Internal medicine, Randomized Controlled Trials as Topic, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Public health, clinical trial, Middle Aged, COVID-19 (Enfermedad), Clinical trial, Research Design, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine, Female, Symptom Assessment, 2706 Critical Care and Intensive Care Medicine, Infection, Coronavirus Infections, Adult, Family medicine, Patients, Pneumonia, Viral, SOCIETY, Clinical Investigations, 610, Core Outcome Sets, Nursing, clinical trial;coronavirus;critical care;infection;patients;sepsis, The Delphi Method in Research and Consensus Building, Betacoronavirus, Sepsis, 616, Health Sciences, Humans, Intensive care medicine, Pandemics, Aged, SARS-CoV-2, COVID-19, Pneumonia, infection, COVID-19 Drug Treatment, critical care, Coronavirus, Critical care, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Surgery
Male, Clinical trial; Coronavirus; Critical care; Infection; Patients; Sepsis; Adult; Aged; COVID-19; Coronavirus Infections; Female; Health Services Accessibility; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Pandemics; Pneumonia, Viral; Randomized Controlled Trials as Topic; Research Design; SARS-CoV-2; Symptom Assessment; Betacoronavirus, Sociology and Political Science, coronavirus, Social Sciences, Incidence and Management of Hip Fractures, FOS: Health sciences, Critical Care and Intensive Care Medicine, patients, Health Services Accessibility, sepsis, Psychological intervention, Outcome Assessment, Health Care, Medicine and Health Sciences, Disease, Management of Delirium in Critical Care Patients, core outcomes, Internal medicine, Randomized Controlled Trials as Topic, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Public health, clinical trial, Middle Aged, COVID-19 (Enfermedad), Clinical trial, Research Design, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Medicine, Female, Symptom Assessment, 2706 Critical Care and Intensive Care Medicine, Infection, Coronavirus Infections, Adult, Family medicine, Patients, Pneumonia, Viral, SOCIETY, Clinical Investigations, 610, Core Outcome Sets, Nursing, clinical trial;coronavirus;critical care;infection;patients;sepsis, The Delphi Method in Research and Consensus Building, Betacoronavirus, Sepsis, 616, Health Sciences, Humans, Intensive care medicine, Pandemics, Aged, SARS-CoV-2, COVID-19, Pneumonia, infection, COVID-19 Drug Treatment, critical care, Coronavirus, Critical care, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Surgery
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