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A MINIMAL COMMON OUTCOME MEASURE SET FOR COVID-19 CLINICAL RESEARCH
WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection: John C. Marshall (St. Michael's Hospital. Toronto, Canada); Srinivas Murthy (BC Children's Hospital. Vancouver, BC, Canada), Janet Diaz (San Francisco Veterans Affairs Health Care System. San Francisco, CA, USA), Neil Adhikari (University of Alberta. Faculty of Medicine and Dentistry. Department of Critical Care Medicine. Edmonton, Canada / Alberta Health Services. Edmonton, Canada), Derek C. Angus (University of Pittsburgh. Pittsburgh, PA, United States), Yaseen M. Arabi (King Saud bin Abdulaziz University for Health Sciences. Riyadh, Jeddah, Saudi Arabia), Kenneth Baillie (University of Edinburgh. Roslin Institute. Genetics and Genomics. Edinburgh, UK), Michael Bauer (Universitätsklinikum Carl Gutav Carus. Department of Psychiatry and Psychotherapy. Dresden, Germany), Scott Berry (University of Texas at Austin. Austin, Texas, United States), Bronagh Blackwood (University Belfast. Belfast, UK), Marc Bonten (Universitair Medisch Centrum Utrecht. Utrecht, Netherlands), Fernando Bozza (Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil), Frank Brunkhorst (Universitätsklinikum Jena. Jena, Thüringen, Germany), Allen Cheng (Monash University. Clayton, Australia), Mike Clarke (Queen's University Belfast. School of Medicine. Centre for Public Health. Dentistry and Biomedical Science. Belfast, UK), Vu Quoc Dat (Hanoi Medical University. Hanoi, Vietnam), Menno de Jong (University of Amsterdam. Amsterdam, Netherlands), Justin Denholm (University of Melbourne. Melbourne, Victoria, Australia), Lennie Derde (Utrecht University. Utrecht, Netherlands), Jake Dunning (Department of Health and Social Care. Public Health England. London, United Kingdom), Xiaobin Feng (Tsinghua University. Beijing, China), Tom Fletcher (Royal Liverpool University Hospital. Tropical and Infectious Disease Unit. Liverpool, UK / Liverpool School of Tropical Medicine. Liverpool, UK), Nadine Foster (Alberta Health Services. Alberta, Canada), Rob Fowler (University of Toronto. Toronto, Canada), Nina Gobat (University of Oxford. Oxford, United Kingdom), Charles Gomersall (The University of Hong Kong. Hong Kong), Anthony Gordon (Imperial College London. London, United Kingdom), Thomas Glueck (Kliniken Südostbayern. Traunstein, Bayern, Germany), Michael Harhay (University of Pennsylvania. Philadelphia, PA, United States), Carol Hodgson (Monash University. Clayton, Victoria, Australia), Peter Horby (University of Oxford. Oxford, United Kingdom), YaeJean Kim (Sungkyunkwan University. Seoul, South Korea), Richard Kojan (Alliance for International Medical Action. Paris, France), Bharath Kumar (Indian Institute of Chemical Technology. Hyderabad, India), John Laffey (National University of Ireland Galway. Galway, Ireland), Denis Malvey (Sem afiliação), Ignacio Martin-Loeches (Trinity College Dublin. Dublin, Ireland), Colin McArthur (Medical Research Institute of New Zealand. Wellington, New Zealand), Danny McAuley (Queen's University Belfast. Belfast, United Kingdom), Stephen McBride (Middlemore Hospital. Department of Infectious Diseases. Auckland, New Zealand), Shay McGuinness (Auckland District Health Board. Auckland, New Zealand), Laura Merson (University of Oxford. Oxford, United Kingdom), Susan Morpeth (Auckland District Health Board. Auckland, New Zealand), Dale Needham (The Johns Hopkins Hospital. Baltimore, United States), Mihai Netea (Radboud University. Department of Internal Medicine and Center for Infectious Diseases. Nijmegen, Netherlands), Myoung-Don Oh (Seoul National University. Gwanak-gu, South Korea), Sabai Phyu (University of Bergen. Gade Institute. Section of Microbiology and Immunology. Bergen, Norway), Simone Piva (Università degli Studi di Brescia. Brescia, Italy), Ruijin Qiu (University of Chinese Medicine. Dongzhimen Hospital. Beijing, China), Halima Salisu-Kabara (Aminu Kano Teaching Hospital. Kano, Nigeria), Lei Shi (National Clinical Research Center for Infectious Diseases. Treatment and Research Center for Infectious Diseases. The Fifth Medical Center of PLA General Hospital. Beijing, China), Naoki Shimizu (St. Marianna University School of Medicine. Department of Pediatrics. Kanagawa, Japan), Jorge Sinclair (Hospital Punta Pacífica. Johns Hopkins Medicine. Universidad de Panamá. Ciudad de Panamá, Panamá), Steven Tong (The Peter Doherty Institute for Infection and Immunity. Melbourne, Australia), Alexis Turgeon (Université Laval. Quebec, QC, Canada), Tim Uyeki (Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. Influenza Division. Atlanta, Georgia, United States), Frank van de Veerdonk (Radboud University. Nijmegen, The Netherlands), Steve Webb (St. John of God Health Care. Perth, Western Australia, Australia), Paula Williamson (University of Liverpool. Department of Biostatistics. Liverpool, United Kingdom), Timo Wolf (Goethe-Universität Frankfurt am Main. Abteilung für Infektiologie. HIV-Center. Frankfurt, Germany), Junhua Zhang (Tianjin University of Traditional Chinese Medicine. Tianjin, China).
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Abstract
Clinical research is necessary for an effective response to an emerging infectious disease outbreak. However, research efforts are often hastily organised and done using various research tools, with the result that pooling data across studies is challenging. In response to the needs of the rapidly evolving COVID-19 outbreak, the Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme, the International Forum for Acute Care Trialists, and the International Severe Acute Respiratory and Emerging Infections Consortium have developed a minimum set of common outcome measures for studies of COVID-19. This set includes three elements: a measure of viral burden (quantitative PCR or cycle threshold), a measure of patient survival (mortality at hospital discharge or at 60 days), and a measure of patient progression through the health-care system by use of the WHO Clinical Progression Scale, which reflects patient trajectory and resource use over the course of clinical illness. We urge investigators to include these key data elements in ongoing and future studies to expedite the pooling of data during this immediate threat, and to hone a tool for future needs.
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Elsevier
Citation
MARSHALL, John C. et al. A minimal common outcome measure set for COVID-19 clinical research. The Lancet Infectious Diseases, v. 20, n. 8, p. 192-197, 2020.DOI
10.1016/S1473-3099(20)30483-7ISSN
1473-3099Notes
Fernando Bozza - Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection: John C. Marshall (St. Michael's Hospital. Toronto, Canada); Srinivas Murthy (BC Children's Hospital. Vancouver, BC, Canada), Janet Diaz (San Francisco Veterans Affairs Health Care System. San Francisco, CA, USA), Neil Adhikari (University of Alberta. Faculty of Medicine and Dentistry. Department of Critical Care Medicine. Edmonton, Canada / Alberta Health Services. Edmonton, Canada), Derek C. Angus (University of Pittsburgh. Pittsburgh, PA, United States), Yaseen M. Arabi (King Saud bin Abdulaziz University for Health Sciences. Riyadh, Jeddah, Saudi Arabia), Kenneth Baillie (University of Edinburgh. Roslin Institute. Genetics and Genomics. Edinburgh, UK), Michael Bauer (Universitätsklinikum Carl Gutav Carus. Department of Psychiatry and Psychotherapy. Dresden, Germany), Scott Berry (University of Texas at Austin. Austin, Texas, United States), Bronagh Blackwood (University Belfast. Belfast, UK), Marc Bonten (Universitair Medisch Centrum Utrecht. Utrecht, Netherlands), Fernando Bozza (Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil), Frank Brunkhorst (Universitätsklinikum Jena. Jena, Thüringen, Germany), Allen Cheng (Monash University. Clayton, Australia), Mike Clarke (Queen's University Belfast. School of Medicine. Centre for Public Health. Dentistry and Biomedical Science. Belfast, UK), Vu Quoc Dat (Hanoi Medical University. Hanoi, Vietnam), Menno de Jong (University of Amsterdam. Amsterdam, Netherlands), Justin Denholm (University of Melbourne. Melbourne, Victoria, Australia), Lennie Derde (Utrecht University. Utrecht, Netherlands), Jake Dunning (Department of Health and Social Care. Public Health England. London, United Kingdom), Xiaobin Feng (Tsinghua University. Beijing, China), Tom Fletcher (Royal Liverpool University Hospital. Tropical and Infectious Disease Unit. Liverpool, UK / Liverpool School of Tropical Medicine. Liverpool, UK), Nadine Foster (Alberta Health Services. Alberta, Canada), Rob Fowler (University of Toronto. Toronto, Canada), Nina Gobat (University of Oxford. Oxford, United Kingdom), Charles Gomersall (The University of Hong Kong. Hong Kong), Anthony Gordon (Imperial College London. London, United Kingdom), Thomas Glueck (Kliniken Südostbayern. Traunstein, Bayern, Germany), Michael Harhay (University of Pennsylvania. Philadelphia, PA, United States), Carol Hodgson (Monash University. Clayton, Victoria, Australia), Peter Horby (University of Oxford. Oxford, United Kingdom), YaeJean Kim (Sungkyunkwan University. Seoul, South Korea), Richard Kojan (Alliance for International Medical Action. Paris, France), Bharath Kumar (Indian Institute of Chemical Technology. Hyderabad, India), John Laffey (National University of Ireland Galway. Galway, Ireland), Denis Malvey (Sem afiliação), Ignacio Martin-Loeches (Trinity College Dublin. Dublin, Ireland), Colin McArthur (Medical Research Institute of New Zealand. Wellington, New Zealand), Danny McAuley (Queen's University Belfast. Belfast, United Kingdom), Stephen McBride (Middlemore Hospital. Department of Infectious Diseases. Auckland, New Zealand), Shay McGuinness (Auckland District Health Board. Auckland, New Zealand), Laura Merson (University of Oxford. Oxford, United Kingdom), Susan Morpeth (Auckland District Health Board. Auckland, New Zealand), Dale Needham (The Johns Hopkins Hospital. Baltimore, United States), Mihai Netea (Radboud University. Department of Internal Medicine and Center for Infectious Diseases. Nijmegen, Netherlands), Myoung-Don Oh (Seoul National University. Gwanak-gu, South Korea), Sabai Phyu (University of Bergen. Gade Institute. Section of Microbiology and Immunology. Bergen, Norway), Simone Piva (Università degli Studi di Brescia. Brescia, Italy), Ruijin Qiu (University of Chinese Medicine. Dongzhimen Hospital. Beijing, China), Halima Salisu-Kabara (Aminu Kano Teaching Hospital. Kano, Nigeria), Lei Shi (National Clinical Research Center for Infectious Diseases. Treatment and Research Center for Infectious Diseases. The Fifth Medical Center of PLA General Hospital. Beijing, China), Naoki Shimizu (St. Marianna University School of Medicine. Department of Pediatrics. Kanagawa, Japan), Jorge Sinclair (Hospital Punta Pacífica. Johns Hopkins Medicine. Universidad de Panamá. Ciudad de Panamá, Panamá), Steven Tong (The Peter Doherty Institute for Infection and Immunity. Melbourne, Australia), Alexis Turgeon (Université Laval. Quebec, QC, Canada), Tim Uyeki (Centers for Disease Control and Prevention. Centers for Disease Control and Prevention. Influenza Division. Atlanta, Georgia, United States), Frank van de Veerdonk (Radboud University. Nijmegen, The Netherlands), Steve Webb (St. John of God Health Care. Perth, Western Australia, Australia), Paula Williamson (University of Liverpool. Department of Biostatistics. Liverpool, United Kingdom), Timo Wolf (Goethe-Universität Frankfurt am Main. Abteilung für Infektiologie. HIV-Center. Frankfurt, Germany), Junhua Zhang (Tianjin University of Traditional Chinese Medicine. Tianjin, China).
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