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, Srinivas Murthy, Janet Diaz, N K Adhikari, Derek C Angus, Yaseen M Arabi, Kenneth Baillie, Michael Bauer, Scott Berry, Bronagh Blackwood, Marc Bonten, Fernando Bozza, Frank Brunkhorst, Allen Cheng, Mike Clarke, Vu Quoc Dat, Menno de Jong, Justin Denholm, Lennie Derde, Jake Dunning, Xiaobin Feng, Tom Fletcher, Nadine Foster, Rob Fowler, Nina Gobat, Charles Gomersall, Anthony Gordon, Thomas Glueck, Michael Harhay, Carol Hodgson, Peter Horby, YaeJean Kim, Richard Kojan, Bharath Kumar, John Laffey, Denis Malvey, Ignacio Martin-Loeches, Colin McArthur, Danny McAuley, Stephen McBride, Shay McGuinness, Laura Merson, Susan Morpeth, Dale Needham, Mihai Netea, Myoung-Don Oh, Sabai Phyu, Simone Piva, Ruijin Qiu, Halima Salisu-Kabara, Lei Shi, Naoki Shimizu, Jorge Sinclair, Steven Tong, Alexis Turgeon, Tim Uyeki, Frank van de Veerdonk, Steve Webb, Paula Williamson, Timo Wolf, Junhua Zhang, WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection, John C Marshall, Srinivas Murthy, Janet Diaz, N K Adhikari, Derek C Angus, Yaseen M Arabi, Kenneth Baillie, Michael Bauer, Scott Berry, Bronagh Blackwood, Marc Bonten, Fernando Bozza, Frank Brunkhorst, Allen Cheng, Mike Clarke, Vu Quoc Dat, Menno de Jong, Justin Denholm, Lennie Derde, Jake Dunning, Xiaobin Feng, Tom Fletcher, Nadine Foster, Rob Fowler, Nina Gobat, Charles Gomersall, Anthony Gordon, Thomas Glueck, Michael Harhay, Carol Hodgson, Peter Horby, YaeJean Kim, Richard Kojan, Bharath Kumar, John Laffey, Denis Malvey, Ignacio Martin-Loeches, Colin McArthur, Danny McAuley, Stephen McBride, Shay McGuinness, Laura Merson, Susan Morpeth, Dale Needham, Mihai Netea, Myoung-Don Oh, Sabai Phyu, Simone Piva, Ruijin Qiu, Halima Salisu-Kabara, Lei Shi, Naoki Shimizu, Jorge Sinclair, Steven Tong, Alexis Turgeon, Tim Uyeki, Frank van de Veerdonk, Steve Webb, Paula Williamson, Timo Wolf, Junhua Zhang

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.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Figures

Figure
Figure
WHO clinical progression scale ECMO=extracorporeal membrane oxygenation. FiO2=fraction of inspired oxygen. NIV=non-invasive ventilation. pO2=partial pressure of oxygen. SpO2=oxygen saturation. *If hospitalised for isolation only, record status as for ambulatory patient.

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Source: PubMed

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