A minimal common outcome measure set for COVID-19 clinical research

Summary 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.

Mike Clarke | Tom Fletcher | Sabai Phyu | Paula Williamson | John Laffey | Anthony Gordon | Ruijin Qiu | Steven Tong | Scott Berry | Derek C Angus | Nina Gobat | Steve Webb | Bharath Kumar | Allen Cheng | Susan Morpeth | Rob Fowler | Alexis Turgeon | Colin McArthur | Laura Merson | Srinivas Murthy | D. Needham | M. Netea | P. Horby | J. Laffey | T. Fletcher | J. Marshall | D. Angus | S. Murthy | P. Williamson | T. Uyeki | S. Tong | R. Fowler | M. Bonten | A. Gordon | A. Cheng | A. Turgeon | M. Harhay | M. Clarke | Y. Arabi | F. Brunkhorst | D. McAuley | L. Merson | C. Gomersall | Janet Diaz | B. Blackwood | S. Piva | F. Bozza | M. Oh | J. Dunning | M. D. de Jong | S. Berry | C. Hodgson | Junhua Zhang | I. Martín-Loeches | J. Denholm | L. Shi | F. L. van de Veerdonk | L. Derde | S. McGuinness | John C Marshall | Shay McGuinness | Marc Bonten | R. Kojan | K. Baillie | S. McBride | Peter Horby | Bronagh Blackwood | Yaseen M Arabi | Kenneth Baillie | Myoung-Don Oh | R. Qiu | S. Webb | Lennie Derde | C. McArthur | Dale Needham | Jake Dunning | Carol Hodgson | N. Gobat | Ignacio Martin-Loeches | John C Srinivas Janet Neil Derek C Yaseen M Kenneth Mic Marshall Murthy Diaz Adhikari Angus Arabi Ba | Janet Diaz | Neil Adhikari | Michael Bauer | Fernando Bozza | Frank Brunkhorst | Vu Quoc Dat | Menno de Jong | Justin Denholm | Xiaobin Feng | Nadine Foster | Charles Gomersall | Thomas Glueck | Michael Harhay | YaeJean Kim | Richard Kojan | Denis Malvey | Danny McAuley | Stephen McBride | Mihai Netea | Simone Piva | Halima Salisu-Kabara | Lei Shi | Naoki Shimizu | Jorge Sinclair | Tim Uyeki | Frank van de Veerdonk | Timo Wolf | Junhua Zhang | S. Morpeth | S. Phyu | T. Wolf | N. Shimizu | V. Q. Dat | Nadine Foster | H. Salisu-Kabara | Michael Bauer | Nirpesh Adhikari | Xia-long Feng | YaeJean Kim | T. Glueck | J. Sinclair | B. Kumar | John C Srinivas Janet N K Derek C Yaseen M Kenneth Mich Marshall Murthy Diaz Adhikari Angus Arabi Ba | Denis Malvey | M. Bauer | Lei Shi | Yaejean Kim | Stephen J. McBride | Simone Piva | V. Dat | J. Marshall

[1]  Nathaniel Hupert,et al.  Clinical Characteristics of Covid-19 in New York City , 2020, The New England journal of medicine.

[2]  G. Bernard,et al.  Comparison of the SpO2/FIO2 ratio and the PaO2/FIO2 ratio in patients with acute lung injury or ARDS. , 2007, Chest.

[3]  Jeremy C Hobart,et al.  Rating scales as outcome measures for clinical trials in neurology: problems, solutions, and recommendations , 2007, The Lancet Neurology.

[4]  G. Keusch,et al.  Clinical trials during epidemics , 2017, The Lancet.

[5]  Yan Zhao,et al.  Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. , 2020, JAMA.

[6]  Estimating clinical severity of COVID-19 from the transmission dynamics in Wuhan, China , 2020, Nature Medicine.

[7]  M. Hughes,et al.  Anti-influenza immune plasma for the treatment of patients with severe influenza A: a randomised, double-blind, phase 3 trial. , 2019, The Lancet. Respiratory medicine.

[8]  Yunpeng Ji,et al.  Potential association between COVID-19 mortality and health-care resource availability , 2020, The Lancet Global Health.

[9]  Xiaolong Qi,et al.  Real estimates of mortality following COVID-19 infection , 2020, The Lancet Infectious Diseases.

[10]  Y. Hu,et al.  Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China , 2020, The Lancet.

[11]  D. Jernigan,et al.  Update: Public Health Response to the Coronavirus Disease 2019 Outbreak — United States, February 24, 2020 , 2020, MMWR. Morbidity and mortality weekly report.

[12]  G. Norman Likert scales, levels of measurement and the “laws” of statistics , 2010, Advances in health sciences education : theory and practice.

[13]  M. Ramakers,et al.  High incidence of venous thromboembolic events in anticoagulated severe COVID‐19 patients , 2020, Journal of Thrombosis and Haemostasis.

[14]  S. Merler,et al.  Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. , 2020, JAMA.

[15]  O. Rafaelsen Personal View , 1987, British medical journal.

[16]  P. Williamson,et al.  Core outcome sets and systematic reviews , 2016, Systematic Reviews.

[17]  T. R. Knapp Treating ordinal scales as interval scales: an attempt to resolve the controversy. , 1990, Nursing research.

[18]  Catharine I Paules,et al.  The Critical Role of Biomedical Research in Pandemic Preparedness. , 2017, JAMA.

[19]  Jane M Blazeby,et al.  Developing core outcome sets for clinical trials: issues to consider , 2012, Trials.

[20]  Hongsheng Liu,et al.  新型冠状病毒肺炎疫情期间肺癌患者临床管理 , 2020, Zhongguo fei ai za zhi = Chinese journal of lung cancer.

[21]  Bill Gates,et al.  Innovation for Pandemics. , 2018, The New England journal of medicine.

[22]  N. Zhou,et al.  Clinical management of lung cancer patients during the outbreak of COVID-19 epidemic , 2020, Infectious Agents and Cancer.

[23]  Yuan Wei,et al.  A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19 , 2020, The New England journal of medicine.

[24]  P. Tugwell,et al.  Outcome measures in rheumatoid arthritis randomised trials over the last 50 years , 2013, Trials.

[25]  Jun Liu,et al.  Chest CT for Typical 2019-nCoV Pneumonia: Relationship to Negative RT-PCR Testing , 2020, Radiology.

[26]  Andrew C. Leon,et al.  Assessing Psychiatric Impairment in Primary Care with the Sheehan Disability Scale , 1997, International journal of psychiatry in medicine.

[27]  K. Yuen,et al.  Clinical Characteristics of Coronavirus Disease 2019 in China , 2020, The New England journal of medicine.

[28]  C. Bock,et al.  Effects of Quantitative Ordinal Scale Design on the Accuracy of Estimates of Mean Disease Severity , 2019, Agronomy.