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Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score.
BMJ. 2020 09 09; 370:m3339.BMJ

Abstract

OBJECTIVE

To develop and validate a pragmatic risk score to predict mortality in patients admitted to hospital with coronavirus disease 2019 (covid-19).

DESIGN

Prospective observational cohort study.

SETTING

International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study (performed by the ISARIC Coronavirus Clinical Characterisation Consortium-ISARIC-4C) in 260 hospitals across England, Scotland, and Wales. Model training was performed on a cohort of patients recruited between 6 February and 20 May 2020, with validation conducted on a second cohort of patients recruited after model development between 21 May and 29 June 2020. PARTICIPANTS: Adults (age ≥18 years) admitted to hospital with covid-19 at least four weeks before final data extraction.

MAIN OUTCOME MEASURE

In-hospital mortality.

RESULTS

35 463 patients were included in the derivation dataset (mortality rate 32.2%) and 22 361 in the validation dataset (mortality rate 30.1%). The final 4C Mortality Score included eight variables readily available at initial hospital assessment: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness, urea level, and C reactive protein (score range 0-21 points). The 4C Score showed high discrimination for mortality (derivation cohort: area under the receiver operating characteristic curve 0.79, 95% confidence interval 0.78 to 0.79; validation cohort: 0.77, 0.76 to 0.77) with excellent calibration (validation: calibration-in-the-large=0, slope=1.0). Patients with a score of at least 15 (n=4158, 19%) had a 62% mortality (positive predictive value 62%) compared with 1% mortality for those with a score of 3 or less (n=1650, 7%; negative predictive value 99%). Discriminatory performance was higher than 15 pre-existing risk stratification scores (area under the receiver operating characteristic curve range 0.61-0.76), with scores developed in other covid-19 cohorts often performing poorly (range 0.63-0.73).

CONCLUSIONS

An easy-to-use risk stratification score has been developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with covid-19 into different management groups. The score should be further validated to determine its applicability in other populations.

STUDY REGISTRATION

ISRCTN66726260.

Authors+Show Affiliations

Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.Medical Research Council, University of Glasgow Centre for Virus Research, Glasgow, UK. Department of Infectious Diseases, Queen Elizabeth University Hospital, Glasgow, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.Institute of Population Health Sciences, University of Liverpool, Liverpool, UK.ISARIC Global Support Centre, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.National Infection Service, Public Health England, London, UK. National Heart and Lung Institute, Imperial College London, London, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.Institute of Microbiology & Infection, University of Birmingham, Birmingham, UK.Institute of Global Health, University College London, London, UK.Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.NIHR Health Protection Research Unit, Institute of Infection, Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.NIHR Health Protection Research Unit, Institute of Infection, Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.ISARIC Global Support Centre, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.ISARIC Global Support Centre, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.Division of Epidemiology and Public Health, University of Nottingham School of Medicine, Nottingham, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.Division of Infection and Immunity, University College London, London, UK.Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK.NIHR Health Protection Research Unit, Institute of Infection, Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK. Walton Centre NHS Foundation Trust, Liverpool, UK.Health Data Research UK, London, UK.Department of Child Life and Health, University of Edinburgh, Edinburgh, UK.NIHR Health Protection Research Unit, Institute of Infection, Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK. Tropical & Infectious Disease Unit, Royal Liverpool University Hospital, Liverpool, UK.National Heart and Lung Institute, Imperial College London, London, UK.Roslin Institute, University of Edinburgh, Edinburgh, UK. Intensive Care Unit, Royal Infirmary Edinburgh, Edinburgh, UK.NIHR Health Protection Research Unit, Institute of Infection, Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK m.g.semple@liverpool.ac.uk. Respiratory Medicine, Alder Hey Children's Hospital, Institute in The Park, University of Liverpool, Alder Hey Children's Hospital, Liverpool L12 2AP, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK. Intensive Care Unit, Royal Infirmary Edinburgh, Edinburgh, UK.Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK. Department of Clinical Surgery, University of Edinburgh, Edinburgh, UK.No affiliation info available

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32907855

Citation

Knight, Stephen R., et al. "Risk Stratification of Patients Admitted to Hospital With Covid-19 Using the ISARIC WHO Clinical Characterisation Protocol: Development and Validation of the 4C Mortality Score." BMJ (Clinical Research Ed.), vol. 370, 2020, pp. m3339.
Knight SR, Ho A, Pius R, et al. Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ. 2020;370:m3339.
Knight, S. R., Ho, A., Pius, R., Buchan, I., Carson, G., Drake, T. M., Dunning, J., Fairfield, C. J., Gamble, C., Green, C. A., Gupta, R., Halpin, S., Hardwick, H. E., Holden, K. A., Horby, P. W., Jackson, C., Mclean, K. A., Merson, L., Nguyen-Van-Tam, J. S., ... Harrison, E. M. (2020). Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. BMJ (Clinical Research Ed.), 370, m3339. https://doi.org/10.1136/bmj.m3339
Knight SR, et al. Risk Stratification of Patients Admitted to Hospital With Covid-19 Using the ISARIC WHO Clinical Characterisation Protocol: Development and Validation of the 4C Mortality Score. BMJ. 2020 09 9;370:m3339. PubMed PMID: 32907855.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk stratification of patients admitted to hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: development and validation of the 4C Mortality Score. AU - Knight,Stephen R, AU - Ho,Antonia, AU - Pius,Riinu, AU - Buchan,Iain, AU - Carson,Gail, AU - Drake,Thomas M, AU - Dunning,Jake, AU - Fairfield,Cameron J, AU - Gamble,Carrol, AU - Green,Christopher A, AU - Gupta,Rishi, AU - Halpin,Sophie, AU - Hardwick,Hayley E, AU - Holden,Karl A, AU - Horby,Peter W, AU - Jackson,Clare, AU - Mclean,Kenneth A, AU - Merson,Laura, AU - Nguyen-Van-Tam,Jonathan S, AU - Norman,Lisa, AU - Noursadeghi,Mahdad, AU - Olliaro,Piero L, AU - Pritchard,Mark G, AU - Russell,Clark D, AU - Shaw,Catherine A, AU - Sheikh,Aziz, AU - Solomon,Tom, AU - Sudlow,Cathie, AU - Swann,Olivia V, AU - Turtle,Lance Cw, AU - Openshaw,Peter Jm, AU - Baillie,J Kenneth, AU - Semple,Malcolm G, AU - Docherty,Annemarie B, AU - Harrison,Ewen M, AU - ,, Y1 - 2020/09/09/ PY - 2020/9/10/entrez PY - 2020/9/11/pubmed PY - 2020/9/17/medline SP - m3339 EP - m3339 JF - BMJ (Clinical research ed.) JO - BMJ VL - 370 N2 - OBJECTIVE: To develop and validate a pragmatic risk score to predict mortality in patients admitted to hospital with coronavirus disease 2019 (covid-19). DESIGN: Prospective observational cohort study. SETTING: International Severe Acute Respiratory and emerging Infections Consortium (ISARIC) World Health Organization (WHO) Clinical Characterisation Protocol UK (CCP-UK) study (performed by the ISARIC Coronavirus Clinical Characterisation Consortium-ISARIC-4C) in 260 hospitals across England, Scotland, and Wales. Model training was performed on a cohort of patients recruited between 6 February and 20 May 2020, with validation conducted on a second cohort of patients recruited after model development between 21 May and 29 June 2020. PARTICIPANTS: Adults (age ≥18 years) admitted to hospital with covid-19 at least four weeks before final data extraction. MAIN OUTCOME MEASURE: In-hospital mortality. RESULTS: 35 463 patients were included in the derivation dataset (mortality rate 32.2%) and 22 361 in the validation dataset (mortality rate 30.1%). The final 4C Mortality Score included eight variables readily available at initial hospital assessment: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness, urea level, and C reactive protein (score range 0-21 points). The 4C Score showed high discrimination for mortality (derivation cohort: area under the receiver operating characteristic curve 0.79, 95% confidence interval 0.78 to 0.79; validation cohort: 0.77, 0.76 to 0.77) with excellent calibration (validation: calibration-in-the-large=0, slope=1.0). Patients with a score of at least 15 (n=4158, 19%) had a 62% mortality (positive predictive value 62%) compared with 1% mortality for those with a score of 3 or less (n=1650, 7%; negative predictive value 99%). Discriminatory performance was higher than 15 pre-existing risk stratification scores (area under the receiver operating characteristic curve range 0.61-0.76), with scores developed in other covid-19 cohorts often performing poorly (range 0.63-0.73). CONCLUSIONS: An easy-to-use risk stratification score has been developed and validated based on commonly available parameters at hospital presentation. The 4C Mortality Score outperformed existing scores, showed utility to directly inform clinical decision making, and can be used to stratify patients admitted to hospital with covid-19 into different management groups. The score should be further validated to determine its applicability in other populations. STUDY REGISTRATION: ISRCTN66726260. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/32907855/Risk_stratification_of_patients_admitted_to_hospital_with_covid_19_using_the_ISARIC_WHO_Clinical_Characterisation_Protocol:_development_and_validation_of_the_4C_Mortality_Score_ L2 - http://www.bmj.com/lookup/pmidlookup?view=long&pmid=32907855 DB - PRIME DP - Unbound Medicine ER -