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Protocol for the development and evaluation of a tool for predicting risk of short-term adverse outcomes due to COVID-19 in the general UK population

By Julia Hippisley-Cox, Ashley Kieran Clift, Carol AC Coupland, Ruth Keogh, Karla Diaz-Ordaz, Elizabeth Williamson, Ewen Harrison, Andrew Hayward, Harry Hemingway, Peter Horby, Nisha Mehta, Jonathan Kieran Benger, Kamlesh Khunti, David Spiegelhalter, Aziz Sheikh, Jonathan Valabhji, Ronan A Lyons, John Robson, Malcolm Gracie Semple, Frank Kee, Peter Johnson, Susan Jebb, Tony Williams, David Coggon

Posted 29 Jun 2020
medRxiv DOI: 10.1101/2020.06.28.20141986

Introduction: Novel coronavirus 2019 (COVID-19) has propagated a global pandemic with significant health, economic and social costs. Emerging emergence has suggested that several factors may be associated with increased risk from severe outcomes or death from COVID-19. Clinical risk prediction tools have significant potential to generate individualised assessment of risk and may be useful for population stratification and other use cases. Methods and analysis: We will use a prospective open cohort study of routinely collected data from 1205 general practices in England in the QResearch database. The primary outcome is COVID-19 mortality (in or out-of-hospital) defined as confirmed or suspected COVID-19 mentioned on the death certificate, or death occurring in a person with SARS-CoV-2 infection between 24th January and 30th April 2020. Our primary outcome in adults is COVID-19 mortality (including out of hospital and in hospital deaths). We will also examine COVID-19 hospitalisation in children. Time-to-event models will be developed in the training data to derive separate risk equations in adults (19-100 years) for males and females for evaluation of risk of each outcome within the 3-month follow-up period (24th January to 30th April 2020), accounting for competing risks. Predictors considered will include age, sex, ethnicity, deprivation, smoking status, alcohol intake, body mass index, pre-existing medical co-morbidities, and concurrent medication. Measures of performance (prediction errors, calibration and discrimination) will be determined in the test data for men and women separately and by ten-year age group. For children, descriptive statistics will be undertaken if there are currently too few serious events to allow development of a risk model. The final model will be externally evaluated in (a) geographically separate practices and (b) other relevant datasets as they become available. Ethics and dissemination: The project has ethical approval and the results will be submitted for publication in a peer-reviewed journal.

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