A UK-based research organization known as UK Coronavirus Clinical Characterization Consortium(ISARIC4C) involves physicians and scientists from preeminent academic medical centers, including university College London, Imperial College London, the University of Liverpool, the University of Edinburgh and the University of Oxford have just introduced a new risk-stratification tool, which can accurately predict the likelihood of deterioration in adults hospitalized with COVID-19. This online tool will be made freely to NHS sites available as of Friday January 8, 2021 and can support clinicians’ decision making, with a hope to improve patient outcomes and of course save lives. Based on 11 underlying measurements routinely connected from patients, such as age, gender and physical measurements (e.g. oxygen levels) along with select standard laboratory tests, the tool calculates a percentage of risk deterioration in what the team refers to as the ‘4C Deterioration Score.’ This online tool builds on the consortium’s previous work developing the ‘4C Mortality Score’ to predict the percentage risk of death from COVID-19 after admission to the hospital. The ‘4C Mortality Score’ is already recommended for use by NHS England to guide anti-viral treatments with Remdesivir. The UK-based team recently had their study results published in The Lancet Respiratory Medicine. By employing this free online tool, moving forward NHS doctors can see both the ‘4C Deterioration Score’ and the ‘4C Mortality Score’ simultaneously. The tool can potentially be embraced and employed in other countries but would need to be tested in those jurisdictions.
TrialSite offers the network a breakdown of this new online tool available in the UK.
What is the study background?
UK Coronavirus Clinical Characterization Consortium (ISARIC4C) is a UK-wide consortium of leading experts in outbreak medicine with a proficient, coordinated and agile research response to COVID-19.
What data did the consortium use to develop the tool?
They used data from 74,944 individuals with COVID-19 admitted to 260 hospitals across England, Scotland and Wales between Feb. 6 and Aug. 26, 2020.
How does it work?
They employed a multivariable logistic regression model (e.g. where several measures are used to predict an outcome), testing 11 measures (age/gender/physical measures/lab tests) against the large patient cohort establishing the how as well as to what degree each of the measures affected the likelihood of deterioration.
What are the 11 measurements?
The 11 measures (demographic, clinical, and laboratory predictors) are age; gender; acquisition of infection in hospital or community; existence of infiltrates (white spots) on lung X-Ray; impairment of consciousness level (defined by the Glasgow Coma Scale); respiratory rate (breaths per minute); oxygen saturation (measured with a finger probe); blood C-reactive protein levels; level of urea (in blood); number of lymphocytes in blood; and whether or not the patient is receiving oxygen (from a breathing aid).
How are the results of the study looking?
The consortium evaluated the tool in nine NHS regions and found it performed similarly well in each area. This suggests that it is likely to be useful across the NHS. Importantly, the new risk score evidenced superiority across the NHS, in comparison to previous risk scores.
Dr. Rishi Gupta with UCL Institute of Global Health and first author of the ISARIC4C study shared, “the scale and wide geographical coverage of the ISARIC4C study across the country was critical to the development of this prediction tool. Our analysis provides very encouraging evidence that the 4C Deterioration tool is likely to be useful for clinicians across England, Scotland and Wales to support clinical decision-making.”
Can the tool be used in other countries?
Yes. The researchers suggest that it could be used in other nations for purposes of risk-stratification but importantly, it should first be evaluated to test its accuracy in these settings.
What is the tool’s value proposition?
Well, according to Professor Mahdad Noursadeghi, UCL Infection & Immunity and Co-senor and corresponding author, “Accurate risk-stratification at the point of admission to hospital will give doctors greater confidence about clinical decisions and planning ahead for the needs of individual patients.”
He continued, “The addition of the new 4C Deterioration Score alongside the 4C Mortality Score will provide clinicians with an evidence-based measure to identify those who will need increased hospital support during their admission, even if they have a low risk of death.”
How can the tool fit into existing workflow and systems?
The authors report that for example the tool could be incorporated into NHS Trusts’ Electronic Health Record System—used to manage all patient care—so that risk scores are automatically generated for patients. TrialSite cannot share with readership what the level of complexity would be but if systems have open APIs this should be relatively easy.
Who provided study funding?
National Institute for Health Research (NIHR) and UK Medical Research Council grants and, of course, support from the consortium’s participating members.
Mahdad Noursadeghi, Doctorate, Fellow Royal College of Physicians, Professor of Infectious Diseases, UCL, and Co-senor and corresponding author,
Dr. Rishi Gupta, NIHR Doctoral Research Fellow, Institute for Global Health, UCL, first author
A list of all study authors can be found here.
Call to Action: Reach out to the group to learn how to set up the tool.