Written by Rebekah Penrice-Randal and Lucia Livoti

Features of 20,133 UK patients in hospital with COVID-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study 1 was published in The British Medical Journal (BMJ) this week. This report defines clinical characteristics of patients in hospital in the UK, using the ISARIC WHO Clinical Characterisation Protocol. We have written a brief summary to define what this means, discuss the report itself and highlight the key findings to aid public understanding.


What is ISARIC?

ISARIC is the acronym for International Severe Acute Respiratory and emerging Infections Consortium. ISARIC are a global federation of clinical research networks, with a core goal of generating evidence to improve clinical care and public health responses. They provide a “proficient, coordinated and agile research response to outbreak-prone infectious diseases”.

You can follow the study on twitter for more updates: @CCPUKstudy


What is the ISARIC WHO Clinical Characterisation Protocol?

A research protocol is the set of documents that includes the instructions for conducting a study, the participant information sheets and consent forms. A clinical research protocol has to be approved by an independent Research Ethics Committee to ensure patient safety and dignity, and in the UK, by the Health Research Authority to ensure that health care resources are used appropriately.

 The ISARIC WHO Clinical Characterisation Protocol for Severe Emerging Infection (ISARIC WHO CCP-UK) was designed in 2012 to understand the clinical characteristics  of “any severe or potentially severe acute infection of public health interest”.

In other words, the study was set up in advance of an outbreak to ask the “who, what and why” of a new disease. Who is affected means, age, sex, ethnicity and underlying medical problems. What means, what does the disease cause any of: breathing problems, diarrhoea, vomiting, sepsis or bleeding.

The ISARIC WHO CCP allows for the collecting of clinical data and biological samples, and their analysis and processing to be done in a globally-harmonised manner. This protocol has been curated by multidisciplinary experts across the world 2, and employed in response to outbreaks such as:

  • Middle Eastern Respiratory Virus Syndrome coronavirus (MERS-CoV) in 2012,
  • Influenza in 2013,
  • Ebola virus in 2014,
  • Monkeypox and MERS-CoV in 2018,
  • Tick-borne encephalitis virus (TBEV) in 2019 and
  • SARS-CoV-2 in 2020.

The ISARIC WHO CCP has been central to the swift and cohesive research response to COVID-19. As a free, readily available resource it has been instrumental in the standardised collection of samples and data for the COVID-19 outbreak. This in turn has allowed clinical investigation to progress as quickly as possible. Global generic documents can be accessed here. Countries are also encouraged to develop “localised” instructions and seek local research permissions. The documents pertaining to UK protocols are available here.


Definitions:

Cohort: a cohort of patients are a group of individuals affected by a common factor, such as a disease, treatments or environmental factors.

Cohort study: cohort studies are central to the study of epidemiology and are often used in the fields of medicine, nursing, psychology and social sciences.

Comorbidity: presence of one or more medical conditions in addition to the condition being studied.

Epidemiology: the study and analysis of factors contributing to disease and health outcomes. In this case it may refer to the frequency and pattern of COVID-19 infection, risk factors, super-spreader events and study of specific populations. 

Median: the median is defined as the ‘middle’ value of a data set, such that other values are equally likely to be above or below.

Risk factor: a factor that increases an individual’s risk or susceptibility to a disease.


Aim of the study:

  • To rapidly understand the clinical characteristics of people severely affected by COVID-19. Severely affected, meaning those who need hospital care.


Why is this work important?

This work is essential to appreciate the clinical features of patients that present with COVID-19 and identify risk factors associated with poor outcome. It is only through the understanding of such aspects that public policy can be informed, particularly around shielding of vulnerable groups and planning of resources such as oxygen and ventilator provision.   


Who took part?

20,133 hospital in-patients with COVID-19 from 208 acute care hospitals across the UK were enrolled into the study. Clinical data was collected from patients admitted to hospital between 6th February and 19th April 2020. Patient outcomes are described as known on 3rd May 2020, as people admitted on the 19th April need at least 14 days to complete their admission or “declare the nature of their illness”.


The Results


Conclusions

The ISARIC WHO CCP-UK is a large ongoing study of patients hospitalised with COVID-19. This study found that the mortality rate was high in those admitted to hospital. Certain risk factors were associated with higher mortality rate such as; increasing age, male sex, and chronic comorbidity, including obesity. This report provides the first clinical insight of hospital patients with COVID-19 in the UK. The data gathered throughout this study will assist decision-making in the management of COVID-19, from patient to nation.

This report acknowledges the 2648 frontline NHS clinical and research staff, volunteer medical students and many researchers, who have worked tirelessly to make this study happen. Thank you to all involved and congratulations from The Science Social.


A note on ‘open access’

Open access journal articles are available to everyone and are not behind a pay wall. This article is freely available to all, if you would like to read the original article click here.

References

1          Docherty, A. B. et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ 369, m1985, doi:10.1136/bmj.m1985 (2020).

2          Dunning, J. W. et al. Open source clinical science for emerging infections. The Lancet Infectious Diseases 14, 8-9, doi:10.1016/S1473-3099(13)70327-X (2014).

Thank you to Professor Calum Semple (@tweediechap), an ISARIC investigator and co-author of the original article for permission to write this blog, and for the valuable comments.

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