The University of Manchester

Academic Institute

No

DARS-NIC-402963-P0Y5D-v0.2

The Coronavirus Clinical Information Network (CO-CIN) has collected data for the International Severe Acute Respiratory Infection Consortium (ISARIC) Coronavirus Clinical Characterisation Consortium through a commission from the Chief Medical Officer to conduct Urgent Public Health Research to provide evidence that informs public health policy in response to the COVID-19 emergency. ISARIC’s purpose is to prevent illness and deaths from infectious disease outbreaks. ISARIC is a global federation of clinical research networks, providing a proficient, coordinated and agile research response to outbreak-prone infectious diseases. The ISARIC Coronavirus Clinical Characterisation Consortium is a UK-wide consortium of leading experts in outbreak medicine with a proficient, coordinated, and agile research response to COVID-19. In 2019 a new virus, SARS coronavirus-2 (SARS-Cov-2) emerged. It seems highly likely that SARS-CoV-2 and its associated disease COVID-19 will cause mortality unprecedented in modern times. This is a new disease. There is a high chance that clinical trials will fail to detect therapeutic effects, by enrolling at the wrong time, or missing key subgroups or endpoints. Concurrent biological phenotyping can mitigate these risks, providing rapid, efficient clinical evidence. CO-CIN response has been planned and tested over the past 8 years within the International Severe Acute Respiratory Infection Consortium (ISARIC). CO-CIN informs the Department of Health and Social Care (DHSC) on a weekly basis about the clinical evolution of disease in the United Kingdom. To achieve this, clinical research nurses and administrators gather anonymised data from clinical notes and enter it into a simple online database. This allows the characterisation of the patients’ clinical features as well as risk factors associated with severity, risk of hospitalisation and death. The information gathered is essential to help health service planning and provision, and to rapidly evaluate the impact of interventions such as new therapeutics or vaccines. The legal basis for the processing and storage of personal data for COCIN is that it is a task in the public interest Article 6(1)(e) it is in the public interest to conduct public health research to provide evidence to inform public health policy in response to the COVID-19 emergency and to understand and report on the risk factors associated COVID-19 and that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes Article 9(2)(j). The research is conducted with relevant Health Research Authority ethical approvals throughout the UK. Since early February, CO-CIN has collected data on over 79,000 patients of all ages requiring admission to hospital with covid-19, and patients in hospital subsequently diagnosed with covid-19 in England, Scotland and Wales, accounting for approximately 60% of all patients admitted to hospital with covid-19 in the UK. Only data from England will be sent to NHS Digital for linkage. Patients are recruited into one of three Tiers. Tier 0 sites are recruited for data collection only without consent, while Tiers 1 and 2 provide consent for sample collection in addition to data collection. The distinction of the study into three Tiers was made to allow for a resource appropriate implementation of the protocol, as it was understood that data and/or sample collection may be limited in some settings. For Tier 0 patients clinical data is collected but no additional biological samples are obtained for research purposes. The minimum clinical data set summarises the illness episode and outcome, with the option to collect additional detailed clinical data at frequent intervals, according to local resources/needs. Given the scale of the current COVID-19 pandemic, and because initially data collection for Tier 0 participants was clinical data only from which the participant could not be identified, consent was not sought. The data is collected by a health care professional who has access to the patient's information by virtue of their clinical role. The addition of collection of NHS number, Date of Birth (DOB) and postcode for Tier 0 participants means they are now able to be identified from the dataset in order to support linkage to other NHS data sources and is currently being done under Control of Patient Information Regulations (COPI). The identifiable data is not made available to researchers. Tier 0 is being retrospectively and prospectively completed with identifying data relying on COPI. The datasets are required primarily to enable CO-CIN to report early and accurate findings to the Scientific Advisory Group for Emergencies (SAGE). Since the early growth phase of COVID-19 in the UK, CO-CIN has presented near real-time epidemiological descriptions and analyses of hospitalised patients with COVID-19. CO-CIN have presented analyses of patient factors including ethnicity, age, comorbidity, and their association with in-hospital mortality, enabling SAGE to make decisions based on near real-time evidence. SAGE will have no access to the NHS Digital data shared under this Agreement. Each of the datasets, including the GDPPR data (which will provide data on shielded patients), is essential to support the analysis for the use cases as these questions cannot be answered using just the available CO-CIN data. Specific questions about shielding, pre-existing patient co-morbidities, and the outcomes for patients are important to be able to understanding the full impact of the disease and interventions. CO-CIN was set up as a pandemic Case Report Form (CRF), and comorbidity categories are broad. There is a need to understand the duration and severity of comorbidities in more granularity. CO-CIN need to be able to report and respond to the impact that multi-morbidity and frailty have on COVID. CO-CIN have detailed data regarding in-hospital sequelae of COVID-19, but require post-discharge follow-up data in. Follow up of contacts with primary and secondary care, and in particular cardio-respiratory and psychiatric sequelae will be imperative to understanding the long-term impact of severe COVID-19. CO-CIN need to be able to report and respond to the longer-term impact COVID-19 is having on hospitalised survivors. CO-CIN have outcomes for patients at hospital discharge (alive, dead, palliative discharge, ongoing rehab). For the majority of patients this is <28 days from hospital admission. CO-CIN need to be able to report the longer-term all-cause and excess mortality for patients hospitalised with covid-19. The data will help to understand the longer-term mortality for patients admitted to hospital with COVID-19 (long-COVID). CO-CIN have shown that diabetes is independently associated with in-hospital mortality for patients with COVID-19, and this partially mediates the relationship between ethnicity and mortality. The data requested is essential to understanding the relationship between diabetes, COVID-19 and mortality, by increased granularity of diabetes comorbidity including duration since diagnosis, complications, comorbidity, ethnicity and longer-term mortality CO-CIN have presented data on hospital acquired infection, level of treatment (oxygen, critical care, invasive ventilation), and specific treatments (including dexamethasone, remdesivir, convalescent plasma). CO-CIN have developed a secure, password protected dashboard where SAGE members are able to access aggregated data with small numbers suppressed. This data is accurate to the same day. The data has been used for modelling by Scientific Pandemic Influenza Group on Modelling (SPI-M), and is the compulsory national registry for patients who receive remdesivir. CO-CIN have produced academic papers published in high impact journals (early general description, paediatrics, risk prediction model, ethnicity) which have supported evidence based practice in UK hospitals. CO-CIN have supported external collaborations with specialty academic groups to explore their patient groups, such as those with interstitial lung disease and HIV. In a subgroup of 2,500 patients, CO-CIN have linked with detailed biological and follow-up data. Use cases for supporting SAGE reporting include the following research questions: - What are the outcomes for patients on the shielding list? - How do patient comorbidities/multi-morbidity contribute to in-hospital mortality in patients admitted to hospital with covid-19? - What is the impact of ethnicity and socio-economic deprivation on outcomes in patients admitted to hospital with covid-19? - Does access to hospital affect outcomes? - What are the longer term sequelae for hospitalised survivors of covid-19? - What is the longer term mortality in patients admitted to hospital with covid-19? - What is the association between diabetes and in-hospital mortality? The following organisations are involved in the study: University of Oxford are the lead organisation for the study and host the data collection, they are the data controller. University of Edinburgh are hosting the research databases and have the data science team that will be analysing the linkage, they are a data processor. University of Liverpool support the hospital recruitment sites. Imperial University are solely analysing the collected sample data and no NHS Digital data. Only the University of Edinburgh will store or have access to the NHS data from England, within its data safe haven.

Expected benefits within the project timescales to April 2021 will include: Reduce deaths associated with COVID-19 Assist commissioners in making decisions to better support patients Identifying COVID-19 trends and risks to public health Enables Department of Health and NHS England to provide guidance and develop policies to respond to the outbreak Controlling and helping to prevent the spread of the virus The Department of Health and NHS England can share a common understanding of activity levels across the system in regard to COVID-19. Better activity data will also enable a more robust national planning process and improve the allocation of resources across the system. This will support the response to the pandemic but also the recovery of services.

11/10/2020

Health and Social Care Act 2012 - s261 - 'Other dissemination of information'; Other-Other(CV19: Regulation 3 (1) of the Health Service (Control of Patient Information) Regulations 2002)

Statutory exemption to flow confidential data without consent

Recurring

TRE