Secondary data linked to the Royal College of General Practitioners (RCGP) Research and Surveillance Centre's (RSC) primary care sentinel data for the purposes of infectious and respiratory diseases surveillance in England

UK Health Security Agency (UKHSA) holds a contract with the Royal Collage of Practitioners (RCGP) who in turn hold a contract with the University of Oxford to deliver information to support surveillance and monitoring of vaccine efficacy on Influenza.

UKHSA, RCGP and University of Oxford are Joint Data Controllers for this request. They require HES and Civil Registration Data (CRD) to look at the outcomes of care, including death to support surveillance and monitoring of vaccine efficacy on Influenza. Most important health outcomes happen in hospital, hospital is where the bulk of health care costs are incurred. The focus of the work will be the impact of influenza and other infections on health the benefit-risk of influenza and other vaccinations. The Royal College of General Practitioners (RCGP) Research Surveillance Centre (RSC), is based at the University of Oxford.

The University of Oxford and UKHSA will have access to the record level data supplied by NHS England under this agreement. The University of Oxford and UKHSA will be the only organisations who access and process the data disseminated under this agreement.

The GDPR Lawful basis for processing the requested data under this agreement are;

UKHSA;

Article 6(1)(e) (Public Task processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller) and Article 9(2)(h) (processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services) and Article 9(2)(i) (processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices)

UKHSA exist to protect and improve the nation's health and wellbeing, and reduce health inequalities.

RCGP;

Article 6(1)(f) processing is necessary for the purposes of the legitimate interests pursued by a controller, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child. This shall not apply to processing carried out by public authorities in the performance of their tasks. 9(2)(i) (processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices)

University of Oxford;

Article 6(1)(e) (Public Task processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller) and Article 9(2)(i) (processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices).

Additionally the request for data is supported by UKHSA as they have an emanation of the Secretary of State for health and social care, to both self-approve the use of Regulation 3 and to grant this approval to third parties processing confidential patient information without consent for purposes that fall under the scope of Regulation 3.

This authority has been in existence since Public Health England (PHE) was established in 2013. PHE was replaced by UKHSA and although the large majority of the Regulation 3 approvals granted since that date have been internal to UKHSA; only a very small number have been granted by UKHSA to third parties. Specifically the work being undertaken under Reg 3 in this application is limited to Communicable Disease surveillance and other risks to public health’.

This secondary care data being requested will be linked at individual level to the Royal College of General Practitioners (RCGP) Research and Surveillance Centre's (RSC) primary care sentinel data for the purposes of infectious and respiratory diseases surveillance in England’. These include feeding back to member practices about their quality of care through a practice dashboard. The key objectives of the work are to: (1) Monitor influenza; (2) Analyse influenza vaccine effectiveness; (3) Understand and predict the impact of influenza and other winter infections on health service utilisation (e.g. older people with co morbid illness may be more likely admitted to hospital. Primary care/general practice data (which is already held) is rich in terms of diagnosis and information about the process of care. However, HES and CRD data provides key information about the outcomes of care (A&E use, hospitalisation and death data)

The University of Oxford have an established sentinel GP influenza surveillance scheme in GP practices across England that monitors Influenza-like-illness and a subset who take virology swabs with the purpose of virologically confirming infection. The University of Oxford have a great deal of experience in using health related data to monitor infectious illnesses. Accessing HES and CRD data will allow the University of Oxford to expand their knowledge about the impact of infectious diseases further; this will both be at the individual patient risk level as well as looking how the University of Oxford could better predict winter pressures on the NHS to support UKHSA and RCGP.

UKHSA is involved in this programme of surveillance and quality improvement. UKHSA is a large organisation whose main aim is to protect and improve the nation’s health and reduce inequalities.

The RCGP RSC and UKHSA have worked together for over 50 years to monitor the progression of infectious illnesses in order to put any action plans in place if needed. UKHSA are funding this surveillance and quality improvement being undertaken through this agreement.

Individual patient level data is required because this allows much more precise statistical analyses to be made, compared with just comparing aggregate data.

The main aim of this project is to build a robust database and reporting system using up-to-date primary and secondary care data at the individual patient level, which can be easily queried; and has the likely variables required for UKHSA reports outlined in the specific outputs section. The database will contain the following variables for each patient (where present):

• Influenza-like-illness appointments: including information on whether or not a virology swab was taken and the outcome of the swab

• Data for the other 32 conditions monitored by University of Oxford as contracted by RCGP RSC on behalf of UKHSA

• To provide national surveillance data about an outbreak or pandemic that was not predicted

• Vaccination status: date of vaccination, type of vaccination

• Co morbid conditions

• Medication which may be associated with better or adverse outcomes.

• A & E visits

• Inpatient appointments, including critical care

• Outpatient appointments

• Mortality data (if applicable).

The database will be used to answer the many associated questions exclusively related to surveillance and monitoring of vaccine efficacy on Influenza. For example, gaining access to HES and CRD data means that the University of Oxford can clearly see the rates of patients who access health care because of influenza related conditions. This will enable the University of Oxford to assess the pressure that is put on the healthcare system during influenza seasons, and devise and test measures to prevent this. Another example relates to comorbidities of disease, reducing the rates of influenza nationwide is of public health interest as influenza can be particularly dangerous for those in high risk groups. HES and CRD data will be used to identify the incidence of flu in those with certain conditions, such as pregnancy or diabetes. This will enable the University of Oxford to identify whether certain conditions are associated with an increased risk of catching influenza, and may lead to individuals with certain conditions being offered vaccinations in future influenza seasons. A further example relates to vaccine effectiveness. The RCGP RSC system is also used to monitor the effectiveness of influenza vaccine on behalf of UKHSA each season. UKHSA make decisions about England’s vaccination programme, and the data the RCGP RSC provides to UKHSA informs their decisions on future influenza vaccinations. The data provided under this agreement will be used to see whether anyone with certain conditions, who are vaccinated, are less likely to use hospital services than those who have not been vaccinated. This will provide further information on vaccine effectiveness in individuals with certain conditions.

The data will be used to support University of Oxford, RCGP and UKHSA in understanding more about the primary and secondary care data at a patient level for the following conditions;

URTI – Upper respiratory infections

LRTI – Lower respiratory infections (pneumonia and acute bronchitis)

Asthma and COPD

These peak as flu circulates and not all flu is diagnosed as flu therefor looking at these conditions will support the influenza overall programme.

Both CRD and HES data will be required:

• HES: Critical Care

• HES: Outpatients

• HES: A&E

• HES: Admitted patient care

• CRD (mortality) data

Since the outbreak of COVID-19 in Wuhan, China, the surveillance programme have been working closely with and under instruction from UKHSA and other national bodies to closely monitor and make plans to deal with any situation that may develop in the UK. A vital part of that will be to monitor the number of suspected COVID-19 cases in the community in a timely way. UKHSA has commissioned the RCGP Research Surveillance Centre to incorporate monitoring of COVID-19 into its virology surveillance scheme.

RCGP RSC and UKHSA will be extending the surveillance to include COVID-19.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Flows of data:

• Data are extracted from practices that are members of the Royal College of General Practitioners (RCGP RSC) Research and Surveillance Network by Apollo. The University of Oxford subcontracts with Apollo to do this as part its contractual responsibilities.

• The University of Oxford, on behalf of RCGP RSC, will provide NHS England with a list of pseudonymised NHS numbers and date of birth for the cohort each quarter.

• NHS England will provide HES Critical Care, Outpatients, A&E, Admitted patient care and CRD data for the cohort to the University of Oxford each quarter for it to link these information to RCGP RSC data.

• University of Oxford will store the data on the secure network.

• University of Oxford will process and aggregate pseudonymised data to produce approved reports for surveillance (as part of the National surveillance process); and quality improvement.

Detailed explanation of flows of data:

a) Data flow from RCGP RSC network member practices to University of Oxford: Apollo extract the data from the practices. Patients who have opted out of data sharing do not have their data extracted, unless they have consented to a specific surveillance programme or study. This extract provides the study with information about patient’s visits to general practices including the date of the appointment, the reason for the visit and any relevant vaccination information. The University of Oxford also receive patient’s NHS numbers and date of births which are pseudonymised using SHA-512 algorithm. Detailed information about this algorithm is held in a separate location by IT services at the University of Oxford. This extract provides University of Oxford with a cohort of participants whose data will then requested from NHS England.

b) University of Oxford to NHS England: The University of Oxford securely transfers a file of identifiers (Pseudonymised NHS Number, date of birth, and Unique Study ID) to NHS England for all non-opt-out patients who are registered with RCGP RSC general practices.

c) NHS England to University of Oxford: NHS England returns linked HES and CRD mortality data including the Unique Study ID and pseudonymised NHS numbers or date of birth to University of Oxford.

d) University of Oxford Storage and processing of data: The data about patients registered with RCGP RSC general practices is stored on the secure server at the University of Oxford which can only be accessed from the University of Oxford. The data will be processed within secure network and dedicated analysis server of the Surveillance Group. The secure network is located behind a firewall within the University’s network, all in-bounded connections are blocked, but out-bounded connections are allowed. Patient level data are held in the database server within the RSC Group’s secure network.

Pseudonymised data will be stored on the database server within the RSC’s secure network. The pseudonymisation algorithm is held in a separate location by IT services at the University of Oxford.

e) University of Oxford process and aggregate pseudonymised data to produce reports. For example, University of Oxford on behalf of RCGP RSC provide a mid-season flu cohort to UKHSA with data up to the end of December. This is a fully pseudonymised patient-level extract collected by a UKHSA statistician using a secure drive. The University of Oxford also produce an end of season report, an annual report and weekly reports that are available to the public and use aggregated data on rates of infectious and allergic conditions.

The RCGP RSC data is controlled and processed by a group of staff who are all based at the University of Oxford; all are mandated to complete information governance training. The group is made up of analysts, academic fellows, Structure Language Query (SQL) developers, RCGP RSC practice liaison officers, a project manager and a head of department. The team work from secure workstations or secure laptops with encrypted drives within the group’s secure network.

Data will only be accessed by individuals within the RSC who have authorisation that are substantive employees of University of Oxford. The authorisation process includes: (1) Contractual requirement to follow IG principles; (2) Using the email registered with Human Resources to complete IG training and to return the certificate; (3) Staff’s email is authorised by the IT department for one year to access the secure network and staff’s computers are configured to allow this; (4) At any point the project managers or Head can have access to the secure network turned off. There is special authorisation to have access to the main database.

Only three SQL developers and one senior project manager can access the main database. Surveillance databases are created for approved analyses once they have been agreed by the RCGP RSC approval committee. This agreed protocol includes the list of variables required for the database. The SQL developers create separate databases for individual projects only including the required variables, for the required time interval.

The HES and CRD data will be linked with the data that the University of Oxford already receives from the RCGP RSC network practices and UKHSA reference laboratories. The linkage between secondary and primary care data would happen via linking pseudonymised NHS numbers in both sets of data. The University of Oxford have used this process for previous projects linking different sets of data, and the linkage has been successful, provided both parties use the same pseudonymisation algorithm (SHA-512).

There will be no requirement nor attempt to re-identify individuals from the data.

The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Historic data are needed because longitudinal data better enable the RSC to predict what might happen in the future; even a small increase in the ability to understand flu and its associated morbidity and mortality would offer benefits for patients and the NHS. Both historical and future data are needed in order to build a robust database and reporting system using up-to-date primary and secondary care data at the individual patient level, which can be easily queried. This will enable the study group to answer a wide range of questions which will have an impact on the provision of health care in England. For example, the data will be used to answer questions posed by UKHSA, who make many decisions about healthcare, such as the vaccination programme, or preventative measures.

The use of national data is needed as the University of Oxford are a national surveillance centre and the cohort are from across England. Practices are recruited to be nationally representative.

Due to the potentially wide variety of adverse events that influenza can cause, it is not seen as appropriate to limit the data to specific health conditions/diagnostic codes or data types. For example, unexpected rise in scarlet fever and winter outbreaks of scabies are examples of unexpected increased incidence of diseases that has been followed.

The use of pseudonymised NHS numbers are essential as the request to link HES and CRD data to the data that the University of Oxford already receives from the RCGP RSC network general practices and UKHSA reference laboratories.

The purpose of linking HES, CRD, and primary care data is to implement a wider and more accurate sentinel surveillance of infectious diseases in England. The main outputs of the RCGP RSC’s surveillance work, which is funded by UKHSA are as follows:

• The RCGP RSC weekly report is circulated to a selected list of recipients on Wednesdays and it is publicly available on Thursdays at 2 pm at the RCGP RSC website (http://www.rcgp.org.uk/clinical-and-research/our-programmes/research-and-surveillance-centre.aspx). This report currently covers incidence rates of 37 infectious and respiratory conditions in England. It is expected that, in future, hospitalisation trends will be included. This is incorporated into the syndromic surveillance carried out by UKHSA on a daily basis, which allow them to determine any urgent priorities for local health protection teams.

• Similar to this, an annual report is published covering the annual trends of the 37 conditions. Each year, this report has a new theme which is explored in a paper submitted to a peer-reviewed journal (usually British Journal of General Practice). Themes explored include demographic disparities in disease presentation, higher rates of consultations for lower respiratory infections for boys, and urban/rural disparities of presentation.

• In January of every year, the University of Oxford provide a mid-season flu cohort to UKHSA with data up to the end of December. This is a fully pseudonymised patient-level extract collected by a UKHSA statistician using a secure drive. This data extract contains details of influenza swabbing, chronic conditions, and vaccination status for each patient. It is hoped to be able to include details of emergency attendances or admission around influenza, pneumonia, or lower respiratory tract infection events. At the end of the flu season (varies from March to May), a second extract is provided updating the first, with data recorded after December.

• The data from both of these extracts is used to estimate seasonal influenza vaccine effectiveness, stratified by comorbidities and demographics. HES data will allow the University of Oxford/UKHSA and RCGP to include the impact of any changes in effectiveness, assessed through changes in hospital admissions/emergencies due to respiratory conditions. The results are published at the mid-season and at the end of season stage, on the peer-reviewed journal Eurosurveillance.

• Important results from either of these will be further analysed and presented at the RCGP annual conference, the UKHSA annual conference, and the UKHSA annual epidemiology conference.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The surveillance work conducted by the RCGP RSC on behalf of the Data Controllers is used by Department of Health, NHS England and UKHSA to monitor trends in a number of infectious conditions. Specifically for influenza, seasonal epidemics are carefully followed, in order to deploy necessary measures as needed to limit the impact on the population. The trends in other conditions inform the development of vaccination programmes or other public health measures. Linking with HES and CRD data can help assess the severity and mortality of a given condition, thereby alerting UKHSA on whether larger measures should be implemented. This could lead to improved healthcare and reduced mortality of certain conditions. Additionally, the link with the HES and CRD data allows The University of Oxford to identify whether a particular flu season is putting additional pressures which means that plans can be out in place in order to prevent or deal with these pressures next season.

Specific benefits

The benefits include improved knowledge of the pressures of certain conditions during the winter period, reduced mortality from influenza, improved vaccine effectiveness and a health system that is more prepared in the event of an influenza outbreak.

Magnitude of benefits

It is expected that these benefits will be nationwide across England, to both patients and staff working in the health care system.

Sequence of events needed to take place in order for benefits to be achieved:

1. Pseudonymised matching and then HES and CRD mortality data are linked with the data the University of Oxford hold at the RSC

2. The University of Oxford analyse the data and identify trends in rates of illnesses, hospital use and mortality in certain groups (i.e. pregnant women, older people, and people with co morbid conditions)

3. The University of Oxford alert UKHSA and the Chief Medical Officer of the findings who will then evaluate the evidence and make health care plans that are in the best interest of the nation’s health.

For example, from the data provided by HES and CRD, UKHSA might identify that certain conditions are associated with higher influenza rates, and therefore the possibility of extending the vaccination programme to this condition might be examined.

The RSC and UKHSA have been working together for many years, to improve the nation’s health. University of Oxford has become important in the process from March 2015 the secure network was established at University of Oxford. The work is funded by UKHSA and the University of Oxford's work has previously been used to influence practice. For example, if high rates of influenza are circulating the University of Oxford will inform the Chief Medical Officer who will then make a decision about whether or not to dispense anti-viral medications at hospitals and general practices.

Not stated in the register.