Avon Community Acquired Pneumonia Surveillance Study: A Pan-pandemic Acute Lower Respiratory Tract Disease Surveillance Study - Denominator by risk group only

Harvey Walsh requires access to NHS England data for the purpose of the following research project:

Avon Community-Acquired Pneumonia Surveillance Study: A Pan-pandemic Acute Lower Respiratory Tract Disease Surveillance Study - Denominator by risk group only.

The following is a summary of the aims of the research project provided by Harvey Walsh:

“The Avon CAP study is being run by the University of Bristol and aims to record all patients admitted with respiratory illness at 2 hospitals in the Bristol area. We will gather data that has already been recorded by the clinical teams treating these patients, including demographics, co-morbidities, outcomes, and the results of the investigations undertaken by the medical team. Persons with acute respiratory illness will also be offered participation in the consented portion of this study involving additional testing for pneumococcal and respiratory syncytial virus (RSV) infection, which will identify more cases of such infections than routine testing. We will then use these data to accurately define the true amount of disease caused by respiratory illness and be able to determine the subgroups of disease (for example by patient co-morbidity, microbiological and radiological diagnosis) and determine the impact of COVID-19 on respiratory disease.

The purpose of this agreement is to produce a denominator number by risk group to support the Avon CAP: A Pan-pandemic Acute Lower Respiratory Tract Disease Surveillance Study is a population-based multi-hospital, active prospective surveillance study designed to determine population-based incidence rates of hospitalised adults ≥18 of age with community-acquired Lower Respiratory Tract Infection (LRTI, including CAP) in Bristol, England.

The data is required to complement the existing study. The current study focuses on patients registered to GP practices within NHS Bristol, North Somerset, and South Gloucestershire Integrated Care Board (ICB) admitted with Acute Lower Respiratory Tract Disorder (ALRTD). This will be complemented by including patients registered to GP practices within NHS Bristol, North Somerset, and South Gloucestershire ICB within the GDPPR data that may not have been admitted to hospital and only appeared and/or treated at a GP practice with ARLTD conditions. This will ensure full coverage of ALRTD patients within the NHS Bristol, North Somerset, and South Gloucestershire ICB, rather than just those that have been admitted to hospital.”

The following NHS England data will be accessed:

• GPES Data for Pandemic Planning and Research (GDPPR) necessary to produce a denominator number by risk group supporting the AvonCAP study.

The GDPPR dataset requested will only be used for COVID-19 research/activities.

The GPDPR data is requested as per the COVID-19 Public Health Directions 2020, sections

- 2.2.1 Understanding COVID-19 and risks to public health, trends in COVID-19 and such risks, and controlling and preventing the spread of COVID-19 and such risks.

- 2.2.3 - understanding information about patient access to health services and adult social care services as a direct or indirect result of COVID-19 and the availability and capacity of those services.

- 2.2.6 Research and planning in relation to Covid-19.

Lower Respiratory Tract infections (LRTI) can be caused by viruses including SARS-CoV-2, respiratory syncytial virus, influenza and bacteria including streptococcus pneumoniae and these infections may result in people seeking medical care for respiratory symptoms or cardiovascular symptoms (acute Lower Respiratory Tract Disease (aLRTD)). The non-pharmacological and pharmacological interventions introduced to mitigate the impact of the COVID-19 burden on the health system has potentially changed both the circulation and transmission of SARS-CoV-2 and other infections that may mimic SARS-CoV-2. The study team is seeking to improve understanding of COVID-19 and the risks to public health from changes in primary care demand, the impact of pharmacological and non-pharmacological interventions, and changes in access to healthcare and service capacity to support better understanding of the COVID-19 pandemic and future health service needs for the management and prevention of aLRTD.

The AvonCAP study team is requesting access to primary care records that will enable the calculation of accurate incidence rates of aLRTD stratified by common comorbidities,

a) for analysis at time points following the start of the COVID-19 pandemic to clarify the denominators for defined risk groups contributing to the aLRTD burden.

b) across population sub-groups who may have experienced inequities in aLRTD due to comorbidities or other demographic features

c) for comparison to laboratory findings to assess variation in incidence rates of SARS-CoV-2 aLRTD against incidence rates of other viral and bacterial causes of aLRTD

On this basis, the study is set up to measure the true burden of acute respiratory disease due to these pathogens during and after the COVID-19 pandemic. It is well known that certain subpopulations are at higher risk of these infections (e.g., persons with diabetes, chronic obstructive pulmonary disease, and immunocompromising conditions) but a paucity of specific incidence data is available for these subpopulations due to the difficulty of obtaining accurate denominators for such calculations. To address this data gap, we seek to calculate risk-factor-specific denominators to allow for generation of such risk-factor-specific incidence estimates from the Bristol AVONCAP study, which will provide accurate, contemporary data to support decision-making for vaccine policy makers in the UK and elsewhere.

COVID-19, pneumococcal disease, and RSV infection are major causes of worldwide mortality and morbidity – particularly among older adults. Improving our understanding of the incidences of these infections in specific high-risk subpopulations and their impact on the NHS will provide data to inform more effective and efficient prevention measures, including vaccination programme policy specifically and public health policy broadly.

The level of the data will be pseudonymised.

The data will be minimised as follows:

Limited to data for a study cohort identified by NHS England as meeting the following criteria:

• All records for patients registered at GP practices only within the Bristol hospital catchment area who are 18 years or over as of 31st March 2021.

Although Pfizer is the study funder, Pfizer will not carry out any data controllership activities.

The University of Bristol, as the study sponsor, have contracted Harvey Walsh to undertake the work and is involved in decisions about the processing of the data. As such, the University of Bristol is a joint data controller.

For Harvey Walsh, the lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party.

Harvey Walsh Ltd has determined the processing is necessary for its legitimate interests in being able to provide tools and services that will benefit healthcare organisations.

Harvey Walsh’s legitimate interest to deliver improved outcomes for patients and benefits to the wider health and social care arena has been fulfilled through the successful management and completion of various projects within the healthcare sector, allowing for earlier diagnosis of certain diseases, uptake of innovation and national policy guidelines, epidemiological research and disease burden analytics.

For University of Bristol, the lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - 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.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes, or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by Pfizer. The funding is specifically for the Avon CAP study described above. Funding is in place until completion.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Pfizer is involved in funding the wider project and is the funder of the Avon CAP study but is not processing or controlling the data requested and will not have any access to the data.

The joint data controllers for the Avon CAP study are the University of Bristol and Harvey Walsh Limited. The University of Bristol is a joint data controller as they are involved in the design of the study.

Harvey Walsh Limited is a joint data controller who also processes the GDPPR data in order to provide analytical services for this study.

A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the original CAP Study data for the purposes described above.

Harvey Walsh will provided the relevant GP Practice codes to NHS England.

NHS England will grant access to the Data via the Secure Data Environment (SDE). The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry-leading analytics tools.

NHS England data will provide the relevant records from the GPES Data for Pandemic Planning and Research (GDPPR) dataset to Harvey Walsh, via NHS England Secure Data Environment (SDE).

The data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable, and all users must comply with the use of the Data as specified in this DSA.

Users are only authorised to access the Data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England.

Analysts processing data utilise a secure Virtual Private Network (VPN) to access a virtual machine within the Cheshire facility. No raw data is stored off-site. All analysts are substantive employees of Harvey Walsh and no data is downloaded and stored outside of the approved location.

The data will not leave England at any time.

Access is restricted to employees or agents of Harvey Walsh.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The aggregated information derived from the data will be combined with aggregated data from other sources, it will be linked to the GP Populations for each age group.

There will be no requirement and no attempt to reidentify individuals when using the data.

Analysts from Harvey Walsh will use the relevant subset of data to analyse trends as described above.

The expected outputs of the processing will be:

- A report of findings to the University of Bristol.

- Publication in a peer-reviewed journal to describe the methodology of estimating a local population denominator for an English hospital similar to the original denominator methodology paper - https://doi.org/10.1017/S0950268822000917. It will be a medical journal but the exact journal targeted is yet to be decided.

- The data will then be used in conjunction with the AvonCAP study prospective data to estimate disease hospitalised acute respiratory tract disease stratified by risk groups. The initial incidence paper is an example of how this was previously reported for aLRTD incidence estimates - https://doi.org/10.1016/j.lanepe.2022.100473 This incidence estimate will be part of the main study output and will be submitted to a journal that is yet to be determined but will be targeting a high impact medical journal such as one that is part of the Lancet or British Medical Journal (BMJ) family of journals.

- Presentations to the University of Bristol.

- Presentation at an appropriate scientific conference e.g. British Thoracic Society Winter Meeting, UK Public Health Science Meeting

The outputs will not contain NHS England data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals

• Presentation at appropriate conferences

• Posters displayed at Scientific / medical conferences such as the British Thoracic Society or the UK Public Health Science Meeting

• Presentations and Reports aimed at the University of Bristol

The target data for dissemination of the outputs is Q4 2024.

How processing of these data is needed to calculate a true disease incidence for acute LRTD, its subgroups, and vaccine-preventable disease that may enable the better allocation and provision of healthcare resources and implementation of public health initiatives to reduce morbidity and mortality, including but not limited to vaccination.

The dissemination is in the public interest as it will assist in the Avon CAP Study which may generate evidence on the most effective vaccination policy for the prevention of disease.

This data dissemination is required to support the ethical research study. Without this dissemination, it will not be possible to derive accurate population and risk denominators for the Avon CAP study.

The outputs may directly contribute to a National Institute for Health and Care Research (NIHR) Ethically approved study. They may provide the first accurate denominator by risk group. This may directly affect the patients within the study, the wider Bristol area of >1 million patients, and also nationally.

Accurate research on who, how, and when to vaccinate a population may benefit patients as well as the wider health and social care arena.

Since the characteristics of the population of Bristol are known in detail, these data may be able to be extrapolated to national level. These data may therefore inform policy on public health interventions to improve the health of those whose data have been systematically collated, the wider Bristol population, and the national population. Furthermore, these data may be analysed to provide insights into healthcare resource allocation, again benefitting the local population and those studied.

This is anticipated to be achieved by the end of 2024.

Yielded Benefits is not a requirement for new applications.