Investigation into sex-specific differences in mortality and complications following elective abdominal aortic aneurysm repair and association with pre-operative co-morbid status.

Imperial College London requires access to NHS England Data for the purpose of the following research project:

Investigation into sex-specific differences in mortality and complications following elective abdominal aortic aneurysm (AAA) repair and association with pre-operative co-morbid status.

An abdominal aortic aneurysm (AAA) is a swelling in part of the main vessel supplying blood to the lower body. AAAs can burst, or ‘rupture’, which can be fatal. To prevent this, AAAs can be repaired, using open surgery (cutting open the abdomen,) or endovascular surgery (relining the vessel from inside). Worldwide, women are more likely than men to die and to suffer complications from elective AAA repair. The reason for this is unknown. Guidance for AAA treatment has been based on what works for men. However, with this strategy, women experience worse results, which suggests that women might benefit from a different care pathway.

It may be the case that women have more medical issues prior to their operation or do not receive the same preoperative investigations which negatively affects their operative outcome. This project will use national data sets collected in the UK on men and women who have undergone elective AAA repair to compare the differences in health status and investigations pre-operatively, and outcomes following repair. This should help us to identify whether there are key differences which we need to look at in more detail and consider changing in our care pathways for AAA repair.

The following is a summary of the aims of the research project provided by the Imperial College London: "The primary objective will be to test the hypothesis that sex-specific differences in co-morbid status and pre-operative standard of care, (appropriate assessment and preventative treatment,) account for the disparity in AAA repair outcomes observed.

The secondary objective will be to evaluate the quality and accuracy of data recorded within the National Vascular Registry."

The following NHS England Data will be accessed:

• HES Admitted Patient Care (APC) - necessary to establish inpatient episodes, including pre-operative interventions (e.g., coronary stenting, coronary artery bypass etc.), and post-operative major cardiovascular complications, re-admissions, and re-interventions.

• Medicines Dispensed in Primary Care (NHSBSA) necessary to evaluate whether patients with AAA in England comparing women and men, who are prescribed medication and receive appropriate cardiovascular preventative treatment in accordance with relevant guidance. This Data will enable examination of the impact of cardiovascular risk prevention on clinical outcomes, adjusting for traditional risk and sociodemographic factors.

• Civil Registration Deaths - necessary to establish long term mortality outcomes and cause of death. Date of death will be required to analyse survival following aortic repair and cause of death will be needed to establish contributing factors - e.g. aortic-related mortality, cardiovascular death.

The level of the Data disseminated will be pseudonymised.

The Data will be minimised as follows:

• Limited to a study cohort of approximately 31,500 patients, identified by the National Vascular Registry (NVR). Data will only be requested for patients who are registered to have undergone an aortic repair in the NVR dataset in England, via linkage in collaboration with the NVR.

• Limited to Data between 2012-2023. For each individual patient, pre-operative Data will be limited to one year prior to AAA repair to allow for capture of pre-operative optimisation in a proportionate manner.

Imperial College London is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

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 project is funded by the NIHR as part of a Doctoral Fellowship. Funding is in place until October 2024.

Data will be accessed by a PhD student enrolled with Imperial College London. The individual has completed mandatory data protection and confidentiality training and is subject to Imperial College London policies on data protection and confidentiality. The individual accessing the Data will do so under the supervision of a substantive employee of Imperial College London. Imperial College London would be responsible and liable for any work carried out by the individual. The PhD student would only work on the Data for the purposes described in this Agreement.

A statistician at the University of Leicester is acting in an advisory capacity to the PhD student and gives oversight into the statistical methodology and interpretation of findings. Although The University of Leicester is the study design lead, the University of Leicester will not carry out any controllership activities.

For this project, a dedicated AAA patient and public involvement group of both male and female patients with AAA has been recruited. The group supported the collection of the Data for the purposes described above.

The Royal College of Surgeons, who host the National Vascular Registry (NVR), will transfer data from the registry cohort to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender, and a unique person ID) for the cohort to be linked with NHS England Data.

For each individual patient, pre-operative Data will be limited to one year prior to AAA repair to allow for capture of pre-operative optimisation in a proportionate manner.

NHS England will provide the relevant records from the HES APC, Mortality and NHSBSA datasets to Imperial College London.

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

The Data will not be transferred to any other location.

The Data will be stored on servers at Imperial College London BDAU.

Virtus Secure Data Centre Limited host the Imperial College London data servers. Virtus Secure Data Centre Limited is not permitted to access the Data.

NEC Software Solutions are the third party used by the RCS to host and manage the data.

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).

The Data will not leave England at any time.

Access is restricted to employees or agents of Imperial College London.

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

The Data will not be linked with any other data.

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

Researchers from Imperial College London will analyse the Data for the purposes as above.

The expected outputs of the processing and the dissemination strategy will be aimed at reaching the largest possible stakeholder audiences.

Approaches will be made to the UK key stakeholders – surgeons, their professional bodies, patients, the public and relevant charities. These include the officers and audit committee for the Vascular Society of Great Britain & Ireland and the Royal College of Surgeons. Collaboration will also be sought internationally (e.g., European Society of Vascular Surgery) and with cardiovascular and women’s health charities for dissemination of relevant aggregated data.

Target audiences:

Academics and clinicians: via peer-reviewed publications in international, high impact journals, the media and conference presentations. As this project is funded by the NIHR, a full account of the research will be provided for the NIHR Journal. A social media presence will be developed and curated by Imperial College, with information and updates will be provided on the project website.

Patients/Public: An easy-to-understand summary of this research in text or video format will be provided on our website and social media platforms, with further patient and public engagement through public lectures/exhibitions, conferences, and open days, such as the Institute of Global Health Innovation (IGHI) Royal Society Summer Science Exhibition.

NHS managers, health care commissioners, recommendation and policy makers (e.g. Vascular Society, Royal College Of Anaesthetists,) Department of Health and specialist providers will be reached via: direct bilateral engagement through established relations, presentation at appropriate meetings and publication platforms such as the Health Services Journal.

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 target date to produce outputs is 2024.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the Data could:

• help the system to better understand the health and care needs of populations.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of regional and national trends in health and social care needs.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• inform decisions on how to effectively allocate and evaluate funding according to health needs.

• provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

Dissemination of the results of this project are in the public interest to reduce the morbidity and mortality associated with AAA repair for both sexes and to empower patients to make informed treatment choices.

As described in 'Expected Outputs', the data dissemination will be targeted at reaching UK key stakeholders – surgeons, their professional bodies, patients, the public and relevant charities. These include the officers and audit committee for the Vascular Society of Great Britain & Ireland and the Royal College of Surgeons.

Collaboration will also be sought internationally (e.g., European Society of Vascular Surgery) and with cardiovascular and women’s health charities for dissemination of relevant data. The results of this endeavour will be measurable via auditing of sex-specific differences in pre-operative investigations and medications, mortality and morbidity outcomes, which are conducted by the NVR.

The AAA patient and public involvement group will advise on interpretation, reporting, and effective public engagement with study findings.

Yielded Benefits is not a requirement for new applications.