A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms (UK-COMPASS).

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool require Hospital Episodes Statistics (HES/ECDS), Diagnostic Imaging Dataset (DID) and HES/ONS linked mortality data for use in a study titled “A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms: The UK COMPlex AneurySm Study (UK-COMPASS).” The UK-COMPASS project is being funded by the National Institute for Health Research - Health Technology Assessment (NIHR-HTA). The Chief Investigator of the NIHR-HTA funded UK-COMPASS project is a consultant surgeon substantively employed by The Liverpool University Hospitals NHS Foundation Trust. The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool require access to NHS England data for the purpose of the following research project: The Liverpool University Hospitals NHS Foundation Trust (LUHFT.) and the University of Liverpool (UOL) are joint data controllers, and also process the data for the purposes described in this agreement. A Risk-adjusted and Anatomically Stratified Cohort Comparison Study of Open Surgery, Endovascular Techniques and Medical Management for Juxtarenal Aortic Aneurysms (UK-COMPASS). The roles of organisations involved currently or previously with this research are as follows: The following is a summary of the aims of the research project provided by the Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool. o Only individuals from The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool make decisions in respect of how and why the data are processed. o Individuals from various external organisations who are named as co-investigators in the study protocol have, at the request of The Liverpool University Hospitals NHS Foundation Trust, contributed to the design of the study by providing advice on aspects of the methodology given they have relevant subject matter expertise as statisticians. o The University of Liverpool and the Liverpool University Hospital NHS Foundation Trust are not obliged to undertake any processing recommended by these individuals but will act on their advice given their subject matter expertise. o The Trial Steering Committee (TSC) consists of independent and non-independent members. The TSC Chair reports back to the funder, the NIHR. o The Trial Steering Committee performs an advisory function to the The Liverpool University Hospitals NHS Foundation Trust for the purpose of this study and is not responsible for determining how or why the NHS England data are processed. The lawful basis of processing this data is in accordance with General Data Protection Regulation point 6(1) e (‘public task’), whereby processing is necessary for the performance of a task in the public interest: the data being processed is inclusive of the entire population undergoing complex aneurysm repair over a specified inclusion period. Conclusions drawn from the analysis of this processed data will benefit future populations through potential adjustment in national treatment strategies to improve survival. The processing of special category data under this data application (specifically with regards to health data) is also covered by GDPR Article 9(2)(j) as it is being performed for research purposes, the legal basis being further supported by Section 2 of Part 1 of Schedule 1 of the DPA 2018. The aim of the study is to answer the question identified by NIHR-HTA Commissioning Board: What are the clinical and cost-effectiveness of strategies for the management of juxtarenal abdominal aortic aneurysm, including fenestrated endovascular repair? [1 paragraph unchanged] AAAs vary in complexity. Juxtarenal AAAs are more complex because they are [96 words unchanged] deaths but are less durable requiring further procedures in the years after. The UK-COMPASS aims to evaluate the clinical and cost-effectiveness of different treatment strategies for juxtarenal abdominal aortic aneurysms. Some patients who are not fit enough to withstand open repair may be able to have endovascular repairs. In some patients no operation may be in their best interest. This study aims to examine how these different treatments compare in terms of clinical benefit and utilisation of NHS resources by analysing the outcomes of all patients aged 25 - 100 years, who had undergone juxtarenal aneurysm treatment in England between November 2017 and October 2019 by assessing 5 years of follow-up data. The study is non-interventional and relies on retrospective data analysis. Its findings are expected to inform national treatment guidelines, improve patient outcomes, and support more efficient allocation of NHS resources by identifying which patients benefit most from specific interventions. Some patients who are not fit enough to withstand open repair may be able to have endovascular repairs. In some patients no operation may be in their best interest. This study aims to examine how these different treatments compare in terms of clinical benefit and utilisation of NHS resources. The primary aims of research project are: The study intends to analyse the outcomes of all - Identify and follow up patients aged 25 - 100 years, -100 who had undergone underwent treatment for juxtarenal aneurysm treatment in England AAAs between November 2017 and October 2019 by assessing 2019, using 5 years of follow-up data. This study is non-interventional. This Agreement permits the UK COMPASS team to receive HES/ECDS, DIDS and ONS mortality data including the NHS number and date of birth of all patients undergoing AAA repair in England over a 2-year period between Nov 2017 and October 2019. - Compare clinical and cost-effectiveness of different treatment modalities, including open surgery, fenestrated endovascular repair (FEVAR), off-label EVAR, and non-operative management. The study relies on linkage with a dataset from the National Vascular Registry (NVR), a national clinical audit commissioned by the Health Quality Improvement Partnership (HQIP). - Support national policy and guideline development, particularly for National Institute for Health and Care Excellence (NICE) and NHS commissioning, by providing evidence on which treatment strategies yield the best outcomes and resource utilisation. NHS England provide HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, DID, ONS Mortality, Outpatients and Critical Care episodes data every 6 months to cover 5 years of follow-up for each patient identified from the initial cohort (1st November 2017 to 31st October 2019). - Enable stratified analysis based on anatomical and physiological characteristics, allowing for personalised treatment recommendations and identification of best practices across UK vascular centres. The UK COMPASS team use this data to examine patients’ scans and utilise data that is routinely collected by the NHS. The HES A&E/ECDS, Critical Care, APC and OP data sets will allow researchers to capture the entire patient journey from pre-operative imaging to treatment, in-patient care and subsequent follow up. The UK-COMPASS team requires access to the APC data set as this identifies the operation that the patient has had and subsequent management whilst an in-patient. This data set provides information that will be necessary to carry out a rigorous clinical and cost-effectiveness analysis. The following NHS England Data will be accessed: The OP data set has also been reviewed and data points from this will allow researchers to see what subsequently happens to patients during their follow up period. This data set will mainly guide the clinical effectiveness evaluation by identifying treatment failures and the subsequent management of these. - Hospital Episode Statistics This will ensure a complete analysis of clinical effectiveness of the different treatment modalities that patients undergo. All data received from NHS England and from NVR (via NHS England acting as a trusted third party) will be pseudonymised. - Admitted Patient Care - Necessary to analyse inpatient procedures, complications, length of stay, and outcomes following different treatment strategies (e.g., open surgery, FEVAR, EVAR). For all data sets, the UK-COMPASS team has limited the data fields requested to only those that are the minimum required to allow researchers to undertake the analysis relevant to the purpose described. The research team has had input from clinicians as well as a health economist in reviewing the data sets and data fields required. The follow up period has been limited to 5 years after treatment as this should be sufficient to observe any differences between treatment groups in the medium term. Significant deviations and “catch up” phenomena of the survival curves of different treatment strategies have been demonstrated consistently by trials comparing treatments for non-complex aneurysms within 5 years of follow-up. Data from the entirety of England will be analysed to gain a national perspective as comparisons to date have been limited to single institutions. - Accident and Emergency - Necessary to capture emergency presentations related to abdominal aortic aneurysms (AAAs), including initial diagnosis and urgent admissions. Available data will be analysed to compare the safety and effectiveness of different treatments, and to see if a particular treatment is better suited for particular features so patients can be offered bespoke treatment strategies. There are no other alternative datasets that can provide this data. The data requested will be the minimum required to carry out analysis for the purpose of this research. - Outpatient - Necessary to track pre-operative consultations, follow-up appointments, and ongoing management of patients post-treatment. The UK-COMPASS team currently have a Data Sharing Agreement (DSA) in place with Healthcare Quality Improvement Partnership (HQIP) for the use of National Vascular Registry (NVR) data. The NVR collects data that is inputted by clinicians following repair of a AAA. This data reflects physiological, anatomical and technical variables. - Critical Care This work will be undertaken by the UK-COMPASS team based at the Royal Liverpool University Hospital (part of the Liverpool University Hospital NHS Foundation Trust) and the Liverpool Clinical Trials Centre, University of Liverpool. Only employees of the Liverpool University Hospital NHS Foundation Trust and the University of Liverpool will have access to the data disseminated by NHS England and, for the avoidance of doubt, this excludes any other collaborators named within the protocol. - Emergency Care Data Set (ECDS) - Necessary to provide detailed information on emergency care episodes, including clinical observations and interventions that may not be fully captured in HES A&E data. This helps assess the urgency and severity of AAA presentations. The study has been designed based on the need to analyse routinely collected data from NHS England and the NVR. A randomised controlled trial is not possible to address the aim as there is no position of equipoise on current treatments for juxtarenal AAA. Currently there is a wide variation in practice across vascular surgical units that treat patients with this condition. - Diagnostic Imaging Dataset (DID) - Necessary to access imaging records (e.g., CT scans, ultrasounds) that confirm AAA diagnosis, assess anatomical complexity, and guide treatment selection. Imaging data is crucial for stratifying patients based on aneurysm characteristics. Under this Agreement, Liverpool University Hospital NHS Foundation Trust and the University of Liverpool will receive or has already received (as indicated) the following: - Civil Registration of Death- Secondary Care Cut - Necessary to obtain accurate mortality data, including date and cause of death, which is essential for evaluating long-term survival outcomes and treatment effectiveness over the 5-year follow-up period. 1) Data in 'Extract #1' (already received) These datasets collectively enable a comprehensive analysis of patient pathways, treatment outcomes, and resource utilisation, supporting the project's aim to identify the most effective and cost-efficient strategies for managing complex AAAs. Extract #1 refers to the identification of a study cohort by ICD operation code meeting the inclusion dates Nov 2017-Oct 2019. The Liverpool University Hospital NHS Foundation Trust previously received this data in full. The level of the Data will be: 2) 'Extract #2' (in progress, partly received) - Pseudonymised Extract #2 refers to follow-up data over 5 years relating to outcomes after aneurysm repair. It will permit comparisons between different methods of repair. It is only be requested for a subset of patients identified from the screening population in Extract #1 (those meeting criteria based on imaging). These patients have already been identified and fed back to NHS England. Follow-up data regarding these patients have already been received by the UK COMPASS team in part, and this will be ongoing until the end of the study. Under the terms of the existing agreement, this data will be received until an end date of Oct 2024. This date was provided as a default end date based on standard DARS contract duration but not does reach the end date of the study. This will permit follow-up data to be received in full for all patients included in the study, as per the study protocol and agreement with the necessary regulatory bodies. The Data will be minimised as follows: 3) 'Extract #2' (in progress, partly received) for inclusion of further patients into the study, in addition to those already identified previously (for backdated data provision): - Limited to a study cohort identified by the Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool as patients treated between 01/11/2017 and 31/10/2024. Additional particiapnts v6 of this DSA- A specific group of patients identified across the country who have an abdominal aortic aneurysm that was not repaired (for several possible reasons). They are also of interest to the study as a comparator arm to the operative treatments. They will be identified from sites across England at a local level, details provided to the study team at LUHFT, and then subsequently passed onto NHS England. For these patients, LUHFT and UOL require the same follow-up data as provided for those patients already included into the study and who are already subject to the provision of ongoing “Extract 2” follow-up data from HES/ECDS, DID and ONS datasets. These patients will require follow-up data from 01/11/2017 until the end of the study which is 31/10/2024 The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool are 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, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The funding is provided by National Institute of Health and Care Research (NIHR). The funding is specifically for the study described. The funder will have no ability to suppress or otherwise limit the publication of findings. Bangor University is a processor acting under the instructions of The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool. Several organisations are involved in the UK-COMPASS study in advisory or oversight roles but do not access or process any patient data. These include the British Society of Interventional Radiology (BSIR), British Society of Cardiovascular Imaging (BSCI), British Society of Cardiovascular CT (BSCCT), and the British Heart Valve Society (BHVS), all of which provide clinical expertise and guidance relevant to the study’s focus areas. Members of the public and patients have contributed to the design of the UK-COMPASS study through involvement in the Liverpool Cardiovascular PPIE (Patient and Public Involvement and Engagement) group, which includes individuals with lived experience of cardiovascular disease. This group reviewed the study’s aims and supported the use of routinely collected data to evaluate treatment outcomes, recognising the public benefit in improving care pathways and resource allocation. Their feedback helped shape the study’s approach to data use, ensuring it aligns with public expectations around privacy, transparency, and meaningful impact.

Processing activities

The study screened all patients in England who have undergone a procedure for an abdominal aneurysm of any sort identified from HES data between the 1st November 2017 and the 31st October 2019. This is a retrospective data review after the procedure has taken place and will be completed every 2 months during the study period to identify all new cases. This amendment adds in an additional cohort who did not undergo a repair (as an intentional clinical decision) to provide a comparator arm for the treatment arms. National Vascular Registry (NVR), based at The Royal College of Surgeons will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, and a unique person ID) for the cohort to be linked with NHS England data. Step 1: NHS England will provide the relevant records from the Hospital Episode Statistics, Emergency Care Data Set (ECDS), Civil Registrations of Death- Secondary Care Cut, and Diagnostic Imaging Data Set (DID) datasets to the Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool. The initial data set comprised of HES and linked DIDs data and was retrieved from NHS England (Extract #1). It included all patients who were at least 1 month post discharge from hospital and included data on the 6 months prior to and up to 1 month after the procedure date. The initial data set was transferred directly from NHS England to the UK-COMPASS Team in a secure environment at the now named Liverpool Clinical Trials Centre. The data for the patients identified at this point (identifying NHS number and date of birth) is kept on a secure server in a secure location in the NHS Picture Archiving and Communications System (PACS) office of the Royal Liverpool University Hospital. This Step has been completed. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient. Step 2: The Data will not be transferred to any other location. The study is only concerned with patients who are treated for a complex juxtarenal abdominal aortic aneurysm (a specific subtype of all aneurysms). Therefore, all patients undergoing AAA repair needed to be screened and ineligible patients removed. In order to select the eligible patients, the researchers reviewed all the corresponding CT scans of patients identified in Step 1. This was done via the PACS system. PACS are digital systems for managing radiological information which are routinely used by clinical staff to review radiological images and reports every day, in every hospital. PACS contains not only radiological images to be simply viewed as they are, but also ‘raw data’ of CT scans (called DICOM data) that are essential for 3-dimensional image analysis using dedicated workstations. DIDs data were needed and processed by the UK-COMPASS team at Liverpool University Hospital NHS Foundation Trust in order to identify CT imaging on patients who have undergone complex AAA repairs. This step has been completed. The Data will be stored on servers at University of Liverpool. Step 3: At the point of retrieving each scan, the UK-COMPASS PACS team replaced all patient identifiable data on the scans with a Study Serial Number and archive them securely within PACS system. The Study Serial Number was linked to the Pseudonymised HES ID. At this point, all patient identifiable data were deleted and neither the scans nor the study data subsequently contained any patient identifiable information. There will be no requirement nor attempt to re-identify individuals. This step has been completed. Step 4: The UK-COMPASS clinical study team at LUHFT then reviewed all the scans and selected patients who are eligible for the study. Anatomical measurements done on scans were entered into the master data set that would accumulate further study data in next steps. This step has been completed. Step 5: Following identification of patients with complex AAA, their pseudonymised HES ID was sent back to NHS England for linkage with data from the National Vascular Registry (NVR). A data sharing agreement was already in place with HQIP to access NVR data based on the data flow described here. NHS England will not send any data to HQIP. The NVR, based at The Royal College of Surgeons, securely transferred a data file containing all patients who have undergone AAA repair to NHS England. This contained the patients’ identifying NHS number and Date of Birth and the fields relating to anatomy, physiology, operative strategy and clinical course post-operatively. NHS England acted as a trusted third party and linked this data with the patients pseudonymised HES ID. This step has been completed. Step 6: NHS England linked (and continues to link) HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, Outpatients, Critical Care, DID and ONS mortality data to the data extract received from NVR, every 6 months using the pseudonymised HES ID. NHS England will remove the identifying information and send the pseudonymised data back to the UK-COMPASS team at LUHFT/UoL. The UK-COMPASS team will complete 6 monthly follow up health and cost analysis, showing the clinical course of patients undergoing complex AAA repair and their subsequent follow up as an out-patient. This data will be linked every 6 months following the initial aneurysm repair and patients will be followed up for a total of 5 years until 31/10/2024 (the new end date of the proposed DARS amendment). Step 7: An addition cohort of patients will be provided to the NHS England team. These have been identified separately as a separate arm of interest in our trial. These patients will be provided as a list of NHS numbers from LUHFT to NHS England on an ongoing basis. The study team would like follow-up for these individuals from the study start date (backdated) which is 01/11/2017 through to the end of follow-up which is 31/10/2024. This has been approved as a CAG and REC amendment. Processing of the data provided by NHS England will only be carried out by individuals who are substantive employees of either the Liverpool University Hospital NHS Foundation Trust or the University of Liverpool, all of whom have been appropriately trained in data protection and confidentiality. There will be no requirement nor attempt to re-identify individuals from the pseudonymised data. The master database data for UK-COMPASS will be stored offline on a local secure server kept within in a locked room in LCTU. [9 paragraphs unchanged] 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) purpose). The findings will be shared with clinicians but these will not include any record level data regarding their patients. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. Remote processing will be from secure locations within England/Wales. The data will not leave England/Wales at any time. Access is restricted to employees of Liverpool University Hospitals NHS Foundation Trust, University of Liverpool and Bangor University who have authorisation from the Principal Investigator. No other organisation is permitted to access the Data. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will be linked at person record level with dataset obtained from NVR. The NVR data includes detailed clinical information such as anatomy, physiology, operative strategy, and post-operative outcomes. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts/researchers from the Liverpool University Hospitals NHS Foundation Trust, University of Liverpool and Bangor University will process/analyse the Data for the purposes described above.

Expected output

This work will lead to peer-reviewed publications in high impact factor journals that will guide clinicians on the treatment of patients with complex AAAs (British Journal of Surgery, Journal of Vascular Surgery, Circulation and the European Journal of Vascular Surgery), treatment guidelines (NICE), commissioning priorities and patient information material. The expected outputs of the processing will be: The UK-COMPASS team expects to publish shortly an academic paper of 3-year longitudinal data based on anatomical observations made on the CT scans reviewed. - A report of findings to NIHR every 6 months to inform the funder of progress and interim results. Analysis of the data will be fed back to commissioners, this will shape future UK wide policy on the management of resources when considering funding the treatment of complex aortic aneurysm surgery. - Submissions to peer-reviewed journals such as British Journal of Surgery, Journal of Vascular Surgery Circulation, and European Journal of Vascular Surgery. A 3-year longitudinal data paper is expected to be published shortly with final dissemination planned for 2025. The UK-COMPASS team have been and will continue to report back to their funder, the NIHR, on a 6 monthly basis. - Presentations to commissioners and NICE to shape UK-wide policy and treatment guidelines for complex aortic aneurysm surgery. MPhil and PhD students will be enrolled as part of the UK-COMPASS study team to contribute to the retrospective data reviews (outlined above) and the work they undertake will contribute to them achieving MPhil and PhDs from the University of Liverpool. For avoidance of doubt, no additional uses of the data, beyond the purpose outlined in this Agreement, will be permitted. - Presentations at appropriate conferences, including: Vascular Society of Great Britain & Ireland (Annual Scientific Meeting: 2021, 2022, 2023), Charing Cross Symposium (London, April 2023), Critical Issues in Aortic Endografting Symposium (Nuremberg, May 2023), International conferences in New York, Malmo, and Brighton. A simplified version - Publication of the findings will be disseminated to charities, patient groups of interest and be published dashboards on the LCTC Liverpool Clinical Trials Centre (LCTC) website with versions available on and via the Vascular Society of Great Britain and Ireland Website as well as the and British Society of Endovascular Therapists websites. All The outputs will be not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the HES Analysis Guide. relevant disclosure rules for the dataset(s) from which the information was derived. Interim findings were publicised at the annual scientific meeting of the Vascular Society of Great Britain and Ireland in November 2022, with a final dissemination taking place in 2025. The outputs will be communicated to relevant recipients through the following dissemination channels: - Journals - Workshops involving Clinical and commissioning stakeholders (implied through engagement with NICE and NHS commissioners). - Public reports reports to NIHR every 6 months and simplified findings shared with charities and patient groups. - Direct bilateral engagement with NICE and NHS commissioners to inform treatment guidelines and commissioning priorities. - Posters displayed at National and international conferences such as the Vascular Society ASM, Charing Cross Symposium, and others. - Patient Information leaflets available to be produced and made available to support informed decision-making. - Public promotion of the research via Liverpool Clinical Trials Centre website and professional society platforms. - Reports aimed at patients/participants. Simplified findings will be shared with patient groups and charities. The target dates for production and dissemination of outputs from the UK-COMPASS study include ongoing six-monthly reports to NIHR, with interim findings already presented at national and international conferences between 2021 and 2023. A three-year longitudinal data paper is expected to be published shortly, and final dissemination of study findings is planned for 2025.

Expected measurable benefits

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 better understand the health and care needs of populations, particularly those with complex juxtarenal abdominal aortic aneurysms (AAA), by analysing outcomes across different treatment strategies. - Lead to the identification and improvement of treatments or interventions, guiding clinicians on the most effective and safest approaches, including open surgery, fenestrated endovascular repair (FEVAR), off-label EVAR, and medical management. - Inform planning of health services and programmes, supporting the centralisation of complex AAA surgeries to fewer, more experienced centres to improve equity of access and outcomes. - Inform decisions on how to effectively allocate and evaluate funding, enabling commissioners to direct resources toward the most clinically and cost-effective treatment strategies. - Provide a mechanism for checking the quality of care, identifying areas of good practice and those needing improvement across NHS vascular units. - Support knowledge creation and exploratory research, contributing to academic publications, MPhil and PhD theses, and informing NICE guidelines and commissioning priorities. The UK-COMPASS study is expected to deliver several specific benefits to patients, subject to its findings. These include improved survival rates and enhanced post-operative quality of life by identifying the most effective treatment strategies for complex abdominal aortic aneurysms. Patients will benefit from more personalised and evidence-based care, with treatment decisions tailored to their anatomical and physiological profiles. The study also supports centralising complex procedures to experienced centres, ensuring patients receive care from the most skilled clinicians. Additionally, the development of patient information materials will empower individuals to make informed choices about their treatment options. It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients. [3 paragraphs unchanged] The findings of UK-COMPASS will allow Commissioners to reallocate funding to ensure [32 words unchanged] the best outcomes being commissioned to undertake these operations in the future. To optimise public benefit from the use of the UK-COMPASS study data, the findings will be published in leading medical journals and presented at major national and international conferences. They will inform clinical guidelines and healthcare policy, with simplified summaries made available online through trusted platforms. Relevant charities and patient groups have been contacted to ensure the findings reach a wider audience and support public understanding and engagement. The UK-COMPASS team expect this study to impact on 1000 patients per year undergoing a complex AAA repair. MPhil and PhD students will be enrolled as part of the UK-COMPASS study team to contribute to the retrospective data reviews (outlined above) and the work they undertake will contribute to them achieving MPhil and PhDs from the University of Liverpool.

Benefits reported

Clinical results were published in a peer-reviewed journal earlier than originally planned due to unexpected findings of importance. Editor's Choice – Comparison of Open Surgery and Endovascular Techniques for Juxtarenal and Complex Neck Aortic Aneurysms: The UK COMPlex AneurySm Study (UK-COMPASS) – Peri-operative and Midterm Outcomes; Vallabhaneni, Srinivasa R. et al. European Journal of Vascular and Endovascular Surgery, Volume 67, Issue 4, 540 - 553. This paper has informed the European guidelines on aneurysm treatment and has been recognised as a landmark research paper internationally and is informing clinical practice throughout the developed world. There has been a series of debates and editorials published on this paper, some examples: Which Direction Does the UK-COMPASS Point To? Björck, Martin et al. European Journal of Vascular and Endovascular Surgery, Volume 67, Issue 4, 533 - 535. Enduring Value of the (UK-) COMPASS Patel, Shaneel R. European Journal of Vascular and Endovascular Surgery, Volume 67, Issue 5, 856 - 857. Even the Uncut Diamond Is Valuable Björck, Martin et al. European Journal of Vascular and Endovascular Surgery, Volume 67, Issue 5, 857 - 858. [1 paragraph unchanged] Debates and multiple podium lectures in international conferences in London, New York, Malmo and Brighton. [19 paragraphs unchanged]

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool require Hospital Episodes Statistics (HES), (HES/ECDS), Diagnostic Imaging Dataset (DID) and HES/ONS linked mortality data for use in [58 words unchanged] consultant surgeon substantively employed by The Liverpool University Hospitals NHS Foundation Trust. The Liverpool University Hospitals NHS Foundation Trust (LUHFT.) and the University of Liverpool (UOL) are joint data controllers, and also process the data for the purposes described in this agreement. [6 paragraphs unchanged] The lawful basis of processing this data is in accordance with General Data Protection Regulation point 6(1)e 6(1) e (‘public task’), whereby processing is necessary for the performance of a task [84 words unchanged] Section 2 of Part 1 of Schedule 1 of the DPA 2018. [5 paragraphs unchanged] This Agreement permits the UK COMPASS team to receive HES, HES/ECDS, DIDS and ONS mortality data including the NHS number and date of [7 words unchanged] in England over a 2-year period between Nov 2017 and October 2019. [1 paragraph unchanged] It was previously requested, and approved, that NHS England provide HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, DID, INS ONS Mortality, Outpatients and Critical Care episodes data every 6 months to cover [7 words unchanged] identified from the initial cohort (1st November 2017 to 31st October 2019). [8 paragraphs unchanged] Under this Agreement, Liverpool University Hospital NHS Foundation Trust and the University of Liverpool will receive or has already received (as indicated) the following (details of amendment requests added below): following: 1) Data in 'Extract #1' (already received): received) [1 paragraph unchanged] 2) 'Extract #2' (in progress, partly received) subject to AMENDMENT request for date extension: Extract #2 refers to follow-up data over 5 years relating to outcomes [81 words unchanged] agreement, this data will be received until an end date of Oct 2023. 2024. This date was provided as a default end date based on standard DARS contract duration but not does reach the end date of the study. We are applying for an amendment to extend this DARS date until 31st December 2024. This will permit follow-up data to be received in full for all [5 words unchanged] as per the study protocol and agreement with the necessary regulatory bodies. 3) 'Extract #2' (in progress, partly received) subject to AMENDMENT request for inclusion of further patients into the study, in addition to those already identified previously (for backdated data provision): CAG amendment has been approved to provide follow-up data to an additional and specific group Additional particiapnts v6 of patients that will be identified and fed back to NHS England. This is a this DSA- A specific group of patients identified across the country who have an abdominal [44 words unchanged] at LUHFT, and then subsequently passed onto NHS England. For these patients, we would like LUHFT and UOL require the same follow-up data as provided for those patients already included into [5 words unchanged] already subject to the provision of ongoing “Extract 2” follow-up data from HES, HES/ECDS, DID and ONS datasets. These patients will require follow-up data from 01/11/2017 until the end of the study which is 31/12/2024. These additional patients will be provided to NHS England by a Cohort Contributor employed by LUHFT. 31/10/2024

Processing activities

[2 paragraphs unchanged] The initial data set was comprised of HES and linked DIDs data and was retrieved from NHS [96 words unchanged] office of the Royal Liverpool University Hospital. This Step has been completed. [11 paragraphs unchanged] The NVR, based at The Royal College of Surgeons, securely transfered transferred a data file containing all patients who have undergone AAA repair to [37 words unchanged] data with the patients pseudonymised HES ID. This step has been completed. Step 6 (Subject of Amendement): Step 6: NHS England linked (and continues to link) HES Accident and Emergency/Emergency Care [92 words unchanged] patients will be followed up for a total of 5 years until 31/12/2024 31/10/2024 (the new end date of the proposed DARS amendment). Step 7 (Subject of Amendement): Step 7: An addition cohort of patients will be provided to the NHS England [49 words unchanged] (backdated) which is 01/11/2017 through to the end of follow-up which is 31/12/2024. 31/10/2024. This has been approved as a CAG and REC amendment. [1 paragraph unchanged] There will be no requirement nor attempt to reidentify re-identify individuals from the pseudonymised data. [1 paragraph unchanged] 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 - i.e.: employees, agents and contractors of the Data Recipient who may have access to that 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) [1 paragraph unchanged]

Unchanged: Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

The Liverpool University Hospitals NHS Foundation Trust and the University of Liverpool require Hospital Episodes Statistics (HES), Diagnostic Imaging Dataset (DID) and HES/Civil Registry HES/ONS linked mortality data for use in a study titled “A Risk-adjusted and [52 words unchanged] consultant surgeon substantively employed by The Liverpool University Hospitals NHS Foundation Trust. [3 paragraphs unchanged] o Individuals from various external organisations who are named as co-investigators in the study Protocol v3 protocol have, at the request of The Liverpool University Hospitals NHS Foundation Trust, [12 words unchanged] of the methodology given they have relevant subject matter expertise as statisticians. [2 paragraphs unchanged] o The Trial Steering Committee performs an advisory function to the The [11 words unchanged] study and is not responsible for determining how or why the NHS Digital England data are processed. [6 paragraphs unchanged] This Agreement permits the UK COMPASS team to receive HES HES, DIDS and DIDS ONS mortality data including the NHS number and date of birth of all patients undergoing AAA repair in England over a 2 year 2-year period between Nov 2017 and October 2019. The study relies on linkage with a dataset from the National Vascular Registry (NVR), a national clinical audit commissioned by the Health Quality Improvement Partnership (HQIP). Now that a separate Data Sharing Agreement has been secured with HQIP to share NVR data, further data from NHS Digital is requested under this Agreement to allow the study to achieve its previously described aims. In order to facilitate linkage to NVR data, NHS Digital will act as a data processor on behalf of the data controllers to receive and link NVR data. It was previously requested requested, and approved, that NHS Digital England provide HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, DID, INS Mortality, Outpatients and Critical Care episodes data every 6 months to cover 5 years of follow up follow-up for each patient identified from the initial cohort 1st (1st November 2017/18 2017 to 31st October 2019. Under this Agreement the Liverpool University Hospital NHS Foundation Trusts requests access to mortality data and DIDS data for the same cohort of patients during follow up. This is crucial in being able to address the primary research question of comparing clinical effectiveness between different treatment options. 2019). The UK COMPASS team plan use this data to examine patients’ scans and utilise data that is routinely collected by [20 words unchanged] journey from pre-operative imaging to treatment, in-patient care and subsequent follow up. The UK-COMPASS team requires access to the APC data set as this identifies the operation that the patient has had and subsequent management whilst an in-patient. This data set provides information that will be necessary to carry out a rigorous clinical and cost-effectiveness analysis. The UK-COMPASS team requires access to the APC data set as this identifies the operation that the patient has had and subsequent management whilst an in-patient. This data set provides information that will be necessary to carry out a rigorous clinical and cost-effectiveness analysis. [1 paragraph unchanged] This will ensure a complete analysis of clinical effectiveness of the different treatment modalities that patients undergo. All data received from NHS England and from NVR (via NHS England acting as a trusted third party) will be pseudonymised. All data received from NHS Digital and from NVR (via NHS Digital acting as a trusted third party) will be pseudonymised. [3 paragraphs unchanged] This work will be undertaken by the UK-COMPASS team based at the Royal Liverpool University Hospital (part of the Liverpool University Hospital NHS Foundation Trust) with additional support from and the Liverpool Clinical Trials Unit, Centre, University of Liverpool. Only employees of the Liverpool University Hospital NHS Foundation Trust and the University of Liverpool will have access to the data disseminated by NHS Digital England and, for the avoidance of doubt, this excludes any other collaborators named within the protocol. The study has been designed based on the need to analyse routinely collected data from NHS Digital England and the NVR. A randomised controlled trial is not possible to address [21 words unchanged] in practice across vascular surgical units that treat patients with this condition. Under this Agreement, Liverpool University Hospital NHS Foundation Trust and the University of Liverpool will receive or has already received (as indicated) the following: following (details of amendment requests added below): 1) New data Data in 'Extract #1': #1' (already received): Extract #1 refers to the identification of a study cohort by ICD [9 words unchanged] The Liverpool University Hospital NHS Foundation Trust previously received this data in full but the research team have since been informed through various sources in the vascular community (both individual expert and the UK National Vascular Registry team) that there are 3 ICD codes used to record aneurysm repair that had not previously been included. These are L19.9, L28.2 and Y26.3. The Liverpool University Hospital NHS Foundation Trust requires Extract #1 data based on these three additional codes . This would enable appropriate analysis of the population in keeping with the overall aims of the study. full. 2) New data in 'Extract #2' (DID): 2) 'Extract #2' (in progress, partly received) subject to AMENDMENT request for date extension: Extract #2 refers to the follow-up data over 5 years relating to outcomes after aneurysm repair. It will permit comparisons between different methods of repair. It will is only be requested for the a subset of patients identified from the screening population in Extract #1 (those with a complex aortic neck meeting criteria based on imaging). The Liverpool University Hospital These patients have already been identified and fed back to NHS Foundation Trust require imaging England. Follow-up data (DID dataset) regarding these patients have already been received by the UK COMPASS team in part, and this will be ongoing until the end of the study. Under the terms of the existing agreement, this data will be received until an end date of Oct 2023. This date was provided as a default end date based on standard DARS contract duration but not does reach the end date of the study. We are applying for Extract #2 an amendment to acquire information regarding imaging during extend this DARS date until 31st December 2024. This will permit follow-up data to be received in full for all patients included in the follow up period. This is crucial information for patients who have undergone AAA repair as they are often enrolled onto a surveillance imaging programme post operatively with different intensities across the different modes of repair. This information will enable the acquisition of post operative imaging results and allow analysis for imaging based complications. This is crucial for clinical and cost effectiveness analyses study, as per the overall aims of study protocol and agreement with the study. necessary regulatory bodies. 3) New data in Extract #2 (Mortality): 3) 'Extract #2' (in progress, partly received) subject to AMENDMENT request for inclusion of further patients into the study, in addition to those already identified previously (for backdated data provision): Extract #2 refers to the follow-up data over 5 years relating to outcomes after aneurysm repair. It will permit comparisons between different methods of repair. It will only be requested for the subset of patients identified from the screening population in Extract #1. The Liverpool University Hospital NHS Foundation Trust require mortality data (only requiring date of death truncated to month and year, and cause of death). This will permit survival analyses between treatment types for both all cause mortality and aneurysm related mortality. The acquisition of mortality data was an original aim of the study but the initial DARS application timing coincided with a merger of HES/ONS that was not yet complete. It was therefore decided to apply for mortality data later. It has now reached the point at which the research team requires this data. CAG amendment has been approved to provide follow-up data to an additional and specific group of patients that will be identified and fed back to NHS England. This is a specific group of patients identified across the country who have an abdominal aortic aneurysm that was not repaired (for several possible reasons). They are also of interest to the study as a comparator arm to the operative treatments. They will be identified from sites across England at a local level, details provided to the study team at LUHFT, and then subsequently passed onto NHS England. For these patients, we would like the same follow-up data as provided for those patients already included into the study and who are already subject to the provision of ongoing “Extract 2” follow-up data from HES, DID and ONS datasets. These patients will require follow-up data from 01/11/2017 until the end of the study which is 31/12/2024. These additional patients will be provided to NHS England by a Cohort Contributor employed by LUHFT. This Agreement also adds the University of Liverpool as a joint data controller. Under previous Agreements the University of Liverpool had only been listed as a data processor. Individuals that are substantively employed by the University of Liverpool play a central role in deciding how the data should be processed. In order to adhere to the GDPR based definition of ‘Data Controller’ and ‘Data Processor’, both organisations should be listed as joint data controllers.

Processing activities

The study will screen screened all patients in England who have undergone a procedure for an abdominal [7 words unchanged] data between the 1st November 2017 and the 31st October 2019. This will be is a retrospective data review after the procedure has taken place and will be completed every 2 months during the study period to identify all new cases. This amendment adds in an additional cohort who did not undergo a repair (as an intentional clinical decision) to provide a comparator arm for the treatment arms. [1 paragraph unchanged] The initial data set was comprised of HES and linked DIDs data and was retrieved from NHS Digital every 2 months England (Extract #1). It includes included all patients who are were at least 1 month post discharge from hospital and will include included data on the 6 months prior to and up to 1 month after the procedure date. The initial data set was transferred directly from NHS Digital England to the UK-COMPASS Team based in a secure environment at the Royal now named Liverpool University Hospital. Clinical Trials Centre. The data collected for the patients identified at this point was the patient identifying (identifying NHS number and date of birth and birth) is kept on a secure server in a locked room secure location in the NHS Picture Archiving and Communications System (PACS) office of the Royal Liverpool University Hospital. This Step has been completed. [1 paragraph unchanged] The study is only concerned with patients who are treated for a complex juxtarenal abdominal aortic aneurysm. aneurysm (a specific subtype of all aneurysms). Therefore, all patients undergoing AAA repair need needed to be screened and ineligible patients removed. In order to select the eligible patients, the researchers review reviewed all the corresponding CT scans of patients identified in Step 1. This is was done via the PACS system. PACS are digital systems for managing radiological [42 words unchanged] that are essential for 3-dimensional image analysis using dedicated workstations. DIDs data are were needed and are processed by the UK-COMPASS team at Liverpool University Hospital NHS Foundation Trust in order to identify CT imaging on patients who have undergone complex AAA repairs. This step has been completed. [1 paragraph unchanged] At the point of retrieving each scan, the UK-COMPASS PACS team replace replaced all patient identifiable data on the scans with a Study Serial Number and archive them securely within PACS system. The Study Serial Number is was linked to the Pseudonymised HES ID. At this point, all patient identifiable data are were deleted and neither the scans nor the study data contain subsequently contained any patient identifiable information. There will be no requirement nor attempt to re-identify individuals. This step has been completed. [1 paragraph unchanged] The UK-COMPASS clinical study team at the Royal Liverpool University Hospital LUHFT then review reviewed all the scans and select selected patients who are eligible for the study. Anatomical measurements done on scans are were entered into the master data set that will would accumulate further study data in next steps. All non-eligible patients are then deleted from the study database and their scans will are also deleted. This step has been completed. Over the duration of the project it is estimated that 4000 patients per year will be received in the initial dataset and of these an estimated 1000 per year will be eligible for inclusion. DIDs are needed and processed by the UK-COMPASS team in order to identify CT imaging on patients who have undergone complex AAA repairs. Selected HES codes are relevant to the screening review. [1 paragraph unchanged] Following identification of patients with complex AAA, their pseudonymised HES ID will be was sent back to NHS Digital England for linkage with data from the National Vascular Registry (NVR). A data sharing agreement is was already in place with HQIP to access NVR data based on the data flow described here. NHS Digital England will not send any data to HQIP. The NVR, based at The Royal College of Surgeons, will securely transfer transfered a data file containing all patients who have undergone AAA repair to NHS Digital. England. This will contain contained the patient patients’ identifying NHS number and Date of Birth and the fields relating to anatomy, physiology, operative strategy and clinical course post-operatively. NHS Digital will act England acted as a trusted third party and link linked this data with the patients pseudonymised HES ID. This step has been completed. Step 6: Step 6 (Subject of Amendement): NHS Digital will link England linked (and continues to link) HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, Outpatients Outpatients, Critical Care, DID and Critical Care episodes ONS mortality data to the data extract received from NVR NVR, every 6 months using the pseudonymised HES ID. NHS Digital England will remove the identifying information and send the pseudonymised data back to the UK-COMPASS team at the Royal Liverpool University Hospital. LUHFT/UoL. The UK-COMPASS team will complete 6 monthly follow up health and cost [7 words unchanged] undergoing complex AAA repair and their subsequent follow up as an out-patient. This data will be linked every 6 months following the initial aneurysm repair and patients will be followed up for a total of 5 years until 31/12/2024 (the new end date of the proposed DARS amendment). This data will be linked every 6 months following the initial aneurysm repair and patients will be followed up for a total of 5 years. Step 7 (Subject of Amendement): Processing of the data provided by NHS Digital will only be carried out by individuals who are substantive employees of either the Liverpool University Hospital NHS Foundation Trust or the University of Liverpool, all of whom have been appropriately trained in data protection and confidentiality. An addition cohort of patients will be provided to the NHS England team. These have been identified separately as a separate arm of interest in our trial. These patients will be provided as a list of NHS numbers from LUHFT to NHS England on an ongoing basis. The study team would like follow-up for these individuals from the study start date (backdated) which is 01/11/2017 through to the end of follow-up which is 31/12/2024. This has been approved as a CAG and REC amendment. Processing of the data provided by NHS England will only be carried out by individuals who are substantive employees of either the Liverpool University Hospital NHS Foundation Trust or the University of Liverpool, all of whom have been appropriately trained in data protection and confidentiality. [3 paragraphs unchanged] No data will be shared with third parties. The findings will be shared with clinicians but these will not include [15 words unchanged] aggregated with small numbers suppressed in line with the HES Analysis Guide.

Expected output

[1 paragraph unchanged] The UK-COMPASS team aims expects to begin publishing publish shortly an academic papers within the first 2 years paper of the project 3-year longitudinal data based on anatomical observations made on the CT scans reviewed. [3 paragraphs unchanged] A simplified version of the findings will be disseminated to charities, patient groups of interest and be published on the LCTU LCTC website with versions available on the Vascular Society of Great Britain and Ireland Website as well as the British Society of Endovascular Therapists websites. [1 paragraph unchanged] Interim findings will be were publicised in at the annual scientific meeting of the Vascular Society of Great Britain and Ireland, Ireland in November 2022, with a final dissemination will take taking place in 2025.

Benefits reported

Thus far no yielded benefits have been achieved. The UK COMPASS team are still in the early stages of analysis and require further data to proceed. Public podium presentation at the largest Vascular Surgery Conference in the UK (Vascular Society of GB&I) in December 2021, 2022 and 2023. Study protocol and Corelab SOP: A risk-adjusted and anatomically stratified cohort comparison study of open surgery, endovascular techniques and medical management for juxtarenal aortic aneurysms-the UK COMPlex AneurySm Study (UK-COMPASS): a study protocol. Patel SR, Ormesher DC, Smith SR, Wong KHF, Bevis P, Bicknell CD, Boyle JR, Brennan JA, Campbell B, Cook A, Crosher AP, Duarte RV, Flett MM, Gamble C, Jackson RJ, Juszczak MT, Loftus IM, Nordon IM, Patel JV, Platt K, Psarelli EE, Rowlands PC, Smyth JV, Spachos T, Taggart L, Taylor C, Vallabhaneni SR. BMJ Open. 2021 Nov 30;11(11):e054493. doi: 10.1136/bmjopen-2021-054493. PMID: 34848524 Oral presentations: UK-COMPASS Mini-session at the Vascular society of Great Britain & Ireland; Brighton, 27-29 Nov 22 1) UK-COMPASS Study overview: Shaneel patel 2) Early results: Mike Jenkins 3) Late Results: Jon Boyle 4) Why not an RCT: S.R.Vallabhaneni Charing Cross Symposium, London, 25-27 April 2023 1) UK-COMPASS Study design: S.R.Vallabhaneni 2) Results and implications for NICE guidelines: Mike Jenkins Critical Issues in Aortic Endografting, International Symposium, Nuremberg, 12, 13 May 2023; Results from UK-COMPASS, S.R.Vallabhaneni

Unchanged: Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: + UNIVERSITY OF LIVERPOOL

Datasets: + Civil Registrations of Death - Secondary Care Cut; + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients; + HES:Civil Registration (Deaths) bridge; + MRIS - Bespoke

Objective for processing

The Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust requires and the University of Liverpool require Hospital Episodes Statistics (HES) and (HES), Diagnostic Imaging Dataset (DID) and HES/Civil Registry linked mortality data for use in a study titled “A Risk-adjusted and Anatomically Stratified Cohort [39 words unchanged] Chief Investigator of the NIHR-HTA funded UK-COMPASS project is a consultant surgeon substantively employed by Royal The Liverpool and Broadgreen University Hospitals NHS Foundation Trust. The Royal Liverpool and Broadgreen University Hospitals NHS Foundation Trust is the sole data controller and also processes the data for this study. Statisticians from the University of Liverpool will are joint data controllers, and also be processing process the data. data for the purposes described in this agreement. [1 paragraph unchanged] o Only individuals from the Royal The Liverpool and Broadgreen University Hospitals NHS Foundation Trust and the University of Liverpool make decisions in respect of how and why the data are processed. o Individuals from the University of Liverpool and other individuals from various external organisations who are named as co-investigators in the study Protocol v3 have, at the request of RLBUHT, The Liverpool University Hospitals NHS Foundation Trust, contributed to the design of the study by providing advice on aspects of the methodology given they have relevant subject matter expertise as statisticians. o RLBUHT is The University of Liverpool and the Liverpool University Hospital NHS Foundation Trust are not obliged to undertake any processing recommended by these individuals but obviously will act on their advice given their subject matter expertise. o Ongoing decisions on the processing of data from NHS Digital are taken by the Trial Management Group which comprises of 3 individuals substantively employed by RLBUHT and a Trials Coordinator employed by the University of Liverpool. The Trials Coordinator does not make decisions in respect of NHS Digital data. The Trials Coordinator provides advice on recruitment of patients to the ‘Quality of Life’ aspect of the UK COMPASS study to complete questionnaires in order to provide data to the trial and this is a completely separate activity to any processing of NHS Digital data. [1 paragraph unchanged] o The Trial Steering Committee performs an advisory function to the RLBUHT The Liverpool University Hospitals NHS Foundation Trust for the purpose of this study and is not responsible for determining how or why the NHS Digital data are processed. Accessing The lawful basis of processing this data is in accordance with General Data Protection Regulation point 6(1)e in that it (‘public task’), whereby processing is necessary for the performance of a task in the public interest: the data being processed is inclusive of the entire population undergoing complex aneurysm repair over a specified inclusion period. Conclusions drawn from the analysis of this processed data will benefit future populations through potential adjustment in national treatment strategies to carry out improve survival. The processing of special category data under this research in order to address the research aims. This data application (specifically with regards to health data) is also covered by GDPR Article 9(2)(j) as it is necessary being performed for public interest in order to ensure that future patients receive research purposes, the optimal treatment for complex aortic aneurysms. legal basis being further supported by Section 2 of Part 1 of Schedule 1 of the DPA 2018. [4 paragraphs unchanged] The study intends to analyse the outcomes of all patients aged 25 - 100 years, undergoing who had undergone juxtarenal aneurysm treatment in England without altering their treatment, during a period of 2 years between November 2017 and collect October 2019 by assessing 5 years of follow-up data. This study is non-interventional. The Royal Liverpool and Broadgreen University Hospitals NHS Trust have an This Agreement with NHS Digital to provide permits the UK COMPASS team to receive HES and DIDS data including the NHS number and date of birth of all patients undergoing AAA repair in England over a 2 year period until 2019/20. between Nov 2017 and October 2019. The study relies on linkage with a dataset from the NVR. National Vascular Registry (NVR), a national clinical audit commissioned by the Health Quality Improvement Partnership (HQIP). Now that a separate Data Sharing Agreement has been secured with HQIP to share NVR data, further data from NHS Digital is requested in under this Agreement to allow the study to achieve their its previously described aims. In order to facilitate linkage to NVR data, NHS Digital will act as a data processor on behalf of the Royal Liverpool and Broadgreen University Hospitals NHS Trust data controllers to receive and link NVR data. The Royal Liverpool and Broadgreen University Hospitals NHS Trust are now requesting It was previously requested that NHS Digital provide HES Accident and Emergency/Emergency Care DataSet, Data Set, Admitted Patient Care, Outpatients and Critical Care episodes data every 6 months [10 words unchanged] identified from the initial cohort 1st November 2017/18 to 31st October 2019. Under this Agreement the Liverpool University Hospital NHS Foundation Trusts requests access to mortality data and DIDS data for the same cohort of patients during follow up. This is crucial in being able to address the primary research question of comparing clinical effectiveness between different treatment options. [1 paragraph unchanged] The UK-COMPASS require team requires access to the APC data set as this identifies the operation that [16 words unchanged] will be necessary to carry out a rigorous clinical and cost-effectiveness analysis. [2 paragraphs unchanged] All data received from NHS Digital and from NVR via (via NHS Digital (acting acting as a trusted third party) will be pseudonymised. For all data sets, the UK-COMPASS have team has limited the data fields requested to only those that are the minimum [24 words unchanged] a health economist in reviewing the data sets and data fields required. The follow up period has been limited to 5 years after treatment as this should be sufficient to observe any differences between treatment groups in the medium term. Significant deviations and “catch up” phenomena of the survival curves of different treatment strategies have been demonstrated consistently by trials comparing treatments for non-complex aneurysms within 5 years of follow-up. Data from the entirety of England will be analysed to gain a national perspective as comparisons to date have been limited to single institutions. [2 paragraphs unchanged] This work will be undertaken by the UK-COMPASS team based at the Royal Liverpool University Hospital (part of the Royal Liverpool University and Broadgreen University Hospitals Hospital NHS Foundation Trust) with additional support from Liverpool Clinical Trials Unit, University of Liverpool. Only employees of the Royal Liverpool and Broadgreen University Hospital NHS Foundation Trust and the University of Liverpool will have access to the data [7 words unchanged] avoidance of doubt, this excludes any other collaborators named within the protocol. [1 paragraph unchanged] The study is not aware of any moral or ethical issues raised by the proposed dissemination of NHS Digital data to the Royal, Liverpool and Broadgreen University Hospitals NHS Trust nor the dissemination of the aggregated study results to the wider public. The study is unaware of any risk of potential harm to the public by the dissemination. Under this Agreement, Liverpool University Hospital NHS Foundation Trust will receive the following: 1) New data in 'Extract #1': Extract #1 refers to the identification of a study cohort by ICD operation code meeting the inclusion dates Nov 2017-Oct 2019. The Liverpool University Hospital NHS Foundation Trust previously received this data in full but the research team have since been informed through various sources in the vascular community (both individual expert and the UK National Vascular Registry team) that there are 3 ICD codes used to record aneurysm repair that had not previously been included. These are L19.9, L28.2 and Y26.3. The Liverpool University Hospital NHS Foundation Trust requires Extract #1 data based on these three additional codes . This would enable appropriate analysis of the population in keeping with the overall aims of the study. 2) New data in 'Extract #2' (DID): Extract #2 refers to the follow-up data over 5 years relating to outcomes after aneurysm repair. It will permit comparisons between different methods of repair. It will only be requested for the subset of patients identified from the screening population in Extract #1 (those with a complex aortic neck on imaging). The Liverpool University Hospital NHS Foundation Trust require imaging data (DID dataset) for Extract #2 to acquire information regarding imaging during the follow up period. This is crucial information for patients who have undergone AAA repair as they are often enrolled onto a surveillance imaging programme post operatively with different intensities across the different modes of repair. This information will enable the acquisition of post operative imaging results and allow analysis for imaging based complications. This is crucial for clinical and cost effectiveness analyses as per the overall aims of the study. 3) New data in Extract #2 (Mortality): Extract #2 refers to the follow-up data over 5 years relating to outcomes after aneurysm repair. It will permit comparisons between different methods of repair. It will only be requested for the subset of patients identified from the screening population in Extract #1. The Liverpool University Hospital NHS Foundation Trust require mortality data (only requiring date of death truncated to month and year, and cause of death). This will permit survival analyses between treatment types for both all cause mortality and aneurysm related mortality. The acquisition of mortality data was an original aim of the study but the initial DARS application timing coincided with a merger of HES/ONS that was not yet complete. It was therefore decided to apply for mortality data later. It has now reached the point at which the research team requires this data. This Agreement also adds the University of Liverpool as a joint data controller. Under previous Agreements the University of Liverpool had only been listed as a data processor. Individuals that are substantively employed by the University of Liverpool play a central role in deciding how the data should be processed. In order to adhere to the GDPR based definition of ‘Data Controller’ and ‘Data Processor’, both organisations should be listed as joint data controllers.

Processing activities

[2 paragraphs unchanged] The initial data set is was comprised of HES and linked DIDs data and will be was retrieved from NHS Digital every 2 months. months (Extract #1). It includes all patients who are at least 1 month post discharge [23 words unchanged] data set was transferred directly from NHS Digital to the UK-COMPASS Team based at the Royal Liverpool University Hospital. The data collected at this point [25 words unchanged] Archiving and Communications System (PACS) office of the Royal Liverpool University Hospital. [4 paragraphs unchanged] At this point, all patient identifiable data are deleted and neither the scans nor the study data contain any patient identifiable information. There will be no requirement or nor attempt to re-identify individuals. [7 paragraphs unchanged] NHS Digital will not be sending send any data to HQIP. [4 paragraphs unchanged] Processing of the data provided by NHS Digital will only be carried out by individuals who are substantive employees of either the Liverpool University Hospital NHS Foundation Trust or the University of Liverpool, all of whom have been appropriately trained in data protection and confidentiality. [4 paragraphs unchanged] The Data will only be used for the purposes described in this Agreement.

Expected output

[7 paragraphs unchanged] Interim findings will be published annually publicised in the annual scientific meeting of the Vascular Society of Great Britain and Ireland, with a final dissemination will take place in 2025.

Expected measurable benefits

[5 paragraphs unchanged] MPhil and PhD students will be enrolled as part of the UK-COMPASS study team to contribute to the retrospective data reviews (outlined above) and the work they undertake will contribute to them achieving MPhil and PhDs from the University of Liverpool.

Benefits reported

Thus far no yielded benefits have been achieved. The UK COMPASS team are still in the early stages of analysis and require further data from this application to proceed.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Emergency Care Data Set (ECDS); + Hospital Episode Statistics Accident and Emergency (HES A and E); + Hospital Episode Statistics Critical Care (HES Critical Care); + Hospital Episode Statistics Outpatients (HES OP)

Objective for processing

The Royal Liverpool and Broadgreen University Hospitals NHS Trust requires Hospital Episodes Statistics (HES) and Diagnostic Imaging Dataset (DID) data for use in a study titled “A Risk-adjusted and Anatomically Stratified Cohort [49 words unchanged] consultant surgeon employed by Royal Liverpool and Broadgreen University Hospitals NHS Trust. The aim of the study is to answer the research question identified by NIHR-HTA Commissioning Board: What are the clinical and cost-effectiveness of strategies for the management of juxtarenal abdominal aortic aneurysm, including fenestrated endovascular repair? The Royal Liverpool and Broadgreen University Hospitals NHS Trust is the sole data controller and also processes the data for this study. Statisticians from the University of Liverpool will also be processing the data. The roles of organisations involved currently or previously with this research are as follows: o Only individuals from the Royal Liverpool and Broadgreen University Hospitals NHS Trust make decisions in respect of how and why the data are processed. o Individuals from the University of Liverpool and other individuals from various external organisations who are named as co-investigators in the study Protocol v3 have, at the request of RLBUHT, contributed to the design of the study by providing advice on aspects of the methodology given they have relevant subject matter expertise as statisticians. o RLBUHT is not obliged to undertake any processing recommended by these individuals but obviously will act on their advice given their subject matter expertise. o Ongoing decisions on the processing of data from NHS Digital are taken by the Trial Management Group which comprises of 3 individuals substantively employed by RLBUHT and a Trials Coordinator employed by the University of Liverpool. The Trials Coordinator does not make decisions in respect of NHS Digital data. The Trials Coordinator provides advice on recruitment of patients to the ‘Quality of Life’ aspect of the UK COMPASS study to complete questionnaires in order to provide data to the trial and this is a completely separate activity to any processing of NHS Digital data. o The Trial Steering Committee (TSC) consists of independent and non-independent members. The TSC Chair reports back to the funder, the NIHR. o The Trial Steering Committee performs an advisory function to the RLBUHT for the purpose of this study and is not responsible for determining how or why the NHS Digital data are processed. Accessing this data is in accordance with General Data Protection Regulation point 6(1)e in that it is necessary to carry out this research in order to address the research aims. This data application is also covered by GDPR Article 9(2)(j) as it is necessary for public interest in order to ensure that future patients receive the optimal treatment for complex aortic aneurysms. The aim of the study is to answer the question identified by NIHR-HTA Commissioning Board: What are the clinical and cost-effectiveness of strategies for the management of juxtarenal abdominal aortic aneurysm, including fenestrated endovascular repair? [3 paragraphs unchanged] The study intends to analyse the outcomes of all patients aged 25 [12 words unchanged] treatment, during a period of 2 years and collect 5 years follow-up data (this would be subject to a further application to NHS Digital). data. The UK-COMPASS team plan to examine patients’ scans and utilise data that is routinely collected by the NHS. Available data will be analysed to compare the safety and effectiveness of different treatments, and to see if a particular treatment is better suited for particular features so patients can be offered bespoke treatment strategies. The Royal Liverpool and Broadgreen University Hospitals NHS Trust have an Agreement with NHS Digital to provide the UK COMPASS team HES and DIDS data including the NHS number and date of birth of all patients undergoing AAA repair in England over a 2 year period until 2019/20. The study relies on linkage with a dataset from the NVR. Now that a separate Data Sharing Agreement has been secured with HQIP to share NVR data, further data from NHS Digital is requested in this Agreement to allow the study to achieve their previously described aims. In order to facilitate linkage to NVR data, NHS Digital will act as a data processor on behalf of the Royal Liverpool and Broadgreen University Hospitals NHS Trust to receive and link NVR data. The Royal Liverpool and Broadgreen University Hospitals NHS Trust are now requesting NHS Digital provide HES Accident and Emergency/Emergency Care DataSet, Admitted Patient Care, Outpatients and Critical Care episodes data every 6 months to cover 5 years of follow up for each patient identified from the initial cohort 1st November 2017/18 to 31st October 2019. The UK COMPASS team plan to examine patients’ scans and utilise data that is routinely collected by the NHS. The HES A&E/ECDS, Critical Care, APC and OP data sets will allow researchers to capture the entire patient journey from pre-operative imaging to treatment, in-patient care and subsequent follow up. UK-COMPASS require access to the APC data set as this identifies the operation that the patient has had and subsequent management whilst an in-patient. This data set provides information that will be necessary to carry out a rigorous clinical and cost-effectiveness analysis. The OP data set has also been reviewed and data points from this will allow researchers to see what subsequently happens to patients during their follow up period. This data set will mainly guide the clinical effectiveness evaluation by identifying treatment failures and the subsequent management of these. This will ensure a complete analysis of clinical effectiveness of the different treatment modalities that patients undergo. All data received from NHS Digital and NVR via NHS Digital (acting as a trusted third party) will be pseudonymised. For all data sets, UK-COMPASS have limited the data fields requested to only those that are the minimum required to allow researchers to undertake the analysis relevant to the purpose described. The research team has had input from clinicians as well as a health economist in reviewing the data sets and data fields required. Available data will be analysed to compare the safety and effectiveness of different treatments, and to see if a particular treatment is better suited for particular features so patients can be offered bespoke treatment strategies. There are no other alternative datasets that can provide this data. The data requested will be the minimum required to carry out analysis for the purpose of this research. The UK-COMPASS team currently have a Data Sharing Agreement (DSA) in place with Healthcare Quality Improvement Partnership (HQIP) for the use of National Vascular Registry (NVR) data. The NVR collects data that is inputted by clinicians following repair of a AAA. This data reflects physiological, anatomical and technical variables. [1 paragraph unchanged] The study has been designed based on the need to analyse routinely collected data from NHS Digital and the NVR. A randomised controlled trial is not possible to address the aim as there is no position of equipoise on current treatments for juxtarenal AAA. Currently there is a wide variation in practice across vascular surgical units that treat patients with this condition. The study is not aware of any moral or ethical issues raised by the proposed dissemination of NHS Digital data to the Royal, Liverpool and Broadgreen University Hospitals NHS Trust nor the dissemination of the aggregated study results to the wider public. The study is unaware of any risk of potential harm to the public by the dissemination.

Processing activities

The study will screen all patients nationally in England who have undergone a procedure for an abdominal aneurysm of any sort identified from HES data between the 1st November 2017 and the 31st October 2019. This will be a retrospective data review after the procedure [7 words unchanged] every 2 months during the study period to identify all new cases. [1 paragraph unchanged] The initial data set will comprise is comprised of HES and linked DID DIDs data and will be retrieved from NHS Digital every 2 months. It will include includes all patients who are at least 1 month post discharge from hospital [11 words unchanged] up to 1 month after the procedure date. The initial data set will be was transferred directly from NHS Digital to the UK-COMPASS Team at the Royal Liverpool University Hospital. The data collected at this point will be was the patient identifying NHS number and date of birth and will be is kept on a secure server in a locked room in the NHS Picture Archiving and Communications System (PACS) office of the Royal Liverpool University Hospital. [1 paragraph unchanged] The study is only concerned with patients who are treated for a [16 words unchanged] ineligible patients removed. In order to select the eligible patients, the researchers will review all the corresponding CT scans of patients identified in Step 1. This will be is done via the PACS system. PACS are digital systems for managing radiological [45 words unchanged] for 3-dimensional image analysis using dedicated workstations. DIDs data are needed and will be are processed by the UK-COMPASS team in order to identify CT imaging on patients who have undergone complex AAA repairs. [1 paragraph unchanged] At the point of retrieving each scan, the UK-COMPASS PACS team will replace all patient identifiable data on the scans with a Study Serial Number and archive them securely within PACS system. The Study Serial Number will be is linked to the Pseudonymised HES ID. At this point, all patient identifiable data are deleted and neither the scans nor the study data will contain any patient identifiable information. The maximum duration the patient identifiable data There will be held before pseudonymisation is 10 weeks. no requirement or attempt to re-identify individuals. [1 paragraph unchanged] The UK-COMPASS clinical study team at the Royal Liverpool University Hospital will then review all the scans and select patients who are eligible for the study. Anatomical measurements done on scans will be are entered into the master data set that will accumulate further study data in next steps. All non-eligible patients will are then be deleted from the study database and their scans will are also be deleted. [1 paragraph unchanged] DIDs are needed and will be processed by the UK-COMPASS team in order to identify CT imaging on patients who have undergone complex AAA repairs. Selected HES codes of are relevant to the screening review. Step 5: Following identification of patients with complex AAA, their pseudonymised HES ID will be sent back to NHS Digital for linkage with data from the National Vascular Registry (NVR). A data sharing agreement is already in place with HQIP to access NVR data based on the data flow described here. NHS Digital will not be sending data to HQIP. The NVR, based at The Royal College of Surgeons, will securely transfer a data file containing all patients who have undergone AAA repair to NHS Digital. This will contain the patient identifying NHS number and Date of Birth and the fields relating to anatomy, physiology, operative strategy and clinical course post-operatively. NHS Digital will act as a trusted third party and link this data with the patients pseudonymised HES ID. Step 6: NHS Digital will link HES Accident and Emergency/Emergency Care Data Set, Admitted Patient Care, Outpatients and Critical Care episodes data to the data extract received from NVR every 6 months using the pseudonymised HES ID. NHS Digital will remove the identifying information and send the pseudonymised data back to the UK-COMPASS team at the Royal Liverpool University Hospital. The UK-COMPASS team will complete 6 monthly follow up health and cost analysis, showing the clinical course of patients undergoing complex AAA repair and their subsequent follow up as an out-patient. This data will be linked every 6 months following the initial aneurysm repair and patients will be followed up for a total of 5 years. There will be no requirement nor attempt to reidentify individuals from the pseudonymised data. [1 paragraph unchanged] All organisations party to this agreement must comply with the Data Sharing [11 words unchanged] that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: - i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). [2 paragraphs unchanged]

Expected output

[1 paragraph unchanged] The UK-COMPASS team aims to begin publishing academic papers within the first year 2 years of the project based on anatomical observations made on the CT scans reviewed. Commissioning guidelines will be produced over the ensuing 7 years. The UK-COMPASS team will also report back to the NIHR on a 6 monthly basis. Analysis of the data will be fed back to commissioners, this will shape future UK wide policy on the management of resources when considering funding the treatment of complex aortic aneurysm surgery. MD and PhD students will be enrolled as part of the UK-COMPASS study team to contribute to the retrospective data reviews (outlined above) and the work they undertake will contribute to them achieving MDs and PhDs from the University of Liverpool. For avoidance of doubt, no additional uses of the data will be permitted. The UK-COMPASS team have been and will continue to report back to their funder, the NIHR, on a 6 monthly basis. A simplified version of the findings will be disseminated to charities, patient groups of interest and be published on the website. MPhil and PhD students will be enrolled as part of the UK-COMPASS study team to contribute to the retrospective data reviews (outlined above) and the work they undertake will contribute to them achieving MPhil and PhDs from the University of Liverpool. For avoidance of doubt, no additional uses of the data, beyond the purpose outlined in this Agreement, will be permitted. A simplified version of the findings will be disseminated to charities, patient groups of interest and be published on the LCTU website with versions available on the Vascular Society of Great Britain and Ireland Website as well as the British Society of Endovascular Therapists websites. [2 paragraphs unchanged]

Expected measurable benefits

[2 paragraphs unchanged] Healthcare It is hoped that healthcare users can expect to would benefit in terms of improved quality of care in the form of [82 words unchanged] appropriate management under the care of the clinicians with the greatest expertise. [2 paragraphs unchanged]

Benefits reported

Yielded Benefits is not a requirement for new applications. Thus far no yielded benefits have been achieved. The UK COMPASS team are still in the early stages of analysis and require further data from this application to proceed.