Emergency Surgery Or noT for common Vascular conditions in the periods before and during COVID-19 (the ESORT-V study)

London School of Hygiene and Tropical Medicine (LSHTM) and University of Bristol, requires access to NHS England data for the purpose of the following research project:

Emergency Surgery Or noT for common Vascular conditions in the periods before and during COVID-19 (the ESORT-V study)

The following is a summary of the aims of the research project provided by London School of Hygiene and Tropical Medicine and the University of Bristol,:

For patients with common vascular conditions, there is little evidence about which patients benefit from urgent versus scheduled operative procedures. For certain patients outcomes could be better if surgery was later, because for example other aspects of the patients’ condition were stabilised. For other patients, vascular disease can deteriorate rapidly, and delaying surgery may lead to substantial morbidity and mortality, for example major stroke or amputation. The Getting it Right First Time (GIRFT) report for emergency general surgery found wide variation across NHS trusts in care quality and outcomes after emergency surgery, which reflect local logistical and resource constraints, but also clinical uncertainty. There is little relevant evidence to inform decisions about the timing of surgery for common vascular conditions and there is much uncertainty about the benefits and risks of urgent surgery versus scheduled surgery.

The ESORT-V study aims to estimate the effectiveness and cost-effectiveness of urgent surgery versus scheduled surgery to help inform clinicians on which patients should be prioritised for urgent surgery. This study will consider hospital admissions for the following vascular conditions and procedures where there is clinical uncertainty regarding optimal surgery time:

- Patients with non-ruptured abdominal aortic aneurysms (AAA) undergoing AAA repair

- Patients undergoing carotid endarterectomy after a stroke/transient ischaemic attack

- Patients with peripheral arterial disease (PAD) undergoing lower limb revascularisation or amputation.

ESORT-V will consider access to urgent and scheduled surgery for patient subgroups (for example, co-morbidities, gender and frailty) and how effectiveness differs before and after the onset of the COVID-19 pandemic. ESORT-V will build on the ongoing “Emergency Surgery OR noT” (ESORT) and “Emergency Surgery OR noT: the impact of COVID-19” (ESORT-C19) studies.

ESORT-V study objectives:

- Clinical and cost-effectiveness of urgent versus elective surgery for common vascular conditions.

- Clinical and cost-effectiveness in specific patient subgroups (e.g. diagnostic subcategories) and the effect of the COVID-19 period.

- Provide recommendations about which subgroups should have ‘urgent’ versus ‘scheduled’ surgery and define subpopulations/comparison groups for a Randomised Controlled Trial (RCT).

Upon data receipt, LSHTM will identify eligible index episodes/admissions and derived variables such as comorbidities, surgical volume and tendency to operate from the HES APC cohort data and 2-year prior data. Subsequent HES episodes will be used to identify patient outcomes in addition to those provided via linkage to Civil Registration (Deaths) data. A single patient-level dataset for each surgery will then be created including the above derived variables. The main analysis will be on these patient-level datasets.

The following NHS England Data will be accessed:

> Hospital Episode Statistics

- Admitted Patient Care – necessary to identify patient characteristics (ethnicity, index of multiple deprivation), comorbidities, to identify previous/subsequent admissions related to vascular surgery and to identify elective and non-elective surgeries. For example, a patient can be admitted as an elective lower limb revascularisation which may not be successful and lead to a non-elective amputation. APC data will also be used to identify patients who should be excluded due to pre-specified inclusion and exclusion criteria, and to determine the primary outcome (days alive and out of hospital).

- Critical Care – necessary for estimating resource use and costs associated with urgent and scheduled vascular surgeries, and to determine the primary outcome (days alive and out of hospital).

- Outpatients – necessary to identify patient pathways to vascular surgery for lower limb revascularisation and amputation procedures, and to determine resource use for the cost-effectiveness analyses.

> Civil Registration Mortality - necessary to obtain date of death, which is required for (i) deriving a primary outcome, and (ii) allocation to the emergency surgery or conservative management arm. The original ESORT study's patient and public involvement (PPI) meetings discussed potential outcomes and highlighted 'days alive and out of hospital' as an important outcome. Accurate measurement of this outcome requires date of death. Date of death is also required to enable an allowance to be made in the analysis for any bias that might arise if death occurs before surgery can occur. This relates to the use of a time window within which surgery must occur (e.g. 7 days) to be defined as 'emergency surgery' and the possibility that a patient may die without having surgery during this window. Date of death will allow the study to identify these patients for each day in the window.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by LSHTM and the University of Bristol, – the cohort (approximate size: 170,000) will consist of patients from the National Vascular Registry (NVR)*, which includes individuals who had vascular surgery from 01/01/2016 to 31/12/2022 for the following reasons:

• Patients with non-ruptured AAA undergoing AAA repair

• Patients undergoing carotid endarterectomy (CE) after stroke/transient ischaemic attack (TIA)

• Patients with peripheral arterial disease (PAD) undergoing lower limb revascularisation/amputation.

The cohort includes elective and emergency surgery for consented and non-consented patients in the NVR with s251 approval for emergency non-consented patients. The cohort excludes patients who have refused consent.

The cohort is defined by a broad eligibility criteria before it is sent to NHS England for linkage. Exclusion criteria is also applied to the cohort before it is sent to NHS England as follows: Any patients falling outside the definitions of (i) non-ruptured AAA undergoing AAA repair, (ii) carotid endarterectomy (CE) after stroke/transient ischaemic attack (TIA) or (iii) peripheral arterial disease (PAD) undergoing lower limb revascularisation/amputation is excluded. The linked NVR-HES data will be used to refine the eligibility criteria. the controllers, do not expect this to be a large proportion and also expect to report results for different (broader and narrower) eligibility criteria.

> Limited to data between 2015/16 - 2023/24

LSHTM and the University of Bristol are the joint controller as the organisations 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)(i) processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the study described.

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

NEC Software Solutions UK Limited sends the cohort identifiers from the NVR on behalf of the Royal College of Surgeons of England (who own the cohort) to NHS England for cohort linkage. NEC Software Solutions UK Limited do not access NHS England data and are not a processor under this DSA.

Data will not flow to other partners (North Bristol NHS Trust, The Royal College of Surgeons of England, Cambridge University Hospitals NHS Foundation Trust) who will only act in an advisory capacity. Clinical representatives of, North Bristol NHS Trust, Cambridge University Hospital NHS Foundation Trust, and University Hospitals Bristol and Weston NHS Foundation Trust. These clinical representatives provide specialist guidance to the study only and do not carry any responsibility for the purpose and means in which data provided under this Agreement are processed. This responsibility lies solely with LSHTM. Clinical co-applicant and research partner responsibilities include attending investigators' meetings, providing input on relevant clinical and policy matters, responding to clinical queries from LSHTM staff processing the data, and providing a clinical interpretation of the outputs of data analyses.

The study design has benefited from Patient and Public Involvement (PPI) through the input of a Patient Research Ambassador Initiative member, and a lay person who has experienced emergency surgery for a common condition. The PPI representatives felt that the design and interpretation of the quantitative study should be informed by experiences of patients presenting as emergency admissions. The PPI representatives therefore helped plan two workshops with public and patient representatives, surgeons, and research commissioners. The design workshop will inform the selection of acute conditions and outcome measures, and the translation workshop will focus on interpretation and communication of results. The PPI representatives have encouraged the team to elicit views of i) surgical patients, ii) non-operative care patients, and iii) expectations of the healthy public via the workshops. LSHTM will work with the LSHTM media department, and their lay representatives to ensure the findings are accessible to a broader public. To help ensure patient benefit, LSHTM’s proposed design workshop will draw on the views of vascular surgeons , national policy makers, commissioners, and service managers. LSHTM have held a PPI design workshop at the project outset, defining the outcomes most important to patients for each condition, and ‘translation’ workshops with PPI representatives to understand how best to translate the study findings to general audiences.

NEC Software Solutions UK Limited will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender, date of surgery and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES and mortality datasets to LSHTM. 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.

The Data will not be transferred to any other location.

The Data will be stored on servers at LSHTM.

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 LSHTM who have authorisation from the principal investigator.

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

The Data will be linked at person record level with cohort pseudonymised data relating to hospital admissions, surgeries, diagnoses and treatments obtained from to the NVR.

The Data will not be linked with any other data.

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

Analysts from the LSHTM will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to NIHR at the end of the study

> Submissions to peer reviewed journals such as the British Medical Journal (BMJ) and the British Journal of Surgery

> Presentations at specific conferences such as the Vascular Society for Great Britain and Ireland Annual Scientific Meeting

> Randomised Controlled Trial proposal for future NIHR HTA application

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

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

> Journals

> Conferences

> Study website; an important repository of information about the study, for both lay and professional audiences.

> ‘Translation’ workshops with PPI representatives will also be held to understand how best to translate the study findings to general audiences. LSHTM’s engagement and dissemination strategy will be informed by their translation workshops. The PPI workshop will focus on how best to communicate findings to patients/service users, and ensure the findings reach the populations of interest. The clinical translation workshop will focus on how to reach both clinicians and commissioners to ensure maximal impact on services.

Outputs are expected to e produced within 12 months of data receipt.

Each year approximately 43,000 vascular surgery procedures are performed in 70 NHS trusts in England. These are some of the highest risk operations for patients and most costly procedures for the NHS and have a significant impact on wider society. The study will deliver short term benefits by identifying patient subgroups of patients for whom ‘urgent’ versus ‘elective’ vascular surgery is clearly worthwhile, to directly inform clinical practice. This will be helpful in handling large waiting lists following on from the COVID-19 pandemic and for informing how surgery should be handled in any future pandemics.

The use of the data could:

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

> 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.

Evidence will be generated from this study about which patient subgroups benefit most from urgent surgery, those in whom elective surgery may be more cost-effective, and those for whom there is sufficient uncertainty around the relative risks and benefits of urgent intervention to justify and inform a future RCT. The results will inform service design for vascular surgery, NICE clinical guidelines, GIRFT and commissioning guides for acute services. LSHTM will also work with NHS RightCare to modify decision aids supporting shared decision making. Results are expected to directly inform clinical practice and contribute to national guideline development (e.g., Vascular Society Quality Improvement Frameworks).

Direct communication of knowledge is key to clinical organisations, and input into clinical guideline development, will be ensured by team members and the vascular surgery Getting It Right First Time team. This will include contributing to NICE and commissioning guides, RCS initiatives and working with NHS RightCare to modify decision aids supporting shared decision making.

Yielded Benefits is not a requirement for new applications.