Evaluation of Local Anaesthesia in the endovascular repair of ruptured abdominal aortic aneurysms: a Target trial and Economic evaluation (ELATE)

​​The Data will be used for the purpose of a research project: Evaluation of Local Anaesthesia in the endovascular repair of ruptured abdominal aortic aneurysms: a Target trial and Economic evaluation (ELATE).

​Ruptured abdominal aortic aneurysm (rAAA) is a time-critical emergency in vascular surgery. Even after endovascular repair, the recommended treatment, approximately 20% of patients die in hospital and 40% die within one year. Despite this, the evidence base to guide anaesthetic decision-making for this procedure remains inadequate. National Institute for Health and Care Excellence (NICE) recommends that clinicians 'consider' local anaesthesia for endovascular repair of ruptured abdominal aortic aneurysm, but this recommendation is based on a small, inconclusive analysis of a randomised controlled trial. Meanwhile, there is wide variation in anaesthetic practice across English vascular centres, with the proportion using local anaesthesia at each centre ranging from 23% to 60%. This variation is unlikely to reflect genuine differences in patient need, and is unlikely to resolve without robust evidence to guide practice. The ELATE study directly addresses that gap.

​The Data will be used to:

​1. Establish the clinical effectiveness and cost-effectiveness of local versus general anaesthesia according to pre-specified patient subgroups, including sex, age, frailty, systolic blood pressure, comorbidity burden, and case severity.

The Royal College of Surgeons will transfer data to NHS England. The data will consist of identifying details NHS Number, Date of Birth and a unique person ID for the cohort to be linked with NHS England data.

​​NHS England will provide the relevant records from the Civil Registrations mortality &HES APC datasets to the London School of Hygiene & Tropical Medicine Secure Server.

​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 be minimised as follows:

​• Limited to a study cohort identified by the Royal College of Surgeons within RVS – will include people aged 50 years and over who receive a particular surgery for a ruptured abdominal aortic aneurysm (emergency endovascular surgical repair) in English hospitals between 5 years before incident and 1 year after incident. This will be supplied by the cohort submitter in 2 columns.

​​The London School of Hygiene & Tropical Medicine​ will perform this linkage.

​​The Data will not be transferred to any other location.

​​The Data will be stored on servers at The London School of Hygiene & Tropical Medicine.

​​​The Data will be backed up on servers at The London School of Hygiene & Tropical Medicine​​.

​​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).

​​There will be no requirement and no attempt to identify specific individuals from the data.

Approved researchers at the London School of Hygiene & Tropical Medicine will link together the datasets using the National Vascular Registry pseudo-ID to create the final NVR-HES linked data.

This method will ensure that at no point does the encrypted NHS Number or full date of birth flow with clinical data. The NVR will retain the list of patient identifiers until the linkage process is complete.

The expected outputs of the processing will be:

​Peer-reviewed publications. The controller anticipate submitting approximately 3-4 papers to peer-reviewed journals, with first submissions expected within 12 months of data access commencing. Publications will cover both empirical findings and methodological advances, and will all be made available open-access. Final submissions will be within approximately 24 months of data access.

Conference presentations. Findings will be presented at national and international scientific and clinical conferences from 12 months after data access begins, including epidemiological meetings (such as the International Society for Pharmacoepidemiology and the Society for Epidemiologic Research) and clinical meetings (such as the European Society of Cardiology congress, British Journal of Surgery Annual Meeting). Abstracts and posters will be produced for each meeting.

Open-source code and software. All analytical code will be published in open-source repositories. Novel statistical methods will be implemented as documented software packages in R, Stata and/or Python to enable adoption by other research teams. This data management and statistical code will be published along with peer-reviewed research articles, submitted within approximately 12-24 months from data access.

Policy briefings and reports. Where appropriate, concise briefing documents summarising findings and their implications will be produced for policymakers and guideline developers, targeting bodies including NICE, NHS England, and relevant professional societies, from 12 months from data receipt.

Patient-facing materials. Plain-language summaries of key findings will be produced in collaboration with the patient public involvement co-investigators, and disseminated via vascular charities and societies, the study website, and participant newsletters. These patient- and public-facing materials will be written along with peer-reviewed publications, submitted within approximately 12-24 months of data access.

​​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.

​​Dissemination will target multiple audiences across the scientific, clinical, policy and patient communities throughout the programme.

For the research and clinical communities, the primary channels are peer-reviewed publications and conference presentations. Co-investigators with leading roles in clinical practice will facilitate translation of findings for clinical colleagues.

For policymakers, the team will draft targeted briefing documents which will be shared with colleagues at NHS England, NICE, and other public health bodies. The team plan to host 2 clinical and patient translation and dissemination workshops during the study to develop dissemination strategies to ensure that the study results have maximum impact on improving patient outcomes and efficiencies for the NHS.

For the public and patient communities, dissemination will be supported by partnerships with vascular charities such as the Vascular Society of Great Britain Special Interest groups, the Bristol Vascular Patient Advisory group, and the NIHR ARC North Thames Research Advisory Panel. Press and media engagement will be pursued where findings are of broad public interest. The team will post regular updates on the project study website, which will be shared with the patient organisations mentioned above: https://www.lshtm.ac.uk/research/centres-projects-groups/elate-project

Ongoing communication across all audiences will use a dedicated programme website and social media presence.​

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.

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

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

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

• Advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as ruptured abdominal aortic aneurysm and emergency vascular surgery.

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

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

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

• Support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Yielded Benefits is not a requirement for new applications.