BASIL-3 Clinical Trial: BAlloon vs. Stenting in Severe Ischaemia of the Leg-3

University of Birmingham (UoB) requires access to NHS Digital data for the purpose of the following research project:

The BASIL-3 Clinical Trial: BAlloon vs. Stenting in Severe Ischaemia of the Leg-3. This is when blood vessels between the hip and knee are blocked.

Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting stents, and plain balloon angioplasty with a bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease. Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.

The following NHS Digital data will be accessed:

• Hospital Episode Statistics (HES) Admitted Patient Care (APC)

• Civil Registration Deaths (Secondary Care Cut)

UoB require mortality and hospital data as this will allow them to double-check the main outcomes against routine data sources, and extend the follow-up of patients in the trial and collect the long-term outcome and health resource usage data without needing further contact with the study participants. This is important as it will link a trial of treatments that may become a clinical standard of care to long-term outcomes that are routinely collected in clinical data but will not be collected during the follow-up period of the trial.

The level of the data will be identifiable which is necessary because although the NHS Digital data is pseudonymised for analysis, on occasions, there could be a justifiable reason for requiring a cohort member to be reidentified within the clinical trial by linking the unique person ID.

The data will be minimised as follows:

• Limited to data for a study cohort of 481 patients who met the inclusion criteria (including having Severe Limb Ischaemia) and consented to participate.

• Limited to data between 2015/16 to 2023/24. For each individual patient, data will only be provided from the date they joined the trial.

• Limited to pseudonymised data only for analysis purposes.

University of Birmingham is the research sponsor and the data controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above.

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

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

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

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

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

The funding is provided by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme, the funding is specifically for the BASIL 3 Trial as described. Funding is in place until January 2024.

The trial has two oversight committees, which comprise of external members who are senior clinicians and statisticians. The Data Monitoring Committee (DMC) safeguards the interests of patients and the integrity of the trial by assessing the safety and efficacy of the intervention and ensuring the trial collects the necessary data. The DMC receives interim analyses provided by the trial statistician but does not have access to trial data. The DMC reports to the Trial Steering Committee (TSC) which provides oversight of the trial and provides advice to the Trial Management Team. The TMC considers DMC recommendations, but do not receive interim analyses or have access to trial data.

Data will only be accessed by substantive employees of the UoB.

A Public and Patient Information and Engagement (PPIE) group was consulted regarding the collection of the data for the purposes described above. PPIE were involved in the setting up of the BASIL-3 trial and were consulted during and after the pause to recruitment post publication of the Katsanos et al., (2018) meta-analysis and they continue to attend yearly meetings and review any amendments to protocols or patient facing documents.

University of Birmingham will transfer data to NHS Digital. The data will consist of identifying details (specifically NHS Number and Date of Birth plus a unique person ID and the individual start date for each participant ('randomisation date') for the cohort of 481 patients to be linked with NHS Digital data.

NHS Digital data will provide the relevant records from the HES APC and Civil Registration Deaths Secondary Care Cut datasets to University of Birmingham.

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 University of Birmingham.

The data will be accessed onsite at the premises of the University of Birmingham only.

The data will not leave England/Wales at any time.

Access is restricted to individuals within the Birmingham Clinical Trials Unit of University of Birmingham who have authorisation from the Principal Investigator. All such individuals are substantive employees of University of Birmingham.

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

Using the Study ID, the NHS Digital data will be linked at person record level with Basil 3 trial data obtained by UoB. NHS Digital data will not be linked to any other data resources used by the trial.

The identifying details will be stored in a separate database to the linked dataset used for analysis. There are technical and organisational controls in place to ensure the NHS Digital data is kept separate from any identifying dataset. All analyses will use the pseudonymised dataset. However, on occasions, there could be a justifiable reason for requiring a cohort member to be reidentified within the clinical trial.

Researchers from the UoB will process the data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to the funder and Research and Ethics Committee (REC) at the end of the study.

• Submissions to peer reviewed journals at the end of the study.

• Presentations to the ICVS - International Conference on Vascular Surgery and the VSGBI - Vascular Society of Great Britain and Ireland and any other appropriate conferences.

• Publication of information on the BASIL 3 website.

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

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

• Journals

• Co-hosted events, for example, conferences

• Public promotion of the research on the study website and social media

Target dates for production and dissemination of the outputs will be Spring 2024.

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

The use of the data could

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

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

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

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

It is expected to provide the most clinical and cost-effective method of treating people with Femoro-popliteal Severe limb ischaemia. This is when blood vessels between the hip and knee are blocked.

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.

Yielded Benefits is not a requirement for new applications.