BEST-4 Heartburn Health Programme - Outcomes (NHS Numbers)

The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust require access to NHS England Data for the purpose of the Heartburn Health Programme, and Barrett’s oESophagus Trial 4 (BEST4) Screening Trial.

The following is a summary of the aims of the Heartburn Health Programme, and BEST4 Screening Trial, provided by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust:

The aim of the Heartburn Health Programme is to create a resource of participants with heartburn, indigestion or acid reflux. The Programme aims to build a community of volunteers with heartburn and allow experts to research issues like:

- How to manage symptoms more effectively and reduce the need for long-term medication

- How to find more serious health problems such as severe inflammation and cancer early, when they are easier to treat

As part of the Heartburn Health Programme, participants will have consented to health-related data collection, and to be contacted regarding specific research opportunities. The BEST4 Screening Trial is one of the first research opportunities that Heartburn Health participants might be eligible to participate in. The aim of the BEST4 Screening Trial is to assess the use of a capsule sponge device as a screening tool to identify signs of the precancerous condition Barret's Oesophagus (BO), which can often be a precursor for Oesophageal Adenocarcinoma (OAC) (cancer of the food pipe).

Using the capsule sponge device could be a simple, alternative method of screening for these conditions. The current screening method for patients who are identified as being high risk is endoscopy, which is an invasive and uncomfortable procedure, as well as being expensive for the NHS and often not easily accessible. The BEST4 Screening Trial will identify if the capsule sponge procedure is a viable alternative to this process, and whether it could improve rates of OAC-associated late-stage disease and death.

The purpose of this Data Sharing Agreement (DSA) is to obtain the NHS Number for participants who have consented to take part in the Heartburn Health Programme. NHS number is not a mandatory field at time of enrolment but is a requirement for the BEST 4 Screening Trial. The NHS number must be put on the sample label before it is sent to the laboratory for processing and is required for all onward referrals to Secondary Care if a sample is positive (estimated to be 13% of all samples taken) or if an emergency endoscopy is required due to the sponge becoming detached. Furthermore, the control arm will be passively followed up via their NHS number to track cancer outcomes and mortality and obtaining the NHS number will help facilitate this.

The following NHS England Data will be accessed:

• Demographics – necessary to verify NHS Numbers collected by the trial directly from participants. Where NHS number was not provided by participants, NHS England will provide it.

The level of the Data will be:

• Identifiable

The Data will be minimised as follows:

• Limited to a study cohort of patients who consented to participate.

• The planned sample size is 120,000 (approximately 40,000 participants in the intervention arm and 80,000 in the control arm).

The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are the research sponsors and the controllers 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)(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.

The funding is provided by Cancer Research UK and the NIHR Health Technology Assessment programme. The funding is specifically for the BEST4 platform which covers the Heartburn Health Programme and the BEST4 Screening trial. Funding is in place until October 2035. The funders will have no ability to suppress or otherwise limit the publication of findings.

Queen Mary University of London (QMUL) is a processor acting under the instructions of the controllers. The Cancer Research UK Clinical Trial Unit at Queen Mary University of London is supporting the day-to-day running and operations of the BEST4 Screening Trial as delegated by the joint controllers.

The following additional organisations are involved in the Heartburn Health Programme and BEST4 Screening Trial as part of the Independent Data Monitoring Committee and Trial Steering Committee. These organisations do not determine how and why NHS England Data is processed under this Agreement; they only provide advice to the Controllers. These organisations are not accessing NHS England Data under this Agreement: East and North Hertfordshire NHS Trust, Imperial College London, University of Birmingham, Queen’s University Belfast, University of Manchester, NHS Greater Glasglow and Clyde, Cardiff University, University of Southampton, Cancer Research UK, and Aintree University Hospital NHS Foundation Trust.

A comprehensive programme involving patient and public engagement was conducted, spanning across different channels such as the BEST4 Patient and Public Involvement (PPI) panel, and more widely across patient groups, social media and other forms of outreach. The primary aim was to gauge public support regarding the Heartburn Health Programme, within the larger context of the BEST4 Screening Trial. The outcomes revealed substantial support for the usage of personal identifiable data. and insights gathered from participants enabling the identification of potential study modifications to accommodate suggestions and address concerns.

The PPI panel also review and contribute to the patient facing material, including patient information sheets, consent statements and forms, Heartburn Health Programme invitation content, and SMS design and the Trial websites.

Commercial Purposes:

Cyted Ltd created and manufacture the Capsule Sponge Technology that is being studied as part of the BEST4 Screening Trial. The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust managed an open tender process with an independent committee for which all members had no conflict of interest. This gave rise to Cyted Ltd being chosen to provide devices and to perform processing and reporting for the BEST4 Screening Trial.

The Lead Investigator for the Heartburn Health Programme and BEST4 Screening Trial, employed by the University of Cambridge, is a named inventor of the Capsule Sponge Technology and associated assays, and holds shares in Cyted Ltd.

If the trial is successful, this could result in wider roll-out of Cyted Ltd’s Capsule Sponge Technology across the NHS and other health systems. This would have a direct financial benefit for Cyted Ltd and its shareholders, and could lead to broader positive publicity for this commercial venture.

On a weekly basis, QMUL will transfer data, which was collected by the programme directly from newly recruited participants, to NHS England. The data will consist of identifying details (specifically NHS Number (where known), Date of Birth, Gender, Name and Postcode) for the cohort to be linked with NHS England data. QMUL will also provide a study ID.

NHS England will provide the relevant records from the PDS dataset to QMUL. The Data will contain one directly identifying data item, NHS Number. This is required to validate and, where applicable, update and complete the details held by the programme.

QMUL will then send a file to delete the participants from the cohort table and will then repeat the process the following week with a new batch of participants.

The Data will be stored on servers at QMUL.

QMUL stores data on the Cloud provided by Arrow Business Communications (ARO).

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).

Remote processing will be from secure locations within: England/Wales. The Data will not leave England/Wales at any time.

Access is restricted to authorised personnel of QMUL.

The Data may be used for the purposes of the BEST4 study and may be used for the purposes of linking health data via NHS England and will be used for all onward referrals to Secondary Care.

The expected outputs of the processing will be complete and validated NHS numbers for each consented participant in the Heartburn Health Programme.

Provision of NHS number is an optional field at time of enrolment to the Heartburn Health Programme and it might not be known to the participant. However, it is an essential variable for the BEST 4 Screening Programme. The direct benefit from having an accurate NHS number for each participant is to support the onward linkage to cancer outcomes, and the NHS number must be put on the sample label it is sent to the laboratory for processing and is required for all onward referrals to Secondary Care.

Recruiting individuals into the Heartburn Health programme is ultimately expected to provide benefits to health and social care by providing a resource from which researchers can access data and samples to conduct and perform future trials and analysis. This in turn is expected to improve the care, treatment and outcomes for patients with heartburn, indigestion or acid reflux.

Additionally, Heartburn Health will act as an education programme, and those individuals participating will be sent regular newsletters providing information to assist with their symptoms, lifestyle and health.

The aims of the Trial to be realised are:

- To evaluate whether screening with capsule sponge improves rates of death due to cancer of the food pipe

- To evaluate the detection of the precancerous condition ‘Barrett’s neoplasia’ by the capsule sponge test when used in targeted screening

- To evaluate the health economic impact of screening with the capsule sponge test in patients on medication for reflux symptoms

Yielded Benefits is not a requirement for new applications.