BEST-4 Heart burn Health Programme - Patient list update service (PLUS)

The data will be used for the purpose of Heartburn Health and Barrett’s oESophagus Trial 4 (BEST4) Screening Trial.

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

The aim of Heartburn Health 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 Heartburn Health, 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.

NHS England will check participant records to determine life status, to minimise the risks of attempting to contact deceased individuals. It will also provide validation failures and update contact information, ensuring data quality and integrity. This process will help the study team ensure respectful, accurate and lawful communication with participants.

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.

Queen Mary University of London (QMUL) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the Personal Demographics Service dataset to QMUL. The Data will contain directly identifying data items including Names, Address, Email Address and Phone Number which are required to provide the study team with the correct addresses and contact details for participants and remove participants who are deceased. NHS England will provide back to QMUL a list of participants who are either deceased or not enough data is provided to result in a match, and a list of participants with updated address details.

The Patient list update service (PLUS) Service is offered as a subscription in which Queen Mary University of London can request updated contact details up to 60 times within a year.

The Data will not be transferred to any other location.

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).

The death data will be linked at record level with participant data held by QMUL using the study IDs to update participant records.

The Data will not be linked with any other data.

The expected outputs of the processing will be:

- Complete and validated participant contact information for each consented participant in the Heartburn Health Programme. Additionally, outputs will identify deceased participants to ensure that the BEST-4 Heartburn Health Programme do not contact these participants unnecessarily.

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.

Verifying participant's life status provides an important safeguard for Heartburn Health. By confirming whether a participant is alive, the service will prevent sending communications to participants who have sadly died, avoiding any inappropriate or distressing contact to their loved ones.

Additionally, NHS England will provide updated participant’s contact details. This will improve the success rate of reminders, supporting recruitment into the BEST4 Screening trial, increase participant retention and attendance at follow up appointments. Together these benefits can help Heartburn Health to connect participants to future studies, helping to answer research questions aimed at improving the health of people with heartburn, indigestion and acid reflux.

Yielded Benefits is not a requirement for new applications.