BEST-4 Heartburn Health Programme - Recruitment
Queen Mary University of London · Academic
In term In term in the September 2026 edition: the latest version runs to 17 December 2028.
- Reference
- DARS-NIC-753801-J5B3X
- Current version
- v2.5
- Term of current version
- 24 February 2026 to 17 December 2028
- Start date
- 26 September 2024
- Data controller
- Joint Data Controller
- Commercial purposes
- Yes
- Sublicensing
- No
- Files released to date
- 0
Data controllers
Why the data was released
Objective for processing
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.
For the BEST4 Screening Trial to achieve its objectives, around 120,000 people will need to be recruited. To recruit this number of individuals to the BEST4 Screening Trial, around 120,000 people will need to be recruited to the Heartburn Health Programme. Not everybody in the wider Programme will be eligible to participate in the Screening Trial.
It is expected that ~8 million people will need to be invited to the Heartburn Health Programme. Invites will happen in batches. NHS England will identify individuals to be contacted based on an expected uptake rate of 2.6%. The phased approach to invitations will enable the Programme to make an ongoing assessment of uptake rate, as well as monitor volumes of complaints. NHS England may identify further eligible individuals to be contacted about the Heartburn Health Programme, should the BEST4 Screening Trial fail to meet their recruitment target.
The following NHS England Data will be accessed:
• Personal Demographics Service – necessary for the purposes of identifying individuals who are eligible to participate in the Heartburn Health programme; and providing key information to the third party messaging provider who have been contracted to contact potential participants.
The level of the Data will be identifiable – necessary because the third party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
Limited to individuals identified by NHS England as meeting the following criteria:
o Male aged 55-79
o Female aged 65-79
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 Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the Heartburn Health Programme. Queen Mary University of London (QMUL), as the dedicated clinical trials unit acting on behalf the controllers, will promote this information via their trial webpage and through NIHR Research Delivery Network distribution mailboxes. NHS England will also promote this information via a dedicated opt-out webpage for the programme on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third party messaging provider (iPLATO - see more information below) for invitations to be sent.
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.
iPLATO are acting as a Processor on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Their responsibility is to receive the lists of potential participants from NHS England and contact them via SMS.
Amazon Web Services (AWS) provide cloud hosting services to iPLATO and will store the Data as contracted by iPLATO.
NHS England, in their capacity as a separate controller, are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to QMUL the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to their third-party provider (iPLATO) for generating the invitation SMS messages
5. Agreeing with QMUL key processing timelines
6. Overseeing performance of iPLATO and alerting performance issues to QMUL
7. Feeding back to QMUL performance in relation to Key Performance Indicators (KPIs) of iPLATO and NHS England
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
10. NHS England will also identify non-responders and send an SMS reminder invitation to non-responders, utilising the NHS England’s NHS Notify service, within 7-21 days after the first message invitation. NHS Notify is an NHS England service which enables a centralised standardised way to send and manage communications. NHS Notify utilise mailing services of third-party mailing providers.
The Trial Management Group constitutes of members from the University of Cambridge, Queen Mary University of London and King’s College London to manage and monitor all aspects of the conduct and progress of the trial, ensure the protocol is adhered to, take appropriate action to safeguard participants and oversee the quality of the trial. Queen Mary University of London and King’s College London will only support how and why NHS England Data is processed in an advisory capacity.
The Principal Investigator and Clinical Lead for the BEST4 Screening Trial is based at King’s College London. They will not be making decisions about how or why the NHS England Data is being used.
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 sponsors. The role of QMUL is not to determine or influence decisions on how or why NHS England Data is used.
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, including the use of personal data without prior consent.
The PPI work was carried out in two work packages. The first work package involved focus groups (10 participants) with members of the public with reflux. Facilitated by a Behavioural Scientist, the focus groups were conducted to gain an in-depth understanding of people’s views and concerns about the invitation plan for the Heartburn Health Programme, and the proposed use of personal data prior to consent. The second work package involved a survey (432 participants) informed by the focus group discussions. The survey provided a broader set of opinions on plans for data use prior to consent.
In summary, the outcomes revealed substantial support for the usage of personal identifiable data without explicit consent. Most participants who engaged in focus group discussions and 91% of respondents from an online survey conveyed their endorsement of this approach. The insights gathered from participants were analysed, enabling the identification of potential study modifications to accommodate suggestions and address concerns expressed by participants.
The PPI panel have also reviewed and contributed 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.
Study Withing a Trial (SWAT) – BEST 4 is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on an SMS received. To enable this, NHS England will process personal identifiers on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust but there will be no release of personal data outside of this DSA.
Cyted Ltd created and manufacture the Capsule Sponge Technology that is being studied as part of the BEST4 Screening Trial. The Lead Investigator for the Heartburn Health Programme and BEST4 Screening Trial 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.
The ultimate impact of the Heartburn Health programme and BEST4 Screening Trial could be a widely available educational platform for patients with heartburn and reflux symptoms, diagnosis of thousands of patients with Barrett’s Oespahagous and Early Cancer, and ultimately the implementation of a national screening programme.
Processing activities
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). Queen Mary University of London (QMUL) will provide to NHS England the core eligibility criteria for those potential participants who will receive invitations. The core eligibility criteria will include the minimum and maximum age, sex, postcode sector, and quantity of individuals within those parameters.
NHS England will use the criteria provided by QMUL to identify potential participants who meet the criteria. NHS England will remove any records where a National Data Opt-Out or programme-specific opt-out has been registered, as well as special categories of people for whom the data should not be disseminated such as those on a witness protection programme.
NHS England will provide the relevant records of the identified potential participants from the Personal Demographics Service dataset to iPLATO. The Data will contain directly identifying data items including Title, First Name, Surname and Contact Number which are required for the purposes of contacting potential participants. iPLATO will also receive additional fields which will enable them to ensure that the correct invitation format and template are used for each round of invitations. iPLATO will use Research Ethics Committee-approved template invitation SMS messages to invite participants to the Programme in batches.
NHS England will also provide an aggregate report with small numbers supressed containing information about gender, age and geographic demographics of the mailing to QMUL for the purposes of confirming that inclusion and exclusion criteria have been met for each mailing. This report will also contain the total number of people who received the SMS message from iPLATO, and the number of people removed from the cohort prior to mailing based on trial-specific opt out, national data opt out, and special categories of people for whom the data should not be disseminated.
For the SWAT, to analyse the uptake associated with each of the invitation SMS templates, Queen Mary University of London (QMUL) will securely send participant identifiers back to NHS England for those who have signed up after receiving an SMS.
NHS England will match the participant identifiers against the original invitation data already held, to produce an Uptake Performance Report. This report will be provided back to QMUL and will contain aggregate numbers only, broken down by demographics and invitation SMS template.
Each time QMUL sends in a new list of consented participants, NHS England will update their original invitation data with the participants who have signed up. Each time a new Uptake Performance Report is produced it will contain accumulative aggregate figures.
NHS England will also use the participant identifiers sent to NHS England by QMUL, to identify non-responders from the original list of invitees. An SMS reminder invitation will be sent to non-responders, utilising the NHS England’s NHS Notify service, within 7-21 days after the first message invitation.
The Data will not be transferred to any other location. iPLATO will contact individuals as specified by QMUL. All potential participants will receive an SMS message containing their Forename, Surname, and an invitation code.
The Data will be stored on servers at iPLATO.
iPLATO stores Data on the Cloud provided by Amazon Web Services (AWS).
The Data will be accessed onsite at the premises of iPLATO, and by authorised personnel via remote access.
The Controllers 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.
Remote processing will be from secure locations within the UK. The Data will not leave the UK at any time.
Access is restricted to substantive employees of NHS England and iPLATO only.
The University of Cambridge, Cambridge University Hospitals NHS Foundation Trust and QMUL are not permitted to access the Data.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality.
The Data will not be linked with any other data.
iPLATO will destroy all Data files received from NHS England within 30 days as instructed by NHS England.
Each time NHS England create and disseminate an extract, the records will be added to a mailing list cohort dataset. Should a fresh extract be produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations. This mailing list dataset will be maintained for six months after the invitation process is complete in case this is required for analysis purposes by QMUL, however it is anticipated that the data quality report will meet the trial's needs for monitoring how many individuals from different demographics were contacted in each 'mailing'. Only aggregated data would be used for such analysis.
Expected output
The expected outputs of this recruitment Agreement will be the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust reaching their recruitment target for the Heartburn Health Programme and BEST4 Screening Trial, having sent adequate numbers of invitations to potentially eligible participants.
As part of the Heartburn Health Programme, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust intend to create a participant group which will generate a resource for additional translational work, for example:
• Behavioural research looking at the awareness of symptoms to look out for, and any other biomarkers indicating people may be at risk at developing Barret’s Oesophagus or Oesophageal cancer
• Studies on disease progression and biomarkers to show disease progression using Capsule Sponge Technology and/or endoscopic samples
• Development of individual patient risk scores, based on Capsule Sponge results and demographic factors, and the possible implications of this
• Comparison of Capsule Sponge Technology with other technologies such as saliva and blood tests to evaluate effectiveness of diagnosis of pre-cancerous conditions and cancer.
Successful recruitment to the BEST4 Screening Trial will enable assessment of the use of the Capsule Sponge device as a screening tool to identify signs of the precancerous condition Barret's Oesophagus, which can often be a precursor for cancer of the food pipe.
Progress against recruitment targets will inform:
• reporting to Cancer Research UK and NIHR through a scientific milestone review linked to the grant award letter
• lay friendly updates to the Heartburn Health programme website and X (formerly Twitter) account
Any reports 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 from which the information was derived. Identifiable data requested from NHS England will only be used to identify and invite potential participants.
The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust hope to reach their recruitment target for the BEST4 Screening Trial, via wider recruitment to the Heartburn Health programme, by 31st December 2026.
Expected measurable benefits
The ability to utilise large message quantities will help to optimise recruitment, in order to deliver the BEST4 Screening Trial and build up the Heartburn Health Programme resource in a timely, effective and efficient manner. Using NHS England’s NHS DigiTrials Recruitment Service to generate mailing lists, in order to send invitations to members of the public about joining the Heartburn Health programme, is expected to significantly increase the recruitment reach of the programme.
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.
Being able to recruit the required number of individuals to the BEST4 Screening Trial, via the wider Heartburn Health Programme, is expected to enable the aims of the trial to be realised, namely:
- 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
The use of the Data from the NHS DigiTrials recruitment service could:
• inform planning and decisions on how to improve equity in participation, both across the wider Heartburn Health programme, and within the individual trials that will rely on this wider pool of potential participants.
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).
The trial team engage with various stakeholders and influencers to ask for their support with engaging members of the public who are eligible to join the Heartburn Health Programme. They will be asked to raise awareness of the Heartburn Health via their own communication channels which will increase familiarity and trust to the text message invite, for example:
• Heartburn Health website
• Integrated Care Boards
• Cancer Alliances
• Research Delivery Networks
• Charities
• Councils
• Healthwatch
• Community Organisations and groups
Benefits reported so far
To be confirmed
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(b)(ii); Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Customer - Data Quality Report - Aggregate (Recruitment) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment) | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-753801-J5B3X-v2.5 24 February 2026 to 17 December 2028
- Title
- BEST-4 Heartburn Health Programme - Recruitment
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-753801-J5B3X-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-02-24 | |
| End date | 2028-12-17 |
Objective for processing
[8 paragraphs unchanged]
For the BEST4 Screening Trial to achieve its objectives,
at least
around
120,000 people will need to be recruited. To recruit this number of individuals to the BEST4 Screening Trial,
over
around
120,000 people will need to be recruited to the Heartburn Health Programme. Not everybody in the wider Programme will be eligible to participate in the Screening Trial.
It is expected that
~4.5
~8
million people will need to be invited to the Heartburn Health Programme.
[59 words unchanged]
Programme, should the BEST4 Screening Trial fail to meet their recruitment target.
[12 paragraphs unchanged]
iPLATO are acting as a Processor on behalf of the University of
[12 words unchanged]
receive the lists of potential participants from NHS England and contact them
accordingly.
via SMS.
[11 paragraphs unchanged]
10. NHS England will also identify non-responders and send an SMS reminder invitation to non-responders, utilising the NHS England’s NHS Notify service, within 7-21 days after the first message invitation. NHS Notify is an NHS England service which enables a centralised standardised way to send and manage communications. NHS Notify utilise mailing services of third-party mailing providers.
[12 paragraphs unchanged]
Processing activities
[7 paragraphs unchanged] NHS England will also use the participant identifiers sent to NHS England by QMUL, to identify non-responders from the original list of invitees. An SMS reminder invitation will be sent to non-responders, utilising the NHS England’s NHS Notify service, within 7-21 days after the first message invitation. [19 paragraphs unchanged]
Unchanged: Expected output, Expected measurable benefits, Benefits reported.
DARS-NIC-753801-J5B3X-v1.2 5 August 2025 to 20 July 2028
- Title
- BEST-4 Heartburn Health Programme - Recruitment
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-753801-J5B3X-v0.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-08-05 | |
| End date | 2028-07-20 |
Objective for processing
[14 paragraphs unchanged]
•
Limited to individuals identified by NHS England as meeting the following criteria:
[2 paragraphs unchanged]
• Limited to the following regional research delivery network areas:
o Yorkshire and Humber
o East Midlands
o East of England
o South East Central
[25 paragraphs unchanged]
Study Withing a Trial (SWAT) – BEST 4 is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on an SMS received. To enable this, NHS England will process personal identifiers on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust but there will be no release of personal data outside of this DSA.
[3 paragraphs unchanged]
Processing activities
[4 paragraphs unchanged] For the SWAT, to analyse the uptake associated with each of the invitation SMS templates, Queen Mary University of London (QMUL) will securely send participant identifiers back to NHS England for those who have signed up after receiving an SMS. NHS England will match the participant identifiers against the original invitation data already held, to produce an Uptake Performance Report. This report will be provided back to QMUL and will contain aggregate numbers only, broken down by demographics and invitation SMS template. Each time QMUL sends in a new list of consented participants, NHS England will update their original invitation data with the participants who have signed up. Each time a new Uptake Performance Report is produced it will contain accumulative aggregate figures. [19 paragraphs unchanged]
Benefits reported
Yielded Benefits is not a requirement for new applications.
To be confirmed
Unchanged: Expected output, Expected measurable benefits.
Objective for processing
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.
For the BEST4 Screening Trial to achieve its objectives, at least 120,000 people will need to be recruited. To recruit this number of individuals to the BEST4 Screening Trial, over 120,000 people will need to be recruited to the Heartburn Health Programme. Not everybody in the wider Programme will be eligible to participate in the Screening Trial.
It is expected that ~4.5 million people will need to be invited to the Heartburn Health Programme. Invites will happen in batches. NHS England will identify individuals to be contacted based on an expected uptake rate of 2.6%. The phased approach to invitations will enable the Programme to make an ongoing assessment of uptake rate, as well as monitor volumes of complaints. NHS England may identify further eligible individuals to be contacted about the Heartburn Health Programme, should the BEST4 Screening Trial fail to meet their recruitment target.
The following NHS England Data will be accessed:
• Personal Demographics Service – necessary for the purposes of identifying individuals who are eligible to participate in the Heartburn Health programme; and providing key information to the third party messaging provider who have been contracted to contact potential participants.
The level of the Data will be identifiable – necessary because the third party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
Limited to individuals identified by NHS England as meeting the following criteria:
o Male aged 55-79
o Female aged 65-79
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 Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the Heartburn Health Programme. Queen Mary University of London (QMUL), as the dedicated clinical trials unit acting on behalf the controllers, will promote this information via their trial webpage and through NIHR Research Delivery Network distribution mailboxes. NHS England will also promote this information via a dedicated opt-out webpage for the programme on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third party messaging provider (iPLATO - see more information below) for invitations to be sent.
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.
iPLATO are acting as a Processor on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Their responsibility is to receive the lists of potential participants from NHS England and contact them accordingly.
Amazon Web Services (AWS) provide cloud hosting services to iPLATO and will store the Data as contracted by iPLATO.
NHS England, in their capacity as a separate controller, are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to QMUL the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to their third-party provider (iPLATO) for generating the invitation SMS messages
5. Agreeing with QMUL key processing timelines
6. Overseeing performance of iPLATO and alerting performance issues to QMUL
7. Feeding back to QMUL performance in relation to Key Performance Indicators (KPIs) of iPLATO and NHS England
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
The Trial Management Group constitutes of members from the University of Cambridge, Queen Mary University of London and King’s College London to manage and monitor all aspects of the conduct and progress of the trial, ensure the protocol is adhered to, take appropriate action to safeguard participants and oversee the quality of the trial. Queen Mary University of London and King’s College London will only support how and why NHS England Data is processed in an advisory capacity.
The Principal Investigator and Clinical Lead for the BEST4 Screening Trial is based at King’s College London. They will not be making decisions about how or why the NHS England Data is being used.
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 sponsors. The role of QMUL is not to determine or influence decisions on how or why NHS England Data is used.
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, including the use of personal data without prior consent.
The PPI work was carried out in two work packages. The first work package involved focus groups (10 participants) with members of the public with reflux. Facilitated by a Behavioural Scientist, the focus groups were conducted to gain an in-depth understanding of people’s views and concerns about the invitation plan for the Heartburn Health Programme, and the proposed use of personal data prior to consent. The second work package involved a survey (432 participants) informed by the focus group discussions. The survey provided a broader set of opinions on plans for data use prior to consent.
In summary, the outcomes revealed substantial support for the usage of personal identifiable data without explicit consent. Most participants who engaged in focus group discussions and 91% of respondents from an online survey conveyed their endorsement of this approach. The insights gathered from participants were analysed, enabling the identification of potential study modifications to accommodate suggestions and address concerns expressed by participants.
The PPI panel have also reviewed and contributed 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.
Study Withing a Trial (SWAT) – BEST 4 is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on an SMS received. To enable this, NHS England will process personal identifiers on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust but there will be no release of personal data outside of this DSA.
Cyted Ltd created and manufacture the Capsule Sponge Technology that is being studied as part of the BEST4 Screening Trial. The Lead Investigator for the Heartburn Health Programme and BEST4 Screening Trial 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.
The ultimate impact of the Heartburn Health programme and BEST4 Screening Trial could be a widely available educational platform for patients with heartburn and reflux symptoms, diagnosis of thousands of patients with Barrett’s Oespahagous and Early Cancer, and ultimately the implementation of a national screening programme.
Expected output
The expected outputs of this recruitment Agreement will be the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust reaching their recruitment target for the Heartburn Health Programme and BEST4 Screening Trial, having sent adequate numbers of invitations to potentially eligible participants.
As part of the Heartburn Health Programme, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust intend to create a participant group which will generate a resource for additional translational work, for example:
• Behavioural research looking at the awareness of symptoms to look out for, and any other biomarkers indicating people may be at risk at developing Barret’s Oesophagus or Oesophageal cancer
• Studies on disease progression and biomarkers to show disease progression using Capsule Sponge Technology and/or endoscopic samples
• Development of individual patient risk scores, based on Capsule Sponge results and demographic factors, and the possible implications of this
• Comparison of Capsule Sponge Technology with other technologies such as saliva and blood tests to evaluate effectiveness of diagnosis of pre-cancerous conditions and cancer.
Successful recruitment to the BEST4 Screening Trial will enable assessment of the use of the Capsule Sponge device as a screening tool to identify signs of the precancerous condition Barret's Oesophagus, which can often be a precursor for cancer of the food pipe.
Progress against recruitment targets will inform:
• reporting to Cancer Research UK and NIHR through a scientific milestone review linked to the grant award letter
• lay friendly updates to the Heartburn Health programme website and X (formerly Twitter) account
Any reports 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 from which the information was derived. Identifiable data requested from NHS England will only be used to identify and invite potential participants.
The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust hope to reach their recruitment target for the BEST4 Screening Trial, via wider recruitment to the Heartburn Health programme, by 31st December 2026.
Benefits reported
To be confirmed
DARS-NIC-753801-J5B3X-v0.2 26 September 2024 to 25 September 2027
- Title
- BEST-4 Heartburn Health Programme - Recruitment
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
Objective for processing
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.
For the BEST4 Screening Trial to achieve its objectives, at least 120,000 people will need to be recruited. To recruit this number of individuals to the BEST4 Screening Trial, over 120,000 people will need to be recruited to the Heartburn Health Programme. Not everybody in the wider Programme will be eligible to participate in the Screening Trial.
It is expected that ~4.5 million people will need to be invited to the Heartburn Health Programme. Invites will happen in batches. NHS England will identify individuals to be contacted based on an expected uptake rate of 2.6%. The phased approach to invitations will enable the Programme to make an ongoing assessment of uptake rate, as well as monitor volumes of complaints. NHS England may identify further eligible individuals to be contacted about the Heartburn Health Programme, should the BEST4 Screening Trial fail to meet their recruitment target.
The following NHS England Data will be accessed:
• Personal Demographics Service – necessary for the purposes of identifying individuals who are eligible to participate in the Heartburn Health programme; and providing key information to the third party messaging provider who have been contracted to contact potential participants.
The level of the Data will be identifiable – necessary because the third party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
• Limited to individuals identified by NHS England as meeting the following criteria:
o Male aged 55-79
o Female aged 65-79
• Limited to the following regional research delivery network areas:
o Yorkshire and Humber
o East Midlands
o East of England
o South East Central
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 Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the Heartburn Health Programme. Queen Mary University of London (QMUL), as the dedicated clinical trials unit acting on behalf the controllers, will promote this information via their trial webpage and through NIHR Research Delivery Network distribution mailboxes. NHS England will also promote this information via a dedicated opt-out webpage for the programme on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third party messaging provider (iPLATO - see more information below) for invitations to be sent.
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.
iPLATO are acting as a Processor on behalf of the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Their responsibility is to receive the lists of potential participants from NHS England and contact them accordingly.
Amazon Web Services (AWS) provide cloud hosting services to iPLATO and will store the Data as contracted by iPLATO.
NHS England, in their capacity as a separate controller, are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to QMUL the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a programme-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to their third-party provider (iPLATO) for generating the invitation SMS messages
5. Agreeing with QMUL key processing timelines
6. Overseeing performance of iPLATO and alerting performance issues to QMUL
7. Feeding back to QMUL performance in relation to Key Performance Indicators (KPIs) of iPLATO and NHS England
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
The Trial Management Group constitutes of members from the University of Cambridge, Queen Mary University of London and King’s College London to manage and monitor all aspects of the conduct and progress of the trial, ensure the protocol is adhered to, take appropriate action to safeguard participants and oversee the quality of the trial. Queen Mary University of London and King’s College London will only support how and why NHS England Data is processed in an advisory capacity.
The Principal Investigator and Clinical Lead for the BEST4 Screening Trial is based at King’s College London. They will not be making decisions about how or why the NHS England Data is being used.
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 sponsors. The role of QMUL is not to determine or influence decisions on how or why NHS England Data is used.
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, including the use of personal data without prior consent.
The PPI work was carried out in two work packages. The first work package involved focus groups (10 participants) with members of the public with reflux. Facilitated by a Behavioural Scientist, the focus groups were conducted to gain an in-depth understanding of people’s views and concerns about the invitation plan for the Heartburn Health Programme, and the proposed use of personal data prior to consent. The second work package involved a survey (432 participants) informed by the focus group discussions. The survey provided a broader set of opinions on plans for data use prior to consent.
In summary, the outcomes revealed substantial support for the usage of personal identifiable data without explicit consent. Most participants who engaged in focus group discussions and 91% of respondents from an online survey conveyed their endorsement of this approach. The insights gathered from participants were analysed, enabling the identification of potential study modifications to accommodate suggestions and address concerns expressed by participants.
The PPI panel have also reviewed and contributed 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.
Cyted Ltd created and manufacture the Capsule Sponge Technology that is being studied as part of the BEST4 Screening Trial. The Lead Investigator for the Heartburn Health Programme and BEST4 Screening Trial 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.
The ultimate impact of the Heartburn Health programme and BEST4 Screening Trial could be a widely available educational platform for patients with heartburn and reflux symptoms, diagnosis of thousands of patients with Barrett’s Oespahagous and Early Cancer, and ultimately the implementation of a national screening programme.
Expected output
The expected outputs of this recruitment Agreement will be the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust reaching their recruitment target for the Heartburn Health Programme and BEST4 Screening Trial, having sent adequate numbers of invitations to potentially eligible participants.
As part of the Heartburn Health Programme, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust intend to create a participant group which will generate a resource for additional translational work, for example:
• Behavioural research looking at the awareness of symptoms to look out for, and any other biomarkers indicating people may be at risk at developing Barret’s Oesophagus or Oesophageal cancer
• Studies on disease progression and biomarkers to show disease progression using Capsule Sponge Technology and/or endoscopic samples
• Development of individual patient risk scores, based on Capsule Sponge results and demographic factors, and the possible implications of this
• Comparison of Capsule Sponge Technology with other technologies such as saliva and blood tests to evaluate effectiveness of diagnosis of pre-cancerous conditions and cancer.
Successful recruitment to the BEST4 Screening Trial will enable assessment of the use of the Capsule Sponge device as a screening tool to identify signs of the precancerous condition Barret's Oesophagus, which can often be a precursor for cancer of the food pipe.
Progress against recruitment targets will inform:
• reporting to Cancer Research UK and NIHR through a scientific milestone review linked to the grant award letter
• lay friendly updates to the Heartburn Health programme website and X (formerly Twitter) account
Any reports 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 from which the information was derived. Identifiable data requested from NHS England will only be used to identify and invite potential participants.
The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust hope to reach their recruitment target for the BEST4 Screening Trial, via wider recruitment to the Heartburn Health programme, by 31st December 2026.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
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November 2024 —
first listed. 1 version: DARS-NIC-753801-J5B3X-v0.2
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September 2025
1 version added: DARS-NIC-753801-J5B3X-v1.2
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March 2026
1 version added: DARS-NIC-753801-J5B3X-v2.5
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-753801-J5B3X, “BEST-4 Heartburn Health Programme - Recruitment”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-753801-j5b3x/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-753801-J5B3X to see the original rows.