Helicobacter Eradication Aspirin Trial (HEAT)

University of Nottingham · Academic

Expired The latest version ended on 13 January 2024. The September 2026 register still lists the agreement, but its term has passed.

Reference: DARS-NIC-389320-R4M6Z
Latest version: v6.2
Term of latest version: 14 January 2021 to 13 January 2024
Start date: Before 14 May 2019
Data controller: Sole Data Controller
Commercial purposes: No
Sublicensing: No
Files released to date: 8

Why the data was released

Objective for processing

Nottingham Health Informatics Service, based at King’s Mill Hospital, house the server which forms part of the secure NHS N3 data network, where the information received from NHS Digital is held.

The University of Nottingham is the data controller and also processes the data for this study. The University of Nottingham is also the Sponsor of the trial and will take full legal responsibility for any activities undertaken as part of the HEAT clinical trial.

TCR Nottingham have been contracted as the data processor, who store and handle the data on the HEAT database (the Managing Director of TCR securely transfers data to and from NHS Digital, as per the Data Sharing Agreement).

Nottingham Digestive Diseases Centre is part of the University of Nottingham. Although other organisations listed in the protocol such as Queens University, Belfast, Glasgow Clinical Research Facility, University of Birmingham, University of Oxford, University of Southampton, and Trial Pharmacist at Nottingham University Hospitals NHS Trust, these organisations are involved in recruitment. They are not involved in the decisions about processing personal data for the purpose of this study.

The protocol states ‘The trial will be overseen by a Trial Steering Committee (TSC) and an Independent Data Monitoring Committee (IDMC) will be established. The TSC and IDMC act in only an advisory capacity. Only the Sponsor (University of Nottingham) has control over how the data from NHS Digital is processed, and this will be processed by authorised team members / statisticians at the University of Nottingham, and the trial’s health economist, now based at the University of Lincoln, who holds an honorary contract with the University of Nottingham.

This project is solely funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. The University of Nottingham provide the funder with a progress report on a monthly basis, and are in regular contact about the progress.

The justification for using Article 6(1)(e) of the GDPR as the legal basis processing, as necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller is summarised briefly as follows:

University of Nottingham are a public authority conducting clinical research with the intention of publication of trial outcomes in clinical journals. Civil Registration/Mortality Data and HES informs overall death rates (any cause) and hospital admission data for the patient cohort selected for analysis.

Processing HES and Civil Registration Mortality Data for the HEAT trial is necessary for 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 HEAT trial will aim to determine cost benefit analysis of intervention, and also if that improves hospital outcomes. The legal basis for the collection, holding and processing of personal data will be under jurisdiction of article 6(1)(e) as ‘task carried out in the public interest’ and article 9(2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016 (the General Data Protection Regulations) and as supported by regulations 8 and 10 and part 1 schedule 1 (4) of the UK Data Protection Act 2018.

Helicobacter Eradication Aspirin Trial (HEAT) is a large double-blind (i.e. neither subject nor those running the study know the identity of their randomised treatment), placebo-controlled randomised multi-centre study set in primary care. There are three primary objectives:

1. Medical: To test the hypothesis that a one week course of Helicobacter pylori (H. pylori) eradication in patients using aspirin ≤325mg daily will reduce the incidence of subsequent adjudicated peptic ulcer bleeding that results in hospitalisation.

2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit.

3. Methodological: To establish a methodology for large simple outcomes studies using electronically extracted Primary Care follow-up data, to reduce costs to a level that enables outcomes studies of clinically important questions to be done without the need for industry support.

The University of Nottingham require all the relevant requested fields within HES under this agreement, and cause of death data, because as part of the secondary analysis of this study, a health economic analysis will be performed comparing many quality of life factors in both arms of the trial (e.g. the cost effective benefit of intervention; length of hospital stay types of services accessed, and other related medical events). For the secondary analysis HES data on all reasons for admissions are required in order to study the impact on other health conditions. To inform the economic analysis it is important to consider the route of admission (elective investigation versus emergency).

Data minimisation has been considered and as part of that process, a health economist has reviewed the list of fields available from HES and confirmed which are required. This is a considerable number of the data fields available, to enable the University's health economist to accurately estimate the cost to the NHS of each admission. In order to minimise collection, the data request is limited to only consented patients, and to only the fields which helps to answer the trial’s questions (i.e. no data on pregnancy admission data for this elderly patient cohort). The University of Nottingham have to be able to link the data to the relevant consented patient, so that when the trial is unblinded, it is known who was in the active versus placebo eradication arm of the study, and can perform the study’s analysis.

The data is required as part of the process of endpoint detection for the HEAT trial. The University of Nottingham collect data on consented patients from NHS Digital to enable them to answer the trial’s hypothesis that H. pylori eradication therapy can reduce the incidence of hospital admissions for ulcer bleeding. In order for the University of Nottingham to be able to assess this, it is essential to know which study patients have been admitted to hospital, so that data can be collated on the admission for the adjudication committee, who decide if a true ulcer bleed (primary endpoint) occurred.

This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint is admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, mortality data (date and cause of death) and patient alerts, whereby patients inform the study of any attendance at hospital. The trial will not link GP records and HES data. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study (https://www.bristol.ac.uk/primaryhealthcare/news/2016/target-study.html).

The primary endpoint for this trial is a hospitalisation for an ulcer bleed; therefore, details of hospital admissions that trial patients experience (i.e. HES data) are required from NHS Digital to ensure that no potential endpoints are missed. Data on hospitalisations will be reviewed and, if it is deemed that a potential endpoint has occurred, then further details will be collected (directly from the medical notes of the admitting hospital) and the event will be adjudicated by a blinded Adjudication Committee (like the trial subjects and investigators, members of the committee do not know the identity of each subject’s randomised treatment.

Consented study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Data is collected from GP practices systems via a Miquest search roughly every 6 months: this search looks for any new relevant information in the patients’ medical record, or any changes since the last upload. Any HES/Mortality data that is received by NHS Digital will not be linked to the GP data.

Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases. The actual hospitals where there are letters of access to see data can vary from month to month, as these are requested on a per trial and per requirement basis, and usually expire after a year. Therefore, it is reapplied for on a need basis, depending on the primary endpoints that are identified.

Potentially eligible patients (over 60 years old taking long-term low-dose aspirin, and who meet all other eligibility criteria) identified from GP records are invited to participate. They receive an invitation letter from their GP practice, and if they would like to take part, are asked to return a reply slip in a pre-paid return envelope to the study team. Those who respond are invited to attend a screening visit at their GP practice (this is several weeks after their initial invitation, so they have plenty of time to consider their study participation). Following consent at their practice, they undergo a brief baseline health assessment and perform a H. pylori breath test. H. pylori positive patients will be randomised to receive eradication treatment or matching placebo. Treatment is dispatched to the patients by post by members of the research team (University of Nottingham staff dispense this from a satellite Pharmacy of Nottingham University Hospitals NHS Trust, and have been trained and are monitored by the Clinical Trials Pharmacist at NUH).

All patient follow-up is electronic. Patients make no follow up visits but can notify the trial office of any relevant [or indeed irrelevant] events. Follow up data is obtained by interrogation of GP electronic records and by routine linkage via NHS Digital to data on deaths (date and cause), and from HES data on hospital admissions.

University of Nottingham cannot reasonably achieve the above in a different way other than accessing HES and Mortality data from NHS Digital.

Processing activities

The trial data are controlled by University of Nottingham as Sponsor of the study, but TCR Nottingham have been contracted as the data processor, who store and handle the data on the HEAT database (the Managing Director of TCR securely transfers data to and from NHS Digital, as per the Data Sharing Agreement).

The HEAT database is stored on an N3 server within the N3 network based at Nottinghamshire Health Informatics Service (formerly King’s Mill Hospital Data Centre). Authorised study staff, who are fully trained on both the trial and relevant regulatory and data protection requirements, can access the data via remote access to the server but the data is not removed from the server. TCR Nottingham manages all access permissions which are set on a per-person basis. Only relevant members of the study team would have access to the data provided by NHS Digital. The study team and trial statistician are all substantive employees of the University of Nottingham.

TCR Nottingham provides two levels of access to the data for staff at University of Nottingham: (i) the full identifiable data is accessible only to individuals for the purpose of facilitating follow-up contact, and (ii) data stripped of identifiers except for initials to mitigate risks of quality errors arising from transposition errors if using only a study screening number. The study screening number is accessible to the research team and only this level of data is used in analyses.

The University of Nottingham confirm all data processors act on the University of Nottingham’s documented instructions.

The University of Nottingham require data from NHS Digital, linked to a patient’s NHS number, to support follow up activities. The patients' NHS number and date of consent will be provided to NHS Digital, to request details of any hospital admissions or deaths since the patient consented to participate. The data will flow from NHS Digital to the N3 server housed at King’s Mill Data Centre, and this server is managed by TCR Nottingham. Relevant members of the study team, based at the University of Nottingham, will be able to access this data, but only via computers linked to the secure NHS N3 server. At the point of being accessed by University of Nottingham staff, this data will be linked by study ID number and patient initials, so not personally identifiable at this stage.

To obtain the HES and death data, the Data Processor will send a list of randomised patient study IDs and NHS numbers, along with dates of consent, and request that NHS Digital provides information on hospital admissions or deaths of patients since their date of consent. This will be returned by NHS Digital to the TCR (Nottingham) Ltd securely, and linked to study ID and NHS number (two identifiers are required to be provided, to ensure that there are no transcription errors, and that the correct events are allocated to the correct patient).

The trial will not link GP records and HES data. At individual patient level, the HES data will be compared with the HEAT database to determine the extent of discrepancies between the detail in the HES data and the data derived from the GP records.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The data requested will not be used for any part of a PhD study/programme.

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

A co-investigator from the University of Lincoln for this project has a signed honorary contract which is in place with the University of Nottingham to access and process the data for the purposes outlined above.

Expected output

The trial will proceed until there are 87 adjudicated cases (there are currently 32 formally adjudicated primary endpoints, and the University of Nottingham estimates reaching the target of 87 by December 2021) and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding.

Patients who have been recruited into the study will be informed of the trial results by letter once these are available, as will all participating GP practices. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet) and will also present details of the study at relevant scientific meetings. For example, the methodology for the study was presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015. The University of Nottingham have also presented the methodology of the trial at local meetings within the University, and at an International Trials Methodology Conference in Brighton in October 2019.

The University of Nottingham have drafted a methodology paper, which is being submitted to the journal Trials for publication.

The final results of the study, for which the NHS Digital data will be used, will be expected towards the end of 2021 for publication in The Lancet, and these results would be presented at the British Society of Gastroenterology (BSG) national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due before the end of 2021.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Expected measurable benefits

The cost of admission and hospital stay for a bleeding peptic ulcer is likely to be approximately £15,000 per patient for the population that will be analysed. Based on calculations for patients participating in the proposed trial (assuming all ultimately undergo eradication treatment) the trial would lead to the projected prevention of 585 hospitalisations at a saving of approximately £5.85 million, and prevention of ~59 deaths, potentially making the trial itself a cost effective therapeutic intervention. Though cost savings in relation to the trial participants is not the primary purpose of the study, these figures are illustrative of potential savings should the trial results have the expected impact on NHS policy.

If the hypothesis of the trial is correct, patients would benefit medically from the study, and the NHS would make significant cost savings. The results would be presented to NICE (via peer-reviewed published papers) and other policy makers (NHS England, Wales, Scotland and Northern Ireland, SIGN - Scottish Intercollegiate Guidelines Network), who may deem that any patient taking aspirin regularly (25% of over 65 years) should be breath tested, and their H. pylori eradicated if present, as the University of Nottingham believe this will halve the bleeding risk for patients. Even if the trial’s hypothesis is incorrect, this knowledge will be of benefit to patients and the NHS. It would inform that antibiotics are not required to treat H. pylori to protect this patient group, and thus reduce antibiotic prescribing, and associated resistance / costs. Patients would also avoid the one week of side effects (nausea / vomiting) from taking the antibiotics.

NIHR application benefits:

The trial is important because it deals with the most significant pathology associated with aspirin taken by 25% of the over 65's for cardiovascular protection. A positive result would increase patient safety, reduce hospitalisations for gastrointestinal bleeding, reduce premature death, decrease medical costs, and expand the number of patients for whom aspirin has no benefits.

The trial represents substantial value for money. Potentially the strategy under investigation could reduce hospitalisations in elderly patients in England, with a reduction in premature deaths by 3700 and financial savings estimated at £370M. The trial will quantify actual savings based on the results obtained.

The trial is highly innovative because it breaks new ground in trial methodology, In particular by replacing face to face trial follow up with the much cheaper approach of semi-automated intermittent interrogation of GP electronic records. Per person it will be one of the cheapest randomised controlled outcome trials ever conducted. It will therefore help to establish an approach where large inexpensive outcomes studies can be applied to many other areas enabling researchers, for the first time, to investigate many questions of medical importance which has previously not been possible because of costs.

The trial is currently in the follow up stages. Initial analysis has found that the methodology is highly feasible because all important steps have been validated and shown to be simple to conduct in a large -2500 patient feasibility study. It is being conducted by the Primary Care Research Networks with a track record for recruitment amongst the highest in the UK. The investigators are among the world leaders for this type of research.

Benefits reported so far

The University of Nottingham have been able to estimate event rates, based on previous data received from NHS Digital, which enabled them to calculate more accurately how many patients are required to take part in the study, and cease recruitment on 31-Oct-17 with 30,024 consented participants. 5357 randomised patients will be the cohort size for this agreement with NHS Digital.

The full trial analysis will not be possible until the applicant can close the trial at the point 87 primary endpoints have been achieved, and all data from NHS Digital helps the applicant to work towards this target.

The trial is in follow-up, and therefore is still blinded at present and therefore the University of Nottingham are not yet able to fully analyse the benefits to patients. However, the overall trial, even before completion, is considered a national success in terms of trial methodology and receive frequent request from research teams at other Universities on the best way of running large-scale pragmatic trials in primary care.

Datasets on the latest version

Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)

Datasets approved under DARS-NIC-389320-R4M6Z-v6.2
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Civil Registrations of Death - Secondary Care Cut	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)
HES:Civil Registration (Deaths) bridge	Identifiable	Non-Sensitive	One-Off	Consent (Reasonable Expectation)
Hospital Episode Statistics Admitted Patient Care (HES APC)	Identifiable	Sensitive	One-Off	Consent (Reasonable Expectation)

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.

Patient opt-outs were not applied to any of the 8 files released under this agreement, across every version. About opt-outs

No files recorded as released under the latest version. 8 were released under earlier versions, shown in the version history.

Version history

The register lists each renewal of this agreement as a separate row. This site has 3 versions — earlier versions existed before this site's records begin.

DARS-NIC-389320-R4M6Z-v6.2 14 January 2021 to 13 January 2024

Title: Helicobacter Eradication Aspirin Trial (HEAT)
Commercial: No
Sublicensing: No
Datasets: 3
Files released: 0

Datasets: Civil Registrations of Death - Secondary Care Cut; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Admitted Patient Care (HES APC)

What changed from DARS-NIC-389320-R4M6Z-v5.8

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-389320-R4M6Z-v5.8
Field	Was	Became
Start date	~~2020-05-14~~	2021-01-14
End date	~~2021-01-13~~	2024-01-13

Expected output

The trial will proceed until there are 87 adjudicated cases (there are [7 words unchanged] the University of Nottingham estimates reaching the target of 87 by December ~~2020)~~ 2021) and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding. [4 paragraphs unchanged]

Unchanged: Objective for processing, Processing activities, Expected measurable benefits, Benefits reported.

DARS-NIC-389320-R4M6Z-v5.8 14 May 2020 to 13 January 2021

Title: Helicobacter Eradication Aspirin Trial (HEAT)
Commercial: No
Sublicensing: No
Datasets: 3
Files released: 4

Datasets: Civil Registrations of Death - Secondary Care Cut; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Admitted Patient Care (HES APC)

What changed from DARS-NIC-389320-R4M6Z-v4.5

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-389320-R4M6Z-v4.5
Field	Was	Became
Start date	~~2019-05-14~~	2020-05-14
End date	~~2020-05-13~~	2021-01-13
Civil Registrations of Death - Secondary Care Cut: type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
HES:Civil Registration (Deaths) bridge: type of data	~~Anonymised - ICO Code Compliant~~	Identifiable
Hospital Episode Statistics Admitted Patient Care (HES APC): type of data	~~Anonymised - ICO Code Compliant~~	Identifiable

Objective for processing

University of Nottingham will use Hospital Episode Statistics (HES) details (inpatient admission details for consented patients) and Civil Registration mortality data to support its programme of research for the HEAT Trial. Nottingham Health Informatics Service, based at King’s Mill Hospital, house the server which forms part of the secure NHS N3 data network, where the information received from NHS Digital is held. The University of Nottingham is the data controller and also processes the data for this study. The University of Nottingham is also the Sponsor of the trial and will take full legal responsibility for any activities undertaken as part of the HEAT clinical trial. TCR Nottingham have been contracted as the data processor, who store and handle the data on the HEAT database (the Managing Director of TCR securely transfers data to and from NHS Digital, as per the Data Sharing Agreement). Nottingham Digestive Diseases Centre is part of the University of Nottingham. Although other organisations listed in the protocol such as Queens University, Belfast, Glasgow Clinical Research Facility, University of Birmingham, University of Oxford, University of Southampton, and Trial Pharmacist at Nottingham University Hospitals NHS Trust, these organisations are involved in recruitment. They are not involved in the decisions about processing personal data for the purpose of this study. The protocol states ‘The trial will be overseen by a Trial Steering Committee (TSC) and an Independent Data Monitoring Committee (IDMC) will be established. The TSC and IDMC act in only an advisory capacity. Only the Sponsor (University of Nottingham) has control over how the data from NHS Digital is processed, and this will be processed by authorised team members / statisticians at the University of Nottingham, and the trial’s health economist, now based at the University of Lincoln, who holds an honorary contract with the University of Nottingham. This project is solely funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme. The University of Nottingham provide the funder with a progress report on a monthly basis, and are in regular contact about the progress. The justification for using Article 6(1)(e) of the GDPR as the legal basis processing, as necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller is summarised briefly as follows: University of Nottingham are a public authority conducting clinical research with the intention of publication of trial outcomes in clinical journals. Civil Registration/Mortality Data and HES informs overall death rates (any cause) and hospital admission data for the patient cohort selected for analysis. Processing HES and Civil Registration Mortality Data for the HEAT trial is necessary for 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 HEAT trial will aim to determine cost benefit analysis of intervention, and also if that improves hospital outcomes. The legal basis for the collection, holding and processing of personal data will be under jurisdiction of article 6(1)(e) as ‘task carried out in the public interest’ and article 9(2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016 (the General Data Protection Regulations) and as supported by regulations 8 and 10 and part 1 schedule 1 (4) of the UK Data Protection Act 2018. [4 paragraphs unchanged] The data is required as part of the process of endpoint detection for the HEAT trial. This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint is admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, mortality data (date and cause of death) and patient alerts, whereby patients inform the study of any attendance at hospital. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study (https://www.bristol.ac.uk/primaryhealthcare/news/2016/target-study.html). The University of Nottingham require all the relevant requested fields within HES under this agreement, and cause of death data, because as part of the secondary analysis of this study, a health economic analysis will be performed comparing many quality of life factors in both arms of the trial (e.g. the cost effective benefit of intervention; length of hospital stay types of services accessed, and other related medical events). For the secondary analysis HES data on all reasons for admissions are required in order to study the impact on other health conditions. To inform the economic analysis it is important to consider the route of admission (elective investigation versus emergency). The justification for using Article 6(1)(e) of the GDRP as the legal basis processing, as necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller is summarised briefly as follows: Data minimisation has been considered and as part of that process, a health economist has reviewed the list of fields available from HES and confirmed which are required. This is a considerable number of the data fields available, to enable the University's health economist to accurately estimate the cost to the NHS of each admission. In order to minimise collection, the data request is limited to only consented patients, and to only the fields which helps to answer the trial’s questions (i.e. no data on pregnancy admission data for this elderly patient cohort). The University of Nottingham have to be able to link the data to the relevant consented patient, so that when the trial is unblinded, it is known who was in the active versus placebo eradication arm of the study, and can perform the study’s analysis. University of Nottingham are a public authority conducting clinical research with the intention of publication of trial outcomes in clinical journals. Civil Registration/Mortality Data and HES informs overall death rates (any cause) and hospital admission data for the patient cohort selected for analysis. The data is required as part of the process of endpoint detection for the HEAT trial. The University of Nottingham collect data on consented patients from NHS Digital to enable them to answer the trial’s hypothesis that H. pylori eradication therapy can reduce the incidence of hospital admissions for ulcer bleeding. In order for the University of Nottingham to be able to assess this, it is essential to know which study patients have been admitted to hospital, so that data can be collated on the admission for the adjudication committee, who decide if a true ulcer bleed (primary endpoint) occurred. Processing HES and Civil Registration Mortality Data for the HEAT trail 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 HEAT trial will aim to determine cost benefit analysis of intervention, and also if that improves hospital outcomes. This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint is admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, mortality data (date and cause of death) and patient alerts, whereby patients inform the study of any attendance at hospital. The trial will not link GP records and HES data. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study (https://www.bristol.ac.uk/primaryhealthcare/news/2016/target-study.html). Consented study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Data is collected from GP practices systems via a Miquest search roughly every 6 months: this search looks for any new relevant information in the patients’ medical record, or any changes since the last upload. Any HES/Mortality data that is recieved by NHS Digital will not be linked to the GP data. The primary endpoint for this trial is a hospitalisation for an ulcer bleed; therefore, details of hospital admissions that trial patients experience (i.e. HES data) are required from NHS Digital to ensure that no potential endpoints are missed. Data on hospitalisations will be reviewed and, if it is deemed that a potential endpoint has occurred, then further details will be collected (directly from the medical notes of the admitting hospital) and the event will be adjudicated by a blinded Adjudication Committee (like the trial subjects and investigators, members of the committee do not know the identity of each subject’s randomised treatment. Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases.The actual hospitals where there is letters of access to see data can vary from month to month, as these are requested on a per trial and per requirement basis, and usually expire after a year. Therefore it is reapplied for on a need basis, depending on the primary endpoints that are identified. Consented study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Data is collected from GP practices systems via a Miquest search roughly every 6 months: this search looks for any new relevant information in the patients’ medical record, or any changes since the last upload. Any HES/Mortality data that is received by NHS Digital will not be linked to the GP data. Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases. The actual hospitals where there are letters of access to see data can vary from month to month, as these are requested on a per trial and per requirement basis, and usually expire after a year. Therefore, it is reapplied for on a need basis, depending on the primary endpoints that are identified. [3 paragraphs unchanged]

Processing activities

[1 paragraph unchanged] The HEAT database is stored on an N3 server within the N3 network based at Nottinghamshire Health Informatics Service ~~(formally~~ (formerly King’s Mill Hospital Data Centre). Authorised study ~~staff~~ staff, who are fully trained on both the trial and relevant regulatory and data protection requirements, can access the data via remote access to the server but the [40 words unchanged] and trial statistician are all substantive employees of the University of Nottingham. TCR Nottingham provides two levels of access to the data for staff at University of Nottingham: (i) the full identifiable data is accessible only to 2 individuals for the purpose of facilitating follow-up contact, and (ii) data stripped [30 words unchanged] research team and only this level of data is used in analyses. The University of Nottingham require data from NHS Digital to support follow up activities. The patients' NHS number and date of consent will be provided to NHS Digital, to request details of any hospital admissions or deaths since the patient consented to participate. The University of Nottingham confirm all data processors act on the University of Nottingham’s documented instructions. The primary endpoint for this trial is a hospitalisation for an ulcer bleed therefore; details of hospital admissions that trial patients experience (i.e. HES data) are required from NHS Digital to ensure that no potential endpoints are missed. Data on hospitalisations will be reviewed and, if it is deemed that a potential endpoint has occurred, then further details will be collected (directly from the medical notes of the admitting hospital) and the event will be adjudicated by a blinded Adjudication Committee (like the trial subjects and investigators (see above)) members of the committee do not know the identity of each subject’s randomised treatment. The University of Nottingham require data from NHS Digital, linked to a patient’s NHS number, to support follow up activities. The patients' NHS number and date of consent will be provided to NHS Digital, to request details of any hospital admissions or deaths since the patient consented to participate. The data will flow from NHS Digital to the N3 server housed at King’s Mill Data Centre, and this server is managed by TCR Nottingham. Relevant members of the study team, based at the University of Nottingham, will be able to access this data, but only via computers linked to the secure NHS N3 server. At the point of being accessed by University of Nottingham staff, this data will be linked by study ID number and patient initials, so not personally identifiable at this stage. The University of Nottingham require all the relevant requested fields within HES under this agreement, and cause of death data, because as part of the secondary analysis of this study, a health economic analysis will be performed comparing many quality of life factors in both arms of the trial (e.g. the cost effective benefit of intervention; length of hospital stay types of services accessed, and other related medical events). For the secondary analysis HES data on all reasons for admissions are required in order to study the impact on other health conditions. To inform the economic analysis it is important to consider the route of admission (elective investigation versus emergency). To obtain the HES and death data, the Data Processor will send a list of randomised patient study IDs and NHS numbers, along with dates of consent, and request that NHS Digital provides information on hospital admissions or deaths of patients since their date of consent. This will be returned by NHS Digital to the TCR (Nottingham) Ltd securely, and linked to study ID and NHS number (two identifiers are required to be provided, to ensure that there are no transcription errors, and that the correct events are allocated to the correct patient). Data minimisation has been considered and as part of that process, a health economist has reviewed the list of fields available from HES and confirmed which are required. This is a considerable number of the data fields available, to enable the University's health economist to accurately estimate the cost to the NHS of each admission. To obtain the HES and death data, the Data Processor will send a list of randomised patient study IDs and NHS numbers, along with dates of consent, and request that NHS Digital provides information on hospital admissions or deaths of patients since their date of consent. This will be returned by NHS Digital to the TCR (Nottingham) Ltd securely, and linked to study ID and NHS number (two identifiers are required to be provided, to ensure that there are no transcription errors, and that the correct events are allocated to the correct patient). [1 paragraph unchanged] All organisations party to this agreement must comply with the Data Sharing [11 words unchanged] that use) by “Personnel” (as defined within the Data Sharing Framework Contract ~~ie:~~ i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). [2 paragraphs unchanged] ~~Data will only be accessed and processed by substantive employees of the University of Nottingham and will not be accessed or processed by any other third parties not mentioned in this agreement.A~~ A co-investigator from the University of ~~Leicester~~ Lincoln for this project has a signed honorary contract which is in place with the University of Nottingham to access and process the data for the purposes outlined above.

Expected output

The trial will proceed until there are 87 adjudicated cases (there are currently 19 32 formally adjudicated primary endpoints, and the University of Nottingham estimates reaching the target of 87 by ~~mid~~ December 2020) and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding. Patients who have been recruited into the study will be informed of the trial results by letter once these are available, as will all participating GP practices. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet), and will also present details of the study at relevant scientific meetings. For example, the methodology for the study was presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015. The final results of the study, for which the NHS Digital data will be used, will be expected in 2020 for publication in The Lancet, and these results would be presented at the British Society of Gastroenterology (BSG) national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due in mid 2020. Patients who have been recruited into the study will be informed of the trial results by letter once these are available, as will all participating GP practices. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet) and will also present details of the study at relevant scientific meetings. For example, the methodology for the study was presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015. The University of Nottingham have also presented the methodology of the trial at local meetings within the University, and at an International Trials Methodology Conference in Brighton in October 2019. The University of Nottingham have drafted a methodology paper, which is being submitted to the journal Trials for publication. The final results of the study, for which the NHS Digital data will be used, will be expected towards the end of 2021 for publication in The Lancet, and these results would be presented at the British Society of Gastroenterology (BSG) national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due before the end of 2021. [1 paragraph unchanged]

Expected measurable benefits

[3 paragraphs unchanged] The trial is important because it deals with the most significant pathology [18 words unchanged] patient safety, reduce hospitalisations for gastrointestinal bleeding, reduce premature death, decrease medical ~~costs~~ costs, and expand the number of patients for whom aspirin has no benefits. [1 paragraph unchanged] The trial is highly innovative because it breaks new ground in trial [5 words unchanged] face to face trial follow up with the much cheaper approach of ~~semi automated~~ semi-automated intermittent interrogation of GP electronic records. Per person it will be one [39 words unchanged] of medical importance which has previously not been possible because of costs. [1 paragraph unchanged]

Benefits reported

The University of Nottingham have been able to estimate event rates, based [5 words unchanged] NHS Digital, which enabled them to calculate more accurately how many patients ~~were~~ are required to take part in the study, and cease recruitment on 31-Oct-17 [6 words unchanged] patients will be the cohort size for this agreement with NHS Digital. [1 paragraph unchanged] The trial is in follow-up, and therefore is still blinded at present and therefore the ~~applicants~~ University of Nottingham are not yet able to fully analyse the benefits to patients. However, the overall trial, even before completion, is considered a national success in terms of trial methodology and receive frequent request from research teams at other Universities on the best way of running large-scale pragmatic trials in primary care. ~~The University of Nottingham are in the process of drafting a copy of a methodology paper for publication.~~

Objective for processing

Nottingham Health Informatics Service, based at King’s Mill Hospital, house the server which forms part of the secure NHS N3 data network, where the information received from NHS Digital is held.

2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit.

University of Nottingham cannot reasonably achieve the above in a different way other than accessing HES and Mortality data from NHS Digital.

Expected output

The trial will proceed until there are 87 adjudicated cases (there are currently 32 formally adjudicated primary endpoints, and the University of Nottingham estimates reaching the target of 87 by December 2020) and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding.

The University of Nottingham have drafted a methodology paper, which is being submitted to the journal Trials for publication.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Benefits reported

DARS-NIC-389320-R4M6Z-v4.5 14 May 2019 to 13 May 2020

Title: Helicobacter Eradication Aspirin Trial (HEAT)
Commercial: No
Sublicensing: No
Datasets: 3
Files released: 4

Datasets: Civil Registrations of Death - Secondary Care Cut; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Admitted Patient Care (HES APC)

Objective for processing

University of Nottingham will use Hospital Episode Statistics (HES) and Civil Registration mortality data to support its programme of research for the HEAT Trial.

2. Economic: To test the hypothesis that the intervention has a positive net monetary benefit.

The data is required as part of the process of endpoint detection for the HEAT trial. This is a large ultra-simple trial which attempts to use electronic data sources to capture possible trial endpoints (primary endpoint is admission to hospital with peptic ulcer bleeding). Other sources of data will be via electronic scrutiny of GP records, mortality data (date and cause of death) and patient alerts, whereby patients inform the study of any attendance at hospital. Cases deemed to have possibly reached an endpoint will have detailed hospital data collated and an Adjudication Committee will evaluate whether patients have had a definite or probable ulcer bleed using the criteria of the TARGET study (https://www.bristol.ac.uk/primaryhealthcare/news/2016/target-study.html).

The justification for using Article 6(1)(e) of the GDRP as the legal basis processing, as necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller is summarised briefly as follows:

Processing HES and Civil Registration Mortality Data for the HEAT trail 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 HEAT trial will aim to determine cost benefit analysis of intervention, and also if that improves hospital outcomes.

Consented study patients give permission for subsequent scrutiny of their records and any death certification. GP data are repetitively uploaded to a bespoke database/management system which has also been prepared to detect and store disease and procedure codes from HES. Data is collected from GP practices systems via a Miquest search roughly every 6 months: this search looks for any new relevant information in the patients’ medical record, or any changes since the last upload. Any HES/Mortality data that is recieved by NHS Digital will not be linked to the GP data.

Permissions are also already in place for access to all the major hospitals where the trial is being conducted (Southampton & the South West, London, Nottingham & East Midlands / South Yorkshire, Durham and the North, Oxford and South East, Birmingham and the West Midlands) to allow nurse access to gather information on possible cases.The actual hospitals where there is letters of access to see data can vary from month to month, as these are requested on a per trial and per requirement basis, and usually expire after a year. Therefore it is reapplied for on a need basis, depending on the primary endpoints that are identified.

University of Nottingham cannot reasonably achieve the above in a different way other than accessing HES and Mortality data from NHS Digital.

Expected output

The trial will proceed until there are 87 adjudicated cases (there are currently 19 formally adjudicated primary endpoints, and the University of Nottingham estimates reaching the target of 87 by mid 2020) and will then be analysed to test the hypothesis that H.pylori eradication reduces the incidence of peptic ulcer bleeding. Patients who have been recruited into the study will be informed of the trial results by letter once these are available, as will all participating GP practices. The main primary outputs of the analysis will be scientific papers/posters covering both the medical and procedural aspects of the study. The University of Nottingham intends to publish the results of the HEAT Study in a major scientific journal (such as The Lancet), and will also present details of the study at relevant scientific meetings. For example, the methodology for the study was presented at the Digestive Diseases Federation Conference in London in June 2015 and at the United Gastroenterology Week Conference in Barcelona in October 2015.

The final results of the study, for which the NHS Digital data will be used, will be expected in 2020 for publication in The Lancet, and these results would be presented at the British Society of Gastroenterology (BSG) national (and potentially international) meetings. As this study is endpoint-driven, the University of Nottingham require hospitalisation / ulcer bleed data regularly throughout the course of the study, as this will help to determine a more accurate end date, based on event rates. There will also be a report for the funder and sponsor at the end of the trial, which is currently due in mid 2020.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide

Benefits reported

The University of Nottingham have been able to estimate event rates, based on previous data received from NHS Digital, which enabled them to calculate more accurately how many patients were required to take part in the study, and cease recruitment on 31-Oct-17 with 30,024 consented participants. 5357 randomised patients will be the cohort size for this agreement with NHS Digital.

The trial is in follow-up, and therefore is still blinded at present and therefore the applicants are not yet able to fully analyse the benefits to patients.

The University of Nottingham are in the process of drafting a copy of a methodology paper for publication.

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, the earliest of which is July 2021.

July 2021 — already listed in the earliest edition this site holds, so it may be older.
3 versions: DARS-NIC-389320-R4M6Z-v4.5, DARS-NIC-389320-R4M6Z-v5.8, DARS-NIC-389320-R4M6Z-v6.2

Cite this page

NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-389320-R4M6Z, “Helicobacter Eradication Aspirin Trial (HEAT)”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-389320-r4m6z/ (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-389320-R4M6Z to see the original rows.