NHS Digital Data Release Register - reformatted

St George's, University of London

Project 1 — DARS-NIC-45477-B9W1L

Opt outs honoured: Yes - patient objections upheld (Section 251)

Sensitive: Sensitive

When: 2018/10 — 2019/01.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(7)

Categories: Identifiable

Datasets:

  • MRIS - Flagging Current Status Report
  • MRIS - Cause of Death Report

Objectives:

Around 400 young people die from sudden cardiac death (SCD) each year in the UK. The majority of these events are due to inherited abnormalities of the heart muscle or electrical systems and are often silent until they present with a cardiac arrest. It was first reported in 2008 that individuals who suffered a cardiac arrest were more likely to have a particular pattern on their resting electrocardiogram (ECG); the Early Repolarisation Pattern (ERP). Subsequent large population cohort studies showed that individuals with the ERP had an increased risk of sudden cardiac death over long-follow up periods. The excess of sudden cardiac deaths occurred in the sixth decade of life and onwards. These studies led to great concern over the significance of the ERP in the general population. Meanwhile the ERP is known to be common in young adults, particularly those who take part in high volumes of regular exercise. There have been no large-scale studies to date in cohorts of young adults with ERP. The intention of this study was firstly to identify the prevalence of the ERP in a large cohort of physically active young adults and to identify whether those with ERP have an increased risk of sudden cardiac death in the short to medium-term. Central to answering this question is to reliably identify those who have suffered sudden cardiac death and correlate these deaths with the presence of the ERP on the ECG. This study forms part of a larger research project, "EVALUATION OF THE 12 LEAD ECG AS A USEFUL TOOL IN IDENTIFYING YOUNG APPARENTLY HEALTHY INDIVIDUALS WITH CARDIAC DISEASE" (REC Ref MH532A) undertaken by clinical researchers at St. George’s Hospital Medical School Research Dept. who have published extensively in the field of ECG screening, sudden cardiac death risk and ECG patterns. The purpose of this larger study is to identify a cost-effective screening method of identifying young individuals with cardiac disease who may be at risk of sudden cardiac death. As described above, sudden cardiac death may occur in individuals with previously asymptomatic heart muscle or electrical diseases. These diseases may be diagnosed with a 12-lead ECG which therefore may be considered as a potential screening tool. This particular application utilises the demographic and ECG data collected to assess the significance of the ERP as described above. Results from this study will then feed back in to the ongoing larger study by determining whether ERP constitutes a significant marker of risk that could be screened for with a 12 lead ECG. This research analyses multiple features of an individuals ECG, looks for the prevalence of known abnormalities associated with conditions that may pose an increased risk of sudden cardiac death and also for novel features which may be associated independently with increased risk. The project has been funded by Cardiac Risk in the Young (CRY), a charitable organisation offering cardiac screening to athletes and young people with the aim of reducing rates of sudden deaths in the young. CRY funded the research for this project as well as providing the infrastructure for collection of data. This data will not form part of any other research project nor be shared with any outside parties. No part of the work is being carried out outside of the UK.

Expected Benefits:

The research output will help inform the cardiology community regarding the risk of the ERP in young adults. The hypothesis is that there will be no increased risk in young adults with ERP. If this is proven, the research will lead to a reduction of unnecessary investigations of asymptomatic individuals with ERP and reduce patient and family anxieties in individuals where ERP is found incidentally. Based upon current knowledge there is confusion amongst practicing cardiologists, sports physicians and general practitioners as to the significance of the ERP in young adults. Consequently individuals can be restricted from physical activity and referred to specialist centres for further investigation. Such investigation uses health resources and can cause significant anxiety to the affected individual. Furthermore, restriction from physical activity can have a wide range of detrimental physical and psychological effects. Publication of the research in high impact medical journals will allow it's wide international circulation. Future studies in this area will also reference the work in subsequent investigations. Through academic publication and presentation it is expected that the findings of the research, if significant, will inform future national and international guidelines on the assessment and management on individuals at risk of sudden death and regarding pre-participation cardiac screening of athletes. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. In many cases, guidelines are adopted or endorsed by the National Institute for Clinical Excellence (NICE) and therefore effectively become mandatory for NHS physicians.

Outputs:

The research output will be submitted to peer-reviewed cardiology and/or general medical journals in the form of an original research article. It is expected that the work will be accepted for publication in a high-impact cardiology-specific journal, such as Circulation, the Journal of the American College of Cardiology (JACC) or the European Heart Journal (EHJ). These journals are widely read amongst the clinical and academic cardiology community worldwide. Articles published in these journal therefore frequently inform clinical practice and are often cited in national and international guideline documents. Only aggregated data, with small number suppressed in line with HES guidance, will be included in any research output. No patient level data will be included. It is expected that the research article will be submitted for peer review within 3 months of receipt of the data from NHS digital. In addition to the written outputs, the research data will be submitted for oral presentation at national and international cardiology conferences such as the British Cardiac Society annual conference, British Heart Rhythm Congress, Euoropean Heart Rhythm Association conference and Heart Rhythm Congress in the USA. Similarly to the journal listed above, these conferences serve to dissipate cutting edge clinical research findings to leading clinical and academic cardiologists. Through this network of academic research presentations the findings, if significant, will lead to changes in national and international guidance on the assessment and management of young adults at apparent risk of sudden cardiac death or undergoing pre-participation ECG screening in the context of elite or amateur sport. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. Summaries of the research findings will also be published by Cardiac Risk in the Young including on their website, via twitter and at the annual CRY International Conference on Sports Cardiology.

Processing:

Completion of the medical questionnaire and acquisition of the ECG were performed by CRY at various sites throughout England and Wales at the time of cardiac screening events. All participants gave written informed consent for their data to be stored and used for research purposes by CRY. Researchers at St. George’s Hospital Medical School Research Dept used this primary source data (i.e. medical questionnaire responses and ECG) were used to construct two databases. The first containing the participants demographic details and the second containing data from the medical questionnaire and ECG. The databases are linked by unique ID numbers and are password protected. These databases are stored at St. George’s Hospital Medical School Research Dept. Access to the local network is via a unique login ID and password protected. St. George’s Hospital Medical School Research Dept. is IG toolkit compliant. Storage of data acquired from CRY medical questionnaires and ECGs at St. George's is covered by the original research protocol and consent process which were agreed by the local REC (ref MH532A)). These databases are not accessible to CRY staff. Data in the demographic database will be provided to NHS Digital with the intention of identifying any member of the cohort who has died and to identify the cause of death in each case if applicable. Data provided will be organised in to three groups; those individuals with no ERP; those with low risk form of ERP and those with the high risk form of ERP. Data flow between St. George’s Hospital Medical School Research Dept. and NHS Digital is covered by section 251 and has been approved both by the local REC and by the confidential advisory group (CAG). St. George’s Hospital Medical School Research Dept. request the numbers of deaths within each group as well as the cause of death as per the death certificate for any deceased individual. Mortality data will be analysed at St. George’s Hospital Medical School Research Dept by an ONS accredited researcher. Final data will be aggregated to prevent the identification of any individual within the study. All research outputs will include aggregated data only suppressed in line with the HES analysis guide. Aggregated data small numbers will be suppressed in line with the HES analysis guidelines. No data will be shared with third parties. Data will not be accessed from outside the UK. 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). ONS Terms and Conditions will be adhered to. The data controller must ensure that there are appropriate contracts and controls in place between the organisation and all persons accessing NHS Digital disseminated data. NHS Digital have the right to audit the controls in place under the data sharing agreement.


Project 2 — DARS-NIC-190086-F5Z7B

Opt outs honoured: Yes - patient objections upheld (Section 251 NHS Act 2006)

Sensitive: Non Sensitive, and Sensitive

When: 2020/04 — 2020/05.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Admitted Patient Care
  • Civil Registration - Deaths

Objectives:

The UK National Screening Committee (UK NSC) does not recommend a national sponsored screening program for cardiac disease in young asymptomatic individuals with no relevant family history. In the most recent UK NSC review the authors highlight the low incidence of sudden cardiac death (SCD) in young adults and raised concerns regarding the performance of the proposed screening tools and in particular the 12-lead ECG. The 12-lead ECG is a representation of the heart's electrical activity recorded from electrodes on the body surface. The true incidence of sudden cardiac death (SCD) in children and young adults is widely debated. Accurate calculation of the incidence requires a precise numerator (number of deaths per year) and an exact denominator (number of participants per year) in the population studied. The reported incidence of SCD in young adults (age 14-35 years) varies widely depending on the group studied and the methodology used and has been reported as low as 1:300,000. In the absence of systematic registries, collection methods using retrospective review of media reports, electronic databases and insurance claims in these early studies, are limited by ascertainment and selection bias which underestimate calculations of incidence. Gauging the effect of preventative strategies such as preparticipation cardiovascular screening (PPS) is limited by unreliable estimates of SCD incidence. Cardiac Risk in the Young (CRY) has provided a voluntary cardiac screening program to children and young individuals since 1996. In this time CRY have screened in excess of 150,000 individuals for conditions associated with SCD. This has formed the largest database of its kind with a well-defined denominator. Up till now research on screening outcomes has primarily focussed on individuals that were flagged as positive by the screening and proceeded to further evaluation. As such they have been able to define the positive predictive value as well as the false discovery rate of the screening programme and in particular the 12-lead ECG. For the first time, this project will explore outcomes in the entire population and in particular individuals whose screening tests were considered normal and were reassured that they did not have any cardiac condition predisposing them to sudden cardiac death. These individuals comprise >90% of the screened population. The organisation requests mortality data for approximately 120,000 consecutive individuals screened over a decade, from 2007 till 2018. These individuals were screened across England, Wales, Scotland and Northern Ireland. Individuals were aged between 14 and 34 years of age at the time of data acquisition. Outcomes will not be compared to an un-screened population and for that reason no control group exists. The following steps have been taken to minimise the data requested: 1. The data request only relates to those individuals in the cohort. Data outcomes from individuals who have undergone cardiac evaluation by other screening providers (not Cardiac Risk in the Young) will not be included. 2. There is no requirement for data which was stored prior to the screening period of the cohort. For this reason, data stored earlier than 2007 is not requested. 3. This study aims to ascertain the prevalence of conditions which are associated with sudden cardiac death. For that reason, the ICD-10 codes have been filtered to reflect these conditions only. 4. This study aims to ascertain the frequency of cardiac interventions which are performed in order to reduce the individual's risk of sudden cardiac death. The OPCS4 codes have been filtered to include these procedures only. 5. This study aims to ascertain the incidence of sudden cardiac death. The timing and location of an individual's collapse/sudden cardiac arrest prior to death can disguise the cause of death. The clinical experience from a dedicated sudden arrhythmic death syndrome service has highlighted this fact. Examples include: Cardiac rarest with resuscitation and survival to hospital admission but died with hypoxic brain injury (stated as cause of death), drowning where circumstances are not clear or appear unusual (without struggle), road traffic accident where circumstances indicate the driver may have collapsed before the trauma related impact (no brake marks, or driver found dead at the hand-wheel of a car that is stationary). Indeed, familial evaluation of such cases has, from experience and others, identified familial forms of the Long QT syndrome, Brugada syndrome and catecholaminergic polymorphic tachycardia which are then attributed to the cause of death retrospectively. These outcomes reflected in the available medical literature. For this reason, the request for all-cause mortality to evaluate the possible number of additional cardiac deaths which manifest atypically and are then incorrectly coded. From these datasets the aim is to identify any individual with: A) sudden cardiac death, B) Sudden Cardiac Arrest (SCA) and C) a diagnosis of a cardiac condition associated with sudden cardiac death. The data will be securely returned to the storage location in the pseudonymised form for outcome analysis. Pilot data from a cohort of 5,000 individuals from the same research group supported by CRY looking at the outcomes of a specific ECG index (early repolarisation) indicates that through this process the study will be able to obtain outcomes in excess of 95% of the individuals screened. This study will be the most comprehensive study on cardiac screening of children and young individuals yet and will be able to define the: 1. The exact incidence of sudden cardiac death in a screened population of young individuals and compare it to reported rates in the UK, 2. Assess the sensitivity, specificity, positive and negative predictive value of cardiac screening overall as well as the individual tests used (12-lead ECG and health questionnaire) of identifying individuals with conditions predisposing to sudden cardiac death, 3. Assess the effectiveness of screening in terms of detecting different conditions predisposing to sudden cardiac death. This study has the potential to define the future approach to PPS not only in the UK, but worldwide. Accurate assessment of SCD incidence, as well as insight into the true performance of commonly used screening tools, will guide the outcome of PPS policies including that of the UK NSC. As a result, the Primary Investigator (PI) and the organisation, believes the processing of such data is justified on legal grounds - GDPR Article 6(1)(e). Data processing is also necessary for reasons of substantial public interest under Article 9(2)(j). This project has the potential to form the basis for a number of other projects including 1. Comparison of mortality rates in a screened compared to a well-defined non-screened population, 2. Assessment of true screening costs, 3. Assess the predictive value of identifying cardiac disease of different ECG indices. Study Rationale A government sponsored screening program, mandated by Italian law, has demonstrated a fall in rates of sudden cardiac death by 89%. Currently no equivalent UK state sponsored program exists. Concerns in part relate to the perceived low incidence of sudden cardiac death (SCD) and sudden cardiac arrest (SCA) in young individuals. This study will provide the most reliable estimate for the incidence rate for SCD and SCA in the literature. Only once a reliable estimate of SCD and SCA is calculated, can the screening community gauge the need for preventative strategies such as cardiac screening. Primary Objectives 1. To define the incidence of sudden cardiac death in a screened population of children and young individuals. 2. To assess the value of cardiac screening overall, individual tests used (12-lead ECG and health questionnaire), as well as specific indices of these tests (specific questions or ECG indices) of identifying individuals with conditions predisposing to sudden cardiac death or sudden cardiac arrest. 3. Assess the effectiveness of screening of detecting different conditions predisposing to sudden cardiac death. Primary aim: • The primary aim is to estimate the incidence of sudden cardiac death and sudden cardiac arrest in a population of individuals who had previously undergone assessment with pre-participation screening over a ten-year period. Secondary aims: • To assess the value of cardiac screening overall, individual tests used (12-lead ECG and health questionnaire), as well as specific indices of these tests (specific questions or ECG indices) of identifying individuals with conditions predisposing to sudden cardiac death or adverse outcomes (sudden cardiac death, sudden cardiac arrest). • Assess the effectiveness of screening of detecting different conditions predisposing to sudden cardiac death. The following organisations are involved: • St George’s, University of London Role: Sole data controller and sole data processor Organisation Type: Academic • Cardiac Risk in the Young Role: Source of funding for study. Owners of source data. Organisation Type: Charity The Principal Investigator is substantively employed at St Georges, University of London but holds an honorary contract at Cardiac Risk in the Young (CRY), so they can access the identifiers from the database. However, no linkage of the NHS Digital data disseminated under this agreement is permitted to the identifiers held at CRY. St George’s, University of London are not permitted to re-identify any members in the cohort. There are no other organisations/commissioners involved in this or wider anticipated projects.

Expected Benefits:

The incidence of sudden cardiac death is widely debated. Previous studies evaluating this figure have used heterogenous passive collection methods with poorly defined population demographics leading to unreliable estimates. The methodological strengths of this study in a large cohort will provide the most reliable estimate of SCD in young individuals in the literature to date. The effectiveness of preventative strategies for SCD can only be evaluated once a reliable estimate of incidence is agreed. This study has the potential to influence the decision on whether there should be a government driven screening programme for SCD which affects at least 400 people a year. Publication of the research in high impact medical journals will allow it's wide international circulation. Future studies in this area will also reference the work in subsequent investigations. Through academic publication and presentation it is expected that the findings of the research, if significant, will inform future national and international guidelines on the assessment and management on individuals at risk of sudden death and regarding pre-participation cardiac screening of athletes. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. In many cases, guidelines are adopted or endorsed by the National Institute for Clinical Excellence (NICE) and therefore effectively become mandatory for NHS physicians.

Outputs:

The research output will be submitted to peer-reviewed cardiology and/or general medical journals in the form of an original research article. It is expected that the work will be accepted for publication in a high-impact cardiology-specific journal, such as Circulation, the Journal of the American College of Cardiology (JACC) or the European Heart Journal (EHJ). These journals are widely read amongst the clinical and academic cardiology community worldwide. Articles published in these journals therefore frequently inform clinical practice are often cited in national and international guideline documents. CRY hold 6 monthly ‘Heart Group Meetings’. The meetings are advertised on the CRY website. The Primary Investigator presented the study to 80 attendees which included individuals within the study cohort. Feedback was positive and there were no concerns about the methodology expressed. Further clarity has been sought by sending emails to the cohort requesting their feedback, this process has begun and was confirmed in a call with the applicant on 13/09/2019, at each screening event questionnaires are given out, each event is attended by approx. 200 people Only aggregated data, with small numbers suppressed in line with HES analysis guidance, will be included in any research output. No patient level data will be included. It is expected that the research article will be submitted for peer review within 3 months of receipt of the data from NHS digital. In addition to the written outputs, the research data will be submitted for oral presentation at national and international cardiology conferences such as the British Cardiac Society annual conference, British Heart Rhythm Congress, European Heart Rhythm Association conference and Heart Rhythm Congress in the USA. Similarly to the journal listed above, these conferences serve to dissipate cutting edge clinical research findings to leading clinical and academic cardiologists. Through this network of academic research presentations the findings, if significant, will lead to changes in national and international guidance on the assessment and management of young adults at apparent risk of sudden cardiac death or undergoing pre- participation ECG screening in the context of elite or amateur sport. Such guideline documents are widely circulated and advertised within clinical service. They inform the basis of clinical practice of cardiologists, sports physicians and general practitioners looking after such individuals. Summaries of the research findings will also be published by Cardiac Risk in the Young including on their website, via twitter and at the annual CRY International Conference on Sports Cardiology.

Processing:

The organisation 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). Completion of the medical questionnaire and acquisition of the ECG were performed by CRY at various sites throughout England and Wales at the time of cardiac screening events. All participants gave written informed consent themselves or via parental consent where applicable for their data to be stored and used for research purposes by CRY. Primary source data (i.e. medical questionnaire responses and ECG) were used to construct two databases. The first containing the participants demographic details and the second containing data from the medical questionnaire and ECG. The databases are linked by unique ID numbers and are password protected. These databases are stored securely on the local network at the central office of Cardiac Risk in the Young. Access to the local network is via a unique login ID and password protected. It cannot be accessed remotely. Identifiers of individuals who participated in the screening and consented to using their data for research will be transferred securely to NHS Digital. The identifiers are required in order for NHS Digital to match each individual to their NHS number. Subsequently, NHS numbers will be matched against a pre-defined set of codes (ICD for diagnosis, OPCS for procedures) on various national databases (Civil Registration Mortality data, Hospital Episode Statistics and Primary Care Mortality). Identifiers will be provided to NHS Digital from St George’s, University of London who will have received them via Cardiac Risk in the Young (CRY). The linked data will flow from NHS Digital to St George’s, University of London via Secure Electronic File Transfer (SEFT). The data-set sent to NHS Digital will include the following demographics for each individual of the cohort: • Name • GP Registration • Date of Birth • Date of Death (if applicable) • Postcode (Unit level) • Gender • Ethnicity These demographics will enhance the linkage rate to each individual’s NHS number. This service will be provided by the Medical Research Information Service (operated by NHS Digital). NHS Digital will then match each individual's NHS number to a selected list of product codes using mortality data. This filtered list of ICD and OPCS-4 codes will be provided to NHS Digital by the organisation. This will include ICD-10 and OPCS-4 codes. These matched data-codes will provide the following outcomes: 1. Episode of death 2. Cause of death 3. Episode of sudden cardiac arrest 4. Diagnosis of cardiac condition associated with sudden cardiac death (e.g. hypertrophic cardiomyopathy) 5. Cardiac intervention to reduce risk of sudden cardiac death (e.g. implantable cardioverter defibrillator) NHS Digital will then link these outcomes to each individual’s unique study number. The linked mortality data will be transferred from NHS Digital to the data processor in the pseudonymised form. This data-set will be stored securely on an encrypted St George's Hospital University of London Data Safe Haven (DaSH) server. Those accessing the data are substantive employees of St George’s Hospital. No attempts will be made to re-identify any individuals under this Data Sharing Agreement. Data provided by the NHS Digital will be analysed at St. George s Hospital Medical School Research Department by the PI who is a substantive employee of St Georges Hospital Medical School and St George’s University London. Record level data will not be shared with any other individual. The data will not be converted back into the identifiable form at any stage. Final data will be aggregated to prevent the identification of any individual within the study. All outputs will be aggregated with small numbers suppresses in line with HES analysis. No data will be shared with third parties. Data will not be accessed from outside the UK.


Project 3 — DARS-NIC-147843-8NKTW

Opt outs honoured: Yes - patient objections upheld (Section 251, Section 251 NHS Act 2006)

Sensitive: Sensitive

When: 2016/04 (or before) — 2020/07.

Repeats: Ongoing

Legal basis: Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7)

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration
  • Civil Registration - Deaths

Objectives:

The aim of the trial is to determine whether healthy people should be screened and treated for H Pylori infection.

Yielded Benefits:

No outputs have been produced as the data analysis plan was designed such that no analysis would be undertaken until sufficient numbers of stomach cancers had occurred. The numbers reported are not sufficient yet.

Expected Benefits:

If the trial determines that screening and subsequent eradication of H Pylori reduces the incidence of stomach cancer this will have an enormous benefit to the whole population in the UK and worldwide. Both screening and eradication (a 1 week course of antibiotics) are simple and cheap. Around 40% of people have H Pylori infection. In 2015 6740 people developed stomach cancer. If screening does work and prevents 20% of stomach cancers then this will mean that over 1,300 stomach cancers will be prevented. With 4 out of 10 people in the UK thought to have H Pylori infection potentially 40% of the population could have their risk of stomach cancer reduced. The extension of our data sharing agreement will allow us to obtain enough cases of stomach cancer to provide the information needed on the value of screening. This trial will provide evidence concerning whether screening for HPylori infection is worthwhile. If the results from the trial are positive then we would be in a position to contact PHE to discuss implementing a population screening programme.

Outputs:

The following outputs will be produced : A peer review paper analysing the results from the trial will be submitted to an open-access peer reviewed journal within one year after sufficient stomach cancers have occurred.This paper should be influential in deciding whether to screen for H Pylori infection . The final report of results will be submitted to CRUK. This will cover all findings of the study. For each paper published, a short presentation may be developed to summarise the findings for a range of stakeholders, including healthcare professionals and patient groups. The study website will provide links to the open access papers and will offer free downloads of accessible summaries of findings. All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide/compliant with the MHSDS disclosure control rules including suppression and rounding.

Processing:

All 62,454 participants in the HPSS have been flagged at NHS Digital. Information on deaths and cancer registrations is requested to be received every 6 months electronically. The electronic information will be downloaded onto a secure server, protected by a fire-wall, based in the Wolfson Institute of Preventive Medicine. The data are then merged with the HPSS study database by the database manager in the Wolfson Institute. The data are stored on the server, with any identifiers stored separately from the clinical information. The database manager provides the study statistician with pseudonymised information on the numbers of deaths and cancer registrations that have occurred since the start of the trial. Data will only be accessed by individuals within the Centre for Environmental and Preventive Medicine who have authorisation from the PI (Sir Nicholas Wald) to access the data for the purpose described, all of whom are substantive employees of QMUL. The core dataset will only be accessed by the data manager within the Wolfson Institute. They will produce subsets of the data that will be accessed by the study statistician. Any other person seeking access toi a subset of the data will have to submit a formal reuest to the PI (Sir Nicholas Wald) and justify from a scientific basis all requested information. 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 of QMUL situated in the Centre for Environmental and Preventive medicine who may have access to that data). No further linkage will be performed. The data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. Data is only requested for those participants in the HPSS study. Some identifiers are necessary to ensure that the correct match with the study participant is made. The BUPA identifiers which were used in this study were not totally unique, causing manual checks to be made when any linkage is performed. No outputs have been produced as the data analysis plan was designed such that no analysis would be undertaken until sufficient numbers of stomach cancers had occurred. The numbers reported are not sufficient yet.