NHS Digital Data Release Register - reformatted
City St Georges, University Of London projects
1 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
MR515 - Randomised Prevention Trial of H. Pylori Screening — NIC-147843-8NKTW
Opt outs honoured: Yes - patient objections upheld, Yes (Excuses: Section 251, Section 251 NHS Act 2006)
Legal basis: Health and Social Care Act 2012 – s261(7), Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 s261(7), Health and Social Care Act 2012 s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'.
Purposes: No (Academic)
Sensitive: Sensitive
When:DSA runs 2018-12 – 2021-11 2019.03 — 2024.10.
Access method: Ongoing, One-Off
Data-controller type: QUEEN MARY UNIVERSITY OF LONDON, ST GEORGE'S, UNIVERSITY OF LONDON, ST. GEORGES HOSPITAL MEDICAL SCHOOL, CITY ST GEORGES, UNIVERSITY OF LONDON
Sublicensing allowed: No
AGD/predecessor discussions: IGARD Minutes - 28 July 2022 final.pdf, IGARD Minutes - 17 March 2022 final.pdf, IGARD Minutes - 4 August 2022.pdf
Datasets:
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
- MRIS - Scottish NHS / Registration
- Civil Registration - Deaths
- Demographics
- Cancer Registration Data
- MRIS - Flagging Current Status Report
- MRIS - Members and Postings Report
- Civil Registrations of Death
Type of data: Identifiable
Objectives:
Helicobacter pylori infection of the stomach accounts for most cases of stomach cancer worldwide. The risk of stomach cancer is about five times greater in infected than in uninfected persons. While the association is accepted as causal, it is not known whether screening and treatment of the infection in middle age can reverse this excess risk. This trial aims to determine if screening for and treating H Pylori infection in middle age reduces the risk of stomach cancer
The Wolfson Institute, QMUL requires cancer notification and death certificates for use in Follow Up of Participants in the Randomised Trial of Helicobacter Pylori Screening (HPSS)
a) Researchers at the Wolfson Institute, QMUL instigated the trial
b) BUPA Wellness Centres were approached to recruit patients
c) Only the named researchers at the Wolfson Institute, QMUL will have access to the record level data supplied by NHS digital.
Researchers at the Wolfson Institute are concerned with screening and decided that a large scale screening trial was needed to establish if population screening for HPylori and treating the infection would reduce the risk of stomach cancer .
A randomised controlled trial was set up to answer this question. Recruitment for the trial was from 1997 to 2006 during which 62,454 people attending ten BUPA Wellness Centres for a medical examination were randomly allocated into screened and control groups. Those screened were offered serological testing for H pylori and, if they were positive, a one week course of eradication treatment. Blood was collected and stored from all participants (screened and control). All participants were flagged with NHS Digital and information on their deaths and cancer notifications has been supplied to the PI since 1997. It was expected that the length of follow-up would be a minimum of 20 years.
When a sufficient number of participants have developed stomach cancer for the results of the trial to have sufficient statistical power the serum samples from all persons who developed stomach cancer and a random sample of those who did not will be retrieved from freezers in the Wolfson Institute and tested for H. pylori. The final comparison will be between the incidence of stomach cancer in the screened and control groups among H pylori positive persons only (rather than all persons). This design, a “nested randomised trial”, maximizes statistical power and substantially reduces cost.
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.