NHS Digital Data Release Register - reformatted

Nuvia Ltd projects

MR183 - EX-EMPLOYEES ATOMIC WEAPONS RESEARCH ESTABLISHMENT
MR110 - UKAEA Mortality Study

109 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

MR183 - EX-EMPLOYEES ATOMIC WEAPONS RESEARCH ESTABLISHMENT — DARS-NIC-147756-SMGHS

Type of data: information not disclosed for TRE projects

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

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , 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)

Purposes: No (Commercial)

Sensitive: Sensitive, and Non Sensitive

When:DSA runs 2018-11-01 — 2021-10-31 2018.03 — 2019.07.

Access method: Ongoing, One-Off

Data-controller type: PUBLIC HEALTH ENGLAND (PHE)

Sublicensing allowed: No

Datasets:

MRIS - Cause of Death Report
MRIS - Cohort Event Notification Report
MRIS - Members and Postings Report
MRIS - Scottish NHS / Registration
MRIS - Bespoke
MRIS - Flagging Current Status Report

Objectives:

Study MR183 is a long standing study of the effects of occupational radiation exposure in the nuclear industry. Much of the knowledge in this area has been gained from studies of the survivors of the two atomic bombs detonated over Japan at the end of the war. However, it is not clear how relevant this study of high doses received instantaneously is, to those exposed in an occupational context, or as members of the public, to much lower doses received over many years. This is why studies of nuclear workers have been, and continue to be, important in setting acceptable exposure levels at work and for the public in the wider environment.

MR183 is a study of mortality and cancer morbidity in the employees of the Atomic Weapons Establishment (AWE) at Aldermaston, the government organisation responsible for research and development of the UK atomic weapons programme. It is among the small group of UK studies that lead the world in this area partly because of the quality of the national mortality and cancer registration systems.

The study commenced in 1979, designed by a team from the London School of Hygiene and Tropical Medicine. The MR183 cohort included everyone employed by AWE from its foundation in 1951 to the end of 1982. The study includes around 22,000 individuals. Of these, only just over half are dead, which is why continued long-term follow-up, with a corresponding increase in statistical power is so important.

The study was initially funded by the AWE and largely carried out by a team from UKAEA, but with reorganisation and privatisation in the nuclear sector, responsibilities have changed and it is now funded by the AWE overseen by the Public Health England (PHE), Centre for Radiation, Chemical and Environmental Hazards, and carried out by Nuvia Limited.

The follow-up data provided by NHS Digital for the MR183 study has been used and will be used in wider collaborative studies taking in the nuclear workforces of several European countries. Such data is, of course, shared in anonymised form with collaborators and only with explicit agreement from the data providers, including NHS Digital, and from workforce representatives. Where data to be shared is anything other than data aggregated with small numbers suppressed the study will seek explicit permission from NHS Digital on a case by case basis via an amendment to the application.

Yielded Benefits:

Studies of the MR183 cohort aim to improve the understanding of the health effects of the low doses of ionising radiation received by nuclear workers. This understanding will benefit the health, not only of nuclear workers, but anyone else who encounters radiation, such as medical radiographers and members of the public exposed because of medical x-rays or radioactive discharges to the environment. If there is evidence that limits to exposure are too lax these benefits will take the form of lowered exposures and reduced health effects. If, on the other hand, the evidence suggests limits are too rigorous the benefits could include time and cost savings. The benefit will be achieved by the authoritative international bodies, ICRP and UNSCEAR, and Public Health England in the UK, influencing Government regulation. thus the benefits of processing. The UNSCEAR 2006 and 2012 reports cited various publications which use MR183 data. Since then, a new set of IRRs was issued in 2017 which were influenced by UNSCEAR reports. From the last renewal a paper* data from this study has been published which shows a significant effect of inhaled plutonium and uranium on lung cancer rates. This is likely to influence future regulation on exposure to inhale radionuclides. Since the last renewal a paper* using data from this study has been published which shows a significant effect of inhaled plutonium and uranium on lung cancer rates. This is likely to influence future regulation on exposure to inhaled radionuclides. *Grellier, J, Atkinson WD, Bull R.K. et al (2017) Risk of Lung Cancer Mortality in Nuclear Workers From Internal Exposure to Alpha Particle-Emitting Radionuclides Epidemiology 28, 675-684

Expected Benefits:

Studies of the MR183 cohort have influenced and are expected to influence the development of the Ionising Radiation Regulations (IRRs) which regulate the exposure of people at work and of the public. The correct regulation of doses benefits the health not only of nuclear workers, but anyone else who works with radiation, such as medical radiographers and members of the public exposed as a result of medical x-rays or radioactive discharges to the environment. The IRRs are directly based on the authoritative recommendations of organisations such as the International Commission on Radiation Protection (ICRP) and the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR). These organisations monitor the latest research literature and will be aware of past and future publications from MR183. In particular the UNSCEAR 2006 and 2012 reports cited various publications which use MR183 data.

No record level data is or will be shared with any other organisation not specified in the application. Any data shared is aggregated with small number suppressed in line with HES Analysis guide.

Outputs:

Outputs were presented as aggregated tables and figures, with suppression of low-numbered cells in line with the HES analysis guide where appropriate. As part of a previous EU funded project, the SHIELD database has been updated with all the internal dosimetry data required to undertake this work. The outputs included peer-reviewed publications and a publicly available web site.
Data from the MR183 cohort has been used in some 13 publications in high-impact peer-reviewed journals. For example:
Beral V, Fraser P, Carpenter L, Booth M, Brown A and Rose G (1988) Mortality of employees of the Atomic Weapons Establishment, 1951-1982. British Medical Journal, 297, 757-770.
Carpenter L, Higgins C, Douglas A, Fraser P, Beral V and Smith P (1994) Combined analysis of mortality in three United Kingdom nuclear industry workforces, 1946-1988. British Journal of Cancer. 78, 1224-1232
Cardis E, Gilbert E, Carpenter L, Howe G, Kato I, Armstrong B, Beral V, Cowper G, Douglas A, Fix J, Fry S, Kaldor J, Lave C, Salmon L, Smith P, Voelz G and Wiggs L (1995) Effects of low doses and low dose rates of external ionizing radiation: cancer mortality among nuclear industry workers in three countries. Radiation Research, 142, 117-132
Johnson, P., Atkinson, WD and Nicholls, JL (1999) Updated analysis of mortality at UK Atomic Weapons Establishments. Southport 1999 - Proceedings of the 6th International SRP Symposium. M.C. Thorne (ed). SRP, London
Roman E, Doyle P, Maconochie N, Davies G, Smith P and Beral V (1999) Cancer in children of nuclear industry employees: report on children aged under 25 years from nuclear industry family study, British Medical Journal; 318, 1443–1450
Burt A, Maconochie N, Doyle P, Roman E (2004) Learning difficulties in children born to male UK nuclear industry employees; analysis from the nuclear industry family study, Occupational & Environmental Medicine, 61, 786-789
Grellier J, Atkinson, W et al (2016) Risk of lung cancer mortality in nuclear workers from internal exposure to alpha particle-emitting radionuclides. Epidemiology (in press)

Future outputs are expected to focus on the health effects of inhaled or ingested radionuclides which have been little studied anywhere hitherto. Outputs will include peer-reviewed publications and a publicly available web site. In all cases data will be presented as aggregated tables and figures, with suppression of low-numbered cells in line with the HES analysis guide where necessary.

Processing:

The data already disseminated will be accessed and processed by substantive employees of Nuvia and only for the purposes described in the application.

MR183 is a flagging study, but the cohort is fixed and no new flagging has taken place for many years, so no data is provided to NHS Digital by Nuvia.

The data received by Nuvia from NHS Digital falls into three categories:
1. Mortality Data
Date, causes and place of death, unique study identifier, together with sufficient identity data to confirm that the flag was correctly set, i.e. name, date of birth, NHS number, occupation, home address.
2. Emigrations and Reregistration
Date of event, unique study identifier, together with sufficient identity data to confirm that the flag was correctly set, i.e. name, date of birth, NHS number.
3. Cancer Registrations
Date of diagnosis, disease code, unique study identifier, but no identity data.

The study has a favourable ethical opinion from the NHS Research Ethics Committee, Oxford C. AWE make regular reports on the study to workforce representatives at Joint Health and Safety Meetings.

Nuvia will not provide access to for any third parties to access record level data, even where these third parties are study partners. The use of this data will be limited to Nuvia for the purpose outlined above only. Data published or provided to third parties will be limited to aggregated data, at area, organisational or cohort-level all subject to small number suppression in line with the HES Analysis Guide.

Nuvia is currently part of a European consortium and is seeking funding to conduct a new study, which would entail data sharing with PHE. Any instances of data sharing or processing of data relating to a new study not outlined in this agreement will be subject to separate applications to NHS Digital.

New data subjects are recognised and added to the SHIELD database when their personnel data is sent to the Health Effects team by UKAEA’s contractors CSC, or by DSRL and Magnox. Annually, radiation dose data arrives from the dosimetry services (ADSs) of the same employers and is linked to the data in SHIELD by name, DOB and National Insurance Number (NIN). Periodically the required details for flagging are sent to NHS Digital and Dumfries. When data comes to the study from NHS Digital, either as event notifications or members and postings listings, it is initially linked to the data in the database using name, DOB and NHS Number. Subsequently, if the study are happy that the correct person has been flagged then the study will link on member number. The study have to retain the identity data in the database even after the routine linkage has taken place, because periodically the study add new categories of exposure data. A recent example is the addition of 70 years’ worth of internal radiation contamination assessments to the SHIELD database.

SHIELD is an Oracle 12 database, hosted on a server which is only accessible to authorised SHIELD users. Within SHIELD the followup data from NHS Digital is only available to those with the accredited researcher approvals. Data security is an important part of the culture of SHIELD users.

Typical analyses would be:
• Calculation of Standardised Mortality Ratios (SMRs) and Registration Ratios (SRRs) to compare the cohort with the national population in terms of mortality and cancer morbidity.
• Calculation of Rate Ratios to compare radiation workers with non-radiation workers in the nuclear industry.
• Tests for trends of mortality and morbidity rates with increasing radiation dose.
• Logistic regression analyses to calculate the Excess Relative Risk per unit of radiation dose.

All processing of ONS data is in accordance with standard ONS terms and conditions.

MR110 - UKAEA Mortality Study — DARS-NIC-147834-LHQ2R