MR1146 & MR1194 - Audit of the effect of age at the first invitation for Breast Screening in the NHSBSP

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Objective for processing

Mortality data were supplied to The University of Oxford by ONS and subsequently the Health and Social Care Information Centre (which has since become requires access to NHS Digital) England data for the purpose of an audit the following research project: Audit of the effect of age at the first invitation for Breast Screening in the NHSBSP. NHS Breast Screening Programme (NHSBSP). This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. The following is a summary of the aims of the research project provided by the University of Oxford: Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required. • Establish whether the age women are when first invited for routine mammogram by the NHSBSP affects mortality from breast cancer. The following information provides background information on the purpose of the original study: • Inform national screening policy and practice regarding the age at first routine mammogram. This audit requires the collation of data from more than one source. Only by using patient identifiable information is it possible to link individual records from different sources. Specifically, patient identifiable information is required in order to link deaths and cancer registrations to the study population drawn from the NHAIS database. It is also needed to estimate the first episode date for women who die before being given an episode date. Once these processes have been completed there is no remaining need for the dataset to include patient identifiable information with the exception of date of birth which is needed to derive age for use in the analysis. The data will be identified only by code number for the subsequent analysis. Outputs and publications from this audit will only present aggregated data. • Contribute to the NHSBSP’s ongoing mission to provide as effective a service as possible. The purpose of this audit is to establish whether the age women are when first invited for routine mammogram by the NHS Breast Screening Programme (NHSBSP) affects mortality from breast cancer. The findings of this audit will inform screening policy and practice regarding the age at first routine mammogram. They will, therefore, have the potential to reduce the risk of dying from breast cancer. The audit will contribute to the NHSBSP’s ongoing mission to provide as effective a service as possible The University of Oxford has access to the following NHS England data: Regular mammography between ages 50 and 70 years has been shown in randomised trials to reduce breast cancer mortality. The NHSBSP provides mammography every three years for all women in the UK aged between 50 and 70 years. Although women are eligible for routine mammography at age 50 years, in practice women are first invited for screening between the 1st January of the year in which they turn 50 and the 31st December of the year in which they turn 52. There is a lack of knowledge as to whether the 3 year range in age at first routine mammogram makes a difference to subsequent mortality from breast cancer. Routine administrative data covering all women of relevant ages in England and Wales provide a unique opportunity to audit the effect of age at first invitation for breast screening. • Demographics • Civil Registration Mortality • Cancer Registrations Retention of the datasets listed above is necessary to enable the study team to achieve the primary objective of establishing whether the age women are when first invited for routine mammogram affects mortality from breast cancer. The level of the data held is identifiable. This is necessary because, although the applicant will pseudonymise the data before analysis, the study requires collation of data from other sources such as records from the National Breast Screening System and NHS England Cancer Outcome datasets. The use of identifiable data enables linkage of individual records from different sources. This agreement permits data retention only. Participant identifiable data and NHS England data will continue to be held in an area inaccessible to researchers. The data is minimised as follows: • Limited to a study cohort identified by the University of Oxford – 1,405,340 women born in England or Wales between 1945-1948 who were alive and on the National Health Application and Infrastructure Services (NHAIS) system (the system used to invite women to screening) at the beginning of the calendar year they turned 50. • Limited to data from 2008 to 2016 only. The University of Oxford is the sole data controller who also process the data for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing 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. This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. Funding is provided by Cancer Research UK. Funding is in place until March 2024 and is provided to the Nuffield Department of Population Health at the University of Oxford, who allocate funding to support this study. There are no other organisations acting in an advisory capacity or as part of an oversight or steering committee. The data provided by NHS England, or its predecessors will be retained for future research but will not be processed for the purposes described for the duration of this agreement. There is no public involvement in the study design.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. No data will flow to NHS England for the purposes of this Agreement. The study data, including data provided by NHS Digital under previous agreements, are currently held by the University of Oxford. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the University of Oxford storage address specified in this Agreement. No data will flow out of NHS England for the purposes of this Agreement. The following provides background on the processing activities undertaken for the original study: Under previous iterations of this Agreement, ONS provided the relevant Demographic and Civil Registry mortality/cancer data to the University of Oxford. Controllership of those datasets has since transferred to NHS England. The data contains directly identifying data items including: Names; NHS Number; Date of Birth; Postcode; and Gender, which are required to link the data at record level with data already held by the University of Oxford. The audit used data from the NHS Central Register (NHSCR) and the National Health Application and Infrastructure Services (NHAIS) systems. The study cohort was identified from NHAIS system as: all women born in 1945-1948 inclusive, who were alive and on the NHAIS system in England and Wales on 1st January of the year in which they turned 50. In the first instance, the study was piloted on the 1945 cohort i.e. women born in 1945 who were alive and on the NHAIS system in England and Wales on 1st January 1995. The data will not be transferred to any other location. The University of Oxford provided to ONS a list of women containing the following data items The data will be stored on servers in the Nuffield Department of Population Health (NDPH) at the University of Oxford only. a) date of birth Backup storage is located in three separate secure rooms within NDPH buildings. Backups should be useable in the event of a disaster at the main site and will be accorded the same physical & electronic protections as live data. b) NHS number The data will be held onsite at the premises of the University of Oxford. c) name The data will not leave England or Wales at any time. d) address This DSA permits retention of the data held within the Cancer Epidemiology Unit in the Nuffield Department of Population Health at the University of Oxford. Access is restricted to individuals within the Cancer Epidemiology Unit in the Nuffield Department of Population Health at the University of Oxford, who have authorisation from the Chief Investigator. All such individuals are substantive employees of the University of Oxford. e) health authority All personnel accessing the data have been appropriately trained in data protection and confidentiality. The following data was returned originally by ONS and subsequently (from 2008 onwards) by NHS Digital: The data has been linked at person record level to trial participants’ records from the National Breast Screening System and NHS England Cancer Outcome datasets. a) cancer registration, type and date There will be no requirement and no attempt to reidentify individuals using the pseudonymised data. b) death, cause and date Access to identifiable data will be restricted to the Senior Database Programmer for retention purposes and future linkage. No analysis or linkage will be conducted under this agreement.

Expected output

No new outputs will be produced under this Data Sharing Agreement. This agreement permits the retention of data only, there are no outputs expected under this agreement. In any future application, the applicant will be required to provide details of the outputs that were produced and disseminated by the study as well as details of any future outputs planned.

Expected measurable benefits

In any future application, the applicant will be required to provide details of the expected benefits resulting from the study. This agreement permits the retention of data only. The following describes expected benefits when research analysis is complete: The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study. The use of the data could: • help the system to better understand the health and care needs of populations. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. • inform planning health services and programmes, for example to improve equity of access, experience and outcomes. • inform decisions on how to effectively allocate and evaluate funding according to health needs. • provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed. The findings from this study are expected to increase knowledge on when women should be offered their first routine mammogram and will inform national breast screening policy. The findings have the potential to reduce the risk of dying from breast cancer. It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making national breast screening policy decisions. Clients will need to take action based on the information provided to them in order to realise the potential improvement opportunities. For example, the outputs of the study might result in a change to national breast screen policy. Research findings will be made accessible to the public via the Age at First Breast Screening Study website at www.ceu.ox.ac.uk/research/the-age-at-first-breast-screening-study which will provide links to open access papers and offer free downloads of accessible summaries of findings. The twitter handles at NDPH (@Oxford_NDPH) and Oxford Medical Sciences Division (@OxfordMedSci) with a combined following of over 11,000 will promote all significant findings. Presentation of research findings at conferences eg. The UK Interdisciplinary Breast Cancer Symposium, a biennial conference for all those with an interest in the prevention, early treatment and diagnosis of breast cancer and the National Cancer Research Institute Conference, an annual conference for all those in the cancer research community Presentation of research findings to the NDPH public advisory panel and the Million Women Study participant panel who advised on the study proposal and who will provide further advice on how to engage with the public around the study’s findings.

Benefits reported

In any future application, the applicant will be required to provide details of the actual benefits achieved as a result of the study. The study is unable to provide any yielded benefits as the study team are unable to undertake analysis until they have taken receipt of all of the data.

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

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

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

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

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