An on-going case-control study to evaluate the NHS Breast Screening Programme (NHSBSP) (ODR1516_167)

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

Objective for processing

[14 paragraphs unchanged] The study has support under section 251 of the NHS Act 2006 to enable the common law duty of confidentiality to be temporarily lifted so that confidential patient information can be processed without consent. Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Benefits reported

[3 paragraphs unchanged] It is taking longer than expected to finish the other two planned [15 words unchanged] effect on case fatality. However, these are at an advanced stage, and we anticipate it is anticipated that work will be complete by late 2024. completed during 2025.

Unchanged: Processing activities, Expected output, Expected measurable benefits.

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

Objective for processing

Queen Mary, University London (QMUL) requests to retain the National Disease Registration Service (NDRS) data previously disseminated by Public Health England (PHE) under the reference ODR1516_167. Following the dissolution of PHE in October 2021 the NDRS function transferred to NHS Digital, since this time NHS Digital have merged into NHS England, which is now responsible for assessing requests for access to/continued access to NDRS data. Queen Mary University of London (QMUL) requires access to NHS England data for the purpose of the following research project: An on-going case-control study to evaluate the NHS Breast Screening Programme (NHSBSP) (ODR1516_167) The following is a summary of the aims of the research project provided by QMUL: [2 paragraphs unchanged] QMUL is the sole data controller and data processor and is responsible for ensuring that data is only processed in line with the purposes set out in this Agreement. The following NDRS datasets are already held: - NDRS Cancer Registrations The level of the Data is: - Identifiable QMUL is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed 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.

Processing activities

No data will flow into or out of NHS England. This Agreement permits continued retention and processing of data already disseminated only. No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). [1 paragraph unchanged] All data retained is strictly confidential and will be stored on a secure database at QMUL. Access to the database will be controlled using a user-specified username and password. No other users other than the Senior Data Manager will have access to identifiable data. There will be no attempt or requirement to re-identify individuals from the pseudonymised data being processed. The Data will be stored on servers at QMUL. The data will only be processed by substantive employees of QMUL who have received appropriate training in data protection and confidentiality. The Data will not leave: England/Wales at any time. Access is restricted to employees or agents of QMUL who have authorisation from the Principal Investigator. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Analysts from QMUL will analyse the Data for the purposes described above.

Expected output

[1 paragraph unchanged] All results published or shared The outputs will not contain NHS England Data and will only contain aggregated data information with small numbers suppressed as appropriate in line with the relevant anonymisation guidance disclosure rules for the dataset(s) from which the information was derived. The team have published two of the planned outputs from this project, the effect of the NHS breast screening on mortality from breast cancer (https://pubmed.ncbi.nlm.nih.gov/33223536/) and the effect of the programme on incidence of breast cancer (https://pubmed.ncbi.nlm.nih.gov/35851849/). It is taking longer than expected to finish the other two planned outputs, the estimation of the programme's effect on incidence of advanced stage disease and its effect on case fatality.

Expected measurable benefits

[1 paragraph unchanged] The team have two planned outputs outstanding, the estimation of the effect of the NHS Breast Screening Programme on stage of disease, and the estimation of its effect on case fatality, in particular estimating the proportions of the survival benefit attributable to stage of disease and the proportion attributable to variations in therapy by screening status.

Benefits reported

Not stated in the previous version; added here.

The team have published two of the planned outputs from this project,

(1) the effect of the NHS breast screening on mortality from breast cancer (https://pubmed.ncbi.nlm.nih.gov/33223536/), showing a substantial and significant reduction in breast cancer mortality with screening, and a longer lasting protection in older women.

(2) The effect of the programme on incidence of breast cancer (https://pubmed.ncbi.nlm.nih.gov/35851849/), finding that overdiagnosis is at worst modest, and that there is no increase in aggressive therapy with screening.

It is taking longer than expected to finish the other two planned outputs, the estimation of the programme's effect on incidence of advanced stage disease and its effect on case fatality. However, these are at an advanced stage, and we anticipate that work will be complete by late 2024.