An ongoing case-control study to evaluate the NHS Bowel Cancer Screening Programme (ODR1516_019)

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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_019. 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 London (QMUL) requires access to NHS England data for the purpose of the following research project: An ongoing case-control study to evaluate the NHS Bowel Cancer Screening Programme (ODR1516_019) The following is a summary of the aims of the research project provided by QMUL: [1 paragraph unchanged] This DSA permits the retention of identifiable NDRS Cancer Registry data previously disseminated by PHE. The data disseminated was limited to individuals diagnosed with Colorectal Cancer between January 2012 to December 2013. 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_019. Following the dissolution of PHE in October 2021 the NDRS function transferred to NHS England, which is now responsible for assessing requests for access to/continued access to NDRS data. 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 NHS England Data will be accessed: · NDRS Cancer Registry data previously disseminated by PHE. The level of the Data will be: · Identifiable The data disseminated was limited to individuals diagnosed with Colorectal Cancer between January 2012 to December 2013. QMUL is the controller and processor 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. 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

Processing activities

No data will flow into to or out NHS England for the purposes of NHS England. this Data Sharing Agreement (DSA). This Agreement permits continued retention and processing of data already disseminated only. 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. 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 at any time. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. [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 being processed. There will be no requirement and no attempt to re-identify individuals when using the Data. The data will only be processed by substantive employees of QMUL who have received appropriate training in data protection and confidentiality.

Expected output

[2 paragraphs 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. While the primary results have been published (Castanon et al, J Natl Cancer Inst 2022; 114: 1262-9), showing a reduction in Dukes D stage cancer with screening, the data set also affords us an opportunity to study the effects of the screening on other stages of disease. In addition, some sensitivity analyses with respect to potential biases are indicated. These are the motivations for the request to extend the agreement.

Expected measurable benefits

The study aims to feed into a body of research that may be used by relevant bodies to improve the national screening programme for bowel cancer. The major benefit is the estimation of the benefit of the bowel screening programme in terms of its effect on incidence of late stage disease. As noted below, the primary results have been published (Castanon et al, J Natl Cancer Inst 2022; 114: 1262-9), showing a reduction in Dukes D stage cancer with screening. However, the data set also affords us an opportunity to study the effects of the screening on other stages of disease. In addition, some sensitivity analyses with respect to potential biases are indicated. For these reasons we are requesting an extension to the data sharing agreement.

Benefits reported

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The primary results have been published (Castanon et al, J Natl Cancer Inst 2022; 114: 1262-9), showing a reduction in Dukes D stage cancer with screening.

FEBRUARY 2024 ACR UPDATE:

QMUL have published results showing that the bowel screening programme is reducing the rate of advanced stage disease and is on target to reduce mortality from colorectal cancer:

Castanon A, Parmar D, Massat NJ, Sasieni P, Duffy SW. Benefit of Biennial Fecal Occult Blood Screening on Colorectal Cancer in England: A Population-Based Case-Control Study. J Natl Cancer Inst 2022;114:1262-9