Bowel-Star UK: Risk-Stratification Study

The programme will be run separately in Scotland, sponsored by ACCORD (a partnership between the University of Edinburgh and NHS Lothian) and Queen Mary University of London in England. A Clinical Collaboration Agreement has been signed by all participating institutions.

The Bowel-Star-UK programme comprises of the following aims:

Through analysis and modelling of existing datasets within the UK NHS Bowel Screening Programmes in England and Scotland to examine:

The feasibility and outcomes of stratified colorectal cancer (CRC) screening based on faecal haemoglobin (fHb) concentration, rather than a single cut-off threshold

Whether a risk assessment process, based on age, sex, Polygenic Risk Score (PRS), family history and lifestyle factors can improve screening performance, over and above fHb concentration-based stratified screening alone

The acceptability of these approaches to participants and practitioners

The impact of stratified screening on organisational processes and costs within the NHS Bowel Cancer Screening, health inequalities and engagement of diverse ethnic minorities

Whether stratified CRC screening within NHS Bowel Screening Programmes can lead to improvements in cost-effectiveness.

The programme comprises of six work packages. This Data Sharing Agreement (DSA) is related to Work Package 1, which involves the extraction and analysis of data from the NHS Bowel Cancer Screening Programme (BSCP) and NDRS Cancer Consolidated and Civil Registration of deaths datasets held by NHS England.

For this work package, the data will be used for the following primary objective:

To analyse and model existing Faecal Immunochemical Testing (FIT) and colonoscopy data from the NHS Bowel Cancer Screening Programme to produce best-available estimates of pathology associated with specific faecal haemoglobin (fHb) levels.

The data will also be used for the following secondary objectives:

· To review existing models examining personal bowel cancer risk factors and Colorectal Cancer (CRC), advanced adenomas and other relevant bowel pathology, to understand how these models might perform in the presence of known fHb levels

· To use both empirical and micro-simulation modelling to identify ‘pre-threshold fHb levels’ with estimates of screening outcomes and costs, for use in the Work Package 2 cohort study (outputs produced through analyses for Work Package 1 will be used to inform planning for Work package 2).

NHS England will create a cohort of individuals who were invited to the NHS Bowel Screening Programme from June 2019.

NHS England will provide the relevant records from the NDRS Cancer Registration, Civil Registrations of Death and NHS Bowel Screening datasets (including screening and colonoscopy data, date of invitation and date FIT kit was returned) to QMUL.

The Data will contain no direct identifying data items but will contain a unique person ID which will be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at the QMUL Data Safe Haven (DSH).

The Data will be accessed onsite at the premises of QMUL and the data will be accessed by authorised personnel via remote access.

The Controller must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

· Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

· Access controls granting users the minimum level of access required are in place;

· Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

· Multifactor authentication (MFA) is required for remote access;

· Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

· All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The expected outputs of the processing will be:

· A report of findings to UK National Screening Committee

· Submissions to peer reviewed journals within 12 months of end of analysis period

· Presentations at academic conferences, specifically those aimed at the cancer early detection and screening community.

The outputs will be communicated to relevant recipients through the following dissemination channels:

· Journals

These further studies are expected to contribute to evidence-based decision-making for the NHS to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study, that is Bowel Cancer Screening invitees.

This is the first work package of six that form the BowelStar programme. The study aims to extract the maximum value from existing screening data, as a prelude to conducting ‘real world’ studies. Although this work package will not result in direct benefits to patients it will inform the subsequent studies, that will benefit patients who are found to be at a higher risk of developing colorectal cancer by the implementation of risk-based CRC screening in the UK.

The programme of work will produce outputs which will facilitate the implementation of risk-based CRC screening in the UK. It will address current evidence gaps, and identify strategies for overcoming barriers to risk-based screening. It is hoped that a risk-based screening program for CRC will be implemented with evidence gained from this work.

As the results of this part of the programme of work is to inform the further work, QMUL do not envisage sharing or advertising the results. However, results from the subsequent work will be communicated to NHS England to inform screening programme improvements and cancer care pathways.

Summaries of key findings will be written in plain English and shared via the Bowel-STAR project webpage, as well as through press releases, conferences etc to reach a broader public audience.

Findings will be presented to the patient and public involvement (PPI) group associated with the project, ensuring results are interpreted in a meaningful way for lay audiences.

QMUL have engaged with charities such as the BowelBabe fund through their funders, CRUK to inform them of the programme and its aims.

Yielded Benefits is not a requirement for new applications.