Yorkshire Cancer Research Bowel Cancer Improvement Programme - PROMs

The University of Leeds requires access to NHS England data for the purpose of the following research project: Yorkshire Cancer Research Bowel Cancer Improvement Programme (YCRBCIP). The overall aims of this programme are to evaluate how much bowel cancer outcomes can be improved by engaging with multidisciplinary teams (MDTs), by collecting, and feeding back to them high quality performance data and providing training and supervision for specialists where a need is identified.

The programme involves both retrospective and prospective data collection. Part of the prospective element involves the collection of two data components covered by one consent process: Patient Reported Outcome Measures (PROMs) and tissue samples. Bowel cancer patients are recruited from the 14 Colorectal Cancer MDTs based in the 14 hospital trusts across Yorkshire and the Humber. PROMs data are collected by asking participants to complete questionnaires covering a range of generic, cancer-specific and bowel cancer specific measures in addition to socio-demographic characteristics at three time points: baseline, twelve months post diagnosis and around three years post diagnosis. Tissue sample data are collected from some of their tissue that is excess to that required for diagnosis and treatment, and sent to the research team to undertake additional novel biomarker testing.

To increase the amount and depth of diagnostic and treatment information available, the prospective data need to be linked with existing routine datasets held by NHS England on an annual basis over the term of the agreement, including:

• NDRS National Cancer Registration Dataset

• NDRS Hospital Episodes Statistics (admissions)

• NDRS National Radiotherapy Dataset

• NDRS Systemic Anticancer Therapy Dataset

• NDRS Diagnostic Imaging Dataset

• NDRS Rapid Registration Dataset

The quantum of data required is to allow the research team an integrated dataset

which provides basic information about bowel cancer care in Yorkshire and high quality intelligence about the management of such patients.

The resulting linked dataset held by the University of Leeds will be identifiable. The data requested will be limited to the cohort of 2000 consented patients (once recruitment has been concluded in December 2025) who have consented to the PROMs and tissue study and to the data items required to answer the study aims. All patients are aged over 18 with a diagnosis of bowel cancer (ICD 10 code C18, 19 or C20) from 01/01/2018 onwards.

All episodes of data are requested 30 days prior diagnosis (with the exception of NDRS HES which is requested 24 months prior to diagnosis and NDRS DID’s which is requested 36 months prior to diagnosis), with 60-Mohths follow-up post-diagnosis.

The University of Leeds is the research sponsor and the data controller responsible for ensuring that the data will only be processed for the purpose described above. The research is funded by Yorkshire Cancer Research with funding in place until December 2026. This programme of work will likely be extended until 2030 with subsequent funding requests to be submitted. The funder will have no ability to suppress or otherwise limit the publication of findings.

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 is in the public interest as the funding from Yorkshire Cancer Research involved peer review and the study received ethical approval from the West Midlands – Solihull Research Ethics Committee (17/WM/0374) both of which provide reassurance that the research is in the public interest. The study was also approved by the Health Research Authority and granted approval for inclusion in the National Institute for Health Research's portfolio of studies in December 2017 (Project ID 227673).

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

University of Leeds are the joint data processor with Microsoft via the Leeds Analytic Secure Environment for Research (LASER) at the University of Leeds where data will be processed and stored. Microsoft Limited provides IT hosting services and IT back up services to the University of Leeds and will store copies of the data as contracted by the University of Leeds.

Members of the project steering group include individuals from Nuffield Department of Population Health at the University of Oxford and Leeds Teaching Hospitals NHS Trust. The individuals act only in an advisory capacity and will not be accessing the data. Data will only be accessed by employees and postgraduate students (PhD or MSc) registered with the University of Leeds. A student seeking access for their own purpose (eg: Masters project) is not covered under this permission.

Two patients and one carer are involved with the PROMs study and have been actively involved in discussing questionnaire content. They have provided feedback on the study protocol and documentation (cover and reminder letters, Information sheet and Consent form). They are members of the PROMs advisory group. In addition, the wider Yorkshire Cancer Research Bowel Cancer Improvement Programme (YCRBCIP) Project Group has a patient representative member who attends monthly meetings.

The national data opt-out does not apply where explicit consent has been obtained from the patient for the specific purpose.

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

The University of Leeds will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Study ID and date of consent) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the routine datasets (National Cancer Registration Dataset, Hospital Episodes Statistics, National Radiotherapy Dataset, Systemic Anticancer Therapy Dataset, Diagnostic Imaging Dataset, Rapid Registration Dataset) to the University of Leeds. The data will contain no direct identifying data items but will contain a unique study ID which can be used to link the data with other record level data already held by the research team. The data will not be transferred to any other location.

The disseminated data will be stored within the Leeds Analytic Secure Environment for Research (LASER), a secure Microsoft Azure cloud-based system provided by the University of Leeds.

LASER uses Microsoft Azure Backup Service to enable backup and restore of data from the Azure cloud.

The data will be accessed by members of the study analysis team via remote access, which comply with the following remote access obligations:

-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;

Access is restricted to employees and postgraduate students (PhD or MSc) registered with the University of Leeds who have authorisation from the Principal Investigator. All personnel accessing the data have been appropriately trained in data protection and confidentiality. It is prohibited to download or copy data to local devices.

The data will remain within LASER at all times. The data will not leave England/Wales at any time.

The data will be linked at person level. Patients are asked to consent to the collection of the PROMs data and collection of tissue samples within the same consent process. The PROMs data and the tissue data use the same study IDs allowing linkage without the need to access to any identifiable data.

The identifying details of consented patients will be stored in a separate environment to the linked dataset used for analysis. The environment storing identifiable data is only accessible to a limited number of the study team (not the same individuals with access to the linked pseudonymised data, where there will be no requirement and no attempt to reidentify individuals). Access to the identifiable data is via safe rooms on the University of Leeds campus and there is no access to external systems or the internet. Imports and exports are managed by the University of Leeds Institute for Data Analysis (LIDA) who manage the LASER platform. All imports and exports are verified, and an audit log kept.

Researchers from the University of Leeds will analyse the data for the purposes described above.

The study team will examine quality of life outcomes of bowel cancer patients across the region, identify areas where outcomes could be improved and develop educational programmes and interventions to address them. Regular updates will be provided to participating Hospital Trusts about the outcomes of the patients they treat.

The expected outputs include:

• Reports sent to the MDTs across Yorkshire and to Yorkshire Cancer Research (the funder) - annual reports plus ad hoc in-depth reports

• Submissions to peer reviewed journals – at least 1 each year

• Presentations to the wider YCRBCIP team (monthly steering group and annual workstream events).

• Presentations at appropriate colorectal cancer or PROMs conferences (annually at The Association of Coloproctology of Great Britain and Ireland ACPGBI in July) (UK national PROMS conference in June)

• Publication of results on YCRBCIP website https://ycrbcip.leeds.ac.uk/

The outputs will only contain aggregated information with small numbers suppressed in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

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

• Journals

• Educational events open to clinical teams, patients and carers

• Social media (through YCRBCIP, University of Leeds, Yorkshire Cancer Research)

• Direct engagement with MDTs across the study region

• Annual study event highlighting programme progress and key achievements

• Presentations/posters at appropriate conferences such as The UK Patient Reported Outcome Measures (PROMs) Research Conference, Cancer Research UK Data-driven cancer research conference and The Association of Coloproctology of Great Britain and Ireland (ACPGBI) Annual Meeting.

• Press/media engagement in response to publication of journal articles and/or other outputs

• Reports given to Yorkshire Cancer Research to provide information on the outcomes of bowel cancer patients across Yorkshire, to inform their future activities

Target dates for production and dissemination of the outputs are from Spring 2024 onwards. The programme is currently funded until October 2025.

The findings of this research programme are expected to inform best practice to improve the care, treatment, experience, and outcomes of bowel cancer patients across the Yorkshire and Humber region. The programme hopes to contribute to the knowledge and understanding of the reasons for differences in outcomes across the region. The PROMs data will enrich other study data and allow for an ‘in-depth’ description of what life is really like for patients with bowel cancer at diagnosis and subsequently.

The use of the data could:

• help the system to better understand the health and care needs of bowel cancer patients.

• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

• advance understanding of regional and national trends in health and social care needs.

• inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

• 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.

• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

At present, the patient voice is not ‘measured’ routinely as part of clinical practice, neglecting the impact of illness and treatment on the everyday lives of patients. This work aims to capture patient-reported information and feed it back to clinical teams to inform, and ultimately improve, outcomes. Looking to the future, such information can inform the integration of PROMs administration into clinical practice. The PROMs used in this study have been selected with input from experts in colorectal cancer and psychosocial care: patients, clinical nurse specialists and doctors. Although the length of the questionnaire would not be feasible to administer in everyday practice, information on which PROMs provide the most meaningful data will be obtained. In the future, risk-stratified follow-up may incorporate clinical indicators and key quality of life indicators to inform the best supportive care.

The funder, Yorkshire Cancer Research, are fully aware of the work undertaken within the programme and will be regularly updated on the results generated. Where it aligns with their priorities, actions can be taken to optimise the potential public benefits from the use of the data and to advertise the findings to a wider audience.

Due to the impact of Covid on site recruitment capacity, the recruitment deadline was extended (from September 2024 to December 2025) and the target recruitment number reduced from 2500 to 2000. This has resulted in preliminary analyses being undertaken, with full analysis and dissemination delayed until 2026 and the resulting yielded benefits being realised.