Evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire: A cluster randomised GP feasibility trial (DOORSTEP)

The University of Hull requires access to NHS England data for the purpose of the following research project:

Evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire: A cluster randomised GP feasibility trial (DOORSTEP)

The following is a summary of the aims of the research project provided by the University of Hull:

Breast cancer is the third most commonly diagnosed cancer in Yorkshire, causing more than 800 deaths per year in the region. Breast screening is one of the key tools to help diagnose breast cancer at an early stage and improve survival rates. Across Yorkshire, in the three years up to 2019/20 an average of 28.6% of invited women had not attended their appointment. Among the non-attenders, a major reason was the difficulty in travelling to the appointment.

This study will assess whether offering free, bookable, door to door transport to and from breast cancer screening appointments could increase the number of women attending screening, by comparing two groups.

1. Intervention arm- Women registered at GPs in group one will receive information about booking free transport alongside their breast screening invitation.

2. Control arm- Women registered at GPs in group two will receive the breast screening invitation as normal with no additional offer of transport.

Permission to use data collected by the Breast Screening Service on women invited for a breast screening appointment will be obtained.

The study expects that providing free transport will increase the overall screening rates, resulting in earlier breast cancer diagnosis and improved survival rates. The findings from this study will inform a larger study.

As a feasibility trial, the primary aim is to assess the feasibility of conducting the future definitive RCT.

The primary feasibility outcomes are:

1. Number of GP practices that agreed to participate and were randomised ahead of the scheduled breast screening invitation window.

2. Percentage of women invited from GP practices located in the 10% most deprived areas.

3. Percentage of intervention invites sent out by the BSS to all women during the scheduled breast screening invitation window.

4. Percentage of women who requested transport who were transported to and from their appointment by the service.

5. Acceptability of the intervention to the women and the service providers.

6. Completion and transfer of the screening and transport service data when required for analysis.

The secondary outcomes are summarised below and are the intended outcomes for the definitive trial, and the data that will help inform sample size calculations for the phase III trial.

1. Screening uptake rates– percentage attendance at screening appointments, exploring if there is a signal of efficacy (increase in screening rates in the transport intervention arm compared to usual care).

2. Transport Intervention uptake rates.

3. Cost-effectiveness – reporting estimates of cost-effectiveness of the transport intervention.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care – necessary because this is the only dataset which contains ethnicity/deprivation data held by NHS England.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• Limited to a study cohort of Hull of 8000 women aged 50- 70

• Limited to data between 1997 and 2024;

• Limited to the following geographic areas: East Riding of Yorkshire (ERY) and Kingston-Upon-Hull (Hull) areas

University of Hull 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 study is being hosted and managed by Hull Health Trials Unit (HHTU) within the Faculty of Health Sciences at the University of Hull.

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.

The funding is provided by Yorkshire Cancer Research. The funding is specifically for the trial described.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Arrow Business Communications Ltd (ARROW) provides IT hosting services to the University of Hull and will store the Data as contracted by the University of Hull. Arrow Business Communications Limited role is solely limited to provisioning, securing and back-up of the Data Safe Haven.

A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.

The Public Advisory Group is made up of 4 women of breast screening age. The group will help to develop the travel survey and ensure that the information provided to participants is written in Plain English. They will be involved in discussions about accessing NHS breast screening data, and the cost effectiveness evaluation. Initial findings will be reviewed for sense checking, and advice on dissemination of the results. They will also be in involved in evaluating the trial and helping to plan the next stage of the research. One woman will join the Trial Management Group, and two women will join the Trial Steering Committee.

Humber and East Yorkshire Breast Screening Service will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, GP practice code and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC dataset to University of Hull. The Data will:

• contain no direct identifying data items but will contain a unique person ID which can 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 within the University of Hull Data Safe Haven (DSH).

The Data will be stored within the University of Hull Data Safe Haven (DSH). This is a Trusted Research Environment (TRE) hosted by Arrow Business Communications Limited.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) 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).

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to individuals within the Hull Health Trials Unit (HHTU) within the Faculty of Health Sciences at the University of Hull who have authorisation from the Principal Investigator. All such individuals are substantive employees of University of Hull.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with routine screening attendance data from the NHS Breast Screening Programme (NHSBSP).

There will be no requirement and no attempt to reidentify individuals when using the Data.

All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the Hull Health Trials Unit (HHTU) within the Faculty of Health Sciences at the University of Hull will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• The study protocol manuscript publication

• Study design synopsis

• Final Study Report

• Submissions to peer reviewed journals

• through local and other relevant clinical networks

• Presentations to national and international meetings

• Participants will be sent a summary of the findings, if requested

• Publication of protocol on the CI and HHTU website.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset from which the information was derived.

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

• Journals

• Poster produced for the University of Hull TRANSFORM event

The services provided to clients are expected to identify improvement opportunities which the client may then exploit by making changes to systems, processes, resources or infrastructure in order to improve patient experience and patient care.

The use of the data could:

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

Women registered at GP practices in the intervention arm will directly benefit from the offer of free door-to-door transport to get to and from their breast screening appointments. They anticipate at least one additional woman to receive a breast cancer diagnosis following attending a screening appointment within the feasibility trial.

This trial will assess the feasibility of conducting a large-scale, definitive, Phase III GP RCT. The research will asses if there is a signal of efficacy, estimate cost effectiveness and data will inform sample size calculations for the future trial. The future benefits include the submission of a funding application in Year 3 for the future definitive trial targeting Yorkshire. There is also potential to expand and apply the findings from this study to other cancer screening programmes where people have to travel to the screening provider (e.g. cervical, lung, prostate, colorectal).

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 policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Not stated in the register.