A service evaluation to review the baseline demographics of patients undergoing radical treatment for oropharyngeal cancer – and a comparison with the TORPEdO study cohort

The Institute of Cancer Research (ICR) requires access to NHS England data for the purpose of: A service evaluation to review the baseline demographics of patients undergoing radical treatment for oropharyngeal cancer – and a comparison with the TORPEdO study cohort.

Proton beam therapy (PBT) is an advanced type of radiotherapy used to treat cancer. It uses protons, rather than photons (X-rays) to deliver radiotherapy. Whilst standard photon (X-ray) radiotherapy passes through the body during treatment, protons can be delivered to the cancer and then stop inside the body, avoiding an exit dose. This can reduce the radiotherapy dose to surrounding healthy tissues and may reduce side-effects for patients. Globally, doctors agree that most children and young adults with cancer may benefit from protons. However, there is little strong scientific evidence that adults with cancer gain meaningful clinical benefit from PBT, especially when compared with advanced photon (X-ray) radiotherapy techniques.

Until recently, NHS patients who needed PBT were offered treatment abroad as part of the NHS Protons Overseas Programme. In recent years, two UK NHS PBT centres have opened, one at the Christie hospital in Manchester and one in University College London Hospital in London. The UK approach to delivering this new technology, is that all patients are either offered treatment as part of routine commissioning (i.e. for children and young adults where the benefit is undisputed), or as part of a study or trial evaluating the benefit of PBT. In this way, the UK will build a portfolio of research identifying which patients benefit most. Where available, trials are discussed with eligible patients within NHS clinics, and patients are asked if they would like to voluntarily participate. There is concern that trials which are limited to certain areas of the country, and for which patients may need to relocate for treatment, such as with PBT, may not represent the general UK population. Patients with some characteristics may be more or less likely to participate in trials. This project aims to explore this.

The only PBT trial that has completed recruitment in the UK is called TORPEdO. TORPEdO randomised patients with oropharyngeal cancer to receive either PBT or photon (X-ray) radiotherapy. It was led by The Christie Hospital and managed by the Institute of Cancer Research Clinical Trials Unit (ICR-CTSU).

The following is a summary of the aims of the processing provided by or on behalf of ICR:

This project will undertake a service evaluation of all patients treated with radiotherapy for oropharyngeal cancer in England, and compare the demographics found in this general population with that of patients participating in TORPEdO. A particular focus will be given to: age, gender, ethnicity, aspects of patient fitness, geographic location (across the UK, rural location, or distance from a radiotherapy centre), socioeconomic group, and co-morbidities, smoking, alcohol use. The recruitment rate, and the impact of COVID-19, will also be considered. To decide whether the group of patients participating in TORPEdO are representative of the general population, any difference between the two groups will be carefully evaluated.

It is important that patients whose data are used in the evaluation reflect the general population. If patients with certain characteristics (e.g. characteristics related to age, ethnicity, gender, or geography) are under-represented, it may mean that certain patient groups are “missing out”, that conclusions may not be “true” for the population as a whole, and thus it may lead to commissioning decisions that don’t take into account the needs of the whole population. This could lead to worsening healthcare inequalities.

If the project identifies patient characteristics which are under-represented in the trial, strategies to mitigate this will be considered and lessons will be shared with investigators designing future PBT studies, as well as patients and advocate groups linked with PBT treatment. The conclusions will also be of interest to commissioners, who decide on provision of PBT within the NHS.

The following NHS England Data will be accessed:

• NDRS Linked HES APC- required to provide information on baseline demographics, in particular co-morbidities.

• NDRS National Radiotherapy Dataset (RTDS)- required to identify patients who have undergone radical oropharyngeal cancer chemoradiotherapy – by reviewing treatment details such as the radiation dose and intent of treatment.

• NDRS Systemic Anti-Cancer Therapy Dataset (SACT)- required to identify patients who have undergone radical oropharyngeal cancer chemoradiotherapy – by reviewing which patients receiving cisplatin chemotherapy as part of their treatment. It also provides details of baseline demographics such as performance status and BMI.

• NDRS Cancer Registrations- required to both identify patients who underwent radical oropharyngeal cancer chemoradiotherapy, and for consideration of baseline demographic data (e.g. age, gender, geographic location, ethnicity, socioeconomic group etc.)

The level of the Data will be Pseudonymised.

The Data will be minimised by requesting data for patients using the following criteria:

1. Diagnosed with oropharyngeal cancer (including ICD10 codes of C09 Malignant neoplasm of the tonsil; and C10 Malignant neoplasm of the oropharynx).

2. Diagnosis in the years 2019 onwards.

3. Patient aged at least 18 years old at time of diagnosis.

4. Treated delivered with external beam radiotherapy (photons or protons).

The Data will also be minimised to the following periods:

• NDRS Cancer Registry data from 01/01/2019 onwards (for all available data), and linked data:

• RTDS data: for 6 months prior and 24 months post diagnosis

• SACT data: for 6 months prior and 24 months post diagnosis

• HES APC: for 24 months prior and 24 months post diagnosis

Data will also be supplied pertaining to any other registered malignancy diagnosis for each patient identified in the criteria above.

Institute of Cancer Research (ICR) is the controller and sponsor and is the organisation responsible for ensuring that the data will only be processed for the purpose described above. Data will be processed by ICR.

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)(i) – public health - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy;

This processing is in the public interest because it will reveal the baseline characteristics of patients receiving radiotherapy as part of radical oropharyngeal cancer treatment in England. By comparing the demographics of patients in the trial with those found in England, under-represented patient characteristics will be identified. This is very important when considering the optimal use and provision of advanced radiotherapy technologies across the NHS. The project will explore strategies to overcome the under-representation of patient groups within trials, and thus improve healthcare inequalities.

The funding is provided by the "The Head and Neck Radiotherapy Charity". The funding is specifically for the project described. Funding is ongoing, with the expectation the project will be undertaken in the next 12 months approximately. The funder will have no ability to suppress or otherwise limit the publications of findings

Data will be accessed by substantive employees of the ICR and PhD students enrolled with The ICR. Any PhD student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to The ICR policies on data protection and confidentiality. Any PhD students accessing the Data will do so under the supervision of a substantive employee of The ICR. The ICR would be responsible and liable for any work carried out by PhD students. These PhD students would only work on the Data for the purposes described in this DSA.

Public and Patient Involvement and Engagement (PPIE) advocates strongly support the project and have helped to refine its design. Individual PPIE advocates will continue to work alongside the project to support the data interpretation and dissemination of its key results. Key PPIE advocates include:

- Director of services and policy at the Brainstrust charity and the PPIE representative for the National Proton Beam Therapy Strategy Group (ex-NCRI CTRad group).

- The RMH / ICR PPI group.

- The RMH and ICR Equity Diversity and Inclusion champions, and group. This is a diverse group with a specific interest in considering the factors that impact public engagement within research that meets regularly.

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

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the NDRS datasets to the ICR. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location. The Data will be stored on servers at ICR.

The Data will be accessed, onsite at the premises of the organisation(s), or remotely on ICR computers on the ICR secure data environment and that are password protected. Data will always remain in the on-site host environment even when working remotely.

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.

- 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 Data will not leave England /Wales at any time.

Access to the dataset will be limited to individual user accounts and will be restricted to named employees (named ICR staff and ICR PhD students), involved in this project.

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

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

Researchers from the ICR will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals – expected submission of a paper to a peer reviewed journal within approximately 12 months of receiving the data.

• Presentations at national / international scientific conferences- these include: international radiotherapy conferences such as ESTRO, ASTRO, international proton beam therapy conference such as PTCOG, or national head and neck conferences such as YORK or BAHNO. These conferences are expected to be within 12 months of receiving the data.

• Lay summaries will be produced to share with interested patient groups – this will be supported by the PPIE groups involved with the project

• This work is primarily for patient benefit, but will also be included in a PhD thesis

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(s) from which the information was derived.

The outputs will be communicated to relevant recipients through Social media e.g. photos of the presentation at a conference posted on social media (e.g. the ICR-CTSU social media activities).

The project results will be of interest to, and will be shared with, PBT highly specialised radiotherapy commissioning policymakers within NHS England, and the proton trial strategy group in the UK.

The data processing will take place within 12 months of receiving the data and will be published promptly thereafter.

The UK proton beam radiotherapy roll-out strategy is centred on delivering an ambitious PBT trial portfolio, with the aim of developing a well-informed, ethical and equitable PBT service. Learning from the successes and limitations of early trials, such as TORPEdO, will support stronger and fairer future PBT trial design and development.

The project aims to identify patient groups who are underserved by PBT trials. This will provide insight into where to focus when supporting patients to consider trials. The project may lead to future research into strategies to mitigate health disparities and promote equity, diversity and inclusion within trials.

It is expected that this project may support decision making, specifically in terms of:

• Routine commissioning policy decisions regarding proton beam therapy. In particular, the potential ongoing provision of radical PBT for oropharyngeal cancer following the completion and publication of TORPEdO trial.

• Design and delivery of future PBT trials / studies, a major part of NHS England PBT Strategy in the UK.

• Healthcare policies used to reduce healthcare inequality in England.

As above, the project investigates the recruitment of patients to PBT trials. The project aims to identify patient groups that are underserved within trials, and thus support future research into strategies which mitigate obstacles to trial recruitment. This will improve equity, diversity and inclusivity within trials, and thus support fairer radiotherapy commissioning.

It is only by recognising the current inequalities in healthcare that they can then start to be addressed. The project will identify patient characteristics or demographics which are associated with under-representation within PBT trials. This may impact how trial results are interpreted and view the success of the current radiotherapy trial service. The study will also generate hypothesis for the causes for under-representation of patient groups, prompting future research into potential mitigating strategies. Key to this will be the involvement of PPIE advocates already involved in the study. The roles of trial design, service delivery structures and patient and public factors will be considered. Results will be distributed to a wide range of stakeholders.

The project is supported by multiple PPIE advocates and groups, including a director of a charity, and a group focused on improving equity diversity and inclusion within healthcare trials. Should the findings warrant it, and with guidance and support of the PPIE advocates, the results will be disseminated to a wide public audience. This might include, as appropriate, advertising the results on social media (including The Institute of Cancer Research social media platforms), discussion and presentations with charities, as well as presentation to potential future PBT trial investigators and conferences.

Not stated in the register.