Tumours of the Central Nervous System: Incidence, Survival and Variation in Treatments (ODR1819_255)

The University of Oxford requires access to NHS England National Disease Registration Service (NDRS) data for the following research project: Tumours of the Central Nervous System: Incidence, Survival and Variation in Treatments (ODR1819_255).

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

1. Characterise the incidence of developing various types of primary Central Nervous System (CNS) tumours since 1971

2. Characterise survival following a primary CNS tumour diagnosis

3. Characterise the medical histories leading to a primary CNS tumour diagnosis

The study will further:

1. Characterise the causes of death attributed to patients dying after a diagnosis of a primary CNS tumour and the factors associated with this risk.

2. Characterise the risk of experiencing a further CNS tumour-related event among patients who have been diagnosed with a primary CNS tumour and the factors associated with this risk.

3. Characterise the risk of subsequent events that may be treatment-related.

The following NHS England National Disease Registration Service (NDRS) National Cancer Registration and Analysis Service (NCRAS) data have already been accessed in support of this study :

- NDRS Cancer registration– necessary to estimate CNS tumour incidence, mortality and survival rates

- NDRS Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to provide information on hospital admissions that may be related to the CNS tumour diagnosis and to describe hospital resource use

- NDRS Hospital Episode Statistics Outpatients (HES OP) - necessary to provide information on outpatient visits following a CNS tumour diagnosis and to describe hospital resource use

- NDRS Hospital Episode Statistics Accident & Emergency (HES A&E) - necessary to provide information on emergency admissions before and following a CNS tumour diagnosis

- NDRS Systemic Cancer Dataset (SACT) - necessary to provide information on chemotherapy treatments received by CNS tumour patients to describe usage and trends over time

- NDRS Radiotherapy Dataset (RTDS) - necessary to provide information on radiotherapy treatments received by CNS tumour patients to describe usage and trends over time

- NDRS Cancer Wait Times (CWT) – necessary to investigate relationships between wait times and CNS tumour diagnoses and their outcomes

Data was released for all individuals who had been diagnosed with a primary CNS tumour between 01/01/1971 to 31/12/2017.

The University of Oxford now wishes to request a refresh of the above-listed datasets for individuals diagnosed with a primary CNS tumour between 01/01/2018 to 31/12/2020.

All data already held, and data being requested is Pseudonymised

The data already held has been minimised as follows:

• Limited to data for a study cohort identified by the NDRS that includes all individuals diagnosed with a primary CNS tumour (defined by specific ICD codes)

• Limited to data for England

• Limited to data between 1st January 1971 and 31st December 2017

The data requested will be minimised as follows:

• Limited to data for a study cohort identified by the NDRS that includes all individuals diagnosed with a primary CNS tumour (defined by specific ICD codes)

• Limited to data for England

• Limited to data between 1st January 2018 and 31st December 2020

The University of Oxford is the controller as the organisation responsible for ensuring that the data will only be processed for the purpose described above. Only the University of Oxford processes the data for the purposes described above.

The lawful basis for processing personal data under the UK General Data Protection Regulation (GDPR) is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is as follows:

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 Nuffield Department of Population Health, University of Oxford funds the project.

Data will be accessed by:

A PhD student affiliated with the University of Oxford, who is undertaking this project in support of the completion of their PhD. The individual has completed mandatory data protection and confidentiality training and is subject to the University of Oxford’s policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of a substantive employee of the University of Oxford. The University of Oxford would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Agreement.

The project team have consulted individuals affected by a CNS tumour (patients and carers) via online support groups regarding the collection and analyses of the data for the purposes described above. This was achieved through individual discussions to identify aspects of research that are of relevance and importance to patients.

In line with the National data opt-out policy, opt-outs are not applied because the data is not Confidential Patient Information as defined in sections 251(10) and (11) of the National Health Service Act 2006.

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 Agreement.

NHS England will provide the relevant records from the following datasets to the University of Oxford:

NDRS Cancer Registration

NDRS Hospital Episode Statistics Admitted Patient Care (HES APC)

NDRS Hospital Episode Statistics Outpatients (HES OP)

NDRS Hospital Episode Statistics Accident & Emergency (HES A&E)

NDRS Systemic Cancer Dataset (SACT)

NDRS National Radiotherapy Dataset (RTDS)

NDRS Cancer Waiting Times (CWT).

Data will contain no direct identifying data items. The data will be pseudonymised and individuals cannot be reidentified through linkage under data in the possession of the recipient.

The data will not be transferred to any other location.

Pseudonymised data will be securely stored within the Nuffield Department of Population Health (NDPH) file store and will remain there until the end of the study.

The University of Oxford (Nuffield Department of Population Health) uses on-campus backup services.

The data will be accessed by authorised personnel onsite at the University of Oxford, and also on some occasions where necessary, via remote access (VPN). Where information is being accessed via VPN individuals are prohibited from downloading or copying data onto local devices.

The data will remain on the servers at the University of Oxford at all times.

The data will only be accessed within England.

Data will be accessed by a PhD student at the University of Oxford. The individual will act as an agent of the University of Oxford and will be operating under the supervision of substantive employees of the University of Oxford.

The data will be linked at the person record level with the dataset(s) already obtained from the National Disease and Registration Service, via a pseudonymised study (patient) ID.

Data will be analysed and processed by a PhD student of the University of Oxford for the purposes described above, and in support of the completion of their PhD.

The processing carried out thus far has produced the following outputs:

• Seminar at the Cancer Epidemiology Unit Seminar Series - Nuffield Department of Population Health (completed December 2019)

• Presentation at the Nuffield Department of Population Health Annual Symposium (completed January 2020)

• Presentation at the Yorkshire Brain Tumour Symposium (completed July 2022)

• Presentation at the British-Irish Meningioma Symposium Annual Symposium (completed October 2022)

• Presentation at the Yorkshire Brain Tumour Symposium (completed July 2022)

• Presentation at the British-Irish Meningioma Symposium Annual Symposium (completed October 2022)

• Presentation at Cancer Research UK Oxford Centre 2023 Annual Symposium (completed March 2023)

The expected outputs of the continued processing will be:

• Submission to peer-reviewed journals on an ongoing basis

• Presentation at the Nuffield Department of Population Health Annual Symposium (expected June 2023)

• Presentation at the British Neuro-Oncology Society Annual Conference (expected July 2023)

• Nuffield Department of Population Health DPhil Students’ Symposium (expected July/August 2023)

• Presentation at the British-Irish Meningioma Symposium Annual Symposium (expected September 2023)

• Submission of PhD thesis (expected January 2024)

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 the following dissemination channels:

• Journals

• Social media

• Posters displayed at conferences and symposia

• Press/media engagement

• Public promotion of the research – shared with major UK brain tumour charities such as Brainstrust, Brain Tumour Research, The Brain Tumour Charity, Brain Tumour Support

Outputs will be produced throughout 2023-2024 as described above.

The study has submitted abstracts to conferences and presented some of the results of our analyses at national conferences as well as seminars within the University of Oxford:

• Seminar at the Cancer Epidemiology Unit Seminar Series - Nuffield Department of Population Health (December 2019)

• Presentation at the Nuffield Department of Population Health Annual Symposium (January 2020)

• Presentation at the Yorkshire Brain Tumour Symposium (July 2022)

• Presentation at the British-Irish Meningioma Symposium Annual Symposium (October 2022)

• Presentation at Cancer Research UK Oxford Centre Annual Symposium (March 2023)

The study has had a manuscript on trends in CNS tumour incidence accepted in January 2023 by the leading scientific journal in the field of neuro-oncology, which is called Neuro-Oncology. https://doi.org/10.1093/neuonc/noad001

The findings of this research study are expected to contribute to evidence-based decision-making for national guidelines on CNS tumours, local decision-makers such as neurosurgeons and neuro-oncologists, and patients to inform best practices to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

• Help the NHS to better understand the health and care needs of the CNS tumour population

• Lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience of CNS tumour patients

• Advance understanding of regional and national trends in health and social care needs for CNS tumour patients

• Advance understanding of the need for, or effectiveness of, preventative health and care measures for the CNS tumour patient population.

The study team has regular contact with all the major UK brain tumour charities (Brainstrust, Brain Tumour Research, The Brain Tumour Charity, and Brain Tumour Support) and will optimise the potential public benefits from the use of the data by disseminating findings (in layperson language) to the tens of thousands of CNS tumour patients and their carers that are part of these groups.

The principal investigator of the study is also a member of the National Cancer Research Institute (NCRI) Brain Group which supports, oversees and facilitates collaborative research on brain and CNS tumours nationally, so the findings can reach a larger audience.

· The manuscript cited in the outputs has proven useful in providing the clinical community with detailed insights into the apparent long-term increase in incidence of CNS tumours in the English population. In particular it has yielded a potential explanation for the observed increases in incidence of non-malignant CNS tumours by identifying important differences in the methods of diagnosis.

· An extension of the work published in the aforementioned manuscript was presented to attendees of the largest annual national meningioma (the most common non-malignant CNS tumour) meeting. This (not yet published) research identified important geographic (regional) variation in national diagnoses of meningiomas and yielded important discussions and new collaborations in order to develop this work further and guide future clinical management.

· The data for this study were originally provided to us via Public Health England prior to NHS England becoming the data controller. Accessing these data has proven useful in allowing the principal investigator to spend extended periods of time thoroughly examining the quality of the national CNS tumour data and identifying areas of improvement which are necessary to conduct high quality and clinically relevant research into these tumours. As a result of this, the principal investigator, alongside two collaborators with experience in epidemiological research pertaining to CNS tumours, have established the Brain Tumour Data Improvement Initiative in early 2023. The goal of this initiative is to engage stakeholders at a national level including data stewards, data users, patients, clinicians, advocacy groups, funders, and charitable organisations in improving the completeness and quality of data on CNS tumours in cancer registries across the four nations. Initial meetings have already taken place and the initiative has attracted attention and support from the CNS tumour patient community, the director of a leading brain tumour charity, the chair of the NCRI Brain Tumour Group, as well as members of the CNS tumour clinical and research community nationally.