Understanding and improving the use of investigations in primary care in patients subsequently diagnosed with cancer (ODR2122_2510)

University of Exeter requires continued access to NHS England Data for the purpose of the following research project:

Understanding and improving the use of investigations in primary care in patients subsequently diagnosed with cancer. ODR2122_2510

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

A study to find out whether, when, and how GP tests can be improved for patients who consult with new symptoms and then go on to be diagnosed with cancer.

Cancer is the leading cause of death in England. Diagnosing cancer at an earlier stage of the disease can improve quality of life and medical outcomes for patients. This is shown in the NHS long term health plan published in January 2019 which set a goal of diagnosing 75% of cancers at an early stage by 2028.

Most people diagnosed with cancer first seek help (consult) for symptoms with their GP (primary care). GPs can investigate these patients with different tests carried out in the community or at the hospital (such as blood tests, imaging, etc.). However, there is little research looking into how often and in what circumstances they are used (or under-used), and whether their use differs between GPs and what causes these potential differences. Additionally, some tests may take some time to arrange which could prolong a patient’s time to hospital referral and cancer diagnosis, but it is not fully understand how often this may happen.

The aim of this study is to address these evidence gaps by looking at the data collected as part of the National Cancer Diagnosis Audit (NCDA).

The University of Exeter, in partnership with University College London (UCL), will access cancer registration and diagnosis audit data collected by the National Cancer Registration and Analysis Service (NCRAS; the cancer registry in England) on patients whose tumours are recorded in the NCDA 2014 (collected during 2016/17) and NCDA 2018 (collected during 2019/20). This will include information such as, age, ethnicity and details of their diagnosis.

Researchers will analyse this data to find out: (1) how primary care investigations are used by GPs in patients diagnosed with cancer, who is more or less likely to be investigated, and the potential impact of investigations on the diagnostic process. And (2) the healthcare system factors that might be influencing between practice variation investigation use and evidence to guide quality improvement efforts.

Before the dissolution of Public Health England (PHE), this request was managed by the PHE Office for Data Release (ODR) under the reference ODR2122_2510. All data being retained under this Agreement was previously disseminated by the ODR.

The following NHS England Data will be accessed:

• NDRS National Cancer Diagnosis Audit (NCDA)

• NDRS Cancer Registrations

Access to the above datasets is necessary because they provide information that is integral to achieving the aim of the study to diagnose cancer earlier.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

Limited to a study cohort identified by NHS England as meeting the following criteria:

• Male and/or female

• Aged: all ages

• Diagnosed with a primary invasive tumour (C00-97x), excluding C44x

• WHERE DATEOFDIAGNOSISBEST in AT_TUMOUR_ENGLAND is between 01/01/2014 and

31/12/2014 OR 01/01/2018 and 31/12/2018

• AND included for case note review by their GP practice in the National Cancer Diagnosis Audit in either 2014 or 2018.

• Restricted to England (using ctry_code = E)

University College London as the research sponsor, and the University of Exeter as the main collaborator, are joint controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above.

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 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 Cancer Research UK. The funding is specifically for the project described. The funder will have no ability to suppress or otherwise limit the publication of findings.

This project is supported by a Cancer Research UK Early Diagnosis Advisory Group EDAG. The study benefits from oversight/steering by the National Cancer Diagnosis Audit methodology/steering groups, with input from colleagues at the UCL and Cancer Research UK. Neither CRUK nor UCL will have access to the data held under this Agreement.

Data will be accessed by:

• Undergraduate, Masters or PhD students affiliated with UCL. Any student working with the data held under this Agreement must have completed mandatory data protection and confidentiality training and are subject to UCL’s policies on data protection and confidentiality. Any students accessing the data will do so under the supervision of a substantive employee of UCL. UCL would be responsible and liable for any work carried out by students. These students would only work on the data for the purposes described in this Agreement.

No data will flow to NHS England for the purposes of this Agreement.

No data is being disseminated under this Agreement. University of Exeter wish to retain NDRS NCRAS data previously disseminated by the PHE ODR. The data contains no direct identifying data items. The data is pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The data will be stored on servers at University of Exeter.

The Data will be accessed onsite at the premises of University of Exeter only.

The data will not leave or be accessed outside the UK at any time.

Access is restricted to employees or agents of University of Exeter who have authorisation from the study lead.

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

The data will not be linked with any other data.

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

Analysts from University of Exeter will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer-reviewed journals

• Presentations at appropriate conferences such as the Society for Academic Primary Care or other national and international cancer research or diagnosis research conferences.

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 datasets from which the information was derived.

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

• Journals

• Social media

• Public reports

• Posters displayed at appropriate conferences

This data will be used in a Cancer Research UK project to examine the use of diagnostic testing in the lead up to a cancer diagnosis. As such it has the potential to inform how testing is used in the NHS in the future to maximise the benefits in terms of cancer diagnosis, and ultimately save lives.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

Through achieving the study’s aims the findings may allow the identification of opportunities for earlier diagnosis that can be obtained by use of blood and other tests (endoscopy, imaging) in primary care among patients who were subsequently diagnosed with cancer.

The study may allow researchers to obtain a granular understanding of variation between different patient groups in the use of diagnostic tests ordered by GPs, therefore identifying opportunities for improvement. The researchers additionally may gain an understanding of the predictors and implications of using or not using the test for the patients, to support the prioritisation of the implementation of the findings, and their incorporation into clinical audit and improvement initiatives.

It is hoped that through the 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.

The findings of the study have so far identified avenues for quality improvement activity relating to the management and referral of suspected cancer.