Identifying Procedure Adjusted Quality Indicators For Upper Gastrointestinal Endoscopy From Multivariable Analysis Of Cohorts With Post Endoscopy Upper Gastrointestinal Cancer (POUGIC) In The National Endoscopy Database (NED) (ODR2021_163)

Sandwell & West Birmingham NHS Trust requires access to NHS England data for the following research project:

Identifying Procedure Adjusted Quality Indicators For Upper Gastrointestinal Endoscopy From Multivariable Analysis Of Cohorts With Post Endoscopy Upper Gastrointestinal Cancer (POUGIC) In The National Endoscopy Database (NED) (ODR2021_163)

The following is a summary of the aims of the research project provided by Sandwell & West Birmingham NHS Trust.

The primary objectives are:

- To assess how accurate endoscopy (flexible telescope examination of the gullet and stomach) is in detecting cancer.

- To identify performance measures of endoscopy that help reduce the risk of missing early signs of cancer during the procedure.

Patients who were diagnosed with oesophageal and stomach cancer from 1st January 2009 to 31st December 2019 in the UK were identified from National Cancer Registration and Analysis Service (NCRAS). Their data was linked to Hospital Episode Statistics (HES) to further identify the patients who had an endoscopy within 5 years prior to their diagnosis. Data was then deidentified by NCRAS before exporting into a NHS information governance toolkit compliant secure area at University Hospital Birmingham NHS Foundation Trust, where it will be analysed by authorised analysts. The study team will identify the hospitals where these endoscopies were performed to look at the variation in the performance of hospitals across the country. Patients with Barrett’s Oesophagus are placed on a structured surveillance pathway, with routine surveillance endoscopies typically occurring at five‑year intervals. A key clinical concern is that individuals under surveillance should not progress to oesophageal cancer; such progression may indicate a failure in the surveillance process. To accurately determine whether a patient was undergoing appropriate surveillance at the time of diagnosis, the study team requires a sufficient historical look‑back period . A six‑year look‑back window is therefore necessary, as a shorter period would risk omitting relevant surveillance events and could compromise the validity of the study’s findings.

The following NHS England Data will be accessed:

- NDRS Cancer Registration

- NDRS Linked HES AE

- NDRS Linked HES APC

- NDRS Linked HES Outpatient

- NDRS Systemic Cancer Therapy Dataset (SACT)

The above listed data sets are necessary to examine various factors, including patient’s age, sex, socioeconomic status and other medical problems which can increase risk of cancer and to identify the characteristics which are associated with having an endoscopy which does not identify the cancer but subsequently patients are found to have cancer.

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 level of the data will be:

- Pseudonymised

The data will be minimised as follows:

- Patients who were diagnosed with oesophageal and stomach cancer from 1st January 2009 to Latest available in the UK

- Limited to a six‑year historical look‑back period to ensure all relevant surveillance events at the time of diagnosis are captured while avoiding omission that could compromise the validity of the study findings.

Sandwell & West Birmingham NHS Trust 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 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.

Analysis of this data is in the public interest as some patients with post endoscopy upper GI cancer will have had their lives shortened or undergone unnecessarily radical and invasive therapy, including surgery, due to failures to diagnose their cancer at an earlier stage. Learning from such events is vital to improving the care of such patients in future.

The funding is provided by National Institute for Health Research (NIHR). The funding is specifically for the study described.

University Hospital Birmingham NHS Foundation Trust is a processor acting under the instructions of Sandwell & West Birmingham NHS Trust to process data for the purpose described above.

Amazon Web Services provides IT hosting services to Sandwell & West Birmingham NHS Trust and will store the Data as contracted by Sandwell & West Birmingham NHS Trust.

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

NHS England provided the relevant records from the NDRS Cancer Registration, NDRS Linked HES AE, NDRS Linked HES APC, NDRS Linked HES Outpatient and NDRS Systemic Cancer Therapy Dataset (SACT) datasets to Sandwell & West Birmingham NHS Trust. 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.

Sandwell & West Birmingham NHS Trust will securely transfer the Data provided under a DSA to University Hospitals Birmingham Foundation Trust for analysis by the informatics team, who are familiar with working with HES and NCRAS data.

The Data will be stored on servers at Sandwell & West Birmingham NHS Trust and University Hospitals Birmingham Foundation Trust.

Sandwell & West Birmingham NHS Trust stores Data on the Cloud provided by Amazon Web Services.

University Hospitals Birmingham Foundation Trust also use Ark data centres who provide physical back-up locations only. Art data centres do not have access to the NHS England data.

The Data will be accessed by authorised personnel via remote access at University Hospitals Birmingham Foundation Trust.

The Controller confirms 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 England. The data will not leave England at any time.

Access is restricted to one individual within the gastroenterology department of Sandwell & West Birmingham NHS Trust and one individual within the Data Science Team, Research Development and Innovation, University Hospitals Birmingham Foundation Trust who have authorisation from the Principal Investigator. All such individuals are substantive employees of Sandwell & West Birmingham NHS Trust and University Hospitals Birmingham Foundation Trust respectively.

Any other organisation other than Sandwell & West Birmingham NHS Trust and University Hospitals Birmingham Foundation Trust is not permitted to access the Data.

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.

One analyst from the Data Science Team, Research Development and Innovation at University Hospitals Birmingham Foundation Trust will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

• Submissions to peer reviewed journals before the end of 2024.

• Presentations at appropriate 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

• At appropriate medical conferences

The target date for production and dissemination of the outputs will be the end of 2024.

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.

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

• 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.

Post endoscopy upper GI cancer (PEUGIC) occurs when patients undergo an endoscopy that does not diagnose cancer in the three years before they are later diagnosed with cancer. This is often a missed opportunity to diagnose cancer earlier, with better patient outcomes if it is, or to prevent cancer altogether by treating pre-malignant lesions. The findings will help identify PEUGIC and its consequences for patients to guide quality improvement efforts to reduce it in future.

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.

The results of analysis of the data will be presented at national and international conferences and published open access in journals. Heartburn Cancer UK and the British Society of Gastroenterology are involved in the projects using the data.

The research team have used the NCRAS and HES linked data set in a number of studies which look at associations for missing cancer at endoscopy.

The main study findings are summarised in the following abstract and full text in press accepted in Endoscopy.

Kamran U, Evison F, Brookes M, et alP176 Differences in endoscopy practices between providers with highest and lowest post endoscopy upper gastrointestinal cancer rates using national endoscopy database. Gut 2023;72:A146-A147.

Findings which are risk factors for missing cancer at endoscopy have been presented nationally and internationally and have won awards from the British society of gastroenterology of best research for patient benefit.

An additional paper using the data set looking at survival outcomes has been written, and it is in the process of being submitted. It is the only paper to date on survival outcomes from missed cancer in endoscopy.