United Kingdom COVID and Gynaecological Cancer Study - UKCOGS ( ODR2021_178 )

Queen Mary University of London (QMUL) requires access to NHS England data for the purpose of the following project: United Kingdom COVID and Gynaecological Cancer Study – UKCOGS

The following is a summary of the aims of the project provided by QMUL:

UKCOGS is a national audit aiming to:

• Evaluate the impact of changes to MDT decision making for gynaecological cancer patient outcomes across the UK in response to the COVID-19 pandemic.

• To document the structural and logistic changes implemented across Gynae-oncology cancer centres in response to the COVID-19 pandemic.

• To quantify the oncological outcome of COVID19 and changes in cancer treatment related to COVID19 in gynaecological oncology patients.

The following NHS England Data will be accessed:

• NDRS Consolidated Dataset

This is necessary because it will allow the evaluation of patients’ experience during the COVID wave. NDRS data will also be compared to identify whether delay in treatment due to the pandemic has impacted oncological outcome for these patients.

The level of the Data will be identifiable which is necessary to link NHS England datasets with data already held by the applicant. This data has been collected separately from NHS England.

The Data will be minimised as follows:

• Limited to a study cohort identified by QMUL of 11500 individuals

Prior to submission to NHS England, this cohort has been minimised to: be:

• Limited to women aged over 18 with gynaecologic cancers who were discussed at MDT at a site participating in the UKCOGS national audit between 01/03/2020 and 01/03/2021;

• Limited to 5 years follow up data from date of diagnosis;

• Limited to the following geographic areas: England

• Limited to conditions relevant to the study identified by specific ICD or OPCS codes;

o ICD codes:

 C51 Malignant neoplasm of vulva,

 C52 Malignant neoplasm of vagina,

 C53 Malignant neoplasm of cervix uteri,

 C54 Malignant neoplasm of corpus uteri,

 C55 Malignant neoplasm of uterus, part unspecified,

 C56 Malignant neoplasm of ovary,

 C57 Malignant neoplasm of other and unspecified female genital organs,

 C58 Malignant neoplasm of placenta;

Queen Mary University of London (QMUL) is the sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. Data will only be accessed by substantive employees of QMUL.

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 Domestic Law which shall be proportionate to the aim pursued, respect 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 funding is provided by British Gynaecological Cancer Society (BGCS). The funding is specifically for the study described. Funding to continue the work described will be sought on an ongoing basis.

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

QMUL is the data controller and will be processing the data.

Data will only be accessed by substantive employees of QMUL.

UKCOGS was designed during the pandemic to capture the impact of COVID19-related changes in the care of Gynaecological Oncology patients. This is supported by a broad range of stakeholders including health professionals, organisations, as well as charities, patient groups and the lay public. They fully support the development of the project, planned analysis, dissemination and have inputted into oversight and management committees. QMUL have engaged and got support and endorsement from gynaecological cancer charities and patient support groups: Ovacome, The Eve Appeal, Target Ovarian Cancer, Ovarian Cancer Action, Jo’s Cervical Cancer Trust, GO Girls, BRCA Umbrella.

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

Barts Cancer Centre (BCC) at Queen Mary University of London (QMUL) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the NDRS Cancer Consolidated Data Sets to Barts Cancer Centre at QMUL. The Data will contain directly identifying data items including Date of Birth and Person ID which are required to link NHS England datasets with data already in REDCap database.

The Data will not be transferred to any other location.

The Data will be stored on servers at QMUL.

QMUL will back-up the data daily as per QMUL policy.

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 in England/Wales. The data will not leave England/Wales at any time.

Access is restricted to employees of QMUL who have authorisation from the Chief Investigator.

No other organisation is permitted to access the Data.

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

The Data will be linked at person record level with dataset(s) obtained from hospital sites. This will allow QMUL to proceed with further analysis to identify the precise effect of COVID19 pandemic on survival and other related outcomes in women with gynaecological cancer.

Once the NHS England data is linked to the data already held by QMUL, the identifiable fields will be destroyed. All analyses will use the pseudonymised dataset. Individuals will not routinely be reidentified when using the pseudonymised dataset unless essential/necessary. There may be appropriate clinical situations (e.g. duty of candour, ethical or safety concerns, or clinical need) where reidentification may be needed and hence, will be undertaken by QMUL. Additionally, this may also be needed for any longer term follow up data which may be provided, with appropriate permissions.

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

The expected outputs of the processing will be:

• Submissions to peer reviewed journals at the end of the audit

• Presentations at specific gynaecological cancer conferences such as European Society of Gynaecological Oncology (ESGO), British Gynaecological Cancer Society (BGCS), International Gynecologic Cancer Society (IGCS).

• Publication of dashboards on QMUL’s website

• Presentations at academic 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 dataset(s) from which the information was derived.

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

• Journals

• Social media

• Public events such as scientific meetings [give details]

• Patient Information leaflets available at charities including Ovacome, The Eve Appeal, Target Ovarian Cancer, Ovarian Cancer Action, Jo’s Cervical Cancer Trust and GO Girls

Once data is received from NHS England, there will be a 4-6-month period of data cleaning, processing and analysis. QMUL is aiming for the first key impact paper to be submitted for peer review in 2025 or early 2026, depending on receival of data. QMUL anticipate outputs will continue over 2025 and 2026 as more analysis is undertaken and completed.

Earlier this year QMUL published outcomes of multiple COVID-19 waves on gynaecological cancer services across the UK which showed a major impact of COVID-19 on gynaecological cancer services, including reduced referrals, operating and highlighted serious staffing shortages. This further supports and emphasises the importance of the proposed work supported through this agreement which will help establish the impact of COVID on gynaecological cancer outcomes, survival and health system impact.

The impact of resultant protocol deviations seen in COVID19 on long-term outcomes remains to be established. This analysis is in the public interest and will be achieved through analysis of the linked outcome data of patients recruited to the UKCOGS national audit. This is essential to capture and analyse the proper impact and identify the best strategies for future surges and similar events, as well as pinpoint best practice changes that will be worth preserving in future. It will enable analysis of the resultant protocol deviations, delayed treatments, changes to standard care on long-term outcomes including recurrence and mortality. This will enable use of granular data collected in UKCOGS for assessment of short- and long-term outcomes of surgical and non-surgical treatments for all patients discussed at the MDTs in the UK. The economic impact of the pandemic on gynaecological cancer care will also be evaluated. This will help plan for the recovery, facilitate better informed patient communication and assist in identifying how to ensure ‘best care’ in future surges of the COVID-19 pandemic and other similar future events.

Public benefit is thus still anticipated from this analysis.

UKCOGS will directly and indirectly benefit patients:

• Counselling and information provision – The project will provide valuable information to clinicians and healthcare professionals in general on the effect of healthcare crises like COVID on treatment planning, decision making and ultimately the chance of affecting cancer survival.

• Precision & focused decision making – The use of granular data collected in UKCOGS for assessment of short and long term outcomes of surgical and non-surgical treatments for all patients will help determine precisely which aspects of care were directly impacted by the COVID-19 pandemic and could potentially have detrimental impact on outcomes. It is also possible that for some patients, deferring or modification of cancer treatments had minimal or no impact on outcomes.

• Policymakers will use this knowledge to inform service adaptations and dictate changes that would minimise future impact of such events on oncological care. UKCOGS will ultimately draw important conclusions to create a response model to future healthcare crises impacting oncological care and beyond.

• Dissemination of information via stakeholders (i.e. Royal College of Obstetricians and Gynaecologists [RCOG], BGCS, charities etc) will familiarise patients and public on how a crisis event can affect oncological care and generate interest on funding future plans to mitigate healthcare crises risks.

• Health economic evaluation: UKCOGS data can be used for healthcare economic evaluation of the effect of COVID19 on oncological care. This can be the first step to proceed with further cost-effectiveness evaluation of interventions (strategies) to approach future crises and mitigate related risks.

QMUL are working with national professional organisations including the RCOG, BGCS, National Cancer Research Institute (NCRI), Gynaecological Cancer Clinical Studies Group and the British Association of Gynaecological Pathologists (BAGP), and findings from this work will directly influence national policy. This will help in planning the ongoing recovery from the impact of COVID19, with many patients having received non-standard care, as well as planning for future public health emergencies.

Lessons from this work can not only quantify the oncological impact of COVID19, but also be generalised to quantify and model the oncological impact of any acute service disruption, including other specialities beyond gynaecological cancer. This can translate into reduced morbidity and mortality from future major service disruptions, and health economic benefits from optimising resource use to the required response level.

Results will be initially measurable by publication in academic journals, and dissemination in general (public) media. The public benefits of these will be measured by the evaluation of changes in national policy and management pathways where relevant, depending on findings from the work.

There would be scope in future to prospectively evaluate additional outcomes and re-auditing to observe improvements, e.g. relating to future emergencies.

This audit is fully supported by the BGCS, RCOG, NCRI, Gynaecological Cancer Clinical Studies Group and BAGP.

QMUL have also engaged with and received endorsement and support from various charities and patient support groups. This allows huge potential to disseminate the findings both in the scientific community and healthcare stakeholders. Engaging with lead charities will act as a catalyst for PPI events where key messages from UKCOGS and related future policy changes will be discussed and communicated.

Not stated in the register.