COVID RT - Assessing the impact of COVID-19 on radiotherapy in the UK.

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Objective for processing

The World Health Organisation (WHO) declared a COVID-19 pandemic on 11th March 2020. Healthcare systems, including the NHS, had to adapt rapidly, focusing resources to support COVID-19 infected patients whilst continuing, where possible, to provide ongoing care for other illnesses, including cancer. This is a request from the University of Leeds and Cancer Research UK to Amend a previously approved Agreement. The Amendment is to add the University of Leeds as a Data Processor so researchers at the University can access and process the data within the Cancer Research UK Trusted Research Environment (TRE) to further assist in achieving the purposes outlined within this Data Sharing Agreement (DSA ). Individuals employed by the University of Leeds have specific expertise and a unique clinical perspective that will be useful in achieving the purposes outlined within this DSA. As the COVID-19 pandemic has evolved, there has been increasing awareness of its “untold toll”, [3] arising as an indirect result of the pandemic on patients with cancer and other conditions. Modelling studies have projected the excess number of cancer deaths at 1 year in England and Northern Ireland due to delayed diagnosis and restricted access to surgery and systemic treatments, predicting 6,270 additional deaths in newly diagnosed patients, and 17, 915 additional deaths if all patients living with cancer are considered [4] The World Health Organisation (WHO) declared a COVID-19 pandemic on 11th March 2020. Healthcare systems, including the NHS, had to adapt rapidly, focusing resources to support COVID-19-infected patients whilst continuing, where possible, to provide ongoing care for other illnesses, including cancer. Radiotherapy contributes to the cure of approximately 40% of all cancers [6], with over 130,000 patients receiving radiotherapy each year in the UK yet has not been included in the modelling studies conducted to date. The studies’ usefulness to inform both radiotherapy practice and public health policy for cancer treatment is therefore restricted, highlighting the need to collect and analyse robust radiotherapy data from patients treated during the pandemic. Whilst cancer surgical services were often significantly disrupted during the COVID peak, radiotherapy services across the UK continued to treat cancer patients in often challenging circumstances. Adjustments to treatment protocols were required and implemented, in order to mitigate risk to patients of contracting COVID-19 (e.g. by reducing the duration of treatment schedules), to provide cancer treatment that would otherwise not be available (e.g. by using radiotherapy instead of surgery when surgery was unavailable) and to reduce the burden on radiotherapy departments affected by a reduced workforce due to staff sickness and isolation. The scale of these changes in radiotherapy practice, the clinical decision making underpinning them and their impact on cancer patient outcomes is unknown. As the COVID-19 pandemic has evolved, there has been increasing awareness of its “untold toll”, [3] arising as an indirect result of the pandemic on patients with cancer and other conditions. Modelling studies have projected the excess number of cancer deaths at 1 year in England and Northern Ireland due to delayed diagnosis and restricted access to surgery and systemic treatments, predicting 6,270 additional deaths in newly diagnosed patients, and 17, 915 additional deaths if all patients living with cancer are considered [4] (All figures correct at time of publication). The National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group (NCRI CTRad) identified the urgent and unmet need to understand the impact of COVID 19 on both radiotherapy patients and the radiotherapy service at a national scale. This led to this study –the COVID RT initiative, which has been developed in partnership with the Royal College of Radiologists (RCR), Society and College of Radiographers (SCoR) and The Institute of Physics and Engineering in Medicine (IPEM). Radiotherapy contributes to the cure of approximately 40% of all cancers [6], with over 130,000 patients receiving radiotherapy each year in the UK yet has not been included in the modelling studies conducted to date. The studies’ usefulness to inform both radiotherapy practice and public health policy for cancer treatment is therefore restricted, highlighting the need to collect and analyse robust radiotherapy data from patients treated during the pandemic. Whilst cancer surgical services were often significantly disrupted during the COVID peak, radiotherapy services across the UK continued to treat cancer patients in often challenging circumstances. Adjustments to treatment protocols were required and implemented, to mitigate the risk to patients of contracting COVID-19 (e.g. by reducing the duration of treatment schedules), to provide cancer treatment that would otherwise not be available (e.g. by using radiotherapy instead of surgery when surgery was unavailable) and to reduce the burden on radiotherapy departments affected by a reduced workforce due to staff sickness and isolation. The scale of these changes in radiotherapy practice, the clinical decision-making underpinning them and their impact on cancer patient outcomes is unknown. The aims of COVID RT are to understand why changes in radiotherapy treatment schedules were implemented during the pandemic and to then explore the impact of these changes on patient outcomes and the UK radiotherapy services. This first request is purely to understand the changes in patients radiotherapy treatment from COVID-19. The National Cancer Research Institute Clinical and Translational Radiotherapy Research Working Group (NCRI CTRad) identified the urgent and unmet need to understand the impact of COVID-19 on both radiotherapy patients and the radiotherapy service at a national scale. This led to this study –the COVID RT initiative, which has been developed in partnership with the Royal College of Radiologists (RCR), the Society and College of Radiographers (SCoR) and The Institute of Physics and Engineering in Medicine (IPEM). This study will give a national picture of the decision making by patients and clinical staff and the impact on patient's treatment. It also provides knowledge of how radiotherapy was used as a bridge to surgery when surgical services weren't viable due to the pandemic and therefore what are the further requirements for cohorts of patients. COVID RT aims to understand why changes in radiotherapy treatment schedules were implemented during the pandemic and to then explore the impact of these changes on patient outcomes and the UK radiotherapy services. This data disseminated under this Agreement is used purely to understand the changes in patients' radiotherapy treatment from COVID-19. The data subjects will be all individuals aged 18 years or over who received radiotherapy in participating UK Cancer centres between March 2020 and August 2021. The study was originally intended to be a rapid study of how the organisational changes for healthcare in the NHS in response to COVID-19 were to impact on radiotherapy services and cancer outcome. The vast majority of cancers occur in adults and so this was where efforts were focused as this was likely where the biggest changes in care would be observed and the biggest population impacted. The study team fully acknowledge that children and young people were also seriously affected by the pandemic but that was not the focus of this study. Rather the focus was intended to try and generate evidence to inform the health service on how best to deploy their radiotherapy resource during the pandemic using the evidence derived from the biggest population affected. This study will give a national picture of the decision-making by patients and clinical staff and the impact on patients' treatment. It also provides knowledge of how radiotherapy was used as a bridge to surgery when surgical services weren't viable due to the pandemic and therefore what are the further requirements for cohorts of patients. Data have been collected by cancer centres across England specifically for this study as part of patient's routine care. This study has not affected the care any patient received. The data subjects will be all individuals aged 18 years or over who received radiotherapy in participating UK Cancer centres between March 2020 and August 2021. The study was originally intended to be a rapid study of how the organisational changes for healthcare in the NHS in response to COVID-19 were to impact radiotherapy services and cancer outcomes. The vast majority of cancers occur in adults and so this was where efforts were focused as this was likely where the biggest changes in care would be observed and the biggest population impacted. The study team fully acknowledge that children and young people were also seriously affected by the pandemic but that was not the focus of this study. Instead, the focus was intended to try and generate evidence to inform the health service on how best to deploy their radiotherapy resource during the pandemic using the evidence derived from the biggest population affected. Each participating Cancer centre has captured data on the study audit form (with their own Caldicott Guardian approval) about their patients. These data sheets have then been submitted to the National Cancer Registration and Analysis Service (NCRAS). Here these data have been combined into a national dataset and pseudonymised (with a linkage file retained by NCRAS should further analyses be undertaken). This agreement is to seek permission/approval to transfer this pesudoymised file into a secure data environment for analysis by Cancer Research UK analysts. The analytical output they produce will then be shared with the wider research study team which include clinicians and academics from the National cancer Research Institute, the Universities of Oxford, Leeds, Cardiff, Swansea and Cancer Centres across the UK. Any such analytical outputs will be subject to statistical disclosure control as agreed by the National Cancer Registration and Analysis Service. Data have been collected by cancer centres across England specifically for this study as part of patients' routine care. This study has not affected the care any patient received. Each participating Cancer centre has captured data on the study audit form (with their own Caldicott Guardian approval) about their patients. These data sheets have then been submitted to the National Cancer Registration and Analysis Service (NCRAS). Here these data have been combined into a national dataset and pseudonymised (with a linkage file retained by NCRAS should further analyses be undertaken). This agreement is to seek permission/approval to transfer this pseudonymised file into a trusted research environment for analysis by Cancer Research UK and University of Leeds analysts. The analytical output they produce will then be shared with the wider research study team which includes clinicians and academics from the National Cancer Research Institute, the Universities of Oxford, Leeds, Cardiff, Swansea and Cancer Centres across the UK. Any such analytical outputs will be subject to statistical disclosure control as agreed by the National Cancer Registration and Analysis Service. [1 paragraph unchanged] Additionally, data will be analysed by individual tumour site sites and other patient characteristics, to characterise the changes made to treatment schedules according to the primary tumour being treated and to understand any increased impact to on any particular segment of the population. [13 paragraphs unchanged] • What lessons can be learned from the changes in practice to ensure an optimal response for future pandemics response for future pandemics A pseudonymised extract of these data will be created and transferred to Cancer Research UK's Trusted Research Environment (TRE). A pseudonymised extract of these data will be created and transferred to Cancer Research UK's Secure Data Environment (SDE). These data will then be analysed within the TRE by named analytical staff employed by Cancer Research UK and the University of Leeds alongside identical data captured from Cancer Centres in Scotland, Wales and Northern Ireland. These data have been captured using the same audit form and sent to the relevant countries' cancer registry where they are compiled into an equivalent pseudonymised dataset. Pooling these will enable a UK-wide analysis. These data will then be analysed within the SDE by named analytical staff at Cancer Research UK alongside identical data captured from Cancer Centres in Scotland, Wales and Northern Ireland. These data have been captured using the same audit form and are being sent to the relevant countries cancer registry where they are compiled into an equivalent pseudonymised dataset. Pooling these will enable a UK wide analysis . Summary results will be calculated and used in this first research project to understand the effect COVID had on radiotherapy treatment as described in the study protocol. The original intention was to seek to link these data to other datasets available within the relevant cancer registry environment so changes in practice could be related to outcome. Obtaining the relevant permissions/approvals to simply access the data captured by the Cancer centres has proven challenging, however, so if the study progresses to undertake the linkages required to look at outcomes this will be the subject of a subsequent application. The data requested to be released in this application will be pseudonymised and will not be linked to other datasets. Summary results will be calculated and used in this first research project to understand the affect COVID had on radiotherapy treatment as described in the study protocol. The original intention was to seek to link these data to other datasets available within the relevant cancer registry environment so changes in practice could be related to outcome. Obtaining the relevant permissions/approvals to simply access the data captured by the Cancer centres has proven challenging, however, so if we progress to undertake the linkages required to look at outcomes this will be the subject of a subsequent application. The data requested to be released in this application will be pseudonymised and will not be linked to other datasets. The joint data controllers for this project are the University of Leeds and Cancer Research UK. The University of Leeds is the listed sponsor for the study. Jointly, the two organisations make the decisions about how the data will be processed for this part of the study. Both Cancer Research UK and the University of Leeds process the data for the purposes outlined within this Data Sharing Agreement. For the purpose of clarity, the University of Oxford does not undertake any data processing activities for this study nor are they a data controller for this study. The joint data controllers for this project are the University of Leeds, and Cancer Research UK. The University of Leeds is the listed sponsor for the study. Jointly, the two organisations make the decisions about how the data will be processed for this part of the study. University of Oxford do not undertake any data processing activities for this study nor are they a data controller for this study. University of Leeds' lawful bases for processing personal data and health data (defined as special category data) for the purposes of this project are: The University of Leeds' lawful bases for processing personal data and health data (defined as special category data) for the purposes of this project are: Article 6(1)(e): Specific task in the ‘public interest’ or task that has a clear basis in law. The research described within this Agreement has been deemed to be in the public interest as a result of the potential benefits to health and social care that it may provide. The basis in law is the University’s, Royal Charter. And; Article 6:1(e): Specific task in the ‘public interest’ or task that has a clear basis in law, and Article 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law. This research has been deemed to be in the public interest as a result of the potential benefits to health and social care. The basis in law is the University’s Royal Charter Article 9:2(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law . [1 paragraph unchanged] Article 6:1(f): Processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, [21 words unchanged] of personal data, in particular where the data subject is a child. CRUK is a registered charity dedicated to saving lives through research, influence and information. CRUK commission, support and undertake research in order to generate evidence which is used to support improvements to the prevention, [26 words unchanged] the COVID-19 pandemic and, thereby, to better inform the NHS, clinicians and decision makers decision-makers in local and central government, as to what both the impact of [28 words unchanged] pandemic or otherwise. The aim is to understand any decisions that negatively affected affect patients and to try and prevent these in future. We The study team consider that these aims fall within the legitimate interests of CRUK and [8 words unchanged] of the data subject posed by this processing are both slight and are outweighed by the aims of the charity to improve cancer outcomes in [8 words unchanged] in 4 people surviving cancer for 10 or more years, by 2034. Article 9:2(j): 9(2)(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law. As a medical research charity, we the study team consider that the proposed processing of data for the purposes of this study, given the aims to asses assess the true impact of COVID-19 on patients and to inform the response [8 words unchanged] fall within the definition of scientific research as laid out in the UK GDPR/ DPA2018. [1 paragraph unchanged] There is already evidence of significant changes in cancer treatment pathways as a result of the COVID-19 pandemic and these will undoubtedly have had a major impact on outcomes from the disease. Evidence is urgently need needed to quantify and address these impacts. [4 paragraphs unchanged]

Processing activities

There will be no flow of identifiable information into NHS Digital. There will be no flow of identifiable information from NHS Digital. The data that will flow to CRUK will be pseudonymised, record level, and special category health data. There will be no subsequent flow of data once the transfer of data from NHS Digital to the CRUK TRE has occured. occurred. Only outputs of analyses that meet CRUK’s statistical disclosure policy will be released from the SDE TRE in accordance with CRUK policies. [2 paragraphs unchanged] These data will be pseudonymised by NHS Digital and transferred securely on to the CRUK Trusted Research Environment hosted by AIMES. CRUK and Leeds will be joint data controllers, with AIMES as a data processor. Aggregated data will then be released from the Trusted Research Environment for the outputs of the study. Before these data can be released from the [8 words unchanged] ensure they are anonymised in line with NHS Digital and CRUK policy. Data will be analysed using statistical software packages to create summary statistical [16 words unchanged] England, Wales, Scotland and Northern Ireland will be pooled to create a UK wide UK-wide dataset. As linkage is not being undertaken and the data received will be [16 words unchanged] will be taken to remove all identifying variables and pseudonymise the dataset prior to before it being released from NHS Digital to the research team. No date data are being matched to publically publicly available data and so no steps are being taken to mitigate the risk of re-identification. [1 paragraph unchanged] Data processing of the data disseminated by NHS Digital is only carried out by substantive employees of the listed data processors (CRUK) processors, CRUK and the University of Leeds, who have been appropriately trained in data protection and confidentiality. Data will only be processed for the purposes as set out in this data sharing agreement. All data will be stored on the CRUK Secure data environment, CRUK's Trusted Research Environment, detailed below, and accessed securely via remote login, secured using two factor two-factor authentication. Data cannot be removed from the SDE. TRE. Only aggregated outputs can be requested to be released from the SDE TRE which are checked to meet CRUK’s statistical disclosure policy before being released from the environment The data will be stored on in a CRUK's Trusted Research Environment, namely CRUK’s Secure Data Environment. This environment, provided and managed by Aimes, AIMES, is ISO27001, 27017, and 27018 accredited and works to the NHS DSPT standards. All data will be held on encrypted servers belonging to and located at Aimes’ AIMES’ offices: The role of AIMES is purely to provide the secure infrastructure for [25 words unchanged] team, will not analyse these data and are not involved in any decision making decision-making of the study.

Expected output

[2 paragraphs unchanged] submissions Submissions to peer reviewed peer-reviewed journals will be made as a result of this study to ensure a peer review process and confidence in the results of the study [2 paragraphs unchanged] The level of data contained in the outputs will be aggregated data with small number suppression applied. Any aggregated data contained in any output will meet Cancer research Research UK’s statistical disclosure policy. The results of this study and the communication plan for results will be determined in order to provide vital information of on the impact of covid to on radiotherapy providers and health services across the UK and will be of use to countries worldwide. The results in peer reviewed peer-reviewed journals will provide the scientific community with a further understanding of the impact of COVID on cancer and contribute to improvements for patients from the current COVID pandemic and any similar future pandemics . pandemics. [4 paragraphs unchanged]

Expected measurable benefits

This project aims to understand why changes were made to RT treatment [28 words unchanged] patients as a result of these changes. It will also lay the ground work groundwork for a follow up follow-up study to understand the impact of these changes on outcomes [1 paragraph unchanged] These data were captured at the height of the pandemic by NHS [42 words unchanged] is in the public interest as if they are not analysed then we researchers will not understand the impact of COVID on radiotherapy of which over [11 words unchanged] study has the potential to improve patient outcomes immediately and in future. The proposed analyses will directly quantify the changes in care that the [20 words unchanged] they are the only data available to achieve our stated aim of understand understanding why changes in radiotherapy treatment schedules were implemented during the pandemic. Non-identifiable data are being processed to understand the impact COVID had on an expected cohort size in excess of more than 50,000 patients who received Radiotherapy during 2020 and early 2021. The results [40 words unchanged] patients across the UK and indeed for any other country worldwide. The aim of the study is aims to understand the impact implications COVID had for patients receiving radiotherapy and therefore to provide evidence for current and future decision making. decision-making. There is no current evidence of the impact covid had on radiotherapy. [23 words unchanged] patients who wouldn’t normally receive radiotherapy received it due to the impact to of other treatment. It is imperative we that the study team understand the impact on patients in order for the health service to make the right decisions for patients now and in the future. [2 paragraphs unchanged] Benefits of the study could start to be achieved immediately and therefore further delays to in undertaking the study could lead to patients not being able to benefit from the results of this study . study.

Benefits reported

Yielded Benefits is not a requirement for new applications. The data has only recently been received, and as such further work will be required in order to yield benefits.