Yorkshire and Humberside Haematology Network Register (YHHN) Comparison Cohort

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Datasets: − Hospital Episode Statistics Accident and Emergency (HES A and E)

Objective for processing

This Agreement is for the purpose of maintaining a comparison cohort for the Yorkshire and Humberside Haematology Network (YHHN). University of York and Hull University Teaching Hospitals NHS Trust require access to NHS England data for the purpose of the following research project: The University of York is the sole organisation processing the Data and is a joint Controller with Hull University Teaching Hospitals NHS Trust. YHHN is a collaboration with a clinical network, and the work is commissioned by Hull University Teaching Hospitals NHS Trust. All YHHN’s activities are agreed and monitored by the Haematology Network’s Audit Committee (the Yorkshire & Humberside Haematology Network Audit Committee). Blood Cancer UK (BCUK) and Cancer Research UK (CRUK) funds YHHN but are not involved in the conduct of the research. Only the University of York have access to Data under this Agreement. Yorkshire and Humberside Haematology Network Register (YHHN) Comparison Cohort Hull University Teaching Hospitals NHS Trust have been involved from the outset of the project as a member of the clinical network that comprises YHHN. Its involvement was formalised in 2009 in a previous approved version of the application to the Central Register for mortality data, where the Trust confirmed that YHHN was being run on behalf of an NHS organisation for the purposes of “public health provision or the management of health services". The following is a summary of the aims of the research project provided by University of York and Hull University Teaching Hospitals NHS Trust: The YHHN is a collaboration with the local Clinical Haematology Network and researchers at University of York. All study activities fall under the auspices of the Network’s Clinical Audit Group, which includes senior academics from the University of York, and is chaired by the Consultant Haematologist and the Medical Director for the Cancer and Clinical Support Health Group at Hull University Teaching Hospitals NHS Trust (HUTH). HUTH acts a joint controller, along with the University of York, its responsibilities include overseeing what personal data are collected, and how these data are stored and used. The Yorkshire and Humberside Haematology Network (YHHN) research project was initiated to address critical gaps in understanding the causes, progression, and healthcare needs of individuals diagnosed with haematological malignancies; cancers that affect the blood, bone marrow, and lymphatic system. The YHHN region comprises the population served by the West Yorkshire and Humber, Coast & Vale Clinical Cancer Alliances. There are 14 hospitals within YHHN, and these hospitals comprise the five multi-disciplinary teams (MDT) that oversee the management of patients diagnosed with haematological malignancies in the Network. All YHHN activities are agreed and monitored by the Haematology Network’s Audit Committee, which is currently chaired by the medical director at Hull & East Yorkshire Hospital NHS Trust. Each MDT in the region is represented by a consultant haematologist at the audit committee. Established in 2004, the YHHN is a collaboration between the University of York and Hull University Teaching Hospitals NHS Trust, supported by national charities such as Cancer Research UK and Blood Cancer UK. The project was designed to collect and analyse real-world data from patients across 14 hospitals in the Yorkshire and Humber region, an area representative of the UK in terms of demographics and clinical practice. This makes the findings broadly applicable to national healthcare planning and policy. The legal basis for processing personal data under the UK GDPR is to perform a task in the public interest. This is covered under Article 6(1)(e); - University of York and Hull University Teaching Hospitals NHS Trust are both public bodies, and it is in the public interest that work is done into providing details on cancer treatments and mortality rates. The personal data requested under this Agreement includes information about a participants' health; these are considered as special category data, and therefore the legal basis for processing these data is processing required for scientific research purposes which is covered under Article 9(2)(j) of the UK GDPR. The research is being conducted to address several critical questions: How do patients with haematological malignancies differ in their healthcare usage and outcomes compared to the general population? What role do socio-economic factors play in diagnosis and survival? And how can this knowledge be used to improve care delivery and inform national policy? YHHN’s cohort of patients with haematological cancers was established in 2004; and NHS England supply YHHN with linked data from Hospital Episode Statistics (HES), Mortality and Cancer Registration Data under Data Sharing Agreements DARS-NIC-390749-C4P0X and DARS-NIC-346859-C9J6J. With the aim of investigating how the health of people with these cancers differs from that of people who do not have cancer, NHS England created a comparison cohort in 2016; matching each YHHN patient newly diagnosed with a haematological cancer during 2009-2016 (N=18,127) to 10 people of the same sex and gender who lived in the YHHN region but did not have a haematogical malignancy (N=181,270). This cohort was linked to the same datasets as the patient cohort, and data on hospital attendances/activity, cancer diagnoses and deaths have been supplied to the University of York since March 2017 under this Agreement (DARS-NIC-06759-X5V7P). In order to examine the impact of area based deprivation on both the diagnosis and the outcome of patients within the case cohort, the Lower Super Output Area (LSOA) of members of the comparison cohort has also been supplied. To answer these, NHS England created a matched comparison cohort in 2016, consisting of over 181,000 individuals without blood cancers, matched by sex, year of birth, and geographic location to 18,127 YHHN patients diagnosed between 2009 and 2016. This cohort is linked to national datasets, including Hospital Episode Statistics (HES), mortality records, and cancer registration data, allowing researchers to track healthcare interactions, treatment outcomes, and survival over time. The research seeks to enhance public health provision and guide the development of evidence-based clinical guidelines and national cancer care services. The project requires an additional two-years of data on the currently linked cohort (2 years for HES data, with updated mortality and cancer registration). This work is jointly funded by CRUK and BCUK via a rolling programme grant and the intention is to retain the data for the same length as time as the case-cohort, as stated on DARS-NIC-390749-C4P0X and DARS-NIC-346859-C9J6J-v1. This would currently be until 01/10/2026 providing a valid data Sharing Agreement is in place with NHS England. The comparison cohort was selected by NHS England in 2016 using the information held on individuals included in YHHN’s patient cohort. Each individual in the comparison cohort is assigned a unique identifier, which allows the University of York to identify the patient that they were matched to. All personal identifying data for the 181,270 individuals in the comparison cohort remain at NHS England and are not made available to the University. The objective of the project remains the same; namely to facilitate a greater understanding of the causes of haematological cancers, as well as their impact on the future health and healthcare needs of those who develop them. In order to do this, comparative activity information (HES) and outcome data (cancer registration, HES and deaths) on individuals that do not have these as cancers are required. The primary aims of the research are: • The research seeks to deepen knowledge about the causes, progression, and outcomes of blood cancers such as leukaemia, lymphoma, and myeloma • By using a matched comparison cohort of individuals without blood cancers, the study aims to identify differences in healthcare usage, survival, and comorbidities. • The study examines how area-based deprivation and other socio-economic variables influence cancer diagnosis, treatment, and outcomes. • The research tracks patients over time to understand the long-term effects of cancer and its treatments on health and healthcare utilization. The following NHS England Data will be accessed: • Cancer Registration Data • Civil Registration of Death • Demographics • Emergency Care Date Set (ECDS) • Hospital Episode Statistics Admitted Patient Care (HES APC) • Hospital Episode Statistics Critical Care (HES CC) • Hospital Episode Statistics Outpatients (HES OP) • Hospital Episode Statistics The datasets above are necessary to allow researchers to track patients' healthcare journeys before diagnosis, during treatment, and into survivorship. This includes inpatient, outpatient, A&E, and emergency care data from as early as 1997/98. Access to long-term historical data helps identify exposures or health events that may have contributed to the development of haematological cancers, sometimes occurring many years before diagnosis. The level of the Data will be: • Pseudonymised The Data will be minimised as follows: Limited to Cohort size of 181,270 The comparison cohort was selected by NHS England in 2016 using the information held on individuals included in YHHN’s patient cohort. Each individual in the comparison cohort is assigned a unique identifier, which allows the University of York to identify the patient that they were matched to. All personal identifying data for the 181,270 individuals in the comparison cohort remain at NHS England and are not made available to the University. University of York and Hull University Teaching Hospitals 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. 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 Blood Cancer UK (BCUK) and Cancer Research UK (CRUK). The funding is specifically for the project described. The funder(s) will have no ability to suppress or otherwise limit the publication of findings. YHHN is also associated with an active patient partnership (https://yhhn.org/partnership), and findings are regularly presented and discussed at a wide range of patient forums. YHHN benefits from an established Patient Partnership (https://yhhn.org/partnership), which was established by us in 2009. Patients and carers can join the Partnership at any time, provide feedback about their experiences and become involved in YHHN research activities. The partnership currently comprises over 800 patients, all of whom have agreed to various degrees of involvement including completing questionnaires, reviewing YHHN literature and taking part in focus group discussions. The partnership has a Steering Group, comprised of YHHN patients and carers, local cancer user group leads, a clinical nurse specialist (and haematology user group lead), consultant haematologist and researchers. The Steering Group meets at regular intervals to tackle any arising matters and discuss new studies, as well as the dissemination of recent findings and future research directions; its members are fully involved in YHHN and in the development of further collaborations/research projects and are currently designing a newsletter to send to members of the partnership to update them of YHHN research activities. One example of a project where user involvement has been instrumental is the National Institute for Health Research (NIHR) funded project “facilitating patient choice in haemato-oncology”, which is predicated on the YHHN Register. This project was developed following discussions at patient focus groups; where concern was repeatedly expressed about the paucity of information available to assist patients in making decisions about their disease management. The project commenced in 2016, and users have played an active role in steering the project, both as applicants and as independent members of the steering committee.

Processing activities

[1 paragraph unchanged] The comparison cohort was selected by NHS England in 2016 using the information held on individuals included in YHHN’s patient cohort. Each individual in the comparison cohort is assigned a unique identifier, which allows the University of York to identify the patient that they were matched to. All personal identifying data for the 181,270 individuals in the comparison cohort remain at NHS England and are not made available to the University. [1 paragraph unchanged] The Data will not be transferred to any other location. All Data are stored at the University of York on two servers in different locations to ensure there is a backup. These are situated in buildings on campus. The Data will not leave England at any time. The Data will not be transferred to any other location. Authorised by the Principal Investigator, Data can only be accessed by a restricted number of study staff who are substantively employed by the University of York. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. Access is not permitted remotely and Data are not shared with any external organisation or individuals who are not employed by the University of York. Hull University Hospitals NHS Trust cannot and will not access the Data. All Data are stored at the University of York on two servers in different locations to ensure there is a backup. These are situated in buildings on campus. No attempt will ever be made to identify individuals from the Data, or link to any further data sets. The Data will not leave England/Wales at any time. HES data to March 2022, mortality to March 2023, and cancer registrations to May 2022 have already been supplied by NHS England. The current agreement, which requests a forward extension of the time period (2 years for HES data, with updated mortality and cancer registration), will align the comparison cohort to the YHHN patient cohort, and permit a more thorough investigation of the health care patterns and needs of patients with haematological malignancies. Access is restricted to employees of University of York who are engaged with the study and have authorisation from the Principal Investigator. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. Access is not permitted remotely and Data are not shared with any external organisation or individuals who are not employed by the University of York. Only University of York is permitted to access the Data. Hull University Hospitals NHS Trust cannot and will not access the Data. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts/researchers from the University of York will process the Data for the purposes described above.

Expected measurable benefits

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. The use of the data could: • help the system to better understand the health and care needs of populations. • lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience. • advance understanding of regional and national trends in health and social care needs. • support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work). [2 paragraphs unchanged] 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. To maximise public benefit from the research, a multi-pronged dissemination strategy will be implemented. This includes publishing findings in peer-reviewed journals and presenting them at scientific and clinical conferences to reach healthcare professionals and researchers. To ensure accessibility for the general public, lay summaries, infographics, and press releases will be developed, with media engagement planned for findings of significant public interest. Additionally, educational webinars and workshops will be organised to explain the implications of the research to patients, carers, and the wider community. Engagement with key stakeholders is also a priority. Relevant charities and patient advocacy groups—such as Blood Cancer UK and Myeloma UK—will be contacted to help share findings and support outreach efforts. Healthcare commissioners, NHS bodies, and policymakers will receive tailored briefings to inform service planning and national cancer strategies. Patient and Public Involvement (PPI) will be embedded throughout the project to ensure that the research remains aligned with patient needs and that dissemination materials are co-developed with those directly affected.

Benefits reported

[1 paragraph unchanged] FEBRUARY 2024 UPDATE: [2 paragraphs unchanged]

Unchanged: Expected output.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Benefits reported

[1 paragraph unchanged] FEBRUARY 2024 ACR UPDATE: [2 paragraphs unchanged]

Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + HES-ID to MPS-ID HES Critical Care

Objective for processing

The University of York is the sole Data Processor and the joint Data Controller with Hull University Teaching Hospitals NHS Trust. YHHN is a collaboration with a clinical network, and the work is commissioned by Hull University Teaching Hospitals NHS Trust. All The Yorkshire and Humberside Haematology Network’s (YHHN’s) activities are agreed and monitored by the Haematology Network’s Audit Committee (the Yorkshire & Humberside Haematology Network Audit Committee). Bloodwise (a charity) and Cancer Research UK funds YHHN but are not involved in the conduct of the research. Only the University of York have access to data under this agreement. This Agreement is for the purpose of maintaining a comparison cohort for the Yorkshire and Humberside Haematology Network (YHHN). Hull University Teaching Hospitals NHS Trust have been involved from the outset of the project as a member of the clinical network that comprises YHHN. It's involvement was formalised in 2009 in a previous approved version of the application to the Central Register, for mortality data (MR1126), where the Trust confirmed that YHHN was being run on behalf of an NHS organisation for the purposes of “public health provision or the management of health services." The University of York is the sole organisation processing the Data and is a joint Controller with Hull University Teaching Hospitals NHS Trust. YHHN is a collaboration with a clinical network, and the work is commissioned by Hull University Teaching Hospitals NHS Trust. All YHHN’s activities are agreed and monitored by the Haematology Network’s Audit Committee (the Yorkshire & Humberside Haematology Network Audit Committee). Blood Cancer UK (BCUK) and Cancer Research UK (CRUK) funds YHHN but are not involved in the conduct of the research. Only the University of York have access to Data under this Agreement. The legal basis for processing personal data under GDPR, is to perform a task in the public interest. This is covered under Article 6(1)(e); - University of York and Hull University Teaching Hospitals NHS Trust are both public bodies, and it is in the public interest that work is done into providing details on cancer treatments and mortality rates. The personal data requested under this agreement includes information about a participants' health; these are considered as special category data, and therefore the legal basis for processing these data is processing required for scientific research purposes which is covered under Article 9(2)(j) of the GDPR. Hull University Teaching Hospitals NHS Trust have been involved from the outset of the project as a member of the clinical network that comprises YHHN. Its involvement was formalised in 2009 in a previous approved version of the application to the Central Register for mortality data, where the Trust confirmed that YHHN was being run on behalf of an NHS organisation for the purposes of “public health provision or the management of health services". Hospital Episode Statistics (HES), Mortality and Cancer data were supplied to the University of York by ther Office for National Statistics (ONS) and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as the Yorkshire and Humberside Haematology Network Register (YHHN) Comparison Cohort. The YHHN is a collaboration with the local Clinical Haematology Network and researchers at University of York. All study activities fall under the auspices of the Network’s Clinical Audit Group, which includes senior academics from the University of York, and is chaired by the Consultant Haematologist and the Medical Director for the Cancer and Clinical Support Health Group at Hull University Teaching Hospitals NHS Trust (HUTH). HUTH acts a joint controller, along with the University of York, its responsibilities include overseeing what personal data are collected, and how these data are stored and used. Previously this was a new application to create a control cohort matched with the YHHN Register and to provide pseudonymised HES data, Personal Demographic Service (PDS) tracking, The PDS is the national electronic database of NHS patient demographic data, such as name, address, date of birth and NHS number. It supports quick and accurate identification of a patient, contact and communication with a patient, and linkage of data and records across care settings and information systems, cancer registration data and ONS mortality for this control cohort. Data on Hospital Episode Statistics (HES), mortality and cancer registrations was required for use in the Yorkshire and Humberside Haematology Network’s (www.YHHN.org) comparison cohort. The work is commissioned by Hull & East Yorkshire Hospitals NHS Trust and funded by Cancer Research UK (CRUK grant number C9474/A18362). Data supplied by NHS Digital are only accessible to approved users within the Epidemiology & Cancer Statistics Group (ECSG) in the Department of Health Sciences at the University of York; no other organisations will have access to record level data obtained via NHS Digital. Under previous iterations of this Agreement, the University of York has received the latest death and cancer registrations, and HES records. In addition, in order to examine the impact of area based deprivation on both the diagnosis and the outcome of patients within the case cohort, the Lower Super Output Area (LSOA) of members of the comparison cohort at the time of their selection is also requested. This key variable, which links to area-based measures derived by ONS and is held for members of the patient cohort, was inadvertently omitted from the original Agreement. YHHN is a collaboration between researchers at the University of York and the Joint Haematology Network Site Specific Group for the West Yorkshire and Humber, Coast & Vale Clinical Alliances (formerly known as the Cancer Networks of Yorkshire and Humber & Yorkshire Coast). [1 paragraph unchanged] YHHN’s cohort of patients with haematological cancers was established in 2004; and NHS Digital supply YHHN with linked data from HES, Mortality and The National Cancer Registration & Analysis Service (NCRAS) (Data Sharing Agreement, DARS-NIC-390749-C4P0X). With the aim of investigating how the health of people with these cancers differs from that of people who do not have cancer, NHS Digital created a comparison cohort in 2016; matching each YHHN patient newly diagnosed with a haematological cancer during 2009-2016 (N=18,127) to 10 people of the same sex and gender who lived in the YHHN region but did not have a haematogical malignancy (N=181,270). This cohort was linked to the same administrative databases as the patient cohort, and data on hospital attendances/activity, cancer diagnoses and deaths were supplied to the University of York in March 2017 (Data Sharing Agreement, DARS-NIC-06759-X5V7P) under this agreement. The legal basis for processing personal data under the UK GDPR is to perform a task in the public interest. This is covered under Article 6(1)(e); - University of York and Hull University Teaching Hospitals NHS Trust are both public bodies, and it is in the public interest that work is done into providing details on cancer treatments and mortality rates. The personal data requested under this Agreement includes information about a participants' health; these are considered as special category data, and therefore the legal basis for processing these data is processing required for scientific research purposes which is covered under Article 9(2)(j) of the UK GDPR. The project requires an additional two-years of data on the currently linked cohort (2 years for HES data, with updated mortality and cancer registration). This work is jointly funded by CRUK and Bloodwise via a rolling programme grant and the intention is to retain the data for the same length as time as the case-cohort, as stated on DARS-NIC-390749-C4P0X. This would currently be until 01/01/2026 provided a valid data Sharing Agreement is in place with NHS Digital.. YHHN’s cohort of patients with haematological cancers was established in 2004; and NHS England supply YHHN with linked data from Hospital Episode Statistics (HES), Mortality and Cancer Registration Data under Data Sharing Agreements DARS-NIC-390749-C4P0X and DARS-NIC-346859-C9J6J. With the aim of investigating how the health of people with these cancers differs from that of people who do not have cancer, NHS England created a comparison cohort in 2016; matching each YHHN patient newly diagnosed with a haematological cancer during 2009-2016 (N=18,127) to 10 people of the same sex and gender who lived in the YHHN region but did not have a haematogical malignancy (N=181,270). This cohort was linked to the same datasets as the patient cohort, and data on hospital attendances/activity, cancer diagnoses and deaths have been supplied to the University of York since March 2017 under this Agreement (DARS-NIC-06759-X5V7P). In order to examine the impact of area based deprivation on both the diagnosis and the outcome of patients within the case cohort, the Lower Super Output Area (LSOA) of members of the comparison cohort has also been supplied. The project requires an additional two-years of data on the currently linked cohort (2 years for HES data, with updated mortality and cancer registration). This work is jointly funded by CRUK and BCUK via a rolling programme grant and the intention is to retain the data for the same length as time as the case-cohort, as stated on DARS-NIC-390749-C4P0X and DARS-NIC-346859-C9J6J-v1. This would currently be until 01/10/2026 providing a valid data Sharing Agreement is in place with NHS England. [1 paragraph unchanged]

Processing activities

The study data, including data provided by NHS Digital under previous Agreements, are currently held by University of York. No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). All data are stored at the University of York on two servers in different locations to ensure there is a backup. These are situated in buildings on campus; the Department of Health Sciences, which is located on the West Campus and the Data Centre, which is on the East Campus. The DSPT for the University of York provides security assurance for both sites. The comparison cohort was selected by NHS England in 2016 using the information held on individuals included in YHHN’s patient cohort. Each individual in the comparison cohort is assigned a unique identifier, which allows the University of York to identify the patient that they were matched to. All personal identifying data for the 181,270 individuals in the comparison cohort remain at NHS England and are not made available to the University. Identifying data was shared with ONS to carry out the linkage between the study data and civil registration data. Participants records were ‘flagged’ with the Office for National Statistics (ONS). ONS notified the study team at the University of York of participants’ deaths (date and cause) and cancer events when they occurred. The ‘flagging for long-term follow up’ service transferred from ONS to the HSCIC in 2008. Data was last supplied in March 2017. NHS England will provide the relevant records from the Hospital Episode Statistics (HES), mortality and cancer registrations datasets for the comparison cohort to the University of York. 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. The comparison cohort was selected by NHS Digital in 2016 using the information held on individuals included in YHHN’s patient cohort (MR1126). Each individual in the comparison cohort was assigned a unique identifier, which allowed the University to identify the patient that they were matched to. All personal identifying data for the 181,270 individuals in the comparison cohort remain at NHS Digital and are not made available to the University. Data for the comparison cohort is pseudonymised. The Data will not be transferred to any other location. All Data are stored at the University of York on two servers in different locations to ensure there is a backup. These are situated in buildings on campus. The Data will not leave England at any time. Comparison cohort data returned to the University by NHS Digital excludes all personal identifiers; data files being downloaded onto the University of York’s Microsoft SQL server running on a secure Windows Server. Authorised by the Principal Investigator, data Data can only be accessed by a restricted number of study staff who are substantively employed by the University of York. Valid authentication using credentials (username All personnel accessing the Data have been appropriately trained in data protection and password) is required to access any data, and levels of access are controlled via group membership and all actions are audited. The SQL server database, which contains data from NHS Digital, can only be accessed on site at the University of York; access confidentiality. Access is not permitted remotely and data Data are not shared with any external organisation or individuals who are not employed by the University of York. Hull University Hospitals NHS Trust cannot and will not access the Data. Outputs are only ever made available in the form of aggregated outputs, with small numbers suppressed in line with the HES Analysis Guide; no No attempt will ever be made to identify individuals from the data, Data, or link to any further data sets. HES data to March 2016, 2022, mortality to March 2017, 2023, and cancer registrations to March 2017 May 2022 have already been supplied by NHS Digital. England. The current agreement, which requests a forward extension of the time period [27 words unchanged] of the health care patterns and needs of patients with haematological malignancies. In addition the Lower Super Output Area (LSOA) of members of the comparison cohort at the time of their selection (which was inadvertently omitted from the initial application) is also requested. LSOAs, which are the small areas defined by ONS for the reporting of national statistics such as deprivation, are already held for the patient cohort. As a marker of socio-economic status, deprivation is an accepted risk factor for many cancers; both in relation to their development and their outcome. Accordingly, comparing the deprivation distribution of individuals in the patient cohort to that of their matched counterparts in the general population cohort is an important part of the analysis.

Expected output

Linked data for the comparison cohort were received from NHS Digital in March 2017. During the first month, data were checked for completeness and representativeness, and analyses are now underway. A summary of interim findings has been provided to the funder (CRUK) as part of the annual reporting cycle, and will also be presented to the clinical Audit Committee who monitor all YHHN’s activities and meet biannually. Data for the comparison cohort have been received from NHS England since March 2017. Since then outputs have included: YHHN expected to prepare reports on three main topics: [1 paragraph unchanged] 2. Estimation of the risk of thrombotic events in patients with polycythemia vera (a slowly developing rare blood cancer where too many red blood cells are produced, thickening the blood) 2. Risk of mature B-cell neoplasms and precursor conditions after joint replacement 3. Examination of the relationship between haematological malignancies and other cancers. 3. Health impact of monoclonal gammopathy of undetermined significance (MGUS) and monoclonal B-cell lymphocytosis (MBL) The peer-reviewed journals targeted for dissemination will be similar to those already published in: British Journal of Cancer, British Journal of Haematology, Blood, British Medical Journal Open, Cancer Epidemiology, Journal of Clinical Oncology, PLoS One, and Value in Health among many others. Likewise, findings will be disseminated at conferences; those that are regularly attended include meetings Pubic Health for England meetings, American and British Societies of Haematology (ASH & BSH), European Haematology Association (EHA), National Awareness and Early Detection Initiative (NAEDI), and the Palliative Care Congress. Data will be published and presented in the form of aggregated outputs, with small numbers suppressed in line with the HES Analysis Guide. YHHN expects to prepare reports on the following main topics: To ensure accessibility, all reports will be published under creative commons attribution 4.0 licence (CC BY); support for this is included in all of the grant applications and the study’s websites will provide links to these open access publications, conference proceedings and copies of reports summarizing the findings. These outputs may be promoted through the study’s Twitter account (@HMRN_UK (114 followers)) and via our funders (@bloodwise_uk (28,800 followers), @CR_UK (310,000 followers)). Lay summaries of the findings will be provided on the YHHN patient/public website (www.YHHN.org) and will be presented at the study’s local user groups and in the newsletter. YHHN also engages with national charities who publish study findings on websites and in their magazines, and regularly invite researchers to present findings from the study at their meetings. 1. Examination of the relationship between haematological malignancies and other cancers The charities that are funding this work are Bloodwise and CRUK, the University of York also have engagement with many of the other national cancer charities including Lymphoma Action and Marie Curie. As a matter of routine the University of York keep Bloodwise and CRUK informed of all research outputs, and it is envisaged that the same routes of dissemination will be used that have previously been done from our case-cohort (MR1126). This includes via websites, social media, press releases and also patient impact days. 2. Risk of developing cardiac events after treatment with tyrosine kinase inhibitors in patients with chonic myeloid leukaemia 3. The association of socio-economic status with the incidence of haematological cancers A summary of findings has and will continute to be provided to the funder (CRUK) as part of the annual reporting cycle, and also presented to the clinical Audit Committee who monitor all YHHN’s activities and meet biannually. The peer-reviewed journals targeted for dissemination will be similar to those already published in: British Journal of Cancer, British Journal of Haematology, Blood, British Medical Journal Open, Cancer Epidemiology, Journal of Clinical Oncology, PLoS One, and Value in Health among many others. Likewise, findings will be disseminated at conferences; those that are regularly attended include meetings Public Health for England meetings, Society for Social Medicine & Population Health, American and British Societies of Haematology (ASH & BSH) and European Haematology Association (EHA) Data will be published and presented in the form of aggregated outputs, with small numbers suppressed in line with the HES Analysis Guide. To ensure accessibility, all reports will be published under creative commons attribution 4.0 licence (CC BY); support for this is included in all of the grant applications and the study’s websites will provide links to these open access publications, conference proceedings and copies of reports summarizing the findings. These outputs may be promoted through the study’s Twitter account (@HMRN_UK (337 followers)) and via our funders @CR_UK (310,000 followers)). Lay summaries of the findings will be provided on the YHHN patient/public website (www.YHHN.org) and will be presented at the study’s local user groups and in the newsletter. YHHN also engages with national charities who publish study findings on websites and in their magazines, and regularly invite researchers to present findings from the study at their meetings. The charities that are funding this work are CRUK and BCUK, the University of York also have engagement with many of the other national cancer charities including Lymphoma Action and Marie Curie. As a matter of routine the University of York keep BCUK and CRUK informed of all research outputs, and it is envisaged that the same routes of dissemination will be used that have previously been done from the case cohort. This includes via websites, social media, press releases and also patient impact days. [7 paragraphs unchanged] All The outputs will not contain NHS England Data and will only data that is contain aggregated information with small numbers suppressed as appropriate in line with the HES Analysis Guide. relevant disclosure rules for the dataset(s) from which the information was derived.

Expected measurable benefits

A major aim of YHHN is to improve care and outcomes for [51 words unchanged] and are of potential importance to national commissioning of cancer care services. Indeed, published information from The YHHN has been used in NICE appraisals, as well as in control cohort, which is the development focus of national guidelines. this Agreement, is key to the provision of further benefit since it allows meaningful comparisons to be made across the life-course between patients with cancer and those without. The creation of a comparison cohort linked to the same national healthcare [59 words unchanged] monitor the impact of future therapeutic changes in the general patient population. Examples where the comparison cohort has been used to examine patters of healthcare have been published as articles as follows 1. Does Life-Expectancy in Patients with Diffuse Large B-Cell Lymphoma Return to Normal? Findings from a UK-Based Population-Based Study 2. Hospital activity before and after diagnosis of monoclonal gammopathy of undetermined significance (MGUS) 3. Risk of mature B‐cell neoplasms and precursor conditions after joint replacement: A report from the Haematological Malignancy Research Network 4. The impact of rheumatological disorders on lymphomas and myeloma: a report on risk and survival from the UK’s population-based Haematological Malignancy Research Network

Benefits reported

The dataset was received in March 2017 and as such, the first analyses comparing the YHHN patient cohort to the general population comparison cohort are currently being conducted. YHHN anticipate that the first reports of findings using the data to be published over the next 12 months. A major aim of YHHN is to improve care and outcomes for patients; and data from the patient cohort have been used in National Institute for Health & Care Excellence (NICE) appraisals, as well as in the development of national guidelines, and impacted on the delivery of patient care. Since receiving the Data, numerous analyses have been conducted comparing the YHHN patient cohort to the general population comparison cohort and the first report by the University of York has been published in the journal Cancer Epidemiology – “The impact of rheumatological disorders on lymphomas and myeloma: a report on risk and survival from the UK’s population-based Haematological Malignancy Research Network”, which examined patterns of secondary care among individuals with lymphoma, comparing them to that seen among their matched controls. This is important since patients with lymphoma are known to be at increased risk of certain other co-morbidities, but the size of the risk(s) and their potential impact on outcome has not been previously examined in the UK. Other reports have since followed including the risk of developing a B-cell lymphoid malignancy after a joint replacement (https://doi.org/10.1002/ijc.32765) and the health impact of monoclonal gammopathy of undetermined significance (MGUS) and monoclonal B-cell lymphocytosis (MBL) (http://dx.doi.org/10.1136/bmjopen-2020-041296). A major aim of YHHN (MR 1126) is to improve care and outcomes for patients; and data from the patient cohort have been used in NICE appraisals and impacted on the delivery of patient care. Importantly, the YHHN area is representative of the UK as a whole in terms of both demography and clinical practice; meaning that results are generalizable and are of potential importance to the national commissioning of cancer care services. The YHHN control cohort, which is the focus of the present application (MR 1325), is key to the provision of further benefit since it allows meaningful comparisons to be made across the life-course between patients with cancer and those without. FEBRUARY 2024 ACR UPDATE: With respect to timelines, the linked control cohort dataset was received from NHS Digital in March 2017 and, following internal checks, the initial analyses are now nearing completion. The first report by the University of York has been submitted to the International Journal of Cancer – “Mature B-cell malignancies and rheumatological disorders: a report on risk and survival from the UK’s Haematological Malignancy Research Network” examines patterns of secondary care among individuals with lymphoma, comparing them to that seen among their matched controls. This is important since patients with lymphoma are known to be at increased risk of certain other co-morbidities, but the size of the risk(s) and their potential impact on outcome has not been previously examined in the UK. This publication is ready to be submitted to the International Journal of Cancer – “Mature B-cell malignancies and rheumatological disorders: a report on risk and survival from the UK’s Haematological Malignancy Research Network” The YHHN comparison cohort is linked to the same national healthcare datasets as the YHHN patient cohort, enabling the healthcare patterns of patients with haematological cancers to be compared to those of the general population. A major aim of YHHN as whole is to improve patient care; and real-world data from the patient cohort have been used in NICE appraisals and impacted on the delivery of patient care. Importantly, the YHHN area is representative of the UK as a whole in terms of both demography and clinical practice; meaning that results are generalizable and are of potential importance to the national commissioning of cancer care services. The YHHN comparison cohort is key to the provision of further benefit since it allows meaningful comparisons to be made across the life course between patients with cancer and those without. Other analyses, several of which are likely to impact on patient care, are ongoing; and YHHN envisage that at least two other reports on this topic will be published in the next 12 months. All published papers and reports, along with conference presentations, are available on the Haematological Malignancy Research Networks website (HMRN), which is the umbrella Network under which YHHN sits. Many of the website outputs contain data from the comparison cohort. One recent example of the data’s value was presented at a 2023 conference (Lamb et al; Are patients with acute myeloid leukaemia (AML) or myelodysplastic syndromes (MDS) more likely than the general population to have a preceding cancer? An analysis from the UK’s population-based haematological malignancy research network (HMRN) https://doi.org/10.1136/jech-2023-SSMabstracts.299). Other recent examples are included in (Roman et al; Pathways of patients with chronic haematological malignancies: a report from the UK’s population-based HMRN), which is in press (National Institute for Health Care Research (NIHR) Programme Grants for Applied Research).

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: + HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST

Datasets: + Cancer Registration Data; + Civil Registrations of Death; + Demographics; + Emergency Care Data Set (ECDS); + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients; + MRIS - Members and Postings Report

Objective for processing

Hospital Episode Statistics (HES), Mortality and Cancer data were supplied to the University of York by ONS and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as the Yorkshire and Humberside Haematology Network Register (YHHN) Comparison Cohort. The University of York is the sole Data Processor and the joint Data Controller with Hull University Teaching Hospitals NHS Trust. YHHN is a collaboration with a clinical network, and the work is commissioned by Hull University Teaching Hospitals NHS Trust. All The Yorkshire and Humberside Haematology Network’s (YHHN’s) activities are agreed and monitored by the Haematology Network’s Audit Committee (the Yorkshire & Humberside Haematology Network Audit Committee). Bloodwise (a charity) and Cancer Research UK funds YHHN but are not involved in the conduct of the research. Only the University of York have access to data under this agreement. This Data Sharing Agreement permits the retention of the data for an interim period but no other processing of the data is permitted. Hull University Teaching Hospitals NHS Trust have been involved from the outset of the project as a member of the clinical network that comprises YHHN. It's involvement was formalised in 2009 in a previous approved version of the application to the Central Register, for mortality data (MR1126), where the Trust confirmed that YHHN was being run on behalf of an NHS organisation for the purposes of “public health provision or the management of health services." Permission to retain the data for the interim period is a practical step to enable the study to comply with the necessary legal and ethical requirements. If, for any reason, it is not possible for the study to meet the necessary requirements, this Agreement will be terminated and destruction of the data will be required. The legal basis for processing personal data under GDPR, is to perform a task in the public interest. This is covered under Article 6(1)(e); - University of York and Hull University Teaching Hospitals NHS Trust are both public bodies, and it is in the public interest that work is done into providing details on cancer treatments and mortality rates. The personal data requested under this agreement includes information about a participants' health; these are considered as special category data, and therefore the legal basis for processing these data is processing required for scientific research purposes which is covered under Article 9(2)(j) of the GDPR. The following information provides background information on the purpose of the original study: Hospital Episode Statistics (HES), Mortality and Cancer data were supplied to the University of York by ther Office for National Statistics (ONS) and subsequently the Health and Social Care Information Centre (which has since become NHS Digital) for the purpose of a research study referred to as the Yorkshire and Humberside Haematology Network Register (YHHN) Comparison Cohort. Previously this was a new application to create a control cohort matched with the YHHN Register and to provide pseudonymised HES data, Personal Demographic Service (PDS) tracking, The PDS is the national electronic database of NHS patient demographic data, such as name, address, date of birth and NHS number. It supports quick and accurate identification of a patient, contact and communication with a patient, and linkage of data and records across care settings and information systems, cancer registration data and ONS mortality for this control cohort. [3 paragraphs unchanged] The YHHN region comprises the population served by the West Yorkshire and [23 words unchanged] oversee the management of patients diagnosed with haematological malignancies in the Network. As stated in the application, all All YHHN activities are agreed and monitored by the Haematology Network’s Audit Committee, which is currently chaired by Professor Russell Patmore, the medical director at Hull & East Yorkshire Hospital NHS Trust. Each MDT in the region is represented by a consultant haematologist at the audit committee. YHHN’s cohort of patients with haematological cancers was established in 2004; and [31 words unchanged] of people with these cancers differs from that of people who do not, not have cancer, NHS Digital created a comparison cohort in 2016; matching each YHHN patient [56 words unchanged] to the University of York in March 2017 (Data Sharing Agreement, DARS-NIC-06759-X5V7P) under this agreement. The project requires an additional two-years of data on the currently linked cohort (2 years for HES data, with updated mortality and cancer registration). Data retention is currently stated as 31/12/2019 and we presume this reflects the period of the CRUK funding, however, this This work is jointly funded by CRUK and Bloodwise via a rolling programme [15 words unchanged] as the case-cohort, as stated on DARS-NIC-390749-C4P0X. This would currently be until 01/01/2026. 01/01/2026 provided a valid data Sharing Agreement is in place with NHS Digital.. [1 paragraph unchanged]

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. The study data, including data provided by NHS Digital under previous Agreements, are currently held by University of York. The study data, including data provided by NHS Digital under previous Agreements, are currently held by University of York. Under this interim extension all devices containing data will be securely locked away in a locked cabinet at the University of York storage address specified in this Agreement. All data are stored at the University of York on two servers in different locations to ensure there is a backup. These are situated in buildings on campus; the Department of Health Sciences, which is located on the West Campus and the Data Centre, which is on the East Campus. The DSPT for the University of York provides security assurance for both sites. The following provides background on the processing activities undertaken for the original study: [1 paragraph unchanged] The comparison cohort was selected by NHS Digital in 2016 using the [52 words unchanged] not made available to the University. Data for the comparison cohort is pseudonymised and does not contain any personal or sensitive fields. pseudonymised. [4 paragraphs unchanged]

Expected output

No new outputs will be produced under this Data Sharing Agreement. Linked data for the comparison cohort were received from NHS Digital in March 2017. During the first month, data were checked for completeness and representativeness, and analyses are now underway. A summary of interim findings has been provided to the funder (CRUK) as part of the annual reporting cycle, and will also be presented to the clinical Audit Committee who monitor all YHHN’s activities and meet biannually. In any future application, the applicant will be required to provide details of the outputs that were produced and disseminated by the study as well as details of any future outputs planned. Linked data for the comparison cohort were received from NHS Digital in March 2017. During the first month, data were checked for completeness and representativeness, and analyses are now underway. A summary of interim findings will be provided to the funder (CRUK) later this year as part of the annual reporting cycle, and will also be presented to the clinical Audit Committee who monitor all YHHN’s activities and meet biannually. [2 paragraphs unchanged] 2. Estimation of the risk of thrombotic events in patients with polycythemia vera. vera (a slowly developing rare blood cancer where too many red blood cells are produced, thickening the blood) [12 paragraphs unchanged]

Expected measurable benefits

In any future application, the applicant will be required to provide details of the expected benefits resulting from the study. [1 paragraph unchanged] The creation of a comparison cohort linked to the same national healthcare [59 words unchanged] monitor the impact of future therapeutic changes in the general patient population. The target date for expected measurable benefits Examples where the comparison cohort has been used to examine patters of healthcare will be by the end of December 2019. have been published as articles as follows 1. Does Life-Expectancy in Patients with Diffuse Large B-Cell Lymphoma Return to Normal? Findings from a UK-Based Population-Based Study 2. Hospital activity before and after diagnosis of monoclonal gammopathy of undetermined significance (MGUS) 3. Risk of mature B‐cell neoplasms and precursor conditions after joint replacement: A report from the Haematological Malignancy Research Network 4. The impact of rheumatological disorders on lymphomas and myeloma: a report on risk and survival from the UK’s population-based Haematological Malignancy Research Network

Benefits reported

In any future application, the applicant will be required to provide details of the actual benefits achieved as a result of the study. [4 paragraphs unchanged]