Cancer Survivorship Studies: national comparator data from routinely collected health service data

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

Datasets: + Medicines dispensed in Primary Care (NHSBSA data)

Objective for processing

The British Childhood Cancer Survivor Study (BCCSS) is a national population-based cohort of almost 35,000 individuals who were diagnosed with cancer under the age of 15 years, between 1940 and 2006, in England, Wales or Scotland, and who survived at least 5 years from diagnosis. The original childhood cohort (MR787) relates to a cohort of individuals diagnosed with cancer between 1940 and 2006, aged under 15 at diagnosis and who survived at least 5 years from diagnosis, in Britain. This cohort was flagged with NHS Digital back in 2008/09 and legislation in place at the time allowed NHS Digital to liaise with Information Services Division (ISD) / NHS Central Register (NHSCR) Scotland to obtain details of cancers, deaths and demographic (NHS status) information for those cohort members who were diagnosed with cancer in Scotland, died in Scotland or who were domiciled in Scotland and registered with a Scottish GP and forward this information routinely to the CCCSS. University of Birmingham’s Centre for Childhood Cancer Survivor Studies (CCCSS) requires access to NHS England data for the purpose of the following research project: Cancer Survivorship Studies: national comparator data from routinely collected health service data The study is to establish a system to monitor the risks of adverse health outcomes and related healthcare activity and cost among these survivors, and to determine how observed risks and costs compare with those expected from the general population to determine subgroups of survivors who experience substantially increased risk and those service users who require more support. The British Childhood Cancer Survivor Study (BCCSS) is a national population-based cohort of almost 35,000 individuals who were diagnosed with cancer under the age of 15 years, between 1940 and 2006, in England, Wales or Scotland, and who survived at least 5 years from diagnosis. [1 paragraph unchanged] The BCCSS and TYACSS cohorts make up the "Cancer Survivorship Cohort" and are maintained by the CCCSS Centre for Childhood Cancer Survivor Studies (CCCSS) at the University of Birmingham, established in 1998 with charity funding from Cancer Research UK and the Kay Kendall Leukaemia Fund. Birmingham. The CCCSS proposes to combine the BCCSS and TYACSS cohorts. This will build the cohorts into one cohort that is as up to date as possible. DARS-NIC-148313-G56YY covers record level data for the Cancer survivorship cohort, this DSA covers a tabulation of aggregate data small numbers unsuppressed. The record level data for the Cancer Survivorship cohort required for this study is the subject of a separate application (DARS-NIC-148313-G56YY). The University of Birmingham requires tabulated data with small numbers in order to categorize the contact the cohort has with the NHS and understand the full health service burden of late effects of treatment. The research has to characterise this burden in terms of: clinical diagnoses, surgical procedures, service contacts, medication prescribed in primary care (GP) and health economics There is no comprehensive national system to monitor adverse health and social outcomes among the entire population of survivors of childhood, teenage and young adult cancer in Britain. However, the University of Birmingham is requesting tabulated data with small numbers in order to categorise the contacts the cohort has with the NHS and understand the full health service burden of late effects of treatment. The research has to characterise this burden in terms of: clinical diagnoses, surgical procedures, service contacts and health economics. For this reason the CCCSS requires population-level data to the 3-character ICD-10 code level, OPCS-4 procedure codes, counts of service contacts for the general population of England to which the health service exposure in the cohort will be compared. The following NHS England Data will be accessed: The tabulation data requested is “Aggregated - Small Numbers Not Suppressed”. There are two important reasons why small, unsuppressed numbers are required; one is epidemiological, and one is statistical. • Hospital Episode Statistics From an epidemiological perspective, the CCCSS is looking at the entire burden of disease in the combined cohort. Thus far cancer survivor cohorts have concentrated on causes of mortality rather than the burden of morbidity. Evidence is emerging that some of the large risk increases observed amongst survivors are in diseases which are rare in the general population though not necessarily diseases which are the primary or underlying cause of death. o Admitted Patient Care From a statistical perspective, historically risk differences have been calculated at individual person years. In many epidemiological studies it is common to observe risk differences in five-year age bands in the general population diseases, especially in chronic diseases which typically will not have a very large gradient of incidence or prevalence within an age band. In cancer survivors however, as their survival typically does not translate into a normal life course, the gradient in a 5-year or 90-year age-band would potentially dilute a risk difference signal. It is accepted practice in cancer survivor cohorts to calculate standardised incidence ratios in single year of age. This means that the CCCSS will require expected admission counts, for example, for all diagnoses for all survivors aged 40, 41, 42 etc., to calculate standardised admission ratios using the accepted method. As some of the diagnoses are likely to be for rare conditions, it is highly likely that some of the data points needed to obtain them are going to contain numbers that are less than 5. o Accident & Emergency The study aim will be to establish a system to monitor the risks of adverse health outcomes and related healthcare activity and cost among these survivors, and to determine how observed risks and costs compare with those expected from the general population to determine subgroups of survivors who experience substantially increased risk and those service users who require more support. o Critical Care – necessary Adverse health outcomes and associated costs would be obtained from electronic record linkage of the cohorts with existing national registries/databases. o Outpatients – necessary The report by the Independent Cancer Taskforce “Achieving World-Class Cancer Outcomes –A Strategy for England 2015-2020” emphasised the importance of risk stratification of cancer survivors in relation to their risk of developing serious adverse health conditions to ensure that the intensity of clinical follow-up care is in proportion to such risk. It is an unfortunate fact that individuals who have survived cancer experience greater risks of adverse health conditions, and greater risks of dying, than is expected from rates of these events in the general population. • Mental Health Minimum Data Set (MHMDS) / Mental Health and Learning Disabilities Data Set (MHLDDS) / Mental Health Services Data Set (MHSDS) The National Cancer Research Institute, NHS-England and Public Health England have each produced cancer strategies which also emphasise the importance of such risk stratification. It is estimated that by 2030 there will be 4 million individuals living with the long-term consequences of cancer and its treatment, but unfortunately there is to date very little research on the problems which they experience, the causes and how they might be prevented or reduced in the future. These data are required in order to identify and compare the observed adverse health and social outcomes in the cohort with the general population of England the CCCSS will require numbers and types of the equivalent adverse health and social outcomes identified from amongst the general population. The purpose and legal basis for the processing of these cohorts by the University of Birmingham to carry out research in their Centre for Childhood Cancer Survivor Studies (CCCSS) does so in the public interest and processing is necessary for archiving purposes in the public interest, scientific or historical research purposes. The level of the Data will be: In particular the legal basis for the processing of these cohorts is covered under GDPR article 6.1(e): Public task: “the processing is necessary for you to perform a task in the public interest or for your official functions, and the task or function has a clear basis in law”. • Aggregate with small numbers unsuppressed Also since the university are processing special category data (health data) this is covered by GDPR 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”. The tabulation will comprise of population-level data to the 3-character ICD-10 code level, OPCS-4 procedure codes, counts of service contacts for the general population of England to which the health service exposure in the cohort will be compared. The CCCSS is seeking to establish a comprehensive system to monitor the risks of adverse health and social outcomes among survivors of childhood, teenage and young adult cancer in Britain by combining the BCCSS and TYACSS cohorts and undertaking national population-based record linkage based investigations of the absolute and excess risks of : University of Birmingham is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above Specific causes of death experienced by 5-year survivors of childhood, teenage and young adult cancer, using civil registration data from the national death registries. The lawful basis for processing personal data under the UK GDPR is: Subsequent primary cancers experienced by 5-year survivors of childhood, teenage and young adult cancer, using the cancer registration data from national cancer registries. 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; Hospitalisation for non-neoplastic conditions among 5-year survivors of childhood, teenage and young adult cancer, using the national Hospital Episode Statistics database for England. The lawful basis for processing special category data under the UK GDPR is: The uptake of the full spectrum of mental health services available within the community among 5-year survivors of childhood, teenage and young adult cancer using the national Mental Health Services Datasets. 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. Further linkage will be undertaken with additional national datasets relating to education, employment, cardiac outcomes and treatment history (chemotherapy and radiotherapy) subject to the appropriate data sharing agreements and ethic approvals being obtained. 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. By identifying and monitoring the risks of adverse health and social outcomes, and the related healthcare activity and cost among these cancer survivors, the CCCSS can identify how observed risks and costs compare with those expected from the general population and determine subgroups of survivors who experience substantially increased risk and who may place a higher demand on services. The funding is provided by Brain Tumour Charity and Children. The funding is specifically for the project described Such large-scale population-based investigations have so far provided the most reliable and unbiased evidence available for: Data will be accessed by: counselling, educating and empowering survivors; • Undergraduate, Masters or PhD students enrolled with University of Birmingham. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to University of Birmingham’s policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of University of Birmingham. University of Birmingham would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA. developing plans for the follow-up and care of survivors; Patient and Public Involvement has been integral to this study from the outset, with survivors providing detailed feedback on the protocol and committing to ongoing involvement. The research aligns with top ten priorities identified by multiple James Lind Alliance initiatives, ensuring relevance to patient needs. Input has been secured through The Brain Tumour Charity’s Research Involvement Network, local and national survivor groups, and international forums such as PanCare, with representation continuing throughout the project via steering groups and advisory roles. This broad engagement guarantees that survivor perspectives shape the research and its dissemination. providing educational material for health care professionals including GPs; evaluating risks and benefits of proposals for types of treatment in the future; providing advice to national authorities in relation to specific groups of survivors who may require further follow-up, surveillance or clinical intervention, and those groups of survivors who could be discharged from follow-up; providing economic evaluation of the expected and actual costs to the health services of treating and supporting cancer survivors Justification for collection of routinely collected NHS data: In order to identify and compare the observed adverse health and social outcomes in the cohort with the general population of England the CCCSS will require numbers and types of the equivalent adverse health and social outcomes identified from amongst the general population. Treatment interventions for children and young adults with cancer have changed over the last three decades, and continue to do so. This is especially relevant to our cohort who have been diagnosed with cancer historically over a long period of time. The CCCSS is seeking to elucidate late effects of treatment, and as treatment has changed of the lengthy period of diagnostic interest, it is essential to undertake a longitudinal study covering the longest period of observation possible for which good quality routinely collected NHS data are available. For this reason the CCCSS has requested data from financial year 1997-8 to the latest available financial year available for the datasets of interest. In order to understand the full health service burden of late effects of treatment, it is necessary to categorise the contacts the cohort has with the NHS. The research has to characterise this burden in terms of: clinical diagnoses, surgical procedures, service contacts and health economics. For this reason the CCCSS requires population-level data to the 3-character ICD-10 code level, OPCS-4 procedure codes, counts of service contacts for the general population of England to which he health service exposure in the cohort will be compared. The CCCSS has carefully reviewed all fields in the Admitted Patient Care dataset with reference to intended processing purposes and outputs and is requesting count data by single year of age and sex of all ICD-10 diagnosis codes and OPCS-4 procedure codes for each of the financial years requested. For the other data sets of interest (e.g. Critical Care, Accident and Emergency, mental health) CCCSS have only requested counts of NHS contacts by single year of age, and sex in the general population of England. The CCCSS will not be capturing any other data items. The combined BCCSS and TYACSS cohorts provide a unique national resource in that it provides national registers of survivors of both childhood cancer and of teenage and young adult cancer. Independent senior researchers in the UK have approached the CCCSS to use subsets of the BCCSS and TYACSS cohorts as a starting point for their own research investigations avoiding duplicating all the work the CCCSS has undertaken in establishing the registries of survivors which the BCCSS and TYACSS represent. These independent researchers need to have funded and peer-reviewed projects and they need to obtain their own separate ethical and legal permissions (if needed) to undertake the research as necessary. Data sharing agreements would be required with input from both Legal Services and Research Governance teams at the University of Birmingham. The CCCSS understands that equivalent permissions and agreements need to be in place to accommodate the equivalent legislation in Scotland. The CCCSS is currently completing an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP) via the Electronic Data Research and Innovation Service (eDRIS). The University of Birmingham is the sole Data Controller as it determines the purposes and means of the processing of personal data. The University of Birmingham also process data disseminated by NHS Digital for the purposes of this research. The Brain Tumour Charity, Children with Cancer, Dutch Cancer Society and Public Health England are funding the study and have no influence on the study design or study outcomes. Patient and Public Involvement (PPI) PPI representatives provided initial feedback on the study protocol, and they are keen to be involved with the project and support the dissemination of the study results. Research Priority Setting Partnership overseen by the James Lind Alliance. The research proposed here has been identified as being among the top-ten research priorities in three Research Priority Setting Partnership initiatives overseen by the James Lind Alliance. Survivors are central to identifying such research priorities in James Lind Alliance led initiatives. Specific PPI group established for research funded by The Brain Tumour Charity. In the development of our successful grant application to The Brain Tumour Charity, CCCSS consulted with their Research Involvement Network (RIN) which is comprised exclusively of survivors of a brain tumour. Twelve members of the RIN fed-back in detail on research proposals and this impacted the research. CCCSS have agreed that two members of the RIN will join the Project Steering Group and therefore be involved over the entire lifetime of the project. Local group of survivors of childhood cancer. The Consultant Paediatric Oncologist at the Birmingham Children’s Hospital has established a local group of about 20 survivors to be consulted on for both clinical and research questions. The Consultant Paediatric Oncologist has indicated that this group may be asked to provide guidance to the survivorship research relating to survivors of childhood cancer. Birmingham Cancer Research UK Centre PPI Group. There is a Cancer Research UK funded Senior Research Nurse at the Birmingham Cancer Research UK Centre who maintains a group of about 20 survivors of a variety of cancer diagnosed at a range of adult ages. CCCSS have consulted with, and will continue to consult with, this group of survivors. Pancare. The CCCSS Director is a founding member of PanCare, an organisation for childhood cancer survivors and their families; clinicians caring for those with, or cured of, cancer; researchers addressing the needs of those with, or cured of childhood cancer. This pan-European organisation meets twice each year and has a significant survivor membership. This provides an international forum to seek input from survivors into research being undertaken or planned. The National Cancer Research Institute –Teenage and Young Adult & Germ Cell Tumour –Clinical Studies Group (NCRI-TYA&GCT-CSG). The CCCSS Director is a member of this national group and there are also two survivors of TYA cancer among the membership. This provides a national forum for input from survivors into survivorship research studies.

Processing activities

All organisations party to this agreement must comply with the data sharing framework contract requirements, including those regarding the use (and purposes of that use) by “personnel” (as defined within the data sharing framework contract i.e. employees, agents and contractors of the data recipient who may have access to that data). No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). NHS Digital will create the requested tabulated (small numbers not suppressed) datasets, then disseminate the data to the University of Birmingham, CCCSS, via SEFT. NHS England disseminated a tabulated (small numbers unsuppressed) dataset to University of Birmingham The CCCSS will not attempt to re-identify any individual or carry out any other activity that may pick up individual characteristics that could lead to identification. The CCCSS will not flag members of cohort in the tabulated flow of data. The Data will not be transferred to any other location. Risks of specific causes of death: The Data will be stored on servers at University of Birmingham Each individual enters risk at the date of 5-year survival and contributes person-years until the exit date (first of emigration date or date of end of ascertainment). Standardised Mortality Ratios (SMRs) and Absolute Excess Risks (AERs) will be calculated as O/E and [(O-E)/py]*10000 where O and E are the observed and expected numbers of deaths, respectively, and ‘py’ is the person-years at risk accumulated. To investigate variation in SMRs and AERs across levels of risk stratification factors. Poisson regression models will be utilised. Poisson regression is the modelling of count data and is used to predict a dependent variable that consists of "count data" given one or more independent variables. Cumulative incidence of death from a specific cause will be estimated treating other causes of death as competing risks. Cumulative incidence of death from a specific cause will be estimated treating other causes of death as competing risks. The Data will be accessed onsite at the premises of University of Birmingham. Risks of subsequent primary neoplasms (SPNs): The Data will not leave the UK at any time. Similar statistical methodology to that described for deaths would be used to determine subgroups of survivors at substantially excess risk of specific SPNs, but the summary measures would be Standardised Incidence Ratios (SIRs) and Absolute Excess Risks (AERs defined as for deaths, in terms of observed (O) and expected (E) numbers of SPNs of a particular site/type, as in the previous work by the CCCSS. Access is restricted to employees of University of Birmingham or Undergraduate, Masters or PhD students enrolled with University of Birmingham. Risk of non-neoplastic adverse health and social outcomes: All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The period at risk begins from the start date for ascertainment of the specific outcome and ends at the current end date of ascertainment provided the survivor does not exit through emigration or death before this end date. The risk of a specific adverse health outcome would be compared over the period at risk using Poisson regression in relation to the risk stratification factors. In this way it would be possible to identify particular subgroups at greatest risk (Internal analysis). University of Birmingham will not attempt to re-identify any individual or carry out any other activity that may pick up individual characteristics that could lead to identification The CCCSS are requesting tabulated data (with small numbers unsuppressed) from general population, for example, the general population hospitalisation, community mental health events classified by age, sex and calendar year. By dividing the number of events in each cell by the general population estimate of those at risk provides an expected rate for the derivation of expected numbers. Again, Poisson regression would be used to compare the observed and expected number, Standardized Hospitalization Ratio (SHR), over the levels of a particular risk factor adjusting for others (external analysis). Researchers from the CCCSS will process the Data for the purposes described above. Cost analysis: Unit costs will be assigned to healthcare activity using standard Department of Health (DoH) guidance. Healthcare Resource Group (HRG) codes will be assigned to secondary care episodes using the DoH Grouper software with sensitivity analysis between year-specific and common-base-year assignment. Prescriptions will be costed using the national tariff for branded medicines and the electronic medicines compendium for generic medicines. On this basis, the cost of subsequent primary neoplasms, the cost of non-neoplastic adverse events and the overall cost-profile of survivors will be described. Comparison of overall costs and cost profiles will be made descriptively through cost-profile visualisation. In parallel with the risk analysis described above, internal analysis will identify predictors of cost using generalised linear models. External analysis based on the same cells as the risk analysis will estimate observed and expected cost compared with the general population. Security: Two of the hard drives will be stored in a fire-proof safe in a locked room within the CCCSS Study Centre which requires a swipe key and two physical locks to access. The third hard drive will be stored in a fire-safe in a separate location within the University of Birmingham College of Medical and Dental Sciences (COLMDS) that satisfies University Security requirements. Only members of the CCCSS will have access to the encryption keys for the external hard drives. Both a manual and electronic log will be kept to record details of access to, and changes to, the databases on the encrypted drives. Any adjustments to identifiable data will be replicated across each version of the database on each separate encrypted drive. The databases will be checked against each other for consistency. A manual log will be kept at the Study Centre along an electronic log with a description of changes, the dates the changes were made and who made the changes that will be kept on each encrypted drive and on the Study Centre network share. The CCCSS and NHS Digital will be informed by COLMDS-IT Services prior to any changes to the location or storage situation of the encrypted drive stored in COLMDS outside of the Study Centre. Any such changes must be agreed between the CCCSS and COLMDS-IT Services. The database of linked data will be stored and maintained according to the Information Security and Management Policy (ISMP) of the University of Birmingham. The ISMP sets out the security arrangements under which sensitive data should be identified, processed and stored, while the Data Protection Policy deals with data protection and privacy. Further information relating to University of Birmingham standards and guidance can be found at: http://itsecurity.bham.ac.uk/policy. In accordance with the ISMP security practices shall be deployed to protect people technology and processes from deliberate attack based on a risk assessment within the framework of an Information Security Management System (ISMS) compatible with ISO27001 and related standards. Data shall be stored on centrally managed stores (file servers) and archived in a manner to facilitate secure disposed of when no longer required. The file servers are located in locked, secure, specialised rooms with appropriate heating and ventilation, on the University of Birmingham Campus. For projects undertaken at the CCCSS the file servers reside in the College of Medical and Dental Sciences (COLMDS). Access to server rooms is limited to UBHAM Information Technology personnel only with swipe card systems. Multiple tape back-ups of the servers occur daily (incremental) and weekly (full) and are stored in fireproof safes in separate locked locations within COLMDS. Access to rooms is limited to UBHAM Information Technology personnel only with swipe card systems. File, database or disk encryption must be used except where compensating controls can be shown to provide an equivalent level and protection. Data transferred over data communication networks shall be encrypted or otherwise protected to University Standards (at least AES 256 compliant). This includes email and other types of electronic messaging. Removable media and mobile devices shall be encrypted to University Standards (at least 128-bit encryption). Access to University systems, IT infrastructure and facilities will only be to authorized persons with a valid ID card, a University assigned username and a password that conforms to University standards (at least 8 characters long, one uppercase letter, at least one lower case letter, at least one digit, at least one non-alphanumeric character, enforced renewal every 180 days). While all members of CCCSS staff have access to a personal file-store account a separate network share will be made available to all Study Centre staff only, for file sharing purposes and storage of the linked data. All CCCSS staff who will have access to the NHS Digital data are substantive employees of University of Birmingham or CCCSS PhD students and have completed the mandatory training on Information Security Awareness, Data Protection and Freedom of Information. All Study Centre staff members are required to sign an undertaking of confidentiality which, if broken, would likely lead to dismissal. All Study Centre staff with access to patient identifiable information have received appropriate training and receive ongoing supervision and support to ensure they are aware of their responsibilities. Study Centre Staff will never disclose identifiable data to third parties. Personal data will be processed according to a valid lawful basis and conditions for processing.

Expected output

The CCCSS shall investigate the variation in absolute and excess risk of deaths, subsequent primary neoplasms and adverse health and social outcomes by comparing the observed cohort with the general population. The expected outputs of the CCCSS processing will be: All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide. • Peer-reviewed publications: Manuscripts prepared for submission to leading international journals such as New England Journal of Medicine, The Lancet, JAMA, and BMJ. Manuscripts will be prepared for publication in international peer-reviewed journals. Authorship eligibility will be determined to be consistent with the requirements of the leading international general medical journal including New England Journal of Medicine, The Lancet, the Journal of the American Medical Association and the British Medical Journal. • Reports for funders: Regular reports summarizing findings and progress. There are already over 100 such manuscripts published using the BCCSS cohort, and about 10 published using the TYACSS cohort. • Website content: A dedicated CCCSS website hosting the Study Protocol, newsletters, and a complete list of publications. Funding bodies will need to be acknowledged within peer-reviewed publications, but they have no rights to alter, delay or prevent such publications. • Conference presentations: Presentations at the Annual Education Day organized by the Late Effects Group of the Children’s Cancer and Leukaemia Group, and other relevant conferences. The CCCSS intends to establish a website for the study which will contain information regarding progress and accessible summaries of the research in the form of regular newsletters. The Study Protocol, a complete list of publications and previous Newsletters will be available on the Study Website. • Engagement with PPI groups: Dissemination of accessible summaries and updates through Patient and Public Involvement groups. Senior members of the CCCSS regularly speak at the Annual Education Day organised by the Late Effects Group of the Children’s Cancer and Leukaemia Group. This is well attended (100 to 150 attendees) by those responsible for the care (doctors and nurses) of survivors of childhood cancer at Centres throughout the UK. • Tables of standardized hospitalization ratios: Outputs comparing secondary care usage between cancer survivors and the general population for a wide range of hospitalizations. The CCCSS Director is a full member of both the Children’s Cancer and Leukaemia Group (CCLG) and the Late Effects Group of the CCLG. 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 various Patient and Public Involvement (PPI) groups (as described in the Objectives of Processing section) are keen to be involved with the project and support the dissemination of the study results. These PPI groups are; The outputs will be communicated through the following channels: - Research Priority Setting Partnership overseen by the James Lind Alliance • Peer-reviewed journals (international medical journals). - The Brain Tumour Charity Research Involvement Network (RIN) • CCCSS website (protocols, newsletters, publication lists). - Local group of survivors of childhood cancer at the Birmingham Children’s Hospital • Annual Education Day of the Late Effects Group (100–150 healthcare professionals). - Birmingham Cancer Research UK Centre PPI Group • Patient and Public Involvement groups, including: - Pancare. >James Lind Alliance Research Priority Setting Partnership - The National Cancer Research Institute –Teenage and Young Adult & Germ Cell Tumour –Clinical Studies Group (NCRI-TYA&GCT-CSG). >Brain Tumour Charity Research Involvement Network Reports for funders and peer-reviewed publications. Specific outputs will comprise tables of standardized hospitalization ratios which will used to measure differences in secondary care usage between a cohort of cancer survivors and the general English population. This will be done for an extensive range of hospitalizations determined by primary and secondary diagnoses. The individual level equivalent data for the cancer cohort required for comparison >Birmingham Children’s Hospital survivor group >Birmingham Cancer Research UK Centre PPI Group >Pancare >NCRI-TYA&GCT-CSG • Public newsletters and accessible summaries. • Direct engagement with funders (acknowledgment only, no influence on publication).

Benefits reported

Yielded Benefits is not a requirement for new applications. Proven impact of previous publications: The evidence which had previously been produced has had an impact in a number of policy and clinical practice areas: • The comprehensive risk stratification evidence produced already in relation to survivors of childhood, teenage and young adult cancer concerning their risk of serious adverse health outcomes in relation to their type of cancer, type of cancer treatment received, treatment era, age at treatment, years from cancer diagnosis, attained age and gender has had impact. Our initial publication concerned with the long-term risk of the total burden of serious adverse health outcomes carried out as part of the National Cancer Survivorship Initiative, identified subgroups of survivors a high, medium and low risk. This publication has recently been used as key evidence in review which NHS England has undertaken of its Service Specifications. In the future every survivor of childhood, teenage or young adult cancer will be assessed in relation to their long-term risk of developing serious adverse health outcomes using our risk stratification tool at the end of treatment and this will inform clinical decisions regarding the intensity of clinical follow-up necessary ranging from survivor self-management with easy and rapid access back into the NHS system at one end, to regular hospital consultant led multi-disciplinary team care at the other. https://www.engage.england.nhs.uk/consultation/childrens-cancer-services/user_uploads/servicespecification-childrens-networks-and-principle-treatment-centres.pdf https://www.engage.england.nhs.uk/consultation/teenager-and-young-adults-cancerservices/user_uploads/service-specification-tya-principal-treatment-centres-and-networks.pdf • The recently established International Late Effects of Childhood Cancer Guideline Harmonization Group (www.ighg.org) led by key European and US investigators aims to produce standard clinical follow-up guidelines for survivors which are as evidence-based as possible and acceptable to clinical communities throughout the world. The CCCSS Director and Senior Colleagues have been closely involved in this initiative and in particular in the development of several recent and on-going international guidelines. • Advising national health authorities of subgroups of survivors with particularly high risks of specific outcomes for potential recall or other intervention. There is on-going work concerning the introduction of screening (colonoscopy/faecal occult blood sampling) for bowel cancer in survivors of childhood cancer who received external beam radiotherapy to the abdominopelvic region; also on-going work into understanding whether there are any ways to reduce the substantial risks of stroke in survivors of childhood, teenage and young adult cancer who received external beam radiotherapy for an intracranial tumour. • The CCCSS Director and Senior Colleagues regularly speak at the Annual Education Day organised by the Late Effects Group of the Children’s Cancer and Leukaemia Group. This is well attended (100 to 150 attendees) by those responsible for the care (doctors and nurses) of survivors of childhood cancer at Centres throughout the UK. • The CCCSS Director and the Senior Lecturer are each full members of both the Children’s Cancer and Leukaemia Group (CCLG) and the Late Effects Group of the CCLG. • The BCCSS receives formal clinical input into its research plans from a CCLG/BCCSS liaison/advisory committee jointly organised by the Late Effects Group of the CCLG and the Cancer Survivorship Group. • The TYACSS receives formal clinical input into its research plans from the NCRI-TYA&GCT-Group of which the CCCSS Director is a full member, and who also chairs the Survivorship Subgroup of the main Group

Unchanged: Expected measurable benefits.