NHS Digital Data Release Register - reformatted

University Hospitals Birmingham NHS Foundation Trust

🚩 University Hospitals Birmingham NHS Foundation Trust received multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. University Hospitals Birmingham NHS Foundation Trust may not have compared the two datasets, but the identifiers are consistent between datasets for the same recipient, and NHS Digital does not know what their recipients actually do.

Project 1 — DARS-NIC-77142-Q4D1D

Opt outs honoured: Yes - patient objections upheld (Mixture of confidential data flow(s) with support under section 251 NHS Act 2006 and non-confidential data flow(s))

Sensitive: Non Sensitive, and Sensitive

When: 2021/03 — 2021/03.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • Civil Registration - Deaths
  • HES:Civil Registration (Deaths) bridge

Objectives:

Cancer is a major cause of morbidity and has become the leading cause of death after solid organ transplantation. There is a shortage of research exploring cancer epidemiology after solid organ transplantation in the UK. As a result, there are no guidelines to advise transplant clinicians about post-transplantation cancer and this may impact upon clinical care. This is especially important as the aetiology, pathophysiology and outcomes of cancer post-transplantation may differ from the general population. The current level of evidence for post-transplant cancer has several limitations. Firstly, the bulk of published evidence comes from transplant cohorts in the United States but this data may not be directly translatable to the United Kingdom. Differences in demographics, immunosuppression regimens and post-transplant practise means transplant outcomes are completely different between the two countries. Previous work has shown cancer epidemiology data is not translatable between kidney transplant cohorts between England and New York State (Jackson-Spence et al. Cancer Medicine 2018). Only two publications have reported cancer epidemiology in the United Kingdom (Collette et al. Am J Transplant 2010; Farrugia et al. Kidney Int 2014). However, both are now outdated in line with significant evolution of delivery of post-transplant care over the last 10-15 years and both fail to integrate multiple registries to obtain a more complete and more integrated pathway of the patient journey. Data regarding transplantation, cancer, hospital episodes and death is currently routinely collected as part of mandatory data collection for different registries but these records are not linked to each other. This means it is impossible to get an integrated insight into cancer epidemiology after solid organ transplantation. We therefore do not know why post-transplant cancer risk is different for different recipients, what morbidity is associated with post-transplant cancer, how outcomes differ for post-transplant cancer versus the general population among many other unanswered questions. This study is called the Epidemiology of Cancer After Solid Organ Transplantation (EpCOT) study. The main objective for the EpCOT project is to link data sets which already exist in isolation to create an integrated data set that can explore post-transplant cancer epidemiology and help answer some of these. This integrated data set will not be used for any research other than that stated in this Purpose Section. University Hospitals Birmingham NHS Foundation Trust (UHB) wants to study an anonymised extract of data from University of Birmingham derived from a cohort of transplant patients provided by NHS Blood and Transplant (NHSBT) (all people included in the register as having had a transplant between 1985 and 2015 - circa 85,000 patients) and a cohort of individuals on the National Cancer Registration and Analysis Service (NCRAS) provided by PHE, linked to pseudonymised data from NHS Digital under this DSA to examine cancer incidence, management, and mortality, along with the resource implications. UHB is acting as the sole Data Controller, while the University of Birmingham is the sole Data Processor. Public Health England and NHS Blood and Transplant (NHSBT) are involved in the wider project as collaborators but are not processing data in any way. They will be providing the cancer and transplant-specific data to NHS Digital for record linkage and will provided the anonymised data to the University of Birmingham with the unique study identifier for the Data Processor to link. This application is not linked to any other wider project and is the first and only project of its type in the United Kingdom. This project will be using an English cohort of 85,410 patients who have received a solid organ transplant (e.g. kidney, liver, heart, lung, pancreas, small bowel) between 01/01/1985 and 31/12/2015 and who have data stored with the UK Transplant Registry (UKTR) by mandatory requirement cross-referenced with individuals on the National Cancer Registration and Analysis Service (NCRAS) held by PHE. After record linkage with the appropriate national population-based data registries, the EpCOT researchers will be able to distinguish solid organ transplant recipients with a diagnosis of post-transplant cancer versus solid organ transplant recipients who do not develop post-transplant cancer. Responding to the need for research into post-transplantation cancer, the aim of the study is to improve delivery of care to solid organ transplant patients in the UK who are at risk or currently living with cancer. The following research questions will be investigated: 1. Compare observed and expected risks of specific causes of deaths, in particular cancer-related death, by linking the UKTR with the national death registry to obtain underlying causes of death and determine factors related to increased risk of specific causes of death post-transplantation. General population mortality rates will be used to calculate expected number of deaths from specific causes and identify subgroups of post-transplant patients (e.g. age, sex, transplant centre, organ type, etc.) at excess risk compared with expected. 2. Investigate survival and causes of death after cancer in post-transplant patients versus individuals from the general population who develop similar new onset cancer of the same age, sex, and calendar year of diagnosis. 3. Compare observed and expected risks of specific cancer types post-transplantation by linking the UKTR with the national cancer registry to obtain observed numbers of cancers and determine factors related to increased risk of specific types of cancer. General population cancer incidence rates will be used to calculate expected numbers of cancers of specific type and identify subgroups of post-transplant patients at excess risk of specific cancers compared with expected. 4. Estimate risk of morbidity requiring hospitalisation both generally and that associated with development of post-transplantation cancer by linking the UKTR with Hospital Episode Statistics (HES). Risk of hospital admissions and procedures (e.g. surgery) for specific morbidities will be investigated. We will calculate expected risks for specific conditions requiring hospitalisation, enabling identification of specific subgroups of post-transplant patients at excess risk compared with expected. DATA REQUESTED This project will require linkage between four data sets: 1) UK Transplant Registry (UKTR) contains transplant-specific data provided by NHS Blood and Transplant (NHSTB); 2) the National Cancer Registry (from the National Cancer Registration and Analysis Service (NCRAS) provided by Public Health England (PHE)); 3) HES APC and OP data for secondary care episodes and procedures (NHS Digital) and 4) Civil Registrations - Deaths data (also NHS Digital). (only a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortalities). This data is already in existence for audit, governance and approved research perspectives within individual registries. However, to obtain a complete picture of the transplant patients journey with a diagnosis of cancer, it is important to link up these data sets to ensure all captured information is available. Only patients who match in both UK Transplant Registry and National Cancer Registry will have their data transferred to the Data Processor. No patient identifiable data is being requested. Data requested is to allow analysis of important epidemiological outcomes only. UHB is requesting the minimum required data to ensure the study outcomes are achieved. UHB has asked for a reduced set of HES data to minimise the amount of information used for the project. They have requested information on mortality but would like only a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortalities. This study is funded by a grant from the Wellcome Institutional Strategic Support Fund through the University of Birmingham. The funder has no role in the conduct of this study and is therefore not a Data Controller.

Expected Benefits:

Despite cancer being a major complication after solid organ transplantation, there are no standards of care to guide clinical decision making and this impacts upon the care given to solid organ transplant recipients with or without cancer (as all are at risk due to the need for lifelong immunosuppression). Solid organ transplantation is frequently in the public arena for discussion and will be more so with the move to opt-out organ donation in England and Scotland during 2020. It is important that the advantages of solid organ transplantation for individuals with end-stage organ failure are balanced by increased awareness and education regarding the immunosuppression-related complications of solid organ transplantation. Cancer is a major cause of morbidity and has become the leading cause of death after solid organ transplantation. It is cited as one of the leading concerns for solid organ transplant recipients themselves. Unfortunately, there is a shortage of research exploring cancer epidemiology after solid organ transplantation in the UK. Much of what we know about cancer management for transplant patients is simply translated from the general population, but this may not be the best model of care for solid organ transplant recipients who have altered risk for cancer due to immunosuppression. The bulk of available data relating to transplant cohorts comes from the United States or Australia/New Zealand and this data may not be translatable to the UK due to different demographics, disease burdens, immunosuppression protocols etc. Therefore, our output will provide clinical evidence for a UK-specific cohort and guide transplant clinicians with better prevention and management techniques. This project has the potential to directly impact upon the care delivered to solid organ transplant recipients in relation to one of the most common and feared immunosuppression-related complications. The dissemination of data for EpCOT will directly influence the development of Standards of Care guidelines to aid transplant clinicians in the delivery of care and aid counselling for solid organ transplant candidates for their actual risk of post-transplant cancers. Targeted EpCOT epidemiological studies will aim to understand some of the following unanswered questions related to the epidemiology of cancer after solid organ transplantation that will have direct impact on care for solid organ transplant recipients: a) Cancer incidence post-transplantation (target 2020) • How many solid organ transplant patients are living with cancer? • How do cancer cases differ between different solid organ transplant recipients? • How do cancer cases differ between transplant and non-transplant patients? Is cancer more aggressive at diagnosis in the context of transplantation? • What are the risk factors for cancer post-transplantation and are some solid organ transplant recipients at greater risk than others? What is the influence of selected immunosuppresant agents on cancer occurrence? • Does cancer occurrence differ between national transplant centres (a reflection of differing immunosuppression regimens across transplant centres)? • What is the risk for cancer occurrence post-transplantation for patients with previous history of cancer? Does that risk differ dependent upon type of cancer? b) Cancer management post-transplantation (target 2020) • Does cancer progress faster in transplant recipients versus a matched cohort of non-transplant cancer patients? • Is management of cancer post-transplantation different in comparison to non-transplant setting? • What is the impact of cancer on solid organ transplant recipients? How does cancer impact upon morbidity post-transplantation such as hospitalisations, complications, procedures etc? • What is the influence of selected immunosuppresant agents on cancer progression? c) Cancer mortality post-transplantation (target 2020) • Is higher cancer-related mortality post-transplantation due to higher incidence, faster progression or both? • Which solid organ transplant recipients are at greater risk for death after a diagnosis of cancer? • How does cancer mortality differ among recipients of different solid organs? d) Resource implications for cancer post-transplantation (target 2020-2021) • What transplant-specific screening strategies may be effective to prevent certain types of cancers? For example, longer periods of dialysis pre-kidney transplantation have been identified as a potential risk factor for post-transplantation renal cell cancer – how long is too long on dialysis pre-transplantation before routine screening may be beneficial? Does risk differ between different dialysis modalities pre-transplantation? • Where should investment be directed to help improve outcomes? • Is there any variation across the country with treatment and outcomes (patient, allograft and cancer-related)? Dissemination of these findings will be done professionally (at congresses, invited lectures and high-impact peer-reviewed publications) and through distribution channels through both local (UBH and University of Birmingham) and national organisations (NHS Blood and Transplant, Public Health England, British Transplantation Society) with stakeholder interest in this project. The benefits will lead to development of Standards of Care guidelines to improve delivery of care for solid organ transplant recipients. This will have an impact upon the approximate 4,000 incident solid organ transplant recipients performed annually in the UK but more importantly upon the approximate 45-50,000 prevalent solid organ transplant recipients alive in the UK at the current moment in time. The immediate benefit of our study will be improved counselling for solid organ transplant candidates by transplant doctors in advance of their transplant surgery using our evidence for what the likely risk of post-transplant cancer will be. This will better inform patients prior to transplantation, to help them make an informed decision about risk versus benefit, and also raise awareness for transplant doctors to monitor post-transplant care appropriately. With development of Standards of Care guidelines, we aim to bring uniformity and best practise evidence to the UK transplant community in view of the current paucity of evidence to guide clinical management and decision making.

Outputs:

The aim of this project is to produce targeted studies looking at the epidemiology of post-transplantation cancer, and this data will be disseminated through presentations at speciality congresses (e.g. British Transplantation Society Annual Congress, European Society for Organ Transplantation) and submitted for publication in leading medical journals. The aim is also to develop Standards of Care guidelines with the Standards Committee of the British Transplantation Society to provide evidence based clinical evidence for direct patient benefit and we have their support and agreement for this. It is also the aim to plan patient-focused dissemination in plain English through various channels of communication for public consumption. Outputs will only contain aggregate data with small numbers suppressed in line with the NHS Digital HES Analysis Guide. Both NHS Blood and Transplant and Public Health England (who provide the initial data cohorts on this project) have mechanisms for dissemination of information to both professional and general population and the EpCOT Researchers will use these to share the results from EpCOT widely. We also aim to do similar research presentation at Research Open Days at both University Hospitals Birmingham and the University of Birmingham. Summary research findings are actively disseminated via social media channels (e.g. @AdnanSharif1979; @UHBResearch; @ImmunologyUoB) and also for the respective partners(@NHSBT_RD; @PHE_uk). We are also planning to work on evidence-based guidelines with the British Transplantation Society and these will be made freely available to the community at their website (https://bts.org.uk/guidelines-standards/). The plan is to produce significant research output for presentation as free communications and submission of manuscripts for peer-reviewed publication consideration. The investigator team has a proven track record of presenting scientific abstract work at meetings and congresses, invited lectures and high-impact peer-reviewed publications to ensure the communication of our research output is provided to the largest, and most diverse, audience possible. This will be undertaken both professionally but also locally (UHB and University of Birmingham) and national organisations (NHS Blood and Transplant, Public Health England, British Transplantation Society) with stakeholder interest in this project. The data will not be shared with any organisation outside the Data Processor so there will be no exploitation of outputs for development of treatment algorithms. The results and output will be used to guide the development of Standards of Care guidelines for transplant clinicians to utilise through working with the Standards Committee of the British Transplantation Society. These dissemination roles will be facilitated by the Data Controller and Data Processor, with the research team in charge of research facilitation. Project partners will be encouraged to disseminate their involvement through social media channels. The dissemination of the Standards of Care guidelines that will be developed will be facilitated through the British Transplantation Society. The aim is for dissemination of data in congresses in 2020 and 2021, with submission of manuscripts for peer-reviewed publications planned for 2020. Development of Standards of Care guidelines will occur from 2021 once the preliminary epidemiological studies have been undertaken and presented. Social media dissemination at various important stages of the project will be undertaken by the lead applicant (@AdnanSharif1979) with relevant organisation and partners tagged.

Processing:

NCRAS (part of PHE) and UKTR (part of NHSBT) will supply NHS Digital with a list of identifying details for their respective cohorts [NHS Number, Date of Birth, Postcode, Pseudonymised Study ID] thus allowing NHS Digital to identify and link those patients who are common to both data sets. NHS Digital will then generate a random unique identifier (large integer) for each linked patient and then return the identifying details originally provided, along with this common identifier, back to NCRAS and UKTR respectively. NCRAS and UKTR will then extract the relevant clinical/health data only relating to the target 85,410 solid organ transplant recipients between the stated time period of 1985-2016. All three organisations will then independently send to the Data Processor their agreed respective data set (cancer data (NCRAS), transplant data (UKTR); HES and mortality data (NHS Digital) as pseudo-anonymised data with the common patient identifier provided by NHS Digital to allow record linkage by the Data Processor. Data linkage will be conducted by the NHS Digital who will facilitate linkage of non-identifiable patient data between various data resources: 1. UK Transplant Registry [provided by NHSBT] will provide a cohort of approximately 85,000 transplant patients. This cohort is static, being made up on patients who underwent transplants between 1985 and 2015. The Information Governance teams at both UHB and UKTR are content there is no need for a DPA in this setting (EpCOT already receive data files from UKTR based on individual requests). 2. National Cancer Registration and Analysis Service (NCRAS) [provided by PHE] PHE will transfer direct identifiers to NHS Digital [NHSNUMBER, BIRTHDATEBEST, POSTCODE, PATIENTID (project specific pseudo ID)] to enable linkage to data held by the UK Transplant Registry. - Cancer site: All cancer sites and morphologies (C00x – C097x and D00 – D48) - Geography: resident in England - Diagnosis dates: 1 January 1985 through 31 December 2017. - Male and female patients aged 0 – 100 - Where there is an unambiguous match, NHS Digital will return a list of pseudonymised patient IDs to PHE. 3. HES data sets (NHS Digital) HES APC Annual Refresh between 1997/98 to 2018/19. HES OP Annual Refresh between start of data set (2003/04) to 2018/19. 4. Civil Registration - Deaths Secondary Care cut data (NHS Digital) - a flag on the resultant cohort indicating that death (any death) has occurred (month and year of death) and cause of death to determine death-specific mortalities. Start of data set to end of 2018/19. Data linkage methodology - The linkage methodology will involve UK Transplant Registry and NCRAS sending to NHS Digital only a list of identifying details for their respective cohorts. - NHS Digital will link the UK Transplant Registry and NCRAS cohorts and determine which patients are common in both data sets. - NHS Digital would then provide a list of pseudonymous IDs of patients common in both data sets to UK Transplant Registry and NCRAS respectively so that they can extract the clinical/health data from their data sets respectively. - NHS Digital to link cohorts to HES and Civil Registration - Deaths [a flag indicating that death has occurred and the months from transplantation to death, and cause of death to determine death-specific mortality] and extract records. - NHS Digital to supply pseudo-records to University of Birmingham with the common patient identifier to facilitate linkage. There will be no need, requirement or possibility to re-identify individuals after record linkage by the Data Processor. The data sent to the Data Processor will be stored on a separate array of disks and accessed on a mapped drive as part of the University of Birmingham campus network. Access to this mapped drive will be limited to the named University researchers who can only access the University of Birmingham campus network with a personalised username/password combination. The personal computers used to access the data will have additional virus checking/data security software installed (Malwarebytes). The separate array of disks will reside in a controlled environment with access only by accredited University IT staff. The data from this disk array will be backed up under a separate storage policy which once deleted will make the data unavailable for restore. The linkage, processing and analysis of the data from UKTR, NCRAS and NHS Digital will only be carried out the specified researchers within the University of Birmingham as the Data Processor who are appropriately trained in data protection and confidentiality. There will be no attempt made to link any data requested under this application to any held under other Data Sharing Agreements. This database of the pseudonymised data will be accessible only to named personnel within the project and will be kept in auditable documents. In addition, analysts fulfilling database administrator role (who are substantive members of the University of Birmingham) will also have access to the database but undertake no processing. At the end of the project the data will be destroyed in line with strict policies and procedures on the destruction of data. No record level information will leave the Data Processor or aggregated data without small number suppression in line with the NHS Digital HES Analysis Guide.


Project 2 — DARS-NIC-381984-B7X3S

Opt outs honoured: No - data flow is not identifiable (Does not include the flow of confidential data)

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2021/04.

Repeats: Ongoing

Legal basis: Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant

Datasets:

  • Summary Hospital-level Mortality Indicator (SHMI) data split by trust and diagnosis group
  • Office for National Statistics Mortality Data
  • Civil Registration - Deaths
  • Summary Hospital-level Mortality Indicator

Objectives:

To produce/analyse statistics using births/deaths data solely to help the NHS perform its duties.

Yielded Benefits:

A range of direct benefits to healthcare have already been delivered during the course of this project. In summary: • NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organisation • NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management • NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare To give a specific example: Within the module NHS hospitals are able to quickly identify areas of potential concern relating to mortality within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisations and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance. This process is used by hospitals up and down the country. Without using the data sets being requested it would be impossible to deliver this benefit to the NHS. This would have a significant impact on a sizeable number of NHS Hospitals across the country. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ governance assurance processes.

Expected Benefits:

The output of analytics available to NHS organisations using the HED system enable NHS clinicians and managers to increase the understanding of patient outcomes and identify areas for improvement and best practice. A range of direct benefits to healthcare have already been delivered during the course of this project. In summary: • NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organisation • NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management • NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare To give a specific example: Within the module NHS hospitals are able to quickly identify areas of potential concern relating to mortality within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisations and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance. This process is used by hospitals up and down the country. Without using the data sets being requested it would be impossible to deliver this benefit to the NHS. This would have a significant impact on a sizeable number of NHS Hospitals across the country. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ governance assurance processes.

Outputs:

The sole outputs are analytics designed to assist the NHS in interrogating and deriving understanding from the SHMI indicator. Where appropriate this will include the ability to support the identification of areas of care apt for clinical case note review. Such outputs are solely provided either via: • a Module made available within the HED system, or • aggregate small number censored reports Within the HED system: The module can contain aggregate-level information and low-level information. The level of data that can be viewed within a module depends on the access level of the named individual user and which organisation they are working for. As such, access to low-level information, including small numbers, is strictly controlled in line with the access controls outlined in the above section on ‘Processing activities’. This means that Hospitals will only have access to low-level information for their own data. Outputs are to be used solely for the purpose of assisting the NHS. Outputs will be used by NHS Clinicians and Managers to: • Assure and manage clinical quality and patient safety within NHS Organisations • Identify trends requiring a clinical review of patient pathways. (Hospital-based users with Caldicott approval are able to investigate metrics and ‘drill-down’ to patient-level information, including local patient identifiers, in order to conduct clinical case note review and route cause analysis) • Increase the understanding of patient outcomes • Identify potential areas for improvement in clinical quality or operational efficiency either within a Hospital or a local healthcare economy • Identify areas of best practice either within hospital Trusts or local healthcare economies All of the above will serve to increase the understanding of patient outcomes in regard to quality, safety, productivity and efficiency benchmarking within the NHS. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of various NHS organisations’ routine reporting and governance assurance processes.

Processing:

Data received from HSCIC is only processed by authorised University Hospitals Birmingham NHS Foundation Trust (UHB) staff on site at UHB. No third parties are involved in the processing of the data. Data received from the HSCIC by UHB is processed in line with a strict protocol and is stored in an access restricted server. This process was recently audited by the HSCIC and found to be robust. The data received is used to create analyses which are provided to the NHS in order to help it perform its duties. Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports. The level of data that can be viewed within the system depends on the access level of the named individual user and which organisation they are working for. No record-level data is provided to any organisation, except where an individual working within an NHS Hospital has the authorisation of their Hospital’s Caldicott Guardian to access patient level information, including sensitive items, for the purposes of conducting clinical review of cases. In such instances a summary (but not all fields present in the raw data) is provided at spell or patient level. For example, the summary will give details of the admission date, method and diagnosis for a patient but not all field relating to the episodes as recorded in the raw data (e.g. date of death is not provided). The data available to users will only relate to patients treated at that Trust.


Project 3 — DARS-NIC-150435-R7X1Q

Opt outs honoured: No - consent provided by participants of research study (Consent (Reasonable Expectation))

Sensitive: Non Sensitive

When: 2018/10 — 2019/06.

Repeats: One-Off

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Categories: Identifiable

Datasets:

  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Outpatients
  • HES:Civil Registration (Deaths) bridge
  • Civil Registration (Deaths) - Secondary Care Cut
  • Civil Registration - Deaths

Objectives:

Stereotactic Ablative Radiotherapy (SABR) is an emerging novel radiation technology. SABR is a specialised radiotherapy treatment planning technique resulting in a high dose to the target with steep dose gradients resulting in rapid dose fall off outside the target area. This results in high biologically effective dose (BED) while minimising the dose received by the normal tissues, and could potentially minimise the radiotherapy treatment toxicity and side effects. The technique requires specialist positioning equipment and/or imaging (stereotaxis) to confirm correct targeting (accuracy) and it can be delivered using either standard linear accelerators or specially designed devices which are dedicated to delivering stereotactic treatments. Using a small number of fractions provides the opportunity for cost savings compared with conventional fractionation or surgical alternatives, and may free up capacity within NHS radiotherapy departments. The current SABR indications for which evidence is rapidly accumulating are: • oligometastatic cancer (3 or fewer sites of metastatic disease) • cancer that has recurred in a site treated previously treated with radiotherapy (re-irradiation) • patients with hepatocellular carcinoma These 3 groups of patients should receive SABR within this Commissioning through Evaluation (CtE) project, which will serve to improve access to SABR within the UK and enable data collection to further expand the current evidence base. It is possible that additional indications will be added to the program in due course, including benign spinal conditions and renal cancer. This study has been commissioned by the National Institute for Health and Care Excellence (NICE) to support NHS England’s Commissioning through Evaluation (CtE) programme. As part of this CtE project the centres delivering SABR treatment will be collecting routine clinical data and data on quality of life, pain symptoms and patient experience using the interim access tool developed by King’s Technology Evaluation Centre (KiTEC - part of King's College London). KiTEC will be undertaking the analysis of this data in order to answer the NHS England evaluation question whether the treatment offers to these patients improved clinical outcomes in combination with less side effects and improved quality of life. The evaluation scheme is being run for three years in a total of fifteen specialised centres in England, although not all centres are offering SABR to all three sets of patients. The first patient was recruited in June of 2015, and it is currently anticipated that patients will be enrolled up until September-2018, with patients being followed up for two years. As of September 2018, the number of patients recruited across all seventeen participating centres is approximately 1,700. This CtE project has HRA ethics approval for the analysis of these patient data already recorded by the NHS Trusts delivering SABR in a pseudonymised format by KiTEC. This is, therefore, a low-risk observational data analysis. The research is non-interventional as it deals with the collation of routine outcome data already collected after patients provide informed consent as part of their clinical management to undergo SABR. Consent to undergo SABR has been undertaken by the individual NHS Trusts. The patients have consented for their data to be analysed by KiTEC. This consent is separate to their treatment consent. This project seeks to identify the impact in secondary care health settings taking into consideration all contacts with hospitals. KiTEC are requesting data from NHS Digital to add to the commissioning through evaluation database that is currently being populated, as patients may see other healthcare professionals outside of the trial, or their participating centre. All of the work will take place within the UK. KiTEC are acting as the sole Data Controller in relation to this study, and have engaged University Hospitals Birmingham (UHB) for the data management element of the study (managing and administering the database), acting under instruction from KiTEC. Additionally, KITEC are responsible for undertaking any analyses, therefore pseudonymised patient-level data will need to be shared between UHB and KiTEC. A report that describes the evidence for the clinical and cost-effectiveness of SABR will be presented to the UK SABR consortium, NHS England, and NICE and will be used to inform future commissioning. Following review by the project's stakeholders, this report will be then submitted for publication in peer review journals. Outputs from the project will contain only data that is aggregated (with small numbers suppressed in line with the HES Analysis Guide). The evaluation should show that there is an improvement in patient outcomes and a reduced burden on the NHS for subsequent treatment of complications and recurrence.

Expected Benefits:

This project is evaluating the effectiveness of Stereotactic Ablative Radiotherapy (SABR), an emerging novel radiation therapy technology in three specific areas outlined. The three areas include: oligometastatic cancer, cancer recurred in a site treated previously with radiotherapy, and patients with hepatocellular carcinoma. SABR is a specialized radiotherapy technique that delivers a high dose of radiation to the tumour while minimising the dose received by normal tissues, potentially minimising radiotherapy treatment toxicity and side effects. This project will look at both the impact on the patients as well as the financial impact to the NHS. This project will determine whether the treatment under investigation has both a positive benefit for patients and the NHS, or whether it has any disadvantages that have not previously been identified. If the findings are positive then this treatment may mean that patients end up undergoing fewer unsuccessful treatments and that the patient experience and survival are improved.

Outputs:

Outputs from the project will contain only data that is aggregated (with small numbers suppressed in line with the HES Analysis Guide). A final report on the analyses will be generated by KiTEC for NHS England and NICE that will answer the questions below: - What is the 1-year and 2-year survival following treatment with SABR for the indications covered by the Commissioning through Evaluation (CtE) scheme (presented as estimates with confidence intervals)? How do these survival estimates compare with the target outcomes (see section 4), in terms of superiority or non-inferiority? - Does treatment with SABR for the clinical indications covered within the CtE scheme increase LC? - What Adverse Events occur as a result of SABR in the CtE cohort of patients? - What is the patient experience of treatment with SABR for the clinical indications covered within the CtE programme? - What is the cost-effectiveness of providing SABR in three subgroups of patients covered within the CtE scheme (oligometastases (liver), HCC, and pelvis re-irradiation)? - What are the outcomes by indication in the CtE cohort of patients? - Are there any factors from the experience of centres participating in the scheme that should be taken into account in terms of future service provision? - Are there any research findings that have become available during the course of the CtE scheme that should be considered alongside the evaluative findings of the CtE scheme? The final report will follow the NHS England and NICE guidelines for the production of such a report. As well as the final report for NHE England and NICE, peer-review papers will be produced by both UHB and KiTEC, these reports will be on aggregate analyses, and will only include supplementary information from HES/ONS which will have the small numbers suppressed. The information may also be presented at relevant national and international conferences. No outputs are planned specifically for any charities or patient groups [because the focus of the study is to influence commissioning policy (through NICE and NHS England), and it is at the point of any decision to change policy that the findings of the study will be addressed to the public], however, the report containing the results of KiTEC’s analysis for the Commissioning through Evaluation (CtE)” programme, when finalised, will be made publicly available. KiTEC will also produce a publication that will be made available to the public through open access; a direct link will be displayed on the KiTEC website.

Processing:

The aggregated SABR procedures numbers by centre, is required on a quarterly basis. This number will be compared with the number of procedures included in the database. Should there be a discrepancy, the data lead or data processor for that centre will need to be contacted. For the avoidance of doubt, this will not require HES data to be shared with the participating centres. KiTEC are acting as the sole Data Controller in relation to this study, and have engaged University Hospitals Birmingham (UHB) for the data management element of the study (managing and administering the database), acting under instruction from KiTEC. KITEC are responsible for undertaking any analyses, therefore pseudonymised patient-level data will need to be shared between UHB and KiTEC. UHB will create a pseudonymised extraction of data on a bi-monthly basis which will be sent to KiTEC for them to complete their analyses. All data shared from UHB to KCL will be pseudonymised. In addition, identifiable data captured in the SABR database will need to be linked to relevant HES/Mortality records. This will enable accurate mortality data to be captured, as well as data on other diagnoses or procedures patients may have had at other departments (internal or external to the treating hospital), thus increasing the accuracy of the recording of both adverse event and mortality in the database. This process will require the collection of identifiable patient data (NHS number as a minimum), as well obtaining access to equivalently identifiable HES/Mortality patient records. UHB will receive and process the data. In order to answer the evaluation question whether the treatment offers to these patients improved clinical outcomes in combination with less side effects and improved quality of life descriptive statistics will be presented to characterise the patient populations. This will include demographic and clinical factors. Estimates of the rates of overall survival and progression-free survival (local control) at 1 year and 2 years following treatment with SABR will be calculated using the Kaplan-Meier method, for each of the three included indications (oligometastatic disease, re-irradiation of pelvis/spine, and hepatocellular carcinoma). A measure of the precision of each estimate will be provided by 95% confidence intervals. Kaplan-Meier graphs will be presented for key outcomes. Survival estimates will be compared narratively with the ‘target outcomes’ for each condition (i.e. not using statistical tests), since the target outcomes were informed by a mixture of relevant literature and expert opinion, and therefore, there is no appropriate ‘sampling error’ which can be attributed to these outcomes (a requirement of statistical tests). The number and percentage of adverse events following treatment with SABR will be presented with 95% confidence intervals, for each of the three indications. The cost-effectiveness of providing SABR in cohorts of patients included in the CtE scheme (oligometastases, re-irradiation and hepatocellular carcinoma (HCC)) will be evaluated using a commonly applied Markov model of cancer. The model will include three states: progression free; progression; and death. Progression will be defined as the failure of local control. Patients accrue costs and quality-adjusted life expectancy for each period or time cycle they spend in either progression-free or progression states. Patients transit in the direction of the arrows with a given probability at the end of each time cycle and the model is run over a defined number of cycles (periods of time) allowing an estimate of total costs and quality-adjusted life expectancy for the cohort over the specified time period. The following describes the flow of data for the SABR Study without data from NHS Digital: 1) Treatment centres collect data about the patients 2) Treatment centres submit the data (routine clinical data, quality of life, pain symptoms, etc.) to UHB. 3) UHB store the data on their servers 4) UHB send bi-monthly extracts of the pseudonymised data to KiTEC for analysis The following describes the flow of data for the SABR Study including a supply of data from NHS Digital: 1) Treatment centres collect data about the patients 2) Treatment centres submit the data (routine clinical data, quality of life, pain symptoms, etc.) to UHB. 3) UHB store the data on their servers 4) UHB provide patient identifiers to NHS Digital which NHS Digital will use to identify relevant HES and mortality data 5) NHS Digital supplies hospital and mortality data to UHB 6) UHB stores the data on their servers 7) UHB send bi-monthly extracts of the pseudonymised data to KiTEC for analysis The only data linkage permitted with NHS Digital data is the link with the data submitted by NHS treatment centres. 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).


Project 4 — DARS-NIC-06605-X1L9Z

Opt outs honoured: Yes - patient objections upheld (Section 251, Section 251 NHS Act 2006)

Sensitive: Sensitive, and Non Sensitive

When: 2016/04 (or before) — 2021/05.

Repeats: Ongoing, One-Off

Legal basis: Health and Social Care Act 2012, Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Section 251 approval is in place for the flow of identifiable data, National Health Service Act 2006 - s251 - 'Control of patient information'. , Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)

Categories: Anonymised - ICO code compliant, Identifiable

Datasets:

  • Hospital Episode Statistics Accident and Emergency
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Hospital Episode Statistics Outpatients
  • Office for National Statistics Mortality Data (linkable to HES)
  • Office for National Statistics Mortality Data
  • Bridge file: Hospital Episode Statistics to Mortality Data from the Office of National Statistics
  • Civil Registration - Deaths
  • Civil Registration (Deaths) - Secondary Care Cut
  • HES:Civil Registration (Deaths) bridge
  • Emergency Care Data Set (ECDS)

Objectives:

The objective is to provide quality and benchmarking analysis that will enable NHS organisations to deliver better services for patients. Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports. This work is commissioned and funded on an ongoing basis by University Hospitals Birmingham NHS FT (UHB) and produced by the Health Informatics Department within the Hospital. The sole objective of this work it is to support both UHB and other NHS Trusts and commissioners in the ongoing monitoring of clinical quality and organisational effectiveness. This purpose is fulfilled either: a) directly, i.e. the NHS Trust holds a subscription to use the HED system, or b) indirectly, i.e. analytics are provided via a non-NHS organization, Pricewaterhouse Coopers (PwC) who hold a subscription to use aggregate small number suppressed data within the system. The customer has reviewed the NHS standard (ISB 1523) relating to anonymisation and can confirm the system is compliant with this. This has also been corroborated by a recent audit from the HSCIC particularly in relation to small numbers suppression. The vast majority of subscriber organisations are NHS Organisations, there is only one non-NHS organization, PwC. This organisation works within the healthcare space and have access to the system solely for the purpose of assisting NHS organisations. UHB currently has approximately 60 clients who subscribe to use the HED tool, with the majority of those being NHS Hospitals (approximately 50 NHS Hospitals). The geographical range of these organisations spread across England, and are not concentrated in one region. The current types of organisations holding a subscription to use the HED tool are limited to: NHS Organisations (figures in brackets indicate current count of organisations holding a subscription) • NHS Hospitals (51 hospitals) • Clinical Commissioning Groups (CCG) (1 CCG) • Commissioning Support Units (CSU) (2 CSU’s) • the Trust Development Authority (TDA) • NHS England • Allied Health Sciences Networks (AHSN) (2 AHSN’s) • Quality Observatories (QO) (2 QO’s) Non-NHS Organisation - (PwC) • Private sector healthcare consultancy providers (PwC Healthcare) Data is required for all England, for multiple reasons. Primarily, because when performing analyses, organisations need to be able to select peers based on casemix for more accurate benchmarking to assist with service improvement and these organisations may not be local or regional based. This is true for both UHB and customers of the UHB HED analytical tool. As an example, some HED customers are regional providers of a specific service and others are specialised hospitals which require benchmarking across the whole of the UK. Secondly the current client base for the HED tool is spread across multiple regions of England and therefore require access to their own data. The years of data required allow for organisations to perform multiple functions, such as being able to demonstrate service improvement over time and visualize trends. PLEASE NOTE: The level of data that can be viewed within the system depends on the access level of the named individual user and which organisation they are working for. A full explanation of this including summary table is in the next section on ‘processing activities’. As previously mentioned, PwC users are UNABLE to access any information within the system that has been produced using ONS data. PwC users are ONLY able to access aggregate level small number suppressed information. To deliver the stated objective a wide range of healthcare indicators are calculated (over 100) and as such various HES data sets including APC, OP, A&E as well as linked ONS data are required. The objective in having as wide an array of relevant indicators as possible is to give NHS managers and clinicians as complete a picture of hospital performance as possible. Therefore the whole dataset is needed and cannot be compressed to certain fields. HES-ONS linked data specifically will be used within this work to look at outcomes analysis and form analytical overviews relating to post discharge mortality. Such overviews relate to standardised post discharge mortality monitoring within distinct clinical cohorts and bespoke long term survival monitoring. This work will increase the understanding of complete pathways of care. Any analysis produced using ONS data will not be made available to non-NHS organisations. Local patient identifier is required within the HED system for direct patient care. HED delivers a national benchmarking system that can provide assurance to hospitals they are providing safe and high quality care and treatment, or signpost areas of concern. The HED system enables trusts to easily identify particular patient cohorts that are statistical outliers and warrant further examination. Local patient identifiers are an essential requirement linking areas that require investigation, to hospital records. Without them trusts would not be able to identify their patients and conduct root cause analyses both for internal governance and also to provide assurance to external regulatory authorities across a range of key indicators ie. HSMR, SHMI. Equally, the Secretary of State for Health has ordered a review of avoidable deaths. Ensuring trusts have access to their local patient identifiers through HED enables them to conduct these audits and therefore focuses attention on eradicating mortalities that could have been prevented. It is essential for root cause analysis that patients can be considered on a case by case basis. The ability to be able to identify patients via HED and then subsequently interact with other datasets and clinical notes held locally is vital to detect required clinical quality improvements. A specific example of this is via Mortality reviews, where HED directly enables organisations to monitor and manage services so that no avoidable harm comes to patients whilst in their care. HED specifically empowers healthcare managers and clinicians to measure patient experience and outcomes benchmarked against their peers (both local and nationally) eg. Length of stay, Mortality, Readmissions. This information is not available locally and delivers clinically relevant outcome data and comparative information to clinicians. Access to local patient identifiers is critical to enable health care professionals to audit their data and clinical practice. This review of individual patient outcomes and experience can evidence the care provided is of a good quality and safe, and also provide assurance to trust boards. In addition access to identifiers will also enable clinicians to review and audit deaths attributed to them in national mortality models. Patient information is only available to organisations who deliver the care. A protocol including Caldicott authorisation form has been approved previously by DAAG (DAAG reference: 240412-a) for controlling access to such sensitive items. This established process ensures that access to sensitive items is restricted to authorised hospital trust staff and was found to be robust during a recent HSCIC Audit. The rationale for allowing PwC access to aggregate level small number suppressed analytics: As some NHS organisations require additional specialist resource to deliver the benefits of using benchmarking information, therefore subscription to the HED tool is required by PwC as: 1. This enables them to have people equipped to provide immediate support to NHS organisations. 2. Providing them with aggregate level information via the tool is the most efficient way of disseminating information in support of this work – the alternative described directly below would clearly create large inefficiencies. 3. It allows such organisations to be autonomous in undertaking work that requires a level of independence and is beneficial to the NHS e.g. the Keogh review. In this instance PwC were commissioned to complete this review independently of any engagement of NHS Trusts involved. It would therefore have been inappropriate for them to ask the Hospitals for the information required to undertake this review. The alternative would be for NHS organisations working with the non-NHS organisations to provide data directly to the non-NHS organisations. This arrangement would have the following detrimental effect on the NHS: 1. It would actively be encouraging NHS-organisations to export data at varying levels from the HED system and send it to non-NHS organisations. By non-NHS organisations having direct access UHB are able to monitor which modules are accessed when and by whom. This negates the need for NHS organisations to export isolated aggregate data and email it outside the NHS. 2. It would introduce a longer lead time for projects which would ultimately cost the NHS more.

Yielded Benefits:

As above

Expected Benefits:

To continue to drive clinical service improvements and benefit patient outcome as demonstrated below. How the data has already benefited health and social care The data is used to provide benchmarking information on areas such as: • Mortality rate • Emergency readmission rate • Length of stay • Day case rate • New to follow-up outpatient ratios • A&E clinical quality indicators The output of analytics available to NHS organisations using the HED system enable NHS clinicians and managers to increase the understanding of patient outcomes and identify areas for improvement and best practice. A range of direct benefits to healthcare have already been delivered during the course of this project. In summary: • NHS Organisations are provided with the information necessary to provide clinical quality and patient safety assurance within their organization • NHS Organisations are able to identify & interrogate areas of poor performance allowing for evidence based health service management • NHS Organisations are able to identify areas of good performance increasing the understanding of best practice in healthcare • Clinicians are supported in undertaking appraisal and revalidation – reflective practice is a vital contributor to ensure high quality care By utilising the outputs and analytics provided, organisations are able to focus and deliver on the three key principles of Health and Social Care: • Patients at the centre of the NHS – the analytics as stated above ensure that organisations are empowered to identify areas of poor performance and can put in place measures to rectify this. They are also then able to demonstrate improvement in these areas over time. As the numerous measures bring together patient safety and operational efficiency, organisations can easily identify areas to target to ensure that the care being given is safe, effective and optimal. • Changing the emphasis of measurement to clinical outcomes – there are multiple modules provided to assist with this focus on clinical outcomes, and the strive to achieve best practice. Organisations are able to ensure they are performing as expected against local and national standards and where necessary identify areas of best practice through benchmarking with peers (locally and nationally). • Empowering health professionals – The tool enables managers and clinicians to make evidence based decisions i.e. supporting business cases, changing patient pathways. HED provides easily accessible dashboards and analytical modules so healthcare professionals are able to review their specialty and service lines to ensure service delivery and patient outcomes are optimal. The system reports information in a timely, meaningful and relevant fashion to various clinical settings. As the analytics are used by providers and commissioners, the GP is empowered to ensure the services provided are delivery best patient care, again keeping the patient at the centre. Equally the analytics are also used by NHS England and NHS TDA to assist with wider reviews of patient care and outcomes, when reviewing governance and areas of accountability. To give a specific example: Each month a range of modules are produced which allow NHS hospitals to identify areas of potential concern relating to mortality within their organisation. Such areas are then investigated further. When appropriate & authorised, the ability to identify a cohort of patients within the organisations and undertake appropriate clinical case note review is invaluable as a part of ensuring good hospital governance. This process is used by hospitals up and down the country, most commonly in the areas of mortality and readmissions management. Without using the data sets being requested it would be impossible to deliver this benefit to the NHS. This would have a significant impact on a sizeable number of NHS Hospitals across the country. The role of Non-NHS Organisations in supporting NHS Organisations: Allowing select private sector healthcare organisations to access aggregate level analytics is beneficial to the NHS as it enable the NHS to quickly access additional specialist resource when it is required. This allows the timely delivery of improvements in clinical quality and/or operational efficiency. Without this option it would be necessary for them to increase or upskill their internal resource. To do so would require longer timescales and prove more costly for the organisation in the long run if there is primarily a short term need. Some further specific benefits relating to private sector access include: 1. Supporting the Keogh review at various levels in terms of creating the initial data packs for the review and also in undertaking subsequent mortality reviews which ultimately resulted in 13 hospitals being taken off special measures by the CQC. 2. Supporting commissioners across an area to have the evidence necessary to understand how to improve the quality and provision of care across a region. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of a significant number of NHS organisations’ monthly reporting and governance assurance processes.

Outputs:

The sole outputs are benchmarked or standardised healthcare indicators such as measures of mortality, survival, discharge and admission trends, readmissions, length of stay, patient safety etc. Such outputs are solely provided either via: • the range of Dashboards and Modules made available within the HED system, or • aggregate small number censored reports Within the HED system: Dashboards will only contain aggregate level information. Modules can contain aggregate level information and low level information. As explained, the level of data that can be viewed within a module depends on the access level of the named individual user and which organisation they are working for. As such, access to low level information, including small numbers, is strictly controlled in line with the access controls outlined in the above section on ‘Processing activities’. Outputs are to be used solely for the purpose of assisting the NHS. Outputs will be used by NHS Clinicians and Managers to: • Assure and manage clinical quality and patient safety within NHS Organisations • Identify trends requiring a clinical review of patient pathways. (Hospital based users with Caldicott approval are able to investigate nationally standardised metrics and ‘drill-down’ to patient level information, including local patient identifiers, in order to conduct clinical case note review and route cause analysis) • Increase the understanding of patient outcomes • Identify potential areas for improvement in clinical quality or operational efficiency either within a Hospital or a local healthcare economy • Identify areas of best practice either within hospital trusts or local healthcare economies • Provide consultants with the information necessary for consultant revalidation All of the above will serve to increase the understanding of patient outcomes in regard to quality, safety, productivity and efficiency benchmarking within the NHS. As mentioned, aggregate level small number censored analytics produced for the HED tool are being made available to one private sector healthcare organization, PwC, who UHB are working with in supporting NHS organisations. Some examples of the specific outcomes of this access are: • Aggregate level analytics have been used to undertake due diligence for both Monitor and CQC. A good example being production of the Keogh review information packs. This information was vital to the extensive work undertaken as part of the Keogh review which has culminated in the majority of the hospitals originally identified being taken out of special measures by the CQC. • A further example is use of aggregate level analytics on elderly care readmissions with a CCG in order to support work helping them to understand how they could reduce avoidable readmissions within their region. It is not appropriate to set a target date for this work as the work streams are ongoing and the outputs already form part of various NHS organisations’ monthly reporting and governance assurance processes.

Processing:

Data received from HSCIC is only processed by authorised UHB staff on site at UHB. No third parties are involved in the processing of the data. Data received from the HSCIC by UHB is processed in line with a strict protocol and is stored in an access restricted server. This process was audited by the HSCIC and found to be robust. The data received is used to create a wide range of healthcare indicators which focus in on the quality, safety, productivity and efficiency of healthcare delivery. Such analysis is solely provided either: via the online Healthcare Evaluation Data (HED) tool, or via bespoke reports. Either of which is only provided to UK organisations. The vast majority of subscriber organisations are NHS Organisations, there is only one non-NHS organization, PwC. This organisation works within the healthcare space and has access to the system solely for the purpose of assisting NHS organisations. Summary of types of users and access controls in place: PwC: Access to aggregate level small number suppressed analytics only formed using HES APC, OP or A&E data (but NOT ONS data) NHS but non-Hospital User: Access to aggregate level small number suppressed analytics only formed using HES APC, OP, A&E and/or ONS linked data. NHS Hospital User: Access to aggregate level small number suppressed analytics only formed using HES APC, OP, A&E or ONS linked data unless Caldicott authorisation is in place to allow access to low level details and/or sensitive items for their own organisation only. No record level HES or ONS data is provided to any organisation, except where an individual working within an NHS Hospital has the authorisation of their Hospital’s Caldicott Guardian to access patient level information, including sensitive items, for the purposes of conducting clinical review of cases. In such instances a summary (but not all fields present in the raw HES or ONS data) is provided at spell or patient level. For example, the summary will give details of the admission date, method and diagnosis for a patient but not all fields relating to the episodes as recorded in the raw HES data.