NHS Digital Data Release Register - reformatted
York And Scarborough Teaching Hospitals NHS Foundation Trust projects
3 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Prevalence of cirrhosis and its related complications amongst patients with hereditary haemochromatosis in England — DARS-NIC-706945-F6W2C
Type of data: information not disclosed for TRE projects
Opt outs honoured: Anonymised - ICO Code Compliant (Does not include the flow of confidential data)
Legal basis: Health and Social Care Act 2012 s261(2)(a)
Purposes: No (NHS Trust)
Sensitive: Sensitive, and Non-Sensitive
When:DSA runs 2024-03-28 — 2027-03-27
Access method: One-Off
Data-controller type: YORK AND SCARBOROUGH TEACHING HOSPITALS NHS FOUNDATION TRUST
Sublicensing allowed: No
Datasets:
- Civil Registrations of Death - Secondary Care Cut
- Hospital Episode Statistics Admitted Patient Care (HES APC)
Objectives:
York and Scarborough Teaching Hospital NHS Foundation Trust requires access to NHS England data for the following research project:
Prevalence of cirrhosis and its related complications amongst patients with hereditary haemochromatosis* in England
* Hereditary haemochromatosis (HH) is an inherited disorder of iron haemostasis characterised by excess iron deposition in various organs such as the liver, pancreas, joints and pituitary gland. HH is one of the most common genetic conditions amongst populations of Northern European ancestry. Due to excess iron deposition in the liver, patients with HH can develop liver stiffness (fibrosis) and progress towards scarring (cirrhosis) putting patients at risk of several complications related to cirrhosis including liver cancer.
The following is a summary of the aims of the research project provided by the controller:
Primary objectives
- To characterise the prevalence of cirrhosis in patients with the genetic disorder of HH and also its related complications which are ascites (fluid in the abdomen), haematemesis (vomiting blood), jaundice (yellowing of the skin or eyes), hepatic encephalopathy (confusion) and hepatocellular carcinoma (liver cancer).
Secondary objectives
- In individuals with cirrhosis, York and Scarborough Teaching Hospital NHS Foundation Trust aim to identify independent risk factors associated with liver cirrhosis to better understand this subpopulation who are more likely to develop advanced liver disease which increases morbidity and mortality.
- Studying the prevalence of non-liver (extrahepatic) related conditions associated with HH, geographical variation in the outcomes of HH patients in England and causes of death amongst those with a diagnosis of HH.
The following NHS England Data will be accessed:
Hospital Episode Statistics Admitted Patient Care (HES APC) necessary to provide the relevant dataset to estimate cirrhosis prevalence and its related complications.
Civil Registration of Death Secondary Care Cut (CRD SCC) necessary to establish causes of death within the research population, focusing on establishing the role of hepatic and the extrahepatic conditions associated with haemochromatosis (HH) as a cause of mortality
The level of the Data will be:
Pseudonymised
The Data will be minimised as follows:
Limited to a study cohort identified by NHS England as meeting the following criteria
- All patients in England with a diagnosis of hereditary haemochromatosis (ICD Code E83.110) and/or undergoing Vensection procedure
- Procedure code X36 will be applied to identify those who have received treatment for HH with venesections.
- These specific codes have been validated for identifying patients with cirrhosis in electronic patient records and have been shared with the Data Access Service to be used when the data is produced.
- The cohort will include individuals who have a diagnosis code of ICD E83.110 and/or any other diagnoses code from a defined list (list supplied to NHE England)
- Approximately 98,000 individuals
Limited to data between 01/04/2007 to 31/03/2023- . This time period will allow adequate capture of patients in England being diagnosed with HH to estimate more accurately the prevalence of cirrhosis in this study population. The proportion of patients being diagnosed with HH has increased as well over recent years with increased awareness of the condition, increased accessibility to genetic testing and screening of first degree relatives. Cirrhosis takes several years to develop as a complication in patients with liver disease including HH. Hence, this time frame will allow for adequate follow-up from HH diagnosis to assess if cirrhosis has developed and also to calculate mortality.
Various geographical and socio-economic fields within the HES APC have been requested. This ties in with one of the aims of studying geographical variation in outcomes of HH patients in England.
York and Scarborough Teaching Hospital NHS Foundation Trust have requested several sensitive data items (Cause of Death, Cause of death non-neonatal, Match rank and Death record used). These sensitive data items are required to identify if mortality is associated with cirrhosis-related complications or other HH-associated conditions. Cause of death non-neonatal is required as well as cause of death because this group of patients may have several co-morbidities which ultimately contribute to their death, receiving only the underlying cause of death may not allow the researchers to fully understand the time lag between diagnosis of HH and death from HH.
York and Scarborough Teaching Hospital NHS Foundation Trust is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.
The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;
The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.
This processing is in the public interest because It is estimated that 1 in 150 people are affected by HH in England. This study will aid the understanding of advanced liver disease in HH patients and help improve the clinical care of this population. The findings could provide modifiable risk factors for cirrhosis in the HH population which will further develop current clinical pathways in managing patients with HH. Analysis from assessing outcomes in different regions will also aid review of current standard of care in these areas.
The funding is provided by Haemochromatosis UK Charity and Scarborough Gastroenterology Research Fund. The funding is specifically for the study described.
The funders will have no ability to suppress or otherwise limit the publication of findings.
The University of Hull is a processor acting under the instructions of York and Scarborough Teaching Hospital NHS Foundation Trust. The University of Hulls role is limited to storage of data within the Data Safe Haven
Arrow Business Communications Limited are a processor of the University of Hull and operates under the instructions of the University of Hull. Arrow Business Communications Limited role is solely limited to provisioning, securing and back-up of the Data Safe Haven.
Data will be accessed by substantive employees of York and Scarborough Teaching Hospital NHS Foundation Trust and the University of Hull
A layperson group who are part of the Research and Development department at York and Scarborough Teaching Hospitals NHS Foundation Trust reviewed the grant application that was submitted to Haemochromatosis UK for charitable funding. The application included information on study aims, design and benefits for patients. The group were supportive of using this study design towards achieving the study aims of defining the prevalence of advanced liver disease in the hereditary haemochromatosis population.
Expected Benefits:
Data analysis from the requested HES and CRD Data will help develop a greater understanding of the proportion of patients with haemochromatosis who develop cirrhosis and the subsequent occurrences of its complications. By making these estimates, the current hepatology health services are able to review their current services to meet the health needs of the HH population they look after. In addition, the study aims to identify risk factors among the HH cohort that predispose them to cirrhosis using the requested HES and CRD data. Identification of these risk factors / associations will help patients and medical teams target modifiable risk factors.
The outcomes of HH patients in the various geographical regions in England will also be evaluated. Any significant geographical variation in outcomes should prompt local teams to review their current standard of care for HH patients. By identifying the prevalence of extrahepatic HH associated conditions, it is hoped that through this research York and Scarborough Teaching Hospital NHS Foundation Trust will be able to quantify the conditions that require attention by clinicians and areas of unmet need. It will also shed light on conditions that may require further research amongst the HH population.
Reviewing the causes of death in the HH population can identify the common causes of mortality in this population and the role of both hepatic and extrahepatic conditions associated with HH as a cause of death. Historically, prior to the development of genetic testing, HH patients were likely to die from liver cancer or cirrhosis with the added complications from diabetes. With earlier diagnosis using genetic testing and effective treatment through venesection, assessing the mortality data using the Civil Registrations of Death database will aid understanding of current mortality directly as a result of HH or its associated complications.
In the longer term, this national level data analysis may aid healthcare strategy and policy on the diagnosis and treatment of HH including the value of population level screening for this common genetic condition amongst those of Northern European descent. The published study results may indirectly be used by patient charities for advocacy. To put into context the potential reach of the study benefits, extrapolating from the UK BioBank data, there are approximately half a million people in England with 2 copies of the C282Y gene that causes haemochromatosis. It is estimated that nearly 100'000 of these individuals have been diagnosed and are being treated for HH in England.
Dissemination of this study using a large dataset will provide a beneficial addition to the current literature on advanced liver disease in patients with HH. By estimating the prevalence of cirrhosis, the true burden of advanced liver disease in this population can be contextualised. In addition, by identifying independent risk factors associated with cirrhosis in the HH population, targeted intervention can be developed in this sub-population. A similar study could be repeated in several years to re-assess the prevalence of cirrhosis and the impact this study would have made in addressing the development of cirrhosis in HH.
The use of this data is expected to improve clinical care of HH patients by improving current understanding through large data based evidence as well updating current clinical guidance and patient care pathways. By highlighting the prevalence of cirrhosis and complications of cirrhosis including liver cancer in this population, it will serve to highlight to healthcare practitioners reviewing and diagnosing this group of patients effectively treat and intervene in the care of these patients. Identified modifiable risk factors from the data, will provide evidence to the wider healthcare community to address the modifiable risk factors to reduce the risk of cirrhosis and its complications which can be incorporated into clinical guidelines by the large hepatology associations such as the European Association for the Study of the Liver and the British Association for the Study of the Liver.
The use of the data could identify geographical variation in clinical outcomes among HH patients which should lead to the review of the clinical care provided to HH patients in these areas followed by effective changes to processes and pathways to ensure adequate and timely assessment and treatment to improve their outcomes. It could also highlight the provision of treatment in these areas using procedural codes from the data. The data could provide the basis for future healthcare strategy and policy for HH patients that involves population level screening.
Identifying the presence of extrahepatic manifestations of HH could identify which conditions are most prevalent and lead to morbidity. This would support knowledge creation and basis for future research into these manifestations and how they can be assess and managed in advanced to prevent morbidity.
One of the funders, Haemochromatosis UK is the largest patient haemochromatosis patient charity in the UK. They are supportive of the study design and objectives and are well placed to advertise and communicate our study findings to their members as well as the wider public through their many communication channels and campaigns.
Should wider action be required to be taken including change in clinical guidelines and/or clinical care pathways, the charity actively participates in the All-Party Parliamentary Group and will be able to advocate and campaign through this channel.
Outputs:
Research analysis and outcomes from the study will have the following outputs:
a) Research project report to sponsor (York and Scarborough Teaching Hospitals NHS Foundation Trust)
- yearly report provided to Trust on status of project including final report summarising study findings and analysis
b) Research project report to funders (Haemochromatosis UK charity and Scarborough Gastroenterology Research Fund)
- 6 monthly report provided to funders on status of project including final report summarising study findings and analysis.
c) Publication in peer reviewed medical journals
- publication in journals such as British Medical Journal (BMJ), Journal of Hepatology (JHep) or Hepatology based on the findings of the study within 2 years of receiving data.
- aim to publish in open access journals to allow reading by interested medical professionals, patients and patient groups.
d) Presentation at national and international hepatology conferences (European Association for the Study of the Liver (EASL) Annual Congress and British Association for the Study of the Liver (BASL) Annual Conference)
- present data in the next 1-2 years at conferences. This may take the form of poster or verbal presentation.
- The BASL Annual Conference attended by hepatologists throughout the UK including England will be an opportunity to highlight any significant geographical variation in outcomes of HH patients thus directly communicating with clinicians in these areas prompting reviews of their local cohort of HH patients
e) British Association of the Study of the Liver Haemochromatosis Special Interest Group.
- The Chief Investigator is an active member of this group of clinicians, academics and scientists all with a keen interest in the care of patients with haemochromatosis (HH). The published findings will be communicated to this group to further generate discussion on the clinical care of HH patients and plan future research into advanced liver disease in the HH population.
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.
Target dates for the production and dissemination of the outputs- approximately 2 years from receiving data.
Processing:
No data will flow to NHS England for the purpose of this Data Sharing Agreement (DSA).
NHS England will provide the relevant records from the HES APC and CRD SCC datasets to the University of Hull. The Data will
contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.
The Data will not be transferred to any other location.
The University of Hull uses offsite backup services provided by Arrow Business Communications Limited.
Data is stored within the University of Hull Data Safe Haven (DSH). This is a trusted research environment hosted by Arrow Business Communications Limited.
Data for each project is logically separated meaning there is no ability to access or link to datasets from other projects within the DSH. When working within the environment users have no way to move data from within the DSH to any device outside of it. All data enters and leaves through a digital airlock which is linked to the above authorisation workflow.
The Data will be accessed by authorised personnel via remote access.
The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.
For remote access:
- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;
- Access controls granting users the minimum level of access required are in place;
- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;
- Multifactor authentication (MFA) is required for remote access;
- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for remote access;
- All remote access is undertaken within the scope of the organisations DSPT (or other security arrangements as per this DSA) and complies with the organisations remote access policy.
The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).
The data will not leave England at any time.
Access is restricted to employees or agents of York and Scarborough Teaching Hospital NHS Foundation Trust or the University of Hull who have authorisation from the Principal Investigator.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality
The Data will not be linked with any other data.
There will be no requirement and no attempt to reidentify individuals when using the Data.