NHS Digital Data Release Register - reformatted

Sheffield Teaching Hospitals NHS Foundation Trust projects

32 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Sheffield Teaching Hospitals NHS Foundation Trust was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Sheffield Teaching Hospitals NHS Foundation Trust may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

Do Patients With Autoimmune Hepatitis Have An Excessive Incidence Of Cardio- And Cerebro- Vascular Disease And Is This Related To Corticosteroid Treatment? — DARS-NIC-636813-T2D1L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 - s261(5)(d); Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2023-10-10 — 2026-10-09

Access method: One-Off

Data-controller type: SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Civil Registrations of Death - Secondary Care Cut
  2. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Sheffield Teaching Hospitals NHS Foundation Trust requires access to NHS England Data for the purpose of the following research project:

“Do patients with autoimmune hepatitis have an excessive incidence of cardio- and cerebrovascular disease and is this related to corticosteroid treatment?”

The following is a summary of the aims of the research project provided by Sheffield Teaching Hospitals NHS Foundation Trust:

“Autoimmune hepatitis (AIH) is a non-infectious liver disease, caused by the immune system damaging the liver. AIH affects 6000-17000 people in the UK of all ages and races. Unlike some liver conditions, AIH is unrelated to lifestyle.

Untreated, AIH is a serious and occasionally fatal disease. Drug treatment (usually steroids) dampens down the immune system, and greatly improves long-term outcome. However, steroids have side effects. Patients usually gain weight and may develop diabetes. These side effects may increase the risk of disease of the blood vessels – so called “vascular disease”, leading to serious conditions such as angina, heart attacks and strokes.

Patients with other conditions treated with steroids (such as rheumatoid arthritis) have a higher risk of vascular disease compared to the general population. Sheffield Teaching Hospitals NHS Foundation Trust wish to see if this is also true in patients with AIH and if there is a link with steroid therapy. If so, this could help drive the development of newer non-steroid treatments for AIH.

The Sheffield, Birmingham and King's College Hospital Liver Units treat many patients with AIH. This study aims to see if vascular disease in patients attending these units is more common than in a “control” group of people, without AIH.

Sheffield Teaching Hospitals NHS Foundation Trust hope to find out if patients with AIH have a greater rate of hospital admissions (or death) with cardio- or cerebrovascular disease (primary outcome) than an age and sex-matched control population. The prevalence of metabolic risk factors, including hypertension, diabetes, and dyslipidaemia will also be compared between “patients” and “controls”, accepting the limitations of hospital coding of these diagnoses.

If the rate of hospital admissions with vascular disease is indeed higher in patients with AIH, Sheffield Teaching Hospitals NHS Foundation Trust will then perform a secondary analysis of the AIH patients only, to determine if there is a relation to the dose and duration of corticosteroid therapy."

The following NHS England Data will be accessed:
• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary to compare information on hospital admissions due to vascular diseases, and vascular-related risk factors, between the AIH and control groups.
• Civil Registrations (Deaths) – necessary to compare mortality rates from vascular disease between the AIH and control groups.

For the majority of the cohort, the level of the Data will be pseudonymised. The level of the Data for the AIH cohort from Sheffield Teaching Hospitals NHS Foundation Trust will be identifiable because Sheffield Teaching Hospitals NHS Foundation Trust hold the identifying details for these patients. However, the Data that will be disseminated under this Data Sharing Agreement will contain no identifying details.

The Data will be minimised as follows:
• Limited to a study cohort identified by Sheffield, Birmingham, and King's College Hospital Liver Units – comprising ~800 patients with AIH; and a control cohort identified by NHS England from the Demographics database, who are matched to the AIH group by UK region, age, and sex.
• Limited to Data between 1989 and 2021. For each patient, Data will only be provided to cover the individual follow-up period.
• Limited to conditions relevant to the study identified by specific diagnosis codes; and associated vascular risk factors.

Sheffield Teaching Hospitals NHS Trust is the research sponsor and the Controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the Controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it will provide information to guide doctors’ decisions about the care of patients with autoimmune hepatitis and hopefully will drive the development of newer non-steroid treatments.

The funding is provided by the Sheffield Teaching Hospitals Liver Unit Research Fund. The funding is for the department and is not specifically limited to the study described.

Small numbers suppressed outputs will be used as part of the study manager’s Doctor of Medicine (MD) thesis registered at the University of Sheffield. The University of Sheffield will not access NHS England Data.

The Birmingham and Kings College Hospital Liver Units will provide NHS England with autoimmune hepatitis patient details but will not access NHS England Data.

All three participating centres have sought feedback from their local Patient and Public Advisory Groups on the study protocol, patient notification letter and patient notification poster. The patient notification letter and poster were updated in accordance with the comments received.

Expected Benefits:

The findings of this research study are expected to contribute to evidence-based decision-making for local decision-makers such as doctors to inform best practice to improve the care, treatment, and experience of AIH patients.

The findings are expected to enable Sheffield Teaching Hospitals NHS Foundation Trust to determine whether the risk of vascular disease is excessive in patients with AIH and (if so) if this increase is associated with corticosteroid treatment. Demonstration of such an association would have implications for management of patients with AIH including (a) limiting the dose and duration of corticosteroid treatment, (b) increased use of steroids with limited systemic side effects and (c) accelerated assessment of newer anti-inflammatory agents for treatment of AIH. Limiting the use of steroid treatments could lead to a reduction in adverse effects such as hypertension, weight gain, hyperlipidaemia, diabetes, and vascular disease, which would be a clear benefit to AIH patients.

The use of the Data could:
• help the system to better understand the health and care needs of populations.
• lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Outputs:

The expected outputs of the processing will be:
• Submissions to peer reviewed journals within a year of Data receipt
• Presentations at the Yorkshire and Humber Liver Network Meeting, and national and international hepatology conferences

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 outputs will be communicated to relevant recipients through the following dissemination channels:
• Journals
• Conference presentations
• Direct bilateral engagement with local and national patient groups

Production and dissemination of the outputs is intended within one year of Data receipt.

Processing:

Sheffield Teaching Hospitals, University Hospitals Birmingham and King's College Hospital will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Name, Date of Birth, Postcode, Sex and a unique person ID), alongside date of AIH diagnosis and date of end of follow-up for the cohort to be linked with NHS England Data.

NHS England will also generate a group of matched-population controls. There will be 10 controls per patient, and they will be individually matched to the corresponding patient for age (within 12 months) and sex. Controls will also live in the same lower super output area (LSOA) as the corresponding patient.

NHS England will provide the relevant records from the HES APC and Civil Registrations (Deaths) datasets to Sheffield Teaching Hospitals NHS Foundation Trust. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The Data will be analysed by the study team at Sheffield Teaching Hospitals to compare survival between the two groups. Further statistical analyses will also be used to examine the influence of other variables, including metabolic risk factors, sex, age and deprivation index.

The Data will be linked at person record level with existing patient data from Sheffield, Birmingham, and Kings College Hospital NHS Foundation Trusts where relevant to ensure participant information is complete and accurate for data analysis purposes.

Sheffield, Birmingham and Kings College Hospital NHS Foundation Trust each have their own database of all patients with AIH presenting to their Liver Units since 1989. These databases have been built over several years by the clinicians caring for these patients. They contain details of the treatment each patient has received, including the dose and duration of corticosteroid treatment. This data, combined with NHS England Data, will be used to determine whether the rate of vascular disease in the AIH patients is related to corticosteroid treatment.

The study manager at Sheffield Teaching Hospitals NHS Foundation Trust will extract a subset of the Data and make this available to other members of the study team to help with Data analysis. This Data will contain the study ID, and dates/diagnoses of each hospital admission. No identifiable patient Data will be made available to other members of the study team, and they will not be able to reidentify patients. This Data will be transferred using a secure password-protected shared drive on the STH network.

The Data will be stored on servers at Sheffield Teaching Hospitals NHS Foundation Trust.

The Data will be accessed on-site at the premises of Sheffield Teaching Hospitals NHS Foundation Trust by authorised personnel only.

Personnel are prohibited from downloading or copying Data to local devices.

The Data will not leave England at any time.

Access is restricted to employees of Sheffield Teaching Hospitals NHS Foundation Trust who have authorisation from the study manager.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from Sheffield Teaching Hospitals NHS Foundation Trust will analyse the Data for the purposes described in ‘Objective for Processing’.

Project 2 — DARS-NIC-156408-MJP0Y

Type of data: information not disclosed for TRE projects

Opt outs honoured: N ()

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(2)(c)

Purposes: ()

Sensitive: Sensitive, and Non Sensitive

When:2017.09 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Scottish NHS / Registration

Objectives:

The data supplied by the NHSIC to Cancer Research Centre will be used only for the approved Medical Research Project MR1081.

Project 3 — DARS-NIC-147842-NL26D

Type of data: information not disclosed for TRE projects

Opt outs honoured: Y ()

Legal basis: Section 251 approval is in place for the flow of identifiable data

Purposes: ()

Sensitive: Sensitive

When:2017.09 — 2017.05.

Access method: Ongoing

Data-controller type:

Sublicensing allowed:

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Scottish NHS / Registration

Objectives:

The data supplied by the NHS IC to Royal Hallamshire Hospital will be used only for the approved Medical Research Project MR777.