NHS Digital Data Release Register - reformatted

Royal Devon And Exeter NHS Foundation Trust projects

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

MR766 - Diabetes Alliance for Research in England (DARE) (Previously EXTRA) — DARS-NIC-147863-CCGZN

Type of data: information not disclosed for TRE projects

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

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), Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c); Informed Patient consent to permit the receipt, processing and release of data by NHS Digital

Purposes: No (NHS Trust)

Sensitive: Non Sensitive, and Sensitive

When:DSA runs 2019-05-12 — 2022-05-11 2017.12 — 2024.01.

Access method: Ongoing, One-Off

Data-controller type: ROYAL DEVON AND EXETER NHS FOUNDATION TRUST, ROYAL DEVON UNIVERSITY HEALTHCARE NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. Demographics
  5. Civil Registration - Deaths
  6. MRIS - Members and Postings Report
  7. Civil Registrations of Death

Objectives:

Both major types of diabetes (Type 1 and Type 2) represent classical “complex disorders” with both genetic and environmental factors playing an important role. There is considerable evidence that genetic factors are important in the development of diabetes. Evidence for this includes the clustering of disease in families, a high concordance rate in identical twins and migration studies. However, the majority of Type 2 forms of diabetes are greatly influenced by environment as shown by the rapidly increasing prevalence in the last two decades. This does not represent an alteration in the population gene frequency but rather changes in the environment, specifically a reduction in physical activity and increased food consumption. Diabetes is a major cause of morbidity and mortality and has been estimated to account for 10% of NHS spending and this is likely to increase. Therefore, understanding how the disease develops, progresses over time and how to prevent complications is a major health priority. Both genetic susceptibility and environment are involved in the development of complications involving the small blood vessels such as retinopathy and large blood vessels such as myocardial infarction and stroke. Each risk factor has its own genetic and environments determinants.

The Diabetes Alliance for Research in England (DARE) study has been set up to establish an epidemiologically based sample of patients with diabetes within the Exeter region. Participants are recruited in the Exeter region and the data requested relates to these participants rather than the full nationwide cohort. The objective of this study will be to extract DNA from blood samples obtained from all consenting diabetic patients and control participants. Clinical information will also be gathered about a participant’s health and wellbeing, family history and diabetes treatment. With specific consent from study participants, we will extract information about their diabetes and related conditions from health records for the duration of the study in order to follow up on participants health status. Study participants will include both the cohort with diabetes and the control group. Genetic and clinical data used in combination will enable the DARE study team to identify genes and gene/environment interactions involved in the development and progression of Type 1 and Type 2 diabetes and in the development of diabetes-related complications, specifically retinopathy and ischaemic heart disease.

The aim of DARE is to investigate and understand diabetes and how it progresses and leads to complications. The increased cardiovascular death rate seen in patients with diabetes is a major problem that needs further study. A key outcome will relate to mortality in diabetes, as previous studies have been unable to report time and cause of death. Therefore, it will be important for the study to process and share information about participants with NHS Digital; this will enable the Royal Devon & Exeter Foundation Trust access to this mortality data.

The DARE Study will also seek specific consent from participants to join a database and to be contacted about future research studies. The database will be used as a way to recruit the most appropriate participants for future diabetes studies. To ensure that personal information about participants is up to date and accurate, DARE needs to ensure this dataset is complete and populated with the latest identifiers (name, current address, whether a participant has left the NHS).

It is therefore a priority to have a very large collection of patients with Type 2 diabetes and associate controls from a defined geographical region to enable this work into susceptibility to progress.

The study has arisen from discussion at meetings held with patients with diabetes (through patients organisation Diabetes UK) who felt that further research into who developed diabetes and who developed diabetes’ complications is important. A patient is on the steering committee and has read and given suggestions on the protocol and patient information sheet.

Yielded Benefits:

No further papers have been written since the last application (four months ago) but it is envisaged that there will be some in the future. Currently, the major benefit is as above in that the organisation can ensure that individuals who are deceased are not tried to be contacted. Outputs from the DARE Study have already made a valuable contribution to clinical care for Diabetes patients at the Royal Devon and Exeter NHS Foundation Trust. A Principal Clinical Scientist at the Royal Devon and Exeter Hospital and his colleagues from the University of Exeter have discovered that the use of a simple urine test, urinary C-peptide: creatinine ratio (UCPCR) offers a practical non-invasive alternative to a C-peptide blood test. A C-peptide test is used to measure if patients with diabetes are making their own insulin. It is often used to find out whether someone has Type 1 or Type 2 diabetes. However, this blood test has been shown to be less reliable in patients whose kidneys are not working properly. The UCPCR test was developed using clinical data and samples donated from DARE participants and the test better reflects the amount of insulin being produced than repeated C-peptide measurements in patients with diabetes and kidney damage. A study led by Dr Christopher Clark an Academic Clinician at the University of Exeter used mortality data provided by NHS Digital to investigate whether differences in blood pressure between arms are associated with vascular disease and increased mortality; as this had not been reported in diabetes. His research was published in Diabetes Care journal. Clark C E, Steele A M, Taylor R S, Shore A C, Ukoumunne O C, Campbell J C. Interarm Blood Pressure Difference in People With Diabetes: Measurement and Vascular and Mortality Implications. Diabetes Care 2014 Jun; 37(6): 1613-1620 There have already been some papers arising from the DARE study published in: - Diabetic Medicine, the official journal of Diabetes UK; The Review of Diabetic Studies; Diabetes Care; Nursing Times. Diabetic Medicine: - A small study with big ambitions: 10 year review examining the impact and achievements of the Diabetes alliance for Research in England (DARE) within the Exeter NIHR Clinical Research Facility, Exeter and beyond. The transcription factor 7-like 2 (TCF7L2) gene is associated with Type 2 diabetes in UK community-based cases, but the risk allele frequency is reduced compared with UK cases selected for genetic studies. Difference in phenotype of patients recruited for genetic studies on an epidemiological rather than a familial based recruitment criteria. Angiotensin-converting enzyme gene insertion/deletion polymorphism is not associated with severe hypoglycaemia in patients with type 2 diabetes. What is the best case collection for defining the role of Type 2 diabetes genes? A comparison of the Diabetes UK Warren 2 Cases (W2C) and The Exeter Research Alliance for Diabetes (EXTRA). The Review of Diabetic Studies: - The Impact of Angiotensin-converting enzyme insertion/deletion polymorphism on severe hypoglycaemia in Type 2 diabetes. Nursing Times: - Implementing a research project on the development of diabetes.

Expected Benefits:

How data from NHS digital is beneficial

The Death data will prevent participants being sent Newsletters after they have died and ensure that the Royal Devon and Exeter NHS Foundation Trust do not cause distress to participants' families. In addition, this will ensure NHS research resources are not wasted on unnecessary contact. Being able to report cause of death. The list clean will ensure that the personal information held about participants is accurate and up to date. The benefit of this will be ensuring no attempt is made by the Trust to contact a participant at an incorrect address or use the incorrect identifiers (name, sex, status). This will help to ensure that research participants are contacted promptly and appropriately to aid further research.

GP patient data show that there are now 4.05 million people with diabetes in the UK, which includes 3.5 million adults who have been diagnosed, an increase of 119,965 compared to the previous year, and an increase of 65%. There are also thought to be 549,000 people with undiagnosed Type 2 diabetes [Quality and Outcomes Framework, Health and Social Care Information Centre, Information Services Division Scotland. Statistics for Wales, Department of Health, Social Services and Public Safety, 2014 – 2015].

The prevalence of diabetes is estimated to rise to 4 million by 2025 and the current cost of diabetes to the NHS is over £1.5m an hour or 10% of the NHS budget for England and Wales. This equates to over £25,000 being spent on diabetes every minute. In total, an estimated £14 billion pounds is spent a year on treating diabetes and its complications, with the cost of treating complications representing the much higher cost (http://www.diabetes.co.uk/cost-of-diabetes.html).

Previous studies have been unable to report time and cause of death. This is a key output which has not yet been reported. The DARE study has prospective data with DNA collected and cause of death and other factors relating to death in diabetes being collected. This will be a key outcome in publications relating to mortality in diabetes.

At present the precise mechanisms that lead to the development of Type 2 diabetes and to diabetic-related microvascular complications (e.g. sight loss and kidney failure) are poorly understood. If it were possible to define the major genes associated with these conditions, it would be a major step in understanding the proteins in our cells that are involved in the cause of Type 2 diabetes and the complications involving the eye and the kidney. This would be a crucial step towards improving scientific understanding giving a new target for treatment. This is desperately needed, as present treatments for both the control of glucose and prevention of complications in diabetes are clearly inadequate.

The benefits are improvements in clinical care that will be published and available to the public.

Outputs:

The results of the study will all be published in leading international scientific journals as well as being disseminated to patients with diabetes by using local publications such as DIRECT, a south west Peninsula-wide Diabetes Charity, Diabetes UK group meetings and national Diabetes UK publications and meetings.

In addition, the study team are aiming to analyse the mortality data to look at predictors of mortality in the diabetes cohort compared with controls. Mortality data from greater numbers of patients is required to achieve a sufficiently robust data set for this question. As part of the DARE study follow up process, The Royal Devon and Exeter NHS Foundation Trust will continue to collect mortality data from NHS Digital to achieve the required dataset for this analysis.

Papers arising from this work will be submitted to internationally recognised journals such as the New England Journal of Medicine, The Lancet and Nature Genetics and/or the top diabetes-specific journals such as Diabetes care, Diabetologia and Diabetic Medicine.

All outputs will contain only aggregate data with small number suppressed in line with the HES analysis guide.

Processing:

This study will be a central resource to allow both cohort and nested case/control studies. It will take place in both primary and secondary care as long as the individual doctors give their permission. The study will involve the integration of clinical information from a variety of sources which will be collected on the patient after he/she has given their permission and been recruited into the study. Health information and clinical measurements will be collected directly from the participant; clinical data will be extracted from primary and secondary health records and biochemistry results extracted from hospital laboratory databases.

The Royal Devon and Exeter NHS Foundation Trust will provide NHS Digital with a spreadsheet containing the study participants’ name, postcode, DOB, gender, NHS number and unique study ID number annually.

Once these identifiers have been tracked, NHS Digital will supply The Royal Devon and Exeter NHS Foundation Trust with bi-annual reports of the full cohorts current status. These reports will contain the same identifiable patient identifiers supplied to NHS Digital as well as latest identifiers, date of death and sensitive cause of death data.

Reports received from NHS Digital will only be accessed by substantive employees of the Royal Devon and Exeter NHS Foundation Trust. Reports will be saved on secure NHS computers.

Updated data will then be added to the secure DARE Study database to ensure no contact is attempted with patients who have passed away.

Those who will be accessing NHS Digital data are substantive employees of Royal Devon and Exeter NHS Foundation Trust, the Chief Investigator holds a joint contract with Royal Devon and Exeter NHS Foundation Trust and the University of Exeter. The statistician is substantively employed by the University of Exeter but holds an honorary contract with the trust. The statistician will only have access to pseudonymised data.

All processing of ONS data will be in line with ONS standard conditions.

CLARITY IBD: Understanding the impact of biologic and immunomodulatory therapy on SARS-CoV-2 Infection and Immunity in Patients with Inflammatory Bowel Disease — DARS-NIC-435152-C0H4N

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - Statutory exemption to flow confidential data without consent, Identifiable, Anonymised - ICO Code Compliant, No (Statutory exemption to flow confidential data without consent, Consent (Reasonable Expectation))

Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002, Consent (Reasonable Expectation); Health and Social Care Act 2012 – s261(2)(c)

Purposes: Yes, No (NHS Trust)

Sensitive: Non Sensitive, and Non-Sensitive, and Sensitive

When:DSA runs 2021-02-23 — 2022-02-22 2021.03 — 2023.11.

Access method: One-Off

Data-controller type: ROYAL DEVON AND EXETER NHS FOUNDATION TRUST, ROYAL DEVON UNIVERSITY HEALTHCARE NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Demographics
  2. COVID-19 Vaccination Status

Objectives:

CLARITY IBD www.clarityibd.org (impaCt of bioLogic therApy on saRs-cov-2 Infection and immunity, https://doi.org/10.1186/ISRCTN45176516) is badged as a UK NIHR COVID-19 urgent public health study (1b) (https://www.nihr.ac.uk/covid-studies/). When referencing the evidence submitted, these objectives and processing information refer to Workflow 1 of the study (not Workflow 2).

Patients with inflammatory bowel disease (IBD) are usually treated with immunosuppressive drugs. By inhibiting the immune system, these drugs increase the risk of serious infections and prevent vaccines fully working. Because COVID-19 is caused by a new virus, SARS-CoV-2, the researchers (Royal Devon and Exeter (RD&E) NHS Foundation Trust) don’t yet know if these drugs increase the risk of infection, life-threatening illness or reduce immunity that usually follows infection or vaccination. As a precaution the UK Government advised patients taking these medicines to follow strict social distancing measures, known as shielding, during lockdown periods. This study will investigate the impact of specific drugs and shielding on COVID-19 infection and subsequent immunity following infection or vaccination. The results of this study will help inform public health policy decisions for patients with IBD as well as millions of other UK patients treated with immunosuppressive drugs.

1. “What are the objectives of processing the data?”
a. To conduct research:
“The data is required to support the following research objectives:
In patients with inflammatory bowel disease, on immunosuppressive medication, RD&E aim to define:
- seroprevalence (number of persons in a population who test positive for a COVID-19 based on nasal/throat swab polymerase chain reaction, commonly performed to assess for acute infection) of SARS-CoV-2 through the early phase of the pandemic
- seroconversion (time period during which SARS-CoV-2 antibodies develop and become detectable in the blood) in patients with confirmed infection by nasal/throat swab
- the magnitude (extent) of SARS-Cov-2 antibodies in patients with confirmed infection
- Demographic factors associated with COVID-19 disease, including gender, age, and deprivation

2. “What is your justification for each individual dataset?”
To achieve these goals outlined in the CLARITY IBD research study, RD&E wish to collect the following data from the Demographics dataset:
- NHS Numbers: For approx. 7,500 patients in whom RD&E have performed SARS-CoV-2 antibody testing on, RD&E require their NHS numbers in order to obtain further information from Public Health England on throat/nasal swab polymerase chain reaction results. RD&E have an agreement in place with Public Health England to supply them with nasal/throat swab polymerase chain reaction COVID-19 testing results.
- Post code: For approx. 11,000 patients in whom RD&E have performed SARS-CoV-2 antibody testing on, RD&E require their residential post code. This will be to investigate the hypothesis that there are regional differences in COVID-19 infection across the UK, and that COVID-19 infection and severity differs across deprivation area.

Please note that there is no biological reason for results not to be extrapolated to patients who are on anti-TNF medicine for non-IBD indications. It is hoped that results will directly be relevant, therefore, to any patent on anti-TNF/biologic therapy studied, including arthritis and psoriasis (the two most common non-IBD indications).

3. “Who are the data subjects?”
The data subjects are a non-consented cohort of approx. 11,000 patients across the UK diagnosed with inflammatory bowel disease on immunosuppressive medication. This cohort was selected to provide a robust sample size to investigate variations impact of immunosuppressive therapy on SARS-CoV-2 infection and immunity, in line with our objectives, and therefore contains a mix of demographics (age, gender, ethnicity) in order to provide a suitably representative sample. Recruitment took place from 09-02-2020 to 30-10-2020 and is now complete so the cohort size will not increase.

RD&E will test >15,000 serum samples from IBD patients for SARS-CoV2 antibodies. These include i) surplus serum samples from UK therapeutic drug monitoring laboratories retained since 09-02-2020 and ii) serum samples from patients recruited to the UK NIHR IBD Bioresource project. For each sample the supplier of the sample (the therapeutic drug monitoring laboratory or the UK NIHR IBD Bioresource) will provide the NHS number, date of birth, sex of the patient, postcode (if available), the date of the serum sample, the drug tested and the name of the referring hospital. These data will be provided for a COVID-19 purpose to the Royal Devon and Exeter NHS Foundation Trust. The study will use surplus serum samples from UK clinical laboratories saved following therapeutic drug monitoring tests. Additional serum samples will be obtained from the UK NIHR IBD Bioresource.

4. “How have you minimised your data request to what is absolutely necessary for your stated objectives?”
“The following data minimisation options have been considered: RD&E are only requesting two variables (NHS number and Post Code)"

5. “Under what GDPR legal basis will you be processing this data?”
“The Royal Devon and Exeter NHS Foundation Trust relies on GDPR 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”.

Justification: The Royal Devon and Exeter NHS Foundation Trust is a NHS hospital, which is considered a public authority under the Data Protection Act 2018. It was legally established under a royal charter which states that one of its functions is to carry out research. This particular research is considered to be in the public interest because of the potential benefits to patient health, including to improve the quality of care for people living with inflammatory arthritis. The data requested is necessary to this research as the same outputs and benefits could not otherwise be achieved.

The Royal Devon and Exeter NHS Foundation Trust relies on GDPR Article 9(2)(j) – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject”.

Justification: The data requested is necessary in order to meet the research objectives and has been minimised in a way that is proportionate to the intended purpose. RD&E has considered the interests of the data subjects including providing a transparent privacy notice that explains this use of data and the rights of data subjects, and data will be securely handled with role-based access controls to limit usage.”

6. “How are you addressing the common law duty of confidentiality?”
The Royal Devon and Exeter NHS Foundation Trust relies on Regulation 3 (4) of the Health Service Control of Patient Information (COPI) Regulations 2002 to temporarily lift the Common Law Duty of Confidentiality. Patient consent for SARS-CoV-2 antibody testing was not sought and no prospective study visits are required.

Justification: "The COPI notice can be relied upon for the processing of confidential patient information for the purposes set out in Reg 3(1) of COPI in order to support the COVID-19 response. In direct relation to the study objectives, Regulation 3(1) confirms that confidential patient information may be processed for:
• recognising trends in such diseases and risks;
• controlling and preventing the spread of such diseases and risks;
• monitoring and managing
o the delivery, efficacy and safety of immunisation programmes

The CLARITY study looks at risk of infection of COVID-19 amongst patients with inflammatory bowel disease treated with immunosuppressant medications. If a difference is found between patients on these treatments, this may have an impact and inform COVID-19 vaccine immunisation strategy/prioritisation for these patients.

Where processing takes place under Reg3(1) COPI, the COPI notice states that confidential patient information must be processed solely for a COVID-19 purpose. In terms of Reg (3) - the processing of confidential patient information for the purposes specified in paragraph (1) may be undertaken by —
(a)the Public Health Laboratory Service [Public Health England will use the NHS numbers and post codes of patients to link to COVID-19 nasal/throat swab polymerase chain reaction results];
(b)persons employed or engaged for the purposes of the health service [the processor of the data, is employed by the Royal Devon and Exeter Hospital, will use the data for Public Health England data linkage only].

The research project has received approval from the Surrey Borders Research Ethics Committee (20/HRA/3114) and Health Research Authority (IRAS: 283251, Protocol number: 2102102).

The funders have no impact on the design or any inputs on the outputs of the study. They will have no access to any NHS Digital data.

Expected Benefits:

This study addresses clinically relevant priority research questions relating to SARS-CoV-2 in a specific patient group. Obtaining estimates of the proportion of those patients already exposed to COVID-19 helps inform our knowledge and future planning. A greater understanding of the impact of immunosuppressive on SARS-CoV-2 acquisition, illness and immunity is needed to help define at risk patient groups and to determine the impact of preventative social distancing strategies.

The data from this study may inform:
1. Alternative prescribing behaviour of immunosuppressive medication during the COVID pandemic if specific immunosuppressive therapies are associated with greater risks of severe COVID disease.
2. Alternative vaccination strategies if immunosuppressive drugs are associated immunosuppressive medication.

Outputs:

Findings will be written up and submitted to a peer-reviewed scientific journal - Gut, the highest ranking gastroenterology journal in the world (hopefully within one month from date of receipt of data to inform both clinical care and public health policy nationally and internationally.).

Findings will be presented by the study team at national and international conferences including the British Society of Gastroenterology annual meeting and the European Crohn’s and Colitis meeting. The study team will prepare a lay summary of the study findings for dissemination to the members of the national patient group, Crohn’s and Colitis UK.

There is also a study management group that meets weekly, whom interim and final results are distributed through. Over 20 consultants across the UK working in district general and tertiary centres working with both children and adults, are members of this group.

RD&E have also produced a patient facing video for the study that has been shared through social media, Crohn’s and Colitis UK charity, and senior figureheads (both clinical and non-clinical) who are ‘IBD champions’.

Processing:

1. “Is there any data flowing to NHS Digital?”
The Royal Devon and Exeter NHS Foundation Trust will transfer to NHS Digital the patient identifiers for approximately 11,000 patients. The identifiers included will be name, date of birth, gender, and NHS number (where applicable) paired with a unique identifier to support pseudonymisation. The data is identifiable and is not available in the public domain.

The patient identifiers will be provided to NHS Digital so that this can be linked to the requested datasets (Demographics data with two identifiable fields - NHS number and/or Post Code). NHS Digital will use the patient identifiers via the Patient Demographic Service for the 11,000 identified patients provide back NHS numbers and/or Post Code only for those patients, thus minimising the total amount of data requested.

By obtaining NHS numbers and Post Codes with the already obtained patient identifiers, more detailed analysis can be carried out on SARS-CoV-2 nasal/throat swab polymerase chain results. This will provide a clearer picture of impact of COVID-19 on patients with inflammatory bowel disease on immunosuppressive therapies.”

2. “What steps will specific data go through, how will it be processed and accessed and what is being done with it at each stage?

“1. NHS Digital will send the NHS number and/or Post Code to the Royal Devon and Exeter NHS Foundation Trust.
2. The Royal Devon and Exeter NHS Foundation Trust will provide that NHS number and/or Post Code to Public Health England in order to obtain SARS-CoV-2 nasal and throat swab polymerase chain reaction results for each patient.
3. Public Health England will then supply this information to the Royal Devon and Exeter NHS Foundation Trust.
4. The Royal Devon and Exeter NHS Foundation Trust will pseudonymise this data, and securely destroy the identifiable data.
5. The Royal Devon and Exeter NHS Foundation Trust will carry out statistical analysis to support the objectives of the CLARITY IBD study on the pseudonymised data set only.
6. The Royal Devon and Exeter NHS Foundation Trust will analyse the full pseudonymised dataset as part of the CLARITY IBD objectives.

Both organisations require identifiable data in order to gather patient-level clinical data in the first instance. However, data will be pseudonymised in order to carry out statistical analysis. Although identifiable data will be received and shared, this is necessary to link clinical datasets.

The Royal Devon and Exeter NHS Foundation Trust have a role in all objectives, and the data will be pseudonymised as soon as possible (ie - after receipt, but before analysis) so that only the minimum necessary data for this purpose is processed. Staff within The Royal Devon and Exeter NHS Foundation have specific expertise relating to care of patients with inflammatory bowel disease on immunosuppressive therapy that will form an important part of this analysis and support the overall objectives.”

3. “Are there any organisations involved in the project other than the controller(s), processor(s) or funder(s) mentioned elsewhere in the application?

“There are no additional organisations involved in this use of data other than the organisations already mentioned elsewhere in this agreement.”

4. “Will you be linking to any other datasets?”
“1. NHS Digital to Public Health England linkage:
a. The dataset to be linked is the SARS-CoV-2 nasal/throat swab polymerase chain reaction, which is under the data controllership of Public Health England. This data is record level and identifiable.
b. The dataset is not publicly available at record level, although aggregate summaries are published.
c. Linkage to this dataset will provide a clearer view of the impact of immunosuppressive therapies in patients with inflammatory bowel disease on SARS-CoV-2 infection and immunity. As a result, results from this study may impact future care of patients on immunosuppressive therapy. The Public Health England dataset contains polymerase chain reaction COVID-19 results that are not available in the Personal Demographics Service.
d. The linkage will be on a deterministic basis using NHS number and/or Post Code. This is the only way to link the datasets.
e. Patients have not given their explicit consent for their data to be linked; the common law duty of confidentiality does apply, but is temporarily lifted under Regulation 3 (4) of the Health Service Control of Patient Information (COPI) Regulations 2002.
f. Data must be processed in a clear identifiably form in order to support linkage, but identifiers will be removed once linkage is completed. The linked data will then be pseudonymised when analysing the data. This will be done at the point of receipt to The Royal Devon and Exeter NHS Foundation Trust.”

5. “Will you be attempting to re-identify individuals?”
“The Royal Devon and Exeter NHS Foundation Trust has no requirement nor will attempt to re-identify the supplied data.”

6. “Will anyone who is not an employee of a named data controller or processor access the data?””

“Data will only be accessed and processed by substantive employees of the data controller and its processors and will not be accessed or processed by any other third parties not mentioned in this agreement. Third party organisations would have to make a formal NHS digital data access request in order to obtain the data-set.”

An exploratory descriptive analysis of the 5-year survivorship of total ankle replacements compared with equivalent rates in administrative datasets with further adjusting for co-varieties — DARS-NIC-178836-V1G3V

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Mixture of confidential data flow(s) with support under section 251 NHS Act 2006 and non-confidential data flow(s))

Legal basis: Health and Social Care Act 2012 - s261 - 'Other dissemination of information'

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2020-10-20 — 2022-10-19 2021.01 — 2021.01.

Access method: One-Off

Data-controller type: ROYAL DEVON AND EXETER NHS FOUNDATION TRUST, ROYAL DEVON UNIVERSITY HEALTHCARE NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. HES:Civil Registration (Deaths) bridge
  3. Hospital Episode Statistics Admitted Patient Care
  4. Civil Registrations of Death - Secondary Care Cut
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

This stand-alone non-research study (service evaluation) being undertaken by the Royal Devon and Exeter NHS Foundation Trust is an exploratory descriptive analysis of the survivorship of total ankle replacements and revision ankle replacements comparing with equivalent rates in administrative data sets. The aim of this study is to analyse data from the UK National Joint Registry (NJR) and from Hospital Episodes Statistics data (NHS Digital) to find out how many ankle replacements fail within 5 years of the surgery. This will be the largest study looking at outcomes of these operations. By analysing this data it will give both surgeons and patients more information on the expected outcomes and risks of complications following ankle replacements. The study hopes to improve knowledge of ankle replacements (and complications arising from them) that will improve future patient outcomes, and has support from the National Joint Registry and is being funded by the British Orthopaedic Foot and Ankle Surgery Society (BOFAS) and the Gwen Fish Orthopaedic Trust (neither funder have influence on the outcomes nor suppress any of the findings of the service evaluation).

Failure rate of ankle replacements
A failure is determined as revision, arthrodesis or amputation. This will enable further information to be to be given to patients in the consenting process, and inform surgeons of the likely outcomes for these patients. It will also determine risk factors for ankle replacement failures.

Over 900 total ankle replacements (TAR) are recorded in the NJR each year. There have been varying results reported with these implants, and considerable research is ongoing assessing long term outcomes of these replacements and comparing total ankle replacements with ankle arthrodesis. A previous systematic review on long term outcomes of ankle replacements found that TAR had a positive impact on patients lives, but was unable to make strong conclusions as previous studies have been small and of poor quality. Currently the failure rates of ankle replacements are unknown as those that are revised to an ankle fusion are poorly recorded at present. Therefore it is important to know the true failure rate of ankle replacements for decision about surgical treatment of ankle arthritis.

Patients that have failure of a total ankle replacement can either have a revision procedure, conversion to an arthrodesis or amputation. The Swedish arthroplasty register has demonstrated 188 failures in 1110 primary TARs. Of these 118 were revised with a salvage arthrodesis and 70 with a revision TAR.

The National Joint Registry for England, Wales, Northern Ireland and the Isle of Man started recording total ankle replacements and revision ankle replacements in 2010. Since then over 3500 ankle replacements have been recorded. When a revision is performed an A2 form should be completed. The risk of revision as reported by the NJR in 2019 is 6.9% at 5 years. BOFAS and the NJR believe that this is under-reported and especially those converted to an ankle arthrodesis or amputation are very poorly recorded. The primary outcome of failure is defined as the removal or exchange of any components of the implanted device inserted during ankle replacement surgery.

The aims of this study are:
1. Calculate the failure rate of total ankle replacements and revision ankle replacements
2. Mortality following total ankle replacements
3. Post-operative complications of total ankle replacements and revision ankle replacements
4. Validation of the NJR data set

The study also hoped to identify the incidence of:
5. Post-operative DVT or PE (within 1 year)
6. Post-operative re-admission (within 1 year)
7. Post-operative MI (within 1 year)
8. Post-operative CVA (within 1 year)
9. Post-operative further surgical procedure
10. Mortality
11. Amputation
12. Revision ankle replacement
13. Ankle arthrodesis

The data linkage proposed by this data sharing agreement will ensure the accuracy and completeness of the data recorded by the NJR. At present it is thought that the data recorded by the NJR does not account for all the failures of ankle replacements. The only feasible way to determine the true failure rate is by linking NJR and NHS Digital data.

The data subjects in the NJR cohort group are all patients undergoing either a primary total ankle replacement or revision ankle replacement between 01 January 2010 and 31 December 2018. The cohort group will be sourced from the UK National Joint Registry. The study will perform a deterministic linkage which requires exact match of the fields from both the NJR and Hospital Episodes Statistics (HES) database to confirm they are from the same patients. This linkage will be performed by NHS Digital using NHS Number, Postcode and Date of Birth. A Study ID will be allocated to each NJR patient record so that the data can be pseudonymised by NHS Digital prior to dissemination back to Royal Devon and Exeter NHS Foundation Trust.

The data requested is from when the replacement was undertaken until present day to get the most complete data set and accuracy of those ankle replacements that have failed. This includes primary ankle replacements and revision ankle replacements.

The study aims to look at data from England and Wales as these are the geographical areas also covered by the NJR.

The sole Data Controller who also processes the data is Royal Devon and Exeter NHS Foundation Trust.

GDPR LEGAL BASIS FOR PROCESSING
The lawful basis for processing data under GDPR has been reviewed against the guidance provided by IGARD and been assessed as acceptable. Article 6(1)(e) (processing is necessary for the performance of a task in the public interest…) and Article 9(2)(i) (Processing is necessary for reasons of public interest in the area of public health…). Royal Devon and Exeter NHS Foundation Trust are performing a Public Task as per the NHS Act 2006 section 43(5), which describes the functions of authorised NHS Foundation Trusts. The data is required for non-research, service evaluation purposes, for improvement and ensuring high standards and quality/safe care. This project is evaluating the actual failure rate of ankle replacements. This is in the public interest so that it is possible to determine how many ankle replacements will fail. It will also ensure that all the ankle replacements being performed are for the correct patient with highest likelihood of implant survival to prevent patient morbidity and disability.

Expected Benefits:

This evaluation aims to determine the true 5 year failure rates of ankle replacements, and which patients are at a high risk of failure. This will enable more informed decisions to be made by clinicians and patients regarding the management of ankle arthritis in individual patients. This study will provide a service evaluation which will improve the current knowledge of ankle replacements potentially improving future patient outcomes.

With increasing numbers of ankle replacements being performed it is vital that the National Joint Register produces accurate data on the outcomes of these prosthesis. This will evaluate the results of all prosthesis being currently implanted in a similar manner to other arthroplasty procedures. This will ensure that patients are receiving accurate information in the consenting process with regards the likely requirement for further surgery due to ankle replacement failure.

At present the only publication which can inform patients of the risks of ankle replacements is a patient information booklet available from the National Joint Registry. This, though, only has the failure rate as those converted to a revision ankle replacement, rather than all those that fail and require further surgery. This document is due for review, and therefore the findings and evaluation from this study will be able to be used when this document is rewritten.

As this study is being undertaken in partnership with the National Joint Register its dissemination will be widespread and will enable guidance on future management to be produced.

There are currently over 900 ankle replacements performed per year in the UK and this number is increasing. By increasing our knowledge it will ensure that the correct patients who are most likely to benefit from ankle replacements are undergoing this procedure.

All outputs will be aggregated with small number suppression applied according to the HES Analysis Guide.

Outputs:

As a result of analysis of the data:
- A report will be made to the National Joint Registry to determine the true failure rates of ankle and revision ankle replacements, and a report will be included in a future NJR annual report.
- Presentations at the British Orthopaedic Foot and Ankle Society Conference and other Orthopaedic conferences.
- A submission to Bone and Joint Journal and other commonly cited Orthopaedic Journals.

Royal Devon and Exeter NHS Foundation Trust has undertaken informal discussions with patients. The main output by undertaking this data analysis is that surgeons will be able to give more informed information to patients that are considering an ankle replacement, as currently it is not known how many of these fail.

The aim is for data analysis and initial reports to be written within 1 year, and published in the National Joint Registry report, which is published annually and is freely available to view from their website.

The NJR have an Implant Outlier Process in place. The NJR Implant Outlier Process identifies implants which fall outside designated patient time incidence rate (PTIR) confidence intervals and is a defined mechanism for contacting the implant manufacturer and regulators in order to provide early warning of issues relating to patient safety, so appropriate action can be taken. Further information about the outlier process is available on the NJR website - https://www.njrcentre.org.uk/njrcentre/NJR-Accountability-and-Transparency-Model/Implant-Outlier-Process.

All outputs will be aggregated with small number suppression applied according to the HES Analysis Guide to avoid potential patient re-identification.