NHS Digital Data Release Register - reformatted
Royal Devon And Exeter NHS Foundation Trust
Project 1 — DARS-NIC-435152-C0H4N
Opt outs honoured: No - Statutory exemption to flow confidential data without consent (Statutory exemption to flow confidential data without consent)
Sensitive: Non Sensitive
When: 2021/03 — 2021/03.
Legal basis: CV19: Regulation 3 (4) of the Health Service (Control of Patient Information) Regulations 2002
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.
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.
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’.
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.”
Project 2 — DARS-NIC-147863-CCGZN
Opt outs honoured: Y, No - consent provided by participants of research study (Reasonable Expectation, Consent (Reasonable Expectation))
Sensitive: Sensitive, and Non Sensitive
When: 2016/04 (or before) — 2020/10.
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)
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
- MRIS - Flagging Current Status Report
- Civil Registration - Deaths
There is considerable evidence that genetic influences are in the development of diabetes. Evidence for this includes the clustering in families of disease, 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. Both major types of diabetes represents classical “complex disorders” with both gene and environment playing an important role. 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 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 vessels such as myocardial infarction and stroke. Each risk factor has its own genetic and environments determinants. 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.
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.
Flagging of patients and controls records on the NHS register with the ONS will be necessary. This will enable information on when patients die and information on their death certificate to be used in this study. This flagging is crucial as the greatly increased death rate from ischaemic heart disease in patients with diabetes needs to be studies in depth.
The aim of the study is to establish an epidemiologically based sample of patients with diabetes within the Exeter region. The major objective will be to collect DNA from all consenting patients and controls. Genetic information will be combined with clinical information to identify genes and gene/environment interaction in the development of Type 1 and Type 2 diabetes and for diabetes related complications specifically retinopathy and ischaemic heart disease. The study has arisen from discussion at meeting 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.
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 an integration of clinical information on patients from variety of sources which will be collected on the patient after he/she has given their permission and been recruited into the study. Flagging of patients and controls records on the NHS register with the ONS will be necessary. This will enable information on when patients die and information on their death certificate to be used in this study. This flagging is crucial as the greatly increased death rate from ischaemic heart disease in patients with diabetes needs to be studies in depth.