NHS Digital Data Release Register - reformatted

King's College Hospital NHS Foundation Trust projects

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

MR1182 - Genetic Longitudinal Study of Ageing — DARS-NIC-147955-M8D2Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, Yes, No, Anonymised - ICO Code Compliant

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), Informed Patient consent to permit the receipt, processing and release of data by NHS Digital, , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(c); Health and Social Care Act 2012 – s261(7)

Purposes: No (NHS Trust, Academic)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2010-07-28 — 2020-07-20 2016.06 — 2023.07.

Access method: Ongoing, One-Off

Data-controller type: KING'S COLLEGE LONDON

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Scottish NHS / Registration
  4. MRIS - Flagging Current Status Report
  5. MRIS - Members and Postings Report
  6. MRIS - Personal Demographics Service
  7. Cancer Registration Data
  8. Civil Registration - Deaths
  9. Demographics
  10. Emergency Care Data Set (ECDS)
  11. Hospital Episode Statistics Accident and Emergency
  12. Hospital Episode Statistics Admitted Patient Care
  13. Hospital Episode Statistics Critical Care
  14. Hospital Episode Statistics Outpatients
  15. Mental Health Minimum Data Set
  16. Civil Registrations of Death
  17. Hospital Episode Statistics Accident and Emergency (HES A and E)
  18. Hospital Episode Statistics Admitted Patient Care (HES APC)
  19. Hospital Episode Statistics Critical Care (HES Critical Care)
  20. Hospital Episode Statistics Outpatients (HES OP)
  21. Mental Health Minimum Data Set (MHMDS)

Objectives:

Genetic Longitudinal Study of Ageing

1. To assess the extent to which age-related deterioration is correlated between different organ systems (cardiovascular, muscle, bone, respiratory function, and vision).
2. To assess how much of variation in longitudinal rates of physiological deterioration is due to genetic and environmental variation.
3. To investigate genetic associations with the five organ systems using candidate gene and genome wide association studies
4. To determine the relative influences on biological ageing (as measured by loss of function/tissue) of environmental factors such as marital status, socio-economic status (income, education, occupation), levels of physical exercise, smoking and alcohol intake, number of children.
5. To investigate the value of putative biomarkers of ageing: serum vitamin D, DHEAS, C-reactive protein, creatinine, retinal vascular calibre, and white cell telomere length

PREgnancy-associated progression of chronic kidney DIsease: development of a Clinical predictive Tool (PREDICT):The National Registry of Rare Kidney Diseases (RaDaR), UK Renal Registry (UKRR), Hospital Episode Statistics(HES), and Maternity Services Data Set (MSDS) Linkage — DARS-NIC-324170-J4P1J

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', Health and Social Care Act 2012 – s261(2)(a)

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2021-02-12 — 2024-02-11 2023.06 — 2023.06.

Access method: One-Off

Data-controller type: KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST, THE RENAL ASSOCIATION

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. MSDS (Maternity Services Data Set)
  3. MSDS (Maternity Services Data Set) v1.5
  4. Hospital Episode Statistics Admitted Patient Care (HES APC)
  5. Maternity Services Data Set (MSDS) v1.5

Objectives:

Chronic kidney disease (CKD) is estimated to affect 3% of pregnant women in high-income countries, (Piccoli et al., 2018, #13860). It is estimated that 15 to 20 000 pregnancies per year in the UK are affected by CKD. However, this number is set to rise due to maternal factors associated with CKD (e.g. obesity and advancing maternal age) and accessibility of assisted conception. Current risk estimates for pregnancy-associated progression of moderate to severe reduction of renal function are based on a small single centre study (n=67). The study produced data from 1971 to 1997 regarding women with moderate to severe renal disease based on a classification that pre-dated the current classification of renal disease into CKD stages 1- 5. CKD 3 -5 covers a wider rage of renal disease from mild to severe. In addition, for many women with rare renal diseases there are no data from sufficient numbers of women to inform likely pregnancy outcomes.

At the moment, there is no reliable way to work out which women with kidney disease are likely to have pregnancy-associated disease progression. The study team at King's College Hospital NHS Foundation Trust and the Department of Women and Children's Health at King's College London have established unique research collaborations to develop a prediction tool for pregnancy-associated progression of CKD using data from approximately 60,000 women. The study team at King's College Hospital NHS Foundation Trust and the Department of Women and Children's Health at King's College London will develop a 'calculator' from information from thousands of pregnant women with kidney disease which can predict how much kidney function women are likely to lose in pregnancy. A preliminary predictive tool for pregnancy progression of CKD will be developed in pre-existing longitudinal cohorts of women recruited to the National Institute for Health Research (NIHR) portfolio studies (Pre-Eclampsia And Chronic Hypertension, rEnal and SLE (PEACHES) and Pregnancy Adaptation in Renal disease Study (PAIRS)).

Of the 60,000 women provided in the cohort to NHS Digital, it is estimated that between approximately 750 and 6,000 cohort members will be identified as pregnant. Fertility rates* in women with CKD are very low. Through the study team's previous studies they have identified only between 5 and 50 women per year with dialysis or kidney transplants to have pregnancies. Therefore they have estimated that there will be very few captured, and have estimated the final number to be between approximately 750 and 6,000 out of the original 60,000.

* Fertility rates as defined by Wiles K, Nelson-Piercy C, Bramham K Reproductive health and pregnancy in women with chronic kidney disease. Nat Rev Nephrol . 2018 Mar;14(3):165-184. doi: 10.1038/nrneph.2017.187.

In order, for predictive tools to be generalisable, multiple external validations in diverse patient groups including individual patient data from population cohorts are necessary. The calculator will then be refined and tested in this proposed data set (UK Rare Renal Diseases Registry (RaDaR)) by the UK RR team and the calculator's predictive performance will be shared with the PREDICT team.

Finally it will be externally validated with three international population data sets from UK (University of Kent Integrated Data), Canada (Ontario Renal Network) and Sweden (Stockholm CREAtinine Measurement (SCREAM). This work will be conducted in collaboration with international experts at the University of Toronto, University of Kent and Karolinska Institute in Stockholm. Collaborators will not have access or input to NHS Digital data or data processing. There will be no linkage between international data sets. These population datasets include comparable parameters to the RaDaR-UKRR dataset and will include pregnancy outcomes for women with kidney disease, laboratory data and baseline demographics. Kent data will be pseudonymised and accessed with a separate data sharing agreement with King's College London. SCREAM data and Ontario Renal Network data will be extracted and cleaned by the local teams, and the prediction tool shared for testing by local teams. This external validation exercise will not involve NHS Digital data.

King's College London's PREDICT team will share their prediction calculator with the Renal Association for testing on their dataset with serum creatinine linkage, and test performance will be shared. King's College London will not have access to any of the RaDaR-PREDICT linkage NHS Digital data and have no control over the methodology or data analysis. They are therefore not considered Data Processors or Data Controllers.

After the study team have developed the 'calculator' they will seek further funding to co-design an online platform or App with service users (Patients and Clinicians) which will be hosted by the UK Renal Registry.

The prediction calculator will allow women, their families and partners and health care professionals to input relevant data (e.g. severity of kidney disease, presence of high blood pressure) and the tool will estimate the chance of kidney function loss as result of pregnancy.

The study is funded by Kidney Research UK Stoneygate-Feehally grant which commenced in Oct 2018: 'PREgnancy-associated progression of chronic kidney DIsease: development of a Clinical predictive Tool (PREDICT)'

The UK Renal Registry (UKRR) is part of the Renal Association, a not for profit organisation registered with the Charity Commission (Registered in England No. 2229663). UKRR have high quality clinical databases open to requests from researchers through data collection from 71 adult and 13 paediatric renal centres. Participation is mandated in England through the NHS National Service Specification and the Chief Executive of each Trust is responsible for adherence to this contract. The majority of women receiving renal replacement therapy (haemodialysis, peritoneal dialysis and transplant) in the UK will be included in the UKRR database.

The National Registry of Rare Kidney Diseases (RaDaR) is a Renal Association initiative designed to pull together information from patients with certain rare kidney diseases and includes women with kidney disease who have had a pregnancy. Currently 101 NHS sites contributing to RaDaR, which includes all UK paediatric renal units and the majority of adult renal centres. To date, over 25,000 patients have been recruited. The data are housed and managed using the same informatics infrastructure as the UK Renal Registry.

Linkage of NHS Digital data with UK Renal Registry data is required in order to generate a new data set for analysis to be used for validation of the prediction tool and to describe pregnancy outcomes for women with kidney disease. The study has approval from Research Ethics Committee and Confidential Advisory Group approval for data to be linked and used for this purpose.

GDPR LEGAL BASIS FOR DATA PROCESSING
Kings College Hospital NHS Foundation Trust’s GDPR Legal Basis for data processing is Article 6(1)(e) (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller). Kings College Hospital NHS Foundation Trust is a public authority. The proposal meets the Article 6 (1) (e) justifications for processing data due to the following public interest: Prediction of pregnancy outcomes was a top three research priority for women and their families who recently attended a RaDaR patient day. In a recent survey of women with Chronic Kidney Disease (CKD), eight out of ten reported that accurate information about risk of kidney damage would influence their decision to conceive. In addition, 18 of 20 clinicians from the "Pregnancy and CKD Rare Renal Disease" group responded to a survey that a predictive tool would have considerable value in their practice. Kidney Care UK and Renal Association patient forums have confirmed that the study is in the public interest and would be welcomed by patients with CKD.

The Renal Association’s GDPR Legal Basis for data processing is Article 6(1)(f) (processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests of fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child). The Renal Association shared a copy of its LIA with NHS Digital. We have assessed this response against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met.

As Health data is a Special Category of Health data, both Data Controllers are additionally using 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). The data are required for research purposes in the public interest – meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The ways in which the processing of data will be of benefit to the public – thereby demonstrating that the processing is in the public interest – are described in the below Section 5d.

Outputs:

The PREDICT Study team will disseminate their findings to clinicians and researchers in the field by publishing the results in peer-reviewed journals and at international conferences. The study team hope to publish their findings in the following journals; Kidney International and Journal of American Society of Nephrology, and present their findings at the UK Kidney Week the American Society of Nephrology Kidney Week.

The PREDICT Study team will also disseminate findings to patients by launching the prediction tool on the RaDaR website, and invite patient charities including Kidney Research UK, Polycystic Kidney Disease Charity and Action on Pre-Eclampsia details to publish the results on their patient information pages. The PREDICT Study team will also publish findings on Twitter.

The PREDICT Study team aim that the research will be accessible to as broad an audience as possible, including researchers in the field as well as patients and clinicians and the media, with the hope that this will encourage further research and changes in clinical guidelines.

All published data will be aggregated, summarising all data into table and figures, with small number suppression applied as per the data set suppression rules for HES and MSDS.

The PREDICT Study team anticipate that preliminary model development results will be disseminated by the end of 2020, and subsequent development and validation to be published by the end of 2021, along with the prediction tool made publicly available.

The PREDICT Study team will seek further funding to develop the tool interface for patients and clinicians. It is anticipated that the tool will be hosted on the RaDaR Pregnancy and CKD website. https://rarerenal.org/rare-disease-groups/pregnancy-and-chronic-kidney-disease-rdg/

LONG TERM HEALTHCARE USAGE OF BARIATRIC/METABOLIC SURGERY COMPARED TO COMMONLY PERFORMED ELECTIVE GENERAL SURGERY PROCEDURES — DARS-NIC-384653-L3N2Q

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, Yes (Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 – s261(7),

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive

When:DSA runs 2021-03-09 — 2022-03-08 2021.09 — 2021.09.

Access method: One-Off

Data-controller type: KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST, KING'S COLLEGE LONDON

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Accident and Emergency
  2. Hospital Episode Statistics Admitted Patient Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Accident and Emergency (HES A and E)
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)
  6. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

Despite substantial evidence of efficacy and cost-effectiveness, less than 0.2% of suitable candidates - according to both NICE and international criteria - currently undergo surgical treatment of obesity and/or type 2 diabetes (bariatric/metabolic surgery) in the UK. Widespread misperceptions about the relative risks of bariatric surgery may act as a major barrier to access of this type of treatment. Despite substantial evidence of low overall mortality and morbidity, both lay and scientific media often define bariatric surgery as “high-risk”, or “dangerous” or “last resort”. These misperceptions may deter appropriate surgical candidates from seeking surgery, reduce referral by primary care providers, and mislead health policies decisions and coverage of bariatric/metabolic surgery by NHS commissioners as well as private health insurance.

To date, no study has compared the perioperative safety and mid-term healthcare utilization of bariatric/metabolic surgery with those of other commonly performed elective surgical procedures.

The aim of this study is to compare short- and mid-term safety outcomes and overall healthcare utilization among patients who underwent bariatric surgery and other types of elective surgical interventions for benign diseases at King’s College Hospital (Adrenal, Antireflux, Bariatric, Gallbladder (inpatients & day surgery), Colorectal, Hernia, Neck surgery). The outcome of the study may help demonstrate the safety of bariatric surgery.

This study will ensure that the information is processed lawfully, fairly and in a transparent manner. The study is relying on GDPR Article 6(1)(e) - the research proposed serves the public interest in better understanding the safety and efficacy of bariatric surgery in comparison to other elective general surgeries.

The need to process special category data (data concerning health) is necessary in achieving the study objective. The healthcare usage and the implications of this type of surgery on the health system in comparison to other more established general surgeries will be made clearer by this research. This may ultimately help in formulating more informed decision by policy makers and commissioners and potentially allow Bariatric Surgery more accessible for a greater number of patients who may benefit from the health improvements it offers. The data that will be used in this scientific research will be pseudonymized and stored safely. The principle of data minimisation will also be adhered to and processing of the data will be limited to the scope of the initial purpose outlined in the application and protocols that received ethical approval. (GDPR Art9(2)(j) in accordance with article 89(1)).

This study has received ethical approval from the HRA and Health and Care Research Wales (HCRW).

By analysing the healthcare usage patterns of the different surgical specialties and comparing it to bariatric surgery, a better understanding regarding the safety of each specialty could be reached. To accurately reflect this, a nationwide search needs to be made to capture all admissions and health visits of individual patients.
This is the first study to date that compares the healthcare usage of different general surgery specialties. There are no other relationships between the proposed project under this application and any wider project, collaboration, associated work or follow up.

The study team from King's College Hospital NHS Foundation Trust and King's College London will retrospectively review data from 100 consecutive patients who underwent bariatric surgery by one of the bariatric surgeons at KCH between February 2014 and March 2015 and compare outcomes with those of additional 700 consecutive patients who, between 2006 and 2015, had undergone other types of elective surgeries for benign diseases at the same Hospital (Adrenal, Antireflux, Gallbladder (inpatients & day surgery), Colorectal, Hernia, Neck surgery). The study team plans to look at mid-term rate of re-admissions and related length of stay, emergency department attendances and outpatient hospital encounters over a period of 5-year from the index surgery. Due to restriction is funding, data regarding GP encounters may be sought in the future and due procedures to request this will be followed.

To accurately capture post-operative healthcare usage, data about nationwide healthcare utilization is needed, specifically England. To achieve this, the study team will provide NHS digital with NHS numbers, sex, and date of birth of patients selected to represent the study population to allow the maximum yield possible. The study team will also provide study specific identifiers to be used by NHS digital when the data is sent back to the team without the NHS identifiers to ensure pseudonymization. The data requested will include data on Hospital Episode Statistics (HES) covering accident and emergency, outpatients and admitted patient care. The dataset will cover any use of hospital healthcare facility that patients may have had since their operation and over 5 years postoperatively. The study team believes that 5 years follow up will allow to accurately reflect the impact of each surgery on healthcare usage and re-admission that may be related to the index operation. The operation date for the patients selected ranges from 2006 to 2015. In order to be able to cover the 5-year postoperative follow-up period of all patients in the cohort from the date of the first procedure, the data requested will span from 2006 (first procedure) – 2020 (end of 5-year follow up). The data period cannot be minimised further given the way NHS digital runs queries.


The study team aimed to minimize the data requested as much as possible without affecting the study outcome. For example, data on ethnicity, religious beliefs, social status and other details were not considered as they do not serve the study purpose.

Both King’s College Hospital and King’s College London are the joint Data controller and processor. No other organizations are involved. The funds needed to cover the expenses of data acquisition and analysis are provided by Ethicon, as part of their Investigator Initiated Study funding committee. Ethicon is dedicated to advancing bariatric surgery and the science and treatment of obesity. Ethicon are also involved with the manufacturing and sale of medical devices used in bariatric surgery. However, Ethicon played no role in the study design and will hold no control or property over the study data or outcome. As per the funding contract, their role is limited to providing the funds needed to acquire the data as part of their Investigator Initiated Study funding committee. The Principal investigator holds full control and responsibility over the data received and study outcomes. To not that the Principal investigator carries out bariatric surgeries in his private practice. However, none of the patients included in the cohort had their operations done privately. In addition, the funds that will be used to acquire the data come from Ethicon as previously detailed and any additional amount will be covered from the Principal investigator research funds at King’s College London. No funding for a private source of income or practice will be used.

Expected Benefits:

The study aims to increase awareness about the potential safety of bariatric surgery by comparing it to other commonly performed elective general surgery procedures. These outcomes may potentially influence policy makers and commissioners' decision making when considering funding for bariatric surgery. This may make bariatric surgery more accessible to patients who could significantly benefit from the positive impact bariatric surgery and weight loss have on multiple medical conditions. Today, less than 0.2% of suitable candidates - according to the National Institute for Health and Care Excellence (NICE) and the international criteria - currently undergo surgical treatment of obesity and/or type 2 diabetes (bariatric/metabolic surgery) in the UK.

The study results will also be disseminated publicly and aim to increase awareness on the safety of bariatric surgery which may encourage patients to discuss it or request access/referral from their GPs Results will be posted on King's College Hospital website. The study team will aim to communicate the findings from the study via press releases to media and news channels such as the BBC and via articles in the newspaper such as the Times, the Guardian.

If study outcomes manage to influence policy makers and commissioners, the benefit will primarily affect patients suffering from obesity and diabetes, which currently affects 29% of adults in the UK. The benefits may have a nationwide effect given the potential impact a change in policy can have on the healthcare cost that is incurred in medically managing these two conditions. A cost that may be significantly reduced by making bariatric surgery more available to suitable candidates.

Outputs:

The main outcome of the study is to assess the overall medium-term healthcare usage of bariatric/metabolic surgery and to compare the healthcare usage of bariatric surgery to other commonly performed elective general surgery procedures. The study also aims to assess the cost of overall healthcare usage of bariatric surgery on a national health system. A longer-term study may be of use in the future to follow- up on the findings of this study, to possibly validate or re-evaluate the conclusions made.

The study manuscript will be submitted to peer reviewed journal for publications. Based on previous experience and communications, it is expected that journals such as Lancet, BMJ, NEJM, SOARD and Obesity surgery would be interested in nationwide studies that look into safety profile, cost to healthcare and surgical outcomes of different surgical specialties, especially bariatric. Study results will also be presented in national and international conferences. Conferences may include but not restricted to BOMSS, IFSO and ASMBS annual meeting. The study team expects that the findings of the study will support that Bariatric surgery does not lead to increased healthcare usage. In fact, it is expected that bariatric surgery will have significantly less healthcare usage than most specialties. The study team hopes that these results may help guide commissioners and authorities when developing policies, guidelines, and funding for bariatric surgery. The study team will aim at communicating these results to the relevant authorities once available. No specific meeting has been scheduled for now, however the PI is routinely involved in meetings and communications about management of Obesity and Diabetes with the relevant authorities, and the study team expects that this will play an important part in disseminating the study results. The study team will also publish the study results on the King’s website in addition to press communications and releases to make it available for the public and increase awareness.

To influence policy makers and commissioners in making bariatric surgery more accessible and available to patients, the study team will present the results to the necessary authorities. The PI is routinely involved in meetings and hearings that discuss the management of Obesity and Diabetes. This will offer access to the relevant authorities and may help in making sure the study outcomes reach the policy makers and results in the change desired. Media interviews and news articles discussing the results will also be sought after to increase awareness about the safety of bariatric surgery which is believed to be the main outcome of the study. The study team expects these results to be available within 6 months of receiving the data from NHS digital.

No direct patient or public involvement took place during the design of the study or selection of the cohort. Nevertheless, as part of the confidentiality advisory group (CAG) application and approval, the study team surveyed the public opinion about the benefit of the study. This was initially planned to be in the form of surveys that would be filled in clinics. However, due to the restrictions imposed by Covid-19, CAG agreed that the study team could use a support group on social media (Nu You) to survey public opinion regarding the study design and goals. This group is private and includes around 500 members of patient who had bariatric surgery along with patients who are awaiting or considering surgery. The overall response was supportive and expressed interest in the knowing the study’s outcome once available.

This study will not result in the development of tools and new technologies.

The outcome will not include any identifiable data, nor will it include study specific identifiers. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide.

The data and the study results will be to sole property of the named data controllers. Funders will have no access to the data from NHS Digital. The data will be managed by the study team and kept under safe storage until the end of the study period, and then destroyed providing NHS Digital with a data destruction certificate. The knowledge and outcomes resulting for the processing of this data will be managed by the principal investigator and presented to appropriate peer reviewed journals.

Only substantive employees of King's College London and King's College Hospital NHS Foundation Trust will have access to the record level data.

The study team aims at having the study manuscript ready within 6 months of receiving the data. The study team does not anticipate any need for extension or renewal.

The study does not have any EU funding.

Processing:

All organisations party to this agreement will comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by "Personnel" (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).

The study team will provide NHS digital with the patient’s NHS number, date of birth and sex to maximize yield. The study team will also provide NHS digital with study specific identifiers that will be used by NHS digital once the data is sent back. The pseudonymized Dataset which will include patients’ health data and healthcare usage will then be sent by NHS digital to the principal investigator (PI), a substantive employee from King's College Hospital NHS Foundation Trust, using Secure Electronic File Transfer (SEFT). Once this is completed, no future data flow is expected. The data sent to the study team will include HES on accident and emergency, outpatients and admitted patient care covering the period between 2006 and 2020. This will allow the study team to capture 5 years of follow up on the cohort. Any patient data extending beyond the 5 years mark from the index operation will not be processed and will be destroyed to NHS Digital's standards. The file linking the NHS number and the study identifiers will be kept under secure lock in a separate file in the PI's office.

Once the dataset is received, the study team will ensure it is stored in a secure storage location in the PI’s office under lock. Access to the Principal investigator office area is restricted by two doors that are accessible only by magnetic security cards. The office itself is secured by a key lock. The data will be stored on the Principal investigator NHS computer which is password protected.
The data will be reviewed by the study team. The Data on each patient will be limited to 5 years follow up and tabulated using the study's ID. Once finalized, the data on all three sets (accident and emergency, outpatient and admitted patient care) will be sent to an experienced statistician for the statistical analysis. The statistician will be a staff of King’s College London (which is both a data processor and controller). The results are reviewed by the study team and finalized before the manuscript is drafted.

Once completed, the manuscript will be submitted to a peer-reviewed journal for publication. The data will be kept for 6 months after publication before being safely destroyed.

The Data will not be linked or matched to publicly available data. There will be no attempt to re-identify individuals.

Data processing will be carried out by employees of KCL and KCH who have been appropriately trained in data protection and confidentiality.

The Data will be stored in the PI’s secured office at premise which is owned by KCL. Access to the office is regulated by magnetic card with security 24/7. The data will be kept on a password-controlled NHS computer. The file containing the data will be password protected once received. To confirm, access to the Principal investigator office area is restricted by two doors that are accessible only by magnetic security cards. The office itself is secured by a key lock. The data will be stored on the Principal investigator NHS computer which is password protected.