Liver transplantation as treatment for patients with hepatocellular carcinoma; a study using existing electronic data.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Data controllers: − THE ROYAL COLLEGE OF SURGEONS OF ENGLAND

Objective for processing

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling London School of Hygiene and Tropical Medicine and Royal College of Surgeons of England to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). The Clinical Effectiveness Unit (CEU) based at The Royal College of Surgeons (RCS) wishes to retain linked data from four large national databases containing information on all patients in the last two decades who have had liver cancer (Hepatocellular Carcinoma (HCC) being the most common liver cancer) and of those patients who have subsequently received a liver transplantation. The CEU is a collaborative research unit formed from both the RCS and London School of Hygiene & Tropical Medicine (LSHTM). The Chief Investigator of this study is the only individual who can make decisions on the means and purpose for which the data are being processed and does so under the employment of LSHTM. Therefore, LSHTM is the sole Data Controller of this study as only they determine how the data is processed . The following provides background information on the purpose of the original study: The London School of Hygiene and Tropical Medicine's lawful basis for processing data under GDPR 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): Consideration has been given to whether the volume of data being requested is proportionate to the expected benefit and, through examination of the expected benefits consideration has been given to whether the task is itself necessary . The Clinical Effectiveness Unit (CEU) based at The Royal College of Surgeons (RCS) requires linked data from four large national databases containing information on all patients in the last two decades who have had liver cancer (Hepatocellular Carcinoma (HCC) being the most common liver cancer) and of those patients who have subsequently received a liver transplantation. The CEU is a collaborative research unit formed from both the RCS and London School of Hygiene & Tropical Medicine (LSHTM) and therefore both RCS and LSHTM are joint data controllers. Article 9(2)(j): 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 London School of Hygiene and Tropical Medicine lawful basis for processing data under GDPR 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): The London School of Hygiene and Tropical Medicine falls into this category as they have a Royal Charter which states for example, "There shall be one Body Corporate and Politic under the name of the London School of Hygiene and Tropical Medicine (“London School”) for the purpose of and with the objects of promoting original research...". Necessary for the performance of the task (for the individual): Consideration has been given to whether the volume of data being requested is proportionate to the expected benefit and, through examination of the expected benefits consideration has been given to whether the task is itself necessary. The Royal College of Surgeons of England's lawful basis for processing data under GDPR 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 Royal College of Surgeons (RCS) is a registered charity (No.212808) with the Charities Commission and is subject to the Charities Act 2011. Chapter 1, Section 4 of the Charities Act establishes that the nature of a charity is to operate for the public benefit if it is for charitable purposes. The purpose of medical research is compatible with the purposes defined within Chapter 3, Section 1(d) of the Charities Act for the advancement of health or for the saving of lives, paragraph 3(b) states that this includes the prevention or relief sickness disease or human suffering. RCS has conducted a legitimate interests assessment to confirm processing is necessary for the purposes of the legitimate interests. RCS have assessed this 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 and has been reviewed by NHS Digital. Processing personal data is necessary for RCS's legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests. Both data controllers are using Article 9(2)(j): 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. [1 paragraph unchanged] Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Each year, more than 4,000 patients are being diagnosed with [39 words unchanged] decades between the acquisition of liver disease and the development of HCC. [2 paragraphs unchanged] In response, the transplant centres have started to use more and more livers from donors who have sustained a cardiac death. They accept It is understood that transplant outcomes with livers from these donors might be worse than [31 words unchanged] spreads to the bloodstream and they become unfit for potentially curative transplantation. The linked data previously requested is minimised to two cohorts of liver cancer patients and liver transplantation patients. The project is funded by the NIHR National Institute of Health Research (NIHR) as part of a Doctoral Research Fellowship (DRF) grant. [1 paragraph unchanged] The National Cancer Registration and Analysis Service (NCRAS) is responsible for cancer registration and was previously run by Public Health England and is responsible for cancer registration. before coming under the controllership of NHS England. Data flows have already occurred whilst NCRAS was under PHE’s control before the service moved to NHS England. UK Liver Transplant Audit (UKLTA) is run by NHS Blood and Transplant (NHSBT) who manage blood and platelet donation, and organ, stem cell and tissue donation and transplantation. The datasets to be were linked from each national database are as follows: - Liver cancer specific dataset: - records of patients diagnosed with liver cancer between 1996 and 2016, 2018, including date of diagnosis, TNM Tumour, Node, Metastasis (TNM) stage, cancer morphology, and treatment indicators will be used, including already linked: Chemotherapy (SACT), Radiotherapy (RTDS) and Radiology Datasets (DID) supplied from NCRAS; [1 paragraph unchanged] Hospital Episode Statistics (HES) datasets (Admitted Patient Care (APC), Outpatients (OP), Critical Care (CC), Accident and Emergency (A&E)) and Civil Registration mortality data supplied from NHS Digital. England. This data will aid in determining comorbidities, treatments and outcomes of patients. To address the GDPR Principle of Data Minimisation at the time of variable selection the detailed process with NHS England was undertaken to ensure that only the required data items were provided. Currently, there is work underway, that is exploring all the HES and mortality data that was previously requested and it is expected that the analysis could provide the new evidence on outcomes following transplantation, and in particular outcomes that have never been able to be assessed before. The study requires historic data from 1997/98 to 2017/18 to determine trends over time in the incidence and outcomes of patients with HCC hence the request for historical HES Accident & Emergency, Critical Care, Outpatient, Admitted Patient Care and mortality data. An Important consideration in identifying any potential improvements (or even decline) in outcomes is assessing the changing patient characteristics of patients with HCC in addition to identifying any significant changes in the services (and or treatment options) that these patients receive i.e. better post-operative critical care, reduced post-operative emergency department attendances, increase outpatient surveillance etc. Fundamentally important to the initial analysis (work package 1 – breakdown below) is also mapping the pathway to the development of HCC. It is known that the development of HCC is often part of a 20-year process from the development of a primary liver disease to cirrhosis and then to cancer. Hence, in order to identify what clinical and sociodemographic factors (in addition to cirrhosis) are important in the development of HCC, LSHTM need the historical data. This is especially relevant of the inpatient (APC) dataset which contain the diagnosis and procedural codes necessary to perform this analysis. [5 paragraphs unchanged] Identifying the main risk factors causing the rise in HCC will encourage NHS services to better identify HCC earlier in patients and thus increase their treatment options. It will is hoped to also help to educate the public in avoiding the high-risk behaviours that can lead to the development of liver disease and subsequent risk of HCC. [6 paragraphs unchanged] Work package 5: Analysing outcomes of liver transplantation in patients with HCC who receive a cardiac death donor liver? liver Exploring the transplantation of livers from cardiac death donors as compared with [20 words unchanged] transplantation of patients with HCC and reduce the number of patients falling of the on waiting list due to spread of their cancer. list.

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. No new Data will flow during the length of this Data Sharing Agreement. The study data, including data provided by NHS Digital England under previous agreements, Agreements, are currently held by London School of Hygiene and Tropical Medicine and Royal College of Surgeons of England . at the Clinical Effectiveness Unit (CEU). [1 paragraph unchanged] PHE (NCRAS) will submit submitted the following identifiers for a cohort of liver cancer patients to NHS Digital: England: NHS number, gender, sex, date of birth, and postcode plus unique Liver Cancer ID. This is for the Cancer Cohort. PHE (NCRAS) will did not have access to the NHS Digital England data and are were providing a cohort only. NHSBT will submit submitted the following identifiers for a cohort of liver transplant patients to NHS Digital: England: NHS number, gender, sex, date of birth, and postcode plus unique Liver Transplant ID. This will be was for the Transplant Cohort. NHSBT will have do not have access to the NHS Digital England data and are were providing a cohort only. PHE (NCRAS) and NHSBT will send sent additional data about these individuals from their respective databases to the CEU. These datasets will contain no identifiers other than unique Liver Cancer ID and Liver Transplant ID respectively. NHS Digital will then add England added both cohorts together to make one cohort and will link linked the combined cohort to HES and mortality data. The data will be was pseudonymised containing no identifiers other than encrypted HESID, Liver Cancer or Liver Transplant person ID and, where applicable, Date of Death. The encrypted HESID will be is the common identifier across all datasets. NHS Digital will supply England supplied the linked HES and mortality data for each matched patient within the cohort of liver cancer and liver transplant patients to a secure data handling facility at the Clinical Effectiveness Unit (CEU) CEU based at The Royal College of Surgeons of England (RCS). The CEU [7 words unchanged] both the RCS and London School of Hygiene & Tropical Medicine (LSHTM). NHS Digital will also supply to the CEU the unique Liver Cancer ID or Liver Transplant ID for any patients from the respective cohorts whose data could not be matched to HES and/or mortality data. In any deterministic linkage of data, there will be a small percentage of patients whose records did not match (i.e. none of the identifiers such as NHS number, D.O.B, postcode correlated). The Liver Cancer and Liver Transplant IDs of unmatched patients will be used by CEU to link back to additional data supplied by NHSBT and NCRAS. These will be used to compare the characteristics of patients who were not matched to HES with those that were in order to assess potential bias arising from the exclusion of their HES and/or mortality data from the analyses. Bias is dangerous to any epidemiological study as it affects the strength of causality that any analysis may display it then also affects the interpretation of the results and credibility of the research. The mainstay of most of the analyses using HES data was on the APC dataset. However exploratory analysis was also performed using linked OP, CC and A&E data. No analysis that LSHTM are aware of, had previously explored linked liver transplant and OP or A&E data making this study novel. More importantly this linked data can provide invaluable information about the success of transplantation as it informs transplant services of metrics commonly used to assess the success of surgery as a whole including post-operative A&E attendances, and requirement of outpatient services. Moving forward the study would like to focus on disseminating these analyses through publication and will be a mainstay of LSHTM’s ongoing work. NHS England supplied to the CEU the unique Liver Cancer ID or Liver Transplant ID for any patients from the respective cohorts whose data could not be matched to HES and/or mortality data. Against the full cohort to be linked, there will be a small percentage of patients whose records did not match (i.e. none of the identifiers such as NHS number, date of birth, postcode correlated). The Liver Cancer and Liver Transplant IDs of unmatched patients will be used by CEU to link back to additional data supplied by NHSBT and NCRAS. These will be used to compare the characteristics of patients who were not matched to HES with those that were in order to assess potential bias arising from the exclusion of their HES and/or mortality data from the analyses. Bias is dangerous to any epidemiological study as it affects the strength of causality that any analysis may display it then also affects the interpretation of the results and credibility of the research. [2 paragraphs unchanged] The CEU requires required the HES and mortality data for all matched patients whether they were [81 words unchanged] with HCC who receive a liver transplant against those who do not. Additionally, the CEU requires has received all HES records of patients with an ICD10 code of ‘C22’ (liver cancer) liver cancer and / or an OPCS4 code of ‘J01’ (liver transplantation) liver transplantation who are not linked to either the NHSBT or NCRAS data set. [40 words unchanged] will be considered to explore the possible bias that this will produce. Data previously supplied by NHS Digital England will only be accessed by the clinical researcher chief investigator and statistical supervisor who are substantive employees of LSHTM and the data manager who is a substantive employee of RCS. RCS . No data will be shared with a third party in any form. All outputs will be aggregated with small numbers supressed suppressed in line with the HES analysis guide. All data will be processed and accessed at the CEU. Justification of years requested in each dataset: The linked dataset will be validated by checking the consistency of cancer diagnoses and treatment across all three databases. Much of CEU's intended analysis is determining trends over time in the incidence and outcomes of patients with HCC hence the request of historical data across all 5 datasets. An Important consideration in identifying any potential improvements (or even decline) in outcomes is assessing the changing patient characteristics of patients with HCC in addition to identifying any significant changes in the services (and or treatment options) that these patients receive i.e. better post-op critical care, reduced post-op emergency department attendances, increase outpatient surveillance etc. Fundamentally important to the initial analysis (work package 1) is also mapping the pathway to the development of HCC. CEU know the development of HCC is often part of a 20-year process from the development of a primary liver disease to cirrhosis and then to cancer. Hence, in order to identify what clinical and sociodemographic factors (in addition to cirrhosis) are important in the development of HCC, CEU need the historical data. This is especially relevant of the inpatient (APC) dataset which contain the diagnosis and procedural codes necessary to perform this analysis. The linked dataset will be validated by checking the consistency of cancer diagnoses and treatment across all three databases. The level of agreement will be detailed using statistics. [1 paragraph unchanged] There will be no data linkage undertaken with NHS Digital England data provided under this agreement Agreement that is not already noted in the agreement. Agreement. Data will only be accessed and processed by substantive employees of The Royal College of Surgeons of England and London School of Hygiene and Tropical Medicine and will not be accessed or processed by any other third parties not mentioned in this agreement.

Expected output

This Agreement permits the secure retention of the data only and no other processing. Publications No new outputs will be produced under this Data Sharing Agreement. During the project, CEU would look to publish a minimum of two high quality research papers in speciality specific or epidemiological based journals (Target: September 2022). Selected journals include; Transplantation; Liver Transplantation; American Journal of Transplantation, The British Journal of Surgery, and The Journal of Clinical Epidemiology. It will be mandatory to recognise all contributory organisations in all publications. Publications: From 2019 to 2020, there were five publications of findings from the use of this data. These were papers on: During the project, CEU would look to publish a minimum of four to five high quality research papers in high impact transplant and cancer specific journals (Target:- January 2018-2020). Selected journals include; Transplantation; Liver Transplantation; American Journal of Transplantation and The British Journal of Cancer. Significant research findings will also be put forward to the external relations departments at the London School of Hygiene and Tropical Medicine and The Royal College of Surgeons, London for further distribution. It will be mandatory to recognise all contributory organisations in all publications. 1.Wallace D, Walker K, Charman S, et al. Assessing the Impact of Suboptimal Donor Characteristics on Mortality After Liver Transplantation: A Time- dependent Analysis Comparing HCC With Non-HCC Patients. Transplantation 2019;103:e89-e98. 2.Wallace D, Cowling T, McPhail MJ, et al. Assessing the Time-Dependent Impact of Performance Status on Outcomes After Liver Transplantation. Hepatology 2020;72:1341-1352. 3.Wallace D, Cowling TE, Walker K, et al. The Impact of Performance Status on Length of Hospital Stay and Clinical Complications Following Liver Transplantation. Transplantation 2020. 4.Wallace D, Cowling TE, Walker K, et al. Liver transplantation outcomes after transarterial chemotherapy for hepatocellular carcinoma. Br J Surg 2020;107:1183-1191. 5.Wallace D, Cowling TE, Walker K, et al. Short- and long-term mortality after liver transplantation in patients with and without hepatocellular carcinoma in the UK. Br J Surg 2020;107:896-905. Presentations Research outputs will be presented at national and international meetings, including the yearly British Transplant Society Annual Congress and the International Liver Transplant Society Annual congress. These meetings will provide the opportunity for CEU's results to positively affect the wider public through influencing policy on the best use of liver transplantation for HCC and non-HCC patients. [1 paragraph unchanged] Research outputs will be presented at national and international meetings. CEU aim for yearly presentations at the British Transplant Society (BTS) Conference with international presentations focused on conferences hosted by the European Society of Transplantation (ESOT). CEU will also aim for an oral presentation at the two-yearly World Transplant Conference (WTC). Cancer specific workshops hosted by the National Cancer Intelligence Network (NCIN) will provide the platform for oral presentations on the main determinants of HCC. 1. British Transplant Society Annual Congress 2017 to 2021 - 8 oral presentations These meetings will provide the opportunity for CEU's results to positively affect the wider public through influencing policy on prevention strategies of the risk factors identified as causing the greatest burden to the hepatocellular carcinoma (HCC) epidemic. 2. International Liver Transplant Society Annual Congress 2019 - 2 oral presentations 3. American Association for Study of Liver Disease Annual Congress 2018 - 3 poster presentations 4 British Association for the Study of the Liver Annual Congress: 2017 - 2018; 4 poster presentations Awards 1. International Liver Transplant Society (ILTS) Young Investigator Award 2019. 2. American Association of Study of Liver Diseases (AASLD) Liver Transplant Surgical Fellow Travel Award, 2018. 3. British Transplant Society Annual Travel Award 2020 [1 paragraph unchanged] British Transplant Society Annual Conference: March 2019 2022 and 2023 World Transplant Conference: 2018 – venue to be determined International Liver Transplant Society Annual Conference: May 2022 and 2023 [1 paragraph unchanged] An update of progress will be made to local patient groups. groups, including the patient group LISTEN at Kings College Hospital. This will be is part of the process of informing NHS patients of CEU's findings and [15 words unchanged] to formulate the best platforms to disseminate the research findings to the public. public . LSHTM are currently in regular contact with some patient groups already and have given talks within the last 6 months. Local NHS Trust Feedback: CEU will use select local meetings within the Institute of Liver Sciences at Kings College Hospital to feedback the results of this thesis. In attendance, will be consultant hepatobiliary and transplant surgeons, hepatologists, junior doctors, clinical nurse specialists, transplant coordinators and NHS service managers. This forum presents an efficient way of translating the output of this research into active clinical practice. It is therefore imperative that these meetings, are conducted on a regular basis throughout the duration of the thesis. The major theme of the project is identifying the extent to which this study can increase the capacity of liver transplantation to meet the increasing demand driven by HCC. It is hoped that highlighting this information will help regulate and in turn drive improvements in treatment selection and outcomes for individual HCC patients. [1 paragraph unchanged] The research outputs indicating the influence of the HCC epidemic and its impact on liver transplantation will be discussed with NHSBT’s Liver Selection and Allocation Working Party and Liver Advisory Group. Results from this thesis can be potentially used by these national committees to determine allocation policy by contributing to the construction of further complex statistical models that NHSBT can use to determine the allocation policy of donor organs. This will result in rapid improvements in patient outcome through maximising the survival benefit of deceased donor livers in HCC patients. The research outputs from this work can continue to inform NHSBT's Liver Advisory Group on the best way to allocate donor livers. All outputs will be aggregated with small numbers supressed suppressed in line with the HES analysis guide.

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. [1 paragraph unchanged] CEU expect this research can make three fundamental contributions. First, it is now recognised that using linked national health based health-based datasets will expand the scope of clinical questions that can be addressed (10). addressed. CEU will demonstrate how linked data can be used to study an [65 words unchanged] capacity of liver transplantation as a potentially curative treatment option for HCC. Second, evaluating liver transplantation as a curative treatment and exposing the liver diseases and treatments options associated with the best and worst outcome has an immediate benefit as it is hoped it will help to improve the information that is available for the [36 words unchanged] the linked dataset, it is hoped to determine whether transplanting organs from DCD Donation after Circulatory Death (DCD) donor’s produces improved survival outcomes. Furthermore, identifying risk factors of post-transplant survival [26 words unchanged] the potential of liver transplantation as a treatment option for HCC patients. [3 paragraphs unchanged] Identifying the main risk factors causing the rise in HCC will may encourage NHS services to better identify HCC earlier in patients and thus increase their treatment options. It is hoped that it will also help to educate the general public in avoiding the high risk behaviors behaviours that can lead to the development of liver disease and subsequent risk of HCC. [1 paragraph unchanged] Evaluating treatment options for patients with HCC will may help identify the best treatment available for patients based on their individual disease and medical conditions. This It is hoped that this will promote the use of effective alternative treatments for HCC whilst potentially easing the pressure on liver transplant services. Research Question 3: What are the factors associated with the best and worst outcomes in patients with HCC, who recieve receive a liver transplant? Identifying individual patient characteristics that are associated with the best and worst outcomes following liver transplantation will is expected may help better identify HCC patients suitable for transplantation. This will It is hoped that this may lead to an improvement in post-operative survival and increase the number of patients with HCC who can undergo liver transplantation. [1 paragraph unchanged] Exploring the transplantation of livers from cardiac death donors as compared with brain stem death donor livers could potentially increase the number of livers suitable for donation. This could lead to the earlier transplantation of patients with HCC and reduce the number of patients falling of the waiting list due to spread of their cancer. Research Question 5: Analysing outcomes of liver transplantation in patients with HCC who receive a cardiac death donor liver? Exploring the transplantation of livers from cardiac death donors as compared with brain stem death donor livers could potentially increase the number of livers suitable for donation. This could lead to the earlier transplantation of patients with HCC and reduce the number of patients on the waiting list. The data is in support of a doctoral research study.

Benefits reported

The overarching theme of the results is that livers donated following circulatory death (DCD) – previously thought to be sub-optimal – produce equivocal results as livers donated after brain stem death (DBD) traditionally thought to be of higher quality. The results will therefore encourage clinicians and patients alike to increase the utilisation of DCD livers and thus increase the number of patients who are receiving a potentially life-saving liver transplantation and decrease the number patients waiting to receive a liver transplantation. V3 – June 2019 To date outputs for the project include: The overarching theme of the results is that livers donated following circulatory death (DCD) – previously thought to be sub-optimal – produce equivalent results as livers donated after brain stem death (Donation after Brainstem Death - DBD) traditionally thought to be of higher quality. The results will therefore encourage clinicians and patients alike to increase the utilisation of DCD livers and thus increase the number of patients who are receiving a potentially life-saving liver transplantation and decrease the number patients waiting to receive a liver transplantation. Poster Presentations V5 – Sept 2021 1. British Transplant Society (BTS) Annual Congress, Harrogate, March 2017 Using linked national health-based datasets has expanded the scope of clinical questions that can be addressed. For example, the study has demonstrated how linked data can be used to study an entire disease pathway from recognising the first presence of aetiological agents and contributing factors to the development of cirrhosis and HCC. 2. British Association for study of the liver (BASL) Annual Congress, Warwick, September 2017. Second, evaluating liver transplantation as a curative treatment and exposing the liver diseases and treatments options associated with the best and worst outcome has improved the information that is available for the selection of potential recipients of a liver transplant and the allocation of donor organs. The potential of liver transplantation as a treatment option for HCC is determined by the limited availability of suitable donor organs. Using the study's linked dataset, it has been established that transplanting organs from DCD donor’s does not negatively impact post-transplant survival and thus is a resource that can utilised further to increase the number of patients with liver disease who receive a liver transplant. Oral Presentations 1. BASL Annual HCC-UK Research Meeting, Newcastle, April 2017 2. British Transplant Society (BTS) Annual Congress, Brighton, March 2018 (x2 presentations) 3. BASL Annual HCC-UK Research Meeting, London, April 2018 4. European Society of Transplantation Annual Conference: July 2018

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling London School of Hygiene and Tropical Medicine and Royal College of Surgeons of England to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance). The following provides background information on the purpose of the original study: [36 paragraphs unchanged]

Processing activities

Under this Agreement, the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement. The study data, including data provided by NHS Digital under previous agreements, are currently held by London School of Hygiene and Tropical Medicine and Royal College of Surgeons of England . The following provides background on the processing activities undertaken prior to this Agreement: [21 paragraphs unchanged]

Expected output

This Agreement permits the secure retention of the data only and no other processing. No new outputs will be produced under this Data Sharing Agreement. [16 paragraphs unchanged]

Expected measurable benefits

This Agreement permits the secure retention of the data only and no other processing. [12 paragraphs unchanged]

Unchanged: Benefits reported.