NHS Digital Data Release Register - reformatted

University Hospitals Bristol And Weston NHS Foundation Trust projects

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

MR1240 - Evaluation of centralisation in head and neck cancer — DARS-NIC-147901-2XMLG

Type of data: information not disclosed for TRE projects

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

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

Purposes: No (NHS Trust)

Sensitive: Sensitive

When:DSA runs 2019-06-01 — 2020-05-31 2017.09 — 2024.04.

Access method: Ongoing, One-Off

Data-controller type: UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. MRIS - Cohort Event Notification Report
  2. MRIS - Cause of Death Report
  3. MRIS - Members and Postings Report
  4. MRIS - Flagging Current Status Report
  5. MRIS - Scottish NHS / Registration
  6. Cancer Registration Data
  7. Civil Registrations of Death
  8. Demographics

Objectives:

The overall aim of the programme is evaluate and disseminate the outcome of centralization in Head and Neck cancer (H&N). In order to accomplish this we will create a clinical cohort of 5,000 people with H&N and follow up this cohort. This study will be large enough to compare groups by age, site and stage. Data are already collected on the care provided to patients with H&N as part of an ongoing National Head and neck cancer audit. The proposed studies will complement these National audit data by investigating the role of patient characteristics not recorded as part of routine care and by examining a broader range of patient centred and clinical outcomes. We will collect data on people with H&N that would include age, sex, diagnosis and treatment. Additional data will be collected on socioeconomic status (including occupation, education and housing): lifestyle (including smoking and alcohol intake); questions on psychological status and general and cancer specific quality of life questions. We will collect a venous blood, saliva and tissue sample for use in future translational studies. The outcome of the study will allow clinicians and managers to design effective patient centred multidisciplinary centralised services for people with H&N.

Yielded Benefits:

To date, 15 peer reviewed papers arising from the study have been published, and these analyses have been presented at a number of scientific meetings. The study is currently supporting around 30 ongoing analysis projects and are part of the World Health Organisation’s International Agency for Research on Cancer (IARC) international consortia, exploring the role of germline and tumour genetics on Head and Neck cancer aetiology and prognosis. As well as published papers findings have been presented at clinical conferences such as BAHNO (British Association of Head & Neck Oncologists) and BAHNON (British Association of Head & Neck Oncology Nurses) and the International Quality of Life Conference for Head & Neck Cancer. To date the findings from Head and Neck 5000 have contributed to knowledge around aetiology and prognosis in people with head and neck cancer. To date these findings have not resulted in any formal changes to policy or guidance but it is anticipated that the work will provide evidence that will inform practice and improve the management of people with head and neck cancer in terms of risk stratification, lifestyle modification and prognostic prediction.

Expected Benefits:

Head and neck cancer (H&N) is one of the commoner cancers with around 7,000 cases per year in England and Wales. The incidence appears to be increasing. The two year all cause mortality is around 35%. A person with H&N requires care from a range of disciplines. These include surgical teams to resect the tumour, dissect the neck and reconstruct the defect; radiotherapists and oncologists to provide radiotherapy and chemotherapy; clinical nurse specialists to offer pre and postoperative support; nutritionists to help with postoperative feeding and nutrition; speech therapists to assist with speech and swallowing; restorative dentists to fit and maintain prostheses and treat dental caries; palliative care physicians to support patients in the terminal stages of H&N and psychologists to provide psychological support. In an attempt to move beyond clinical outcomes, such as the surgical result or survival, quality of life scores have been developed for people with H&N and are being used to guide and monitor response to treatment. Despite their importance there is limited evidence on the modifiable psychological and social determinants of coping for people with H&N. There is thus a need to assess a broad range of patient centred outcomes in studies of H&N.

Outputs:

We will continue the follow up through flagging so participants that survive remain in the study for
10+ years. The MRIS will enable us to trace and identify those that have died to ensure that we do not send out further questionnaires. Furthermore, the flagging will provide ongoing notifications about our participants and will allow the study to compare morbidity and mortality outcomes across different centres. We will also be able to analyze the broad range of patient centred outcomes collected in the study in relation to morbidity and mortality.

Processing:

The overall objective of the study is to recruit a clinical cohort of 5,000 people with H&N and then follow up this cohort for two years. This study will be large enough to compare groups by age, site and stage. Specifically, the objectives are to:
1. Compare morbidity and mortality outcomes across different centres.
2. Compare quality of life outcomes across different centres.
3. Describe the individual economic cost of head and neck cancer care.
4. Identify prognostic indicators for head and neck cancer.
5. Create a resource for translational and applied research in head and neck cancer.
Research nurses at each participating H&N cancer centre together with the research team will recruit and collect data:
• Obtain consent
• Baseline collection
- Collect blood, saliva and tissue sample accordance with the established biological sample protocol
- Administer the base line questionnaire at the clinic
- Provide the additional baseline questionnaire pack to be completed at home which should be sent back to the research team in the provided prepaid envelope.
• The patients will be flagged with the NHS Information Centre (NHSIC) and followed for two years.
• At 4 months, the research team will send out the 4 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack.
• At 12 months, the research team will send out the 12 month questionnaire pack to the participants enrolled for self completion at their home together with a prepaid envelope to return the questionnaire pack.

The Sunflower Study — DARS-NIC-170647-Z0B6H

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No, Identifiable (Consent (Reasonable Expectation))

Legal basis: Consent (Reasonable Expectation), Consent (Reasonable Expectation); Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

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

When:DSA runs 2020-09-30 — 2023-09-29 2021.01 — 2024.04.

Access method: One-Off, Ongoing

Data-controller type: LEEDS TEACHING HOSPITALS NHS TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. HES:Civil Registration (Deaths) bridge
  2. Emergency Care Data Set (ECDS)
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Admitted Patient Care
  5. Hospital Episode Statistics Critical Care
  6. Civil Registration - Deaths
  7. Hospital Episode Statistics Accident and Emergency
  8. Diagnostic Imaging Dataset
  9. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  10. Civil Registration (Deaths) - Secondary Care Cut
  11. HES-ID to MPS-ID HES Accident and Emergency
  12. HES-ID to MPS-ID HES Admitted Patient Care
  13. HES-ID to MPS-ID HES Outpatients
  14. Civil Registrations of Death - Secondary Care Cut
  15. Diagnostic Imaging Data Set (DID)
  16. Hospital Episode Statistics Accident and Emergency (HES A and E)
  17. Hospital Episode Statistics Admitted Patient Care (HES APC)
  18. Hospital Episode Statistics Critical Care (HES Critical Care)
  19. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The data requested from NHS Digital in this Data Sharing Agreement will be used as part of a research study - called the Sunflower Study - which aims to provide the NHS with evidence as to whether testing for common bile duct (CBD) stones before gallbladder surgery is worthwhile or not in patients at low to moderate risk of having stones.

Around 70,000 patients a year undergo gallbladder surgery. Gallbladder stones may pass from the gallbladder to the CBD where they may remain without symptoms, cause problems including pain, jaundice and acute pancreatitis, or they may pass spontaneously into the gut. When patients are assessed for gallbladder stones, information about the CBD is also obtained using imaging techniques including ultrasound scan. This, together with blood tests, is used to assess the risk of CBD stones - high, moderate or low. In patients at high risk of CBD stones, it is national and international practice to recommend further investigation and treatment. However, further investigation and treatment of patients at low to moderate risk of CBD stones is controversial, and guidance and practice varies.

DATA CONTROLLERS
The University of Bristol and Leeds Teaching Hospitals NHS Trust are the Data Controllers for this Data Sharing Agreement (DSA).
Leeds Teaching Hospitals NHS Trust will have oversight of the processes in their role of Sponsor and Data Controllerband have a research contract for this study with the Secretary of State for Health [SD_5.0]. At no point will Leeds Teaching Hospitals NHS Trust have access to any record level data - they will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines.

DATA PROCESSORS
The University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust are the Data Processors for this DSA.

STUDY COLLABORATORS
Nottingham University Hospitals NHS Trust, Sunderland Royal Hospital, NHS Coventry and Rugby Clinical Commissioning Group and University Hospitals Birmingham NHS Foundation Trust are study collaborators on the collaboration agreement who will not have a role as either data controller or data processor - their role in the study is as co-applicant and these organisations are represented on the study management group. They have no say over the methodology or processing of the data in this study and will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines.

This study has been funded by the NIHR (16/142/04) under the NIHR Health Technology Assessment award. The NIHR are the funder but take no further part in decisions made with the data or the study. Leeds Teaching Hospitals NHS Trust will have oversight of the study processes in their role of Sponsor and have a research contract for this study with the Secretary of State for Health. However, they will only have access to data that is aggregated with small numbers suppressed in line with the HES analysis guidelines. The study is supported by the Royal College of Surgeons Bristol Surgical Trials Centre and NIHR CTU funding. These two organisations will have no control or influence over the study or how NHS Digital data will be processed, and will have no sight of any record level data.

The University of Bristol study team are undertaking a large randomised controlled trial in 50+ hospitals in the United Kingdom to determine whether testing for CBD stones before gallbladder surgery or not has an impact on the number of patients admitted to hospital for treatment of a complication of their gallstones in the 18 months following recruitment to the study. The study team at the University of Bristol are following up study participants for a median of 12 months after consent to the study to collect quality of life information using a patient completed questionnaire.

The University of Bristol study team will use HES data to capture information used to derive the primary outcome, which is any hospital admission for treatment of a complication of gallstones, whether in the CBD or gallbladder, within 18 months of randomisation. These complications may occur at any time after referral/randomisation, i.e. before or after gallbladder surgery. The study team in Bristol will use mortality data to capture information on deaths of study participants. The HES and mortality data will also be used to inform a health economics analysis, by identifying NHS hospital care and diagnostic imaging provided after the index admission for gallbladder surgery, with the aim of estimating the cost and cost-effectiveness of pre-operative investigations for CBD stones compared to no pre-operative investigations. Patients undergoing gallbladder surgery will be asked for consent to take part in the Sunflower study. This will include consent for their identifiable data to be sent to NHS Digital. The current participant cohort number is approx. 2,000 and estimated to reach approx. 14,000 by the end of the DSA.

The pseudonymised data provided by NHS Digital under this DSA will be linked to study data collected by the co-coordinating centre, the registered Clinical Trials and Evaluation Unit (CTEU) (which is part of the University of Bristol but based on the premises of University Hospitals Bristol and Weston NHS Foundation Trust), and returned to the study team at University Hospitals Bristol and Weston NHS Foundation Trust. The study team at University Hospitals Bristol and Weston NHS Foundation Trust will undertake data cleaning, pseudonymise the data and then undertake the primary outcome analysis for the study.

The Sunflower study will run for 6 years from December 2018 - 4 years of recruitment, median 1 year of follow up and 1 year of data analysis and dissemination. University Hospitals Bristol NHS Foundation Trust is requesting cumulative data for each year that the study is running from 2018. The study requires data for the duration of study recruitment (4 years from December 2018) and then a minimum of 18 months of follow up from the date of randomisation (i.e. patients recruited in the last year of recruitment will only require data for 18 months, patients recruited earlier in the recruitment phase will require data for a longer period). This will allow for some interim analysis of the primary outcome by the study team at University Hospitals Bristol and Weston NHS Foundation Trust, to ensure that the data provided is sufficient to allow the research question to be answered. The data will also inform the Data Monitoring and Safety Committee on the progress and safety of the study, as the HES data will form the primary outcome of the study. Some data from the period of a year prior to the start of recruitment is also requested, to allow the history of the participants to be characterised - this does not include the mortality data set.

LEGAL BASIS
Data is being processed under Article 6(1)(e) and Article 9(2)(j) as a task in the public interest, as part of an NIHR funded ethically approved clinical trial. This is a task in the public interest as processing is necessary for scientific research purposes.

This application relies on participant consent to satisfy the duty of confidentiality. NHS Digital has considered the adequacy of the consent materials in relation to the application and has determined on balance that Data flow is compatible with the consent. Recruitment commenced in December 2018 and is ongoing.

Expected Benefits:

Imaging of the common bile duct in patients with symptomatic gallstones symptoms has been a topic of controversy for many years. This research has been identified as important in the commissioned call. There are about 70,000 gallbladder operations performed each year in the UK and approximately 80% of patients have moderate or mild risk of CBD stones. The Sunflower study will provide evidence to inform decision-making at a policy and individual patient level. It could lead to a reduction in the demand for pre-operative imaging and reduce the time taken for patients to have gallbladder surgery. If the study can confirm that no pre-operative imaging is non-inferior to pre-operative imaging, this evidence could be incorporated into national guidance. However, there is also the possibility that the study may show that it is justified to image the common bile duct of every patient with gallstone symptoms. The study team at University Hospitals Bristol and Weston NHS Foundation Trust anticipate that this evidence would inform policy makers by 2025.

The HES data will allow the study team to provide this high quality evidence, as it will provide accurate information on hospital admission for treatment of a complication of gallstones within 18 months of randomisation. This would not be possible to obtain from patients due to the huge administrative burden (the sample size is 13,680 patients) and the inaccuracy of patient reported information.

The embedded health economics analysis will use HES, DIDS and Mortality data to estimate the cost and cost-effectiveness of pre-operative imaging compared to no pre-operative imaging in patients with symptomatic gallstones undergoing gallbladder surgery at low or moderate risk of common bile duct stones. DIDS data will provide study health economists with information on the use of imaging during the follow up period, which will allow appropriate costing of healthcare during this period. Mortality data will be used to calculate Quality Adjusted Life Years, a measure of quality adjusted survival. The study team at University Hospitals Bristol and Weston NHS Foundation Trust expect these health economic analyses to be used by the NHS and other healthcare providers to inform their future decisions regarding the provision of pre-operative imaging for gallbladder surgery by 2025.

Outputs:

The data from this study will be used to produce outputs including publications in peer-reviewed academic journals (target journal of New England Journal of Medicine), and presentations at national and international conferences. A simplified version of the findings will also be disseminated as a results leaflet to participants in the cohort who have requested this, in accordance with advice from the PPI group about how best to do this effectively.

There will also be wider dissemination activities e.g. via social media. The study-specific Twitter account will be used throughout the study to provide updates on activities, milestones, etc. The account will also be used to disseminate the study outputs in an accessible manner, which may include the use of infographics, animations, podcasts, video recordings, etc. The Twitter account for the Bristol Trials Centre will also be used for dissemination activities. Study outputs will also be provided on the study website (https://sunflowerstudy.blogs.bristol.ac.uk/home/)

A Health Technology Assessment report to the funding body will be sent to the NIHR in May 2024, and will provide a summary of the work undertaken during the life of the study. The target journals for the main study paper and other related publications (e.g. health economics, qualitative) have not been identified, but these will be Open Access and should be completed by early 2025. These will communicate the results of the primary and secondary outcomes of the study. The main study paper should be published in Summer 2024. A summary for stakeholders will be provided in late 2024, and will be aimed both externally (e.g. general public/patients, media, commissioners) and internally (e.g. participating Trust stuff, operational staff).

All outputs will be reviewed by the Chief Investigator and other collaborators, as necessary. Once a study publication has been drafted, it will be circulated to members of the Study Executive Group (where these collaborating organisations are represented) for review and comment. At no point will the Study Executive Group members see the record level, unsuppressed data used for analyses included in publications. Instead, their view is sought on the content and presentation of publications, such that they satisfy the criteria of named author. These members would not be deciding what analyses to undertake or how the data should be used, but instead commenting on the presentation of study results. The Study Executive Group members comprise the Chief Investigator, core members of the study team from the Bristol Trials Centre (including the study manager and statistician), study co-applicants including surgeons, surgical trainees and radiologists, the Public and Patient Involvement lead, health economists and members of the Qualitative Recruitment Intervention team.

Findings will be shared with the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (AUGIS) and the Great Britain and Ireland Hepato Pancreato Biliary Association (GBIHPBA). The Chief Investigator and co-applicants have close links with these groups who are already aware and supportive of the study and awaiting its results. The study team at University Hospitals Bristol and Weston NHS Foundation Trust intend to make presentations to both of them. Presentations will be given at national and international conferences relevant to gallbladder surgery e.g. The International Hepatopancreatobiliary Association and other sister Societies (e.g. European and African Hepatopancreatobiliary Association and the American Hepatopancreatobiliary Association). The study team at University Hospitals Bristol and Weston NHS Foundation Trust expect that the results of the study will be used by NHS England to formulate a commissioning policy and will inform national and international guidelines.

Outputs will contain only aggregate level data with small numbers suppressed in line with HES analysis guide.

Processing:

The study aims to determine whether testing for common bile duct stones before gallbladder surgery or not has an impact on the number of patients admitted to hospital for treatment of a complication of their gallstones in the 18 months following recruitment to the study (the primary outcome). The study team will use data on A&E, critical care and inpatient admissions and their diagnostic codes, outpatient admissions and their outcome (e.g. indication for surgery) and requests for diagnostic imaging (DIDS) (a key component in the diagnosis of a gallstone complication) in order to determine the number of patients admitted for treatment of a complication of their gallstones. These data sets will also enable the health economists to determine the NHS resources utilised by study participants during their follow up period, to establish the relative cost and cost-effectiveness of each study intervention. DIDS data will provide the health economists with information on the use of imaging during the follow up period, to allow appropriate costing of healthcare during this period. Mortality data will be used by the health economists as the date of death will enable them to calculate Quality Adjusted Life Years, a measure of quality adjusted survival.

Only relevant data (e.g. admissions under specific ICD-10 codes) will be analysed as part of the study. The data used will align with that required to determine the primary outcome. The primary outcome looks at three main areas; i) hospital admissions for treatment of a complication of gallstones, ii) complications during admission for laparoscopic cholecystectomy or readmissions for complications of laparoscopic cholecystectomy, and iii) complications during endoscopic retrograde cholangiopancreatography.

DATA REQUESTED
The following annual drop of record level data sets for 17/18, 18/19, 19/20, 20/21, 21/22 (i.e. to end of DSA) have been requested in this application:
- Emergency Care Data Set (ECDS)
- HES Admitted Patient Care (APC),
- HES Critical Care (CC),
- HES Outpatients (OP),
- HES Accident and Emergency (A&E),
- Diagnostic Imaging Dataset (DIDs),
- Civil Registration (Deaths) - Summary Care Record.
Bridging files to enable the linkage of one dataset to another for meaningful analysis of the data has also been requested.

These datasets have been selected to allow study patient admissions to hospital to be identified. Patients could be admitted to a variety of settings within a hospital, hence the requirement to request several HES datasets. The health economics analysis also requires information on outpatient admissions, imaging requests and patient deaths to accurately cost patients healthcare and calculate Quality Adjusted Life Years. The datasets selected will all be used for study analyses, and data will be pseudonymised by NHS Digital. The fields selected within each data set have been carefully considered and minimised such that only items which will be used in study analyses have been selected. The study will be providing a cohort to NHS Digital, so minimising the number of patients for whom data will be received to only those of interest (i.e. those in the study cohort). HES data is requested for 1 year prior to the study randomisation date (with the exception of mortality data) to characterise the history of patients. Cumulative data is requested on an annual basis for the duration of the study. This is requested to allow the study Data Monitoring and Safety Committee to regularly review patient safety ensuring that patients in one study group are, for example, not reporting a significantly increased number of readmissions compared to the other study group. This is vital to ensure that safety of participants and support the ethics of continuing the trial. The final data extract will contain a minimum of 18 months of follow up data for all patients in the study cohort and will be used for the main study and health economics analyses.

The current participant cohort number is approx. 2,000 and estimated to reach approx. 14,000 by the end of the agreement.

METHODOLOGY
1. Patients undergoing gallbladder surgery will be asked for consent to take part in the Sunflower study. This will include consent for their identifiable data to be sent to NHS Digital. A cumulative cohort of patients who have consent to participate in the study will be created (for each scheduled data drop).

2. The cohort's patient identifiable data (NHS Number, Date of Birth, Surname, Forename, Sex, Post Code) along with a Study ID and their randomisation date will be sent by University Hospitals Bristol and Weston NHS Foundation Trust to NHS Digital via a Secure Electronic File Transfer system (SEFT).

3. Pseudonymised record level Hospital Episode Statistics (HES) data, Mortality and Diagnostic Imaging data (DIDs) linked to the cohort will be returned by NHS Digital to University Hospitals Bristol and Weston NHS Foundation Trust via a Secure Electronic File Transfer system (SEFT). Data will be pseudonymised to remove all identifiers, with only a pseudo-Study ID remaining.

Data will be provided for 12 months prior to the study randomisation date (with the exception of mortality data), and for a minimum of 18 months post the randomisation date.

The study team at University Hospitals Bristol and Weston NHS Foundation Trust will first check the degree of successful linkage with the HES data and, if low, explore patterns in the Sunflower study data set that might explain this. The study team will then code the relevant Sunflower study data to the pseudonymised HES records, ready to undertake the primary outcome analysis.

Staff responsible for processing will hold honorary contracts with University Hospitals Bristol and Weston NHS Foundation Trust, and substantive contracts with the University of Bristol. The NHS Digital data requested in this Data Sharing Agreement will be stored on University Hospitals Bristol and Weston NHS Foundation Trust managed servers, and will only be accessible by authorised users. Identifiable data is stored in a patient database on a secure NHS SQL server . The pseudonymised data is stored in secured folders which are set up for specific user access only on a separate secure NHS document server. Both servers are protected by an NHS Firewall and access to them requires log-in with NHS user name and password.

All processing will take place within University Hospitals Bristol and Weston NHS Foundation Trust. Data will not be accessed remotely, and access will only be made available to authorised users. The only exception to this is the data recipient who will download the NHS Digital data directly into the required server folder using a secure NHS remote access portal which requires a password and authentication code, ready for the study team to analyse the data on site. This will be a direct download from NHS Digital's Secure Electronic Transfer Service to the University Hospitals Bristol NHS Foundation Trust's server and no data will be stored or processed on the data recipient's remote device.

SECURITY
Relevant pseudonymised data will be securely shared with the health economics team at the University of Bristol using encrypted email. The study team at University Hospitals Bristol and Weston NHS Foundation Trust will provide the health economists at the University of Bristol with the document ‘Accessing Encrypted Emails Guide for Non-NHSmail users' published by NHS Digital, and the health economists will register for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail' published by NHS Digital will be followed. The coordinating centre at University Hospitals Bristol and Weston NHS Foundation Trust will use an NHS.net email account to send the data via encrypted email to the health economists at the University of Bristol. The data attached to the email will also be password protected. The study team at University Hospitals Bristol and Weston NHS Foundation Trust will provide the password to the health economists at the University of Bristol via telephone.

At no point will the health economists have access to patient identifiable data. The health economists at the University of Bristol will use NHS reference costs (https://improvement.nhs.uk/resources/reference-costs/) to cost hospital care during patient follow up in the study. Hospital stays will be costed using Healthcare Resource Group codes included in the pseudonymised HES data set. Pseudonymised data will be stored on University of Bristol managed servers, and will only be accessible by authorised users via remote access. The University of Bristol health economists will use a secure Remote Desktop platform to access the data remotely. Access is managed by secured username and password and saving files outside of the server environment is disabled.

Data will only be accessed and processed by substantive employees of the University of Bristol who hold honorary contracts with University Hospitals Bristol and Weston NHS Foundation Trust, and will not be accessed or processed by any other third parties not mentioned in this agreement.

Leeds Teaching Hospitals NHS Trust will have oversight of the processes in their role of Sponsor and Data Controller. At no point will Leeds Teaching Hospitals NHS Trust have access to any record level data - they will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines.

Identifiable data will not appear in outputs. Outputs will be aggregated with small number suppression applied as per the HES Analysis Guide. Identifiable data will not be supplied to third parties.

HES and ECDS DISCLOSURE RULES / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, you must make sure that:
· cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table.
· Zeros (0) do not need to be suppressed.
· All other counts will be rounded to the nearest 5.
Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

All organisations party to this agreement must 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data).

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

The CIPHER study - UK Cohort study to Investigate the prevention of Parastomal Hernia — DARS-NIC-134719-D5W2Y

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2023-01-28 — 2026-01-27 2023.05 — 2023.05.

Access method: One-Off

Data-controller type: ROYAL DEVON UNIVERSITY HEALTHCARE NHS FOUNDATION TRUST, UNIVERSITY OF BRISTOL

Sublicensing allowed: No

Datasets:

  1. Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
  2. Civil Registrations of Death - Secondary Care Cut
  3. Diagnostic Imaging Data Set (DID)
  4. Emergency Care Data Set (ECDS)
  5. HES:Civil Registration (Deaths) bridge
  6. Hospital Episode Statistics Accident and Emergency (HES A and E)
  7. Hospital Episode Statistics Admitted Patient Care (HES APC)
  8. Hospital Episode Statistics Critical Care (HES Critical Care)
  9. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England.

The Royal Devon University Healthcare NHS Foundation Trust (RDUH) and the University of Bristol require access to NHS Digital data for the purpose of the following research project: The CIPHER study – UK Cohort study to Investigate the prevention of Parastomal Hernia (PSH).

The following is a summary of the aims of the research project provided on behalf of RDUH and the University of Bristol:

“The CIPHER study is an ethically approved study with patients providing consent to participate. Participants understand how their data will be used and why. This study collected data about key technical surgical steps used during stoma formation and followed up the participants to establish the incidence of symptomatic and radiologically confirmed PSH.

“The formation of a stoma can be associated with future complications, including the risk of developing a PSH. PSH are relatively common and affect approximately 40% of patients within 2 years of their bowel surgery. Complications of PSH can be severe and are known to negatively influence patients’ quality of life. Both patient and surgical factors are believed to influence the development of PSH. However, the way in which surgeons create stomata is very varied and research is needed to investigate whether these factors influence the risk of developing a PSH. Modification of the technical aspects of surgery may reduce the incidence of PSH and could lead to improvements in the health of patients, better quality of life, a reduction in direct stoma appliance and accessory costs and fewer PSH repairs. The modifications offer the potential for significant savings for the NHS as well as benefit for individual patients. Unfortunately, existing studies on surgical technique relating to stoma formation are limited by poor design and generalisability and, consequently, further high-quality research is urgently needed.

“In 2014, the NIHR released a commissioned funding call for the “Prevention of Parastomal Hernia Formation”. The Royal Devon University Healthcare NHS Foundation Trust responded to this call with the support of the Bristol Trials Centre (BTC, University of Bristol) with an application for funding for the CIPHER study. To date, Phase A of the study has been completed. The aim of Phase A was to undertake feasibility work to inform the design of Phase B. This included identifying the surgical steps and other factors relevant to PSH development and developing a Patient Reported Outcome Measure to use in Phase B to identify symptomatic PSH.”

During the conception of this project study representatives met with patients, representatives of patient organisations (Colostomy, Ileostomy & Urostomy Associations) and professionals to garner feedback on the proposed study and to continue to engage with the PSH community. Patients have been involved in the design of the study and two patient representatives are on the Study Steering Committee.

"The CIPHER study (Phase B; CIPHER-B) aims to establish the incidence of symptomatic and radiologically confirmed PSH during a minimum of 2 years follow up. Additionally, CIPHER aims to evaluate the effects of key technical surgical steps during index stoma formation on the risk of subsequent PSH formation.

“Specific objectives of CIPHER-B are:
1. To describe the incidence of PSH formation within 2 years of formation of all types of stomata;
2. To describe the risk of PSH for different types of stoma;
3. To describe the risk of PSH according to how the stoma trephine is created;
4. To describe the relative risk of PSH following index stoma creation with or without mesh;
5. To describe the relative risk of PSH following index stoma creation with prophylactic mesh according to mesh position;
6. To describe the relative risk of PSH with different trephine shapes in the mesh;
7. To estimate the cost effectiveness of commonly used types of mesh in prevention PSH and improving health related quality of life.”

For Phase B of the project, the following NHS Digital data will be accessed:
• Hospital Episode Statistics Admitted Patient Care, Critical Care, Accident & Emergency, Outpatients – necessary to calculate the incidence of PSH, describe the specific risks of PSH for different types of stoma, describe hospital resource use of patients who develop PSH, and enable the study team to estimate the cost effectiveness of modifying surgical techniques.
• Emergency Care Data Set (ECDS) – necessary because this dataset replaced HES Accident & Emergency data
• Diagnostic Imaging Dataset (DIDS) – necessary to identify patients who develop a PSH
• Civil Registration Mortality – necessary to identify patients who die during follow up and describe the specific risks of PSH for different types of stoma

The level of the data will be:
• Identifiable – necessary to ensure that the data linkage has been successful

The data will be minimised as follows :
• Limited to data for a study cohort of participants that consented to take part in the CIPHER study
• Limited to data between 2017/18 – 2022/23. For each individual patient, data will only be provided from the date 6 months prior to the date of their index surgery and until the date of withdrawal or end of follow-up period. End of follow-up is defined as 3 months after a patient's last follow up questionnaire. Questionnaires were sent bi-annually with the last questionnaires sent on 01/09/2022. End of follow-up period is therefore between June 2022 and December 2022 for patients who have not withdrawn.

Royal Devon University Healthcare NHS Foundation Trust (RDUH) as the research sponsor, and the University of Bristol as the main collaborator, are joint data controllers as the organisations responsible for ensuring that the data will only be processed for the purpose described above.

The statisticians in the Bristol Trials Centre (BTC, University of Bristol) will make the decision about how the data will be analysed and RDUH will have oversight of the processes in their role of Sponsor. At no point will RDUH have access to any NHS Digital data – they will only see the aggregated outputs with small numbers suppressed in line with the NHS Digital analysis guidelines.

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

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

This processing is in the public interest because the study has the potential to significantly benefit society by addressing an important area of clinical uncertainty for patients at risk of developing PSH. This research priority was supported by a recent survey of The Association of Coloproctology of Great Britain and Ireland (ACPGBI) that ranked optimisation of methods to prevent and repair PSH as the second most important research question not related to cancer. For these reasons, the processing also meets the conditions of Schedule 1 Part 1 paragraph 4 of the Data Protection Act 2018.

The funding is provided by the National Institute for Health and Care Research (NIHR) (14/166/01) under the NIHR Health Technology Assessment award. The funding is specifically for the study described. Funding is in place until April 2023.

The University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is a data processor acting under the instructions of the data controllers. UHBW’s role is limited to providing IT hosting services, sending and receiving data to and from NHS Digital and removing identifiable data before transfer to the University of Bristol. UHBW will store NHS Digital data as contracted by University of Bristol and RDUH.

University of Birmingham are a study collaborator on the funding application. They support the study in an advisory capacity and do not make any decisions determining the study purposes, determine the manner in which the data will be processed, nor have any access to NHS Digital data. This co-applicant is not considered by the CIPHER study team as Data Processor or Data Controller.

Identifiable data will be accessed by:
• Individuals employed by the University of Bristol with UHBW contracts.

Pseudonymised data will be accessed by:
• Individuals employed by the University of Bristol.

Expected Benefits:

The CIPHER study has the potential to significantly benefit society by addressing an important area of clinical uncertainty for patients at risk of developing PSH. This research priority was supported by a recent survey of the Association of Coloproctology of Great Britain and Ireland (ACPGBI) that ranked optimisation of methods to prevent and repair PSH as the second most important research question not related to cancer. The ACPGBI Patient Consultation Exercise involved representatives of national inflammatory bowel disease, colorectal cancer, ileostomy and colostomy patient support groups who discussed and ranked 24 different research topics.

The use of the data could support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work), and advance understanding of regional and national trends in health and social care needs.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of knowledge that is considered by organisations who may wish to build upon this to pursue a randomised controlled trial (RCT).

The RCT would look to establish whether certain surgical techniques reduce the incidence of PSH. Subsequent changes in guidance could then benefit patients.

Outputs:

The data from this study will be used to produce outputs including publications in peer-reviewed academic journals, professional media (e.g. to stoma care nurses) and presentation at national and international conferences. A simplified version of the findings will also be disseminated as newsletters to patients, in accordance with advice from the patient and public involvement (PPI) group about how best to do this effectively. The findings will also be reported as a report to the funder in the form of a Health Technology Assessment monograph, and to other health care stakeholders with an interest in research.

The outputs will not contain NHS Digital data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

A report to the funding body will be sent to the National Institute for Health and Care Research and will provide a summary of the work undertaken during the life of the study. The target journals for the main study paper and other related publications have not been identified, but these will be Open Access and should be completed by summer 2024. These will communicate the results of the primary and secondary outcomes of the study. A summary for stakeholders will be provided and will be aimed both externally (e.g. general public/patients, media) and internally (e.g. participating Trust stuff, operational staff).

All outputs will be reviewed by the Chief Investigator and other collaborators, as necessary.

Findings will be shared with the Association of Coloproctology of Great Britain & Ireland (ACPGBI), Colostomy Association (a patient support organisation) and the Association of Stoma Care Nurses. The Chief Investigator has close links with these groups who are already aware and supportive of the study and awaiting its results. The study team intend to make presentations to all of them. Presentations will be given at national and international conferences relevant to colorectal surgery. This is intended to occur in ~Autumn 2024.

Engagement with patient support groups (e.g. Colostomy UK; Ileostomy and Internal Pouch Association) and relevant surgical societies (ACPGBI, The Association of Stoma Care Nurses UK) will ensure the results are targeted to the relevant staff and patient groups.

Processing:

Data for ~2175 consenting patients will be transferred from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) to NHS Digital. The data will consist of identifying details (specifically NHS Number, Date of Birth, start and end dates of study involvement, and a unique person ID) for the cohort to be linked with NHS Digital data. The start date will be a pre-calculated date per patient which is 6 months prior to their index stoma formation surgery. The end date for a patient will be either their withdrawal date or the end of the study follow-up period.

NHS Digital data will provide the relevant records from the HES, ECDS, Civil Registration Mortality and Diagnostic Imaging Datasets to UHBW. The data will contain directly identifying data items including NHS Number and Date of Birth which are required to ensure effective linkage of the data at record level with data already held by the recipient.

UHBW will pseudonymise the data and securely transfer this to the University of Bristol.

The data will be stored on servers at UHBW and the University of Bristol encapsulated Virtual Machine (EVM) – a secure purpose-built secure research server. The EVM provides a secure way for approved University of Bristol substantive employees who are part of the CIPHER research team to access the data from approved University of Bristol computers. The EVM is hosted in the Virtus Data Centre in Slough.

Patient identifiable data will be accessed remotely by substantive employees of the University of Bristol who hold an honorary contract with UHBW. Access is restricted to employees or agents of UHBW who have authorisation from the Chief Investigator.

Pseudonymised data will be accessed onsite at the premises of the University of Bristol. Access is restricted to employees or agents of University of Bristol who have authorisation from the Chief Investigator.

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

The data will not leave the UK at any time.

Employees or agents of RDUH are only permitted to access anonymised data including information derived from NHS Digital data. Such datasets will adhere to the relevant suppression rules.

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

The data will be linked at person record level with health and questionnaire data obtained from research sites during the study.

The identifying details will be stored in a separate database to the NHS Digital linked dataset used for analysis. All analyses will use the pseudonymised dataset. Pseudonymised study data will be analysed by individuals with access to the patient identifiable data. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Researchers from the University of Bristol with a UHBW honorary contract will process the data to send and receive data to and from NHS Digital, and remove identifiable data before transfer to the University of Bristol.

Researchers from University of Bristol will analyse the data as described in order to find out which surgical factors are linked with PSH.

HES/ONS data for the AIRWAYS-2 cluster randomised trial. — DARS-NIC-35562-V6G5W

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable (Section 251, Section 251 NHS Act 2006)

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

Purposes: No (NHS Trust)

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

When:DSA runs 2019-08-02 — 2022-08-01 2019.05 — 2019.05.

Access method: One-Off

Data-controller type: SOUTH WESTERN AMBULANCE SERVICE NHS FOUNDATION TRUST, UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST, UNIVERSITY OF OXFORD

Sublicensing allowed: No

Datasets:

  1. Hospital Episode Statistics Admitted Patient Care
  2. Hospital Episode Statistics Critical Care
  3. Hospital Episode Statistics Outpatients
  4. Hospital Episode Statistics Accident and Emergency
  5. Civil Registration - Deaths
  6. HES:Civil Registration (Deaths) bridge
  7. Civil Registration (Deaths) - Secondary Care Cut
  8. Civil Registrations of Death - Secondary Care Cut
  9. Hospital Episode Statistics Accident and Emergency (HES A and E)
  10. Hospital Episode Statistics Admitted Patient Care (HES APC)
  11. Hospital Episode Statistics Critical Care (HES Critical Care)
  12. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

This study has been funded by the NIHR (12/167/102) under the NIHR Health Technology Assessment Award as part of an Open Call.

Data provided by NHS Digital will be used as part of a research project which will provide the NHS with evidence of how best to treat out of hospital cardiac arrests (OHCA). The study team are undertaking a large randomised controlled trial (RCT) in four English NHS ambulance services and 100 hospitals to determine whether placing a breathing tube in the windpipe (intubation) or the best available supraglottic airway device (called the i-gel) gives the best chance of recovery following OHCA. The four English NHS ambulance services involved are South Western Ambulance Service NHS Foundation Trust (SWAST), Yorkshire Ambulance Service NHS Trust (YAS), East of England Ambulance Service NHS Trust (EAST) and East Midlands Ambulance Service NHS Trust (EMAS). The study team are following up recruited patients for 6 months after OHCA to find out the quality of life of survivors and the NHS resources used. The study team will use HES/ONS data to capture secondary care resource use and deaths that occur after OHCA during study follow up.

Objectives for data processing are to:

- determine which intervention (intubation or i-gel) is more clinically effective and cost effective for treating OHCA;

- optimise the care pathway for patients with OHCA in the NHS;

- improve the outcomes of patients with OHCA in the UK.

HES/ONS data provided by NHS Digital will be linked to trial data collected by the Clinical Trials and Evaluation Unit, University Hospitals Bristol NHS Foundation Trust. University Hospitals Bristol NHS Foundation Trust will share the linked data with the health economists at the Nuffield Department of Population Health, University of Oxford, who will conduct an economic evaluation for the study. The data to be shared will be at record level, and will initially be sent to the ONS named users. The data will be shared with the health economists at the Nuffield Department of Population Health, University of Oxford via the study database, which is stored on NHS servers. Health economists will be required to set up a database account and will be granted access to a specific 'Downloads' section of the study database. At no point will the health economists have access to patient identifiable data on the study database. Files to be downloaded will be password encrypted.

Yielded Benefits:

The main trial results have been published, with a number of additional papers to follow. This has been supported by a wide range of dissemination activity, and the outputs from the trial are now being translated into clinical practice. The trial team are closely monitoring clinical guidance and practice nationally and internationally in order to collect evidence of impact, as outlined in the benefits statement. The study anticipate that clear indications of this will be seen in due course. The trial has also enhanced research capacity and delivery in the ambulance services in England.

Expected Benefits:

Because resuscitation for OHCA is strongly protocol driven, the study team anticipates that the findings from AIRWAYS-2 will be readily adopted into practice (by 2019) through changes to accepted guidelines. Changes to internationally accepted resuscitation guidelines are made by ILCOR, the International Liaison Committee on Resuscitation. ILCOR was formed in 1992 to provide a forum for liaison between principal resuscitation organisations worldwide. At present, ILCOR comprises representatives of:
American Heart Association (AHA)
European Resuscitation Council (ERC) (includes the Resuscitation Council UK)
Heart and Stroke Foundation of Canada (HSFC)
Australian and New Zealand Committee on Resuscitation (ANZCOR)
Resuscitation Councils of Southern Africa (RCSA)
Inter American Heart Foundation (IAHF)
Resuscitation Council of Asia (RCA)

One of the AIRWAYS-2 co-applicant team is a past Chairman of the Resuscitation Council UK. They are Editor-in-Chief of the journal Resuscitation and Vice-Chairman of the European Resuscitation Council, the immediate past co-chairman of ILCOR and co-editor for the 2015 international resuscitation guidelines. Professor Nolan is ideally placed to ensure that the findings from AIRWAYS-2 are immediately incorporated into ILCOR's rapid review process (see https://volunteer.heart.org/apps/pico/Pages/default.aspx ) and then into internationally accepted and adopted resuscitation guidance, thereby ensuring rapid and effective implementation. Supported by the wider research team, Professor Nolan will ensure that ILCOR is fully updated on the findings of AIRWAYS-2 as soon as these become available.

Expected benefits include;
- improved clinical outcomes for patients with OHCA
- evidence-based guidelines
- reduction in inequalities as a result of clear guidelines for treatment in OHCA patients
- rationalisation of training and equipment in ambulance services
- answers to questions about the cost effectiveness of different airway management for the NHS and society as a whole.

The report to the funding body will be sent to the NIHR, and will provide a summary of the work undertaken during the life of the project. The target journals for the main study paper and cost effectiveness publications have not been identified, but these will be Open Access. These will communicate the results of the primary and secondary outcomes. The summary for stakeholders will be aimed both externally (e.g. general public/patients, media, commissioners) and internally (e.g. participating Trust stuff, operational staff).
All outputs will be reviewed by the Chief Investigator and other collaborators, as necessary.

Outputs:

- Report to funding body (HTA): October 2018
- Main study paper: Clinical effectiveness: September 2018
- Cost effectiveness publication: January 2019
- Summary to relevant stakeholders: January 2019

The report to the funding body will be sent to the NIHR, and will provide a summary of the work undertaken during the life of the project. The target journals for the main study paper and cost effectiveness publications have not been identified, but these will be Open Access. These will communicate the results of the primary and secondary outcomes of the study. The summary for stakeholders will be aimed both externally (e.g. general public/patients, media, commissioners) and internally (e.g. participating Trust stuff, operational staff).

All outputs will be reviewed by the Chief Investigator and other collaborators, as necessary. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide.

Findings will be shared with the National Association of Ambulance Medical Directors (NASMED), the National Ambulance Research Steering Group and the Research and Publications Committee of the Royal College of Emergency Medicine. The Chief Investigator and co-applicants have close links with these groups which are already aware of the trial and awaiting its results, and the study team intend to make presentations at all of them. The Chief Investigator is also the National Clinical Director for Urgent and Emergency Care at NHS England, and so is ideally placed to support national dissemination and implementation. An electronic summary of the results will be circulated widely in a range of formats, and made publicly available. Presentations will be given at national and international conferences relevant to pre-hospital care and emergency medicine. Examples include the 999 EMS Research Forum, the Annual Scientific Meeting of the Royal College of Emergency Medicine, the International Conference on Emergency Medicine and the American Heart Association Resuscitation Science Symposium.

The data will not be linked to any other data not already noted in this agreement.

Processing:

Patient identifiable data (Study ID, NHS Number, Date of Birth, Surname, Forename, Gender, Postcode) will be sent by UHBristol to NHS Digital. HES/ONS data will be returned by NHS Digital to UHBristol. The coordinating centre at UHBristol will undertake 4 main tasks using the HES/ONS data: (1) Check the degree of successful linkage with HES and, if low, explore patterns in the AIRWAYS-2 data set that might explain this, (2) Cross check the length of ICU stay and hospital stay with the information collected on the AIRWAYS-2 data collection forms, including filling in any missing data which can be ascertained from HES. These outcomes will be analysed and reported by the Bristol team, (3) Cross-check and update the survival status of patients who consented to active follow-up where missing. This data is currently missing for 148 patients. This outcome is analysed and reported by the Bristol team, and (4) Code relevant AIRWAYS-2 trial data to the HES records ready for the health economic analysis to proceed.

Following these tasks, the linked trial and HES records will be pseudonymised by the coordinating centre at UHBristol and transferred to the Nuffield Department of Population Health (NDPH) at the University of Oxford. Please note that the Health Economics Research Centre (HERC) is part of the Nuffield Department of Population Health who will undertake analysis.
This pseudonymised data will be shared with the health economists at the Nuffield Department of Population Health at University of Oxford using encrypted email. The coordinating centre at UHBristol will provide the health economists in Oxford with the document ‘Accessing Encrypted Emails Guide for Non-NHSmail users, HSCIC’, and the health economists will register for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail, HSCIC’ will be followed. The coordinating centre at UHBristol will use an NHS.net email account to send the data via encrypted email to the health economists in Oxford. The data attached to the email will also be password protected. The coordinating centre in Bristol will provide the password to the health economists in Oxford via telephone. At no point will the health economists have access to patient identifiable data. SWAST will have oversight of the processes in their role of Sponsor. At no point will SWAST have access to any record level data - they will only see the aggregated outputs with small numbers suppressed in line with the HES analysis guidelines.

Patient identifiable data for AIRWAY-2 patients will be sent to NHS digital along with each patients' unique study ID, in order that HES/ONS data for these patients can be sent back, with a unique study ID together with patient identifiers and relevant data items from HES/ONS.

These data will be linked to the trial data by the team named at CTEU Bristol. The dataset (including HES and ONS data) will be validated before being pseudonymised for transfer to the health economists at the Nuffield Department of Population Health at University of Oxford.

The trial aims to determine whether the i-gel is superior to tracheal intubation in non-traumatic OHCA in adults, in terms of both clinical and cost effectiveness.

One of the secondary outcome measures is mortality; the ONS data will be used to assist in the estimation of the difference in mortality between groups. Those patients who are deceased upon arrival at hospital are included within the study.

One of the main objectives of the study in line with the NIHR objective is to estimate the cost effectiveness of the trial interventions; data (including HES and ONS data) will be used to estimate the costs and Quality Adjusted Life Years (QALYs) gained by each patient over the course of the 6 months of follow-up, and these estimates will be used in the cost-effectiveness analysis. For each patient, data on survival (some of which will be ONS data) and quality of life estimates from survivors will be used to estimate QALYs gained to 6 months. Costs and QALYs will be summarised by trial group.

Explanation of organisations involved in the study can be found below;

South Western Ambulance Service NHS Foundation Trust hold the contract with the DH for the study. Data Controller (joint)
SWAS NHS Trust will have no access to the record level data.

University of Oxford Data Controller (joint) Will have access to the record level data pseudonymised

University Hospital Bristol NHS Foundation Trust Data Controller (joint) will have access to the record level data with identifiers.

University West of England Bristol , Royal United Hospital Bath NHS Trust and Imperial College London were initially involved in the grant proposal and provided initial clinical input into the protocol. These organisations do not have any influence over how the data is being analysed, they will not have access to any data other that what is put in the public domain.


All organisations party to this agreement must 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data).

South Western Ambulance Service NHS Foundation Trust and the University of Bristol will not have access to any of the data as a processor and will only see aggregated outputs with small numbers suppressed.

There will be no data linkage undertaken with NHS Digital data provided under this agreement that is not already noted in the agreement.

The data controller(s) is/are responsible for the activities of all individuals (“Individuals”) who have access to the patient data disseminated by NHS Digital ("Data") and are engaged by any data controller or data processor listed in this agreement, regardless of whether such Individual is described as an employee, contractor, secondee, PhD or post-doctoral student or honorary employee.