NHS Digital Data Release Register - reformatted

University Hospitals Bristol and Weston NHS Foundation Trust

Project 1 — DARS-NIC-170647-Z0B6H

Opt outs honoured: No - data flow is not identifiable (Consent (Reasonable Expectation))

Sensitive: Non Sensitive, and Sensitive

When: 2021/01 — 2021/02.

Repeats: One-Off

Legal basis: Consent (Reasonable Expectation)

Categories: Anonymised - ICO code compliant

Datasets:

  • HES:Civil Registration (Deaths) bridge
  • Emergency Care Data Set (ECDS)
  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Admitted Patient Care
  • Hospital Episode Statistics Critical Care
  • Civil Registration - Deaths
  • Hospital Episode Statistics Accident and Emergency
  • Diagnostic Imaging Dataset
  • Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset

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.