The Sunflower Study

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

Datasets: + Civil Registrations of Death

Objective for processing

The University of Bristol and Leeds Teaching Hospitals NHS Trust require access to NHS England data for the purpose of the following research project: The Sunflower Study. The following is a summary of the aims of the research project provided on behalf of the controllers: The Sunflower Study. The Sunflower Study is a research study which aims to provide the NHS with evidence as to whether MRCP scanning to test for common bile duct (CBD) stones before gallbladder surgery is worthwhile or not in patients at low to moderate risk of having stones. The following is a summary of the aims of the research project provided by The University of Bristol and Leeds Teaching Hospital NHS Trust: 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. The Sunflower Study is a major clinical trial which aims to improve decision-making in gallbladder surgery. Around 70,000 patients a year undergo gallbladder surgery. Gallbladder stones may pass from the gallbladder to the common bile duct (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. some receive pre-operative imaging, while others go straight to surgery. 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. To address this variation in clinical practice, the Sunflower Study is evaluating two approaches: one group of patients undergoes imaging prior to surgery, while the other proceeds directly to surgery without imaging. The objective is to determine whether preoperative testing for CBD stones influences the rate of hospital admissions for gallstone-related complications within 18 months of study enrolment. The study team at the University of Bristol is conducting a large-scale, randomised controlled trial across more than 50 hospitals in the United Kingdom. The trial aims to assess the impact of preoperative CBD stone testing on patient outcomes. Participants are being followed for a median of 18 months post-consent, during which quality of life data is collected via patient-completed questionnaires. The aims of the study are : - To determine whether no imaging is as clinically effective as pre-operative imaging with Magnetic Resonance Cholangiopancreatography (MRCP) in patients undergoing gallbladder removal who are at low or moderate risk of CBD stones - To estimate the difference between the two groups in the proportion of participants requiring hospital admission for treatment of complications related to gallstones in the gallbladder or CBD, and those related to laparoscopic cholecystectomy. - To assess differences in a range of secondary outcomes, including symptoms and complications associated with gallstones and surgery. - To evaluate the cost-effectiveness of MRCP imaging compared to no imaging, helping determine whether routine imaging is financially justified within the NHS. [7 paragraphs unchanged] - Civil Registration (Deaths) - Summary Care Record. of Deaths Bridging files to enable the linkage of one dataset to another for meaningful analysis of the data has also been requested. The datasets requested from NHS England have been carefully selected to support the objectives of the Sunflower Study. These datasets enable the identification of hospital admissions, including when and why patients were admitted, the procedures they underwent, and any associated complications. The Emergency Care Data Set (ECDS) captures emergency department visits, which are essential for identifying acute complications. The Diagnostic Imaging Dataset (DIDS) provides information on imaging requests and usage, which is critical for evaluating the role and cost-effectiveness of MRCP scans. While the Civil Registration of Deaths data is necessary for calculating the quality adjusted life years. This is a key metric in health economics used to assess the cost-effectiveness of medical interventions such as whether MRCP imaging improves survival or quality of life compared to no imaging. 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. 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 England. 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 have provided a cohort to NHS England, so minimising the number of patients for whom data will be received to only those of interest (i.e. those in the study cohort). 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. [1 paragraph unchanged] · - Identifiable – necessary to enable linkage of the Data with study data [48 words unchanged] data cleaning, pseudonymise the data and then undertake the primary outcome analysis. The Sunflower study will continue to run until November 2025. Patient recruitment is planned to continue until June 2024 allowing for median 1 year of follow up and 6 months of data analysis and dissemination. Cumulative data are required annually until August 2026. The study requires data for the duration of study recruitment and then a minimum of 12 months of follow up from the date of randomisation (i.e. patients recruited in the last year of recruitment will only require data for 12 months, patients recruited earlier in the recruitment phase will require data for a longer period). 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. The Data will be minimised as follows: Background: - Limited to a study cohort identified by the University of Bristol and Leeds Teaching Hospitals NHS Trust – This will include current participant cohort number of approx. 5,500 and estimated to reach approx. 7,500 by the end of the DSA. 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. 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 18 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 England. The current participant cohort number is approx. 5,500 and estimated to reach approx. 7,500 by the end of the DSA*. [1 paragraph unchanged] Leeds Teaching Hospitals NHS Trust will have oversight of the processes in their role of Sponsor and Controller and have a research contract for this study with the Secretary of State for Health. 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. [4 paragraphs unchanged] 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 processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care. The funding is provided by National Institute for Health and Care Research (NIHR). The funding is specifically for the study described [2 paragraphs unchanged] The Sunflower Study is funded by the NIHR HTA Programme (project number 16/142/04). Leeds Teaching Hospitals NHS Trust will have oversight of the processes in their role of Sponsor and Controller and have a research contract for this study with the Secretary of State for Health. 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. Members of the public and patients have played a meaningful role in shaping the design and data use strategy of the Sunflower Study. Patient and public involvement (PPI) representatives were engaged during the early stages of study development to ensure that the research questions, methods, and data usage aligned with public expectations and ethical standards. Their input helped refine the study’s approach to data minimisation, consent processes, and the balance between clinical benefit and privacy. Diverse public views were considered through consultations and feedback sessions, particularly regarding the acceptability of using pseudonymised NHS data for research. These discussions supported the decision to limit data access to only those participants who have consented to take part in the study and to ensure that only essential data fields are requested.

Processing activities

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 England. A cumulative cohort of patients who have consent to participate in the study will be created (for each scheduled data drop). The University of Bristol and Leeds Teaching Hospitals NHS Trust will transfer data to NHS England. 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 have been sent by University Hospitals Bristol and Weston NHS Foundation Trust to NHS England. The data will consist of identifying details specifically NHS Number, Date Of Birth, Family Name, Given Name, Gender, Postcode and a unique person ID for the cohort to be linked with NHS England. Pseudonymised record level Hospital Episode Statistics (HES) data, Mortality and Diagnostic Imaging data (DIDs) linked to the cohort will be returned by NHS England to University Hospitals Bristol and Weston NHS Foundation Trust. Data will be pseudonymised to remove all identifiers, with only a pseudo-Study ID remaining. NHS England will provide the relevant records from the 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 of Deaths datasets to the University of Bristol and Leeds Teaching Hospitals NHS Trust. Data will be provided for median 18 months post the randomisation date (for patients recruited in the last year of recruitment). The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient. The study team at University of Bristol 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. The Data will not be transferred to any other location. The NHS England Data 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 username and password. The Data will be stored on servers at University Hospitals Bristol and Weston NHS Foundation Trust. Access will only be made available to authorised users. The only exception to this is the data recipient who will download the NHS England's 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. This will be a direct download from NHS England's Secure Electronic Transfer Service to the University Hospitals Bristol and Weston NHS Foundation Trust's server and no data will be stored or processed on the data recipient's remote device. The Data will be accessed by authorised personnel via remote access. 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 England, and the health economists will register for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail' published by NHS England 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. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. 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. Authorised users 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. For remote access: Data will only be accessed and processed by substantive employees of the University of Bristol as Data Controller, and will not be accessed or processed by any other third parties not mentioned in this agreement. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; 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. - Access controls granting users the minimum level of access required are in place; Identifiable data will not appear in outputs. Outputs will be aggregated with small number suppression applied as per the guidance provided on the Disclosure Control Methodology for HES and ECDS website. Identifiable data will not be supplied to third parties. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). Remote processing will be from secure locations within England and Wales. The data will not leave England and Wales at any time. Access is restricted to employees of the University of Bristol and the University Hospitals Bristol and Weston NHS Foundation Trust who have authorisation from the Principal Investigator. Leeds Teaching Hospitals NHS Trust is not permitted to access the Data. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset. Analysts/researchers from the the University of Bristol and the University Hospitals Bristol and Weston NHS Foundation Trust will process/analyse the Data for the purposes described above.

Unchanged: Expected output, Expected measurable benefits, Benefits reported.

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

Datasets: − Hospital Episode Statistics Accident and Emergency (HES A and E)

Objective for processing

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. The University of Bristol and Leeds Teaching Hospitals NHS Trust require access to NHS England data for the purpose of the following research project: The Sunflower Study. The following is a summary of the aims of the research project provided on behalf of the controllers: The Sunflower Study is a research study which aims to provide the NHS with evidence as to whether MRCP scanning to test for common bile duct (CBD) stones before gallbladder surgery is worthwhile or not in patients at low to moderate risk of having stones. 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. The following NHS England Data will be accessed: - 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 England. 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 have provided a cohort to NHS England, so minimising the number of patients for whom data will be received to only those of interest (i.e. those in the study cohort). 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 level of the Data will be: · Identifiable – necessary to enable linkage of the Data with study data collected by the co-coordinating centre, the Bristol Trials Centre (which is based in the University of Bristol but with access to patient data held on servers from the University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)). The study team from the Bristol Trials Centre will conduct all data cleaning, pseudonymise the data and then undertake the primary outcome analysis. The Sunflower study will continue to run until November 2025. Patient recruitment is planned to continue until June 2024 allowing for median 1 year of follow up and 6 months of data analysis and dissemination. Cumulative data are required annually until August 2026. The study requires data for the duration of study recruitment and then a minimum of 12 months of follow up from the date of randomisation (i.e. patients recruited in the last year of recruitment will only require data for 12 months, patients recruited earlier in the recruitment phase will require data for a longer period). 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. Background: [1 paragraph unchanged] DATA CONTROLLERS 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 18 months after consent to the study to collect quality of life information using a patient completed questionnaire. The University of Bristol and Leeds Teaching Hospitals NHS Trust are the Data Controllers for this Data Sharing Agreement (DSA). 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 England. The current participant cohort number is approx. 5,500 and estimated to reach approx. 7,500 by the end of the 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. The University of Bristol and Leeds Teaching Hospitals NHS Trust are the Controllers as the organisations responsible for ensuring that the Data will only be processed for the purpose described above. DATA PROCESSORS Leeds Teaching Hospitals NHS Trust will have oversight of the processes in their role of Sponsor and Controller and have a research contract for this study with the Secretary of State for Health. 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. The University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust are the Data Processors for this DSA. The lawful basis for processing personal data under the UK GDPR is: STUDY COLLABORATORS 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; 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. The lawful basis for processing special category data under the UK GDPR is: 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. Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The 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. 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. 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 University Hospitals Bristol and Weston NHS Foundation Trust is a processor acting under the instructions of the controllers. 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. 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 controller or 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. 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. The Sunflower Study is funded by the NIHR HTA Programme (project number 16/142/04). 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.

Processing activities

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. 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 England. A cumulative cohort of patients who have consent to participate in the study will be created (for each scheduled data drop). 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. 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 have been sent by University Hospitals Bristol and Weston NHS Foundation Trust to NHS England. DATA REQUESTED Pseudonymised record level Hospital Episode Statistics (HES) data, Mortality and Diagnostic Imaging data (DIDs) linked to the cohort will be returned by NHS England to University Hospitals Bristol and Weston NHS Foundation Trust. Data will be pseudonymised to remove all identifiers, with only a pseudo-Study ID remaining. 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: Data will be provided for median 18 months post the randomisation date (for patients recruited in the last year of recruitment). - Emergency Care Data Set (ECDS) The study team at University of Bristol 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. - HES Admitted Patient Care (APC), The NHS England Data 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 username and password. - HES Critical Care (CC), Access will only be made available to authorised users. The only exception to this is the data recipient who will download the NHS England's 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. This will be a direct download from NHS England's Secure Electronic Transfer Service to the University Hospitals Bristol and Weston NHS Foundation Trust's server and no data will be stored or processed on the data recipient's remote device. - HES Outpatients (OP), 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 England, and the health economists will register for the encryption service. Guidance in the document ‘Encryption Guide for NHSmail' published by NHS England 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. - HES Accident and Emergency (A&E), 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. Authorised users 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. - Diagnostic Imaging Dataset (DIDs), Data will only be accessed and processed by substantive employees of the University of Bristol as Data Controller, and will not be accessed or processed by any other third parties not mentioned in this agreement. - 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. [1 paragraph unchanged] Identifiable data will not appear in outputs. Outputs will be aggregated with small number suppression applied as per the guidance provided on the Disclosure Control Methodology for HES Analysis Guide. and ECDS website. 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.

Expected output

[2 paragraphs unchanged] A Health Technology Assessment report to the funding body will be sent to the NIHR in May 2024, November 2025, and will provide a summary of the work undertaken during the life [16 words unchanged] health economics, qualitative) have not been identified, but these will be Open Access and should be completed by early 2025. Access. These will communicate the results of the primary and secondary outcomes of the study. The main study paper should be published in Summer 2024. 2026. A summary for stakeholders will be provided in late 2024, shortly afterwards, and will be aimed both externally (e.g. general public/patients, media, commissioners) and internally (e.g. participating Trust stuff, operational staff). [3 paragraphs unchanged]

Expected measurable benefits

Imaging of the common bile duct in patients with symptomatic gallstones symptoms [141 words unchanged] Weston NHS Foundation Trust anticipate that this evidence would inform policy makers by 2025. shortly after completion of the study. The HES data will allow the study team to provide this high [26 words unchanged] 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. [1 paragraph unchanged]

Benefits reported

Yielded Benefits is not a requirement for new applications. The Data have provided reassurance to the independent data monitoring and safety committee that the trial is safe for participants. The Data have also been interrogated to determine the events (ICD and OPCS codes) that will be used to determine the primary and key secondary outcomes in the trial. The full benefit of the Data will not be realised until trial recruitment and follow-up is complete and the Data are analysed and reported.