pre-DIRECT - All cause mortality following hip fracture

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

Datasets: + Civil Registrations of Death · − Civil Registrations of Death - Secondary Care Cut; − HES:Civil Registration (Deaths) bridge; − Hospital Episode Statistics Accident and Emergency (HES A and E); − Hospital Episode Statistics Critical Care (HES Critical Care); − Hospital Episode Statistics Outpatients (HES OP)

Objective for processing

The University of Oxford requires HES and Civil Registration (mortality) data for the purpose of the ‘pre-DIRECT’ study which aims to investigate the causes of deaths in patients with hip fracture. The mortality is very high, up to 30% at 12-months following hip fracture. In 2013 there were more than 61,000 hip fractures across England, Wales and Northern Ireland. There has been much research into the rates of mortality after hip fracture but systematic large-scale analysis of the causes of mortality is lacking. The University of Oxford requires access to NHS England data for the purpose of the following project: The University of Oxford is a public authority whose principal objects are the advancement of learning by teaching and research. Under these circumstances this application satisfies article 6(1)(e) of the GDPR legislation for processing that is necessary for the performance of a task in the public interest. Pre-DIRECT - All cause mortality following hip fracture In line with Article 9(2)(h) of the GDPR, and in order to improve the care and management of patients, it is important to understand the causes behind the high mortality rates. It is proposed that analysing the causes of death in patients with hip fracture will elucidate the reasons for such high mortality rates. This stand alone study aims to identify trends in the cause of death for patients who die in the first year following their hip fracture. By analysing the case mix included in the data, groups of patients who are at risk from particular causes of mortality in the year following the hip fracture will be identified. Further research could then investigate appropriate follow-up and preventative strategies that are targeted to reduce the risk for these patients. The following is a summary of the aims of the project provided by the University of Oxford: The project requires data about patients over 60 years of age undergoing hip fracture surgery from the Falls and Fragility. Fracture Audit Programme (FFFAP) linked with HES and civil registration mortality data. Data were requested from 2010 to 2017, the earliest date of available data up to the most recent available at the time of application. This maximum period, covering all patients with hip fracture in England and Wales, yields the most data available from which to draw robust conclusions. Restricting the dataset might mask important temporal or geographical variations across England and Wales. Only patient-level data can yield the necessary information to draw conclusions about causes of death following hip fracture so no less obtrusive methods were available. Only those data needed for case mix adjustment or determining outcome were used in the processing – all other data were removed by NHS England and Crown Informatics during preparation of the linked datasets. This project is a service evaluation into patient outcomes following hip fracture. The University of Oxford requires HES and Civil Registration (mortality) data for the purpose of investigating the causes of death in patients with hip fracture. The mortality rate is very high; up to 30% 1-year following hip fracture. Contemporary systematic largescale analysis of the mortality rates and causes of mortality is required to understand where and in whom the biggest gains lie in reducing mortality after hip fracture. With 70,000 hip fractures being entered to the NHFD each year across England, Wales and Northern Ireland, The National Hip Fracture Database (NHFD) is the largest national dataset available to estimate such information. Major groupings of mortality, such as cardiovascular disease (CVD), stroke, and infection that exist within the data will be assessed and all cause and cause specific mortality rates over time will be reported using survival analyses. Variation across the hospitals using mixed effects regression models will be reported and explored. Civil Registration Mortality data is required to be able to explore variation in patient demographics which might explain differences in causes of death in the hip fracture population. Previous studies have reported that age, sex and fracture type are all predictors of mortality in other international hip fracture populations. The following NHS England Data will be accessed: The project requires dates of death in order to be able to explore the trends in the data across the ten-year life of the NHFD. Without these dates the project would not be able to explore secular trend in mortality, which has been marked in the wider UK population. It is clinically important to be able to understand if trends seen in mortality are those seen in the UK population generally or if there are specific challenges in the hip fracture population. > Hospital Episode Statistics (HES) Linked HES A&E, APC, OP and CC data will allow NDORMS to assess the validity of hip fracture diagnosis and assess case ascertainment within the NHFD. The linkage with Civil Registration Mortality data will provide information on cause and date of death. With ~65,000 hip fractures being entered to the NHFD each year and an overall all-cause mortality rate of 6.7% at 30-days; the NHFD is the largest national dataset available to estimate such information. Major groupings of mortality, such as venous thromboembolism (VTE), stroke, infection that exist within the data will be assessed and all cause and cause specific mortality rates over time will be reported using survival analyses. Variation across the hospitals using mixed effects regression models will be reported and explored. - Admitted Patient Care (APC) – necessary to assess the validity of hip fracture diagnoses and assess case ascertainment within the NHFD and will also enable patients’ clinical characteristics prior to their hip fracture to be captured for case-mix adjustment. This study will involve several organisations. The University of Oxford is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose. The Falls and Fragility Fracture Audit Programme (FFFAP), part of the national audit programme of the Healthcare Quality Improvement Partnership (HQIP), will provide a list of all hip fractures sustained in the UK over the last ten years. HQIP is the data controller for FFFAP data and Crown Informatics is their data processor. Crown Informatics will generate the bespoke cohort from the NHFD for linkage by NHS England to HES and Civil Registration Mortality data. The project only requires pseudonymised data. > Civil Registration Mortality – necessary to be able to investigate causes of death in the hip fracture population. The project requires dates of death to be able to explore secular trends in mortality at various period after hip fracture across the 14-year life of the NHFD. It is clinically important to be able to understand if trends seen in mortality are those seen in the UK population generally or if there are specific challenges in the hip fracture There are no ethical and/or moral issues regarding dissemination of these data as they will be presented at aggregate level so that no individuals are identifiable and the outputs will help clinicians provide best care in the future. population. The study is funded by grant income and underpinned by support from the Musculoskeletal theme of Biomedical Research Centre (BRC) and The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) and sponsored by the University of Oxford. Under v1.7 of the Data Sharing Agreement data was relocated from NDORMS to The Nuffield Department of Population Health (NDPH) where Members of the research team are located. NDORMS and NDPH both sit within the Medical Sciences Division of the University of Oxford. The level of the Data will be: NHS England will act as a trusted third party to securely link all datasets and send the University of Oxford a pseudonymised dataset for the analyses. > Pseudonymised The Data will be minimised as follows: - Limited to cohort provided by Crown Informatics (approximately 900,000 individuals), consisting of all patients recorded in The National Hip Fracture Database (NHFD), over 60 years of age undergoing hip fracture surgery between 2011 to 2025. - Limited to data between 2010/11 to latest available The University of Oxford is the sponsor and controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. 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)(h) - processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3; In line with Article 9(2)(h) of the GDPR, and in order to improve the care and management of patients, it is important to understand the causes behind the high mortality rates. It is proposed that analysing the causes of death in patients with hip fracture will elucidate the reasons for such high mortality rates. This service evaluation aims to identify trends in the cause of death for patients who die following their hip fracture. By analysing the case mix included in the data, groups of patients who are at risk from particular causes of mortality following hip fracture will be ascertained. Further research could then investigate appropriate follow-up and preventative strategies that are targeted to reduce the risk for these patients. The funding comes from multiple sources. Current funders include: - The Oxford Biomedical Research Centre (BRC) - Orthopaedics Research UK - The Nuffield Department of Population Health Funding to continue the work described will be sought on an ongoing basis. The funders will have no ability to suppress or otherwise limit the publication of findings. Data will be accessed by: - Substantive employees of the University of Oxford

Processing activities

The project uses data from National Hip Fracture Database (NHFD) , which is contained within the FFFAP, in relation to patients over 60 years of age undergoing hip fracture surgery. The following personal identifiers were provided to NHS England, a trusted third party, from NHFD for linkage to HES data and date of death and cause of death, : NHS numbers, date of birth, gender, postcode and unique NHFD identifier. NHS England transferred a pseudonymised NHFD dataset to NDORMS for analysis, along with age, gender and clinical data. Crown Informatics will transfer data to NHS England. The data will consist of identifying details (specifically NHS numbers, date of birth, gender and postcode) and a unique person ID for the cohort to be linked with NHS England data. To facilitate the linkage of the data sets, the following occurred: NHS England will provide the relevant records from the HES and deaths datasets to the University of Oxford alongside the unique pseudonymised person ID provided by Crown Informatics. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. 1. Crown Informatics sent the following identifying data to NHS England: NHS Number, Date of Birth, full postcode and FFFAP ID (a study ID for the Falls and Fragility Fracture Audit Programme); The Data will not be transferred to any other location. 2. NHS England extracted the HES and mortality data linked to the cohorts whose identifiers were supplied by Crown Informatics; The Data will be stored on servers at the University of Oxford. 3. NHS England created a separate HES extract of individuals who had hospital episodes with specific ICD10 and OPCS codes indicating a fall or fracture whose identifiers were not included in the cohort and whose identifiers were supplied by Crown Informatics; The Data will be accessed by authorised personnel both on-site and via remote access. 4. NHS England removed the identifying information and disseminated both extracts to the University of Oxford as pseudonymised data. The linked extract also contained the FFFAP ID supplied by Crown Informatics. 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. 5. Crown Informatics sent pseudonymised data from National Hip Fracture database (NHFD) and FFFAP ID to NDORMS. For remote access: 6. NDORMS have used the FFFAP ID to combine the FFFAP data and the linked HES and mortality data. - 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; Validation of hip fracture diagnosis: - Access controls granting users the minimum level of access required are in place; Hip fracture patients can be identified in HES using search strings dependent upon International Classification of Diseases (ICD) or Office of Population Censuses and Surveys (OPCS) coding or both. Considering NHFD audit data as the gold standard, NDORMS will compare hip fracture events in NHFD to HES, searched using each candidate search string, by calculating sensitivity, specificity, positive and negative predictive values. Events in HES will not be counted if the event is present in both datasets but with more than a 60-day interval. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; Estimation of all-cause mortality and cause-specific mortality: Categories for causes of death will be generated from the ICD codes attributed to each identified death in the dataset. This will allow estimation of risks and hazards of all-cause and cause-specific mortality following hip fracture. - Multifactor authentication (MFA) is required for remote access; The University of Oxford will store the data on University owned, password-protected secure, encrypted hard drives within a secure room at the University. Access to the room, computers and files will only be available to authorised employees for the stated processing activities. Data will be transferred between NDORMS and NDPH under this Agreement using the University of Oxford secure file transfer protocols based on the University of Oxford secure servers. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide. No record level data falling under this agreement will be shared with any third-party. - 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. There will be no requirement or attempt to re-identify and individuals. 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). 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 – i.e. employees, agents and contractors of the Data Recipient who may have access to that data. Data processing will only be carried out by substantive employees of the data processors and data controllers, all of whom are trained in data protection and confidentiality. The Data will not leave England/Wales at any time. Access is restricted to employees of the University of Oxford who have authorisation from the Principal Investigator. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts from the University of Oxford will process the Data for the purposes described above.

Expected output

Work has continued on the analysis which completed in May 2023. Final work is completing on preparation of a manuscript for submission to the Bone and Joint Publishing house for a free to access publication. We anticipate a period of peer review during which time it is likely that requests may be made for further analyses which is whey an extension is now requested. We anticipate that all review comments will be finalised soon. The expected outputs of the processing will be: In addition, to support the publication we will submit to (inter)national conferences, an abstract of the work at: - Submissions to peer reviewed journals • British Orthopaedic Association - Presentations at appropriate national and International conferences, such as British Orthopaedic Association, International Fragility Fracture Network and Orthopaedic Trauma Society of Great Britain and Ireland • International Fragility Fracture Network The outputs will not contain NHS England 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. • Orthopaedic Trauma Society of Great Britain and Ireland The outputs will be communicated to relevant recipients through the following dissemination channels: The purpose of these publications and presentations is to disseminate the project’s findings to the clinical community and raise discussion on how the results might influence the design of services provided to patients suffering a hip fracture. - Journals All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide. - Conferences

Expected measurable benefits

As part of the Falls and Fragility Fracture Audit Programme (FFFAP) within the Clinical Effectiveness and Evaluation Unit at the RCP, the NHFD has now developed into a comprehensive quality improvement initiative and includes several elements which will be supported through this work: This work has generated a justification for and planning considerations required to conduct a definitive trial (the DIRECT trial) aimed at reducing hip fracture mortality, which has now been fully funded, and is supported by NIHR. The randomized trial aims to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis in patients sustaining hip fracture. • a framework to support local and national audit work It is expected that the updated analyses and outputs, benefiting from more contemporary data available in this version of the Data Sharing Agreement will in place both clinical targets and methodological structures to facilitate further research into reducing mortality after hip fracture within the UK. • an infrastructure for service evaluation and research work The University of Oxford expect these benefits to be realised by 70,000 patients annually in England. As well as the indirect patient benefit of this work providing a structure for future research, the University of Oxford also expect the outputs to directly benefit other research groups in UK and plan to provide musculoskeletal-focused charities. • a resource of specialist information, expertise and networking This work is expected to identify groups of patients who are at risk from particular causes of mortality in both the short-term (< 12 months) and longer-term (12+ months). This will provide a basis for researchers to investigate appropriate follow-up and preventative strategies that are targeted to reduce mortality for these patients. The benefit aimed to be achieved for patients is better patient care by improving our understanding of where and in whom the biggest gains lie in reducing mortality after hip fracture. The risk of death after hip fracture is highest shortly after the event, but remains elevated above what would be expected if the fracture did not occur for many years. Evaluating risk of death and the causes of death beyond 12 months after hip fracture is therefore essential to fully understand the long-term impact of hip fracture and its sequelae to identify further opportunities to prevent early death, early and later on in the care pathway after fracture. The data processing under this Agreement will support: Two examples are provided: • The first understanding anywhere in the world of cause-specific mortality following hip fracture. There are no published reports of the contribution of different types of disease and illness to the overall mortality associated with hip fracture. - If it is found that short or long-term mortality rates depend on the method of hip fracture surgery, then the publication of this finding may justify the need for a trial into the choice of surgery given to patients, and will inform the need for the trial to consider long-term mortality. Case mix analysis may even demonstrate that the risk of mortality after hip fracture surgery types varies by demographic characteristics, allowing surgery provision to become more targeted. • The development of clinical solutions within service design and delivery to specifically target the important causes of mortality after hip fracture. - If it is found that heart attacks are a common cause of mortality both within and beyond 12 months after hip fracture, then the publication of this finding may prompt further research into the nature and length of follow-up cardiology care offered to patients with hip fracture depending on how long the risk of death from heart attacks remains elevated for. Case mix analysis from the study may even demonstrate more specific groups at risk from heart disease allowing follow-up care to become more targeted. • Generating unique specialist information which can be used across the NHS and the world to enhance expertise. With these data it is hoped that the following will be achieved: • Calculation of absolute mortality hazard after hip fracture • Calculation of sub-group adjusted mortality hazard after hip fracture • Absolute proportion of mortality attributed to different major system dysfunction Targets for further prospective research to reduce cause-specific mortality. For example, if it is found that the most common cause of mortality is a myocardial infarction (heart attack) then the publication of this finding may prompt further research into the follow-up cardiology care offered to patients with hip fracture. Case mix analysis from the study may even demonstrate more specific groups at risk from heart disease allowing follow-up care to become more targeted. The dissemination plan is to produce three distinct outputs, which will be published in the scientific media as well as distributed through the FFFAP social media networks and PPI networks. These outputs are: 1. Case ascertainment of NHFD compared with HES records 2. All cause and cause specific mortality 3. Suitability of NHFD as a registry to embed randomised trials

Benefits reported

The outputs will put in place both clinical targets and methodological structures to facilitate research into reducing mortality after hip fracture within the UK. The University of Oxford expect these benefits to be realised by 65,000 patients annually in England, Wales and Northern Ireland. As well as the indirect patient benefit of this work providing a structure for future research, the University of Oxford also expect the outputs to directly benefit other research groups in UK and plan to provide HDR(UK) with the University of Oxford’s outputs for further dissemination. The benefits will be available immediately on production of the outputs and success has been determined by the successful launching of such a registry enabled study; the team have been successful at generating a justification for and planning considerations required to conduct a definitive trial (the DIRECT trial) aimed at reducing hip fracture mortality, which has now been fully funded, and is supported by NIHR. This randomised trial aims to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis for patients sustaining hip fracture. The benefits will be available immediately on production of the outputs and success has been determined by the successful launching of such a registry enabled study; the team have been successful at generating a justification for and planning considerations required to conduct a definitive trial (the DIRECT trial) aimed at reducing hip fracture mortality, which has now been fully funded, and is supported by NIHR (Award ID: NIHR159321). This randomised trial aims to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis for patients sustaining hip fracture.

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

Expected output

Work has continued on the analysis which completed in May 2023. Final [11 words unchanged] the Bone and Joint Publishing house for a free to access publication. We expect to submit this in November 2023. We anticipate a period of peer review during which time it is [14 words unchanged] is now requested. We anticipate that all review comments will be finalised before August 2024. soon. [6 paragraphs unchanged]

Benefits reported

The processing of the data has now been completed to develop the reports for the above outputs. If the University of Oxford are awarded an extension The University of Oxford expect to able to produce each of the outputs before the end date of the extension. The outputs will put in place both clinical targets and methodological structures to facilitate research into reducing mortality after hip fracture within the UK. The University of Oxford expect these benefits to be realised by 65,000 patients annually in England, Wales and Northern Ireland. As well as the indirect patient benefit of this work providing a structure for future research, the University of Oxford also expect the outputs to directly benefit other research groups in UK and plan to provide HDR(UK) with the University of Oxford’s outputs for further dissemination. The outputs will put in place both clinical targets and methodological structures to facilitate research into reducing mortality after hip fracture within the UK. the University of Oxford expect these benefits to be realised by 65,000 patients annually in England, Wales and Northern Ireland. As well as the indirect patient benefit of this work providing a structure for future research the University of Oxford also expect the outputs to directly benefit other research groups in UK and plan to provide HDR(UK) with the University of Oxford’s outputs for further dissemination. The benefits will be available immediately on production of the outputs and success has been determined by the successful launching of such a registry enabled study; the team have been successful at generating a justification for and planning considerations required to conduct a definitive trial (the DIRECT trial) aimed at reducing hip fracture mortality, which has now been fully funded, and is supported by NIHR (Award ID: NIHR159321). This randomised trial aims to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis for patients sustaining hip fracture. The benefits will be available immediately on production of the outputs and success will be determined by the successful launching of such a registry enabled study within the next 12-36 months. The work has already supported the application for a NIHR HTA Stage 2 grant entitled DIRECT for a randomised trial to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis for patients sustaining hip fracture.

Unchanged: Objective for processing, Processing activities, Expected measurable benefits.

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

Objective for processing

The University of Oxford requires HES and Civil Registration (mortality) data for the purpose of the ‘pre-DIRECT’ study which aims to investigate the causes of death’s deaths in patients with hip fracture. The mortality is very high, up to 30% at 12months 12-months following hip fracture. In 2013 there were more than 61,000 hip fractures [18 words unchanged] fracture but systematic large-scale analysis of the causes of mortality is lacking. [2 paragraphs unchanged] The project requires data about patients over 60 years of age undergoing hip fracture surgery from the Falls and Fragility The project requires data about patients over 60 years of age undergoing hip fracture surgery from the Falls and Fragility. Fracture Audit Programme (FFFAP) linked with HES and civil registration mortality data. Data were requested from 2010 to 2017, the earliest date of available data up to the most recent available at the time of application. This maximum period, covering all patients with hip fracture in England and Wales, yields the most data available from which to draw robust conclusions. Restricting the dataset might mask important temporal or geographical variations across England and Wales. Only patient-level data can yield the necessary information to draw conclusions about causes of death following hip fracture so no less obtrusive methods were available. Only those data needed for case mix adjustment or determining outcome were used in the processing – all other data were removed by NHS England and Crown Informatics during preparation of the linked datasets. Fracture Audit Programme (FFFAP) linked with HES and civil registration mortality data. Data were requested from 2010 to 2017; the earliest date of available data up to the most recent available at the time of application. This maximum period, covering all patients with hip fracture in England and Wales, yields the most data available from which to draw robust conclusions. Restricting the dataset might mask important temporal or geographical variations across England and Wales. Only patient-level data can yield the necessary information to draw conclusions about causes of death following hip fracture so no less obtrusive methods were available. Only those data needed for casemix adjustment or determining outcome were used in the processing – all other data were removed by NHS Digital and Crown Informatics during preparation of the linked datasets. [2 paragraphs unchanged] Linked HES A&E, APC, OP and CC data will allow NDORMS to assess the validity of hip fracture diagnosis and assess case ascertainment within the NHFD. Linked HES A&E, APC, OP and CC data will allow NDORMS to assess the validity of hip fracture diagnosis and assess case ascertainment within the NHFD. The linkage with Civil Registration Mortality data will provide information on cause and date of death. With ~65,000 hip fractures being entered to the NHFD each year and an overall all-cause mortality rate of 6.7% at 30-days; the NHFD is the largest national dataset available to estimate such information. Major groupings of mortality, such as venous thromboembolism (VTE), stroke, infection that exist within the data will be assessed and all cause and cause specific mortality rates over time will be reported using survival analyses. Variation across the hospitals using mixed effects regression models will be reported and explored. The linkage with Civil Registration Mortality data will provide information on cause and date of death. With ~65,000 hip fractures being entered to the NHFD each year and an overall all-cause mortality rate of 6.7% at 30-days; the NHFD is the largest national dataset available to estimate such information. Major groupings of mortality, such as venous thromboembolism (VTE), stroke, infection that exist within the data will be assessed and all cause and cause specific mortality rates over time will be reported using survival analyses. Variation across the hospitals using mixed effects regression models will be reported and explored. This study will involve several organisations. The University of Oxford is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose. The Falls and Fragility Fracture Audit Programme (FFFAP), part of the national audit programme of the Healthcare Quality Improvement Partnership (HQIP), will provide a list of all hip fractures sustained in the UK over the last ten years. HQIP is the data controller for FFFAP data and Crown Informatics is their data processor. Crown Informatics will generate the bespoke cohort from the NHFD for linkage by NHS England to HES and Civil Registration Mortality data. The project only requires pseudonymised data. This study will involve several organisations. The University of Oxford is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose. The Falls and Fragility Fracture Audit Programme (FFFAP), part of the national audit programme of the Healthcare Quality Improvement Partnership (HQIP), will provide a list of all hip fractures sustained in the UK over the last ten years. HQIP is the data controller for FFFAP data and Crown Informatics is their data processor. Crown Informatics will generate the bespoke cohort from the NHFD for linkage by NHS Digital to HES and Civil Registration Mortality data. The project only requires pseudonymised data. [1 paragraph unchanged] Delays in data production has slowed progress and the study therefore requires a 12 month extension period for analysis at the University of Oxford. [1 paragraph unchanged] NHS Digital England will act as a trusted third party to securely link all datasets and send the University of Oxford a pseudonymised dataset for the analyses.

Processing activities

The project uses data from National Hip Fracture Database (NHFD) , which [14 words unchanged] undergoing hip fracture surgery. The following personal identifiers were provided to NHS Digital, England, a trusted third party, from NHFD for linkage to HES data and [8 words unchanged] NHS numbers, date of birth, gender, postcode and unique NHFD identifier. NHS Digital England transferred a pseudonymised NHFD dataset to NDORMS for analysis, along with age, gender and clinical data. [1 paragraph unchanged] 1. Crown Informatics sent the following identifying data to NHS Digital: England: NHS Number, Date of Birth, full postcode and FFFAP ID (a study ID for the Falls and Fragility Fracture Audit Programme); 2. NHS Digital England extracted the HES and mortality data linked to the cohorts whose identifiers were supplied by Crown Informatics; 3. NHS Digital England created a separate HES extract of individuals who had hospital episodes with [14 words unchanged] included in the cohort and whose identifiers were supplied by Crown Informatics; 4. NHS Digital England removed the identifying information and disseminated both extracts to the University of Oxford as pseudonymised data. The linked extract also contained the FFFAP ID supplied by Crown Informatics. [9 paragraphs unchanged]

Expected output

Within 12 months of receiving the extension to retain and process the data the following will be produced: Work has continued on the analysis which completed in May 2023. Final work is completing on preparation of a manuscript for submission to the Bone and Joint Publishing house for a free to access publication. We expect to submit this in November 2023. We anticipate a period of peer review during which time it is likely that requests may be made for further analyses which is whey an extension is now requested. We anticipate that all review comments will be finalised before August 2024. 1. Peer-reviewed publication of UK hip fracture mortality risk and cause of death In addition, to support the publication we will submit to (inter)national conferences, an abstract of the work at: 2. Peer to peer dissemination of findings through (inter)national conferences: [4 paragraphs unchanged] The University of Oxford had originally planned to produce these outcomes 12 months from originally receiving approval from DARS to use the data. However due to the unprecedented current climate, the University of Oxford is applying for a 12 month extension to continue processing the data. [1 paragraph unchanged]

Expected measurable benefits

[13 paragraphs unchanged] The dissemination plan is to produce three distinct outputs, which wil will be published in the scientific media as well as distributed through the FFFAP social media networks and PPI networks. These outputs are: [3 paragraphs unchanged]

Benefits reported

The processing of the data has now been completed to develop the [15 words unchanged] University of Oxford expect to able to produce each of the outputs within before the next 12 months. end date of the extension. The outputs will put in place both clinical targets and methodological structures [49 words unchanged] University of Oxford also expect the outputs to directly benefit other research group sin groups in UK and plan to provide HDR(UK) with the University of Oxford’s outputs for further dissemination. [1 paragraph unchanged] The work has already supported the application for a NIHR HTA Stage 2 grant entitled DIRECT for a randomised trial to investigate the most appropriate treatment strategies for venous thromboembolism prophylaxis for patients sustaining hip fracture.

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

Objective for processing

The University of Oxford requires HES and Civil Registration (mortality) data for [16 words unchanged] with hip fracture. The mortality is very high, up to 30% at 12-months 12months following hip fracture. In 2013 there were more than 61,000 hip fractures [18 words unchanged] fracture but systematic large-scale analysis of the causes of mortality is lacking. [2 paragraphs unchanged] The project requires data about patients over 60 years of age undergoing hip fracture surgery from the Falls and Fragility Fracture Audit Programme (FFFAP) linked with HES and civil registration mortality data. Data were requested from 2010 to 2017; the earliest date of available data up to the most recent available at the time of application. This maximum period, covering all patients with hip fracture in England and Wales, yields the most data available from which to draw robust conclusions. Restricting the dataset might mask important temporal or geographical variations across England and Wales. Only patient-level data can yield the necessary information to draw conclusions about causes of death following hip fracture so no less obtrusive methods were available. Only those data needed for casemix adjustment or determining outcome were used in the processing – all other data were removed by NHS Digital and Crown Informatics during preparation of the linked datasets. The project requires data about patients over 60 years of age undergoing hip fracture surgery from the Falls and Fragility Fracture Audit Programme (FFFAP) linked with HES and civil registration mortality data. Data were requested from 2010 to 2017; the earliest date of available data up to the most recent available at the time of application. This maximum period, covering all patients with hip fracture in England and Wales, yields the most data available from which to draw robust conclusions. Restricting the dataset might mask important temporal or geographical variations across England and Wales. Only patient-level data can yield the necessary information to draw conclusions about causes of death following hip fracture so no less obtrusive methods were available. Only those data needed for casemix adjustment or determining outcome were used in the processing – all other data were removed by NHS Digital and Crown Informatics during preparation of the linked datasets. [4 paragraphs unchanged] This study will involve several organisations. The University of Oxford is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose. The Falls and Fragility Fracture Audit Programme (FFFAP), part of the national audit programme of the Healthcare Quality Improvement Partnership (HQIP), will provide a list of all hip fractures sustained in the UK over the last ten years. HQIP is the data controller for FFFAP data and Crown Informatics is their data processor. Crown Informatics will generate the bespoke cohort from the NHFD for linkage by NHS Digital to HES and Civil Registration Mortality data. The project only requires pseudonymised data. This study will involve several organisations. The University of Oxford is the sole data controller and also processes the data for this study. No other organisations process the data for this purpose. The Falls and Fragility Fracture Audit Programme (FFFAP), part of the national audit programme of the Healthcare Quality Improvement Partnership (HQIP), will provide a list of all hip fractures sustained in the UK over the last ten years. HQIP is the data controller for FFFAP data and Crown Informatics is their data processor. Crown Informatics will generate the bespoke cohort from the NHFD for linkage by NHS Digital to HES and Civil Registration Mortality data. The project only requires pseudonymised data. [2 paragraphs unchanged] The study is funded by grant income and underpinned by support from [14 words unchanged] Rheumatology and Musculoskeletal Sciences (NDORMS) and sponsored by the University of Oxford. Although Under v1.7 of the Data Sharing Agreement data is currently stored within NDORMS, members was relocated from NDORMS to The Nuffield Department of Population Health (NDPH) where Members of the research team are located in The Nuffield Department of Population Health. The University of Oxford are therefore requesting permission to relocate the data storage and processing from NDORMS to NDPH. located. NDORMS and NDPH both sit within the Medical Sciences Division of the University of Oxford. [1 paragraph unchanged]

Expected output

[7 paragraphs unchanged] The University of Oxford had originally planned to produce these outcomes 12 months from originally receiving approval from DARS to use the data. However after delays in data production, due to the unprecedented current climate, the University of Oxford is applying for a 12 month extension to continue processing the data. [1 paragraph unchanged]

Expected measurable benefits

[9 paragraphs unchanged] • Calculation of absolute mortality hazard risk after hip fracture • Calculation of sub-group adjusted mortality hazard risk after hip fracture [2 paragraphs unchanged] The dissemination plan is to produce three distinct outputs, which wil be published in the scientific media as well as distributed through the FFFAP social media networks and PPI networks. These outputs are: 1. Case ascertainment of NHFD compared with HES records 2. All cause and cause specific mortality 3. Suitability of NHFD as a registry to embed randomised trials

Benefits reported

Due to delays in production The processing of the data no yielded benefits have has now been achieved. completed to develop the reports for the above outputs. If the University of Oxford are awarded a an extension The University of Oxford expect to able to produce each of the outputs within the next 12 month extension to access the data all expected measurable benefits are expected to be achieved. months. The outputs will put in place both clinical targets and methodological structures to facilitate research into reducing mortality after hip fracture within the UK. the University of Oxford expect these benefits to be realised by 65,000 patients annually in England, Wales and Northern Ireland. As well as the indirect patient benefit of this work providing a structure for future research the University of Oxford also expect the outputs to directly benefit other research group sin UK and plan to provide HDR(UK) with the University of Oxford’s outputs for further dissemination. The benefits will be available immediately on production of the outputs and success will be determined by the successful launching of such a registry enabled study within the next 12-36 months.

Unchanged: Processing activities.