Periprosthetic femoral fractures: data, management and outcomes

Imperial College London requires access to NHS England data for the purpose of the following research project:

Periprosthetic femoral fractures: data, management and outcomes

The following is a summary of the aims of the research project provided by Imperial College London:

Imperial College London Dr Foster Unit (ICL DFU) requires Civil Registrations of Death data to be linked to the National Hip Fracture Database (NHFD, supplied by Crown Informatics Ltd) to examine mortality following hospital admission for a periprosthetic femoral fracture (PPFF). This is part of a three-year overarching project, in which four databases will be analysed: Hospital Episodes Statistics (HES), National Joint Register and the Trauma Audit and Research Network (now renamed as NMTR).

This Data Sharing Agreement (DSA) will permit the linkage of NHFD to Civil Registration data and return the de-identified data to ICL DFU for research purposes. The HES data already held under a separate DSA will not be linked with the deaths data requested under this DSA.

In brief, the objectives of the whole NIHR-funded project are:

1. Assess the variation between hospitals in England in how these patients are managed and their outcomes

2. Obtain healthcare professionals’ views on how patients should be managed, collecting new qualitative data from interviews and service case studies

3. Obtain patients’, family members’ and carers’ views on what they want from care before, during and after fracture treatment, including, for instance, on whether they would be willing to travel to a specialised centre

4. Define measures of quality of care to assess future improvement efforts and explore the best way to collect any necessary additional data for these measures

This DSA relates to objectives 1 and 4 above. The project began on Dec 1, 2022, and will run for a minimum of 36 months.

The following will be investigated: time trends and variations in mortality, both at 30 days after hospitalisation and via time-to-death analyses, by hospital, by treatment (revision, fixation, other procedure vs no main procedure) and by a combination of the two, including what factors (patient and hospital) influence mortality, both all-cause and for some specific causes. This is an observational study, meaning that it involves no interventions or treatments other than those already given by NHS teams during daily patient care. For this project, it is important to be able to capture deaths occurring following discharge from hospital to assess the full mortality burden relating to that hospitalisation. Out of hospital deaths are particularly useful for surgical outcomes, e.g. for the calculation of total 30-day post-operative death rates, as the effect of premature discharge (in terms of mortality) would otherwise go unnoticed. Longer-term follow-up of hospitalised patients, e.g. using one-year survival, necessitates being able to capture all deaths, not just those occurring in hospital.

The following NHS England Data will be accessed:

> Civil Registration Mortality – necessary because mortality following admission for this type of fracture is an important patient outcome for this project. The NHFD publishes 30-day mortality rates on its website by hospital in England and Wales, and ICL DFU aim to compare such rates with those obtained from the other three databases at hospital level. In addition, knowing the date and cause of death will allow the ICL DFU to understand differences in time to death and its cause by hospital and by procedure. For these reasons, the provider details, pseudonymised patient ID matching that in the NHFD, date of death, causes of death are required for all hospitals in NHFD.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by Imperial College London (estimated size: 8,000 - 10,000) – the cohort includes patients over 18 years old with a PPFF recorded on the NHFD.

> National Data is required to allow comparison with the other databases, which are also national, and for inter-hospital comparisons.

Imperial College London is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the project described.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Crown Informatics Limited’s role is limited to collecting and storing the data from the hospitals for the NHFD audit and sending the cohort identifiers to NHS England for cohort linkage purposes. They do not have any access to the NHS England Data held under this DSA, nor any role in how this Data is processed.

Imperial College London uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

This request requires linkage to NHFD that HQIP are controller of. Crown Informatics Ltd are HQIP’s processor and hold the data. Crown Informatics Ltd currently link NHFD and Civil Registration data on behalf of NHFD for the purposes of audit. ICL are requesting the same linkage from the same organisations but for research purposes. These organisations are not involved in the project beyond supplying the data.

Imperial College London's PPI co-applicant and their carer are invited to all team meetings, at which the study team present interim findings and discuss next steps. If the PPI co-applicant is unable to attend, the project PPI lead brings them up to speed afterwards. The PPI co-applicant also reviewed and approved the grant application to NIHR, who are funding this work. All NIHR grant applications undergo review by subject experts and public contributors.

With the PPI co-applicant and PPI advisory group, Imperial College London will co-produce patient resources to help people understand their PPFF and its management, including what to expect when in hospital and during rehabilitation. This will be informed by the findings across the study and is something the PPI co-applicant was keen on from the outset. This will take the information resource for hip fracture from the NHFD website as a starting point.

No PPI consultation has been conducted specifically around the use of identifiable data in the data flows and data linkage outlined in this application. However, we had to submit a data application form for the NHFD to the Falls and Fragility Fracture Audit Programme (FFFAP), which has patients on its committees: see https://www.hqip.org.uk/howa-patient-panel-is-driving-improvemen t/ for details of patient involvement. Feedback included a recommendation to go beyond just 30-day death rate (as a yes/no) variable and look at the number of days between fracture and death. The project team’s PPI group will be sought to obtain their views on dissemination of the outputs to the public.

Crown Informatics Ltd will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Name, Date of Birth, Postcode, Gender and a unique person ID) for the cohort to be linked with NHS England Data.

NHS England will provide the relevant records from the mortality dataset to Imperial College London. 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 Data will be stored on servers at Imperial College London.

Imperial College London uses offsite data centre services provided by VIRTUS data centre. VIRTUS provide access to the building where the Data is stored only and have no access to the Data. Imperial College London own the servers on which the Data is stored.

The Data will be accessed by authorised personnel via remote access.

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.

For remote access:

- 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;

- Access controls granting users the minimum level of access required are in place;

- 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/Wales. The data will not leave England/Wales at any time.

Access is restricted to employees of Imperial College London.

Access to confidential patient identifiable data is restricted to employees of Crown Informatics Ltd.

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

The Data will be linked at person record level with linked to the National Hip Fracture Database (NHFD) obtained from Crown Informatics Ltd).

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 Imperial College London will process the Data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to the funder, NIHR. NIHR will receive brief progress summaries every 6 months during the project and a full report at its end.

> Submissions to peer reviewed journals. Target journals are orthopaedic ones (for example, the Injury, Bone and Joint Journal).

> Presentations to the study team and stakeholders

> Presentations at appropriate conferences. Target conferences include HSRUK, British Orthopaedics Association, British Hip Society and the Fragility Fracture Network.

> A resource for patients and families detailing what to expect from PPFF treatment and recovery. This is likely to contain some statistics derived from the analysis of project data such as on survival.

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.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Presentations

> Conferences

> Study website updates

> Social media

NIHR progress reports are due bi-annually until the end of the project. The first journal submission is expected approximately 9 months following data receipt, and another approximately 16 months following data receipt.

The number of hip and knee replacements is likely to continue to grow, due to factors such as population ageing and higher body mass indices. This in turn will mean an increasing incidence of PPFFs. Imperial College London’s published HES study for England found 13,565 patients who had 18,888 admissions between 1 April 2015 and 31 December 2018, with a 13% year-on-year increase. More recent HES data shows that this rise has continued bar the temporary post COVID-19 lockdown dip. Knowledge of the death rates, time to death, cause of death, and variations in these quantities by treatment and by hospital is key for subsequent NHS quality improvement policies and for planning future clinical trials where there is clinical uncertainty about the best treatment for a given subgroup of patients. Dissemination the project’s results is essential to inform future quality improvement initiatives. These will aim to reduce the amount of unnecessary variation in how PPFF patients are treated and reduce the rate of poor outcomes such as death and disability.

The results of this study will serve as a benchmark against which the NHS and its hospitals can evaluate progress. The likely timescale for the realisation of these benefits is of the order of 3-5 years after publication of the results.

The use of the data could:

- help the system to better understand the health and care needs of populations.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

- advance understanding of regional and national trends in health and social care needs.

- inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

- inform decisions on how to effectively allocate and evaluate funding according to health needs.

- provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

Findings on how patients should be managed and on the level of and reasons for variation in decision-making and outcomes between hospitals will inform NICE guidelines and the Get It Right First Time programme. This in turn is expected to help surgeons and teams make better and more consistent treatment decisions, ultimately benefiting their future patients by better outcomes and reduced suffering. Reducing the number of poor outcomes should also save care costs in the future.

The project team includes representatives from three of the databases to be used (NHFD, NJR and TARN), facilitating engagement with those organisations, as well as relevant professional bodies such as the British Hip Society, the Royal Colleges, British Orthopaedic Association, revision hip and knee networks, NHS England, NICE, and relevant physiotherapist and nursing bodies throughout.

Yielded Benefits is not a requirement for new applications.