Evaluating Clinical Outcomes in Hip, Knee, Foot, and Ankle Surgery

The University of Oxford and University of Bristol require access to NHS England data for the purpose of the following research project:

Evaluating Clinical Outcomes in Hip, Knee, Foot, and Ankle Surgery

The following is a summary of the aims of the research project:

“The purpose of this project is to analyse national hospital episode data to determine the rate of adverse events associated with commonly performed orthopaedic procedures of the lower limbs, investigate the impact of surgeon and unit volume on outcomes, and benchmark proposed thresholds for care outcomes (rate of adverse events or outcomes) that could permit the monitoring of the quality of care and outcomes in the future.

Building upon previous work (DARS-NIC-68703-R4Y6C-v3.5), these national data will be used to identify adverse events for a range of commonly performed hip, knee, foot, and ankle interventions. This study proposes to determine the rate of complications (such as infection, pulmonary embolism, stroke, heart attack, amputation, death) that occur following these procedures along with the risk of readmission, reoperation and revision surgery. The impact of surgeon and treating unit volume will be analysed for individual procedures or groups of similar procedures. National Joint Registry data shows that low volume caseload surgeons may have a higher reoperation rate, but a similar analysis has not been performed in the Hospital Episode Statistics for joint replacement to investigate whether similar results can be reported, and no such analysis has been performed for the other commonly performed orthopaedic procedures.”

The following NHS England data will be accessed:

• Hospital Episode Statistics (HES) Admitted Patient Care (APC)

• Civil Registration Mortality.

• Patient Reported Outcome Measures (PROMs)

The data requested are required for the analysis of the following:

- to construct a co-morbidity profile for patients (5-year look back Charlson comorbidity index).

- Analyse trends in the rates of procedures being performed (e.g., changes related to the publication of evidence)

- trends in the rates of complications and trends in associations between procedures over time – such as the association between ankle fracture surgery and subsequent ankle replacement or fusion for osteoarthritis, knee fracture surgery and subsequent knee replacement, etc.

- provide adequate numbers for valid analysis of the less commonly performed procedures.

The level of the data will be Pseudonymised.

The data will be minimised as follows:

- Limited to data for a study cohort identified by NHS England as meeting the following criteria:

- Patients who underwent a procedure identified by a prespecified list of OPCS codes limited to orthopaedic procedures and limited anatomically to hip, knee, foot or ankle between 1998 and 2023

- Limited to data between 1998 and 2024. For each individual patient, HES data will only be provided from the date 5 years before the qualifying procedure and all data after until 2024. 5-years look back and the follow up period is necessary as there is no long term outcome data for these procedures. It makes the best use of all of the patient data requested, maximising the potential benefits and impact of the work. For less commonly performed procedures, this allows a larger sample to be analysed increasing the statistical validity of the work.

The University of Oxford and University of Bristol will be data controllers and the organisations 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)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research and aims to produce publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the Academy of Medical Sciences. The funding is specifically for the project described. Funding is in place until the end of this agreement.

Data will be accessed by:

A PhD student enrolled with the University of Oxford. The individual has completed mandatory data protection and confidentiality training and is subject to the University of Oxford's policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of a substantive employee of the University of Oxford. The University of Oxford would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Data Sharing Agreement (DSA).

Data will also be accessed by:

• An Individual holding an honorary contract under the supervision of a substantive employee of the University of Bristol for the purposes described in this DSA only. The University of Bristol must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

A Public and Patient Information and Engagement group were consulted regarding the collection of the data for the purposes described above. The study will develop plain English summaries of findings for communication to patients and members of the public. These will be freely available and published on the NDORMS website (ndorms.ox.ac.uk). The findings may also be presented at patient and public engagement events. The proposed analysis plan and outputs have been reviewed and approved by an established patient and public involvement (PPI) group.

No data will flow to NHS England for the purposes of this agreement.

NHS England will provide the relevant records from the HES APC, Civil Registration Mortality and PROMS datasets to the University of Oxford. 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.

The University of Oxford will extract all of the NHS England Data held at the University of Oxford and securely transfer this to the University of Bristol.

The data will be stored on servers at the University of Oxford and University of Bristol respectively.

The data will be accessed either onsite at the premises of the University of Oxford or via a virtual private network environment on University of Bristol servers.

The Controller 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. The data will not leave: England at any time.

Data will be accessed by an individual with an honorary contract with the University of Bristol. The individual will act as an agent of the University of Bristol at all times under supervision from employees of the University of Bristol. Aside from this individual, access is restricted to employees or agents of the University of Bristol and the University of Oxford who have authorisation from the Chief 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.

Researchers from the University of Oxford and University of Bristol will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to the British Orthopaedic Association (BOA) to produce British Orthopaedic Association Standards (BOASts) which are guidelines on the management of orthopaedic conditions. The evidence generated from the proposed work may inform new BOASts or updates to current BOASts.

• Submissions to peer reviewed journals. The first publication target is 18 months from data receipt, with further publications at 6 monthly intervals.

• Presentations to the British Association of Surgeons of the Knee (BASK), British Orthopaedic Association (BOA), British Hip Society (BHS), and British Orthopaedic Foot and Ankle Society (BOFAS) Annual Meetings are targets for the presentation of the proposed work. International dissemination will also be sought, through journal publications and conferences such as the American Academy of Orthopaedic Surgeons (AAOS) and European Federation of National Associations of Orthopaedics and Traumatology (EFORT).

• Public reports: The study will develop Plain English summaries of findings for communicate to patients and members of the public - these will be freely available and accessible via the University of Bristol website (https://www.bristol.ac.uk/translational-health-sciences/research/musculoskeletal/orthopaedic/). The findings may also be presented at patient and public engagement events.

• Publication of dashboards on the University of Oxfords' website, including social media engagement with patients, surgeons, researchers, and allied health professionals. The NDORMs Twitter account (@ndorms) will be used to announce study progress and results. This is intended to engage patients, surgeons, and researchers with research outputs as they are produced.

• Public reports: The study will develop Plain English summaries of findings for communication to patients and members of the public - these will be freely available and published on the NDORMS website (ndorms.ox.ac.uk). The findings may also be presented at patient and public engagement events.

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 datasets from which the information was derived.

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

• Journals

• Workshops involving patient and public engagement events and groups

• Social media

• Public reports

• Industry newsletters

The target date for publication of the results and other outputs is spring 2025.

The use of the data could:

• help the health and social care 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.

The study aims to improve health practice, reducing harm by disseminating findings on the rate of complications associated with orthopaedic procedures performed for the hip, knee, foot, and ankle. This work is in the public interest in the context of the expected measurable benefits.

Analysis will be reported for the studied procedures in different populations of patients and factors associated with a higher risk of adverse events will be summarised. Variation will be studied and reported along with trends at a geographic level.

The impact of hospital and surgeon volume on outcomes will be studied and reported and this is likely to inform improvements to care through recommendations on service design and care pathways. It is highly likely that complication rates vary by health provider (hospital or surgeon level) for these procedures and this investigation will be important in benchmarking care so that an outlier hospital, for example, could be identified in the future to improve outcomes and avoid harms. It is likely that surgeons with a higher volume practice in some procedures may have better outcomes, but it is not known for which procedures this is important – this study may help to define the procedures that are best performed by more specialist surgeons with a high volume of experience rather than ‘generalists’ performing smaller numbers. This may not be case for all procedures, but it not currently known if this is the case for procedures other than joint replacement.

The outcomes from this study may inform patients and surgeons about the risks of procedures and aims to support the shared decision-making process and could lead to fewer high-risk procedures being performed where this risk was previously unknown. Adverse outcomes for certain procedures performed for similar indications may be identified and compared. For example, in foot and ankle surgery, outcomes of ankle replacement and ankle arthrodesis will be compared. These two procedures can be offered for similar indications but there is little information to inform patients and surgeons on relative risks of rarer but serious adverse events. This is because the number of these procedures performed in single centres is usually small and numbers reported in series in the literature also too small to be adequately powered to report this information.

The study outcomes may inform NHS managers, commissioners and other health professionals of the outcomes and predictors of outcome for some of the most common orthopaedic procedures. This may encourage a change in practice where necessary, for example due to geographic variation or inappropriately high rates of surgery or higher than expected complication rates. The study outcomes may provide commissioners with evidence of any factors that can explain or address unwarranted variation.

In summary, it is hoped that some of the measurable benefits to health and or social care will be:

1. Patients may be better informed and empowered in the shared decision-making process around these surgical procedures. They may have a better understanding of the risks and long-term outcomes, and this may be invaluable in the consenting process. This improvement could benefit hundreds of thousands of patients undergoing hip, knee, foot and ankle procedures each year.

2. Surgeons may be informed and supported in delivering evidence-based surgery. This may change practice, encouraging ineffective procedures to be abandoned or improve decision making by providing rich data on the relative risks of procedures. The findings of this study may be disseminated to surgeons through journal publications, conference presentations, and communication through social media and the British Orthopaedic Association (BOA).

3. NHS commissioners may be supported in decision making around pathway design and service improvement. For example, for any specific procedures where low volumes are shown to be associated with poor outcomes. Some types of procedures or procedures for certain groups of patients may be found to be of limited benefit or of unacceptably high risk, and such procedures could be recommended for decommissioning. This may lead to large cost savings and ensure patients do not undergo procedures with high risks of adverse events for limited or no benefit. Similarly, the outcomes could help ensure patients do not undergo treatment on a care pathway that could be optimised, for example, in a higher volume centre (should the data analysis support such a recommendation).

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Analysis is ongoing. Publications are currently being written and prepared.