Developments

TORUS Registries

After a considerable time and a great deal of discussion, it has been confirmed by NHSEI and the DH, that funding will not be available to take forward the proposal to integrate the group of orthopaedic registries that form the BOA TORUS programme, under the umbrella of the NJR, to create a Musculo-skeletal registry. This does not mean that those TORUS registries will not get support with finance or governance, but that this is to be done through the GIRFT programme, rather than by alignment with the NJR.
 

NJR website development

In Spring 2022, we launched our new NJR website at www.njrcentre.org.uk. Our in-house communication team designed and built the architecture and structure for the new website in a completely new content management system, working with a collaborative approach alongside our NJR management team, clinicians and our valued patient-representatives for input in reviewing and creating new web content. 

As our public-facing information portal, the aim of the development has been to enable increased functionality to make the website more engaging and provide us with the opportunity to develop new supplementary visual material so that we can tell you more about the work we do and demonstrate more imaginatively how the NJR continues to benefit all of our stakeholders across the orthopaedic sector.

Implant scanning/never events

In 2018, the NHS Healthcare Safety Investigation Branch identified a requirement to reduce the number of ‘Never Events’ associated with joint replacement surgery. The NJR was identified as a means by which this could be achieved. 

For hip surgery, a Never Event is where there is a mismatch in size between the acetabular cup/liner and the head or where different brands of head and stem are used in modular components. For knees, a Never Event relates to side, e.g. a left-sided component being put into a right knee. 

To address this potential problem, NJR’s data entry system was updated to enable it to detect potential Never Events and to warn the data entry user. At the same time as warning the user, the system generates emails to our staff so that this can be investigated. If an alert is confirmed as a genuine Never Event, the Consultant in Charge of the patient is then contacted by a surgeon member of the NJR Steering Committee to confirm what action, if any, will be taken. 

A very small number of actual Never Events are identified in this way each year but the number of ‘false alarms’ is considerably higher. These alarms are most often likely to be due to mistakes only in the data entry system, such as having selected the wrong side for the operation or using the wrong label detail for recording the implants.  

As part of this focus on Never Events, we have worked to deliver the validation rules that are applied in data entry to an external environment, so that it can be used in support of intra-operative checks. We have developed an Application Programming Interface (API) so that hospital theatre systems can interface with NJR’s checking rules. We have also developed desktop and smartphone applications so that clinical teams can carry out validation checks even if their hospital does not have a compatible front-end system.

For more information about how to access the NJR’s implant scanning tools, please visit our website. 

Research Programme

With such a rich data pool of around 3.5 million records, the NJR’s research activity has been developed over a number of years and has led to a large number of important and impactful publications – delivering valuable evidence about how joint replacement surgery works with the key aim of being used to improve patient safety and outcomes.

The NJR now commissions an ongoing programme of research with the University of Bristol and University of Oxford and this focuses on four specific research topics for detailed examination. These projects are jointly led by a clinician from the NJR team and a clinical academic from the University of Bristol, guiding expert statisticians in the work to ensure that the analysis is of the highest possible quality.

The current NJR research programme consists of these topics:

•    Inequalities in provision and outcomes of joint replacement performed in England
•    Development of an Orthopaedic Arthroplasty Specific Morbidity Index
•    Factors associated with revision and its outcomes
•    Examination of data quality in the national PROMs programme

We also support external researchers to access and use NJR data for research under strict data control measures. The NJR research committee reviews submissions from researchers across the country, and advises and supports in ensuring that NJR data can be best used to inform and improve practice. A full portfolio of external research applications can be found at https://www.njrcentre.org.uk/research/research-requests/. Over 70% of all research projects are now led by groups external to the NJR and we continue to work closely with external researchers to improve accessibility further.

In January 2022, we held out first NJR Research Webinar focusing on supporting researchers on accessing NJR data for their studies. We were delighted to welcome prospective research applicants from across the UK to hear presentations on data access and analysis from our expert team. The videos of the event are freely available on our Youtube channel.

The NJR Data Access Portal (DAP) has been developed to streamline research applications by providing a secure working environment, including analysis tools, for researchers and users of NJR data, whilst enabling the NJR to manage and control our data more effectively. By providing access to the data without the need for datasets to be sent to third-parties, it is anticipated that the governance burden that research teams face will be significantly reduced. 

PROMs

Following a meeting of the NJR Steering Committee in 2018, it was agreed to establish a PROMs working group, which is led by the Chair of the NJR’s Research Committee, Professor Mark Wilkinson. This group oversees a number of workstreams that involve the collection, analysis and reporting of patient reported metrics.

Assessment of PROMs data quality: As the NJR increasingly uses PROMs metrics from the national PROMs programme (undertaken by NHS Digital) alongside revision and mortality endpoints, an examination of the quality and representativeness of national PROMs for the population of patients in England who have hip and knee replacement surgery is now being undertaken. This important work, that is being carried out by the University of Bristol and University of Oxford on behalf of the NJR, aims to ensure that clinicians, hospital managers and regulators can have confidence in using patient reported metrics to assure quality.

Use of PROMs in implant reports: The NJR now routinely includes reporting of PROMs metrics in implant reports that are made available to manufacturers via the NJR Supplier Feedback service. This means that patient reported metrics can be considered alongside revision rates when examining the performance of an implant or construct. Increasingly, regulatory bodies internationally are requiring PROMs to be included as part of industry submissions to support device assurance. 

Shoulder PROMs: For shoulder replacement joint surgery, we commenced six-month follow-up questionnaires in April 2017 for patients who had undergone surgery after 1 October 2016. Three-year follow-up was commenced in October 2019. We continue to struggle with a disappointingly low rate (<25%) of pre-operative PROMs submissions and encourage units to capture this important data from all of their patients. Response rates to questionnaires sent directly to patients at their home addresses post-surgery averages at just over 80%.

Component classification/database

In 2018, the NJR started working with the German Arthroplasty Registry (EPRD) to develop a common classification system for defining the attributes of hip and knee arthroplasty components. This classification has now been adopted by both registries with each managing their own local databases, which are populated by industry implant suppliers.

Our own component database is now fully implemented across Supplier Feedback services and attributes are being completed by industry. Use of this classification data for NJR reporting will commence in 2021/22.

Both the NJR and EPRD have now agreed to license the component classification system to the International Society of Arthroplasty Registers (ISAR) for their International Prosthesis Library (IPL) platform, meaning the hip and knee components can be classified in the same way in registries across much of the world. This work will provide numerous valuable benefits: improving the comparability of data, increasing the opportunity to pool results for identifying poor outcomes and decreasing the burden on industry colleagues in data upload.

During 2022/23, we will be working closely with our international colleagues to start developing a common classification system for shoulder replacement surgery, which will feed into our development of a shoulder component database.

NJR Connect - Data Services

In 2019, we commissioned the development of a cloud-ready, platform-based application framework for provision of future NJR services. The rationale for the implementation of the new NJR IT platform includes a focus on the need to develop a modern, unified environment with the ability to move to a cloud-based infrastructure. The platform development will include enabling new services that will transfer across stakeholder user groups, so that functionality and developments can be replicated across all systems on the portal. Optimisation of modules for access on mobile devices will also be included.

The first phase of development (iteration 1) transferred clinician feedback services into the new environment along with a more interactive reporting service. This was launched in March 2021 and included the following modules:

•    Interactive outcomes and clinical practice reports
•    Consultant and Surgeon Level Report (CLR & SLR)
•    Annual Clinical Report (ACR)
•    Clinical Outcomes Publication Preview (COP)
•    Clinician Profile Edit
•    User Contact Database

Iterations 2 and 3 followed during 2021/22 and included development of other NJR services:

•    Component Database 
•    Supplier Feedback, including interactive reporting services (SF)
•    Interactive Management Feedback Service (MF)
•    New availability of Implant Data Library
•    New semantic layer to aid researcher access to NJR data – with enhanced data dictionary

We are continuing to look at further opportunities to enhance the capability of NJR Connect to provide reporting services to all our stakeholder user groups and expect to implement a continuous programme of enhancements over the coming years.
 

Minimum Data Set (MDS) Development 

During the year, the Minimum Data Set Working group (MDSWG) has met several times to review possible changes to the data we collect.

Suggested changes were submitted by a range of NJR stakeholders, including orthopaedic specialist societies, implant manufacturing industry, NJR delivery contractors and surgeons.

Changes were considered against the following criteria:

a.    The need to keep the MDS up-to-date and to reflect changes in clinical practice.

b.    The effect of changes on the structure of the database maintained by the Lot 1 contractor and the subsequent effect on NJR reporting systems and outputs.

c.    The need of the Lot 2 contractor to be able to effectively analyse the data collected. 

d.    The effect of any changes on the data already held in the database and whether such changes would lead to a restriction in the size of the dataset available for analysis. 

e.    To ensure standard definitions of interventions and end points of interest are maintained across all of the MDS forms where at all possible.

f.    The cost and administrative burden the changes would entail.

g.    Scientific scrutiny of the impact of proposed changes to the MDS.

h.    Any other factors that the group consider relevant.

MDSv8 is now moving into development and is expected to launch early in 2023. The key changes to the dataset are:

•    Primary hip hemiarthroplasty will now be collected as part of the MDSv8. Conversions to a total hip replacement (THR) from a hemiarthroplasty will now be recorded on a H2 revision form

•    A new form (RO) to capture ‘Reoperations other than revision’ will be introduced for non-revision operations involving joint replacements. These include fixation of periprosthetic fracture, manipulation under anaesthesia, soft tissue repairs and DAIR without modular exchange. Procedures where one or more components are added to, removed from or modified in a joint replacement will continue to be recorded on the relevant revision forms.

•    Dual consultant operating will now be able to be recorded on all forms in cases where two consultants are operating together (as opposed to one assisting the other).

•    Megaprothesis used in cancer or complex trauma surgery will now have a separate form for data capture.

•    Focal knee replacements will now be recorded on knee primary (K1) forms and conversion from focal replacements to unicompartmental or total knee replacements will be recorded on knee revision (K2) forms.

•    The complexity of hip and knee revision surgery will be captured on revision (H2 and K2 forms). 

•    Glenoid morphology will be collected as part of shoulder primary (S1) forms.

•    A new field will be added to all forms to indicate that a procedure has been performed in the context of a clinical trial.

For more information about MDSv8, please see here.

Data Quality Audit Programme

Our NJR Data Quality Audit programme has been devised to assess the completeness and quality of the data submitted to the registry. This enables us to compare patient records for procedures recorded in local hospitals’ databases (e.g. Patient Administration Systems (PAS)) to that in the registry, with the aim of investigating the accuracy of the number of joint replacement procedures submitted to the registry, compared to the number carried out.

The importance of the NJR Data Quality Audit is clear when considered in the context of our primary aims. To achieve those aims, there are two principal outcomes of interest to the NJR: revision surgery and mortality volumes.
 
The occurrence of revision surgery is often an indicator of either implant failure or poor surgical performance. This is determined by linking a primary joint replacement procedure to a subsequent procedure, which typically occurs a number of years later. Therefore, compliance with reporting revision surgical procedures is essential to estimate implant failure rates and the quality of surgical performance more accurately.

Mortality data is collected from Civil Registration data, which is obtained from NHS Digital, and linked to individual patient records within the registry. However, it is important to know that joint replacement is a very successful operation with a very low mortality rate and all surgeons and hospitals have outcomes in line with the expected range.

In 2020/21, we began a national roll-out of a semi-automated data quality audit process, which enables units to check their data on a monthly or quarterly basis. This has greatly reduced the number of mismatches that have to be checked each time the audit is run, and the pilot suggests this rapidly becomes part of the normal workflow. This roll-out is underway for hip, knee, elbow, ankle and shoulder data and all hospitals have now completed an audit of their 2018/19 and 2019/20 data, and many hospitals have started auditing their 2020/21 data. If you work for a hospital that has not yet signed up for the programme, please contact enquiries@njrcentre.org.uk or see further information on the NJR website.

We continue to reward hospitals with good data quality as part of our Data Quality Provider Awards scheme. From 2023/24, the criteria for the awards will change and we will be offering gold, silver and bronze awards for units who are able to demonstrate good systems to identify and capture NJR procedures, with the highest level of awards being attainable by units who can deliver 100% compliance rates.

To ensure that more historic data anomalies could be addressed in elbow surgery, we worked with the British Elbow and Shoulder Society (BESS) and the British Orthopaedic Trainees Association (BOTA) to carry out a national manual audit of elbow joint replacement data. This involved surgical trainees reviewing patient records to identify and capture any cases that were seen to be missing from the registry. 

We also carried out an audit this year looking at missing components in dual mobility hip replacement procedures. This involved the participation of 178 hospitals, who worked with us, retrospectively examining their records of these procedures and identifying missing components. Consequently, the number of invalid constructs in dual mobility hip procedures has substantially reduced from 1,553 to now only 132. 

Similar spotlight data quality improvement exercises using this methodology are being planned, with a further project to identify and correct invalid constructs in shoulder procedures likely to take place later in 2022/23.