This year, the NJR has started a programme of work which aims to profile the successes and benefits that the NJR has realised over the past 17 years. This work will examine the practical tools and reporting systems that NJR makes available to its users as well as the benefits to society of a comprehensive national registry.
The first phase of this work has focussed on outlining to hospital executives what the tangible benefits are to their services that become available by subscribing to the NJR. This summary of benefits has been sent out to all NHS and independent sector units.
The second phase of the work will take place during FY2020/21 and will be overseen by Professor Ashley Blom and Professor Mark Wilkinson. This will take a broader view of the improvements in arthroplasty practice and benefits to hospitals, surgeons, patients, regulators and policymakers that have been associated with the development of the NJR over the years.
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, Never Events are 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.
The data entry system was changed 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 NJR Centre staff so that this can be investigated. If an alert is confirmed as a genuine Never Event, the Consultant in Charge is contacted by a surgeon member of the NJR Steering Committee to confirm what action, if any, will be taken.
A very small number of 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 in data entry, such as selecting the wrong side for the operation or using the wrong label detail for recording the implants.
As part of this focus on never events, the NJR has been working to deliver the validation rules that the NJR applies in data entry to an external environment, so that it can be used in support of intra-operative checks. An Application Programming Interface (API) has been developed so that hospital theatre systems can interface with NJR’s checking rules. A smartphone application is also being developed so that clinical teams can carry out validation checks even if their hospital does not have a compatible front-end system.
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.
The NJR now commissions an ongoing programme of research from the University of Bristol and this focusses on a rolling programme of four research topics for detailed examination. These projects are jointly led by a clinician from the NJR and a clinical academic from the University of Bristol guiding expert statisticians to ensure that the analysis is of the highest possible quality.
The NJR research programme currently consists of these topics:
• Inequalities in provision and outcomes of arthroplasty performed in England
• Development of an Orthopaedic Arthroplasty Specific Morbidity Index
• Factors associated with revision and its outcomes
• Surgical approach for primary hip and knee replacements
The NJR also supports external research groups to access and use NJR data for research. The NJR research committee reviews submissions from groups 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 NJR research applications can be found at https://www.njrcentre.org.uk/njrcentre/Research/Research-Portfolio
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 its 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.
Following a meeting of the NJR Steering Committee in 2018, it was agreed to establish a PROMs working group, 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.
ePREMs: In April 2020, the NJR started an electronic Patient Reported Experience Measures (ePREMs) pilot. The NJR would like to communicate with patients who have had a joint replacement, to invite them to participate in completing a questionnaire in relation to their experience of their joint surgery. It is hoped that they will share their experiences with the NJR and it is intended to use this feedback to improve the healthcare given to all patients. The project and invitation to patients to complete the questionnaire will be run for 12 months as an initial pilot. Thereafter the project will be extended, if deemed successful, and the outcomes will be further communicated.
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 on behalf of the NJR will aim 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 made available to manufacturers via the NJR Supplier Feedback platform. 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 submissions to support device assurance. The NJR is currently developing a system that will make a library of these implant reports available to clinical teams – it is hoped to launch that platform in 2021/22.
Shoulder PROMs: For shoulder replacement joint surgery, the NJR commenced regular six-month follow-up in April 2017 for patients who had undergone surgery after 1 October 2016. The disappointingly low rate of pre-operative submissions is being addressed by the British Elbow and Shoulder Society, in conjunction with the NJR and the Getting It Right First Time (GIRFT) programme. Response rates to questionnaires sent directly to patients at their home addresses post-surgery averages at just over 80%.
The NJR’s Data Quality Audit programme has been designed to assess the completeness and quality of the data submitted to the NJR. It enables the NJR to compare patient records for procedures recorded in local hospitals’ databases (e.g. Patient Administration Systems) to those in the registry, with the aim of investigating the accuracy of the number of arthroplasty procedures submitted to the NJR, compared to the number carried out.
The importance of the Data Quality Audit is clear when considered in the context of the NJR’s primary aims. To achieve those aims, there are two principal outcomes of interest to the NJR: revision surgery and mortality.
Revision surgery is an indicator of implant failure or surgical performance. This is determined by linking a primary arthroplasty procedure to a subsequent procedure which typically occurs a number of years after the primary procedure. Therefore, compliance with reporting revision surgical procedures is essential to estimate implant failure rates and surgical performance more accurately.
Mortality data is collected from Civil Registration Data which is obtained from NHS Digital and linked to individuals within the NJR. However, it is important to remember that joint replacement is a very successful operation with a very low mortality rate and, currently, all surgeons and hospitals have outcomes in line with the expected range.
The current audit process has successfully validated the method of checking for missing records but has proved time and labour intensive for both NJR and hospital staff. The NJR is now beginning a national roll out of a semi-automated process which enables units to check their data quality on a monthly or quarterly basis. This will greatly reduce 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 and knee data. If your hospital wishes to be included in the next cohort of hospitals, please contact enquiries@njrcentre.org.uk or via the NJR website.
Having completed a pilot audit of shoulder replacement entries in the North East of England, shoulders will next be included in the automated audit process followed by elbows and ankles, with a full roll out across all joints by the end of FY2020/21.
In order to ensure that more historic data anomalies are able to be addressed in elbow surgery, the NJR is working with the British Elbow and Shoulder Society (BESS) to carry out a national manual audit of elbow arthroplasty data involving surgical trainees reviewing patient records and identifying missing cases. For more information, please contact BESS on njrelbowaudit@gmail.com
In June 2018, the NJR went live with the latest version of the dataset, Minimum Dataset Version 7 (MDSv7), which represented a number of significant changes to the data collection.
A series of minor updates were made to MDSv7 in March 2020 as detailed below:
Robotic Surgery: Given that there has been an increase in the use of robots in joint replacement surgery, this practice now needs to be formally recorded in the NJR. For both the hip and knee primary forms (H1 and K1), a new field: ‘Robotic surgery used?’ has been included. If ‘Yes’ is selected, it is necessary to select the robot name from a drop down list.
Email address and mobile phone number: As part of an NJR pilot of collecting Patient Reported Experience Measures (PREMs) for patients who have had a joint replacement, people will be contacted to invite them to participate in completing a questionnaire. To enable the NJR to conduct this feedback exercise it is necessary to collect patient contact information and the new NJR Consent Form and data entry system will include fields for both patient email address and mobile phone number. A patient can still consent to inclusion in the NJR even if they choose not to share their contact details.
Consultee Consent: A requirement has been placed on the NJR to record those instances where a third party, or ‘Consultee’, has recorded either ‘Yes’ or ‘No’ for consent. This is for cases where a patient is admitted as an emergency or for where the patient lacks the mental capacity to provide informed consent. The Consultee may be a family member, guardian, carer, or clinician not directly involved in the care of the patient. Most hospitals will have designated staff who can consent on behalf of patients.
During this current financial year, initial planning will commence for the next major update to the NJR MDS. Clinical teams who submit NJR data from their hospitals are encouraged to share any suggestions for improvements. Any suggestions can be submitted to your Regional Clinical Coordinator or to njr@njr.org.uk