1 Fracture-related infection and the benefits of a registry

Fracture-related infection (FRI) is a severe complication following skeletal trauma and is associated with high patient morbidity and healthcare costs.¹ A recent systematic review comprising 3701 patients from 93 studies highlighted the heterogeneity of treatment protocols and the lack of standardised outcome parameters. They concluded that in order to better understand the relationship between treatment protocols, risk factors and outcomes, critical data such as patient demographics, antimicrobial choice and causative organisms require further study.²

Previously, the lack of a universally accepted definition of FRI further contributed to the scarcity of evidence on diagnostic strategies and protocols tailored to FRI. This has led to treatment concepts for FRI being adopted from prosthetic joint infection (PJI) algorithms.³ In 2018, an international expert consensus definition was published with a set of confirmatory and suggestive criteria which have since been validated.^4,5 There is a now a growing awareness that FRI is a unique entity with increasing opportunity for clinicians to standardise management using sound scientific evidence and thus allowing the establishment of an infection registry. Registries are key to understanding real world data at scale. One example within orthopaedics is the National Joint Registry (NJR), described as a global exemplar of an implantable medical device registry, which has over 3.5 million procedure records submitted. The benefits of the NJR have been well documented and it continues to be the benchmark for registries.⁶

2 The Bone and Joint Infection Registry (BAJIR) – development & outcomes

In 2013 the draft service specification for bone and joint infection management was published by the National Health Service (NHS) in England. In response the Bone and Joint Infection Registry (www.bajir.org) was established in 2018, capturing bone and joint infection cases presenting to hospitals in England and Wales. The aim of BAJIR, as stated in their mission statement, is ‘to improve the care of patients presenting with these conditions through analysis of collected data on their illnesses and treatments’.⁷ Ultimately, collected data on demographics, co-morbidities, pathogens, treatment strategies and outcomes will be used to gain an understanding of the burden of disease and inform best practice, direct research and guide healthcare commissioners. Fig. 1 shows selected data entry required for each patient submitted on the registry website. Baseline patient-related outcome measures (PROMS) are collected by the clinical team at time of diagnosis, interventions and complications; after which, the central BAJIR team directly contact the patient at 6 months, then follow-up PROMS. The legal basis for enrolment within the registry is Section 251 in England and Wales, but formal consent is required within 18 months, and this is managed by the central BAJIR team.

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Fig. 1 Selected data entry required for each fracture-related infection patient.

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At the time of writing, over 40 NHS Trusts have recorded over 800 confirmed infection cases on BAJIR and this continues to grow. The registry was updated in 2022 leading to the development of two distinct pathways for FRI and native osteomyelitis (rather than grouping all under ‘osteomyelitis’), which will improve the quality of data collected. The BAJIR 2022 annual report provides a summary of the 82 patients with confirmed osteomyelitis submitted to the registry with a breakdown of anatomical site, chronicity and treatment.⁸ We look forward to reporting FRI-specific data on an increasing number of patients in subsequent years.

The registry, funded by contributions from industry and NHS England, is hosted by Northumbria Healthcare NHS Trust and is overseen by a steering committee comprising orthopaedic surgeons with an interest in infection, microbiologists, academics and patients. BAJIR engagement has increased exponentially over recent months, helped in part by increasing links with the British Association for Surgery of the Knee (BASK) and British Hip Society (BHS). Data submission to BAJIR is mandated in the revision knee British Orthopaedic Association Standards for Trauma & Orthopaedics on managing Prosthetic Joint Infection (BOAST)⁹ and British Hip Society Surgical Standard (BHSSS) document on managing Peri-Prosthetic Infection,¹⁰ but is not currently part of the FRI BOAST. It does, however, state that Trusts should have clinical governance structures in place to review FRI primary outcome measures and the registry clearly contributes to this.¹¹ The FRI aspect of BAJIR continues to evolve and there is strong support within the executive committee to work with the British Limb Reconstruction and Orthopaedic Trauma Societies to further develop the registry.

3 BAJIR MDT

A recent key development for BAJIR is the MDT module. The module allows for a unit's FRI MDT to be run through the BAJIR software; with the ability to access and update the patient's record, include details of surgeries performed, microbiological and laboratory results, antibiotic prescription and record the outcomes of discussion. An example patient summary report, produced at the conclusion of the MDT meeting, is depicted in Fig. 2 which can be inserted into the patient's paper or electronic record.

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Fig. 2 Example of fracture-related infection MDT summary.

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Through the MDT software, patients can be referred from one Trust to another (if both are registered with BAJIR) to support regional networks. Both Trusts then have the ability to update the patient's record and MDT decisions can be recorded and shared without delay. BAJIR provides an audit log of all MDT meetings, including all patients discussed, their outcomes and the clinicians present. A dashboard of process measures and outcomes is available to participating units.

4 Joining BAJIR

Information regarding the registry joining process, documentation required and contact details are provided through the BAJIR website (www.bajir.org).¹² Buy-in from all subspecialty colleagues, including the microbiology department, and early involvement of your Trust's information governance (IG) team is recommended as this tends to be the rate limiting step. The BAJIR administrative team have great experience in navigating the information governance processes and a well-developed information pack is available for Information Governance teams via the website. An understanding of the 2018 national data opt-out and how that is implemented in your Trust is advisable.

5 Obstacles and issues with BAJIR

“For the strength of the pack is the wolf, and the strength of the wolf is the pack.”¹³

These words are apt when discussing the obstacles and issues with setting up and maintaining a registry. The power of a registry lies in its ability to record data of unselected cases in a systematic and comprehensive manner to provide a representative view of the current practice. Its utility is reliant heavily on engagement, from both institutions and individuals, as well as accuracy of the data recorded. In many units, due to a lack of financial support, data entry is dependent on fellows and nurse specialists which is unlikely to be sustainable in the long-term. BAJIR have attempted to address the issue of engagement through; 1) the ongoing involvement of key stakeholders, including patient groups and specialist societies, in the development of the registry; 2) creation of multimedia resources to assist departments and institutions through the information governance application¹⁰ and data entry¹⁴; 3) inclusion in national guidelines¹⁵; and 4) representation at national society meetings such as the British Orthopaedic Association and British Hip Society.

Issues pertaining to the completion and veracity of registry data have been previously outlined by Lemaignen et al.¹⁶. Using their experience of setting up the French registry for complex bone and joint infections to oversee the “Centre de reference des infections ostéoarticulaires complexes” (CRIOAc)) network they were able to report on the completion and accuracy of their data. Initially, they found significant heterogeneity (5–58% completion) in the data collection, across fields and between centres, which led to implementation of a basic semi-automatic text analysis to extract and combine information from both structured and unstructured data sources. Through this measure the authors were able to achieve 89% data completeness and 88% accuracy.¹⁶ It was suggested that further improvements could be made through data linkage to more established healthcare registries allied with the use of natural language processing algorithms to utilise unstructured data sources such as electronic patient records. BAJIR is currently completing data linkage to the “Hospital Episode Statistics” (HES) database, which contains details of all admissions, Emergency Department attendances, and outpatient appointments at NHS hospitals in England¹⁷ in a bid to improve data collection and governance. This validation step is the same as that used by the National Joint Registry but includes validation of both procedures and comorbidities. It is worth noting that the French registry does not collect systematic follow-up data which therefore limits its use for therapeutic evaluations.

6 Conclusion

BAJIR is the only prospective orthopaedic infection registry of its kind, although international efforts are starting, working with a shared dataset (https://pubmed.ncbi.nlm.nih.gov/33433125/). The recent update of the FRI data set allows for comprehensive data capture for these patients and the MDT module helps to support regional networking. With greater patient numbers, the potential to generate data, guide research and ultimately inform best practice will prove invaluable.

Declarations of competing interest

None.

Funding

None.

Author contribution

Conception: MR, writing: KP/JT, editing: MP/MR.

Ethical approval

Not applicable.

Patient Consent

Not applicable.

Data availability

Not applicable.