British Orthopaedic Foot and Ankle Registry – Where are we now, and where are we going?

Lyndon Mason, Edward Wood and Paul Halliwell

Lyndon Mason is a Consultant Trauma and Orthopaedic Surgeon in the Liverpool University Hospitals Foundation Trust. Lyndon is the foot and ankle trauma lead in the Liverpool Orthopaedic Trauma Service and has published widely on foot and ankle trauma management. He is the Chairperson for the Outcomes Committee in the British Orthopaedic Foot and Ankle Society.

Edward Wood is a Trauma and Orthopaedic Consultant in the Countess of Chester Hospital NHS Foundation Trust. He is Co-opted Chairperson for the Outcomes Committee in the British Orthopaedic Foot and Ankle Society.

Paul Halliwell is a Trauma and Orthopaedic Consultant in the Royal Surrey County NHS Trust. He is Previous Chairperson British Orthopaedic Foot and Ankle Society Outcomes Committee and President-Elect of the British Orthopaedic Foot and Ankle Society.

Where we are in 2021

On the 21st of February 2018, the then Secretary of State for Health and Social Care in the UK, Jeremy Hunt, issued a statement in the House of Commons in response to the reports about harmful side effects from medicines and medical devices. A review was commissioned to consider how to strengthen the patient voice in order to help build a ‘system that listens, hears and acts – with speed, compassion and proportionality’ [1]. Patient groups had campaigned for years, if not decades, to achieve this acknowledgement. An independent safety review was commissioned for medicines and medical devices led by Baroness Cumberlege, with specific investigation of two medicines and one medical device. reported outcomes measures (PROMS)”. This recommendation is important due to its need for centralised data collection on all patients with implantable devices and the prospective collection of PROMS data on all patients.

On 8th July 2020, the First Do No Harm Report Unified Structure (TORUS) project for several (otherwise known as the Cumberlege Report) years, which includes the majority of the was published (Figure 1) [2]. The review found that musculoskeletal registries outside the National the system in which patients concerns could be raised regarding medicines and medical devices was “disjointed, siloed, unresponsive and defensive”. A total of nine recommendations were made. Recommendation number seven was of particular importance to orthopaedic registries. It stated that “A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures (PROMS)”. This recommendation is important due to its need for centralised data collection on all patients with implantable devices and the prospective collection of PROMS data on all patients.

In July 2021, the government published their response to the Cumberlege report (Figure 1) [3]. In chapter 8, the government accepted the aforementioned recommendation number seven, legislating through the Medicines and Medical Devices Act 2021, to give power to the secretary of state to regulate for the establishment of a UK-wide Medical Device Information System (MDIS). Central to the development of the MDIS is PROMS. Patient centred registries have been high on the agenda at BOFAS for some time, and we have been working closely with the BOA as part of the Trauma and Orthopaedic Registries Unified Structure (TORUS) project for several years, which includes the majority of the musculoskeletal registries outside the National Joint Registry. Both the BOA and BOFAS have welcomed the opportunity of the Cumberlege Report to promote the importance of robust prospective collection of validated, patient centred clinical outcome measures.

Figure 1: The Cumberlege report

Lessons from the BOFAS Registry

The BOFAS registry is neither the oldest nor the largest patient outcome registry in musculoskeletal disease in the UK. However, it is one of the few registries which is both funded and managed solely by its specialty society and its members. Collection of PROMS is central to the BOFAS registry. It was initially formed as a national audit tool to allow foot and ankle surgeons to know their own results, with patients filling in their own scores prospectively using an electronic portal. As the data collection has increased and matured, we have been able to produce an Annual Report for each of the last three years.

Despite the Registry’s major growth, this has been due primarily to input of enthusiasts working without support. Only 80 of BOFAS’ membership of 465 (17.20%) are registered, active contributors despite the Registry being available to all and funded by members’ subscriptions. Its use is entirely voluntary. The number of patient pathways created on the registry has increased almost exponentially in the last three years but still captures only a small percentage of the BOFAS members’ activity. (Figure 2) [4].

Figure 2: The number of BOFAS pathways created by year and pathway type.

Although the sheer difficulty in absorbing further tasks into already-busy clinical lives undoubtedly plays a significant part in this low engagement, there are two practical issues which continue to impede colleagues:

1. Permission from Trust Information Governance Officers (IGO) is required to permit consenting patients to be contacted for collection of PROMS. There is enormous variability in the extent and type of documentation demanded of potential users. The registries would welcome standardisation on this front.

2. Busy surgeons cannot afford to spend time inputting data and contacting patients for their responses without reducing their clinical activity. Some Trusts appreciate the importance of data collection so employ dedicated staff, but this is far from ubiquitous. Even with these difficulties, the basis for a mandated registry is in place, with most barriers being the lack of support and centralisation.

Accuracy and quality of data

Analysis of the BOFAS registry data was performed in 2020 by Birmingham University. Across the three pathways analysed (ankle arthrodesis, 1st metatarsophalangeal joint arthrodesis and general foot and ankle) the rate of PROM completion significantly reduced over time: PROMS collection at 1 year dropped below 20%. The registry primarily uses email addresses to contact patients to collect PROMS. Approximately 25% of patients do not possess or use an email address which partly explains the above. In those with email addresses they may end up in junk mail, old email addresses or simply be ignored. The registry moved to use additional text message data collection this year in the hope of increasing the yearly data collection of PROMS.

The current compliance on completion of tasks in the registry is approximately 60% over the last two years (Figure 3). It is likely however that funding for staff to directly collect this data, either face to face or by phone, is likely to achieve the most success. The general data has supported the success of the procedures in all PROMS, even with very variable nature the procedures had been performed.

Figure 3: The compliance data on outstanding task completion on the registry by month.

Unlike arthroplasty surgery, where techniques can be relatively standardised, foot and ankle surgery encompass many diverse procedures, and standardisation would be difficult to achieve. Therefore, picking apart implant level data with such variability requires massive and complete data sets. For an all-encompassing MDIS to be successful, data entry would need to be mandated and staff allocated to the collection of data.

General Data Protection Regulation (GDPR)

The Data Protection Act 2018 is the UK’s implementation of the GDPR, which all TORUS registries undertook measures to comply with. Registry data is currently regarded as supplemental to a patient’s normal clinical records. Therefore, the legal basis for collection and processing is the patient’s consent in common with other registries such as the NJR. In time, the data might be regarded as sufficiently in the patient’s best interests that consent is not required.

Information governance across the UK is dependent on the information governance officer of the trust. Navigating past the Information Governance Officer (IGO) of each trust remains one of the greatest challenges of a surgeon wanting to collect PROMS on their patients. Current advice from the Information Commissioner is that potential registry users must be granted permission to consent their patients to submit data by their Trust’s Medical Director (MD). MDs do so on the recommendation of their IGO. IGOs vary enormously in the compliance requirements and documentation imposed on applicants. In many cases the process is impenetrably onerous and deters surgeons from participating. This remains one of the greatest challenges for a surgeon wanting to collect PROMS on their patients.

Appraisal requirements

Participation in available national audits is a General Medical Council (GMC) requirement under Good Medical Practice [5]. Reflection on the outcomes of these audits is expected to form part of the supporting information to demonstrate quality improvement activity at appraisal. The BOFAS Registry is a national audit and is available to all foot and ankle surgeons who are members of the society. Surgical disciplines lend themselves to evidence capture, and a registry is an ideal method of demonstrating the nature and success of one’s practice. As registries become more established, and Responsible Officers awareness of them increases, we anticipate appraisers asking for specific evidence of such activity. The BOFAS Registry incorporates a downloadable Revalidation Report for this reason. As a requirement of every medical and surgical practitioner, more facilities should be put in place in every hospital to allow registry use and completion of data.

Conclusion

The landscape in the NHS regarding registries is changing very quickly. The political developments, due to the Cumberlege report and the government’s response this year, appear to be in favour of the creation of an all-specialty PROMS registry for all surgical interventions. The BOFAS registry is well placed to share experience in the development of a MDIS, especially the pitfalls in data capture in real-life clinical environments.

The BOFAS Registry can be accessed via the BOFAS website: www.bofas.org.uk/clinician/bofas-registry/registry-login.

References

1. House of Commons (2018). Medicines and Medical Devices Safety Review. Volume 636: debated on Wednesday 21 February 2018. Available from https://hansard.parliament.uk/ commons/2018-02-21/debates/7DA2E2F3- E1E6-40CB-8061-680E0399CA97/MedicinesAndMedicalDevicesSafetyReview.

2. Cumberlege J (2020). First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review Open Government Licence. Available from www.immdsreview.org.uk/downloads/ IMMDSReview_Web.pdf.

3. Department of Health and Social Care (2021). Government response to the Report of the Independent Medicines and Medical Devices Safety Review. Available from https://www.webarchive.org.uk/wayback/ archive/20200805110914/https://www. immdsreview.org.uk/Report.html.

4. BOFAS (2021). BOFAS Registry Annual Report. Available from www.bofas.org.uk/Portals/0/Registry%20Documents/Annual%20Reports/BOFAS%20Registry%20Report%202021.pdf?ver=_z7ZdvZ9llHjbITDLuZCGg%3d%3d.

5. General Medical Council (2020). Guidance on supporting information for appraisal and revalidation. Available at: www. gmc-uk.org/registration-and-licensing/ managing-your-registration/revalidation/ guidance-on-supporting-information-forappraisal-and-revalidation.