Update on the National Registry for Hearing Implants
It has been a very busy year for the National Registry for Hearing Implants (NRHI) steering group, with significant progress being made towards our eventual goal of a registry for all implanted hearing devices. The primary aim of the registry remains to improve safety and outcomes for hearing implant users in the UK.
In the last year the NRHI has been adopted under the new NHS England ‘Outcomes Registry Programme’ (ORP – previously MDOR/MDIS). This overarching programme aims to capture key data on all types of implanted medical devices in due course. The data collected by the ORP will be on two levels. Firstly a single ‘core dataset’ for all implantable medical devices, which will cover details of the device used (including unique device identifier or UDI), patient, date & place of surgery and surgeon. Secondly, individual specialties may set up additional ‘outcome datasets’ with clinical information relevant to the type of device.
A suite of outcome datasets have been developed for cochlear implants - these include relevant clinical information, complications, and in future will include patient-reported outcomes (PROMs and PREMs). Other registries being developing in parallel with the NRHI include neural implants, breast and cosmetic implants and pelvic floor implants.
Trusts in England have already received notice that they will soon be required to complete core datasets for all type IIb and III medical devices. This will include cochlear implants, ABI, active bone conduction implants and MEI (as type III) and other bone conduction implants (as type IIb).
The ORP have funded development of a national online portal for data submission. They will also support ongoing data analysis and reporting.
Progress to date
In order to progress work on the NRHI, Katherine Wilson, Kate Hanvey, Debi Vickers, Jenny Townsend and Dan Jiang have been working closely with NHSE, ORP, and NEC (the registry software provider) to provide expert clinical input. We have now completed User Test Acceptance for the Registry dataset and data-entry portal. A pilot version of the registry is now ready to test by a few CI centres, as soon as final governance approvals are in place to start entering ‘live’ patient data. A manual/handbook and training resources to support registry users are nearly completed, including a series of webinars supported by live Q&As. We understand that each site will have their own optimal process for entering registry data, so will aim to provide flexible support, including on the use of barcode scanners or paper proformas if required.
We have also begun work on widening patient engagement into the ongoing registry development, utilising the new BCIG PPIE group. Our first focus group activity took place in early October and focussed on patient views on the options for adult PROMs. A second group will consider paediatric PROMs.
NHSE and the NRHI steering group are currently actively engaging with the Welsh, Scottish and Northern Irish governments to explore alignment, governance and data sharing arrangements for the NHRI and the wider outcome registries programme.
A pilot of the NRHI core and outcomes datasets is planned for Spring 2024. The pilot sites will be St Thomas’s, Birmingham and Cambridge (plus North Wales, if we can get cross-border arrangements agreed in time).
A plan for training the registry sites will be trialled in Spring 2024 for the pilot sites first, with the intention of extending training to all UK CI Centres by mid-2024. Rollout is planned throughout 2024, with NHSE eventually mandating reporting to the ORP in England.
Once the first data is being collected, work will begin on data analysis and reporting, including establishing a committee for reporting and outlier analysis. Centres will be able to access their own data, with a series of regular published reports produced for the public domain. There will be patient/service user involvement at all stages of this process.
Patient reported outcomes (PROMs and PREMs) will follow shortly; the intention is that the registry system will contact patients automatically by email at defined intervals and ask patients to submit their responses into an online portal e.g. via their mobile phone. Missing responses can be automatically ‘chased’ by the registry if required. Response by post will also remain an option for those who do not wish to engage digitally.
Longer term, the NRHI steering group will change focus towards data quality monitoring and development of clinical outcome datasets and new portal forms for the remaining hearing implant types. These will complement and extend the core dataset that should, by then, already be in use. We hope to achieve integration of the portal with Auditbase to pull through some clinical data automatically, in order to reduce the load on clinicians. We are also exploring the possibility of linking the registry to manufacturers, to allow a single point of device registration.
Keep in touch: please feel free to email Katherine, Kate, Jenny, Debi or Dan if you have any registry-related questions or comments!