
As the Cumberlege Review and Paterson Inquiry made clear, having accurate and timely data on treatments and outcomes is critical to patient safety. NHS England is working to strengthen this data by implementing a central database to collect key details of implantable devices at the time of operation. The new Outcomes and Registry Platform will bring existing registries together for the first time and introduce new registries.
The first to go live at the start of 2024 is the new National Registry of Hearing Implants, a registry specifically for cochlear implants. These are electrodes that are inserted into the inner ear to directly stimulate the auditory nerve and provide a sense of hearing for people who are profoundly deaf.
Patients undergoing cochlear implant surgeries can range from very young babies right through to elderly people. The new registry will enable robust comparisons between surgical techniques, implants, surgeons and hospitals. It will also provide an early-warning system for safety concerns and support continued improvement in patient outcomes.
From the start of the project, we have prioritised collaboration between patients, clinicians, regulators and medical device manufacturers. This includes using different techniques, such as focus groups and user journey mapping sessions, to examine current challenges, potential benefits and possible innovations. Patients and representatives from cochlear implant manufacturers also sit on our clinical steering board, guiding the overall direction of the registry.
This collaboration has informed every aspect of our work, including how patient feedback is sought. To be effective, registries need to hold data not just on clinical outcomes but also on how patients feel over time. This information, which covers healthcare outcomes and their perceptions of the overall experience, is collected through surveys at certain points, for example one year and then four years after the implant has been fitted. By understanding patients’ views on the type of information required and the way questions are phrased, we can make sure we communicate to the right people at the right time. Through this, we hope to maximise the number of responses and therefore improve the registry’s effectiveness.
Tricia Kemp is the co-ordinator for the Cochlear Implanted Childrens Support Group and is our patient representative on the steering group and has imputed into registry and patient outcome data collection specifications and data security. ‘It is vital that cochlear implant users and their parents and carers are involved and have the opportunity to input to the development. This will ensure that the views and interests of those whose data is contained within the registry are represented and protected.’
The cochlear implant registry will evolve to include all hearing implants and procedures, for example bone conduction implants. We will continue working with patients, clinicians, regulators and industry to review the data and to roadmap future developments.
Scott Pryde is Programme Director for NHS England’s Outcomes and Registries Programme, and Katherine Wilson is the Clinical Steering Group Chair of the programme.