The NHS England Outcomes and Registries Programme was established in 2022 to develop a single, unified registry solution – the Outcome Registries Platform. The platform consolidates existing implantable device-level registries and implements new outcome registry data collections to address data and vigilance gaps, enabling the prevention of patient safety issues and adverse outcomes.
The programme builds upon an improved model for patient engagement and involvement, and maximise governance, clinical leadership, and specialty-specific data roadmaps to deliver patient-centred change.
In collaboration with the devolved administrations, the programme is also developing an approach to enable secure data sharing, system interoperability and UK-wide coverage, where it is appropriate to do so.
What is an outcome registry?
Outcome registries are organised systems that use observational methods to collect routine, uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Important features of registries include:
- Collection of high quality, high volume patient, practice and population-level data
- Development input and expertise from clinical leadership
- Availability of enriched, comparative data for multiple upstream patient safety and quality improvement purposes
- Timely feedback of data to inform clinical decision-making.
Outcome registries can often be confused with clinical audits that measure care against explicit audit criteria as part of a quality improvement cycle. Data is collected less frequently in audits and often with lower levels of data granularity than in routine registry data collections.
Outcome Registries Platform (ORP)
Over 2 million patients a year undergo a procedure that includes a high-risk medical device. Whereas in some procedures, some exemplar registries monitor patient safety and outcomes.
The ORP addresses the need for a more consistent approach to assure safety and satisfactory outcomes, and fulfils the recommendations of the Independent Medicine and Medical Device Safety Review (IMMDS) (2020) and Paterson Inquiry (2020).
“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 both in terms of the device safety and patient reported outcomes measures.”
Recommendation 7 of First Do No Harm, IMMDS Review, 2020, chaired by Baroness Cumberlege.
The ORP will record key details of the patient procedure including the clinicians involved, and the high-risk devices used, and link these to clinical observational and patient outcome data to improve patient safety and outcomes.
NHS England has a priority list of new and established registries that ew are consolidating on a single platform. These registries cover vascular, pelvic floor, breast (including cosmetic), cochlear and trauma medical procedures. Subsequent registry datasets will be linked to, or integrated in the ORP and have been developed alongside Patient Reported Outcome Measures [PROMS) and Patient Reported Experience Measures (PREMs).
What will the benefit be to patients?
The fundamental purpose of the ORP is to capture and use data from NHS and private healthcare providers to detect and predict issues relating to patient safety and outcomes, and prevent harm to future patients. The registry will also:
- maximise data for surveillance, benchmarking and recall activities
- increase transparency and accountability
- enhance research and development
- reduce costs of participation.
Accurate data that is routinely collected at the point of care and linked to patient outcomes will allow clinicians and commissioners to turn intelligence into actionable improvements. The ORP data will be used to:
- help identify patients who have received specific implants that are subsequently performing poorly
- determine how long different types of implants last
- empower patients by helping them find out more about the devices available to them
- help surgeons choose the best devices for their patients
- improve patient safety by monitoring how well implants, surgeons and hospitals perform and take action where necessary
- give hospitals, surgeons and implant manufacturers feedback about their performance to help them improve patient care
- invite patients to take part in feedback activities about their surgery, so that patient outcomes, experience and satisfaction can be assessed and monitored.
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