Background

The first QRISK® model to estimate 10 year risk of cardiovascular disease was published in 2007. It was followed by an updated model (QRISK®2) in 2008, which included ethnic origin and additional risk factors (type 2 diabetes, rheumatoid arthritis, atrial fibrillation, and chronic renal disease). Since then, QRISK®2 has been updated annually and recalibrated to the latest version of the QResearch database. The QRISK® algorithms have been validated by using UK Primary Care databases such as QResearch, Clinical Practice Research Datalink (CPRD), The Health Improvement Network (THIN), and clinical cohorts as well as in international populations. Their use has been evaluated in observational studies, cost effectiveness evaluations, and clinical trials. A recent scoping review of 17 studies showed that the QRISK®2 was the most accurate cardiovascular disease (CVD) risk calculator for several study populations.

QRISK®2 is now used across England’s Health Service (NHS England) and recommended in the NHS Quality and Outcomes Framework, guidance from the National Institute of Health and Care Excellence, and NHS Health Check. The tool is used in the Quality and Outcomes Framework (QOF) and in other health prevention activities including health checks. It is now the NHS recommended approach for the prediction of CVD risk in NICE Clinical Guideline 181 – “Cardiovascular Disease: Risk assessment and reduction, including lipid modification” (NICE, 2016).

QRISK®3 APIs and algorithms are due to be registered as devices by the Medicines and Healthcare products Regulatory Agency (MHRA). NICE Guidelines now recommend using QRISK®3 to assess the 10 year risk of cardiovascular disease.

Outline Plan

Supplier Solutions must be fully compliant with this specification by the Effective Date at which point Suppliers will be assured against the implementation of calculating QRISK®3 scores.

Suppliers have two methods for implementing this change:

Option 1: Incorporate Endeavour Predict Services QRISK®3 APIs

Endeavour Health Charitable Trust has an API that allows third-party Suppliers with Foundation Solutions to integrate QRISK®3 calculations into their Solutions; these are known as Endeavour Predict Services.

See QRISK®3 - Endeavour Knowledge Base for more information.

Option 2: Implement own inbuilt QRISK®3 algorithm

Alternatively, Suppliers can develop a calculation tool within their own Solution using the QRISK®3 algorithm.

See QRISK®3 for more information.

MHRA have indicated that the algorithms for QRISK®3 are medical devices and will require registration with the MHRA. There will also be the need to appoint a single UK Responsible Person for each of the devices, who will carry out specified tasks, such as registration.

Summary of Change

Full Specification

The updated Patient Information Maintenance - GP Capability will be added at a later date. Proposed changes can be viewed in the Summary of Change above.

Assurance Approach

Suppliers will be asked to demonstrate their mitigations against the pre-identified risks through completion of the NHS England Solution Assurance Risk log submission, supported with an online demonstration by the Supplier to a group of NHS England representatives.

Suppliers will provide evidence that the Solution is registered with the MHRA as a medical device.