Evidence generation plan for artificial intelligence (AI) technologies to aid opportunistic detection of vertebral fragility fractures: early value assessment
1 Purpose of this document
NICE's early value assessment of artificial intelligence (AI) technologies to aid opportunistic detection of vertebral fragility fractures recommends that BriefCase-Triage, CINA-VCF Quantix, HealthVCF, HealthOST and IB Lab FLAMINGO can be used in the NHS during the evidence generation period. Stakeholders should consider whether the technologies are likely to remain available on the UK market and supported by their companies before generating evidence to address the evidence gaps. Evidence generation should preferably be on technologies that will still be available in the NHS after the evidence generation period.
This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to collecting the information needed to address the evidence gaps. Evidence generated through other study approaches will also be considered. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence.
The company is responsible for ensuring that data collection and analysis takes place.
Guidance on commissioning and procurement of the technology will be provided by NHS England.
NICE will withdraw all or part of the guidance if a company does not meet the conditions in section 4 on monitoring.
At the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a format that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.
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