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Evidence generation plan for: GID-HTE10059 Artificial intelligence (AI) technologies to aid opportunistic detection of vertebral fragility fractures: Early Value Assessment

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1 Purpose of this document

NICE's early value assessment of artificial intelligence (AI) technologies to aid the opportunistic detection of vertebral fragility fractures recommends that BriefCase-Triage, CINA-VCF Quantix, HealthVCF and IB Lab FLAMINGOcan be used in the NHS during 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 the guidance if the company does not meet the conditions in section 4 on monitoring.

After 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.