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Evidence generation plan for HTE10065 Digital technologies for applying algorithms to spirometry to support asthma and COPD diagnosis in primary care and community diagnostic centres

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1 Purpose of this document

NICE's early-use assessment of digital technologies for applying algorithms to spirometry to support asthma and COPD diagnosis in primary care and community diagnostic centres recommends that ArtiQ.Spiro can be used in the NHS during the evidence generation period. The other technologies that were assessed can only be used in research and are not covered in this plan.

This plan outlines the evidence gaps and what data needs to be collected for a NICE review of the technology again in the future. It is not a study protocol but suggests an approach to generating 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 take place. 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 company 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 technology can be routinely adopted in the NHS.