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  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any additional equality or health inequalities issues we should consider?

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Document

    Are there any other relevant ongoing studies that address the evidence gaps?

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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2 Evidence gaps

This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.

The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The company can strengthen the evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. This will help the committee to make a recommendation by ensuring it has a better understanding of the patient or healthcare system benefits of the technology.

2.1 Essential evidence for future committee decision making

Diagnostic accuracy

The committee noted that information about diagnostic accuracy, including the number of false-positive and false-negative results when the technology is used as part of NHS care pathways, was not reported adequately. More evidence is needed on the sensitivity and specificity of the technology, ideally compared with current NHS care. This is particularly important in an undiagnosed population.

Impact on the NHS care pathway

A key part of the committee discussion was around the impact of on the NHS care pathway for asthma and COPD. For example, spirometry algorithms could improve access to diagnosis of asthma and COPD in primary care and community diagnostic centres. Collecting evidence on this will help the committee understand how using the technology will affect care in the NHS.

Long-term resource-use data

More information is needed on how using the technology would affect resource use during and after implementation, to help the committee understand its long-term resource use impacts. Key areas that will help to address this evidence gap are:

  • long-term resource-use costs, such as staff time, band and accreditation of healthcare professionals using the technology spirometry algorithms to support asthma and COPD diagnosis

  • technology cost per patient of implementing the technology in the primary or community care diagnostic pathway.

2.2 Evidence that further supports committee decision making

Effectiveness in different subgroups

The committee noted that the current evidence comparing the technology's effectiveness in some subgroups is limited. It recommended for any evidence generated for subgroups who may benefit more from the technology, such as those for whom access to spirometry is currently limited or lacking altogether.