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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • 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 equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    We would like to draw your attention to the new minimum evidence standards section (section 5). Please consider it and comment on whether it reflects sufficient criteria for future NICE recommendations of digital technologies for supporting self-management of COPD.

  • Question on Document

    Are there any implementation considerations for digital technologies for supporting self-management of COPD that we may have missed?
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Evidence generation plan

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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 companies 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 impact of the technologies.

2.1 Essential evidence for future committee decision making

Impact of the digital technologies compared with standard self-management of COPD without digital technologies

The technologies should be compared with non-digital standard care in the NHS, which may include face-to-face appointments and monitoring. This committee identified a need for information showing the effect of the technologies compared with standard care for the following evidence gaps:

  • long-term clinical improvement

  • resource use

  • health-related quality of life

  • engagement and adherence

  • adverse events.

Long-term clinical improvement in COPD using a validated measure

Evidence considered by the committee indicates that using digital technologies improves COPD when measured using the COPD Assessment Test (CAT) score and the number of exacerbations. There is limited robust data to show that the technologies improve COPD symptoms over a long follow-up period. Data collected for 1 year or more will help the committee to understand the clinical and cost effectiveness of the technologies.

Resource use

More information is needed on resource use to calculate the cost effectiveness of the technologies. This should include overall costs, and the broader resource impact that COPD has on the healthcare system. The committee identified key areas that will help to address this evidence gap:

  • healthcare resource use associated with the technologies and NHS standard care, for example:

    • exacerbation-related costs

    • primary care visits

    • hospital visits, admissions and readmissions related to COPD

  • implementation costs, for example, set up and training costs and staff time needed to support the service

  • technology costs including licence costs.

Engagement and adherence

Evidence on intervention completion rates, patient preference, and uptake rates will help the committee assess the real-world uptake of the technologies. It will also help assess how acceptable the technologies are for people who use them to self-manage their COPD.

Adverse events

Reporting intervention-related adverse events is essential to assess any risk associated with the technologies' use in the NHS.

2.2 Evidence that further supports committee decision making

Effectiveness in different subgroups

The committee noted that the current evidence comparing the technologies' effectiveness in some subgroups is limited. It recommended for any evidence generated to consider the following groups:

  • people living in urban areas compared with people living in rural areas

  • people with a new COPD diagnosis

  • people with an existing COPD diagnosis

  • severity of COPD stratified using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification

  • people recently discharged from hospital, within 4 weeks of a COPD exacerbation.

Where the technologies are used in the care pathway

The committee noted that it is currently unclear exactly where in the care pathway the technologies will be used. Further information about this will support its understanding of how the technologies will be used.