How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Document

    Are there any additional implementation factors that need to be considered?

  • Question on Document

    Please let us know of any other ongoing studies with the technologies to include in table 1
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan for GID-HTE10020 Digital health technologies to help manage symptoms of psychosis and prevent relapse

Closed for comments This consultation ended on at   Request commenting lead permission

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

Clinical effectiveness in the longer term

Evidence is needed on the clinical effectiveness of the technologies when used with or without standard care psychological therapies, including in the longer term. This will help the committee to understand whether the technologies are clinically and cost effective. Evidence is needed on:

  • change in symptoms targeted by the technology (for AVATAR Therapy and SlowMo) or monitored by the technology (for CareLoop)

  • rate of relapse or worsening of symptoms and time to relapse

  • functional outcomes including social functioning and personal recovery.

Healthcare resource use

Using the technologies could free up resources that could increase access to treatment or reduce waiting times. More information is needed on resource use to assess whether the technologies are cost effective, including:

  • implementation and training costs associated with the use of the technology in the clinical pathway

  • healthcare professional grade and time needed to support or deliver treatment

  • resource consequences associated with relapse such as hospitalisation.

2.2 Evidence that further supports committee decision making

Engagement with the technologies

More evidence is needed to:

  • assess uptake of the technologies and completion rate

  • assess patient and staff experiences of using the technologies

  • understand how use varies in particular groups

  • assess how frequency of use (continued or repeat use) affects clinical benefit.

Information on patient characteristics is also needed to evaluate differences in access to the technologies and the potential impact on health inequalities.