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 long term
Evidence is needed on the clinical effectiveness of the technologies when used with or without standard care psychological therapies, including in the long term. This will help the committee to understand whether the technologies are clinically and cost effective. Evidence is needed on:
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change in target psychosis symptoms managed by the technology (for AVATAR Therapy and SlowMo) or monitored by the technology (for CareLoop)
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rate of relapse or worsening of symptoms and time to relapse
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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:
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implementation and training costs associated with using the technology in the clinical pathway
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healthcare professional grade and time needed to support or deliver treatment
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resource costs associated with relapse such as hospital stay costs.
Adverse events related to the technologies
Some serious adverse events have been reported in the published studies for all the technologies. Safety monitoring and more data on adverse events would help the committee decide whether the technologies can continue to be used safely in the NHS in the longer term and understand which adverse events are directly related to use of these technologies.
2.2 Evidence that further supports committee decision making
Engagement with the technologies
More evidence is needed to:
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assess uptake of the technologies and completion rate
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assess patient and staff experiences of using the technologies
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understand how use varies in particular groups
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assess how frequency of use (continued or repeat use) affects clinical benefit.
Information on the characteristics of people using the technologies is also needed to evaluate differences in access to the technologies and the potential impact on health inequalities.