Evidence generation plan for digital therapy for chronic tic disorders and Tourette syndrome: Neupulse
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 developer can strengthen the evidence base by addressing the other evidence gaps (see section 2.2). 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 compared with NHS standard care
There is limited evidence on the effectiveness of Neupulse in comparison with standard care. Further evidence should compare Neupulse with psychocoeducation, which the committee agreed should be delivered either through face-to-face or online appointments. Information about the impact that the technology has on people's symptoms should be recorded using the Yale Global Tic Severity Scale total scores, the Clinical Global Impression Score – Improvement, and ideally the Goal Based Outcomes scale. Also, information about the impact of the technology on daily life, for example on self-esteem, social interactions and school or work attendance and performance should be collected.
Longer-term data on the clinical impact of Neupulse
It is unclear if the technology leads to a clinical benefit beyond 4 weeks. Follow ups should be recorded at 3 and 6 months after commencing or ongoing use of the intervention, and ideally at 12 and 18 months. This would improve the data available to populate future health-economic models and reduce uncertainty.
Resource use
More information on how using the technology would affect resource use in the NHS, during and after implementation is needed to help the committee understand the technology's cost effectiveness. Resource estimates should include training costs and the broader impact of the technology on services, for example those provided by local specialist clinics and carers. This could free up resources that could be used to increase access to treatment or clinical assessment.
2.2 Evidence that further supports committee decision making
Clinical and cost effectiveness in different subgroups
There is limited evidence for people in different subgroups, such as those with severe tic disorders and those with diagnosed comorbidities, including:
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attention deficit hyperactivity disorder (ADHD)
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obsessive-compulsive disorder
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autism spectrum disorder
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mood disorders and
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anxiety.
More information about the impact of Neupulse in people with these conditions will support future committee decision making.
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