Evidence generation plan for digital therapy for chronic tic disorders and Tourette syndrome: ORBIT

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 their evidence base by addressing any 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

The impact of the Online Remote Behavioural Intervention for Tics (ORBIT) technology on people's daily lives is uncertain. Further analysis of the data collected in the ORBIT-UK trial is needed to reduce the uncertainty. The data includes information on the impact that the technology has on people's symptoms measured using the Yale Global Tic Severity Scale, the Clinical Global Impression Score – Improvement, and ideally the Goal Based Outcomes scale. Qualitative data should include those collected from the child or young person, and their parents or carers. Ideally, this should include the impact on daily life, for example on self-esteem, social interactions and school or work attendance and performance.

To supplement existing data collected at 6 and 18 months, further analyses of the ORBIT‑UK trial data is needed on outcomes collected at 3 and 12 months after the intervention. Further analyses at these time-points will support health-economic modelling and reduce uncertainty in projections to distant time horizons.

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 the impact of the technology on services, for example those provided by local specialist clinics (including 'e-coach' time) and carers. This could free up resources that could be used to increase access to treatment or clinical assessment. The ongoing ORBIT study will collect some of these data as part of a budget impact assessment.

2.2 Evidence that further supports committee decision making

Clinical and cost effectiveness in different subgroups

There is limited evidence for subgroups of children and young people with diagnosed comorbidities, including:

  • attention deficit hyperactivity disorder (ADHD)

  • obsessive-compulsive disorder

  • autism spectrum disorder

  • mood disorders and

  • anxiety.

More information is also needed on the efficacy of ORBIT in people who have severe tic disorders, and in people from different ethnic backgrounds. There is no evidence for ORBIT in adults. Evidence on the use of ORBIT in adults would support future assessments on the impact of the technology in this population.

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