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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 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

    Comparative evidence about remission, relapse and mortality with the technology used as a self-help intervention

    To evaluate the efficacy of this technology, it is essential to have comparative data on remission, relapse and mortality outcomes when used as a self-help intervention. Current evidence does not adequately show how the technology works compared with standard NHS care, making it difficult to determine its clinical value in a real-world setting. Understanding the impact on these outcomes is key to assessing whether the technology can help improve long-term wellbeing and quality of life.

    Long-term effectiveness and outcomes

    There is currently no evidence showing outcomes beyond 3 to 6 months. To fully understand the effectiveness of the technology, it is important to assess the sustainability of any impact that it has on clinical outcomes. To evaluate this, it is essential to collect comparative and longitudinal data on key outcomes such as remission, relapse and health-related quality of life. Other outcomes, like days missed from school or work, use of support services and any changes in NHS resource use should also be captured to reflect patient and system level impacts. The technology is intended to be used while people are waiting for support or treatment. But, understanding how it affects service use once accessed is important, because the technology may reduce the need for more intensive support later.

    Reasons for high attrition and barriers to engagement

    The available evidence showed that many people did not complete their treatment on the digital intervention. This leads to uncertainty about the effectiveness of the interventions. Further data collection is needed to better understand how many people are likely to stop the digital treatment prematurely and why, including potential barriers to engagement.

    Resource and care pathway impact

    There was not enough evidence to understand the resource costs and whether the digital technology would change the care pathway in the NHS. Further information about the costs of the technology and the healthcare professional resource necessary to support it are needed to drive economic modelling. Information on the technology's potential to reduce healthcare professional visits or its possible impact on waiting times or other service outcomes would also inform a future model.

    2.2 Evidence that further supports committee decision making

    Generalisability and population diversity

    To assess the impact of this technology on people's health, it is important to understand the efficacy of the technology across age groups, different ethnicities, genders and socio-economic backgrounds. Ideally, when the effectiveness of the technology is studied, the population in question reflects the population who would access care in the NHS.

    Equity and accessibility concerns

    There is currently no research into how accessible this digital technology is for people with limited digital literacy, limited access to devices or who may struggle to use digital self-help tools. Understanding these barriers is necessary to determine how the technology could be applied in the NHS. It is also important to identify which patient groups are not being offered the technology because of its inaccessibility. This could include people with learning disabilities or without access to private mobile devices.