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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    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 companies 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 technologies.

    2.1 Essential evidence for future committee decision making

    Quality of data and immediate impact on clinical assessment

    Evidence on the quality of the data collected by the technologies, and their impact on subsequent clinical assessment is limited. The committee decided that the quality of the data collected by the technologies could be estimated pragmatically using time-savings.

    Impact of the technologies on clinical decision making and quality of life

    There is limited evidence around the impact of the technologies on clinical decision making. Further evidence on the impact of changes in treatments or service use after using the technologies will support future clinical- and cost-effectiveness modelling. The potential impact could include:

    • the choice of treatment prescribed

    • step-ups or step-downs in medication

    • changes in the service pathway followed compared with current practice

    • changes in clinical outcomes, ideally measured using:

      • the Patient Health Questionnaire 9 (PHQ‑9) for depression

      • Generalised Anxiety Disorder-7 (GAD‑7) for anxiety

      • the Work and Social Adjustment Scale (WSAS) for the extent to which mental health problems interfere with daily life.

    Resource and service impact

    More evidence is needed to determine whether the technologies offer time-savings before or during a clinical assessment. Information is also needed on whether any time-savings offered translate into more clinical assessments each day or a reduction in waiting-list times. Data on the number of self-referrals from using the technologies is needed to reduce uncertainty around the potential burden on NHS Talking Therapies services. Further information is also needed on the costs of using the technologies in the NHS to support future economic modelling.

    2.2 Evidence that further supports committee decision making

    User engagement and experience

    Further evidence on intervention completion rates and user reported outcomes, including user preferences and acceptability, will help NICE's committee:

    • assess the real-world uptake of the technologies

    • identify any potential barriers to using the technologies.

    There is some evidence that the technologies may improve access to mental health services for people from ethnic minority backgrounds. Further data collection on user-characteristics (for example, ethnic background) or service characteristics (for example, geographic location or service size) will support subgroup analyses to assess accessibility of the technologies in different populations.