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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    1 Recommendations

    Can be used in the NHS while more evidence is generated

    1.1

    Two digital technologies can be used in the NHS while more evidence is generated, to deliver pulmonary rehabilitation programmes for adults with chronic obstructive pulmonary disease (COPD). The technologies are:

    • myCOPD

    • SPACE for COPD.

      These technologies can be used once they have appropriate regulatory approval and meet the standards within NHS England's Digital Technology Assessment Criteria (DTAC).

    1.2

    The company (my mhealth) and technology developer (University Hospitals of Leicester NHS Trust) must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generation plan) and contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may withdraw the guidance if these conditions are not met.

    1.3

    At the end of the evidence generation period (3 years), the company and technology developer should submit the evidence to NICE in a form that can be used for decision making. NICE will review the evidence and assess if the technologies can be routinely adopted in the NHS.

    Can only be used in research

    1.4

    More research is needed on 5 digital technologies to deliver pulmonary rehabilitation programmes for adults with COPD. The technologies are:

    • Clinitouch

    • Kaia COPD

    • Rehab Guru

    • Wellinks and

    • Active+me REMOTE.

    1.5

    Access to the technologies in 1.4 should be through company, research, or non-core NHS fundings and clinical and financial risks should be appropriately managed.

    Evidence generation and more research

    1.6

    Evidence generation and more research is needed:

    • on how well the digital technologies work compared with:

    • measuring the following outcomes:

      • health-related quality of life and exercise capacity (using validated measures)

      • resource use, including technology costs, exacerbation-related costs, and implementation costs

      • uptake rates

      • intervention completion rates

      • patient preference

      • adverse events

      • exacerbation rate

      • hospitalisation from exacerbation

      • long-term effect up to 12 months.

    • on where the technologies will be used in the care pathway

    • reporting outcomes in the following subgroups:

      • people living in urban areas compared with people living in rural areas

      • people with a new COPD diagnosis compared with those with an existing diagnosis

      • people who depend on supplemental oxygen to manage COPD

      • people recently discharged from hospital after an exacerbation.

    Potential benefits of use in the NHS with evidence generation

    • Access: There is a gap in service provision for pulmonary rehabilitation, with only 13% of people eligible being offered it. Digital technologies to deliver pulmonary rehabilitation may help people who may not be able to access face-to-face sessions. For example, when there is no face-to-face pulmonary rehabilitation programme available, for people living in rural areas where there may be limited or no face-to-face sessions, for people unable to travel because of how severe their COPD is, and for people who cannot or do not want to take time off work. The digital technologies will not replace face-to-face pulmonary rehabilitation in the care pathway.

    • Clinical benefit: Clinical evidence suggests that myCOPD and SPACE for COPD may improve exercise capacity and symptoms of COPD. There are no particular safety concerns with using digital technologies to deliver pulmonary rehabilitation. The technologies may address an unmet need for people with COPD who are eligible for pulmonary rehabilitation but who are not offered it.

    • Resources: Digital technologies to deliver pulmonary rehabilitation could be cheaper to provide than face-to-face sessions when comparing the license costs of the technologies and staff time, with the staff time for delivery of face-to-face pulmonary rehabilitation (but this is uncertain because the training and implementation costs are not known).

    • Equality: Men aged over 50 from deprived areas are more likely to have COPD. Increasing access to pulmonary rehabilitation may have the potential to improve their clinical outcomes.

    Managing the risk of use in the NHS with evidence generation

    • Costs: There may be costs associated with implementation, staff training, integration with NHS systems such as EMIS, and providing smart devices that need an internet connection.

    • Equality: Support and resources may be needed for people:

      • unfamiliar with digital technologies

      • without access to smart devices or the internet

      • with visual, hearing, or cognitive impairment, problems with manual dexterity or a learning disability

      • with a mental health condition

      • with a lower reading ability (including people unable to read English)

      • experiencing homelessness

      • living in a multiple occupancy household

      • having residential care

      • with cultural, ethnic or religious backgrounds that may affect whether they do pulmonary rehabilitation. For example, some people may not want to attend a mixed-sex exercise class.

    The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources for myCOPD and SPACE for COPD. It includes how the evidence gaps (see section 3.9) could be resolved through real-world evidence studies.

    For more detail on the committee's considerations about the evidence gaps for the technologies in 1.4, see sections 3.9 and 3.10.