3 Committee discussion
NICE's medical technologies advisory committee considered evidence on digital technologies to deliver pulmonary rehabilitation programmes for people with chronic obstructive pulmonary disease (COPD) from several sources, including an early value assessment (EVA) report by the external assessment group (EAG), and an overview of that report. Full details are in the project documents for this guidance on the NICE website.
Unmet need
3.1
The 2015 National COPD Audit Programme report suggested an unmet need in the provision of face-to-face rehabilitation. The clinical experts explained that this was despite face-to-face pulmonary rehabilitation being recommended by NICE and the British Thoracic Society. The clinical experts explained that digitally supported pulmonary rehabilitation would help people who cannot, or do not want to, access face-to-face pulmonary rehabilitation. The committee defined the group of people who this guidance will apply to as those who cannot have or do not want face-to-face pulmonary rehabilitation.
Implementation
3.2
The committee considered information governance and NHS England's Digital Technology Assessment Criteria (DTAC) compliance. The companies and technology developer explained that the technologies were all compliant with GDPR. Some of the technologies that can only be used in research were not yet DTAC compliant, but the companies without DTAC approval were working towards this.
3.3
The clinical experts explained that barriers to implementation would include:
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digital literacy
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language and cultural considerations
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social and environmental factors
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staff training needed to deliver digital pulmonary rehabilitation
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additional resources needed, and
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usability of the technologies.
The clinical experts also explained that an additional barrier to implementation of these technologies is ensuring that people who are offered them adhere to the programme. They explained that monitoring COPD remotely takes significant time and resource.
Patient considerations
3.4
The patient experts explained that while improved exercise capacity is one of the key outcomes, the effect of pulmonary rehabilitation on people with COPD was far-reaching and holistic. They thought that any interventions that deliver potential benefits to people with COPD should be available. One explained based on their own experience without digital technologies they would not have been able to participate in pulmonary rehabilitation because of their dependence on supplemental oxygen. The other explained that participating in pulmonary rehabilitation provides a means of social support. They explained that digital technologies should not exclude the 'human touch' of the camaraderie and social aspect of pulmonary rehabilitation. A charity also emphasised the importance of the social aspect. They highlighted the social benefits of pulmonary rehabilitation, such as people learning about their condition, being able to meet others going through something similar, and sharing their experiences. These social aspects need to be considered when using digital technologies to deliver pulmonary rehabilitation.
3.5
Both patient experts acknowledged the constraints on capacity to deliver face-to-face pulmonary rehabilitation, and that these technologies could be useful in addressing this. An example was to provide pulmonary rehabilitation for people who were on a waiting list to start another course of pulmonary rehabilitation after completing a face-to-face programme.
3.6
Regarding exercise capacity measures, a patient expert questioned if using validated measures such as the 6‑minute walk test was appropriate for people with advanced COPD. But there was no consensus on an alternative measure that was more appropriate for these people.
Benefits of the technologies
3.7
The committee discussed the potential of digital technologies to increase access to pulmonary rehabilitation and to address the unmet need of people who are eligible for face-to-face rehabilitation but are not offered it or cannot have it. Clinical experts explained that digital technologies to deliver pulmonary rehabilitation programmes should be used to overcome barriers to participation, and not to deal with backlogs for face-to-face services. This is in line with the British Thoracic Society's 2023 clinical statement on pulmonary rehabilitation, which stated that face-to-face pulmonary rehabilitation is the preferred treatment option for people with COPD. The committee agreed that digital technologies for pulmonary rehabilitation provide another option for people with COPD, but they will not replace face-to-face pulmonary rehabilitation in the care pathway.
3.8
For SPACE for COPD, the committee was aware that this technology is being developed into a new programme that offers both pulmonary and cardiac rehabilitation. When reviewing the guidance, the committee will revisit its recommendation and assess any new evidence on the new programme.
Clinical effectiveness
Evidence from research studies
3.9
The evidence was not evenly distributed across the technologies and clinical outcomes. There were 11 studies across the 7 technologies. myCOPD and SPACE for COPD had well-designed randomised controlled trials that reported outcomes relevant to NICE's scope. The committee noted that the evidence on these 2 technologies supports the concept of non-inferiority between digitally supported pulmonary rehabilitation and face-to-face pulmonary rehabilitation, particularly in exercise capacity. This evidence did not raise any particular concerns about adverse events and exacerbations. Overall, this evidence showed potential clinical benefits for people who are eligible for pulmonary rehabilitation, and the potential to address an unmet need (see section 3.7). There were concerns about the generalisability of the results because some effects did not reach clinical significance, and there was potential underperformance of comparators. This could be explained by the comparator arms in some of the trials being suboptimal rather than 'gold standard' pulmonary rehabilitation. The committee concluded that myCOPD and SPACE for COPD can be used in the NHS while more evidence is generated to address these concerns.
3.10
For the other 5 technologies, evidence on effectiveness or safety was limited or lacking. The evidence for Kaia Health COPD did not align with NICE's scope because it was done outside of the UK and compared the technology with standard care (not face-to-face pulmonary rehabilitation considered as standard care in the UK). For Active+me REMOTE, Clinitouch and Wellinks, the evidence was limited in quality. For Rehab Guru, there was a lack of evidence. Given the uncertainty about the potential benefits of these 5 technologies, the committee recommended more research to understand the benefits.
Comparison with national audit data
3.11
For walking distance, the trial data suggested that digital pulmonary rehabilitation was non-inferior to face-to-face pulmonary rehabilitation. But the outcomes were compared with data from the National COPD Audit Programme, which suggested that digitally supported pulmonary rehabilitation could be on par with or less effective than face-to-face pulmonary rehabilitation. The EAG explained that this could be because of a difference between some of the 'usual care' arms of the trials and the face-to-face pulmonary rehabilitation used in the audit data. They also explained that this was an observational comparison and not statistically robust. A clinical expert explained that this comparison should not be considered definitive, because of differences in how the outcome measures are generated (only people who completed a programme are included in the National COPD Audit Programme). So, more research is needed using comparators that follow the British Thoracic Society's guideline for face-to-face pulmonary rehabilitation.
Equality considerations
3.12
There were multiple equality considerations noted by the committee. These included general and digital literacy, not speaking English or having English as a second language, age, access to equipment and internet access. The committee recognised that additional support and resources may be needed for people who are unfamiliar with digital technologies or people who do not have access to smart devices or the internet. Most of the companies stated that they were either making plans to develop or had developed their technology to be available in another language. A clinical expert explained that digital technologies could actually be an enabler for those with language difficulties because it would allow people to rewatch and reread instructions as much as they wanted to.
Costs and resource use
3.13
A cost-consequences analysis was done using data from the 2015 National COPD Audit Programme, with walking distance as the outcome. It suggested that Clinitouch, myCOPD, SPACE for COPD and Rehab Guru could offer potential cost savings caused by reduced healthcare professional time. This was despite these technologies being slightly less effective than face-to-face pulmonary rehabilitation.
3.14
An exploratory cost-effectiveness analysis using 2015 National COPD Audit Programme data as the comparator, suggested that Clinitouch, myCOPD, SPACE for COPD and Rehab Guru were found to be cost saving and less effective than face-to-face pulmonary rehabilitation, when considering walking distance as the outcome.
3.15
For Active+me REMOTE, a hybrid model (offer of usual care and provision of the app) was used. Depending on the number of in-person supervised sessions assumed, both cost-consequences and exploratory-cost effectiveness analyses indicated that this technology could either be cost saving or more costly, but slightly less effective than face-to-face pulmonary rehabilitation using 2015 National COPD Audit Programme data.
3.16
Economic analysis was not possible for Kaia Health and Wellinks because of a lack of cost information.
3.17
The committee noted that there were differences in effectiveness when using different comparators and difference sources of data (the trial data and the UK audit data [there were differences in how the outcome measures were generated for the UK audit data]). When taking into account licence costs and healthcare professional time for delivery only, the technologies appeared cheaper to provide than face-to-face pulmonary rehabilitation. But this did not take into account other potential costs related to staff training and implementation. The EAG agreed that the difference in effectiveness was uncertain and that the health economic evaluation was for exploratory purposes only. The committee recommended that data be collected, including comparisons with appropriate comparators, to enable a full, robust, health economic evaluation.
3.18
Evidence for Active+me REMOTE assessed a hybrid model of digital and face-to-face pulmonary rehabilitation. The committee understood that some people choose to attend a full course of in-person supervised sessions, as well as using the app to supplement these sessions, or for monitoring. Because of this, the intervention then may not address the unmet need in the NHS, of those who cannot have or do not want face-to-face pulmonary rehabilitation. The committee also understood that the hybrid model created uncertainty about if the technology was cost saving or cost incurring.
Evidence gap review
3.19
For all the technologies, the evidence gaps related to the population, comparator and outcomes.
Population
3.20
The patient experts highlighted that people with advanced COPD who are dependent on supplemental oxygen were underrepresented in the research. The clinical experts agreed. They also stated that people with a recent diagnosis should be considered for future research, along with those recently discharged from hospital following an exacerbation. The committee noted that there was no comparison of outcomes for people living in urban and rural settings.
Comparator
3.21
The comparators in the research were heterogeneous. The committee agreed that all comparators of face-to-face pulmonary rehabilitation should follow the British Thoracic Society standards. The specialist committee members highlighted that there was a gap in the evidence relating to comparison against waiting lists and no treatment.
Outcomes
3.22
Gaps in the outcomes included heterogeneity in the exercise capacity outcome measures, waiting list data, health-related quality of life data (which can be translated into quality-adjusted life years), information on adverse events and hospitalisation because of an exacerbation, and exacerbation rates. The committee noted that long-term data was also needed to evaluate the true effectiveness of these technologies. The companies and technology developer agreed with this.