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Guidance assessment consultation document for: HTE10030 Digital technologies to support self-management of COPD: early value assessment

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3 Committee discussion

NICE's medical technologies advisory committee considered evidence on digital technologies to support self-management 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

COPD is a long-term and progressive respiratory condition that can cause breathlessness, a persistent chesty cough, persistent wheezing, and frequent chest infections. The incidence of COPD in the UK is increasing (see section 2.15). COPD is a common cause of emergency hospital admissions, accounting for 1 in 8 UK hospital admissions. The 2017/2018 National Asthma and COPD Audit Programme (NACAP) COPD clinical audit (PDF) reports that 23.9% of people are readmitted within 30 days and 43.2% within 90 days after discharge, highlighting the importance of effective self-management to prevent exacerbations and readmissions.

Implementation

3.2

The clinical experts and patient experts explained that barriers to implementation of the digital technologies would include:

  • the point where the digital technology is used in the care pathway

  • digital literacy and setting up the technology for users

  • language and cultural considerations

  • social and environmental factors

  • additional resources needed in terms of healthcare professionals' time

  • ensuring data that is captured is beneficial to users and healthcare professionals

  • usability of the technologies.

The clinical experts also explained that an additional barrier to implementing these technologies is ensuring that staff are not overburdened. The likelihood of this occurring likely depends on the amount and format of clinical information being shared, which may be difficult and time consuming for healthcare professionals to interpret. But clinical experts suggested that, because the technologies are to support self-management, less input may be needed from staff. Users should be better equipped to manage their condition themselves, seeking medical advice only if needed.

Patient considerations

3.3

Patient experts explained that they thought that digital technologies were predominantly focused on supporting the healthcare professionals, rather than people with COPD. One of the patient experts also emphasised that COPD management should be a partnership between healthcare professionals and the person with COPD (as well as carers, when applicable).

3.4

Although the patient experts had not used the technologies, they agreed that there may be potential benefits for the user. The patient experts suggested that the technologies should provide advice on triggers, like environmental factors, and tracking of routine symptoms that may cause a person's health to deteriorate and lead to an exacerbation. They suggested that having this information was equally as important as the general health monitoring aspects of the technologies.

3.5

Although the evidence base predominantly included people with more severe and established COPD, the patient experts stated that people with COPD should have access to these technologies early in the care pathway, from the point of diagnosis. They suggested that earlier intervention with supported self-management using digital technologies could delay the worsening of COPD. This would not only benefit people with COPD (and their carers, when applicable), but could also be cost saving to the NHS.

3.6

The patient experts suggested that these technologies could supplement routine primary care appointments, but not completely replace them, because they felt that there should still be clinical oversight from healthcare teams.

Benefits of the technologies

3.7

The committee discussed the potential of digital technologies to improve COPD care through effective self-management and to address the unmet need of people who are unable to access appointments with their healthcare team.

3.8

Clinical experts explained that digital technologies to support self-management can provide timely education and individualised COPD plans, including exacerbation action plans for people at risk of exacerbations, in line with NICE's guideline on chronic obstructive pulmonary disease in over 16s: diagnosis and management. These technologies can also improve other aspects of COPD care, including inhaler technique and recognising exacerbations. The clinical experts emphasised that people with COPD would still need face-to-face reviews at least annually, even when using digital technologies for self-management. They explained that people with COPD should be on the primary care COPD register and should attend a follow-up review in primary care at least once a year, and more often if needed. Both patient experts and clinical experts thought that these technologies may help provide information for the annual review. The committee agreed that digital technologies to support self-management would provide another option for people with COPD, but they would not completely replace all appointments in the care pathway.

3.9

Because of the wide range of features in the digital technologies that contribute to self-management, the committee wanted to clarify which aspects of the technologies are most useful for self-management. The committee considered that remote patient monitoring might not be a tool used regularly, because self-management of COPD should generally function independently of clinical oversight from the healthcare team. The experts stated that people with more severe COPD might need additional face-to-face care rather than self-management. The committee suggested that stratification according to the severity of COPD and the features of the technologies would be useful when generating evidence to help inform practice.

Clinical effectiveness

Evidence from research studies
3.10

The evidence was not evenly distributed across the technologies and clinical outcomes. Prioritisation for study selection, extraction, and synthesis was based on the relevance to the decision problem scope and the quality of evidence, with the highest quality and most relevant evidence selected for each scoped technology. The EAG prioritised 17 studies across 10 technologies. Outcomes were inconsistently reported across the evidence base, using different tools, different reporting methods and different timepoints, making it difficult to draw meaningful conclusions from the evidence base. When more than 1 comparative study reported the same outcome measure, the direction and size of effect was not consistent across studies. There was a consistent direction of effect for some outcomes in people with acute exacerbations of COPD, but not all differences reached statistical significance. Not all technologies had evidence for all key outcomes. Data was limited for quality of life, GP visits and exacerbations, with the most data available for respiratory function and hospital admissions. A number of limitations across the evidence base were also identified. Samples in the randomised controlled trials were not adequately powered for appropriate clinical outcome measures, limiting their ability to identify statistically significant differences. Many trials had short follow-up periods, limiting the generalisability of the evidence to NHS settings where COPD self-management technologies are expected to be used as long-term tools. Details of usual care were generally not adequately reported, making comparisons between studies difficult. Also, the features of the evaluated technologies were often unclear, affecting the generalisability of the evidence between studies and technologies. The variability in the length of time since hospitalisation in the post-discharge group and the unclear COPD severity in the other 6 studies further impacted generalisability. The extent of overlap with the COVID-19 pandemic varied and was sometimes unclear, making it difficult to generalise findings across studies done before and after the pandemic. The committee acknowledged these limitations in the evidence base, and considered this uncertainty when making recommendations.

3.11

Randomised controlled trial (RCT) or cluster RCT evidence was prioritised for 3 technologies in this assessment. RCTs have the most methodologically robust study design, producing evidence that is more likely to identify any differences between the technologies and standard care. But the committee noted that the RCT and cluster RCT evidence identified had limitations. All RCT evidence had small sample sizes, limiting their ability to assess statistical significance. Also, most of the RCT evidence applied a non-intention-to-treat analysis method, excluding people who were eligible for inclusion in the trial after randomisation. This may have impacted the results by excluding people who did not fully adhere to the study protocol as intended. Some RCT evidence had baseline imbalances between treatment arms, despite an appropriate randomisation method being used. The cluster RCT evidence applied non-intention-to-treat analysis for some outcomes, again limiting the number of people included in the analysis and potentially introducing bias in the selection of the reported results. The cluster RCT evidence was in a non-UK setting, meaning the contents of standard COPD care and how these relate the NHS are unknown, limiting the generalisability of this evidence. These limitations in the RCT and cluster RCT evidence meant that the committee was unable to conclude with certainty whether the differences in outcomes were attributable solely to the technologies, and if these differences would be seen in NHS practice.

3.12

Ten studies reported COPD severity, with 9 of these studies only involving people who have had an acute exacerbation of COPD. One of these studies recruited people immediately after discharge from the emergency department or hospital admission for a COPD exacerbation. One study recruited people within 2 weeks of their discharge from hospital for an exacerbation, while 1 study did not report the timeframe or number of previous exacerbations needed for recruitment. One study recruited people with at least 2 exacerbations in the past 12 months. The other 5 studies recruited between 6 and 24 months after an exacerbation leading to hospitalisation. Because the evidence from the acute exacerbation subgroup was broadly positive, the committee discussed whether the recommendation could be limited to this population. Clinical experts and committee members agreed that by recruiting people who have had an acute exacerbation of COPD, there is a tendency for the COPD to improve over time, independently of the technology. This may overestimate the impact of the digital technology. The committee suggested that this effect should be explored in the evidence generation plan through RCTs. Clinical and patient experts agreed that there would be more benefit from the technologies if they prevented the initial exacerbation, rather than waiting to offer a self-management technology after clinical deterioration.

3.13

The evaluated evidence did not raise any particular concerns about adverse events associated with the digital technologies. Overall, the committee agreed that the evidence showed potential clinical benefits for people using technologies for supported self-management, and had the potential to address an unmet need. There were concerns about the generalisability of the results because some effects did not reach the level of clinical significance, and there was potential underperformance of comparators because these were not clearly defined in some studies.

3.14

The committee concluded that Active+me REMOTE, Clinitouch, COPDhub, COPDPredict, Lenus, Luscii, myCOPD, and SPACE for COPD can be used in the NHS while more evidence is generated, because they showed potential benefit in their existing evidence base. More research is needed on Doccla before it can be used in the NHS.

3.15

For the other 4 technologies, evidence on effectiveness was limited or lacking, or there was no information provided by the company. No relevant evidence was identified for patientMpower and Current Health, and Current Health is no longer available in the UK. No information was provided for DOC@HOME. Wellinks is not currently used in the NHS and does not have regulatory approval. The committee made no recommendations for these 4 technologies.

Equality considerations

3.16

Equality considerations highlighted to the committee included general and digital literacy, speaking a different language to English or having English as a second language, and access to equipment and internet. The committee recognised that additional support and resources may be needed for people who are unfamiliar with digital technologies or who do not have access to smart devices or the internet. Most of the companies stated that their technologies are available in other languages. The companies also stated that they promote engagement and digital inclusion by supporting people with onboarding and training when the technology is initially prescribed. One company indicated that socially and economically deprived areas show a higher uptake of digital health services relative to less deprived areas. The committee understood that additional support may be needed for people with accessibility needs or who are unable to read or understand English. But the digital technologies are not intended to replace face-to-face contact so usual care will still be an available option for people with COPD.

Costs and resource use

3.17

A cost-comparison model was developed to assess the potential benefits of the technologies over a 1‑year period. Limited evidence was available to model the potential impact of digital technologies to support self-management of COPD for all companies. The model focused on estimating resource use, such as GP visits, non-hospitalised exacerbations, and hospitalisations. The EAG excluded costs related to mortality to avoid double-counting. The effectiveness of the digital technologies was evaluated based on potential reductions in resource use.

3.18

The results of the economic modelling suggested a potential cost saving of £337 per person when using digital technologies compared with standard care. The committee acknowledged uncertainties in the data used to inform the modelling, particularly the impact of digital technologies on healthcare resource use, such as hospitalisations because of COPD. The committee also noted that, because the data predominantly came from people with severe COPD, the results may report a higher potential benefit than may be the case for people with less severe COPD, particularly for those recently experiencing acute exacerbations. Both the committee and clinical experts agreed that the average hospital admissions used in the economic model represented a more severe COPD cohort compared to mild-to-moderate cases and this should be considered when interpreting the results.

3.19

The only difference in the economic model between the different technologies was the cost of the technology, because all other assumptions remained constant. Costs varied among companies, affecting the assessment when comparing technologies based on price alone. The EAG highlighted that one limitation of the model was pricing uncertainty because of different factors, including setup fees, licence fees varying depending on number of users, and the possibility that some technologies may offer medical devices as part of their package (which was not costed). The economically justifiable price was estimated at £620 per person, with 1 technology exceeding this cost. The results are indicative and not perfectly representative of all digital technology providers.

3.20

The committee noted that the results should be considered cautiously because of the limitations of the clinical data informing the modelling. The comparative effectiveness of digital interventions was unclear, particularly in mixed or unclear treatment settings. Some studies showed benefits, but others did not, reflecting the heterogeneous nature of the evidence and varied methodologies used. Potential improvements in COPD management using digital technologies were indicated by improvements in COPD Assessment Test scores, inhaler use, and reductions in exacerbations and admissions. But results were mixed and somewhat inconsistent across different patient populations and studies.

3.21

Sensitivity and scenario-based analysis indicated that digital technologies generally remained cost saving except in scenarios with the highest costs of the digital technologies, and when there was no reduction in hospitalisation rates. The cost of hospitalisation in the base case, based on the latest NHS cost data, was significantly higher than in previous iterations. So, using a lower cost for hospitalisation reduced the cost-saving potential of digital technologies.

3.22

The committee agreed that the general direction of efficacy data for digital technologies was positive, suggesting improvements over standard care. By reducing hospitalisations, exacerbations and GP visits, digital technologies to support self-management of COPD are likely to be cost saving rather than cost incurring.

Evidence gap review

3.23

For all the technologies, the evidence gaps related to the population, intervention and outcomes, including resource use and health-related quality of life.

Population
3.24

The patient and clinical experts highlighted that people with newly diagnosed COPD should be included in the recommendation population, rather that only those with established COPD diagnoses, including the subgroup of people with acute exacerbations of COPD. This is because if COPD progression is delayed, this can have positive impacts on people with COPD and their carers and families. Also, delayed COPD progression could lead to reduced resource use, such as fewer emergency department visits and admissions, which would have a positive impact on the NHS. The committee agreed that only recommending the technologies for the subgroup with acute exacerbations of COPD could introduce bias and overestimate the impact of the technologies, because of natural variations in people's COPD.

3.25

The committee noted the short time horizons of the trials and agreed with clinical experts that long-term studies with a minimum data collection period of 1 year would be useful to capture the effectiveness and resource use of the technologies.

3.26

The committee discussed the importance of stratifying COPD severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. It noted that individuals with a more severe GOLD classification may need more intensive care, and clinical effectiveness and resource use may vary depending on COPD severity. Capturing outcome data such as health-related quality of life or respiratory function would provide valuable insights into how digital technologies impact people with different severity levels of COPD. The committee agreed that it would be beneficial to include this information in future studies, to better understand and optimise the use of digital technologies in managing COPD.

3.27

The committee noted that there was no comparison of outcomes for people living in urban and rural settings.

Intervention
3.28

The committee was aware that it is important to capture patient preferences and experiences as well as uptake and adherence rates for these technologies. Because these technologies are heterogeneous and have different functionalities, it would be useful to capture which features of these technologies are contributing to the outcomes recorded.

Outcomes
3.29

Gaps in the outcomes included inconsistent reporting of outcome data across a wide range of measures, making it difficult to draw conclusions. The evidence gaps included respiratory function, health-related quality of life, and details on the number of exacerbations, hospital visits, and outpatient visits. The committee noted that long-term data was also needed to evaluate the true effectiveness of these technologies. The companies and technology developers agreed with this.