myCOPD for managing chronic obstructive pulmonary disease

The committee noted that evidence from 2 randomised controlled trials (the RESCUE and EARLY trials) and real-world evaluations showed that myCOPD had clinical benefits for self-managing chronic obstructive pulmonary disease (COPD). Populations included in the studies were heterogeneous in terms of the severity of COPD. The committee accepted that the evidence suggests clinical benefits showing improved inhaler technique, COPD assessment test (CAT) score and 6‑minute walk test. RESCUE showed encouraging results, but it was designed as a feasibility study. Evidence on the effect of using myCOPD for self-managing COPD on health service use was limited. RESCUE showed that there were fewer hospital readmissions for acute exacerbations of COPD in people using myCOPD compared with people having standard care. The difference was not statistically significant. The external assessment centre (EAC) explained that the small study sample size had limited power to show an effect on clinical outcomes. The committee agreed that more evidence is needed to clearly show the clinical and healthcare system benefits of myCOPD for self-managing COPD (see the section on further research).

The evidence presented on using myCOPD for pulmonary rehabilitation included 1 non-inferiority trial (TROOPER) and real-world evidence. In the trial, all clinical outcomes using myCOPD were not worse than conventional face-to-face pulmonary rehabilitation. The committee accepted that the trial was well designed but noted methodological concerns from the EAC about the power calculations, such as the selection of the non-inferiority limit (for further details, see the EAC assessment report addendum). It also considered that the trial was limited by being a single-site study. The TROOPER study authors acknowledged the small sample size and suggested that a larger randomised controlled trial would be needed to change clinical practice. The committee concluded that a larger randomised controlled trial was needed to be confident in the findings of the TROOPER study.

A commissioning expert from NHS Dorset clinical commissioning group (CCG) explained that the evaluation of digital health technologies is complex. They noted that considerations should not only focus on the clinical benefits of the technology, but also the patient experience, the usability of the technology and the role of the health service team. A survey done by NICE's public involvement programme suggested that people found myCOPD easy to use. The committee concluded that the usability and patient experience of the technology for both patients and the healthcare system are important considerations.

The company confirmed that myCOPD has been used across health services for self-managing COPD and pulmonary rehabilitation. The clinical experts advised that the health service team, both clinical and non-clinical, plays an important role in keeping people engaged with myCOPD. The commissioning expert stated that their team provided support for people to register and set up the app for self-managing their symptoms. Ongoing support from non-clinical digital support workers is provided at different time points via text messaging, over the phone or by setting up face-to-face appointments to help maintain patient engagement. Similarly, the clinical expert said that people who used myCOPD for pulmonary rehabilitation in their service had a weekly call from the clinical team during the 6‑week pulmonary rehabilitation course to support their progress in the programme. The company also confirmed that digital health advisers have been included as part of a contract to support the implementation of the technology and to ensure that clinical and digital support teams are fully trained.

The committee understood that myCOPD uptake data varied widely across services. It acknowledged there are many factors influencing how much it was used, including the COVID‑19 pandemic. The commissioning expert said that real-time uptake data was available from Dorset CCG, where uptake for self-management increased from 43% to 65% in 2021. The committee questioned whether the uptake rates observed in Dorset were likely to be realised in other regions. A clinical expert advised that uptake of myCOPD for pulmonary rehabilitation in their service was around 26% in 2018; however, no recent uptake data was available. The committee agreed that understanding the uptake of myCOPD across different regions and settings, for both self-management and pulmonary rehabilitation, is important to ensure its value for money (see sections 3.10 and 3.11). It concluded that this information could easily be collected as real-world evidence.

Clinical experts explained that myCOPD has been implemented as an option alongside existing services in their practice. People have the option to choose whether or not to use it depending on preference. The experts noted that the populations in their regions using myCOPD were mainly older white British people living in areas with different levels of socioeconomic deprivation. The company confirmed that the average age of myCOPD users is 74 years old. The commissioning expert said that the implementation of myCOPD improved patients' access to health services in areas of deprivation. The committee also discussed the English language skills needed to use myCOPD. The average reading age needed to use myCOPD is between 8 and 12 years. The clinical experts noted that myCOPD may be difficult to use for people who are not able to use a smart device easily, such as those with a visual or cognitive impairment, limited manual dexterity, or with hearing loss. They added that in their experience, some people with COPD would prefer not to use the digital tool, while others found it helpful. The committee concluded that further evidence of myCOPD's use in a wide range of socioeconomic backgrounds, ethnicities and ages is needed to understand its effect on health inequalities.

The committee understood that clinical parameters in the AECOPD model (see section 3.7 for details about the models) for self-management were based on RESCUE, a feasibility trial with fewer than 50 patients. It noted that the key drivers of cost saving in this model were the uptake of myCOPD and hospital readmissions, and both parameters were uncertain (see sections 3.10 and 3.11). The PR model has 3 treatment options, so people were able to choose myCOPD, face-to-face pulmonary rehabilitation or a hybrid format which consisted of face-to-face sessions and myCOPD. Results from TROOPER were used in the PR model. Key drivers for cost savings in this model were the uptake of myCOPD, both alone and in the hybrid format, and the number of people referred for pulmonary rehabilitation. The committee considered that the key uncertainty for the PR model related to the assumption of non-inferiority of pulmonary rehabilitation services delivered by the myCOPD app compared with face-to-face pulmonary rehabilitation (see section 4.2). It also considered that more information is needed on the uptake rate of myCOPD when it is used for pulmonary rehabilitation (see section 4.5).

myCOPD has potential for clinical benefits, but more evidence is needed to reduce uncertainties. The committee considered that comparative evidence is needed to show the clinical benefits of using myCOPD in 2 populations:

• people using it to self-manage COPD

• people referred to pulmonary rehabilitation.
  
  For self-management, a randomised controlled trial is preferred to show the clinical benefits of myCOPD. This could be powered based on the encouraging results in the RESCUE study. However, a high-quality comparative observational study designed to minimise bias in the results may provide acceptable evidence. Outcomes such as rates of exacerbations, hospital readmissions and unscheduled care appointments should be considered alongside patient-reported outcomes such as health-related quality of life. For pulmonary rehabilitation, further evidence is needed to show the clinical benefits of myCOPD. This could be a randomised controlled trial which is powered based on the encouraging results in the TROOPER study or a well-designed comparative observational study. Key outcomes will be the CAT score and 6‑minute walk test, ideally supported by additional longer-term outcomes such as rates of exacerbations and hospital admissions.

Real-world data could be used to inform the uptake rates in the economic modelling. It should also include qualitative data on patient experience using myCOPD such as patient preferences and adherence.