3 Committee discussion

The diagnostics advisory committee considered evidence on Kinesia 360, KinesiaU, PDMonitor, Personal KinetiGraph (PKG), and STAT-ON for remote monitoring of Parkinson's disease from several sources, including a diagnostics assessment report and an overview of that report. Full details are in the project documents for this guidance.

People with Parkinson's disease could benefit from remote monitoring technologies

3.1 Patient experts explained the potential benefits of easy-to-use and unobtrusive remote monitoring options for Parkinson's disease. This included contributing to a 'feeling of normality', prolonging a level of independence, acting as an urgency signal to accelerate further care, and reducing anxiety around in-person visits. It could also help with describing symptoms to healthcare professionals, which can be very difficult, particularly when trying to describe how symptoms change over time. A patient expert also explained that the reports the technologies generate can help them understand their condition. The committee noted that remote monitoring technologies could make remote care easier, so that healthcare professionals could do appointments by telephone or video call, so people did not have to travel as often to meet in person. This would reduce travel costs and could reduce how much their condition feels like a medical condition, particularly in the earlier stages. However, patient experts said that the disease can be isolating for people with Parkinson's disease and carers, and that face to face appointments can help with this. The committee also noted that the technology may not be suitable for everyone with Parkinson's disease, for example for people who are particularly frail, use a wheelchair, are confined to bed, or have missing limbs or cognitive or sensory impairment. In some cases, additional support may be needed to help people to use the remote monitoring devices. The committee noted that the devices differ in how they work and where sensors are attached, so some may be more suited to some people than others, for example people with missing limbs or with restricted movement. It recognised that offering face to face appointments is still essential, and that remote assessment would not replace this entirely, but could offer more flexible options for care for some people. Clinical experts emphasised the importance of making training and other user-support resources accessible to people and making sure that they are suitable for people with hearing loss or visual impairment. Experts also said that time between review appointments can be very variable (see section 3.4) and prolonged, so having the option of using the remote monitoring devices could provide reassurance and a safety net for checking symptoms between clinical appointments. The committee concluded that devices for remote monitoring offer a range of potential benefits to people with Parkinson's disease.

Carers could benefit from remote technologies monitoring symptoms

3.2 The patient experts said that current methods of assessing symptoms can heavily rely on observations made by carers, and their ability to communicate these to clinical experts. The size of responsibility for this causes a lot of stress and anxiety, particularly as the condition progresses and if the carer is the main source of information about changes in symptoms. There can also be disagreement between a person with Parkinson's disease and their carer about the extent of symptoms, which can be a difficult discussion. Technology that could provide an objective review of symptoms can help discussions and take pressure off the carer. Patient experts also said that if someone with Parkinson's disease does not have a carer living with them, or if their carer has cognitive issues, then the potential value of the technologies would be much greater. The committee also recognised that the carer's quality of life is affected by the severity of symptoms of the person with Parkinson's disease, and the responsibilities associated with managing medication and hospital visits. Patient experts explained that caring for people with Parkinson's disease can mean that carers put off managing their own health issues, and that their experience was that this can affect a carer's health-related quality of life considerably, and so increase costs to the NHS. Travel for in-person appointments can be difficult for carers who may need to take time off work, particularly if they are the only earner, so being able to use remote appointments more would help. The committee recognised that objective remote monitoring technologies may help alleviate stress and anxiety for carers, assist in communication with healthcare professionals, and could save time at hospital appointments by providing a starting point for discussions. It therefore concluded that it was important to consider any impact of the technologies on carers in its decision making.

The technologies could be used in many different ways in the NHS and how they would fit into the care pathway is not clear

3.3 The clinical experts explained that the technologies could be used in many different ways in the NHS. For example, before regularly scheduled appointments with healthcare professionals, after treatment changes to help titrate dosage, to indicate if a further review appointment with a healthcare professional is needed, or for use with people who are having issues with symptoms. They said that centres currently using these technologies did so in very different ways. Experts noted that it was important that the technologies were integrated into care pathways, including training for clinical teams and for people with Parkinson's and their carers. They noted that using the technology could mean that care pathways are altered. How the technologies would be used if adopted was not clear and could have a big impact on clinical and cost effectiveness. Studies identified by the external assessment group (EAG) that compared the devices with standard care used the technologies in different ways: Woodrow et al. (2020) used the PKG at 5-week intervals for up to 25 weeks; Isaacson et al. (2021) used the Kinesia 360 to optimise rotigotine dosage when motor symptoms were not controlled well enough. There was therefore little data showing the impact of the devices if they were used in ways that could be adopted by the NHS, for example to identify people who need a review appointment with a healthcare professional. The EAG explained that there was little evidence on the technologies when used in the UK. It also pointed out that how the technology is used greatly affected cost-effectiveness estimates (see section 3.9). The committee concluded that the technologies could be used in many different ways in the NHS and how they would fit into the care pathway is not clear.

The level of care in Parkinson's disease varies and remote monitoring may become increasingly important

3.4 The clinical and patient experts explained that, although NICE's guideline on Parkinson's disease recommends reviewing people every 6 to 12 months, this does not always happen in practice. They said the level of care provided varied across the NHS. Clinical experts added that the number of people with Parkinson's disease is increasing, which will place further pressure on the healthcare system. There are also backlogs for review appointments because of COVID-19 disruptions. Patient experts said the technology could be a way to assess people with difficulties accessing services. They said it was also a way of identifying issues in the lengthy gaps between reviews (see section 3.1). The committee noted that the size of benefit of adopting the technologies may vary depending on current local care. It also noted that increasing pressures on NHS services may mean that the technologies are likely to become increasingly beneficial.

Clinical effectiveness

The reference standard in identified accuracy studies is imperfect and may underestimate technology performance

3.5 The EAG said that there is no clearly established reference standard for measuring Parkinson's disease symptoms to establish test accuracy beyond clinician and patient assessment. A potential benefit of the technologies is that they may more accurately evaluate symptoms than patient recall or clinical opinion, so a reference standard based on this (as used in accuracy studies identified by the EAG in its systematic review) could underestimate technology performance. The committee noted that accuracy estimates may not be the best outcome to assess the performance of these technologies.

There is limited evidence on how much the technologies can improve symptoms or health-related quality of life

3.6 Only 3 studies had data comparing clinical outcomes with the technologies against not using the technologies. Two of these (which assessed the Kinesia 360) were small randomised controlled trials. The largest study (which assessed the PKG and was by Woodrow et al.) reported clinical improvements in terms of statistically significant reductions in the Unified Parkinson's Disease Rating Scale (UPDRS) 3 (motor examination), UPDRS 4 (complications of therapy), total UPDRS score and PDQ-39 (Parkinson's Disease Questionnaire 39). The committee noted that the trial was not randomised. It understood that there could have been a systematic difference between the centres included in the trial and their catchment areas because people were allocated to PKG based on the centre they attended. Clinical experts also pointed out that the PKG was used every 5 weeks in the Woodrow et al. study, which would not be realistic in the NHS. Standard care in the study's comparator arms also may not represent NHS care. Because the length of follow up from the available studies was relatively short, there was also a lack of data on how long any benefit of the devices lasted once they were not used any more. Also, the EAG did not identify any data specifically on the populations who were identified in the scope as likely to have particular benefit from the technologies. These included people with communication barriers and people from black, Asian and minority ethnic family backgrounds, because symptoms can vary by ethnicity. The committee concluded that, while the identified studies gave some indication of how the technologies could benefit people with Parkinson's disease, there was considerable uncertainty about the likely size of this if the technologies were adopted in the NHS.

Most of the evidence is in people having maintenance therapy

3.7 Clinical and patient experts suggested that the technologies may be particularly useful for people who are eligible for more advanced therapies such as deep brain stimulation. But the EAG said the only evidence on the devices' comparative effectiveness was in the maintenance stage of Parkinson's disease. The committee understood that the devices may perform differently in these different populations.

How much remote monitoring devices would change decisions about care in the NHS is uncertain

3.8 Clinical experts said that, as well as changes to medication, symptoms can be managed with other changes to care like physiotherapy and exercise. Only the PKG had data on how the technologies can change decisions about care. The proportion of people who had a change in clinical management as a result of the PKG varied considerably (between 31.8% and 79%). A UK study reported that the PKG provided additional information in 45.5% of cases. In studies of clinician opinion, between 4% and 41% agreed that the PKG provided enough additional information to consider making treatment adjustments. The committee concluded that there was uncertainty about how much using remote monitoring devices would change care for people in the NHS.

Cost effectiveness

Device cost is a major driver of cost effectiveness

3.9 In the EAG's model, the intervention arm resulted in a higher incremental cost compared with standard care. Device cost was the largest driver of this. The EAG said that this cost depended on how often the devices were modelled as being used (see section 3.3) and the cost per use. The technologies had differing payment mechanisms: pay per use, a subscription model or outright purchase of the device. The committee noted that the payment options differed in terms of requirements for upfront investment and on how reversible a decision to start using a technology would be. The committee recalled that the technologies could be used in various ways in the NHS (see section 3.3 and noted that the EAG had modelled use at varying frequencies. This included one-time use (at baseline) and routine use (every 6 months) in its base cases, and a recurrent use scenario analysis (at 6 and 18 months in place of clinical appointments). How frequently the technologies were used had a big influence on device-related costs, and on cost-effectiveness estimates.

Because of the uncertainty about the devices' impact on health-related quality of life, cost effectiveness is also uncertain

3.10 The committee recalled that there was uncertainty about the size of impact that device use would have on symptoms if used in the NHS (see section 3.6). The size of the impact from the Woodrow trial was used in the EAG's model to inform estimates of health-related quality of life. The EAG also had to make assumptions about how long any benefit would last for after using the device. Sensitivity analyses showed that cost-effectiveness estimates were very sensitive to this assumption. The committee concluded that the size and longevity of the benefits of device-guided decisions about care was very uncertain, and consequently so were cost-effectiveness estimates produced by the EAG's model.

Chaudhuri et al. (2022) is likely to have overestimated how device use would affect resource use and how long any benefit would last for

3.11 Cost-effectiveness modelling reported by Chaudhuri et al. (2022) estimated that the PKG would be cost saving by £17,362, whereas in the EAG's model the PKG was cost incurring. Both models compared the PKG with standard care. The committee questioned the approach used in Chaudhuri et al., which took scores with PKG use on the UPDRS from Woodrow et al. and converted them to the Hoehn and Yahr scale. They then used this to calculate resource costs. The committee noted that the EAG had been unable to verify or validate the approach used by Chaudhuri et al. It was also not clear if the symptom improvements observed from using the technologies could realistically translate into the large-scale changes in healthcare use predicted by this model. A clinical expert said that it was very unlikely that remote monitoring devices would have the effect shown on the Hoehn and Yahr scale. The EAG added that in Woodrow et al., device use did not have a statistically significant effect on the Hoehn and Yahr scores (-0.044, standard error 0.097 for adjusted data). It also said that in the Chaudhuri model, the PKG's effect on symptoms was assumed to last for 5 years with only limited waning of effect after that, although there was no evidence for this. Clinical experts noted that there are no disease-modifying treatments available for Parkinson's disease that can stop progression. The committee concluded that the Chaudhuri et al. model was likely to have overestimated how much the PKG can reduce healthcare-associated resource costs, and how long the benefit from PKG-guided care on symptoms would last for.

The broader impact of remote monitoring device use on resources is uncertain

3.12 The EAG's assessment report noted a UK survey that reported that people with Parkinson's disease interact with 18 different healthcare professions. The EAG had suggested that more data on healthcare professions involved with patient consultation could identify further areas in which remote monitoring device-aided care could reduce costs. Patient experts also explained that the cost of providing care to people with Parkinson's disease can differ significantly according to whether they have a live-in carer, a paid carer or no carer at all. Costs related to social care were not included in the EAG's model because of a lack of data. Any impact of remote monitoring devices on these costs, for example delaying when someone with Parkinson's disease goes into a care home, could have been missed. The companies said that the EAG's model did not include costs related to falls and hip fractures prevented, which they said could be an uncaptured benefit if the devices did improve symptom management. The EAG explained that there was a lack of data to inform this. Also, because of a lack of data, that its analysis was constrained to the management phase of Parkinson's disease. It understood that falls, hip fractures and social care costs are largely confined to the advanced stages of the disease. The committee concluded that the EAG's model may have underestimated the impact of using remote monitoring devices on some resources and associated costs. However, other costs related to implementing the devices, for example interconnectivity, may be higher in practice.

The EAG's model did not capture the potential impact of remote monitoring on carers

3.13 The committee recalled that remote monitoring devices could benefit carers (see section 3.2). But, because of a lack of data, the EAG's model did not include costs or health-related quality of life for them. The committee noted that relatively small improvements in quality adjusted life years (QALYs) caused by device use (perhaps related to carer benefits) could have a large impact on cost-effectiveness results, depending on the analysis used. The committee concluded that there was considerable uncertainty about how much the remote monitoring devices could affect carers, and noted that this had not been captured in the EAG's model.

The value of the technology may be underestimated, or was not estimated, by the EAG's model for some groups

3.14 There was not enough evidence for the EAG to be able to do subgroup analyses for people who have communication barriers, people from black, Asian and minority ethnic family backgrounds, or people from different socio-economic backgrounds. These populations were identified at scoping as being potentially likely to gain additional benefits from the technology. The patient experts noted that remote monitoring may also benefit people who are having difficulty attending consultations, or getting care because services are at full capacity. The EAG had also not been able to model how remote monitoring devices might work for people being considered for advanced therapies, such as deep brain stimulation, because there was not enough evidence.

Remote monitoring technologies have considerable promise, but more data is needed to estimate their likely true cost effectiveness

3.15 The committee recognised the promise that remote monitoring devices offer to people with Parkinson's disease and their carers (see section 3.1 and 3.2). These devices could also help with increasing capacity pressures on the NHS. But their cost effectiveness was very uncertain, and there are several areas of uncertainty for which more data is needed to more accurately estimate it (see section 4). The PKG has the most evidence, but the committee recalled that there was uncertainty about how well data from the main trial for this technology (Woodrow et al.) represents how well the device would work in the NHS (see section 3.6).

The remote monitoring technologies can be used in the NHS while further data is collected

3.16 The committee considered the risks associated with using the technologies in the NHS while further data is collected. Clinical and patient experts said that their main concern about potentially worse patient outcomes with their use was if the devices were poorly implemented. For example if they were used to entirely replace face to face appointments, and were not integrated into care pathways. The experts also said that remote monitoring devices were already being used in some NHS centres. The committee noted that the overall cost impact of using the devices was uncertain and was to a large extent dictated by how much the companies charged. How the devices are charged for also varied (see section 3.9). The committee concluded that this was important for commissioners to consider, because the devices were likely to differ in terms of ongoing or irrecoverable costs if a later decision was made to stop using the technologies, for example if further data collection showed they did not work as well as anticipated.

Research considerations

More data collection is needed in populations that represent the potential use and benefits of the devices in the NHS

3.17 There was no or limited data for several populations who could particularly benefit from the remote monitoring technologies (see section 3.14), including people who might be helped by advanced therapies.

How are you taking part in this consultation?

Devices for remote monitoring of Parkinson's disease