Authors' objectives: Parkinson’s disease is a brain condition causing a progressive loss of co ordination and movement problems. Around 145,500 people have Parkinson’s disease in the United Kingdom. Levodopa is the most prescribed treatment for managing motor symptoms in the early stages. Patients should be monitored by a specialist every 6–12 months for disease progression and treatment of adverse effects. Wearable devices may provide a novel approach to management by directly monitoring patients for bradykinesia, dyskinesia, tremor and other symptoms. They are intended to be used alongside clinical judgement. To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson’s disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON. Parkinson’s disease (PD) is a condition that affects the brain, resulting in a progressive loss of co-ordination as well as movement problems. In the early stages of PD, the three main motor symptoms are shaking (tremor), slowness of movement (bradykinesia) and muscle stiffness (rigidity). There are around 145,500 people living with PD in the UK. The risk of developing the disease increases sharply with age. Levodopa is the most prescribed treatment for managing the motor symptoms of PD in the early stages. However, it may be associated with significant motor complications, including response fluctuations and dyskinesias (involuntary movements). Response fluctuations are characterised by large variations in motor performance, with normal function during the ‘on’ period, and weakness and restricted mobility during the ‘off’ period. Deep brain stimulation and levodopa–carbidopa intestinal gel can be considered in people with advanced PD whose symptoms do not respond adequately to best medical therapy. The National Institute for Health and Care Excellence (NICE) recommends that people with Parkinson’s disease (PwP) should be seen by a specialist every 6–12 months initially, then more often with increasing disease complexity, although this is often difficult because of the increasingly ageing population and demands on PD services. Remote monitoring devices are intended to be used alongside clinical judgement to assess disease severity and help manage PD symptoms and adverse effects of treatment. Results of the monitoring are analysed remotely and a summary provided to the specialist physician and/or to the patient. The data should be used to determine whether any changes in the treatment regimen are desirable, in consultation with the patient. This assessment considers only wearable, remote monitoring devices that produce results with no input, or limited input, from the user. Five relevant devices were identified for consideration: Personal KinetiGraph (PKG) Movement Recording System (Global Kinetics); Kinesia 360 motor assessment system (Great Lakes NeuroTechnologies); KinesiaU motor assessment system (Great Lakes NeuroTechnologies); PDMonitor (PD Neurotechnology); and STAT-ON (Sense4Care). To determine the clinical and cost-effectiveness of the five included remote monitoring devices in PwP.

Authors' results and conclusions: Fifty-seven studies of Personal KinetiGraph, 15 of STAT-ON, 3 of Kinesia 360, 1 of KinesiaU and 1 of PDMonitor were included. There was some evidence to suggest that Personal KinetiGraph can accurately measure bradykinesia and dyskinesia, leading to treatment modification in some patients, and a possible improvement in clinical outcomes when measured using the Unified Parkinson’s Disease Rating Scale. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical impact. The evidence for Kinesia 360, KinesiaU and PDMonitor is insufficient to draw any conclusions on their value in clinical practice. The base-case results for Personal KinetiGraph compared to standard of care for one-time and routine use resulted in incremental cost-effectiveness ratios of £67,856 and £57,877 per quality-adjusted life-year gained, respectively, with a beneficial impact of the Personal KinetiGraph on Unified Parkinson’s Disease Rating Scale domains III and IV. The incremental cost-effectiveness ratio results for Kinesia 360 compared to standard of care for one-time and routine use were £38,828 and £67,203 per quality-adjusted life-year gained, respectively. Personal KinetiGraph could reasonably be used in practice to monitor patient symptoms and modify treatment where required. There is too little evidence on STAT-ON, Kinesia 360, KinesiaU or PDMonitor to be confident that they are clinically useful. The cost-effectiveness of remote monitoring appears to be largely unfavourable with incremental cost-effectiveness ratios in excess of £30,000 per quality-adjusted life-year across a range of alternative assumptions. The main driver of cost-effectiveness was the durability of improvements in patient symptoms. The EAG considers that the evidence for PKG shows that it could be of use in clinical practice, provided it can be made cost-effective. It provides useful information on key symptoms of PD, including bradykinesia, dyskinesia and tremor. The use of PKG leads to changes in treatment management for at least some patients, and possible improvement in symptoms. Although there is some promising evidence for STAT-ON and Kinesia 360, the EAG considers that the evidence is currently not sufficient to be confident that these technologies will produce clinical benefits for patients. The EAG considers that there is too little evidence for KinesiaU or PDMonitor to draw any conclusions regarding their clinical value. Almost all current evidence relates to patients receiving pharmacological therapy, mainly levodopa. The EAG notes that, at present, it is unclear whether PKG or other remote monitoring technologies offer any clinical benefit in other patients, such as those receiving advanced therapies. Concerns about potential bias, together with the other limitations in the available evidence, means that cost-effectiveness estimates are highly uncertain. Key uncertainties relate to the magnitude and durability of treatment effects. The results of the economic analysis are largely unfavourable with ICERs in excess of thresholds typically adopted by NICE.

Authors' methods: We performed systematic reviews of all evidence on the five devices, outcomes included: diagnostic accuracy, impact on decision-making, clinical outcomes, patient and clinician opinions and economic outcomes. We searched MEDLINE and 12 other databases/trial registries to February 2022. Risk of bias was assessed. Narrative synthesis was used to summarise all identified evidence, as the evidence was insufficient for meta-analysis. One included trial provided individual-level data, which was re-analysed. A de novo decision-analytic model was developed to estimate the cost-effectiveness of Personal KinetiGraph and Kinesia 360 compared to standard of care in the UK NHS over a 5-year time horizon. The base-case analysis considered two alternative monitoring strategies: one-time use and routine use of the device. The evidence was limited in extent and often low quality. For all devices, except Personal KinetiGraph, there was little to no evidence on the clinical impact of the technology. Systematic review Systematic reviews were conducted following the general principles recommended in the Centre for Reviews and Dissemination (CRD) guidance and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Comprehensive searches of the literature were conducted to identify all studies relating to the use of the five remote continuous monitoring devices. MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov and other databases and registries were searched on 1 February 2022. Two reviewers independently screened all titles and abstracts. All clinical studies of any of the five included devices, where used in people with PD (of any severity or stage), were eligible for inclusion. The key comparator was clinical judgement of disease symptoms without the use of remote monitoring devices; however, included studies did not have to have a comparator group. Outcomes of interest included: association and diagnostic accuracy between outputs of remote monitoring (such as bradykinesia score, dyskinesia score) and clinical measures [such as Unified Parkinson’s Disease Rating Scale (UPDRS) score or clinical judgement of symptoms]; all impacts on clinical decision-making, such as changes in therapy and dose modification; all clinical outcomes, such as UPDRS or Hoehn and Yahr scores, morbidities and mortality; and all patient, carer or clinician opinions on the technologies. Data reported in publications were extracted by one reviewer and independently checked by a second reviewer. Study quality was assessed using suitable tools, such as Quality Assessment of Diagnostic Accuracy Studies-2 for diagnostic accuracy studies and the Cochrane Risk-of-Bias tool for clinical trials. Evidence was synthesised using a narrative synthesis approach. The results of data extraction were presented in structured tables and as a narrative summary. A broad thematic synthesis was used to identify key issues arising from the extracted evidence. Due to the diversity of reporting across studies, meta-analysis was not feasible for any outcomes. One clinical trial provided its individual participant data; this was re-analysed for this report.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR135437

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/YDSL3294

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/YDSL3294

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk