■帕金森氏病是一种导致逐渐失去协调性和运动问题的脑部疾病。在英国,大约有145,500人患有帕金森病。左旋多巴是在早期阶段管理运动症状的最处方治疗。应每6-12个月由专科医生监测患者的疾病进展和不良反应的治疗。可穿戴设备可以通过直接监测患者的运动迟缓,提供一种新的管理方法。运动障碍,震颤等症状。它们旨在与临床判断一起使用。
■确定用于监测帕金森病的五种设备的临床和成本效益:个人动力学图,Kinesia360,KinesiaU,PDMonitor和STAT-ON。
■我们对五种设备的所有证据进行了系统评价,结果包括:诊断准确性,对决策的影响,临床结果,患者和临床医生的意见和经济结果。我们检索了截至2022年2月的MEDLINE和其他12个数据库/试验登记处。评估偏倚风险。叙事综合被用来总结所有确定的证据,因为证据不足以进行荟萃分析.其中一项试验提供了个人水平的数据,重新分析。开发了一个从头决策分析模型,以估算个人运动图和Kinesia360在5年时间范围内与英国NHS护理标准相比的成本效益。基本情况分析考虑了两种替代监测策略:一次性使用和设备的常规使用。
■57项个人动力学图谱研究,15个STAT-ON,包括Kinesia360的3个,KinesiaU的1个和PDMonitor的1个。有一些证据表明,个人运动图可以准确地测量运动迟缓和运动障碍,导致一些患者的治疗改变,使用统一帕金森病评定量表测量时,临床结果可能有所改善。STAT-ON的证据表明它可能对诊断症状有价值,但目前尚无证据表明其临床影响。Kinesia360,KinesiaU和PDMonitor的证据不足以就其在临床实践中的价值得出任何结论。与一次性和常规使用的护理标准相比,PersonalKinetiGraph的基本案例结果导致每质量调整生命年增加67,856英镑和57,877英镑的成本效益比,分别,个人动力学图对统一帕金森病评定量表III和IV域的有益影响。与一次性和常规使用的护理标准相比,Kinesia360的增量成本效益比结果为每获得质量调整生命年38,828英镑和67,203英镑,分别。
■证据的范围有限,质量通常很低。对于所有设备,除了个人动力学图,该技术的临床影响几乎没有证据。
■个人动力学图可以合理地在实践中用于监测患者症状并在需要时修改治疗。关于STAT-ON的证据太少了,Kinesia360,KinesiaU或PDMonitor确信它们在临床上有用。远程监测的成本效益似乎在很大程度上不利,在一系列替代假设中,每质量调整生命年的增量成本效益比超过30,000英镑。成本效益的主要驱动因素是患者症状改善的持久性。
■本研究注册为PROSPEROCRD42022308597。
■该奖项由美国国家卫生与护理研究所(NIHR)证据综合计划(NIHR奖项参考:NIHR135437)资助,并在《卫生技术评估》中全文发表;卷。28号30.有关更多奖项信息,请参阅NIHR资助和奖励网站。
帕金森氏病是一种导致协调性丧失和运动问题的脑部疾病。左旋多巴是治疗早期疾病的最佳处方。患者应每6-12个月由专科医生就诊,以评估其治疗需求。可穿戴设备(如智能手表)可以通过直接监测患者的疾病症状,包括震颤和运动迟缓(运动迟缓)来帮助管理。或治疗的副作用,如不自主运动(运动障碍)。这项评估考虑了五种可穿戴设备的临床和经济价值:PersonalKinetiGraph,STAT-ON,Kinesia360,KinesiaU和PDMonitor。我们搜索了医学数据库,找到了这五种设备的所有研究。我们评估了这些研究的质量并回顾了它们的结果。我们发现了77项有关该设备的研究。有一些证据表明,个人运动图可以准确地测量运动迟缓和运动障碍,导致一些患者的治疗改变,和症状的可能改善。STAT-ON的证据表明它可能对诊断症状有价值,但目前尚无证据证明其临床价值。Kinesia360,KinesiaU和PDMonitor没有足够的证据得出任何结论。进行了经济分析,以调查使用这些技术中的任何一种是否在经济上可行。经济分析发现,相对于在NHS中实施远程监控设备的额外成本,远程监控设备产生的生活质量收益很小。因此,与目前的护理标准相比,没有一种远程监护设备物有所值.
UNASSIGNED: 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.
UNASSIGNED: To determine the clinical and cost-effectiveness of five devices for monitoring Parkinson\'s disease: Personal KinetiGraph, Kinesia 360, KinesiaU, PDMonitor and STAT-ON.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This study is registered as PROSPERO CRD42022308597.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135437) and is published in full in Health Technology Assessment; Vol. 28, No. 30. See the NIHR Funding and Awards website for further award information.
Parkinson’s disease is a brain condition causing loss of co-ordination and movement problems. Levodopa is the most prescribed treatment for early disease. Patients should be seen by a specialist every 6–12 months to assess their treatment needs. Wearable devices (like smart watches) may aid management by directly monitoring patients for disease symptoms including tremor and slowness of movement (bradykinesia), or side effects of treatment like involuntary movement (dyskinesia). This assessment considered the clinical and economic value of five wearable devices: Personal KinetiGraph, STAT-ON, Kinesia 360, KinesiaU and PDMonitor. We searched medical databases to find all studies of the five devices. We assessed the quality of these studies and reviewed their results. We found 77 studies of the devices. 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 symptoms. The evidence for STAT-ON suggested it may be of value for diagnosing symptoms, but there is currently no evidence on its clinical value. There was insufficient evidence for Kinesia 360, KinesiaU and PDMonitor to draw any conclusions. An economic analysis was conducted to investigate whether using any of these technologies is economically viable. The economic analysis found that the quality-of-life benefits generated by remote monitoring devices were small relative to the additional costs of implementing them in the NHS. As such, none of the remote monitoring devices were good value for money when compared with the current standard of care.