Burq Maximilien, Rainaldi Erin, Ho King Chung, Chen Chen, Bloem Bastiaan R, Evers Luc J W, Helmich Rick C, Myers Lance, Marks William J, Kapur Ritu
Verily Life Sciences, South San Francisco, CA, USA.
Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, the Netherlands.
NPJ Digit Med. 2022 May 23;5(1):65. doi: 10.1038/s41746-022-00607-8.
Sensor-based remote monitoring could help better track Parkinson's disease (PD) progression, and measure patients' response to putative disease-modifying therapeutic interventions. To be useful, the remotely-collected measurements should be valid, reliable, and sensitive to change, and people with PD must engage with the technology. We developed a smartwatch-based active assessment that enables unsupervised measurement of motor signs of PD. Participants with early-stage PD (N = 388, 64% men, average age 63) wore a smartwatch for a median of 390 days. Participants performed unsupervised motor tasks both in-clinic (once) and remotely (twice weekly for one year). Dropout rate was 5.4%. Median wear-time was 21.1 h/day, and 59% of per-protocol remote assessments were completed. Analytical validation was established for in-clinic measurements, which showed moderate-to-strong correlations with consensus MDS-UPDRS Part III ratings for rest tremor (⍴ = 0.70), bradykinesia (⍴ = -0.62), and gait (⍴ = -0.46). Test-retest reliability of remote measurements, aggregated monthly, was good-to-excellent (ICC = 0.75-0.96). Remote measurements were sensitive to the known effects of dopaminergic medication (on vs off Cohen's d = 0.19-0.54). Of note, in-clinic assessments often did not reflect the patients' typical status at home. This demonstrates the feasibility of smartwatch-based unsupervised active tests, and establishes the analytical validity of associated digital measurements. Weekly measurements provide a real-life distribution of disease severity, as it fluctuates longitudinally. Sensitivity to medication-induced change and improved reliability imply that these methods could help reduce sample sizes needed to demonstrate a response to therapeutic interventions or disease progression.
基于传感器的远程监测有助于更好地跟踪帕金森病(PD)的进展,并衡量患者对假定的疾病修饰治疗干预措施的反应。为了发挥作用,远程收集的测量数据应有效、可靠且对变化敏感,并且PD患者必须参与这项技术。我们开发了一种基于智能手表的主动评估方法,能够对PD的运动体征进行无监督测量。早期PD患者(N = 388,64%为男性,平均年龄63岁)佩戴智能手表的时间中位数为390天。参与者在诊所进行了一次无监督运动任务,在远程进行了为期一年的每周两次的运动任务。脱落率为5.4%。平均佩戴时间为每天21.1小时,按方案完成的远程评估中有59%。对诊所测量建立了分析验证,结果显示与共识性MDS-UPDRS第三部分中静止性震颤(⍴ = 0.70)、运动迟缓(⍴ = -0.62)和步态(⍴ = -0.46)的评分具有中度至强相关性。每月汇总的远程测量的重测信度良好至优秀(ICC = 0.75 - 0.96)。远程测量对多巴胺能药物的已知效果敏感(开与关时Cohen's d = 0.19 - 0.54)。值得注意的是,诊所评估往往不能反映患者在家中的典型状态。这证明了基于智能手表的无监督主动测试的可行性,并确立了相关数字测量的分析有效性。每周测量提供了疾病严重程度的实际分布情况,因为它会随时间纵向波动。对药物引起的变化的敏感性和更高的可靠性意味着这些方法有助于减少证明对治疗干预或疾病进展有反应所需的样本量。