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Implementation of Mobile Health Technologies in Clinical Trials of Movement Disorders: Underutilized Potential.
Neurotherapeutics ( IF 5.6 ) Pub Date : 2020-07-30 , DOI: 10.1007/s13311-020-00901-x
Carlo Alberto Artusi 1 , Gabriele Imbalzano 1 , Andrea Sturchio 2 , Andrea Pilotto 3, 4 , Elisa Montanaro 1 , Alessandro Padovani 3 , Leonardo Lopiano 1 , Walter Maetzler 5 , Alberto J Espay 2
Affiliation  

Mobile health technologies (mHealth) are patient-worn or portable devices aimed at increasing the granularity and relevance of clinical measurements. The implementation of mHealth has the potential to decrease sample size, duration, and cost of clinical trials. We performed a review of the ClinicalTrials.gov database using a standardized approach to identify adoption in and usefulness of mHealth in movement disorders interventional clinical trials. Trial phase, geographical area, availability of data captured, constructs of interest, and outcome priority were collected. Eligible trials underwent quality appraisal using an ad hoc 5-point checklist to assess mHealth feasibility, acceptability, correlation with patient-centered outcome measures, and clinical meaningfulness. A total of 29% (n = 54/184) registered trials were using mHealth, mainly in Parkinson’s disease and essential tremor (59.3% and 27.8%). In most cases, mHealth were used in phase 2 trials (83.3%) as secondary outcome measures (59.3%). Only five phase 3 trials, representing 9.3% of the total, used mHealth (1 as primary outcome measure, 3 as secondary, and 1 as tertiary). Only 3.7% (n = 2/54) of all trials used mHealth for measuring both motor and non-motor symptoms, and 23.1% (n = 12/52) used mHealth for unsupervised, ecologic outcomes. Our findings suggest that mHealth remain underutilized and largely relegated to phase 2 trials for secondary or tertiary outcome measures. Efforts toward greater alignment of mHealth with patient-centered outcomes and development of a universal, common-language platform to synchronize data from one or more devices will assist future efforts toward the integration of mHealth into clinical trials.



中文翻译:


移动医疗技术在运动障碍临床试验中的实施:潜力未得到充分利用。



移动医疗技术 (mHealth) 是患者佩戴的或便携式设备,旨在提高临床测量的粒度和相关性。移动医疗的实施有可能减少临床试验的样本量、持续时间和成本。我们使用标准化方法对ClinicalTrials.gov数据库进行了审查,以确定移动医疗在运动障碍介入临床试验中的采用和有用性。收集试验阶段、地理区域、捕获数据的可用性、感兴趣的结构和结果优先级。符合条件的试验使用特别的 5 点检查表进行质量评估,以评估 mHealth 的可行性、可接受性、与以患者为中心的结果测量的相关性以及临床意义。共有 29% ( n = 54/184) 的注册试验使用 mHealth,主要针对帕金森病和原发性震颤(59.3% 和 27.8%)。在大多数情况下,mHealth 在 2 期试验中 (83.3%) 作为次要结局指标 (59.3%) 使用。只有 5 项 3 期试验(占总数的 9.3%)使用了 mHealth(1 项作为主要结局指标,3 项作为次要结局指标,1 项作为三级结局指标)。所有试验中只有 3.7% ( n = 2/54) 使用 mHealth 来测量运动和非运动症状,23.1% ( n = 12/52) 使用 mHealth 来测量无人监督的生态结果。我们的研究结果表明,移动医疗仍然没有得到充分利用,并且在很大程度上被降级为二级或三级结局指标的第二阶段试验。努力使移动医疗与以患者为中心的结果更加一致,并开发一个通用的通用语言平台来同步来自一台或多台设备的数据,这将有助于未来将移动医疗整合到临床试验中。

更新日期:2020-07-31
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