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A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach
Digital Biomarkers Pub Date : 2020-11-26 , DOI: 10.1159/000512513
Lynn Rochester , Claudia Mazzà , Arne Mueller , Brian Caulfield , Marie McCarthy , Clemens Becker , Ram Miller , Paolo Piraino , Marco Viceconti , Wilhelmus P. Dartee , Judith Garcia-Aymerich , Aida A. Aydemir , Beatrix Vereijken , Valdo Arnera , Nadir Ammour , Michael Jackson , Tilo Hache , Ronenn Roubenoff ,

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

中文翻译:

为数字移动成果的开发、验证和批准提供信息的路线图:Mobilise-D 方法

医疗保健必须迅速适应 COVID-19,这反过来又凸显了对促进远程访问和监测的工具的迫切需求。包括身体佩戴设备在内的数字健康技术提供了一种使用数字结果来衡量和监测疾病状态的解决方案,并提供对患者和医疗保健专业人员都有意义的结果。身体移动的远程监控就是一个典型的例子,因为移动是可以通过数字和远程方式进行评估的最先进的方式之一。行动不便也是许多健康状况的一个重要特征,可提供健康信息和干预目标。真实世界,持续的数字移动测量(数字移动结果或 DMO)为对医疗保健条件的新见解提供了机会,以补充现有的移动测量。接受和批准的 DMO 尚未广泛使用。广泛认识到需要进行大规模协作以解决采用的关键步骤。Mobilise-D 就是一个例子。它是由来自学术界和工业界的 34 家机构组成的多学科联盟,由欧洲创新药物倡议 2 联合承诺资助。Mobilise-D 的成员正在合作解决在临床试验和最终医疗保健中采用 DMO 的关键步骤。为实现这一目标,该联盟制定了路线图,为帕金森病、多发性硬化症、慢性阻塞性肺疾病和股骨近端骨折的恢复。在这里,我们旨在描述所提议的方法,并提供对 Mobilise-D 联盟正在进行和计划中的工作的高级看法。最终,Mobilise-D 旨在通过提供与设备无关的软件、标准和强大的验证来刺激 DMO 的广泛采用,以便将数字结果从概念转化为临床试验和医疗保健的使用。
更新日期:2020-11-26
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