Rochester Lynn, Mazzà Claudia, Mueller Arne, Caulfield Brian, McCarthy Marie, Becker Clemens, Miller Ram, Piraino Paolo, Viceconti Marco, Dartee Wilhelmus P, Garcia-Aymerich Judith, Aydemir Aida A, Vereijken Beatrix, Arnera Valdo, Ammour Nadir, Jackson Michael, Hache Tilo, Roubenoff Ronenn
Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
The Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
Digit Biomark. 2020 Nov 26;4(Suppl 1):13-27. doi: 10.1159/000512513. eCollection 2020 Winter.
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.
医疗保健行业不得不迅速适应新冠疫情，这反过来凸显了对便利远程问诊和监测工具的迫切需求。包括可穿戴设备在内的数字健康技术提供了一种解决方案，利用数字结果来测量和监测疾病状态，并提供对患者和医疗保健专业人员都有意义的结果。对身体活动能力的远程监测就是一个典型例子，因为活动能力是可以通过数字方式进行远程评估的最先进指标之一。活动能力丧失也是许多健康状况的一个重要特征，既可以反映健康状况，也是干预的目标。现实世界中对活动能力的连续数字测量（数字活动结果或DMO）为深入了解医疗状况提供了机会，对现有的活动能力测量起到补充作用。目前被认可和批准的DMO尚未广泛应用。大家普遍认识到需要开展大规模合作努力来攻克采用过程中的关键步骤。“Mobilise-D”就是一个例子。它是一个由来自学术界和产业界的34个机构组成 的多学科联盟，由欧洲创新药物计划2联合事业资助。“Mobilise-D”的成员正在合作解决DMO在临床试验以及最终在医疗保健中被采用的关键步骤。为实现这一目标，该联盟制定了一项路线图，为帕金森病、多发性硬化症、慢性阻塞性肺疾病以及股骨近端骨折康复方面的DMO的开发、验证和批准提供指导。在此，我们旨在描述所提议的方法，并对“Mobilise-D”联盟正在进行和计划开展的工作进行概述。最终，“Mobilise-D”旨在通过提供与设备无关的软件、标准和强有力的验证来促进DMO的广泛采用，以便将数字结果从概念转化为在临床试验和医疗保健中的应用。
