Background: The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational and interventional clinical research. Method: We conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles on clinical research published between January 2010 and May 2016 in which mobile devices were used to measure study outcomes. We screened each publication for specific inclusion and exclusion criteria. We then identified and qualitatively summarized the use of mobile outcome assessments in clinical research, including the type and design of the study, therapeutic focus, type of mobile device(s) used, and specific mobile outcomes reported. Results: The search retrieved 2,530 potential articles of interest. After screening, 88 publications remained. Twenty-five percent of the publications (n = 22) described mobile outcomes used in interventional research, and the rest (n = 66) described observational clinical research. Thirteen therapeutic areas were represented. Five categories of mobile devices were identified: (1) inertial sensors, (2) biosensors, (3) pressure sensors and walkways, (4) medication adherence monitors, and (5) location monitors; inertial sensors/accelerometers were most common (reported in 86% of the publications). Among the variety of mobile outcomes, various assessments of physical activity were most common (reported in 74% of the publications). Other mobile outcomes included assessments of sleep, mobility, and pill adherence, as well as biomarkers assessed using a mobile device, including cardiac measures, glucose, gastric reflux, respiratory measures, and intensity of head-related injury. Conclusion: Mobile devices are being widely used in clinical research to assess outcomes, although their use in interventional research to assess therapeutic effectiveness is limited. For mobile devices to be used more frequently in pivotal interventional research – such as trials informing regulatory decision-making – more focus should be placed on: (1) consolidating the evidence supporting the clinical meaningfulness of specific mobile outcomes, and (2) standardizing the use of mobile devices in clinical research to measure specific mobile outcomes (e.g., data capture frequencies, placement of device). To that aim, this manuscript offers a broad overview of the various mobile outcome assessments currently used in observational and interventional research, and categorizes and consolidates this information for researchers interested in using mobile devices to assess outcomes in interventional research.

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使用移动设备衡量临床研究结果，2010-2016 年：系统文献综述

背景：近年来，由于技术的快速发展，移动设备在临床研究中的使用取得了长足的进步。总体目标是告知未来在介入临床研究中使用移动设备来测量主要结果，我们对观察和介入临床研究中移动设备的使用和通过移动设备测量的临床结果（移动结果）进行了系统回顾。方法：我们使用一系列搜索词进行了 PubMed 搜索，以检索 2010 年 1 月至 2016 年 5 月期间发表的临床研究同行评审文章，其中使用移动设备来衡量研究结果。我们筛选了每份出版物的具体纳入和排除标准。然后，我们确定并定性总结了移动结果评估在临床研究中的使用，包括研究的类型和设计、治疗重点、使用的移动设备类型以及报告的具体移动结果。结果：搜索检索到 2,530 篇潜在感兴趣的文章。经过筛选，剩下88篇出版物。25% 的出版物 (n = 22) 描述了介入研究中使用的移动结果，其余 (n = 66) 描述了观察性临床研究。代表了十三个治疗领域。确定了五类移动设备：（1）惯性传感器，（2）生物传感器，（3）压力传感器和走道，（4）药物依从性监视器，以及（5）位置监视器；惯性传感器/加速度计最为常见（86% 的出版物均有报道）。在各种移动结果中，对身体活动的各种评估最为常见（74% 的出版物中有报道）。其他移动结果包括睡眠、活动能力和服药依从性的评估，以及使用移动设备评估的生物标志物，包括心脏测量、血糖、胃反流、呼吸测量和头部相关损伤的强度。结论：移动设备在临床研究中广泛用于评估结果，但在介入研究中评估治疗效果的使用有限。为了使移动设备在关键介入研究（例如为监管决策提供信息的试验）中更频繁地使用，应更加关注：（1）整合支持特定移动结果的临床意义的证据，以及（2）标准化在临床研究中使用移动设备来测量特定的移动结果（例如，数据捕获频率、设备的放置）。为此，本手稿对目前观察和介入研究中使用的各种移动结果评估进行了广泛的概述，并为有兴趣使用移动设备评估介入研究结果的研究人员对这些信息进行了分类和整合。