Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.
Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research.
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DOI：
10.1159/000502951
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发表时间：
2019-09-01
影响因子：
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通讯作者：
Karlin, Daniel R
中科院分区：
文献类型：
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作者：
Badawy, Reham;Hameed, Farhan;Karlin, Daniel R
数字健康技术(智能手机、智能手表和其他穿戴在身上的传感器)可以作为新的工具，在临床护理和研究中帮助诊断和远程客观监测个人的疾病症状。尽管如此，由于数据的可解释性不足和监管机构的接受程度，此类数字健康技术尚未在临床研究中广泛展示其价值。元数据，即伴随和描述主要数据的数据，可以被用来更好地理解传感器数据的上下文，并且可以帮助数据管理、数据共享和后续数据分析。学术界和行业研究界提出了对数字健康技术的数据和元数据标准的需求，监管当局也注意到了这一点。因此，为了解决这一未得到满足的需求，我们在此提出了一套反映监管指南并可用作概念图的元数据集，以(1)向研究人员提供他们在数字健康研究中应收集的元数据的信息，旨在增加其数据的可解释性和互换性，以及(2)指导标准开发组织如何扩展其现有标准以纳入数字健康技术。除了支持数字保健技术研究的现有模式外，拟议的元数据集还包括与临床试验和医疗器械有关的现有标准。我们在帕金森氏症的背景下特别说明了这一点，作为一种广泛的其他慢性疾病的模型，远程监测在护理和科学上都是有用的。我们邀请科学和临床研究界将拟议的元数据集应用于正在进行和计划中的研究。如果拟议的元数据有不足之处，我们请用户为其正在进行的修订作出贡献，以便在快速发展的技术格局中保持足够程度的共识。
Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual's disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson's disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.