Supplementary Material for: Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research

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.

数字健康技术（智能手机、智能手表及其他可穿戴传感器）可作为新型工具，在临床诊疗与科研场景中辅助个体疾病症状的诊断及远程客观监测。然而，受限于数据可解释性不足与监管认可度缺失，此类数字健康技术尚未能在临床研究中广泛彰显其应用价值。元数据（Metadata），即伴随并描述原始数据的数据，可用于更精准地解析传感器数据的上下文场景，同时助力数据管理、数据共享与后续数据分析。学界与产业界的研究共同体已就数字健康技术的数据与元数据标准提出需求，监管机构亦对此予以重视。为此，为填补这一未被满足的需求空白，本文提出一套契合监管指南的元数据集，该数据集可作为一份概念蓝图，实现两大目标：其一，为数字健康研究中的研究者提供应采集元数据的指引，以提升其研究数据的可解释性与可交换性；其二，指导标准制定机构如何扩展现有标准以纳入数字健康技术。本套拟议元数据集的制定参考了现行临床试验与医疗器械相关标准，以及已支撑数字健康技术研究的现有数据模式。我们以帕金森病为具体案例展开阐释，将其作为诸多其他慢性疾病的研究范本——此类慢性疾病的远程监测在临床诊疗与科研领域均具备应用价值。我们呼吁学界与临床研究共同体将本套拟议元数据集应用于正在开展及计划推进的研究工作。若本套元数据集存在不足，我们恳请使用者参与其后续修订，以便在快速迭代的技术环境中维持足够的行业共识。