Department of Applied Natural Sciences, Technische Hochschule Lübeck, Lübeck, Germany.
Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland.
BMJ Health Care Inform. 2024 Apr 8;31(1):e100914. doi: 10.1136/bmjhci-2023-100914.
BACKGROUND: Technological devices such as smartphones, wearables and virtual assistants enable health data collection, serving as digital alternatives to conventional biomarkers. We aimed to provide a systematic overview of emerging literature on 'digital biomarkers,' covering definitions, features and citations in biomedical research. METHODS: We analysed all articles in PubMed that used 'digital biomarker(s)' in title or abstract, considering any study involving humans and any review, editorial, perspective or opinion-based articles up to 8 March 2023. We systematically extracted characteristics of publications and research studies, and any definitions and features of 'digital biomarkers' mentioned. We described the most influential literature on digital biomarkers and their definitions using thematic categorisations of definitions considering the Food and Drug Administration Biomarkers, EndpointS and other Tools framework (ie, data type, data collection method, purpose of biomarker), analysing structural similarity of definitions by performing text and citation analyses. RESULTS: We identified 415 articles using 'digital biomarker' between 2014 and 2023 (median 2021). The majority (283 articles; 68%) were primary research. Notably, 287 articles (69%) did not provide a definition of digital biomarkers. Among the 128 articles with definitions, there were 127 different ones. Of these, 78 considered data collection, 56 data type, 50 purpose and 23 included all three components. Those 128 articles with a definition had a median of 6 citations, with the top 10 each presenting distinct definitions. CONCLUSIONS: The definitions of digital biomarkers vary significantly, indicating a lack of consensus in this emerging field. Our overview highlights key defining characteristics, which could guide the development of a more harmonised accepted definition.
背景:智能手机、可穿戴设备和虚拟助手等技术设备能够实现健康数据的采集,它们是传统生物标志物的数字化替代品。我们旨在提供一篇关于“数字生物标志物”的系统综述,涵盖生物医学研究中数字生物标志物的定义、特征和引用情况。
方法:我们分析了 PubMed 中所有标题或摘要中使用“数字生物标志物(s)”的文章,纳入了截至 2023 年 3 月 8 日涉及人类的任何研究以及综述、社论、观点或基于意见的文章。我们系统地提取了出版物和研究的特征,以及提到的任何“数字生物标志物”的定义和特征。我们通过对定义进行主题分类,描述了数字生物标志物最有影响力的文献及其定义,考虑了美国食品和药物管理局生物标志物、终点和其他工具框架(即数据类型、数据收集方法、生物标志物的目的),并通过文本和引文分析分析了定义的结构相似性。
结果:我们在 2014 年至 2023 年期间使用“数字生物标志物”识别出 415 篇文章(中位数为 2021 年)。大多数(283 篇;68%)是原始研究。值得注意的是,287 篇(69%)文章未提供数字生物标志物的定义。在有定义的 128 篇文章中,有 127 个不同的定义。其中,78 个考虑了数据收集,56 个考虑了数据类型,50 个考虑了目的,23 个包含了所有三个组成部分。有定义的 128 篇文章的中位数引用次数为 6 次,前 10 名的每篇文章都提出了不同的定义。
结论:数字生物标志物的定义差异很大,表明在这个新兴领域缺乏共识。我们的综述强调了关键的定义特征,这可能有助于制定更协调一致的公认定义。
BMJ Health Care Inform. 2024-4-8
Cochrane Database Syst Rev. 2022-2-1
Health Technol Assess. 2001
J Med Internet Res. 2022-7-6
J Med Internet Res. 2019-5-31
Lipids Health Dis. 2025-7-30
NPJ Digit Med. 2025-6-16
Auris Nasus Larynx. 2025-5-21
BMC Psychiatry. 2025-4-16
Alzheimers Dement (Amst). 2025-3-11
Front Toxicol. 2025-1-8
J Prev Alzheimers Dis. 2022
JMIR Mhealth Uhealth. 2022-10-24
NPJ Digit Med. 2022-8-8