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Abstract：
Assessing vital signs such as heart rate (HR) by wearable devices in a lifestyle-related environment provides widespread opportunities for public health related research and applications. Commonly, consumer wearable devices assessing HR are based on photoplethysmography (PPG), where HR is determined by absorption and reflection of emitted light by the blood. However, methodological differences and shortcomings in the validation process hamper the comparability of the validity of various wearable devices assessing HR. Towards Intelligent Health and Well-Being: Network of Physical Activity Assessment (INTERLIVE) is a joint European initiative of six universities and one industrial partner. The consortium was founded in 2019 and strives towards developing best-practice recommendations for evaluating the validity of consumer wearables and smartphones. This expert statement presents a best-practice validation protocol for consumer wearables assessing HR by PPG. The recommendations were developed through the following multi-stage process: (1) a systematic literature review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, (2) an unstructured review of the wider literature pertaining to factors that may introduce bias during the validation of these devices and (3) evidence-informed expert opinions of the INTERLIVE Network. A total of 44 articles were deemed eligible and retrieved through our systematic literature review. Based on these studies, a wider literature review and our evidence-informed expert opinions, we propose a validation framework with standardised recommendations using six domains: considerations for the target population, criterion measure, index measure, testing conditions, data processing and the statistical analysis. As such, this paper presents recommendations to standardise the validity testing and reporting of PPG-based HR wearables used by consumers. Moreover, checklists are provided to guide the validation protocol development and reporting. This will ensure that manufacturers, consumers, healthcare providers and researchers use wearables safely and to its full potential.
摘要：
在与生活方式相关的环境中通过可穿戴设备评估诸如心率(HR)之类的生命体征为公共卫生相关的研究和应用提供了广泛的机会。通常,消费者可穿戴设备评估HR是基于光电体积描记术(PPG)，其中HR由血液对发射光的吸收和反射决定。然而,方法学上的差异和验证过程中的缺陷阻碍了各种可穿戴设备评估HR有效性的可比性.迈向智能健康和福祉：身体活动评估网络（INTERLIVE）是由六所大学和一个工业合作伙伴共同发起的欧洲倡议。该联盟成立于2019年，致力于制定最佳实践建议，以评估消费者可穿戴设备和智能手机的有效性。本专家声明提供了消费者可穿戴设备通过PPG评估HR的最佳实践验证方案。建议是通过以下多阶段过程制定的：（1）基于系统评价和荟萃分析的首选报告项目的系统文献综述，（2）对有关在验证这些设备期间可能引入偏见的因素的更广泛文献进行非结构化审查，以及（3）INTERLIVE网络的循证专家意见。通过我们的系统文献综述，总共有44篇文章被认为是合格的。基于这些研究,更广泛的文献综述和我们的循证专家意见，我们提出了一个使用六个领域的标准化建议的验证框架：目标人群的考虑，标准度量，指标度量，测试条件,数据处理和统计分析。因此，本文提出了标准化消费者使用的基于PPG的HR可穿戴设备的有效性测试和报告的建议。此外，提供检查表以指导验证方案的制定和报告。这将确保制造商，消费者,医疗保健提供者和研究人员安全地使用可穿戴设备，并充分发挥其潜力。
