Institute of Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sport University Cologne, Cologne, Germany.
Department of Sports Medicine, Norwegian School of Sport Sciences, Oslo, Norway.
Br J Sports Med. 2021 Jul;55(14):767-779. doi: 10.1136/bjsports-2020-103148. Epub 2021 Jan 4.
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.
在与生活方式相关的环境中，使用可穿戴设备评估心率（HR）等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，评估 HR 的消费者可穿戴设备基于光体积描记法（PPG），其中 HR 通过血液对发射光的吸收和反射来确定。然而，方法学上的差异和验证过程中的缺陷阻碍了评估 HR 的各种可穿戴设备的有效性的可比性。迈向智能健康与福祉：身体活动评估网络（INTERLIVE）是六个大学和一个工业伙伴的联合欧洲倡议。该联盟成立于 2019 年，致力于为评估消费者可穿戴设备和智能手机的有效性制定最佳实践建议。本专家声明提出了一种用于通过 PPG 评估 HR 的消费者可穿戴设备的最佳实践验证协议。该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）对可能在这些设备验证过程中引入偏差的更广泛文献的非结构化综述，以及（3）INTERLIVE 网络的循证专家意见。通过我们的系统文献综述，共确定了 44 篇符合条件的文章并进行了检索。基于这些研究，通过更广泛的文献综述和我们循证的专家意见，我们提出了一个具有标准化建议的验证框架，使用六个领域：目标人群的考虑因素、标准测量、指标测量、测试条件、数据处理和统计分析。因此，本文提出了建议，以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。此外，还提供了检查表，以指导验证协议的制定和报告。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。
