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.

Consumer wearable and smartphone devices provide an accessible means to objectively measure physical activity (PA) through step counts. With the increasing proliferation of this technology, consumers, practitioners and researchers are interested in leveraging these devices as a means to track and facilitate PA behavioural change. However, while the acceptance of these devices is increasing, the validity of many consumer devices have not been rigorously and transparently evaluated. The 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 to develop best-practice recommendations for evaluating the validity of consumer wearables and smartphones. This expert statement presents a best-practice consumer wearable and smartphone step counter validation protocol. A two-step process was used to aggregate data and form a scientific foundation for the development of an optimal and feasible validation protocol: (1) a systematic literature review and (2) additional searches of the wider literature pertaining to factors that may introduce bias during the validation of these devices. The systematic literature review process identified 2897 potential articles, with 85 articles deemed eligible for the final dataset. From the synthesised data, we identified a set of six key domains to be considered during design and reporting of validation studies: target population, criterion measure, index measure, validation conditions, data processing and statistical analysis. Based on these six domains, a set of key variables of interest were identified and a ‘basic’ and ‘advanced’ multistage protocol for the validation of consumer wearable and smartphone step counters was developed. The INTERLIVE consortium recommends that the proposed protocol is used when considering the validation of any consumer wearable or smartphone step counter. Checklists have been provided to guide validation protocol development and reporting. The network also provide guidance for future research activities, highlighting the imminent need for the development of feasible alternative ‘gold-standard’ criterion measures for free-living validation. Adherence to these validation and reporting standards will help ensure methodological and reporting consistency, facilitating comparison between consumer devices. Ultimately, this will ensure that as these devices are integrated into standard medical care, consumers, practitioners, industry and researchers can use this technology safely and to its full potential.

Background: Concussion is one of the most common sports-related injuries, with little understood about the modifiable and nonmodifiable risk factors. Researchers have yet to evaluate the association between modifiable sensorimotor function variables and concussive injury. Purpose: To investigate the association between dynamic balance performance, a discrete measure of sensorimotor function, and concussive injuries. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: A total of 109 elite male rugby union players were baseline tested in dynamic balance performance while wearing an inertial sensor and prospectively followed during the 2016-2017 rugby union season. The sample entropy of the inertial sensor gyroscope magnitude signal was derived to provide a discrete measure of dynamic balance performance. Logistic regression modeling was then used to investigate the association among the novel digital biomarker of balance performance, known risk factors of concussion (concussion history, age, and playing position), and subsequent concussive injury. Results: Participant demographic data (mean ± SD) were as follows: age, 22.6 ± 3.6 years; height, 185 ± 6.5 cm; weight, 98.9 ± 12.5 kg; body mass index, 28.9 ± 2.9 kg/m ² ; and leg length, 98.8 ± 5.5 cm. Of the 109 players, 44 (40.3%) had a history of concussion, while 21 (19.3%) sustained a concussion during the follow-up period. The receiver operating characteristic analysis for the anterior sample entropy demonstrated a statistically significant area under the curve (0.64; 95% CI, 0.52-0.76; P < .05), with the cutoff score of anterior sample entropy ≥1.2, which maximized the sensitivity (76.2%) and specificity (53.4%) for identifying individuals who subsequently sustained a concussion. Players with suboptimal balance performance at baseline were at a 2.81-greater odds (95% CI, 1.02-7.74) of sustaining a concussion during the rugby union season than were those with optimal balance performance, even when controlling for concussion history. Conclusion: Rugby union players who possess poorer dynamic balance performance, as measured by a wearable inertial sensor during the Y balance test, have a 3-times-higher relative risk of sustaining a sports-related concussion, even when controlling for history of concussion. These findings have important implications for research and clinical practice, as it identifies a potential modifiable risk factor. Further research is required to investigate this association in a large cohort consisting of males and females across a range of sports.