Assessing the Subjective Effectiveness of Sensorimotor Insoles (SMIs) in Reducing Pain: A Descriptive Multicenter Pilot Study.

This pilot study aimed to investigate the use of sensorimotor insoles in pain reduction, different orthopedic indications, and the wearing duration effects on the development of pain. Three hundred and forty patients were asked about their pain perception using a visual analog scale (VAS) in a pre-post analysis. Three main intervention durations were defined: VAS_post: up to 3 months, 3 to 6 months, and more than 6 months. The results show significant differences for the within-subject factor "time of measurement", as well as for the between-subject factor indication (p < 0.001) and worn duration (p < 0.001). No interaction was found between indication and time of measurements (model A) or between worn duration and time of measurements (model B). The results of this pilot study must be cautiously and critically interpreted, but may support the hypothesis that sensorimotor insoles could be a helpful tool for subjective pain reduction. The missing control group and the lack of confounding variables such as methodological weaknesses, natural healing processes, and complementary therapies must be taken into account. Based on these experiences and findings, a RCT and systematic review will follow.

Recommendations for determining the validity of consumer wearable heart rate devices: expert statement and checklist of the INTERLIVE Network.

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.

Recommendations for determining the validity of consumer wearable and smartphone step count: expert statement and checklist of the INTERLIVE network.

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.