Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.

Human movement has been the subject of investigation since the fifth century when early scientists and researchers attempted to model the human musculoskeletal system. The anatomical complexities of the human body have made it a constant source of research to this day with many anatomical, physiological, mechanical, environmental, sociological and psychological studies undertaken to define its key elements. These studies have utilised modern day techniques to assess human movement in many illnesses. One such modern technique has been direct measurement by accelerometry, which was first suggested in the 1970s but has only been refined and perfected during the last 10-15 years. Direct measurement by accelerometry has seen the introduction of the successful implementation of low power, low cost electronic sensors that have been employed in clinical and home environments for the constant monitoring of patients (and their controls). The qualitative and quantitative data provided by these sensors make it possible for engineers, clinicians and physicians to work together to be able to help their patients in overcoming their physical disability. This paper presents the underlying biomechanical elements necessary to understand and study human movement. It also reflects on the sociological elements of human movement and why it is important in patient life and well being. Finally the concept of direct measurement by accelerometry is presented with past studies and modern techniques used for data analysis.

Wearable technology comprises miniaturized sensors (eg, accelerometers) worn on the body and/or paired with mobile devices (eg, smart phones) allowing continuous patient monitoring in unsupervised, habitual environments (termed free‐living). Wearable technologies are revolutionizing approaches to health care as a result of their utility, accessibility, and affordability. They are positioned to transform Parkinson's disease (PD) management through the provision of individualized, comprehensive, and representative data. This is particularly relevant in PD where symptoms are often triggered by task and free‐living environmental challenges that cannot be replicated with sufficient veracity elsewhere. This review concerns use of wearable technology in free‐living environments for people with PD. It outlines the potential advantages of wearable technologies and evidence for these to accurately detect and measure clinically relevant features including motor symptoms, falls risk, freezing of gait, gait, functional mobility, and physical activity. Technological limitations and challenges are highlighted, and advances concerning broader aspects are discussed. Recommendations to overcome key challenges are made. To date there is no fully validated system to monitor clinical features or activities in free‐living environments. Robust accuracy and validity metrics for some features have been reported, and wearable technology may be used in these cases with a degree of confidence. Utility and acceptability appears reasonable, although testing has largely been informal. Key recommendations include adopting a multidisciplinary approach for standardizing definitions, protocols, and outcomes. Robust validation of developed algorithms and sensor‐based metrics is required along with testing of utility. These advances are required before widespread clinical adoption of wearable technology can be realized. © 2016 International Parkinson and Movement Disorder Society

Measurement of gait is becoming important as a tool to identify disease and disease progression, yet to date its application is limited largely to specialist centers. Wearable devices enables gait to be measured in naturalistic environments, however questions remain regarding validity. Previous research suggests that when compared with a laboratory reference, measurement accuracy is acceptable for mean but not variability or asymmetry gait characteristics. Some fundamental reasons for this have been presented, (e.g., synchronization, different sampling frequencies) but to date this has not been systematically examined. The aims of this study were to: 1) quantify a comprehensive range of gait characteristics measured using a single triaxial accelerometer-based monitor; 2) examine outcomes and monitor performance in measuring gait in older adults and those with Parkinson's disease (PD); and 3) carry out a detailed comparison with those derived from an instrumented walkway to account for any discrepancies. Fourteen gait characteristics were quantified in 30 people with incident PD and 30 healthy age-matched controls. Of the 14 gait characteristics compared, agreement between instruments was excellent for four (ICCs 0.913-0.983); moderate for four (ICCs 0.508-0.766); and poor for six characteristics (ICCs 0.637-0.370). Further analysis revealed that differences reflect an increased sensitivity of accelerometry to detect motion, rather than measurement error. This is most likely because accelerometry measures gait as a continuous activity rather than discrete footfall events, per instrumented tools. The increased sensitivity shown for these characteristics will be of particular interest to researchers keen to interpret “real-world” gait data. In conclusion, use of a body-worn monitor is recommended for the measurement of gait but is likely to yield more sensitive data for asymmetry and variability features.

Gait is emerging as a powerful diagnostic and prognostic tool, and as a surrogate marker of disease progression for Parkinson’s disease (PD). Accelerometer-based body worn monitors (BWMs) facilitate the measurement of gait in clinical environments. Moreover they have the potential to provide a more accurate reflection of gait in the home during habitual behaviours. Emerging research suggests that measurement of gait using BWMs is feasible but this has not been investigated in depth. The aims of this study were to explore (i) the impact of environment and (ii) ambulatory bout (AB) length on gait characteristics for discriminating between people with PD and age-matched controls. Fourteen clinically relevant gait characteristics organised in five domains (pace, variability, rhythm, asymmetry, postural control) were quantified using laboratory based and free-living data collected over 7 days using a BWM placed on the lower back in 47 PD participants and 50 controls. Free-living data showed that both groups walked with decreased pace and increased variability, rhythm and asymmetry compared to walking in the laboratory setting. Four of the 14 gait characteristics measured in free-living conditions were significantly different between controls and people with PD compared to two measured in the laboratory. Between group differences depended on bout length and were more apparent during longer ABs. ABs ≤ 10s did not discriminate between groups. Medium to long ABs highlighted between-group significant differences for pace, rhythm and asymmetry. Longer ABs should therefore be taken into account when evaluating gait characteristics in free-living conditions. This study provides encouraging results to support the use of a single BWM for free-living gait evaluation in people with PD with potential for research and clinical application.

Gait is an important clinical assessment tool since changes in gait may reflect changes in general health. Measurement of gait is a complex process which has been restricted to the laboratory until relatively recently. The application of an inexpensive body worn sensor with appropriate gait algorithms (BWM) is an attractive alternative and offers the potential to assess gait in any setting. In this study we investigated the use of a low-cost BWM, compared to laboratory reference using a robust testing protocol in both younger and older adults. We observed that the BWM is a valid tool for estimating total step count and mean spatio-temporal gait characteristics however agreement for variability and asymmetry results was poor. We conducted a detailed investigation to explain the poor agreement between systems and determined it was due to inherent differences between the systems rather than inability of the sensor to measure the gait characteristics. The results highlight caution in the choice of reference system for validation studies. The BWM used in this study has the potential to gather longitudinal (real-world) spatio-temporal gait data that could be readily used in large lifestyle-based intervention studies, but further refinement of the algorithm(s) is required.