Breaking down the Digital Fortress: The Unseen Challenges in Healthcare Technology-Lessons Learned from 10 Years of Research.

Healthcare is undergoing a fundamental shift in which digital health tools are becoming ubiquitous, with the promise of improved outcomes, reduced costs, and greater efficiency. Healthcare professionals, patients, and the wider public are faced with a paradox of choice regarding technologies across multiple domains. Research is continuing to look for methods and tools to further revolutionise all aspects of health from prediction, diagnosis, treatment, and monitoring. However, despite its promise, the reality of implementing digital health tools in practice, and the scalability of innovations, remains stunted. Digital health is approaching a crossroads where we need to shift our focus away from simply looking at developing new innovations to seriously considering how we overcome the barriers that currently limit its impact. This paper summarises over 10 years of digital health experiences from a group of researchers with backgrounds in physical therapy-in order to highlight and discuss some of these key lessons-in the areas of validity, patient and public involvement, privacy, reimbursement, and interoperability. Practical learnings from this collective experience across patient cohorts are leveraged to propose a list of recommendations to enable researchers to bridge the gap between the development and implementation of digital health tools.

Listening to the patients' voice: a conceptual framework of the walking experience.

BACKGROUND: walking is crucial for an active and healthy ageing, but the perspectives of individuals living with walking impairment are still poorly understood. OBJECTIVES: to identify and synthesise evidence describing walking as experienced by adults living with mobility-impairing health conditions and to propose an empirical conceptual framework of walking experience. METHODS: we performed a systematic review and meta-ethnography of qualitative evidence, searching seven electronic databases for records that explored personal experiences of walking in individuals living with conditions of diverse aetiology. Conditions included Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture, heart failure, frailty and sarcopenia. Data were extracted, critically appraised using the NICE quality checklist and synthesised using standardised best practices. RESULTS: from 2,552 unique records, 117 were eligible. Walking experience was similar across conditions and described by seven themes: (i) becoming aware of the personal walking experience, (ii) the walking experience as a link between individuals' activities and sense of self, (iii) the physical walking experience, (iv) the mental and emotional walking experience, (v) the social walking experience, (vi) the context of the walking experience and (vii) behavioural and attitudinal adaptations resulting from the walking experience. We propose a novel conceptual framework that visually represents the walking experience, informed by the interplay between these themes. CONCLUSION: a multi-faceted and dynamic experience of walking was common across health conditions. Our conceptual framework of the walking experience provides a novel theoretical structure for patient-centred clinical practice, research and public health.

Mobilizing Patient and Public Involvement in the Development of Real-World Digital Technology Solutions: Tutorial.

Although the value of patient and public involvement and engagement (PPIE) activities in the development of new interventions and tools is well known, little guidance exists on how to perform these activities in a meaningful way. This is particularly true within large research consortia that target multiple objectives, include multiple patient groups, and work across many countries. Without clear guidance, there is a risk that PPIE may not capture patient opinions and needs correctly, thereby reducing the usefulness and effectiveness of new tools. Mobilise-D is an example of a large research consortium that aims to develop new digital outcome measures for real-world walking in 4 patient cohorts. Mobility is an important indicator of physical health. As such, there is potential clinical value in being able to accurately measure a person's mobility in their daily life environment to help researchers and clinicians better track changes and patterns in a person's daily life and activities. To achieve this, there is a need to create new ways of measuring walking. Recent advancements in digital technology help researchers meet this need. However, before any new measure can be used, researchers, health care professionals, and regulators need to know that the digital method is accurate and both accepted by and produces meaningful outcomes for patients and clinicians. Therefore, this paper outlines how PPIE structures were developed in the Mobilise-D consortium, providing details about the steps taken to implement PPIE, the experiences PPIE contributors had within this process, the lessons learned from the experiences, and recommendations for others who may want to do similar work in the future. The work outlined in this paper provided the Mobilise-D consortium with a foundation from which future PPIE tasks can be created and managed with clearly defined collaboration between researchers and patient representatives across Europe. This paper provides guidance on the work required to set up PPIE structures within a large consortium to promote and support the creation of meaningful and efficient PPIE related to the development of digital mobility outcomes.

Assessing real-world gait with digital technology? Validation, insights and recommendations from the Mobilise-D consortium.

BACKGROUND: Although digital mobility outcomes (DMOs) can be readily calculated from real-world data collected with wearable devices and ad-hoc algorithms, technical validation is still required. The aim of this paper is to comparatively assess and validate DMOs estimated using real-world gait data from six different cohorts, focusing on gait sequence detection, foot initial contact detection (ICD), cadence (CAD) and stride length (SL) estimates. METHODS: Twenty healthy older adults, 20 people with Parkinson's disease, 20 with multiple sclerosis, 19 with proximal femoral fracture, 17 with chronic obstructive pulmonary disease and 12 with congestive heart failure were monitored for 2.5 h in the real-world, using a single wearable device worn on the lower back. A reference system combining inertial modules with distance sensors and pressure insoles was used for comparison of DMOs from the single wearable device. We assessed and validated three algorithms for gait sequence detection, four for ICD, three for CAD and four for SL by concurrently comparing their performances (e.g., accuracy, specificity, sensitivity, absolute and relative errors). Additionally, the effects of walking bout (WB) speed and duration on algorithm performance were investigated. RESULTS: We identified two cohort-specific top performing algorithms for gait sequence detection and CAD, and a single best for ICD and SL. Best gait sequence detection algorithms showed good performances (sensitivity > 0.73, positive predictive values > 0.75, specificity > 0.95, accuracy > 0.94). ICD and CAD algorithms presented excellent results, with sensitivity > 0.79, positive predictive values > 0.89 and relative errors < 11% for ICD and < 8.5% for CAD. The best identified SL algorithm showed lower performances than other DMOs (absolute error < 0.21 m). Lower performances across all DMOs were found for the cohort with most severe gait impairments (proximal femoral fracture). Algorithms' performances were lower for short walking bouts; slower gait speeds (< 0.5 m/s) resulted in reduced performance of the CAD and SL algorithms. CONCLUSIONS: Overall, the identified algorithms enabled a robust estimation of key DMOs. Our findings showed that the choice of algorithm for estimation of gait sequence detection and CAD should be cohort-specific (e.g., slow walkers and with gait impairments). Short walking bout length and slow walking speed worsened algorithms' performances. Trial registration ISRCTN - 12246987.

Design and validation of a multi-task, multi-context protocol for real-world gait simulation.

BACKGROUND: Measuring mobility in daily life entails dealing with confounding factors arising from multiple sources, including pathological characteristics, patient specific walking strategies, environment/context, and purpose of the task. The primary aim of this study is to propose and validate a protocol for simulating real-world gait accounting for all these factors within a single set of observations, while ensuring minimisation of participant burden and safety. METHODS: The protocol included eight motor tasks at varying speed, incline/steps, surface, path shape, cognitive demand, and included postures that may abruptly alter the participants' strategy of walking. It was deployed in a convenience sample of 108 participants recruited from six cohorts that included older healthy adults (HA) and participants with potentially altered mobility due to Parkinson's disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF). A novelty introduced in the protocol was the tiered approach to increase difficulty both within the same task (e.g., by allowing use of aids or armrests) and across tasks. RESULTS: The protocol proved to be safe and feasible (all participants could complete it and no adverse events were recorded) and the addition of the more complex tasks allowed a much greater spread in walking speeds to be achieved compared to standard straight walking trials. Furthermore, it allowed a representation of a variety of daily life relevant mobility aspects and can therefore be used for the validation of monitoring devices used in real life. CONCLUSIONS: The protocol allowed for measuring gait in a variety of pathological conditions suggests that it can also be used to detect changes in gait due to, for example, the onset or progression of a disease, or due to therapy. TRIAL REGISTRATION: ISRCTN-12246987.

A systematic review of the intervention characteristics, and behavior change theory and techniques used in mother-daughter interventions targeting physical activity.

Growing gender disparities in levels of physical inactivity put women and female youths at a greater risk of associated health problems. Mother-daughter interventions have been proposed as means to promote physical activity in this at-risk cohort. However, there is a lack of clarity as to if and why these types of interventions might be effective. This systematic review examined the intervention characteristics, and behavior change theory and techniques used in these interventions to promote physical activity for mothers and daughters. PubMed, EMBASE, PsycINfO, CINAHL and Cochrane Library (Wiley) databases were searched for English language studies from inception to 13th May 2020. Interventions of any design that targeted daughters and mothers' physical activity were included. Data was extracted using the Template for Intervention Description and Replication (TIDieR) checklist, and the Behavior Change Technique (BCT) Taxonomy v1. 4962 articles were screened and 11 unique studies met the inclusion criteria. The risk of bias in studies was generally high. Narrative summary highlighted that many studies used social cognitive theory as a theoretical foundation, were based in the community and less than three months in duration with multiple sessions per week. Thirty-seven behavior change techniques were identified across studies. Some techniques were deemed potentially effective including credible source, information on the health consequences of the behavior and the self-regulatory techniques of goal-setting, self-monitoring and problem-solving. Future research should consider the use of the TIDieR guidelines and BCT Taxonomy v1 to improve the quality of information for intervention development, implementation, and reporting phases.

It's not about the capture, it's about what we can learn": a qualitative study of experts' opinions and experiences regarding the use of wearable sensors to measure gait and physical activity.

BACKGROUND: The use of wearable sensor technology to collect patient health data, such as gait and physical activity, offers the potential to transform healthcare research. To maximise the use of wearable devices in practice, it is important that they are usable by, and offer value to, all stakeholders. Although previous research has explored participants' opinions of devices, to date, limited studies have explored the experiences and opinions of the researchers who use and implement them. Researchers offer a unique insight into wearable devices as they may have access to multiple devices and cohorts, and thus gain a thorough understanding as to how and where this area needs to progress. Therefore, the aim of this study was to explore the experiences and opinions of researchers from academic, industry and clinical contexts, in the use of wearable devices to measure gait and physical activity. METHODS: Twenty professionals with experience using wearable devices in research were recruited from academic, industry and clinical backgrounds. Independent, semi-structured interviews were conducted, audio-recorded and transcribed. Transcribed texts were analysed using inductive thematic analysis. RESULTS: Five themes were identified: (1) The positives and negatives of using wearable devices in research, (2) The routine implementation of wearable devices into research and clinical practice, (3) The importance of compromise in protocols, (4) Securing good quality data, and (5) A paradigm shift. Researchers overwhelmingly supported the use of wearable sensor technology due to the insights that they may provide. Though barriers remain, researchers were pragmatic towards these, believing that there is a paradigm shift happening in this area of research that ultimately requires mistakes and significant volumes of further research to allow it to progress. CONCLUSIONS: Multiple barriers to the use of wearable devices in research and clinical practice remain, including data management and clear clinical utility. However, researchers strongly believe that the potential benefit of these devices to support and create new clinical insights for patient care, is greater than any current barrier. Multi-disciplinary research integrating the expertise of both academia, industry and clinicians is a fundamental necessity to further develop wearable devices and protocols that match the varied needs of all stakeholders.

Assessing the usability of wearable devices to measure gait and physical activity in chronic conditions: a systematic review.

BACKGROUND: The World Health Organisation's global strategy for digital health emphasises the importance of patient involvement. Understanding the usability and acceptability of wearable devices is a core component of this. However, usability assessments to date have focused predominantly on healthy adults. There is a need to understand the patient perspective of wearable devices in participants with chronic health conditions. METHODS: A systematic review was conducted to identify any study design that included a usability assessment of wearable devices to measure mobility, through gait and physical activity, within five cohorts with chronic conditions (Parkinson's disease [PD], multiple sclerosis [MS], congestive heart failure, [CHF], chronic obstructive pulmonary disorder [COPD], and proximal femoral fracture [PFF]). RESULTS: Thirty-seven studies were identified. Substantial heterogeneity in the quality of reporting, the methods used to assess usability, the devices used, and the aims of the studies precluded any meaningful comparisons. Questionnaires were used in the majority of studies (70.3%; n = 26) with a reliance on intervention specific measures (n = 16; 61.5%). For those who used interviews (n = 17; 45.9%), no topic guides were provided, while methods of analysis were not reported in over a third of studies (n = 6; 35.3%). CONCLUSION: Usability of wearable devices is a poorly measured and reported variable in chronic health conditions. Although the heterogeneity in how these devices are implemented implies acceptance, the patient voice should not be assumed. In the absence of being able to make specific usability conclusions, the results of this review instead recommends that future research needs to: (1) Conduct usability assessments as standard, irrespective of the cohort under investigation or the type of study undertaken. (2) Adhere to basic reporting standards (e.g. COREQ) including the basic details of the study. Full copies of any questionnaires and interview guides should be supplied through supplemental files. (3) Utilise mixed methods research to gather a more comprehensive understanding of usability than either qualitative or quantitative research alone will provide. (4) Use previously validated questionnaires alongside any intervention specific measures.

The Importance of Real-World Validation of Machine Learning Systems in Wearable Exercise Biofeedback Platforms: A Case Study.

Machine learning models are being utilized to provide wearable sensor-based exercise biofeedback to patients undertaking physical therapy. However, most systems are validated at a technical level using lab-based cross validation approaches. These results do not necessarily reflect the performance levels that patients and clinicians can expect in the real-world environment. This study aimed to conduct a thorough evaluation of an example wearable exercise biofeedback system from laboratory testing through to clinical validation in the target setting, illustrating the importance of context when validating such systems. Each of the various components of the system were evaluated independently, and then in combination as the system is designed to be deployed. The results show a reduction in overall system accuracy between lab-based cross validation (>94%), testing on healthy participants (n = 10) in the target setting (>75%), through to test data collected from the clinical cohort (n = 11) (>59%). This study illustrates that the reliance on lab-based validation approaches may be misleading key stakeholders in the inertial sensor-based exercise biofeedback sector, makes recommendations for clinicians, developers and researchers, and discusses factors that may influence system performance at each stage of evaluation.

An Objective Methodology for the Selection of a Device for Continuous Mobility Assessment.

Continuous monitoring by wearable technology is ideal for quantifying mobility outcomes in "real-world" conditions. Concurrent factors such as validity, usability, and acceptability of such technology need to be accounted for when choosing a monitoring device. This study proposes a bespoke methodology focused on defining a decision matrix to allow for effective decision making. A weighting system based on responses (n = 69) from a purpose-built questionnaire circulated within the IMI Mobilise-D consortium and its external collaborators was established, accounting for respondents' background and level of expertise in using wearables in clinical practice. Four domains (concurrent validity, CV; human factors, HF; wearability and usability, WU; and data capture process, CP), associated evaluation criteria, and scores were established through literature research and group discussions. While the CV was perceived as the most relevant domain (37%), the others were also considered highly relevant (WU: 30%, HF: 17%, CP: 16%). Respondents (~90%) preferred a hidden fixation and identified the lower back as an ideal sensor location for mobility outcomes. Overall, this study provides a novel, holistic, objective, as well as a standardized approach accounting for complementary aspects that should be considered by professionals and researchers when selecting a solution for continuous mobility monitoring.

Evaluation of an E-Learning Training Program to Support Implementation of a Group-Based, Theory-Driven, Self-Management Intervention For Osteoarthritis and Low-Back Pain: Pre-Post Study.

BACKGROUND: By adaptation of the face-to-face physiotherapist-training program previously used in the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) feasibility trial, an asynchronous, interactive, Web-based, e-learning training program (E-SOLAS) underpinned by behavior and learning theories was developed. OBJECTIVE: This study investigated the effect of the E-SOLAS training program on relevant outcomes of effective training and implementation. METHODS: Thirteen physiotherapists from across Ireland were trained via E-SOLAS by using mixed methods, and seven physiotherapists progressed to implementation of the 6-week group-based SOLAS intervention. The effectiveness of E-SOLAS was evaluated using the Kirkpatrick model at the levels of reaction (physiotherapist engagement and satisfaction with E-SOLAS training methods and content), learning (pre- to posttraining changes in physiotherapists' confidence and knowledge in delivering SOLAS content and self-determination theory-based communication strategies, administered via a SurveyMonkey questionnaire), and behavior (fidelity to delivery of SOLAS content using physiotherapist-completed weekly checklists). During implementation, five physiotherapists audio recorded delivery of one class, and the communication between physiotherapists and clients was assessed using the Health Care Climate Questionnaire (HCCQ), the Controlling Coach Behaviour Scale (CCBS), and an intervention-specific measure (ISM; 7-point Likert scale). A range of implementation outcomes were evaluated during training and delivery (ie, acceptability, appropriateness, feasibility, fidelity, and sustainability of E-SOLAS) using a posttraining feedback questionnaire and individual semistructured telephone interviews. RESULTS: With regard to their reaction, physiotherapists (n=13) were very satisfied with E-SOLAS posttraining (median 5.0; interquartile range 1.0; min-max 4.0-5.0) and completed training within 3-4 weeks. With regard to learning, there were significant increases in physiotherapists' confidence and knowledge in delivery of all SOLAS intervention components (P<.05). Physiotherapists' confidence in 7 of 10 self-determination theory-based communication strategies increased (P<.05), whereas physiotherapists' knowledge of self-determination theory-based strategies remained high posttraining (P>.05). In terms of behavior, physiotherapists delivered SOLAS in a needs supportive manner (HCCQ: median 5.2, interquartile range 1.3, min-max 3.7-5.8; CCBS: median 6.6, interquartile range 1.0, min-max 5.6-7.0; ISM: median 4.5, interquartile range 1.2, min-max 2.8-4.8). Fidelity scores were high for SOLAS content delivery (total %mean fidelity score 93.5%; SD 4.9%). The posttraining questionnaire and postdelivery qualitative interviews showed that physiotherapists found E-SOLAS acceptable, appropriate, feasible, and sustainable within primary care services to support the implementation of the SOLAS intervention. CONCLUSIONS: This study provides preliminary evidence of the effectiveness, acceptability, and feasibility of an e-learning program to train physiotherapists to deliver a group-based self-management complex intervention in primary care settings, which is equivalent to face-to-face training outcomes and would support inclusion of physiotherapists in a definitive trial of SOLAS.

"You are either sporty or you are not" A Qualitative Exploration of Pre-Teen Girls of Low-Socioeconomic Position Experiences of Being Physically Active.

BACKGROUND: Eighty one percent of adolescents do not meet the recommended physical activity (PA) guidelines with levels of physical activity declining steadily with age and more pronounced in girls of low socioeconomic position (SEP). Furthermore, early adolescence is a time when the rate of decline in PA is most severe amongst girls, placing them at an increased likelihood of developing negative health outcomes associated with physical inactivity. In response, the aim of this study was to explore low-SEP pre-teen girls' experiences of being physically active and to understand their perceptions of the individual, social and environmental factors that influence these experiences. METHODS: Focus groups were conducted with 107 girls aged 10 - 12 years from four urban and three rural primary schools. Reflexive thematic analysis was used to analyse the data, with themes mapped to the relevant domains of the Theoretical Domains Framework (TDF). RESULTS: Themes highlighted how skills and confidence underpin girls' self-identity for PA. Girls described how their social network (i.e., peers, family, coaches and teachers) shaped their experiences of being active. Girls recognised how being active was impacted by the challenges and opportunities in their local community (e.g., lack of facilities and anti-social behaviour). CONCLUSION: This study provides insight into low-SEP pre-teen girls' experiences of being physically active in both rural and urban locations, while highlighting the complex interplay of individual, social and environmental factors. Additionally, the use of the TDF presents an in-depth behavioural diagnosis which can be used to inform future theory-based interventions to promote low-SEP pre-teen girls PA.

"It's what mothers do." A qualitative exploration of mothers' experiences of supporting their daughter to be physically active.

OBJECTIVE: Girls are more at risk than boys of the non-communicable diseases associated with insufficient levels of physical activity (PA), therefore it is important to explore the reasons why girls maintain or cease to be physically active. Maternal support plays an important role in girl's PA, yet the factors influencing mothers' support of their PA have received limited exploration. In response, the aim of this study was to explore, mothers' experiences of supporting their daughters to be physically active and their perceptions of the factors that might influence these experiences. METHOD: Semi-structured interviews were conducted with a purposive sample of mothers (n = 29) of girls (Mean age = 10.9 years; SD = 0.6). Reflexive Thematic Analysis was used to analyse the data, with themes mapped to the relevant domains of the Theoretical Domains Framework. RESULTS: Themes highlighted how mothers described providing PA support as an inherent part of their parental role and how their role was influenced by their own PA identity. Mothers recognised that the type and amount of support they provided was impacted by the community setting in which they lived. Mothers acknowledged how the role of others (e.g., partners, grandparents, peers) added a layer of complexity to supporting their daughters to be active. CONCLUSION: This study advances our understanding of maternal PA support behaviours recognising the complex interplay of individual, social and environmental factors. Additionally, the use of the Theoretical Domains Framework presents an in-depth behavioural diagnosis which can be used to inform future theory-based interventions to promote parent support of children's PA.

Six-Month Pilot Testing of a Digital Health Tool to Support Effective Self-Care in People With Heart Failure: Mixed Methods Study.

BACKGROUND: Digital tools may support people to self-manage their heart failure (HF). Having previously outlined the human-centered design development of a digital tool to support self-care of HF, the next step was to pilot the tool over a period of time to establish people's acceptance of it in practice. OBJECTIVE: This study aims to conduct an observational pilot study to examine the usability, adherence, and feasibility of a digital health tool for HF within the Irish health care system. METHODS: A total of 19 participants with HF were provided with a digital tool comprising a mobile app and the Fitbit Charge 4 and Aria Air smart scales for a period of 6 months. Changes to their self-care were assessed before and after the study with the 9-item European HF Self-care Behavior Scale (EHFScBS) and the Minnesota Living with HF Questionnaire (MLwHFQ) using a Wilcoxon signed rank test. After the study, 3 usability questionnaires were implemented and descriptively analyzed: the System Usability Scale (SUS), Wearable Technology Motivation Scale (WTMS), and Comfort Rating Scale (CRS). Participants also undertook a semistructured interview regarding their experiences with the digital tool. Interviews were analyzed deductively using the Theoretical Domains Framework. RESULTS: Participants wore their devices for an average of 86.2% of the days in the 6-month testing period ranging from 40.6% to 98%. Although improvements in the EHFScBS and MLwHFQ were seen, these changes were not significant (P=.10 and P=.70, respectively, where P>.03, after a Bonferroni correction). SUS results suggest that the usability of this system was not acceptable with a median score of 58.8 (IQR 55.0-60.0; range 45.0-67.5). Participants demonstrated a strong motivation to use the system according to the WTMS (median 6.0, IQR 5.0-7.0; range 1.0-7.0), whereas the Fitbit was considered very comfortable as demonstrated by the low CRS results (median 0.0, IQR 0.0-0.0; range 0.0-2.0). According to participant interviews, the digital tool supported self-management through increased knowledge, improved awareness, decision-making, and confidence in their own data, and improving their social support through a feeling of comfort in being watched. CONCLUSIONS: The digital health tool demonstrated high levels of adherence and acceptance among participants. Although the SUS results suggest low usability, this may be explained by participants uncertainty that they were using it fully, rather than it being unusable, especially given the experiences documented in their interviews. The digital tool targeted key self-management behaviors and feelings of social support. However, a number of changes to the tool, and the health service, are required before it can be implemented at scale. A full-scale feasibility trial conducted at a wider level is required to fully determine its potential effectiveness and wider implementation needs.

Mobilise-D insights to estimate real-world walking speed in multiple conditions with a wearable device.

This study aimed to validate a wearable device's walking speed estimation pipeline, considering complexity, speed, and walking bout duration. The goal was to provide recommendations on the use of wearable devices for real-world mobility analysis. Participants with Parkinson's Disease, Multiple Sclerosis, Proximal Femoral Fracture, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, and healthy older adults (n = 97) were monitored in the laboratory and the real-world (2.5 h), using a lower back wearable device. Two walking speed estimation pipelines were validated across 4408/1298 (2.5 h/laboratory) detected walking bouts, compared to 4620/1365 bouts detected by a multi-sensor reference system. In the laboratory, the mean absolute error (MAE) and mean relative error (MRE) for walking speed estimation ranged from 0.06 to 0.12 m/s and - 2.1 to 14.4%, with ICCs (Intraclass correlation coefficients) between good (0.79) and excellent (0.91). Real-world MAE ranged from 0.09 to 0.13, MARE from 1.3 to 22.7%, with ICCs indicating moderate (0.57) to good (0.88) agreement. Lower errors were observed for cohorts without major gait impairments, less complex tasks, and longer walking bouts. The analytical pipelines demonstrated moderate to good accuracy in estimating walking speed. Accuracy depended on confounding factors, emphasizing the need for robust technical validation before clinical application.Trial registration: ISRCTN - 12246987.

Real-World Gait Detection Using a Wrist-Worn Inertial Sensor: Validation Study.

BACKGROUND: Wrist-worn inertial sensors are used in digital health for evaluating mobility in real-world environments. Preceding the estimation of spatiotemporal gait parameters within long-term recordings, gait detection is an important step to identify regions of interest where gait occurs, which requires robust algorithms due to the complexity of arm movements. While algorithms exist for other sensor positions, a comparative validation of algorithms applied to the wrist position on real-world data sets across different disease populations is missing. Furthermore, gait detection performance differences between the wrist and lower back position have not yet been explored but could yield valuable information regarding sensor position choice in clinical studies. OBJECTIVE: The aim of this study was to validate gait sequence (GS) detection algorithms developed for the wrist position against reference data acquired in a real-world context. In addition, this study aimed to compare the performance of algorithms applied to the wrist position to those applied to lower back-worn inertial sensors. METHODS: Participants with Parkinson disease, multiple sclerosis, proximal femoral fracture (hip fracture recovery), chronic obstructive pulmonary disease, and congestive heart failure and healthy older adults (N=83) were monitored for 2.5 hours in the real-world using inertial sensors on the wrist, lower back, and feet including pressure insoles and infrared distance sensors as reference. In total, 10 algorithms for wrist-based gait detection were validated against a multisensor reference system and compared to gait detection performance using lower back-worn inertial sensors. RESULTS: The best-performing GS detection algorithm for the wrist showed a mean (per disease group) sensitivity ranging between 0.55 (SD 0.29) and 0.81 (SD 0.09) and a mean (per disease group) specificity ranging between 0.95 (SD 0.06) and 0.98 (SD 0.02). The mean relative absolute error of estimated walking time ranged between 8.9% (SD 7.1%) and 32.7% (SD 19.2%) per disease group for this algorithm as compared to the reference system. Gait detection performance from the best algorithm applied to the wrist inertial sensors was lower than for the best algorithms applied to the lower back, which yielded mean sensitivity between 0.71 (SD 0.12) and 0.91 (SD 0.04), mean specificity between 0.96 (SD 0.03) and 0.99 (SD 0.01), and a mean relative absolute error of estimated walking time between 6.3% (SD 5.4%) and 23.5% (SD 13%). Performance was lower in disease groups with major gait impairments (eg, patients recovering from hip fracture) and for patients using bilateral walking aids. CONCLUSIONS: Algorithms applied to the wrist position can detect GSs with high performance in real-world environments. Those periods of interest in real-world recordings can facilitate gait parameter extraction and allow the quantification of gait duration distribution in everyday life. Our findings allow taking informed decisions on alternative positions for gait recording in clinical studies and public health. TRIAL REGISTRATION: ISRCTN Registry 12246987; https://www.isrctn.com/ISRCTN12246987. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2021-050785.

Acceptability of wearable devices for measuring mobility remotely: Observations from the Mobilise-D technical validation study.

Background: This study aimed to explore the acceptability of a wearable device for remotely measuring mobility in the Mobilise-D technical validation study (TVS), and to explore the acceptability of using digital tools to monitor health. Methods: Participants (N = 106) in the TVS wore a waist-worn device (McRoberts Dynaport MM + ) for one week. Following this, acceptability of the device was measured using two questionnaires: The Comfort Rating Scale (CRS) and a previously validated questionnaire. A subset of participants (n = 36) also completed semi-structured interviews to further determine device acceptability and to explore their opinions of the use of digital tools to monitor their health. Questionnaire results were analysed descriptively and interviews using a content analysis. Results: The device was considered both comfortable (median CRS (IQR; min-max) = 0.0 (0.0; 0-20) on a scale from 0-20 where lower scores signify better comfort) and acceptable (5.0 (0.5; 3.0-5.0) on a scale from 1-5 where higher scores signify better acceptability). Interviews showed it was easy to use, did not interfere with daily activities, and was comfortable. The following themes emerged from participants' as being important to digital technology: altered expectations for themselves, the use of technology, trust, and communication with healthcare professionals. Conclusions: Digital tools may bridge existing communication gaps between patients and clinicians and participants are open to this. This work indicates that waist-worn devices are supported, but further work with patient advisors should be undertaken to understand some of the key issues highlighted. This will form part of the ongoing work of the Mobilise-D consortium.

Reverse Engineering of Digital Measures: Inviting Patients to the Conversation.

Background: Digital measures offer an unparalleled opportunity to create a more holistic picture of how people who are patients behave in their real-world environments, thereby establishing a better connection between patients, caregivers, and the clinical evidence used to drive drug development and disease management. Reaching this vision will require achieving a new level of co-creation between the stakeholders who design, develop, use, and make decisions using evidence from digital measures. Summary: In September 2022, the second in a series of meetings hosted by the Swiss Federal Institute of Technology in Zürich, the Foundation for the National Institutes of Health Biomarkers Consortium, and sponsored by Wellcome Trust, entitled "Reverse Engineering of Digital Measures," was held in Zurich, Switzerland, with a broad range of stakeholders sharing their experience across four case studies to examine how patient centricity is essential in shaping development and validation of digital evidence generation tools. Key Messages: In this paper, we discuss progress and the remaining barriers to widespread use of digital measures for evidence generation in clinical development and care delivery. We also present key discussion points and takeaways in order to continue discourse and provide a basis for dissemination and outreach to the wider community and other stakeholders. The work presented here shows us a blueprint for how and why the patient voice can be thoughtfully integrated into digital measure development and that continued multistakeholder engagement is critical for further progress.

Ecological validity of a deep learning algorithm to detect gait events from real-life walking bouts in mobility-limiting diseases.

Introduction: The clinical assessment of mobility, and walking specifically, is still mainly based on functional tests that lack ecological validity. Thanks to inertial measurement units (IMUs), gait analysis is shifting to unsupervised monitoring in naturalistic and unconstrained settings. However, the extraction of clinically relevant gait parameters from IMU data often depends on heuristics-based algorithms that rely on empirically determined thresholds. These were mainly validated on small cohorts in supervised settings. Methods: Here, a deep learning (DL) algorithm was developed and validated for gait event detection in a heterogeneous population of different mobility-limiting disease cohorts and a cohort of healthy adults. Participants wore pressure insoles and IMUs on both feet for 2.5 h in their habitual environment. The raw accelerometer and gyroscope data from both feet were used as input to a deep convolutional neural network, while reference timings for gait events were based on the combined IMU and pressure insoles data. Results and discussion: The results showed a high-detection performance for initial contacts (ICs) (recall: 98%, precision: 96%) and final contacts (FCs) (recall: 99%, precision: 94%) and a maximum median time error of -0.02 s for ICs and 0.03 s for FCs. Subsequently derived temporal gait parameters were in good agreement with a pressure insoles-based reference with a maximum mean difference of 0.07, -0.07, and <0.01 s for stance, swing, and stride time, respectively. Thus, the DL algorithm is considered successful in detecting gait events in ecologically valid environments across different mobility-limiting diseases.