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.
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.
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.
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.
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.
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.
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.
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.
Abstract
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.
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 (
= 10) in the target setting (>75%), through to test data collected from the clinical cohort (
= 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.
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.
•The Template for Intervention Description and Replication was used to extract data.•Many studies used social cognitive theory as a theoretical foundation.•Thirty-seven different behavior change techniques were reported across studies.•Having a credible source and receiving information on being active was important.•The use of self-regulatory related behavior change techniques was promising.
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.
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 (
= 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.
Wearable devices are valuable assessment tools for patient outcomes in contexts such as clinical trials. To be successfully deployed, however, participants must be willing to wear them. Another ...concern is that usability studies are rarely published, often fail to test devices beyond 24 hours, and need to be repeated frequently to ensure that contemporary devices are assessed.
This study aimed to compare multiple wearable sensors in a real-world context to establish their usability within an older adult (>50 years) population.
Eight older adults wore seven devices for a minimum of 1 week each: Actigraph GT9x, Actibelt, Actiwatch, Biovotion, Hexoskin, Mc10 Biostamp_RC, and Wavelet. Usability was established through mixed methods using semistructured interviews and three questionnaires, namely, the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), and an acceptability questionnaire. Quantitative data were reported descriptively and qualitative data were analyzed using deductive content analysis. Data were then integrated using triangulation.
Results demonstrated that no device was considered optimal as all scored below average in the SUS (median, IQR; min-max=57.5, 12.5; 47.5-63.8). Hexoskin was the lowest scored device based on the IMI (3.6; 3.4-4.5), while Biovotion, Actibelt, and Mc10 Biostamp_RC achieved the highest median results on the acceptability questionnaire (3.6 on a 6-point Likert scale). Qualitatively, participants were willing to accept less comfort, less device discretion, and high charging burdens if the devices were perceived as useful, namely through the provision of feedback for the user. Participants agreed that the purpose of use is a key enabler for long-term compliance. These views were particularly noted by those not currently wearing an activity-tracking device. Participants believed that wrist-worn sensors were the most versatile and easy to use, and therefore, the most suitable for long-term use. In particular, Actiwatch and Wavelet stood out for their comfort. The convergence of quantitative and qualitative data was demonstrated in the study.
Based on the results, the following context-specific recommendations can be made: (1) researchers should consider their device selection in relation to both individual and environmental factors, and not simply the primary outcome of the research study; (2) if researchers do not wish their participants to have access to feedback from the devices, then a simple, wrist-worn device that acts as a watch is preferable; (3) if feedback is allowed, then it should be made available to help participants remain engaged; this is likely to apply only to people without cognitive impairments; (4) battery life of 1 week should be considered as a necessary feature to enhance data capture; (5) researchers should consider providing additional information about the purpose of devices to participants to support their continued use.
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.
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.