The development and preliminary evaluation of a clinician e-learning training platform for a neonatal sepsis risk monitor for use in ICU settings.

BACKGROUND: Training clinicians on the use of hospital-based patient monitoring systems (PMS) is vital to mitigate the risk of use errors and of frustration using these devices, especially when used in ICU settings. PMS training is typically delivered through face-to-face training sessions in the hospital. However, it is not always feasible to deliver training in this format to all clinical staff given some constraints (e.g., availability of staff and trainers to attend in-person training sessions and the costs associated with face-to-face training). OBJECTIVE: The literature indicates that E-learning has the potential to mitigate barriers associated with time restrictions for trainers and trainees and evidence shows it to be more flexible, and convenient for learners in healthcare settings. This study aimed to develop and carry out a preliminary evaluation via a case study of an e-learning training platform designed for a novel neonatal sepsis risk monitor system (Digi-NewB). METHODS: A multi-modal qualitative research case study approach was used, including the analysis of three qualitative data sources: (i) audio/video recordings of simulation sessions in which participants were asked to operate the system as intended (e.g., update the clinical observations and monitor the sepsis risk), (ii) interviews with the simulation participants and an attending key opinion leader (KOL), who observed all simulation sessions, and (iii) post-simulation survey. RESULTS: After receiving ethical approval for the study, nine neonatal intensive care unit (NICU) nurses completed the online training and participated in the simulation and follow-up interview sessions. The KOL was also interviewed, and seven out of the nine NICU nurses answered the post-simulation survey. The video/audio analysis of the simulations revealed that participants were able to use and interpret the Digi-NewB interface. Interviews with simulation participants and the KOL, and feedback extracted from the survey, revealed that participants were overall satisfied with the training platform and perceived it as an efficient and effective method to deliver medical device training. CONCLUSIONS: This study developed an online training platform to train clinicians in the use of a critical care medical device and carried out a preliminary evaluation of the platform via a case study. The e-learning platform was designed to supplement and enhance other training approaches. Further research is required to evaluate the effectiveness of this approach.

Design of a Planner-Based Intervention to Facilitate Diet Behaviour Change in Type 2 Diabetes.

Diet behaviour is influenced by the interplay of the physical and social environment as well as macro-level and individual factors. In this study, we focus on diet behaviour at an individual level and describe the design of a behaviour change artefact to support diet behaviour change in persons with type 2 diabetes. This artefact was designed using a human-centred design methodology and the Behaviour Change Wheel framework. The designed artefact sought to support diet behaviour change through the addition of healthy foods and the reduction or removal of unhealthy foods over a 12-week period. These targeted behaviours were supported by the enabling behaviours of water consumption and mindfulness practice. The artefact created was a behaviour change planner in calendar format, that incorporated behaviour change techniques and which focused on changing diet behaviour gradually over the 12-week period. The behaviour change planner forms part of a behaviour change intervention which also includes a preparatory workbook exercise and one-to-one action planning sessions and can be customised for each participant.

Augmenting Critical Care Patient Monitoring Using Wearable Technology: Review of Usability and Human Factors.

BACKGROUND: Continuous monitoring of the vital signs of critical care patients is an essential component of critical care medicine. For this task, clinicians use a patient monitor (PM), which conveys patient vital sign data through a screen and an auditory alarm system. Some limitations with PMs have been identified in the literature, such as the need for visual contact with the PM screen, which could result in reduced focus on the patient in specific scenarios, and the amount of noise generated by the PM alarm system. With the advancement of material science and electronic technology, wearable devices have emerged as a potential solution for these problems. This review presents the findings of several studies that focused on the usability and human factors of wearable devices designed for use in critical care patient monitoring. OBJECTIVE: The aim of this study is to review the current state of the art in wearable devices intended for use by clinicians to monitor vital signs of critical care patients in hospital settings, with a focus on the usability and human factors of the devices. METHODS: A comprehensive literature search of relevant databases was conducted, and 20 studies were identified and critically reviewed by the authors. RESULTS: We identified 3 types of wearable devices: tactile, head-mounted, and smartwatch displays. In most cases, these devices were intended for use by anesthesiologists, but nurses and surgeons were also identified as potentially important users of wearable technology in critical care medicine. Although the studies investigating tactile displays revealed their potential to improve clinical monitoring, usability problems related to comfort need to be overcome before they can be considered suitable for use in clinical practice. Only a few studies investigated the usability and human factors of tactile displays by conducting user testing involving critical care professionals. The studies of head-mounted displays (HMDs) revealed that these devices could be useful in critical care medicine, particularly from an ergonomics point of view. By reducing the amount of time the user spends averting their gaze from the patient to a separate screen, HMDs enable clinicians to improve their patient focus and reduce the potential of repetitive strain injury. CONCLUSIONS: Researchers and designers of new wearable devices for use in critical care medicine should strive to achieve not only enhanced performance but also enhanced user experience for their users, especially in terms of comfort and ease of use. These aspects of wearable displays must be extensively tested with the intended end users in a setting that properly reflects the intended context of use before their adoption can be considered in clinical settings.

Identifying Barriers and Facilitators to Diet and Physical Activity Behaviour Change in Type 2 Diabetes Using a Design Probe Methodology.

Treatment of Type 2 Diabetes (T2D) typically involves pharmacological methods and adjunct behavioural modifications, focused on changing diet and physical activity (PA) behaviours. Changing diet and physical activity behaviours is complex and any behavioural intervention in T2D, to be successful, must use an appropriate suite of behaviour change techniques (BCTs). In this study, we sought to understand the perceived barriers and facilitators to diet and PA behaviour change in persons with T2D, with a view to creating artefacts to facilitate the required behaviour changes. The Design Probe was chosen as the most appropriate design research instrument to capture the required data, as it enabled participants to reflect and self-document, over an extended period of time, on their daily lived experiences and, following this reflection, to identify their barriers and facilitators to diet and PA behaviour change. Design Probes were sent to 21 participants and 13 were fully completed. A reflective thematic analysis was carried out on the data, which identified themes of food environment, mental health, work schedule, planning, social support, cravings, economic circumstances and energy associated with diet behaviour. Similar themes were identified for PA as well as themes of physical health, weather, motivation and the physical environment.

Applicability and tolerability of electrical stimulation applied to the upper and lower leg skin surface for cueing applications in Parkinson's disease.

Due to possible sensory impairments in people with Parkinson's disease, several methodological aspects of electrical stimulation as a potential cueing method remain to be explored. This study aimed to investigate the applicability and tolerability of sensory and motor electrical stimulation in 10 people with Parkinson's disease. The study focused on assessing the electrical stimulation voltages and visual analogue scale discomfort scores at the electrical sensory, motor, discomfort, and pain thresholds. Results show that sensory electrical stimulation at the tibialis anterior, soleus, hamstrings, and quadriceps stimulation sites was applicable and tolerable for 6/10, 10/10, 9/10, and 10/10 participants, respectively. Furthermore, motor electrical stimulation at the tibialis anterior, soleus, hamstrings, and quadriceps stimulation sites were applicable and tolerable for 7/10, 7/10, 7/10, and 8/10 participants, respectively. Interestingly, the thresholds for the lower leg were higher than those of the upper leg. The data presented in this paper indicate that sensory and motor electrical stimulation is applicable and tolerable for cueing applications in people with Parkinson's disease. Sensory electrical stimulation was applicable and tolerable at the soleus and quadriceps sites. Motor electrical stimulation was not tolerable for two participants at any of the proposed stimulation sites. Therefore, future studies investigating motor electrical stimulation cueing, should apply it with caution in people with Parkinson's disease.

Novel Interface Designs for Patient Monitoring Applications in Critical Care Medicine: Human Factors Review.

BACKGROUND: The patient monitor (PM) is one of the most commonly used medical devices in hospitals worldwide. PMs are used to monitor patients' vital signs in a wide variety of patient care settings, especially in critical care settings, such as intensive care units. An interesting observation is that the design of PMs has not significantly changed over the past 2 decades, with the layout and structure of PMs more or less unchanged, with incremental changes in design being made rather than transformational changes. Thus, we believe it well-timed to review the design of novel PM interfaces, with particular reference to usability and human factors. OBJECTIVE: This paper aims to review innovations in PM design proposed by researchers and explore how clinicians responded to these design changes. METHODS: A literature search of relevant databases, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, identified 16 related studies. A detailed description of the interface design and an analysis of each novel PM were carried out, including a detailed analysis of the structure of the different user interfaces, to inform future PM design. The test methodologies used to evaluate the different designs are also presented. RESULTS: Most of the studies included in this review identified some level of improvement in the clinician's performance when using a novel display in comparison with the traditional PM. For instance, from the 16 reviewed studies, 12 studies identified an improvement in the detection and response times, and 10 studies identified an improvement in the accuracy or treatment efficiency. This indicates that novel displays have the potential to improve the clinical performance of nurses and doctors. However, the outcomes of some of these studies are weakened because of methodological deficiencies. These deficiencies are discussed in detail in this study. CONCLUSIONS: More careful study design is warranted to investigate the user experience and usability of future novel PMs for real time vital sign monitoring, to establish whether or not they could be used successfully in critical care. A series of recommendations on how future novel PM designs and evaluations can be enhanced are provided.

Comparison of the Hemodynamic Performance of Two Neuromuscular Electrical Stimulation Devices Applied to the Lower Limb.

Currently, 1% of the population of the Western world suffers from venous leg ulcers as a result of chronic venous insufficiency. Current treatment involves the use of moist wound healing, compression bandages, and intermittent pneumatic compression. Neuromuscular electrical stimulation is a novel potential new therapeutic method for the promotion of increased lower limb hemodynamics. The aim of this study was to measure the hemodynamic changes in the lower limb with the use of two neuromuscular electrical stimulation devices. Twelve healthy volunteers received two neuromuscular stimulation device interventions. The GekoTM and National University of Ireland (NUI) Galway neuromuscular electrical stimulation devices were randomized between dominant and non-dominant legs. Hemodynamic measurements of peak venous velocity (cm/s), the time average mean velocity (TAMEAN) (cm/s), and ejected volume (mL) of blood were recorded. Peak venous velocity was significantly increased by the GekoTM and the NUI Galway device compared to baseline blood flow (p < 0.0001), while only the voluntary contraction produced significant increases in TAMEAN and ejected volume (both p < 0.05). Neuromuscular muscular electrical stimulation can produce adequate increases in lower limb hemodynamics sufficient to prevent venous stasis. Greater use of neuromuscular stimulation devices could be considered in the treatment of conditions related to chronic venous insufficiency but requires further research.

Parents' and healthcare professionals' perceptions of the use of live video recording in neonatal units: a focus group study.

BACKGROUND: The emerging use of video in neonatology units raises ethical and practical questions. This study aims to gain a better understanding of the suitability, limitations and constraints concerning the use of live video as a tool in neonatal clinical practice. The perceptions of parents and healthcare professionals in regard to live video were examined. METHODS: Nine focus groups were conducted in four neonatal units involving 20 healthcare professionals and 19 parents. Data were triangulated using transcripts and field notes and analyzed using inductive and semantic thematic analysis. RESULTS: The seven major themes that emerged from the healthcare professionals focus groups were (i) the impact of video recording on healthcare professionals' behavior; (ii) the impact on parents; (iii) forensic issues;(iv) guarantee of use; (v) benefits for the newborn; (vi) methodology of use; and (vii) technical considerations & feasibility. The five major themes that emerged from parents focus groups were (i) benefits for the newborn and care enhancement; (ii) impact on parents and potential benefits in case of newborn child/parent separation; (iii) informed consent and guarantee of use;(iv) concern about a possible disruptive impact on healthcare professionals; and (v) data protection. CONCLUSION: Both parents and healthcare professionals found video recording useful and acceptable if measures were taken to protect the data and mitigate any negative impacts on healthcare professionals.

Double-Tap Interaction as an Actuation Mechanism for On-Demand Cueing in Parkinson's Disease.

Freezing of Gait (FoG) is one of the most debilitating symptoms of Parkinson's disease and is an important contributor to falls. When the management of freezing episodes cannot be achieved through medication or surgery, non-pharmacological methods, such as cueing, have emerged as effective techniques, which ameliorates FoG. The use of On-Demand cueing systems (systems that only provide cueing stimuli during a FoG episode) has received attention in recent years. For such systems, the most common method of triggering the onset of cueing stimuli, utilize autonomous real-time FoG detection algorithms. In this article, we assessed the potential of a simple double-tap gesture interaction to trigger the onset of cueing stimuli. The intended purpose of our study was to validate the use of double-tap gesture interaction to facilitate Self-activated On-Demand cueing. We present analyses that assess if PwP can perform a double-tap gesture, if the gesture can be detected using an accelerometer's embedded gestural interaction recognition function and if the action of performing the gesture aggravates FoG episodes. Our results demonstrate that a double-tap gesture may provide an effective actuation method for triggering On-Demand cueing. This opens up the potential future development of self-activated cueing devices as a method of On-Demand cueing for PwP and others.

A Technological Review of Wearable Cueing Devices Addressing Freezing of Gait in Parkinson's Disease.

Freezing of gait is one of the most debilitating symptoms of Parkinson's disease and is an important contributor to falls, leading to it being a major cause of hospitalization and nursing home admissions. When the management of freezing episodes cannot be achieved through medication or surgery, non-pharmacological methods such as cueing have received attention in recent years. Novel cueing systems were developed over the last decade and have been evaluated predominantly in laboratory settings. However, to provide benefit to people with Parkinson's and improve their quality of life, these systems must have the potential to be used at home as a self-administer intervention. This paper aims to provide a technological review of the literature related to wearable cueing systems and it focuses on current auditory, visual and somatosensory cueing systems, which may provide a suitable intervention for use in home-based environments. The paper describes the technical operation and effectiveness of the different cueing systems in overcoming freezing of gait. The "What Works Clearinghouse (WWC)" tool was used to assess the quality of each study described. The paper findings should prove instructive for further researchers looking to enhance the effectiveness of future cueing systems.

Sensory Electrical Stimulation Cueing May Reduce Freezing of Gait Episodes in Parkinson's Disease.

Introduction: Freezing of gait (FoG) is a movement abnormality that presents with advancing Parkinson's disease (PD) and is one of the most debilitating symptoms of the disease. The mainstay of nonpharmacological management of FoG is typically through external cueing techniques designed to relieve or prevent the freezing episode. Previous work shows that electrical stimulation may prove useful as a gait guidance technique, but further evidence is required. The main objective of this study was to determine whether a "fixed" rhythmic sensory electrical stimulation (sES) cueing strategy would significantly (i) reduce the time taken to complete a walking task and (ii) reduce the number of FoG episodes occurring when performing the task. Methods: 9 participants with idiopathic PD performed a self-identified walking task during both control (no cue) and cueing conditions. The self-identified walking task was a home-based daily walking activity, which was known to result in FoG for that person. A trained physiotherapist recorded the time taken to complete the walking task and the number of FoG episodes which occurred during the task. Data were analyzed by paired t-tests for both the time to complete a walking task and the number of FoG episodes occurring. Results: sES cueing resulted in a reduction in the time taken to complete a walking task and in the number of FoG episodes occurring during performance of this task by 14.23 ± 11.15% (p=0.009) and 58.28 ± 33.89% (p=0.002), respectively. Conclusions: This study shows a positive effect of "fixed" rhythmic sES on the time taken to complete a walking task and on the number of FoG episodes occurring during the task. Our results provide evidence that sES cueing delivered in a "fixed" rhythmic manner has the potential to be an effective cueing mechanism for FoG prevention.

Does culture affect usability? A trans-European usability and user experience assessment of a falls-risk connected health system following a user-centred design methodology carried out in a single European country.

BACKGROUND: User-centred design (UCD) is a process whereby the end-user is placed at the centre of the design process. The WIISEL (Wireless Insole for Independent and Safe Elderly Living) system is designed to monitor fall risk and to detect falls, and consists of a pair of instrumented insoles and a smartphone app. The system was designed using a three-phase UCD process carried out in Ireland, which incorporated the input of Irish end-users and multidisciplinary experts throughout. OBJECTIVE: In this paper we report the results of a usability and user experience (UX) assessment of the WIISEL system in multiple countries and thus establish whether the UCD process carried out in Ireland produced positive usability and UX results outside of Ireland. METHODS: 15 older adults across three centres (Ireland, Italy and Israel) were recruited for a three-day trial of the system in their home. Usability and UX data were captured using observations, interviews and usability questionnaires. RESULTS: The system was satisfactory in terms of the usability and UX feedback from the participants in all three countries. There was no statistically significant difference in the usability scores for the three countries tested, with the exception of comfort. CONCLUSIONS: A connected health system designed using a UCD process in a single country resulted in positive usability and UX for users in other European countries.

Enhancing Home Health Mobile Phone App Usability Through General Smartphone Training: Usability and Learnability Case Study.

BACKGROUND: Each year, millions of older adults fall, with more than 1 out of 4 older people experiencing a fall annually, thereby causing a major social and economic impact. Falling once doubles one's chances of falling again, making fall prediction an important aspect of preventative strategies. In this study, 22 older adults aged between 65 and 85 years were trained in the use of a smartphone-based fall prediction system. The system is designed to continuously assess fall risk by measuring various gait and balance parameters using a smart insole and smartphone, and is also designed to detect falls. The use case of the fall prediction system in question required the users to interact with the smartphone via an app for device syncing, data uploads, and checking system status. OBJECTIVE: The objective of this study was to observe the effect that basic smartphone training could have on the user experience of a group that is not technically proficient with smartphones when using a new connected health system. It was expected that even short rudimentary training could have a large effect on user experience and therefore increase the chances of the group accepting the new technology. METHODS: All participants received training on how to use the system smartphone app; half of the participants (training group) also received extra training on how to use basic functions of the smartphone, such as making calls and sending text messages, whereas the other half did not receive this extra training (no extra training group). Comparison of training group and no extra training group was carried out using metrics such as satisfaction rating, time taken to complete tasks, cues required to complete tasks, and errors made during tasks. RESULTS: The training group fared better in the first 3 days of using the system. There were significant recorded differences in number of cues required and errors committed between the two groups. By the fourth and fifth day of use, both groups were performing at the same level when using the system. CONCLUSIONS: Supplementary basic smartphone training may be critical in trials where a smartphone app­based system for health intervention purposes is being introduced to a population that is not proficient with technology. This training could prevent early technology rejection and increase the engagement of older participants and their overall user experience with the system.

A "HOLTER" for Parkinson's disease: Validation of the ability to detect on-off states using the REMPARK system.

The treatment of Parkinson's disease (PD) with levodopa is very effective. However, over time, motor complications (MCs) appear, restricting the patient from leading a normal life. One of the most disabling MCs is ON-OFF fluctuations. Gathering accurate information about the clinical status of the patient is essential for planning treatment and assessing its effect. Systems such as the REMPARK system, capable of accurately and reliably monitoring ON-OFF fluctuations, are of great interest. OBJECTIVE: To analyze the ability of the REMPARK System to detect ON-OFF fluctuations. METHODS: Forty-one patients with moderate to severe idiopathic PD were recruited according to the UK Parkinson's Disease Society Brain Bank criteria. Patients with motor fluctuations, freezing of gait and/or dyskinesia and who were able to walk unassisted in the OFF phase, were included in the study. Patients wore the REMPARK System for 3days and completed a diary of their motor state once every hour. RESULTS: The record obtained by the REMPARK System, compared with patient-completed diaries, demonstrated 97% sensitivity in detecting OFF states and 88% specificity (i.e., accuracy in detecting ON states). CONCLUSION: The REMPARK System detects an accurate evaluation of ON-OFF fluctuations in PD; this technology paves the way for an optimisation of the symptomatic control of PD motor symptoms as well as an accurate assessment of medication efficacy.

Diet Behavior Change Techniques in Type 2 Diabetes: A Systematic Review and Meta-analysis.

OBJECTIVE: Dietary behavior is closely connected to type 2 diabetes. The purpose of this meta-analysis was to identify behavior change techniques (BCTs) and specific components of dietary interventions for patients with type 2 diabetes associated with changes in HbA1c and body weight. RESEARCH DESIGN AND METHODS: The Cochrane Library, CINAHL, Embase, PubMed, PsycINFO, and Scopus databases were searched. Reports of randomized controlled trials published during 1975-2017 that focused on changing dietary behavior were selected, and methodological rigor, use of BCTs, and fidelity and intervention features were evaluated. RESULTS: In total, 54 studies were included, with 42 different BCTs applied and an average of 7 BCTs used per study. Four BCTs-"problem solving," "feedback on behavior," "adding objects to the environment," and "social comparison"-and the intervention feature "use of theory" were associated with >0.3% (3.3 mmol/mol) reduction in HbA1c. Meta-analysis revealed that studies that aimed to control or change the environment showed a greater reduction in HbA1c of 0.5% (5.5 mmol/mol) (95% CI -0.65, -0.34), compared with 0.32% (3.5 mmol/mol) (95% CI -0.40, -0.23) for studies that aimed to change behavior. Limitations of our study were the heterogeneity of dietary interventions and poor quality of reporting of BCTs. CONCLUSIONS: This study provides evidence that changing the dietary environment may have more of an effect on HbA1c in adults with type 2 diabetes than changing dietary behavior. Diet interventions achieved clinically significant reductions in HbA1c, although initial reductions in body weight diminished over time. If appropriate BCTs and theory are applied, dietary interventions may result in better glucose control.

Human-Centered Design Study: Enhancing the Usability of a Mobile Phone App in an Integrated Falls Risk Detection System for Use by Older Adult Users.

BACKGROUND: Design processes such as human-centered design (HCD), which involve the end user throughout the product development and testing process, can be crucial in ensuring that the product meets the needs and capabilities of the user, particularly in terms of safety and user experience. The structured and iterative nature of HCD can often conflict with the necessary rapid product development life-cycles associated with the competitive connected health industry. OBJECTIVE: The aim of this study was to apply a structured HCD methodology to the development of a smartphone app that was to be used within a connected health fall risk detection system. Our methodology utilizes so called discount usability engineering techniques to minimize the burden on resources during development and maintain a rapid pace of development. This study will provide prospective designers a detailed description of the application of a HCD methodology. METHODS: A 3-phase methodology was applied. In the first phase, a descriptive "use case" was developed by the system designers and analyzed by both expert stakeholders and end users. The use case described the use of the app and how various actors would interact with it and in what context. A working app prototype and a user manual were then developed based on this feedback and were subjected to a rigorous usability inspection. Further changes were made both to the interface and support documentation. The now advanced prototype was exposed to user testing by end users where further design recommendations were made. RESULTS: With combined expert and end-user analysis of a comprehensive use case having originally identified 21 problems with the system interface, we have only seen and observed 3 of these problems in user testing, implying that 18 problems were eliminated between phase 1 and 3. Satisfactory ratings were obtained during validation testing by both experts and end users, and final testing by users shows the system requires low mental, physical, and temporal demands according to the NASA Task Load Index (NASA-TLX). CONCLUSIONS: From our observation of older adults' interactions with smartphone interfaces, there were some recurring themes. Clear and relevant feedback as the user attempts to complete a task is critical. Feedback should include pop-ups, sound tones, color or texture changes, or icon changes to indicate that a function has been completed successfully, such as for the connection sequence. For text feedback, clear and unambiguous language should be used so as not to create anxiety, particularly when it comes to saving data. Warning tones or symbols, such as caution symbols or shrill tones, should only be used if absolutely necessary. Our HCD methodology, designed and implemented based on the principles of the International Standard Organizaton (ISO) 9241-210 standard, produced a functional app interface within a short production cycle, which is now suitable for use by older adults in long term clinical trials.

A Human-Centered Design Methodology to Enhance the Usability, Human Factors, and User Experience of Connected Health Systems: A Three-Phase Methodology.

BACKGROUND: Design processes such as human-centered design, which involve the end user throughout the product development and testing process, can be crucial in ensuring that the product meets the needs and capabilities of the user, particularly in terms of safety and user experience. The structured and iterative nature of human-centered design can often present a challenge when design teams are faced with the necessary, rapid, product development life cycles associated with the competitive connected health industry. OBJECTIVE: We wanted to derive a structured methodology that followed the principles of human-centered design that would allow designers and developers to ensure that the needs of the user are taken into account throughout the design process, while maintaining a rapid pace of development. In this paper, we present the methodology and its rationale before outlining how it was applied to assess and enhance the usability, human factors, and user experience of a connected health system known as the Wireless Insole for Independent and Safe Elderly Living (WIISEL) system, a system designed to continuously assess fall risk by measuring gait and balance parameters associated with fall risk. METHODS: We derived a three-phase methodology. In Phase 1 we emphasized the construction of a use case document. This document can be used to detail the context of use of the system by utilizing storyboarding, paper prototypes, and mock-ups in conjunction with user interviews to gather insightful user feedback on different proposed concepts. In Phase 2 we emphasized the use of expert usability inspections such as heuristic evaluations and cognitive walkthroughs with small multidisciplinary groups to review the prototypes born out of the Phase 1 feedback. Finally, in Phase 3 we emphasized classical user testing with target end users, using various metrics to measure the user experience and improve the final prototypes. RESULTS: We report a successful implementation of the methodology for the design and development of a system for detecting and predicting falls in older adults. We describe in detail what testing and evaluation activities we carried out to effectively test the system and overcome usability and human factors problems. CONCLUSIONS: We feel this methodology can be applied to a wide variety of connected health devices and systems. We consider this a methodology that can be scaled to different-sized projects accordingly.