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.

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.

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.

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.

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.

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.

Real-Time Constant Monitoring of Fall Risk Index by Means of Fully-Wireless Insoles.

Constant monitoring of gait in real life conditions is considered the best way to assess Fall Risk Index (FRI) since most falls happen out of the ideal conditions in which clinicians are currently analyzing the patient's behavior. This paper presents the WIISEL platform and results obtained through the use of the first full-wireless insole devices that can measure almost all gait related data directly on the feet (not in the upper part of the body as most existing wearable solutions). The platform consists of a complete tool-chain: insoles, smartphone & app, server & analysis tool, FRI estimation and user access. Results are obtained by combining parameters in a personalized way to build individual fall risk index assessed by experts with the help of data analytics. New FRI has been compared with standards that validate the quality of its prediction in a statistically significant way. That qualitatively relevant information is being provided to the platform users, being either end-users/patients, relatives or caregivers and the related clinicians to ideally assess about their long term evolution.

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.

A Multi-Stage Human Factors and Comfort Assessment of Instrumented Insoles Designed for Use in a Connected Health Infrastructure.

Wearable electronics are gaining widespread use as enabling technologies, monitoring human physical activity and behavior as part of connected health infrastructures. Attention to human factors and comfort of these devices can greatly positively influence user experience, with a subsequently higher likelihood of user acceptance and lower levels of device rejection. Here, we employ a human factors and comfort assessment methodology grounded in the principles of human-centered design to influence and enhance the design of an instrumented insole. A use case was developed and interrogated by stakeholders, experts, and end users, capturing the context of use and user characteristics for the instrumented insole. This use case informed all stages of the design process through two full design cycles, leading to the development of an initial version 1 and a later version 2 prototype. Each version of the prototype was subjected to an expert human factors inspection and controlled comfort assessment using human volunteers. Structured feedback from the first cycle of testing was the driver of design changes implemented in the version 2 prototype. This prototype was found to have significantly improved human factors and comfort characteristics over the first version of the prototype. Expert inspection found that many of the original problems in the first prototype had been resolved in the second prototype. Furthermore, a comfort assessment of this prototype with a group of young healthy adults showed it to be indistinguishable from their normal footwear. This study demonstrates the power and effectiveness of human factors and comfort assessment methodologies in influencing and improving the design of wearable devices.

Patients' views and experiences of technology based self-management tools for the treatment of hypertension in the community: A qualitative study.

BACKGROUND: Patients with hypertension in the community frequently fail to meet treatment goals. The optimal way to organize and deliver care to hypertensive patients has not been clearly identified. The powerful on-board computing capacity of mobile devices, along with the unique relationship individuals have with newer technologies, suggests that they have the potential to influence behaviour. However, little is known regarding the views and experiences of patients using such technology to self-manage their hypertension and associated lifestyle behaviours. The aim of this study was to explore patients' views and experiences of using technology based self-management tools for the treatment of hypertension in the community. METHODS: This focus group study was conducted with known hypertensive patients over 45 years of age who were recruited in a community setting in Ireland. Taped and transcribed semi-structured interviews with a purposeful sample involving 50 participants in six focus groups were used. Framework analysis was utilized to analyse the data. RESULTS: Four key inter-related themes emerged from the analysis: individualisation; trust; motivation; and communication. The globalisation of newer technologies has triggered many substantial and widespread behaviour changes within society, yet users are unique in their use and interactions with such technologies. Trust is an ever present issue in terms of its potential impact on engagement with healthcare providers and motivation around self-management. The potential ability of technology to influence motivation through carefully selected and tailored messaging and to facilitate a personalised flow of communication between patient and healthcare provider was highlighted. CONCLUSIONS: Newer technologies such as mobile devices and the internet have been embraced across the globe despite technological challenges and concerns regarding privacy and security. In the design and development of technology based self-management tools for the treatment of hypertension, flexibility and security are vital to allow and encourage patients to customise, personalise and engage with their devices.

Human centred design considerations for connected health devices for the older adult.

Connected health devices are generally designed for unsupervised use, by non-healthcare professionals, facilitating independent control of the individuals own healthcare. Older adults are major users of such devices and are a population significantly increasing in size. This group presents challenges due to the wide spectrum of capabilities and attitudes towards technology. The fit between capabilities of the user and demands of the device can be optimised in a process called Human Centred Design. Here we review examples of some connected health devices chosen by random selection, assess older adult known capabilities and attitudes and finally make analytical recommendations for design approaches and design specifications.