Systematic Improvement of a Bolus Calculator That Is on the Market: A User-Centric Approach.

BACKGROUND: State-of-the-art diabetes self-management includes the usage of (software) tools, such as Bolus Calculators, to support patients with their therapeutic decisions. The development of such medical devices comes with strict obligations to ensure the safety and performance for the user; however, it is also necessary to continue to evaluate such aspects after the products are introduced into the market. In addition, such aspects cannot always be sufficiently validated by clinical trials; they need real-world evaluation to systematically improve such tools while they are on the market. METHODS: The approach described here uses innovative ways of generating user-centric evidence to improve the bolus calculator, including (1) human factor engineering, (2) analysis of glycemic real-world data, (3) patient-reported outcomes, and (4) machine-generated behavioral measurements. RESULTS: The combination of the diverse techniques to optimize the bolus calculator triggered changes in the user experience: a significant reduction in hypoglycemic events, -0.52% (±0.05), P < .01, n=3480, an increased diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire [DTSQ] +9.90, P < .01, n=217), as well as an increased acceptance rate of bolus calculations, +15.73 (±0.89), P < .01, n=3436, were observed. CONCLUSIONS: Altogether, human factor engineering and different forms of real-world data support fast and direct adaptations and improvements in products used for diabetes therapy.

The Development of the Smartphone Proficiency Questionnaire for Chinese Older Adults (SPQ-COA).

While mobile technology is rapidly evolving, it remains a challenge for some older adults to use smartphones worldwide. To address this issue through tailored skill training and product design, this study developed a questionnaire to assess the smartphone proficiency of older adults. The Smartphone Proficiency Questionnaire for Chinese Older Adults (SPQ-COA) assessed proficiency based on 30 up-to-date tasks (e.g., mobile payment), that covered common operations in daily life of Chinese older adults. The questionnaire was distributed to 452 older adults (age ≥60), as well as 100 young adults (age: 18-30) as a control group. The questionnaire performed well in terms of reliability, difficulty, and discrimination. Among older adults, higher scores were associated with lower age, longer daily use duration, more years of use, higher monthly income, and higher education level, further validating the questionnaire. Overall, the SPQ-COA is a valid tool for evaluating Chinese older adults' smartphone usage skills.

Addressing human factors in the recognition and management of local anaesthetic systemic toxicity.

In the perioperative environment, local anaesthetics are commonly administered to patients to provide analgesia and anaesthesia for a large range of surgical procedures. Although rare, their use can result in systemic toxicity, which is a life-threatening complication, underscoring the importance of early recognition and prompt management to mitigate patient risks. This article evaluates the impact of human factors and other aspects such as insufficient monitoring, errors in drug administration and poor adherence to safety protocols on the development and management of local anaesthetic systemic toxicity and provides practical considerations to minimise its occurrence.

Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols.

OBJECTIVE: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice? METHODS: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them. RESULTS: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients. CONCLUSION: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).

Improving the introduction of telemedicine in pre-hospital emergency medicine: understanding users and how acceptability, usability and effectiveness influence this process.

INTRODUCTION: Increasing numbers of ambulance calls, vacant positions and growing workloads in Emergency Medicine (EM) are increasing the pressure to find adequate solutions. With telemedicine providing health-care services by bridging large distances, connecting remote providers and even patients while using modern communication technologies, such a technology seems beneficial. As the process of developing an optimal solution is challenging, a need to quantify involved processes could improve implementation. Existing models are based on qualitative studies although standardised questionnaires for factors such as Usability, Acceptability and Effectiveness exist. METHODS: A survey was provided to participants within a German county. It was based on telemedical surveys, the System Usabilty Scale (SUS) and earlier works describing Usability, Acceptability and Effectiveness. Meanwhile a telemedical system was introduced in the investigated county. A comparison between user-groups aswell as an exploratory factor analysis (EFA) was performed. RESULTS: Of n = 91 included participants n = 73 (80,2%) were qualified as emergency medical staff (including paramedics n = 36 (39,56%), EMTs n = 28 (30,77%), call handlers n = 9 (9,89%)) and n = 18 (19,8%) as emergency physicians. Most participants approved that telemedicine positively impacts EM and improved treatment options with an overall Usabilty Score of 68,68. EFA provided a 3-factor solution involving Usability, Acceptability and Effectiveness. DISCUSSION: With our results being comparable to earlier studies but telemedicine only having being sparsely introduced, a positive attitude could still be attested. While our model describes 51,28% of the underlying factors, more research is needed to identify further influences. We showed that Usability is correlated with Acceptability (strong effect), Usability and Effectiveness with a medium effect, likewise Acceptability and Effectiveness. Therefore available systems need to improve. Our approach can be a guide for decision makers and developers, that a focus during implementation must be on improving usability and on a valid data driven implementation process.

The Chartered Institute of Ergonomics and Human Factors at 75: perspectives on contemporary challenges and future directions for Ergonomics and Human Factors.

As the UK's Chartered Institute of Ergonomics and Human Factors (CIEHF) celebrates its 75th anniversary, it is worth reflecting on our discipline's contribution, current state, and critical future endeavours. We present the perspectives of 18 EHF professionals who were asked to respond to five questions regarding the impact of EHF, contemporary challenges, and future directions. Co-authors were in agreement that EHF's impact has been only limited to date and that critical issues require resolution, such as increasing the number of suitably qualified practitioners, resolving the research-practice gap, and increasing awareness of EHF and its benefits. Frequently discussed future directions include advanced emerging technologies such as artificial intelligence, the development of new EHF methods, and enhancing the quality and reach of education and training. The majority felt there will be a need for EHF in 75 years; however, many noted that our methods will need to adapt to meet new needs.Practitioner statement: This article provides the perspectives of 18 Ergonomics and Human Factors (EHF) professionals on the impact of EHF, contemporary challenges and critical future directions, and changes that are necessary to ensure EHF remains relevant in future. As such, it provides important guidance on future EHF research and practice.

Re-imagining the future state of the ventricular assist device controller interface through human-centered design.

BACKGROUND: Ventricular assist devices (VADs) are effective therapy for patients with end-stage heart failure. Current VAD controllers offer improved interactivity, yet limitations of the visual, tactile, and auditory interface persist that impact patient experience and quality of life (QoL). This study explores how VAD controllers can be redesigned using a human-centered design approach to enhance the emotional and functional experience of the device for patients. METHODS: VAD patients (n = 21), caregivers (n = 4) and healthcare practitioners (n = 24) were interviewed to uncover design opportunities. From this, a series of realistic scenarios to design for emerged. A "design by analogy" method took inspiration from existing consumer products to ideate new functionality for the VAD wearable system, creating concepts for a controller interface and paired wearable device. An additional 15 patients and 2 caregivers were engaged to explore current VAD controller experiences and evaluate the future-state concepts. RESULTS: This research validated the need for increased automation and emergency functionality in VAD controllers, including remote monitoring of data, accurate communication of battery status, and automated medical alerts for critical device alarms. "Manage my health," "Feeling normal," "Social belonging," "Feeling safe," and "Sense of control" emerged as key patient concerns to be met by future VAD controller designs. CONCLUSIONS: The study demonstrated an innovative and relevant approach to improve usability of future VAD peripherals. By considering both emotional and functional perspectives in the design of lifesaving medical devices such as VADs, device manufacturers can uncover new opportunities to improve patient QoL through improved user experiences.

Faces of Oppression: Future directions for Ergonomics and Human Factors.

The growing interest in Diversity, Equity, and Inclusion (DEI) centred work in the field of Ergonomics and Human Factors (EHF) can greatly benefit from Iris Young's Five Faces of Oppression theory, which details how well-intentioned systems can perpetuate harm in a number of ways. We call for a greater focus on systems of oppression in EHF research and practice along with increased collaboration with social sciences to tackle important societal issues. This article reviews the current state of research in the child welfare domain and provides examples for how cognitive engineering approaches can take inspiration from the social sciences to help create a more equitable future. These examples outline the potential mutualism between social sciences and EHF and the way this collaboration might dismantle various oppressive systems.

EHF work is often situated within sociotechnical systems that can generate oppression, or injustices imposed on social groups by societal structures. This publication shows the value that social science frameworks and literature can bring to EHF practice by supporting a more nuanced understanding of these systems of oppression.

Human Factors in AI-Driven Digital Solutions for Increasing Physical Activity: Scoping Review.

BACKGROUND: Artificial intelligence (AI) has the potential to enhance physical activity (PA) interventions. However, human factors (HFs) play a pivotal role in the successful integration of AI into mobile health (mHealth) solutions for promoting PA. Understanding and optimizing the interaction between individuals and AI-driven mHealth apps is essential for achieving the desired outcomes. OBJECTIVE: This study aims to review and describe the current evidence on the HFs in AI-driven digital solutions for increasing PA. METHODS: We conducted a scoping review by searching for publications containing terms related to PA, HFs, and AI in the titles and abstracts across 3 databases-PubMed, Embase, and IEEE Xplore-and Google Scholar. Studies were included if they were primary studies describing an AI-based solution aimed at increasing PA, and results from testing the solution were reported. Studies that did not meet these criteria were excluded. Additionally, we searched the references in the included articles for relevant research. The following data were extracted from included studies and incorporated into a qualitative synthesis: bibliographic information, study characteristics, population, intervention, comparison, outcomes, and AI-related information. The certainty of the evidence in the included studies was evaluated using GRADE (Grading of Recommendations Assessment, Development, and Evaluation). RESULTS: A total of 15 studies published between 2015 and 2023 involving 899 participants aged approximately between 19 and 84 years, 60.7% (546/899) of whom were female participants, were included in this review. The interventions lasted between 2 and 26 weeks in the included studies. Recommender systems were the most commonly used AI technology in digital solutions for PA (10/15 studies), followed by conversational agents (4/15 studies). User acceptability and satisfaction were the HFs most frequently evaluated (5/15 studies each), followed by usability (4/15 studies). Regarding automated data collection for personalization and recommendation, most systems involved fitness trackers (5/15 studies). The certainty of the evidence analysis indicates moderate certainty of the effectiveness of AI-driven digital technologies in increasing PA (eg, number of steps, distance walked, or time spent on PA). Furthermore, AI-driven technology, particularly recommender systems, seems to positively influence changes in PA behavior, although with very low certainty evidence. CONCLUSIONS: Current research highlights the potential of AI-driven technologies to enhance PA, though the evidence remains limited. Longer-term studies are necessary to assess the sustained impact of AI-driven technologies on behavior change and habit formation. While AI-driven digital solutions for PA hold significant promise, further exploration into optimizing AI's impact on PA and effectively integrating AI and HFs is crucial for broader benefits. Thus, the implications for innovation management involve conducting long-term studies, prioritizing diversity, ensuring research quality, focusing on user experience, and understanding the evolving role of AI in PA promotion.

Implementation and adoption of SOAP-M and SBAR at a German anesthesiology department - a single-center survey study.

BACKGROUND: Checklists are a common tool used in order to mitigate risks caused by human factors and can facilitate the safe induction of anesthesia as well as handovers. SBAR (Situation, Background, Assessment, Recommendation) is a checklist recommended by the WHO and DGAI for handovers, while SOAP-M (Suction, Oxygen, Airway, Pharmaceuticals, Monitoring) is a checklist for the induction of anesthesia. This study investigates the implementation and adoption of these two checklists. METHODS: We conducted a single-center online survey one year after the implementation of SOAP-M and SBAR at a university hospital's anesthesiology department, using scales from three validated questionnaires to assess safety attitudes as well as the behavior of staff and the perceived usefulness of the checklists. RESULTS: Staff with a high score in general attitude towards patient safety, as determined by the safety attitudes questionnaire, considered both checklists useful additions to their work environment. Nurses and physicians (p = 0.102) as well as groups divided according to work experience (p = 0.077) showed no significant differences in using SOAP-M and SBAR. Perceived usefulness was significantly higher (p < 0.001) among users of the checklists, and the same goes for positive reinforcement (p < 0.001), social cues (p = 0.0215) and goal cues (p = 0.0252). CONCLUSION: SOAP-M and SBAR are perceived as useful checklists for patient handovers and anesthesia induction by tertiary referral hospital's employees with high score in general safety attitude and were therefore commonly used one year after their introduction. No significant difference in checklist adoption between occupations as well as groups divided according to work experience could be found. Perceived usefulness is significantly higher among users of the checklist, who feel using the checklists provides more support.

Influences of Vehicle Communication on Human Driving Reactions: A Simulator Study on Reaction Times and Behavior for Forensic Accident Analysis.

Cooperative intelligent transport systems (C-ITSs) are mass-produced and sold in Europe, promising enhanced safety and comfort. Direct vehicle communication, known as vehicle-to-everything (V2X) communication, is crucial in this context. Drivers receive warnings about potential hazards by exchanging vehicle status and environmental data with other communication-enabled vehicles. However, the impact of these warnings on drivers and their inclusion in accident reconstruction remains uncertain. Unlike sensor-based warnings, V2X warnings may not provide a visible reason for the alert, potentially affecting reaction times and behavior. In this work, a simulator study on V2X warnings was conducted with 32 participants to generate findings on reaction times and behavior for accident reconstruction in connection with these systems. Two scenarios from the Car-2-Car Communication Consortium were implemented: "Stationary Vehicle Warning-Broken-Down Vehicle" and "Dangerous Situation-Electronic Emergency Brake Lights". Volkswagen's warning concept was utilized, as they are the sole provider of cooperative vehicles in Europe. Results show that V2X warnings without visible reasons did not negatively impact reaction times or behavior, with average reaction times between 0.58 s (steering) and 0.69 s (braking). No significant distraction or search for warning reasons was observed. However, additional information in the warnings caused confusion and was seldom noticed by subjects. In this study, participants responded correctly and appropriately to the shown false-positive warnings. A wrong reaction triggering an accident is possible but unlikely. Overall, V2X warnings showed no negative impacts compared with sensor-based systems. This means that there are no differences in accident reconstruction regarding the source of the warning (sensors or communication). However, it is important that it is known that there was a warning, which is why the occurrence of V2X warnings should also be saved in the EDR in the future.

Human Factors Validation of a Wearable, On-Body Infusor for Subcutaneous Administration of Furosemide.

Purpose: Furoscix® (subcutaneous furosemide) is administered using a wearable On-Body Infusor (OBI) and is approved for the treatment of congestion associated with heart failure (HF). The purpose of this study was to assess the safe and effective use of the OBI and Instructions for Use (IFU) by patients with HF, caregivers, and healthcare practitioners (HCPs). Methods: Sixty participants (patients, n=30; caregivers, n=15; HCPs, n=15) were evaluated on completion of OBI use tasks and IFU knowledge tasks in a simulated use environment. Fifteen of the patients received OBI/IFU training before evaluation. Results: Overall, 893/900 (99.2%) use tasks and 2211/2220 (99.6%) knowledge tasks were completed successfully, without differences due to training. The most common (n=6) use error was failure to wipe skin or cartridge tip with an alcohol wipe. Errors were due to forgetfulness/misinterpretation rather than IFU clarity. Conclusion: The subcutaneous furosemide OBI can be safely and effectively used by patients, caregivers, and HCPs, regardless of training.

Development of an evidence-based swimming representative military task to assess swimming competency in the British Army.

BACKGROUND: There is a requirement for British Army personnel to operate in/around water. Assessing role-related swimming/water competence will support personnel to conduct their job-roles safely and effectively. OBJECTIVE: To undertake a Job-Task Analysis (JTA) of British Army personnel when working in/around water and use this information to develop a Swimming Representative Military Task (RMT) to assess swimming/water competence. METHODS: Workshops, surveys, and observations were used to conduct a JTA, which identified and described job-tasks conducted by British Army personnel in/around water. Ergonomic analysis of these job-tasks identified seven water-based physical actions, which were considered fundamental for all personnel to be competent in performing. These seven actions guided design of a Swimming RMT, which was subsequently conducted twice by 103 serving personnel (89 men, 11 women) and once by 65 recruits (49 men, 16 women). RESULTS: The RMT comprised of entering the water in combat fatigues and webbing, removing webbing, swimming 50 m, and staying afloat for up to 10 minutes. During RMT trials, in trial 1, 85% of serving personnel and 74% of recruits successfully completed the RMT, which increased to 93% in serving personnel for trial 2. Across trials 1 and 2, all three timed RMT elements showed moderate-high correlational reliability (ICC range: 0.462-0.791). On average, serving personnel were quicker to complete the 50 m swim phase compared to recruits (91±24 s vs. 100±26 s; U = 2575.0, rb = -0.192, p = 0.039). CONCLUSIONS: The JTA-informed Swimming RMT provides an assessment of the minimum role-related swimming/water competence standard for British Army personnel.

Cognitive biases in pediatric cardiac care.

Medical practitioners are entrusted with the pivotal task of making optimal decisions in healthcare delivery. Despite rigorous training, our confidence in reasoning can fail when faced with pressures, uncertainties, urgencies, difficulties, and occasional errors. Day-to-day decisions rely on swift, intuitive cognitive processes known as heuristic or type 1 decision-making, which, while efficient in most scenarios, harbor inherent vulnerabilities leading to systematic errors. Cognitive biases receive limited explicit discussion during our training as junior doctors in the domain of paediatric cardiology. As pediatric cardiologists, we frequently confront emergencies necessitating rapid decision-making, while contending with the pressures of stress, fatigue, an earnest interest in "doing the right thing" and the impact of parental involvement. This article aims to describe cognitive biases in pediatric cardiology, highlighting their influence on therapeutic interventions for congenital heart disease. Whether future pediatric cardiologists or experienced professionals, understanding and actively combating cognitive biases are essential components of our ongoing medical education. Furthermore, it is our responsibility to thoroughly examine our own practices in our unwavering commitment to providing high-quality care.

Evaluating current and future pedestrian mid-block crossing safety treatments using virtual reality simulation.

Virtual reality (VR) simulation offers a proactive, cost effective, immersive, and low risk platform for studying pedestrian safety. Within immersive virtual environments (IVEs), existing and alternative design conditions and intelligent transportation systems (ITS) technologies can be directly compared, prior to real-world implementation, to assess the impacts alternatives may have on pedestrian safety, perception, and behavior. Environmental factors can be controlled within IVEs so that test trials are replicable and directly comparable. Coupled with stated preference feedback, participants' observed preferences and behavior provide a comprehensive understanding of the impacts of proposed design alternatives. This research presents a case study of pedestrian behavior with three different mid-block crossing safety treatments modeled within a one-to-one scale IVE replication of a real-world location in Charlottesville, Virginia. The three safety treatments consider both passive and active collision avoidance designs and technologies, including (1) the existing painted crosswalk, (2) the addition of rectangular rapid flashing beacons (RRFBs), and (3) a pedestrian to everything (P2X) ITS phone application. Additionally, this paper demonstrates a VR simulation experimental design and framework for testing pedestrian safety treatments within naturalistic and replicable IVEs to assess both stated and observed preferences and behaviors of pedestrians. Repeated measures ANOVA indicated changes in both accepted gap size (p = 0.001) and crossing speed (p < 0.001) with alternative safety treatments. Generalized mixed models showed that pedestrians waited for statistically larger gap sizes (p = 0.02) without the assistance of alternative safety technologies (RRFBs and P2X application) and pedestrians crossed the street significantly faster (p = 0.001) without the alternative safety technologies, leading to unsafe dashing behavior. Through post-experiment surveys, it was found that participants perceived the As Built environment to be the least safe of the three treatments and that their sense of risk within the IVE was realistic. Considering both the observed crossing behavior and stated feedback, pedestrians exhibited intentionally unsafe darting behavior without assistive safety technology. This study demonstrates how VR simulation may be leveraged to study both stated preferences and observed behavior for understanding the safety implications of alternative roadway designs, providing a proactive approach for assessing and designing for pedestrian safety.

Incorporating a Hands-On Device-Based Activity in a Human Factors Biomedical Engineering Course in Sub-Saharan Africa.

A challenge in building the biomedical engineering human factors course at Malawi University of Business and Applied Sciences was integrating meaningful direct experiences with medical products. The instructor also noticed a significant gap between the topics in the course and their surrounding clinical context, a low-income setting. Recognizing that devices should be designed and evaluated in the context of the local users' needs and situations, new hands-on modules were created and implemented in this BME human factors course. Students were asked to critically evaluate and make recommendations to improve the human factors aspects of the software and hardware of the IMPALA, a vital signs monitoring device developed for use in Malawi. Engaging with this medical device, students observed and understood many issues discussed in human factors, including the design of ports, controls, and other user interfaces. The collaboration between the course and the IMPALA project harnessed the local expertise of students to improve the design of a new patient monitoring system. Thus, the IMPALA project itself benefited from this collaboration. Second, students greatly benefited from applying the class concepts to the IMPALA. Students were engaged far more during the interactive components than during the lecture components. Many students successfully translated their knowledge on human factors to their final-year design project.