Development of a Smart Mobile Data Module for Fetal Monitoring in E-Healthcare.

The fetal heart rate (FHR) is a marker of fetal well-being in utero (when monitoring maternal and/or fetal pathologies) and during labor. Here, we developed a smart mobile data module for the remote acquisition and transmission (via a Wi-Fi or 4G connection) of FHR recordings, together with a web-based viewer for displaying the FHR datasets on a computer, smartphone or tablet. In order to define the features required by users, we modelled the fetal monitoring procedure (in home and hospital settings) via semi-structured interviews with midwives and obstetricians. Using this information, we developed a mobile data transfer module based on a Raspberry Pi. When connected to a standalone fetal monitor, the module acquires the FHR signal and sends it (via a Wi-Fi or a 3G/4G mobile internet connection) to a secure server within our hospital information system. The archived, digitized signal data are linked to the patient's electronic medical records. An HTML5/JavaScript web viewer converts the digitized FHR data into easily readable and interpretable graphs for viewing on a computer (running Windows, Linux or MacOS) or a mobile device (running Android, iOS or Windows Phone OS). The data can be viewed in real time or offline. The application includes tools required for correct interpretation of the data (signal loss calculation, scale adjustment, and precise measurements of the signal's characteristics). We performed a proof-of-concept case study of the transmission, reception and visualization of FHR data for a pregnant woman at 30 weeks of amenorrhea. She was hospitalized in the pregnancy assessment unit and FHR data were acquired three times a day with a Philips Avalon® FM30 fetal monitor. The prototype (Raspberry Pi) was connected to the fetal monitor's RS232 port. The emission and reception of prerecorded signals were tested and the web server correctly received the signals, and the FHR recording was visualized in real time on a computer, a tablet and smartphones (running Android and iOS) via the web viewer. This process did not perturb the hospital's computer network. There was no data delay or loss during a 60-min test. The web viewer was tested successfully in the various usage situations. The system was as user-friendly as expected, and enabled rapid, secure archiving. We have developed a system for the acquisition, transmission, recording and visualization of RCF data. Healthcare professionals can view the FHR data remotely on their computer, tablet or smartphone. Integration of FHR data into a hospital information system enables optimal, secure, long-term data archiving.

Inter and intra-individual differences in steering wheel hand positions during a simulated driving task.

This paper describes an experimental study focusing onto the way drivers use the steering wheel while performing a 2D tracking task. The stimulus during this task was a steering wheel angle signal recorded in real situations involving turns and straight lines performed at about 30 km/h. The hand positions of 20 volunteers were recorded in 6 steering scenarios involving 7 road geometries using a 3D motion capture system. The hand movement data were analysed via a descriptive/inferential procedure: each hand was considered using nine indicators - eight membership value averages linked to eight fuzzy angle windows and a frequency value related to the off steering wheel position - while the indicators were investigated using multiple correspondence analysis and non-parametric global and post-hoc tests. Results showed that inter-individual differences were larger than intra-individual differences. Considering 2 × 9 = 18 windows, the inter-individual differences mainly appeared during two main kinds of steering hand strategies: with versus without crossing hands, the latter being the most often used (17 among 20 participants). The intra-individual data showed that some drivers maintained a nearly identical strategy for all road geometries, while other drivers changed their hand position with the direction and/or maximum angle value of the turn. Practitioner Summary: Understanding hand position strategy could be used to design steering wheel assistance in relation to a driver's physical resources with a view to adapting the steering wheel to disabled drivers.

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).

Randomized controlled open-label trial to evaluate prioritization software for the secondary triage of patients in the pediatric emergency department.

BACKGROUND: The continual increase in patient attendance at the emergency department (ED) is a worldwide health issue. The aim of this study was to determine whether the use of a secondary prioritization software reduces the patients' median length of stay (LOS) in the pediatric ED. METHODS: A randomized, controlled, open-label trial was conducted over a 30-day period between March 15th and April 23rd 2021 at Lille University Hospital. Work days were randomized to use the patient prioritization software or the pediatric ED's standard dashboard. All time intervals between admission and discharge were recorded prospectively by a physician not involved in patient care during the study period. The study's primary endpoint was the LOS in the pediatric ED, which was expected to be 15 min shorter in the intervention group than in the control group. The secondary endpoints were specific time intervals during the stay in the pediatric ED and levels of staff satisfaction. RESULTS: 1599 patients were included: 798 in the intervention group and 801 in the control group. The median [interquartile range] LOS was 172 min [113-255] in the intervention group and 167 min [108-254) in the control group (p = 0.46). In the intervention group, the time interval between admission to the first medical evaluation for high-priority patients and the time interval between the senior physician's final evaluation and patient discharge were shorter (p < 0.01). The median satisfaction score was 68 [55-80] (average). CONCLUSION: The patients' total LOS was not significantly shorter on days of intervention. However, use of the electronic patient prioritization tool was associated with significant decreases in some important time intervals during care in the pediatric ED. CLINICALTRIALS: gov: NCT05994196 Trial registration number: NCT05994196. Date of registration: August 16th, 2023.

Detectability of use errors in summative usability tests of medical devices: Impact of the test environment.

The regulations on summative usability evaluations of medical devices (MDs) emphasize that the test environment must have sufficient ecological validity for generalization to real-life use. Here, we examined the influence of environmental fidelity (a component of ecological validity) on the detectability of MD use errors. A total of 140 participants participated in a summative usability evaluation of an anaphylactic shock auto-injector device under either a high-fidelity condition or a condition acceptable from the manufacturer's perspective, lower-fidelity condition. The numbers of errors detected in each condition were compared by applying descriptive statistics and logistic and Poisson multivariate regressions. We found that the level of fidelity did not influence the overall number of use errors detected but did influence the detection of certain use errors. To optimize the test environment and increase the detection of use errors, each environmental feature's role in the test task should first be examined.

Integration of a new technology into a work system: a case study of a smart drinking glass in French nursing homes.

PURPOSE: To reduce the risk of dehydration in older adults, the French company Auxivia has developed a smart drinking glass (SDG) that can measure the amount of water drunk. The present study looked at the various work systems (WSs) designed for use of the SDG in a nursing home. The study's objectives were to (i) determine the WSs' impact on the staff's ability to comply with the device's prerequisites and ensure the device's effective use and (ii) draw up guidelines on designing work systems. MATERIALS AND METHODS: At three nursing homes in France, two independent observers performed 9 h of observations at each site and a total of 29 interviews. RESULTS: Decisions concerning implementation and the resulting WSs have an impact on the tasks to be performed, the tasks' inherent constraints and the use of the SDG. It is essential to take account of the sociotechnical system as a whole before integrating a technology. Ideally, the introduction of an SDG will go unnoticed by staff and residents; however, our results emphasize the value of highlighting work constraints via a human factors analysis. CONCLUSIONS: It is essential to take account of sociotechnical WSs as a whole when integrating a technology.Implications for rehabilitationFor caregivers, better measurement of the amount of water drunk by older adults might help to prevent dehydration.For service providers, better knowledge of how work systems influence the nursing home staff's ability to comply with the smart drinking glass's prerequisites might improve the device implementation process.For managers, a nursing home's work systems should take account of the smart drinking glass's prerequisites on one hand and the home's environment and constraints on the other.

Improving Parents' Experience in the Pediatric Emergency Waiting Room: Researching the Most Optimal Design for an Information Tool.

To improve parents' experience in the pediatric emergency waiting room by means of an information tool, the information needs of parents and pediatric patients need to be determined. It is necessary to find an optimal design for the information needed to be understandable by and useful to the parents. This paper presents the first step of designing an information tool aiming to improve patient/parent experience, encourage the understanding of the care process, and optimize the patient-caregiver relationship. In order to acquire insight into parents' information needs, exploratory interviews were conducted and benchmark research had been performed. Furthermore, one focus group session with parents was conducted to identify their information needs, determine the format of the information tool, and visualize the best ideas by using paper mock-ups. The focus group concluded that parents prefer an information screen to a smartphone application. The designed mock-up visualizes and explains the care process, and represents one's position in the waiting queue. The mock-up was evaluated through questionnaires.

Specifications for the Routine Implementation of Federated Learning in Hospitals Networks.

We collected user needs to define a process for setting up Federated Learning in a network of hospitals. We identified seven steps: consortium definition, architecture implementation, clinical study definition, data collection, initialization, model training and results sharing. This process adapts certain steps from the classical centralized multicenter framework and brings new opportunities for interaction thanks to the architecture of the Federated Learning algorithms. It is open for completion to cover a variety of scenarios.

Competitive Usability Evaluation of Electronic Health Records: Preliminary Results of a Case Study.

It is necessary for hospitals to be able to compare the usability of electronic health records (EHR) before acquisition. Adding usability as a critical element of the procurement process is therefore crucial. During the competitive usability evaluation of several EHRs, the usability walkthrough method has the potential of making end-users more active in the procurement process than demonstrations. This case study presents first results of a comparison of three EHRs performed by nine representative end-users. All users uncovered usability problems while performing their scenarios. The results show that none of the EHRs evaluated is without major usability problems. These problems have been well-known to human factors researchers for a long time.

Aero-Sim: A User-Centred Testbed for the Evaluation of Devices as Protection from Droplets and/or Aerosol Contaminations.

Concerns over high transmission risk of SARS-CoV-2 have led to innovation and usage of an aerosol box to protect healthcare workers during airway intubation in patients with COVID-19. However, only a few studies have examined the impact of these aerosol boxes on the dispersion of droplets and aerosols, which are both thought to be significant contributors to the spread of COVID-19. In addition, to our knowledge, only a few studies have included in the concerned testbeds elements of the work context, which nevertheless have an impact on the use of the device.

Applying a Human-Centered Design to Develop a Patient Prioritization Tool for a Pediatric Emergency Department: Detailed Case Study of First Iterations.

BACKGROUND: Overcrowding in the emergency departments has become an increasingly significant problem. Patient triage strategies are acknowledged to help clinicians manage patient flow and reduce patients' waiting time. However, electronic patient triage systems are not developed so that they comply with clinicians' workflow. OBJECTIVE: This case study presents the development of a patient prioritization tool (PPT) and of the related patient prioritization algorithm (PPA) for a pediatric emergency department (PED), relying on a human-centered design process. METHODS: We followed a human-centered design process, wherein we (1) performed a work system analysis through observations and interviews in an academic hospital's PED; (2) deduced design specifications; (3) designed a mock PPT and the related PPA; and (4) performed user testing to assess the intuitiveness of the icons, the effectiveness in communicating patient priority, the fit between the prioritization model implemented and the participants' prioritization rules, and the participants' satisfaction. RESULTS: The workflow analysis identified that the PPT interface should meet the needs of physicians and nurses, represent the stages of patient care, and contain patient information such as waiting time, test status (eg, prescribed, in progress), age, and a suggestion for prioritization. The mock-up developed gives the status of patients progressing through the PED; a strip represents the patient and the patient's characteristics, including a delay indicator that compares the patient's waiting time to the average waiting time of patients with a comparable reason for emergency. User tests revealed issues with icon intuitiveness, information gaps, and possible refinements in the prioritization algorithm. CONCLUSIONS: The results of the user tests have led to modifications to improve the usability and usefulness of the PPT and its PPA. We discuss the value of integrating human factors into the design process for a PPT for PED. The PPT/PPA has been developed and installed in Lille University Hospital's PED. Studies are carried out to evaluate the use and impact of this tool on clinicians' situation awareness and prioritization-related cognitive load, prioritization of patients, waiting time, and patients' experience.

Impact of Work Organization on Technology Use: The Case of Hydration Process with a Smart Drinking Glass.

This paper presents preliminary results from a larger project led with the French company Auxivia. The latter offers a smart drinking glass (SDG), supporting monitoring daily water intakes of elderly people and helping identify residents to encourage. Contexts and work organizations can deeply differ from a nursing home to another and can impact the use of the SDG. Based on a comparison between two nursing homes, we unveil the impact of both work organizations on the integration of technology requirements. We discuss the results by providing recommendations to improve the integration of SDGs in various work organizations.

Lessons Learned from Implementing a Patient Prioritization Tool Designed with End-Users in a Pediatric Emergency Ward.

INTRODUCTION: Overcrowding is a common problem in emergency departments. This is true for adult and pediatric emergency department (PED) and issues are potentially important (e.g. quality of care, financial, social, ethical). Optimum is one among several solutions implemented to fight this phenomenon. It is an electronic patient prioritization tool for PED devoted to non-vital emergencies. First usage assessments reported the tool was not used by the PED staffs despite their strong involvement during the development. AIM: This paper aims at understanding why the PED staff did not use the Optimum system that has been designed with them and for them, through a user-centered design process. METHOD: PED staffs answered answer a short survey about their usage of Optimum. Depending on their answer (user vs. non-user), they either underwent an individual semi-structured interview or an unstructured one. Interviews were audio-recorded and transcribed and, from each interview, meaningful semantic units representing the reasons for using/non-using Optimum were extracted and organized iteratively following a grounded approach by three ergonomics experts till a consensus was reached. RESULTS: 12 interviews have been performed with 6 physicians, 5 nurses and 1 auxiliary nurse. Overall, the prioritization tool Optimum have received a mixed response from the PED staff: Optimum display is neither understood nor trusted by users. Moreover, it is mainly used to estimate the PED attendance rate and not to prioritize patients. DISCUSSION: This study shows how much it is difficult to implement new tool in wards despite a user-centered development and without being included in the daily used patient management tool.

Building Usability Knowledge for Health Information Technology: A Usability-Oriented Analysis of Incident Reports.

BACKGROUND: The contribution of usability flaws to patient safety issues is acknowledged but not well-investigated. Free-text descriptions of incident reports may provide useful data to identify the connection between health information technology (HIT) usability flaws and patient safety. OBJECTIVES: This article examines the feasibility of using incident reports about HIT to learn about the usability flaws that affect patient safety. We posed three questions: (1) To what extent can we gain knowledge about usability issues from incident reports? (2) What types of usability flaws, related usage problems, and negative outcomes are reported in incidents reports? (3) What are the reported usability issues that give rise to patient safety issues? METHODS: A sample of 359 reports from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database was examined. Descriptions of usability flaws, usage problems, and negative outcomes were extracted and categorized. A supplementary analysis was performed on the incidents which contained the full chain going from a usability flaw up to a patient safety issue to identify the usability issues that gave rise to patient safety incidents. RESULTS: A total of 249 reports were included. We found that incident reports can provide knowledge about usability flaws, usage problems, and negative outcomes. Thirty-six incidents report how usability flaws affected patient safety (ranging from incidents without consequence, to death) involving electronic patient scales, imaging systems, and HIT for medication management. The most significant class of involved usability flaws is related to the reliability, the understandability, and the availability of the clinical information. CONCLUSION: Incidents reports involving HIT are an exploitable source of information to learn about usability flaws and their effects on patient safety. Results can be used to convince all stakeholders involved in the HIT system lifecycle that usability should be considered seriously to prevent patient safety incidents.

User Driven Design: First Step in Involving Healthcare Consumers and Clinicians in Developing a Collaborative Platform to Prevent Cardiovascular Diseases.

To prevent cardiovascular diseases, eHealth solutions may be used as tools, involving health care consumers in the set-up of their prevention plan, a fundamental condition for improving their long-term adherence to the plan. This paper presents the first step in a web platform design aiming to support the co-elaboration by health care consumers and clinicians of personalized prevention plans. Applying a user driven innovation approach, first, a questionnaire and semi-structured interviews were combined to identify clinicians' needs. Then, three focus group sessions with consumers and clinicians were organized to identify their needs, creating the system workflows, its graphical user interface, and its navigation paths, with the best ideas shaped by paper mockups. An interactive mockup was designed including 30 screens (ex. user dashboards, desk for co-elaborating plan). This user driven approach enabled to design not only the technology and its graphical user interface, but also a prevention plan design process.

Preliminary Evaluation of an Electronic Patient Prioritization Tool for Pediatric Emergency Department.

The study presents the evaluation of the reliability of the information displayed on the user interface of a homegrown electronic patient prioritization tool dedicated to pediatric emergency department (namely Optimum). Two ergonomists shadowed physicians and nurses throughout their shift in order to (i) identify consistencies and discrepancies between the actual step of the patients in the care process and their assigned step in Optimum and (ii) to understand the causes of the discrepancies. Even if some discrepancies are noted, results show that Optimum provides a quite good reflection of the actual position of the patients in the care process. The use of ethnographic methods allows to understand the cause of the discrepancies.

Usability Validation of Medical Devices: Issues in Identifying Potential Use Errors.

In order to prevent use errors with their medical devices, manufacturers have to integrate a safety-oriented usability engineering process in their product development lifecycle. A critical step of this process is the identification of potential use-errors. Standards and guidelines recommend to triangulate several sources of information e.g. scientific literature, incident reports, manufacturer's files and user's feedbacks. This paper presents lessons learned from applying these recommendations during an international project. We identify issues with (i) searching literature and databases, and (ii) interpreting collected data. Nevertheless triangulation of information sources allows to identify different types of use errors therefore providing valuable lists of potential use errors. Issuing recommendations aim at making easier this critical task.

Methodology to automatically detect abnormal values of vital parameters in anesthesia time-series: Proposal for an adaptable algorithm.

Abnormal values of vital parameters such as hypotension or tachycardia may occur during anesthesia and may be detected by analyzing time-series data collected during the procedure by the Anesthesia Information Management System. When crossed with other data from the Hospital Information System, abnormal values of vital parameters have been linked with postoperative morbidity and mortality. However, methods for the automatic detection of these events are poorly documented in the literature and differ between studies, making it difficult to reproduce results. In this paper, we propose a methodology for the automatic detection of abnormal values of vital parameters. This methodology uses an algorithm allowing the configuration of threshold values for any vital parameters as well as the management of missing data. Four examples illustrate the application of the algorithm, after which it is applied to three vital signs (heart rate, SpO2, and mean arterial pressure) to all 2014 anesthetic records at our institution.

Design and evaluation of a patient website to reduce crowding in emergency departments: a preliminary study.

The study aims to identify the information useful to support a patients' EDs' choice in order to design a patient Web-based system. For that purpose, a focus group and a formative user test have been performed. The results show that five types of information can be relevant. The spontaneous favored information is the "distance" to EDs. The "Wait time", that is sanctified in literature, is only used in a second time. A larger summative evaluation should be planned to evaluate and validate the befits of this kind of tool.