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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.
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http://dx.doi.org/10.1016/j.apergo.2024.104266 | DOI Listing |
JMIR Med Educ
September 2025
Faculty of Nursing, University of Calgary, Calgary, AB, Canada.
The integration of digital health and informatics competencies into health care education in Canada is essential for preparing a workforce capable of leveraging health care technologies to enhance care delivery and patient outcomes. Despite significant advancements, the current educational landscape in digital health remains inconsistent, characterized by fragmented curricula and uneven competency attainment. Addressing these gaps requires an innovative reframing of digital health competencies guided by a robust, outcomes-oriented framework.
View Article and Find Full Text PDFAppl Clin Inform
August 2025
Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, United States.
Clinical decision support (CDS) tools in electronic health records (EHRs) often face low uptake due to limited usability, workflow integration, and other implementation issues. We recently designed and implemented the STRATIFY-CDS tool, which calculates a validated risk-prediction model and recommends disposition for emergency department (ED) patients with acute heart failure. Despite applying human-centered design and implementation science strategies, initial utilization in the first 3 months of the STRATIFY-CDS tool was just 3%.
View Article and Find Full Text PDFJMIR Hum Factors
July 2025
Research Center on Aging, Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke, 1036 Rue Belvédère S, Sherbrooke, QC, J1H 4C4, Canada, 1 8197802220 ext 45657.
Background: Aging is associated with various challenges, especially concerning mobility. Transportation planning e-tools are currently available to provide older adults with real-time travel information and help them choose trip options. However, many older adults find them challenging to use, as they are not tailored to their specific needs, such as lack of accessibility to the different means of transportation.
View Article and Find Full Text PDFEar Hear
June 2025
VA Rehabilitation R&D, National Center for Rehabilitative Auditory Research, Portland, Oregon, USA.
Objectives: To examine associations between factors in domains of general health, hearing status, and demography, and subsequent long-term persistence of hearing aid (HA) use. By examining only non-modifiable factors available before HA fitting, we focus on potential indicators of a need for additional clinical effort to achieve satisfactory outcomes.
Design: The initial dataset consisted of Electronic Health Records spanning 2012-2017, for all (731,231) patients with HA orders from U.
J Clin Med
May 2025
Department of Medical Device Engineering and Management, Yonsei University College of Medicine, Seoul 06229, Republic of Korea.
: This study aimed to enhance the usability of patient monitoring systems by integrating the Early Warning Score (EWS) function and improving user interface elements. The EWS function is expected to enable the early detection of acute deterioration and prompt medical intervention, while the optimized design supports rapid decision-making by nursing staff. : Two formative usability evaluations were conducted to identify user requirements and improve the device design.
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