Expert review of medical devices · 2025
Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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van den Kroonenberg Daniel L, Went Jurre, Jager Auke, Garrido-Utrilla Anna, Trappenburg Jaap C A, Postema Arnoud W, Beerlage Harrie P, Oddens Jorg R
Аннотация
OBJECTIVE: Three-dimensional multiparametric ultrasound (3D mpUS) shows promise for accurately diagnosing prostate cancer. However, its technical complexity presents usability challenges. Human Factor Engineering (HFE) studies the interaction between devices and users, by reducing human error, increasing productivity, and enhancing safety. The objective is to develop a training program for 3D mpUS using HFE (NCT04605276).
METHODS: This study employs a human-centered design approach, a principle of HFE, with a formative and summative phase. In the formative phase, six trainees underwent 3D mpUS training and iteratively provided feedback. The summative phase included 15 trainees who completed the finalized training, probe and ultrasound machine handling, contrast agent (CA) preparation, and conducting 3D mpUS. Performance was evaluated through observing 23 tasks.
RESULTS: Feedback from the formative phase led to several improvements. In the summative phase, all pass criteria were met, most errors were related to CA administration or inadequate acquisition termination. Trainee confidence in independently performing 3D mpUS was high, with 93% of scans meeting quality standards.
CONCLUSION: HFE proved effective in generating feedback to improve the training program for 3D mpUS acquisition. The training ensured that users were well prepared to perform the 3D mpUS procedure with minimal errors and a short learning curve.
METHODS: This study employs a human-centered design approach, a principle of HFE, with a formative and summative phase. In the formative phase, six trainees underwent 3D mpUS training and iteratively provided feedback. The summative phase included 15 trainees who completed the finalized training, probe and ultrasound machine handling, contrast agent (CA) preparation, and conducting 3D mpUS. Performance was evaluated through observing 23 tasks.
RESULTS: Feedback from the formative phase led to several improvements. In the summative phase, all pass criteria were met, most errors were related to CA administration or inadequate acquisition termination. Trainee confidence in independently performing 3D mpUS was high, with 93% of scans meeting quality standards.
CONCLUSION: HFE proved effective in generating feedback to improve the training program for 3D mpUS acquisition. The training ensured that users were well prepared to perform the 3D mpUS procedure with minimal errors and a short learning curve.