发展三维经直肠前列腺多参数超声训练:人因工程方法。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI:10.1080/17434440.2025.2473632
Daniel L van den Kroonenberg, Jurre Went, Auke Jager, Anna Garrido-Utrilla, Jaap C A Trappenburg, Arnoud W Postema, Harrie P Beerlage, Jorg R Oddens
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引用次数: 0

摘要

目的:三维多参数超声(3D mpUS)有望准确诊断前列腺癌。然而,它的技术复杂性带来了可用性方面的挑战。人为因素工程(HFE)研究设备和用户之间的交互,通过减少人为错误,提高生产力和增强安全性。目标是开发一个使用HFE (NCT04605276)的3D校园培训计划。方法:本研究采用以人为本的设计方法,即HFE原则,分为形成阶段和总结阶段。在形成阶段,六名学员接受了3D校园培训,并反复提供反馈。总结阶段包括15名学员,他们完成了最后的培训;探头和超声机器操作,造影剂(CA)制备,并进行3D mpUS。通过观察23个任务来评估绩效。结果:形成阶段的反馈导致了一些改进。在总结阶段,所有通过标准都得到满足,大多数错误与CA管理或不适当的收购终止有关。学员对独立执行3D mpUS的信心很高,93%的扫描符合质量标准。结论:HFE能够有效地产生反馈,从而改善三维校园信息获取的训练方案。培训确保用户做好充分准备,以最小的错误和短的学习曲线执行3D mpUS程序。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach.

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.

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