University of Shanghai for Science and Technology, Shanghai, China.
The Ninth People's Hospital Affiliated With the Medical College of Shanghai Jiaotong University, Shanghai, China.
Surg Innov. 2020 Apr;27(2):193-202. doi: 10.1177/1553350619893236. Epub 2020 Jan 10.
HoloLens-based mixed-reality surgical navigation system (MR-SNS) technology has made great progress. However, the methodology for evaluating users' perceptions concerning the safety, comfort, and efficiency of MR-SNS is still in its infancy. This study was intended to develop a method to systematically evaluate an existing MR-SNS system during actual clinical applications. This method differs from other existing methods currently used in industry, education, and device maintenance. Based on analytical hierarchy process theory and ergonomics evaluation methods, in this article, we propose a novel multicriteria evaluation model for a HoloLens-based MR-SNS. The model includes factors such as comfort, safety, and effectiveness, and is performed in an actual clinical application. A comprehensive experimental platform and scoring system that can analyze all indicators was built. The validation test showed no statistically significant differences in the accuracy of the 3 different movement patterns ( = .95, > .05). However, the static pattern showed the best accuracy. In addition, no significant difference ( = .68, > .05) in accuracy was found under 4 kinds of illuminance. A comparison of the results of this evaluation model and the input from experts who use the HoloLens-based MR-SNS in hospitals, indicated that this model has good precision (100%), recall (80%), and F1-measure (88.89%). The results highlighted the full efficacy of the proposed model in determining whether this system can be used in clinical trials to provide indicators for preliminary ex ante feasibility studies. This article describes the lessons learned from conducting this evaluation study of MR-SNS as part of the design process.
基于 HoloLens 的混合现实手术导航系统 (MR-SNS) 技术取得了重大进展。然而，评估用户对 MR-SNS 的安全性、舒适性和效率感知的方法仍处于起步阶段。本研究旨在开发一种方法，以便在实际临床应用中系统地评估现有的 MR-SNS 系统。该方法与目前在工业、教育和设备维护中使用的其他现有方法不同。基于层次分析法理论和人体工程学评价方法，本文提出了一种基于 HoloLens 的新型多准则 MR-SNS 评价模型。该模型包括舒适性、安全性和有效性等因素，并在实际临床应用中进行评估。建立了一个全面的实验平台和评分系统，可以分析所有指标。验证测试表明，3 种不同运动模式的准确性没有统计学差异（ =.95， >.05）。然而，静态模式的准确性最佳。此外，在 4 种照度下，准确性没有显著差异（ =.68， >.05）。该评价模型的结果与医院使用基于 HoloLens 的 MR-SNS 的专家输入进行比较，表明该模型具有良好的精度（100%）、召回率（80%）和 F1 度量（88.89%）。结果表明，该系统可以用于临床试验，为初步事前可行性研究提供指标。本文介绍了在进行这项基于 HoloLens 的 MR-SNS 评价研究过程中学到的经验教训。
