标题：3D打印个体化外固定支具预编程设计模板的初步可用性评估

      作者：邹诚实 1，张弛 2，陈建文 1，李开成 3    1.慈溪市中西医结合医疗健康集团慈溪市中医医院放射科，浙江 宁波 315300；2.慈溪市中西医结合医疗健康集团慈溪市中医医院骨科，浙江 宁波 315300；3.上海交通大学医学院附属第九人民医院海南分院(海南西部中心医院)放射科，海南 儋州 571700

      卷次： 2022年33卷9期

      【摘要】 目的 评估医务人员是否可以在临床实践中有效地使用3D打印个体化外固定支具预编程设计模板来快速制作骨科外固定支具。方法 2020年10月，选取慈溪市中医医院的1名志愿者为研究对象。基于三维扫描仪及开源几何造型引擎的外固定支具建模系统制作的踝关节支具预编程设计模板共包含5个任务：志愿者小腿准备、小腿三维扫描及模型生成、踝关节支具样条曲线和裙边生成、支具面片生成、挖透气孔及放置锁紧装置。所有任务经介绍性演示后，由5名随机选择的医务人员分别完成整个操作过程，最终生成支具模型。依据 ISO 9241-11标准，使用R语言计算有效性和效率、使用单项难易度问题(SEQ)及系统可用性量表(SUS)评价满意度来评估该预编程设计模板的可用性。使用SPSS非参数检验进行统计学分析。结果 用户有效性均超过平均值78.00%，但小腿三维扫描及模型生成的任务有效性仅60.00%为最低，其次是支具面片生成；时间效率0.18目标/min，几乎达到专家效率的一半水平，总体相对效率达到81.30%；用户的任务平均SEQ值为4.80~5.60，且用户间SEQ值比较差异无统计学意义(P>0.05)，但其中得分较低的任务有小腿三维扫描及模型生成、支具面片生成；SUS评分平均为80.50分，高于80.30分的优秀线，且所有用户分数均高于68.00的及格线。结论 3D打印个体化外固定支具预编程设计模板具有良好的可用性，可以让非专业设计人员在合理的时间内轻松直观的设计出产品。
      【关键词】 3D打印；支具；骨科；个体化；可用性；模板
      【中图分类号】 R197.39 【文献标识码】 A 【文章编号】 1003—6350（2022）09—1162—06

Preliminary usability evaluation of pre-programmed design template for individualized 3D printed externalorthoses.
ZOU Cheng-shi 1, ZHANG Chi 2, CHEN Jian-wen 1, LI Kai-cheng 3. 1. Department of Radiology, Cixi IntegratedTraditional Chinese and Western Medicine Medical and Health Group of Cixi Traditional Chinese Medicine Hospital, Ningbo315300, Zhejiang, CHINA; 2. Department of Orthopaedics, Cixi Traditional Chinese Medicine Hospital Cixi IntegratedTraditional Chinese and Western Medicine Medical and Health Group, Ningbo 315300, Zhejiang, CHINA; 3. Department ofRadiology, Hainan Branch, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine(Hainan Western Central Hospital), Danzhou 571700, Hainan, CHINA
【Abstract】 Objective To evaluate whether medical staff can effectively make use of the pre-programmed de-sign template for individualized 3D printed external orthoses, and produce orthopedic external orthoses quickly in clini-cal practice. Methods In October 2020, a volunteer from Cixi Traditional Chinese Medicine Hospital was chosen asthe research object. The pre-programmed design template for 3D printed ankle orthoses is made from an open sourcegeometric modeling engine system for external orthoses modeling based on the 3D scanner. The whole process consistsof five tasks: preparing to scan the calf of the volunteer, 3D scanning and modeling of calf, generating spline curves andskirts of the ankle orthoses, generating orthoses surfaces, digging vents and placing locking devices. After completingthe introductory statements of all tasks, 5 medical personnel were randomly selected to accomplish the task, generatingthe orthoses eventually. The effectiveness and efficiency were calculated using the R language, and the usability of thepre-programmed design template was evaluated using the single easy question (SEQ) and the system usability scale(SUS) based on the ISO 9241-11 standard. SPSS nonparametric test was used to analyze the statistics. Results All ef-fectiveness indicators of each participant exceeded the average value (78.00%). However, the task completion rate of3D scanning and modeling of calf was the lowest (only 60.00% ), followed by generating orthoses surfaces. Thetime-based efficiency was 0.18 goals/min, almost half the level of expert efficiency, and the overall relative efficiencyreached 81.30%. The average task SEQ value of all users was 4.80-5.60, and there was no significant difference in SEQvalue between users (P>0.05). The tasks with relatively low scores included 3D scanning and modeling of calf, generat-ing of orthoses surfaces. The average SUS score was 80.50, which was higher than 80.30 of the excellent score, and thescores of all users were higher than the passing score with a value of 68.00. Conclusion Pre-programmed design templatefor individualized 3D printed external orthoses has high usability, and it can enable nonprofessionals to design products eas-ily in reasonable time.
      【Key words】 3D Printing; Orthoses; Orthopaedics; Individualized; Usability; Template