Department of Urology and Urosurgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
RaVeNNA 4pi-Consortium of the German Federal Ministry of Education and Research (BMBF), Mannheim, Germany.
J Endourol. 2021 Aug;35(8):1257-1264. doi: 10.1089/end.2020.0900. Epub 2021 Mar 9.
To create and evaluate a realistic, anatomically accurate, and user-friendly bladder phantom for reproducible endourological training purposes and endoscope mastery. The anatomy of full bladders was mapped from human computed tomography datasets. After a 3D model development process, content evidence and response process evidence (RPE) of the phantom were evaluated using the system usability scale (SUS), 5-point Likert scale questionnaires, and task execution of experienced urologists (U) and endoscopy-naive medical students (MS) in two training sessions (first second). Required validation cohort sizes (1:10) of the evaluating urologists ( = 12) and students ( = 115) were precalculated. Time measurements were recorded. Students were additionally evaluated by a validated global psychomotor assessment score (GPSS). Group comparisons were calculated by the Mann-Whitney test. All tests were two sided with < 0.05 considered statistically significant. Content evidence was assessed by urologists with an "excellent" SUS score of 89.4 ± 5.9 and an average "agreement" of ≥4 pts in the Likert scale questionnaires. RPE was assessed by intra- and intergroup time comparison for the execution of endoscopic tasks (cystoscopy [CY], guidewire insertion, and tumor biopsy). For CY, U: first 17.6 ± 4.4 seconds second 12.4 ± 2.0 seconds, = 0.002; MS: first 56.6 ± 28.2 seconds second 28.6 ± 14.7 seconds, < 0.001; U MS: first U 17.6 ± 4.4 seconds first MS 56.6 ± 28.2 seconds, < 0.001, second U 12.4 ± 2.0 seconds second MS 28.6 ± 14.7 seconds, < 0.001. Significant time differences were documented for all tasks and sessions ( < 0.001). Additionally, significant GPSS differences were recorded between the sessions (GPSS: first 20.4 ± 5.1 pts second 24.7 ± 4.0 pts, < 0.001). Our low-fidelity 3D-printed bladder, called BladCap, is an easy-to-assemble, inexpensive, and robust phantom. We present data, which establish construct validity to support use as a clinical training device.
为了实现可重复的内镜培训目的和内镜掌握，创建并评估一种真实、解剖准确且用户友好的膀胱模型。 全膀胱的解剖结构是从人体计算机断层扫描数据集中映射出来的。经过 3D 模型开发过程，使用系统可用性量表（SUS）、5 分李克特量表问卷以及经验丰富的泌尿科医生（U）和内镜初学者医学学生（MS）在两个培训课程（第一和第二）中的任务执行，对模型的内容证据和响应过程证据（RPE）进行了评估。根据预先计算的评估泌尿科医生（n=12）和学生（n=115）的验证队列大小（1:10），记录了时间测量值。学生还通过经过验证的整体运动技能评估分数（GPSS）进行了评估。组间比较通过曼-惠特尼检验计算。所有检验均为双侧检验， < 0.05 被认为具有统计学意义。 内容证据由泌尿科医生进行评估，他们的 SUS 评分为 89.4 ± 5.9，李克特量表问卷中的平均“一致性”得分≥4 分。RPE 通过执行内镜任务（膀胱镜检查[CY]、导丝插入和肿瘤活检）的组内和组间时间比较进行评估。对于 CY，U：第一 17.6 ± 4.4 秒，第二 12.4 ± 2.0 秒， = 0.002；MS：第一 56.6 ± 28.2 秒，第二 28.6 ± 14.7 秒， < 0.001；U:MS：第一 U 17.6 ± 4.4 秒，第一 MS 56.6 ± 28.2 秒， < 0.001，第二 U 12.4 ± 2.0 秒，第二 MS 28.6 ± 14.7 秒， < 0.001。所有任务和课程都记录了显著的时间差异（ < 0.001）。此外，课程之间还记录了显著的 GPSS 差异（GPSS：第一 20.4 ± 5.1 分，第二 24.7 ± 4.0 分， < 0.001）。 我们的低保真 3D 打印膀胱模型称为 BladCap，易于组装、价格低廉且坚固耐用。我们提供的数据建立了结构有效性，支持将其用作临床培训设备。
