Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY.
Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.
Brachytherapy. 2021 Sep-Oct;20(5):1062-1069. doi: 10.1016/j.brachy.2021.05.007. Epub 2021 Jun 27.
To quantitatively evaluate through automated simulations the clinical significance of potential high-dose rate (HDR) prostate brachytherapy (HDRPB) physics errors selected from our internal failure-modes and effect analysis (FMEA).
A list of failure modes was compiled and scored independently by 8 brachytherapy physicists on a one-to-ten scale for severity (S), occurrence (O), and detectability (D), with risk priority number (RPN) = SxOxD. Variability of RPNs across observers (standard deviation/average) was calculated. Six idealized HDRPB plans were generated, and error simulations were performed: single (N = 1722) and systematic (N = 126) catheter shifts (craniocaudal; -1cm:1 cm); single catheter digitization errors (tip and connector needle-tips displaced independently in random directions; 0.1 cm:0.5 cm; N = 44,318); and swaps (two catheters swapped during digitization or connection; N = 528). The deviations due to each error in prostate D90%, urethra D20%, and rectum D1cm were analyzed using two thresholds: 5-20% (possible clinical impact) and >20% (potentially reportable events).
Twenty-nine relevant failure modes were described. Overall, RPNs ranged from 6 to 108 (average ± 1 standard deviation, 46 ± 23), with responder variability ranging from 19% to 184% (average 75% ± 30%). Potentially reportable events were observed in the simulations for systematic shifts >0.4 cm for prostate and digitization errors >0.3 cm for the urethra and >0.4 cm for rectum. Possible clinical impact was observed for catheter swaps (all organs), systematic shifts >0.2 cm for prostate and >0.4 cm for rectum, and digitization errors >0.2 cm for prostate and >0.1 cm for urethra and rectum.
A high variability in RPN scores was observed. Systematic simulations can provide insight in the severity scoring of multiple failure modes, supplementing typical FMEA approaches.
通过自动化模拟定量评估从我们的内部失效模式和影响分析(FMEA)中选择的潜在高剂量率(HDR)前列腺近距离放射治疗(HDRPB)物理误差的临床意义。
编制了一份失效模式清单,并由 8 名近距离放射治疗物理学家独立进行评分,评分范围为 1 到 10,用于严重程度(S)、发生(O)和可检测性(D),风险优先数(RPN)= SxOxD。计算了观察者之间 RPN 标准差/平均值的变异性。生成了 6 个理想化的 HDRPB 计划,并进行了误差模拟:单个(N=1722)和系统(N=126)导管移位(头侧尾侧;-1cm:1cm);单个导管数字化误差(尖端和连接器针尖端独立随机方向移位;0.1cm:0.5cm;N=44318);以及交换(两个导管在数字化或连接过程中交换;N=528)。使用两个阈值(5-20%(可能有临床影响)和>20%(可能报告事件))分析了每个误差在前列腺 D90%、尿道 D20%和直肠 D1cm 中的偏差。
描述了 29 种相关的失效模式。总体而言,RPN 范围为 6 至 108(平均值±1 个标准差,46±23),响应者变异性范围为 19%至 184%(平均值 75%±30%)。在模拟中观察到系统移位>0.4cm 时前列腺、数字化误差>0.3cm 时尿道和>0.4cm 时直肠存在潜在可报告事件。当导管交换(所有器官)、前列腺系统移位>0.2cm 和直肠>0.4cm 以及前列腺数字化误差>0.2cm 和尿道和直肠>0.1cm 时,观察到可能的临床影响。
观察到 RPN 评分的高度变异性。系统模拟可以深入了解多种失效模式的严重程度评分,补充典型的 FMEA 方法。