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使用模拟技术定量评估高剂量率前列腺近距离放射治疗中的物理误差的临床严重程度。

Quantifying clinical severity of physics errors in high-dose rate prostate brachytherapy using simulations.

机构信息

Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, NY.

Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.

出版信息

Brachytherapy. 2021 Sep-Oct;20(5):1062-1069. doi: 10.1016/j.brachy.2021.05.007. Epub 2021 Jun 27.

Abstract

PURPOSE

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).

METHODS AND MATERIALS

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).

RESULTS

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.

CONCLUSIONS

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.

摘要

目的

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。

方法和材料

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。

结果

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。

结论

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。

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