Colbert Caroline M, Melancon Dustin, Kang John, Ford Eric C, Smith Wade P
Department of Radiation Oncology, University of Washington. Division of Radiation Oncology, Fred Hutch Cancer Center, Seattle, Washington.
Department of Radiation Oncology, University of Washington. Division of Radiation Oncology, Fred Hutch Cancer Center, Seattle, Washington.
Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):873-880. doi: 10.1016/j.ijrobp.2025.04.009. Epub 2025 Apr 28.
When adopting a new therapeutic technology, a comparison to a standard of care is needed. We aim to directly compare the specific safety implications of adaptive radiation therapy (ART) to those of traditional image guided radiation therapy (IGRT), as implemented on a ring gantry linear accelerator with kilovoltage cone beam computed tomography-based online ART capability.
An interdisciplinary committee performed a failure modes and effects analysis based on the American Association of Physicists in Medicine (AAPM) Task Group 100 method addressing initial treatment planning, quality assurance, and treatment delivery for both IGRT-alone and IGRT with ART on the Varian Ethos. Failure modes were categorized by process step and associated clinical roles, scored by severity, occurrence, and detectability, and ranked by risk priority number (RPN). Failure modes shared by IGRT and ART were scored and analyzed comparatively.
We identified 33 unique system failure modes as part of the IGRT-alone workflow, and 9 additional failure modes specific to ART. Most high-risk IGRT-alone system failure modes were associated with initial treatment planning errors. High-risk ART failure modes also included errors related to adaptive replanning. Reanalysis of 33 IGRT-alone failure modes in the ART setting found an overall decrease in median RPN from 96 (IQR, 56-144) to 72 (IQR, 32-120; P = .035). RPN decreased for 12 failure modes, with the greatest change observed among the highest-ranked failure modes for IGRT-alone.
Although online ART introduces new avenues for error in the adaptive replanning process, the enhanced staffing and iterative plan review reduce the risk associated with systematic errors originating in initial treatment planning. The finding that the RPN decreased in the adaptive setting provides a unique motivation for the adoption of ART from a patient safety perspective, beyond the well-documented dosimetric benefit of ART.
在采用一种新的治疗技术时，需要与护理标准进行比较。我们旨在直接比较自适应放射治疗（ART）与传统图像引导放射治疗（IGRT）在具有千伏锥形束计算机断层扫描在线ART功能的环形机架直线加速器上实施时的特定安全影响。
一个跨学科委员会基于美国医学物理学家协会（AAPM）任务组100方法进行了故障模式和影响分析，该方法涉及单独的IGRT以及在Varian Ethos上结合ART的IGRT的初始治疗计划、质量保证和治疗交付。故障模式按流程步骤和相关临床角色进行分类，按严重程度、发生频率和可检测性进行评分，并按风险优先数（RPN）进行排序。对IGRT和ART共有的故障模式进行评分并进行比较分析。
我们确定了33种独特的系统故障模式作为单独IGRT工作流程的一部分，以及9种特定于ART的额外故障模式。大多数高风险的单独IGRT系统故障模式与初始治疗计划错误相关。高风险的ART故障模式还包括与自适应重新计划相关的错误。在ART环境中对33种单独IGRT故障模式进行重新分析发现，RPN中位数总体从96（四分位间距，56 - 144）降至72（四分位间距，32 - 120；P = 0.035）。12种故障模式的RPN降低，在单独IGRT排名最高的故障模式中观察到最大变化。
虽然在线ART在自适应重新计划过程中引入了新的出错途径，但增加的人员配备和迭代计划审查降低了与初始治疗计划中系统性错误相关的风险。在自适应环境中RPN降低这一发现，从患者安全角度为采用ART提供了独特的动机，这超出了ART已充分记录的剂量学益处。
