摘要
目的 探讨失效模式和效应分析(FMEA)在肺癌立体定向体部放射治疗(SBRT)流程风险管理中的应用效果。方法 回顾性分析2020-02-01-2023-01-31于苏州大学附属第一医院放疗科接受SBRT的199例肺癌患者临床资料。根据实施不同风险管理方法的时段将患者分为2组,对照组(2020-02-01-2021-07-31)103例执行常规放疗质控风险管理;观察组(2021-08-01-2023-01-31)96例应用基于FMEA的风险管理。采用FMEA方法对肺癌SBRT流程中的各个实施环节进行分析,计算风险优先指数(RPN),以识别出流程中潜在高风险因素的关键节点。对于RPN>125分的高风险环节,制定优先改进措施。采用t检验比较FMEA实施前后2组患者的RPN及摆位误差的差异,并使用χ^(2)=检验分析2组放疗不良事件发生率的差异。结果 观察组在11项失效模式的RPN评分低于与对照组,差异有统计学意义,均P<0.001;4种不良事件总发生率从实施前(对照组)10.67%降低至1.04%(观察组),差异有统计学意义,χ^(2)==8.145,P=0.004。观察组3个方向(左右、头脚和腹背方向)上摆位误差低于对照组,差异有统计学意义,t值分别为2.747、4.576和4.034,P值分别为0.006,<0.001和<0.001。结论 将FMEA应用于肺癌SBRT流程的风险管理有助于避免和减少与放疗相关的潜在风险,降低不良事件发生率,提高临床实践的安全性,同时能进一步提高放射治疗的精度。
Objective To explore the application effectiveness of Failure Mode and Effects Analysis(FMEA)in risk management within the process of Stereotactic Body Radiotherapy(SBRT)for lung cancer.Methods A retrospective analysis was conducted on the clinical data of 199 lung cancer patients who underwent SBRT treatment at the Department of Radiation Oncology,the First Affiliated Hospital of Soochow University,from February 1,2020,to January 31,2023.The patients were divided into two groups based on the timing of implementing different risk management methods:the control group(February 1,2020,to July 31,2021)with 103 cases,and the observation group(August 1,2021,to January 31,2023)with 96 cases.Patients in the control group underwent conventional radiotherapy quality control risk management,while patients in the observation group applied risk management based on Failure Mode and Effect Analysis(FMEA).Using the FMEA method to analyze each implementation step in the lung cancer SBRT process,calculate the Risk Priority Index(RPN)to identify key nodes of potential high-risk factors within the process.For high-risk steps with an RPN>125,prioritize improvement measures.Using t-tests to compare the differences in RPN and positioning errors between the two groups before and after implementing FMEA,and utilizing χ^(2) tests to compare the disparities in the occurrence rates of adverse events in radiotherapy.Results The observation group's RPN scores for ll failure modes were significantly lower than those of the control group,and all differences were statistically significant(P<0.001).The overall incidence of four types of adverse events decreased from 10.67%(control group)before implementation to 1.04%(observation group),with a statistically significant difference(χ^(2)=8.145,P=0.004).The observation group exhibited significantly lower positioning errors in three directions(left-right,head-foot,and anterior-posterior)compared to those of the control group,with statistically significant differences(t-values were 2.747,4.576 and 4.034,P-values were 0.006,<0.001 and<0.001,respectively).Conclusion Incorporating FMEA into the risk management process of lung cancer SBRT can effectively mitigate potential radiotherapy-related risks,decrease the occurrence of adverse events,and enhance clinical safety,as well as improve the precision of radiotherapy delivery.
作者
蒋华
薛姣
徐文涛
张汝婷
顾松
秦颂兵
JIANG Hua;XUE Jiao;XU Wentao;ZHANG Ruting;GU Song;QIN Songbing(Department of Radiation Oncology,the First Affiliated Hospital of Soochow University,Suzhou,Jiangsu 215006,China;Department of Radiation Oncology,Suzhou GuangCi Cancer Hospital,Suzhou,Jiangsu 215000,China)
出处
《中华肿瘤防治杂志》
CAS
北大核心
2024年第6期369-375,共7页
Chinese Journal of Cancer Prevention and Treatment
基金
江苏省医学重点学科项目(ZDXK202235)。
关键词
肺癌
失效模式和效应分析
风险优先指数
立体定向体部放射治疗
风险管理
摆位误差
lung cancer
failure mode and effects analysis
risk priority number
stereotactic body radiation therapy
risk management
setup error