Hindmarsh Jonathan, Dieterich Sonja, Booth Jeremy, Keall Paul
Image X Institute, Faculty of Medicine and Health, University of Sydney, Eveleigh, New South Wales, Australia.
Department of Radiation Oncology, UC Davis Medical Center, Sacramento, California, USA.
Med Phys. 2025 Sep;52(9):e18110. doi: 10.1002/mp.18110.
Prospective hazard analysis (PHA) was introduced to the wider medical physics community by the initiation of American association of physicists in medicine task group 100 in 2003. Since then, there has been increasing interest in the applicability of PHA to radiotherapy for the purpose of keeping patients safe and assessing the risks within the whole practice of radiotherapy. The purpose of this research was to review the PHA literature focusing on which techniques and technologies have been assessed, how they have been assessed, and what can be learnt.
The search for English language, peer-reviewed, full-text articles was conducted across five databases and the citations of three seminal papers using a common search strategy. The collation, filtration, and analysis of articles was conducted in accordance with the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement reporting standard utilizing the following PICOS approach: Population: x-ray external beam radiation therapy, Intervention: prospective hazard analysis, Comparison: none, Outcome: patient safety, Study characteristics: details of applied technique.
689 unique studies were identified. 62 were determined to be eligible for inclusion. PHA has been applied to C-arm treatment systems (17), stereotactic radiosurgery (8), TomoTherapy (6), stereotactic body radiotherapy (5), Ethos (5), Halcyon (3), MRIdian (3), review activities (3), commissioning (2), unity (1), volumetric modulated arc therapy (1), surface guidance (1), CyberKnife (1), RefleXion (1) and other novel software and hardware systems (6). Disciplines involved in the studies were physicists (92%), physicians (75%), radiation therapists or dosimetrists (71%), external experts (38%), and facilitators (33%). Failure mode and effects analysis (FMEA) was used in 75% of studies, 10% used FMEA derived methods, 10% used system theoretic process analysis, and 5% used other methods. From the FMEA studies, 579 high-risk failure modes were extracted covering all aspects of the radiotherapy process, 50% applied to patient treatment delivery sessions and 25% applied to contouring and treatment planning. The mitigation strategies recommended by studies tended to add to the departmental workload.
62 studies were identified that used PHA in radiotherapy, within the included studies: patient journey was the most analyzed process, of the disciplines physicists were involved in the most studies, FMEA the most common technique, and the delivery of patient treatment was the greatest source of high-risk failure modes.
2003年美国医学物理学家协会任务组100发起了前瞻性危害分析（PHA），并将其引入更广泛的医学物理领域。从那时起，人们对PHA在放射治疗中的适用性越来越感兴趣，目的是确保患者安全并评估放射治疗整个实践过程中的风险。本研究的目的是回顾PHA文献，重点关注哪些技术和工艺已得到评估、它们是如何被评估的，以及能学到什么。
使用通用搜索策略，在五个数据库以及三篇开创性论文的参考文献中搜索英文、同行评审的全文文章。文章的整理、筛选和分析按照系统评价和荟萃分析的首选报告项目（PRISMA）声明报告标准，采用以下PICOS方法进行：研究对象：X射线外照射放疗，干预措施：前瞻性危害分析，对照：无，结局：患者安全，研究特征：应用技术的细节。
共识别出689项独特研究。其中62项被确定符合纳入标准。PHA已应用于C形臂治疗系统（17项）、立体定向放射外科（8项）、螺旋断层放疗（6项）、立体定向体部放疗（5项）、Ethos（5项）、Halcyon（3项）、MRIdian（3项）、审查活动（3项）、调试（2项）、Unity（1项）、容积调强弧形放疗（1项）、表面引导（1项）、射波刀（1项）、RefleXion（1项）以及其他新型软件和硬件系统（6项）。参与研究的学科包括物理学家（92%）、医生（75%）、放射治疗师或剂量师（71%）、外部专家（38%）和协调员（33%）。75%的研究使用了失效模式与效应分析（FMEA），10%使用了FMEA衍生方法，10%使用了系统理论过程分析，5%使用了其他方法。从FMEA研究中，提取了579个涵盖放射治疗过程各个方面的高风险失效模式，50%适用于患者治疗交付环节，25%适用于轮廓勾画和治疗计划。研究推荐的缓解策略往往会增加科室工作量。
确定了62项在放射治疗中使用PHA的研究，在所纳入的研究中：患者就医过程是分析最多的过程，物理学家参与的研究最多，FMEA是最常用的技术，患者治疗交付是高风险失效模式的最大来源。
