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多中心适应性膀胱试验中“当日计划”选择的质量保证:预入组IGRT指导与评估模块的实施

Quality assuring "Plan of the day" selection in a multicentre adaptive bladder trial: Implementation of a pre-accrual IGRT guidance and assessment module.

作者信息

Patel Emma, Tsang Yat, Baker Angela, Callender Jenny, Hafeez Shaista, Hall Emma, Hansen Vibeke Nordmark, Lewis Rebecca, McNair Helen, Miles Elizabeth, Huddart Robert

机构信息

Radiotherapy Physics Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom.

National Radiotherapy Trials Quality Assurance Group, Mount Vernon Hospital, Northwood, United Kingdom.

出版信息

Clin Transl Radiat Oncol. 2019 Jul 24;19:27-32. doi: 10.1016/j.ctro.2019.07.006. eCollection 2019 Nov.

Abstract

BACKGROUND AND PURPOSE

Hypofractionated bladder RT with or without image guided adaptive planning (HYBRID) is a multicentre clinical trial investigating "Plan of the Day" (PoD) adaptive radiotherapy for bladder cancer. To ensure correct PoD selection a pre-accrual guidance and assessment module was developed as part of an image guided radiotherapy quality assurance (IGRT QA) credentialing programme. This study aimed to evaluate its feasibility and effectiveness across multiple recruiting centres.

MATERIALS AND METHODS

Individuals from participating centres remotely accessed an image database in order to complete the PoD module. An assessment score of ≥83% was required in order to receive QA approval. A questionnaire was used to gather user feedback on the module. PoD decisions for the first patient at each recruiting centre were retrospectively reviewed for protocol adherence.

RESULTS

71 radiation therapists (RTTs) from 10 centres completed the PoD module. The median assessment score was 92% (Range: 58-100%) with 79% of RTTs passing the assessment on first attempt. All questionnaire respondents reported that the PoD module prepared them for plan selection. In 51/60 of on-trial treatments reviewed, the PoD selected by the centre agreed with QA reviewers.

CONCLUSIONS

The PoD QA module was successfully implemented in a multicentre trial and enabled pre-accrual assessment of protocol understanding. This increased operator confidence and resulted in appropriate PoD selection on-trial.

摘要

背景与目的

采用或不采用图像引导自适应计划的膀胱低分割放疗(HYBRID)是一项多中心临床试验,旨在研究膀胱癌的“当日计划”(PoD)自适应放疗。为确保正确选择PoD,作为图像引导放射治疗质量保证(IGRT QA)认证计划的一部分,开发了一个预入组指导与评估模块。本研究旨在评估其在多个招募中心的可行性和有效性。

材料与方法

参与中心的人员远程访问图像数据库以完成PoD模块。为获得QA批准,评估分数需≥83%。使用问卷收集用户对该模块的反馈。对每个招募中心首位患者的PoD决策进行回顾性审查,以确保符合方案。

结果

来自10个中心的71名放射治疗师(RTT)完成了PoD模块。评估分数中位数为92%(范围:58 - 100%),79%的RTT首次尝试即通过评估。所有问卷受访者均表示PoD模块使他们为计划选择做好了准备。在审查的60例试验性治疗中的51例中,中心选择的PoD与QA审查员的意见一致。

结论

PoD QA模块在多中心试验中成功实施,并能够在入组前评估对方案的理解。这增强了操作人员的信心,并导致试验中PoD的选择恰当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f94/6675972/c0d67254a465/gr1.jpg

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