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临床试验 放射技师识别在英国首个质子束治疗中心实施全国性临床试验计划所面临的首要挑战。

Clinical Trials Radiographers identifying priority challenges associated with implementing a national programme of clinical trials in the United Kingdom's first proton beam therapy centre.

作者信息

Davies Lucy S C, McHugh Louise, Falk Sally, Bridge Jacqui, Amaro Philip F, Whiteside Lee, Bailey Rachael, Webb Julie, Eccles Cynthia L

机构信息

Department of Radiotherapy, The Christie NHS Foundation Trust, Manchester M20 4BX, United Kingdom.

Proton Beam Therapy, The Christie NHS Foundation Trust, Manchester M20 4BX, United Kingdom.

出版信息

BJR Open. 2024 May 23;6(1):tzae012. doi: 10.1093/bjro/tzae012. eCollection 2024 Jan.

Abstract

OBJECTIVES

This article is an evaluation of the current trial processes within a national proton beam therapy (PBT) clinical trial service in the United Kingdom. The work within the article identifies priority challenges associated with the implementation of PBT trials with a view to improving patient trial processes.

METHODS

The nominal group technique (NGT) was used. Five Clinical Trials Radiographers were asked the target question "what are the major challenges when implementing PBT clinical trials and facilitating PBT trial-related activities?" Participants individually and silently listed their challenges to the target question. Following this, group discussion clarified and refined responses. Participants then individually selected five challenges that they deemed most pertinent to the target question, giving a weighted score (out of 10). Individual scores were combined to provide a ranked, weighted order of challenges. Further group discussion identified improvement strategies to the highest scored challenges.

RESULTS

After combining lists generated by participants, 59 challenges were identified. Group discussion eliminated 27 responses. Eighteen were merged, resulting in 14 challenges. The two challenges that ranked highest were: (i) lack of initial understanding of the responsibilities of teams and who the relevant stakeholders were, and (ii) that a national PBT service requires the provision of shared care across multi-disciplinary teams and sites. Improvement areas include the development of shared protocols, clarifying stakeholder responsibilities and improving communication between centres to streamline PBT trial processes.

CONCLUSIONS

This work has identified priority areas requiring development to improve the conduct of a national PBT clinical trials programme.

ADVANCES IN KNOWLEDGE

This is the first publication to evaluate current clinical trial processes for the United Kingdom's PBT service.

摘要

目的

本文评估了英国国家质子束治疗(PBT)临床试验服务中的当前试验流程。文章中的工作确定了与PBT试验实施相关的优先挑战,以期改善患者试验流程。

方法

采用名义群体技术(NGT)。向五名临床试验放射技师询问目标问题“开展PBT临床试验并促进与PBT试验相关活动时的主要挑战是什么?”参与者各自默默地列出他们对目标问题的挑战。在此之后,小组讨论对回答进行了澄清和完善。参与者随后各自选出他们认为与目标问题最相关的五个挑战,并给出加权分数(满分10分)。将个人分数合并,得出挑战的排名加权顺序。进一步的小组讨论确定了针对得分最高的挑战的改进策略。

结果

合并参与者列出的清单后,共确定了59项挑战。小组讨论排除了27项回答。18项被合并,最终得到14项挑战。排名最高的两项挑战是:(i)对团队职责以及相关利益相关者是谁缺乏初步了解,以及(ii)国家PBT服务需要跨多学科团队和地点提供共享护理。改进领域包括制定共享方案、明确利益相关者职责以及改善中心之间的沟通,以简化PBT试验流程。

结论

这项工作确定了需要发展的优先领域,以改善国家PBT临床试验项目的开展。

知识进展

这是第一篇评估英国PBT服务当前临床试验流程的出版物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a56/11170212/4c50aa7d5b2b/tzae012f1.jpg

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