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QUADRANT 研究:当前状况和提高欧洲医学放射程序临床审核采用率和实施率的建议。放射治疗视角。

The QuADRANT study: Current status and recommendations for improving uptake and implementation of clinical audit of medical radiological procedures in Europe. The radiotherapy perspective.

机构信息

Servei de Radiofísica i Radioprotecció, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; European Society for Radiotherapy and Oncology, Brussels, Belgium.

Dept. of Radiation Oncology, Institute of Oncology Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Slovenia; European Society for Radiotherapy and Oncology, Brussels, Belgium.

出版信息

Radiother Oncol. 2023 Sep;186:109772. doi: 10.1016/j.radonc.2023.109772. Epub 2023 Jun 28.

Abstract

BACKGROUND

QuADRANT was a research project funded by the European Commission to evaluate clinical audit uptake and implementation across Europe, with an emphasis on clinical audit as mandated within the BSSD (Basic Safety Standards Directive).

AIM

Focusing on the QuADRANT objectives - to obtain an overview of European clinical audit activity; identify good practices, resources, barriers and challenges; provide guidance and recommendations going forwards; identify the potential for European Union action on quality and safety focusing on the field of radiotherapy.

RESULTS

A pan-European survey, expert interviews and a literature review conducted within the framework of the QuADRANT project indicated that developments in national clinical audit infrastructure are required. While in radiotherapy, there is a strong tradition and high level of experience of dosimetry audits and well-established practice through the IAEA's QUATRO audits, few countries have a well-established comprehensive clinical audit programme or international/national initiatives on tumour specific clinical audits. Even if sparse, the experience from countries with established system of quality audits can be used as role-models for national professional societies to promote clinical audit implementation. However, resource allocation and national prioritisation of clinical audit are needed in many countries. National and international societies should take the initiative to promote and facilitate training and resources (guidelines, experts, courses) for clinical audits. Enablers used to enhance clinical audit participation are not widely employed. Development of hospital accreditation programmes can facilitate clinical audit uptake. An active and formalised role for patients in clinical audit practice and policy development is recommended. Because there is a persisting variation in European awareness of BSSD clinical audit requirements, work is needed to improve dissemination of information on the legislative requirements relating to clinical audit in the BSSD and in relation to inspection processes. The aim is to ensure these include clinical audit and that they encompass all clinics and specialties involved in medical applications using ionising radiation.

CONCLUSION

QuADRANT provided an overarching view of clinical audit practice in Europe, with all its related aspects. Unfortunately, it showed that the awareness of the BSSD requirements for clinical audit are highly variable. Therefore, there is an urgent need to dedicate efforts towards ensuring that regulatory inspections also incorporate an assessment of clinical audit program(s), affecting all aspects of clinical work and specialties involved in patient exposure to ionising radiation.

摘要

背景

QUADRANT 是欧盟资助的一个研究项目,旨在评估欧洲的临床审核采用和实施情况,重点是 BSSD(基本安全标准指令)规定的临床审核。

目的

专注于 QUADRANT 的目标——获得对欧洲临床审核活动的概述;确定良好实践、资源、障碍和挑战;提供未来的指导和建议;确定欧盟在质量和安全方面的行动潜力,重点关注放射治疗领域。

结果

QUADRANT 项目框架内进行的泛欧调查、专家访谈和文献综述表明,需要发展国家临床审核基础设施。虽然在放射治疗方面,剂量审核方面有很强的传统和高水平的经验,并且通过 IAEA 的 QUATRO 审核建立了良好的实践,但很少有国家有完善的全面临床审核计划或针对肿瘤特定临床审核的国际/国家倡议。即使经验很少,已经建立质量审核系统的国家的经验也可以作为国家专业协会促进临床审核实施的榜样。然而,许多国家需要分配资源并优先考虑临床审核。国家和国际协会应主动促进和便利临床审核的培训和资源(指南、专家、课程)。用于增强临床审核参与的促进因素并未广泛采用。制定医院认证计划可以促进临床审核的采用。建议在临床审核实践和政策制定中积极并正式地让患者参与。由于欧洲对 BSSD 临床审核要求的认识存在差异,因此需要开展工作,以提高有关 BSSD 中临床审核立法要求的信息传播,并与检查过程相关。目的是确保这些要求包括临床审核,并涵盖涉及使用电离辐射的医疗应用的所有诊所和专业。

结论

QUADRANT 提供了欧洲临床审核实践的全面概述,包括其所有相关方面。不幸的是,它表明对 BSSD 临床审核要求的认识存在很大差异。因此,迫切需要努力确保监管检查还包括对临床审核计划的评估,影响涉及电离辐射患者暴露的所有临床工作和专业。

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