象限项目:通过临床审计提高放射学程序的质量和安全性。

The QuADRANT project: Enhancing quality and safety in radiological procedures through clinical audit.

作者信息

Brusadin Gianfranco, Brady Adrian P, Hierath Monika, Howlett David C

机构信息

Quality and Risk Management Department, Gustave-Roussy, 114, rue Édouard-Vaillant, 94805 Villejuif, France.

University College Cork, Department of Radiology, College Road, Cork, T12 AK54, Ireland.

出版信息

Cancer Radiother. 2025 Aug 11;29(5-6):104689. doi: 10.1016/j.canrad.2025.104689.

Abstract

PURPOSE

The project entitled "Quality Improvement Through Clinical Audit in Diagnostic (Including Interventional) Radiology, Radiotherapy and Nuclear Medicine (Including Therapies)" (QuADRANT) was conceived to thoroughly assess the state of clinical audit implementation across Europe, regarding the medical application of ionizing radiation. The central aim was to elevate the quality and safety standards in radiological procedures. This initiative arose from the understanding that consistent and rigorous clinical audit is fundamental for enhancing patient outcomes and adhering to safety regulations in cancer treatment using radiation. The project aimed to address the observed variations in how clinical audit was being applied across Europe.

MATERIAL AND METHODS

The QuADRANT project employed a comprehensive methodology to gather data. This included an extensive review of existing literature, European regulations, and international guidelines pertinent to clinical audit in radiological procedures. National surveys were conducted, reaching out to representatives from European Union member states and other selected countries to collect information on national frameworks, methodologies, existing barriers, and facilitating factors. In-depth case studies, involving site visits and interviews with various stakeholders such as healthcare professionals and policymakers, provided deeper insights. Expert consultations with specialists in medical physics, radiation oncology, and quality assurance further enriched the data. Workshops were also held to engage national stakeholders in discussions about legal requirements, benefits, and good practices of clinical audit. The collected data was systematically analysed to identify key trends, common challenges, successful strategies, and areas ripe for improvement, leading to the formulation of evidence-based recommendations.

RESULTS

The project observed significant variations in the adoption and maturity of clinical audit programs across European countries, even within individual nations. While some countries demonstrated well-established practices, particularly concerning dosimetry audits in radiotherapy, a widespread and comprehensive clinical audit program covering all radiological procedures was often lacking. Data collection for audit purposes was frequently inconsistent, with common deviations from standard practice noted in patient data registration, diagnosis, treatment details, and the recording of adverse events. Many countries reported limited financial and human resources allocated to clinical audit. A general lack of awareness among healthcare professionals regarding the specific requirements and benefits of clinical audit was also identified. Organizational culture sometimes presented resistance to systematic quality improvement initiatives. Challenges were noted in data quality and the burden associated with manual data entry for audit purposes. Furthermore, a lack of central coordination at the national level often resulted in fragmented audit efforts.

DISCUSSION

The observed variations in clinical audit implementation highlight the necessity for a more harmonized and robust approach across Europe. The absence of standardized methodologies impedes effective benchmarking and the sharing of best practices among institutions and countries. The resource limitations and lack of awareness underscore a need for increased investment and targeted education campaigns to promote a culture of continuous quality improvement. The identified data collection inconsistencies indicate a critical area for intervention, suggesting the need for improved digital infrastructure and standardized reporting mechanisms to facilitate meaningful audits. For radiotherapy specifically, the findings emphasize that while some aspects like dosimetry are well-audited, a broader, more systematic audit of the entire treatment pathway, including advanced technologies and multidisciplinary team interactions, is often underdeveloped.

CONCLUSION

The QuADRANT project successfully provided a comprehensive overview of clinical audit practices in radiological procedures throughout Europe, identifying both achievements and substantial shortcomings. It underscored the critical need for strengthening national infrastructure, increasing resource allocation, and elevating the prioritisation of clinical audit. The project outcomes were published by the European Commission as part of Radiation Protection Series. Furthermore, the project's insights were instrumental in shaping the European Commission's recommendations on clinical audits establishing a crucial framework for harmonizing national clinical audit systems. The ongoing impact of the project is evident in subsequent initiatives like the Clinical Audit Implementation in Europe (CLAUD-IT) project on improving clinical audit practice in European Union member states radiological procedures.

摘要

目的

名为“通过诊断(包括介入)放射学、放射治疗和核医学(包括治疗)中的临床审计提高质量”(QuADRANT)的项目旨在全面评估欧洲在电离辐射医学应用方面临床审计实施的状况。核心目标是提高放射学程序的质量和安全标准。该倡议源于这样一种认识,即持续且严格的临床审计对于改善癌症放射治疗中的患者结局以及遵守安全法规至关重要。该项目旨在解决欧洲各地临床审计应用方式存在的差异。

材料与方法

QuADRANT项目采用了全面的方法来收集数据。这包括广泛审查与放射学程序临床审计相关的现有文献、欧洲法规和国际指南。开展了国家层面的调查,与欧盟成员国及其他选定国家的代表取得联系,以收集有关国家框架、方法、现有障碍和促进因素的信息。深入的案例研究,包括实地考察以及与医疗保健专业人员和政策制定者等各类利益相关者进行访谈,提供了更深入的见解。与医学物理、放射肿瘤学和质量保证方面的专家进行的咨询进一步丰富了数据。还举办了研讨会,让国家层面的利益相关者参与关于临床审计的法律要求、益处和良好实践的讨论。对收集到的数据进行系统分析,以确定关键趋势、常见挑战、成功策略以及有待改进的领域,从而形成基于证据的建议。

结果

该项目观察到欧洲各国在临床审计项目的采用和成熟度方面存在显著差异,甚至在个别国家内部也是如此。虽然一些国家展示了成熟的做法,特别是在放射治疗剂量测定审计方面,但往往缺乏涵盖所有放射学程序的广泛且全面的临床审计项目。用于审计目的的数据收集常常不一致,在患者数据登记、诊断、治疗细节以及不良事件记录方面,常见与标准做法的偏差。许多国家报告称,分配给临床审计的财政和人力资源有限。还发现医疗保健专业人员普遍对临床审计的具体要求和益处认识不足。组织文化有时对系统性质量改进举措存在抵触。在数据质量以及用于审计目的的手动数据录入负担方面存在挑战。此外,国家层面缺乏中央协调往往导致审计工作分散。

讨论

临床审计实施中观察到的差异凸显了欧洲采取更统一、更有力方法的必要性。缺乏标准化方法阻碍了机构和国家之间有效的基准比较以及最佳实践的分享。资源限制和认识不足强调需要增加投资并开展有针对性的教育活动,以促进持续质量改进的文化。所确定的数据收集不一致表明了一个关键的干预领域,这意味着需要改进数字基础设施和标准化报告机制,以促进有意义的审计。特别是对于放射治疗而言,研究结果强调,虽然剂量测定等一些方面审计良好,但对包括先进技术和多学科团队互动在内的整个治疗路径进行更广泛、更系统的审计往往不够完善。

结论

QuADRANT项目成功全面概述了欧洲各地放射学程序的临床审计实践,既指出了成就,也指出了重大不足。它强调了加强国家基础设施、增加资源分配以及提高临床审计优先级的迫切需求。该项目的成果由欧盟委员会作为辐射防护系列的一部分予以发布。此外,该项目的见解有助于塑造欧盟委员会关于临床审计的建议,为协调国家临床审计系统建立了关键框架。该项目的持续影响在后续举措中显而易见,例如欧洲临床审计实施(CLAUD - IT)项目,其旨在改善欧盟成员国放射学程序中的临床审计实践。

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