背景:确保放射肿瘤学患者的安全对于提供高质量的医疗保健至关重要。患者安全指标(PSIs)提供了一种识别机制,量化和评估风险和安全措施的有效性。然而,目前,德国没有专门为放射肿瘤学量身定制的PSIs。本研究旨在:(1)创建专门为放射肿瘤学设置设计的PSIs,(2)开发并在心理上验证用于评估德国放射肿瘤学设施安全性的仪器,以及(3)评估在常规临床实践中实施该仪器的可行性。最终确定的问卷将作为放射肿瘤科的自我评估工具,帮助他们评估他们在确保患者安全方面的功效,优先考虑安全干预措施,并随时间跟踪性能。
方法:我们正在进行为期3年的工作,混合方法研究以实现我们的目标。对于PSI的识别,我们将对PubMed数据库进行全面审查,以及审查国家和国际准则和建议。为了完善初始指标集,我们将咨询专家,包括医生,医学物理学家,护士,管理人员和放射治疗师通过焦点小组。我们将采用Delphi研究进行最终共识和指标选择。此外,患者的观点将通过成立一个项目患者委员会来纳入,该委员会在整个项目阶段都会开会。我们将把确定的PSI重新制定成问卷项目。问卷的清晰度和可理解性将通过认知访谈得到验证,随后在来自德国放射肿瘤科的150多名参与者中进行心理测试。问卷的最终版本将在常规医疗机构中实施,我们将在半结构化访谈中采访个人用户,了解他们对问卷的体验。我们将召开随后的专家研讨会,讨论研究结果,并探索更广泛实施问卷的途径。最终的问卷将通过Web应用程序进行访问。我们在此将研究报告作为预结果报告。
背景:本研究的伦理批准由汉堡伦理委员会批准(批准号:2023-101018-BO-ff)。该试验由ARO(ArbeitsgemeinschaftRadioonkologie/德国癌症协会放射肿瘤学工作组)注册,协议编号2023-03,在德国注册的临床试验编号为DRKS00034690。研究结果将发表在会议论文和演讲以及期刊论文中,重点是开放获取期刊。结果还将在第三阶段的执行讲习班期间传播,这将涉及不同的利益相关者群体。
背景:DRKS00034690。
BACKGROUND: Ensuring patient safety in radiation oncology is crucial for delivering high-quality healthcare. Patient safety indicators (PSIs) provide a mechanism for identifying, quantifying and evaluating risks and the effectiveness of safety measures. However, there is currently no specialised set of PSIs tailored for radiation oncology in Germany. This study seeks to: (1) create PSIs specifically designed for radiation oncology settings, (2) develop and psychometrically validate an instrument for assessing safety in German radiation oncology facilities and (3) evaluate the feasibility of implementing this instrument in routine clinical practice. The finalised questionnaire will serve as a self-assessment instrument for radiation oncology departments, aiding them in evaluating their efficacy in ensuring patient safety, prioritising safety interventions and tracking performance over time.
METHODS: We are undertaking a 3-year, mixed methods study to address our objectives. For the identification of PSIs, we will conduct a comprehensive review on the PubMed database, along with reviewing national and international guidelines and recommendations. To refine the initial set of indicators, we will consult with experts, including physicians, medical physicists, nurses, administrators and radiation therapists through focus groups. We will employ a Delphi study for the final consensus and selection of indicators. Additionally, the perspectives of patients will be incorporated by formation of a project patient\'s committee which meets throughout the project phases. We will reformulate the identified PSIs into questionnaire items. The questionnaire\'s clarity and comprehensibility will be validated through cognitive interviews, followed by psychometric testing in a pilot group of over 150 participants from German radiation oncology departments. The final version of the questionnaire will then be implemented in routine healthcare settings and we will interview individual users about their experiences with the questionnaire in semistructured interviews. We will convene a subsequent expert workshop to discuss the study results and explore avenues for the questionnaire\'s broader implementation. The finalised questionnaire will be made accessible via a web app. We hereby present the study potocol as a pre-results report.
BACKGROUND: Ethical approval for this study was granted by the Hamburg Ethics Committee (Approval Number: 2023-101018-BO-ff). This trial is registered by the ARO (Arbeitsgemeinschaft Radioonkologie /working group for radiation oncology of the German Cancer Society), protocol number 2023-03 and in the German register for clinical trials with the number DRKS00034690. Study results will be published in conference papers and talks as well as journal papers with focus on open access journals. The results will be also disseminated during the implementation workshop in phase III, which will involve a diverse group of stakeholders.
BACKGROUND: DRKS00034690.