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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Detailed review and analysis of complex radiotherapy clinical trial planning data: Evaluation and initial experience with the SWAN software system.
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Detailed review and analysis of complex radiotherapy clinical trial planning data: Evaluation and initial experience with the SWAN software system.

机译：复杂放射治疗临床试验计划数据的详细审查和分析：SWAN软件系统的评估和初步经验。

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AIM: Contemporary radiotherapy clinical trials typically require complex three-dimensional (3D) treatment planning. This produces large amounts of data relating technique and dose delivery for correlation with patient outcomes. Assessment of the quality of this information is required to ensure protocol compliance, to quantify the variation in treatments given to patients and to enhance the power of studies to determine correlates of patient outcomes. MATERIALS AND METHODS: A software system ('SWAN') was developed to facilitate the objective analysis, quality-assurance and review of digital treatment planning data from multi-centre radiotherapy trials. The utility of this system was assessed on the basis of its functionality and our experience of its use in the context of multi-centre clinical trials and trials-support activities. RESULTS: The SWAN system has been shown to have the functionality required for use in several multi-centre trials, including automated review and archive processes. Approximately 800 treatment plans from over 30 participating institutions have so far been assessed with the system for several treatment planning scenarios. To illustrate this we include a description of the use of the system for a large-recruitment prostate radiotherapy trial being undertaken in Australasia, including examples of how the review process has changed clinical practice. CONCLUSION: The successful implementation of SWAN has been demonstrated in a number of clinical trials. The software provides an opportunity for comprehensive review of treatment parameters that could impact on clinical outcomes and trial results. Such quality-assurance (QA) has previously been difficult or impossible to achieve, particularly for a clinical trial involving large numbers of patients. Such reviews have highlighted inconsistencies in clinical practice that have since been addressed through feedback from the review process. The process of data collection and review should be undertaken by dedicated, experienced and skilled staff in order to ensure efficiency.
机译：目的：当代放射疗法临床试验通常需要复杂的三维（3D）治疗计划。这产生了大量与技术和剂量输送有关的数据，以与患者预后相关。需要对此信息的质量进行评估，以确保符合方案，量化给予患者治疗的差异并增强研究以确定患者预后相关性的能力。材料和方法：开发了一个软件系统（'SWAN'），以促进客观分析，质量保证和审查来自多中心放疗试验的数字治疗计划数据。该系统的实用性是根据其功能以及我们在多中心临床试验和试验支持活动中的使用经验进行评估的。结果：SWAN系统已显示出具有在多个多中心试验中使用所需的功能，包括自动审查和存档过程。迄今为止，已经针对该系统针对几种治疗计划方案评估了来自30多个参与机构的大约800个治疗计划。为了说明这一点，我们对在澳大拉西亚进行的大规模招募前列腺放射治疗试验中使用该系统的情况进行了说明，包括审查过程如何改变临床实践的示例。结论：SWAN的成功实施已在许多临床试验中得到证明。该软件为全面审查可能影响临床结果和试验结果的治疗参数提供了机会。以前很难或不可能实现这种质量保证（QA），特别是对于涉及大量患者的临床试验而言。此类审查突显了临床实践中的矛盾之处，此后已通过来自审查过程的反馈来解决。数据收集和审查过程应由敬业，经验丰富和熟练的人员进行，以确保效率。

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