Quality assurance remains a neglected component of many trials, particularly for technical interventions, such as surgery and radiotherapy, for which quality of treatment is an important component in defining outcomes. We aimed to evaluate evidence for the processes used in radiotherapy quality assurance of clinical trials. A systematic review was undertaken focusing on use of a pre-trial outlining benchmark case and subsequent on-trial individual case reviews of outlining for recruited patients. These pre-trial and on-trial checks are used to ensure consistency and standardisation of treatment for each patient recruited to the trial by confirming protocol compliance. Non-adherence to the trial protocol has been shown to have a negative effect on trial outcomes. 29 studies published between January, 2000, and December, 2022, were identified that reported on either outlining benchmark case results or outlining individual case review results, or both. The trials identified varied in their use of radiotherapy quality assurance practices and reporting of outcomes was inconsistent. Deviations from trial protocols were frequent, particularly regarding outlining. Studies correlating benchmark case results with on-trial individual case reviews provided mixed results, meaning firm conclusions could not be drawn regarding the influence of the pre-trial benchmark case on subsequent on-trial performance. The optimal radiotherapy quality assurance processes were unclear, and there was little evidence available. Improved reporting of outcomes from radiotherapy quality assurance programmes is needed to develop an evidence base for the optimal approach to radiotherapy quality assurance in trials.

中文翻译：

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放射治疗试验质量保证流程：系统评价

质量保证仍然是许多试验中被忽视的组成部分，特别是对于手术和放疗等技术干预而言，治疗质量是确定结果的重要组成部分。我们的目的是评估临床试验放射治疗质量保证过程的证据。进行了系统审查，重点关注审前概述基准案例的使用以及随后对招募患者概述的试验中个别案例审查。这些试验前和试验中检查用于通过确认方案合规性来确保招募参加试验的每位患者治疗的一致性和标准化。不遵守试验方案已被证明会对试验结果产生负面影响。 2000 年 1 月至 2022 年 12 月期间发表的 29 项研究被发现报告了概述基准案例结果或概述了个别案例审查结果，或两者兼而有之。确定的试验在放射治疗质量保证实践的使用方面各不相同，并且结果报告不一致。与试验方案的偏差经常发生，特别是在大纲方面。将基准案例结果与审判中的个案审查相关联的研究得出了不同的结果，这意味着无法就预审基准案例对后续审判表现的影响得出明确的结论。最佳的放射治疗质量保证流程尚不清楚，而且几乎没有可用的证据。需要改进放射治疗质量保证计划的结果报告，以便为试验中放射治疗质量保证的最佳方法建立证据基础。