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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05).
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Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05).

机译：随机神经性骨痛试验的质量保证经验（Trans-Tasman放射肿瘤学小组，96.05）。

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Background and PURPOSE: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270).Materials and METHODS: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol.RESULTS: Only one patient was found conclusively notto have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/-10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P=0.44).CONCLUSIONS: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation.
机译：背景与目的：跨塔斯曼放射肿瘤学组96.05是一项前瞻性随机对照试验，比较了在放疗（RT）的五个部分中单一的8 Gy和20 Gy治疗因骨转移引起的神经性疼痛。本文总结了前234例患者的质量保证（QA）活动（应计目标270）。材料和方法：每组患者大约进行一次队列研究后，进行独立审核以评估患者是否符合资格/排除标准和治疗指标部位的适当性连续45例患者。报告的严重不良事件（SAE）以索/马尾神经压迫或在索引部位发展为病理性骨折的形式进行了调查，并分批提交给独立数据监测委员会。最后，对前234名患者中的每位患者进行了RT处方页和治疗记录的源数据验证，以评估对方案的依从性。结果：只有一名患者最终没有真正的神经性疼痛，并且没有发现“地理上的” RT字段未命中。在五次审核（225名患者）中，发现的其他资格标准侵权的总体发生率为8％，首次审核后有了显着改善。随机分组的SAE在任何阶段都没有统计学上的显着差异。 RT方案变化的比率为22％，涉及14个促成中心中的10个，尽管主要剂量违规率（方案剂量的+/- 10％以上）仅为6％，而随机分组的差异无统计学意义（ P = 0.44）。结论：质量保证审核是RT试验（包括评估姑息终点的试验）必不可少的但很耗时的组成部分。我们的经验证实，研究启动后，所有方面都应立即开始。

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