Department of Radiation Oncology, National Cancer Institue of Singapore, National University Hospital, 5 Lower Kent Road, Singapore, 119074, Singapore.
Radiat Oncol. 2018 Jun 7;13(1):108. doi: 10.1186/s13014-018-1053-7.
Good radiotherapy reporting in clinical trials of prostate radiotherapy is important because it will allow accurate reproducibility of radiotherapy treatment and minimize treatment variations that can affect patient outcomes. The aim of our study is to assess the quality of prostate radiotherapy (RT) treatment reporting in randomized controlled trials in prostate cancer.
We searched MEDLINE for randomized trials of prostate cancer, published from 1996 to 2016 and included prostate RT as one of the intervention arms. We assessed if the investigators reported the ten criteria adequately in the trial reports: RT dose prescription method; RT dose-planning procedures; organs at risk (OAR) dose constraints; target volume definition, simulation procedures; treatment verification procedures; total RT dose; fractionation schedule; conduct of quality assurance (QA) as well as presence or absence of deviations in RT treatment planning and delivery. We performed multivariate logistic regression to determine the factors that may influence the quality of reporting.
We found 59 eligible trials. There was significant variability in the quality of reporting. Target volume definition, total RT dose and fractionation schedule were reported adequately in 97% of included trials. OAR constraints, simulation procedures and presence or absence of deviations in RT treatment planning and delivery were reported adequately in 30% of included trials. Twenty-four trials (40%) reported seven criteria or more adequately. Multivariable logistic analysis showed that trials that published their quality assurance results and cooperative group trials were more likely to have adequate quality in reporting in at least seven criteria.
There is significant variability in the quality of reporting on prostate radiotherapy treatment in randomized trials of prostate cancer. We need to have consensus guidelines to standardize the reporting of radiotherapy treatment in randomized trials.
临床试验中良好的放射治疗报告对于前列腺放射治疗非常重要,因为它可以确保放射治疗的准确重现,最大限度地减少可能影响患者结果的治疗变化。我们的研究旨在评估前列腺癌随机对照试验中前列腺放射治疗(RT)治疗报告的质量。
我们在 MEDLINE 中搜索了 1996 年至 2016 年发表的前列腺癌随机试验,并将前列腺 RT 作为干预臂之一纳入研究。我们评估了研究人员在试验报告中是否充分报告了以下十个标准:RT 剂量处方方法;RT 剂量计划程序;危险器官(OAR)剂量限制;靶区定义、模拟程序;治疗验证程序;总 RT 剂量;分割方案;质量保证(QA)的进行以及 RT 治疗计划和交付是否存在偏差。我们进行了多变量逻辑回归分析,以确定可能影响报告质量的因素。
我们发现了 59 项符合条件的试验。报告的质量存在显著差异。97%的纳入试验充分报告了靶区定义、总 RT 剂量和分割方案。30%的纳入试验充分报告了 OAR 限制、模拟程序以及 RT 治疗计划和交付是否存在偏差。24 项试验(40%)充分报告了七个或更多标准。多变量逻辑分析表明,公布质量保证结果的试验和合作组试验更有可能在至少七个标准中有足够的报告质量。
在前列腺癌的随机试验中,前列腺放射治疗报告的质量存在显著差异。我们需要有共识指南来规范放射治疗在随机试验中的报告。