Arifin Andrew J, Tan Vivian S, Yan Michael, Warner Andrew, Boldt R G, Chen Hanbo, Rodrigues George B, Palma David A, Louie Alexander V
Division of Radiation Oncology, London Regional Cancer Program, London, Ontario, Canada.
Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Adv Radiat Oncol. 2023 Jan 21;8(3):101178. doi: 10.1016/j.adro.2023.101178. eCollection 2023 May-Jun.
Although the frequency of noninferiority trials is increasing, the consistency of the reporting of these trials can vary. The aim of this systematic review was to assess the reporting quality of radiation therapy noninferiority trials.
The PubMed, Embase, and Cochrane databases were queried for randomized controlled radiation therapy trials with noninferiority hypotheses published in English between January 2000 and July 2022, and this was performed by an information scientist. Descriptive statistics were used to summarize data.
Of 423 records screened, 59 (14%) were included after full-text review. All were published after 2003 and open label. The most common primary cancer type was breast (n = 15, 25%). Altered radiation fractionation (n = 26, 45%) and radiation de-escalation (n = 11, 19%) were the most common types of interventions. The most common primary endpoints were locoregional control (n = 17, 29%) and progression-free survival (n = 14, 24%). Fifty-three (90%) reported the noninferiority margin, and only 9 (17%) provided statistical justification for the margin. The median absolute noninferiority margin was 9% (interquartile range, 5%-10%), and the median relative margin was 1.51 (interquartile range, 1.33-2.04). Sample size calculations and confidence intervals were reported in 54 studies (92%). Both intention-to-treat and per-protocol analyses were reported in 27 studies (46%). In 31 trials (53%), noninferiority of the primary endpoint was reached.
There was variability in the reporting of key components of noninferiority trials. We encourage consideration of additional statistical reasoning such as guidelines or previous trials in the selection of the noninferiority margin, reporting both absolute and relative margins, and the avoidance of statistically vague or misleading language in the reporting of future noninferiority trials.
尽管非劣效性试验的频率在增加，但这些试验报告的一致性可能有所不同。本系统评价的目的是评估放射治疗非劣效性试验的报告质量。
信息科学家在PubMed、Embase和Cochrane数据库中检索了2000年1月至2022年7月期间以英文发表的具有非劣效性假设的随机对照放射治疗试验。采用描述性统计来汇总数据。
在筛选的423条记录中，经过全文审查后纳入了59条（14%）。所有研究均在2003年之后发表且为开放标签。最常见的原发性癌症类型是乳腺癌（n = 15，25%）。改变放疗分割（n = 26，45%）和放疗降阶梯（n = 11，19%）是最常见的干预类型。最常见的主要终点是局部区域控制（n = 17，29%）和无进展生存期（n = 14，24%）。53项研究（90%）报告了非劣效性界值，只有9项研究（17%）为该界值提供了统计学依据。绝对非劣效性界值的中位数为9%（四分位间距，5%-10%），相对界值的中位数为1.51（四分位间距，1.33-2.04）。54项研究（92%）报告了样本量计算和置信区间。27项研究（46%）报告了意向性分析和符合方案分析。在31项试验（53%）中，主要终点达到了非劣效性。
非劣效性试验关键组成部分的报告存在差异。我们鼓励在选择非劣效性界值时考虑额外的统计推理，如指南或既往试验，同时报告绝对和相对界值，并在未来非劣效性试验的报告中避免使用统计上模糊或有误导性的语言。
