Mathoulin-Pelissier Simone, Gourgou-Bourgade Sophie, Bonnetain Franck, Kramar Andrew
Clinical Research Department, Institut Bergonié, Regional Comprehensive Cancer Center, Bordeaux, France.
J Clin Oncol. 2008 Aug 1;26(22):3721-6. doi: 10.1200/JCO.2007.14.1192.
Several publications showed that the standards for reporting randomized clinical trials (RCTs) might not be entirely suitable. Our aim was to evaluate the reporting of survival end points in cancer RCTs.
A search in MEDLINE databases identified 274 cancer RCTs published in 2004 in four general medical journals and four clinical oncology journals. Eligible articles were those that reported primary analyses of RCT with survival end points. Methodologists reviewed and scored the articles according to seven key points: prevalence of complete definition of survival end points (time of origin, survival events, censoring events) and relevant information about their analyses (estimation or effect size, precision, number of events, patients at risk). Concordance of key points was evaluated from a random subsample.
After screening, 125 articles were selected; 104 trials were phase III (83%) and 98 publications (78%) were obtained from oncology journals. Among these RCTs, a total of 267 survival end points were recorded, and overall survival (OS) was the most frequent outcome (118 terms, 44%). Survival terms were totally defined for 113 end points (42%) in 65 articles (52%). Accurate information about analysis was retrieved for 73 end points (27%) in 40 articles (32%). The less well-defined information was the number of patients at risk (55%). The reliability was good (kappa = 0.72). Finally, according to the key points, optimal reporting was found in 33 end points (12%) or 10 publications.
A majority of articles failed to provide a complete reporting of survival end points, thus adding another source of uncontrolled variability.
多项研究表明，随机临床试验（RCT）的报告标准可能并不完全适用。我们的目的是评估癌症RCT中生存终点的报告情况。
在MEDLINE数据库中进行检索，确定了2004年发表在4种综合医学期刊和4种临床肿瘤学期刊上的274项癌症RCT。符合条件的文章是那些报告了以生存终点为主要分析内容的RCT。方法学家根据七个关键点对文章进行审查和评分：生存终点完整定义（起始时间、生存事件、删失事件）的普遍性及其分析的相关信息（估计值或效应量、精度、事件数量、风险患者数量）。从随机子样本中评估关键点的一致性。
筛选后，选择了125篇文章；104项试验为III期试验（83%），98篇出版物（78%）来自肿瘤学期刊。在这些RCT中，共记录了267个生存终点，总生存（OS）是最常见的结果（118项，44%）。65篇文章（52%）中的113个终点（42%）的生存术语得到了完全定义。40篇文章（32%）中的73个终点（27%）获得了关于分析的准确信息。定义不太明确的信息是风险患者数量（55%）。可靠性良好（kappa = 0.72）。最后，根据关键点，在33个终点（12%）或10篇出版物中发现了最佳报告。
大多数文章未能提供生存终点的完整报告，从而增加了另一个无法控制的变异性来源。
