Reanalyses of Randomized Clinical Trial Data
Reanalyses of Randomized Clinical Trial Data
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DOI：
10.1001/jama.2014.9646
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发表时间：
2014-09-10
影响因子：
120.7
通讯作者：
Ioannidis, John P. A.
中科院分区：
文献类型：
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作者：
Ebrahim, Shanil;Sohani, Zahra N.;Ioannidis, John P. A.
重新分析随机临床试验（RCT）数据可以帮助科学界评估所报道的试验结果的有效性。目的：识别已发表的RCT数据再分析，描述原始试验和再分析在方法学和其他方面的差异，评估进行再分析的作者的独立性，并评估再分析是否改变了原始文章对应该接受治疗的患者类型或数量的解释。设计：我们完成了MEDLINE从成立到2014年3月9日的电子检索，以确定所有已发表的研究，这些研究完成了对先前发表的RCT的个体患者数据的再分析，解决了与原始RCT相同的假设。四个数据提取器独立筛选文章并提取数据。主要结局和测量：治疗效果的方向和幅度、统计学意义的改变，以及对应接受治疗的患者类型或人数的解释。结果：我们在36篇已发表的文章中确定了37篇符合条件的再分析，其中5篇由完全独立的作者进行（2篇基于公开数据，2篇基于应要求提供的数据；1篇的数据可用性尚不清楚）。再分析的差异最常见的是统计或分析方法（n = 18）和感兴趣结果的定义或测量（n = 12）。4次再分析改变了治疗效果的方向，2次改变了治疗效果的大小，4次改变了结果的统计学意义。13例（35%）的重新分析导致了与原文不同的解释，3例（8%）显示了不同的患者应该接受治疗；1(3%)，应该治疗更少的患者；9人（24%）认为应该治疗更多的患者。结论和相关性迄今为止，已经发表了少量的rct再分析。只有少数是由完全独立的作者进行的。在已发表的重新分析中，有35%的研究结果发生了变化，得出的结论与原文章中关于应接受治疗的患者类型和数量的结论不同。
IMPORTANCE Reanalyses of randomized clinical trial (RCT) data may help the scientific community assess the validity of reported trial results.OBJECTIVES To identify published reanalyses of RCT data, to characterize methodological and other differences between the original trial and reanalysis, to evaluate the independence of authors performing the reanalyses, and to assess whether the reanalysis changed interpretations from the original article about the types or numbers of patients who should be treated.DESIGN We completed an electronic search of MEDLINE from inception to March 9, 2014, to identify all published studies that completed a reanalysis of individual patient data from previously published RCTs addressing the same hypothesis as the original RCT. Four data extractors independently screened articles and extracted data.MAIN OUTCOMES AND MEASURES Changes in direction and magnitude of treatment effect, statistical significance, and interpretation about the types or numbers of patients who should be treated.RESULTS We identified 37 eligible reanalyses in 36 published articles, 5 of which were performed by entirely independent authors (2 based on publicly available data and 2 on data that were provided on request; data availability was unclear for 1). Reanalyses differed most commonly in statistical or analytical approaches (n = 18) and in definitions or measurements of the outcome of interest (n = 12). Four reanalyses changed the direction and 2 changed the magnitude of treatment effect, whereas 4 led to changes in statistical significance of findings. Thirteen reanalyses (35%) led to interpretations different from that of the original article, 3 (8%) showing that different patients should be treated; 1 (3%), that fewer patients should be treated; and 9 (24%), that more patients should be treated.CONCLUSIONS AND RELEVANCE A small number of reanalyses of RCTs have been published to date. Only a few were conducted by entirely independent authors. Thirty-five percent of published reanalyses led to changes in findings that implied conclusions different from those of the original article about the types and number of patients who should be treated.