Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis
Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis
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DOI：
10.1016/j.jclinepi.2007.03.013
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发表时间：
2008-01-01
影响因子：
7.2
通讯作者：
Gluud, Christian
中科院分区：
文献类型：
--
作者：
Wetterslev, Jorn;Thorlund, Kristian;Gluud, Christian
背景和目的：累积荟萃分析容易产生虚假的P<；0.05，因为随着试验数据的积累，重复检验显著性。Meta分析中的信息量至少应等于一项有充分证据的试验的样本量。试验序贯分析(TSA)对应于单个试验的分组序贯分析，可应用于Meta分析以评估证据。研究设计和地点：随机选择6个新生儿Meta分析，至少有5个试验报告二项结果。计算了低偏倚、异质性调整后的信息量和假设干预效果为15%时确定的信息量。这些被用来构建试验序贯监测边界。结果：5个Meta分析显示早期潜在的P<；005值可能是假的。在三个重要的荟萃分析中，累积的z曲线跨越了两个边界，建立了干预效应的确凿证据。在两个不显著的荟萃分析中，累积的z曲线越过了P=0.05，但没有越过界限，显示出早期潜在的虚假P<；0.05值。在一项不显着的Meta分析中，累积的z曲线从未超过P=0.05或边界。结论：在Meta分析中，TSA可以确定何时达到确凿的证据。(C)2008 Elsevier Inc.保留所有权利。
Background and Objective: Cumulative meta-analyses are prone to produce spurious P < 0.05 because of repeated testing of significance as trial data accumulate. Information size in a meta-analysis should at least equal the sample size of an adequately powered trial. Trial sequential analysis (TSA) corresponds to group sequential analysis of a single trial and may be applied to meta-analysis to evaluate the evidence.Study Design and Setting: Six randomly selected neonatal meta-analyses with at least five trials reporting a binary outcome were examined. Low-bias heterogeneity-adjusted information size and information size determined from an assumed intervention effect of 15% were calculated. These were used for constructing trial sequential monitoring boundaries. We assessed the cumulative z-curves' crossing of P = 0.05 and the boundaries.Results: Five meta-analyses showed early potentially spurious P < 0.05 values. In three significant meta-analyses the cumulative z-curves crossed both boundaries, establishing firm evidence of an intervention effect. In two nonsignificant meta-analyses the cumulative z-curves crossed P = 0.05, but never the boundaries, demonstrating early potentially spurious P < 0.05 values. In one nonsignificant meta-analysis the cumulative z-curves never crossed P = 0.05 or the boundaries.Conclusion: TSAs may establish when firm evidence is reached in meta-analysis. (C) 2008 Elsevier Inc. All rights reserved.