Statistical analysis of individual participant data meta-analyses: a comparison of methods and recommendations for practice.

Statistical analysis of individual participant data meta-analyses: a comparison of methods and recommendations for practice.
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DOI:
10.1371/journal.pone.0046042
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发表时间:
2012
期刊:
影响因子:
3.7
通讯作者:
Stewart LA
Stewart LA
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Stewart GB;Altman DG;Askie LM;Duley L;Simmonds MC;Stewart LA

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从研究中获取“原始”数据而不是汇总数据的个体参与者数据 (IPD) 荟萃分析通常采用“两阶段”分析方法,试验中的 IPD 生成汇总指标,并使用标准荟萃分析方法将其组合起来。最近,一系列“单阶段”方法将所有个体参与者数据结合在一个荟萃分析中,被认为提供了一种更强大、更灵活的方法。然而,它们实施起来更加复杂,并且需要统计支持。本研究使用数据集来比较不同复杂性的“两阶段”和“单阶段”模型,以确定从这些方法获得的结果是否具有临床意义。我们纳入了 24 项随机对照试验的数据,这些试验评估抗血小板药物预防妊娠期先兆子痫的作用。我们进行了两阶段和一阶段 IPD 荟萃分析,以估计总体治疗效果并探索潜在的治疗相互作用,从而使特定类型的妇女及其婴儿可能从接受抗血小板药物中获得不同的获益。两阶段和一阶段方法给出了相似的结果,显示了使用抗血小板药物的益处(相对风险 0.90,95% CI 0.84 至 0.97)。这两种方法都表明任何特定类型的女性都或多或少地从抗血小板药物中受益。不同类型的一阶段模型之间的结果没有实质性差异。对于这些数据,两阶段和一阶段的分析方法会产生类似的结果。尽管一阶段模型为探索模型结构提供了灵活的环境,并且在与参与者类型相关的研究模式中非常有用,干预和结果掩盖了试验中的类似关系,但其使用提供的额外见解可能不会超过随机对照试验综合中常规应用的统计支持成本。在结合大型随机试验的信息时,考虑进行 IPD 荟萃分析的研究人员不一定会因为认为需要复杂的统计方法而被阻止。
Individual participant data (IPD) meta-analyses that obtain “raw” data from studies rather than summary data typically adopt a “two-stage” approach to analysis whereby IPD within trials generate summary measures, which are combined using standard meta-analytical methods. Recently, a range of “one-stage” approaches which combine all individual participant data in a single meta-analysis have been suggested as providing a more powerful and flexible approach. However, they are more complex to implement and require statistical support. This study uses a dataset to compare “two-stage” and “one-stage” models of varying complexity, to ascertain whether results obtained from the approaches differ in a clinically meaningful way. We included data from 24 randomised controlled trials, evaluating antiplatelet agents, for the prevention of pre-eclampsia in pregnancy. We performed two-stage and one-stage IPD meta-analyses to estimate overall treatment effect and to explore potential treatment interactions whereby particular types of women and their babies might benefit differentially from receiving antiplatelets. Two-stage and one-stage approaches gave similar results, showing a benefit of using anti-platelets (Relative risk 0.90, 95% CI 0.84 to 0.97). Neither approach suggested that any particular type of women benefited more or less from antiplatelets. There were no material differences in results between different types of one-stage model. For these data, two-stage and one-stage approaches to analysis produce similar results. Although one-stage models offer a flexible environment for exploring model structure and are useful where across study patterns relating to types of participant, intervention and outcome mask similar relationships within trials, the additional insights provided by their usage may not outweigh the costs of statistical support for routine application in syntheses of randomised controlled trials. Researchers considering undertaking an IPD meta-analysis should not necessarily be deterred by a perceived need for sophisticated statistical methods when combining information from large randomised trials.
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期刊: CLINICAL TRIALS
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发表时间: 2011-09-01
影响因子: 9.8
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DOI: 10.1002/sim.918
发表时间: 2001-08-15
影响因子: 2
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