论文标题

随机临床试验的荟萃分析中的偏差校正方法,没有调整零泄漏的结果

A Bias Correction Method in Meta-analysis of Randomized Clinical Trials with no Adjustments for Zero-inflated Outcomes

论文作者

Zhou, Zhengyang, Xie, Minge, Huh, David, Mun, Eun-Young

论文摘要

许多临床终点措施,例如每周消耗的标准饮料数量或患者住在医院的天数,都是计数零过多的数据。但是,在临床试验的分析中,有时会忽略此类结果的零膨胀性。这导致了对研究水平干预效应的偏见,因此在荟萃分析中对总体干预效应的有偏见估计。当前的研究提出了一种新型的统计方法,即零通胀偏置校正(ZIBC)方法,该方法可以考虑使用Poisson回归模型时引入的偏差,尽管在随机临床试验的结果分布中膨胀的零率很高。这种校正方法仅需要从单个研究中的摘要信息来纠正干预效应估计,就好像它们是使用零泄漏的泊松回归模型适当估计的,因此,当单个参与者级别的数据在某些研究中不可用时,它对荟萃分析具有吸引力。仿真研究和实际数据分析表明,在大多数情况下,ZIBC方法在纠正零通胀偏置方面表现良好。

Many clinical endpoint measures, such as the number of standard drinks consumed per week or the number of days that patients stayed in the hospital, are count data with excessive zeros. However, the zero-inflated nature of such outcomes is sometimes ignored in analyses of clinical trials. This leads to biased estimates of study-level intervention effect and, consequently, a biased estimate of the overall intervention effect in a meta-analysis. The current study proposes a novel statistical approach, the Zero-inflation Bias Correction (ZIBC) method, that can account for the bias introduced when using the Poisson regression model, despite a high rate of inflated zeros in the outcome distribution of a randomized clinical trial. This correction method only requires summary information from individual studies to correct intervention effect estimates as if they were appropriately estimated using the zero-inflated Poisson regression model, thus it is attractive for meta-analysis when individual participant-level data are not available in some studies. Simulation studies and real data analyses showed that the ZIBC method performed well in correcting zero-inflation bias in most situations.

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