Abstract

The use of multiple imputation (MI) to address missing data has improved the quality of clinical trial reporting but has also introduced the nuisance of results that are subject to sampling variability introduced by using a finite number of imputations. There is a tradeoff between ensuring that enough imputations are used to obtain accurate results for decision making while at the same time keeping the number of imputations low enough to avoid computational bottlenecks. We propose a rule for evaluating this tradeoff that extends the familiar idea of exact reproducibility of statistical results: enough imputations are used if an independent round of MI yields exactly the same result when rounded to the chosen reporting precision, with high probability. We explore how this reproducibility rule can be used derive simple criteria for choosing the number of imputations at the planning stage of a clinical trial.

摘要

使用多重插补 (MI) 解决缺失数据提高了临床试验报告的质量，但也引入了受使用有限数量插补引入的抽样变异性影响的结果的麻烦。在确保使用足够的插补以获得准确的决策结果，同时保持足够低的插补数量以避免计算瓶颈之间存在权衡。我们提出了一个评估这种权衡的规则，该规则扩展了统计结果精确可重复性的熟悉想法：如果独立轮次 MI 在舍入到所选报告精度时产生完全相同的结果，则使用足够的插补，并且概率很高。