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对来信的回应:“基于标准和参考的条件均值填补:监管机构和试验统计学家需注意!”。

Rejoinder to the letter: "Standard and reference-based conditional mean imputation: Regulators and trial statisticians be aware!".

机构信息

Data & Statistical Sciences, Pharma Development, Roche, Basel, Switzerland.

Data & Statistical Sciences, Pharma Development, Roche, Welwyn Garden City, UK.

出版信息

Pharm Stat. 2024 Sep-Oct;23(5):604-610. doi: 10.1002/pst.2374. Epub 2024 Apr 17.

Abstract

We appreciate Cro et al.'s efforts to bring wider attention to the debate surrounding variance estimation for reference-based imputation methods. However, we believe that the way this debate is presented as "multiple imputation" versus "conditional mean imputation" can be misleading. Both of these imputation methods rely on identical assumptions and provide essentially identical treatment effect estimates. While conditional mean imputation naturally focuses on the frequentist repeated sampling variance, we show here that it can be easily adapted to target a variance with similar properties to Rubin's variance. Therefore, conditional mean imputation combined with jackknife resampling remains a valid and effective deterministic method for handling missing data under missing-at-random or reference-based assumptions regardless of the user's preference for variance estimation. We also reappraise the frequentist variance by arguing that it correctly reflects the strong assumptions of reference-based imputation. In contrast, we are not aware of any frequentist or Bayesian framework under which Rubin's variance provides correct inference.

摘要

我们感谢 Cro 等人努力引起人们对参考基础推断方法的方差估计的争论的关注。然而,我们认为,这种争论被呈现为“多重插补”与“条件均值插补”的方式可能具有误导性。这两种插补方法都依赖于相同的假设,并提供基本相同的处理效应估计。虽然条件均值插补自然侧重于频率派的重复抽样方差,但我们在这里表明,它可以很容易地适应以 Rubin 的方差为目标的方差。因此,条件均值插补与刀切重抽样相结合,仍然是一种有效的确定性方法,可用于处理缺失数据,前提是缺失数据是随机缺失或基于参考的,无论用户对方差估计的偏好如何。我们还通过论证认为,它正确地反映了基于参考的插补的强假设,重新评估了频率派方差。相比之下,我们不知道在任何频率派或贝叶斯框架下,Rubin 的方差提供了正确的推断。

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