Wageningen University and Research, Biometris, Droevendaalsesteeg 1, 6708, PB, Wageningen, the Netherlands.
Wageningen University and Research, Biometris, Droevendaalsesteeg 1, 6708, PB, Wageningen, the Netherlands.
Food Chem Toxicol. 2023 Aug;178:113928. doi: 10.1016/j.fct.2023.113928. Epub 2023 Jul 3.
Equivalence testing is an important component of safety assessments, used for example by the European Food Safety Authority, to allow new food or feed products on the market. The aim of such tests is to demonstrate equivalence of characteristics of test and reference crops. Equivalence tests are typically univariate and applied to each measured analyte (characteristic) separately without multiplicity correction. This increases the probability of making false claims of equivalence (type I errors) when evaluating multiple analytes simultaneously. To solve this problem, familywise error rate (FWER) control using Hochberg's method has been proposed. This paper demonstrates that, in the context of equivalence testing, other FWER-controlling methods are more powerful than Hochberg's. Particularly, it is shown that Hommel's method is guaranteed to perform at least as well as Hochberg's and that an "adaptive" version of Bonferroni's method, which uses an estimator of the proportion of non-equivalent characteristics, often substantially outperforms Hommel's method. Adaptive Bonferroni takes better advantage of the particular context of food safety where a large proportion of true equivalences is expected, a situation where other methods are particularly conservative. The different methods are illustrated by their application to two compositional datasets and further assessed and compared using simulated data.
等效性检验是安全性评估的一个重要组成部分,例如,欧洲食品安全局就使用等效性检验来允许新的食品或饲料产品进入市场。此类检验旨在证明受试作物和参照作物的特性具有等效性。等效性检验通常是单变量的,并且对每个单独测量的分析物(特性)进行检验,而不进行多重性校正。当同时评估多个分析物时,这会增加错误声称等效性(I 型错误)的可能性。为了解决这个问题,已经提出了使用 Hochberg 方法进行总体错误率(FWER)控制。本文表明,在等效性检验的背景下,其他 FWER 控制方法比 Hochberg 方法更有效。特别是,证明了 Hommel 方法至少与 Hochberg 方法一样有效,并且 Bonferroni 方法的一种“自适应”版本,该方法使用非等效特性比例的估计值,通常会大大优于 Hommel 方法。自适应 Bonferroni 可以更好地利用食品安全的特定背景,在这种情况下,预计会有很大比例的真实等效性,而其他方法在这种情况下特别保守。通过将这些方法应用于两个组成数据集来说明这些方法,并使用模拟数据进一步评估和比较这些方法。