A sample size calibration approach for the p-value problem in huge samples

Abstract

The inclusion of covariates in the model often affects not only the estimates of meaningful variables of interest but also its statistical significance. Such gap between statistical and subject-matter significance is a critical issue in huge sample studies. A popular huge sample study, the sample cohort data from Korean National Health Insurance Service, showed such gap of significance in the inference for the effect of obesity on cause of mortality, requiring careful consideration. In this regard, this paper proposes a sample size calibration method based on a Monte Carlo t (or z)-test approach without Monte Carlo simulation, and also proposes a test procedure for subject-matter significance using this calibration method in order to complement the deflated p-value in the huge sample size. Our calibration method shows no subject-matter significance of the obesity paradox regardless of race, sex, and age groups, unlike traditional statistical suggestions based on p-values.