P-values and decision-making: discussion of 'Limitations of empirical calibration of p-values using observational data'.
Gruber and Tchetgen Tchetgen bring up many important limitations of p-value calibration as applied to the assessment of the safety and effectiveness of medications in secondary administrative data. In this discussion, I further examine the role of study design and selection of comparators in interpreting p-value calibration results, and we consider the advantages and disadvantages of automation in the epidemiology of medications, including p-value calibration. Copyright © 2016 John Wiley & Sons, Ltd.
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, U.S.A.
Jessica M
0000-0002-8941-4116
JM
Franklin
D002138:Calibration; D003627:Data Interpretation, Statistical; D003657:Decision Making; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D012107:Research Design
confounding; drug safety; p-value; p-value calibration; pharmacoepidemiology; pharmacovigilance