Valid randomization-based p-values for partially post hoc subgroup analyses.

Stat Med

Department of Statistics, Harvard University, 1 Oxford St., Cambridge, MA, 02138, U.S.A.

Published: October 2015

By 'partially post-hoc' subgroup analyses, we mean analyses that compare existing data from a randomized experiment-from which a subgroup specification is derived-to new, subgroup-only experimental data. We describe a motivating example in which partially post hoc subgroup analyses instigated statistical debate about a medical device's efficacy. We clarify the source of such analyses' invalidity and then propose a randomization-based approach for generating valid posterior predictive p-values for such partially post hoc subgroups. Lastly, we investigate the approach's operating characteristics in a simple illustrative setting through a series of simulations, showing that it can have desirable properties under both null and alternative hypotheses.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4656045PMC
http://dx.doi.org/10.1002/sim.6531DOI Listing

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