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Sensitivity analysis for a partially missing binary outcome in a two‐arm randomized clinical trial
Author(s) -
Liublinska Victoria,
Rubin Donald B.
Publication year - 2014
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.6197
Subject(s) - missing data , computer science , robustness (evolution) , sensitivity (control systems) , outcome (game theory) , binary number , randomized controlled trial , tipping point (physics) , data mining , machine learning , statistics , artificial intelligence , medicine , mathematics , biochemistry , chemistry , arithmetic , mathematical economics , surgery , electrical engineering , electronic engineering , engineering , gene
Although recent guidelines for dealing with missing data emphasize the need for sensitivity analyses, and such analyses have a long history in statistics, universal recommendations for conducting and displaying these analyses are scarce. We propose graphical displays that help formalize and visualize the results of sensitivity analyses, building upon the idea of ‘tipping‐point’ analysis for randomized experiments with a binary outcome and a dichotomous treatment. The resulting ‘enhanced tipping‐point displays’ are convenient summaries of conclusions obtained from making different modeling assumptions about missingness mechanisms. The primary goal of the displays is to make formal sensitivity analysesmore comprehensible to practitioners, thereby helping them assess the robustness of the experiment's conclusions to plausible missingness mechanisms. We also present a recent example of these enhanced displays in amedical device clinical trial that helped lead to FDA approval. Copyright © 2014 John Wiley & Sons, Ltd.