This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 61
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307113
Title: Design of Nonrandomized Medical Device Trials Based on Subclassification Using Propensity Score Quintiles
Author(s): Greg Maislin*+ and Donald B. Rubin
Companies: Biomedical Statistical Consulting and Harvard University
Address: 1357 GardenRd, Wynnewood, PA, 19096,
Keywords: Propensity score ; non-randomized trial ; observational study ; bias reduction ; orthopedic device

Motivation for making comparisons between non-randomized cohorts is increasing; especially in orthopedic device studies designed to provide evidence of safety and effectiveness; where patients can be savvy and knowledgeable. Many sponsors possess cohorts enrolled in prior PMA or 510(k) studies. Propensity score (PS) approaches are designed to minimize selection bias in non-randomized group comparisons. We present a heuristic for PS modeling building in line with methods in Rosenbaum and Rubin (1984), Rubin (2001), and Imbens and Rubin (2009). The process poses no concern for Type I error inflation because no outcome data is used. Instead, it should be viewed as part of the 'design of the observational study'. Graphical techniques will be presented capable of showing a non-statistical audience that balance among observed variables is at least as good as expected through randomization.

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