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