JSM Preliminary Online Program
This is the preliminary program for the 2009 Joint Statistical Meetings in Washington, DC.

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Activity Number: 528
Type: Contributed
Date/Time: Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305271
Title: Ceiling and Regression Effects on Clinical Endpoints in Medical Device Studies
Author(s): Daniel P. Reyner*+
Companies: Zimmer Holdings, Inc
Address: P.O.Box 708, Warsaw, IN, 46581-0708,
Keywords: ceiling effect ; regression to the mean ; nested analysis ; clinical endpoints ; medical device ; othopaedic
Abstract:

Ceiling effects and regression to the mean have both received attention in the orthopedic literature. However, ceiling effects common to medical device studies have often been misclassified as regression effects while effects of regression to the mean have either received less attention or been ignored. This paper demonstrates ceiling effects and regression to the mean via a specific clinical endpoint common in medical device studies. A method of (nested) analysis, proposed for analysis, will be provided, motivated, and applied. Results obtained from analyses will be discussed.

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Revised September, 2008