JSM 2004 - Toronto

Abstract #300348

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Activity Number: 101
Type: Topic Contributed
Date/Time: Monday, August 9, 2004 : 10:30 AM to 12:20 PM
Sponsor: WNAR
Abstract - #300348
Title: Mean Changes vs. Dichotomous Definitions of Improvement
Author(s): Jennifer J. Anderson*+
Companies: Boston University
Address: 38 Harvard St., Arlington, MA, 02476,
Keywords: improvement criteria ; dichotomy ; rheumatoid arthritis ; ankylosing spondylitis ; simulation ; multivariate normal
Abstract:

In several areas within rheumatology dichotomous definitions of improvement are in use in the reporting of clinical trials, but it is to be expected that continuous definitions would offer improved discrimination between treatment groups. Nevertheless, a well-constructed dichotomous outcome (usually a composite) has advantages of clinical sense and specificity and may, under a variety of realistic conditions, have power that closely approximates that of standard continuous outcome measures. This has been seen for established dichotomous outcome definitions for two rheumatological conditions, rheumatoid arthritis (RA) and ankylosing spondylitis (AS). Simulation studies have been performed using multivariate normal generated data that approximates actual trial data for each of RA and AS patients. They demonstrate relative power of several dichotomous and continuous outcomes in realistic situations for each of RA and AS. These results will be presented and discussed.

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Revised March 2004