JSM 2005 - Toronto

Abstract #303415

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 309
Type: Topic Contributed
Date/Time: Tuesday, August 9, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biometrics Section
Abstract - #303415
Title: Analyses of Short- and Long-term Treatment Effects on Longitudinal Quality of Life
Author(s): Donna Ankerst*+ and Caroline Jiang
Companies: Sylvia Lawry Centre for Multiple Sclerosis Research and The Queen's Medical Center
Address: Hohenlindener Str 1, Muenchen, D-81677, Germany
Keywords: Quality of life ; Non-ignorable missing data ; clinical trial
Abstract:

To economically differentiate the short- and long-term impact of therapy on patient QOL in clinical trials, assessments are typically performed at a small number of relevant time points that include baseline, mid-therapy, immediately, and at extended times after therapy. The population mean QOL trajectories may be nonlinear, with either improvements or deteriorations during treatment followed by retreats to baseline levels or sustained improvements. There may be missing data resulting from a dropout mechanism that is nonignorable, as patients with deteriorating health are more likely to be lost to followup. We provide a comprehensive pattern mixture time factor (PMTF) model for assessing nonlinear short- and long-term treatment effects in the presence of nonignorable missing data. The PMTF model makes explicit the assumptions concerning missing data, which are not identifiable and must be varied, resulting in a sensitivity analysis of treatment effects.


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Revised March 2005