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Activity Number: 518
Type: Contributed
Date/Time: Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #304686
Title: Treatment-Outcome Complex and Analysis of Observational Data
Author(s): Lev S. Sverdlov*+
Companies: Schering-Plough Research Institute
Address: 50 Lawrence Rd, Springfield, NJ, 07081,
Keywords: treatment-outcome complex ; observational data ; therapeutic process ; longitudinal ; efficacy ; effectiveness
Abstract:

A concept of a treatment-outcome complex (TOC) will be presented in the context of analysis of the effects of drugs using observational data. A classic experimental approach does not apply toward this analysis because of a bias due to non-random assignment of patients to treatments. Also while measuring an outcome at any moment of treatment of a chronic disorder we in fact assess neither a severity of the condition, nor the effect of treatment. Rather it is a momentary functional state of the patient under the influence of therapy. The concept of TOC models a therapeutic process as a sequence of the functional states and integrates cross-sectional and longitudinal aspects of the process. The opportunities and limitations of analysis of observational data to assess intended and unintended effects of treatment in the framework of this approach will be discussed.


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