Examining Predictors of the Physical and Mental Components of Quality of Life in the TOP MS Study (P07.103)

Abstract

Objective: To assess the most effective predictors of the Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-12 used to assess quality of life in the Treatment Optimization in MS (TOP MS) Study. Background Several MS patient characteristics may be associated with the PCS and MCS including patient age, disability status and levels of fatigue, perceived cognitive deficits and depression. Design/Methods: Potential participants for the TOP MS study were identified at specialty pharmacies with medication therapy management programs. Signed informed consent forms were returned to the pharmacies and study enrollment produced log-on instructions for the study website. At baseline and at regular intervals over 24 months, enrolled participants receive reminders to respond to surveys, including the SF-12 Health Survey, self-reported EDSS, Fatigue Severity Scale (FSS), Perceived Deficits Questionnaire (PDQ), and Patient Health Questionnaire (PHQ-depression). Self-reported responses are entered directly into the study database. Multiple regression analyses were used to identify predictors of the PCS and MCS. Results: The array of patient characteristics that was highly effective at predicting the PCS included patient age, self-reported EDSS, and scores on the FSS, PDQ, and PHQ (adjusted R 2 = .620, p 2 = .467, p Conclusions: While the same set of patient characteristics was highly effective at predicting the PCS and MCS, depression was a unique and mediating variable between disability and MCS while the PCS had two independent predictors: disability and fatigue. Supported by: Teva Pharmaceuticals. Disclosure: Dr. Oleen-Burkey has received personal compensation for activities with Teva Neuroscience. Dr. Oleen-Burkey holds stock and/or stock options in Pfizer, Inc and Teva Neuroscience. Dr. Oleen-Burkey has received research support from Teva Neuroscience. Dr. Zwibel has received personal compensation for activities with Serono, Inc., and Teva Neuroscience. Dr. Zwibel has received research support from Teva Neuroscience. Dr. Coyle has received personal compensation for activities with Acorda Therapeutics, Avanir Pharmaceuticals, Bayer Pharmaceuticals Corporation, Biogen Idec, Genzyme Corporation, Novartis, Questcor, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Coyle has received personal compensation in an editorial capacity for NEURA. Dr. Coyle has received research support from Serono, Inc., Novartis, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Denney has received personal compensation for activities with Teva Neuroscience Inc. as a consultant.Dr. Denney has received research support from Serono Inc.