How Satisfied with Their Treatment Are Patients with MS? Psychometric Evaluation of the Treatment Satisfaction Questionnaire for Medication (TSQM) (P3.236)

OBJECTIVE: To evaluate aspects of the measurement performance of the Treatment Satisfaction Questionnaire for Medication (TSQM, version 1.4), applying traditional psychometric methodology and using data from the TENERE study (NCT00883337) conducted in patients with relapsing multiple sclerosis (RMS). BACKGROUND: TSQM performance was previously evaluated in patients with 9 chronic diseases. The questionnaire comprises 11 items generating 4 domain scores: Effectiveness (2 items); Side Effects (4 items); Convenience (3 items); Global Satisfaction (2 items). DESIGN/METHODS: Patients (n=324) were randomized to receive oral teriflunomide 14mg or 7mg, or subcutaneous (sc) IFNβ-1a for 48-114 weeks. TSQM data completeness was investigated by computing item-level missing data, targeting via score distributions (floor/ceiling effects), and internal consistency using Cronbach’s alpha. Confirmatory factor analysis (CFA) assessed support for item groupings. Convergent and discriminant construct validity was analyzed by correlating TSQM domain scores with treatment failure, confirmed relapses, adverse events (AEs), and mode of administration. Responsiveness was evaluated by computing effect sizes (ES) (Cohen’s d). RESULTS: There were few missing data ( 0.90, all domains). CFA supported item groupings. Validity was supported by between-group (within-domain) differences with statistical significance and small to large ES, including: Effectiveness (treatment failure/success [ P =0.028, ES=0.35], relapses/no relapse [ P =0.041, ES=0.33]); Side Effects (AEs leading to treatment discontinuation/no discontinuation [ P =0.020, ES=3.25], nervous system disorders/none [ P =0.009, ES=0.35], general disorders or administration-site conditions/none [ P P P =0.006, ES=0.43], relapses/no relapse [ P =0.011, ES=0.41]). CONCLUSIONS: This analysis supports the measurement performance of the TSQM in the context of treatment trials for RMS. In TENERE, treatment satisfaction with teriflunomide exceeded that for scIFNβ-1a, demonstrating patient acceptance of teriflunomide as a treatment for RMS. Study Supported by: Genzyme, a Sanofi company. Disclosure: Dr. Patrick has received personal compensation for activities with Biogen Idec. Dr. Hobart has received personal compensation for activities with Biogen Idec, Acorda Therapeutics, Novartis, and Merck Serono. Dr. Dive-Pouletty has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc. Dr. Bozzi has received personal compensation for activities with Sanofi as an employee. Dr. Coyle has received personal compensation for activities with AbbVie, Accordant, Acorda, Bayer, Biogen, EMD Serono, Inc., Genentech, Genzyme, Mylan, Novartis, and Teva as a consultant.