Measuring treatment satisfaction in MS: Is the Treatment Satisfaction Questionnaire for Medication fit for purpose?

Patrick Vermersch, Jeremy Hobart, Catherine Dive-Pouletty, Sylvie Bozzi, Steven Hass, Patricia K Coyle, Patrick Vermersch, Jeremy Hobart, Catherine Dive-Pouletty, Sylvie Bozzi, Steven Hass, Patricia K Coyle

Abstract

Background: The Treatment Satisfaction Questionnaire for Medication (TSQM) was designed to assess patient treatment satisfaction in chronic diseases. Its performance has not been examined in multiple sclerosis (MS). The 14 items of the TSQM cover four domains: Effectiveness, Side Effects, Convenience, and Global Satisfaction.

Objective: To evaluate performance of the TSQM in patients with relapsing MS, using data collected from the TENERE study (NCT00883337), in which 324 patients received oral teriflunomide or subcutaneous interferon beta-1a for ⩾48 weeks.

Methods: Five measurement properties were examined using traditional psychometric methods: data completeness, scale-to-sample targeting, scaling assumptions, reliability (including test-retest), and construct validity (internal: item-level scaling success, confirmatory factor analysis, and exploratory factor analysis; external: convergence, discrimination, and group differences).

Results: There were few (<2%) missing item data; domain scores could be computed for all patients. Score distributions were skewed toward higher satisfaction; two domains had marked ceiling effects. Scaling assumptions were supported. Internal consistency reliability was high (Cronbach's α > 0.90). Internal validity tests supported item groupings. Correlations supported convergent and discriminant construct validity; hypothesis testing supported group differences validity.

Conclusion: This investigation found the TSQM to be a useful tool, exhibiting good psychometric measurement properties in patients with relapsing MS in the TENERE study.

Keywords: Multiple sclerosis; disease-modifying therapy; outcomes assessment; psychometrics; relapsing-remitting; teriflunomide; treatment satisfaction.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: P.V. received honoraria, consulting fees (Almirall, Bayer, Biogen Idec, GSK, Merck Serono, Novartis, Sanofi Genzyme, and Teva), and research support (Bayer, Biogen Idec, Merck Serono, and Sanofi Genzyme). J.H. received honoraria, consulting fees (Acorda, Biogen Idec, Critical Path Institute, LORA group, MAPI Research Institute, and Sanofi Genzyme), license fee payments or royalty payments (Plymouth University receives fees for the use of rating scales developed as part of author’s research), and research support (Biogen Idec, Novartis, and Merck Serono). C.D.-P. was an employee of Sanofi Genzyme at the time of data analysis. S.B. and S.H. are employees of Sanofi Genzyme. P.K.C. received consulting fees (AbbVie, Accordant, Acorda, Bayer, Biogen, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, and Teva) and research support (Actelion, Genentech/Roche, Novartis, and Opexa).

Figures

Figure 1.
Figure 1.
FDA roadmap to patient-focused outcome measurement in clinical trials. Reproduced with permission from the US Food and Drug Administration.
Figure 2.
Figure 2.
Confirmatory factor analysis of the TSQM. TSQM: Treatment Satisfaction Questionnaire for Medication (version 1.4). Ovoids represent unobserved variables (domains); rectangles represent observed variables (items); arrows represent the hypothesized links between the variables; parameters relative to each arrow are standardized estimates of the strength of association between the linked variables. Root mean square error of approximation, 0.067; Normed Fit Index, 0.958; Goodness-of-Fit Index, 0.925; Adjusted Goodness-of-Fit Index, 0.884; Standardized Root Mean Square Residual, 0.044.

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