Adaptation and validation of a Spanish version of the treatment burden questionnaire in patients with multiple sclerosis

María Célica Ysrraelit, Marcela Paula Fiol, Fernando Vazquez Peña, Sandra Vanotti, Sergio Adrián Terrasa, Viet Thi Tran, Victor Manuel Montori, Jorge Correale

Research output: Contribution to journalArticle

Abstract

Background: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). Methods: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients' sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. Results: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs = 0.467, p = 0.006), negative correlation with QoL (rs - 0.446, p = 0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p = 0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p = 0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p = 0.002). Conclusions: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.

Original languageEnglish (US)
Article number209
JournalBMC Neurology
Volume19
Issue number1
DOIs
StatePublished - Aug 27 2019

Fingerprint

Multiple Sclerosis
Therapeutics
Surveys and Questionnaires
Medication Adherence
Quality of Life
Fatigue
Pharmacology
Injections
Sex Education
Resource Allocation
Health Resources
Workload
Focus Groups
Statistical Factor Analysis
Comorbidity

Keywords

  • Minimally disruptive medicine
  • Multiple sclerosis
  • Patient-reported-outcome
  • QoL
  • Questionnaires
  • Treatment burden

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Ysrraelit, M. C., Fiol, M. P., Peña, F. V., Vanotti, S., Terrasa, S. A., Tran, V. T., ... Correale, J. (2019). Adaptation and validation of a Spanish version of the treatment burden questionnaire in patients with multiple sclerosis. BMC Neurology, 19(1), [209]. https://doi.org/10.1186/s12883-019-1441-0

Adaptation and validation of a Spanish version of the treatment burden questionnaire in patients with multiple sclerosis. / Ysrraelit, María Célica; Fiol, Marcela Paula; Peña, Fernando Vazquez; Vanotti, Sandra; Terrasa, Sergio Adrián; Tran, Viet Thi; Montori, Victor Manuel; Correale, Jorge.

In: BMC Neurology, Vol. 19, No. 1, 209, 27.08.2019.

Research output: Contribution to journalArticle

Ysrraelit, María Célica ; Fiol, Marcela Paula ; Peña, Fernando Vazquez ; Vanotti, Sandra ; Terrasa, Sergio Adrián ; Tran, Viet Thi ; Montori, Victor Manuel ; Correale, Jorge. / Adaptation and validation of a Spanish version of the treatment burden questionnaire in patients with multiple sclerosis. In: BMC Neurology. 2019 ; Vol. 19, No. 1.
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AU - Vanotti, Sandra

AU - Terrasa, Sergio Adrián

AU - Tran, Viet Thi

AU - Montori, Victor Manuel

AU - Correale, Jorge

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N2 - Background: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). Methods: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients' sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. Results: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs = 0.467, p = 0.006), negative correlation with QoL (rs - 0.446, p = 0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p = 0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p = 0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p = 0.002). Conclusions: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.

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