Contributions
Abstract: EP1410
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Background: Treatment burden (TB) refers to the workload imposed by healthcare on patients and its effect on quality of life (Qol). The Treatment Burden Questionnaire (TBQ) aims to assess TB under varying conditions and treatment contexts. In this study, we evaluated the validity and reliability of a Spanish version of the TBQ for use in MS patients.
Method: The TBQ was translated into Spanish applying a forward-backward translation method. Wording and possible exclusion of items were assessed during a pretest by two focus groups and during semi-structured interviews. A sample including 162 heterogeneous MS patients completed the TBQ. A subgroup of 33 patients also completed the following tests: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite, Symbol Digit Modalities Test, Brief International Cognitive Assessment for Multiple Sclerosis, Multiple Sclerosis International Quality of Life Questionnaire, Fatigue Severity Scale, MOS social support scale, Beck Depression Inventory, Moriski Medication adherence scale-4 and Hospital Anxiety and Depression Scale.
Results: A final pretest version of the TBQ was obtained following 2 focus group sessions and 25 interviews including 38 MS patients (25 females), aged 42.7 + 7.9 years, EDSS 2.1 (range 0-8[1] [2] ). After approval by original authors of the questionnaire, a new item was added as a result of uncertainty over complementary study results, which emerged as an additional burden. 162 randomly selected MS patients answered the modified version. Following statistical analysis, items relating to self-monitoring, dietary changes and physical activity were eliminated due to poor factorial load. Results of Confirmatory Factor Analysis supported a 3-factor structure: 1) burden related to pharmacological treatment, 2) comprehensive health assistance; and 3) psycho-social-economic context. Composite reliability was > 0.8 for all factors. Total TBQ and modified TBQ13 results showed positive correlation with fatigue (TBQ total r=0.467, p 0.006) (TBQ13 r=0.512, p 0.002) and negative correlation with Qol (TBQtotal r=- 0.480, p 0.005)(TBQ13 r =-0.483, p 0.004). No correlation with EDSS or other scales was observed.
Conclusions: We found the Spanish language version of the modified TBQ to be a reliable instrument, and provide evidence of its use in assessing treatment burden in Spanish-speaking MS patients.
Disclosure: This study was supported by Novartis IIT.In the last three years:
Dr. Fiol has received reimbursement for developing educational presentations, advisory boards and travel/accommodations stipends from Merck Argentina, Biogen Argentina, Genzyme Argentina, Bayer Inc, Novartis Argentina and TEVA Argentina.
Dr. Ysrraelit has received reimbursement for developing educational presentations, advisory boards and travel/accommodations stipends from Merck Argentina, Biogen Argentina, Genzyme Argentina, Bayer Inc and Novartis Argentina.
Dr S Vanotti has received reimbursement for developing educational presentations from Biogen Argentina and Novartis Argentina.
Dr. Vasquez has received reimbursement for research coaching presentations and travel/accommodations stipends by Fundación MF para el Desarrollo de la Medicina Familiar y la Atención Primaria, Argentina.
Dr. Terrasa has received reimbursement for research coaching presentations and travel/accommodations stipends by Fundación MF para el Desarrollo de la Medicina Familiar y la Atención Primaria, Argentina.
Dr Correale is a board member of Merck-Serono Argentina, Novartis Argentina, Genzyme LATAM, Genzyme global, Biogen-Idec LATAM, and Merck-Serono LATAM. He is part of the Steering Committee for the clinical trials of Ofatumumab (Novartis Global). Dr. Correale has received reimbursement for developing educational presentations for Merck-Serono Argentina, Merck-Serono LATAM, Biogen-Idec Argentina, Genzyme Argentina, Novartis Argentina, Novartis LATAM, Novartis Global, and TEVA Argentina as well as professional travel/accommodations stipends
Abstract: EP1410
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Background: Treatment burden (TB) refers to the workload imposed by healthcare on patients and its effect on quality of life (Qol). The Treatment Burden Questionnaire (TBQ) aims to assess TB under varying conditions and treatment contexts. In this study, we evaluated the validity and reliability of a Spanish version of the TBQ for use in MS patients.
Method: The TBQ was translated into Spanish applying a forward-backward translation method. Wording and possible exclusion of items were assessed during a pretest by two focus groups and during semi-structured interviews. A sample including 162 heterogeneous MS patients completed the TBQ. A subgroup of 33 patients also completed the following tests: Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite, Symbol Digit Modalities Test, Brief International Cognitive Assessment for Multiple Sclerosis, Multiple Sclerosis International Quality of Life Questionnaire, Fatigue Severity Scale, MOS social support scale, Beck Depression Inventory, Moriski Medication adherence scale-4 and Hospital Anxiety and Depression Scale.
Results: A final pretest version of the TBQ was obtained following 2 focus group sessions and 25 interviews including 38 MS patients (25 females), aged 42.7 + 7.9 years, EDSS 2.1 (range 0-8[1] [2] ). After approval by original authors of the questionnaire, a new item was added as a result of uncertainty over complementary study results, which emerged as an additional burden. 162 randomly selected MS patients answered the modified version. Following statistical analysis, items relating to self-monitoring, dietary changes and physical activity were eliminated due to poor factorial load. Results of Confirmatory Factor Analysis supported a 3-factor structure: 1) burden related to pharmacological treatment, 2) comprehensive health assistance; and 3) psycho-social-economic context. Composite reliability was > 0.8 for all factors. Total TBQ and modified TBQ13 results showed positive correlation with fatigue (TBQ total r=0.467, p 0.006) (TBQ13 r=0.512, p 0.002) and negative correlation with Qol (TBQtotal r=- 0.480, p 0.005)(TBQ13 r =-0.483, p 0.004). No correlation with EDSS or other scales was observed.
Conclusions: We found the Spanish language version of the modified TBQ to be a reliable instrument, and provide evidence of its use in assessing treatment burden in Spanish-speaking MS patients.
Disclosure: This study was supported by Novartis IIT.In the last three years:
Dr. Fiol has received reimbursement for developing educational presentations, advisory boards and travel/accommodations stipends from Merck Argentina, Biogen Argentina, Genzyme Argentina, Bayer Inc, Novartis Argentina and TEVA Argentina.
Dr. Ysrraelit has received reimbursement for developing educational presentations, advisory boards and travel/accommodations stipends from Merck Argentina, Biogen Argentina, Genzyme Argentina, Bayer Inc and Novartis Argentina.
Dr S Vanotti has received reimbursement for developing educational presentations from Biogen Argentina and Novartis Argentina.
Dr. Vasquez has received reimbursement for research coaching presentations and travel/accommodations stipends by Fundación MF para el Desarrollo de la Medicina Familiar y la Atención Primaria, Argentina.
Dr. Terrasa has received reimbursement for research coaching presentations and travel/accommodations stipends by Fundación MF para el Desarrollo de la Medicina Familiar y la Atención Primaria, Argentina.
Dr Correale is a board member of Merck-Serono Argentina, Novartis Argentina, Genzyme LATAM, Genzyme global, Biogen-Idec LATAM, and Merck-Serono LATAM. He is part of the Steering Committee for the clinical trials of Ofatumumab (Novartis Global). Dr. Correale has received reimbursement for developing educational presentations for Merck-Serono Argentina, Merck-Serono LATAM, Biogen-Idec Argentina, Genzyme Argentina, Novartis Argentina, Novartis LATAM, Novartis Global, and TEVA Argentina as well as professional travel/accommodations stipends