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An observational study demonstrating the adherence and ease of use of the injector device, RebiSmart®

M. Vališ, J. Šarláková, S. Halúsková, B. Klímová, P. Potužník, M. Peterka, K. Kuča, P. Štourač, J. Mareš, Z. Pavelek,

. 2020 ; 17 (5) : 719-724. [pub] 20200421

Language English Country Great Britain

Document type Clinical Trial, Phase IV, Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't

Background: Adherence to Multiple Sclerosis (MS) treatment is considered one of the crucial factors for ensuring optimal clinical outcomes. Research has shown that the use of self-injector devices improves patient compliance with treatment. Therefore, the main purpose of this study is to evaluate the ease of use of RebiSmart® 2.0 in clinically isolated syndrome/relapsing-remitting MS patients during 12 months treatment period.Methods: A total number of 290 subjects entered into data collection; 249 (86%) of them completed the whole 12 months study period. The primary endpoints and the secondary endpoints were assessed by the User Study Questionnaire. Adherence data were retrieved from RebiSmart® 2.0 (Menu - Dose History) on the respective patient's visit. Outcome measures also included Expanded Disability Status Score, Kurtzke Functional Systems, and Modified Social Support Survey, Modified Social Support Survey-5.Results: This study demonstrated a very high proportion (>95%) of patients with a positive rating of the overall ease of use and the overall convenience of RebiSmart®. The proportion of patients with a positive rating of the ease of use by individual domains and the functions of RebiSmart® were also high (>80%).Conclusion: The findings demonstrate a very good perception of the usability of the device by patients overall and in its individual functions.

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$a Vališ, Martin $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czech Republic.
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$a Background: Adherence to Multiple Sclerosis (MS) treatment is considered one of the crucial factors for ensuring optimal clinical outcomes. Research has shown that the use of self-injector devices improves patient compliance with treatment. Therefore, the main purpose of this study is to evaluate the ease of use of RebiSmart® 2.0 in clinically isolated syndrome/relapsing-remitting MS patients during 12 months treatment period.Methods: A total number of 290 subjects entered into data collection; 249 (86%) of them completed the whole 12 months study period. The primary endpoints and the secondary endpoints were assessed by the User Study Questionnaire. Adherence data were retrieved from RebiSmart® 2.0 (Menu - Dose History) on the respective patient's visit. Outcome measures also included Expanded Disability Status Score, Kurtzke Functional Systems, and Modified Social Support Survey, Modified Social Support Survey-5.Results: This study demonstrated a very high proportion (>95%) of patients with a positive rating of the overall ease of use and the overall convenience of RebiSmart®. The proportion of patients with a positive rating of the ease of use by individual domains and the functions of RebiSmart® were also high (>80%).Conclusion: The findings demonstrate a very good perception of the usability of the device by patients overall and in its individual functions.
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$a Šarláková, Jana $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czech Republic.
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$a Halúsková, Simona $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czech Republic.
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$a Klímová, Blanka $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czech Republic.
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$a Potužník, Pavel $u Department of Neurology, Faculty of Medicine and University Hospital Plzeň, Charles University in Prague, Plzeň, Czech Republic.
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$a Peterka, Marek $u Department of Neurology, Faculty of Medicine and University Hospital Plzeň, Charles University in Prague, Plzeň, Czech Republic.
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$a Kuča, Kamil $u Faculty of Science, Department of Chemistry, University of Hradec Králové, Hradec Králové, Czech Republic.
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$a Štourač, Pavel $u Department of Neurology, University Hospital and Masaryk University, Brno, Czech Republic.
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$a Mareš, Jan $u Department of Neurology, Faculty of Medicine, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.
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$a Pavelek, Zbyšek $u Department of Neurology, Faculty of Medicine and University Hospital Hradec Králové, Charles University in Prague, Hradec Králové, Czech Republic.
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