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    Prevalence of and risk factors for cognitive impairment in patients with relapsing-remitting multiple sclerosis: Multi-center, controlled trial
    (Elsevier Sci Ltd, 2018) Ozakbas, Serkan; Turkoglu, Recai; Tamam, Yusuf; Terzi, Murat; Taskapilioglu, Ozlem; Yucesan, Canan; Baser, Hatice Limoncu
    Background: Cognitive impairment (CI) is a common problem in multiple sclerosis (MS), may occur either in early or late phase of the disease, and impairs quality of life. Objectives: This study aimed to determine the prevalence of CI and related risk factors in relapsing-remitting MS (RRMS) patients in Turkey. Methods: The present cross-sectional, multi-center, and nationally representative study included RRMS patients. Sociodemographic characteristics, cognitive functions and additional outcomes were compared between patients with and without CI. Results: The analyses included 487 RRMS patients. According to the BRB-N battery results, CI prevalence was 53.7%. There was a negative significant correlation of BRB-N subtests with age, disease duration, and EDSS and MSNQ-patient rated scores. On the logistic regression analysis, increased age, living in village/rural area, high income level, and high EDSS score were significant increasing risk factors in the development of CI. Conclusions: This is the first national cognitive data obtained from MS in Turkey, which is a country between Europe and Asia and thus has characteristics of both continents. The similarity of the results of the present study obtained from Turkey to the Western-based data indicates that CI is universal in MS and the main factors affecting CI have not changed.
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    Testing patient-reported outcome measurement equivalence in multinational clinical trials: An exemplar using the 12-item Multiple Sclerosis Walking Scale
    (SAGE Publications Inc., 2017) Dib, Hussein; Tamam, Yusuf; Terzi, Murat; Hobart, Jeremy
    Background: Although multinational clinical trials frequently use patient-reported outcomes to measure efficacy, measurement equivalence across cultures and languages, a scientific requirement, is rarely tested. Clinically accessible accounts are rare; exemplars are needed. Objective: To develop and test a Turkish version of the Multiple Sclerosis Walking Scale (MSWS-12v2) as a clinical exemplar for examining measurement equivalence. Methods: The MSWS-12v2 Turkish (MSWS-12v2T) was developed using recognised methods for linguistic equivalence. Rasch measurement theory was used to examine measurement performance (multiple tests of targeting, scale performance, and person measurement) and measurement equivalence (differential item functioning). UK data (n = 3310) were used for comparisons and differential item functioning testing. Results: One hundred and twenty-four people from two Turkish centres completed the MSWS-12v2T. Rasch measurement theory evidence supported MSWS-12v2T as reliable (person separation = 0.96) and valid (thresholds ordered; no concerning item misfit, bias, or person misfit). However, four items demonstrated significantly different performance between UK and Turkish samples. These item differences significantly affected scores (person measurements) at the group-level (p < 0.001). Individual person differences were less pronounced. Conclusions: Linguistic equivalence does not guarantee measurement equivalence; independent testing is required. Rasch measurement theory enables sophisticated and unique examinations of cross-cultural measurement equivalence and we recommend this be tested routinely in pivotal multiple sclerosis clinical trials.
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    Use of follow-on fingolimod for multiple sclerosis: Analysis of effectiveness and patient reported outcomes in a real-world clinical setting
    (Elsevier Ltd., 2023) Altunan, Bengü; Efendi, Hüsnü; Köseoğlu, Mesrure; Terzi, Murat; Kotan, Dilcan; Tamam, Yusuf; Ünal, Aysun
    Background: Follow-on disease modifying therapies (FO-DMTs) do not always require Phase III studies. There are concerns that cheaper FO-DMTs are only used to reduce healthcare costs. However, the well-being of people with MS (pwMS) should be a priority. We aimed to evaluate the efficacy, safety and treatment satisfaction of one of the FO- Fingolimod (FTY) used in Turkey with the approval of Turkish Ministry of Health. Methods: PwMS under FTY were recruited from 13 centers and real-world data and answers of satisfaction and adherence statements of pwMS on FTY treatment were analyzed. Results: Data of 239 pwMS were obtained. The duration of FTY treatment was 2.5 ± 0.8 (1–4) years in pwMS who were included in the study and whose treatment continued for at least one year. Significant decreases in annual relapse rate (p < 0.001), Expanded Disability Status Scale (p < 0.001) and neuroimaging findings (p < 0.001) were observed. While 64% of the patients were satisfied and 71.5% were found to adherent with this FO-FTY. Conclusion: This multicenter retrospective study found that the efficacy, safety and treatment adherence of a prescribed FO-FTY were consistent with the results of real-world studies. Studies including real-world data may provide guidance to address issues related to FO-FTY use.