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      Confirmed disability progression provides limited predictive information regarding future disease progression in multiple sclerosis

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          Abstract

          Background

          Although confirmed disability progression (CDP) is a common outcome in multiple sclerosis (MS) clinical trials, its predictive value for long-term outcomes is uncertain.

          Objective

          To investigate whether CDP at month 24 predicts subsequent disability accumulation in MS.

          Methods

          The Comprehensive Longitudinal Investigation of Multiple Sclerosis at Brigham and Women’s Hospital includes participants with relapsing-remitting MS or clinically isolated syndrome with Expanded Disability Status Scale (EDSS) scores ≤5 (N = 1214). CDP was assessed as a predictor of time to EDSS score 6 (EDSS 6) and to secondary progressive MS (SPMS) using a Cox proportional hazards model; adjusted models included additional clinical/participant characteristics. Models were compared using Akaike’s An Information Criterion.

          Results

          CDP was directionally associated with faster time to EDSS 6 in univariate analysis (HR = 1.61 [95% CI: 0.83, 3.13]). After adjusting for month 24 EDSS, CDP was directionally associated with slower time to EDSS 6 (adjusted HR = 0.65 [0.32, 1.28]). Models including CDP had worse fit statistics than those using EDSS scores without CDP. When models included clinical and magnetic resonance imaging measures, T2 lesion volume improved fit statistics. Results were similar for time to SPMS.

          Conclusions

          CDP was less predictive of time to subsequent events than other MS clinical features.

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          Most cited references22

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          Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).

          J. Kurtzke (1983)
          One method of evaluating the degree of neurologic impairment in MS has been the combination of grades (0 = normal to 5 or 6 = maximal impairment) within 8 Functional Systems (FS) and an overall Disability Status Scale (DSS) that had steps from 0 (normal) to 10 (death due to MS). A new Expanded Disability Status Scale (EDSS) is presented, with each of the former steps (1,2,3 . . . 9) now divided into two (1.0, 1.5, 2.0 . . . 9.5). The lower portion is obligatorily defined by Functional System grades. The FS are Pyramidal, Cerebellar, Brain Stem, Sensory, Bowel & Bladder, Visual, Cerebral, and Other; the Sensory and Bowel & Bladder Systems have been revised. Patterns of FS and relations of FS by type and grade to the DSS are demonstrated.
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            Validity of the Symbol Digit Modalities Test as a cognition performance outcome measure for multiple sclerosis

            Cognitive and motor performance measures are commonly employed in multiple sclerosis (MS) research, particularly when the purpose is to determine the efficacy of treatment. The increasing focus of new therapies on slowing progression or reversing neurological disability makes the utilization of sensitive, reproducible, and valid measures essential. Processing speed is a basic elemental cognitive function that likely influences downstream processes such as memory. The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) includes representatives from advocacy organizations, Food and Drug Administration (FDA), European Medicines Agency (EMA), National Institute of Neurological Disorders and Stroke (NINDS), academic institutions, and industry partners along with persons living with MS. Among the MSOAC goals is acceptance and qualification by regulators of performance outcomes that are highly reliable and valid, practical, cost-effective, and meaningful to persons with MS. A critical step for these neuroperformance metrics is elucidation of clinically relevant benchmarks, well-defined degrees of disability, and gradients of change that are deemed clinically meaningful. This topical review provides an overview of research on one particular cognitive measure, the Symbol Digit Modalities Test (SDMT), recognized as being particularly sensitive to slowed processing of information that is commonly seen in MS. The research in MS clearly supports the reliability and validity of this test and recently has supported a responder definition of SDMT change approximating 4 points or 10% in magnitude.
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              Fatigue in multiple sclerosis.

              Fatigue is a frequent symptom in multiple sclerosis (MS) that can interfere with a patient's daily functioning. The cause of MS fatigue, its clinical characteristics, and its relationship to other symptoms remain poorly understood. Structured interviews were conducted with 32 patients with MS and 33 normal healthy adults. Fatigue proved to be both more frequent and more severe among the patients with MS. Multiple sclerosis fatigue was unrelated to either depression or global impairment. Multiple sclerosis fatigue appears to be a distinct clinical entity, often disabling, that can be distinguished from normal fatigue, affective disturbance, and neurologic impairment.
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                Author and article information

                Contributors
                Journal
                Mult Scler J Exp Transl Clin
                Mult Scler J Exp Transl Clin
                MSO
                spmso
                Multiple Sclerosis Journal - Experimental, Translational and Clinical
                SAGE Publications (Sage UK: London, England )
                2055-2173
                11 April 2021
                Apr-Jun 2021
                : 7
                : 2
                : 2055217321999070
                Affiliations
                Brigham and Women’s Hospital, Boston, MA, USA
                Analysis Group, Boston, MA, USA
                Bristol Myers Squibb, Princeton, NJ, USA
                Brigham and Women’s Hospital, Boston, MA, USA
                Author notes
                [*]Brigham and Women’s Hospital, 090020 60 Fenwood Rd, Boston, MA 02115, USA. bchealy@ 123456mgh.harvard.edu
                Author information
                https://orcid.org/0000-0001-5272-2425
                https://orcid.org/0000-0002-9897-4422
                Article
                10.1177_2055217321999070
                10.1177/2055217321999070
                8042549
                33953937
                f27a5849-0d31-4489-b22d-24e772d97dfc
                © The Author(s) 2021

                Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 9 February 2021
                : 9 February 2021
                Funding
                Funded by: Bristol-Myers Squibb, FundRef https://doi.org/10.13039/100002491;
                Categories
                Original Research Paper
                Custom metadata
                April-June 2021
                ts2

                disability progression,long-term follow-up,multiple sclerosis,outcome measures

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