MRI-Based Measurement of Brain Stem Cross-Sectional Area in Relapsing-Remitting Multiple Sclerosis

2015 ◽  
Vol 25 (6) ◽  
pp. 1002-1006 ◽  
Author(s):  
Tomos R. Chivers ◽  
Cris S. Constantinescu ◽  
Christopher R. Tench
Keyword(s):  
Multiple Sclerosis ◽  
Brain Stem ◽  
Cross Sectional Area ◽  
Sectional Area ◽  
Cross Sectional ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Comparison of the EDSS, Timed 25-Foot Walk, and the 9-Hole Peg Test as Clinical Trial Outcomes in Relapsing-Remitting Multiple Sclerosis

Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012690
Author(s):  
Marcus W. Koch ◽  
Jop P. Mostert ◽  
Jerry S. Wolinsky ◽  
Fred D. Lublin ◽  
Bernard Uitdehaag ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Cross Sectional ◽  
Link Type ◽  
Kaplan Meier ◽  
Relapsing Remitting ◽  
Disability Outcome ◽  
Remitting Multiple Sclerosis ◽  
Presentation Methods ◽  
Relapsing Remitting Multiple Sclerosis

Background:Clinical trials in relapsing-remitting multiple sclerosis (RRMS) usually use the Expanded Disability Status Scale (EDSS) as their primary disability outcome measure, while the more recently developed outcomes timed 25 foot walk (T25FW) and nine hole peg test (NHPT) may be more useful and patient-relevant.Objective:To compare the EDSS to the T25FW and NHPT in a large RRMS randomized controlled trial (RCT) dataset.Methods:We used the dataset from CombiRx (clinicaltrials.gov identifier NCT00211887), a large phase 3 RCT, to compare the EDSS to the alternative outcomes T25FW and NHPT. We investigated disability worsening versus similarly defined improvement, unconfirmed versus confirmed and sustained disability change, and the presentation methods cumulative Kaplan-Meier survival curves versus cross-sectional disability worsening.Results:CombiRx included 1,008 participants. A comparison of confirmed versus sustained worsening events showed that throughout the trial, there were substantially fewer sustained than confirmed events, with a positive predictive value of confirmed for sustained worsening at 24 months of 0.73 for the EDSS, 0.73 for the T25FW, and 0.8 for the NHPT. More concerning was the finding that worsening on the EDSS occurred as frequently as similarly defined improvement throughout the three years of follow up, and that improvement rates increased in parallel with worsening rates. The T25FW showed low improvement rates of below 10% throughout the trial. We also found that Kaplan-Meier survival analysis, the standard presentation and analysis method in modern RRMS trials, yields exaggerated estimates of disability worsening. Using the Kaplan-Meier method, the proportion of patients with worsening events steadily increases, until it reaches several fold the number of events seen with more conservative analysis methods. For 3 month CDW at 36 months the ‘Kaplan-Meier’ method yields 2.6 fold higher estimates for the EDSS, 2.9 fold higher estimates for the T25FW and 5.1 fold higher estimates for the NHPT compared to a more conservative presentation of the same data.Discussion:Our analyses raise concerns about using the EDSS as the standard disability outcome in RRMS trials, and suggest that the T25FW may be a more useful measure. These findings are relevant for the design and critical appraisal of RCTs.

scholarly journals Burden of Relapsing-Remitting Multiple Sclerosis on Workers in the US: A Cross-sectional Analysis of Survey Data

2019 ◽  
Author(s):  
Jacqueline Nicholas ◽  
Batul Electricwala ◽  
Lulu K. Lee ◽  
Kristen M Johnson
Keyword(s):  
Multiple Sclerosis ◽  
Healthcare Resource ◽  
Work Productivity ◽  
Healthcare Resource Utilization ◽  
Cross Sectional ◽  
Work Impairment ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Sectional Analysis ◽  
Relapsing Remitting Multiple Sclerosis

Abstract Background: Multiple sclerosis (MS) is prevalent among working age individuals (20-60 years), leading to high burden on work productivity. Few data are available about the absenteeism and presenteeism in employed individuals with MS in comparison to non-MS personnel. This study aimed to quantify the burden of illness of employed US adults with relapsing-remitting multiple sclerosis (RRMS) and examine burden by levels of work impairment. Methods: A retrospective cross-sectional analysis was conducted using patient-reported responses from the US National Health and Wellness Survey (NHWS). Data from NHWS 2015-2016 were analyzed from 196 employed RRMS respondents who were matched 1:4 to employed respondents without MS based on demographic and general health characteristics. Demographic and general health characteristics for employed RRMS individuals were analyzed by levels of work impairment (none, 1-30%; 31-68%; 69-100%). Work productivity (absenteeism, presenteeism, and work impairment), decrements in health-related quality of life (HRQoL) (short form-36, EQ-5D), and healthcare resource utilization (HCRU) were compared to determine the burden of RRMS. Results: After propensity score matching, the levels of absenteeism and presenteeism were 2 and 1.8 times higher in the employed RRMS population than the employed non-MS population, respectively (P<0.001 for both). HRQoL was significantly lower in employed respondents with RRMS than those without MS (P<0.001 for all). Employed respondents with RRMS had significantly more HCRU over 6 months compared to those without MS (P<0.001). Furthermore, among employed RRMS respondents, greater levels of impairment were associated with increasing disease severity, greater healthcare resource use, fatigue, and cognitive impairment and inversely associated with mental and physical HRQoL (P<0.0001 for all). Conclusions: Among employed individuals, respondents with RRMS had lower, work productivity, HRQoL, and higher HCRU as compared with those without MS. Given the large impact RRMS has on work impairment, a need exists to manage individuals on therapies that improve HRQoL, reduce symptoms, and improve their ability to perform in the workforce. Keywords: Absenteeism, presenteeism, healthcare resource utilization, relapsing-remitting multiple sclerosis, work impairment.

Sign in / Sign up

Export Citation Format

Share Document