Sustained improvement in Expanded Disability Status Scale as a new efficacy measure of neurological change in multiple sclerosis: treatment effects with natalizumab in patients with relapsing multiple sclerosis

2011 ◽  
Vol 17 (8) ◽  
pp. 970-979 ◽  
Author(s):  
J Theodore Phillips ◽  
Gavin Giovannoni ◽  
Fred D Lublin ◽  
Paul W O’Connor ◽  
Chris H Polman ◽  
...  

Background: Validated measures of sustained improvements in neurological function have not been established for multiple sclerosis (MS) clinical studies. Objective: To evaluate sustained Expanded Disability Status Scale (EDSS) change as a potential indicator of neurological improvement and as an outcome measure in MS clinical studies. Methods: Analyses were performed on patients ( n = 620) from the pivotal natalizumab study AFFIRM with baseline EDSS scores ≥2.0. Cumulative probabilities of neurological improvement, defined as a 1.0-point decrease in EDSS score sustained for ≥12 weeks, were estimated by Kaplan–Meier analysis. A Cox proportional hazards model identified associated baseline factors and examined treatment effects. Results: Sustained improvement (as well as sustained worsening) in neurological disability was seen in AFFIRM patients. Sustained EDSS changes correlated well with quality of life measurements (SF36 and VAS). Natalizumab increased the cumulative probability of improvement over 2 years by 69% versus placebo (HR = 1.69; 95% CI 1.16–2.45; p = 0.006). Sensitivity analyses showed consistent benefits of natalizumab with variations in improvement magnitude and duration, and baseline disease activity. Conclusion: These analyses demonstrate that sustained EDSS improvement is an additional measure that is sensitive to treatment effects over 2 years and correlates with quality of life. Further research is warranted to validate its use as an MS study clinical outcome.

2015 ◽  
Vol 17 (6) ◽  
pp. 268-274 ◽  
Author(s):  
Fatemeh Moghaddam Tabrizi ◽  
Moloud Radfar

Background: Quality of life (QOL) is impaired in multiple sclerosis (MS) in part due to physical disability. MS-associated fatigue and poor sleep are common and treatable features of MS that affect QOL. We assessed the association between fatigue, sleep quality, and QOL in people with MS. Methods: Cross-sectional data were collected from 217 patients with MS. Health-related QOL (MS Quality of Life-54), fatigue (Fatigue Severity Scale [FSS]), and sleep quality (Pittsburgh Sleep Quality Inventory [PSQI]) were assessed. Expanded Disability Status Scale scores were also provided by a qualified neurologist. Results: The mean ± SD age of the 217 patients was 32.6 ± 8.6 years, and 79% were female. One hundred fifty-two patients (70.0%) were classified as poor sleepers based on PSQI scores; 122 (56.2%) had significant fatigue based on FSS results. The mean ± SE physical (PCS) and mental (MCS) health composite scores of the MSQOL-54 were 40.12 ± 1.27 and 43.81 ± 1.61, respectively. There was a strong statistically significant positive correlation between PCS scores and MCS (r = 0.58), FSS (r = 0.49), and PSQI (r = 0.52) scores. MCS scores were strongly correlated with FSS (r = 0.53) and PSQI (r = 0.35) scores. Age exhibited statistically significant negative correlations with PCS (r = −0.21) and MCS (r = −0.58) scores, and was statistically significantly correlated with FSS (r = 0.23) and PSQI (r = 0.21) scores. Expanded Disability Status Scale scores were strongly correlated with FSS scores. Conclusions: These findings support screening of fatigue severity and sleep quality and their effects on QOL.


2010 ◽  
Vol 8 (1) ◽  
pp. 55 ◽  
Author(s):  
Sabine Twork ◽  
Susanne Wiesmeth ◽  
Milena Spindler ◽  
Markus Wirtz ◽  
Sabine Schipper ◽  
...  

Author(s):  
Fraser Moore ◽  
Christina Wolfson ◽  
Lubo Alexandrov ◽  
Yves Lapierre

Background:Quality of life instruments provide information that traditional outcome measures used in studies of multiple sclerosis do not. It is unclear if longer, disease-specific instruments provide more useful information than shorter, more general instruments, or whether patients prefer one type to another.Methods:We conducted a cross-sectional study of quality of life in a multiple sclerosis clinic population using a mailed questionnaire that combined three different quality of life instruments; the SF-36, the Multiple Sclerosis Quality of Life Instrument-54, and the EuroQol EQ-5D. We assessed the feasability of using each instrument and patient preference for each, calculated correlation coefficients for the summary scores of each instrument and other measures of disease severity, and calculated odds ratios from proportional odds models comparing each instrument with the Expanded Disability Status Scale.Results:We did not find substantial differences between the three instruments. All were well-received by patients, and over 75% felt that the combination of the three instruments best assessed their quality of life. For each instrument there was substantial variability between patients with similar quality of life scores in terms of their disability (as assessed by the Expanded Disability Status Scale and their own perception of their disease severity and quality of life (on simple 1-10 scales).Conclusion:Quality of life instruments are easy to use and well-received by patients, regardless of their length. There do not appear to be clinically important differences between general and disease-specific instruments. Each instrument appears to measure something other than a patient’s disability or perception of their own disease severity or quality of life.


2021 ◽  
Vol 10 (23) ◽  
pp. 5607
Author(s):  
Silvia Cerea ◽  
Marta Ghisi ◽  
Marco Pitteri ◽  
Maddalena Guandalini ◽  
Lauren B. Strober ◽  
...  

The aim of the study is to investigate the impact of coping strategies on Health-Related Quality of Life (HRQoL) and physical disability assessed with the Expanded Disability Status Scale (EDSS) of people with multiple sclerosis (pwMS). PwMS were asked to focus on “MS diagnosis” as the core stressor. One hundred eight pwMS completed the Coping Responses Inventory-Adult form (CRI-Adult), the Multiple Sclerosis Quality of Life-29 (MSQoL-29), and the Depression Anxiety Stress Scale-21 (DASS-21). Multiple regression analyses (first block: EDSS, disease duration, and DASS-21) revealed that physical MSQoL-29 was positively associated with Alternative Rewards and negatively with Resigned Acceptance of the CRI-Adult. The mental MSQoL-29 was positively associated with Problem-Solving and negatively with Emotional Discharge. The Expanded Disability Status Scale (EDSS; first block: disease duration and general distress) was negatively associated with Positive Reappraisal. The Analysis of covariance (ANCOVA) revealed that pwMS with lower physical disability showed higher scores in Positive Reappraisal and lower scores in Emotional Discharge than pwMS with a higher physical disability. Coping strategies can play a role on HRQoL and physical disability in pwMS above and beyond EDSS, disease duration, and general distress. Psychological interventions should be considered in pwMS since the time of diagnosis to promote engagement in adaptive coping strategies and contrast the maladaptive ones.


2014 ◽  
Vol 21 (11) ◽  
pp. 1468-1472 ◽  
Author(s):  
Eduardo Fernández-Jiménez ◽  
Peter A. Arnett

Background: Determining the relative importance of factors that predict quality of life (QoL) in people with multiple sclerosis (MS) must be addressed through multiple regression metrics, e.g. relative weights, which are designed to solve colinearity problems. Objective: We aimed to compare disease variables, Expanded Disability Status Scale (EDSS), depressive symptomatology (BDI-FS), cognitive performance and coping in predicting MS patients’ QoL, using relative weights. Methods: We assessed 97 patients with MS, using the Functional Assessment of MS (FAMS) as the criterion. Results: EDSS predicted global and physical QoL domains, whereas BDI-FS predicted general contentment and global QoL. Conclusion: EDSS and BDI-FS are relevant determinants of QoL in people with MS.


2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Abdul Latif Hamdan ◽  
Sahar Farhat ◽  
Rami Saadeh ◽  
Iyad El-Dahouk ◽  
Abla Sibai ◽  
...  

Objective. To investigate the voice-related quality of life in a group of patients with multiple sclerosis.Participants. A total of 87 subjects (59 MS subjects and 28 controls) participated in this study.Main Outcome Measures. Variables included presence or absence of phonatory symptoms, duration of the disease, the expanded disability status scale (EDSS), the severity of fatigue, and depression. All patients were asked to fill the Voice Handicap Index.Results. The average age was 35.47 years + 10.92 with 39% being males. The average duration of the disease was 77.93 months. The EDSS score was 1.94 + 1.84, the FSS score was 4.07 + 2.09, and the HRSD was 7.28 + 7.70. Only 7 subjects out of the 59 had vocal symptoms compared to 3 in the control group. There was no significant difference in the VHI total score between cases (5.9 + 15.5) and controls (5.4 + 8.2). There was a positive correlation between VHI total score, FSS score, and HRSD (Pvalues of 0.011 and <0.01.Conclusion. The voice-related quality of life in MS is within normal with no disability.


2013 ◽  
Vol 04 (03) ◽  
pp. 278-282 ◽  
Author(s):  
Karthik Nagaraj ◽  
Arun B Taly ◽  
Anupam Gupta ◽  
Chandrajit Prasad ◽  
Rita Christopher

ABSTRACTObjective: This prospective study was carried out to observe the prevalence of fatigue in patients with multiple sclerosis (MS) and its effect on quality-of-life (QoL). Study Design and Setting: Prospective observational study in a University Tertiary Research Hospital in India. Patients and Methods: A total of 31 patients (25 females) with definite MS according to McDonald ′s criteria presented in out-patient/admitted in the Department of Neurology (between February 2010 and December 2011) were included in the study. Disease severity was evaluated using the Kurtzke′s expanded disability status scale (EDSS). Fatigue was assessed using Krupp′s fatigue severity scale (FSS). QoL was assessed by the World Health Organization QoL-BREF questionnaire. Results: The mean age of patients was 30.1 ± 9.1 years. The mean age at first symptom was 25.23 ± 6.4 years. The mean number of relapses was 4.7 ± 3.6 in the patients. The mean duration of illness was 4.9 ± 4.4 years. The mean EDSS score was 3.5 ± 2.2. Mean fatigue score was 38.7 ± 18.5 (cut-off value 36 in FSS). The prevalence of fatigue in patients with MS was 58.1% (18/31). MS patients with fatigue were significantly more impaired (P < 0.05) on all QoL domains (i.e., physical, psychosocial, social, and environment) than MS patients without fatigue. Conclusion: Prevalence of fatigue was found to be high in the MS patients in the study. All four domains of QoL were significantly more impaired in the group with fatigue than in those without fatigue.


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