scholarly journals Outcome measures assisting treatment optimization in multiple sclerosis

2021 ◽  
Author(s):  
Gabriel Pardo ◽  
Samantha Coates ◽  
Darin T. Okuda
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
New Technology ◽  
Wearable Sensors ◽  
Neurological Impairment ◽  
Treatment Optimization ◽  
Disease Evolution ◽  
Disability Status ◽  
Multiple Outcome ◽  
Made In

Abstract Objective To review instruments used to assess disease stability or progression in persons with multiple sclerosis (pwMS) that can guide clinicians in optimizing therapy. Methods A non-systematic review of scientific literature was undertaken to explore modalities of monitoring symptoms and the disease evolution of MS. Results Multiple outcome measures, or tools, have been developed for use in MS research as well as for the clinical management of pwMS. Beginning with the Expanded Disability Status Scale, introduced in 1983, clinicians and researchers have developed monitoring modalities to assess all aspects of MS and the neurological impairment it causes. Conclusions Much progress has been made in recent decades for the management of MS and for the evaluation of disease progression. New technology, such as wearable sensors, will provide new opportunities to better understand changes in function, dexterity, and cognition. Essential work over the decades since EDSS was introduced continues to improve our ability to treat this debilitating disease.

Disease progression in multiple sclerosis: combining physicians’ and patients’ perspectives?

2010 ◽  
Vol 17 (2) ◽  
pp. 234-240 ◽  
Author(s):  
JJ Kragt ◽  
JM Nielsen ◽  
FAH van der Linden ◽  
CH Polman ◽  
BMJ Uitdehaag
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Outcome ◽  
Disease Progression ◽  
Outcome Measures ◽  
Added Value ◽  
Impact Scale ◽  
Disability Status ◽  
The Impact ◽  
Nine Hole Peg Test ◽  
Combine Outcome

Background: To assess disease progression in multiple sclerosis (MS) several outcome measures are available. The interrelation of changes on different scales has not been studied extensively and the concept of combining scales has only recently been introduced in MS. Objective: To explore combining different clinical outcome measures in the evaluation of disease progression in MS. Methods: In 553 patients we studied the presence of relevant changes according to standard definitions on the Expanded Disability Status Scale (EDSS), Nine-Hole Peg Test (9HPT), Timed 25-Foot Walk (T25FW) and the Multiple Sclerosis Impact Scale (MSIS-29). We examined ‘exclusive worsening’ (worsening on one measure while not worsening on any other measure) and ‘opposing changes’ (worsening on one measure while improving on another measure). Finally, we investigated the impact of combining assessments. Results: Based on the EDSS alone, 140 patients progressed. However, almost twice as many (275) showed worsening on any of the clinical outcome measures. Exclusive worsening was observed in 37 patients on the EDSS, 13 on the 9HPT, 39 on the T25FW and 44 on the MSIS physical. Of all worsened patients 76 (28%) showed opposing changes, a phenomenon predominantly observed when combining physician-based and patient-derived outcome measures. Conclusion: When assessing disease progression in MS, sensitivity to change can be increased by combining different outcome measures. The added value is especially present when combining measures from different perspectives. However, further research is needed to evaluate the optimal way to combine outcome measures before implementing this strategy in clinical studies.

scholarly journals Treatment Optimization in MS: Canadian MS Working Group Updated Recommendations

2013 ◽  
Vol 40 (3) ◽  
pp. 307-323 ◽  
Author(s):  
Mark S. Freedman ◽  
Daniel Selchen ◽  
Douglas L. Arnold ◽  
Alexandre Prat ◽  
Brenda Banwell ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Working Group ◽  
Current Approach ◽  
Treatment Optimization ◽  
Disability Status ◽  
Rational Choices ◽  
Medium Level ◽  
Level Of Concern ◽  
High Level ◽  
Practical Recommendations

The Canadian Multiple Sclerosis Working Group (CMSWG) developed practical recommendations in 2004 to assist clinicians in optimizing the use of disease-modifying therapies (DMT) in patients with relapsing multiple sclerosis. The CMSWG convened to review how disease activity is assessed, propose a more current approach for assessing suboptimal response, and to suggest a scheme for switching or escalating treatment. Practical criteria for relapses, Expanded Disability Status Scale (EDSS) progression and MRI were developed to classify the clinical level of concern as Low, Medium and High. The group concluded that a change in treatment may be considered in any RRMS patient if there is a high level of concern in any one domain (relapses, progression or MRI), a medium level of concern in any two domains, or a low level of concern in all three domains. These recommendations for assessing treatment response should assist clinicians in making more rational choices in their management of relapsing MS patients.

How similar are commonly combined criteria for EDSS progression in multiple sclerosis?

2006 ◽  
Vol 12 (6) ◽  
pp. 782-786 ◽  
Author(s):  
J J Kragt ◽  
J M Nielsen ◽  
F AH van der Linden ◽  
B MJ Uitdehaag ◽  
C H Polman
Keyword(s):  
Multiple Sclerosis ◽  
Neurological Impairment ◽  
Point Change ◽  
Perceived Disability ◽  
Number Of Patients ◽  
Sum Score ◽  
Disability Status ◽  
Edss Score ◽  
The Difference ◽  
Quantitative Scoring

Introduction Measuring disease progression is an important aspect of multiple sclerosis (MS) clinical trials. Commonly applied disability endpoints include time to clinically meaningful Expanded Disability Status Scale (EDSS) change, or the number of patients in whom such a change has occurred. Typically, clinically meaningful EDSS change has been defined as a change of 1.0 point on Kurtzke’s EDSS in patients with an entry EDSS score of 5.5 or lower, or 0.5 point in patients with a higher EDSS score. Our goal was to evaluate whether these changes can be considered as similar. Therefore, we compared EDSS changes to corresponding changes in the Guy’s Neurological Disability Scale (GNDS), which is a measure of patient perceived disability, and the Multiple Sclerosis Functional Composite (MSFC), which is an examination-based quantitative scoring of neurological impairment. Methods From a large longitudinal database, we selected two groups of patients with a clinically meaningful change in EDSS score according to the usual criteria: patients with EDSS change]/1.0 for baseline EDSS 5/5.5 and patients with EDSS change]/0.5 for baseline EDSS]/6.0. We compared changes in GNDS sum score and in MSFC score between both groups. Results In the group with baseline EDSS]/6.0, GNDS and MSFC changes were higher than in patients with baseline EDSS 5/5.5. The difference in change was 1.00 (95% confidence interval (CI): / 0.35 to 2.36) for the GNDS and 0.412 (95% CI: 0.300-0.525) for the MSFC. Conclusion Our results indicate that a 0.5 point EDSS change in patients with baseline EDSS / 6.0 cannot be considered equal to a 1.0 point change in patients with baseline EDSS 5/5.5.

Reliability of Outcome Measures in Clinical Trials in Secondary Progressive Multiple Sclerosis

Neurology ◽  
2020 ◽  
Vol 96 (1) ◽  
pp. e111-e120 ◽  
Author(s):  
Marcus W. Koch ◽  
Jop Mostert ◽  
Pavle Repovic ◽  
James D. Bowen ◽  
Bernard Uitdehaag ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Progressive Multiple Sclerosis ◽  
Secondary Progressive Multiple Sclerosis ◽  
Disability Progression ◽  
Secondary Progressive ◽  
Randomized Controlled ◽  
Disability Status ◽  
Over Time

ObjectiveTo investigate the reliability of clinical outcomes in secondary progressive multiple sclerosis (SPMS) trials, we compared the frequency of progression and improvement events on different clinical outcome measures in the placebo arms of 2 large randomized controlled trial (RCT) datasets.MethodsUsing original trial data from the placebo arms of IMPACT (International MS Secondary Progressive Avonex Controlled Trial) and ASCEND (A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis), 2 large RCTs in SPMS, we compared disability progression and similarly defined improvement with and without 3- or 6-month confirmation on the outcome measures Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT), and their combinations.ResultsIn both datasets, the EDSS showed the highest rates of improvement over time, and the smallest difference between progression and improvement rates, followed by the T25FW and the 9HPT. For the T25FW and 9HPT, improvement rates were fairly stable over time and remained at below or around the 10% level. For the EDSS, improvement rates increased in parallel with disability progression rates.ConclusionsAll investigated outcome measures in SPMS showed some evidence of random variation and measurement error, the T25FW and 9HPT less so than the more established outcome EDSS. Our findings are relevant for the design and critical appraisal of trials in SPMS.

A questionnaire to assess neurological impairment in multiple sclerosis

1998 ◽  
Vol 4 (5) ◽  
pp. 444-451 ◽  
Author(s):  
Douglas S Goodin
Keyword(s):  
Multiple Sclerosis ◽  
Computer Program ◽  
Rating Scale ◽  
Test Group ◽  
Neurological Impairment ◽  
Self Report ◽  
Disability Score ◽  
Single Measure ◽  
Functional Scores ◽  
Disability Status

This study assessed the feasibility of using a self-report questionnaire to measure neurological impairment in multiple sclerosis (MS). Thirty patients aged 21-67 years participated. Each patient was examined and scored on three commonly used impairment scales; the extended disability status scale (EDSS), the neurologic rating scale (NRS) and the ambulation index (AI). Two other scales were also determined; the sum of the EDSS functional scores (SFS), and a five point scale rating functional status (FS). The physician also filled out a copy of the questionnaire based on interview and examination of the patient. All of these scores were determined and the physicial questionnaire filled out blind to the patient's answers on their self-report questionnaire. The first 15 consecutive patients served as the pilot group to develop a computer program to convert answers on the questionnaire into predicted scores on each of the five scales. The second 15 patients served as the independent test group to assess the validity of the computer program. Using this program, both patient and physician questionnaires accurately predicted (r40.87) the scores on each of the five scales measured manually. In addition, the scores on all five scales were highly cross-correlated (r40.85) suggesting that, in fact, each measured a similar attribute of MS (i.e., impairment). Therefore, the five scales were combined into a single measure, the mean disability score (MDS), which showed the highest correlations (r40.95) of any scale between the predicted scores and the actual scores determined by examination. The results of this study indicate that the self-report questionnaire is a valid measure of neurological impairment in MS and, thus, that it can be used to survey this health outcome in an MS population. Moreover, this questionnaire can be filled out by a physician (based directly on the neurological examination) and, together with the computer program for scoring each patient, can be used to provide consistent scoring in clinical trials.

Tau protein: a possible prognostic factor in optic neuritis and multiple sclerosis

2011 ◽  
Vol 18 (5) ◽  
pp. 592-599 ◽  
Author(s):  
J Frederiksen ◽  
K Kristensen ◽  
JMC Bahl ◽  
M Christiansen
Keyword(s):  
Multiple Sclerosis ◽  
Prognostic Factor ◽  
Optic Neuritis ◽  
Tau Protein ◽  
Protein Concentration ◽  
Protein A ◽  
Neurological Impairment ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Risk Of Progression

Background: Tau protein has been proposed as biomarker of axonal damage leading to irreversible neurological impairment in MS. CSF concentrations may be useful when determining risk of progression from ON to MS. Objective: To investigate the association between tau protein concentration and 14-3-3 protein in the cerebrospinal fluid (CSF) of patients with monosymptomatic optic neuritis (ON) versus patients with monosymptomatic onset who progressed to multiple sclerosis (MS). To evaluate results against data found in a complete literature review. Methods: A total of 66 patients with MS and/or ON from the Department of Neurology of Glostrup Hospital, University of Copenhagen, Denmark, were included. CSF samples were analysed for tau protein and 14-3-3 protein, and clinical and paraclinical information was obtained from medical records. Results: The study shows a significantly increased concentration of tau protein in CSF from patients with relapsing–remitting MS and patients monosymptomatic at onset who progressed to MS, but interestingly no increased tau protein concentration in monosymptomatic ON. The concentration of tau protein was significantly correlated to Expanded Disability Status Scale score. No 14-3-3 protein was detected in any CSF sample. Conclusions: The results of this study invite further exploration of the possible role of tau protein as a prognostic factor to predict progression from ON to MS in future studies.

Longitudinal correlates of fatigue in multiple sclerosis

2008 ◽  
Vol 15 (2) ◽  
pp. 258-261 ◽  
Author(s):  
E Patrick ◽  
C Christodoulou ◽  
LB Krupp ◽  
Keyword(s):  
Multiple Sclerosis ◽  
New York ◽  
Depressive Symptoms ◽  
New York State ◽  
Neurological Impairment ◽  
Common Symptom ◽  
Expanded Disability Status Scale ◽  
Disability Status ◽  
Relapsing Remitting

Objective To determine the predictors of longitudinal changes in fatigue based on pain, mood, and neurological impairment across multiple sclerosis (MS) subtypes. Background Fatigue is the most common symptom of MS but remains poorly understood. The New York State Multiple Sclerosis Consortium (NYSMSC) database offers a unique opportunity to longitudinally assess a variety of potential fatigue correlates in a very large and diverse MS sample. Design/Methods This study examined baseline and 1-year follow-up data on 2768 patients drawn from the NYSMSC database regarding fatigability, pain, depressive symptoms, MS subtype, and expanded disability status scale (EDSS). Correlates and predictors of fatigue were assessed in correlational and multiple regression analyses. Results Baseline fatigue, pain, and depression accounted for 34.6% of the variance in 1-year follow-up fatigue scores. Fatigue was lower in relapsing–remitting subjects than in other MS subtypes. Fatigue consistently correlated at baseline and follow-up with depressive symptoms, pain severity, and EDSS. Changes in fatigue correlated with changes in other variables. Conclusions Predictors of fatigue at 1 year include baseline fatigue, pain, mood, and EDSS. These symptoms are also correlated at baseline, follow-up, and in change scores. Identifying predictors of fatigue may facilitate patient management.

scholarly journals Wearable sensors can reliably quantify gait alterations associated with disability in people with progressive multiple sclerosis in a clinical setting

2020 ◽  
Vol 267 (10) ◽  
pp. 2897-2909 ◽  
Author(s):  
Lorenza Angelini ◽  
William Hodgkinson ◽  
Craig Smith ◽  
Jessie Moorman Dodd ◽  
Basil Sharrack ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Wearable Sensors ◽  
Progressive Multiple Sclerosis ◽  
Sensor Data ◽  
Clinical Settings ◽  
Motion Sensors ◽  
Healthy Controls ◽  
Inertial Motion ◽  
Disability Status ◽  
Clinical Tools

Abstract Gait disability in people with progressive multiple sclerosis (MS) is difficult to quantify using existing clinical tools. This study aims to identify reliable and objective gait-based biomarkers to monitor progressive multiple sclerosis (MS) in clinical settings. During routine clinical visits, 57 people with secondary progressive MS and 24 healthy controls walked for 6 minutes wearing three inertial motion sensors. Fifteen gait measures were computed from the sensor data and tested for between-session reliability, for differences between controls and people with moderate and severe MS disability, and for correlation with Expanded Disability Status Scale (EDSS) scores. The majority of gait measures showed good to excellent between-session reliability when assessed in a subgroup of 23 healthy controls and 25 people with MS. These measures showed that people with MS walked with significantly longer step and stride durations, reduced step and stride regularity, and experienced difficulties in controlling and maintaining a stable walk when compared to controls. These abnormalities significantly increased in people with a higher level of disability and correlated with their EDSS scores. Reliable and objective gait-based biomarkers using wearable sensors have been identified. These biomarkers may allow clinicians to quantify clinically relevant alterations in gait in people with progressive MS within the context of regular clinical visits.

Depression, coping and level of neurological impairment in multiple sclerosis

1997 ◽  
Vol 3 (4) ◽  
pp. 254-258 ◽  
Author(s):  
David C Mohr ◽  
Donald E Goodkin ◽  
Nicole Gatto ◽  
Judy Van Der Wende
Keyword(s):  
Multiple Sclerosis ◽  
Problem Solving ◽  
Neurological Impairment ◽  
Coping Behaviors ◽  
Neurologic Impairment ◽  
Cognitive Reframing ◽  
Disability Status ◽  
Multiple Sclerosis Patients ◽  
The Relationship ◽  
Different Levels

This study examined the relationship between coping and depression in multiple sclerosis patients, and how that relationship varies at different levels of physical impairment One-hundred and one patients with clinically definite MS were assessed using the Kurtzke Expanded Disability Status Scale (EDSS), the Ways of Coping Inventory (WCI) with three sub-scales developed by Wineman et al,25 and the Beck Depression Inventory (BDI). Depression was significantly higher at more advanced levels of neurologic impairment than at lower levels. Escape-Avoidance and Emotional Respite were positively related to level of depression. Planful Problem-Solving and Cognitive Reframing were negatively related to depression. An interaction between coping, depression, and level of neurologic impairment was observed in which Planful Problem-Solving and Cognitive Reframing were more strongly related to depression at higher levels of impairment The interaction effect for Escape-Avoidance and Emotional Respite with depression and level of impairment did not reach significance. It was concluded that there is a significant interaction between level of neurologic impairment, coping behaviors, and depression in patients with MS.

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