Measuring Disability Progression with the Multiple Sclerosis Functional Composite

US Neurology ◽  
2010 ◽  
Vol 06 (02) ◽  
pp. 91
Author(s):  
Kristen M Krysko ◽  
Paul W O’Connor ◽  
◽  
Keyword(s):  
Multiple Sclerosis ◽  
Objective Measure ◽  
Strong Correlations ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Continuous Scale ◽  
Disability Status ◽  
Primary Disability ◽  
Disability Outcome ◽  
Serial Addition

The multiple sclerosis functional composite (MSFC) is a three-part quantitative objective measure of neurologic function, measuring leg (timed 25-foot walk [25FTW]), arm (nine-hole peg test [9HPT]), and cognitive (three-second paced auditory serial addition test [PASAT3]) function. The MSFC was developed to be a more sensitive measure of disability than the expanded disability status scale (EDSS) and has excellent reliability. Validity is supported by moderately strong correlations with EDSS, brain atrophy, and quality of life. Advantages of the MSFC include its continuous scale and inclusion of several disease dimensions. Limitations include practice effects, the lack of a visual function component, variations in reference populations, and limited understanding of clinically relevant MSFCz-score changes. MSFCz-score change has been used as a secondary end-point in MS trials, but EDSS progression remains the primary disability outcome. A new approach to MSFC data involves defining MSFC progression as worsening in an MSFC component by 15–20% over three months. With further study, this could be used as a primary disability outcome in future clinical trials.

scholarly journals Measuring Disability Progression with the Multiple Sclerosis Functional Composite

2011 ◽  
Vol 6 (1) ◽  
pp. 31
Author(s):  
Kristen M Krysko ◽  
Paul W O Connor ◽  
◽  
Keyword(s):  
Multiple Sclerosis ◽  
Objective Measure ◽  
Strong Correlations ◽  
Z Score ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Continuous Scale ◽  
Primary Disability ◽  
Disability Outcome ◽  
Serial Addition

The multiple sclerosis functional composite (MSFC) is a three-part quantitative objective measure of neurologic function, measuring leg (Timed 25-foot Walk [25FTW]), arm (Nine-hole Peg Test [9HPT]) and cognitive (Three-second Paced Auditory Serial Addition Test [PASAT3]) function. The MSFC was developed to be a more sensitive measure of disability than the expanded disability status scale (EDSS) and has excellent reliability. Validity is supported by moderately strong correlations with EDSS, brain atrophy and quality of life. Advantages of the MSFC include its continuous scale and inclusion of several disease dimensions. Limitations include practice effects, the lack of a visual function component, variations in reference populations and limited understanding of clinically relevant MSFC z-score changes. MSFC z-score change has been used as a secondary end-point in MS trials, but EDSS progression remains the primary disability outcome. A new approach to MSFC data involves defining MSFC progression as worsening in an MSFC component by 15–20% over three months. With further study, this could be used as a primary disability outcome in future clinical trials.

Revisiting The Multiple Sclerosis Functional Composite: proceedings from the National Multiple Sclerosis Society (NMSS) Task Force on Clinical Disability Measures

2012 ◽  
Vol 18 (8) ◽  
pp. 1074-1080 ◽  
Author(s):  
D Ontaneda ◽  
N LaRocca ◽  
T Coetzee ◽  
RA Rudick
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measure ◽  
Task Force ◽  
Critical Path ◽  
Washington Dc ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Score Method ◽  
National Multiple Sclerosis Society ◽  
Disability Outcome

This article describes proceedings from a meeting of the National Multiple Sclerosis Society (NMSS) Task Force on Clinical Disability Measures (the TF). The TF was appointed by the NMSS Research Programs Advisory Committee with the goal of pooling and analyzing existing datasets to explore the utility of novel disability outcome measures based on the Multiple Sclerosis Functional Composite (MSFC) approach. The TF seeks to determine the suitability of the MSFC approach as a primary clinical outcome measure for registration trials in MS. The TF met in Washington, DC, Dec. 14 and 15, 2011, and provided unanimous support for a collaborative approach involving representatives from academic medicine, the pharmaceutical industry, regulatory agencies, the NMSS and the Critical Path Institute. There was also unanimous agreement that analysis of existing datasets would be useful in making progress toward the objective. The TF placed high value on determining the clinical meaning of individual component measures for the MSFC, and in establishing optimal analysis methods for MSFC so that scores would be more interpretable than the originally recommended z-score method. The background for a collaborative project aimed at developing an improved disability outcome measure is described in this paper.

Psychometrics and normative data for the Multiple Sclerosis Functional Composite: replacing the PASAT with the Symbol Digit Modalities Test

2009 ◽  
Vol 16 (2) ◽  
pp. 228-237 ◽  
Author(s):  
AS Drake ◽  
B. Weinstock-Guttman ◽  
SA Morrow ◽  
D. Hojnacki ◽  
FE Munschauer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Work Disability ◽  
Task Force ◽  
Neurological Disability ◽  
Promising Alternative ◽  
Functional Composite ◽  
Continuous Scale ◽  
Serial Addition ◽  
Composite Scores ◽  
Normal Controls

The MS Functional Composite (MSFC) is a continuous scale of neurological disability for patients with multiple sclerosis (MS). Cognition is represented by the Paced Auditory Serial Addition Test (PASAT), although the Symbol Digit Modalities Test (SDMT) has been proposed as a promising alternative. MSFC scores were calculated using either the PASAT or the SDMT with the following reference populations: National Multiple Sclerosis Society (NMSS) Task Force, 400 MS patients, and 100 normal controls. A subgroup of 115 patients was followed longitudinally, with a test—retest interval of 2.3 ± 1.2 years. Pearson correlations were calculated and analyses of variance (ANOVAs) were used to assess relationships among the MSFC components and composite scores, and differences in performance between patients and controls. Longitudinal changes were also assessed. Logistic regression was performed to determine which MSFC scores are most predictive of diagnosis, course, and work disability. All MSFCs had similar test—retest reliability and correlations with other measures including neurological disability, depression, and fatigue. The SDMT showed slightly better validity with respect to predicting diagnosis, course, and work disability, although the amount of variance accounted for was similar for each version of the MSFC. Our data, derived from a large sample of MS patients and normal controls, supports the validity of both PASAT and SDMT versions of the MSFC. Because the SDMT has slightly better predictive validity and has a relatively easier administration procedure, some clinicians and researchers may wish to replace the PASAT with the SDMT in future calculations of the MSFC using the calculation methods provided in this manuscript.

No evidence for an effect on brain atrophy rate of atorvastatin add-on to interferon β1b therapy in relapsing–remitting multiple sclerosis (the ARIANNA study)

2016 ◽  
Vol 22 (9) ◽  
pp. 1163-1173 ◽  
Author(s):  
Roberta Lanzillo ◽  
Mario Quarantelli ◽  
Carlo Pozzilli ◽  
Maria Trojano ◽  
Maria Pia Amato ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Brain Atrophy ◽  
Composite Score ◽  
Expanded Disability Status Scale ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: A previous phase 2 trial has suggested that statins might delay brain atrophy in secondary progressive multiple sclerosis. Objectives: The objective of this study was to evaluate the effect of atorvastatin add-on therapy on cerebral atrophy in relapsing–remitting multiple sclerosis. Methods: This randomised, placebo-controlled study compared atorvastatin 40 mg or placebo add-on therapy to interferon β1b for 24 months. Brain magnetic resonance imaging, multiple sclerosis functional composite score, Rao neuropsychological battery and expanded disability status scale were evaluated over 24 months. Results: A total of 154 patients were randomly assigned, 75 in the atorvastatin and 79 in the placebo arms, with a comparable drop-out rate (overall 23.4%). Brain atrophy over 2 years was not different in the two arms (−0.38% and −0.32% for the atorvastatin and placebo groups, respectively). Relapse rate, expanded disability status scale, multiple sclerosis functional composite score or cognitive changes were not different in the two arms. Patients withdrawing from the study had a higher number of relapses in the previous 2 years ( P=0.04) and a greater probability of relapsing within 12 months. Conclusions: Our results suggest that the combination of atorvastatin and interferon β1b is not justified in early relapsing–remitting multiple sclerosis and adds to the body of evidence indicating an absence of significant radiological and clinical benefit of statins in relapsing–remitting multiple sclerosis.

scholarly journals Delayed-release dimethyl fumarate and disability assessed by the Multiple Sclerosis Functional Composite: Integrated analysis of DEFINE and CONFIRM

2016 ◽  
Vol 2 ◽  
pp. 205521731663411 ◽  
Author(s):  
Gavin Giovannoni ◽  
Ralf Gold ◽  
Ludwig Kappos ◽  
Douglas L Arnold ◽  
Amit Bar-Or ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Dimethyl Fumarate ◽  
Integrated Analysis ◽  
Phase 3 ◽  
Functional Composite ◽  
Delayed Release ◽  
Multiple Sclerosis Functional Composite ◽  
Efficacious Treatment ◽  
Serial Addition ◽  
Significant Superiority

The effect of delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) on the Multiple Sclerosis Functional Composite (MSFC) was assessed using integrated Phase 3 DEFINE and CONFIRM data. Patients treated with DMF ( n = 769) demonstrated significant superiority on the MSFC, and each component, compared with placebo ( n = 771) over two years: mean change for DMF vs placebo was 0.054 vs −0.053 on MSFC; −0.088 vs −0.286 on Timed 25-Foot Walk, 0.047 vs 0.003 on 9-Hole Peg Test and 0.178 vs 0.123 on Paced Auditory Serial Addition Test. DMF was an efficacious treatment for patients with MS.

Progression on the Multiple Sclerosis Functional Composite in multiple sclerosis: what is the optimal cut-off for the three components?

2010 ◽  
Vol 16 (7) ◽  
pp. 862-867 ◽  
Author(s):  
LVAE Bosma ◽  
JJ Kragt ◽  
L. Brieva ◽  
Z. Khaleeli ◽  
X. Montalban ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Progression ◽  
Signal To Noise Ratio ◽  
Functional Decline ◽  
Functional Composite ◽  
Multiple Sclerosis Functional Composite ◽  
Serial Addition ◽  
Relative Differences ◽  
Relative Change ◽  
Clinical Disease Progression

For the Timed 25-Foot Walk (T25FW) and 9-Hole Peg Test (9HPT), components of the Multiple Sclerosis Functional Composite (MSFC), cut-off points of 20% change have previously been defined as meaningful endpoints of functional decline. Recently, however, a 15% change of MSFC components was introduced. The objective of this study was to determine optimal cut-offs for all MSFC components to indicate clinical disease progression in a primary progressive (PP) multiple sclerosis (MS) population. T25FW, 9HPT and the Paced Auditory Serial Addition Test (PASAT) were performed in 161 patients with PPMS with a 2-year interval. Absolute and relative differences in test scores were calculated. For each cut-off point of relative change, proportions of patients who progressed (deterioration beyond cut-off value) and improved (improvement beyond cut-off value) were calculated. Further, we calculated the ratio of ‘improved’ versus ‘progressed’ patients. Line graphs were created indicating: percentage progressed patients, percentage improved patients, and ratio of improved versus progressed patients. The optimal cut-off was determined by searching the cut-off point with the lowest ratio of improved versus progressed patients, while at the same time capturing a substantial amount of progression. For both T25FW and 9HPT, the ratio between patients that improved and worsened clearly decreased between the cut-offs of 15% and 20%. For the PASAT, the ratio between patients improved and worsened was persistently poor. In conclusion, a cut-off of 20% for both T25FW and 9HPT has a better signal-to-noise ratio than lower values (e.g. 15%) and is therefore preferable for the assessment of disease progression. No satisfactory cut-off point for the PASAT could be determined.

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