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

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.

2011 ◽  
Vol 6 (1) ◽  
pp. 31
Author(s):  
Kristen M Krysko ◽  
Paul W O Connor ◽  
◽  

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.


2005 ◽  
Vol 63 (1) ◽  
pp. 127-132 ◽  
Author(s):  
Charles P. Tilbery ◽  
Maria Fernanda Mendes ◽  
Rodrigo Barbosa Thomaz ◽  
Bianca Etelvina Santos de Oliveira ◽  
Giorge Luiz Ribeiro Kelian ◽  
...  

A Multiple Sclerosis Functional Composite Measure (MSFC) é escala para avaliação dos pacientes portadores de esclerose múltipla, desenvolvida pela National Multiple Sclerosis Society dos EUA em 1994, que envolve uma composição de três testes - 9-Hole Peg Test, Timed 25-Foot Walk e PASAT - abrangendo de maneira multidimensional as principais funções neurológicas comprometidas nestes pacientes. A MSFC foi aplicada em 91 indivíduos sadios com o objetivo de padronizá-la na população brasileira para posterior uso nos diversos centros de tratamento e pesquisa no Brasil.


US Neurology ◽  
2010 ◽  
Vol 06 (02) ◽  
pp. 91
Author(s):  
Kristen M Krysko ◽  
Paul W O’Connor ◽  
◽  

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.


2002 ◽  
Vol 8 (5) ◽  
pp. 359-365 ◽  
Author(s):  
R A Rudick ◽  
G Cutter ◽  
S Reingold

With the advent and widespread use of partially effective disease modifying drug therapies for multiple sclerosis (MS), future clinical trials will undoubtedly test experimental interventions against standard therapy, or will test combinations of drugs against standard therapy. In either case, incremental progress in slowing disability progression in future MS clinical trials will require much larger sample sizes, more sensitive outcome measures, or a combination of the two. Because improved clinical outcome methods would likely accelerate progress in MS therapeutics, the National Multiple Sclerosis Society (NMSS) convened an international task force in 1994 to recommend improved clinical outcome measures. As the result of a two-year process of discussion and data analysis, the task force recommended the Multiple Sclerosis Functional Composite (MSFC) as a new clinical outcome measure for future MS trials. MSFC consists of timed tests of walking, arm function, and cognitive function, expressed as a single score along a continuous scale. The task force recommended that MSFC be included in future MS trials, and recommended a series of validation studies. Subsequent studies have provided evidence that MSFC correlates moderately with Expanded Disability Status Scale (EDSS), and that correlation is driven by strong correlations with the ambulatory function component; arm function and cognitive function correlate at lower levels with EDSS. The MSFC correlates better than EDSS with magnetic resonance imaging (MRI) variables, including brain atrophy, and shows significant correlation with patient-reported disease-related quality of life (QOL). MSFC and short-term change in MSFC correlate with future clinical and MRI status, and the strength of the correlations compares favorably with well-known cardiovascular risk factors. The studies in aggregate indicate that MSFC and MSFC change are clinically meaningful, and that MSFC has substantial advantages over alternative clinical outcome measures for MS clinical trials.


2007 ◽  
Vol 13 (7) ◽  
pp. 909-914 ◽  
Author(s):  
R.J. Fox ◽  
J.-C. Lee ◽  
R.A. Rudick

A reference population is used when integrating the individual components of the Multiple Sclerosis Functional Composite (MSFC) into a single composite score. The choice of reference populations may have a significant impact on the resulting MSFC score, yet the impact of different reference populations has not been evaluated. We evaluated the impact of different reference populations when deriving the Multiple Sclerosis Functional Composite (MSFC) in a group of MS patients followed longitudinally for two years. Reference populations included the study population at baseline ( n = 60), a group of healthy controls ( n = 18) and the National MS Society Task Force reference population ( n = variable). We found that the choice of reference population had a significant impact on the resulting MSFC Z-score, sometimes compromising the statistical sensitivity to change over time. Our results suggest that longitudinal studies employing a multisystem composite Z-score should use a reference population with similar patients, which can most easily be achieved by using the baseline measures of the population under study. These results have significant implications to sample size estimates for longitudinal clinical studies and therapeutic trials. Multiple Sclerosis 2007; 13: 909—914. http://msj.sagepub.com


2009 ◽  
Vol 16 (2) ◽  
pp. 228-237 ◽  
Author(s):  
AS Drake ◽  
B. Weinstock-Guttman ◽  
SA Morrow ◽  
D. Hojnacki ◽  
FE Munschauer ◽  
...  

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.


2021 ◽  
Vol 429 ◽  
pp. 118095
Author(s):  
Rocco Capuano ◽  
Alvino Bisecco ◽  
Alessandro D'Ambrosio ◽  
Manuela Altieri ◽  
Renato Docimo ◽  
...  

Work ◽  
2020 ◽  
Vol 67 (1) ◽  
pp. 81-94 ◽  
Author(s):  
Phillip Rumrill ◽  
Jian Li ◽  
David Strauser ◽  
Richard T. Roessler ◽  
Malachy Bishop ◽  
...  

BACKGROUND: Multiple sclerosis (MS) is an intrusive disease that significantly affects labor force participation. OBJECTIVE: This study examined the extent to which factors at the personal, health and function, and environmental/career maintenance levels contribute to the predictability power for quality of life among employed people with MS. METHOD: Participants consisted of 523 members of nine National Multiple Sclerosis Society chapters representing 21 states and Washington, DC. These individuals were employed at the time of the survey, and they were primarily middle age (average age of 48 years) and Caucasian (74%). RESULTS: The final hierarchical multiple regression model explained 54 percent of the variability in participants’ quality of life scores, although none of the hypothesized personal/demographic predictors were significant. Participants who perceived better overall health and lower levels of stress, who experienced less severe cognitive and mobility-related MS symptoms, and who expressed stronger job-person matches and higher levels of job satisfaction reported higher quality of life scores than did other participants. CONCLUSIONS: The findings underscore the complexity involved in predicting perceived quality of life among employed people with MS. Implications of these findings for future research and clinical practice are discussed.


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