Optimal reference population for the multiple sclerosis functional composite

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

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.


2019 ◽  
Vol 88 (10) ◽  
pp. 644-651
Author(s):  
Tobias Leniger ◽  
Maike Heiker ◽  
Andrea Ghadimi

Zusammenfassung Ziel der Studie Der Multiple Sclerosis Functional Composite (MSFC) bewertet mit den Untertests Lauf- und Handfunktion sowie Kognition die Funktionseinschränkungen der Multiplen Sklerose (MS). In der medizinischen Rehabilitation könnte der MSFC sich als hilfreiches Assessmentinstrument für die sozialmedizinische Leistungsempfehlung zur Erwerbsfähigkeit (SLE) am Ende der stationären Rehabilitation erweisen. Ziel der Studie war, eine Korrelation des MSFC mit der SLE zu überprüfen, deren Gültigkeit sechs Monate nach der Rehabilitation erfragt wurde. Methodik In einer retrospektiven, unizentrischen Längsschnittstudie wurde der MSFC zu Beginn (t0) und zum Ende (t1) der stationären Rehabilitation bei 84 Rehabilitanden mit MS im erwerbsfähigen Alter erhoben. Der MSFC (Gesamtscore, Untertests) wurde mit der SLE am Ende der Rehabilitation korreliert (positive SLE: ≥ 3h täglich, negative SLE: < 3h täglich). Sechs Monate nach der Rehabilitation wurde der Return to Work (RTW) erfragt (positiver RTW: ≥ 3h täglich, negativer RTW: < 3h täglich). Ergebnis 70 der 84 Rehabilitanden (83 %) erhielten eine positive SLE. Sie zeigten hinsichtlich epidemiologischer, MS- und rehabilitations-spezifischer Charakteristika keinen Unterschied zu den 14 Rehabilitanden mit negativer SLE. Rehabilitanden mit positiver SLE wiesen im Vergleich zu denen mit negativer SLE signifikant bessere MSFC-Werte im Gesamtscore (z-Score: + 0,11 vs. −0,55, p < 0,001), in den Untertests Kognition (PASAT-3: 42,3 Punkte vs. 27,7 Punkte; p < 0,001) und Lauffunktion (T25FW: 5,1 s vs. 6,7s; p = 0,002) auf. Hingegen war die Handfunktion (NHPT: 23,4 s vs. 26,5s; p = 0,064) ohne signifikanten Unterschied. Beide Gruppen zeigten im Verlauf der Rehabilitation (t0; t1) nichtsignifikante Verbesserungen (Gesamtscore, Untertests). Bei 31 der 84 Rehabilitanden (37 %) konnte der RTW nach sechs Monaten erhoben werden. 90 % der 31 Rehabilitanden beurteilten die SLE als zutreffend. Eine positive SLE korrelierte signifikant mit einem positiven RTW nach sechs Monaten (r = 0,411; p = 0,022). Keine signifikante Assoziation bestand zwischen dem MSFC(t1) (Gesamtscore, Untertests) und dem RTW nach sechs Monaten. Schlussfolgerung Auf Funktionsebene korreliert der MSFC im Gesamtscore (z-Score ≥ 0) signifikant mit einer positiven SLE bei Entlassung, deren Validität mit dem RTW sechs Monate nach der Rehabilitation belegt wurde. Maßgeblich waren die Untertests Kognition und Lauffunktion. In der medizinischen Rehabilitation der MS bietet sich daher der Einsatz des MSFC an, um basierend auf dem ermittelten Funktionsniveau eine fundierte Teilhabeempfehlung in Form der SLE zu entwickeln.


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.


2002 ◽  
Vol 8 (5) ◽  
pp. 366-371 ◽  
Author(s):  
B MJ Uitdehaag ◽  
H J Adèr ◽  
T JA Roosma ◽  
V de Groot ◽  
N F Kalkers ◽  
...  

The Multiple sclerosis functional composite (MSFC) has been recommended as a clinical outcome measure to be used in future MS trials. A specific characteristic of the MSFC is that it is defined as a measure of impairment relative to a reference population. Using different reference populations affects actual MSFC scores. If the selection of a reference population also has an effect on sensitivity to change of the MSFC, comparison of data from clinical trials will be almost impossible when different reference populations are used. We studied the effect of the selection of a reference population on the outcome of a trial by simulating 343 intervention trials and comparing results obtained by using three different reference populations: two previously published MS patient populations and a healthy population. Scores of the healthy population were collected in the first part of the study. The effects of sex, age and education level on test scores of healthy subjects were studied as well. In the healthy controls, sex, age and education level had a different impact on individual test scores of MSFC components and overall MSFC score. Our study shows that, with the use of the MSFC, the selection of different reference populations does not affect the trial statistics and significance, but it does affect comparability of results between different trials, and complicates the clinical interpretation of any observed change.


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 ◽  
...  

2019 ◽  
Vol 5 (1) ◽  
pp. 205521731983725 ◽  
Author(s):  
RH Gross ◽  
SH Sillau ◽  
AE Miller ◽  
C Farrell ◽  
SC Krieger

Background The Multiple Sclerosis Severity Score (MSSS), combining the Expanded Disability Status Scale (EDSS) and disease duration, attempts to stratify multiple sclerosis (MS) patients based on their rate of progression. Its prognostic ability in the individual patient remains unproven. Objectives To assess the stability of MSSS within individual persons with MS in a longitudinal cohort, to evaluate whether certain factors influence MSSS variability, and to explore the ability of MSSS to predict future ambulatory function. Methods A single-center retrospective review was performed of patients following a single provider for at least 8 years. Mixed model regression modeled MSSS over time. A Kaplan–Meier survival plot was fitted, using change of baseline MSSS by at least one decile as the event. Cox modeling assessed the influence of baseline clinical and demographic factors on the hazard of changing MSSS by at least one decile. Linear models evaluated the impact of baseline EDSS, baseline MSSS, and other factors on the Timed 25-Foot Walk (T25FW). Results Out of 122 patients, 68 (55.7%) deviated from baseline MSSS by at least one decile. Final T25FW had slightly weaker correlation to baseline MSSS than to baseline EDSS, which was moderately strongly correlated with future log T25FW. Conclusion Individual MSSS scores often vary over time. Clinicians should exercise caution when using MSSS to prognosticate.


Neurology ◽  
2001 ◽  
Vol 56 (10) ◽  
pp. 1324-1330 ◽  
Author(s):  
R. A. Rudick ◽  
G. Cutter ◽  
M. Baier ◽  
E. Fisher ◽  
D. Dougherty ◽  
...  

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