RehabMeasures Instrument
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  2. Multiple Sclerosis Functional Composite

Multiple Sclerosis Functional Composite

Last Updated

Purpose

The MSFC was developed by the National Multiple Sclerosis Society Task Force to address limitations and unidimensionality of prior existing functional status outcomes such as the EDSS.

Link to Instrument

Instrument Details

Acronym MSFC

Area of Assessment

Cognition
Gait
Upper Extremity Function

Assessment Type

Performance Measure

Cost

Free

Diagnosis/Conditions

  • Multiple Sclerosis

Populations

Multiple Sclerosis

Key Descriptions

  • The MSFC consists of three component parts:
    1) Timed 25-foot Walk Test (T25FW)
    2) 9-Hole Peg Test (9HPT)
    3) 3-second version of the Paced Auditory Serial Addition Test (PASAT-3)
  • The full MSFC consists of:
    1) 2 trials of the T25FW
    2) 4 trials (2 on each hand) of the 9HPT
    3) 1 trial of the PASAT-3
  • The PASAT-3 scores is the number of correct answers.
  • The 9HPT score is somewhat more complicated. The mean scores of the two 9HPT trials for each hand is calculated, and then the reciprocal of the mean times each hand is averaged.
  • The composite score is created by converting the score for each component into a Z-score and then averaging the Z-scores. A reference population is required to create the Z-score.
  • Component scores are entered into a formula with scores from the reference population in order to derive the means and standard deviations required to determine Z-scores.
  • A detailed description of scoring methods can be found in the MSFC Administration and Scoring Manual.
  • A score of +1 indicates that, on average, an individual scored 1 SD better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.
  • It is suggested that the reference population be drawn from within the study or clinical group, however, existing reference group information can be used to facilitate between studies comparisons of MSFC scores.

Number of Items

3

Equipment Required

  • Measured 25-foot walkway
  • 9HPT kit
  • PASAT-3 audiocassette or CD
  • stopwatch
  • forms to record data
  • a calculator with simple statistical functions

Time to Administer

10-20 minutes

Required Training

Reading an Article/Manual

Age Ranges

Adolescent

13 - 17

years

Adult

18 - 64

years

Elderly Adult

65 +

years

Instrument Reviewers

Initially reviewed by Kathleen Brandfass, MS, PT and the MS EDGE task force in the neurology section of the APTA in August, 2011.

ICF Domain

Body Structure
Body Function

Measurement Domain

Cognition
Motor

Professional Association Recommendation

Recommendations for use of the instrument from the Neurology Section of the American Physical Therapy Association’s Multiple Sclerosis Taskforce (MSEDGE), Parkinson’s Taskforce (PD EDGE), Spinal Cord Injury Taskforce (PD EDGE), Stroke Taskforce (StrokEDGE), Traumatic Brain Injury Taskforce (TBI EDGE), and Vestibular Taskforce (Vestibular EDGE) are listed below. These recommendations were developed by a panel of research and clinical experts using a modified Delphi process.

For detailed information about how recommendations were made, please visit:  http://www.neuropt.org/go/healthcare-professionals/neurology-section-outcome-measures-recommendations

Abbreviations:

 

HR

Highly Recommend

R

Recommend

LS / UR

Reasonable to use, but limited study in target group / Unable to Recommend

NR

Not Recommended

 

Recommendations based on level of care in which the assessment is taken:

 

Acute Care

Inpatient Rehabilitation

Skilled Nursing Facility

Outpatient

Rehabilitation

Home Health

MS EDGE

NR

R

R

HR

R

 

Recommendations based on EDSS Classification:

 

EDSS 0.0 – 3.5

EDSS 4.0 – 5.5

EDSS 6.0 – 7.5

EDSS 8.0 – 9.5

MS EDGE

R

R

R

R

 

Recommendations for entry-level physical therapy education and use in research:

 

Students should learn to administer this tool? (Y/N)

Students should be exposed to tool? (Y/N)

Appropriate for use in intervention research studies? (Y/N)

Is additional research warranted for this tool (Y/N)

MS EDGE

No

Yes

Yes

No

Considerations

Each component test requires active participation. A lack of ability or motivation to walk, to perform upper extremity function and or to participate in the cognitive test will all contribute to limitations in information. 

For research purposes, it is recommended that the reference data be created from baseline data from the sample under study (NMSS Manual). While this provides useful information for Z-score calculation within the sample, it limits the generalizability of the results. Using a broader reference database may improve generalizability, but may result in Z-scores that do not accurately reflect individual performance. Care must be taken in the choice of reference database as information compared to different reference database as information compared to different reference databases can have a marked impact on the MSFC Z-score to the point of altering statistical sensitivity. Although the MSFC was created as a multidimensional measure, it does not measure some important constructs such as vision. Limitations of the PASAT-3 as component of the MSFC have been described. Different versions of the MSFC which include the T25WT, the 9HPT and a different measure of cognitive function was more sensitive than the original MSFC in discriminating impairments in cognition. The MSFC has limited clinical utility (inpatient rehab, home health, skilled nursing and outpatient practice settings). Its use is primarily recommended for research or in population-level clinical care.

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Multiple Sclerosis

back to Populations

Minimally Clinically Important Difference (MCID)

Multiple Sclerosis:

(Hobart J, Bosma LV, Rudick RA, Schwid SR et al, 2004, 2009, 2010, 2002)

  • Most literature describes a 20% change in composite score as the MCID, although a 15% chance was more sensitive at detecting disease progression. A 20% change has also been described as the MCID for individual item scores for the 9HPT and the T25FW. There is some conflict over MCID for the PASAT-3. Some studies found no clearly identified MCID, while others suggest that a change of 0.5 standard deviation is a MCID for the PASAT-3

Normative Data

Multiple Sclerosis:

(Fisher et al, 2002)

  • Scores from the NMSS Task Force database can be found on in MSFC Administration and Scoring Manual, otherwise, the comparison data set is generated from baseline data collected from the group being examined

Test/Retest Reliability

Multiple Sclerosis:

(Cohen et al, 2000)

  • Excellent test-retest reliability (ICC = 0.96)
  • Excellent test-retest reliability over 4 test cycles; n = 426 PWMS; mean EDSS = 5.3 (1.1) (ICC = 0.87)
  • Excellent test-retest reliability between tests 3 and 4 (ICC = 0.90) (Solari et al, 2005)
  • Examined practice effects of the individual components of the MSFC and recommends a single pretesting trial of the T25WT, 3 pretest trials of the PASAT-3, and 4 pretest trials of the 9HPT

Interrater/Intrarater Reliability

Multiple Sclerosis:

(Cohen et al, 2000; n = 10 PWMS; mean EDSS = 5.2, range = 3.5 – 6.5)

  • Excellent intrarater reliability over 6 repeated tests (ICC = 0.88)
  • Excellent intrarater reliability between trials 4 and 5 (ICC = 0.97)
  • Excellent interrater reliability (ICC = 0.95 – 0.96) (Solari et al, 2005; n = 32 PWMS; mean EDSS = 4.5, range = 2.0 – 7.0)
  • Excellent intrarater reliability over 4 repeated tests (ICC = 0.97)
  • Excellent interrater reliability (ICC = 0.96)

Criterion Validity (Predictive/Concurrent)

Multiple Sclerosis:

Correlations between MSFC and EDSS: 

(Cohen, Fischer, Hobart, Hoogervorst, Kalkers, Miller et al, 2001, 1999, 2004, 2002, 2001, 2000)

  • Adequate to Excellent correlation in total population (r = -0.47 - -0.80) 

 

(Kalkers, Kragt, Rudick et al, 2001, 2008, 2001)

  • Adequate to Excellent in people with Primary Progressive MS (r = -0.316 - -0.69) 

 

(Kalkers et al, 2001)

  • Excellent in people with Secondary Progressive MS (r = -0.60)
  • Adequate in people with Relapsing Remitting MS (r = -0.38) 

 

Correlations between MSFC change and EDSS change: 

(Hoogervorst, Cutter et al, 2002, 1999)

  • Poor correlation between two measures at 1 year (r = -0.22 - -0.24) 

 

(Rudick et al 2001)

  • Adequate correlation between two measures at 8.1 years (r = -0.45) 

 

(Cutter et al, 1999)

  • Poor correlation with EDSS group less than or greater to 3.5 (r = -0.18)
  • Adequate correlation with EDSS group greater than 3.5 (r = -0.30) 

 

Correlations between the MSFC and MRI findings:

(Kalkers et al, 2001)

  • Poor correlation with T1-weighted hypointense lesion (r = -0.24)
  • Poor correlation with T2-weighted lesion load (r = -0.25) 

 

(Solari et al, 2005)

  • Adequate correlation with T1/T2 lesion load, brain atrophy, magnetic transference ratio and mean diffusion (r < -0.50) 

 

(Kalkers et al, 2001)

  • Adequate correlation with ventricular fraction (r = -0.40) 

 

(Rudick, Kalkers, Fisher et al, 2001, 2001, 2000)

  • Adequate correlation with brain parenchymal fraction (r = 0.36 – 0.498)
  • Adequate correlation with delayed measures of brain parenchymal fraction (r = 0.42 – 0.52)
  • Poor correlation with change over time in MSFC and change over time in brain parenchymal fraction (r= 0.23 – 0.30) 

 

(Rudick et al, 2001)

  • MSFC predicted MSFC and MRI status at 8 years with comparison to MRI status at 2 years
  • Baseline MSFC had an OR of 2.72 for predicting EDSS score at 8 years, and MSFC change between baseline and 2 year follow up had an OR of 3.05 for predicting EDSS score at 8 years
  • Baseline MSFC had an OR of 4.37 to predict severe brain atrophy at 8 years, and MSFC change between baseline and 2 year follow up had an OR of 3.10 to predict severe brain atrophy at 8 years
  • Baseline MSFC had an OR of 2.20 to predict a change from relapsing-remitting to secondary progressive disease type at 8 years, and MSFC change score between baseline and 2 year follow up hand an OR of 3.86 to predict a change from relapsing-remitting to secondary progressive disease type at 8 years

 

(Cutter, Fisher et al, 1999, 2000)

  • Across MS disease type and severity, a 1 standard deviation change in MSFC over a 1 year period results in a 1.6 odds ratio of a sustained worsening in EDSS

 

MSFC and Other Measures: 

(Miller et al, 2000) 

  • Adequate correlation with MSFC and the Short Form Health Survey (SF-36) Physical Component Summary score (r = 0.41)
  • Poor correlation with the MSFC and Impact Scale and the physical subscale (r = -0.13 and -0.12)
  • Poor correlation with MSFC and EDSS range of 0 – 3 (r = -0.21 - -0.15)
  • Adequate correlation with self-reported employment status with EDSS range of 0 – 3 and 3.5 – 6.5 (r = 0.21 and r = 0.32) 

 

(Hoogercorst et al, 2004)

  • Adequate correlation with MSFC and Guys Neurological Disability Scale measures with 188 PWMS and mean EDSS score of 4.2 (2.0) (r = -0.58 - -0.57) 

 

(McGuigan et al, 2004)

  • Adequate correlation with MSFC and MS Impact Scale-29 with 102 PWMS and mean EDSS of 3.9 and a combined sample of 172 PWMS and mean EDSS of 4.4 (r = 0.577)

Construct Validity

Multiple Sclerosis:

(Hobart et al, 2004)

  • The MSFC was more precise than the EDSS in detecting between groups differences across four MRI markers. The EDSS was 23% as precise as the MSFC in discrimination by T1 lesion volume, 58% as precise in discrimination by T2 lesion volume, 35% as precise in discrimination by brain parenchymal fraction, and 33% as precise in discrimination by ventricular faction

Floor/Ceiling Effects

Multiple Sclerosis:

(Solari et al, 2005)

  • Excellent ceiling effect for the T25FW and 9HPT
  • Possibility of floor effect on the T25FW if person is unable to complete the walk safely

Responsiveness

Multiple Sclerosis:

(Kragt et al, 2008; n = 161 with primary progressive MS; EDSS median = 5.0)

  • A worsening of MSFC from baseline to 1 year follow up predicted later worsening of EDSS (sensitivity = 0.49; specificity = 0.55; negative predictive validity = 0.39; negative predictive validity = 0.65; positive likelihood ration = 1.09; negative likelihood ratio = 0.93)

Bibliography

Bosma, L., Kragt, J., et al. (2010). "Progression on the Multiple Sclerosis Functional Composite in multiple sclerosis: what is the optimal cut-off for the three components?" Multiple Sclerosis 16(7): 862-867. Find it on PubMed

Cohen, J. A., Cutter, G. R., et al. (2001). "Use of the multiple sclerosis functional composite as an outcome measure in a phase 3 clinical trial." Archives of neurology 58(6): 961. Find it on PubMed

Cohen, J. A., Fischer, J. S., et al. (2000). "Intrarater and interrater reliability of the MS functional composite outcome measure." Neurology 54(4): 802-806. Find it on PubMed

Cutter, G. R., Baier, M. L., et al. (1999). "Development of a multiple sclerosis functional composite as a clinical trial outcome measure." Brain 122(5): 871-882. Find it on PubMed

Drake, A. S., Weinstock-Guttman, B., et al. (2010). "Psychometrics and normative data for the Multiple Sclerosis Functional Composite: replacing the PASAT with the Symbol Digit Modalities Test." Mult Scler 16(2): 228-237. Find it on PubMed

Fischer, J. S., Rudick, R. A., et al. (1999). "The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force." Mult Scler 5(4): 244-250. Find it on PubMed

Fisher, E., Rudick, R., et al. (2000). "Relationship between brain atrophy and disability: an 8-year follow-up study of multiple sclerosis patients." Multiple Sclerosis 6(6): 373-377. Find it on PubMed

Fox, R. J., Lee, J. C., et al. (2007). "Optimal reference population for the multiple sclerosis functional composite." Mult Scler 13(7): 909-914. Find it on PubMed

Goldman, M. D., Motl, R. W., et al. (2010). "Possible clinical outcome measures for clinical trials in patients with multiple sclerosis." Ther Adv Neurol Disord 3(4): 229-239. Find it on PubMed

Hobart, J., Kalkers, N., et al. (2004). "Outcome measures for multiple sclerosis clinical trials: relative measurement precision of the Expanded Disability Status Scale and Multiple Sclerosis Functional C omposite." Multiple Sclerosis 10(1): 41-46. Find it on PubMed

Hoogervorst, E. L., Kalkers, N. F., et al. (2002). "A study validating changes in the multiple sclerosis functional composite." Arch Neurol 59(1): 113-116. Find it on PubMed

Hoogervorst, E. L. J., Kalkers, N., et al. (2004). "The patient's perception of a (reliable) change in the Multiple Sclerosis Functional C omposite." Multiple Sclerosis 10(1): 55-60. Find it on PubMed

Kalkers, N., Bergers, E., et al. (2001). "Optimizing the association between disability and biological markers in MS." Neurology 57(7): 1253-1258. Find it on PubMed

Kalkers, N., Bergers, L., et al. (2001). "Concurrent validity of the MS Functional Composite using MRI as a biological disease marker." Neurology 56(2): 215-219. Find it on PubMed

Kragt, J. J., Thompson, A. J., et al. (2008). "Responsiveness and predictive value of EDSS and MSFC in primary progressive MS." Neurology 70(13 Pt 2): 1084-1091. Find it on PubMed

McGuigan, C. and Hutchinson, M. (2004). "The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure." Journal of Neurology, Neurosurgery & Psychiatry 75(2): 266-269. Find it on PubMed

Miller, D. M., Rudick, R. A., et al. (2000). "Clinical significance of the multiple sclerosis functional composite: relationship to patient-reported quality of life." Arch Neurol 57(9): 1319-1324. Find it on PubMed

Polman, C. H. and Rudick, R. A. (2010). "The multiple sclerosis functional composite: a clinically meaningful measure of disability." Neurology 74 Suppl 3(17 Supplement 3): S8-15. Find it on PubMed

Rudick, R., Cutter, G., et al. (2001). "Use of the Multiple Sclerosis Functional Composite to predict disability in relapsing MS." Neurology 56(10): 1324-1330. Find it on PubMed

Rudick, R., Cutter, G., et al. (2002). "The multiple sclerosis functional composite: a new clinical outcome measure for multiple sclerosis trials." Multiple sclerosis 8(5): 359-365. Find it on PubMed

Rudick, R. A., Polman, C. H., et al. (2009). "Assessing disability progression with the Multiple Sclerosis Functional Composite." Mult Scler 15(8): 984-997. Find it on PubMed

Schwid, S., Goodman, A., et al. (2002). "Quantitative functional measures in MS: What is a reliable change?" Neurology 58(8): 1294-1296. Find it on PubMed

Solari, A., Radice, D., et al. (2005). "The multiple sclerosis functional composite: different practice effects in the three test components." J Neurol Sci 228(1): 71-74. Find it on PubMed

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