Concurrent validity of the MS Functional Composite using MRI as a biological disease marker
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Abstract
Introduction: The MS Functional Composite (MSFC), a recently developed outcome measure for MS clinical trials measuring three dimensions (ambulation/leg function, arm/hand function, and cognition), was applied to 134 patients with MS to study the concurrent validity, using MRI measurements as a biological disease marker. The results were compared to correlations between the traditionally applied Expanded Disability Status Scale (EDSS) and MRI measurements in the same patients.
Methods: The assessments of MSFC and EDSS were performed in combination with brain MRI. MRI consisted of T1- and T2-weighted images, from which the hypointense and hyperintense lesion loads were quantified.
Results: The MSFC score ranged from −2.54 to 0.99. The median EDSS was 3.0 (interquartile range [IQR] 1.5 to 6.0). The median T2-weighted lesion load was 8.4 cm3 (IQR 3.4 to 19.8) and the median T1-weighted lesion load was 1.1 cm3 (IQR 0.3 to 3.2). Correlations between the MSFC and both T1 (−0.24) and T2 (−0.25) lesion loads were demonstrated, but not between the EDSS and both MRI parameters. Significant correlations between MSFC components and T1 and T2 lesion loads existed for cognitive function and arm/hand function, but not for ambulation. If relapse-onset patients (relapsing-remitting and secondary progressive) were combined, the correlation between MSFC and MRI parameters became stronger for both T1 (−0.37) and T2 lesion loads (−0.35).
Conclusions: The authors present the concurrent validity of the MSFC with a biological disease marker by showing correlations with MRI. Specifically, they demonstrate significant correlations with cognition and arm/hand function assessments, domains that are not well represented in the EDSS.
- Received May 12, 2000.
- Accepted September 22, 2000.
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