Intrarater and interrater reliability of the MS functional composite outcome measure

Objective: To assess practice effects, and intrarater and interrater reliab ility of the MS functional composite (MSFC) outcome measure. Background: To address the poor reliability and insensitivity to change of available MS c linical rating scales, the National MS Society's Clinical Outcomes Assessme nt Task Force developed the MSFC, a multidimensional quantitative clinical outcome measure that includes tests of leg function/ambulation (Timed 25-Fo ot Walk), arm function (Nine-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). Methods: Ten patients with secondary progre ssive MS underwent six testing sessions over a 2-week period. The MSFC was administered by the same examining technician in the first five sessions an d by the other technician in the sixth, Patients were reassessed by both te chnicians after 6 months (sessions 7 and 8), The MSFC score was calculated as the mean of the Z scores of the three components. A pooled dataset deriv ed from secondary progressive MS patients in the placebo arms of previous c linical trials and natural history studies served as the reference populati on to standardize scores. Results: Practice effects were evident initially but stabilized by the fourth administration. The intraclass correlation coe fficient (ICC) was 0.97 for the MSFC for session 4 versus session 5 (intrar ater reliability). The ICC was 0.95 for session 5 versus session 6 (interra ter reliability), and was 0.96 for session 7 versus session 8 when patients were reassessed 6 months later, Conclusions: The MS functional composite ( MSFC) outcome measure had excellent intrarater and interrater reliability w hen standardized procedures were used to train examining technicians and to assess patients. Prebaseline testing sessions should be included in clinic al trials employing the MSFC to compensate for practice effects.