Brain, Vol. 122, No. 5, 871-882,
May 1999
© 1999 Oxford University Press
Development of a multiple sclerosis functional composite as a clinical trial outcome measure
1 AMC Cancer Research Center, Lakewood, Colarado, 2 Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, Ohio, 3 Dept of Neurology, State University of New York, Buffalo, 4 Maimonides Medical Center, Brooklyn, 5 Research Programs, National Multiple Sclerosis Society, New York, New York, 6 Neurology Service, VA Wadsworth Hospital Center, Los Angeles, 7 Department of Neurology, UCLA Medical Center, Los Angeles, California, 8 Department of Neurology, Mayo Clinic, Rochester, Minnesota, 9 Allegheny University for the Health Sciences, Philadelphia, Pennsylvania, 10 Section of Neuropsychology, MCW Clinic at Froedtert, Milwaukee, Wisconsin, 11 Department of Statistics, University of British Columbia, Vancouver, 12 Montreal Neurological Institute, Montreal, Quebec, Canada, 13 Service De Neurologie, Hopital de l'Antiquaille, Lyon, France, 14 The National Hospital for Neurology and Neurosurgery, London, UK, 15 Department of Neurology, Auckland Hospital, Auckland, New Zealand
Correspondence to:
Dr Gary Cutter, AMC Cancer Research Center, Center for Research Methodology and Biometrics, 1600 Pierce St, Lakewood, CO 80214, USA E-mail: cutterg{at}amc.org
The primary clinical outcome measure for evaluating multiple sclerosis in clinical trials has been Kurtzke's expanded disability status scale (EDSS). New therapies appear to favourably impact the course of multiple sclerosis and render continued use of placebo control groups more difficult. Consequently, future trials are likely to compare active treatment groups which will most probably require increased sample sizes in order to detect therapeutic efficacy. Because more responsive outcome measures will be needed for active arm comparison studies, the National Multiple Sclerosis Society's Advisory Committee on Cinical Trials of New Agents in Multiple Sclerosis appointed a Task Force that was charged with developing improved clinical outcome measures. This Task Force acquired contemporary clinical trial and historical multiple sclerosis data for meta-analyses of primary and secondary outcome assessments to provide a basis for recommending a new outcome measure. A composite measure encompassing the major clinical dimensions of arm, leg and cognitive function was identified and termed the multiple sclerosis functional composite (MSFC). The MSFC consists of three objective quantitative tests of neurological function which are easy to administer. Change in this MSFC over the first year of observation predicted subsequent change in the EDSS, suggesting that the MSFC is more sensitive to change than the EDSS. This paper provides details concerning the development and testing of the MSFC.
multiple sclerosis clinical outcome measure
EDSS = expanded disability status scale; MSFC = multiple sclerosis functional composite; PASAT = paced auditory serial addition test; SDMT = symbol digit modality test
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P. Soelberg Sorensen, J. Haas, F. Sellebjerg, T. Olsson, M. Ravnborg, and the TARIMS Study Group IV immunoglobulins as add-on treatment to methylprednisolone for acute relapses in MS Neurology, December 14, 2004; 63(11): 2028 - 2033. [Abstract] [Full Text] [PDF]
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E L. Hoogervorst, J N. Zwemmer, B Jelles, C H Polman, and B M. Uitdehaag Multiple Sclerosis Impact Scale (MSIS-29): relation to established measures of impairment and disability Multiple Sclerosis, October 1, 2004; 10(5): 569 - 574. [Abstract] [PDF]
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F. M. Boneschi, M. Rovaris, G. Comi, and M. Filippi The use of magnetic resonance imaging in multiple sclerosis: lessons learned from clinical trials Multiple Sclerosis, August 1, 2004; 10(4): 341 - 347. [Abstract] [PDF]
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J Sastre-Garriga, M Comabella, L Brieva, A Rovira, M Tintore, and X Montalban Decreased MMP-9 production in primary progressive multiple sclerosis patients Multiple Sclerosis, August 1, 2004; 10(4): 376 - 380. [Abstract] [PDF]
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C. McGuigan and M. Hutchinson Confirming the validity and responsiveness of the Multiple Sclerosis Walking Scale-12 (MSWS-12) Neurology, June 8, 2004; 62(11): 2103 - 2105. [Abstract] [Full Text] [PDF]
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K. M Healey, S. Z Pavletic, J. Al-Omaishi, M P. Leuschen, S. J Pirruccello, M. L Filipi, C. Enke, M. M. Ursick, F. Hahn, J D Bowen, et al. Discordant functional and inflammatory parameters in multiple sclerosis patients after autologous haematopoietic stem cell transplantation Multiple Sclerosis, June 1, 2004; 10(3): 284 - 289. [Abstract] [PDF]
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J. Cohen, G. Cutter, F. Lublin, and S. Schwid The MS Co-O perative Research (MS-CORE) group: an alternate approach to fostering multicenter studies Multiple Sclerosis, June 1, 2004; 10(3): 332 - 335. [PDF]
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L. Kappos Effect of drugs in secondary disease progression in patients with multiple sclerosis Multiple Sclerosis, June 1, 2004; 10(1_suppl): S46 - S55. [Abstract] [PDF]
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L. Kappos Effect of drugs in secondary disease progression in patients with multiple sclerosis Multiple Sclerosis, May 1, 2004; 10(3_suppl): S46 - S55. [Abstract] [PDF]
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C McGuigan, A McCarthy, C Quigley, L Bannan, S A Hawkins, and M Hutchinson Latitudinal variation in the prevalence of multiple sclerosis in Ireland, an effect of genetic diversity J. Neurol. Neurosurg. Psychiatry, April 1, 2004; 75(4): 572 - 576. [Abstract] [Full Text] [PDF]
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K. Schmierer, D. R Altmann, N. Kassim, H. Kitzler, C. M Kerskens, C. A Doege, O. Aktas, J. D Lunemann, D. H Miller, F. Zipp, et al. Progressive change in primary progressive multiple sclerosis normal-appearing white matter: a serial diffusion magnetic resonance imaging study Multiple Sclerosis, April 1, 2004; 10(2): 182 - 187. [Abstract] [PDF]
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C Vaney, S Vaney, and D T Wade SaGA S, the Short and Graphic A bility Score: an alternative scoring method for the motor components of the Multiple Sclerosis Functional C omposite Multiple Sclerosis, April 1, 2004; 10(2): 231 - 242. [Abstract] [PDF]
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C McGuigan and M Hutchinson The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure J. Neurol. Neurosurg. Psychiatry, February 1, 2004; 75(2): 266 - 269. [Abstract] [Full Text] [PDF]
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J Hobart, N Kalkers, F Barkhof, B Uitdehaag, C Polman, and A Thompson Outcome measures for multiple sclerosis clinical trials: relative measurement precision of the Expanded Disability Status Scale and Multiple Sclerosis Functional C omposite Multiple Sclerosis, February 1, 2004; 10(1): 41 - 46. [Abstract] [PDF]
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E L. Hoogervorst, N F Kalkers, G R Cutter, B M. Uitdehaag, and C H Polman The patient's perception of a (reliable) change in the Multiple Sclerosis Functional C omposite Multiple Sclerosis, February 1, 2004; 10(1): 55 - 60. [Abstract] [PDF]
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M. Gadea, M. C. Martinez-Bisbal, L. Marti-Bonmati, R. Espert, B. Casanova, F. Coret, and B. Celda Spectroscopic axonal damage of the right locus coeruleus relates to selective attention impairment in early stage relapsing-remitting multiple sclerosis Brain, January 1, 2004; 127(1): 89 - 98. [Abstract] [Full Text] [PDF]
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F. D. Lublin, M. Baier, and G. Cutter Effect of relapses on development of residual deficit in multiple sclerosis Neurology, December 9, 2003; 61(11): 1528 - 1532. [Abstract] [Full Text] [PDF]
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L. J. Balcer, M. L. Baier, J. A. Cohen, M. F. Kooijmans, A. W. Sandrock, M. L. Nano-Schiavi, D. C. Pfohl, M. Mills, J. Bowen, C. Ford, et al. Contrast letter acuity as a visual component for the Multiple Sclerosis Functional Composite Neurology, November 25, 2003; 61(10): 1367 - 1373. [Abstract] [Full Text] [PDF]
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G. T. Ingle, V. L. Stevenson, D. H. Miller, and A. J. Thompson Primary progressive multiple sclerosis: a 5-year clinical and MR study Brain, November 1, 2003; 126(11): 2528 - 2536. [Abstract] [Full Text] [PDF]
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B Weinstock-Guttman, M Baier, R Stockton, A Weinstock, T Justinger, F Munschauer, C Brownscheidle, J Williams, E Fisher, D Miller, et al. Pattern reversal visual evoked potentials as a measure of visual pathway pathology in multiple sclerosis Multiple Sclerosis, October 1, 2003; 9(5): 529 - 534. [Abstract] [PDF]
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S. M Gold, H. Schulz, A. Monch, K.-H. Schulz, and C. Heesen Cognitive impairment in multiple sclerosis does not affect reliability and validity of self-report health measures Multiple Sclerosis, August 1, 2003; 9(4): 404 - 410. [Abstract] [PDF]
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A randomized controlled study of the acute and chronic effects of cooling therapy for MS Neurology, June 24, 2003; 60(12): 1955 - 1960. [Abstract] [Full Text] [PDF]
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D. M Miller, R. A Rudick, M. Baier, G. Cutter, D. S Doughtery, B. Weinstock-Guttman, M. K Mass, E. Fisher, and N. Simonian Factors that predict Health-Related Q uality of Life in patients with relapsing -remitting multiple sclerosis Multiple Sclerosis, February 1, 2003; 9(1): 1 - 5. [Abstract] [PDF]
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M W Nortvedt and T Riise The use of quality of life measures in multiple sclerosis research Multiple Sclerosis, February 1, 2003; 9(1): 63 - 72. [Abstract] [PDF]
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R H. Benedict, F Munschauer, R Linn, C Miller, E Murphy, F Foley, and L Jacobs Screening for multiple sclerosis cognitive impairment using a self-administered 15-item questionnaire Multiple Sclerosis, February 1, 2003; 9(1): 95 - 101. [Abstract] [PDF]
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