Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials

We compared the ability of the Kurtzke Expanded Disability Status Scale (EDSS) and a composite outcome of non-physician-based measures of time to ambulate 25 feet (TA) and manual dexterity (the Box and Block Test [BBT], and 9-Hole Peg Test [9HPT]) to discriminate treatment effects in the Phase III s...

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Published in:Multiple sclerosis 1998-12, Vol.4 (6), p.480-486
Main Authors: Goodkin, D E, Priore, R L, Wende, K E, Campion, M, Bourdette, D N, Herndon, R M, Fischer, J S, Jacobs, L D, Cookfair, D L, Rudick, R A, Richert, J R, Salazar, A M, Granger, C V, Simon, J H, Alam, J J, Bartoszak, D M, Braiman, J, Brownscheidle, C M, Coats, M E, Cohan, S L, Dougherty, D S, Kinke, R P, Mass, M K, Munschauer, F E, Pullicino, P M, Scherokman, B J, Weinstock-Guttman, B, Whitham, R H
Format: Article
Language:English
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Summary:We compared the ability of the Kurtzke Expanded Disability Status Scale (EDSS) and a composite outcome of non-physician-based measures of time to ambulate 25 feet (TA) and manual dexterity (the Box and Block Test [BBT], and 9-Hole Peg Test [9HPT]) to discriminate treatment effects in the Phase III study of interferon beta-1a. A log-rank comparison of Kaplan-Meier curves by treatment group showed the non-physicianbased composite of BBT, 9HPT, and TA was of comparable sensitivity (P=0.013) in discriminating sustained treatment failure as the EDSS alone (P=0.029). The composite of BBT, 9HPT, TA, and EDSS was more sensitive (P=0.009) in discriminating sustained treatment failure than the EDSS alone. Compositive outcomes of the EDSS and non-physician-based measures of manual dexterity and timed ambulation provide an appealing strategy to reduce the number of patients required to discriminate treatment effects in MS clinical trials.
ISSN:1352-4585
1477-0970
DOI:10.1177/135245859800400604