Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials. The Multiple Sclerosis Collaborative Research Group (MSCRG)

• Published in: Multiple sclerosis Vol. 4; no. 6; p. 480
• 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, Kinkel, R P, Mass, M K, Munschauer, 3rd, F E, Whitham, R H
• Format: Journal Article
• Language: English
• Published: England 01-12-1998
• Subjects: Clinical Trials as Topic; Disability Evaluation; Hand - physiopathology; Humans; Methods; Motor Skills - physiology; Multiple Sclerosis - drug therapy; Multiple Sclerosis - physiopathology; Psychomotor Performance; Sensitivity and Specificity; Survival Analysis; Time Factors; Treatment Failure; Treatment Outcome; Walking - physiology
• ISSN: 1352-4585

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-physician-based 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.