| Literature DB >> 9987756 |
D E Goodkin1, R L Priore, K E Wende, M Campion, D N Bourdette, R M Herndon, J S Fischer, L D Jacobs, D L Cookfair, R A Rudick, J R Richert, A M Salazar, C V Granger, J H Simon, J J Alam, D M Bartoszak, J Braiman, C M Brownscheidle, M E Coats, S L Cohan, D S Dougherty, R P Kinkel, M K Mass, F E Munschauer, R H Whitham.
Abstract
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.Entities:
Mesh：
Year: 1998 PMID： 9987756 DOI： 10.1177/135245859800400604
Source DB: PubMed Journal: Mult Scler ISSN： 1352-4585 Impact factor: 6.312