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

D. E. Goodkin, 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. CohanD. S. Dougherty, R. P. Kinkel, M. K. Mass, F. E. Munschauer, P. M. Pullicino, B. J. Scherokman, B. Weinstock-Guttman, R. H. Whitham

Research output: Contribution to journalArticle

25 Scopus citations

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-la. A log-rank comparison of Kaplan-Meier curves by treatment group showed the non-physician-based composite of BET, 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.

Original languageEnglish (US)
Pages (from-to)480-486
Number of pages7
JournalMultiple Sclerosis
Volume4
Issue number6
StatePublished - Dec 1 1998

Keywords

  • Clinical trials
  • Multiple sclerosis
  • Outcome measures

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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    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., ... Whitham, R. H. (1998). Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials. Multiple Sclerosis, 4(6), 480-486.