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

Mult Scler. 1998 Dec;4(6):480-6. doi: 10.1177/135245859800400604.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • 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