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, Dennis 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 & 8 others D. S. Dougherty, R. P. Kinkel, Michele Mass, F. E. Munschauer, P. M. Pullicino, B. J. Scherokman, B. Weinstock-Guttman, Ruth Whitham

Research output: Contribution to journalArticle

25 Citations (Scopus)

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 - 1998

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Clinical Trials
Treatment Failure
Interferon-beta
Walking
Therapeutics

Keywords

  • Clinical trials
  • Multiple sclerosis
  • Outcome measures

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials. / Goodkin, D. E.; Priore, R. L.; Wende, K. E.; Campion, M.; Bourdette, Dennis; 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, Michele; Munschauer, F. E.; Pullicino, P. M.; Scherokman, B. J.; Weinstock-Guttman, B.; Whitham, Ruth.

In: Multiple Sclerosis, Vol. 4, No. 6, 1998, p. 480-486.

Research output: Contribution to journalArticle

Goodkin, DE, Priore, RL, Wende, KE, Campion, M, Bourdette, D, Herndon, RM, Fischer, JS, Jacobs, LD, Cookfair, DL, Rudick, RA, Richert, JR, Salazar, AM, Granger, CV, Simon, JH, Alam, JJ, Bartoszak, DM, Braiman, J, Brownscheidle, CM, Coats, ME, Cohan, SL, Dougherty, DS, Kinkel, RP, Mass, M, Munschauer, FE, Pullicino, PM, Scherokman, BJ, Weinstock-Guttman, B & Whitham, R 1998, 'Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials', Multiple Sclerosis, vol. 4, no. 6, pp. 480-486.
Goodkin, D. E. ; Priore, R. L. ; Wende, K. E. ; Campion, M. ; Bourdette, Dennis ; 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, Michele ; Munschauer, F. E. ; Pullicino, P. M. ; Scherokman, B. J. ; Weinstock-Guttman, B. ; Whitham, Ruth. / Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials. In: Multiple Sclerosis. 1998 ; Vol. 4, No. 6. pp. 480-486.
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AU - Priore, R. L.

AU - Wende, K. E.

AU - Campion, M.

AU - Bourdette, Dennis

AU - Herndon, R. M.

AU - Fischer, J. S.

AU - Jacobs, L. D.

AU - Cookfair, D. L.

AU - Rudick, R. A.

AU - Richert, J. R.

AU - Salazar, A. M.

AU - Granger, C. V.

AU - Simon, J. H.

AU - Alam, J. J.

AU - Bartoszak, D. M.

AU - Braiman, J.

AU - Brownscheidle, C. M.

AU - Coats, M. E.

AU - Cohan, S. L.

AU - Dougherty, D. S.

AU - Kinkel, R. P.

AU - Mass, Michele

AU - Munschauer, F. E.

AU - Pullicino, P. M.

AU - Scherokman, B. J.

AU - Weinstock-Guttman, B.

AU - Whitham, Ruth

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