Comparing the ability of various compositive outcomes to discriminate treatment effects in MS clinical trials
| Autor: | Frederick Munschauer, J. S. Fischer, Michele Mass, Diane Cookfair, John R. Richert, Ruth H. Whitham, Dennis Bourdette, Michael E. Coats, M. Campion, Barbara J. Scherokman, Carol M. Brownscheidle, Carl V. Granger, R. P. Kinkel, Donald E. Goodkin, Robert M. Herndon, Roger L. Priore, Lawrence Jacobs, Bianca Weinstock-Guttman, John J. Alam, RA Rudick, David S. Dougherty, Stanley Cohan, Andres M. Salazar, K. E. Wende, David M. Bartoszak, Patrick M. Pullicino, Jack H. Simon, J. Braiman |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
030506 rehabilitation
medicine.medical_specialty business.industry Treatment outcome Composite outcomes Outcome measures Kurtzke Expanded Disability Status Scale Treatment failure Clinical trial 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Neurology immune system diseases medicine Physical therapy Neurology (clinical) 0305 other medical science business 030217 neurology & neurosurgery |
| Zdroj: | Multiple Sclerosis. 4:480-486 |
| ISSN: | 1477-0970 1352-4585 |
| Popis: | 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-physicianbased 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|