The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability.

File Description SizeFormat 
1352458517723718.pdfPublished version960.58 kBAdobe PDFDownload
Title: The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability.
Author(s): LaRocca, NG
Hudson, LD
Rudick, R
Amtmann, D
Balcer, L
Benedict, R
Bermel, R
Chang, I
Chiaravalloti, ND
Chin, P
Cohen, JA
Cutter, GR
Davis, MD
DeLuca, J
Feys, P
Francis, G
Goldman, MD
Hartley, E
Kapoor, R
Lublin, F
Lundstrom, G
Matthews, PM
Mayo, N
Meibach, R
Miller, DM
Motl, RW
Mowry, EM
Naismith, R
Neville, J
Panagoulias, J
Panzara, M
Phillips, G
Robbins, A
Sidovar, MF
Smith, KE
Sperling, B
Uitdehaag, BM
Weaver, J
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
Item Type: Journal Article
Abstract: BACKGROUND: The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed by the National MS Society to develop improved measures of multiple sclerosis (MS)-related disability. OBJECTIVES: (1) To assess the current literature and available data on functional performance outcome measures (PerfOs) and (2) to determine suitability of using PerfOs to quantify MS disability in MS clinical trials. METHODS: (1) Identify disability dimensions common in MS; (2) conduct a comprehensive literature review of measures for those dimensions; (3) develop an MS Clinical Data Interchange Standards Consortium (CDISC) data standard; (4) create a database of standardized, pooled clinical trial data; (5) analyze the pooled data to assess psychometric properties of candidate measures; and (6) work with regulatory agencies to use the measures as primary or secondary outcomes in MS clinical trials. CONCLUSION: Considerable data exist supporting measures of the functional domains ambulation, manual dexterity, vision, and cognition. A CDISC standard for MS ( http://www.cdisc.org/therapeutic#MS ) was published, allowing pooling of clinical trial data. MSOAC member organizations contributed clinical data from 16 trials, including 14,370 subjects. Data from placebo-arm subjects are available to qualified researchers. This integrated, standardized dataset is being analyzed to support qualification of disability endpoints by regulatory agencies.
Publication Date: 11-Aug-2017
Date of Acceptance: 2-Jul-2017
URI: http://hdl.handle.net/10044/1/52717
DOI: https://dx.doi.org/10.1177/1352458517723718
ISSN: 1352-4585
Publisher: SAGE Publications
Journal / Book Title: Multiple Sclerosis Journal
Copyright Statement: © 2017 The Author(s). This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Keywords: MS disability
clinical trial database
data standards
performance outcome measures
regulatory qualification
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
1103 Clinical Sciences
1109 Neurosciences
Neurology & Neurosurgery
Publication Status: Published
Conference Place: England
Appears in Collections:Department of Medicine
Faculty of Medicine



Items in Spiral are protected by copyright, with all rights reserved, unless otherwise indicated.

Creative Commons