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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/25965

Title: The MSOAC approach to developing performance outcomes to measure andmonitor multiple sclerosis disability
Authors: LaRocca, Nicholas G.
Hudson, Lynn D.
Rudick, Richard
Amtmann, Dagmar
Balcer, Laura
Benedict, Ralph
Bermel, Robert
Chang, Ih
Chiaravalloti, Nancy D.
Chin, Peter
Cohen, Jeffrey A.
Cutter, Gary R.
Davis, Mat D.
DeLuca, John
Feys, Peter
Francis, Gordon
Goldman, Myla D.
Hartley, Emily
Kapoor, Raj
Lublin, Fred
Lundstrom, Gary
Matthews, Paul M.
Mayo, Nancy
Meibach, Richard
Miller, Deborah M.
Motl, Robert W.
Mowry, Ellen M.
Naismith, Rob
Neville, Jon
Panagoulias, Jennifer
Panzara, Michael
Phillips, Glenn
Robbins, Ann
Sidovar, Matthew F.
Smith, Kathryn E.
Sperling, Bjorn
Uitdehaag, Bernard M.J.
Weaver, Jerry
Issue Date: 2017
Citation: Multiple Sclerosis Journal,
Status: Early View
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.
URI: http://hdl.handle.net/1942/25965
DOI: 10.1177/1352458517723718
ISSN: 1352-4585
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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