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- Title
The MSOAC approach to developing performance outcomes to measure and monitor 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
- 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 (<ext-link>http://www.cdisc.org/therapeutic#MS</ext-link>) 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.
- Subjects
MULTIPLE sclerosis; HEALTH outcome assessment; CLINICAL trials; MULTIPLE sclerosis research; MULTIPLE sclerosis treatment
- Publication
Multiple Sclerosis Journal, 2018, Vol 24, Issue 11, p1469
- ISSN
1352-4585
- Publication type
Article
- DOI
10.1177/1352458517723718