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

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 MJ ; Weaver, Jerry

Multiple sclerosis, 2018-10, Vol.24 (11), p.1469-1484 [Periódico revisado por pares]

London, England: SAGE Publications

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Título:
The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability
Autor: 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 MJ ; Weaver, Jerry
Assuntos: Clinical trials ; Cognition ; Consortia ; Data processing ; Databases, Factual ; Disability Evaluation ; Humans ; Literature reviews ; Multiple Sclerosis ; Original Research Papers ; Outcome Assessment, Health Care - standards ; Regulatory agencies
É parte de: Multiple sclerosis, 2018-10, Vol.24 (11), p.1469-1484
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
Descrição: 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.
Editor: London, England: SAGE Publications
Idioma: Inglês

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

London, England: SAGE Publications

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