Dataset Information

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

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.

SUBMITTER: LaRocca NG

PROVIDER: S-EPMC6174619 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

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

LaRocca Nicholas G NG Hudson Lynn D LD Rudick Richard R Amtmann Dagmar D Balcer Laura L Benedict Ralph R Bermel Robert R Chang Ih I Chiaravalloti Nancy D ND Chin Peter P Cohen Jeffrey A JA Cutter Gary R GR Davis Mat D MD DeLuca John J Feys Peter P Francis Gordon G Goldman Myla D MD Hartley Emily E Kapoor Raj R Lublin Fred F Lundstrom Gary G Matthews Paul M PM Mayo Nancy N Meibach Richard R Miller Deborah M DM Motl Robert W RW Mowry Ellen M EM Naismith Rob R Neville Jon J Panagoulias Jennifer J Panzara Michael M Phillips Glenn G Robbins Ann A Sidovar Matthew F MF Smith Kathryn E KE Sperling Bjorn B Uitdehaag Bernard Mj BM Weaver Jerry J

Multiple sclerosis (Houndmills, Basingstoke, England) 20170811 11

<h4>Background</h4>The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed by the National MS Society to develop improved measures of multiple sclerosis (MS)-related disability.<h4>Objectives</h4>(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.<h4>Methods</h4>(1) Identify disability dimensions common in MS; (2) conduct a com ...[more]

PMID: 28799444

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Dataset Information

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

Background

Objectives

Methods

Conclusion

Publications

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

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