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Updated: Feb 24, 2026
The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
Published on: June 30, 2014
The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability
Nicholas G LaRocca1, Lynn D Hudson2, Richard Rudick3
1National Multiple Sclerosis Society, New York, NY, USA.
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.
Insights
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) developed standardized methods to measure multiple sclerosis (MS) disability. This effort aims to improve clinical trial outcomes and regulatory qualification of new MS disability measures.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- The National Multiple Sclerosis Society established the Multiple Sclerosis Outcome Assessments Consortium (MSOAC).
- MSOAC aims to create superior methods for assessing multiple sclerosis (MS)-related disability.
- Focus is on developing and validating functional performance outcome measures (PerfOs).
Purpose of the Study:
- To review existing literature and data on functional performance outcome measures (PerfOs).
- To evaluate the suitability of PerfOs for quantifying MS disability in clinical trials.
- To support the qualification of MS disability endpoints by regulatory agencies.
Main Methods:
- Identification of common MS disability dimensions.
- Comprehensive literature review of relevant outcome measures.
- Development of a Clinical Data Interchange Standards Consortium (CDISC) data standard for MS.
- Creation of a standardized, pooled clinical trial data database.
- Analysis of pooled data to assess psychometric properties of candidate measures.
- Collaboration with regulatory agencies for endpoint qualification.
Main Results:
- Established evidence supports measures for ambulation, manual dexterity, vision, and cognition.
- A CDISC standard for MS has been published, facilitating data pooling.
- Clinical data from 16 trials, encompassing 14,370 subjects, were contributed by MSOAC members.
- Pooled data from placebo arms are accessible to qualified researchers.
- The integrated dataset is undergoing analysis to support regulatory qualification of disability endpoints.
Conclusions:
- Existing data support the use of specific functional domains for MS disability assessment.
- The developed CDISC standard enables effective data pooling for MS clinical trials.
- The ongoing analysis of pooled data is crucial for the regulatory qualification of novel MS disability endpoints.
