| Title: |
The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability |
| Authors: |
LaRocca, NG; Hudson, LD; Rudick, R; Amtmann, D; Balcer, L; Benedict, R; Bermel, R; Chang, I; Chiaravalloti, ND; Chin, P; Cohen, JA; Cutter, GR; Davis, MD; DeLuca, J; Feys, P; Francis, G; Goldman, MD; Hartley, E; Kapoor, R; Lublin, F; Lundstrom, G; Matthews, PM; Mayo, N; Meibach, R; Miller, DM; Motl, RW; Mowry, EM; Naismith, R; Neville, J; Panagoulias, J; Panzara, M; Phillips, G; Robbins, A; Sidovar, MF; Smith, KE; Sperling, B; Uitdehaag, BM; Weaver, J; Multiple Sclerosis Outcome Assessments Consortium (MSOAC) |
| Contributors: |
Medical Research Council (MRC) |
| Source: |
1484 ; 1469 |
| Publisher Information: |
SAGE Publications |
| Publication Year: |
2017 |
| Collection: |
Imperial College London: Spiral |
| Subject Terms: |
Science & Technology; Life Sciences & Biomedicine; Clinical Neurology; Neurosciences; Neurosciences & Neurology; MS disability; performance outcome measures; data standards; clinical trial database; regulatory qualification; CONTRAST LETTER ACUITY; FUNCTIONAL COMPOSITE; PROGRESSIVE MS; STATUS SCALE; VALIDITY; IMPACT; IMPAIRMENT; EMPLOYMENT; HEALTH; SPEED; Multiple Sclerosis Outcome Assessments Consortium (MSOAC); 1103 Clinical Sciences; 1109 Neurosciences; Neurology & Neurosurgery |
| Subject Geographic: |
England |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
Multiple Sclerosis Journal; http://hdl.handle.net/10044/1/52717; https://dx.doi.org/10.1177/1352458517723718; MR/K501013/1; MR/N026934/1 |
| DOI: |
10.1177/1352458517723718 |
| Availability: |
http://hdl.handle.net/10044/1/52717; https://doi.org/10.1177/1352458517723718 |
| Rights: |
© 2017 The Author(s). This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
| Accession Number: |
edsbas.F949B3EA |
| Database: |
BASE |