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http://hdl.handle.net/1942/25965
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DC Field | Value | Language |
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dc.contributor.author | LaRocca, Nicholas G. | - |
dc.contributor.author | Hudson, Lynn D. | - |
dc.contributor.author | Rudick, Richard | - |
dc.contributor.author | Amtmann, Dagmar | - |
dc.contributor.author | Balcer, Laura | - |
dc.contributor.author | Benedict, Ralph | - |
dc.contributor.author | Bermel, Robert | - |
dc.contributor.author | Chang, Ih | - |
dc.contributor.author | Chiaravalloti, Nancy D. | - |
dc.contributor.author | Chin, Peter | - |
dc.contributor.author | Cohen, Jeffrey A. | - |
dc.contributor.author | Cutter, Gary R. | - |
dc.contributor.author | Davis, Mat D. | - |
dc.contributor.author | DeLuca, John | - |
dc.contributor.author | FEYS, Peter | - |
dc.contributor.author | Francis, Gordon | - |
dc.contributor.author | Goldman, Myla D. | - |
dc.contributor.author | Hartley, Emily | - |
dc.contributor.author | Kapoor, Raj | - |
dc.contributor.author | Lublin, Fred | - |
dc.contributor.author | Lundstrom, Gary | - |
dc.contributor.author | Matthews, Paul M. | - |
dc.contributor.author | Mayo, Nancy | - |
dc.contributor.author | Meibach, Richard | - |
dc.contributor.author | Miller, Deborah M. | - |
dc.contributor.author | Motl, Robert W. | - |
dc.contributor.author | Mowry, Ellen M. | - |
dc.contributor.author | Naismith, Rob | - |
dc.contributor.author | Neville, Jon | - |
dc.contributor.author | Panagoulias, Jennifer | - |
dc.contributor.author | Panzara, Michael | - |
dc.contributor.author | Phillips, Glenn | - |
dc.contributor.author | Robbins, Ann | - |
dc.contributor.author | Sidovar, Matthew F. | - |
dc.contributor.author | Smith, Kathryn E. | - |
dc.contributor.author | Sperling, Bjorn | - |
dc.contributor.author | Uitdehaag, Bernard M.J. | - |
dc.contributor.author | Weaver, Jerry | - |
dc.date.accessioned | 2018-05-07T11:18:31Z | - |
dc.date.available | 2018-05-07T11:18:31Z | - |
dc.date.issued | 2018 | - |
dc.identifier.citation | Multiple Sclerosis Journal, 24 (11), p. 1469-1484 | - |
dc.identifier.issn | 1352-4585 | - |
dc.identifier.uri | http://hdl.handle.net/1942/25965 | - |
dc.description.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. | - |
dc.description.sponsorship | The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: MSOAC is funded largely through the National Multiple Sclerosis Society grant (no. RG 4869-A-1) to the Critical Path Institute. Annual dues from sponsors supplement the NMSS grant. | - |
dc.language.iso | en | - |
dc.rights | 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). | - |
dc.subject.other | MS disability; performance outcome measures; data standards; clinical trial database; regulatory qualification | - |
dc.title | The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability | - |
dc.type | Journal Contribution | - |
dc.identifier.epage | 1484 | - |
dc.identifier.issue | 11 | - |
dc.identifier.spage | 1469 | - |
dc.identifier.volume | 24 | - |
local.bibliographicCitation.jcat | A1 | - |
local.contributor.corpauthor | Multiple Sclerosis Outcome Assessments Consortium (MSOAC) | - |
local.type.refereed | Refereed | - |
local.type.specified | Article | - |
dc.identifier.doi | 10.1177/1352458517723718 | - |
dc.identifier.isi | 000446533000013 | - |
item.validation | ecoom 2019 | - |
item.fulltext | With Fulltext | - |
item.accessRights | Open Access | - |
item.fullcitation | 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 M.J. & Weaver, Jerry (2018) The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability. In: Multiple Sclerosis Journal, 24 (11), p. 1469-1484. | - |
item.contributor | LaRocca, Nicholas G. | - |
item.contributor | Hudson, Lynn D. | - |
item.contributor | Rudick, Richard | - |
item.contributor | Amtmann, Dagmar | - |
item.contributor | Balcer, Laura | - |
item.contributor | Benedict, Ralph | - |
item.contributor | Bermel, Robert | - |
item.contributor | Chang, Ih | - |
item.contributor | Chiaravalloti, Nancy D. | - |
item.contributor | Chin, Peter | - |
item.contributor | Cohen, Jeffrey A. | - |
item.contributor | Cutter, Gary R. | - |
item.contributor | Davis, Mat D. | - |
item.contributor | DeLuca, John | - |
item.contributor | FEYS, Peter | - |
item.contributor | Francis, Gordon | - |
item.contributor | Goldman, Myla D. | - |
item.contributor | Hartley, Emily | - |
item.contributor | Kapoor, Raj | - |
item.contributor | Lublin, Fred | - |
item.contributor | Lundstrom, Gary | - |
item.contributor | Matthews, Paul M. | - |
item.contributor | Mayo, Nancy | - |
item.contributor | Meibach, Richard | - |
item.contributor | Miller, Deborah M. | - |
item.contributor | Motl, Robert W. | - |
item.contributor | Mowry, Ellen M. | - |
item.contributor | Naismith, Rob | - |
item.contributor | Neville, Jon | - |
item.contributor | Panagoulias, Jennifer | - |
item.contributor | Panzara, Michael | - |
item.contributor | Phillips, Glenn | - |
item.contributor | Robbins, Ann | - |
item.contributor | Sidovar, Matthew F. | - |
item.contributor | Smith, Kathryn E. | - |
item.contributor | Sperling, Bjorn | - |
item.contributor | Uitdehaag, Bernard M.J. | - |
item.contributor | Weaver, Jerry | - |
crisitem.journal.issn | 1352-4585 | - |
crisitem.journal.eissn | 1477-0970 | - |
Appears in Collections: | Research publications |
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File | Description | Size | Format | |
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1352458517723718.pdf | Published version | 537.01 kB | Adobe PDF | View/Open |
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