Potential outcome measures and trial design issues for multiple system atrophy
Identifieur interne : 001680 ( Istex/Curation ); précédent : 001679; suivant : 001681Potential outcome measures and trial design issues for multiple system atrophy
Auteurs : Susanne May [États-Unis] ; Sid Gilman [États-Unis] ; B. Brooke Sowell [États-Unis] ; Ronald G. Thomas [États-Unis] ; Matthew B. Stern [États-Unis] ; Amy Colcher [États-Unis] ; Caroline M. Tanner [États-Unis] ; Neng Huang [États-Unis] ; Peter Novak [États-Unis] ; Stephen G. Reich [États-Unis] ; Joseph Jankovic [États-Unis] ; William G. Ondo [États-Unis] ; Phillip A. Low [États-Unis] ; Paola Sandroni [États-Unis] ; Axel Lipp [États-Unis] ; Frederick J. Marshall [États-Unis] ; Frederick Wooten [États-Unis] ; Clifford W. Shults [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-12-15.
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Abstract
Multiple system atrophy (MSA) is a neurodegenerative disorder exhibiting a combination of parkinsonism, cerebellar ataxia, and autonomic failure. A disease‐specific scale, the Unified Multiple System Atrophy Rating Scale (UMSARS), has been developed and validated to measure progression of MSA, but its use as an outcome measure for therapeutic trials has not been evaluated. On the basis of twelve months of follow‐up from an observational study of 67 patients with probable MSA, we evaluated three disease‐specific scores: Activities of Daily Living, Motor Examination, and a combined score from the UMSARS and two general health scores, the Physical Health and Mental Health scores of the SF‐36 health survey, for their use as outcome measures in a therapeutic trial. We discuss related design issues and provide sample size estimates. Scores based on the disease‐specific UMSARS seemed to be equal or superior to scores based on the SF‐36 health survey. They appeared to capture disease progression, were well correlated and required the smallest sample size. The UMSARS Motor Examination score exhibited the most favorable characteristics as an outcome measure for a therapeutic trial in MSA with 1 year of follow‐up. © 2007 Movement Disorder Society
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DOI: 10.1002/mds.21734
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Ondo</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, Texas</wicri:regionArea></affiliation></author><author><name sortKey="Low, Phillip A" sort="Low, Phillip A" uniqKey="Low P" first="Phillip A." last="Low">Phillip A. Low</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Sandroni, Paola" sort="Sandroni, Paola" uniqKey="Sandroni P" first="Paola" last="Sandroni">Paola Sandroni</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Lipp, Axel" sort="Lipp, Axel" uniqKey="Lipp A" first="Axel" last="Lipp">Axel Lipp</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Marshall, Frederick J" sort="Marshall, Frederick J" uniqKey="Marshall F" first="Frederick J." last="Marshall">Frederick J. Marshall</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Rochester, Rochester, New York</wicri:regionArea></affiliation></author><author><name sortKey="Wooten, Frederick" sort="Wooten, Frederick" uniqKey="Wooten F" first="Frederick" last="Wooten">Frederick Wooten</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Virginia Health System, Charlottesville, Virginia, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Virginia Health System, Charlottesville, Virginia</wicri:regionArea></affiliation></author><author><name sortKey="Shults, Clifford W" sort="Shults, Clifford W" uniqKey="Shults C" first="Clifford W." last="Shults">Clifford W. 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Brooke" last="Sowell">B. Brooke Sowell</name><affiliation wicri:level="1"><mods:affiliation>Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California</wicri:regionArea></affiliation></author><author><name sortKey="Thomas, Ronald G" sort="Thomas, Ronald G" uniqKey="Thomas R" first="Ronald G." last="Thomas">Ronald G. Thomas</name><affiliation wicri:level="1"><mods:affiliation>Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Family and Preventive Medicine, University of California, San Diego, La Jolla, California</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Department of Neurosciences, University of California, San Diego, La Jolla, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurosciences, University of California, San Diego, La Jolla, California</wicri:regionArea></affiliation></author><author><name sortKey="Stern, Matthew B" sort="Stern, Matthew B" uniqKey="Stern M" first="Matthew B." last="Stern">Matthew B. Stern</name><affiliation wicri:level="1"><mods:affiliation>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Colcher, Amy" sort="Colcher, Amy" uniqKey="Colcher A" first="Amy" last="Colcher">Amy Colcher</name><affiliation wicri:level="1"><mods:affiliation>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital, Philadelphia, Pennsylvania, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital, Philadelphia, Pennsylvania</wicri:regionArea></affiliation></author><author><name sortKey="Tanner, Caroline M" sort="Tanner, Caroline M" uniqKey="Tanner C" first="Caroline M." last="Tanner">Caroline M. Tanner</name><affiliation wicri:level="1"><mods:affiliation>Parkinson's Institute, Sunnyvale, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Institute, Sunnyvale, California</wicri:regionArea></affiliation></author><author><name sortKey="Huang, Neng" sort="Huang, Neng" uniqKey="Huang N" first="Neng" last="Huang">Neng Huang</name><affiliation wicri:level="1"><mods:affiliation>Parkinson's Institute, Sunnyvale, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Institute, Sunnyvale, California</wicri:regionArea></affiliation></author><author><name sortKey="Novak, Peter" sort="Novak, Peter" uniqKey="Novak P" first="Peter" last="Novak">Peter Novak</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Boston University, Boston, Massachusetts, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Boston University, Boston, Massachusetts</wicri:regionArea></affiliation></author><author><name sortKey="Reich, Stephen G" sort="Reich, Stephen G" uniqKey="Reich S" first="Stephen G." last="Reich">Stephen G. Reich</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Maryland, School of Medicine, Baltimore, Maryland, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Maryland, School of Medicine, Baltimore, Maryland</wicri:regionArea></affiliation></author><author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, Texas</wicri:regionArea></affiliation></author><author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Baylor College of Medicine, Houston, Texas, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Baylor College of Medicine, Houston, Texas</wicri:regionArea></affiliation></author><author><name sortKey="Low, Phillip A" sort="Low, Phillip A" uniqKey="Low P" first="Phillip A." last="Low">Phillip A. Low</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Sandroni, Paola" sort="Sandroni, Paola" uniqKey="Sandroni P" first="Paola" last="Sandroni">Paola Sandroni</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Lipp, Axel" sort="Lipp, Axel" uniqKey="Lipp A" first="Axel" last="Lipp">Axel Lipp</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, Mayo Clinic, Rochester, Minnesota</wicri:regionArea></affiliation></author><author><name sortKey="Marshall, Frederick J" sort="Marshall, Frederick J" uniqKey="Marshall F" first="Frederick J." last="Marshall">Frederick J. Marshall</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Rochester, Rochester, New York</wicri:regionArea></affiliation></author><author><name sortKey="Wooten, Frederick" sort="Wooten, Frederick" uniqKey="Wooten F" first="Frederick" last="Wooten">Frederick Wooten</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University of Virginia Health System, Charlottesville, Virginia, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of Virginia Health System, Charlottesville, Virginia</wicri:regionArea></affiliation></author><author><name sortKey="Shults, Clifford W" sort="Shults, Clifford W" uniqKey="Shults C" first="Clifford W." last="Shults">Clifford W. Shults</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurosciences, University of California, San Diego, La Jolla, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurosciences, University of California, San Diego, La Jolla, California</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>Veterans Affairs San Diego Healthcare System, San Diego, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Veterans Affairs San Diego Healthcare System, San Diego, California</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2007-12-15">2007-12-15</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">16</biblScope><biblScope unit="page" from="2371">2371</biblScope><biblScope unit="page" to="2377">2377</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">770418AEC2F49F8EF9BC9B62A1A39C98D79F68B2</idno><idno type="DOI">10.1002/mds.21734</idno><idno type="ArticleID">MDS21734</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinsonism</term><term>SF‐36</term><term>UMSARS</term><term>power, study design</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Multiple system atrophy (MSA) is a neurodegenerative disorder exhibiting a combination of parkinsonism, cerebellar ataxia, and autonomic failure. A disease‐specific scale, the Unified Multiple System Atrophy Rating Scale (UMSARS), has been developed and validated to measure progression of MSA, but its use as an outcome measure for therapeutic trials has not been evaluated. On the basis of twelve months of follow‐up from an observational study of 67 patients with probable MSA, we evaluated three disease‐specific scores: Activities of Daily Living, Motor Examination, and a combined score from the UMSARS and two general health scores, the Physical Health and Mental Health scores of the SF‐36 health survey, for their use as outcome measures in a therapeutic trial. We discuss related design issues and provide sample size estimates. Scores based on the disease‐specific UMSARS seemed to be equal or superior to scores based on the SF‐36 health survey. They appeared to capture disease progression, were well correlated and required the smallest sample size. The UMSARS Motor Examination score exhibited the most favorable characteristics as an outcome measure for a therapeutic trial in MSA with 1 year of follow‐up. © 2007 Movement Disorder Society</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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