MovDisordV3, Main, Curation, bibRecord, 002C67

Potential outcome measures and trial design issues for multiple system atrophy

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Potential 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.

RBID : ISTEX:770418AEC2F49F8EF9BC9B62A1A39C98D79F68B2

Descripteurs français

Pascal (Inist)
- Atrophie multisystématisée, Parkinsonisme, Pathologie du système nerveux, Pronostic.

English descriptors

KwdEn :
- Aged, Antiparkinson Agents (therapeutic use), Cerebellar Diseases (physiopathology), Cerebellar Diseases (therapy), Clinical Trials as Topic, Disability Evaluation, Disease Progression, Female, Humans, Levodopa (therapeutic use), Male, Middle Aged, Multiple System Atrophy (epidemiology), Multiple System Atrophy (physiopathology), Multiple System Atrophy (therapy), Multiple system atrophy, Nervous system diseases, Parkinsonism, Prognosis, Research Design, Risk Factors, SF‐36, Sample Size, Socioeconomic Factors, Treatment Outcome, UMSARS, power, study design.
MESH :
- chemical , therapeutic use : Antiparkinson Agents, Levodopa.
- epidemiology : Multiple System Atrophy.
- physiopathology : Cerebellar Diseases, Multiple System Atrophy.
- therapy : Cerebellar Diseases, Multiple System Atrophy.
- Aged, Clinical Trials as Topic, Disability Evaluation, Disease Progression, Female, Humans, Male, Middle Aged, Research Design, Risk Factors, Sample Size, Socioeconomic Factors, Treatment Outcome.

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

Url:

https://api.istex.fr/document/770418AEC2F49F8EF9BC9B62A1A39C98D79F68B2/fulltext/pdf

DOI: 10.1002/mds.21734

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ISTEX:770418AEC2F49F8EF9BC9B62A1A39C98D79F68B2

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Cerebellar Diseases (physiopathology)</term>
<term>Cerebellar Diseases (therapy)</term>
<term>Clinical Trials as Topic</term>
<term>Disability Evaluation</term>
<term>Disease Progression</term>
<term>Female</term>
<term>Humans</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multiple System Atrophy (epidemiology)</term>
<term>Multiple System Atrophy (physiopathology)</term>
<term>Multiple System Atrophy (therapy)</term>
<term>Multiple system atrophy</term>
<term>Nervous system diseases</term>
<term>Parkinsonism</term>
<term>Prognosis</term>
<term>Research Design</term>
<term>Risk Factors</term>
<term>SF‐36</term>
<term>Sample Size</term>
<term>Socioeconomic Factors</term>
<term>Treatment Outcome</term>
<term>UMSARS</term>
<term>power, study design</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Multiple System Atrophy</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Cerebellar Diseases</term>
<term>Multiple System Atrophy</term>
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<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Cerebellar Diseases</term>
<term>Multiple System Atrophy</term>
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<keywords scheme="MESH" xml:lang="en"><term>Aged</term>
<term>Clinical Trials as Topic</term>
<term>Disability Evaluation</term>
<term>Disease Progression</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Research Design</term>
<term>Risk Factors</term>
<term>Sample Size</term>
<term>Socioeconomic Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Atrophie multisystématisée</term>
<term>Parkinsonisme</term>
<term>Pathologie du   système nerveux</term>
<term>Pronostic</term>
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<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>
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<author><name sortKey="Gilman, Sid" sort="Gilman, Sid" uniqKey="Gilman S" first="Sid" last="Gilman">Sid Gilman</name>
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<s3>USA</s3>
<sZ>2 aut.</sZ>
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<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
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<sZ>1 aut.</sZ>
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<sZ>4 aut.</sZ>
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<placeName><region type="state">Californie</region>
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<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
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</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurosciences, University of California, San Diego</s1>
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<sZ>1 aut.</sZ>
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<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
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<author><name sortKey="Stem, Matthew B" sort="Stem, Matthew B" uniqKey="Stem M" first="Matthew B." last="Stem">Matthew B. Stem</name>
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<s2>Philadelphia, Pennsylvania</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Colcher, Amy" sort="Colcher, Amy" uniqKey="Colcher A" first="Amy" last="Colcher">Amy Colcher</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital</s1>
<s2>Philadelphia, Pennsylvania</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</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="2"><inist:fA14 i1="05"><s1>Parkinson's Institute</s1>
<s2>Sunnyvale, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Neng Huang" sort="Neng Huang" uniqKey="Neng Huang" last="Neng Huang">NENG HUANG</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Parkinson's Institute</s1>
<s2>Sunnyvale, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Novak, Peter" sort="Novak, Peter" uniqKey="Novak P" first="Peter" last="Novak">Peter Novak</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Department of Neurology, Boston University</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
</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="2"><inist:fA14 i1="07"><s1>Department of Neurology, University of Maryland, School of Medicine</s1>
<s2>Baltimore, Maryland</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</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="2"><inist:fA14 i1="08"><s1>Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
</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="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sandroni, Paola" sort="Sandroni, Paola" uniqKey="Sandroni P" first="Paola" last="Sandroni">Paola Sandroni</name>
<affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lipp, Axel" sort="Lipp, Axel" uniqKey="Lipp A" first="Axel" last="Lipp">Axel Lipp</name>
<affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</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="2"><inist:fA14 i1="10"><s1>Department of Neurology, University of Rochester</s1>
<s2>Rochester, New York</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wooten, Frederick" sort="Wooten, Frederick" uniqKey="Wooten F" first="Frederick" last="Wooten">Frederick Wooten</name>
<affiliation wicri:level="2"><inist:fA14 i1="11"><s1>Department of Neurology, University of Virginia Health System</s1>
<s2>Charlottesville, Virginia</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Virginie</region>
</placeName>
</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="2"><inist:fA14 i1="02"><s1>Department of Neurosciences, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><inist:fA14 i1="12"><s1>Veterans Affairs San Diego Healthcare System</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">08-0147084</idno>
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<idno type="wicri:Area/PascalFrancis/Corpus">001361</idno>
<idno type="wicri:Area/PascalFrancis/Curation">001958</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">001530</idno>
<idno type="wicri:doubleKey">0885-3185:2007:May S:potential:outcome:measures</idno>
<idno type="wicri:Area/Main/Merge">004120</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Potential Outcome Measures and Trial Design Issues for Multiple System Atrophy</title>
<author><name sortKey="May, Susanne" sort="May, Susanne" uniqKey="May S" first="Susanne" last="May">Susanne May</name>
<affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Family and Preventive Medicine, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
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</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurosciences, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
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</inist:fA14>
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<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Gilman, Sid" sort="Gilman, Sid" uniqKey="Gilman S" first="Sid" last="Gilman">Sid Gilman</name>
<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Department of Neurology, University of Michigan</s1>
<s2>Ann Arbor, Michigan</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sowell, B Brooke" sort="Sowell, B Brooke" uniqKey="Sowell B" first="B. Brooke" last="Sowell">B. Brooke Sowell</name>
<affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Department of Family and Preventive Medicine, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
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<placeName><region type="state">Californie</region>
</placeName>
</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="2"><inist:fA14 i1="01"><s1>Department of Family and Preventive Medicine, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Department of Neurosciences, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
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</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stem, Matthew B" sort="Stem, Matthew B" uniqKey="Stem M" first="Matthew B." last="Stem">Matthew B. Stem</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital</s1>
<s2>Philadelphia, Pennsylvania</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Colcher, Amy" sort="Colcher, Amy" uniqKey="Colcher A" first="Amy" last="Colcher">Amy Colcher</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>Parkinson's Disease and Movement Disorders Center, Pennsylvania Hospital</s1>
<s2>Philadelphia, Pennsylvania</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</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="2"><inist:fA14 i1="05"><s1>Parkinson's Institute</s1>
<s2>Sunnyvale, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Neng Huang" sort="Neng Huang" uniqKey="Neng Huang" last="Neng Huang">NENG HUANG</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Parkinson's Institute</s1>
<s2>Sunnyvale, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Novak, Peter" sort="Novak, Peter" uniqKey="Novak P" first="Peter" last="Novak">Peter Novak</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Department of Neurology, Boston University</s1>
<s2>Boston, Massachusetts</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
</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="2"><inist:fA14 i1="07"><s1>Department of Neurology, University of Maryland, School of Medicine</s1>
<s2>Baltimore, Maryland</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Maryland</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><inist:fA14 i1="08"><s1>Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</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="2"><inist:fA14 i1="08"><s1>Department of Neurology, Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
</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="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sandroni, Paola" sort="Sandroni, Paola" uniqKey="Sandroni P" first="Paola" last="Sandroni">Paola Sandroni</name>
<affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lipp, Axel" sort="Lipp, Axel" uniqKey="Lipp A" first="Axel" last="Lipp">Axel Lipp</name>
<affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Department of Neurology, Mayo Clinic</s1>
<s2>Rochester, Minnesota</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
</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="2"><inist:fA14 i1="10"><s1>Department of Neurology, University of Rochester</s1>
<s2>Rochester, New York</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wooten, Frederick" sort="Wooten, Frederick" uniqKey="Wooten F" first="Frederick" last="Wooten">Frederick Wooten</name>
<affiliation wicri:level="2"><inist:fA14 i1="11"><s1>Department of Neurology, University of Virginia Health System</s1>
<s2>Charlottesville, Virginia</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Virginie</region>
</placeName>
</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="2"><inist:fA14 i1="02"><s1>Department of Neurosciences, University of California, San Diego</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
<affiliation wicri:level="2"><inist:fA14 i1="12"><s1>Veterans Affairs San Diego Healthcare System</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint><date when="2007">2007</date>
</imprint>
</series>
</biblStruct>
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<seriesStmt><title level="j" type="main">Movement disorders</title>
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<keywords scheme="Pascal" xml:lang="fr"><term>Atrophie multisystématisée</term>
<term>Parkinsonisme</term>
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<term>Pronostic</term>
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<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.</div>
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<wicri:regionArea>Department of Neurology, Boston University, Boston, Massachusetts</wicri:regionArea>
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<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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<author><name sortKey="Sandroni, Paola" sort="Sandroni, Paola" uniqKey="Sandroni P" first="Paola" last="Sandroni">Paola Sandroni</name>
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<term>Cerebellar Diseases (therapy)</term>
<term>Clinical Trials as Topic</term>
<term>Disability Evaluation</term>
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<term>Humans</term>
<term>Levodopa (therapeutic use)</term>
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<term>Multiple System Atrophy (physiopathology)</term>
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<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>
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Movement Disorders (revue)

Potential outcome measures and trial design issues for multiple system atrophy

Potential outcome measures and trial design issues for multiple system atrophy

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