Determination of minimal clinically important change in early and advanced Parkinson's disease.
Identifieur interne : 001381 ( PubMed/Checkpoint ); précédent : 001380; suivant : 001382Determination of minimal clinically important change in early and advanced Parkinson's disease.
Auteurs : Robert A. Hauser [États-Unis] ; Peggy AuingerSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2011.
English descriptors
- KwdEn :
- Antiparkinson Agents (therapeutic use), Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Indans (therapeutic use), Levodopa, Male, Neuroprotective Agents (therapeutic use), Parkinson Disease (classification), Parkinson Disease (drug therapy), Placebo Effect, ROC Curve, Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Indans, Neuroprotective Agents.
- classification : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Levodopa, Male, Placebo Effect, ROC Curve, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in "off" time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies.
DOI: 10.1002/mds.23638
PubMed: 21437987
Affiliations:
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Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Auinger, Peggy" sort="Auinger, Peggy" uniqKey="Auinger P" first="Peggy" last="Auinger">Peggy Auinger</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2011">2011</date><idno type="doi">10.1002/mds.23638</idno><idno type="RBID">pubmed:21437987</idno><idno type="pmid">21437987</idno><idno type="wicri:Area/PubMed/Corpus">001363</idno><idno type="wicri:Area/PubMed/Curation">001363</idno><idno type="wicri:Area/PubMed/Checkpoint">001381</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Determination of minimal clinically important change in early and advanced Parkinson's disease.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Auinger, Peggy" sort="Auinger, Peggy" uniqKey="Auinger P" first="Peggy" last="Auinger">Peggy Auinger</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson Agents (therapeutic use)</term><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Indans (therapeutic use)</term><term>Levodopa</term><term>Male</term><term>Neuroprotective Agents (therapeutic use)</term><term>Parkinson Disease (classification)</term><term>Parkinson Disease (drug therapy)</term><term>Placebo Effect</term><term>ROC Curve</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Indans</term><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disability Evaluation</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Levodopa</term><term>Male</term><term>Placebo Effect</term><term>ROC Curve</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Two common primary efficacy outcome measures in Parkinson's disease (PD) are change in Unified Parkinson's Disease Rating Scale (UPDRS) scores in early PD and change in "off" time in patients with motor fluctuations. Defining the minimal clinically important change (MCIC) in these outcome measures is important to interpret the clinical relevance of changes observed in clinical trials and other situations. We analyzed data from 2 multicenter, placebo-controlled, randomized clinical trials of rasagiline; TEMPO studied 404 early PD subjects, and PRESTO studied 472 levodopa-treated subjects with motor fluctuations. An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">21437987</PMID><DateCreated><Year>2011</Year><Month>04</Month><Day>26</Day></DateCreated><DateCompleted><Year>2011</Year><Month>08</Month><Day>24</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>26</Volume><Issue>5</Issue><PubDate><Year>2011</Year><Month>Apr</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. 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An anchor-based approach using clinical global impression of improvement (CGI-I) was used to determine MCIC for UPDRS scores and daily "off" time. MCIC was defined as mean change in actively treated subjects rated minimally improved on CGI-I. Receiver operating characteristic (ROC) curves defined optimal cutoffs discriminating between changed and unchanged subjects. MCIC for improvement in total UPDRS score (parts I-III) in early PD was determined to be -3.5 points based on mean scores and -3.0 points based on ROC curves. In addition, we found an MCIC for reduction in "off" time of 1.0 hours as defined by mean reduction in "off" time in active treated subjects self-rated as minimally improved on CGI-I minus mean reduction in "off" time in placebo-treated subjects self-rated as unchanged (1.9-0.9 hours). We hypothesize that many methodological factors can influence determination of the MCIC, and a range of values is likely to emerge from multiple studies.</AbstractText><CopyrightInformation>Copyright © 2011 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hauser</LastName><ForeName>Robert A</ForeName><Initials>RA</Initials><AffiliationInfo><Affiliation>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA. rhauser@health.usf.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Auinger</LastName><ForeName>Peggy</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><CollectiveName>Parkinson Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType 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PubStatus="entrez"><Year>2011</Year><Month>3</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2011</Year><Month>3</Month><Day>26</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2011</Year><Month>8</Month><Day>25</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.23638</ArticleId><ArticleId IdType="pubmed">21437987</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><noCountry><name sortKey="Auinger, Peggy" sort="Auinger, Peggy" uniqKey="Auinger P" first="Peggy" last="Auinger">Peggy Auinger</name></noCountry><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. 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