Determination of minimal clinically important change in early and advanced Parkinson's disease
Identifieur interne : 001158 ( Istex/Corpus ); précédent : 001157; suivant : 001159Determination of minimal clinically important change in early and advanced Parkinson's disease
Auteurs : Robert A. Hauser ; Peggy AuingerSource :
- Movement Disorders [ 0885-3185 ] ; 2011-04.
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- KwdEn :
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. © 2011 Movement Disorder Society
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DOI: 10.1002/mds.23638
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ISTEX:6AD41568559AA8DC0476C834E96F42BC72AE4B3FLe document en format XML
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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. 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Although clinical trials of rasagiline were analyzed in this study, Teva Pharmaceuticals was not involved and did not sponsor this study.This data‐mining project was supported by the Parkinson's Disease Foundation's Advancing Parkinson's Treatments Innovations Grant to the Parkinson Study Group.Full financial disclosures and author roles may be found in the online version of this article.</note><note>Parkinson's Disease Foundation's</note><note>Parkinson Study Group</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Determination of minimal clinically important change in early and advanced Parkinson's disease</title><author><orgName>on behalf of the Parkinson Study Group</orgName></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Parkinson's Disease and Movement Disorders Center, NPF Center of Excellence, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, FL 33606, USA</p></note><affiliation>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Peggy</forename><surname>Auinger</surname><roleName type="degree">MS</roleName></persName><affiliation>Department of Neurology, Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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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. © 2011 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>minimal clinically important change</term></item><item><term>Parkinson's disease</term></item><item><term>clinical global impression</term></item><item><term>treatment</term></item><item><term>clinical trial</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2010-07-23">Received</change><change when="2010-11-22">Registration</change><change when="2011-04">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/6AD41568559AA8DC0476C834E96F42BC72AE4B3F/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. 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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. © 2011 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p><b>Relevant conflict of interest/financial disclosures:</b> Dr. Hauser has received fees from Teva Pharmaceuticals for consulting, advisory board participation, and speaker programs. Although clinical trials of rasagiline were analyzed in this study, Teva Pharmaceuticals was not involved and did not sponsor this study.</p><p>This data‐mining project was supported by the Parkinson's Disease Foundation's Advancing Parkinson's Treatments Innovations Grant to the Parkinson Study Group.</p><p>Full financial disclosures and author roles may be found in the online version of this article.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 4-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Determination of minimal clinically important change in early and advanced Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Minimal Clinically Important Change in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Determination of minimal clinically important change in early and advanced Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USA</affiliation><description>Correspondence: Parkinson's Disease and Movement Disorders Center, NPF Center of Excellence, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, FL 33606, USA</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Peggy</namePart><namePart type="family">Auinger</namePart><namePart type="termsOfAddress">MS</namePart><affiliation>Department of Neurology, Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the Parkinson Study Group</namePart><description>Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, Florida, USADepartment of Neurology, Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</description></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2011-04</dateIssued><dateCaptured encoding="w3cdtf">2010-07-23</dateCaptured><dateValid encoding="w3cdtf">2010-11-22</dateValid><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="tables">4</extent><extent unit="references">15</extent><extent unit="words">5602</extent></physicalDescription><abstract 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. © 2011 Movement Disorder Society</abstract><note type="additional physical form">Author Roles and Disclosures</note><note type="content">*Relevant conflict of interest/financial disclosures: Dr. Hauser has received fees from Teva Pharmaceuticals for consulting, advisory board participation, and speaker programs. Although clinical trials of rasagiline were analyzed in this study, Teva Pharmaceuticals was not involved and did not sponsor this study. This data‐mining project was supported by the Parkinson's Disease Foundation's Advancing Parkinson's Treatments Innovations Grant to the Parkinson Study Group. Full financial disclosures and author roles may be found in the online version of this article.</note><note type="funding">Parkinson's Disease Foundation's</note><note type="funding">Parkinson Study Group</note><subject lang="en"><genre>Keywords</genre><topic>minimal clinically important change</topic><topic>Parkinson's disease</topic><topic>clinical global impression</topic><topic>treatment</topic><topic>clinical trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>26</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>813</start><end>818</end><total>6</total></extent></part></relatedItem><identifier type="istex">6AD41568559AA8DC0476C834E96F42BC72AE4B3F</identifier><identifier type="DOI">10.1002/mds.23638</identifier><identifier type="ArticleID">MDS23638</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2011 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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