Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study
Identifieur interne : 002533 ( Main/Corpus ); précédent : 002532; suivant : 002534Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study
Auteurs : Andreas R. Kupsch ; Nin Bajaj ; Frederick Weiland ; Antonio Tartaglione ; Susanne Klutmann ; Melanie Buitendyk ; Paul Sherwin ; Ann Tate ; Igor D. GrachevSource :
- Journal of Neurology, Neurosurgery & Psychiatry [ 0022-3050 ] ; 2012-06.
Abstract
Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.
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DOI: 10.1136/jnnp-2011-301695
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title><author><name sortKey="Kupsch, Andreas R" sort="Kupsch, Andreas R" uniqKey="Kupsch A" first="Andreas R" last="Kupsch">Andreas R. Kupsch</name><affiliation><mods:affiliation>Department of Neurology, University Medicine Berlin, Berlin, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bajaj, Nin" sort="Bajaj, Nin" uniqKey="Bajaj N" first="Nin" last="Bajaj">Nin Bajaj</name><affiliation><mods:affiliation>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</mods:affiliation></affiliation></author><author><name sortKey="Weiland, Frederick" sort="Weiland, Frederick" uniqKey="Weiland F" first="Frederick" last="Weiland">Frederick Weiland</name><affiliation><mods:affiliation>Sutter Health, Roseville, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Tartaglione, Antonio" sort="Tartaglione, Antonio" uniqKey="Tartaglione A" first="Antonio" last="Tartaglione">Antonio Tartaglione</name><affiliation><mods:affiliation>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</mods:affiliation></affiliation></author><author><name sortKey="Klutmann, Susanne" sort="Klutmann, Susanne" uniqKey="Klutmann S" first="Susanne" last="Klutmann">Susanne Klutmann</name><affiliation><mods:affiliation>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Buitendyk, Melanie" sort="Buitendyk, Melanie" uniqKey="Buitendyk M" first="Melanie" last="Buitendyk">Melanie Buitendyk</name><affiliation><mods:affiliation>i3 Statprobe, Burlington, Ontario, Canada</mods:affiliation></affiliation></author><author><name sortKey="Sherwin, Paul" sort="Sherwin, Paul" uniqKey="Sherwin P" first="Paul" last="Sherwin">Paul Sherwin</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Tate, Ann" sort="Tate, Ann" uniqKey="Tate A" first="Ann" last="Tate">Ann Tate</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Grachev, Igor D" sort="Grachev, Igor D" uniqKey="Grachev I" first="Igor D" last="Grachev">Igor D. Grachev</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: igor.grachev@ge.com</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D</idno><date when="2012" year="2012">2012</date><idno type="doi">10.1136/jnnp-2011-301695</idno><idno type="url">https://api.istex.fr/document/EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D/fulltext/pdf</idno><idno type="wicri:Area/Main/Corpus">002533</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title><author><name sortKey="Kupsch, Andreas R" sort="Kupsch, Andreas R" uniqKey="Kupsch A" first="Andreas R" last="Kupsch">Andreas R. Kupsch</name><affiliation><mods:affiliation>Department of Neurology, University Medicine Berlin, Berlin, Germany</mods:affiliation></affiliation></author><author><name sortKey="Bajaj, Nin" sort="Bajaj, Nin" uniqKey="Bajaj N" first="Nin" last="Bajaj">Nin Bajaj</name><affiliation><mods:affiliation>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</mods:affiliation></affiliation></author><author><name sortKey="Weiland, Frederick" sort="Weiland, Frederick" uniqKey="Weiland F" first="Frederick" last="Weiland">Frederick Weiland</name><affiliation><mods:affiliation>Sutter Health, Roseville, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Tartaglione, Antonio" sort="Tartaglione, Antonio" uniqKey="Tartaglione A" first="Antonio" last="Tartaglione">Antonio Tartaglione</name><affiliation><mods:affiliation>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</mods:affiliation></affiliation></author><author><name sortKey="Klutmann, Susanne" sort="Klutmann, Susanne" uniqKey="Klutmann S" first="Susanne" last="Klutmann">Susanne Klutmann</name><affiliation><mods:affiliation>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Buitendyk, Melanie" sort="Buitendyk, Melanie" uniqKey="Buitendyk M" first="Melanie" last="Buitendyk">Melanie Buitendyk</name><affiliation><mods:affiliation>i3 Statprobe, Burlington, Ontario, Canada</mods:affiliation></affiliation></author><author><name sortKey="Sherwin, Paul" sort="Sherwin, Paul" uniqKey="Sherwin P" first="Paul" last="Sherwin">Paul Sherwin</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Tate, Ann" sort="Tate, Ann" uniqKey="Tate A" first="Ann" last="Tate">Ann Tate</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation></author><author><name sortKey="Grachev, Igor D" sort="Grachev, Igor D" uniqKey="Grachev I" first="Igor D" last="Grachev">Igor D. Grachev</name><affiliation><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: igor.grachev@ge.com</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of Neurology, Neurosurgery & Psychiatry</title><title level="j" type="abbrev">J Neurol Neurosurg Psychiatry</title><idno type="ISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2012-06">2012-06</date><biblScope unit="volume">83</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="620">620</biblScope></imprint><idno type="ISSN">0022-3050</idno></series><idno type="istex">EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D</idno><idno type="DOI">10.1136/jnnp-2011-301695</idno><idno type="href">jnnp-83-620.pdf</idno><idno type="ArticleID">jnnp-2011-301695</idno><idno type="PMID">22492213</idno><idno type="local">jnnp;83/6/620</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0022-3050</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract">Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.</div></front></TEI><istex><corpusName>bmj</corpusName><author><json:item><name>Andreas R Kupsch</name><affiliations><json:string>Department of Neurology, University Medicine Berlin, Berlin, Germany</json:string></affiliations></json:item><json:item><name>Nin Bajaj</name><affiliations><json:string>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</json:string></affiliations></json:item><json:item><name>Frederick Weiland</name><affiliations><json:string>Sutter Health, Roseville, California, USA</json:string></affiliations></json:item><json:item><name>Antonio Tartaglione</name><affiliations><json:string>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</json:string></affiliations></json:item><json:item><name>Susanne Klutmann</name><affiliations><json:string>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</json:string></affiliations></json:item><json:item><name>Melanie Buitendyk</name><affiliations><json:string>i3 Statprobe, Burlington, Ontario, Canada</json:string></affiliations></json:item><json:item><name>Paul Sherwin</name><affiliations><json:string>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>Ann Tate</name><affiliations><json:string>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</json:string></affiliations></json:item><json:item><name>Igor D Grachev</name><affiliations><json:string>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</json:string><json:string>E-mail: igor.grachev@ge.com</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Movement disorders</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>DaTscan</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>SPECT</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>parkinsonian syndromes</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical management</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>diagnosis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>neuropsychology</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>neurophysiology</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dementia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Alzheimer's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>consciousness</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>nuclear medicine</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>pet</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p>0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p>0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.</abstract><qualityIndicators><score>8.476</score><pdfVersion>1.4</pdfVersion><pdfPageSize>595.276 x 793.701 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>15</keywordCount><abstractCharCount>1714</abstractCharCount><pdfWordCount>6850</pdfWordCount><pdfCharCount>46378</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>248</abstractWordCount></qualityIndicators><title>Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title><pmid><json:string>22492213</json:string></pmid><genre><json:string>research-article</json:string></genre><host><volume>83</volume><pages><first>620</first></pages><issn><json:string>0022-3050</json:string></issn><issue>6</issue><genre></genre><language><json:string>unknown</json:string></language><eissn><json:string>1468-330X</json:string></eissn><title>Journal of Neurology, Neurosurgery & Psychiatry</title></host><publicationDate>2012</publicationDate><copyrightDate>2012</copyrightDate><doi><json:string>10.1136/jnnp-2011-301695</json:string></doi><id>EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>BMJ Publishing Group Ltd</publisher><availability><p>BMJ</p></availability><date>2012-04-06</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title><author><persName><forename type="first">Andreas R</forename><surname>Kupsch</surname></persName><affiliation>Department of Neurology, University Medicine Berlin, Berlin, Germany</affiliation></author><author><persName><forename type="first">Nin</forename><surname>Bajaj</surname></persName><affiliation>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</affiliation></author><author><persName><forename type="first">Frederick</forename><surname>Weiland</surname></persName><affiliation>Sutter Health, Roseville, California, USA</affiliation></author><author><persName><forename type="first">Antonio</forename><surname>Tartaglione</surname></persName><affiliation>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</affiliation></author><author><persName><forename type="first">Susanne</forename><surname>Klutmann</surname></persName><affiliation>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</affiliation></author><author><persName><forename type="first">Melanie</forename><surname>Buitendyk</surname></persName><affiliation>i3 Statprobe, Burlington, Ontario, Canada</affiliation></author><author><persName><forename type="first">Paul</forename><surname>Sherwin</surname></persName><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation></author><author><persName><forename type="first">Ann</forename><surname>Tate</surname></persName><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation></author><author corresp="yes"><persName><forename type="first">Igor D</forename><surname>Grachev</surname></persName><email>igor.grachev@ge.com</email><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation></author></analytic><monogr><title level="j">Journal of Neurology, Neurosurgery & Psychiatry</title><title level="j" type="abbrev">J Neurol Neurosurg Psychiatry</title><idno type="pISSN">0022-3050</idno><idno type="eISSN">1468-330X</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2012-06"></date><biblScope unit="volume">83</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="620">620</biblScope></imprint></monogr><idno type="istex">EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D</idno><idno type="DOI">10.1136/jnnp-2011-301695</idno><idno type="href">jnnp-83-620.pdf</idno><idno type="ArticleID">jnnp-2011-301695</idno><idno type="PMID">22492213</idno><idno type="local">jnnp;83/6/620</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2012-04-06</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.</p></abstract><textClass><keywords scheme="keyword"><list><head>Keywords</head><item><term>DaTscan</term></item><item><term>SPECT</term></item><item><term>parkinsonian syndromes</term></item><item><term>clinical management</term></item><item><term>diagnosis</term></item><item><term>neuropsychology</term></item><item><term>neurophysiology</term></item><item><term>clinical</term></item><item><term>dementia</term></item><item><term>Alzheimer's disease</term></item><item><term>consciousness</term></item><item><term>nuclear medicine</term></item><item><term>Parkinson's disease</term></item><item><term>pet</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2012-04-06">Created</change><change when="2012-06">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">jnnp</journal-id><journal-id journal-id-type="nlm-ta">J Neurol Neurosurg Psychiatry</journal-id><journal-id journal-id-type="publisher-id">jnnp</journal-id><journal-title>Journal of Neurology, Neurosurgery & Psychiatry</journal-title><abbrev-journal-title abbrev-type="publisher">J Neurol Neurosurg Psychiatry</abbrev-journal-title><abbrev-journal-title>J Neurol Neurosurg Psychiatry</abbrev-journal-title><issn pub-type="ppub">0022-3050</issn><issn pub-type="epub">1468-330X</issn><publisher><publisher-name>BMJ Publishing Group Ltd</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">jnnp-2011-301695</article-id><article-id pub-id-type="doi">10.1136/jnnp-2011-301695</article-id><article-id pub-id-type="other">jnnp;83/6/620</article-id><article-id pub-id-type="other">jnnp;jnnp-2011-301695</article-id><article-id pub-id-type="pmid">22492213</article-id><article-id pub-id-type="other">620</article-id><article-id pub-id-type="other">jnnp-2011-301695</article-id><article-categories><subj-group subj-group-type="heading"><subject>Movement disorders</subject></subj-group><series-title>Research paper</series-title></article-categories><title-group><article-title>Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kupsch</surname><given-names>Andreas R</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bajaj</surname><given-names>Nin</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Weiland</surname><given-names>Frederick</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Tartaglione</surname><given-names>Antonio</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Klutmann</surname><given-names>Susanne</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Buitendyk</surname><given-names>Melanie</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Sherwin</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Tate</surname><given-names>Ann</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Grachev</surname><given-names>Igor D</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib></contrib-group><aff id="aff1"><label>1</label>Department of Neurology, University Medicine Berlin, Berlin, Germany</aff><aff id="aff2"><label>2</label>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</aff><aff id="aff3"><label>3</label>Sutter Health, Roseville, California, USA</aff><aff id="aff4"><label>4</label>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</aff><aff id="aff5"><label>5</label>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</aff><aff id="aff6"><label>6</label>i3 Statprobe, Burlington, Ontario, Canada</aff><aff id="aff7"><label>7</label>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</aff><author-notes><corresp><label>Correspondence to</label> Dr Igor D Grachev, Clinical Development, GE Healthcare, Princeton, NJ 08540, USA; <email>igor.grachev@ge.com</email></corresp></author-notes><pub-date pub-type="epub-original"><day>6</day><month>4</month><year>2012</year></pub-date><pub-date pub-type="ppub"><month>6</month><year>2012</year></pub-date><pub-date pub-type="epub"><day>6</day><month>4</month><year>2012</year></pub-date><volume>83</volume><volume-id pub-id-type="other">83</volume-id><volume-id pub-id-type="other">83</volume-id><issue>6</issue><issue-id pub-id-type="other">jnnp;83/6</issue-id><issue-id pub-id-type="other">6</issue-id><issue-id pub-id-type="other">83/6</issue-id><fpage>620</fpage><history><date date-type="received"><day>24</day><month>10</month><year>2011</year></date><date date-type="rev-recd"><day>27</day><month>12</month><year>2011</year></date><date date-type="accepted"><day>13</day><month>2</month><year>2012</year></date></history><permissions><copyright-statement>© 2012, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</copyright-statement><copyright-year>2012</copyright-year></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="jnnp-83-620.pdf"></self-uri><abstract><sec><title>Background</title><p>This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS).</p></sec><sec><title>Methods</title><p>A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups.</p></sec><sec><title>Results</title><p>There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration.</p></sec><sec><title>Conclusions</title><p>DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">http://ClinicalTrials.gov</ext-link> Identifier: <ext-link ext-link-type="clintrialgov" xlink:href="NCT00382967">NCT00382967</ext-link>.</p></sec></abstract><kwd-group><kwd>DaTscan</kwd><kwd>SPECT</kwd><kwd>parkinsonian syndromes</kwd><kwd>clinical management</kwd><kwd>diagnosis</kwd><kwd>neuropsychology</kwd><kwd>neurophysiology</kwd><kwd>clinical</kwd><kwd>dementia</kwd><kwd>Alzheimer's disease</kwd><kwd>consciousness</kwd><kwd>nuclear medicine</kwd><kwd>Parkinson's disease</kwd><kwd>pet</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><partName>Research paper</partName><title>Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><partName>Research paper</partName><title>Impact of DaTscan SPECT imaging on clinical management, diagnosis, confidence of diagnosis, quality of life, health resource use and safety in patients with clinically uncertain parkinsonian syndromes: a prospective 1-year follow-up of an open-label controlled study</title></titleInfo><name type="personal"><namePart type="given">Andreas R</namePart><namePart type="family">Kupsch</namePart><affiliation>Department of Neurology, University Medicine Berlin, Berlin, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nin</namePart><namePart type="family">Bajaj</namePart><affiliation>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Frederick</namePart><namePart type="family">Weiland</namePart><affiliation>Sutter Health, Roseville, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Antonio</namePart><namePart type="family">Tartaglione</namePart><affiliation>Department of Neurology, S. Andrea Hospital and Ass. Sistema Nervoso, La Spezia, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Susanne</namePart><namePart type="family">Klutmann</namePart><affiliation>Department of Nuclear Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Melanie</namePart><namePart type="family">Buitendyk</namePart><affiliation>i3 Statprobe, Burlington, Ontario, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paul</namePart><namePart type="family">Sherwin</namePart><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ann</namePart><namePart type="family">Tate</namePart><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal" displayLabel="corresp"><namePart type="given">Igor D</namePart><namePart type="family">Grachev</namePart><affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</affiliation><affiliation>E-mail: igor.grachev@ge.com</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article"></genre><originInfo><publisher>BMJ Publishing Group Ltd</publisher><dateIssued encoding="w3cdtf">2012-06</dateIssued><dateCreated encoding="w3cdtf">2012-04-06</dateCreated><copyrightDate encoding="w3cdtf">2012</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract>Background This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967.</abstract><subject><genre>Keywords</genre><topic>DaTscan</topic><topic>SPECT</topic><topic>parkinsonian syndromes</topic><topic>clinical management</topic><topic>diagnosis</topic><topic>neuropsychology</topic><topic>neurophysiology</topic><topic>clinical</topic><topic>dementia</topic><topic>Alzheimer's disease</topic><topic>consciousness</topic><topic>nuclear medicine</topic><topic>Parkinson's disease</topic><topic>pet</topic></subject><relatedItem type="host"><titleInfo><title>Journal of Neurology, Neurosurgery & Psychiatry</title></titleInfo><titleInfo type="abbreviated"><title>J Neurol Neurosurg Psychiatry</title></titleInfo><genre type="Journal">journal</genre><identifier type="ISSN">0022-3050</identifier><identifier type="eISSN">1468-330X</identifier><identifier type="PublisherID">jnnp</identifier><identifier type="PublisherID-hwp">jnnp</identifier><identifier type="PublisherID-nlm-ta">J Neurol Neurosurg Psychiatry</identifier><part><date>2012</date><detail type="volume"><caption>vol.</caption><number>83</number></detail><detail type="issue"><caption>no.</caption><number>6</number></detail><extent unit="pages"><start>620</start></extent></part></relatedItem><identifier type="istex">EEC4400A36ADE5DF769EE0A4A4B2ECC43AEA676D</identifier><identifier type="DOI">10.1136/jnnp-2011-301695</identifier><identifier type="href">jnnp-83-620.pdf</identifier><identifier type="ArticleID">jnnp-2011-301695</identifier><identifier type="PMID">22492213</identifier><identifier type="local">jnnp;83/6/620</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2012, Published by the BMJ Publishing Group Limited. 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