How valid is dopamine transporter imaging as a surrogate marker in research trials in Parkinson's disease?
Identifieur interne : 003762 ( PubMed/Checkpoint ); précédent : 003761; suivant : 003763How valid is dopamine transporter imaging as a surrogate marker in research trials in Parkinson's disease?
Auteurs : Paul K. Morrish [Royaume-Uni]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2003.
English descriptors
- KwdEn :
- Biological Markers (analysis), Brain (radionuclide imaging), Clinical Trials as Topic, Disease Progression, Humans, Neuroprotective Agents (therapeutic use), Parkinson Disease (drug therapy), Parkinson Disease (radionuclide imaging), Reproducibility of Results, Sensitivity and Specificity, Tomography, Emission-Computed, Tomography, Emission-Computed, Single-Photon.
- MESH :
- chemical , analysis : Biological Markers.
- drug therapy : Parkinson Disease.
- radionuclide imaging : Brain, Parkinson Disease.
- chemical , therapeutic use : Neuroprotective Agents.
- Clinical Trials as Topic, Disease Progression, Humans, Reproducibility of Results, Sensitivity and Specificity, Tomography, Emission-Computed, Tomography, Emission-Computed, Single-Photon.
Abstract
To use functional imaging data as indices of disease progression, it is essential that methods are valid. It is not possible for that validation to come from pathology and the methods can only gain validity from the relationship to clinical indices of progression. Validity as a measurement of disease progression depends upon sensitivity to clinical progression, low scan-to-scan error, and resilience to confounding effects. Data from the available dopamine transporter (DAT) positron emission tomography (PET) and single photon emission computed tomography (SPECT) studies are examined for these three key factors. Presently, there are insufficient data to enable the satisfactory design of neuroprotection studies and to enable statements on their relevance to disease progression and neuroprotection. The recently completed CALM-PD neuroimaging study is examined. There is sufficient doubt surrounding the sensitivity, reproducibility, and confounding effects in this study that these data should not be used to formulate a decision on de novo therapy in Parkinson's disease.
DOI: 10.1002/mds.10581
PubMed: 14531048
Affiliations:
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Morrish</name><affiliation wicri:level="1"><nlm:affiliation>Hurstwood Park Neurological Centre, Princess Royal Hospital, East Sussex, United Kingdom. paul.morrish@bsuh.nhs.uk</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Hurstwood Park Neurological Centre, Princess Royal Hospital, East Sussex</wicri:regionArea><wicri:noRegion>East Sussex</wicri:noRegion></affiliation></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2003" type="published">2003</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Biological Markers (analysis)</term><term>Brain (radionuclide imaging)</term><term>Clinical Trials as Topic</term><term>Disease Progression</term><term>Humans</term><term>Neuroprotective Agents (therapeutic use)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (radionuclide imaging)</term><term>Reproducibility of Results</term><term>Sensitivity and Specificity</term><term>Tomography, Emission-Computed</term><term>Tomography, Emission-Computed, Single-Photon</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analysis" xml:lang="en"><term>Biological Markers</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="radionuclide imaging" xml:lang="en"><term>Brain</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Neuroprotective Agents</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term><term>Disease Progression</term><term>Humans</term><term>Reproducibility of Results</term><term>Sensitivity and Specificity</term><term>Tomography, Emission-Computed</term><term>Tomography, Emission-Computed, Single-Photon</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To use functional imaging data as indices of disease progression, it is essential that methods are valid. It is not possible for that validation to come from pathology and the methods can only gain validity from the relationship to clinical indices of progression. Validity as a measurement of disease progression depends upon sensitivity to clinical progression, low scan-to-scan error, and resilience to confounding effects. Data from the available dopamine transporter (DAT) positron emission tomography (PET) and single photon emission computed tomography (SPECT) studies are examined for these three key factors. Presently, there are insufficient data to enable the satisfactory design of neuroprotection studies and to enable statements on their relevance to disease progression and neuroprotection. The recently completed CALM-PD neuroimaging study is examined. There is sufficient doubt surrounding the sensitivity, reproducibility, and confounding effects in this study that these data should not be used to formulate a decision on de novo therapy in Parkinson's disease.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">14531048</PMID><DateCreated><Year>2003</Year><Month>10</Month><Day>07</Day></DateCreated><DateCompleted><Year>2004</Year><Month>03</Month><Day>29</Day></DateCompleted><DateRevised><Year>2007</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>18 Suppl 7</Volume><PubDate><Year>2003</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>How valid is dopamine transporter imaging as a surrogate marker in research trials in Parkinson's disease?</ArticleTitle><Pagination><MedlinePgn>S63-70</MedlinePgn></Pagination><Abstract><AbstractText>To use functional imaging data as indices of disease progression, it is essential that methods are valid. It is not possible for that validation to come from pathology and the methods can only gain validity from the relationship to clinical indices of progression. Validity as a measurement of disease progression depends upon sensitivity to clinical progression, low scan-to-scan error, and resilience to confounding effects. Data from the available dopamine transporter (DAT) positron emission tomography (PET) and single photon emission computed tomography (SPECT) studies are examined for these three key factors. Presently, there are insufficient data to enable the satisfactory design of neuroprotection studies and to enable statements on their relevance to disease progression and neuroprotection. The recently completed CALM-PD neuroimaging study is examined. There is sufficient doubt surrounding the sensitivity, reproducibility, and confounding effects in this study that these data should not be used to formulate a decision on de novo therapy in Parkinson's disease.</AbstractText><CopyrightInformation>Copyright 2003 Movement Disorder Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Morrish</LastName><ForeName>Paul K</ForeName><Initials>PK</Initials><AffiliationInfo><Affiliation>Hurstwood Park Neurological Centre, Princess Royal Hospital, East Sussex, United Kingdom. paul.morrish@bsuh.nhs.uk</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015415">Biological Markers</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018696">Neuroprotective Agents</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015415">Biological Markers</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000032">analysis</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D001921">Brain</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000531">radionuclide imaging</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002986">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018450">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018696">Neuroprotective Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000531">radionuclide imaging</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015203">Reproducibility of Results</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012680">Sensitivity and Specificity</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D014055">Tomography, Emission-Computed</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D015899">Tomography, Emission-Computed, Single-Photon</DescriptorName></MeshHeading></MeshHeadingList><NumberOfReferences>34</NumberOfReferences></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2003</Year><Month>10</Month><Day>8</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2004</Year><Month>3</Month><Day>30</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2003</Year><Month>10</Month><Day>8</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">14531048</ArticleId><ArticleId IdType="doi">10.1002/mds.10581</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Royaume-Uni</li></country></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Morrish, Paul K" sort="Morrish, Paul K" uniqKey="Morrish P" first="Paul K" last="Morrish">Paul K. 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