Impact of disclosure of individual imaging results in a multi-center Parkinson clinical trial.
Identifieur interne : 000034 ( PubMed/Checkpoint ); précédent : 000033; suivant : 000035Impact of disclosure of individual imaging results in a multi-center Parkinson clinical trial.
Auteurs : Danna Jennings [États-Unis] ; Shirley Eberly [États-Unis] ; David Oakes [États-Unis] ; John Seibyl [États-Unis] ; Ken Marek [États-Unis] ; Ira Shoulson [États-Unis]Source :
- Journal of Parkinson's disease ; 2014.
English descriptors
- KwdEn :
- Antipsychotic Agents (therapeutic use), Carbazoles (therapeutic use), Cocaine (analogs & derivatives), Dopamine Plasma Membrane Transport Proteins (metabolism), Female, Health Surveys, Humans, Longitudinal Studies, Male, Parkinson Disease (drug therapy), Parkinson Disease (radionuclide imaging), Radiopharmaceuticals, Retrospective Studies, Tomography, Emission-Computed, Single-Photon, Treatment Outcome.
- MESH :
- chemical , analogs & derivatives : Cocaine.
- chemical , metabolism : Dopamine Plasma Membrane Transport Proteins.
- chemical , therapeutic use : Antipsychotic Agents, Carbazoles.
- drug therapy : Parkinson Disease.
- radionuclide imaging : Parkinson Disease.
- Female, Health Surveys, Humans, Longitudinal Studies, Male, Radiopharmaceuticals, Retrospective Studies, Tomography, Emission-Computed, Single-Photon, Treatment Outcome.
Abstract
Little is known about the impact of providing individual research results to clinical trial participants or the impact of sharing such data.
DOI: 10.3233/JPD-140383
PubMed: 25062961
Affiliations:
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pubmed:25062961Le document en format XML
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wicri:level="2"><nlm:affiliation>Institute for Neurodegenerative Disorders, New Haven, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Institute for Neurodegenerative Disorders, New Haven, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Eberly, Shirley" sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><affiliation wicri:level="2"><nlm:affiliation>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><affiliation wicri:level="2"><nlm:affiliation>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Seibyl, John" sort="Seibyl, John" uniqKey="Seibyl J" first="John" last="Seibyl">John Seibyl</name><affiliation wicri:level="2"><nlm:affiliation>Institute for Neurodegenerative Disorders, New Haven, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Institute for Neurodegenerative Disorders, New Haven, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Marek, Ken" sort="Marek, Ken" uniqKey="Marek K" first="Ken" last="Marek">Ken Marek</name><affiliation wicri:level="2"><nlm:affiliation>Institute for Neurodegenerative Disorders, New Haven, CT, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Institute for Neurodegenerative Disorders, New Haven, CT</wicri:regionArea><placeName><region type="state">Connecticut</region></placeName></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation wicri:level="1"><nlm:affiliation>Program for Regulatory Science & Medicine (PRSM), Georgetown University, Washington, D.C., USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Program for Regulatory Science & Medicine (PRSM), Georgetown University, Washington, D.C.</wicri:regionArea><wicri:noRegion>D.C.</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal of Parkinson's disease</title><idno type="e-ISSN">1877-718X</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antipsychotic Agents (therapeutic use)</term><term>Carbazoles (therapeutic use)</term><term>Cocaine (analogs & derivatives)</term><term>Dopamine Plasma Membrane Transport Proteins (metabolism)</term><term>Female</term><term>Health Surveys</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (radionuclide imaging)</term><term>Radiopharmaceuticals</term><term>Retrospective Studies</term><term>Tomography, Emission-Computed, Single-Photon</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Cocaine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Dopamine Plasma Membrane Transport Proteins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antipsychotic Agents</term><term>Carbazoles</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>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Female</term><term>Health Surveys</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Radiopharmaceuticals</term><term>Retrospective Studies</term><term>Tomography, Emission-Computed, Single-Photon</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Little is known about the impact of providing individual research results to clinical trial participants or the impact of sharing such data.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25062961</PMID><DateCreated><Year>2014</Year><Month>12</Month><Day>03</Day></DateCreated><DateCompleted><Year>2015</Year><Month>08</Month><Day>19</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1877-718X</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>4</Issue><PubDate><Year>2014</Year></PubDate></JournalIssue><Title>Journal of Parkinson's disease</Title><ISOAbbreviation>J Parkinsons Dis</ISOAbbreviation></Journal><ArticleTitle>Impact of disclosure of individual imaging results in a multi-center Parkinson clinical trial.</ArticleTitle><Pagination><MedlinePgn>629-38</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3233/JPD-140383</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Little is known about the impact of providing individual research results to clinical trial participants or the impact of sharing such data.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The objective of this follow-up study was to evaluate the desire of participants for learning their imaging results and the impact of this information on their perception of their PD diagnosis and care.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The Parkinson Research Examination of CEP-1347 Trial (PRECEPT) evaluated the experimental treatment CEP-1347 obtaining dopamine transporter imaging at baseline and 22 months as a secondary outcome. Dopamine transporter imaging and results were categorized as 'dopamine transporter deficit', 'no dopamine transporter deficit' or 'indeterminate.' Self-administered surveys were provided on three occasions to subjects who chose to learn their dopamine transporter imaging results: prior to receiving imaging data, immediately following receipt of imaging information, and three months following image disclosure.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">656/777 subjects (84.4%) consented to receive their individual imaging data, comprising overall result categories of 86.3% 'dopamine transporter deficit', 10.4% 'no dopamine transporter deficit', and 3.4% 'indeterminate.' 99.6% of subjects believed their decision to receive data was correct. Following disclosure of imaging results, 97% of the 'dopamine transporter deficit' and 'indeterminate' subjects believed they had Parkinson disease compared with 34% of 'no dopamine transporter deficit' subjects. About 45% of participants reported that learning individual imaging data resulted in improved understanding of their diagnosis.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The majority of research participants chose to learn their individual dopamine transporter imaging results and were satisfied with their decision. Disclosure of imaging information resulted in improved understanding of parkinsonian symptoms in nearly half of subjects, and less belief among 'no dopamine transporter deficit' subjects that they had a diagnosis of Parkinson disease.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jennings</LastName><ForeName>Danna</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Institute for Neurodegenerative Disorders, New Haven, CT, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Eberly</LastName><ForeName>Shirley</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oakes</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Department of Biostatistics and Computational Biology, University of Rochester, Rochester, 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sort="Eberly, Shirley" uniqKey="Eberly S" first="Shirley" last="Eberly">Shirley Eberly</name><name sortKey="Marek, Ken" sort="Marek, Ken" uniqKey="Marek K" first="Ken" last="Marek">Ken Marek</name><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><name sortKey="Seibyl, John" sort="Seibyl, John" uniqKey="Seibyl J" first="John" last="Seibyl">John Seibyl</name><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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