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 : 002200 ( Main/Curation ); précédent : 002199; suivant : 002201Impact 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 [Allemagne] ; Nin Bajaj [Royaume-Uni] ; Frederick Weiland [États-Unis] ; Antonio Tartaglione [Italie] ; Susanne Klutmann [Allemagne] ; Melanie Buitendyk [Canada] ; Paul Sherwin [États-Unis] ; Ann Tate [États-Unis] ; Igor D. Grachev [États-Unis]Source :
- 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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Igor D. Grachev<affiliation><mods:affiliation>E-mail: igor.grachev@ge.com</mods:affiliation><wicri:noCountry code="no comma">E-mail: igor.grachev@ge.com</wicri:noCountry></affiliation>Le document en format XML
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Kupsch</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, University Medicine Berlin, Berlin, Germany</mods:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University Medicine Berlin, Berlin</wicri:regionArea></affiliation></author><author><name sortKey="Bajaj, Nin" sort="Bajaj, Nin" uniqKey="Bajaj N" first="Nin" last="Bajaj">Nin Bajaj</name><affiliation wicri:level="1"><mods:affiliation>Derbyshire Royal Infirmary, Neurology Department, Derby, UK</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Derbyshire Royal Infirmary, Neurology Department, Derby</wicri:regionArea></affiliation></author><author><name sortKey="Weiland, Frederick" sort="Weiland, Frederick" uniqKey="Weiland F" first="Frederick" last="Weiland">Frederick Weiland</name><affiliation wicri:level="1"><mods:affiliation>Sutter Health, Roseville, California, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Sutter Health, Roseville, California</wicri:regionArea></affiliation></author><author><name sortKey="Tartaglione, Antonio" sort="Tartaglione, Antonio" uniqKey="Tartaglione A" first="Antonio" last="Tartaglione">Antonio Tartaglione</name><affiliation wicri:level="1"><mods:affiliation>Department of Neurology, S. 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Grachev</name><affiliation wicri:level="1"><mods:affiliation>Clinical Development, GE Healthcare, Princeton, New Jersey, USA</mods:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Development, GE Healthcare, Princeton, New Jersey</wicri:regionArea></affiliation><affiliation><mods:affiliation>E-mail: igor.grachev@ge.com</mods:affiliation><wicri:noCountry code="no comma">E-mail: igor.grachev@ge.com</wicri:noCountry></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></record>Pour manipuler ce document sous Unix (Dilib)
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