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

BackgroundThis 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).MethodsA total of 19 univers...

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Veröffentlicht in:Journal of neurology, neurosurgery and psychiatry neurosurgery and psychiatry, 2012-06, Vol.83 (6), p.620-628
Hauptverfasser: Kupsch, Andreas R, Bajaj, Nin, Weiland, Frederick, Tartaglione, Antonio, Klutmann, Susanne, Buitendyk, Melanie, Sherwin, Paul, Tate, Ann, Grachev, Igor D
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container_issue 6
container_start_page 620
container_title Journal of neurology, neurosurgery and psychiatry
container_volume 83
creator Kupsch, Andreas R
Bajaj, Nin
Weiland, Frederick
Tartaglione, Antonio
Klutmann, Susanne
Buitendyk, Melanie
Sherwin, Paul
Tate, Ann
Grachev, Igor D
description BackgroundThis 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).MethodsA 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.ResultsThere 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
doi_str_mv 10.1136/jnnp-2011-301695
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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.ResultsThere 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&lt;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&lt;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.ConclusionsDaTscan 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 numberhttp://ClinicalTrials.gov Identifier: NCT00382967.</description><identifier>ISSN: 0022-3050</identifier><identifier>EISSN: 1468-330X</identifier><identifier>DOI: 10.1136/jnnp-2011-301695</identifier><identifier>PMID: 22492213</identifier><identifier>CODEN: JNNPAU</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Alzheimer's disease ; Biological and medical sciences ; clinical ; clinical management ; Clinical medicine ; consciousness ; DaTscan ; dementia ; diagnosis ; Disease Management ; Dopamine ; Female ; Follow-Up Studies ; Humans ; Iodine Radioisotopes ; Male ; Medical sciences ; Middle Aged ; Movement disorders ; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis ; Neurology ; neurophysiology ; neuropsychology ; Nortropanes ; nuclear medicine ; Parkinson's disease ; Parkinsonian Disorders - diagnosis ; Parkinsonian Disorders - diagnostic imaging ; Parkinsonian Disorders - psychology ; parkinsonian syndromes ; Patient Acceptance of Health Care - psychology ; pet ; Predictive Value of Tests ; Prospective Studies ; Quality of life ; Quality of Life - psychology ; Safety - statistics &amp; numerical data ; SPECT ; Tomography, Emission-Computed, Single-Photon - methods ; Tomography, Emission-Computed, Single-Photon - psychology ; Tremor (Muscular contraction)</subject><ispartof>Journal of neurology, neurosurgery and psychiatry, 2012-06, Vol.83 (6), p.620-628</ispartof><rights>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.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright: 2012 (c) 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.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b497t-6bc91ed33f94efc3eafed5e01fde5c63332f81f1e045cfaee9c9ba2b464b8f6f3</citedby><cites>FETCH-LOGICAL-b497t-6bc91ed33f94efc3eafed5e01fde5c63332f81f1e045cfaee9c9ba2b464b8f6f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jnnp.bmj.com/content/83/6/620.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttps://jnnp.bmj.com/content/83/6/620.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,776,780,3183,23550,27901,27902,77569,77600</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=25952436$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22492213$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kupsch, Andreas R</creatorcontrib><creatorcontrib>Bajaj, Nin</creatorcontrib><creatorcontrib>Weiland, Frederick</creatorcontrib><creatorcontrib>Tartaglione, Antonio</creatorcontrib><creatorcontrib>Klutmann, Susanne</creatorcontrib><creatorcontrib>Buitendyk, Melanie</creatorcontrib><creatorcontrib>Sherwin, Paul</creatorcontrib><creatorcontrib>Tate, Ann</creatorcontrib><creatorcontrib>Grachev, Igor D</creatorcontrib><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><title>Journal of neurology, neurosurgery and psychiatry</title><addtitle>J Neurol Neurosurg Psychiatry</addtitle><description>BackgroundThis 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).MethodsA 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.ResultsThere 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&lt;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&lt;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.ConclusionsDaTscan 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 numberhttp://ClinicalTrials.gov Identifier: NCT00382967.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alzheimer's disease</subject><subject>Biological and medical sciences</subject><subject>clinical</subject><subject>clinical management</subject><subject>Clinical medicine</subject><subject>consciousness</subject><subject>DaTscan</subject><subject>dementia</subject><subject>diagnosis</subject><subject>Disease Management</subject><subject>Dopamine</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Iodine Radioisotopes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Movement disorders</subject><subject>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</subject><subject>Neurology</subject><subject>neurophysiology</subject><subject>neuropsychology</subject><subject>Nortropanes</subject><subject>nuclear medicine</subject><subject>Parkinson's disease</subject><subject>Parkinsonian Disorders - diagnosis</subject><subject>Parkinsonian Disorders - diagnostic imaging</subject><subject>Parkinsonian Disorders - psychology</subject><subject>parkinsonian syndromes</subject><subject>Patient Acceptance of Health Care - psychology</subject><subject>pet</subject><subject>Predictive Value of Tests</subject><subject>Prospective Studies</subject><subject>Quality of life</subject><subject>Quality of Life - psychology</subject><subject>Safety - statistics &amp; numerical data</subject><subject>SPECT</subject><subject>Tomography, Emission-Computed, Single-Photon - methods</subject><subject>Tomography, Emission-Computed, Single-Photon - psychology</subject><subject>Tremor (Muscular contraction)</subject><issn>0022-3050</issn><issn>1468-330X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNks1v1DAQxQMC0e3CnROyhJCQ2EBsx8mGG1raUql8SCwf4mI5znjrxXHSOKHkv2fCbgviUqJIkTy_efOceVH0kCbPKeXZi633bcwSSmOe0KwQt6MZTbNlzHny9U40SxLGsCKSg-gwhG0yPcviXnTAWFowRvns1uFp3Srdk8aQ12odtPLk44ej1ZrYWm2s35DGE-2st1o5UiuvNlCD7xeksmrjm2DDgujGG1uB1zDJ_FW4GJSz_TidOmtgQc5Buf6cdBCaoUN8CECUr0hQBpCznrSqt6gfyKVF8GqyG8mA8l2vfiPdd-tD4y2aDaOvuqaG8JIo0nZNaEH39gcQGo-gOmIa55rLeGgnE8g3LfjYqRLcZLvvsAw4vx-q8X501ygX4MH-O48-HR-tV2_is_cnp6tXZ3GZFnkfZ6UuKFScmyIFozmg90pAQk0FQmecc2aW1FBIUqGNAih0USpWpllaLk1m-Dx6utNFuxcDhF7WNmhwTnlohiCpEDRjuKL8ZjShebFMhRD_g7I8LTi-8-jxP-gW1-HxzpLmS4qDEUMq2VEa_2rowMi2w1B0I0rJKX1ySp-c0id36cOWR3vhoayhum64ihsCT_aAwqg50ymvbfjDiUKwlGfIxTvOhh5-Xtdx8TLLeS7ku88rKY6_nKxE-k2-Rf7Zji_r7c02fwFpkgTK</recordid><startdate>20120601</startdate><enddate>20120601</enddate><creator>Kupsch, Andreas R</creator><creator>Bajaj, Nin</creator><creator>Weiland, Frederick</creator><creator>Tartaglione, Antonio</creator><creator>Klutmann, Susanne</creator><creator>Buitendyk, Melanie</creator><creator>Sherwin, Paul</creator><creator>Tate, Ann</creator><creator>Grachev, Igor D</creator><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group LTD</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>88I</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>M2P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>7T2</scope><scope>7TK</scope><scope>7U2</scope><scope>C1K</scope></search><sort><creationdate>20120601</creationdate><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>Kupsch, Andreas R ; Bajaj, Nin ; Weiland, Frederick ; Tartaglione, Antonio ; Klutmann, Susanne ; Buitendyk, Melanie ; Sherwin, Paul ; Tate, Ann ; Grachev, Igor D</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b497t-6bc91ed33f94efc3eafed5e01fde5c63332f81f1e045cfaee9c9ba2b464b8f6f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alzheimer's disease</topic><topic>Biological and medical sciences</topic><topic>clinical</topic><topic>clinical management</topic><topic>Clinical medicine</topic><topic>consciousness</topic><topic>DaTscan</topic><topic>dementia</topic><topic>diagnosis</topic><topic>Disease Management</topic><topic>Dopamine</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Iodine Radioisotopes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Movement disorders</topic><topic>Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis</topic><topic>Neurology</topic><topic>neurophysiology</topic><topic>neuropsychology</topic><topic>Nortropanes</topic><topic>nuclear medicine</topic><topic>Parkinson's disease</topic><topic>Parkinsonian Disorders - diagnosis</topic><topic>Parkinsonian Disorders - diagnostic imaging</topic><topic>Parkinsonian Disorders - psychology</topic><topic>parkinsonian syndromes</topic><topic>Patient Acceptance of Health Care - psychology</topic><topic>pet</topic><topic>Predictive Value of Tests</topic><topic>Prospective Studies</topic><topic>Quality of life</topic><topic>Quality of Life - psychology</topic><topic>Safety - statistics &amp; numerical data</topic><topic>SPECT</topic><topic>Tomography, Emission-Computed, Single-Photon - methods</topic><topic>Tomography, Emission-Computed, Single-Photon - psychology</topic><topic>Tremor (Muscular contraction)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kupsch, Andreas R</creatorcontrib><creatorcontrib>Bajaj, Nin</creatorcontrib><creatorcontrib>Weiland, Frederick</creatorcontrib><creatorcontrib>Tartaglione, Antonio</creatorcontrib><creatorcontrib>Klutmann, Susanne</creatorcontrib><creatorcontrib>Buitendyk, Melanie</creatorcontrib><creatorcontrib>Sherwin, Paul</creatorcontrib><creatorcontrib>Tate, Ann</creatorcontrib><creatorcontrib>Grachev, Igor D</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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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.ResultsThere 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&lt;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&lt;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.ConclusionsDaTscan 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 numberhttp://ClinicalTrials.gov Identifier: NCT00382967.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd</pub><pmid>22492213</pmid><doi>10.1136/jnnp-2011-301695</doi><tpages>9</tpages></addata></record>
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ispartof Journal of neurology, neurosurgery and psychiatry, 2012-06, Vol.83 (6), p.620-628
issn 0022-3050
1468-330X
language eng
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source MEDLINE; BMJ Journals - NESLi2
subjects Adult
Aged
Aged, 80 and over
Alzheimer's disease
Biological and medical sciences
clinical
clinical management
Clinical medicine
consciousness
DaTscan
dementia
diagnosis
Disease Management
Dopamine
Female
Follow-Up Studies
Humans
Iodine Radioisotopes
Male
Medical sciences
Middle Aged
Movement disorders
Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis
Neurology
neurophysiology
neuropsychology
Nortropanes
nuclear medicine
Parkinson's disease
Parkinsonian Disorders - diagnosis
Parkinsonian Disorders - diagnostic imaging
Parkinsonian Disorders - psychology
parkinsonian syndromes
Patient Acceptance of Health Care - psychology
pet
Predictive Value of Tests
Prospective Studies
Quality of life
Quality of Life - psychology
Safety - statistics & numerical data
SPECT
Tomography, Emission-Computed, Single-Photon - methods
Tomography, Emission-Computed, Single-Photon - psychology
Tremor (Muscular contraction)
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
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