Impact of placebo assignment in clinical trials of Parkinson's disease.
Identifieur interne : 000B96 ( Ncbi/Merge ); précédent : 000B95; suivant : 000B97Impact of placebo assignment in clinical trials of Parkinson's disease.
Auteurs : Christopher G. Goetz [États-Unis] ; Kimberly Janko ; Lucy Blasucci ; Jean A. JaglinSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2003.
English descriptors
- KwdEn :
- Aged, Clinical Trials as Topic (methods), Cohort Studies, Ethics, Medical, Female, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (epidemiology), Parkinson Disease (psychology), Patient Selection, Placebo Effect, Placebos (therapeutic use), Questionnaires, Recognition (Psychology).
- MESH :
- chemical , therapeutic use : Placebos.
- drug therapy : Parkinson Disease.
- epidemiology : Parkinson Disease.
- methods : Clinical Trials as Topic.
- psychology : Parkinson Disease.
- Aged, Cohort Studies, Ethics, Medical, Female, Humans, Male, Middle Aged, Patient Selection, Placebo Effect, Questionnaires, Recognition (Psychology).
Abstract
Informed consent procedures in placebo-controlled trials are developed to ensure that subjects entering studies clearly understand the possibility of placebo assignment. The extent of patient understanding and the impact of learning that they were assigned placebo treatment have not been extensively studied. By using a standardized questionnaire, we interviewed 50 consecutive placebo-treated patients from 14 placebo-controlled clinical trials of Parkinson's disease (PD) after completion of their involvement. All patients interviewed understood that their study contained a placebo arm. All had hoped to receive the study drug rather than placebo, and more than half the subjects believed they had improved clinically during their placebo exposure. Positive impressions of enrollment in placebo-controlled trials were more frequent than negative, included helping to advance science (86%); liking the experience, education, and attention associated with the clinical trial (90%); and participating in research for the benefit of other patients as well as for themselves (80%). If another placebo-controlled trial was offered, 88% expressed that they would possibly, likely, or definitely be interested in enrollment. PD patients clearly understand the concept of placebo-controlled trials they complete them, but they are inaccurate in assessing whether they received placebo treatment. Although most wish they received the active compound being tested, the overall view of participation in placebo-controlled trials is viewed very positively by PD patients.
DOI: 10.1002/mds.10504
PubMed: 14534918
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Goetz</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurological Sciences, Rush University/Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. cgoetz@rush.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurological Sciences, Rush University/Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612</wicri:regionArea><wicri:noRegion>Illinois 60612</wicri:noRegion></affiliation></author><author><name sortKey="Janko, Kimberly" sort="Janko, Kimberly" uniqKey="Janko K" first="Kimberly" last="Janko">Kimberly Janko</name></author><author><name sortKey="Blasucci, Lucy" sort="Blasucci, Lucy" uniqKey="Blasucci L" first="Lucy" last="Blasucci">Lucy Blasucci</name></author><author><name sortKey="Jaglin, Jean A" sort="Jaglin, Jean A" uniqKey="Jaglin J" first="Jean A" last="Jaglin">Jean A. 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Goetz</name><affiliation wicri:level="1"><nlm:affiliation>Department of Neurological Sciences, Rush University/Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. cgoetz@rush.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurological Sciences, Rush University/Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612</wicri:regionArea><wicri:noRegion>Illinois 60612</wicri:noRegion></affiliation></author><author><name sortKey="Janko, Kimberly" sort="Janko, Kimberly" uniqKey="Janko K" first="Kimberly" last="Janko">Kimberly Janko</name></author><author><name sortKey="Blasucci, Lucy" sort="Blasucci, Lucy" uniqKey="Blasucci L" first="Lucy" last="Blasucci">Lucy Blasucci</name></author><author><name sortKey="Jaglin, Jean A" sort="Jaglin, Jean A" uniqKey="Jaglin J" first="Jean A" last="Jaglin">Jean A. Jaglin</name></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>Aged</term><term>Clinical Trials as Topic (methods)</term><term>Cohort Studies</term><term>Ethics, Medical</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (epidemiology)</term><term>Parkinson Disease (psychology)</term><term>Patient Selection</term><term>Placebo Effect</term><term>Placebos (therapeutic use)</term><term>Questionnaires</term><term>Recognition (Psychology)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Placebos</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Cohort Studies</term><term>Ethics, Medical</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Patient Selection</term><term>Placebo Effect</term><term>Questionnaires</term><term>Recognition (Psychology)</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Informed consent procedures in placebo-controlled trials are developed to ensure that subjects entering studies clearly understand the possibility of placebo assignment. The extent of patient understanding and the impact of learning that they were assigned placebo treatment have not been extensively studied. By using a standardized questionnaire, we interviewed 50 consecutive placebo-treated patients from 14 placebo-controlled clinical trials of Parkinson's disease (PD) after completion of their involvement. All patients interviewed understood that their study contained a placebo arm. All had hoped to receive the study drug rather than placebo, and more than half the subjects believed they had improved clinically during their placebo exposure. Positive impressions of enrollment in placebo-controlled trials were more frequent than negative, included helping to advance science (86%); liking the experience, education, and attention associated with the clinical trial (90%); and participating in research for the benefit of other patients as well as for themselves (80%). If another placebo-controlled trial was offered, 88% expressed that they would possibly, likely, or definitely be interested in enrollment. PD patients clearly understand the concept of placebo-controlled trials they complete them, but they are inaccurate in assessing whether they received placebo treatment. Although most wish they received the active compound being tested, the overall view of participation in placebo-controlled trials is viewed very positively by PD patients.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">14534918</PMID><DateCreated><Year>2003</Year><Month>10</Month><Day>09</Day></DateCreated><DateCompleted><Year>2004</Year><Month>02</Month><Day>23</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</Volume><Issue>10</Issue><PubDate><Year>2003</Year><Month>Oct</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. 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Positive impressions of enrollment in placebo-controlled trials were more frequent than negative, included helping to advance science (86%); liking the experience, education, and attention associated with the clinical trial (90%); and participating in research for the benefit of other patients as well as for themselves (80%). If another placebo-controlled trial was offered, 88% expressed that they would possibly, likely, or definitely be interested in enrollment. PD patients clearly understand the concept of placebo-controlled trials they complete them, but they are inaccurate in assessing whether they received placebo treatment. Although most wish they received the active compound being tested, the overall view of participation in placebo-controlled trials is viewed very positively by PD patients.</AbstractText><CopyrightInformation>Copyright 2003 Movement Disorder Society</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Goetz</LastName><ForeName>Christopher G</ForeName><Initials>CG</Initials><AffiliationInfo><Affiliation>Department of Neurological Sciences, Rush University/Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 60612, USA. cgoetz@rush.edu</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Janko</LastName><ForeName>Kimberly</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Blasucci</LastName><ForeName>Lucy</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Jaglin</LastName><ForeName>Jean A</ForeName><Initials>JA</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</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="D010919">Placebos</NameOfSubstance></Chemical></ChemicalList><CitationSubset>E</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D002986">Clinical Trials as Topic</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000379">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D015331">Cohort Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004992">Ethics, Medical</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000453">epidemiology</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000523">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018579">Patient Selection</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D015990">Placebo Effect</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D010919">Placebos</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D011795">Questionnaires</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D021641">Recognition (Psychology)</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="KIE">127386</OtherID><OtherID Source="NRCBL">VF 18.3</OtherID><KeywordList Owner="KIE"><Keyword MajorTopicYN="N">Biomedical and Behavioral Research</Keyword><Keyword MajorTopicYN="N">Empirical Approach</Keyword></KeywordList><GeneralNote Owner="KIE">10 refs.</GeneralNote><GeneralNote Owner="KIE">KIE Bib: human experimentation/research design</GeneralNote></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2003</Year><Month>10</Month><Day>10</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2004</Year><Month>2</Month><Day>24</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2003</Year><Month>10</Month><Day>10</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">14534918</ArticleId><ArticleId IdType="doi">10.1002/mds.10504</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country></list><tree><noCountry><name sortKey="Blasucci, Lucy" sort="Blasucci, Lucy" uniqKey="Blasucci L" first="Lucy" last="Blasucci">Lucy Blasucci</name><name sortKey="Jaglin, Jean A" sort="Jaglin, Jean A" uniqKey="Jaglin J" first="Jean A" last="Jaglin">Jean A. Jaglin</name><name sortKey="Janko, Kimberly" sort="Janko, Kimberly" uniqKey="Janko K" first="Kimberly" last="Janko">Kimberly Janko</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G" last="Goetz">Christopher G. Goetz</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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