Ethics of sham surgery: Perspective of patients
Identifieur interne : 002859 ( Main/Exploration ); précédent : 002858; suivant : 002860Ethics of sham surgery: Perspective of patients
Auteurs : Samuel A. Frank [États-Unis] ; Renee Wilson [États-Unis] ; Robert G. Holloway [États-Unis] ; Carol Zimmerman [États-Unis] ; Derick R. Peterson [États-Unis] ; Karl Kieburtz [États-Unis] ; Scott Y. H. Kim [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2008-01.
Descripteurs français
- Pascal (Inist)
- Wicri :
English descriptors
- KwdEn :
- Aged, Demography, Ethics, Ethics, Clinical, Female, Gene therapy, Genetic Therapy (methods), Human, Humans, Male, Middle Aged, Nervous system diseases, Neurosurgical Procedures (ethics), Parkinson Disease (surgery), Parkinson Disease (therapy), Parkinson disease, Parkinson's disease, Placebo, Placebos, Questionnaires, Single-Blind Method, Surgery, gene therapy, placebo controlled trials, sham surgery.
- MESH :
- chemical : Placebos.
- ethics : Neurosurgical Procedures.
- methods : Genetic Therapy.
- surgery : Parkinson Disease.
- therapy : Parkinson Disease.
- Aged, Demography, Ethics, Clinical, Female, Humans, Male, Middle Aged, Questionnaires, Single-Blind Method.
Abstract
Sham surgery is used as a control condition in neurosurgical clinical trials in Parkinson's disease (PD) but remains controversial. This study aimed to assess the perspective of patients with PD and the general public on the use of sham surgery controls. We surveyed consecutive patients from a university‐based neurology outpatient clinic and a community‐based general internal medicine practice. Background information was provided regarding PD and two possible methods of testing the efficacy of a novel gene transfer procedure, followed by questions that addressed participants' opinions related to the willingness to participate and permissibility of blinded and unblinded trial designs. Two hundred eighty‐eight (57.6%) patients returned surveys. Patients with PD expressed less willingness to participate in the proposed gene transfer surgery trials. Unblinded studies received greater support, but a majority would still allow the use of sham surgery. Those in favor of sham surgery were more educated and more likely to use societal perspective rationales. Patients with PD are more cautious about surgical research participation than patients with non‐PD. Their policy views were similar to others', with a majority supporting the use of sham controls. Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21775
Affiliations:
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Le document en format XML
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Frank</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Massachusetts</region></placeName><wicri:cityArea>Department of Neurology, Boston University School of Medicine, Boston</wicri:cityArea></affiliation></author><author><name sortKey="Wilson, Renee" sort="Wilson, Renee" uniqKey="Wilson R" first="Renee" last="Wilson">Renee Wilson</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Neurology, University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Holloway, Robert G" sort="Holloway, Robert G" uniqKey="Holloway R" first="Robert G." last="Holloway">Robert G. Holloway</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Neurology, University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Zimmerman, Carol" sort="Zimmerman, Carol" uniqKey="Zimmerman C" first="Carol" last="Zimmerman">Carol Zimmerman</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Neurology, University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Peterson, Derick R" sort="Peterson, Derick R" uniqKey="Peterson D" first="Derick R." last="Peterson">Derick R. Peterson</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Biostatistics and Computational Biology, University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">État de New York</region></placeName><wicri:cityArea>Department of Neurology, University of Rochester, Rochester</wicri:cityArea></affiliation></author><author><name sortKey="Kim, Scott Y H" sort="Kim, Scott Y H" uniqKey="Kim S" first="Scott Y. H." last="Kim">Scott Y. H. Kim</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Department of Psychiatry, the Bioethics Program, and the Center for Behavioral and Decision Sciences in Medicine, University of Michigan, Ann Arbor</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2008-01">2008-01</date><biblScope unit="vol">23</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="63">63</biblScope><biblScope unit="page" to="68">68</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">D3248C0EF522C99D62389D99BA85264A555C3F71</idno><idno type="DOI">10.1002/mds.21775</idno><idno type="ArticleID">MDS21775</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Demography</term><term>Ethics</term><term>Ethics, Clinical</term><term>Female</term><term>Gene therapy</term><term>Genetic Therapy (methods)</term><term>Human</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Neurosurgical Procedures (ethics)</term><term>Parkinson Disease (surgery)</term><term>Parkinson Disease (therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Placebo</term><term>Placebos</term><term>Questionnaires</term><term>Single-Blind Method</term><term>Surgery</term><term>gene therapy</term><term>placebo controlled trials</term><term>sham surgery</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Placebos</term></keywords><keywords scheme="MESH" qualifier="ethics" xml:lang="en"><term>Neurosurgical Procedures</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Genetic Therapy</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Demography</term><term>Ethics, Clinical</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Questionnaires</term><term>Single-Blind Method</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Chirurgie</term><term>Ethique</term><term>Homme</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Thérapie génique</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Chirurgie</term><term>Homme</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Sham surgery is used as a control condition in neurosurgical clinical trials in Parkinson's disease (PD) but remains controversial. This study aimed to assess the perspective of patients with PD and the general public on the use of sham surgery controls. We surveyed consecutive patients from a university‐based neurology outpatient clinic and a community‐based general internal medicine practice. Background information was provided regarding PD and two possible methods of testing the efficacy of a novel gene transfer procedure, followed by questions that addressed participants' opinions related to the willingness to participate and permissibility of blinded and unblinded trial designs. Two hundred eighty‐eight (57.6%) patients returned surveys. Patients with PD expressed less willingness to participate in the proposed gene transfer surgery trials. Unblinded studies received greater support, but a majority would still allow the use of sham surgery. Those in favor of sham surgery were more educated and more likely to use societal perspective rationales. Patients with PD are more cautious about surgical research participation than patients with non‐PD. Their policy views were similar to others', with a majority supporting the use of sham controls. Future research needs to determine whether eliciting more considered judgments of laypersons would reveal different levels of support for sham surgery. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Massachusetts</li><li>Michigan</li><li>État de New York</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Frank, Samuel A" sort="Frank, Samuel A" uniqKey="Frank S" first="Samuel A." last="Frank">Samuel A. Frank</name></region><name sortKey="Holloway, Robert G" sort="Holloway, Robert G" uniqKey="Holloway R" first="Robert G." last="Holloway">Robert G. Holloway</name><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><name sortKey="Kim, Scott Y H" sort="Kim, Scott Y H" uniqKey="Kim S" first="Scott Y. H." last="Kim">Scott Y. H. Kim</name><name sortKey="Peterson, Derick R" sort="Peterson, Derick R" uniqKey="Peterson D" first="Derick R." last="Peterson">Derick R. Peterson</name><name sortKey="Wilson, Renee" sort="Wilson, Renee" uniqKey="Wilson R" first="Renee" last="Wilson">Renee Wilson</name><name sortKey="Zimmerman, Carol" sort="Zimmerman, Carol" uniqKey="Zimmerman C" first="Carol" last="Zimmerman">Carol Zimmerman</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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