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Sham surgery controls in Parkinson's disease clinical trials: Views of participants

dc.contributor.authorKim, Scott Y.H.en_US
dc.contributor.authorDe Vries, Raymonden_US
dc.contributor.authorHolloway, Robert G.en_US
dc.contributor.authorWilson, Reneeen_US
dc.contributor.authorParnami, Sonalien_US
dc.contributor.authorKim, H. Myraen_US
dc.contributor.authorFrank, Samuelen_US
dc.contributor.authorKieburtz, Karlen_US
dc.date.accessioned2012-10-02T17:20:30Z
dc.date.available2013-10-18T17:47:29Zen_US
dc.date.issued2012-09-15en_US
dc.identifier.citationKim, Scott Y.H.; De Vries, Raymond; Holloway, Robert G.; Wilson, Renee; Parnami, Sonali; Kim, H. Myra; Frank, Samuel; Kieburtz, Karl (2012). "Sham surgery controls in Parkinson's disease clinical trials: Views of participants ." Movement Disorders 27(11): 1461-1465. <http://hdl.handle.net/2027.42/93771>en_US
dc.identifier.issn0885-3185en_US
dc.identifier.issn1531-8257en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/93771
dc.description.abstractBackground: Sham surgery controls are increasingly used in neurosurgical clinical trials in Parkinson's disease (PD) but remain controversial. We interviewed participants of such trials, specifically examining their understanding and attitudes regarding sham surgery. Methods: We conducted semistructured qualitative interviews with participants of 3 sham surgery–controlled trials for PD, focusing on their understanding of sham design, their reactions to it, its impact on decision making, and their understanding of posttrial availability of the experimental intervention and its impact on decisions to participate. Results: All subjects (n = 90) understood the 2‐arm design; most (86%) described the procedural differences between the arms accurately. Ninety‐two percent referred to scientific or regulatory reasons as rationales for the sham control, with 62% specifically referring to the placebo effect. Ninety‐one percent said posttrial availability of the experimental intervention had a strong (48%) or some (43%) influence on their decision to participate, but only 68% understood the conditions for posttrial availability. Conclusions: Most subjects in sham surgery–controlled PD trials comprehend the sham surgery design and its rationale. Although there is room for improvement, most subjects of sham surgery trials appear to be adequately informed. © 2012 Movement Disorder Societyen_US
dc.publisherWiley Subscription Services, Inc., A Wiley Companyen_US
dc.subject.otherSham Surgeryen_US
dc.subject.otherBioethicsen_US
dc.subject.otherParkinson's Diseaseen_US
dc.subject.otherGene Therapyen_US
dc.titleSham surgery controls in Parkinson's disease clinical trials: Views of participantsen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.contributor.affiliationumDepartment of Psychiatry, University of Michigan, Ann Arbor, Michigan, USAen_US
dc.contributor.affiliationumCenter for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Michigan, USAen_US
dc.contributor.affiliationumDepartment of Medical Education, University of Michigan, Ann Arbor, Michigan, USAen_US
dc.contributor.affiliationumDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, USAen_US
dc.contributor.affiliationumCenter for Bioethics and Social Sciences in Medicine, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109, USAen_US
dc.contributor.affiliationotherCenter for Human Experimental Therapeutics, University of Rochester, Rochester, New York, USAen_US
dc.contributor.affiliationotherDepartment of Neurology, University of Rochester, Rochester, New York, USAen_US
dc.contributor.affiliationotherDepartment of Community and Preventive Medicine, University of Rochester, Rochester, New York, USAen_US
dc.contributor.affiliationotherDepartment of Neurology, Boston University, Boston, Massachusetts, USAen_US
dc.contributor.affiliationotherDepartment of Environmental Medicine, University of Rochester, Rochester, New York, USAen_US
dc.identifier.pmid22927064en_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/93771/1/25155_ftp.pdf
dc.identifier.doi10.1002/mds.25155en_US
dc.identifier.sourceMovement Disordersen_US
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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