MovDisordV3, Main, Exploration, bibRecord, 000F86

Sham Surgery Controls in Parkinson's Disease Clinical Trials: Views of Participants

Identifieur interne : 000F86 ( Main/Exploration ); précédent : 000F85; suivant : 000F87

Sham Surgery Controls in Parkinson's Disease Clinical Trials: Views of Participants

Auteurs : Scott Y. H. Kim [États-Unis] ; Raymond De Vries [États-Unis] ; Robert G. Holloway [États-Unis] ; Renee Wilson [États-Unis] ; Sonali Parnami [États-Unis] ; H. Myra Kim [États-Unis] ; Samuel Frank [États-Unis] ; Karl Kieburtz [États-Unis]

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0393108

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Chirurgie, Essai clinique, Thérapie génique.
Wicri :
- topic : Chirurgie.

English descriptors

KwdEn :
- Attitude, Clinical Trials as Topic (psychology), Clinical trial, Female, Gene therapy, Humans, Male, Nervous system diseases, Parkinson Disease (psychology), Parkinson Disease (surgery), Parkinson disease, Questionnaires, Research Design, Surgery.
MESH :
- psychology : Clinical Trials as Topic, Parkinson Disease.
- surgery : Parkinson Disease.
- Attitude, Female, Humans, Male, Questionnaires, Research Design.

Abstract

Background: 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.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3703438

Affiliations:

Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Attitude</term>
<term>Clinical Trials as Topic (psychology)</term>
<term>Clinical trial</term>
<term>Female</term>
<term>Gene therapy</term>
<term>Humans</term>
<term>Male</term>
<term>Nervous system diseases</term>
<term>Parkinson Disease (psychology)</term>
<term>Parkinson Disease (surgery)</term>
<term>Parkinson disease</term>
<term>Questionnaires</term>
<term>Research Design</term>
<term>Surgery</term>
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<front><div type="abstract" xml:lang="en">Background: 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.</div>
</front>
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<name sortKey="De Vries, Raymond" sort="De Vries, Raymond" uniqKey="De Vries R" first="Raymond" last="De Vries">Raymond De Vries</name>
<name sortKey="De Vries, Raymond" sort="De Vries, Raymond" uniqKey="De Vries R" first="Raymond" last="De Vries">Raymond De Vries</name>
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<name sortKey="Holloway, Robert G" sort="Holloway, Robert G" uniqKey="Holloway R" first="Robert G." last="Holloway">Robert G. Holloway</name>
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<name sortKey="Wilson, Renee" sort="Wilson, Renee" uniqKey="Wilson R" first="Renee" last="Wilson">Renee Wilson</name>
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Movement Disorders (revue)

Sham Surgery Controls in Parkinson's Disease Clinical Trials: Views of Participants

Sham Surgery Controls in Parkinson's Disease Clinical Trials: Views of Participants

Source :

Descripteurs français

English descriptors

Abstract

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	Movement Disorders (revue)
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