MovDisordV3, Main, Exploration, bibRecord, 001161

Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials

Identifieur interne : 001161 ( Main/Exploration ); précédent : 001160; suivant : 001162

Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials

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

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0183704

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Etude comparative, Chirurgie, Traitement, Prise de décision.
Wicri :
- topic : Chirurgie, Prise de décision.

English descriptors

KwdEn :
- Aged, Attitude to Health, Comparative study, Decision Making, Decision making, Female, Humans, Male, Middle Aged, Nervous system diseases, Neurosurgery (psychology), Parkinson Disease (psychology), Parkinson Disease (surgery), Parkinson disease, Research Subjects (psychology), Risk Assessment, Surgery, Treatment.
MESH :
- psychology : Neurosurgery, Parkinson Disease, Research Subjects.
- surgery : Parkinson Disease.
- Aged, Attitude to Health, Decision Making, Female, Humans, Male, Middle Aged, Risk Assessment.

Abstract

Concerns have been raised that persons with serious illnesses participating in high-risk research, such as PD patients in sham surgery trials, have unrealistic expectations and are vulnerable to exploitation. A comparison of enrollees and decliners of such research may provide insights about the adequacy of decision making by potential subjects. We compared 61 enrollees and 10 decliners of two phase II neurosurgical intervention (i.e., cellular and gene transfer) trials for PD regarding their demographic and clinical status, perceptions and attitudes regarding research risks, potential direct benefit, and societal benefit, and perspectives on the various potential reasons for and against participation. In addition to bivariate analyses, a logistic regression model examined variables regarding risks and benefits as predictors of participation status. Enrollees perceived lower risk of harm while tolerating higher risk of harm and were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, whereas the fact that the study's purpose was not solely to benefit them was rated as "not a reason" against participation. Hope for benefit and altruism were rated higher than expectation of benefit as reasons in favor of participation for both groups. Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research because of hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and does not imply a failure to understand the main purpose of research.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3323770

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en">Concerns have been raised that persons with serious illnesses participating in high-risk research, such as PD patients in sham surgery trials, have unrealistic expectations and are vulnerable to exploitation. A comparison of enrollees and decliners of such research may provide insights about the adequacy of decision making by potential subjects. We compared 61 enrollees and 10 decliners of two phase II neurosurgical intervention (i.e., cellular and gene transfer) trials for PD regarding their demographic and clinical status, perceptions and attitudes regarding research risks, potential direct benefit, and societal benefit, and perspectives on the various potential reasons for and against participation. In addition to bivariate analyses, a logistic regression model examined variables regarding risks and benefits as predictors of participation status. Enrollees perceived lower risk of harm while tolerating higher risk of harm and were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, whereas the fact that the study's purpose was not solely to benefit them was rated as "not a reason" against participation. Hope for benefit and altruism were rated higher than expectation of benefit as reasons in favor of participation for both groups. Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research because of hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and does not imply a failure to understand the main purpose of research.</div>
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<name sortKey="De Vries, Raymond G" sort="De Vries, Raymond G" uniqKey="De Vries R" first="Raymond G." last="De Vries">Raymond G. De Vries</name>
<name sortKey="De Vries, Raymond G" sort="De Vries, Raymond G" uniqKey="De Vries R" first="Raymond G." last="De Vries">Raymond G. De Vries</name>
<name sortKey="Frank, Samuel A" sort="Frank, Samuel A" uniqKey="Frank S" first="Samuel A." last="Frank">Samuel A. Frank</name>
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<name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name>
<name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name>
<name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name>
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<name sortKey="Wilson, Renee M" sort="Wilson, Renee M" uniqKey="Wilson R" first="Renee M." last="Wilson">Renee M. Wilson</name>
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Movement Disorders (revue)

Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials

Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials

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Abstract

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	Movement Disorders (revue)
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