Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials
Identifieur interne : 000151 ( Pmc/Curation ); précédent : 000150; suivant : 000152Comparison 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.
Abstract
Concerns have been raised that persons with serious illnesses participating in high risk research, such as Parkinson disease (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 2 neurosurgical intervention (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, were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, while 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 due to hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and it does not imply a failure to understand the main purpose of research.
Url:
DOI: 10.1002/mds.24940
PubMed: 22314796
PubMed Central: 3323770
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<country xml:lang="fr">États-Unis</country>
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</placeName>
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">Concerns have been raised that persons with serious illnesses participating in high risk research, such as Parkinson disease (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.</p>
</sec>
<sec sec-type="methods" id="S2"><title>Methods</title>
<p id="P2">We compared 61 enrollees and 10 decliners of two phase 2 neurosurgical intervention (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.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Enrollees perceived lower risk of harm while tolerating higher risk of harm, were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, while 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.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research due to hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and it does not imply a failure to understand the main purpose of research.</p>
</sec>
</div>
</front>
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<front><journal-meta><journal-id journal-id-type="nlm-journal-id">8610688</journal-id>
<journal-id journal-id-type="pubmed-jr-id">5937</journal-id>
<journal-id journal-id-type="nlm-ta">Mov Disord</journal-id>
<journal-id journal-id-type="iso-abbrev">Mov. Disord.</journal-id>
<journal-title-group><journal-title>Movement Disorders</journal-title>
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<article-id pub-id-type="manuscript">NIHMS350307</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
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</article-categories>
<title-group><article-title>Comparison of Enrollees and Decliners of Parkinson Disease Sham Surgery Trials</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Kim</surname>
<given-names>Scott Y.H.</given-names>
</name>
<degrees>MD, PhD</degrees>
<xref rid="A1" ref-type="aff">1</xref>
<xref rid="A5" ref-type="aff">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Wilson</surname>
<given-names>Renee M.</given-names>
</name>
<degrees>MA</degrees>
<xref rid="A9" ref-type="aff">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kim</surname>
<given-names>H. Myra</given-names>
</name>
<degrees>ScD</degrees>
<xref rid="A2" ref-type="aff">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Holloway</surname>
<given-names>Robert G.</given-names>
</name>
<degrees>MD, MPH</degrees>
<xref rid="A6" ref-type="aff">6</xref>
<xref rid="A7" ref-type="aff">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>De Vries</surname>
<given-names>Raymond G.</given-names>
</name>
<degrees>PhD</degrees>
<xref rid="A3" ref-type="aff">3</xref>
<xref rid="A4" ref-type="aff">4</xref>
<xref rid="A5" ref-type="aff">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Frank</surname>
<given-names>Samuel A.</given-names>
</name>
<degrees>MD</degrees>
<xref rid="A10" ref-type="aff">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kieburtz</surname>
<given-names>Karl</given-names>
</name>
<degrees>MD, MPH</degrees>
<xref rid="A6" ref-type="aff">6</xref>
<xref rid="A8" ref-type="aff">8</xref>
<xref rid="A9" ref-type="aff">9</xref>
</contrib>
</contrib-group>
<aff id="A1"><label>1</label>
Department of Psychiatry, University of Michigan, Ann Arbor, MI</aff>
<aff id="A2"><label>2</label>
Department of Biostatistics, University of Michigan, Ann Arbor, MI</aff>
<aff id="A3"><label>3</label>
Department of Medical Education, University of Michigan, Ann Arbor, MI</aff>
<aff id="A4"><label>4</label>
Department of Sociology, University of Michigan, Ann Arbor, MI</aff>
<aff id="A5"><label>5</label>
Center for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, MI</aff>
<aff id="A6"><label>6</label>
Department of Neurology, University of Rochester, Rochester, NY</aff>
<aff id="A7"><label>7</label>
Department of Community and Preventive Medicine, University of Rochester, Rochester, NY</aff>
<aff id="A8"><label>8</label>
Department of Environmental Medicine, University of Rochester, Rochester, NY</aff>
<aff id="A9"><label>9</label>
Center for Human Experimental Therapeutics, University of Rochester, Rochester, NY</aff>
<aff id="A10"><label>10</label>
Department of Neurology, Boston University School of Medicine, Boston, MA</aff>
<author-notes><corresp id="FN1">Corresponding author: Scott Y. H. Kim, MD, PhD, Center for Bioethics and Social Sciences in Medicine, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109, USA, 734-615-8377, fax 734-936-8944, <email>scottkim@med.umich.edu</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>18</day>
<month>1</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="epub"><day>7</day>
<month>2</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="ppub"><month>4</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>1</day>
<month>4</month>
<year>2013</year>
</pub-date>
<volume>27</volume>
<issue>4</issue>
<fpage>506</fpage>
<lpage>511</lpage>
<abstract><sec id="S1"><title>Background</title>
<p id="P1">Concerns have been raised that persons with serious illnesses participating in high risk research, such as Parkinson disease (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.</p>
</sec>
<sec sec-type="methods" id="S2"><title>Methods</title>
<p id="P2">We compared 61 enrollees and 10 decliners of two phase 2 neurosurgical intervention (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.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">Enrollees perceived lower risk of harm while tolerating higher risk of harm, were more action oriented, but did not have more advanced disease. Both groups rated hope for benefit as a strong reason to participate, while 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.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">Enrollees and decliners are different in their views and attitudes toward risk. Although both are attracted to research due to hopes of personal benefit, this hope is clearly distinguishable from an expectation of benefit and it does not imply a failure to understand the main purpose of research.</p>
</sec>
</abstract>
<kwd-group><kwd>Parkinson disease</kwd>
<kwd>sham surgery</kwd>
<kwd>therapeutic misconception</kwd>
<kwd>decision making</kwd>
<kwd>gene transfer</kwd>
</kwd-group>
</article-meta>
</front>
</pmc>
</record>
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