Impact of placebo assignment in clinical trials of Parkinson's disease
Identifieur interne : 004067 ( Main/Exploration ); précédent : 004066; suivant : 004068Impact of placebo assignment in clinical trials of Parkinson's disease
Auteurs : Christopher G. Goetz [États-Unis] ; Kimberly Janko [États-Unis] ; Lucy Blasucci [États-Unis] ; Jean A. Jaglin [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2003-10.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Aged, Clinical Trials as Topic (methods), Clinical trial, Cohort Studies, Comprehension, Ethics, Medical, Evaluation, Female, Human, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (epidemiology), Parkinson Disease (psychology), Parkinson disease, Parkinson's disease, Patient Selection, Placebo, Placebo Effect, Placebo effect, Placebos (therapeutic use), Questionnaire, Questionnaires, Recognition (Psychology), clinical trials, placebo.
- MESH :
- chemical , therapeutic use : Placebos.
- drug therapy : Parkinson Disease.
- epidemiology : Parkinson Disease.
- methods : Clinical Trials as Topic.
- psychology : Parkinson Disease.
- Aged, Cohort Studies, Ethics, Medical, Female, Humans, Male, Middle Aged, Patient Selection, Placebo Effect, Questionnaires, Recognition (Psychology).
Abstract
Informed consent procedures in placebo‐controlled trials are developed to ensure that subjects entering studies clearly understand the possibility of placebo assignment. The extent of patient understanding and the impact of learning that they were assigned placebo treatment have not been extensively studied. By using a standardized questionnaire, we interviewed 50 consecutive placebo‐treated patients from 14 placebo‐controlled clinical trials of Parkinson's disease (PD) after completion of their involvement. All patients interviewed understood that their study contained a placebo arm. All had hoped to receive the study drug rather than placebo, and more than half the subjects believed they had improved clinically during their placebo exposure. Positive impressions of enrollment in placebo‐controlled trials were more frequent than negative, included helping to advance science (86%); liking the experience, education, and attention associated with the clinical trial (90%); and participating in research for the benefit of other patients as well as for themselves (80%). If another placebo‐controlled trial was offered, 88% expressed that they would possibly, likely, or definitely be interested in enrollment. PD patients clearly understand the concept of placebo‐controlled trials they complete them, but they are inaccurate in assessing whether they received placebo treatment. Although most wish they received the active compound being tested, the overall view of participation in placebo‐controlled trials is viewed very positively by PD patients. © 2003 Movement Disorder Society
Url:
DOI: 10.1002/mds.10504
Affiliations:
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Le document en format XML
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Jaglin</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurological Sciences, Rush University/Rush‐Presbyterian‐St. Luke's Medical Center, Chicago, Illinois</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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The extent of patient understanding and the impact of learning that they were assigned placebo treatment have not been extensively studied. By using a standardized questionnaire, we interviewed 50 consecutive placebo‐treated patients from 14 placebo‐controlled clinical trials of Parkinson's disease (PD) after completion of their involvement. All patients interviewed understood that their study contained a placebo arm. All had hoped to receive the study drug rather than placebo, and more than half the subjects believed they had improved clinically during their placebo exposure. Positive impressions of enrollment in placebo‐controlled trials were more frequent than negative, included helping to advance science (86%); liking the experience, education, and attention associated with the clinical trial (90%); and participating in research for the benefit of other patients as well as for themselves (80%). If another placebo‐controlled trial was offered, 88% expressed that they would possibly, likely, or definitely be interested in enrollment. PD patients clearly understand the concept of placebo‐controlled trials they complete them, but they are inaccurate in assessing whether they received placebo treatment. Although most wish they received the active compound being tested, the overall view of participation in placebo‐controlled trials is viewed very positively by PD patients. © 2003 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Illinois</li></region></list><tree><country name="États-Unis"><region name="Illinois"><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G." last="Goetz">Christopher G. Goetz</name></region><name sortKey="Blasucci, Lucy" sort="Blasucci, Lucy" uniqKey="Blasucci L" first="Lucy" last="Blasucci">Lucy Blasucci</name><name sortKey="Jaglin, Jean A" sort="Jaglin, Jean A" uniqKey="Jaglin J" first="Jean A." last="Jaglin">Jean A. Jaglin</name><name sortKey="Janko, Kimberly" sort="Janko, Kimberly" uniqKey="Janko K" first="Kimberly" last="Janko">Kimberly Janko</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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