Disclosing the potential impact of placebo controls in antidepressant trials
Background Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention. Aims To...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2015-06-01
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| Series: | BJPsych Open |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2056472400000752/type/journal_article |
| _version_ | 1811157069823213568 |
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| author | Stephanie C. Chen Cheryl McCullumsmith Scott Y. H. Kim |
| author_facet | Stephanie C. Chen Cheryl McCullumsmith Scott Y. H. Kim |
| author_sort | Stephanie C. Chen |
| collection | DOAJ |
| description |
Background
Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention.
Aims
To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT.
Method
We randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT.
Results
A greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm.
Conclusions
Disclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants.
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| first_indexed | 2024-04-10T05:01:08Z |
| format | Article |
| id | doaj.art-2c4acfc2faa64cfaa91f9c829602e06b |
| institution | Directory Open Access Journal |
| issn | 2056-4724 |
| language | English |
| last_indexed | 2024-04-10T05:01:08Z |
| publishDate | 2015-06-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | BJPsych Open |
| spelling | doaj.art-2c4acfc2faa64cfaa91f9c829602e06b2023-03-09T12:28:36ZengCambridge University PressBJPsych Open2056-47242015-06-0111510.1192/bjpo.bp.115.000109Disclosing the potential impact of placebo controls in antidepressant trialsStephanie C. Chen0Cheryl McCullumsmith1Scott Y. H. Kim2Department of Bioethics, Clinical Center, National Institutes of Health, BethesdaDepartment of Psychiatry, University of Cincinnati, CincinnatiDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda and Department of Psychiatry, University of Michigan, Ann Arbor Background Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention. Aims To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT. Method We randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT. Results A greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm. Conclusions Disclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants. https://www.cambridge.org/core/product/identifier/S2056472400000752/type/journal_article |
| spellingShingle | Stephanie C. Chen Cheryl McCullumsmith Scott Y. H. Kim Disclosing the potential impact of placebo controls in antidepressant trials BJPsych Open |
| title | Disclosing the potential impact of placebo controls in antidepressant trials |
| title_full | Disclosing the potential impact of placebo controls in antidepressant trials |
| title_fullStr | Disclosing the potential impact of placebo controls in antidepressant trials |
| title_full_unstemmed | Disclosing the potential impact of placebo controls in antidepressant trials |
| title_short | Disclosing the potential impact of placebo controls in antidepressant trials |
| title_sort | disclosing the potential impact of placebo controls in antidepressant trials |
| url | https://www.cambridge.org/core/product/identifier/S2056472400000752/type/journal_article |
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