Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos
Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos
Background
Placebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.
Methods and Findings
We conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.
Conclusions
PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials.
e39661
Bishop, Felicity L.
1f5429c5-325f-4ac4-aae3-6ba85d079928
Adams, Alison E.M.
c80db8e9-fc9b-4b25-beb7-dd133bc678a5
Kaptchuk, Ted J.
6cd4a592-d697-4fed-8eaf-980b2e5f860d
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
27 June 2012
Bishop, Felicity L.
1f5429c5-325f-4ac4-aae3-6ba85d079928
Adams, Alison E.M.
c80db8e9-fc9b-4b25-beb7-dd133bc678a5
Kaptchuk, Ted J.
6cd4a592-d697-4fed-8eaf-980b2e5f860d
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Bishop, Felicity L., Adams, Alison E.M., Kaptchuk, Ted J. and Lewith, George
(2012)
Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos.
PLoS ONE, 7 (6), .
(doi:10.1371/journal.pone.0039661).
Abstract
Background
Placebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.
Methods and Findings
We conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50:50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.
Conclusions
PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials.
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Published date: 27 June 2012
Organisations:
Primary Care & Population Sciences, Psychology
Identifiers
Local EPrints ID: 340962
URI: http://eprints.soton.ac.uk/id/eprint/340962
ISSN: 1932-6203
PURE UUID: d69926f3-0a30-4730-b8ba-1ef496b7dbeb
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Date deposited: 09 Jul 2012 10:38
Last modified: 15 Mar 2024 03:15
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Contributors
Author:
Alison E.M. Adams
Author:
Ted J. Kaptchuk
Author:
George Lewith
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