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Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals

BACKGROUND: Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claim...

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Autores principales: Rogers, Wendy, Hutchison, Katrina, Skea, Zoë C, Campbell, Marion K
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223753/
https://www.ncbi.nlm.nih.gov/pubmed/25341496
http://dx.doi.org/10.1186/1472-6939-15-78
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author Rogers, Wendy
Hutchison, Katrina
Skea, Zoë C
Campbell, Marion K
author_facet Rogers, Wendy
Hutchison, Katrina
Skea, Zoë C
Campbell, Marion K
author_sort Rogers, Wendy
collection PubMed
description BACKGROUND: Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect. DISCUSSION: In this paper we investigate justifications for placebo-controlled surgical trials and suggest three measures for strengthening their ethical acceptability. We argue that, given the extent, irreversibility and cost of surgical interventions, there is a need for the best possible evidence about their efficacy. In some cases, the strongest evidence will be from placebo-controlled surgical trials, especially where interventions are for outcomes (such as pain) that are likely to elicit a placebo response. In the second part of the paper, we propose three specific measures to increase the ethical acceptability of placebo-controlled surgical trials. The first is structured consultation with the relevant patient community about the risks and benefits of particular placebo-controlled surgical trials. The second seeks to address the therapeutic misconception through the use of educational materials, informed by patient consultation. Finally, we argue for ethical consideration of non-surgeon clinicians who are necessarily involved in the delivery of placebo-surgical interventions. SUMMARY: If there is no appropriate surgical comparator and the risks can be reduced to the absolute minimum (given the type of placebo procedure required), and the research has the support of the relevant patient community, there may be grounds for judging that the potential benefits of specific placebo-controlled surgical trials outweigh the risks. If so justified, the ethical acceptability of placebo-controlled surgical trials can be enhanced through using educational measures to address participant vulnerability, and by recognizing clinicians who are necessary participants in the research.
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spelling pubmed-42237532014-11-08 Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals Rogers, Wendy Hutchison, Katrina Skea, Zoë C Campbell, Marion K BMC Med Ethics Debate BACKGROUND: Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect. DISCUSSION: In this paper we investigate justifications for placebo-controlled surgical trials and suggest three measures for strengthening their ethical acceptability. We argue that, given the extent, irreversibility and cost of surgical interventions, there is a need for the best possible evidence about their efficacy. In some cases, the strongest evidence will be from placebo-controlled surgical trials, especially where interventions are for outcomes (such as pain) that are likely to elicit a placebo response. In the second part of the paper, we propose three specific measures to increase the ethical acceptability of placebo-controlled surgical trials. The first is structured consultation with the relevant patient community about the risks and benefits of particular placebo-controlled surgical trials. The second seeks to address the therapeutic misconception through the use of educational materials, informed by patient consultation. Finally, we argue for ethical consideration of non-surgeon clinicians who are necessarily involved in the delivery of placebo-surgical interventions. SUMMARY: If there is no appropriate surgical comparator and the risks can be reduced to the absolute minimum (given the type of placebo procedure required), and the research has the support of the relevant patient community, there may be grounds for judging that the potential benefits of specific placebo-controlled surgical trials outweigh the risks. If so justified, the ethical acceptability of placebo-controlled surgical trials can be enhanced through using educational measures to address participant vulnerability, and by recognizing clinicians who are necessary participants in the research. BioMed Central 2014-10-23 /pmc/articles/PMC4223753/ /pubmed/25341496 http://dx.doi.org/10.1186/1472-6939-15-78 Text en © Rogers et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Debate
Rogers, Wendy
Hutchison, Katrina
Skea, Zoë C
Campbell, Marion K
Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title_full Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title_fullStr Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title_full_unstemmed Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title_short Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
title_sort strengthening the ethical assessment of placebo-controlled surgical trials: three proposals
topic Debate
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4223753/
https://www.ncbi.nlm.nih.gov/pubmed/25341496
http://dx.doi.org/10.1186/1472-6939-15-78
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