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Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework

Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed “informed”, potential participants should be provided with a range of information abo...

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Autores principales: Gillies, Katie, Campbell, Marion K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612082/
https://www.ncbi.nlm.nih.gov/pubmed/31277693
http://dx.doi.org/10.1186/s13063-019-3489-y
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author Gillies, Katie
Campbell, Marion K.
author_facet Gillies, Katie
Campbell, Marion K.
author_sort Gillies, Katie
collection PubMed
description Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed “informed”, potential participants should be provided with a range of information about the trials (e.g., the trial aims, the anticipated benefits and potential risks of the trial, and their right to withdraw consent at any time). However, it is well documented that simple provision of this information does not ensure that participants make truly informed decisions. Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking. Therefore, this article, drawing on theoretical and empirical insights, outlines a framework for the development and evaluation of decision aids for people considering taking part in a clinical trial.
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spelling pubmed-66120822019-07-16 Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework Gillies, Katie Campbell, Marion K. Trials Methodology Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed “informed”, potential participants should be provided with a range of information about the trials (e.g., the trial aims, the anticipated benefits and potential risks of the trial, and their right to withdraw consent at any time). However, it is well documented that simple provision of this information does not ensure that participants make truly informed decisions. Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking. Therefore, this article, drawing on theoretical and empirical insights, outlines a framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. BioMed Central 2019-07-05 /pmc/articles/PMC6612082/ /pubmed/31277693 http://dx.doi.org/10.1186/s13063-019-3489-y Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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 Methodology
Gillies, Katie
Campbell, Marion K.
Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title_full Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title_fullStr Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title_full_unstemmed Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title_short Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
title_sort development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6612082/
https://www.ncbi.nlm.nih.gov/pubmed/31277693
http://dx.doi.org/10.1186/s13063-019-3489-y
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