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

Kate Gillies; Marion K Campbell

doi:10.1186/s13063-019-3489-y

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

Kate Gillies (Corresponding Author), Marion K Campbell

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Abstract

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.

Original language	English
Article number	401
Journal	Trials
Volume	20
DOIs	https://doi.org/10.1186/s13063-019-3489-y
Publication status	Published - 5 Jul 2019

Keywords

Informed consent
Clinical trials
Decision aids
Decision support
Complex interventions
Conceptual framework
WOMEN
INFORMED-CONSENT
INTERVENTIONS
RANDOMIZED CONTROLLED-TRIAL
PARTICIPATION

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Development and evaluation of decision aids for people considering taking part in a clinical trial a conceptual framework
© The Author(s). 2019 Open Access This 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
Final published version, 2.34 MBLicence: CC BY

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Gillies, K., & Campbell, M. K. (2019). Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework. Trials, 20, [401]. https://doi.org/10.1186/s13063-019-3489-y

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abstract = "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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note = "Funding This research was supported by the MRC Methodology Fellowship (KG MR/L01193X/1. The Health Services Research Unit, University of Aberdeen, receives core funding from the Chief Scientist Office of the Scottish Government Health and Social Care Directorate. Authors{\textquoteright} contributions KG and MC conceived the idea for the article. KG wrote the first draft of the manuscript. KG and MC contributed to further development of the manuscript. Both reviewed and approved the final manuscript.",

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