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

Research output: Contribution to journalArticle

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 languageEnglish
Article number401
JournalTrials
Volume20
DOIs
Publication statusPublished - 5 Jul 2019

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Decision Support Techniques
Clinical Trials
Informed Consent
Decision Making
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine (miscellaneous)

Cite this

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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’ 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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