A systematic review of risk communication in clinical trials: How does it influence decisions to participate and what are the best methods to improve understanding in a trial context?

PloS One
Maeve Coyle, Katie Gillies

Abstract

Effective risk communication is challenging. Ensuring potential trial participants' understand 'risk' information presented to them is a key aspect of the informed consent process within clinical trials, yet minimal research has looked specifically at how to communicate probabilities to support decisions about trial participation. This study reports a systematic review of the literature focusing on presentation of probabilistic information or understanding of risk by potential trial participants. A search strategy for risk communication in clinical trials was designed and informed by systematic reviews of risk communication in treatment and screening contexts and supplemented with trial participation terms. Extracted data included study characteristics and the main interventions/findings of each study. Explanatory studies that investigated the methods for presenting probabilistic information within participant information leaflets for a clinical trial were included, as were interventions that focused on optimising understanding of probabilistic information within the context of a clinical trial. The search strategy identified a total of 4931 studies. Nineteen papers were selected for full text screening, and seven studies inclu...Continue Reading

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Feb 4, 2021·JCO Oncology Practice·Cathy EngStacey Stein

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