Linguistic strategies for improving informed consent in clinical trials among low health literacy patients

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Language/s: English
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Short Description:

Evidence-based guidance on how to improve informed consent processes for patients being invited to participate in clinical research.

Key Concepts addressed:

Details

Message Conditions

Control Condition

Sometimes, cancer patients are offered the opportunity to receive treatment as part of a randomized clinical study. Please answer the following questions about your opinions on randomized clinical studies.

Plain Language Condition

In a randomized cancer clinical study, patients are put into groups and each group is given a different treatment plan. This helps doctors find out if one treatment plan is better than another. In order to make sure the clinical study is fair, doctors cannot choose which group the patient joins. Patients are assigned (or randomized) to their group by chance (not doctor or patient choice).

Gambling Metaphor Condition

In a randomized cancer clinical study, patients are put into groups and each group is given a different treatment plan. This helps doctors find out if one treatment plan is better than another. In order to make sure the clinical study is fair, doctors cannot choose which group the patient joins. Patients are assigned (or randomized) to their group by chance (not doctor or patient choice). It is helpful for some patients to think about randomization as being like the flip of a coin. Just as there is an equal chance that a flipped coin will land on heads or tails, a patient has an equal chance of being in any of the groups being compared in the clinical study.

Benign Metaphor Condition

In a randomized cancer clinical study, patients are put into groups and each group is given a different treatment plan. This helps doctors find out if one treatment plan is better than another. In order to make sure the clinical study is fair, doctors cannot choose which group the patient joins. Patients are assigned (or randomized) to their group by chance (not doctor or patient choice). It is helpful for some patients to think about randomization as being like the sex of a baby. Just as a pregnant woman has an equal chance of giving birth to a male or female baby, a patient has an equal chance of being in any of the groups being compared in the clinical study.

Authors: Janice L. Krieger, Jordan M. Neil, Yulia A. Strekalova, Melanie A. Sarge

Affiliations of authors: STEM Translational Communication Center (JLK, JMN, YAS), Department of Advertising (JLK), and Division of Graduate Studies and Research (YAS), College of Journalism and Communications, University of Florida; Department of Advertising, College of Media and Communication, Texas Tech University (MAS), Gainesville, FL, Lubbock, TX.

Correspondence to: Janice L. Krieger, PhD, 2024 Weimer Hall University of Florida Gainesville, FL 32611, STEM Translational Communication Center, College of Journalism and Communications, University of Florida (e-mail: janicekrieger@ufl.edu).

Evaluation details

Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients
Janice L. Krieger Jordan M. Neil Yulia A. Strekalova Melanie A. Sarge
J Natl Cancer Inst (2017) 109 (3): djw233. DOI: https://doi.org/10.1093/jnci/djw233

ABSTRACT

Background: Improving informed consent to participate in randomized clinical trials (RCTs) is a key challenge in cancer communication. The current study examines strategies for enhancing randomization comprehension among patients with diverse levels of health literacy and identifies cognitive and affective predictors of intentions to participate in cancer RCTs.

Methods: Using a post-test-only experimental design, cancer patients (n = 500) were randomly assigned to receive one of three message conditions for explaining randomization (ie, plain language condition, gambling metaphor, benign metaphor) or a control message. All statistical tests were two-sided.

Results: Health literacy was a statistically significant moderator of randomization comprehension (P = .03). Among participants with the lowest levels of health literacy, the benign metaphor resulted in greater comprehension of randomization as compared with plain language (P = .04) and control (P = .004) messages. Among participants with the highest levels of health literacy, the gambling metaphor resulted in greater randomization comprehension as compared with the benign metaphor (P = .04). A serial mediation model showed a statistically significant negative indirect effect of comprehension on behavioral intention through personal relevance of RCTs and anxiety associated with participation in RCTs (P < .001).

Conclusions: The effectiveness of metaphors for explaining randomization depends on health literacy, with a benign metaphor being particularly effective for patients at the lower end of the health literacy spectrum. The theoretical model demonstrates the cognitive and affective predictors of behavioral intention to participate in cancer RCTs and offers guidance on how future research should employ communication strategies to improve the informed consent processes.

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