Improved Trial Participation by Simplifying Informed Consent Language

Randomized, controlled trials (RCTs) are essential for advancing medical research and care, but only a small portion of patients with cancer participate in clinical trials, which could be attributed to low health literacy and poor understanding of the informed consent process. According to a study by Janice Krieger, PhD, of the STEM Translational Communication Center at the University of Florida, and co-authors, clarifying this process through plain language or metaphors could help increase RCT participation.

“Randomization is a highly technical term for which there are no lay-language synonyms,” Dr. Krieger and co-authors wrote. “Thus, health-care providers often struggle to adequately translate this concept for patients, especially those with low literacy.”

The researchers randomly assigned 500 cancer patients who had been diagnosed within two years of the study to receive information about the IC process through one of four “message strategies”:

  • control message (n=117)
  • plain language (using shorter sentence structure and nontechnical language; n=128)
  • gambling metaphor (comparing randomization to flipping a coin; n=132)
  • benign metaphor (comparing randomization to the chance of a pregnancy resulting in a male or female child; n=123)

Among all patients, randomization comprehension (the extent to which patients understood that treatment allocation was not associated with physician preference, patient preference, or patient health status) was greatest for those who heard the gambling metaphor and the benign metaphor (p<0.001 for both).

Though previous research has suggested that plain language is the most effective style for educating patients with lower health-literacy levels, this study found that the effectiveness of each message strategy corresponded with health literacy levels (FIGURE). For example, participants with the highest literacy rate showed greater comprehension with the gambling metaphor, compared with the benign metaphor (p=0.04). Participants in the lowest literacy group, exhibited greater comprehension with the benign metaphor, compared with plain language (p=0.04) and control (p=0.004) messages.

Limitations of this study include the sample messages not containing information specific to a particular RCT or the types of treatments being compared.

Source: Krieger JL, Neil JM, Strekalova YA, et al. Linguistic strategies for improving informed consent in clinical trials among low health literacy patients. J Natl Cancer Inst. 2017;109:djw233.