Language Barrier: Helping Patients to Understand Randomization in Clinical Trials

Melanie Sarge, PhD

Melanie Sarge, PhD

A common hurdle for clinical trials is the lack of participation from patients with cancer. Many factors can affect whether patients decide to participate in a clinical trial, including their understanding of randomization within the clinical trial process. When clinicians explain randomization, it can differ from patient to patient and often depends on the individual patient’s level of health literacy.

As Melanie Sarge, PhD, an assistant professor in the College of Media and Communication at Texas Tech University explains, “Overall, the rate for clinical trial participation is about 3% to 5% for Americans. At the same time, clinical trials are imperative for this generation in advancing knowledge and medical treatment as well as patient care.”

Janice Krieger, PhD, led a research group that included Sarge, which studied the relationship between a patient’s health literacy and the effectiveness of various linguistic strategies used to help them understand the randomization of treatment in clinical trials. Krieger is an associate professor and director of STEM Transitional Communication Centers at the University of Florida.

For their study, the research team analyzed which commonly used linguistic strategies for explaining randomization produced the highest levels of comprehension among individuals with both low and high levels of health literacy.

To do this, they evaluated the “gambling” and the “baby,” or “benign,” metaphors. The gambling metaphor compared a patient’s odds of being assigned to the treatment arm of a trial to that of coin flip—a 50—50 chance. In the “baby” metaphor, those odds are equated with that of correctly guessing a baby’s gender, with an equal chance of having a boy or a girl. This was also called the “benign” metaphor as it “does not imply a win–loss scenario,” according to Sarge.

The gambling metaphor worked better for those patients who had higher health literacy, whereas the baby metaphor worked better for patients with lower health literacy. For patients with mid-level health literacy (between high and low), both metaphors and plain language had about the same effect.

Receiving, understanding, and processing medical information in the clinic is critical for a patient with cancer, but it can be difficult for a number of reasons. A patient considering participating in a clinical trial has a lot of information to consider before he or she can make an informed decision, meaning comprehension holds even higher stakes. Informed consent is required in clinical trials for both medical and ethical reasons.

In addition, while health literacy can affect a patient’s ability to comprehend medical information, there are other barriers that can influence a patient’s decision of whether to participate in a clinical trial.

Patients often worry that not being selected to a certain group would result in a diminished level of care, regardless of reassurance that this is not the case. Additionally, there is sometimes a feeling that patients will not be receiving treatment that is specifically tailored to them.

Those considering a clinical trial may also experience concerns about a reduction in quality of life, potential side effects from the experimental treatment and the feeling that this treatment is their last chance.

Overall, the researchers found a negative correlation between patients’ understanding of randomization and their willingness to participate in clinical trials.

“When patients have greater comprehension of the randomization process and realize it is not a tailored treatment, it is less personally relevant,” Sarge said. “That increases anxiety and, in turn, we found, decreases the intention to participate.”

Despite these patient concerns, randomization is crucial as it enables meaningful comparisons where conclusions could not otherwise be drawn about the effectiveness of one treatment versus another.

Krieger is leading further research examining patient concerns and willingness to participate when a cancer advocate shares individual stories of participation.

“This type of communication research is extremely important for finding the language that will make [practitioners] feel more comfortable talking to patients about clinical trials as an option,” Sarge stressed.

“Equipping them with the message strategies they need to be able to increase understanding and willingness to participate is vital. However, while we’re giving doctors recommendations on how to increase comprehension among certain groups, they need to keep in mind they might be lowering personal relevance and giving [some patients] more anxiety.”

“It is important for the doctor or another health practitioner to be there to help with the additional psychosocial barriers that exist.”