Editor’s Note: Dr. Emmanuel (Manny) Aryee (he/him) is a pediatric resident at Children’s Hospital of Milwaukee and this year’s Editorial Fellow at Pediatrics. -Rachel Y. Moon, MD, Associate Editor, Digital Media, Pediatrics
Have you ever wondered what happens when a participant in a clinical trial comes across a question they don't understand? Do they guess or skip it?
This was the exact dilemma that Lena, a parent participating in a National Institutes of Health (NIH) trial on asthma management for her 6-year-old, faced. While she was completing the baseline survey in Spanish, she read the question: “En últimas cuatro semanas, cuántos días experimentó su hijo sibilancias?” (translated: "In the last 4 weeks, how many days did your child have wheezing?"). She did not understand the word “sibilancias” (wheezing) and answered, “0 days” and subsequently decided to stop participating in the trial.
Lena's experience highlights the broader issue of underrepresentation of marginalized groups in clinical trials. For certain populations, such as those from low-income households, minoritized backgrounds, or with low health literacy, factors like language barriers and cultural differences can decrease participant recruitment, comprehension, and engagement in clinical trials.
Grace Ryan, PhD, Melissa Goulding, PhD, and colleagues from the University of Massachusetts Chan Medical School advocate for cognitive interviewing as a way to tackle one of these barriers—the understanding of questions—in their article entitled “Advancing Equitable Participation in Pediatric Clinical Trials Through Cognitive Interviewing,” which is slated for early release in Pediatrics this week (10.1542/peds.2024-068666).
The authors define cognitive interviewing as a “qualitative technique that elicits participant input to refine surveys by decreasing response error, limiting response burden on participants, and establishing content validity.” By directly asking participants about their understanding of survey questions, researchers can identify and address potential issues such as:
- Poor translation of surveys.
- Question clarity.
- Reading level.
- Cultural and linguistic nuances.
To improve the inclusivity of clinical trials, Dr. Ryan encourages researchers to:
- Integrate cognitive interviewing into early stages of clinical trial preparation.
- Use cognitive interviewing to ensure professional translations account for reading level, comprehension, health literacy, and cultural/regional linguistic differences in target populations.
- Prioritize hiring multilingual and multicultural research team members to conduct cognitive interviewing.
Even if you are not involved in clinical research, this article will make you think about the words that we take for granted—and use with our patients. In particular, consider patients and families who speak languages other than English. Do they understand you when you use words like “wheezing?”
