A research brief, “Disparities by Ethnicity in Enrollment of a Clinical Trial,” examines if implicit bias on the part of physicians played a role in the selection of participants for a clinical trial on children hospitalized for bronchiolitis. The brief, published in the February 2022 Pediatrics (published online Jan. 19), consisted of a secondary analysis of data from the Bronchiolitis Follow-up Intervention Trial (NCT03354325). Physicians caring for eligible patients were asked to verify that the patient could be appropriate for the intervention (as-needed post-hospitalization follow-up) and included a rationale for those they deemed ineligible. The rationale for exclusion included clinical and social justifications such as chronic illness, perceived low parent health literacy or social risk. Physicians determined that 506 (92%) of the 548 eligible patients would be appropriate for the intervention. Of those deemed appropriate for intervention, 29% were of Hispanic ethnicity, compared to 52% Hispanic ethnicity among patients considered not appropriate. Physicians more often determined that Hispanic patients were not appropriate for as-needed follow-up and excluded them from trial participation, compared to non-Hispanic patients. However, among those approached for enrollment, Hispanic participants demonstrated equivalent acceptance and adoption of the as-needed follow-up strategy compared to non-Hispanic participants. The authors noted that prior research suggests that clinic visits involve more time burden and financial sacrifices for Black and Hispanic patients. In other words, patients with potentially the most to gain from this intervention were less likely to be offered the intervention. The authors suggest that future trials should consider interventions addressing provider and researcher biases at the time of participant screening to maximize diverse and inclusive participation.
Editors’ note: A solicited commentary, “Physician Bias and Clinical Trial Participation in Underrepresented Populations,” is published in the same issue of Pediatrics.
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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults.