172 - Language, Socioeconomic Factors, Sexual Orientation and Gender Identity in Published Pediatric Clinical Trials, 2011-2020

Poster Number: 172
Publication Number: 172.412

Chris A. Rees, Emory University School of Medicine, Atlanta, GA, United States; Amanda Stewart, Boston Children's Hospital, Boston, MA, United States; Elyse Portillo, Texas Children's Hospital/Baylor College of Medicine, Houston, TX, United States; Sagar D. Mehta, Emory University School of Medicine, Atlanta, GA, United States; Elorm Avakame, Columbia University Irving Medical Center, New York, NY, United States; Jasmyne Jackson, Boston Children's Hospital, Boston, MA, United States; Jheanelle McKay, Boston Children's Hospital, Boston, MA, United States; kenneth michelson, Boston Children's Hospital, Boston, MA, United States; Christopher Duggan, Boston Children's Hospital, Boston, MA, United States; Eric W. Fleegler, Boston Children's Hospital, Boston, MA, United States

Background: Determining representativeness of clinical trials has the potential to inform future priorities and trial recruitment strategies.

Objective: To evaluate rates and trends in reporting of participant/caregiver preferred language, socioeconomic factors, sexual orientation, and gender identity in published pediatric clinical trial results.

Design/Methods: We conducted a cross-sectional study of published articles reporting pediatric clinical trials in the United States published in five leading general pediatric and five leading general medical journals from January 1, 2011-December 31, 2020. Reporting of participant/caregiver preferred language, socioeconomic factors (e.g., household income, insurance status, and caregiver education, etc.), sexual orientation, and gender identity were extracted from published pediatric clinical trial results.

Results: Of the 612 published pediatric clinical trials, 29.6% (n=181) reported participant/caregiver preferred language (64.6% [n=117/181] exclusively enrolled participants whose preferred language was English). Only 47.9% (n = 293) of published trials reported some measure of participant socioeconomic factors. From 2011-2020, there was a relative increase in reporting of participant/caregiver preferred language (6.9% per year, 95% CI 0.5-13.7) and socioeconomic factors (5.7% per year, 95% CI -1.0-11.8) (Figure). Only 1.5% (n=9/282) of published trial results with exclusively school-age or adolescent participants reported any measure of participant sexual orientation and 0.7% (n=2/282) reported participant gender identity. Published trials that evaluated behavioral interventions and screening/referral or health services interventions were more likely to report participant/caregiver preferred language and socioeconomic factors than trials for devices or procedures.Conclusion(s): Participant/caregiver preferred language, socioeconomic factors, participant sexual orientation and gender identity were infrequently reported in pediatric clinical trial results, despite recognition of these factors as social determinants of health. To achieve more inclusive pediatric clinical trial enrollment practices, participant/caregiver preferred language, socioeconomic factors, and sexual orientation and gender identity should be incorporated into routine trial registration, design, funding decisions, and result reporting.
Figure. Trends in reporting of participant preferred language and socioeconomic status from 2011-2020.