Reporting of Important Social Determinants of Health in Pediatric Clinical Trials

Abstract

Introduction: The objective of this study was to determine the rates and trends in the reporting of preferred language, socioeconomic factors, sexual orientation, and gender identity in published pediatric clinical trials.

Methods: A cross-sectional study of pediatric clinical trials conducted in the U.S. published from January 1, 2011 through December 31, 2020 in 5 general pediatric and 5 general medical journals with the highest impact factor in their respective fields was performed. Outcomes were reporting of preferred language, socioeconomic factors, sexual orientation, and gender identity. In late 2021, descriptive statistics and logistic regression to understand how reporting of preferred language and socioeconomic factors changed over time were performed.

Results: Of 612 trials, 29.6% (n=181) reported preferred language. Among these, 64.6% (n=117 of 181) exclusively enrolled participants whose preferred language was English. From 2011 to 2020, there was a relative increase in the reporting of preferred language (8.6% per year, 95% CI=1.8, 16.0). Socioeconomic factors were reported in 47.9% (n=293) of trials. There was no significant change in the reporting of socioeconomic factors (8.2% per year, 95% CI= -1.9, 15.1). Only 5.1% (9 of 179) of published trial results among adolescent participants reported any measure of sexual orientation, and 1.1% (2 of 179) reported gender identity.

Conclusions: Preferred language, socioeconomic factors, sexual orientation, and gender identity were infrequently reported in pediatric clinical trial results despite these characteristics being increasingly recognized as social determinants of health. To achieve more inclusiveness and to reduce unmeasured disparities, these characteristics should be incorporated into routine trial registration, design, funding decisions, and reporting.