Research Methods|Articles in Press

Reporting of Important Social Determinants of Health in Pediatric Clinical Trials

Published:January 06, 2023DOI:


      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.


      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.


      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.


      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.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Preventive Medicine
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Harris LM
        • Dreyer BP
        • Mendelsohn AL
        • et al.
        Liquid medication dosing errors by Hispanic parents: role of health literacy and English proficiency.
        Acad Pediatr. 2017; 17: 403-410
        • Portillo EN
        • Stack AM
        • Monuteaux MC
        • Curt A
        • Perron C
        • Lee LK
        Association of limited English proficiency and increased pediatric emergency department revisits.
        Acad Emerg Med. 2021; 28: 1001-1011
        • Cohen AL
        • Rivara F
        • Marcuse EK
        • McPhillips H
        • Davis R.
        Are language barriers associated with serious medical events in hospitalized pediatric patients?.
        Pediatrics. 2005; 116: 575-579
        • Khan A
        • Yin HS
        • Brach C
        • et al.
        Association between parent comfort with English and adverse events among hospitalized children.
        JAMA Pediatr. 2020; 174e203215
        • Rees CA
        • Pryor S
        • Choi B
        • et al.
        The influence of insurance type on interfacility pediatric emergency department transfers.
        Am J Emerg Med. 2017; 35: 1907-1909
        • Chang L
        • Rees CA
        • Michelson KA.
        Association of socioeconomic characteristics with where children receive emergency care.
        Pediatr Emerg Care. 2022; 38: e264-e267
        • Rees CA
        • Monuteaux MC
        • Raphael JL
        • Michelson KA.
        Disparities in pediatric mortality by neighborhood income in United States emergency departments.
        J Pediatr. 2020; 219 (e3): 209-215
        • Colvin JD
        • Zaniletti I
        • Fieldston ES
        • et al.
        Socioeconomic status and in-hospital pediatric mortality.
        Pediatrics. 2013; 131: e182-e190
        • Hasegawa K
        • Stoll SJ
        • Ahn J
        • Kysia RF
        • Sullivan AF
        • Camargo Jr., CA
        Association of insurance status with severity and management in ED Patients with asthma exacerbation.
        West J Emerg Med. 2016; 17: 22-27
        • Aristizabal P
        • Winestone LE
        • Umaretiya P
        • Bona K.
        Disparities in pediatric oncology: the 21st century opportunity to improve outcomes for children and adolescents with cancer.
        Am Soc Clin Oncol Educ Book. 2021; 41: e315-e326
        • Buchmueller T
        • Carpenter CS.
        Disparities in health insurance coverage, access, and outcomes for individuals in same-sex versus different-sex relationships, 2000–2007.
        Am J Public Health. 2010; 100: 489-495
        • Martin-Storey A.
        Gender, sexuality, and gender nonconformity: understanding variation in functioning.
        Child Dev Perspect. 2016; 10: 257-262
        • Russell ST
        • Fish JN.
        Mental health in lesbian, gay, bisexual, and transgender (LGBT) youth.
        Annu Rev Clin Psychol. 2016; 12: 465-487
        • Baams L
        • Wilson BDM
        • ST Russell
        LGBTQ youth in unstable housing and foster care.
        Pediatrics. 2019; 143e20174211
        • Dankwa-Mullan I
        • Rhee KB
        • Williams K
        • et al.
        The science of eliminating health disparities: summary and analysis of the NIH summit recommendations.
        Am J Public Health. 2010; 100: S12-S18
        • Office for Human Research Protections, HHS
        Informed consent of subjects who do not speak English.
        Office for Human Research Protections, HHS, Washington, DC1995 (Published November 9Accessed September 7, 2021)
        • U.S. Food and Drug Administration
        Enhancing the diversity of clinical trial populations—eligibility criteria, enrollment practices, and trial designs guidance for industry.
        Food and Drug Administration, Rockville, MD: U.S2020 (Published NovemberAccessed September 7, 2021)
      1. Coordination of sexual and gender minority mental health research at NIMH. NIH. Accessed August 31, 2021.

      2. Lesbian, gay, bisexual, and transgender health. Healthy People 2020, HHS, Office of Disease Prevention and Health Promotion. Accessed August 31, 2021.

      3. Institute of Medicine (U.S.) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. The health of lesbian, gay, bisexual, and transgender people: building a foundation for better understanding.
        National Academies Press (U.S), Washington, DC2011 (PublishedAccessed August 31, 2022)
        • The Joint Commission
        Advancing effective communication, cultural competence, and patient- and family-centered care for the lesbian, gay, bisexual, and transgender (LGBT): a field guide.
        The Joint Commission, Oakbrook Terrace, IL2014 (PublishedAccessed August 31, 2021)
      4. National Academies of Sciences, Engineering, and Medicine, Understanding the Status and Well-Being of Sexual and Gender Diverse Populations, 2020, National Academies Press; Washington, DC. Accessed August 31, 2021.

      5. Healthy people 2020 health disparities data widget. HHS. Updated June 21, 2021. Accessed August 31, 2021.

        • Lion KC.
        Caring for children and families with limited English proficiency: current challenges and an agenda for the future.
        Hosp Pediatr. 2017; 7: 59-61
        • Hartling L
        • Scott-Findlay S
        • Johnson D
        • et al.
        Bridging the gap between clinical research and knowledge translation in pediatric emergency medicine.
        Acad Emerg Med. 2007; 14: 968-977
        • Nalven T
        • Spillane NS
        • Schick MR
        • Weyandt LL.
        Diversity inclusion in United States opioid pharmacological treatment trials: a systematic review.
        Exp Clin Psychopharmacol. 2021; 29: 524-538
        • Alegria M
        • Sud S
        • Steinberg BE
        • Gai N
        • Siddiqui A.
        Reporting of participant race, sex, and socioeconomic status in randomized clinical trials in general medical journals, 2015 vs 2019.
        JAMA Netw Open. 2021; 4e2111516
        • Baker KE
        • Streed Jr, CG
        • Durso LE.
        Ensuring that LGBTQI+ people count - collecting data on sexual orientation, gender identity, and intersex status.
        N Engl J Med. 2021; 384: 1184-1186
        • Rees CA
        • Stewart AM
        • Mehta S
        • et al.
        Reporting of participant race and ethnicity in published U.S. pediatric clinical trials from 2011 to 2020.
        JAMA Pediatr. 2022; 176e220142
      6. Web of Science. Journal Citation Reports. Accessed November 18, 2020.

      7. NIH. NIH's definition of a clinical trial; Published 2017. Accessed January 15, 2021.

        • Harris PA
        • Taylor R
        • Thielke R
        • Payne J
        • Gonzalez N
        • Conde JG.
        Research Electronic Data Capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support.
        J Biomed Inform. 2009; 42: 377-381
        • Dietrich S
        • Hernandez E.
        Language use in the United States: 2019.
        U.S. Census Bureau, Washington, DC2022 (American Community Survey Reports) (Published AugustAccessed September 30, 2022)
      8. US Health and Human Services. Section 1557: Ensuring Meaningful Access for Individuals with Limited English Proficiency. Accessed August 31, 2021.

        • Curt AM
        • Kanak MM
        • Fleegler EW
        • Stewart AM.
        Increasing inclusivity in patient centered research begins with language.
        Prev Med. 2021; 149106621
      9. U.S. Department of Justice. The president executive order 13166-improving access to services for persons with limited English proficiency department of justice enforcement of Title VI of the Civil Rights Act of 1964-national origin discrimination against persons with limited English. Fed Regist. Accessed August 31, 2021.

        • HHS, Centers for Medicare & Medicaid Services (CMS)
        Nondiscrimination in health and health education programs or activities, delegation of authority.
        Fed Regist. 2020; 85 (Accessed March 15, 2022): 37160-37248
        • Spector-Bagdady K
        • Lombardo PA
        U.S. Public Health Service STD experiments in Guatemala (1946–1948) and their aftermath.
        Ethics Hum Res. 2019; 41: 29-34
        • Scharff DP
        • Mathews KJ
        • Jackson P
        • Hoffsuemmer J
        • Martin E
        • Edwards D.
        More than Tuskegee: understanding mistrust about research participation.
        J Heal Care Poor Underserved. 2010; 21: 879-897
      10. U.S. Department of Health and Human Services. HHS finalizes rule on section; 1557. Protecting Civil Rights in Healthcare, Restoring the Rule of Law, and Relieving Americans of Billions in Excessive Costs. Accessed March 20, 2022.

        • Diamond L
        • Izquierdo K
        • Canfield D
        • Matsoukas K
        • Gany F.
        A systematic review of the impact of patient-physician non-English language concordance on quality of care and outcomes.
        J Gen Intern Med. 2019; 34: 1591-1606
        • Mannix R
        • Chiang V
        • Stack AM.
        Insurance status and the care of children in the emergency department.
        J Pediatr. 2012; 161 (e3): 536-541
        • Cook Q
        • Argenio K
        • Lovinsky-Desir S.
        The impact of environmental injustice and social determinants of health on the role of air pollution in asthma and allergic disease in the United States.
        J Allergy Clin Immunol. 2021; 148 (e5): 1089-1101
        • Barrett JT
        • Lee LK
        • Monuteaux MC
        • Farrell CA
        • Hoffmann JA
        • Fleegler EW.
        Association of county-level poverty and inequities with firearm-related mortality in U.S. youth.
        JAMA Pediatr. 2022; 176e214822
        • Farrell CA
        • Fleegler EW
        • Monuteaux MC
        • Wilson CR
        • Christian CW
        • Lee LK.
        Community poverty and child abuse fatalities in the United States.
        Pediatrics. 2017; 139e20161616
        • Jutte DP
        • Badruzzaman RA
        • Thomas-Squance R.
        Neighborhood poverty and child health: investing in communities to improve childhood opportunity and well-being.
        Acad Pediatr. 2021; 21: S184-S193
        • Naccarella L
        • Guo S.
        A Health equity implementation approach to child health literacy interventions.
        Children (Basel). 2022; 9: 1284
        • Repetti RL
        • Taylor SE
        • Seeman TE.
        Risky families: family social environments and the mental and physical health of offspring.
        Psychol Bull. 2002; 128: 330-366
      11. NIH policy on sex as a biological variable. NIH. Accessed December 2, 2021.

        • Zaza S
        • Kann L
        • Barrios LC.
        Lesbian, gay, and bisexual adolescents: population estimate and prevalence of health behaviors.
        JAMA. 2016; 316: 2355-2356
        • Kann L
        • Olsen EO
        • McManus T
        • et al.
        Sexual identity, sex of sexual contacts, and health-related behaviors among students in grades 9–12 - United States and selected sites, 2015.
        MMWR Surveill Summ. 2016; 65: 1-202
        • Rapoport E
        • Athanasian CE
        • Adesman A.
        Prevalence of nonheterosexual identity and same-sex sexual contact among high school students in the U.S. from 2015 to 2019.
        JAMA Pediatr. 2021; 175: 970-972
        • Kidd KM
        • Sequeira GM
        • Douglas C
        • et al.
        Prevalence of gender-diverse youth in an urban school district.
        Pediatrics. 2021; 147e2020049823
      12. BRFSS questionnaire; 2020. Centers for Disease Control and Prevention. Accessed December 15, 2021.

      13. Protocol - biological sex assigned at birth. PhenX Toolkit. Accessed December 15, 2021.

      14. Protocol – sexual orientation. PhenX Toolkit. Accessed December 15, 2021.

      15. Cheloff AZ, Jarvie E, Tabaac AR, et al. Sexual orientation, gender identity, and sex development: recommendations for data collection and use in clinical, research, and administrative settings. Published 2022. Accessed February 11, 2022.

      16. Protocol - social determinants of health collections. PhenX Toolkit. Accessed October 1, 2021.

        • Ragavan MI
        • Cowden JD.
        The complexities of assessing language and interpreter preferences in pediatrics.
        Heal Equity. 2018; 2: 70-73