Reporting of Important Social Determinants of Health in Pediatric Clinical Trials.

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.

Reporting of Participant Race and Ethnicity in Published US Pediatric Clinical Trials From 2011 to 2020.

Importance: Equitable representation of participants who are members of racial and ethnic minority groups in clinical trials enhances inclusivity in the scientific process and generalizability of results. Objective: To assess participant race and ethnicity in pediatric clinical trials published from 2011 to 2020. Design, Setting, and Participants: This cross-sectional study examined articles reporting pediatric clinical trials conducted in the US published in 5 leading general pediatric and 5 leading general medical journals from January 1, 2011, to December 31, 2020. Main Outcomes and Measures: Reporting of participant race and ethnicity and comparison of enrolled participants vs US census populations of pediatric racial and ethnic groups in published clinical trials. Results: The study included 612 articles reporting pediatric clinical trials during the study period, with 565 618 total participants (median per trial, 200 participants [IQR, 90-571 participants]). Of the 612 articles, 486 (79.4%) reported participant race and 338 (55.2%) reported participant ethnicity. From 2011 to 2020, relative rates of reporting of participant race increased by 7.9% per year (95% CI, 0.2%-16.3% per year) and reporting of ethnicity increased by 11.4% per year (95% CI, 4.8%-18.4% per year). Among articles reporting race and ethnicity, the method of assignment was not reported in 261 of 511 articles (51.1%) and 207 of 359 articles (57.7%), respectively. Black/African American children were enrolled proportionally more than the US population of Black/African American children (odds ratio [OR], 1.88; 95% CI, 1.87-1.89). Hispanic/Latino children were enrolled commensurately with the US population of Hispanic/Latino children (OR, 1.02; 95% CI, 1.01-1.03). American Indian/Alaska Native (OR, 0.82; 95% CI, 0.79-0.85), Asian (OR, 0.56; 95% CI, 0.55-0.57), and Native Hawaiian/Pacific Islander (OR, 0.66; 95% CI, 0.61-0.72) children were enrolled significantly less compared with the respective US populations of these groups. White children were enrolled less than expected (OR, 0.84; 95% CI, 0.84-0.85) but represented 188 156 (46.0%) of participants in trials reporting race or ethnicity. Conclusions and Relevance: This cross-sectional study revealed that the proportion of published pediatric clinical trials that reported participant race and ethnicity increased from 2011 to 2020, but participant race and ethnicity were still underreported. Disparities existed in pediatric clinical trial enrollment of American Indian/Alaska Native, Asian, and Native Hawaiian/Pacific Islander children. The greater representation of Black/African American children compared with the US population suggests inclusive research practices that could be extended to other historically disenfranchised racial and ethnic groups.

Antiracism in Academic Medicine: Fixing the Leak in the Pipeline of Black Physicians.

Black physicians remain severely underrepresented in academic medicine despite the documented benefits of a diverse medical faculty. Only 3.6% of academic medical faculty self-report as Black or African American. Efforts to improve faculty diversity at academic medical institutions nationwide have not made meaningful impacts. Sustained improvements in faculty diversity cannot be achieved without an actively antiracist approach, including the intentional transformation of policies, practices, and systems that persistently produce worse outcomes for Black medical students, trainees, and faculty.

Associations of DNA Methylation Mortality Risk Markers with Congenital Microcephaly from Zika Virus: A Study of Brazilian Children Less than 4 Years of Age.

BACKGROUND: Zika virus (ZIKV)-associated congenital microcephaly is an important contributor to pediatric death, and more robust pediatric mortality risk metrics are needed to help guide life plans and clinical decision making for these patients. Although common etiologies of pediatric and adult mortality differ, early life health can impact adult outcomes-potentially through DNA methylation. Hence, in this pilot study, we take an early step in identifying pediatric mortality risk metrics by examining associations of ZIKV infection and associated congenital microcephaly with existing adult DNA methylation-based mortality biomarkers: GrimAge and Zhang's mortality score (ZMS). METHODS: Mortality measures were calculated from previously published HumanMethylationEPIC BeadChip data from 44 Brazilian children aged 5-40 months (18 with ZIKV-associated microcephaly; 7 normocephalic, exposed to ZIKV in utero; and 19 unexposed controls). We used linear models adjusted for chronological age, sex, methylation batch and white blood cell proportions to evaluate ZIKV and mortality marker relationships. RESULTS: We observed significant decreases in GrimAge-component plasminogen activator inhibitor-1 [PAI-1; ß = -2453.06 pg/ml, 95% confidence interval (CI) -3652.96, -1253.16, p = 0.0002], and ZMS-site cg14975410 methylation (ß = -0.06, 95% CI -0.09, -0.03, p = 0.0003) among children with microcephaly compared to controls. PAI-1 (ß = -2448.70 pg/ml, 95% CI -4384.45, -512.95, p = 0.01) and cg14975410 (ß = 0.01, 95% CI -0.04, 0.06, p = 0.64) results in comparisons of normocephalic, ZIKV-exposed children to controls were not statistically significant. CONCLUSION: Our results suggest that elements of previously-identified adult epigenetic markers of mortality risk are associated with ZIKV-associated microcephaly, a known contributor to pediatric mortality risk. These findings may provide insights for efforts aimed at developing pediatric mortality markers.

Firearm Laws and Firearm Homicides: A Systematic Review.

Importance: Firearm homicide is a leading cause of injury death in the United States, and there is considerable debate over the effectiveness of firearm policies. An analysis of the effectiveness of firearm laws on firearm homicide is important to understand optimal policies to decrease firearm homicide in the United States. Objective: To evaluate the association between firearm laws and preventing firearm homicides in the United States. Evidence Review: We evaluated peer-reviewed articles from 1970 to 2016 focusing on the association between US firearm laws and firearm homicide. We searched PubMed, CINAHL, Lexis/Nexis, Sociological Abstracts, Academic Search Premier, the Index to Legal Periodicals and Books, and the references from the assembled articles. We divided laws into 5 categories: those that (1) curb gun trafficking, (2) strengthen background checks, (3) improve child safety, (4) ban military-style assault weapons, and (5) restrict firearms in public places and leniency in firearm carrying. The articles were assessed using the standardized Guide to Community Preventive Services data collection instrument and 5 additional quality metrics: (1) appropriate data source(s) and outcome measure(s) were used for the study, (2) the time frame studied was adequate, (3) appropriate statistical tests were used, (4) the analytic results were robust, and (5) the disaggregated results of control variables were consistent with the literature. Findings: In the aggregate, stronger gun policies were associated with decreased rates of firearm homicide, even after adjusting for demographic and sociologic factors. Laws that strengthen background checks and permit-to-purchase seemed to decrease firearm homicide rates. Specific laws directed at firearm trafficking, improving child safety, or the banning of military-style assault weapons were not associated with changes in firearm homicide rates. The evidence for laws restricting guns in public places and leniency in gun carrying was mixed. Conclusions and Relevance: The strength of firearm legislation in general, and laws related to strengthening background checks and permit-to-purchase in particular, is associated with decreased firearm homicide rates. High-quality research is important to further evaluate the effectiveness of these laws. Legislation is just 1 part of a multipronged approach that will be necessary to decrease firearm homicides in the United States.

Minority Faculty Development Programs and Underrepresented Minority Faculty Representation at US Medical Schools.

IMPORTANCE: Diversity initiatives have increased at US medical schools to address underrepresentation of minority faculty. OBJECTIVE: To assess associations between minority faculty development programs at US medical schools and underrepresented minority faculty representation, recruitment, and promotion. DESIGN: Secondary analysis of the Association of American Medical Colleges Faculty Roster, a database of US medical school faculty. PARTICIPANTS: Full-time faculty at schools located in the 50 US states or District of Columbia and reporting data from 2000-2010. EXPOSURE: Availability of school-wide programs targeted to underrepresented minority faculty in 2010. MAIN OUTCOMES AND MEASURES: Percentage of underrepresented minority faculty, defined as self-reported black, Hispanic, Native American, Alaskan Native, Native Hawaiian, or Pacific Islander faculty. Percentage of underrepresented minority faculty was computed by school and year for all faculty, newly appointed faculty, and newly promoted faculty. Panel-level analyses that accounted for faculty clustering within schools were conducted and adjusted for faculty- and school-level variables. RESULTS: Across all schools, the percentage of underrepresented minority faculty increased from 6.8% (95% CI, 6.7%-7.0%) in 2000 to 8.0% (95% CI, 7.8%-8.2%) in 2010. Of 124 eligible schools, 36 (29%) were identified with a minority faculty development program in 2010. Minority faculty development programs were heterogeneous in composition, number of components, and duration. Schools with minority faculty development programs had a similar increase in percentage of underrepresented minority faculty as schools without minority faculty development programs (6.5%-7.4% vs 7.0%-8.3%; odds ratio [OR], 0.91 [95% CI, 0.72-1.13]). After adjustment for faculty and school characteristics, minority faculty development programs were not associated with greater representation of minority faculty (adjusted OR, 0.99 [95% CI, 0.81-1.22]), recruitment (adjusted OR, 0.97 [95% CI, 0.83-1.15]), or promotion (adjusted OR, 1.08 [95% CI, 0.91-1.30]). In subgroup analyses, schools with programs of greater intensity (present for ≥5 years and with more components) were associated with greater increases in underrepresented minority representation than schools with minority faculty development programs of less intensity. CONCLUSIONS AND RELEVANCE: The percentage of underrepresented minority faculty increased modestly from 2000 to 2010 at US medical schools. The presence of a minority faculty development program targeted to underrepresented minority faculty was not associated with greater underrepresented minority faculty representation, recruitment, or promotion. Minority faculty development programs that were of greater intensity were associated with greater increases in underrepresented minority faculty representation.

An environmental scan of faculty diversity programs at U.S. medical schools.

PURPOSE: To update the information available on the number and type of faculty diversity programs at U.S. MD-degree-granting medical schools. METHOD: The authors conducted an environmental scan of the 124 MD-degree-granting medical schools included in the 2010 Faculty Roster. They interviewed key informants in the faculty affairs and/or minority affairs offices and conducted Web site searches to identify relevant schoolwide programs. Using a conceptual framework, they categorized the faculty programs that they identified into four domains: mentorship, career development, social climate, and financial support. RESULTS: Of 124 eligible schools, the authors interviewed key informants from 84 schools (67.7%) and conducted Web site searches for 40 schools (32.2%). They identified diversity programs at 36 schools (29.0%) including mentoring (20/36; 16.1%), career development (20/36; 16.1%), social climate (17/36; 13.7%), and financial support programs (15/36; 12.1%). Schools with diversity programs were similar to schools without diversity programs in terms of year established, public/private status, and designation as historically black but were more likely to rank in the highest quartile and have a greater number of total faculty, and less likely to be located in the South. CONCLUSIONS: Less than a third of medical schools had programs targeting underrepresented minority (URM) faculty, and those programs that existed differed in scope and goals. These findings suggest that a lack of resources and a preference for programs that target all faculty may limit the development of programs targeting URM faculty. Future research should examine whether diversity programs contribute to URM faculty recruitment and retention.