Open source approaches for pediatric global health technologies.

Access to medical technologies is a critical component of universal access to care; however, the advancement of technologies for children has historically lagged behind those for adults. The small market size, anatomic and physiologic variability, and legal and ethical implications pose unique barriers to developing and commercialising paediatric biomedical innovations. These challenges are magnified in low-resource settings (LRS), which often lack appropriate regulatory oversight, support for service contracts, and supply chain capacity. The COVID-19 pandemic exposed shortcomings in the traditional industry model for medical technologies, while also catalysing open-source approaches to technology development and dissemination. Open-source pathways - where products are freely licenced to be distributed and modified - addressed key shortages in critical equipment. Relatedly, we argue that open-source approaches can accelerate paediatric global health technology development. Open-source approaches can be tailored to clinical challenges independent of economic factors, embrace low-cost manufacturing techniques, and can be highly customisable. Furthermore, diverse stakeholders, including families and patients, are empowered to participate in collaborative communities of practice. How to regulate the development, manufacture, and distribution of open-source technologies remains an ongoing area of exploration. The need for democratised innovation must be carefully balanced against the imperatives of safety and quality for paediatric-specific solutions. This can be achieved, in part, through close coordination between national regulatory agencies and decentralised networks where products can be peer-reviewed and tested. Altogether, there is significant potential for open source to advance more equitable and sustainable medical innovations for all children.

Impact of the COVID-19 Pandemic on Blood Lead Testing in Children in the United States.

The study objective was to evaluate the impact of the coronavirus disease (COVID-19) pandemic on pediatric blood lead testing in the United States. Clinical laboratory pediatric (ages <6 years) blood lead level (BLL) tests performed by Quest Diagnostics, January 2019-March 2022, were analyzed. Patients were categorized by age, by sex, and, through matching by ZIP code with US Census data, for race, ethnicity, pre-1950 housing, and poverty estimates. Over 2.8 million results from children (<6 years old) from all 50 states and the District of Columbia were included. Compared to March-May 2019, BLL testing was lower by 53.6% in March-May 2020 and lower by 14.6% in March-May 2021. Testing rebounded more for children in predominantly White non-Hispanic communities and among children living in communities, based on ZIP codes, with the least pre-1950 housing stock and lowest poverty rates. The proportion of children with BLL at or above the United States Centers for Disease Control and Prevention reference values of 3.5 and 5.0 µg/dL fell by 19% and 24%, respectively, in 2021 versus 2019. In conclusion, pediatric BLL testing has rebounded from sharp declines during the early pandemic period but unevenly. Declines in the proportion of children with elevated BLL should be interpreted with caution, as testing rebounds were less robust among communities with the highest risk of lead poisoning, notably communities with the oldest housing stock and higher poverty rates. More public health efforts are needed to address lead toxicity throughout the United States, especially in communities that did not experience a full rebound subsequent to the early COVID-19 pandemic period.

Impact of the COVID-19 Pandemic on Childhood Lead Testing and Blood Lead Levels.

OBJECTIVE: To evaluate the effect of the COVID-19 pandemic on childhood lead testing and blood lead levels. METHODS: A retrospective analysis of lead tests and results was performed across 3 urban medical centers during the pre-COVID-19 (March 10, 2019-March 9, 2020) and COVID-19 (March 10, 2020-March 10, 2022) periods. Interrupted time series analysis with quasi-Poisson regression was used to evaluate changes in lead testing between study periods. The relationship between sociodemographic features with detectable (≧2 µg/dL) and elevated (≧3.5 µg/dL) blood lead levels (BLLs) was assessed with multivariable logistic regression. RESULTS: Among a total of 16,364 lead tests across 10,362 patients, weekly testing rates significantly decreased during COVID-19 (relative risk (RR) 0.64, 95% (confidence interval) CI 0.53-0.78). Census tracts with the greatest proportion of pre-1950s housing had a stronger association with detectable BLLs during the COVID-19 period (pre-COVID-19 adjusted odds ratio (aOR) 1.73, 95% CI 1.35-2.20; aOR 2.58, 95% CI 2.13-3.12; interaction P value .014). When limited to 1 year following COVID-19 (March 10, 2020-March 10, 2021), the association between both elevated BLLs (pre-COVID-19: aOR 1.49, 95% CI 0.87-2.53; COVID-19: aOR 3.51, 95% CI 1.98-6.25; interaction P value .032) and detectable BLLs with pre-1950s housing were greater during the COVID-19 period (pre-COVID-19: aOR 1.73, 95% CI 1.35-2.20; COVID-19: aOR 2.56, 95% CI 1.95-3.34; interaction P value .034). CONCLUSIONS: The COVID-19 pandemic led to a significant reduction in lead surveillance and magnified the effect of known risk factors for lead exposure. Concerted clinical, public health, and community advocacy are needed to address care gaps and excess cases of lead poisoning.

Evaluation of Housing Affordability Among US Resident Physicians.

This cross-sectional study evaluates the extent of housing unaffordability among US residency programs.

Race and Ethnicity Reporting and Representation in Pediatric Clinical Trials.

BACKGROUND AND OBJECTIVES: Representative enrollment of racial and ethnic minoritized populations in biomedical research ensures the generalizability of results and equitable access to novel therapies. Previous studies on pediatric clinical trial diversity are limited to subsets of journals or disciplines. We aimed to evaluate race and ethnicity reporting and representation in all US pediatric clinical trials on ClinicalTrials.gov. METHODS: We performed a cross-sectional study of US-based clinical trials registered on ClinicalTrials.gov that enrolled participants aged <18 years old between October 2007 and March 2020. We used descriptive statistics, compound annual growth rates, and multivariable logistic regression for data analysis. Estimates of US population statistics and disease burden were calculated with the US Census, Kids' Inpatient Database, and National Survey of Children's Health. RESULTS: Among 1183 trials encompassing 405 376 participants, race and ethnicity reporting significantly increased from 27% in 2007 to 87% in 2018 (P < .001). The median proportional enrollment of Asian American children was 0.6% (interquartile range [IQR], 0%-3.7%); American Indian, 0% (IQR, 0%-0%); Black, 12% (IQR, 2.9%-28.4%); Hispanic, 7.1% (IQR, 0%-18.6%); and white 66.4% (IQR, 41.5%-81.6%). Asian American, Black, and Hispanic participants were underrepresented relative to US population demographics. Compared with expected proportions based on disease prevalence and hospitalizations, Asian American and Hispanic participants were most consistently underrepresented across diagnoses. CONCLUSIONS: While race and ethnicity reporting in pediatric clinical trials has improved, the representative enrollment of minoritized participants remains an ongoing challenge. Evidence-based and policy solutions are needed to address these disparities to advance biomedical innovation for all children.

The utilization of clinical decision support tools to identify neonatal hypothermia and its associated risk factors: A prospective observational study.

Hypothermia (axillary temperature less than 36.5°) is a major source of neonatal morbidity and mortality, with a disproportionate burden of disease in low- and middle-income countries. Despite the importance of thermoregulation on newborn outcomes, the global epidemiologic landscape of neonatal hypothermia is poorly characterized. Clinical decision support (CDS) software provides point-of-care recommendations to guide clinical management and may support data capture in settings with limited informatics infrastructure. Towards this end, we conducted a prospective observational study of the NoviGuide, a novel CDS platform for newborn care, at four health facilities in Uganda between September 2022 to May 2021. Data were extracted from clinical information (e.g. axillary temperature, birth weight, gestational age) entered into the NoviGuide by nurses and midwives on newborns within 24 hours of delivery. Descriptive statistics and multivariable logistic regression were used to evaluate neonatal temperature profiles and the association between hypothermia and clinical features. Among 1,027 completed assessments, 30.5% of entries had neonatal hypothermia with significant variation across study sites. On multivariable logistic regression analysis, we found that hypothermia was independently associated with pre-term birth (Adjusted Odd's Ratio [aOR] 2.62, 95% Confidence interval [CI] 1.38-4.98), sepsis/concern for sepsis (aOR 2.73, 95% CI 2.90-3.94), and hypoglycemia/concern for hypoglycemia (aOR 1.78, 95% CI 1.17-2.72). Altogether, neonatal hypothermia was commonly entered into the NoviGuide and associated clinical characteristics aligned with previous studies based on conventional data collection instruments. Our results should be contextualized within unique technical and operational features of CDS tools, including a bias towards acutely ill patients and limited quality control. Nonetheless, this study demonstrates that a CDS used voluntarily by clinicians has the potential to fill key data gaps and drive quality improvement towards reducing neonatal hypothermia in low resource settings.

A Prescription for Internet: Feasibility of a Tablet Loaner Program to Address Digital Health Inequities.

OBJECTIVE: The coronavirus disease 2019 pandemic accelerated the adoption of telehealth technologies. Persistent disparities in telecommunication devices, internet connectivity, and digital literacy, however, undermine the potential for telemedicine to reduce barriers to health care access. Health systems may have a role in addressing these structural inequities. We describe the operationalization and feasibility of an internet-enabled tablet loaner program at a freestanding children's hospital. METHODS: Between October 2020 and October 2021, pediatricians enrolled families through ambulatory clinics at an academic urban freestanding children's hospital. Eligibility criteria included difficulty accessing virtual care due to lack of stable internet or device. Tablets featured an unlimited data package, access to the patient portal, and virtual visit platform. A private technology company managed device configuration and distribution. To characterize program impact, we compared the proportion of completed clinical encounters during the intervention compared with a preintervention period (March 2020-October 2020) and conducted a qualitative survey with program participants. Participant and visit characteristics were obtained from the electronic medical record and summarized with descriptive statistics. RESULTS: A total of 111 families participated in the tablet loaner program, the majority of whom were Hispanic (51.4%) and black, non-Hispanic (26.1%), and publicly insured (64.9%). Between the preintervention and intervention periods, there was a significant increase in completed video- and phone-based virtual visits (75.3 vs. 79.1%, p = 0.038). The proportion of video-based only visits increased from 82.9 to 88.9%. p < 0.001. Families reported that the tablet improved the patient's ability to receive medical care (93.7%) and was easy to use (93.9%). CONCLUSION: The tablet loaner initiative was associated with an improvement in markers of virtual visit engagement and health care experience. Efforts to expand telemedicine equity must consider technological access and digital literacy as well as broad coalitions across industry, government, and community organizations.

A Community-Based COVID-19 Vaccine Education Initiative.

Coronavirus disease 2019 (COVID-19) has had a disparate impact on Black and Latinx communities. Even before the COVID-19 pandemic, inaccessibility and distrust of the medical community rooted in historical oppression led to hesitancy about medical interventions. In Boston, COVID-19 vaccination rates of Black and Latinx adolescents lagged behind their white and Asian peers. In response, Boston Medical Center created community vaccine clinic sites across Suffolk County. Pediatric resident physicians subsequently partnered with Boston Medical Center to establish an accompanying education program entitled "Ask-a-Doc" to help improve health literacy and address vaccine hesitancy that focused on Black and Latinx adolescents. In partnership with multidisciplinary stakeholders, including Boston Public School leaders, Ask-a-Doc pediatric resident physicians staffed 46 community vaccine events in 15 zip codes. At these events, 1521 vaccine doses were administered, with most administered to Black and Latinx community members. As of January 1, 2022, 67% of 51 first-year pediatric resident physicians had participated. Ask-A-Doc is an example of a community-based intervention that directly targets health inequities and misinformation and demonstrates that pediatric resident physicians can meaningfully engage in community outreach with sufficient protected time, resources, and institutional support. The resulting connections may lead to greater trust and credibility within systematically oppressed communities.