Derivation and Internal Validation of a Novel Risk Assessment Tool to Identify Infants and Young Children at Risk for Post-Discharge Mortality in Dar es Salaam, Tanzania and Monrovia, Liberia.

OBJECTIVE: To derive and validate internally a novel risk assessment tool to identify young children at risk for all-cause mortality ≤60 days of discharge from hospitals in sub-Saharan Africa. STUDY DESIGN: We performed a prospective observational cohort study of children aged 1-59 months discharged from Muhimbili National Hospital in Dar es Salaam, Tanzania and John F. Kennedy Medical Center in Monrovia, Liberia (2019 to 2022). Caregivers received telephone calls up to 60 days after discharge to ascertain participant vital status. We collected socioeconomic, demographic, clinical, and anthropometric data during hospitalization. Candidate variables with P<0.20 in bivariate analyses were included in a multivariable logistic regression model with best subset selection to identify risk factors for the outcome. We internally validated our tool using bootstrapping with 500 repetitions. RESULTS: There were 1,933 young children enrolled in the study. The median (interquartile range) age was 11 (4, 23) months and 58.7% were male. In total, 67 (3.5%) died during follow-up. Ten variables contributed to our tool (total possible score 82). Cancer (adjusted odds ratio [aOR] 10.6, 95% CI 2.58, 34.6), pedal edema (aOR 6.94, 95% CI 1.69, 22.6), and leaving against medical advice (aOR 6.46, 95% CI 2.46, 15.3) were most predictive of post-discharge mortality. Our risk assessment tool demonstrated good discriminatory value (optimism corrected area under the receiver operating characteristic curve 0.77), high precision, and sufficient calibration. CONCLUSIONS: After validation, this tool may be used to identify young children at risk for post-discharge mortality to direct resources for follow-up of high-risk children.

Morbidity and unplanned healthcare encounters after hospital discharge among young children in Dar es Salaam, Tanzania and Monrovia, Liberia.

BACKGROUND: Researchers and healthcare providers have paid little attention to morbidity and unplanned healthcare encounters for children following hospital discharge in low- and middle-income countries. Our objective was to compare symptoms and unplanned healthcare encounters among children aged <5 years who survived with those who died within 60 days of hospital discharge through follow-up phone calls. METHODS: We conducted a secondary analysis of a prospective observational cohort of children aged <5 years discharged from neonatal and paediatric wards of two national referral hospitals in Dar es Salaam, Tanzania and Monrovia, Liberia. Caregivers of enrolled participants received phone calls 7, 14, 30, 45, and 60 days after hospital discharge to record symptoms, unplanned healthcare encounters, and vital status. We used logistic regression to determine the association between reported symptoms and unplanned healthcare encounters with 60-day post-discharge mortality. RESULTS: A total of 4243 participants were enrolled and had 60-day vital status available; 138 (3.3%) died. For every additional symptom ever reported following discharge, there was a 35% greater likelihood of post-discharge mortality (adjusted odds ratio [aOR] 1.35, 95% confidence interval [CI] 1.10 to 1.66; p=0.004). The greatest survival difference was noted for children who had difficulty breathing (2.1% among those who survived vs 36.0% among those who died, p<0.001). Caregivers who took their child home from the hospital against medical advice during the initial hospitalisation had over eight times greater odds of post-discharge mortality (aOR 8.06, 95% CI 3.87 to 16.3; p<0.001) and those who were readmitted to a hospital had 3.42 greater odds (95% CI 1.55 to 8.47; p=0.004) of post-discharge mortality than those who did not seek care when adjusting for site, sociodemographic factors, and clinical variables. CONCLUSION: Surveillance for symptoms and repeated admissions following hospital discharge by healthcare providers is crucial to identify children at risk for post-discharge mortality.

Building a framework to decolonize global emergency medicine.

Background: Global emergency medicine (GEM) is situated at the intersection of global health and emergency medicine (EM), which is built upon a history of colonial systems and institutions that continue to reinforce inequities between high-income countries (HICs) and low- and middle-income countries (LMICs) today. These power imbalances yield disparities in GEM practice, research, and education. Approach: The Global Emergency Medicine Academy (GEMA) of the Society for Academic Emergency Medicine formed the Decolonizing GEM Working Group in 2020, which now includes over 100 worldwide members. The mission is to address colonial legacies in GEM and catalyze sustainable changes and recommendations toward decolonization at individual and institutional levels. To develop recommendations to decolonize GEM, the group conducted a nonsystematic review of existing literature on decolonizing global health, followed by in-depth discussions between academics from LMICs and HICs to explore implications and challenges specific to GEM. We then synthesized actionable solutions to provide recommendations on decolonizing GEM. Results: Despite the rapidly expanding body of literature on decolonizing global health, there is little guidance specific to the relatively new field of GEM. By applying decolonizing principles to GEM, we suggest key priorities for improving equity in academic GEM: (1) reframing partnerships to place LMIC academics in positions of expertise and power, (2) redirecting research funding toward LMIC-driven projects and investigators, (3) creating more equitable practices in establishing authorship, and (4) upholding principles of decolonization in the education of EM trainees from LMICs and HICs. Conclusions: Understanding the colonial roots of GEM will allow us to look more critically at current health disparities and identify inequitable institutionalized practices within our profession that continue to uphold these misguided concepts. A decolonized future of GEM depends on our recognition and rectification of colonial-era practices that shape structural determinants of health care delivery and scientific advancement.

Identifying delays in healthcare seeking and provision: The Three Delays-in-Healthcare and mortality among infants and children aged 1-59 months.

Delays in illness recognition, healthcare seeking, and in the provision of appropriate clinical care are common in resource-limited settings. Our objective was to determine the frequency of delays in the "Three Delays-in-Healthcare", and factors associated with delays, among deceased infants and children in seven countries with high childhood mortality. We conducted a retrospective, descriptive study using data from verbal autopsies and medical records for infants and children aged 1-59 months who died between December 2016 and February 2022 in six sites in sub-Saharan Africa and one in South Asia (Bangladesh) and were enrolled in Child Health and Mortality Prevention Surveillance (CHAMPS). Delays in 1) illness recognition in the home/decision to seek care, 2) transportation to healthcare facilities, and 3) the receipt of clinical care in healthcare facilities were categorized according to the "Three Delays-in-Healthcare". Comparisons in factors associated with delays were made using Chi-square testing. Information was available for 1,326 deaths among infants and under 5 children. The majority had at least one identified delay (n = 854, 64%). Waiting >72 hours after illness recognition to seek health care (n = 422, 32%) was the most common delay. Challenges in obtaining transportation occurred infrequently when seeking care (n = 51, 4%). In healthcare facilities, prescribed medications were sometimes unavailable (n = 102, 8%). Deceased children aged 12-59 months experienced more delay than infants aged 1-11 months (68% vs. 61%, P = 0.018). Delays in seeking clinical care were common among deceased infants and children. Additional study to assess the frequency of delays in seeking clinical care and its provision among children who survive is warranted.

Emergency Department Volume and Delayed Diagnosis of Serious Pediatric Conditions.

Importance: Diagnostic delays are common in the emergency department (ED) and may predispose to worse outcomes. Objective: To evaluate the association of annual pediatric volume in the ED with delayed diagnosis. Design, Setting, and Participants: This retrospective cohort study included all children younger than 18 years treated at 954 EDs in 8 states with a first-time diagnosis of any of 23 acute, serious conditions: bacterial meningitis, compartment syndrome, complicated pneumonia, craniospinal abscess, deep neck infection, ectopic pregnancy, encephalitis, intussusception, Kawasaki disease, mastoiditis, myocarditis, necrotizing fasciitis, nontraumatic intracranial hemorrhage, orbital cellulitis, osteomyelitis, ovarian torsion, pulmonary embolism, pyloric stenosis, septic arthritis, sinus venous thrombosis, slipped capital femoral epiphysis, stroke, or testicular torsion. Patients were identified using the Healthcare Cost and Utilization Project State ED and Inpatient Databases. Data were collected from January 2015 to December 2019, and data were analyzed from July to December 2023. Exposure: Annual volume of children at the first ED visited. Main Outcomes and Measures: Possible delayed diagnosis, defined as a patient with an ED discharge within 7 days prior to diagnosis. A secondary outcome was condition-specific complications. Rates of possible delayed diagnosis and complications were determined. The association of volume with delayed diagnosis across conditions was evaluated using conditional logistic regression matching on condition, age, and medical complexity. Condition-specific volume-delay associations were tested using hierarchical logistic models with log volume as the exposure, adjusting for age, sex, payer, medical complexity, and hospital urbanicity. The association of delayed diagnosis with complications by condition was then examined using logistic regressions. Results: Of 58 998 included children, 37 211 (63.1%) were male, and the mean (SD) age was 7.1 (5.8) years. A total of 6709 (11.4%) had a complex chronic condition. Delayed diagnosis occurred in 9296 (15.8%; 95% CI, 15.5-16.1). Each 2-fold increase in annual pediatric volume was associated with a 26.7% (95% CI, 22.5-30.7) decrease in possible delayed diagnosis. For 21 of 23 conditions (all except ectopic pregnancy and sinus venous thrombosis), there were decreased rates of possible delayed diagnosis with increasing ED volume. Condition-specific complications were 11.2% (95% CI, 3.1-20.0) more likely among patients with a possible delayed diagnosis compared with those without. Conclusions and Relevance: EDs with fewer pediatric encounters had more possible delayed diagnoses across 23 serious conditions. Tools to support timely diagnosis in low-volume EDs are needed.

Identifying neonates at risk for post-discharge mortality in Dar es Salaam, Tanzania, and Monrovia, Liberia: Derivation and internal validation of a novel risk assessment tool.

INTRODUCTION: The immediate period after hospital discharge carries a large burden of childhood mortality in sub-Saharan Africa. Our objective was to derive and internally validate a risk assessment tool to identify neonates discharged from the neonatal ward at risk for 60-day post-discharge mortality. METHODS: We conducted a prospective observational cohort study of neonates discharged from Muhimbili National Hospital in Dar es Salaam, Tanzania, and John F Kennedy Medical Centre in Monrovia, Liberia. Research staff called caregivers to ascertain vital status up to 60 days after discharge. We conducted multivariable logistic regression analyses with best subset selection to identify socioeconomic, demographic, clinical, and anthropometric factors associated with post-discharge mortality. We used adjusted log coefficients to assign points to each variable and internally validated our tool with bootstrap validation with 500 repetitions. RESULTS: There were 2344 neonates discharged and 2310 (98.5%) had post-discharge outcomes available. The median (IQR) age at discharge was 8 (4, 15) days; 1238 (53.6%) were male. In total, 71 (3.1%) died during follow-up (26.8% within 7 days of discharge). Leaving against medical advice (adjusted OR [aOR] 5.62, 95% CI 2.40 to 12.10) and diagnosis of meconium aspiration (aOR 6.98, 95% CI 1.69 to 21.70) conferred the greatest risk for post-discharge mortality. The risk assessment tool included nine variables (total possible score=63) and had an optimism corrected area under the receiver operating characteristic curve of 0.77 (95% CI 0.75 to 0.80). A score of ≥6 was most optimal (sensitivity 68.3% [95% CI 64.8% to 71.5%], specificity 72.1% [95% CI 71.5% to 72.7%]). CONCLUSIONS: A small number of factors predicted all-cause, 60-day mortality after discharge from neonatal wards in Tanzania and Liberia. After external validation, this risk assessment tool may facilitate clinical decision making for eligibility for discharge and the direction of resources to follow-up high risk neonates.

Risk factors for moderate acute malnutrition among children with acute diarrhoea in India and Tanzania: a secondary analysis of data from a randomized trial.

BACKGROUND: Moderate acute malnutrition (MAM) affects over 30 million children aged < 5 years worldwide. MAM may confer a greater risk of developing severe malnutrition and even mortality in children. Assessing risk factors for MAM may allow for earlier recognition of children at risk of deleterious health outcomes. OBJECTIVE: To determine risk factors associated with the prevalence and development of MAM among children aged 6 to 59 months with acute diarrhoea who received treatment with oral rehydration solution and zinc supplementation. METHODS: We conducted a secondary analysis of data from a randomized, dose-finding trial of zinc among children with acute diarrhoea in India and Tanzania. We used regression models to assess risk factors for prevalent MAM at the start of diarrhoea treatment and to identify risk factors associated with the development of MAM at 60 days. MAM was defined as weight for length (or height) Z score ≤-2 and > -3 or mid-upper arm circumference < 12.5 and ≥ 11.5 cm. RESULTS: A total of 4,500 children were enrolled; 593 (13.2%) had MAM at the baseline. MAM at baseline was significantly less common among children in Tanzania than in India (adjusted risk ratio [aRR] 0.37, 95% confidence interval [CI]: 0.30, 0.44, P < 0.001), in children aged 24- < 60 months versus 6- < 12 months (aRR 0.46, 95% CI: 0.38, 0.56, P < 0.001), and in families with household wealth index higher than the median (aRR 0.79, 95% CI: 0.68, 0.92, P = 0.002). Sixty days after outpatient treatment and follow-up, 87 (2.5%) children developed MAM. When compared to children aged 6- < 12 months, children aged 24- < 60 months had a 52% lower risk of developing MAM. Every one unit increase in weight for length (or height) Z score at enrolment was associated with a 93% lower risk of developing MAM during follow-up. CONCLUSIONS: Among children with diarrhoea, younger children and those from households with lower wealth were at greater risk of MAM. These children may benefit from targeted interventions focusing on feeding (targeted nutrition support for at-risk households) and follow up in order to reduce the occurrence of MAM and its consequences.

Global Emergency Medicine: A Scoping Review of the Literature from 2022.

OBJECTIVE: The objective was to identify the highest quality global emergency medicine (GEM) research published in 2022. The top articles are compiled in a comprehensive list of all the year's GEM articles and narrative summaries are performed on those included. METHODS: A systematic PubMed search was conducted to identify all GEM articles published in 2022 and included a manual supplemental screen of 11 organizational websites for gray literature (GRAY). A team of trained reviewers and editors screened all identified titles and abstracts, based on three case definition categories: disaster and humanitarian response (DHR), emergency care in resource-limited settings (ECRLS), and emergency medicine development (EMD). Articles meeting these definitions were independently scored by two reviewers using rubrics for original research (OR), review (RE) articles, and GRAY. Articles that scored in the top 5% from each category as well as the overall top 5% of articles were included for narrative summary. RESULTS: The 2022 search identified 58,510 articles in the main review, of which 524 articles screened in for scoring, respectively, 30% and 18% increases from last year. After duplicates were removed, 36 articles were included for narrative summary. The GRAY search identified 7755 articles, of which 33 were scored and one was included for narrative summary. ECRLS remained the largest category (27; 73%), followed by DHR (7; 19%) and EMD (3; 8%). OR articles remained more common than RE articles (64% vs. 36%). CONCLUSIONS: The waning of the COVID-19 pandemic has not affected the continued growth in GEM literature. Articles related to prehospital care, mental health and resilience among patients and health care workers, streamlining pediatric infectious disease care, and disaster preparedness were featured in this year's review. The continued lack of EMD studies despite the global growth of GEM highlights a need for more scholarly dissemination of best practices.

Research Priorities for Pediatric Emergency Care to Address Disparities by Race, Ethnicity, and Language.

Importance: Health care disparities are well-documented among children based on race, ethnicity, and language for care. An agenda that outlines research priorities for disparities in pediatric emergency care (PEC) is lacking. Objective: To investigate research priorities for disparities in PEC among medical personnel, researchers, and health care-affiliated community organizations. Design, Setting, and Participants: In this survey study, a modified Delphi approach was used to investigate research priorities for disparities in PEC. An initial list of research priorities was developed by a group of experienced PEC investigators in 2021. Partners iteratively assessed the list through 2 rounds of electronic surveys using Likert-type responses in late 2021 and early 2022. Priorities were defined as achieving consensus if they received a score of highest priority or priority by at least 60% of respondents. Asynchronous engagement of participants via online web-conferencing platforms and email correspondence with electronic survey administration was used. Partners were individuals and groups involved in PEC. Participants represented interest groups, research and medical personnel organizations, health care partners, and laypersons with roles in community and family hospital advisory councils. Participants were largely from the US, with input from international PEC research networks. Outcome: Consensus agenda of research priorities to identify and address health care disparities in PEC. Results: PEC investigators generated an initial list of 27 potential priorities. Surveys were completed by 38 of 47 partners (80.6%) and 30 of 38 partners (81.1%) in rounds 1 and 2, respectively. Among 30 respondents who completed both rounds, there were 7 family or community partners and 23 medical or research partners, including 4 international PEC research networks. A total of 12 research priorities achieved the predetermined consensus threshold: (1) systematic efforts to reduce disparities; (2) race, ethnicity, and language data collection and reporting; (3) recognizing and mitigating clinician implicit bias; (4) mental health disparities; (5) social determinants of health; (6) language and literacy; (7) acute pain-management disparities; (8) quality of care equity metrics; (9) shared decision-making; (10) patient experience; (11) triage and acuity score assignment; and (12) inclusive research participation. Conclusions and Relevance: These results suggest a research priority agenda that may be used as a guide for investigators, research networks, organizations, and funding agencies to engage in and support high-priority disparities research topics in PEC.

Racial & ethnic disparities in geographic access to critical care in the United States: A geographic information systems analysis.

OBJECTIVE: It is important to identify gaps in access and reduce health outcome disparities, understanding access to intensive care unit (ICU) beds, especially by race and ethnicity, is crucial. Our objective was to evaluate the race and ethnicity-specific 60-minute drive time accessibility of ICU beds in the United States (US). DESIGN: We conducted a cross-sectional study using road network analysis to determine the number of ICU beds within a 60-minute drive time, and calculated adult intensive care bed ratios per 100,000 adults. We evaluated the US population at the Census block group level and stratified our analysis by race and ethnicity and by urbanicity. We classified block groups into four access levels: no access (0 adult intensive care beds/100,000 adults), below average access (>0-19.5), average access (19.6-32.0), and above average access (>32.0). We calculated the proportion of adults in each racial and ethnic group within the four access levels. SETTING: All 50 US states and the District of Columbia. PARTICIPANTS: Adults ≥15 years old. MAIN OUTCOME MEASURES: Adult intensive care beds/100,000 adults and percentage of adults national and state) within four access levels by race and ethnicity. RESULTS: High variability existed in access to ICU beds by state, and substantial disparities by race and ethnicity. 1.8% (n = 5,038,797) of Americans had no access to an ICU bed, and 26.8% (n = 73,095,752) had below average access, within a 60-minute drive time. Racial and ethnic analysis showed high rates of disparities (no access/below average access): American Indians/Alaskan Native 12.6%/28.5%, Asian 0.7%/23.1%, Black or African American 0.6%/16.5%, Hispanic or Latino 1.4%/23.0%, Native Hawaiian and other Pacific Islander 5.2%/35.0%, and White 2.1%/29.0%. A higher percentage of rural block groups had no (5.2%) or below average access (41.2%), compared to urban block groups (0.2% no access, 26.8% below average access). CONCLUSION: ICU bed availability varied substantially by geography, race and ethnicity, and by urbanicity, creating significant disparities in critical care access. The variability in ICU bed access may indicate inequalities in healthcare access overall by limiting resources for the management of critically ill patients.

Community-Acquired Pneumonia in Children.

ABSTRACT: Community-acquired pneumonia (CAP) is the most common cause of childhood mortality globally. In the United States, CAP is a leading cause of pediatric hospitalization and antibiotic use and is associated with substantial morbidity. There has been a dramatic shift in microbiological etiologies for CAP in children over time as pneumococcal pneumonia has become less common and viral etiologies have become predominant. There is no commonly agreed on approach to the diagnosis of CAP in children. When indicated, antimicrobial treatment should consist of narrow-spectrum antibiotics. In this article, we will describe the current understanding of the microbiological etiologies, clinical presentation, diagnostic approach, risk factors, treatment, and future directions in the diagnosis and management of pediatric CAP.

A cross-sectional analysis of publication of pediatric global health abstracts from seven major international conferences.

Research presented at conferences may increase context-specific evidence in low- and middle-income countries (LMICs), where global childhood disease burden is greatest and where massive relative deficits in research persist. Publication of studies presented at conferences is necessary for complete results dissemination. Our objective was to determine the frequency of publication of pediatric global health conference abstracts and to identify factors associated with publication. We conducted a cross-sectional study of abstracts that reported pediatric research conducted in at least one LMIC presented at seven major scientific conferences in 2017, 2018, and 2019. We used PubMed, EMBASE and Google Scholar to search for publications of the results presented as abstracts. We created a Kaplan-Meier curve to determine the cumulative incidence of publications and used predetermined abstract-level factors to create a multivariable Cox proportional hazard model to identify factors associated with time to publication. There were 8,105 abstracts reviewed and 1,433 (17.7%) reported pediatric research conducted in one or more LMICs. The probability of publication of pediatric global health abstracts was 33.6% (95% confidence interval [CI] 31.2-36.1%) at 24 months and 46.6% (95% CI 44.0-49.3%) at 48 months. Abstracts that reported research conducted in East Asia and Pacific (adjusted hazard ratio [aHR] 3.06, 95% CI 1.74-5.24), South Asia (aHR 2.25, 95% CI 1.30-3.91%), and upper-middle-income countries (1.50, 95% CI 1.12-2.02) were published sooner than those that reported research in LMICs in Europe and Central Asia and lower-middle-income countries, respectively. Fewer than half of pediatric global health abstracts were published in peer-reviewed journals up to four years after presentation at international conferences. Efforts are urgently needed to promote the widespread and long-lasting dissemination of pediatric research conducted in LMICs presented as abstracts to provide a more robust evidence base for both clinical care and policy related to child health.

Provider adherence to clinical care recommendations for infants and children who died in seven low- and middle-income countries in the Child Health and Mortality Prevention Surveillance (CHAMPS) network.

Background: Most childhood deaths globally are considered preventable through high-quality clinical care, which includes adherence to clinical care recommendations. Our objective was to describe adherence to World Health Organization recommendations for the management of leading causes of death among children. Methods: We conducted a retrospective, descriptive study examining clinical data for children aged 1-59 months who were hospitalized and died in a Child Health and Mortality Prevention Surveillance (CHAMPS) catchment, December 2016-June 2021. Catchment areas included: Baliakandi and Faridpur, Bangladesh; Kersa, Haramaya, and Harar, Ethiopia; Kisumu and Siaya, Kenya; Bamako, Mali; Manhiça and Quelimane, Mozambique; Makeni, Sierra Leone; Soweto, South Africa. We reviewed medical records of those who died from lower respiratory tract infections, sepsis, malnutrition, malaria, and diarrheal diseases to determine the proportion who received recommended treatments and compared adherence by hospitalization duration. Findings: CHAMPS enrolled 460 hospitalized children who died from the leading causes (median age 12 months, 53.0% male). Median hospital admission was 31 h. There were 51.0% (n = 127/249) of children who died from lower respiratory tract infections received supplemental oxygen. Administration of intravenous fluids for sepsis (15.9%, n = 36/226) and supplemental feeds for malnutrition (14.0%, n = 18/129) were uncommon. There were 51.4% (n = 55/107) of those who died from malaria received antimalarials. Of the 80 children who died from diarrheal diseases, 76.2% received intravenous fluids. Those admitted for ≥24 h more commonly received antibiotics for lower respiratory tract infections and sepsis, supplemental feeds for malnutrition, and intravenous fluids for sepsis than those admitted <24 h. Interpretation: Provision of recommended clinical care for leading causes of death among young children was suboptimal. Further studies are needed to understand the reasons for deficits in clinical care recommendation adherence. Funding: Bill & Melinda Gates Foundation.

Reporting and Representation of Participant Race and Ethnicity in National Institutes of Health-Funded Pediatric Clinical Trials.

Importance: Enrolling racially and ethnically diverse pediatric research participants is critical to ensuring equitable access to health advances and generalizability of research findings. Objectives: To examine the reporting of race and ethnicity for National Institutes of Health (NIH)-funded pediatric clinical trials and to assess the representation of pediatric participants from different racial and ethnic groups compared with distributions in the US population. Design, Setting, and Participants: This cross-sectional study included NIH-funded pediatric (ages 0-17 years) trials with grant funding completed between January 1, 2017, and December 31, 2019, and trial results reported as of June 30, 2022. Exposures: National Institutes of Health policies and guidance statements on the reporting of race and ethnicity of participants in NIH-funded clinical trials. Main Outcomes and Measures: The main outcome was reporting of participant race and ethnicity for NIH-funded pediatric clinical trials in publications and ClinicalTrials.gov. Results: There were 363 NIH-funded pediatric trials included in the analysis. Reporting of race and ethnicity data was similar in publications and ClinicalTrials.gov, with 90.3% (167 of 185) of publications and 93.9% (77 of 82) of ClinicalTrial.gov reports providing data on race and/or ethnicity. Among the 160 publications reporting race, there were 43 different race classifications, with only 3 publications (1.9%) using the NIH-required categories. By contrast, in ClinicalTrials.gov, 61 reports (79.2%) provided participant race and ethnicity using the NIH-specified categories (P < .001). There was racially and ethnically diverse enrollment of pediatric participants, with overrepresentation of racial and ethnic minority groups compared with the US population. Conclusions and Relevance: This cross-sectional study of NIH-funded pediatric clinical trials found high rates of reporting of participant race and ethnicity, with diverse representation of trial participants. These findings suggest that the NIH is meeting its directive of ensuring diverse participant enrollment in the research it supports.

Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial.

BACKGROUND: Despite substantial illness burden and healthcare utilization conferred by pain from vaso-occlusive episodes (VOE) in children with sickle cell disease (SCD), disease-modifying therapies to effectively treat SCD-VOE are lacking. The aim of the Sickle Cell Disease Treatment with Arginine Therapy (STArT) Trial is to provide definitive evidence regarding the efficacy of intravenous arginine as a treatment for acute SCD-VOE among children, adolescents, and young adults. METHODS: STArT is a double-blind, placebo-controlled, randomized, phase 3, multicenter trial of intravenous arginine therapy in 360 children, adolescents, and young adults who present with SCD-VOE. The STArT Trial is being conducted at 10 sites in the USA through the Pediatric Emergency Care Applied Research Network (PECARN). Enrollment began in 2021 and will continue for 5 years. Within 12 h of receiving their first dose of intravenous opioids, enrolled participants are randomized 1:1 to receive either (1) a one-time loading dose of L-arginine (200 mg/kg with a maximum of 20 g) administered intravenously followed by a standard dose of 100 mg/kg (maximum 10 g) three times a day or (2) a one-time placebo loading dose of normal saline followed by normal saline three times per day at equivalent volumes and duration as the study drug. Participants, research staff, and investigators are blinded to the participant's randomization. All clinical care is provided in accordance with the institution-specific standard of care for SCD-VOE based on the 2014 National Heart, Lung, and Blood Institute guidelines. The primary outcome is time to SCD-VOE pain crisis resolution, defined as the time (in hours) from study drug delivery to the last dose of parenteral opioid delivery. Secondary outcomes include total parental opioid use and patient-reported outcomes. In addition, the trial will characterize alterations in the arginine metabolome and mitochondrial function in children with SCD-VOE. DISCUSSION: Building on the foundation of established relationships between emergency medicine providers and hematologists in a multicenter research network to ensure adequate participant accrual, the STArT Trial will provide definitive information about the efficacy of intravenous arginine for the treatment of SCD-VOE for children. TRIAL REGISTRATION: The STArT Trial was registered in ClinicalTrials.gov on April 9, 2021, and enrollment began on June 21, 2021 (NCT04839354).

Data Sharing for Pediatric Clinical Trials Funded by the US National Institutes of Health.

This cross-sectional study assesses declared data sharing in publications for a recent set of pediatric clinical trials funded by the US National Institutes of Health (NIH).

Predictive value of clinician impression for readmission and postdischarge mortality among neonates and young children in Dar es Salaam, Tanzania and Monrovia, Liberia.

BACKGROUND: There are no validated clinical decision aids to identify neonates and young children at risk of hospital readmission or postdischarge mortality in sub-Saharan Africa, leaving the decision to discharge a child to a clinician's impression. Our objective was to determine the precision of clinician impression to identify neonates and young children at risk for readmission and postdischarge mortality. METHODS: We conducted a survey study nested in a prospective observational cohort of neonates and children aged 1-59 months followed 60 days after hospital discharge from Muhimbili National Hospital in Dar es Salaam, Tanzania or John F. Kennedy Medical Center in Monrovia, Liberia. Clinicians who discharged each enrolled patient were surveyed to determine their perceived probability of the patient's risk of 60-day hospital readmission or postdischarge mortality. We calculated the area under the precision-recall curve (AUPRC) to determine the precision of clinician impression for both outcomes. RESULTS: Of 4247 discharged patients, 3896 (91.7%) had available clinician surveys and 3847 (98.7%) had 60-day outcomes available: 187 (4.8%) were readmitted and 120 (3.1%) died within 60 days of hospital discharge. Clinician impression had poor precision in identifying neonates and young children at risk of hospital readmission (AUPRC: 0.06, 95% CI: 0.04 to 0.08) and postdischarge mortality (AUPRC: 0.05, 95% CI: 0.03 to 0.08). Patients for whom clinicians attributed inability to pay for future medical treatment as the reason for risk for unplanned hospital readmission had 4.76 times the odds hospital readmission (95% CI: 1.31 to 17.25, p=0.02). CONCLUSIONS: Given the poor precision of clinician impression alone to identify neonates and young children at risk of hospital readmission and postdischarge mortality, validated clinical decision aids are needed to aid in the identification of young children at risk for these outcomes.

Has Authorship in the Decolonizing Global Health Movement Been Colonized?

Background: Decolonization in global health is a recent movement aimed at relinquishing remnants of supremacist mindsets, inequitable structures, and power differentials in global health. Objective: To determine the author demographics of publications on decolonizing global health and global health partnerships between low- and middle-income countries (LMICs) and high-income countries (HICs). Methods: We conducted a cross-sectional analysis of publications related to decolonizing global health and global health partnerships from the inception of the selected journal databases (i.e., Medline, CAB Global Health, EMBASE, CINAHL, and Web of Science) to November 14, 2022. Author country affiliations were assigned as listed in each publication. Author gender was assigned using author first name and the software genderize.io. Descriptive statistics were used for author country income bracket, gender, and distribution. Findings: Among 197 publications on decolonizing global health and global health partnerships, there were 691 total authors (median 2 authors per publication, interquartile range 1, 4). Publications with author bylines comprised exclusively of authors affiliated with HICs were most common (70.0%, n = 138) followed by those with authors affiliated both with HICs and LMICs (22.3%, n = 44). Only 7.6% (n = 15) of publications had author bylines comprised exclusively of authors affiliated with LMICs. Over half (54.0%, n = 373) of the included authors had names that were female and female authors affiliated with HICs most commonly occupied first author positions (51.8%, n = 102). Conclusions: Authors in publications on decolonizing global health and global health partnerships have largely been comprised of individuals affiliated with HICs. There was a marked paucity of publications with authors affiliated with LMICs, whose voices provide context and crucial insight into the needs of the decolonizing global health movement.