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Migrant families face challenges to health and well-being from COVID-19. We deployed Mobile Health for Migrant Health (mHealth-4-Mhealth) to migrant families, a household-based program with mHealth-assisted at-home testing and linkages to community resources. We assessed the reach, adoption, and implementation of the program among rural migrant families enrolled in the Title IC Nebraska Migrant Education Program from February 2022 to July 2023. We describe successful adoption and longitudinal use of mHealth screening tools for severe acute respiratory syndrome coronavirus 2 infection risk and social determinants of health. (Am J Public Health. Published online ahead of print August 22, 2024:e1-e5. https://doi.org/10.2105/AJPH.2024.307746).
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BACKGROUND: The goal of Project Austin, an initiative to improve emergency care for rural children who are medically complex (CMC), is to provide an Emergency Information Form (EIF) to their parents/caregivers, to local Emergency Medical Services, and Emergency Departments. EIFs are standard forms recommended by the American Academy of Pediatrics that provide pre-planned rapid response instructions, including medical conditions, medications, and care recommendations, for emergency providers. Our objective is to describe the workflows and perceived utility of the provided emergency information forms (EIFs) in the acute medical management of CMC. METHODS: We sampled from two key stakeholder groups in the acute management of CMC: four focus groups with emergency medical providers from rural and urban settings and eight key informant interviews with parents/caregivers enrolled in an emergency medical management program for CMC. Transcripts were thematically analyzed in NVivo© by two coders using a content analysis approach. The thematic codes were combined into a codebook and revised the themes present through combining relevant themes and developing of sub-themes until they reached consensus. RESULTS: All parents/caregivers interviewed were enrolled in Project Austin and had an EIF. Emergency medical providers and parents/caregivers supported the usage of EIFs for CMC. Parents/caregivers also felt EIFs made emergency medical providers more prepared for their child. Providers identified that EIFs helped provide individualized care, however they were not confident the data was current and so felt unsure they could rely on the recommendations on the EIF. CONCLUSION: EIFs are an easy way to engage parents, caregivers, and emergency medical providers about the specifics of a care for CMC during an emergency. Timely updates and electronic access to EIFs could improve their value for medical providers.
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Cuidadores , Servicios Médicos de Urgencia , Niño , Humanos , Flujo de Trabajo , Servicio de Urgencia en Hospital , Academias e InstitutosRESUMEN
OBJECTIVE: The objective of this paper was to determine inhaled corticosteroid (IC) use in infants with bronchopulmonary dysplasia (BPD), define the interhospital variation of IC administration to infants with BPD, and compare clinical, demographic, and hospital factors associated with IC use. STUDY DESIGN: Using the Pediatric Health Information System database, a retrospective multicenter cohort of 4,551 infants born at <32 weeks of gestation with developing BPD was studied. The clinical, demographic, and hospital characteristics of infants exposed and not exposed to ICs were compared. RESULTS: IC use varied markedly between hospitals, ranging from 0 to 66% of infants with BPD exposed to ICs. Increased annual BPD census was not associated with IC use. In total, 25% (1,144 out of 4,551) of patients with BPD and 43% (536 out of 1,244) of those with severe BPD received ICs. Increased IC exposure was associated with lower birth weight and gestational age, days on respiratory support, need for positive pressure ventilation at 36-week postmenstrual age, need for tracheostomy, and increased use of systemic steroids, bronchodilators, and diuretics. CONCLUSION: IC exposure is common in infants with BPD, with substantial interhospital variability. IC use was associated with more severe disease. Hospital experience did not account for the wide variability in IC use by the hospital. Further research into the effects of ICs use is urgently needed to help guide their use in this vulnerable population. KEY POINTS: · The risks and benefits of IC use in infants with BPD are incompletely understood.. · IC use is common in infants with BPD (25%) and severe BPD (43%) varies widely by hospital (0-66% of patients with BPD received an IC).. · Hospital experience did not account for the wide interhospital variation in IC use..
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We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children's participation in state-of-the-art clinical trials.
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/estadística & datos numéricos , Creación de Capacidad/organización & administración , Protección a la Infancia/estadística & datos numéricos , Ensayos Clínicos como Asunto/normas , Indígenas Norteamericanos/estadística & datos numéricos , Niño , Humanos , Proyectos de Investigación , Seguridad , Estados UnidosRESUMEN
OBJECTIVE: Management of febrile infants 60 days and younger for suspected serious infection varies widely. Clinical practice guidelines (CPGs) are intended to improve clinician adherence to evidence-based practices. In 2011, a CPG for managing febrile infants was implemented in an urban children's hospital with simultaneous release of an electronic order set and algorithm to guide clinician decisions for managing infants for suspected serious bacterial infection. The objective of the present study was to determine the association of CPG implementation with order set use, clinical practices, and clinical outcomes. METHODS: Records of febrile infants 60 days and younger from February 1, 2009, to January 31, 2013, were retrospectively reviewed. Clinical documentation, order set use, clinical management practices, and outcomes were compared pre-CPG and post-CPG release. RESULTS: In total, 1037 infants pre-CPG and 930 infants post-CPG implementation were identified. After CPG release, more infants 29 to 60 days old underwent lumbar puncture (56% vs 62%, P = 0.02). Overall antibiotic use and duration of antibiotic use decreased for infants 29 to 60 days (57% vs 51%, P = 0.02). Blood culture and urine culture obtainment remained unchanged for older infants. Diagnosed infections, hospital readmissions, and length of stay were unchanged. Electronic order sets were used in 80% of patient encounters. CONCLUSIONS: Antibiotic use and lumbar puncture performance modestly changed in accordance with CPG recommendations provided in the electronic order set and algorithm, suggesting that the presence of embedded prompts may affect clinician decision-making. Our results highlight the potential usefulness of these decision aids to improve adherence to CPG recommendations.
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Infecciones Bacterianas , Toma de Decisiones Clínicas , Fiebre , Adhesión a Directriz , Sistemas de Entrada de Órdenes Médicas , Algoritmos , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/terapia , Fiebre/diagnóstico , Fiebre/terapia , Humanos , Lactante , Recién Nacido , Readmisión del Paciente , Guías de Práctica Clínica como Asunto , Estudios RetrospectivosRESUMEN
Importance: Preventive interventions are needed to protect residents and staff of skilled nursing and assisted living facilities from COVID-19 during outbreaks in their facilities. Bamlanivimab, a neutralizing monoclonal antibody against SARS-CoV-2, may confer rapid protection from SARS-CoV-2 infection and COVID-19. Objective: To determine the effect of bamlanivimab on the incidence of COVID-19 among residents and staff of skilled nursing and assisted living facilities. Design, Setting, and Participants: Randomized, double-blind, single-dose, phase 3 trial that enrolled residents and staff of 74 skilled nursing and assisted living facilities in the United States with at least 1 confirmed SARS-CoV-2 index case. A total of 1175 participants enrolled in the study from August 2 to November 20, 2020. Database lock was triggered on January 13, 2021, when all participants reached study day 57. Interventions: Participants were randomized to receive a single intravenous infusion of bamlanivimab, 4200 mg (n = 588), or placebo (n = 587). Main Outcomes and Measures: The primary outcome was incidence of COVID-19, defined as the detection of SARS-CoV-2 by reverse transcriptase-polymerase chain reaction and mild or worse disease severity within 21 days of detection, within 8 weeks of randomization. Key secondary outcomes included incidence of moderate or worse COVID-19 severity and incidence of SARS-CoV-2 infection. Results: The prevention population comprised a total of 966 participants (666 staff and 300 residents) who were negative at baseline for SARS-CoV-2 infection and serology (mean age, 53.0 [range, 18-104] years; 722 [74.7%] women). Bamlanivimab significantly reduced the incidence of COVID-19 in the prevention population compared with placebo (8.5% vs 15.2%; odds ratio, 0.43 [95% CI, 0.28-0.68]; P < .001; absolute risk difference, -6.6 [95% CI, -10.7 to -2.6] percentage points). Five deaths attributed to COVID-19 were reported by day 57; all occurred in the placebo group. Among 1175 participants who received study product (safety population), the rate of participants with adverse events was 20.1% in the bamlanivimab group and 18.9% in the placebo group. The most common adverse events were urinary tract infection (reported by 12 participants [2%] who received bamlanivimab and 14 [2.4%] who received placebo) and hypertension (reported by 7 participants [1.2%] who received bamlanivimab and 10 [1.7%] who received placebo). Conclusions and Relevance: Among residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection. Further research is needed to assess preventive efficacy with current patterns of viral strains with combination monoclonal antibody therapy. Trial Registration: ClinicalTrials.gov Identifier: NCT04497987.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Neutralizantes/uso terapéutico , Antivirales/uso terapéutico , COVID-19/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/inmunología , Antivirales/efectos adversos , Antivirales/inmunología , Instituciones de Vida Asistida , COVID-19/epidemiología , Método Doble Ciego , Aprobación de Drogas , Femenino , Personal de Salud , Humanos , Inmunización Pasiva , Incidencia , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , SARS-CoV-2/aislamiento & purificación , Índice de Severidad de la Enfermedad , Instituciones de Cuidados Especializados de Enfermería , Adulto JovenRESUMEN
OBJECTIVE: To determine factors associated with adverse outcomes among febrile young infants with invasive bacterial infections (IBIs) (ie, bacteremia and/or bacterial meningitis). STUDY DESIGN: Multicenter, retrospective cohort study (July 2011-June 2016) of febrile infants ≤60 days of age with pathogenic bacterial growth in blood and/or cerebrospinal fluid. Subjects were identified by query of local microbiology laboratory and/or electronic medical record systems, and clinical data were extracted by medical record review. Mixed-effect logistic regression was employed to determine clinical factors associated with 30-day adverse outcomes, which were defined as death, neurologic sequelae, mechanical ventilation, or vasoactive medication receipt. RESULTS: Three hundred fifty infants met inclusion criteria; 279 (79.7%) with bacteremia without meningitis and 71 (20.3%) with bacterial meningitis. Forty-two (12.0%) infants had a 30-day adverse outcome: 29 of 71 (40.8%) with bacterial meningitis vs 13 of 279 (4.7%) with bacteremia without meningitis (36.2% difference, 95% CI 25.1%-48.0%; P < .001). On adjusted analysis, bacterial meningitis (aOR 16.3, 95% CI 6.5-41.0; P < .001), prematurity (aOR 7.1, 95% CI 2.6-19.7; P < .001), and ill appearance (aOR 3.8, 95% CI 1.6-9.1; P = .002) were associated with adverse outcomes. Among infants who were born at term, not ill appearing, and had bacteremia without meningitis, only 2 of 184 (1.1%) had adverse outcomes, and there were no deaths. CONCLUSIONS: Among febrile infants ≤60 days old with IBI, prematurity, ill appearance, and bacterial meningitis (vs bacteremia without meningitis) were associated with adverse outcomes. These factors can inform clinical decision-making for febrile young infants with IBI.
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Bacteriemia/complicaciones , Fiebre/complicaciones , Meningitis Bacterianas/complicaciones , Antibacterianos/administración & dosificación , Bacteriemia/mortalidad , Estudios de Cohortes , Femenino , Fiebre/mortalidad , Humanos , Lactante , Mortalidad Infantil , Recién Nacido , Masculino , Meningitis Bacterianas/mortalidad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVES: The Rochester criteria were developed to identify febrile infants aged 60 days or younger at low-risk of bacterial infection and do not include cerebrospinal fluid (CSF) testing. Prior studies have not specifically assessed criteria performance for bacteremia and bacterial meningitis (invasive bacterial infection). Our objective was to determine the sensitivity of the Rochester criteria for detection of invasive bacterial infection. METHODS: Retrospective cohort study of febrile infants aged 60 days or younger with invasive bacterial infections evaluated at 8 pediatric emergency departments from July 1, 2012, to June 30, 2014. Potential cases were identified from the Pediatric Health Information System using International Classification of Diseases, Ninth Revision diagnosis codes for bacteremia, meningitis, urinary tract infection, and fever. Medical record review was then performed to confirm presence of an invasive bacterial infection and to evaluate the Rochester criteria: medical history, symptoms or ill appearance, results of urinalysis, complete blood count, CSF testing (if obtained), and blood, urine, and CSF culture. An invasive bacterial infection was defined as growth of pathogenic bacteria from blood or CSF culture. RESULTS: Among 82 febrile infants aged 60 days or younger with invasive bacterial infection, the sensitivity of the Rochester criteria were 92.7% (95% confidence interval [CI], 84.9%-96.6%) overall, 91.7% (95% CI, 80.5%-96.7%) for neonates 28 days or younger, and 94.1% (95% CI, 80.9%-98.4%) for infants aged 29 to 60 days old. Six infants with bacteremia, including 1 neonate with bacterial meningitis, met low-risk criteria. CONCLUSIONS: The Rochester criteria identified 92% of infants aged 60 days or younger with invasive bacterial infection. However, 1 neonate 28 days or younger with meningitis was classified as low-risk.
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Bacteriemia/diagnóstico , Fiebre/etiología , Meningitis Bacterianas/diagnóstico , Infecciones Urinarias/diagnóstico , Recuento de Células Sanguíneas , Cultivo de Sangre/estadística & datos numéricos , Líquido Cefalorraquídeo/microbiología , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Fiebre/diagnóstico , Humanos , Lactante , Recién Nacido , Masculino , Estudios Retrospectivos , Sensibilidad y Especificidad , UrinálisisRESUMEN
OBJECTIVES: To help guide empiric treatment of infants ≤60 days old with suspected invasive bacterial infection by describing pathogens and their antimicrobial susceptibilities. STUDY DESIGN: Cross-sectional study of infants ≤60 days old with invasive bacterial infection (bacteremia and/or bacterial meningitis) evaluated in the emergency departments of 11 children's hospitals between July 1, 2011 and June 30, 2016. Each site's microbiology laboratory database or electronic medical record system was queried to identify infants from whom a bacterial pathogen was isolated from either blood or cerebrospinal fluid. Medical records of these infants were reviewed to confirm the presence of a pathogen and to obtain demographic, clinical, and laboratory data. RESULTS: Of the 442 infants with invasive bacterial infection, 353 (79.9%) had bacteremia without meningitis, 64 (14.5%) had bacterial meningitis with bacteremia, and 25 (5.7%) had bacterial meningitis without bacteremia. The peak number of cases of invasive bacterial infection occurred in the second week of life; 364 (82.4%) infants were febrile. Group B streptococcus was the most common pathogen identified (36.7%), followed by Escherichia coli (30.8%), Staphylococcus aureus (9.7%), and Enterococcus spp (6.6%). Overall, 96.8% of pathogens were susceptible to ampicillin plus a third-generation cephalosporin, 96.0% to ampicillin plus gentamicin, and 89.2% to third-generation cephalosporins alone. CONCLUSIONS: For most infants ≤60 days old evaluated in a pediatric emergency department for suspected invasive bacterial infection, the combination of ampicillin plus either gentamicin or a third-generation cephalosporin is an appropriate empiric antimicrobial treatment regimen. Of the pathogens isolated from infants with invasive bacterial infection, 11% were resistant to third-generation cephalosporins alone.
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Antibacterianos/uso terapéutico , Bacterias/aislamiento & purificación , Infecciones Bacterianas/epidemiología , Servicio de Urgencia en Hospital , Infecciones Bacterianas/tratamiento farmacológico , Infecciones Bacterianas/microbiología , Estudios Transversales , Femenino , Humanos , Incidencia , Lactante , Recién Nacido , Masculino , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
This article is one of ten reviews selected from the Annual Update in Intensive Care and Emergency Medicine 2017. Other selected articles can be found online at http://ccforum.com/series/annualupdate2017 . Further information about the Annual Update in Intensive Care and Emergency Medicine is available from http://www.springer.com/series/8901 .
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Infecciones Bacterianas/complicaciones , Fiebre/terapia , Virosis/complicaciones , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/terapia , Fiebre/etiología , Fiebre/historia , Historia del Siglo XX , Hospitalización , Humanos , Lactante , Recién Nacido , Padres/psicología , Guías de Práctica Clínica como Asunto , Virosis/diagnóstico , Virosis/terapiaRESUMEN
Sepsis diagnosis remains based largely on clinical presentation despite significant advances in the understanding of underlying pathophysiology and host-pathogen interactions. The systematic review article by Zonneveld and colleagues in the previous issue of Critical Care describes another potential avenue of study for using biomarkers for sepsis diagnosis and prognostication. Soluble leukocyte adhesion molecules and their associated sheddase enzymes vary in detectable levels and activity in patients in relation to immunologic status, age, and systemic inflammation, including in the setting of sepsis. Unfortunately, studies of these molecules as diagnostic or prognostic aids (or both) in sepsis have thus far been disappointing. Zonneveld and colleagues propose two potential avenues to enhance the performance characteristics of soluble adhesion molecules and their sheddases in sepsis diagnosis and prognosis: (a) identifying age-adjusted normal values for soluble leukocyte adhesion molecules and their sheddases and (b) investigating simultaneous measurement of both soluble adhesion molecules and sheddases in integrated sepsis evaluation schema. This commentary discusses the proposed solutions of Zonneveld and colleagues in more detail and outlines additional considerations that should be addressed in order to develop robust and valid diagnostic and prognostic tools for clinicians managing patients with sepsis.
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Moléculas de Adhesión Celular/sangre , Sepsis/sangre , Sepsis/fisiopatología , HumanosRESUMEN
BACKGROUND: Nearly 25% of antibiotics prescribed to children are inappropriate or unnecessary, subjecting patients to avoidable adverse medication effects and cost. METHODS: We conducted a quality improvement initiative across 118 hospitals participating in the American Academy of Pediatrics Value in Inpatient Pediatrics Network 2020 to 2022. We aimed to increase the proportion of children receiving appropriate: (1) empirical, (2) definitive, and (3) duration of antibiotic therapy for community-acquired pneumonia, skin and soft tissue infections, and urinary tract infections to ≥85% by Jan 1, 2022. Sites reviewed encounters of children >60 days old evaluated in the emergency department or hospital. Interventions included monthly audit with feedback, educational webinars, peer coaching, order sets, and a mobile app containing site-specific, antibiogram-based treatment recommendations. Sites submitted 18 months of baseline, 2-months washout, and 10 months intervention data. We performed interrupted time series (analyses for each measure. RESULTS: Sites reviewed 43 916 encounters (30 799 preintervention, 13 117 post). Overall median [interquartile range] adherence to empirical, definitive, and duration of antibiotic therapy was 67% [65% to 70%]; 74% [72% to 75%] and 61% [58% to 65%], respectively at baseline and was 72% [71% to 72%]; 79% [79% to 80%] and 71% [69% to 73%], respectively, during the intervention period. Interrupted time series revealed a 13% (95% confidence interval: 1% to 26%) intercept change at intervention for empirical therapy and a 1.1% (95% confidence interval: 0.4% to 1.9%) monthly increase in adherence per month for antibiotic duration above baseline rates. Balancing measures of care escalation and revisit or readmission did not increase. CONCLUSIONS: This multisite collaborative increased appropriate antibiotic use for community-acquired pneumonia, skin and soft tissue infections, and urinary tract infection among diverse hospitals.
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Antibacterianos , Mejoramiento de la Calidad , Infecciones Urinarias , Humanos , Antibacterianos/uso terapéutico , Infecciones Urinarias/tratamiento farmacológico , Niño , Estados Unidos , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Preescolar , Lactante , Programas de Optimización del Uso de los Antimicrobianos , Infecciones de los Tejidos Blandos/tratamiento farmacológico , Neumonía/tratamiento farmacológico , Femenino , Adhesión a Directriz , Pautas de la Práctica en Medicina , Prescripción Inadecuada/prevención & control , MasculinoRESUMEN
OBJECTIVES: Addressing parental/caregivers' coronavirus disease 2019 (COVID-19) vaccine hesitancy is critical to improving vaccine uptake in children. Common concerns have been previously reported through online surveys, but qualitative data from KII and focus groups may add much-needed context. Our objective was to examine factors impacting pediatric COVID-19 vaccine decision-making in Black, Spanish-speaking, and rural white parents/caregivers to inform the content design of a mobile application to improve pediatric COVID-19 vaccine uptake. METHODS: Parents/caregivers of children aged 2 to 17 years from groups disproportionately affected by COVID-19-related vaccine hesitancy (rural-dwelling persons of any race/ethnicity, urban Black persons, and Spanish-speaking persons) were included on the basis of their self-reported vaccine hesitancy and stratified by race/ethnicity. Those expressing vaccine acceptance or refusal participated in KII, and those expressing hesitancy in focus groups. Deidentified transcripts underwent discourse analysis and thematic analysis, both individually and as a collection. Themes were revised until coders reached consensus. RESULTS: Overall, 36 participants completed the study: 4 vaccine acceptors and 4 refusers via KIIs, and the remaining 28 participated in focus groups. Participants from all focus groups expressed that they would listen to their doctor for information about COVID-19 vaccines. Infertility was a common concern, along with general concerns about vaccines. Vaccine decision-making was informed by the amount of information available to parents/caregivers, including scientific research; possible positive and negative long-term effects; and potential impacts of vaccination on preexisting medical conditions. CONCLUSIONS: Parents/caregivers report numerous addressable vaccine concerns. Our results will inform specific, targeted interventions for improving COVID-19 vaccine confidence.
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Vacunas contra la COVID-19 , COVID-19 , Humanos , Niño , COVID-19/prevención & control , Investigación Cualitativa , Grupos Focales , Padres , VacunaciónRESUMEN
BACKGROUND AND OBJECTIVES: Recommendations for parenteral antibiotic therapy duration in bacterial meningitis in young infants are based predominantly on expert consensus. Prolonged durations are generally provided for proven and suspected meningitis and are associated with considerable costs and risks. The objective of the study was to review the literature on the duration of parenteral antibiotic therapy and outcomes of bacterial meningitis in infants <3 months old. METHODS: We searched PubMed, Embase, and the Cochrane Library for publications until May 31, 2021. Eligible studies were published in English and included infants <3 months old with bacterial meningitis for which the route and duration of antibiotic therapy and data on at least 1 outcome (relapse rates, mortality, adverse events, duration of hospitalization, or neurologic sequelae) were reported. RESULTS: Thirty-two studies were included: 1 randomized controlled trial, 25 cohort studies, and 6 case series. The randomized controlled trial found no difference in treatment failure rates between 10 and 14 days of therapy. One cohort study concluded that antibiotic courses >21 days were not associated with improved outcomes as compared with shorter courses. The remaining studies had small sample sizes and/or did not stratify outcomes by therapy duration. Meta-analysis was not possible because of the heterogeneity of the treatments and reported outcomes. CONCLUSIONS: Rigorous, prospective clinical trial data are lacking to determine the optimal parenteral antibiotic duration in bacterial meningitis in young infants. Given the associated costs and risks, there is a pressing need for high-quality comparative effectiveness research to further study this question.
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Antibacterianos , Meningitis Bacterianas , Humanos , Lactante , Estudios de Cohortes , Estudios Prospectivos , Antibacterianos/uso terapéutico , Meningitis Bacterianas/tratamiento farmacológicoRESUMEN
Introduction: Pediatric clinical trials are difficult to conduct, leading to off-label use of medication in children based on results of trials with adults. As a unique population, children deserve to have appropriately tested therapies. The purpose of this study was to evaluate pediatric caregivers' beliefs and perceived barriers to participation in clinical trials. Methods: The study was completed within the Sunflower Pediatric Clinical Trials Research Extension (SPeCTRE), an affiliate of the IDeA States Pediatric Clinical Trials Network (ISPCTN). This was a cross-sectional survey, adapted from the Pediatric Research Participation Questionnaire. A convenience sample of pediatric caregivers was recruited in three areas of a highly rural Midwestern state between 2017 and 2018. Results: A total of 159 caregivers completed surveys; the majority (72.3%) were previously familiar with clinical trials, but less than 20% had ever been invited to participate. Caregivers were willing to consider enrolling their child if a physician in whom they had high trust recommended the trials (H = 10.1, p = 0.04) and if there were perceived benefits, such as access to tests and medications not covered by insurance (correlation coefficient [CC] = 0.4, p < 0.01) and compensation for time and travel (CC = 0.3, p = 0.04). Conclusions: Trust in their physician highly influences likelihood of a caregiver consenting to have their child participate in a clinical trial. Therefore, to facilitate opportunities for children to participate in clinical trials, physicians need to be trained so they can offer trials locally. In addition, trials need to offer benefits, such as increased access to tests and medications as well as appropriate compensation.
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BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. METHODS: Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. DISCUSSION: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT05386355 . Registered on May 23, 2022.
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COVID-19 , Telemedicina , Vacunas , Niño , Humanos , Vacunas contra la COVID-19 , Pandemias/prevención & control , COVID-19/prevención & control , Vacunación , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Importance: To our knowledge, there are no published randomized clinical trials of recruitment strategies. Rigorously evaluated successful recruitment strategies for children are needed. Objective: To evaluate the feasibility of 2 recruitment methods for enrolling rural children through primary care clinics to assess whether either or both methods are sufficiently effective for enrolling participants into a clinical trial of a behavioral telehealth intervention for children with overweight or obesity. Design, Setting, and Participants: This cluster-randomized clinical trial of 2 recruitment methods was conducted at 4 primary care clinics in 4 separate states. Each clinic used both recruitment methods in random order. Clinic eligibility criteria included at least 40% pediatric patients with Medicaid coverage and at least 100 potential participants. Eligibility criteria for children included a rural home address, age 6 to 11 years, and body mass index at or above the 85th percentile. Recruitment began February 3, 2020, and randomization of participants occurred on August 17, 2020. Data were analyzed from October 3, 2021, to April 21, 2022. Interventions: Two recruitment methods were assessed: the active method, for which a list of potential participants seen within the past year at each clinic was generated through the electronic health record and consecutively approached by research staff based on visit date to the clinic, and the traditional method, for which recruitment included posters, flyers, social media, and press release. Clinics were randomized to the order in which the 2 methods were implemented in 4-week periods, followed by a 4-week catch-up period using the method found most effective in previous periods. Main Outcomes and Measures: For each recruitment method, the number and proportion of randomized children among those who were approached was calculated. Results: A total of 104 participants were randomized (58 girls [55.8%]; mean age, 9.3 [95% CI, 9.0-9.6] years). Using the active method, 535 child-parent dyads were approached and 99 (18.5% [95% CI, 15.3%-22.1%]) were randomized. Using the traditional method, 23 caregivers expressed interest, and 5 (21.7% [95% CI, 7.5%-43.7%]) were randomized. All sites reached full enrollment using the active method and no sites achieved full enrollment using the traditional method. Mean time to full enrollment was 26.3 (range, 21.0-31.0) days. Conclusions and Relevance: This study supports the use of the active approach with local primary care clinics to recruit children with overweight and obesity from rural communities into clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04142034.
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Sobrepeso , Población Rural , Femenino , Estados Unidos , Humanos , Niño , Índice de Masa Corporal , Obesidad , Atención Primaria de SaludAsunto(s)
Cultivo de Sangre , Infecciones Comunitarias Adquiridas/sangre , Niño , Humanos , NeumoníaRESUMEN
BACKGROUND AND OBJECTIVES: Data on invasive bacterial infection (IBI), defined as bacteremia and/or bacterial meningitis, in febrile infants aged <60 days old primarily derive from smaller, dated studies conducted at large, university-affiliated medical centers. Our objective with the current study was to determine current prevalence and epidemiology of IBI from a contemporary, national cohort of well-appearing, febrile infants at university-affiliated and community-based hospitals. PATIENTS AND METHODS: Retrospective review of well-appearing, febrile infants aged 7 to 60 days was performed across 31 community-based and 44 university-affiliated centers from September 2015 to December 2017. Blood and cerebrospinal fluid bacterial culture results were reviewed and categorized by using a priori criteria for pathogenic organisms. Prevalence estimates and subgroup comparisons were made by using descriptive statistics. RESULTS: A total of 10 618 febrile infants met inclusion criteria; cerebrospinal fluid and blood cultures were tested from 6747 and 10 581 infants, respectively. Overall, meningitis prevalence was 0.4% (95% confidence interval [CI]: 0.2-0.5); bacteremia prevalence was 2.4% (95% CI: 2.1-2.7). Neonates aged 7 to 30 days had significantly higher prevalence of bacteremia, as compared with infants in the second month of life. IBI prevalence did not differ between community-based and university-affiliated hospitals (2.7% [95% CI: 2.3-3.1] vs 2.1% [95% CI: 1.7-2.6]). Escherichia coli and Streptococcus agalactiae were the most commonly identified organisms. CONCLUSIONS: This contemporary study of well-appearing, febrile infants supports previous epidemiological estimates of IBI prevalence and suggests that the prevalence of IBI may be similar among community-based and university-affiliated hospitals. These results can be used to aid future clinical guidelines and prediction tool development.
Asunto(s)
Bacteriemia , Infecciones Bacterianas , Meningitis Bacterianas , Bacteriemia/diagnóstico , Bacteriemia/epidemiología , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/epidemiología , Fiebre/epidemiología , Humanos , Lactante , Recién Nacido , Meningitis Bacterianas/diagnóstico , Meningitis Bacterianas/epidemiología , Prevalencia , Estudios RetrospectivosRESUMEN
OBJECTIVE: Variation in bronchiolitis management by race and ethnicity within emergency departments (EDs) has been described in single-center and prospective studies, but large-scale assessments across EDs and inpatient settings are lacking. Our objective is to describe the association between race and ethnicity and bronchiolitis management across 37 U.S. freestanding children's hospitals from 2015 to 2018. METHODS: Using the Pediatric Health Information System, we analyzed ED and inpatient visits from November 2015 to November 2018 of children with bronchiolitis 3 to 24 months old. Rates of use for specific diagnostic tests and therapeutic measures were compared across the following race/ethnicity categories: 1) non-Hispanic White (NHW), 2) non-Hispanic Black (NHB), 3) Hispanic, and 4) other. The subanalyses of ED patients only and children < 1 year old were performed. Mixed-effect logistic regression was performed to compare the adjusted odds of receiving specific test/treatment using NHW children as the reference group. RESULTS: A total of 134,487 patients met inclusion criteria (59% male, 28% NHB, 26% Hispanic). Adjusted analysis showed that NHB children had higher odds of receiving medication associated with asthma (odds ratio [OR] = 1.27, 95% confidence interval [CI] = 1.22 to 1.32) and lower odds of receiving diagnostic tests (blood cultures, complete blood counts, viral testing, chest x-rays; OR = 0.78, 95% CI = 0.75 to 0.81) and antibiotics (OR = 0.58, 95% CI = 0.52 to 0.64) than NHW children. Hispanic children had lower odds of receiving diagnostic testing (OR = 0.94, 95% CI = 0.90 to 0.98), asthma-associated medication (OR = 0.92, 95% CI = 0.88 to 0.96), and antibiotics (OR = 0.74, 95% CI = 0.66 to 0.82) compared to NHW children. CONCLUSION: NHB children more often receive corticosteroid and bronchodilator therapies; NHW children more often receive antibiotics and chest radiography. Given that current guidelines generally recommend supportive care with limited diagnostic testing and medical intervention, these findings among NHB and NHW children represent differing patterns of overtreatment. The underlying causes of these patterns require further investigation.