Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions: A Consensus Statement.

Importance: There is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions. Objective: To identify the most important and feasible RCT questions for children hospitalized with common conditions. Design, Setting, and Participants: For this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to September 29, 2022. Forty-six individuals from 30 different institutions participated in the process. Stage 1 involved construction of RCT questions for the 10 most common pediatric conditions leading to hospitalization. Participants used condition-specific guidelines and reviews from a structured literature search to inform their development of RCT questions. During stage 2, RCT questions were refined and scored according to importance. Stage 3 incorporated public comment and feasibility with the prioritization of RCT questions. Main Outcomes and Measures: The main outcome was RCT questions framed in a PICO (population, intervention, control, and outcome) format and ranked according to importance and feasibility; score choices ranged from 1 to 9, with higher scores indicating greater importance and feasibility. Results: Forty-six individuals (38 who shared demographic data; 24 women [63%]) from 30 different institutions participated in our modified Delphi process. Participants included children's hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (n = 2), biostatisticians (n = 2), and other researchers (n = 11). The process yielded 62 unique RCT questions, most of which are pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Overall scores for importance and feasibility of the RCT questions ranged from 1 to 9, with a median of 5 (IQR, 4-7). Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis). Conclusions and Relevance: This consensus statementhas identified the most important and feasible RCT questions for children hospitalized with common conditions. This list of RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for hospitalized children.

Improving Guideline-Concordant Care for Febrile Infants Through a Quality Improvement Initiative.

OBJECTIVES: We aimed to examine the impact of a quality improvement (QI) collaborative on adherence to specific recommendations within the American Academy of Pediatrics' Clinical Practice Guideline (CPG) for well-appearing febrile infants aged 8 to 60 days. METHODS: Concurrent with CPG release in August 2021, we initiated a QI collaborative involving 103 general and children's hospitals across the United States and Canada. We developed a multifaceted intervention bundle to improve adherence to CPG recommendations for 4 primary measures and 4 secondary measures, while tracking 5 balancing measures. Primary measures focused on guideline recommendations where deimplementation strategies were indicated. We analyzed data using statistical process control (SPC) with baseline and project enrollment from November 2020 to October 2021 and the intervention from November 2021 to October 2022. RESULTS: Within the final analysis, there were 17 708 infants included. SPC demonstrated improvement across primary and secondary measures. Specifically, the primary measures of appropriately not obtaining cerebrospinal fluid in qualifying infants and appropriately not administering antibiotics had the highest adherence at the end of the collaborative (92.4% and 90.0% respectively). Secondary measures on parent engagement for emergency department discharge of infants 22 to 28 days and oral antibiotics for infants 29 to 60 days with positive urinalyses demonstrated the greatest changes with collaborative-wide improvements of 16.0% and 20.4% respectively. Balancing measures showed no change in missed invasive bacterial infections. CONCLUSIONS: A QI collaborative with a multifaceted intervention bundle was associated with improvements in adherence to several recommendations from the AAP CPG for febrile infants.

Direct Admission Program Implementation: A Qualitative Analysis of Variation Across Health Systems.

OBJECTIVES: Direct admission (DA) to the hospital has the potential to improve family satisfaction and timeliness of care by bypassing the emergency department. Using the RE-AIM implementation framework, we sought to characterize variation across health systems in the reach, effectiveness, adoption, and implementation of a DA program from the perspectives of parents and multidisciplinary clinicians. METHODS: As part of a stepped-wedge cluster randomized trial to compare the effectiveness of DA to admission through the emergency department, we evaluated DA rates across 69 clinics and 3 health systems and conducted semi-structured interviews with parents and clinicians. We used thematic analysis to identify themes related to the reach, effectiveness, adoption, and implementation of the DA program and applied axial coding to characterize thematic differences across sites. RESULTS: Of 2599 hospitalizations, 171 (6.6%) occurred via DA, with DA rates varying 10-fold across health systems from 0.9% to 9.3%. Through the analysis of 137 interviews, including 84 with clinicians and 53 with parents, we identified similarities across health systems in themes related to perceived program effectiveness and patient and family engagement. Thematic differences across sites in the domains of program implementation and clinician adoption included variation in transfer center efficiency, trust between referring and accepting clinicians, and the culture of change within the health system. CONCLUSIONS: The DA program was adopted variably, highlighting unique challenges and opportunities for implementation in different hospital systems. These findings can inform future quality improvement efforts to improve transitions to the hospital.

Trends in Distance Traveled for Common Pediatric Conditions for Rural-Residing Children.

This cohort study uses state inpatient data to assess changes in distance traveled over time for hospitalization of common pediatric conditions in rural-residing children.

Pediatric Hospitalization Trends at Children's and General Hospitals, 2000-2019.

This study examines whether pediatric inpatient care has been redistributed from general hospitals into children's hospitals.

Development of the Pediatric Hospitalization Admission Survey of Experience (PHASE) Measure.

BACKGROUND: Although significant research is devoted to transitions of care at discharge, few measures assess the quality of transitions into the hospital. Our objective was to develop a caregiver-reported quality measure to evaluate the pediatric hospital admission experience. METHODS: Measure development included: (1) adapting items from existing instruments; (2) an expert-consensus process to prioritize survey items; (3) cognitive pretesting with caregivers (n = 16); and (4) pilot testing revised items (n = 27). Subsequently, the survey was administered to caregivers at 2 children's hospitals and 1 general hospital from February 2020 through November 2021. Item reduction statistics and exploratory factor analysis were performed followed by confirmatory factor analysis. Domain scores were calculated using a top-box approach. Known-group validity and indices of model fit were evaluated. RESULTS: The initial survey included 25 items completed by 910 caregivers. Following item reduction and the exploratory factor analysis, 14 items were mapped to 4 domains: (1) Patient and Family Engagement, (2) Information Sharing, (3) Effectiveness of Care Delivery, and (4) Timeliness of Care. The confirmatory factor analysis and validity testing supported the factor structure. Domain scores ranged from 49% (95% confidence interval, 46-53) for Timelines of Care to 81% (95% confidence interval, 65-84) for Patient and Family Engagement, with significant differences between general and children's hospitals in Information Sharing and Effectiveness of Care Delivery. CONCLUSIONS: A 4-domain caregiver-reported hospital admission experience measure demonstrated acceptable validity and psychometric properties across children's and general hospitals. This measure can be used to evaluate the quality of transitions into the hospital and to focus quality improvement efforts.

Prevalence of Urinary Tract Infection, Bacteremia, and Meningitis Among Febrile Infants Aged 8 to 60 Days With SARS-CoV-2.

Importance: The prevalence of urinary tract infection (UTI), bacteremia, and bacterial meningitis in febrile infants with SARS-CoV-2 is largely unknown. Knowledge of the prevalence of these bacterial infections among febrile infants with SARS-CoV-2 can inform clinical decision-making. Objective: To describe the prevalence of UTI, bacteremia, and bacterial meningitis among febrile infants aged 8 to 60 days with SARS-CoV-2 vs without SARS-CoV-2. Design, Setting, and Participants: This multicenter cross-sectional study was conducted as part of a quality improvement initiative at 106 hospitals in the US and Canada. Participants included full-term, previously healthy, well-appearing infants aged 8 to 60 days without bronchiolitis and with a temperature of at least 38 °C who underwent SARS-CoV-2 testing in the emergency department or hospital between November 1, 2020, and October 31, 2022. Statistical analysis was performed from September 2022 to March 2023. Exposures: SARS-CoV-2 positivity and, for SARS-CoV-2-positive infants, the presence of normal vs abnormal inflammatory marker (IM) levels. Main Outcomes and Measures: Outcomes were ascertained by medical record review and included the prevalence of UTI, bacteremia without meningitis, and bacterial meningitis. The proportion of infants who were SARS-CoV-2 positive vs negative was calculated for each infection type, and stratified by age group and normal vs abnormal IMs. Results: Among 14 402 febrile infants with SARS-CoV-2 testing, 8413 (58.4%) were aged 29 to 60 days; 8143 (56.5%) were male; and 3753 (26.1%) tested positive. Compared with infants who tested negative, a lower proportion of infants who tested positive for SARS-CoV-2 had UTI (0.8% [95% CI, 0.5%-1.1%]) vs 7.6% [95% CI, 7.1%-8.1%]), bacteremia without meningitis (0.2% [95% CI, 0.1%-0.3%] vs 2.1% [95% CI, 1.8%-2.4%]), and bacterial meningitis (<0.1% [95% CI, 0%-0.2%] vs 0.5% [95% CI, 0.4%-0.6%]). Among infants aged 29 to 60 days who tested positive for SARS-CoV-2, 0.4% (95% CI, 0.2%-0.7%) had UTI, less than 0.1% (95% CI, 0%-0.2%) had bacteremia, and less than 0.1% (95% CI, 0%-0.1%) had meningitis. Among SARS-CoV-2-positive infants, a lower proportion of those with normal IMs had bacteremia and/or bacterial meningitis compared with those with abnormal IMs (<0.1% [0%-0.2%] vs 1.8% [0.6%-3.1%]). Conclusions and Relevance: The prevalence of UTI, bacteremia, and bacterial meningitis was lower for febrile infants who tested positive for SARS-CoV-2, particularly infants aged 29 to 60 days and those with normal IMs. These findings may help inform management of certain febrile infants who test positive for SARS-CoV-2.

Urban-rural disparities in interfacility transfers for children during COVID-19.

PURPOSE: We aimed to identify temporal trends and differences in urban and rural pediatric interfacility transfers (IFTs) before and during the COVID-19 pandemic. METHODS: We conducted a cross-sectional analysis of IFT among children <18 years from January 2019 to June 2022 using the Pediatric Health Information System. The primary outcome was IFTs from general hospitals to referral children's hospitals. The primary exposure was patient rurality, defined by Rural-Urban Commuting Area codes. We categorized IFTs into medical, surgical, and mental health diagnoses and analyzed trends by month. We calculated observed-to-expected (O-E) ratios of pre-pandemic (March 2019-Feb 2020) transfers compared to pandemic year 1 (March 2020-Feb 2021) and year 2 (March 2021-February 2022) using Poisson modeling. FINDINGS: Of 419,250 IFTs, 18.8% (n = 78,751) were experienced by rural-residing children. The O-E ratio of IFT in year 1 for urban children was 14.0% (95% confidence interval [CI] 13.8, 14.2) and 14.8% (95% CI 14.4, 15.3) for rural children compared to pre-pandemic (P = .0001). In year 2, transfers rebounded with IFTs for rural-residing children increasing more than urban-residing children (101.7% [95% CI 100.1, 103.4] compared to 90.7% [95% CI 89.0, 90.4], P < .0001). For mental-health indications in year 2, rural transfer ratios were higher than urban, 126.8% (95% CI, 116.7, 137.6) compared to 113.7% (95% CI 109.9, 117.6), P = .0168. CONCLUSIONS: Pediatric IFTs decreased dramatically during pandemic year 1. In year 2, while medical and surgical transfers continued to lag pre-pandemic volumes, transfers for mental health indications significantly exceeded pre-pandemic levels, particularly among rural-residing children.

Trends in Prevalence of Bacterial Infections in Febrile Infants During the COVID-19 Pandemic.

OBJECTIVES: Our objective was to describe the prevalence of urinary tract infection (UTI) and invasive bacterial infection (IBI) in febrile infants during the coronavirus disease 2019 pandemic. METHODS: We conducted a multicenter cross-sectional study that included 97 hospitals in the United States and Canada. We included full-term, well-appearing infants 8 to 60 days old with a temperature of ≥38°C and an emergency department visit or hospitalization at a participating site between November 1, 2020 and March 31, 2022. We used logistic regression to determine trends in the odds of an infant having UTI and IBI by study month and to determine the association of COVID-19 prevalence with the odds of an infant having UTI and IBI. RESULTS: We included 9112 infants; 603 (6.6%) had UTI, 163 (1.8%) had bacteremia without meningitis, and 43 (0.5%) had bacterial meningitis. UTI prevalence decreased from 11.2% in November 2020 to 3.0% in January 2022. IBI prevalence was highest in February 2021 (6.1%) and decreased to 0.4% in January 2022. There was a significant downward monthly trend for odds of UTI (odds ratio [OR] 0.93; 95% confidence interval [CI]: 0.91-0.94) and IBI (OR 0.90; 95% CI: 0.87-0.93). For every 5% increase in COVID-19 prevalence in the month of presentation, the odds of an infant having UTI (OR 0.97; 95% CI: 0.96-0.98) or bacteremia without meningitis decreased (OR 0.94; 95% CI: 0.88-0.99). CONCLUSIONS: The prevalence of UTI and IBI in eligible febrile infants decreased to previously published, prepandemic levels by early 2022. Higher monthly COVID-19 prevalence was associated with lower odds of UTI and bacteremia.

HEROIC Trials to Answer Pragmatic Questions for Hospitalized Children.

Although the number of randomized controlled trials (RCTs) published each year involving adult populations is steadily rising, the annual number of RCTs published involving pediatric populations has not changed since 2005. Barriers to the broader utilization of RCTs in pediatrics include a lower prevalence of disease, less available funding, and more complicated regulatory requirements. Although child health researchers have been successful in overcoming these barriers for isolated diseases such as pediatric cancer, common pediatric diseases are underrepresented in RCTs relative to their burden. This article proposes a strategy called High-Efficiency RandOmIzed Controlled (HEROIC) trials to increase RCTs focused on common diseases among hospitalized children. HEROIC trials are multicenter RCTs that pursue the rapid, low-cost accumulation of study participants with minimal burden for individual sites. Five key strategies distinguish HEROIC trials: (1) dispersed low-volume recruitment, in which a large number of sites (50-150 hospitals) enroll a small number of participants per site (2-10 participants per site), (2) incentivizing site leads with authorship, training, education credits, and modest financial support, (3) a focus on pragmatic questions that examine simple, widely used interventions, (4) the use of a single institutional review board, integrated consent, and other efficient solutions to regulatory requirements, and (5) scaling the HEROIC trial strategy to accomplish multiple trials simultaneously. HEROIC trials can boost RCT feasibility and volume to answer fundamental clinical questions and improve care for hospitalized children.

Understanding trust between pediatric hospitalists and outpatient clinicians during hospital admissions: A multisite qualitative analysis.

BACKGROUND: During transitions between sites of care, clinicians must build trust with colleagues to make decisions that ensure safe, high-quality care. OBJECTIVES: This study explored factors that could influence trust between outpatient clinicians and pediatric hospitalists when children are referred for hospital admission. DESIGN, SETTING, AND PARTICIPANTS: We conducted an analysis of 41 semistructured interviews with outpatient clinicians and pediatric hospitalists from May 2020 through October 2021 across three healthcare systems participating in a multisite comparative effectiveness study of pediatric direct and emergency department admissions. INTERVENTION, MAIN OUTCOMES, AND MEASURES: Qualitative interviews. A conceptual model for trust between outpatient clinicians and pediatric hospitalists during hospital admission referral. Interviews were professionally transcribed, verified for accuracy, and analyzed using a combination of inductive and deductive. RESULTS: We identified two primary domains: (1) interpersonal trust and (2) trust-by-proxy. Interpersonal trust included five relational factors that influenced collaboration between clinicians: antecedent relationships, confidence in others clinical abilities, understanding others' practice culture, recognition of available resources, and power dynamic. An individual clinicians' assessment of risk and past clinical experiences also influenced trust during clinical decision-making. Trust-by-proxy represented system-level factors that could influence trust, independent of any pre-existing relationships, including communication infrastructure, guidelines and protocols, the organizational culture, and professional courtesy. CONCLUSION: Interpersonal and system-level factors influence trust between outpatient clinicians and hospitalists during decision-making encounters. System-level factors may serve as a proxy for trust when clinicians do not have pre-existing interpersonal relationships. These factors could be explored as an explicit target of interventions to improve interdisciplinary collaboration and decision-making between hospitalists and primary care clinicians.

Impact of Diagnostic Criteria on UTI Prevalence in Young Infants With Jaundice: A Meta-analysis.

BACKGROUND AND OBJECTIVE: Previously reported prevalence of urinary tract infections (UTIs) in infants with jaundice range from <1% to 25%. However, UTI criteria are variable and, as demonstrated in a meta-analysis on UTI prevalence in bronchiolitis, disease prevalence is greatly impacted by disease definition. The objective of this study was to conduct a systemic review and meta-analysis examining the impact of including positive urinalysis (UA) results as a diagnostic criterion on the estimated UTI prevalence in young infants with jaundice. METHODS: The data sources used were Medline (1946-2020) and Ovid Embase (1976-2020) through January 2020 and bibliographies of retrieved articles. We selected studies reporting UTI prevalence in young infants with jaundice. Data were extracted in accordance with meta-analysis of observational studies in epidemiology guidelines. Random-effects models produced a weighted pooled event rate with 95% confidence intervals (CI). RESULTS: We screened 526 unique articles by abstract and reviewed 53 full-text articles. We included 32 studies and 16 contained UA data. The overall UTI prevalence in young infants with jaundice from all 32 studies was 6.2% (95% CI, 3.9-8.9). From the 16 studies with UA data, the overall UTI prevalence was 8.7% (95% CI, 5.1-13.2), which decreased to 3.6% (95% CI, 2.0-5.8) with positive UA results included as a diagnostic criterion. CONCLUSIONS: The estimated UTI prevalence in young infants with jaundice decreases substantially when UA results are incorporated into the UTI definition. Due to the heterogeneity of study subjects' ages and definitions of jaundice, positive UA results, and UTI, there is uncertainty about the exact prevalence and about which infants with hyperbilirubinemia warrant urine testing.

Behavioral and Psychological Aspects of the Physician Experience with Deimplementation.

INTRODUCTION: Deimplementation, or the structured elimination of non-evidence-based practices, faces challenges distinct from those associated with implementation efforts. These barriers may be related to intrinsic psychological factors, as perceptions and emotions surrounding the discontinuation of established practices appear to differ from those associated with practice adoption. This study aims to explore barriers and facilitators experienced by pediatric clinicians engaging in deimplementation projects. METHODS: We used behavioral economics concepts to inform our qualitative study design following a theory-informed inductive approach. We conducted semistructured interviews with participants from two national quality improvement collaboratives where the primary outcomes were deimplementation measures. Using purposeful sampling, we recruited project leaders at institutions in the top and bottom quartiles from within each collaborative. Finally, we conducted a thematic analysis using a combination of inductive and deductive coding. RESULTS: In total, we interviewed participants from 12 high-performing sites and 7 low-performing sites. Participants identified nine concepts associated with successful deimplementation practice and three psychological barriers that impacted behavior change: (1) loss, (2) fear, and (3) action bias. Participants further identified four overarching strategies for mitigating the identified psychological barriers, including (1) making allowance for nonconformism; (2) permission to change; (3) normalizing; and (4) reframing. CONCLUSION: There is potential for more effective deimplementation through the proactive incorporation of an awareness of specific psychological barriers of loss, fear, and action bias, as well as specific mitigation strategies to address the psychocognitive experience.

Healthcare Quality for Acute Illness during the COVID-19 Pandemic: A Multisite Qualitative Analysis.

The coronavirus disease 2019 (COVID-19) pandemic incited substantial changes to acute care delivery, including the rapid scale-up of telehealth and numerous changes to in-person care. This study explored health system changes associated with the COVID-19 pandemic and their influences on pediatric acute care delivery and quality of care. METHODS: We conducted 38 semistructured interviews May-November 2020 with families and clinicians from 3 US regions, eliciting their perspectives and experiences regarding changes to acute care delivery during the pandemic. Interviews were analyzed using a general inductive approach to identify relationships between clinical care infrastructure, care processes, and healthcare quality. RESULTS: Emerging knowledge of COVID-19 epidemiology and associated restrictions influenced care-seeking behaviors and clinical infrastructure and processes. Infrastructure changes included the closure of some clinics, limited "sick visit" hours and locations, and increased resources for telehealth. Modified care processes included the assignment of clinicians to specific roles, limitations on sibling attendance, increased referrals to other clinics, and iterative development of procedures and protocols. Although intended to increase safety, these changes appear to have decreased access, timeliness, and equity of care. High-quality care was supported by telephone triage processes, in-person visits following initial assessments by telehealth, and identification of diagnoses and populations best-suited to telehealth versus in-person care. CONCLUSIONS: Changes in acute care delivery during the COVID-19 pandemic may have negatively impacted healthcare quality in some domains. Implementation of pediatric-specific guidelines and decision aids describing diagnoses, populations, and procedures best-suited to telehealth may improve the quality of acute care delivery.

Strategies to Improve the Quality of Team-Based Care for Neonatal Abstinence Syndrome.

BACKGROUND: Prioritizing nonpharmacologic care for neonatal abstinence syndrome (NAS) requires a team-based care (TBC) approach to facilitate staff and family engagement. We aimed to identify the important structures and processes of care for TBC of infants with NAS and quality of care outcomes that are meaningful to care team members (including parents). METHODS: Using a Donabedian framework, we conducted semistructured interviews from May to October 2019 with care team members at 3 community hospitals, including parents, nurses, social workers, physicians, lactation nurses, child protective services, volunteers, and hospital administrators. We used thematic analysis to identify important structures, processes of care, and outcomes. RESULTS: We interviewed 45 interprofessional care team members: 35 providers and 10 parents. Structures critical to providing TBC included (1) building a comprehensive network of interprofessional team members and (2) creating an NAS specialized unit. Necessary processes of care included (1) prioritizing early involvement of interprofessional team members, (2) emphasizing nonjudgmental incorporation of previous experience with addiction, (3) establishing clear roles and expectations, and (4) maintaining transparency with social services. Lastly, we identified 9 outcomes resulting from these identified structures and processes that are meaningful to care team members to assess the quality of care for infants with NAS. CONCLUSIONS: In this study, we identify important structures, processes of care, and meaningful outcomes to enhance and evaluate TBC for infants with NAS. Hospitals that adopt and implement these structures and processes have the potential to improve the quality of care for infants, caregivers, and providers who care for these infants.

Pediatric Conditions Requiring Minimal Intervention or Observation After Interfacility Transfer.

Increasing regionalization of pediatric care has led to interfacility transfer of children with general pediatric conditions at rates similar to those of high-risk adults, which may delay appropriate treatment. We sought to identify common medical diagnoses that did not require significant advanced intervention and that had high rates of discharge within 1 day of interfacility transfer. Using the Pediatric Health Information System (PHIS) database, we identified all transfers into PHIS-participating children's hospitals in 2019. We excluded encounters for mental health, labor/maternity, primary newborn diagnoses, and direct admissions to an intensive care unit. Eligible encounters were categorized by duration of hospitalization and basic vs advanced intervention after transfer. Of 286,905 transfers, 197,386 (68.6%) met inclusion criteria. Cough, febrile seizures, croup, and allergic reactions required advanced interventions <10% of the time, and patients with these diagnoses were most commonly discharged within 1 day after transfer. These conditions are potential targets for building pediatric capacity in non-pediatric hospitals.