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Association Between Pediatric Clinical Trials and Global Burden of Disease

Fewer clinical trials are performed in children compared with other patient populations. It is unknown how well existing pediatric clinical trials are aligned with the needs of children, both in high-income countries and globally.

There is only moderate correlation between clinical trial activity and pediatric burden of disease, with certain conditions substantially underrepresented in the current research portfolio. Our findings provide a benchmark for prioritizing conditions for study, analyzing gaps, and identifying funding priorities. (Read the full article)




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Two-Year Impact of the Alternative Quality Contract on Pediatric Health Care Quality and Spending

Payment arrangements that blend global budgets with pay-for-performance are proliferating. However, little is known about how these contracts affect pediatric health care quality and spending for children with and without special health care needs receiving care from large provider organizations.

A prototypical global budget contract significantly improved preventive care quality measures tied to pay-for-performance, especially for children with special health care needs. It did not alter trends for spending or for quality measures that were not tied to pay-for-performance. (Read the full article)




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Outcomes in Hospitalized Pediatric Patients With Systemic Lupus Erythematosus

Systematic health disparities in adults with systemic lupus erythematosus are well documented and are likely driven by biologic as well as modifiable factors. Sociodemographic factors and health care delivery characteristics have been associated with poor outcomes.

In hospitalized children with systemic lupus erythematosus, race and ethnicity were associated with increased risk for ICU admissions, end-stage renal disease, and death. Identification of sociodemographic factors associated with outcomes is important to address the needs of these vulnerable patients. (Read the full article)




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Xylitol Syrup for the Prevention of Acute Otitis Media

Xylitol given as a gum or syrup 5 times daily has been shown to reduce the incidence of acute otitis media in children, but this dosing schedule is unlikely to be feasible for many families.

A regimen of viscous xylitol syrup in a dose of 5 g 3 times daily was ineffective in preventing recurrences of acute otitis media in otitis-prone children. (Read the full article)




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Adherence to Label and Device Recommendations for Over-the-Counter Pediatric Liquid Medications

Due to reports of unintentional overdoses, in 2011 the US Food and Drug Administration finalized voluntary recommendations for dosing devices included with over-the-counter (OTC) liquid medications. The Consumer Healthcare Products Association previously endorsed similar recommendations for devices and dosing directions.

This study assessed dosing directions and devices for national brand name OTC liquid medications, available after a voluntary FDA guidance, and found high levels of adherence to most recommendations. Further improvement efforts should prioritize recommendations directly addressing potential dosing errors. (Read the full article)




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Association of Maternal Self-Medication and Over-the-Counter Analgesics for Children

Self-medication with over-the-counter (OTC) analgesics, particularly paracetamol (PCM), among children is widespread and increasing. Parents often administer the medicine. The health care system has little knowledge or possibility to regulate OTC medication, and use of PCM for children may be partly unjustified.

Maternal frequent self-medication with OTC analgesics is associated with frequent use of OTC analgesics, particularly PCM, among 6- to 11-year-old schoolchildren, even when the child’s frequency of pain is accounted for. (Read the full article)




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Management of Febrile Neonates in US Pediatric Emergency Departments

Recommended management of febrile neonates (≤28 days) includes blood, urine, and cerebrospinal fluid cultures with hospital admission for antibiotic therapy. No study has reported adherence to standard recommendations in the management of febrile neonates in US pediatric emergency departments.

There is wide variation in adherence to recommended management of febrile neonates. High rates of serious infections in admitted patients but low return rates for missed infections in discharged patients suggest additional studies needed to understand variation from current recommendations. (Read the full article)




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A Pacifier-Activated Music Player With Mother's Voice Improves Oral Feeding in Preterm Infants

Preterm infants must develop oral feeding skills before successfully transitioning to home. Pacifier-activated devices playing selected music can improve nonnutritive sucking in preterm infants. A mother’s voice is a positive auditory stimulus for infants.

A brief intervention with a pacifier-activated music player using mother’s voice can decrease tube feeding duration without adverse effects on stress or growth. Operant conditioning with positive reinforcement is an effective developmental strategy to improve preterm infants’ feeding skills. (Read the full article)




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Safety of Medical Interventions in Children Versus Adults

Drug use in pediatrics is often based on adult efficacy data. Clinically significant discrepancies between adults and children may exist. To our knowledge, there is no large-scale evaluation of evidence comparing rates of adverse events between adults and children.

Available evidence on the comparative safety of pharmacologic interventions in adults versus children is inconclusive. In a third of meta-analyses, twofold or greater differences were identified between adults and children, and some clinically important discrepancies were also found. (Read the full article)




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Postconcussive Symptom Exaggeration After Pediatric Mild Traumatic Brain Injury

After mild traumatic brain injury, most youth recover well. A minority of patients report persistent symptoms, which relate to both injury and noninjury factors. In adult studies, validity test performance is 1 noninjury factor that relates to persistent symptoms.

This is the first pediatric study to demonstrate that validity test failure is associated with increased symptoms after mild traumatic brain injury. The findings suggest that some symptoms conceptualized as injury-related "postconcussive" problems are better explained by exaggeration or feigning. (Read the full article)




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National Trends Over 25 Years in Pediatric Kidney Transplant Outcomes

Kidney transplantation is the optimal treatment of children with end-stage renal disease. The field of pediatric kidney transplantation has changed over time with regard to immunosuppression, surgical technique, organ allocation policy, and rates of living donor transplantation.

Outcomes after pediatric kidney transplantation in the United States have improved over time, independent of changes in recipient, donor, and transplant characteristics. These improvements were most dramatic within the first posttransplant year and among the most highly sensitized patients. (Read the full article)




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Pediatric Data Sharing in Genomic Research: Attitudes and Preferences of Parents

We previously reported that parents of children enrolled in genomic research made more restrictive data sharing (DS) decisions than adults. The ethics of pediatric DS have been discussed, but reasons for differences in decision-making have not been explored.

We present an empirically based discussion of attitudes toward and preferences for DS obtained from structured interviews of adult patients and parents of pediatric patients enrolled in genomic research studies. Parents expressed more concern about future risks than adult participants. (Read the full article)




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Attention-Deficit/Hyperactivity Disorder in Young Children: Predictors of Diagnostic Stability

Approximately 50% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD) at <7 years of age in the community do not meet criteria for ADHD over time. There is a need to examine predictors of diagnostic stability in young children with ADHD.

Predictors of diagnostic stability from early to middle childhood include child’s baseline externalizing and internalizing symptoms, parental history of psychopathology, and socioeconomic status. These predictors may guide treatment planning at the time of ADHD diagnosis. (Read the full article)




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Common and Costly Hospitalizations for Pediatric Mental Health Disorders

The pediatric mental health burden is substantial, with >4 million children meeting criteria for a mental health disorder. Mental health is a key priority for national pediatric inpatient quality measures, but little is known about admitted patients and their diagnoses.

Nationally, nearly 10% of hospitalizations in children >3 years are for primary mental health diagnoses. The most common and costly are depression, bipolar disorder, and psychosis. Fewer free-standing children’s hospitalizations (3%) were for mental health admissions, although diagnostic distributions were similar. (Read the full article)




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Racial and Ethnic Differences Associated With Feeding- and Activity-Related Behaviors in Infants

Although expert consensus and previous literature document the importance of early feeding and activity behaviors and practices in preventing obesity and the risks of early rapid weight gain, few studies have rigorously assessed obesity-related behaviors by caregivers of infants.

This study demonstrates the high prevalence of behaviors thought to increase risk for obesity in a diverse, large sample of parent/2-month-old dyads and finds that many behaviors vary by race and ethnicity, suggesting the potential for culturally tailored interventions. (Read the full article)




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Collaborative Care Outcomes for Pediatric Behavioral Health Problems: A Cluster Randomized Trial

Integrated or collaborative care intervention models have revealed gains in provider care processes and outcomes in adult, child, and adolescent populations with mental health disorders. However optimistic, conclusions are not definitive due to methodologic limitations and a dearth of studies.

This randomized trial provides further evidence for the efficacy of an on-site intervention (Doctor Office Collaborative Care) coordinated by care managers for children's behavior problems. The findings provide support for integrated behavioral health care using novel provider and caregiver outcomes. (Read the full article)




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Postmarketing Trials and Pediatric Device Approvals

Medical devices approved for adults can be used to treat children despite the lack of rigorous evidence. In 2007, Congress passed the Pediatric Medical Device Safety and Improvement Act to stimulate pediatric device development.

Most pediatric devices approved since the legislative change have had limited premarket study in children, with pediatric patients representing <10% of trial participants. Postmarketing studies required by the US Food and Drug Administration also yielded limited additional pediatric data. (Read the full article)




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Infant Self-Regulation and Early Childhood Media Exposure

Several studies suggest that excessive media use in early childhood predicts poorer developmental outcomes. It has not been studied whether infants with self-regulation problems, who may be at higher developmental risk, develop excessive media use habits.

This study shows that infants and toddlers with self-regulation difficulties (ie, problems with self-soothing, sleep, emotional regulation, and attention) view more media at 2 years of age, independent of other important confounders. (Read the full article)




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Unmet Needs of Siblings of Pediatric Stem Cell Transplant Recipients

The American Academy of Pediatrics has recommended that sibling donors should have an independent advocate. Defining the need for and role of this advocate is hampered by a lack of empirical data.

This study provides prospective family data regarding siblings’ experiences during HLA typing and donation pre- and posttransplantation. Most family members, including the siblings, perceive no choice in typing or donation, yet have few concerns and report positive aspects to participating. (Read the full article)




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Supply and Utilization of Pediatric Subspecialists in the United States

There is wide variation in pediatric subspecialty supply in the United States. The impact of this variation in supply on utilization and child and family disease burden is not known.

Among children with special health care needs, living in a county with lower subspecialty supply was associated with lower perceived need for subspecialty care, lower subspecialty utilization, and no meaningful differences in examined measures of child and family disease burden. (Read the full article)




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Practice-Tailored Facilitation to Improve Pediatric Preventive Care Delivery: A Randomized Trial

Children receive only half of recommended health care; disadvantaged children have higher risk of unmet needs. Practice coaching combined with quality improvement using rapid-cycle feedback has potential to help practices meet quality standards and improve pediatric health care delivery.

The Practice-tailored Facilitation Intervention led to large and sustained improvements in preventive service delivery, including substantial numbers of disadvantaged children, and in multiple simultaneous health care domains. Practice-tailored facilitation holds promise as a method to advance pediatric preventive care delivery. (Read the full article)




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Pediatric Medical Complexity Algorithm: A New Method to Stratify Children by Medical Complexity

Quality measures developed by the Pediatric Quality Measures Program are required to assess disparities in performance according to special health care need status. Methods are needed to identify children according to level of medical complexity in administrative data.

The Pediatric Medical Complexity Algorithm is a new, publicly available algorithm that identifies the small proportion of children with complex chronic disease in Medicaid claims and hospital discharge data with good sensitivity and good to excellent specificity. (Read the full article)




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Predicting Service Use for Mental Health Problems Among Young Children

A large majority of preschool and young school age children with mental health problems do not receive services and little is known about the determinants of service use in this age group.

Behavioral, not emotional, disorders increase service use but only if impairment is present. Such impairment may operate via increased parental burden and parent and caregiver problem recognition. Low socioeconomic status has an independent effect increasing service use. (Read the full article)




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The Pediatric AIDS Corps: A 5-Year Evaluation

Demographic data concerning health care providers working long-term in resource-limited areas with religious groups or other government or nongovernment organizations are limited. Health outcomes from these programs vary with the focus of the individual program.

This study describes the composition and evaluation of a long-term global health corps program. Other groups interested in long-term physician placement in resource-limited areas will be able to use these data while developing their program. (Read the full article)




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Youth Ice Hockey Injuries Over 16 Years at a Pediatric Trauma Center

Participation in youth ice hockey is increasing. Players are prone to injury because of the nature of the game. Injury patterns vary based on age, gender, and degree of contact permitted.

This study adds an updated description of injuries sustained by youth ice hockey players and associated demographic patterns, with emphasis on seriously injured children. It also evaluates health care utilization and outcomes related to youth ice hockey injuries. (Read the full article)




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The Transition to ICD-10-CM: Challenges for Pediatric Practice

The US health care system transition to the ICD-10-CM will occur in October 2015. The logistical and financial impact of the transition for billing codes frequently used by pediatricians has not been studied.

The findings of this study evaluate the government-provided mappings from ICD-9-CM to ICD-10-CM for accuracy and provide the diagnostic codes used by pediatricians, which may be adversely affected by the transition to ICD-10-CM. (Read the full article)




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Rate of Spending on Chronic Conditions Among Medicaid and CHIP Recipients

Previous analyses have documented that the prevalence of children with chronic conditions is growing and is responsible for increased growth in hospital charges; however, such utilization trends have not been documented in Medicaid and the Children’s Health Insurance Program.

From 2007 through 2010 in Illinois, children with chronic conditions became Medicaid and Children’s Health Insurance Program recipients at a higher rate than healthy children. In contrast to studies of hospital data, this analysis found per-member spending decreases in most chronic condition groups. (Read the full article)




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The Medical Cost of Abusive Head Trauma in the United States

Children with shaken-baby syndrome, or abusive head trauma (AHT), have lasting health and development problems. The long-term medical cost of AHT is unknown.

Patients with AHT had higher inpatient, outpatient, and drug costs compared with other children for 4 years after their abuse diagnosis, amounting to tens of thousands of dollars in excess and preventable medical care per patient with AHT. (Read the full article)




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Effectiveness of Anti-TNF{alpha} for Crohn Disease: Research in a Pediatric Learning Health System

Studies on adult patients who have Crohn disease have shown a comparative benefit of anti-TNFα versus placebo and thiopurines. These same studies have not been done in children, because of time, cost, and ethical (withholding an efficacious treatment) challenges.

Anti-TNFα therapy administered in routine practice to children with Crohn disease was more effective than usual care at achieving clinical and corticosteroid-free remission. Using data from the ImproveCareNow learning health system for observational research is feasible and produces valuable evidence. (Read the full article)




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Caregiver-Mediated Intervention for Low-Resourced Preschoolers With Autism: An RCT

Mixed results exist regarding the efficacy of caregiver-mediated interventions for children who have ASD. To date, randomized controlled studies have rarely compared 2 active interventions; none have focused on targeting families who are low-resourced in the community.

Significant improvements were found in social communication of children who have autism when caregivers received a hands-on caregiver training intervention in the home. These are the first data from a low-intensity, short-term intervention with low-resourced families. (Read the full article)




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Five-Year Follow-up of Community Pediatrics Training Initiative

Compared with their peers, pediatric residents who report exposure to community settings anticipate greater future community involvement at the end of training. The impact of community pediatrics training on actual future community involvement is not known.

Pediatricians exposed to enhanced community pediatrics training during residency report greater participation in community activities and greater related skills than their peers nationally. (Read the full article)




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Pediatric Advance Directives: Parents' Knowledge, Experience, and Preferences

As the number of chronically ill children grows in the United States, end-of-life discussions and advance directives (AD) will become increasingly important. Although pediatric palliative care is gaining interest, little is known about parental preferences regarding ADs for chronically ill children.

Knowledge about ADs is limited among caregivers of children who have chronic illness. However, interest in creating ADs is high, suggesting an unmet need and opportunity for health care providers to improve the care of children who have chronic illness. (Read the full article)




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Socioeconomic Status and Wait Times for Pediatric Surgery in Canada

Socioeconomic status (SES) often influences timeliness of health care delivery, even in publicly funded systems. Children need prompt surgical care for a variety of time-sensitive developmental conditions, and children of lower SES may be especially vulnerable to delays in surgery.

It is unknown whether a publicly funded system’s ability to provide timely pediatric surgical care is related to SES. In 39 327 consecutive surgical cases, we demonstrate that SES need not influence timeliness of surgical care in a publicly funded system. (Read the full article)




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Unit of Measurement Used and Parent Medication Dosing Errors

There is growing support for adopting the milliliter as the standard unit for liquid medication instruction; teaspoon and tablespoon units can be confusing and may endorse kitchen spoon use. There are concerns that parents may not understand milliliter-based instructions.

Parents who used milliliter-only units made fewer dosing errors than those who used teaspoon or tablespoon units. Moving to a milliliter-only standard could reduce confusion and decrease medication errors, especially for parents with low health literacy and non-English speakers. (Read the full article)




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A Clinical Prediction Rule for the Severity of Congenital Diaphragmatic Hernias in Newborns

Predicting high-risk populations in congenital diaphragmatic hernia (CDH) can help target care strategies. Prediction rules for infants with CDH often lack validation, are aimed at a prenatal population, and are of limited generalizability. We cannot currently discriminate the highest risk neonates during the crucial period shortly after birth.

This clinical prediction rule was developed and validated on an international database. It discriminates patients and high, intermediate, and low risk of mortality; is easy to apply; and is generalizable to most infants with CDH. (Read the full article)




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Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy

Most therapeutic products used in children have not been studied in that population. There is a need for special incentives and market protection (pediatric exclusivity) to compensate drug sponsors for studying these products in children.

Of 189 products studied under pediatric exclusivity, 173 (92%) received new labeling information. Pediatric efficacy was not established for 78 (42%), including 81% of oncology drugs. Probability of demonstrating efficacy was related to therapeutic area and year exclusivity was granted. (Read the full article)




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Treatment Outcomes of Overweight Children and Parents in the Medical Home

Pediatricians need to treat overweight in early childhood. Family-based interventions in specialized clinics are efficacious in children age 8 years and older. Data regarding treatment of younger children are limited in specialty clinics and primary care.

This study shows that a 12-month family-based behavioral intervention in primary care is more efficacious compared with Control condition with a child-only focus. Weight outcome differences between Intervention and Control persist in children and parents after a 12-month follow-up. (Read the full article)




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Cost-Benefit Analysis of a Medical Emergency Team in a Children's Hospital

Numerous studies have demonstrated clinical benefits of medical emergency team (MET) implementation, including reductions in mortality, cardiac arrests, and critical deterioration events. No studies have evaluated the financial costs and benefits of METs.

The costs of operating an MET can plausibly be recouped with a modest reduction in critical deterioration events. Hospitals reimbursed with bundled payments could see real financial savings by reducing critical deterioration events with a MET. (Read the full article)




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Brain Injury and Altered Brain Growth in Preterm Infants: Predictors and Prognosis

Term MRI can assist in identifying the nature and extent of brain injury in preterm infants. However, brain injury detected by MRI does not fully account for neurodevelopmental impairments, particularly cognitive and behavioral impairments, common in preterm survivors.

In addition to brain injury, an assessment of brain growth by using one-dimensional measurements on MRI is helpful for predicting neurodevelopment. Two different patterns of impaired brain growth are observed that relate independently to early cognitive development in preterm infants. (Read the full article)




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Telephone Peer Counseling of Breastfeeding Among WIC Participants: A Randomized Controlled Trial

In-person peer counseling to pregnant and new mothers has been shown to improve breastfeeding modestly in three US RCTs. But this level of support for WIC is unlikely to be scaled up nationally in the current fiscal environment.

We randomly assigned WIC clients to a telephone peer counseling program relative to standard WIC support for breastfeeding. Nonexclusive breastfeeding among Spanish-speakers increased at 1, 3, and 6 months, but the program had much less of an effect on English-speaking clients. (Read the full article)




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Automated Conversation System Before Pediatric Primary Care Visits: A Randomized Trial

A substantial gap exists between what is recommended for effective primary care of children and what takes place. Patient-centered health information technologies have been used to gather information and counsel parents, however, have not been integrated directly with electronic health records nor been speech-based to improve decision-making at the point-of-care.

This study shows that a ubiquitous technology, the telephone, can be successfully used to automatically assess and counsel parents before pediatric primary care visits as well as inform their primary care clinicians in a way that is feasible and effective for multiple important issues. (Read the full article)




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Defining and Determining Medical Necessity in Medicaid Managed Care

Clinical decisions must be medically necessary to be approved by insurers. There is a federally mandated medical necessity standard for children in Medicaid, but not in private plans. American Academy of Pediatrics policy calls on pediatricians to help define pediatric medical necessity.

This study reviewed pediatric medical necessity definitions in Medicaid state statutes, regulations, and provider manuals. The federal standard was not replicated on all levels, and provider manuals were least likely to have it. Pediatricians should engage in defining pediatric standards. (Read the full article)




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Characteristics of a Pediatric Hospice Palliative Care Program Over 15 Years

Palliative care is an increasingly important element of pediatric care for children with noncurable, terminal conditions. Freestanding hospices represent one model of care provision; however, little research on this approach has been conducted.

This report documents the experience of North America’s first freestanding hospice over 15 years to better understand the characteristics of children and families enrolled and to establish baseline information for future studies and program planning. (Read the full article)




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Maintenance of Certification Part 4 Credit and Recruitment for Practice-Based Research

Pediatric primary care has undergone a cultural shift. Changes in electronic health records, certification requirements, and practice structure have left many physicians feeling too busy to participate in research. Practice-based research networks must adapt to fit the current climate.

Adding quality improvement activities that meet Maintenance of Certification Part 4 criteria to research study design adds value to a practice-based research protocol. This incentive meets the needs of busy physicians, and may help researchers meet study recruitment goals. (Read the full article)




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Use of Neonatal Chest Ultrasound to Predict Noninvasive Ventilation Failure

Lung ultrasound outperforms conventional radiology in the emergency diagnosis of pneumothorax and pleural effusions. In the pediatric age, lung ultrasound has been also successfully applied to the fluid-to-air transition after birth and to rapid pneumonia diagnosis.

Nasal ventilation has dramatically decreased the need for invasive mechanical respiratory support. This study demonstrates that, after a short trial on nasal continuous positive airway pressure, lung ultrasonography reliably predicts the failure of noninvasive ventilation unlike the conventional chest radiogram. (Read the full article)




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Characteristics of Recurrent Utilization in Pediatric Emergency Departments

Although frequent utilizers of emergency departments (EDs) are targeted for quality improvement initiatives across the United States, little is known about the health services these patients receive in the ED.

Eight percent of children account for 24% of ED visits and 31% of all costs. Frequent utilizers of pediatric EDs, especially infants without a chronic condition, are least likely to need medications, testing, and hospital admission during their ED visits. (Read the full article)




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Behavioral Health Services Following Implementation of Screening in Massachusetts Medicaid Children

Behavioral health (BH) screening is known to increase identification of children with BH issues, but in small-scale studies, rates of follow-up after screening have been reported to be low.

This study examines the relationship between BH screening and the receipt of BH services in Massachusetts Medicaid children. Nearly 60% of children identified with BH problems received BH services, but only 30% of newly identified children received BH services. (Read the full article)




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Emergency Hospitalizations for Unsupervised Prescription Medication Ingestions by Young Children

Despite child-resistant packaging requirements for most medications and safe storage education for all medicines, tens of thousands of young children are brought to emergency departments and thousands are hospitalized annually after ingesting prescription medications. Targeted prevention efforts may be needed.

Twelve medications were implicated in nearly half of hospitalizations for prescription medication ingestions. Buprenorphine and clonidine were most commonly implicated and had the highest hospitalization rates when accounting for outpatient use. Prevention efforts should focus on most commonly implicated medications. (Read the full article)




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Pertussis Immunization in Infancy and Adolescent Asthma Medication

Childhood immunization might contribute to an increase in asthma prevalence. Previous studies have been contradictory, and many lack sufficiently large control groups of nonimmunized children.

Pertussis immunization in infancy does not increase the risk of asthma medication in adolescents. Our study presents convincing evidence that pertussis immunization in early childhood can be considered safe with respect to long-term development of asthma. (Read the full article)




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Single-Family Room Care and Neurobehavioral and Medical Outcomes in Preterm Infants

The single-family room (SFR) NICU is a major response to improve care and reduce developmental morbidity in preterm infants. However, no studies have examined how and why this model is associated with changes in medical and neurobehavioral outcome.

This study shows improved medical and neurodevelopmental outcome in infants hospitalized in the SFR model of care. More important, improvements occurred specifically in relation to increases in maternal involvement and developmental support afforded by the SFR environment. (Read the full article)