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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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Effectiveness of Trivalent Flu Vaccine in Healthy Young Children

In the United States, given the high burden of disease, influenza vaccine is recommended for all children from age 6 months. The paucity of vaccine effectiveness data in children <2 years has led some to argue against routine vaccination in this age group.

This study reveals the effectiveness of trivalent influenza vaccine in young children and supports the current Advisory Committee on Immunization Practices recommendation. This study provides the strongest evidence to date confirming the effectiveness of trivalent influenza vaccine in children <2 years of age. (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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Attributable Cost and Length of Stay for Central Line-Associated Bloodstream Infections

Central line–associated bloodstream infections (CLABSI) are common types of hospital-acquired infections associated with high morbidity and cost. In recent years, quality improvement initiatives have demonstrated how to reduce the incidence of CLABSI.

This study presents nationally representative estimates of the cost and length of stay attributable to pediatric CLABSI. We make the business case to justify quality improvement prevention initiatives and the adoption of strategies for cost-effective management of CLABSI. (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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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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Comparison of Rapid Cranial MRI to CT for Ventricular Shunt Malfunction

Rapid cranial MRI is a radiation-free method to assess children with possible ventricular shunt malfunction. However, the test performance of rapid cranial MRI has never been compared with that of cranial CT, the current reference standard.

The accuracy of rapid cranial MRI was not inferior to that of CT for diagnosing ventricular shunt malfunction. Rapid cranial MRI is an important radiation-sparing diagnostic alternative for children presenting emergently with possible ventricular shunt malfunction. (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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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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Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial

The Centers for Disease Control and Prevention recommends that health departments in all 50 states deliver AFIX (Assessment, Feedback, Incentives, and eXchange) consultations to 25% of federally funded vaccine providers each year. AFIX effectively raises vaccination coverage among young children.

AFIX consultations achieved short-term gains in coverage for 11- to 12-year-olds for vaccines in the adolescent platform. No gains occurred for older adolescents or over the long term. Consultations were equally effective when delivered in-person or by webinar. (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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Inhaled Nitric Oxide Use in Neonates With Congenital Diaphragmatic Hernia

The role of inhaled nitric oxide (INO) in the treatment of newborns with congenital diaphragmatic hernia (CDH) is poorly defined and not rigorously proven. Contemporary rates of INO use for CDH have not been reported.

INO use in neonates with CDH is widespread, and has increased in many US tertiary pediatric hospitals without associated decrease in extracorporeal membrane oxygenation use or mortality. (Read the full article)




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Weighted Blankets and Sleep in Autistic Children--A Randomized Controlled Trial

Children with autism sleep poorly compared with their peers. Sensory integration, including use of weighted blankets, is proposed as a means to reduce arousal and stress. There is, however, no evidence that weighted blankets can improve sleep for these children.

This is the first robust study to evaluate the impact of weighted blankets and show that they do not improve sleep parameters in children with autism spectrum disorder. (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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Reducing Distress in Mothers of Children With Autism and Other Disabilities: A Randomized Trial

Mothers of children with neurodevelopmental disabilities often experience poor health, high stress, anxiety, and depression. Highly stressed parents are less effective in their parenting roles, risking their children's developmental progress.

Evidence-based interventions in mindfulness and positive psychology significantly reduce distress in mothers of children with disabilities. Well-trained peer-mentors are effective interventionists. Adult-oriented services are needed for these mothers to improve their mental health and sustain their caregiving over the long-term. (Read the full article)




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Mode of Obstetrical Delivery and Type 1 Diabetes: A Sibling Design Study

Several studies have revealed an association between cesarean section (CS) and childhood type 1 diabetes. Most of these studies lacked important information on indication for CS and induction of labor. It is unknown whether the reported associations are causal.

Using a cohort of 2.6 million children we found an association between elective CS and type 1 diabetes. The sibling analysis suggested the association is not causal. The findings are crucial evidence to advise women on mode of delivery choice. (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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High-dose Vitamin A With Vaccination After 6 Months of Age: A Randomized Trial

The World Health Organization recommends using vaccination contacts to deliver high-dose vitamin A supplementation (VAS) to children aged 6 to 59 months. The effect of this policy on overall child mortality has not been assessed.

In this first randomized controlled trial of VAS at routine vaccination contacts after 6 months, VAS had no overall effect on mortality but was associated with reduced mortality in girls and increased mortality in boys. (Read the full article)




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Restrictive Eating Disorders Among Adolescent Inpatients

Recent case reports have described acute life-threatening complications in adolescents who present to health services having lost large amounts of weight but who are not underweight. Little is known about the frequency of life-threatening complications in these adolescents.

Over 6 years, we found more than a fivefold increase in the incidence of hospitalized adolescents who, apart from not being underweight, have diagnostic features of anorexia nervosa. This group experienced a similar profile of acute complications of anorexia nervosa. (Read the full article)




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Adoption of Cardiovascular Risk Reduction Guidelines: A Cluster-Randomized Trial

Cardiovascular risk begins in childhood. New clinical guidelines established a care strategy for lowering risks. Incorporation of guidelines into routine practice lags due to barriers related to knowledge and attitudes about guidelines, as well as behaviors of practitioners, patients, and clinical systems.

This study demonstrated that a multifaceted approach including tools, education, and support for changes in practice systems can accelerate the adoption of guidelines during routine pediatric well-child visits, compared with dissemination of the guidelines alone. (Read the full article)




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Smart-Phone Obesity Prevention Trial for Adolescent Boys in Low-Income Communities: The ATLAS RCT

Adolescent males from low-income communities are a group at increased risk of obesity and related health concerns. Obesity prevention interventions targeting adolescents have so far had mixed success. Targeted interventions, tailored for specific groups, may be more appealing and efficacious.

A multicomponent school-based intervention using smartphone technology can improve muscular fitness, movement skills, and key weight-related behaviors among low-income adolescent boys. (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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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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Using CD4 Percentage and Age to Optimize Pediatric Antiretroviral Therapy Initiation

In HIV-infected children, decisions to start antiretroviral therapy must weigh immunologic benefits against potential risks. Current guidelines recommend using CD4 percentage and age when deciding to start treatment. Population-level effects of these factors on immunologic recovery are unknown.

Starting antiretroviral therapy at higher CD4 percentages and younger ages maximizes potential for immunologic recovery. However, not all benefits are sustained, and viral failure may occur. Our results help clinicians better weigh immunologic benefits against viral failure risks. (Read the full article)




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Variation in Care of the Febrile Young Infant <90 Days in US Pediatric Emergency Departments

Various low-risk criteria have been developed to guide management of the febrile young infant (<90 days), but they differ in age criteria, recommendations, and implementation. Therefore, variation in care is likely but has not been previously studied.

There is wide variation in testing, treatment, and overall resource utilization in management of the febrile young infant across all 3 age groups: ≤28, 29 to 56, and 57 to 89 days. There may be opportunities to improve care variation without compromising outcomes. (Read the full article)




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Effects of the FITKids Randomized Controlled Trial on Executive Control and Brain Function

Physical activity programs have been shown to have positive implications for children’s cognitive performance and brain structure and function. However, additional randomized controlled trials are needed to determine whether daily physical activity influences executive control and its neural underpinnings.

The randomized controlled trial, designed to meet daily physical activity recommendations, used behavioral and electrophysiological measures of brain function to demonstrate enhanced attentional inhibition and cognitive flexibility among prepubertal children. (Read the full article)




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Off-Hours Admission to Pediatric Intensive Care and Mortality

Admissions to the ICU during off-hours (nights and weekends) have been variably associated with increased mortality in both adults and children. Changes in staffing patterns, patient characteristics, or other factors may have influenced this relationship over time.

This study demonstrates in a large, current, multicenter database sample that off-hours admissions to PICUs are not associated with increased risk-adjusted mortality. Admissions in the morning from 6:00 am to 10:59 am are associated with increased mortality and warrant further attention. (Read the full article)




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Pediatricians' Communication About Weight With Overweight Latino Children and Their Parents

Little is known about how pediatricians communicate with overweight Latino children and their parents regarding overweight and obesity.

Findings suggest that many overweight Latino children and their parents do not receive direct communication that the child is overweight, weight-management plans, culturally relevant dietary recommendations, or follow-up visits. (Read the full article)




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Sustainability of a Parental Tobacco Control Intervention in Pediatric Practice

Parental smoking cessation helps eliminate children’s exposure to tobacco smoke. A child’s visit to the doctor provides a teachable moment for parental smoking cessation. Effective strategies to help parents quit smoking are available for implementation.

Evidence-based outpatient intervention for parents who smoke can be delivered successfully after the initial implementation. Maximizing parental quit rates in the pediatric context will require more complete and sustained systems-level integration. (Read the full article)




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Feedback on Oral Presentations During Pediatric Clerkships: A Randomized Controlled Trial

Delivering competent oral case presentations is an important clinical communication skill, yet effective means of improving trainees’ presentations have not been identified.

Oral presentation feedback sessions facilitated by faculty by using an 18-item competency-based evaluation form early in pediatric clerkships improved medical students’ subsequent oral presentations. Medical schools should consider implementing this evidence-supported practice. (Read the full article)




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Urokinase Versus VATS for Treatment of Empyema: A Randomized Multicenter Clinical Trial

There are discrepancies regarding which treatment is best in clinical practice for children with parapneumonic empyema, with some authors favoring video-assisted thoracoscopy and others favoring intrapleural fibrinolytic agents.

This study is one of the few randomized clinical trials on this subject in children and the first multicenter trial. It exclusively included patients with septated empyema. Thoracoscopy and fibrinolysis with urokinase were equally effective for this condition. (Read the full article)




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Variability in ADHD Care in Community-Based Pediatrics

In 2000/2001, the American Academy of Pediatrics published recommendations for attention-deficit/hyperactivity disorder (ADHD) care. According to pediatricians’ self-report of adoption of these guidelines, community-based ADHD care appears to be marginally adequate.

Using reviews of >1500 patient charts, this study demonstrates that community-based ADHD care is not consistent with evidence-based practice. Furthermore, variability in much of community-based ADHD care is unrelated to the provider, suggesting that innovative, system-wide interventions are needed to improve ADHD care. (Read the full article)




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A Randomized Trial on Screening for Social Determinants of Health: the iScreen Study

Despite growing interest around clinical screening for health-related social and environmental risk factors, little evidence exists regarding screening formats that maximize disclosure of psychosocial information.

This study compares psychosocial and socioeconomic adversity disclosure rates in face-to-face interviews versus electronic formats in a large, urban pediatric emergency department. (Read the full article)




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Changes in Child Mortality Over Time Across the Wealth Gradient in Less-Developed Countries

In developed countries, child health disparities across wealth gradients are commonly widening; at the same time, child mortality in low- and middle-income countries is declining. Whether these declines are associated with widening or narrowing disparities is unknown.

A systematic analysis of the evidence on child mortality gradients by wealth in less-developed countries shows that mortality is declining fastest among the poorest in most countries, leading to declining disparities in this important indicator of child health. (Read the full article)




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Pediatric Exposure to Laundry Detergent Pods

Case studies, abstracts, and small-sample research studies have shown that laundry detergent pods pose important poisoning risks to young children.

From 2012 through 2013, 17 230 children exposed to laundry detergent pods were reported to US poison control centers. Among children exposed, 4.4% were hospitalized and 7.5% experienced a moderate or major medical outcome, including 1 confirmed death. (Read the full article)




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Validation of a Clinical Prediction Rule for Pediatric Abusive Head Trauma

Pediatric Brain Injury Research Network investigators recently derived a highly sensitive clinical prediction rule for pediatric abusive head trauma (AHT).

The performance of this AHT screening tool has been validated. Four clinical variables, readily available at the time of admission, detect pediatric AHT with high sensitivity in intensive care settings. (Read the full article)




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Age-Based Risk Factors for Pediatric ATV-Related Fatalities

Younger age has been identified as an independent risk factor for all-terrain vehicle (ATV)-related injuries. Since the mid-1980s, one-third of ATV-related deaths have involved children younger than 18 years of age.

Using national data, we found both similarities and differences between pediatric age groups in the contribution of known risk factors to ATV-related deaths. The observed differences suggest the importance of targeting injury prevention approaches to specific age ranges. (Read the full article)




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Coparenting Breastfeeding Support and Exclusive Breastfeeding: A Randomized Controlled Trial

Fathers’ attitude and support affects breastfeeding outcomes. Fathers are currently not targeted in breastfeeding support and care provided by health care professionals. Breastfeeding interventions delivered to fathers have been shown to increase breastfeeding exclusivity and duration.

A coparenting breastfeeding support intervention delivered to mothers and fathers in the postpartum period showed beneficial effects on breastfeeding duration, paternal breastfeeding confidence, breastfeeding help provided by fathers, and mothers’ satisfaction with fathers’ involvement with breastfeeding. (Read the full article)




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Pediatric Germ Cell Tumors From 1987 to 2011: Incidence Rates, Time Trends, and Survival

Germ cell tumors in children are heterogeneous and rare neoplasms that occur in various locations, such as gonads, the central nervous system, and the pelvis. The incidence rate has been increasing in some countries.

Population-based analyses of germ cell tumors in children are rare. This population-based study describes the incidence rates, trends, and survival of germ cell tumors in German children from 1987 to 2011. (Read the full article)




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Off-Label Prescribing in Pediatric Outpatients

Off-label prescribing in children has been widely described. There has been growing awareness and action from regulatory bodies since 2006 to promote drug assessment in children and rational prescribing.

In comparison with a similar study done in 2000, there was no significant change in off-label prescribing in children. In contrast with the previous findings, off-label prescribing did not increase risk for adverse drug reactions. (Read the full article)




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Text Message Reminders for Second Dose of Influenza Vaccine: A Randomized Controlled Trial

Influenza vaccine coverage is low, and young children in need of 2 doses in a given season are at particular risk, with less than half receiving both doses. Text message vaccine reminders increase receipt of first dose of influenza vaccine.

Little is known about what types of text message reminders are most effective, including embedding educational information. We demonstrate that text message reminders increase timely receipt of the second dose of influenza vaccine and embedding health literacy information improves effectiveness. (Read the full article)




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Registry-Linked Electronic Influenza Vaccine Provider Reminders: A Cluster-Crossover Trial

Frequency of influenza vaccination is low, partially because of missed opportunities to vaccinate. Barriers to implementing successful influenza vaccination reminders in the electronic health record include alert fatigue and incomplete vaccination information due to scattered records.

A noninterruptive, immunization information system–linked influenza vaccination reminder can increase vaccination late in the winter when fewer vaccine doses are usually administered. Tailoring the reminder to clinicians’ needs can increase its use. (Read the full article)




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Use of Electronic Health Record Systems by Office-Based Pediatricians

In 2009, only 58% of pediatricians were using electronic health records (EHRs), most of which were lacking pediatric functionality. The American Recovery and Reinvestment Act (ARRA) of 2009 accelerated the implementation of EHRs in pediatric offices.

The effects of ARRA have remained largely unmeasured in pediatrics. This study provides information on the prevalence and functionalities of EHRs, as well as physicians’ perceptions. (Read the full article)




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Benefits of Strict Rest After Acute Concussion: A Randomized Controlled Trial

Expert consensus recommends rest after concussion with stepwise return to activity. Animal and retrospective human data suggest that early mental and physical activity may worsen outcome. There are no pediatric studies testing the efficacy of recommending strict rest after concussion.

Recommending strict rest postinjury did not improve outcome and may have contributed to increased symptom reporting. Usual care (rest for 1–2 days with stepwise return to activity) is currently the best discharge strategy for pediatric mild traumatic brain injury/concussion. (Read the full article)