The prevalence of research with biological specimens has led to a debate over what type of consent is needed to obtain biological specimens from minors and store them for future studies. In most cases, parental permission is needed to obtain samples from minors. In addition, almost all commentators and guidelines maintain that researchers need the consent of the donors if they want to continue to store the samples and make them available for future studies after the donors reach the age of majority. In this Ethics Rounds, we argue that this near-consensus view is mistaken on the grounds that the agreement of the parents at the time of obtaining samples provides sufficient permission to store them and use them in research even after the donors turn 18 years old.
Historically linked to sea voyagers in the 18th century, scurvy has become extremely rare during the last century in developed countries. However, it is still present in some at-risk populations and often overlooked in pediatric patients with restricted diets due to behavioral, neurodevelopmental, or psychiatric problems. So far, the only known etiology of developing scurvy is nutritional deficiency of vitamin C. In this report, we describe the case of a 3-year-old previously healthy Swiss girl without any history of previous poor dietary intake, who presented a picture of systemic inflammation including persisting fever, palpable purpura located on the extensor sides of the extremities, refusal to bear weight, and gingival bleeding. Blood tests revealed a significant increase of inflammatory markers and hypoalbuminemia. Full-body MRI revealed symmetrical bone marrow edema consistent with findings in previously reported cases of children with scurvy. After starting a high-dose oral vitamin C supplementation, the patient showed rapid clinical, laboratory, and radiologic improvement, but after stopping the treatment 4 months later, the patient developed relapse symptoms with pronounced fatigue, refusing to walk, and hair loss. These symptoms led us to restart the oral supplementation, which resulted in secondary normalization of her condition. The cause of her symptoms still remains unclear and presents the first case to our knowledge describing scurvy symptoms that are not directly linked to deficient dietary intake.
Little is known about opioid prescribing for children without severe conditions. We studied the prevalence of and indications for outpatient opioid prescriptions and the incidence of opioid-related adverse events in this population.METHODS:
This retrospective cohort study between 1999 and 2014 included Tennessee Medicaid children and adolescents aged 2 to 17 without major chronic diseases, prolonged hospitalization, institutional residence, or evidence of a substance use disorder. We estimated the annual prevalence of outpatient opioid prescriptions and incidence of opioid-related adverse events, defined as an emergency department visit, hospitalization, or death related to an opioid adverse effect.RESULTS:
There were 1 362 503 outpatient opioid prescriptions; the annual mean prevalence of opioid prescriptions was 15.0%. The most common opioid indications were dental procedures (31.1% prescriptions), outpatient procedure and/or surgery (25.1%), trauma (18.1%), and infections (16.5%). There were 437 cases of opioid-related adverse events confirmed by medical record review; 88.6% were related to the child’s prescription and 71.2% had no recorded evidence of deviation from the prescribed regimen. The cumulative incidence of opioid-related adverse events was 38.3 of 100 000 prescriptions. Adverse events increased with age (incidence rate ratio = 2.22; 95% confidence interval, 1.67–2.96; 12–17 vs 2–5 years of age) and higher opioid doses (incidence rate ratio = 1.86 [1.45–2.39]; upper versus lower dose tertiles).CONCLUSIONS:
Children without severe conditions enrolled in Tennessee Medicaid frequently filled outpatient opioid prescriptions for acute, self-limited conditions. One of every 2611 study opioid prescriptions was followed by an opioid-related adverse event (71.2% of which were related to therapeutic use of the prescribed opioid).
Families of children with mental health conditions face heavy economic burdens. One of the objectives of the Mental Health Parity and Addiction Equity Act (MHPAEA) is to reduce the financial burden for those with intensive mental health service needs. Few researchers to date have examined MHPAEA’s effects on children with mental health conditions and those with particularly high mental health expenditures.METHODS:
A difference-in-differences approach was used to compare commercially insured children ages 3 to 18 years (in 2008) who were continuously enrolled in plans newly subject to parity under MHPAEA to children continuously enrolled in plans never subject to parity. Data included inpatient, outpatient, and pharmaceutical claims for 2008–2012 from 3 national commercial insurers. We examined annual mental health service use and spending outcomes.RESULTS:
Among children with mental health conditions who were enrolled in plans subject to parity, parity was associated with $140 (95% confidence interval: –$196 to –$84) lower average annual out-of-pocket (OOP) mental health spending than expected given changes in the comparison group. Among children who were ≥85th percentile in total mental health spending, parity was associated with $234 (–$391 to –$76) lower average annual OOP mental health spending.CONCLUSIONS:
MHPAEA was associated with increased financial protection on average for children with mental health conditions and among those at the higher end of the spending distribution. However, estimated reductions in OOP spending were likely too modest to have substantially reduced financial burden on families of children with particularly high mental health expenditures.
Adverse early-life experience may affect preterm delivery later in life through priming of stress response. We aim to investigate the links between out-of-home care (OHC) experience in childhood, as a proxy of severe adversities, on subsequent risk of preterm delivery.METHODS:
A register-based national cohort of all women born in Sweden between 1973 and 1977 (N = 175 821) was crosslinked with information on these women’s subsequent deliveries as recorded in the Swedish medical birth register. During 1986–2012, 343 828 livebirths of these women were identified. The associations between women’s OHC experience and her risk of preterm delivery were analyzed through logistic regression models, adjusting for women’s own preterm birth, intrauterine growth, and childhood socioeconomic situation.RESULTS:
Compared with women that never entered OHC, women with OHC experience up to and after age 10 were both associated with increased risks of preterm delivery (adjusted odds ratio [aOR] = 1.23 [95% confidence interval 1.08–1.40] and aOR = 1.29 [1.13–1.48], respectively). Women who experienced OHC before or at 10 years of age had increased risk of both spontaneous and medically indicated preterm delivery (aOR = 1.19 [1.03–1.38] and aOR = 1.27 [1.02–1.59], respectively). Women who experienced OHC after age 10 had a more pronounced risk of medically indicated preterm delivery (aOR = 1.76 [1.44–2.16]) than for spontaneous preterm delivery (aOR = 1.08 [0.92–1.27]).CONCLUSIONS:
Women who were placed in OHC in childhood had increased risk of preterm delivery independent from their own perinatal history. Stress response, as 1 consequence of early life adversities, may take its toll on women’s reproductive health and their offspring, calling for integrative efforts in preventing early life adversity.
Pediatric functional abdominal pain disorders are common, costly, and disabling. Clinical anxiety is highly prevalent and is associated with increased pain and functional disability. Thus, a psychological screening process is recommended but is infrequently used in current practice.METHODS:
A screening process for patient-reported anxiety (Screen for Child Anxiety and Related Disorders), functional disability (Functional Disability Inventory), and pain levels was implemented in a large gastroenterology division within a major medical center. Quality improvement methods and traditional analytic approaches were used to test the feasibility and outcomes of routine screening in patients ages 8 to 18 with abdominal pain.RESULTS:
Screening rates increased from <1% to >80%. A total of 1291 patients who reported having abdominal pain completed the screening during the first 6 months. Clinically significant anxiety (43.1%), at least moderate disability (45%), and elevated pain (61.5%) were common in children with abdominal pain. The presence of clinically significant anxiety corresponded with higher pain and pain-related disability. Twenty-one percent of youth had clinical elevations in all 3 areas. In such instances, medical providers received an automated prompt to tailor care, including to consider a psychological referral. After the project implementation, psychological referral rates increased from 8.3 per 1000 patients to 15.2 per 1000 patients.CONCLUSIONS:
Systematic screening for anxiety, pain, and pain-related disability as a routine part of medical care can be reliably implemented with clinically meaningful results. Future directions include examining the role of anxiety over the long-term and reducing clinician burden.
Pediatric practitioners whose expertise is primarily focused on the care of children within health settings in the United States are increasingly engaged in global child health (GCH). The wide spectrum of this involvement may include incorporating short-term or longer-term GCH commitments in clinical care, teaching and training, mentoring, collaborative research, health policy, and advocacy into a pediatric career. We provide an overview of routes of engagement, identify resources, and describe important considerations for and challenges to better equipping US pediatric practitioners to participate in meaningful GCH experiences. This article is part of a series on GCH describing critical issues relevant to caring for children from an international perspective.
In this issue of Pediatrics, Berkman et al argue that parental permission to obtain samples is sufficient to continue storing them and using them for research after the pediatric participant reaches the age of majority. In this Ethics Rounds, we argue that there are important ethical reasons for obtaining consent from participants when they reach majority. However, these reasons must be balanced with the aim of efficiently and economically conducting research that benefits children. Given current guidance from the relevant regulatory bodies, it remains necessary to obtain consent for the continued use of identified pediatric samples when participants reach the age of majority unless the institutional review board grants a waiver of consent. However, we argue that waivers of consent should more frequently be granted by institutional review boards and used for this purpose.
Management of pediatric emergencies is challenging for ambulatory providers because these rare events require preparation and planning tailored to the expected emergencies. The current recommendations for pediatric emergencies in ambulatory settings are based on 20-year-old survey data. We aimed to objectively identify the frequency and etiology of pediatric emergencies in ambulatory practices.METHODS:
We examined pediatric emergency medical services (EMS) runs originating from ambulatory practices in the greater Indianapolis metropolitan area between January 1, 2012, and December 31, 2014. Probabilistic matching of pickup location addresses and practice location data from the Indiana Professional Licensing Agency were used to identify EMS runs from ambulatory settings. A manual review of EMS records was conducted to validate the matching, categorize illnesses types, and categorize interventions performed by EMS. Demographic data related to both patients who required treatment and practices where these events occurred were also described.RESULTS:
Of the 38 841 pediatric EMS transports that occurred during the 3-year period, 332 (0.85%) originated from ambulatory practices at a rate of 42 per 100 000 children per year. The most common illness types were respiratory distress, psychiatric and/or behavioral emergencies, and seizures. Supplemental oxygen and albuterol were the most common intervention, with few critical care level interventions. Community measures of low socioeconomic status were associated with increased number of pediatric emergencies in ambulatory settings.CONCLUSIONS:
Pediatric emergencies in ambulatory settings are most likely due to respiratory distress, psychiatric and/or behavioral emergencies, or seizures. They usually require only basic interventions. EMS data are a valuable tool for identifying emergencies in ambulatory settings when validated with external data.
Transient hypothyroidism can present itself as clinically asymptomatic or with few symptoms. Early treatment with levothyroxine (L-T4) prevents complications related to this disorder. We report a case of a male infant with concomitant short bowel syndrome and transient hypothyroidism treated with rectal L-T4. A 4-month-and-10-day-old boy with previous gastroschisis underwent multiple surgical approaches for small bowel resection and developed short bowel syndrome. We suspected hypothyroidism because of jaundice (direct bilirubin up to 59 mg/dL), the absence of evacuation, oral diet intolerance, and intestinal dysmotility. Because of a thyrotropin level of 34.45 μIU/mL and a free thyroxine level of 0.64 ng/dL, the diagnosis was confirmed. Because fasting was demanding, we started the patient on rectal diluted L-T4. After 4 weeks, the patient had spontaneous peristalsis, improvement of jaundice (direct bilirubin: 4.6 mg/dL), and normalized free thyroxine and thyrotropin values. In the present case, the patient was diagnosed with hypothyroidism and was on absolute fasting. An alternative route of drug administration was warranted. We empirically prescribed rectal diluted L-T4 when intravenous and suppository L-T4 were not available. This method was proven to be safe and effective in improving the patient’s clinical and biochemical status. Rectal L-T4 is a possible alternative route of administration to treat hypothyroidism in patients who are unable to take the medication orally.
Firearms are a leading cause of injury and death for children and adolescents in the United States. We examined how hospitalization rates for firearm injuries differ for rural and urban populations.METHODS:
The Kids’ Inpatient Database was used to identify hospitalizations for firearm injuries in patients <20 years of age by using International Classification of Diseases, Ninth Revision external-cause-of-injury codes. Data from 2006, 2009, and 2012 were analyzed to compare demographics and intent (assault, self-inflicted, unintentional, and undetermined). Urban-rural classification was based on patients' county of residence. Rates were calculated by using weighted cases and US Census data.RESULTS:
There were 21 581 hospitalizations for firearm injuries. The overall hospitalization rate was higher in urban versus rural areas (risk ratio [RR] = 1.95; 95% confidence interval [CI]: 1.81–2.10). Rates were highest for assaults in urban 15- to 19-year-olds (RR = 7.82; 95% CI: 6.48–9.44). Unintentional injuries were the leading cause of hospitalizations in younger age groups in all urban and rural locations. Rates for unintentional injuries were lower among urban versus rural 5- to 9-year-olds (RR = 0.47; 95% CI: 0.36–0.63) and 10- to 14-year-olds (RR = 0.44; 95% CI: 0.37–0.52).CONCLUSIONS:
Hospitalizations for firearm assaults among urban 15- to 19-year-olds represent the highest injury rate. Notably, hospitalizations are lower for urban versus rural 5- to 9-year-olds and 10- to 14-year-olds, and unintentional firearm injuries are most common among these groups. Preventative public health approaches should address these differences in injury epidemiology.
Patient safety concerns over the past 2 decades have prompted widespread efforts to reduce adverse events (AEs). It is unclear whether these efforts have resulted in reductions in hospital-wide AE rates. We used a validated safety surveillance tool, the Global Assessment of Pediatric Patient Safety, to measure temporal trends (2007–2012) in AE rates among hospitalized children.METHODS:
We conducted a retrospective surveillance study of randomly selected pediatric inpatient records from 16 teaching and nonteaching hospitals. We constructed Poisson regression models with hospital random intercepts, controlling for patient age, sex, insurance, and chronic conditions, to estimate changes in AE rates over time.RESULTS:
Examining 3790 records, reviewers identified 414 AEs (19.1 AEs per 1000 patient days; 95% confidence interval [CI] 17.2–20.9) and 210 preventable AEs (9.5 AEs per 1000 patient days; 95% CI 8.2–10.8). On average, teaching hospitals had higher AE rates than nonteaching hospitals (26.2 [95% CI 23.7–29.0] vs 5.1 [95% CI 3.7–7.1] AEs per 1000 patient days, P < .001). Chronically ill children had higher AE rates than patients without chronic conditions (33.9 [95% CI 24.5–47.0] vs 14.0 [95% CI 11.8–16.5] AEs per 1000 patient days, P < .001). Multivariate analyses revealed no significant changes in AE rates over time. When stratified by hospital type, neither teaching nor nonteaching hospitals experienced significant temporal AE rate variations.CONCLUSIONS:
AE rates in pediatric inpatients are high and did not improve from 2007 to 2012. Pediatric AE rates were substantially higher in teaching hospitals as well as in patients with more chronic conditions.
Thirty million children are currently covered by public insurance; however, the future funding and structure of public insurance are uncertain. Our objective was to determine the number, estimated costs, and demographic characteristics of hospitalizations that would become ineligible for public insurance reimbursement under 3 federal poverty level (FPL) eligibility scenarios.METHODS:
In this retrospective cohort study using the 2014 State Inpatient Databases, we included all pediatric (age <18) hospitalizations in 14 states from January 1, 2014, to December 31, 2014, with public insurance as the primary payer. We linked each patient’s zip code to the American Community Survey to determine the likelihood of the patient being below 3 different public insurance income eligibility thresholds (300%, 200%, and 100% of the FPL). Multiple simulations were used to describe newly ineligible hospitalizations under each threshold.RESULTS:
In 775 460 publicly reimbursed hospitalizations in 14 states, reductions in eligibility limits to 300%, 200%, or 100% of the FPL would have resulted in large numbers of newly ineligible hospitalizations (~155 000 [20% of hospitalizations] for 300%, 440 000 [57%] for 200%, and 650 000 [84%] for 100% of the FPL), equaling $1.2, $3.1, and $4.4 billion of estimated child hospitalization costs, respectively. Patient demographics differed only slightly under each eligibility threshold.CONCLUSIONS:
Reducing public insurance eligibility limits would have resulted in numerous pediatric hospitalizations not covered by public insurance, shifting costs to families, other insurers, or hospitals. Without adequately subsidized commercial insurance, this reflects a potentially substantial economic hardship for families and hospitals serving them.
Adolescent substance use is a prevalent modifiable health behavior; understanding long-term trends is essential to inform prevention efforts and public health policy. We investigated changes in the proportion of substance nonuse among adolescents over a 40-year period and associations between abstinence and individual risk and protective factors.METHODS:
Data from the nationally representative Monitoring the Future survey, administered 1975–2014, were analyzed to determine the annual proportion of abstinent students. The 2014 Monitoring the Future cohort was analyzed to determine associations between nonuse and risk and protective factors.RESULTS:
The prevalence of abstaining seniors between 1976 and 2014 increased fivefold for lifetime abstinence and more than doubled for past 30 days; similar increases were reported by younger students between 1991 and 2014. Trend lines were distinct for alcohol, which increased steadily over the past 38 years; tobacco, which increased dramatically over the past 20 years; and marijuana and illicit drugs, which increased slightly, although not consistently, between 1976 and 2014. In 2014, students that identified as male, African American, or other race and those who reported greater religious commitment were significantly more likely to report lifetime abstinence. Students that lived in single-parent households, spent more evenings out, worked more hours during the school year, and reported lower grades and more truancy had lower abstinence rates.CONCLUSIONS:
Abstinence is a realistic choice for a growing proportion of high school students. With the differences in abstinence trends for individual substances, we suggest strategies for advancing prevention efforts.
A large number of studies have shown a relationship between language disorders and problem behaviors; however, methodological differences have made it difficult to draw conclusions from this literature.OBJECTIVE:
To determine the overall impact of language disorders on problem behaviors in children and adolescents between the ages of birth and 18 years and to investigate the role of informant type, age, and type of problem behavior on this relationship.DATA SOURCES:
We searched PubMed, EBSCO, and ProQuest.STUDY SELECTION:
Studies were included when a group of children with language disorders was compared with a group of typically developing children by using at least 1 measure of problem behavior.DATA EXTRACTION:
Effect sizes were derived from all included measures of problem behaviors from each study.RESULTS:
We included 47 articles (63 153 participants). Meta-analysis of these studies revealed a difference in ratings of problem behaviors between children with language disorders and typically developing children of moderate size (g = 0.43; 95% confidence interval 0.34 to 0.53; P < .001). Age was entered as a moderator variable, and results showed that the difference in problem behavior ratings increases with child age (increase in g for each additional year in age = 0.06; 95% confidence interval 0.02 to 0.11; P = .004).LIMITATIONS:
There was considerable heterogeneity in the measures of problem behaviors used across studies.CONCLUSIONS:
Children with language disorders display greater rates of problem behaviors compared with their typically developing peers, and this difference is more pronounced in older children.
Refusal of intramuscular (IM) vitamin K administration by parents is an emerging problem. Our objective was to assess the frequency of and factors associated with refusal of IM vitamin K administration in well newborns in the United States.METHODS:
We determined the number of newborns admitted to well newborn units whose parents refused IM vitamin K administration in the Better Outcomes through Research for Newborns network and, in a nested patient-control study, identified factors associated with refusal of IM vitamin K administration by using a multiple logistic regression model.RESULTS:
Of 102 878 newborns from 35 Better Outcomes through Research for Newborns sites, parents of 638 (0.6%) refused IM vitamin K administration. Frequency of refusal at individual sites varied from 0% to 2.3%. Exclusive breastfeeding (adjusted odds ratio [aOR] = 3.4; 95% confidence interval [CI]: 2.1–5.5), non-Hispanic white race and/or ethnicity (aOR = 1.7; 95% CI: 1.2–2.4), female sex (aOR = 1.6; 95% CI: 1.2–2.3), gestational age (aOR = 1.2; 95% CI: 1.1–1.4), and mother’s age (aOR = 1.05; 95% CI: 1.02–1.08) were significantly associated with refusal of IM vitamin K administration. Refusal of the administration of both ocular prophylaxis and hepatitis B vaccine was also strongly associated with refusal of IM vitamin K administration (aOR = 88.7; 95% CI: 50.4–151.9).CONCLUSIONS:
Refusal of IM vitamin K by parents of newborns is a significant problem. Interventions to minimize risks to these newborns are needed.
Our aim was to determine and compare the incidences of sensory impairments among very preterm (VP) (<32 + 0/7 weeks), moderately preterm (MP) (32 + 0/7–33 + 6/7 weeks), late preterm (LP) (34 + 0/7–36 + 6/7 weeks), and term infants (≥37 weeks) and to establish risk factors of neurosensory disabilities.METHODS:
This national register study included all live-born infants in Finland between 1991 and 2008. Infants who died before the age of 1 year, who had any major congenital anomaly, or had missing data were excluded (n = 21 007; 2.0%). A total of 1 018 256 infants were analyzed. Incidences of hearing loss, visual disturbances or blindness, other ophthalmologic disorders, and retinopathy of prematurity were determined for gestational age (GA) groups. Risk factors of hearing loss and visual disturbances or blindness were analyzed.RESULTS:
The incidences of sensory impairments decreased with advancing GA at birth (P < .001). The most prominent factors associated with increased risks of hearing loss and visual impairment were intracranial hemorrhage and convulsions. VP (odds ratio [OR] 2.34; 95% confidence interval [CI] 1.75–3.14) and LP (OR 1.26; 95% CI 1.04–1.52) births were associated with an increased risk of hearing loss, and VP (OR 1.94; 95% CI 1.55–2.44), MP (OR 1.42; 95% CI 1.11–1.80), and LP (OR 1.31; 95% CI 1.16–1.49) births predicted an increased risk of visual impairment.CONCLUSIONS:
Incidences of sensory impairment decreased with increasing GA at birth. The most prominent risk factors predictive of sensory disabilities were intracranial hemorrhage and convulsions. VP and LP births were associated with an increased risk of hearing loss, and VP, MP, and LP births were associated with an increased risk of visual impairment.
Placental abruption causes asphyxia and leads to high perinatal mortality. Our objective was to study the overall mortality and causes of death among children born after placental abruption.METHODS:
Data on children born from singleton pregnancies complicated by placental abruption between 1987 and 2005 were collected from the Finnish Medical Birth Register, the Hospital Discharge Register, and the Cause-of-Death Register. A reference group consisted of children born from pregnancies without placental abruption. After excluding stillbirths, the final study sample comprised 3888 children born after placental abruption (index children) and 12 530 referent children. The main outcome measure was overall mortality.RESULTS:
By the end of 2013, there were 280 deaths among the index children and 107 deaths among the referent children. Compared with the referent children, the overall mortality among the index children was significantly increased (hazard ratio: 8.70; 95% confidence interval 6.96–10.90). During the neonatal period (0–27 days) the mortality was nearly 15-fold (14.8; 10.9–20.0), birth-related asphyxia being the leading cause of death (108; 34–341). The mortality remained high during days 28 to 365 (10.3; 4.83–21.8) and beyond 365 days (1.70; 1.03–2.79). Furthermore, the overall mortality was increased among the index children born at 32 to 36 + 6 gestational weeks (2.77; 1.54–4.98) and at ≥37 weeks (4.98; 3.54–6.99) and among children with a birth weight of 2500 g or more (5.94; 4.33–8.14).CONCLUSIONS:
The impact of abruption on offspring mortality extends far beyond the perinatal period. This is mainly due to birth-related asphyxia and prematurity-related consequences.
Intrathecal baclofen pumps are commonly used in pediatric patients with spastic cerebral palsy. Baclofen binds to -aminobutyric acid receptors to inhibit both monosynaptic and polysynaptic reflexes at the spinal cord level. The blockade stops the release of excitatory transmitters and thereby decreases muscle contraction. It is commonly used for lower limb spasticity and has been shown to improve postural ability and functional status. The US Food and Drug Administration has approved baclofen for the treatment of spasticity of cerebral or spinal origin in adult and pediatric patients 4 years or older. Various complications of baclofen pumps are described in the literature. Immediately after surgery, problems from infection can arise and range from superficial skin infections to meningitis and bacteremia. Another early complication includes cerebrospinal fluid leak that can be observed by notable swelling beneath the lumbar incision. Additional problems that arise later are usually from the mechanics of the pump and catheter. Pump-related complications include failure, migration, and flipping. Catheter-related complications include disconnection, occlusion, fracture, or kink. Most of these complications typically lead to baclofen withdrawal, although there are a few case reports of overdose due to mechanical causes. Here we describe 2 cases of individuals experiencing complications of excessive baclofen exposure after significant changes in the atmospheric pressure due to travel involving ambient altitude change. These cases reflect the need to discuss this potential complication with families and patients with baclofen pumps before travel to high elevations.