According to the temporal theory of autism spectrum disorders (ASDs), audiovisual changes in environment, particularly those linked to facial and verbal language, are often too fast to be faced, perceived, and/or interpreted online by many children with ASD, which could help explain their facial, verbal, and/or socioemotional interaction impairments. Our goal here was to test for the first time the impact of slowed-down audiovisual information on verbal cognition and behavior in 2 boys with ASD and verbal delay. Using 15 experimental sessions during 4 months, both boys were presented with various stimuli (eg, pictures, words, sentences, cartoons) and were then asked questions or given instructions regarding stimuli. The audiovisual stimuli and instructions/questions were presented on a computer's screen and were always displayed twice: at real-time speed (RTS) and at slowed-down speed (SDS) using the software Logiral. We scored the boys’ verbal cognition performance (ie, ability to understand questions/instructions and answer them verbally/nonverbally) and their behavioral reactions (ie, attention, verbal/nonverbal communication, social reciprocity), and analyzed the effects of speed and order of the stimuli presentation on these factors. According to the results, both participants exhibited significant improvements in verbal cognition performance with SDS presentation compared with RTS presentation, and they scored better with RTS presentation when having SDS presentation before rather than after RTS presentation. Behavioral reactions were also improved in SDS conditions compared with RTS conditions. This initial evidence of a positive impact of slowed-down audiovisual information on verbal cognition should be tested in a large cohort of children with ASD and associated speech/language impairments.
In patients with appendicitis, the risk of perforation increases with time from onset of symptoms. We sought to determine if time from emergency department (ED) physician evaluation until operative intervention is independently associated with appendiceal perforation (AP) in children.METHODS:
We conducted a planned secondary analysis of children aged 3 to 18 years with appendicitis enrolled in a prospective, multicenter, cross-sectional study of patients with abdominal pain (<96 hours). Time of initial physical examination and time of operation were recorded. The presence of AP was determined using operative reports. We analyzed whether duration of time from initial ED physician evaluation to operation impacted the odds of AP using multivariable logistic regression, adjusting for traditionally suggested risk factors that increase the risk of perforation. We also modeled the odds of perforation in a subpopulation of patients without perforation on computed tomography.RESULTS:
Of 955 children with appendicitis, 25.9% (n = 247) had AP. The median time from ED physician evaluation to operation was 7.2 hours (interquartile range: 4.8–8.5). Adjusting for variables associated with perforation, duration of time (≤ 24 hours) between initial ED evaluation and operation did not significantly increase the odds of AP (odds ratio = 1.0, 95% confidence interval, 0.96–1.05), even among children without perforation on initial computed tomography (odds ratio = 0.95, 95% confidence interval, 0.89–1.02).CONCLUSIONS:
Although duration of abdominal pain is associated with AP, short time delays from ED evaluation to operation did not independently increase the odds of perforation.
A deficiency in signal transducer and activator of transcription 3 (STAT3) is responsible for autosomal dominant hyperimmunoglobulin E syndrome, an immunodeficiency syndrome causing Staphylococcus aureus, Streptococcus pneumonia, Haemophilus influenzae, and, rarely, Pseudomonas aeruginosa and Aspergillus sp infections. Currently, intracellular pathogens are not targeted in the management of severe infections. The pathophysiologic mechanism of hyperimmunoglobulin E syndrome immunodeficiency has recently been linked to a disorder in the T helper 17 pathway and disruption of the interleukin -23/interleukin-17 axis. We report an unusual case of severe pleuropneumopathy by Ureaplasma urealyticum in a teenage girl with STAT3-deficient hyperimmunoglobulin E syndrome (STAT3 HIES). A previous case of severe lung infection by Mycoplasma pneumoniae has already been described in a STAT3-deficient patient, but U urealyticum has never been reported in patients with STAT3 HIES. After a review of the literature, it seems that the specific immunodeficiency pathway of STAT3 HIES exposes STAT3 HIES patients to Ureaplasma lung infections because the pathophysiology of STAT3 HIES and Ureaplasma is based on STAT3 and T helper 17 cells.
Evaluation of hypoglycemia in a patient with known diabetes mellitus, although usually straightforward, can at times be challenging. We present the case of an 8 year-old Latina girl initially diagnosed with type 1 diabetes mellitus in the setting of multiple autoimmune disorders, including dermatomyositis and lupus nephritis. She subsequently developed signs of insulin resistance and severe hypoglycemia, which was found to be due to insulin-receptor autoantibodies. This condition, known as type B insulin resistance, is a rare, heterogeneous metabolic disease that may feature hypoglycemia in the setting of extreme insulin resistance and hyperinsulinemia and, in this case, masqueraded as type 1 diabetes mellitus. The presence of hypoglycemia in the setting of multiple autoimmune disorders should prompt consideration of autoimmune-mediated hypoglycemia. In addition to immunologic modifying therapies, advances in diabetes care in the form of continuous glucose monitoring have provided an additional tool to manage recurrent hypoglycemia.
Behavioral Problems and Socioemotional Competence at 18 to 22 Months of Extremely Premature Children
Behavior and socioemotional development are crucial aspects of child development .METHODS:
A total of 2505 children born at <27 weeks’ gestation was evaluated at 18 to 22 months’ corrected age between January 1, 2008 and December 12, 2012 (86% follow-up). The Brief Infant and Toddler Social and Emotional Assessment was used to evaluate behavioral and socioemotional problems. Cognition and language were evaluated by using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Logistic regression analysis was used to evaluate for perinatal and demographic factors associated with behavioral problems (≥75th percentile) and delayed socioemotional competence (≤15th percentile). Structural equation modeling with bootstrapping was used to identify possible associated risk factors and Bayley-III scores as mediators.RESULTS:
Thirty-five percent (873) of children had behavioral problems, and 26% (637) displayed deficits in socioemotional competence. Male sex, public insurance, mothers with less than a high school education, and lower maternal age were associated with behavioral problems. Deficits in competence were associated with lower birth weight, public insurance, mothers with less than a high school education, and abnormal neuromotor exam. Bayley-III language and cognitive scores were significant mediators of the relationships between risk factors and both behavioral and competence scores (P < .05).CONCLUSIONS:
Extremely premature children are at risk for behavioral problems and deficits in socioemotional competence. Sociodemographic factors were associated with both socioemotional competence and behavioral problems. Deficits in socioemotional competence were also associated with neuromotor abnormalities and cognitive and language function
A 16-year-old boy with a recent diagnosis of night terrors was evaluated for recurrent early morning hypoglycemia after an early morning seizure. Evaluation in clinic with critical laboratories identified hyperinsulinemic hypoglycemia. Additional investigation revealed a sporadic insulinoma as the etiology of his hypoglycemia and all symptoms were resolved after pancreaticoduodenectomy. The importance of obtaining critical laboratory samples is highlighted and appropriate radiologic, medical, and pathologic testing is discussed. We additionally review the medical and surgical management of hyperinsulinemic hypoglycemia. A discussion of multiple endocrine neoplasia type 1 associated insulinomas is included as well. This case highlights the importance of considering hypoglycemia in the evaluation of night terrors and new-onset seizures.
Spain implemented a partial smoking ban in 2006 followed by a comprehensive ban in 2011. The objective was to examine the association between these smoke-free policies and different perinatal complications.METHODS:
Cross-sectional study including all live births between 2000 and 2013. Selected adverse birth outcomes were: preterm births (<37 gestational weeks), small for gestational age (SGA; <10th weight percentile according to Spanish reference tables), and low birth weight (<2500 g). We estimated immediate and gradual rate changes after smoking bans by using overdispersed Poisson models with different linear trends for 2000 to 2005 (preban), 2006 to 2010 (partial ban), and 2011 to 2013 (comprehensive ban). Models were adjusted for maternal sociodemographics, health care during the delivery, and smoking prevalence during pregnancy.RESULTS:
The comprehensive ban was associated with preterm birth rate reductions of 4.5% (95% confidence interval [CI]: 2.9%–6.1%) and 4.1% (95% CI: 2.5%–5.6%) immediately and 1 year after implementation, respectively. The low birth weight rate also dropped immediately (2.3%; 95% CI: 0.7%–3.8%) and 1 year after the comprehensive ban implementation (3.5%; 95% CI: 2.1%–5.0%). There was an immediate reduction in the SGA rate at the onset of the partial ban (4.9%; 95% CI: 3.5%–6.2%), which was sustained 1 year postimplementation. Although not associated with the comprehensive ban at the onset, the SGA rate declined by 1.7% (95% CI: 0.3%–3.1%) 1 year postimplementation.CONCLUSIONS:
The implementation of the Spanish smoke-free policies was associated with a risk reduction for preterm births and low birth weight infants, especially with the introduction of the more restrictive ban.
There are limited data guiding vancomycin dosing practices in the pediatric population to target the goal troughs recommended by national vancomycin guidelines. In this study, we sought to improve adherence to guideline trough targets through a quality improvement intervention.METHODS:
A retrospective analysis was first conducted to assess baseline performance. A multidisciplinary team then developed and implemented a standardized dosing algorithm recommending 15 mg/kg per dose for mild and moderate infections (goal trough: 10–15 µg/mL) and 20 mg/kg per dose for severe infections (goal trough: 15–20 µg/mL), both delivered every 6 hours (maximum single dose: 750 mg). The impact of the intervention was evaluated prospectively using standard statistics and quality improvement methodology. The outcome measures included the percentage of patients with an initial therapeutic trough and the time to therapeutic trough.RESULTS:
A total of 116 patients (49 preintervention, 67 postintervention) were included. Postintervention, there was a significant increase in the percentage of patients with an initial therapeutic trough (6.1% to 20.9%, P = .03) and in the percentage of patients with initial troughs between 10 and 20 µg/mL (8.2% to 40.3%, P < .001). The time to therapeutic trough decreased from 2.78 to 1.56 days (P = .001), with the process control chart showing improved control postintervention. Vancomycin-related toxicity was unchanged by the intervention (6.1% versus 4.5%; P = .70).CONCLUSIONS:
Using quality improvement methodology with standardized higher initial vancomycin doses, we demonstrated improved adherence to national trough guidelines without noted safety detriment.
We estimated racial/ethnic differences in attention-deficit/hyperactivity disorder (ADHD) care quality and treatment continuity among Medicaid-enrolled children.METHODS:
Using Medicaid data from 9 states (2008 to 2011), we identified 172 322 youth (age 6 to 12) initiating ADHD medication. Outcome measures included: (1) adequate follow-up care in the (a) initiation and (b) continuation and maintenance (C&M) treatment phases; (2) combined treatment with medication and psychotherapy (versus medication alone); (3) medication discontinuation; and (4) treatment disengagement (ie, discontinued medication and received no psychotherapy). Logistic regressions controlled for confounding measures.RESULTS:
Among those initiating medication, three-fifths received adequate follow-up care in the initiation and C&M phases, and under two-fifths received combined treatment. Compared with whites, African American youth were less likely to receive adequate follow-up in either phase (P < .05), whereas Hispanic youth were more likely to receive adequate follow-up in the C&M phase (P < .001). African American and Hispanic youth were more likely than whites to receive combined treatment (P < .05). Over three-fifths discontinued medication, and over four-tenths disengaged from treatment. Compared with whites, African American and Hispanic children were 22.4% and 16.7% points more likely to discontinue medication, and 13.1% and 9.4% points more likely to disengage from treatment, respectively (P < .001).CONCLUSIONS:
Care quality for Medicaid-enrolled youth initiating ADHD medication is poor, and racial/ethnic differences in these measures are mixed. The most important disparities occur in the higher rates of medication discontinuation among minorities, which translate into higher rates of treatment disengagement because most youth discontinuing medication receive no psychotherapy.
Bullying is a significant public health concern, and it has received considerable attention from the media and policymakers over the past decade, which has led some to believe that it is increasing. However, there are limited surveillance data on bullying to inform our understanding of such trends over the course of multiple years. The current study examined the prevalence of bullying and related behaviors between 2005 and 2014 and explored whether any such changes varied across schools or as a function of school-level covariates.METHODS:
Youth self-reports of 13 indicators of bullying and related behaviors were collected from 246 306 students in 109 Maryland schools across 10 years. The data were weighted to reflect the school populations and were analyzed by using longitudinal hierarchical linear modeling to examine changes over time.RESULTS:
The covariate-adjusted models indicated a significant improvement over bullying and related concerns in 10 out of 13 indicators (including a decrease in bullying and victimization) for in-person forms (ie, physical, verbal, relational) and cyberbullying. Results also showed an increase in the perceptions that adults do enough to stop bullying and students’ feelings of safety and belonging at school.CONCLUSIONS:
Prevalence of bullying and related behaviors generally decreased over this 10-year period with the most recent years showing the greatest improvements in school climate and reductions in bullying. Additional research is needed to identify factors that contributed to this declining trend.
The current study aimed to investigate the relationship between advanced pubertal development and adolescent dating abuse (ADA) and to test if this relationship is moderated by friendship group characteristics in a nationally representative sample of US girls.METHODS:
Data were drawn from wave 1 and 2 (1995–1996) of the National Longitudinal Study of Adolescent to Adult Health. The sample included 3870 girls aged 13 to 17 years, all of whom were in romantic and/or nonromantic sexual relationships. Relative pubertal development was measured as perceived physical development as compared with peers of the same age and race and age at menarche at wave 1. Participants reported at wave 2 whether they had experienced any verbal or physical abuse in their relationships. Friendship group characteristics included the percentage of boy friends, older friends, and friends’ risk behavior level.RESULTS:
Negative binomial regression analyses revealed an interaction between advanced pubertal development and percentage of boy friends on ADA victimization, adjusted for age, race, parents’ marital status, household income, number of relationships, self-esteem, self-control, and antisocial behavior history. Advanced pubertal development was associated with more ADA victimization when girls’ friendship groups comprised a higher percentage of boys.CONCLUSIONS:
Findings highlight the importance of pubertal timing and friendship group characteristics to ADA victimization. Early pubertal development is a risk marker for ADA victimization, particularly when a higher percentage of girls’ friends are boys. Pediatricians and adolescent health specialists should be sensitive to the elevated risk for ADA victimization in early-maturing girls.
The safety of cough and cold medication (CCM) use in children has been questioned. We describe the safety profile of CCMs in children <12 years of age from a multisystem surveillance program.METHODS:
Cases with adverse events (AEs) after ingestion of at least 1 index CCM ingredient (brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, doxylamine, guaifenesin, phenylephrine, and pseudoephedrine) in children <12 years of age were collected from 5 data sources. An expert panel determined relatedness, dose, intent, and risk factors. Case characteristics and AEs are described.RESULTS:
Of the 4202 cases reviewed, 3251 (77.4%) were determined to be at least potentially related to a CCM, with accidental unsupervised ingestions (67.1%) and medication errors (13.0%) the most common exposure types. Liquid (67.3%), pediatric (75.5%), and single-ingredient (77.5%) formulations were most commonly involved. AEs occurring in >20% of all cases included tachycardia, somnolence, hallucinations, ataxia, mydriasis, and agitation. Twenty cases (0.6%) resulted in death; most were in children <2 years of age (70.0%) and none involved a therapeutic dose. The overall reported AE rate was 0.573 cases per 1 million units (ie, tablets, gelatin capsules, or liquid equivalent) sold (95% confidence interval, 0.553–0.593) or 1 case per 1.75 million units.CONCLUSIONS:
The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose. Accidental unsupervised ingestions were the most common exposure types and single-ingredient, pediatric liquid formulations were the most commonly reported products. These characteristics present an opportunity for targeted prevention efforts.
We examined the associations between birth weight and intelligence at 3 different adult ages.METHODS:
The Copenhagen Perinatal Cohort is comprised of children born in Copenhagen from 1959 to 1961. Information on birth weight and ≥1 tests of intelligence was available for 4696 members of the cohort. Intelligence was assessed at a mean age of 19 years with the Børge Priens Prøve test, at age 28 years with the Wechsler Adult Intelligence Scale, and at age 50 years with the Intelligenz-Struktur-Test 2000 R.RESULTS:
Birth weight was significantly associated with intelligence at all 3 follow-up assessments, with intelligence scores increasing across 4 birth weight categories and declining for the highest birth weight category. The adjusted differences between those in the <2.5kg birth weight group and those in the 3.5 to 4.00kg group were >5 IQ points at all 3 follow-up assessments, corresponding to one-third of a SD. The association was stable from young adulthood into midlife,and not weaker at age 50 years. Adjustment for potential confounding factors, including infant socioeconomic status and gestational age, did not dilute the associations, and associations with intelligence were evident across the normal birth weight range and so were not accounted for by low birth weight only.CONCLUSIONS:
The association between birth weight and intelligence is stable from young adulthood into midlife. These long-term cognitive consequences may imply that even small shifts in the distribution of birth size, in normal-sized infants as well, may have a large impact at the population level.
Delayed puberty is a common condition defined as the lack of sexual maturation by an age ≥2 SD above the population mean. In the absence of an identified underlying cause, the condition is usually self-limited. Although self-limited delayed puberty is largely believed to be a benign developmental variant with no long-term consequences, several studies have suggested that delayed puberty may in fact have both harmful and protective effects on various adult health outcomes. In particular, height and bone mineral density have been shown to be compromised in some studies of adults with a history of delayed puberty. Delayed puberty may also negatively affect adult psychosocial functioning and educational achievement, and individuals with a history of delayed puberty carry a higher risk for metabolic and cardiovascular disorders. In contrast, a history of delayed puberty appears to be protective for breast and endometrial cancer in women and for testicular cancer in men. Most studies on adult outcomes of self-limited delayed puberty have been in small series with significant variability in outcome measures and study criteria. In this article, we review potential medical and psychosocial issues for adults with a history of self-limited delayed puberty, discuss potential mechanisms underlying these issues, and identify gaps in knowledge and directions for future research.
The number of births in the United States increased by 1% between 2013 and 2014, to a total of 3 988 076. The general fertility rate rose 1% to 62.9 births per 1000 women. The total fertility rate also rose 0.3% in 2014, to 1862.5 births per 1000 women. The teenage birth rate fell to another historic low in 2014, 24.2 births per 1000 women. The percentage of all births to unmarried women declined to 40.2% in 2014, from 40.6% in 2013. In 2014, the cesarean delivery rate declined to 32.2% from 32.7% in 2013. The preterm birth rate declined for the seventh straight year in 2014 to 9.57%; the low birth weight rate was unchanged at 8.00%. The infant mortality rate decreased to a historic low of 5.82 infant deaths per 1000 live births in 2014. The age-adjusted death rate for 2014 was 7.2 deaths per 1000 population, down 1% from 2013. Crude death rates for children aged 1 to 19 years did not change significantly between 2013 and 2014. Unintentional injuries and suicide were, respectively, the first and second leading causes of death in this age group. These 2 causes of death jointly accounted for 46.5% of all deaths to children and adolescents in 2014.
Nutritional guidance for infants and toddlers is lacking, and the diets of American children in the first 2 years of life are not well characterized.METHODS:
Cross-sectional data from the NHANES were used to describe the diets of 0- to 23-month-olds in the United States. Participants with complete dietary data were eligible for the analysis (N = 2359). Linear regression models were constructed to identify changes from 2005 to 2008 and from 2009 to 2012 in food and beverage consumption, both overall and within sociodemographic groups.RESULTS:
We observed several trends toward meeting early-feeding recommendations, such as a decline in the prevalence of complementary feeding among 0- to 5-month-olds. However, the prevalence of vegetable consumption was consistently lower than desired (~25% of 6- to 11-month-olds and 20% of 12- to 23-month-olds had no reported vegetable consumption on dietary recall days in the 2009–2012 set). Subgroup analyses revealed that some trends were limited to certain populations (eg, a decline in juice consumption was observed among 6- to 11-month-old non-Hispanic whites and non-Hispanic blacks but not among Mexican Americans), and additional trends emerged within groups (eg, the prevalence of breast milk consumption declined among 0- to 5-month-old Mexican Americans).CONCLUSIONS:
Although there have been some improvements in the diets of 0- to 23-month-olds in recent years, there are areas in which this population continues to fall short of current recommendations. This underscores the need for additional policy guidance for providers and education for parents and caretakers on helping infants and toddlers achieve healthy diets.
Non–cigarette tobacco marketing is less regulated and may promote cigarette smoking among adolescents. We quantified receptivity to advertising for multiple tobacco products and hypothesized associations with susceptibility to cigarette smoking.METHODS:
Wave 1 of the nationally representative PATH (Population Assessment of Tobacco and Health) study interviewed 10 751 adolescents who had never used tobacco. A stratified random selection of 5 advertisements for each of cigarettes, e-cigarettes, smokeless products, and cigars were shown from 959 recent tobacco advertisements. Aided recall was classified as low receptivity, and image-liking or favorite ad as higher receptivity. The main dependent variable was susceptibility to cigarette smoking.RESULTS:
Among US youth, 41% of 12 to 13 year olds and half of older adolescents were receptive to at least 1 tobacco advertisement. Across each age group, receptivity to advertising was highest for e-cigarettes (28%–33%) followed by cigarettes (22%–25%), smokeless tobacco (15%–21%), and cigars (8%–13%). E-cigarette ads shown on television had the highest recall. Among cigarette-susceptible adolescents, receptivity to e-cigarette advertising (39.7%; 95% confidence interval [CI]: 37.9%–41.6%) was higher than for cigarette advertising (31.7%; 95% CI: 29.9%–33.6%). Receptivity to advertising for each tobacco product was associated with increased susceptibility to cigarette smoking, with no significant difference across products (similar odds for both cigarette and e-cigarette advertising; adjusted odds ratio = 1.22; 95% CI: 1.09–1.37).CONCLUSIONS:
A large proportion of US adolescent never tobacco users are receptive to tobacco advertising, with television advertising for e-cigarettes having the highest recall. Receptivity to advertising for each non–cigarette tobacco product was associated with susceptibility to smoke cigarettes.
The incidence of neonatal abstinence syndrome (NAS), a constellation of neurologic, gastrointestinal, and musculoskeletal disturbances associated with opioid withdrawal, has increased dramatically and is associated with long hospital stays. At our institution, the average length of stay (ALOS) for infants exposed to methadone in utero was 22.4 days before the start of our project. We aimed to reduce ALOS for infants with NAS by 50%.METHODS:
In 2010, a multidisciplinary team began several plan-do-study-act cycles at Yale New Haven Children’s Hospital. Key interventions included standardization of nonpharmacologic care coupled with an empowering message to parents, development of a novel approach to assessment, administration of morphine on an as-needed basis, and transfer of infants directly to the inpatient unit, bypassing the NICU. The outcome measures included ALOS, morphine use, and hospital costs using statistical process control charts.RESULTS:
There were 287 infants in our project, including 55 from the baseline period (January 2008 to February 2010) and 44 from the postimplementation period (May 2015 to June 2016). ALOS decreased from 22.4 to 5.9 days. Proportions of methadone-exposed infants treated with morphine decreased from 98% to 14%; costs decreased from $44 824 to $10 289. No infants were readmitted for treatment of NAS and no adverse events were reported.CONCLUSIONS:
Interventions focused on nonpharmacologic therapies and a simplified approach to assessment for infants exposed to methadone in utero led to both substantial and sustained decreases in ALOS, the proportion of infants treated with morphine, and hospital costs with no adverse events.
Peer victimization is common among youth and associated with substance use. Yet, few studies have examined these associations longitudinally or the psychological processes whereby peer victimization leads to substance use. The current study examined whether peer victimization in early adolescence is associated with alcohol, marijuana, and tobacco use in mid- to late adolescence, as well as the role of depressive symptoms in these associations.METHODS:
Longitudinal data were collected between 2004 and 2011 from 4297 youth in Birmingham, Alabama; Houston, Texas; and Los Angeles County, California. Data were analyzed by using structural equation modeling.RESULTS:
The hypothesized model fit the data well (Root Mean Square Error of Approximation [RMSEA] = 0.02; Comparative Fit Index [CFI] = 0.95). More frequent experiences of peer victimization in the fifth grade were associated with greater depressive symptoms in the seventh grade (B[SE] = 0.03[0.01]; P < .001), which, in turn, were associated with a greater likelihood of alcohol use (B[SE] = 0.03[0.01]; P = .003), marijuana use (B[SE] = 0.05[0.01]; P < .001), and tobacco use (B[SE] = 0.05[0.01]; P < .001) in the tenth grade. Moreover, fifth-grade peer victimization was indirectly associated with tenth-grade substance use via the mediator of seventh-grade depressive symptoms, including alcohol use (B[SE] = 0.01[0.01]; P = .006), marijuana use (B[SE] = 0.01[0.01]; P < .001), and tobacco use (B[SE] = 0.02[0.01]; P < .001).CONCLUSIONS:
Youth who experienced more frequent peer victimization in the fifth grade were more likely to use substances in the tenth grade, showing that experiences of peer victimization in early adolescence may have a lasting impact by affecting substance use behaviors during mid- to late adolescence. Interventions are needed to reduce peer victimization among youth and to support youth who have experienced victimization.
In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations.