Outcome of BMI2+: Motivational Interviewing to Reduce BMI Through Primary Care AAP PROS Practices.

BACKGROUND: Pediatric obesity rates in the United States remain at an all-time high. Pediatric primary care clinicians and registered dietitians can help treat childhood obesity, and motivational interviewing (MI) has shown promising effects in prior trials. METHODS: We randomized 18 pediatric primary care practices to receive the Brief Motivational Interviewing to Reduce BMI or BMI2+ intervention or continue with usual care (UC). Practices were recruited through the American Academy of Pediatrics Pediatric Research in Office Settings network. The intervention comprised 4 components1: in-person and telehealth MI counseling by pediatric clinicians; 4 recommended sessions,2 6 telephone MI counseling sessions from a registered dietitian,3 text message reminders and tailored motivational messages, and4 parent educational materials. The main outcome was the change in the percentage of the 95th percentile of BMI. The study was conducted 2017 through 2021. RESULTS: There was a significant treatment x time interaction (b = 0.017, 95% confidence interval: [0.0066-0.027]) for the main outcome, favoring the UC group, with youth in the intervention arm showing a greater relative increase in their percent of the 95th percentile. CONCLUSIONS: There was no overall benefit of the intervention and, contrary to expectations, youth in the intervention arm gained more weight, based on percent of the distance from the 95th percentile than matched youth from UC practices. The absolute excess weight gain among intervention relative to UC youth was small, approximately 0.5 BMI units and 1 kg over 2 years. We offer several potential explanations for these unexpected findings.

Performance Feedback for Human Papillomavirus Vaccination: A Randomized Trial From the American Academy of Pediatrics Pediatric Research in Office Settings Research Network.

OBJECTIVE: To test the hypothesis that a feedback-based intervention would reduce human papillomavirus (HPV) vaccine missed opportunities. METHODS: In a longitudinal cluster randomized controlled trial of 48 pediatric primary care practices, we allocated half the practices to receive a sequential, multicomponent intervention phased over consecutive periods. In a prior trial (period 1), communication skills training reduced missed opportunities for the initial HPV vaccine dose at well visits but not at acute/chronic visits. The current trial (period 2) evaluated the added value of performance feedback to clinicians after communication training. Performance feedback consisted of an introductory training module, weekly electronic "Quick Tips," and 3 individualized performance feedback reports to clinicians. We fit logistic regression models for the primary outcome of HPV vaccination missed opportunities using generalized estimating equations with independence working correlation, accounting for clustering at the practice level. RESULTS: Performance feedback resulted in a 3.4 (95% confidence interval [CI]: -6.8, 0.0) percentage point greater reduction in missed HPV vaccine opportunities for the intervention versus control group during acute/chronic visits for subsequent HPV vaccinations (dose 2 or 3). However, during well visits for HPV vaccination dose #1, intervention practices increased missed opportunities (worsened) by 4.2 (95% CI: 1.0, 7.4) percentage points more than control practices, reducing the prior period 1 improvements and blunting the overall effect of performance feedback. We did not observe differences for the other visit/dose categories. CONCLUSIONS: Performance feedback improved HPV vaccination for one subset of visits (acute/chronic, subsequent HPV vaccinations due), but not for well visits.

Missed Opportunities for Adolescent Immunizations at Well-Care Visits During the COVID-19 Pandemic.

PURPOSE: The Coronavirus Disease 2019 pandemic disrupted healthcare, but the impact on vaccination missed opportunities (MOs, vaccine-eligible visits without vaccination) is unknown. We evaluated pandemic-related trends in MOs at adolescent well-care visits for three vaccines: human papillomavirus; quadrivalent meningococcal conjugate; and tetanus, diphtheria, and acellular pertussis (Tdap). METHODS: We analyzed electronic health record data from 24 pediatric primary care practices in 13 states from 1/1/2018 to 12/31/2021. Segmented logistic regression estimated risk differences for MOs during the pandemic relative to prepandemic trends. RESULTS: Among 106,605 well-care visits, we observed decreases in MOs prepandemic followed by an increase in MOs during the pandemic for all three vaccines. Relative to prepandemic, MOs increased for human papillomavirus (+15.9%, 95% confidence interval [CI]: 11.7%, 20.1%), meningococcal conjugate (+9.4%, 95% CI: 5.2%, 13.7%), and tetanus, diphtheria, and acellular pertussis (Tdap) (+ 8.2%, 95% CI: 4.3%, 12.1%). DISCUSSION: Increases in vaccine MOs during the pandemic equaled or exceeded pre-pandemic decreases. Reducing MOs in adolescent well-care could raise vaccine coverage.

Clinician Prompts for Human Papillomavirus Vaccination: A Cluster Randomized Trial.

OBJECTIVE: We assessed the impact of an online intervention using clinician prompts for human papillomavirus (HPV) vaccination with a cluster randomized controlled trial. METHODS: The randomized trial occurred July 2021-January 2022 in 48 primary care pediatric practices (24 intervention, 24 control) across the US. We trained clinicians via two online learning modules, plus weekly ''quick tips'' delivered via text or email. The training taught practices to implement a staff prompt to the clinician (e.g., printed reminders placed on the keyboard) plus electronic health record (EHR) prompts (if not already done) at well and acute/chronic visits for initial and subsequent HPV vaccination. We assessed missed opportunities for HPV vaccination using logistic regression models accounting for clustering by practice on an intent to treat basis. Surveys assessed facilitators and barriers to using prompts. RESULTS: During the 6-month intervention, missed opportunities for HPV vaccination increased (worsened) in both intervention and control groups. However, at well child care visits, missed opportunities for the initial HPV vaccine increased by 4.5 (95% CI: -9.0%, -0.1%) percentage points less in intervention versus control practices. Change in missed opportunities for subsequent doses at well child care and non-well child care visits did not differ between trial groups. An end-of trial survey found understaffing as a common challenge. CONCLUSIONS: Clinician prompts reduced missed opportunities for HPV vaccination at well child care visits. Understaffing related to the COVID-19 pandemic may have led to worsening missed opportunities for both groups and likely impeded practices in fully implementing changes.

Fidelity evaluation of the dialogue around respiratory illness treatment (DART) program communication training.

OBJECTIVE: To evaluate receipt fidelity of communication training content included in a multifaceted intervention known to reduce antibiotic over-prescribing for pediatric acute respiratory tract infections (ARTIs), by examining the degree to which clinicians implemented the intended communication behavior changes. METHODS: Parents were surveyed regarding clinician communication behaviors immediately after attending 1026 visits by children 6 months to < 11 years old diagnosed with ARTIs by 53 clinicians in 18 pediatric practices. Communication outcomes analyzed were whether clinicians: (A) provided both a combined (negative + positive) treatment recommendation and a contingency plan (full implementation); (B) provided either a combined treatment recommendation or a contingency plan (partial implementation); or (C) provided neither (no implementation). We used mixed effects multinomial logistic regression to determine whether these 3 communication outcomes changed between baseline and the time periods following each of 3 training modules. RESULTS: After completing the communication training, the adjusted probability of clinicians fully implementing the intended communication behavior changes increased by an absolute 8.1% compared to baseline (95% Confidence Interval [CI]: 2.4%, 13.8%, p = .005). CONCLUSIONS: Our findings support the receipt fidelity of the intervention's communication training content. PRACTICAL IMPLICATIONS: Clinicians can be trained to implement communication behaviors that may aid in reducing antibiotic over-prescribing for ARTIs.

Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial.

Importance: Missed opportunities for human papillomavirus (HPV) vaccination during pediatric health care visits are common. Objectives: To evaluate the effect of online communication training for clinicians on missed opportunities for HPV vaccination rates overall and at well-child care (WCC) visits and visits for acute or chronic illness (hereafter referred to as acute or chronic visits) and on adolescent HPV vaccination rates. Design, Setting, and Participants: From December 26, 2018, to July 30, 2019, a longitudinal cluster randomized clinical trial allocated practices to communication training vs standard of care in staggered 6-month periods. A total of 48 primary care pediatric practices in 19 states were recruited from the American Academy of Pediatrics Pediatric Research in Office Settings network. Participants were clinicians in intervention practices. Outcomes were evaluated for all 11- to 17-year-old adolescents attending 24 intervention practices (188 clinicians) and 24 control practices (177 clinicians). Analyses were as randomized and performed on an intent-to-treat basis, accounting for clustering by practice. Interventions: Three sequential online educational modules were developed to help participating clinicians communicate with parents about the HPV vaccine. Weekly text messages were sent to participating clinicians to reinforce learning. Statisticians were blinded to group assignment. Main Outcomes and Measures: Main outcomes were missed opportunities for HPV vaccination overall and for HPV vaccine initiation and subsequent doses at WCC and acute or chronic visits (visit-level outcome). Secondary outcomes were HPV vaccination rates (person-level outcome). Outcomes were compared during the intervention vs baseline. Results: Altogether, 122 of 188 clinicians in intervention practices participated; of these, 120, 119, and 116 clinicians completed training modules 1, 2, and 3, respectively. During the intervention period, 29 206 adolescents (14 664 girls [50.2%]; mean [SD] age, 14.2 [2.0] years) made 15 888 WCC and 28 123 acute or chronic visits to intervention practices; 33 914 adolescents (17 069 girls [50.3%]; mean [SD] age, 14.2 [2.0] years) made 17 910 WCC and 35 281 acute or chronic visits to control practices. Intervention practices reduced missed opportunities overall by 2.4 percentage points (-2.4%; 95% CI, -3.5% to -1.2%) more than controls. Intervention practices reduced missed opportunities for vaccine initiation during WCC visits by 6.8 percentage points (-6.8%; 95% CI, -9.7% to -3.9%) more than controls. The intervention had no effect on missed opportunities for subsequent doses of the HPV vaccine or at acute or chronic visits. Adolescents in intervention practices had a 3.4-percentage point (95% CI, 0.6%-6.2%) greater improvement in HPV vaccine initiation compared with adolescents in control practices. Conclusions and Relevance: This scalable, online communication training increased HPV vaccination, particularly HPV vaccine initiation at WCC visits. Results support dissemination of this intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03599557.

Persistent Hypertension in Children and Adolescents: A 6-Year Cohort Study.

OBJECTIVES: To determine the natural history of pediatric hypertension. METHODS: We conducted a 72-month retrospective cohort study among 165 primary care sites. Blood pressure measurements from two consecutive 36 month periods were compared. RESULTS: Among 398 079 primary care pediatric patients ages 3 to 18, 89 347 had ≥3 blood pressure levels recorded during a 36-month period, and 43 825 children had ≥3 blood pressure levels for 2 consecutive 36-month periods. Among these 43 825 children, 4.3% (1881) met criteria for hypertension (3.5% [1515] stage 1, 0.8% [366] stage 2) and 4.9% (2144) met criteria for elevated blood pressure in the first 36 months. During the second 36 months, 50% (933) of hypertensive patients had no abnormal blood pressure levels, 22% (406) had elevated blood pressure levels or <3 hypertensive blood pressure levels, and 29% (542) had ≥3 hypertensive blood pressure levels. Of 2144 patients with elevated blood pressure in the first 36 months, 70% (1492) had no abnormal blood pressure levels, 18% (378) had persistent elevated blood pressure levels, and 13% (274) developed hypertension in the second 36-months. Among the 7775 patients with abnormal blood pressure levels in the first 36-months, only 52% (4025) had ≥3 blood pressure levels recorded during the second 36-months. CONCLUSIONS: In a primary care cohort, most children initially meeting criteria for hypertension or elevated blood pressure had subsequent normal blood pressure levels or did not receive recommended follow-up measurements. These results highlight the need for more nuanced initial blood pressure assessment and systems to promote follow-up of abnormal results.

Missed opportunities for human papillomavirus vaccination at office visits during which influenza vaccine was administered: An AAP pediatric research in office settings (PROS) national primary care research network study.

INTRODUCTION: Little is known about missed opportunities (MOs) for HPV vaccination during primary care visits at which influenza vaccination is delivered. METHODS: We extracted electronic health records for HPV vaccine-eligible 11-to-17-year-olds. We assessed the proportion of visits during which an influenza vaccine was given and an HPV vaccine was due, but not given (i.e., MOs). RESULTS: Of 56,135 eligible visits, 57.5% represented MOs for HPV vaccination. MOs were more common at visits where an initial versus subsequent HPV vaccine dose was due (68.6% vs. 31.3%) and for acute/chronic and nurse-only visits compared to preventive visits (74.0% and 80.2% vs. 36.7%). In a multivariable model, MOs were more likely for the initial HPV dose and for non-preventive visits, but did not vary by patient sex/age. CONCLUSIONS: HPV vaccine MOs were common during visits where influenza vaccine was administered. Increasing simultaneous administration of HPV and influenza vaccines could increase HPV vaccine coverage.

Reducing paediatric overweight and obesity through motivational interviewing: study protocol for a randomised controlled trial in the AAP PROS research network.

INTRODUCTION: Primary care remains an underused venue for prevention and management of paediatric overweight and obesity. A prior trial demonstrated a significant impact of paediatrician/nurse practitioner (Ped/NP)-and registered dietitian (RD)-delivered motivational interviewing (MI) on child body mass index (BMI). The study described here will test the effectiveness of an enhanced version of this primary care-based MI counselling intervention on child BMI. METHODS AND ANALYSIS: This cluster randomised effectiveness trial includes 24 Ped/NPs from 18 paediatric primary care practices that belong to the American Academy of Pediatrics (AAP) national Pediatric Research in Office Settings (PROS) practice-based research network. To date, practices have been randomised (nine to intervention and nine to usual care). Intervention Ped/NPs have been trained in MI, behavioural therapy, billing/coding for weight management and study procedures. Usual care Ped/NPs received training in billing/coding and study procedures only. Children 3- 11 years old with BMI >the 85th percentile were identified via electronic health records (EHRs). Parents from intervention practices have been recruited and enrolled. Over about 2 years, these parents are offered approximately 10 MI-based counselling sessions (about four in person sessions with their child's Ped/NP and up to six telephonic sessions with a trained RD). The primary outcome is change in child BMI (defined as per cent from median BMI for age and sex) over the study period. The primary comparison is between eligible children in intervention practices whose parents enrol in the study and all eligible children in usual care practices. Data sources will include EHRs, billing records, surveys and counselling call notes. ETHICS AND DISSEMINATION: Institutional Review Board approval was obtained from the AAP. All Ped/NPs provided written informed consent, and intervention group parents provided consent and Health Insurance Portability and Accountability Act (HIPAA) authorisation. Findings will be disseminated through peer-reviewed publications, conference presentations and appropriate AAP channels. TRIAL REGISTRATION NUMBER: NCT03177148; Pre-results.

Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness.

BACKGROUND: One-third of outpatient antibiotic prescriptions for pediatric acute respiratory tract infections (ARTIs) are inappropriate. We evaluated a distance learning program's effectiveness for reducing outpatient antibiotic prescribing for ARTI visits. METHODS: In this stepped-wedge clinical trial run from November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges. Visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection for children 6 months to <11 years old without recent antibiotic use were included. Clinicians received the intervention as 3 program modules containing online tutorials and webinars on evidence-based communication strategies and antibioti c prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months. The primary outcome was overall antibiotic prescribing rates for all ARTI visits. Mixed-effects logistic regression compared prescribing rates during each program module and a postintervention period to a baseline control period. Odds ratios were converted to adjusted rate ratios (aRRs) for interpretability. RESULTS: Among 72 723 ARTI visits by 29 762 patients, intention-to-treat analyses revealed a 7% decrease in the probability of antibiotic prescribing for ARTI overall between the baseline and postintervention periods (aRR 0.93; 95% confidence interval [CI], 0.90-0.96). Second-line antibiotic prescribing decreased for streptococcal pharyngitis (aRR 0.66; 95% CI, 0.50-0.87) and sinusitis (aRR 0.59; 95% CI, 0.44-0.77) but not for acute otitis media (aRR 0.93; 95% CI, 0.83-1.03). Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70). CONCLUSIONS: This program reduced antibiotic prescribing during outpatient ARTI visits; broader dissemination may be beneficial.

Improving pediatric practice immunization rates through distance-based quality improvement: a feasibility trial from PROS.

The feasibility and effectiveness of a distance-based quality improvement model were examined in a cohort of Pediatric Research in Office Settings (PROS) practices, with the goal of improving immunization rates and practitioner behaviors and attitudes. Of an initially assessed 82 practices, 29 with baseline rates of < or =88% for children 8 to 15 months of age were randomized into year-long paper-based education or distance-based quality improvement intervention groups. Outcomes were utility/helpfulness of quality improvement modalities, immunization rate change, and behavior/attitude change. Quality improvement participants attended approximately 75% of monthly conference calls but used the quality improvement Listserv and Web site infrequently (mean 1.09 and 0.92 uses, respectively). Helpfulness ratings of quality improvement modalities mirrored usage. Analyses revealed a 4.9% increase in quality improvement group immunization rates (P = .061), a 0.8% education group increase (P = .752), and a 4.1% difference between groups (P = .261). More quality improvement practices adopted systems identifying children behind in immunizations. A distance-based quality improvement model is feasible and may improve immunization rates.

Clinician practice patterns: linking to community resources for childhood aggression.

Creating links to community resources for childhood aggression is one component of office-based violence prevention. Evidence is lacking regarding the effect of training clinicians to make these referrals and families' responses to them. Clinicians who received training (n=47) and parents (1093) were queried on the provision of referrals immediately after the visit. Fewer than half of clinicians (45%) reported making a community referral. A third of providers (37%) noted difficulty in identifying local resources. Training clinicians to utilize community resources for childhood aggression does not often result in creating community links for this purpose.

Timing of Puberty in Overweight Versus Obese Boys.

BACKGROUND AND OBJECTIVE: Studies of the relationship of weight status with timing of puberty in boys have been mixed. This study examined whether overweight and obesity are associated with differences in the timing of puberty in US boys. METHODS: We reanalyzed recent community-based pubertal data from the American Academy of Pediatrics' Pediatric Research in Office Settings study in which trained clinicians assessed boys 6 to 16 years for height, weight, Tanner stages, testicular volume (TV), and other pubertal variables. We classified children based on BMI as normal weight, overweight, or obese and compared median age at a given Tanner stage or greater by weight class using probit and ordinal probit models and a Bayesian approach. RESULTS: Half of boys (49.9%, n = 1931) were white, 25.8% (n = 1000) were African American, and 24.3% (n = 941) were Hispanic. For genital development in white and African American boys across a variety of Tanner stages, we found earlier puberty in overweight compared with normal weight boys, and later puberty in obese compared with overweight, but no significant differences for Hispanics. For TV (≥3 mL or ≥4 mL), our findings support earlier puberty for overweight compared with normal weight white boys. CONCLUSIONS: In a large, racially diverse, community-based sample of US boys, we found evidence of earlier puberty for overweight compared with normal or obese, and later puberty for obese boys compared with normal and overweight boys. Additional studies are needed to understand the possible relationships among race/ethnicity, gender, BMI, and the timing of pubertal development.

Preschool ADHD Diagnosis and Stimulant Use Before and After the 2011 AAP Practice Guideline.

OBJECTIVE: To evaluate the change in the diagnosis of attention-deficit/hyperactivity disorder (ADHD) and prescribing of stimulants to children 4 to 5 years old after release of the 2011 American Academy of Pediatrics guideline. METHODS: Electronic health record data were extracted from 63 primary care practices. We included preventive visits from children 48 to 72 months old receiving care from January 2008 to July 2014. We compared rates of ADHD diagnosis and stimulant prescribing before and after guideline release using logistic regression with a spline and clustering by practice. Patterns of change (increase, decrease, no change) were described for each practice. RESULTS: Among 87 067 children with 118 957 visits before the guideline and 56 814 with 92 601 visits after the guideline, children had an ADHD diagnosis at 0.7% (95% confidence interval [CI], 0.7% to 0.8%) of visits before and 0.9% (95% CI, 0.8% to 0.9%) after guideline release and had stimulant prescriptions at 0.4% (95% CI, 0.4% to 0.4%) of visits in both periods. A significantly increasing preguideline trend in ADHD diagnosis ended after guideline release. The rate of stimulant medication use remained constant before and after guideline release. Patterns of change from before to after the guideline varied significantly across practices. CONCLUSIONS: Release of the 2011 guideline that addressed ADHD in preschoolers was associated with the end of an increasing rate of diagnosis, and the rate of prescribing stimulants remained constant. These are reassuring results given that a standardized approach to diagnosis was recommended and stimulant treatment is not first-line therapy for this age group.

Variations in Mental Health Diagnosis and Prescribing Across Pediatric Primary Care Practices.

BACKGROUND: Primary care pediatricians increasingly care for children's mental health problems, but little is known about practice-level variation in diagnosis and psychotropic medication prescribing practices. METHODS: This retrospective review of electronic heath records from 43 US primary care practices included children aged 4 to 18 years with ≥1 office visit from January 1, 2009, to June 30, 2014. We examined variability in diagnosis and psychotropic prescribing across practices using logistic regression with practice fixed effects and evaluated associations of the availability of colocated or community-based mental health providers or the proportion of children in foster care with diagnosis and prescribing using generalized linear mixed models. RESULTS: Among 294 748 children, 40 932 (15%) received a mental health diagnosis and 39 695 (14%) were prescribed psychotropic medication. Attention deficit/hyperactivity disorder was most commonly diagnosed (1%-16% per practice). The proportion of children receiving any psychotropic medication (4%-26%) and the proportion receiving ≥2 medication classes (1%-12%) varied across practices. Prescribing of specific medication classes also varied (stimulants, 3%-18%; antidepressants, 1%-12%; α-agonists, 0%-8%; second-generation antipsychotics, 0%-5%). Variability was partially explained by community availability of psychiatrists (significantly higher odds of a diagnosis or prescription when not available) but not by colocation of mental health professionals or percentage of children in foster care. CONCLUSIONS: The prevalence of mental health diagnosis and psychotropic medication prescribing varies substantially across practices and is only partially explained by psychiatrist availability. Research is needed to better define the causes of variable practice-level diagnosis and prescribing and implications for child mental health outcomes.

Comparative Effectiveness Research Through a Collaborative Electronic Reporting Consortium.

The United States lacks a system to use routinely collected electronic health record (EHR) clinical data to conduct comparative effectiveness research (CER) on pediatric drug therapeutics and other child health topics. This Special Article describes the creation and details of a network of EHR networks devised to use clinical data in EHRs for conducting CER, led by the American Academy of Pediatrics Pediatric Research in Office Settings (PROS). To achieve this goal, PROS has linked data from its own EHR-based "ePROS" network with data from independent practices and health systems across the United States. Beginning with 4 of proof-of-concept retrospective CER studies on psychotropic and asthma medication use and side effects with a planned full-scale prospective CER study on treatment of pediatric hypertension, the Comparative Effectiveness Research Through Collaborative Electronic Reporting (CER(2)) collaborators are developing a platform to advance the methodology of pediatric pharmacoepidemiology. CER(2) will provide a resource for future CER studies in pediatric drug therapeutics and other child health topics. This article outlines the vision for and present composition of this network, governance, and challenges and opportunities for using the network to advance child health and health care. The goal of this network is to engage child health researchers from around the United States in participating in collaborative research using the CER(2) database.

Changing patterns of alpha agonist medication use in children and adolescents 2009-2011.

OBJECTIVES: The purpose of this study was to describe rates and patterns of long- and short-acting alpha agonist use for behavioral problems in a primary care population following Food and Drug Administration (FDA) approval of the long-acting alpha agonists guanfacine and clonidine. METHODS: Children and adolescents 4-18 years of age, who received an alpha agonist prescription between 2009 and 2011, were identified from a sample of 45 United States primary care practices in two electronic health record-based research networks. Alpha agonist receipt was identified using National Drug Codes and medication names. The proportion of subjects receiving long- and short-acting prescriptions in each year was calculated and examined with respect to reported mental health diagnoses, and whether indications for use were on-label, had evidence from clinical trials, or had no trial evidence. RESULTS: In a cohort of 282,875 subjects, 27,671 (10%) received any psychotropic medication and only 4,227 subjects (1.5%) received at least one prescription for an alpha agonist, most commonly a short-acting formulation (83%). Only 20% of alpha agonist use was on-label (use of long-acting formulations for attention-deficit/hyperactivity disorder [ADHD]). Most subjects (68%) received alpha agonists for indications with evidence of efficacy from clinical trials but no FDA approval, primarily short-acting formulations for ADHD and autism; 12% received alpha agonists for diagnoses lacking randomized clinical trial evidence in children, including sleep disorders and anxiety, or for which there was no documented mental health diagnosis. Rates of long-acting alpha agonist use increased more than 20-fold from 0.2% to 4%, whereas rates of short-acting alpha agonist use grew only slightly between 2009 and 2011 from 10.6% to 11.3%. CONCLUSIONS: Alpha agonist use was uncommon in this population, and most subjects received short-acting forms for conditions that were off-label, but with clinical trial evidence. The safety and efficacy of use for conditions, including sleep disorders and anxiety, lacking evidence from randomized trials, warrant further investigation.

Secondary sexual characteristics in boys: data from the Pediatric Research in Office Settings Network.

BACKGROUND: Data from racially and ethnically diverse US boys are needed to determine ages of onset of secondary sexual characteristics and examine secular trends. Current international studies suggest earlier puberty in boys than previous studies, following recent trend in girls. METHODS: Two hundred and twelve practitioners collected Tanner stage and testicular volume data on 4131 boys seen for well-child care in 144 pediatric offices across the United States. Data were analyzed for prevalence and mean ages of onset of sexual maturity markers. RESULTS: Mean ages for onset of Tanner 2 genital development for non-Hispanic white, African American, and Hispanic boys were 10.14, 9.14, and 10.04 years and for stage 2 pubic hair, 11.47, 10.25, and 11.43 years respectively. Mean years for achieving testicular volumes of ≥ 3 mL were 9.95 for white, 9.71 for African American, and 9.63 for Hispanic boys; and for ≥ 4 mL were 11.46, 11.75, and 11.29 respectively. African American boys showed earlier (P < .0001) mean ages for stage 2 to 4 genital development and stage 2 to 4 pubic hair than white and Hispanic boys. No statistical differences were observed between white and Hispanic boys. CONCLUSIONS: Observed mean ages of beginning genital and pubic hair growth and early testicular volumes were 6 months to 2 years earlier than in past studies, depending on the characteristic and race/ethnicity. The causes and public health implications of this apparent shift in US boys to a lower age of onset for the development of secondary sexual characteristics in US boys needs further exploration.