Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children.

Background: Limiting the duration of antimicrobial treatment constitutes a potential strategy to reduce the risk of antimicrobial resistance among children with acute otitis media.

Methods: We assigned 520 children, 6 to 23 months of age, with acute otitis media to receive amoxicillin-clavulanate either for a standard duration of 10 days or for a reduced duration of 5 days followed by placebo for 5 days. We measured rates of clinical response (in a systematic fashion, on the basis of signs and symptomatic response), recurrence, and nasopharyngeal colonization, and we analyzed episode outcomes using a noninferiority approach.

Emergence of Streptococcus pneumoniae serogroups 15 and 35 in nasopharyngeal cultures from young children with acute otitis media.

Background: Surveillance of children with acute otitis media (AOM) for nasopharyngeal colonization with Streptococcus pneumoniae before, during and after the introduction of 7-valent pneumococcal conjugate vaccine (PCV7) indicated the near-complete elimination of PCV7 strains and the emergence of pneumococcal serotype 19A.

Methods: To determine effects of the introduction of 13-valent pneumococcal conjugate vaccine (PCV13) on pneumococcal nasopharyngeal colonization, we obtained nasopharyngeal cultures from 228 children 6 through 23 of age months presenting with a new episode of AOM during 2012 and 2013 and enrolled in an ongoing clinical trial of antimicrobial efficacy. All children had received at least 2 doses of PCV13.

Are nasopharyngeal cultures useful in diagnosis of acute bacterial sinusitis in children?

The diagnosis of acute bacterial sinusitis can be challenging because symptoms of acute sinusitis and an upper respiratory tract infection (URI) overlap. A rapid test, if accurate in differentiating sinusitis from URI, could be helpful in the diagnostic process. We examined the utility of nasopharyngeal cultures in identifying the subgroup of children with a clinical diagnosis of acute sinusitis who are least likely to benefit from antimicrobial therapy (those with completely normal sinus radiographs).

Signs and symptoms that differentiate acute sinusitis from viral upper respiratory tract infection.

Objective: Differentiating acute bacterial sinusitis from viral upper respiratory tract infection (URI) is challenging; 20% to 40% of children diagnosed with acute sinusitis based on clinical criteria likely have an uncomplicated URI. The objective of this study was to determine which signs and symptoms could be used to identify the subgroup of children who meet current clinical criteria for sinusitis but who nevertheless have a viral URI.

Methods: We obtained sinus radiographs in consecutive children meeting a priori clinical criteria for acute sinusitis.

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.

Importance: A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design.

Objective: To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial.

Treatment of acute otitis media in children under 2 years of age.

Background: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.

Methods: We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.

Pneumococcal resistance and serotype 19A in Pittsburgh-area children with acute otitis media before and after introduction of 7-valent pneumococcal polysaccharide vaccine.

Methods: Before and after introduction of pneumococcal conjugate vaccine (PCV7), the authors obtained nasopharyngeal (NP) specimens from 3 groups of children aged 6 to 23 months with acute otitis media (AOM): group 1 (pre-PCV7), group 2 (early post-PCV7), and group 3 (late post-PCV7).

Results: Of the Streptococcus pneumoniae isolates, the proportion that were vaccine serotypes (VTs) declined progressively (60.4% vs 48.

Pain management in young children undergoing diagnostic tympanocentesis.

Objective: To describe the pain associated with diagnostic tympanocentesis and to gather preliminary data comparing the efficacy of 3 methods of pain reduction for tympanocentesis.

Methods: In children 6 to 36 months of age undergoing tympanocentesis for acute otitis media, the authors measured pain and distress throughout all phases of the procedure and recovery using physiological (heart rate) and behavioral measures (cry duration, Global Mood Scale score, and pain visual analog scales). They compared--in a randomized controlled trial--3 pain reduction interventions: acetaminophen, acetaminophen plus codeine, and ibuprofen plus midazolam.

How do parents of preverbal children with acute otitis media determine how much ear pain their child is having?

Unlabelled: The objective of this study was to determine how parents of preverbal children determine whether their child is having otalgia. We constructed 8 cases describing a 1-year-old child with acute otitis media (AOM) using various combinations of the following 6 observable symptoms: fussiness, ear tugging, eating less, fever, sleeping difficulty, and playing less. Parents of children with a history of AOM presenting for well or sick appointments to an ambulatory clinic were asked to assign a pain level to each case on a visual analog scale.

Mastering diagnostic skills: Enhancing Proficiency in Otitis Media, a model for diagnostic skills training.

Objective: We developed a program for training in the diagnosis of otitis media that included images illustrating various otoscopic findings, mnemonic guides to recollection, and discrimination sessions that included feedback and assessments of diagnostic skills.

Methods: We prepared a computerized, interactive curriculum, Enhancing Proficiency in Otitis Media (ePROM), that was centered around assemblages of clinically diverse, still and video images of tympanic membranes (TMs). To assess curriculum effectiveness, we constructed a test, the Diagnostic Ear Assessment Resource, that consisted of 50 video TM images.

Development of a patient-reported outcome measure for children with streptococcal pharyngitis.

Objective: The objective of this study was to develop a patient-reported outcome measure (Strep-PRO) for assessing symptoms of group A Streptococcus (GAS) pharyngitis from the child's point of view and to present preliminary data on its internal reliability, construct validity, and responsiveness.

Methods: We selected 8 symptoms for inclusion in the Strep-PRO. We used the Strep-PRO to assess improvement in children who were aged 5 to 15 years and had confirmed GAS pharyngitis.

New vaccines against otitis media: projected benefits and cost-effectiveness.

Objective: New vaccines that offer protection against otitis media caused by nontypeable Haemophilus influenzae and by Moraxella catarrhalis are under development. However, the potential health benefits and economic effects of such candidate vaccines have not been systematically assessed.

Methods: We created a computerized model to compare the projected benefits and costs of (1) the currently available 7-valent pneumococcal conjugate vaccine, (2) a candidate pneumococcal-nontypeable H influenzae vaccine that has been tested in Europe, (3) a hypothetical pneumococcal-nontypeable H influenzae-Moraxella vaccine, and (4) no vaccination.

Bowel habits and toilet training in a diverse population of children.

Objectives: To gather data concerning bowel habits and toilet training of developmentally normal children ages 5 to 8 years.

Methods: A questionnaire containing information on age, race, and sex was completed anonymously by a parent in 9 pediatric practices. Recall information was elicited about onset and completion of toilet training, frequency and quality of stooling, size of bowel movements, and behavioral components of defecation.

An examination of attitudes, knowledge, and clinical practices among Pennsylvania pediatricians regarding breastfeeding and smoking.

Background And Objective: The most recent American Academy of Pediatrics policy statement clearly supports breastfeeding for smoking mothers. The impact of this recommendation on pediatricians' counseling and prescribing practices is unclear. This study describes Pennsylvania pediatricians' attitudes, knowledge, and practices regarding breastfeeding, maternal smoking, and smoking cessation.

Translating an evidence-based intervention for pediatric overweight to a primary care setting.

The objective of this study was to train pediatric providers to address weight, body mass index (BMI), diet, and physical activity with parents. Children aged 8 to 12 years with BMI of >or=85th percentile were eligible if accompanied by a parent. The intervention was a family-based, 11-session behavioral program focusing on healthy eating and physical activity.

Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis media.

Background: Acute otitis media (AOM) is the most common childhood diagnosis, leading to prescription of an antibiotic in the United States. Although antibiotics are used in children with AOM, in part, to shorten the duration of symptoms, no instruments have been developed to track early changes in symptoms from the parent's point of view. The goal of the present study was to develop and evaluate a parent-reported symptom scale for children with AOM (AOM-SOS) for use as an outcome measure in AOM treatment trials.

Responsiveness and construct validity of a symptom scale for acute otitis media.

Background: Because resolution of symptoms is a primary goal of antimicrobial therapy in children with acute otitis media (AOM), measurement of symptoms in studies of antimicrobial effectiveness in such children is important. We have developed a scale for measuring symptoms of AOM in young children (AOM-SOS), and we present data on its construct validity and responsiveness.

Methods: We followed children 3 months to 3 years of age with AOM, who were receiving antimicrobial treatment, using the AOM-SOS scale.

Spectral gradient acoustic reflectometry compared with tympanometry in diagnosing middle ear effusion in children aged 6 to 24 months.

Objectives: To evaluate the accuracy of spectral gradient acoustic reflectometry (SGAR) in children aged 6 to 24 months, and to compare SGAR with tympanometry.

Design: Comparison of diagnostic tests.

Setting: Inner-city primary care center in Pittsburgh, Pennsylvania.

Studying injury prevention: practices, problems, and pitfalls in implementation.

This prospective, randomized, controlled trial was conducted to determine feasibility and effectiveness of a chronic care model approach to injury prevention compared with standard anticipatory guidance. Enrolled caregivers of children aged 0 to 5 years received focused counseling from a physician and health assistant, educational handouts, phone follow-up, and access to free safety devices and automobile restraint evaluations. Only 35.

Tympanostomy tubes and developmental outcomes at 9 to 11 years of age.

Background: Developmental impairments in children have been attributed to persistent middle-ear effusion in their early years of life. Previously, we reported that among children younger than 3 years of age with persistent middle-ear effusion, prompt as compared with delayed insertion of tympanostomy tubes did not result in improved cognitive, language, speech, or psychosocial development at 3, 4, or 6 years of age. However, other important components of development could not be assessed until the children were older.

Tympanometric findings and the probability of middle-ear effusion in 3686 infants and young children.

Objective: We examined relationships between tympanometric findings and the presence or absence of middle-ear effusion in a population-based sample of children under the age of 3 years.

Methods: In a study of children's development in relation to early-life otitis media, we enrolled 6350 infants soon after birth and evaluated them regularly for the presence of middle-ear effusion. In 3686 of the children, we compared tympanometric findings with otoscopic diagnoses.

Developmental outcomes after early or delayed insertion of tympanostomy tubes.

Background: To prevent later developmental impairments, myringotomy with the insertion of tympanostomy tubes has often been undertaken in young children who have persistent otitis media with effusion. We previously reported that prompt as compared with delayed insertion of tympanostomy tubes in children with persistent effusion who were younger than three years of age did not result in improved developmental outcomes at three or four years of age. However, the effect on the outcomes of school-age children is unknown.

Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years.

The MacArthur-Bates Communicative Development Inventories (CDI; Dale, 1996; Fenson et al., 1994), parent reports about language skills, are being used increasingly in studies of theoretical and public health importance. This study (N = 113) correlated scores on the CDI at ages 2 and 3 years with scores at age 3 years on tests of cognition and receptive language and measures from parent-child conversation.

Penicillin susceptibility of pneumococcal isolates causing acute otitis media in children: seasonal variation.

Background: During the past decade, the prevalence of nonsusceptible Streptococcus pneumoniae strains that cause acute otitis media (AOM) has increased to approximately 30%, and the proportion of fully resistant strains has also increased. The purpose of this study was to determine whether seasonal variation in resistance exists among pneumococcal isolates from children with AOM.

Methods: Between 1991 and 2003, children 2 months-8 years of age diagnosed with AOM according to stringent criteria underwent tympanocentesis in various clinical trials.