Association Between Nasopharyngeal Colonization and Clinical Outcome in Children With Acute Otitis Media.

Background: Young children with acute otitis media (AOM) frequently exhibit nasopharyngeal colonization with either Streptococcus pneumoniae, Haemophilus influenzae or both pathogens. We aimed to determine if antibiotics could be spared or shortened in those without nasopharyngeal colonization with either pathogen.

Methods: In 2 separate randomized clinical trials in children aged 6-23 months with stringently-diagnosed AOM, we performed bacterial cultures on nasopharyngeal specimens collected at the time of diagnosis.

Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.

Background: Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.

Methods: We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.

Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.

Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6.4 mg clavulanate/kg of body weight/day commonly causes diarrhea. We examined whether an A/C formulation containing lower concentrations of clavulanate would result in less diarrhea while maintaining plasma levels of amoxicillin and clavulanate adequate to eradicate middle-ear pathogens and to achieve clinical success.

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.

Toward an Improved Scale for Assessing Symptom Severity in Children With Acute Otitis Media.

The objective of the present study was to determine whether changes in the previously developed 7-item Acute Otitis Media Severity of Symptoms scale could improve its responsiveness and its longitudinal construct validity. The items "diminished activity" and "diminished appetite" had low or borderline levels of responsiveness and longitudinal construct validity. Dropping these items seems to be potentially advantageous.

Determination of the minimal important difference for the acute otitis media severity of symptom scale.

Background: We previously developed and validated the acute otitis media severity of symptom (AOM-SOS) scale for rating symptoms of AOM in young children. In this report, we sought to estimate the minimal important difference (MID) for change in AOM-SOS scores.

Methods: In a group of children 6-24 months of age with AOM enrolled in a recently reported placebo-controlled clinical trial of antibiotic efficacy, we compared changes in AOM-SOS scores with parental assessments of change over a 24-hour period.

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.

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.

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.

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.

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.

Early histories of school-aged children with attention-deficit/hyperactivity disorder.

In a prospective study of developmental outcomes in relation to early-life otitis media, behavioral, cognitive, and language measures were administered to a large, diverse sample of children at 2, 3, 4, 6, and 9-11 years of age (N = 741). At 9-11 years of age, 9% of the children were categorized as having attention-deficit/hyperactivity disorder (ADHD) based on parent report. Compared to the non-ADHD group, the ADHD group had higher (i.