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.

Corticosteroids to prevent kidney scarring in children with a febrile urinary tract infection: a randomized trial.

Background: To evaluate the efficacy of adjuvant systemic corticosteroids in reducing kidney scarring. A previous study suggested that use of adjuvant systemic corticosteroids reduces kidney scarring in children radiologically confirmed to have extensive pyelonephritis. Efficacy of corticosteroids for children with febrile urinary tract infection (UTI) has not been studied.

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.

Subject-centered free-response ROC (FROC) analysis.

Purpose: To develop an approach of estimating subject-centered free-response receiver operating characteristic (FROC) curve for providing patient-centered inferences regarding detection-localization characteristics of a diagnostic system.

Methods: The authors examine properties of the conventional, target-centered, FROC curve and demonstrate that in scenarios where the diagnostic performance correlates with the total number of targets on a subject, it may lead to inadequate inferences from the perspective of possible benefits to a patient. Following solutions to patient-centered approaches in other applications, the authors define a subject-centered FROC curve and develop its formulation as a covariate-adjusted FROC curve.

On use of partial area under the ROC curve for evaluation of diagnostic performance.

Evaluation of diagnostic performance is a necessary component of new developments in many fields including medical diagnostics and decision making. The methodology for statistical analysis of diagnostic performance continues to develop, offering new analytical tools for conventional inferences and solutions for novel and increasingly more practically relevant questions. In this paper, we focus on the partial area under the Receiver Operating Characteristic (ROC) curve or pAUC.

Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: a randomized, placebo-phase trial.

Objective: To assess the safety and efficacy of rituximab in a randomized, double-blind, placebo-phase trial in adult and pediatric myositis patients.

Methods: Adults with refractory polymyositis (PM) and adults and children with refractory dermatomyositis (DM) were enrolled. Entry criteria included muscle weakness and ≥2 additional abnormal values on core set measures (CSMs) for adults.

Identifying children with vesicoureteral reflux: a comparison of 2 approaches.

Purpose: Various screening approaches have been proposed to identify the subgroup of children with urinary tract infection who have vesicoureteral reflux. However, few studies have compared the sensitivity of screening approaches in a representative population of young children. We compared the sensitivities of the top-down ((99m)technetium dimercaptosuccinic acid renal scan to screen) and biomarker based (C-reactive protein level at presentation) approaches in identifying children with vesicoureteral reflux.

Development of an algorithm for the diagnosis of otitis media.

Background: The relative importance of signs and symptoms in the diagnosis of otitis media has not been adequately evaluated. This has led to a large degree of variation in the criteria used to diagnose otitis media, which has resulted in inconsistencies in clinical care and discrepant research findings.

Methods: A group of experienced otoscopists examined children presenting for primary care.

Otoscopic signs of otitis media.

Background: Lack of agreed-upon diagnostic criteria for acute otitis media (AOM) has led to inconsistencies in clinical care, misleading research results, and misguided educational efforts. The objective of this study was to examine findings that expert otoscopists use when diagnosing AOM.

Methods: A group of experienced otoscopists examined 783 children presenting for primary care.

Localized detection and classification of abnormalities on FFDM and tomosynthesis examinations rated under an FROC paradigm.

Objective: The purpose of our study was to assess diagnostic performance when retrospectively interpreting full-field digital mammography (FFDM) and breast tomosynthesis examinations under a free-response receiver operating characteristic (FROC) paradigm.

Materials And Methods: We performed FROC analysis of a previously reported study in which eight experienced radiologists interpreted 125 examinations, including 35 with verified cancers. The FROC paradigm involves detecting, locating, and rating each suspected abnormality.

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.

Use of likelihood ratios for comparisons of binary diagnostic tests: underlying ROC curves.

Purpose: When comparing binary test results from two diagnostic systems, superiority in both "sensitivity" and "specificity" also implies differences in all conventional summary indices and locally in the underlying receiver operating characteristics (ROC) curves. However, when one of the two binary tests has higher sensitivity and lower specificity (or vice versa), comparisons of their performance levels are nontrivial and the use of different summary indices may lead to contradictory conclusions. A frequently used approach that is free of subjectivity associated with summary indices is based on the comparison of the underlying ROC curves that requires the collection of rating data using multicategory scales, whether natural or experimentally imposed.

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.

Is an ROC-type response truly always better than a binary response in observer performance studies?

Rationale And Objectives: The aim of this study was to assess similarities and differences between methods of performance comparisons under binary (yes or no) and receiver-operating characteristic (ROC)-type pseudocontinuous (0-100) rating data ascertained during an observer performance study of interpretation of full-field digital mammography (FFDM) versus FFDM plus digital breast tomosynthesis.

Materials And Methods: Rating data consisted of ROC-type pseudocontinuous and binary ratings generated by eight radiologists evaluating 77 digital mammographic examinations. Overall performance levels were summarized with a conventionally used probability of correct discrimination or, equivalently, the area under the ROC curve (AUC), which under a binary scale is related to Youden's index.

Time to diagnosis and performance levels during repeat interpretations of digital breast tomosynthesis: preliminary observations.

Rationale And Objectives: To compare time to interpretation and diagnostic performance levels during repeat readings of full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) in a retrospective study.

Materials And Methods: Three experienced radiologists twice interpreted 125 selected examinations, 35 with verified cancers and 90 negative for cancer during a period of 22 months using FFDM alone followed by a combined FFDM + DBT mode. Changes in time to "review and rate" these examinations as well as in diagnostic performance levels where assessed.

Adenoidectomy for otitis media with effusion in 2-3-year-old children.

Objective: To compare the efficacy of three surgical treatment combinations - myringotomy and tympanostomy tube insertion (M&T), adenoidectomy with M&T (A-M&T), and adenoidectomy with myringotomy (A-M) - in reducing middle-ear disease in young children with chronic OME.

Methods: Children 24-47 months of age, with a history of bilateral middle-ear effusion (MEE) for at least 3 months, unilateral for 6 months or longer or unilateral for 3 months after extrusion of a tympanostomy tube, unresponsive to recent antibiotic, were randomly assigned to either M&T, A-M&T, or A-M. Treatment assignment was stratified by age (24-35 months, 36-47 months), nasal obstruction (no, yes) and previous history of M&T (no, yes).