D. Kathleen Colborn

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. RESULTS Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae. CONCLUSIONS Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).

Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years.

BACKGROUND A main indication for the insertion of tympanostomy tubes in infants and young children is persistent otitis media with effusion, reflecting concern that this condition may cause lasting impairments of speech, language, cognitive, and psychosocial development. However, evidence of such relations is inconclusive, and evidence is lacking that the insertion of tympanostomy tubes prevents developmental impairment. METHODS We enrolled 6350 healthy infants from 2 to 61 days of age and evaluated them regularly for middle-ear effusion. Before the age of three years 429 children with persistent effusion were randomly assigned to have tympanostomy tubes inserted either as soon as possible or up to nine months later if effusion persisted. In 402 of these children we assessed speech, language, cognition, and psychosocial development at the age of three years. RESULTS By the age of three years, 169 children in the early-treatment group (82 percent) and 66 children in the late-treatment group (34 percent) had received tympanostomy tubes. There were no significant differences between the early-treatment group and the late-treatment group at the age of three years in the mean (+/-SD) scores on the Number of Different Words test, a measure of word diversity (124+/-32 and 126+/-30, respectively); the Percentage of Consonants Correct-Revised test, a measure of speech-sound production (85+/-7 vs. 86+/-7); the General Cognitive Index of McCarthy Scales of Childrens Abilities (99+/-14 vs. 101+/-13); or on measures of receptive language, sentence length, grammatical complexity, parent-child stress, and behavior. CONCLUSIONS In children younger than three years of age who have persistent otitis media, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at the age of three years.

History of recurrent sore throat as an indication for tonsillectomy. Predictive limitations of histories that are undocumented.

As part of a prospective study of indications for tonsillectomy and adenoidectomy, we followed closely 65 children with histories of recurrent throat infection that seemed impressive (at least seven episodes in one year, five in each of two consecutive years or three in each of three consecutive years), but lacked documentation. During the first year of observation, only 11 children (17 per cent) had episodes of throat infection with clinical features and patterns of frequency conforming to those described in their presenting histories. Of the remaining 54 children, 43 (80 per cent) experienced no, one or two observed episodes each, and most of the episodes were mild. We conclude that undocumented histories of recurrent throat infection do not validly forecast subsequent experience and hence do not constitute an adequate basis for subjecting children to tonsillectomy.

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. The clinical probabilities of acute otitis media and of otitis media with effusion were generated from multivariate analyses of data from 2 large health maintenance organizations and from the Pittsburgh Child Development/Otitis Media Study cohort. Other probabilities, costs, and quality-of-life values were derived from published and unpublished sources. The base-case analysis assumed vaccine dose costs of

Early versus delayed insertion of tympanostomy tubes for persistent otitis media: developmental outcomes at the age of three years in relation to prerandomization illness patterns and hearing levels

65 for the 7-valent pneumococcal conjugate vaccine,

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

100 for the pneumococcal-nontypeable H influenzae vaccine, and

Factors That Influence Parental Decisions to Participate in Clinical Research: Consenters vs Nonconsenters

125 for the pneumococcal-nontypeable H influenzae–Moraxella vaccine. RESULTS. With no vaccination, we projected that 13.7 million episodes of acute otitis media would occur annually in US children aged 0 to 4 years, at an annual cost of

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

3.8 billion. The 7-valent pneumococcal conjugate vaccine was projected to prevent 878000 acute otitis media episodes, or 6.4% of those that would occur with no vaccination; the corresponding value for the pneumococcal–nontypeable H influenzae vaccine was 3.7 million (27%) and for the pneumococcal–nontypeable H influenzae–Moraxella vaccine was 4.2 million (31%). Using the base-case vaccine costs, pneumococcal–nontypeable H influenzae vaccine use would result in net savings compared with nontypeable 7-valent pneumococcal conjugate use. Conversely, pneumococcal–nontypeable H influenzae–Moraxella vaccine use would not result in savings compared with pneumococcal–nontypeable H influenzae vaccine use, but would cost

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

48 000 more per quality-adjusted life-year saved. The results were sensitive to variations in assumptions on vaccine effectiveness and vaccine dose costs but not to variations in other assumptions. CONCLUSIONS. New candidate vaccines against otitis media have the potential to prevent millions of disease episodes in the United States annually. If priced comparably with other recently introduced vaccines, these new otitis vaccines could achieve cost-effectiveness comparable with or more favorable than that of the 7-valent pneumococcal conjugate vaccine.

Shortened Antimicrobial Treatment for Acute Otitis Media in Young Children

Background. Whether prompt insertion of tympanostomy tubes in children with persistent early life otitis media prevents or minimizes subsequent developmental impairment has been the subject of conflicting opinions and differing approaches to management. Methods. We randomly assigned 429 children with persistent middle ear effusion (MEE) before the age of 3 years to have tympanostomy tubes inserted either as soon as possible or up to 9 months later if MEE persisted. In 402 of these children, we found no significant differences at age 3 years between the 2 treatment groups in mean scores on any measure of speech, language and cognition and in 401 of the children no significant differences in measures of psychosocial development. We then examined outcomes within subgroups of children who might have been the most severely affected, namely those who had been randomized on the basis of bilateral, continuous MEE rather than unilateral and/or discontinuous MEE and those who had the greatest degrees of hearing loss. Results. In none of the subgroups we considered were scores on any outcome measure significantly more favorable in children in the early treatment group than in children in the late treatment group. Conclusions. In otherwise normal children who have MEE, during the first 3 years of life within the durations we studied, prompt insertion of tympanostomy tubes does not measurably improve developmental outcomes at age 3 years, irrespective of whether MEE has been continuous or discontinuous and unilateral or bilateral and whether or not MEE has been accompanied by mild to moderate hearing loss.