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 Children's 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.

Language, speech sound production, and cognition in three-year-old children in relation to otitis media in their first three years of life.

OBJECTIVE: As part of a prospective study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between children's cumulative duration of middle ear effusion (MEE) in their first 3 years of life and their scores on measures of language, speech sound production, and cognition at 3 years of age. METHODS: We enrolled 6350 healthy infants by 2 months of age who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small town/rural and 4 suburban private pediatric practices. We intensively monitored the children's middle ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. Children who met specified minimum criteria regarding the persistence of MEE became eligible for a clinical trial in which they were assigned randomly to undergo tympanostomy tube placement either promptly or after a defined extended period if MEE remained present. From among those remaining, we selected randomly, within sociodemographic strata, a sample of 241 children who represented a spectrum of MEE experience from having no MEE to having MEE whose cumulative duration fell just short of meeting randomization criteria. In subjects so selected, the estimated duration of MEE ranged from none to 65.6% of the first year of life and 44.8% of the first 3 years of life. In these 241 children we assessed language development, speech sound production, and cognition at 3 years of age, using both formal tests and conversational samples. RESULTS: We found weak to moderate, statistically significant negative correlations between children's cumulative durations of MEE in their first year of life or in age periods that included their first year of life, and their scores on formal tests of receptive vocabulary and verbal aspects of cognition at 3 years of age. However, the percent of variance in these scores explained by time with MEE in the first year of life beyond that explained by sociodemographic variables ranged only from 1.2% to 2.9%, and the negative correlations were concentrated in the subgroup of children whose families had private health insurance (rather than Medicaid). We found no significant correlations in the study population as a whole or in any subgroup between time with MEE during antecedent periods and children's scores on measures of spontaneous expressive language, speech sound production, or other measured aspects of cognition. In contrast, by wide margins, scores on all measures were consistently highest among the most socioeconomically advantaged children and lowest among the most socioeconomically disadvantaged children. CONCLUSIONS: Our findings suggest either that persistent early-life MEE actually causes later small, circumscribed impairments of receptive language and verbal aspects of cognition in certain groups of children or that unidentified, confounding factors predispose children both to early-life otitis media and to certain types of developmental impairment. Findings in the randomized clinical trial component of the larger study should help distinguish between causality and confounding as explanations for our findings.language, speech, cognition, development, otitis media, middle ear effusion.

Parental stress and parent-rated child behavior in relation to otitis media in the first three years of life.

OBJECTIVE: As part of a long-term study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we tested relationships between parents' ratings of parent-child stress at ages 1, 2, and 3 years, and of their children's behavior problems at ages 2 and 3 years, and the children's cumulative duration of middle-ear effusion (MEE) in their first 3 years of life. METHODS: We enrolled healthy infants by age 2 months who presented for primary care at 1 of 2 urban hospitals or 1 of 2 small-town/rural and 4 suburban private pediatric practices. We obtained standardized baseline measures of parental stress; we intensively monitored the children's middle-ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 3 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated children for otitis media according to specified guidelines. We obtained parent ratings of parental stress using the Parenting Stress Index/Short Form when the children reached ages 1, 2, and 3 years, and parent ratings of children's behavior using the Child Behavior Checklist when the children reached ages 2 and 3 years. RESULTS: In 2278 children we found no substantial relationships between parents' ratings of parent-child stress when the children reached ages 1, 2, and 3 years, or of their children's behavior problems at ages 2 and 3 years, and the cumulative duration of the children's MEE during antecedent periods. On the other hand, ratings both of parent-child stress and of behavior problems were consistently highest among the most socioeconomically disadvantaged children and lowest among the most socioeconomically advantaged children. Ratings also tended to be highest among children whose parents' baseline stress scores were highest. CONCLUSIONS: Parent-child stress and children's behavior problems in the first 3 years of life, as rated by parents, bear little or no relationship to the children's previous cumulative duration of MEE.

Adenoidectomy and adenotonsillectomy for recurrent acute otitis media: parallel randomized clinical trials in children not previously treated with tympanostomy tubes.

CONTEXT: Adenoidectomy and adenotonsillectomy are commonly performed in US children to reduce the occurrence of persistent or recurrent otitis media, but evidence supporting the efficacy of the operations is limited. OBJECTIVES: To test the efficacy of adenoidectomy and adenotonsillectomy in children with persistent or recurrent otitis media who had not previously undergone tube placement and to compare the relative efficacy of adenoidectomy alone vs adenotonsillectomy in such children. DESIGN: Two parallel randomized clinical trials. SETTING AND PARTICIPANTS: A total of 461 children aged 3 to 15 years were enrolled at Children's Hospital of Pittsburgh, Pa, between April 1980 and April 1994. Four hundred ten children were observed for up to 3 years. INTERVENTIONS: Children without recurrent throat infection or tonsillar hypertrophy (304 enrolled; 266 followed up) were randomized to either an adenoidectomy, adenotonsillectomy, or control group; children who had such conditions (157 enrolled; 144 followed up) were randomized to an adenotonsillectomy or control group. MAIN OUTCOME MEASURES: Occurrence rate of episodes of acute otitis media by treatment group and estimated proportion of time with otitis media. RESULTS: In both trials, most subjects were eligible because of recurrent acute otitis media, with or without persistent otitis media with effusion. A total of 47 children assigned to surgical treatment groups had no surgery. The efficacy of surgery in both trials was modest and limited mainly to the first follow-up year. The largest differences in that year were found in the 3-way trial between the adenotonsillectomy group and the control group: mean annual rate of episodes of acute otitis media, 1.4 vs 2.1 (P<.001); and mean estimated percentage of time with otitis media, 18.6% vs 29.9% (difference, 11.3%; 95% confidence interval, 4.4%-18.2%; P=.002). Perioperative and postoperative complications or other adverse events occurred not infrequently, especially among subjects undergoing adenotonsillectomy (14.6%). CONCLUSIONS: Our study showed limited and short-term efficacy of both adenoidectomy and adenotonsillectomy; given the risks, morbidity, and costs of these procedures, these data suggest that neither operation should ordinarily be considered as a first surgical intervention in children whose only indication is recurrent acute otitis media.

Assessment of adenoidal obstruction in children: clinical signs versus roentgenographic findings.

OBJECTIVE: As part of a comprehensive study of indications for tonsillectomy and adenoidectomy, we investigated the reliability of standardized clinical assessments and standardized roentgenographic assessments of adenoidal obstruction of the nasopharynx, and the degree of correlation between clinical assessments and roentgenographic assessments. METHODS: We rated the degree of patients' mouth breathing and patients' speech hyponasality on a 4-point scale (none = 1; mild = 2; moderate = 3; marked = 4), we averaged the ratings for each child to obtain a Nasal Obstruction Index, and we determined levels of interobserver agreement concerning the ratings. We classified lateral soft-tissue roentgenograms of the nasopharynx, based on assessments of adenoid size and of nasopharyngeal airway patency, as showing either no obstruction, borderline obstruction, or obstruction, and we determined levels of inter- and intraobserver agreement concerning the classifications. Finally, we determined correlations in individual patients between clinical ratings and roentgenographic ratings of nasal/nasopharyngeal obstruction, and calculated the predictive values of clinical ratings based on roentgenographic ratings as the gold standard. RESULTS: In sets of paired examinations, weighted kappa values for interobserver agreement concerning mouth breathing (total, 235 children) and speech hyponasality (total, 648 children) ranged from 0.84 to 0.91. The value for interobserver agreement concerning roentgenographic assessment of nasopharyngeal airway status (207 children) was 0.92, and for intraobserver agreement (191 children) 0.88. The Kendall's tau b value for concordance between Nasal Obstruction Index values and roentgenographic ratings (1033 children) was 0.51. Nasal Obstruction Index values at the lower and upper extremes--i.e., 1.0 and > or = 3.5, respectively--were highly predictive of concordant roentgenographic ratings. CONCLUSIONS: We conclude that standardized clinical ratings of the degree of children's mouth breathing and speech hyponasality provide reliable and reasonably valid assessments of the presence and degree of adenoidal obstruction of the nasopharyngeal airway. These clinical assessments are particularly valid at the extremes of either marked obstruction or no obstruction. Clinical assessment alone may be insufficient to establish the presence of adenoidal obstruction, but clinical assessment alone when findings are unequivocally negative can suffice to rule out adenoidal obstruction with a high degree of confidence.

Otitis media in 2253 Pittsburgh-area infants: prevalence and risk factors during the first two years of life.

OBJECTIVE: As part of a long-term study of possible effects of early-life otitis media on speech, language, cognitive, and psychosocial development, we set out to delineate the occurrence and course of otitis media during the first 2 years of life in a sociodemographically diverse population of infants, and to identify related risk factors. METHODS: We enrolled healthy infants by age 2 months who presented for primary care at one of two urban hospitals or one of two small town/rural and four suburban private pediatric practices. We intensively monitored the infants' middle-ear status by pneumatic otoscopy, supplemented by tympanometry, throughout their first 2 years of life; we monitored the validity of the otoscopic observations on an ongoing basis; and we treated infants for otitis media according to specified guidelines. RESULTS: We followed 2253 infants until age 2 years. The proportions developing > or = 1 episode of middle-ear effusion (MEE) between age 61 days (the starting point for data analysis) and ages 6, 12, and 24 months, respectively, were 47.8%, 78.9%, and 91.1%. Overall, the mean cumulative proportion of days with MEE was 20.4% in the first year of life and 16.6% in the second year of life. Tympanostomy-tube placement was performed on 1.8% and 4.2% of the infants during the first and second years of life, respectively. By every measure, the occurrence of MEE was highest among urban infants and lowest among suburban infants; these differences were greatest in the earliest months of life. Overall, unadjusted mean cumulative proportions of days with MEE were higher among boys than girls, higher among black than white infants, and higher among Medicaid than private health insurance enrollees. Cumulative proportions of days with MEE varied directly with the number of smokers in the household and with the number of other children to whom infants were exposed, whether at home or in day care, and varied inversely with birth weight, maternal age, level of maternal education, a socioeconomic index, and duration of breastfeeding. After adjustment, using multivariate analysis, the only variables that each remained independently and significantly related to the cumulative proportion of days with MEE were: during the first year of life, study site grouping, sex, the socioeconomic index, breastfeeding for > or = 4 months, the number of smokers in the household, and an index rating the degree of exposure to other children at home or in day care; and during the second year of life, sex, the socioeconomic index, and the child exposure index. The duration of breastfeeding and the degree of exposure to tobacco smoke contributed little to the explained variance; most was attributable to differences in the socioeconomic index and the child exposure index. CONCLUSIONS: Contrary to findings in many previous reports, the prevalence of otitis media during the first 2 years of life among lower-socioeconomic-status black infants appears to be as high as, if not higher than among lower-socioeconomic-status white infants, and certainly higher than among middle-class white infants. Among middle-class white infants the prevalence may also be higher than commonly assumed. The most important sociodemographic risk factors for otitis media appear to be low socioeconomic status and repeated exposure to large numbers of other children, whether at home or in day care.

Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement. Results of parallel randomized and nonrandomized trials.

We studied the efficacy of adenoidectomy in 213 children who had received tympanostomy-tube placement because of persistent and/or recurrent otitis media and had again developed otitis media after tubal extrusion. Ninety-nine of the children were assigned randomly to either an adenoidectomy group or a control group; in a separate trial, 114 children whose parents withheld consent for randomization were assigned according to parental preference. In both trials, control group outcomes appeared to have been biased favorably by the withdrawal of certain severely affected subjects from control status to receive adenoidectomy. Nonetheless, in both trials, adenoidectomy group outcomes were more favorable than control group outcomes during the first 2 follow-up years. Statistically significant differences were found mainly in the randomized trial, where during the first and second years, respectively, adenoidectomy subjects had 47% and 37% less time with otitis media than control subjects and 28% and 35% fewer suppurative (acute) episodes than control subjects. We conclude that adenoidectomy is warranted on an individualized basis for children who develop recurrent otitis media after extrusion of tympanostomy tubes.

Efficacy of tonsillectomy for recurrent throat infection in severely affected children. Results of parallel randomized and nonrandomized clinical trials.

We studied the efficacy of tonsillectomy, or tonsillectomy with adenoidectomy, in 187 children severely affected with recurrent throat infection. Ninety-one of the children were assigned randomly to either surgical or nonsurgical treatment groups, and 96 were assigned according to parental preference. In both the randomized and nonrandomized trials, the effects of tonsillectomy and of tonsillectomy with adenoidectomy were similar. By various measures, the incidence of throat infection during the first two years of follow-up was significantly lower (P less than or equal to 0.05) in the surgical groups than in the corresponding nonsurgical groups. Third-year differences, although in most cases not significant, also consistently favored the surgical groups. On the other hand, in each follow-up year many subjects in the nonsurgical groups had fewer than three episodes of infection, and most episodes among subjects in the nonsurgical groups were mild. Of the 95 subjects treated with surgery, 13 (14 per cent) had surgery-related complications, all of which were readily managed or self-limited. These results warrant the election of tonsillectomy for children meeting the trials' stringent eligibility criteria, but also provide support for nonsurgical management. Treatment for such children must therefore be individualized.

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.