A randomised controlled trial of surgery for glue ear. A randomized study of the surgical management of children with persistent otitis media with effusion associated with a hearing impairment. Generalizability of trial results based on randomized versus nonrandomized allocation of OME infants to ventilation tubes or watchful waiting. Otoscopic, impedance, and audiometric findings in glue ear treated by adenoidectomy and tonsillectomy. A prospective randomised study. Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial. Conservative treatment of otitis media with effusion by autoinflation of the middle ear. The long-term outcome of nonsuppurative otitis media with effusion. The effect of ventilation tubes on language development in infants with otitis media with effusion: A randomized trial. Tympanic membrane abnormalities and hearing levels at the ages of 5 and 6 years in relation to persistent otitis media and tympanostomy tube insertion in the first 3 years of life: a prospective study incorporating a randomized clinical trial.
To assess the effect of five different surgical treatments for glue ear (secretory otitis media) on improvement in hearing and, assuming one or more treatments to be effective, to identify the appropriate indications for surgery.
                Randomised controlled trial of children receiving (a) adenoidectomy, bilateral myringotomy, and insertion of a unilateral grommet; (b) adenoidectomy, unilateral myringotomy, and insertion of a unilateral grommet; (c) bilateral myringotomy and insertion of a unilateral grommet; and (d) unilateral myringotomy and insertion of a grommet. Children were followed up at seven weeks, six months, 12 months, and 24 months by symptom history and clinical investigations.
                Otolaryngology department in an urban hospital.
                149 Children aged 4-9 years who were admitted for surgery for glue ear and who had no history of previous operations on tonsils, adenoids, or ears and no evidence of sensorineural deafness. Inadequate follow up information on levels of hearing and on middle ear function was obtained from 22.
                Mean hearing loss (dB) of the three worst heard frequencies between 250 and 4000 Hz, results of impedance tympanometry, and parental views on their child's progress.
                In the 127 children for whom adequate information was available ears in which a grommet had been inserted performed better in the short term (for at least six months) than those in which no grommet had been inserted, irrespective of any accompanying procedure. Most of the benefit had disappeared by 12 months. Adenoidectomy produced a slight improvement that was not significant, though was sustained for at least two years. The ears of children who had had an adenoidectomy with myringotomy and grommet insertion, however, continued to improve so that two years after surgery about 50% had abnormal tympanometry compared with 83% of those who had had only myringotomy and grommet insertion, and 93% of the group that had had no treatment. Logistic regression analyses identified preoperative hearing level as the single best predictor of good outcome from surgery. Other variables contributed little additional predictive power.
                If the principal objective of surgery for glue ear is to restore hearing then our study shows that insertion of grommets is the treatment of choice. The addition of an adenoidectomy will increase the likelihood of restoration of normal function of the middle ear but will not improve hearing. When deciding appropriate indications for surgery, a balance has to be made between performing unnecessary operations and failing to treat patients who might benefit from surgical intervention. Preoperative audiometry scores might be the best predictor in helping to make this decision. The object of this study was to compare the effect on the hearing of the insertion of a grommet, with or without adenoidectomy, against a non-surgically managed control ear in children with persistent hearing impairment due to otitis media with effusion. Seventy-eight children (44 boys, 34 girls, mean age 5.8 years) with documented bilateral otitis media with effusion associated with a bilateral hearing impairment (pure tone average air conduction thresholds over 0.5, 1 and 2 kHz of > or = 25 dB HL) over a three month period were admitted to a randomized, controlled trial. Each child was randomized to have or not to have an adenoidectomy. The ears in each child were then randomly allocated to have a grommet (tympanostomy tube) inserted. The children's hearing status was reviewed six and 12 months post-operatively. During follow-up, should a child redevelop a persistent bilateral hearing impairment (as defined above) for three months they were managed with a hearing aid. Thus no child had repeat insertion of a grommet. Surgery of each type had an effect on the hearing and the presence of otitis media with effusion at six months post-operatively but not at 12 months when it was no different from natural resolution. If resolution of the otitis media with effusion is the outcome measure, then adenoidectomy alone is significantly better than no surgery but only in boys rather than in girls. Even in boys it only resolves about 60 per cent of effusions. However, when combined with a grommet (one insertion) adenoidectomy gives no greater resolution (89 per cent compared with 86 per cent).(ABSTRACT TRUNCATED AT 250 WORDS) The objective was to study the generalizability of trial results by comparing randomized patients to eligible but nonrandomized patients who received the same management. Implementation of trial results is only justifiable when the results can be generalized to the total domain population. The design was a multicentre randomized controlled trial on the effect of early screening and treatment with ventilation tubes on infants with otitis media with effusion. Randomized (n = 187) and nonrandomized eligible patients (n = 133) were followed up. The study population comprised children who were detected by auditory screening at the age of 9-12 months and who were subsequently diagnosed with persistent bilateral otitis media with effusion for 4-6 months. A significant difference was found in the distribution of some prognostic factors: more randomized children had older siblings, did not attend day care and had mothers with a lower educational level than the nonrandomized children. These factors, however, did not modify the outcome. No differences were found in mean hearing levels between the randomized and nonrandomized children: in both the randomized and nonrandomized children ventilation tubes improved the hearing level, especially after 6 months. However, in the long term (12 months), the hearing levels were equal again. The results of the randomized and nonrandomized patients were comparable. The results of this trial appear to be generalizable to the total domain population. The procedure of following up both randomized and nonrandomized patients is recommended when there is concern about selective participation and reduced generalizability. 150 children aged between 2 and 9 years (mean 5.25 years) with chronic bilateral otitis media with effusion were randomly allocated to three groups who, in addition to unilateral myringotomy and grommet insertion, would have an adenotonsillectomy, an adenoidectomy, or neither. The contralateral ear was assessed. Otoscopic, impedance, and audiometric findings were recorded preoperatively and at six and twelve months postoperatively. Subtraction of the no-surgery results indicates that at twelve months adenoidectomy produces otoscopic resolution of OME in 41.7% and no-peak/peak conversion of impedance in 29.8%. The hearing gain from adenoidectomy alone was similar to that resulting from insertion of a grommet alone, but the children having adenoidectomy required fewer reinsertions to maintain adequate subjective hearing thresholds in the treated ear (26% versus 54%). Tonsillectomy conferred no additional benefit. Without treatment there was a small but significant improvement in all indices at twelve months but not at six months postoperatively. Otitis media with effusion (OME) is the most common cause of hearing loss in children and is generally treated by elective surgery. We compared in children with persistent OME the effect on speech and language development of immediate surgery (ventilation-tube insertion) and watchful waiting before surgery.
                We did a randomised controlled trial with masked outcome assessment in Bristol Children's Hospital, Bristol, UK. We included 186 children born between April 1, 1991, and Dec 31, 1992, who had confirmed bilateral OME and bilateral hearing impairment of 25-70 dB of at least 3 months' duration. Children were randomly assigned surgery within 6 weeks (n=92), or 9 months of watchful waiting (n=90), after which bilateral tube insertion was done if required. We assessed hearing loss, expressive language, and verbal comprehension at 9 months and 18 months.
                At 9 months, standardised scores for expressive language and verbal comprehension differed between groups with marginal significance after adjustment for baseline differences (p=0.04 and p=0.028, respectively). At 9 months, verbal comprehension and expressive language skills in the watchful-waiting group were 3.24 months behind those in the early-surgery group. The watchful-waiting group was delayed on these two measures compared with their age-expected levels. 18 months after randomisation, 85% of children in the watchful-waiting group had received surgery and groups did not differ significantly.
                There is some benefit from ventilation-tube insertion for expressive language and verbal comprehension but the timing of surgery is not critical. A total of 85 children on the waiting list for grommet insertion aged between 3 and 10 years with bilateral chronic otitis media with effusion (OME) were assigned at random to an observation or treatment group. Those in the treatment group were given the Otovent device to use three times a day for the duration of the study and both groups were then seen at monthly intervals for 3 months for pneumatic otoscopy and tympanometry. Statistically significant improvement was seen in those using the treatment with a compliance of more than 70%. This was detected on the outcome measures of tympanometry and pneumatic otoscopy after 1, 2 and 3 months. No side effects were demonstrated. We conclude that autoinflation is an effective short-term treatment for children with OME when used regularly under supervision. Seventy-four children were enrolled in a double-blind placebo-controlled study to define the outcome of nonsuppurative otitis media with effusion (OME) over a 12-week period. Participants were randomly assigned to one of three treatment groups: pseudoephedrine (4 mg/kg/day), chlorpheniramine (0.35 mg/kg/day), or placebo. The children were reexamined at 2, 4, 8, and 12 weeks after enrollment unless earlier dismissed from the study because OME resolved or acute suppurative otitis media developed. Of the 66 children completing the study protocol, 44 percent had resolved OME, 38 percent developed acute suppurative otitis media, 14 percent had unresolved OME, and 4 percent developed severe hearing loss or medication side effects by the end of 12 weeks. The greatest incidence of both suppurative otitis media and resolution of OME occurred by 2 weeks of follow-up. There was no significant difference in resolution of effusion between treatment groups. Children who were 18 months of age or older with unilateral effusion had the best likelihood of resolution. To study the effectiveness of ventilation tubes on the language development in infants with persistent otitis media with effusion (OME). All existing studies addressed children 3 years of age or older. Currently, OME is detected and treated with ventilation tubes at a younger age. Because of the critical relationship between age, hearing, and language development, we conducted a study of the effects of ventilation tubes on language development in infants 1 to 2 years old with persistent OME.
                A multicenter, randomized, controlled trial (embedded in a cohort) with 2 treatment arms: 1) treatment with ventilation tubes (VT group; n = 93); or 2) with a period of watchful waiting (WW group; n = 94). Hearing loss and expressive and comprehensive language were assessed every 6 months, while tympanometry and otoscopy were performed every 3 months. Other factors with potential influence on language development were also included: adenoidectomy, hospital, attending day care, sex, age at randomization, educational level of the mother, upper respiratory infections, and the native country of the parents and older siblings. The trial was designed to allow for the detection of a mean difference in language development of 3 months or more between children allocated to the VT and WW groups.
                No relevant differences were found in expressive or comprehensive language between the 2 groups after adjustment for educational level of the mother, IQ of the child, and differences at baseline. A principal component analysis showed that in the VT group, the children with frequent complaints improved 1.6 months more in comprehensive language than those with no or some complaints. The children with favorable language stimulation, however, did not improve more than the children with less favorable stimulation. No differences were found for expressive language among the various clusters. The probability to improve >3 months in comprehensive language was.48 (95% confidence interval [CI]:.29-.68) for children with highly educated mothers versus.09 (95% CI:.02-.30) for children whose mothers had a low educational level. In the WW group, these changes were.30 (95% CI:.14-.53) and.14 (95% CI:.04-.35), respectively. The probability to improve >4 months in expressive language was.52 (95% CI:.32-.71) for children with highly educated mothers versus.06 (95% CI:.01-.31) for children whose mothers had a low educational level. In the WW group these changes were.42 (95% CI:.23-.64) and.11 (95% CI:.03-.35), respectively. In addition, there were delays in expressive language in both groups compared with their age expected values. The comprehensive language of the children who were effusion-free during the follow-up (n = 54) improved 1.5 months (95% CI: -.2-3.2) more than that of the children who had persistent effusion during the entire follow-up (n = 28). No differences were found for expressive language development. Disregarding the intervention contrast, improvements in hearing seemed to be related to improvements in language development, especially in verbal comprehension.
                In this study, we used the Reynell, Schlichting, and Lexi tests to study the relation between early persistent OME and language development. These tests are directly related to normal language, widely accepted, and validated. It cannot be ruled out that more specific measures such as auditory perception tests would have produced more differences between groups, but the focus was on general language development. A total of 10 children in the WW group received treatment with ventilation tubes during follow-up. A further 11 children dropped out during the trial. A sensitivity analysis with the 10 children who received ventilation tubes did not change the results, and baseline differences were not found between the 11 children who dropped out and those who completed the trial.
                In the total group of infants with persistent OME, ventilation tubes did not h One current practice guideline recommends myringotomy with tympanostomy tube insertion (M&T) for young children in whom middle-ear effusion (MEE) has persisted for 3 months, and another recommends the procedure after MEE has persisted for 4 to 6 months provided that a bilateral hearing loss of > or=20 dB is present. Sequelae of M&T are not uncommon, but the extent to which these sequelae are attributable to M&T itself or to the middle-ear disease that prompted the procedure or to both has not been clear. Our objective in the present study was to examine the prevalence of various tympanic membrane (TM) abnormalities in otherwise healthy children at the age of 5 years and hearing levels at the age of 6 years in relation to persistent MEE and M&T in the children's first 3 years of life.
                In a prospective study of child development in relation to early-life otitis media, we randomly assigned 429 children who met specified criteria regarding the persistence of MEE in their first 3 years of life to undergo M&T either promptly (the "early-treatment" group) or after a defined extended period if MEE remained present (the "late-treatment" group). We also followed a representative sample of 241 children who ranged from having no MEE to having MEE whose cumulative duration fell just short of meeting randomization criteria for the clinical trial (the "nontrial" group). Most of the children in each group underwent both otomicroscopic examination at the age of 5 years and audiometric testing at the age of 6 years, at times when they were free of MEE. Among these children, M&T had been performed in 82.3% of those in the early-treatment group, 38.1% of those in the late-treatment group, and 3.0% of those in the nontrial group.
                At the age of 5 years, we found 1 or more types of TM abnormality in 1 or both ears in 70.7%, 42.5%, and 9.5% of the children in the early-treatment, late-treatment, and nontrial groups, respectively. Within the 3 groups, however, among children who received tubes, the proportions who had an abnormality of some type were similar, namely, 82.6%, 80.4%, and 83.3%, respectively. The corresponding proportions among children who had not received tubes were 15.4%, 19.3%, and 7.2%, respectively. Segmental atrophy and tympanosclerosis were the most common abnormalities found. At the age of 6 years, mean pure-tone average audiometric thresholds in the early-treatment, late-treatment, and nontrial groups, respectively, were 6.18 dB, 5.49 dB, and 4.63 dB in left ears and 6.17 dB, 6.02 dB, and 4.32 dB in right ears. The thresholds in the early- and late-treatment groups did not differ significantly, but the thresholds in the early- and late-treatment groups were each significantly higher than in the nontrial group. Within the early- and late-treatment groups, we found no significant relation between hearing levels and the presence or type of TM abnormalities.
                In otherwise healthy children who have persistent MEE during their first 3 years of life, ready resort to M&T results in far more TM abnormalities at age 5 than does selective management in which most children do not receive the procedure. With these differing approaches, however, hearing levels at age 6 do not differ. Regardless of whether children with persistent early-life MEE receive M&T, they have more TM abnormalities at age 5 and negligibly poorer hearing at age 6 than do children who had less or no otitis media. Longer term otologic and audiologic outcomes of persistent early-life MEE and of M&T remain to be determined. In view of 1) the present findings and the remaining uncertainties concerning sequelae, 2) the fact that M&T involves certain immediate risks--albeit minimal--and substantial cost, and 3) previously reported findings in the study's randomized clinical trial that show no developmental advantage at ages 3 and 4 years accruing from children's having received prompt M&T, a prolonged period of watchful waiting seems desirable in otherwise healthy children who are younger than 3 years and have persistent, asymptomatic MEE that is not complicated by sensorineural or severe conductive hearing loss, balance dysfunction, or severe TM retraction.
In children with OME the effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children. No effect was found on other child outcomes but data on these were sparse. No study has been performed in children with established speech, language, learning or developmental problems so no conclusions can be made regarding treatment of such children.