Otite media con versamento

The question whether persistent otitis media with effusion (OME) early in life results in lasting developmental impairments remains unresolved and a matter of controversy. The episodic and variable hearing impairment associated with OME, occurring during supposedly "critical" or "sensitive" developmental periods the first few years of life, has been held responsible by a number of authors for various types of developmental impairments found in later childhood, after both OME and hearing loss presumably have been resolved.

Impairments of development have been reported in four separate domains: language, speech, cognition, and psychosocial development. Accordingly, various authorities have called for mass screening for asymptomatic middle-ear effusion (MEE) in young children, and concerns about presumed developmental effects of OME have been advanced as providing potential or definite justification for surgical interventions, the most common of which, by far, is tympanostomy-tube placement. A systematic national survey in United States in 1994 found that approximately 580,000 such operations had been performed that year in children under 15 years old, and 313,000 in children under 3 years old.

Definitive determination of whether these supposed relationships between early-life OME and later developmental outcome indeed exist would have major developmental, quality-of-life, and health care implications. If the relief of persistent OME in infants and young children by early tympanostomy-tube placement were shown to be beneficial developmentally, it would follow that efforts by physicians to detect OME in infants and young children should be intensified by means of more frequent and more careful otoscopic examination, mass screening programs for OME using tympanometry should be instituted widely, and the numbers of children subjected to tympanostomy-tube placement and/or adenoidectomy should increase.

Increases in these health-care efforts and expenditures would strain health-care systems and economies, but the increases would presumably be justified by the improvements in children's development that would be expected to result, with accompanying beneficial impact on their educational achievement, social and behavioral competence, quality of life, and social and economic status.

On the other hand, if OME at commonly encountered levels of frequency and duration were shown not to be a developmental risk factor, and if early tympanostomy-tube placement in children with persistent OME were found not to be beneficial developmentally, surveillance for OME in otherwise well children would undoubtedly decrease, monitoring of children after episodes of AOM would undoubtedly be relaxed, and the numbers of children receiving tympanostomy-tube placement and/or adenoidectomy probably would substantially decrease, since many tube operations, particularly in asymptomatic children, are being performed primarily because of concern about developmental outcomes. Under such circumstances, current health care efforts and expenditures could be reduced substantially without risk to children's development or to their later psychological, emotional, social, or economic well-being.

Many studies of possible associations between early-life OM and later-life developmental impairment have been reported in the past 30 years. The studies vary widely in design, methods, and quality, and in the specific developmental areas--speech, language, cognitive, and/or psychosocial--being tested. Findings of the studies were mixed. Some of the studies found associations between early OM and later developmental impairments of one type or another, whereas other studies did not. Statistically significant associations in particular developmental domains were found in some studies but not in others. In short, the results have been confusingly contradictory. Many of the studies have been subjected to critical review. Most studies employed retrospective, case-control designs and suffered from the limitations inherent in such designs.

Other limitations common among these studies--as well as among the relatively few prospective, cohort studies--included: small sample size; nonrepresentativeness of subjects; risk of selection bias; exclusive reliance on tympanometry for diagnosing OM; presence of mild hearing loss or tympanometric abnormalities--or lack of information concerning these variables--at the time of developmental testing; questionable age-appropriateness, validity, reliability, and comprehensiveness of developmental tests; inadequate blinding of examiners; and selective presentation or emphasis of positive findings. These various limitations have contributed to uncertainty as to whether associations actually exist between early-life OM occurring at common levels of frequency and duration, and later-life developmental impairments.

All studies reported to date have been studies of association, i.e., of whether developmental impairments were associated with excessive degrees of OM in earlier childhood. However, even if the positive studies had not had the limitations cited and an association between early OM and later developmental impairments had indeed been established, the question of causality would remain, because it is possible, if not likely, that various factors--genetic, perinatal, or environmental--may predispose children both to early-life OM and to later-life developmental impairments. Under such circumstances, early OM would be associated with the impairments, but not causally, and might be considered a marker or predictor rather than a cause.

A definitive study should answer four main questions:

• Are there, in fact, associations between OME occurring at common levels of frequency and duration during the first few years of life, and lasting impairments of speech, language, cognitive, or psychosocial development?
• If such associations exist, are they causal in nature, or are they attributable instead to common underlying factors?
• If persistent OME causes developmental impairments of one kind or another, what is the subsequent course of the impairments? Are they transient or fixed, reversible or irreversible?
• In infants and young children with persistent OME, does prompt tube placement result in improved developmental outcomes?

In 1991, with support mainly from our National Institutes of Health we began a study at Children's Hospital of Pittsburgh designed to answer these questions. Over a period of 4 1/2 years, 6,351 healthy infants aged less than 2 months and representing a broad sociodemographic spectrum were enrolled.

The design and early findings of the study will be discussed, but definitive answers to the key questions will not be available for several years. In the meantime, faced with continuing uncertainty about long-term developmental effects of persistent early-life OME, how should clinicians proceed with decision-making about the advisability and timing of tympanostomy-tube placement? In 1994 in the United States a federal agency assembled a panel of experts who drew up guidelines, based on "limited scientific evidence and Panel consensus," for treating OME in children aged 1 through 3 years.

The guidelines recommend strongly against tube placement for bilateral OME of less than 3 months' duration. For children with bilateral OME of 3 months' duration and a hearing threshold of 20 decibels or higher in the better-hearing ear, the guidelines recommend either antibiotic treatment or tube placement. If the duration of bilateral OME has been 4 to 6 months and the hearing threshold is similarly elevated, the guidelines recommend tube placement.

My own opinion also is based on limited evidence, and reflects my own clinical observations and biases. In particular, the opinion reflects a view of the child as resilient and adaptable. First, my best guess is that bilateral OME persisting for up to 1 year during the first 3 years of life is harmless in the long run, even though short-term disturbances of speech and language development probably do result in some children. Second, I believe it important that children not be subjected to tube placement without having first been treated adequately with an antimicrobial drug that is resistant to beta-lactamases. Finally, I believe that no single guideline can adequately deal with the diverse factors that need to be considered in arriving at sensible and appropriate clinical judgments about individual children.

I concur with the guideline disapproving tube placement for bilateral OME of less than 3 months' duration. Beyond that period, the physician will wish to take into account a number of individual factors: the child's hearing acuity; the level of speech development; the prior history, including tolerance of various antimicrobial drugs; the current otologic status; the nature of available anesthetic and surgical services; and certainly the parents' wishes after they have been informed fully about the respective risks of watchful waiting and of tube placement.