PEDIATRICS Vol. 107 No. 5 May 2001, pp. 1175-1176

COMMENTARY:
Management of Otitis Media and Functional Outcomes Related to Language, Behavior, and Attention: Is It Time to Change Our Approach?

Outcomes research assesses the end results of health care from the perspective of those who receive the care, those who provide it, and those who pay for it. The article by Karin Minter and her colleagues¹ at the Frank Porter Graham Child Development Center in Chapel Hill, North Carolina, provides important new information related to the functional outcomes of otitis media (OM) in early childhood. Their study documenting the relationship of otitis media with effusion (OME) and hearing loss with functional measures of attention and behavior obtained from parents, teachers, and clinicians appears in this issue of Pediatrics.¹ They conducted this prospective cohort study in 85 children whose middle ear and hearing status had been closely monitored from 6 months to 4 years of age. The diagnosis of OME was based on both pneumatic otoscopy and tympanometry. Audiologists who were unaware of the middle ear findings performed hearing assessments. The validated measures used to assess outcomes included the behavior rating scale of the Bayley Scales of Infant Development, the Parenting Stress Index, the Social Skills rating system, and the Conners' Teacher/Parent Rating Scale. Children's attention and behavior were assessed during infancy, preschool, and first grade. Mother's education, socioeconomic status, child gender, child care quality, and a measure of the home environment (home screening questionnaire) were included as covariates in all analyses. When these covariates were considered, there were no significant correlations between OME or hearing loss with any of the measures of attention and behavior at any age during the first 6 years of life.

In a previous publication, the investigators failed to document an association between otitis or hearing loss and the acquisition of language skills in this population.² The availability of this new data as well as the recent publication of several prospective cohort studies and a randomized clinical trial of ventilating tubes (VT) in Pediatrics should lead to a reassessment of current guidelines for the medical and surgical management of OME.

The diagnosis and management of OM, the most common childhood bacterial infection, remains one of our most challenging and difficult clinical problems. OM, or inflammation of the middle ear space, includes a continuum of conditions involving both acute otitis media (AOM) and OME.³ AOM is commonly defined as inflammation of the middle ear presenting with rapid onset of signs and symptoms such as otalgia, fever, irritability, anorexia, or vomiting. OME is usually defined by the presence of an asymptomatic middle ear effusion, although it can be associated with a "plugged ear" feeling. Otoscopic findings of inflammation associated with AOM may include decreased tympanic membrane mobility with a bulging contour (recognized by impaired visibility of the ossicular landmarks), a yellow and/or red color, exudate, or bullae. Findings that suggest OME include visualization of air fluid levels and diminished membrane mobility when the membrane is translucent. OME can also be associated with negative middle ear pressure suggested by prominence of the lateral process, a more horizontal orientation of the malleus, and better mobility with negative pressure. Both AOM and OME can be associated with decreased tympanic membrane mobility, a flat type B tympanogram, and a mild to moderate conductive hearing loss. Bacterial pathogens can be isolated frequently from purulent, serous, and mucoid effusions regardless of the presence of membrane inflammation or clinical symptoms. The pathophysiologic mechanisms of AOM and OME are quite complex and involve the interrelationships between viral and bacterial infection as well as other host and environmental factors, especially exposure to passive cigarette smoke. Although middle ear effusions can precede the development of AOM, they are also a common consequence of the inflammation associated with AOM.

Proper diagnosis and management of OM is not a trivial financial concern to the health care system. The total cost for children 13 years of age and younger has been estimated at $5.3 billion, of which 12.1% is related to antibiotics, 56.3% to patient visits, and 31.6% to surgery.⁴ Twenty-five to thirty-five percent of all otitis cases have been estimated to be OME,⁵ and a substantial portion of the OM-related surgery is for the management of OME. High rates of antibiotic treatment of AOM and OME have been a major contributor to the rise in antimicrobial-resistant bacterial strains causing disease.⁶ The use of more expensive antibiotics being used to cover resistant pathogens has added to the health care financial costs. However, this unintended consequence of otitis management has not been considered in most estimates of OM-related expenditures.

The rationale for aggressive medical and surgical approach to OME has been based on the theory that OM and hearing loss can delay the acquisition of language skills, alter behavior, and affect attention patterns. According to this theory children are more vulnerable to the effects of persistent or fluctuating conductive hearing loss during the first 2 to 3 years of life when a young child is experiencing the most rapid phases of receptive and expressive language development. Children with hearing loss early in life may not establish the normal response mechanisms to conversing and inappropriately learn to "tune out" certain types of stimuli. This may cause later attention and behavioral problems. Does the available evidence support this theory? The 2 types of studies that best address this question are observational cohort studies and randomized intervention trials. Observational cohort studies prospectively document middle ear status and hearing levels during early childhood and later assess language, behavior, and attention outcomes. Prospective studies are desirable because of the importance of carefully documenting middle ear and hearing status during early childhood. Randomized trials of interventions such as VT that are likely to restore hearing allow for a comparison of functional outcomes. Regardless of the study design, it is important to analyze the outcomes according to varying otitis and hearing loss characteristics including the degree of hearing loss, type of loss (fluctuating or prolonged), unilateral or bilateral involvement, and the specific timing of the otitis in relation to the developmental phase. In addition, the impact of OME and hearing loss varies according to population characteristics. Therefore, the interpretation of the findings also requires consideration of many confounding factors known to be strongly associated with language, behavior, and attention such as gender, family socioeconomic status, maternal age and education, quality of child care, and associated medical conditions. Unfortunately, it is not possible to adequately perform a meta-analysis of the many studies addressing these issues because the studies have used different measures of language, attention, and behavior and have used different observers. Given these considerations, it is not surprising that studies with small sample sizes with different populations, otitis characteristics, and outcome measures should report conflicting results.

In the clinical practice guideline published by the Agency for Health Care Policy and Research in 1994, the panel considered the then available evidence that OM and hearing loss affected language, behavior, and attention.⁵ Because of conflicting findings and methodologic inadequacies of studies available at that time, the report stated that insufficient evidence was available to support a causal relationship. The panel called for new studies that would overcome the methodologic deficiencies.

The findings of several of these new studies have recently been published. Many of the study design issues have been addressed in a prospective study conducted in Pittsburgh, Pennsylvania, which enrolled >2000 children from a racially and economically diverse population.^7,8 Children with known risk factors associated with developmental delay such as prematurity, serious illness, or neonatal asphyxia were excluded, as were children who were at risk of developmental problems because of severe family dysfunction, or inadequate parenting related to maternal substance abuse or having an adolescent mother. This study reported a negligible association between the presence of unilateral or bilateral middle ear effusion and parent-reported language developmental skills during the first 2 years of life.⁷ Another publication reporting data from this study found a negligible association between time with unilateral and or bilateral effusions and measures of attention and behavior assessed by the Parental Stress Index/short form at 1, 2, and 3 years of age and parent ratings of child behavior using the Child Behavior checklist at 2 and 3 years of age.⁸

Rovers and colleagues⁹ published findings of a randomized trial performed in the Netherlands that assessed the effect of VT on language development in young children 16 to 24 months old with OME. After adjusting for such factors as mother's educational level and the child's IQ, the study found no relevant differences in language skills after 6 and 12 months between the 93 children treated with VT and the 94 managed with watchful waiting (WW). Improvement in language skills was most strongly associated with the educational levels of the mother. An important finding was the similarity in improved hearing levels after 6 and 12 months of follow-up in the 2 groups (6 months of follow-up: 10.2 decibels [dB] in the VT group vs 4.6 dB in the WW group; 12 months of follow-up: 13.1 dB in the VT group vs 8.5 dB in the WW group).

Taken as a whole, the new data obtained in young children from Pennsylvania, North Carolina, and the Netherlands are consistent and reassuring that the presence of asymptomatic middle ear effusions in otherwise normal young children is unlikely to cause harm. The available evidence supports WW in these children without treatment with antibiotics, steroids, or surgery. These children should probably be followed every 3 months to monitor their language development and identify any progressive ear pathology such as retraction pockets, adhesive otitis, or choesteatoma that requires surgery. The very low incidence rate of this pathology in children with OME does not support the use of preventive surgery before initial findings of these conditions become apparent. Furthermore, complication rates of VT and adenoidectomies are higher than the spontaneous development of progressive ear pathology in untreated, otherwise well children with OME. The Agency for Health Care Policy and Research guideline for management of OME seems reasonable for young children who are at higher risk of developmental delay for medical reasons or already have a documented language delay or alteration of behavior or attention. These children have a higher risk of being affected by a hearing loss and the greater chance of benefiting from an intervention that restores normal hearing. Until data are available for this population, it seems prudent to continue to treat OME more aggressively in this high-risk population.

Were we naïve to believe that medical and surgical interventions to cure OME and restore normal hearing would be a silver bullet to promote language development and prevent subsequent behavior and attention problems? The recently published studies all suggest that parenting is a much more powerful force than antibiotics and surgery in promoting language development. In their book Meaningful Differences in the Everyday Experience of Young American Children, Hart and Risley¹⁰ describe vocabulary differences in 3- and 6-year-olds from low-, medium-, and high-income families and the subsequent impact on school readiness and long-term learning. In their longitudinal study they determined that economically advantaged children hear about 30 million words in the home setting before age 3. Low-income children hear <10 million words. The ratio of encouragement (affirmative sounds and gestures) to discouragement (prohibitions) is important. They found that encouragement is high among high-income families. Discouragement outweighs encouragement in low-income families. Hart and Risley concluded that the amount of conversation and parent interaction (through play) coupled with the amount of encouragement a child receives by age 3 is the most meaningful difference across social strata affecting school readiness and later school performance. Would children be better served if we could transfer the expenditures that have been used to treat OME with antibiotics and surgery to community, child care, and physician-based programs that motivate parents and other caregivers to talk with and encourage young children? Should our pediatric research identify practice-based language and literacy promotion approaches¹¹ that will eliminate the word gap heard by children living in low-income compared with high-income families? This type of outcomes research and subsequent child health policy would make the most sense from the perspective of those who receive the care, those who provide it, and those who pay for it.

Steve Berman, MD
Department of Pediatrics
University of Colorado School of Medicine
Children's Hospital
Denver, CO 80218

FOOTNOTES

Received for publication Oct 3, 2000; accepted Oct 3, 2000.

Address correspondence to Steve Berman, MD, Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital, 1056 E. 19th Ave, Box B032, Denver, CO 80218. E-mail: berman.stephen{at}tchden.org

ABBREVIATIONS

OM, otitis media; OME, otitis media with effusion; VT, ventilating tubes; AOM, acute otitis media; WW, watchful waiting; dB, decibel.

REFERENCES

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