Background and Objectives

Uncertainty about the effectiveness of tympanostomy tubes (TT) for children with otitis media, indications for tympanostomy in children, effectiveness of antibiotics for children with tube otorrhea, and the need for prophylactic water precaution devices prompted the Agency for Healthcare Research and Quality to commission a review of the evidence to help inform recommendations concerning surgical indications and management strategies for TT placement.

Otitis media is often preceded by a viral upper respiratory tract infection that causes Eustachian tube obstruction, negative middle ear pressure, and accumulation of fluid in this normally air-filled space. Acute otitis media (AOM) is defined as the presence of fluid in the middle ear with signs and symptoms of an acute infection, such as fever and ear pain. Otitis media with effusion (OME) is defined as the presence of fluid in the middle ear behind an intact tympanic membrane without signs and symptoms of an acute infection.^1,2 OME is defined as chronic OME, if effusion persists for 3 months or longer.¹ Acute otitis media and chronic OME have shared causes. Children with chronic OME are prone to recurrent AOM episodes, and after an AOM episode all children have OME for some time.³

Myringotomy with TT placement is the most common ambulatory surgery performed on children in the United States⁴, with 667,000 TT placed in children under the age of 15 in 2006.⁵ The proceedings of the National Summit on Overuse, convened in 2012, based on sample of continually enrolled children into a treatment pathways database and a Medicaid database, reported that 2.5 percent of all U.S. children 2 years old and older had TT inserted in 2010.⁶

A 1994 study reported indications for TT placement in children: 30 percent were for chronic OME, 24 percent for recurrent AOM, and 46 percent of surgical candidates had both recurrent AOM and chronic OME.⁷

Chronic OME can result in hearing deficits, which put a child at risk for speech and language delays, behavioral changes, and poor academic achievement. Recurrent AOM has been shown to impact quality of life for patients and their caregivers.⁸ The comparative effectiveness of TT for chronic OME and recurrent AOM is likely influenced by the many factors that affect the prognosis for middle ear disease in children, including current age, age at first diagnosis, frequency of respiratory tract infections, and day care exposure.⁹ Children with middle ear effusions that are bilateral and continuously present are likely at higher risk. Tube lifespan is likely to be an important mediator of effectiveness.

Because recurrent AOM and chronic OME have shared causes, and for many patients represent a continuum, it may be important to consider children’s risk of these conditions and risk of important outcomes under various treatments for these conditions when researching or planning a child’s optimal management. A risk-centered approach might involve differential management of children with otitis media by their risk of important outcomes, as obtained from risk prediction models, which may be preferable to algorithms that use a single threshold for duration or frequency of a diagnosis.¹⁰

Along these lines we note that certain children, including those with Down syndrome and cleft palate, have a very high risk for middle ear disease. In a retrospective review of patients with Down syndrome, the authors found that the majority of patients required two or more sets of tubes during their childhood.¹¹ Due to the effects of palatal dysfunction on Eustachian tube function, children with cleft palate also have a high incidence of OME and associated hearing loss.¹² The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) clinical practice guideline (CPG) identifies a subpopulation of children who may be at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors.¹ The inclination to treat OME more aggressively in these children is reflected in a study that found that approximately 1 in 6 children with autism spectrum disorder underwent TT placement.¹³

The AAO-HNS CPG concludes that the efficacy of TT for preventing recurrent AOM is unclear, with systematic reviews reporting insufficient evidence, small short-term benefits, or moderate benefits of similar magnitude to antibiotic prophylaxis. They note the overall favorable natural history of otitis media without persistent middle ear effusion.¹⁴ The AAO-HNS CPG recommends that clinicians should offer TT to children with recurrent AOM and middle ear effusions based on shared decisionmaking with the child’s caregiver. They conclude that there is no benefit if one considers only randomized controlled trials with AOM that clears between episodes (without chronic OME) and recommend that tubes not be placed in children with recurrent AOM who have a normal ear examination at the time of assessment for tube candidacy.¹ The American Academy of Pediatrics CPG discourages routine use of prophylactic antibiotics to prevent recurrent AOM.¹⁵ The reluctance to use antibiotic prophylaxis because of concerns about antibiotic resistance may result in increased use of TT in children with recurrent AOM. Attempts to promote the use of more rigorous criteria for the diagnosis of AOM may also result in improved effectiveness of TT.

A 2014 review by Tsao and Goode provides a narrative summary of their search for evidence regarding water precautions to prevent post-TT otorrhea.¹⁶ They discuss systematic reviews published in 1999 and 2002 and a randomized controlled a trial published in 2005 and conclude that water precautions should not be routinely advised.

Acute otorrhea is common after TT placement.¹⁷ Postoperative otorrhea (up to 30 days after surgery) is common and reflects, in part, underlying (preoperative) middle ear glandular changes and inflammation. Some otorrhea is to be expected, since the role of the tube is to ventilate the middle ear. Episodes of otorrhea that reflect acute bacterial infection may be otherwise asymptomatic and less troublesome than AOM episodes in children with intact eardrums.¹⁸ However, otorrhea may be associated with a foul odor, fever, or pain, and may negatively affect quality of life. Treatment is aimed at eradicating bacterial infection and reducing the duration and severity of symptoms.¹⁹ A number of subgroups of acute otorrhea exist, including: 1) otorrhea in the immediate postoperative period, 2) otorrhea caused by the same pathogens as AOM, including Moraxella catarrhalis, Haemophilus influenzae, and Streptococcus pneumoniae, and 3) otorrhea resulting from superinfection with Staphylococcus aureus, including methicillin resistant Staphylococccus aureus (MRSA), and Pseudomonas associated with biofilms.²⁰

The objectives for the systematic review are to synthesize information on the effectiveness of TT in children with chronic otitis media with effusion and recurrent acute otitis media, to summarize the frequency of adverse effects and/or complications associated with TT placement, to synthesize information on the necessity for water precautions in children with TT, and to assess the effectiveness of available treatments for otorrhea in children who have TT.

Key Questions

With input from clinical experts during Topic Refinement, and from the Public, during a public review period, we developed the following Key Questions and study eligibility criteria.

Key Question 1.

For children with chronic otitis media with effusion, what is the effectiveness of TT, compared to watchful waiting, on resolution of middle ear effusion, hearing and vestibular outcomes, quality of life, and other patient-centered outcomes?

1. What factors (such as age, age of onset, duration of effusion, comorbidities, and sociodemographic risk factors) predict which children are likely to benefit most from the intervention?
2. Does obtaining a hearing test help identify which children are more likely to benefit from the intervention?

Key Question 2.

For children with recurrent acute otitis media, what is the effectiveness of TT, compared to watchful waiting with episodic or prophylactic antibiotic therapy, on the frequency and severity of otitis media, quality of life, and other patient-centered outcomes?

1. What factors (such as age, age of onset, number of recurrences, presence of persistent middle ear effusion, comorbidities, sociodemographic risk factors, history of complications of acute otitis media, antibiotic allergy or intolerance) predict which children are likely to benefit from the intervention?

Key Question 3.

What adverse events, surgical complications, and sequelae are associated with inserting TT in children with either chronic otitis media with effusion or recurrent acute otitis media?

Key Question 4.

Do water precautions reduce the incidence of TT otorrhea or affect quality of life?

Key Question 5.

In children with TT otorrhea, what is the comparative effectiveness of topical antibiotic drops versus systemic antibiotics or watchful waiting on duration of otorrhea, quality of life, or need for tube removal?

Analytic Frameworks

The analytic frameworks in Figures 1 through 3 describe the specific linkages associating the populations of interest, exposures, modifying factors, and outcomes of interest the assessment of studies that examine the association between TT placement and intermediate and final health outcomes and harms (KQs 1, 2 and 3; Figure 1), need for water precautions (KQ 4; Figure 2), and treatment of otorrhea (KQ 5; Figure 3).

Figure 1

TT in Children with chronic OME or recurrent AOM (Key Questions 1, 2, and 3). OME=otitis media with effusion; AOM=acute otitis media; TT=tympanostomy tubes; KQ=Key Question

Figure 2

Need for water precautions in children with TT (Key Question 4). OME=otitis media with effusion; AOM=acute otitis media; TT=tympanostomy tubes; KQ=Key Question

Figure 3

Treatment of otorrhea in children with TT (Key Question 5). OME=otitis media with effusion; AOM=acute otitis media; TT=tympanostomy tubes; KQ=Key Question