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Topic Suggestion Description

Date submitted: August 11, 2014

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

What are the indications for inserting tympanostomy tubes how many Otitis Media w Effusion or Acute Otitis Media episodes in what time frameShould clinicians obtain a hearing test prior to inserting tympanostomy tubesShould clinicians prescribe topical antibiotic eardrops andor antibiotics for children with uncomplicated acute tympanostomy tube otorrheaDo children with tubes need to wear prophylactic water precautions earplugs or headbandsChildren aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubesBENEFITS Tympanostomy tube insertion is associated with shortterm quality of life QoL improvements.1 Otitis media can affect QoL for the child and caregiver. In one study of children with chronic otitis media with effusion OME or recurrent acute otitis media AOM 88 of caregivers were worried or concerned about their childs ear infections or middle ear fluid at least some of the time with 42 spending most or all of their time preoccupied with their childs condition.2 Physical suffering was a problem for 85 of children emotional distress for 76 and activity limitations for 57. Another investigation of children with otitis media noted that 31 of caregivers had to cancel family activities 29 reported lack of sleep and 12 missed work or school.3The efficacy of tympanostomy tubes in managing chronic OME recurrent AOM or both has been studied in randomized controlled trials RCTs and systematic reviews. For children with chronic OME tube insertion reduces the prevalence of middle ear effusion MEE by 32 in the first year and improves average hearing levels HLs by 5 to 12 dB.45 Although RCTs have in general not found a significant impact of tympanostomy tube insertion on speech language or cognitive outcomes46 the trials typically included only healthy children without developmental delays at entry. A nonrandomized study however did show improved caregiver perception of speech and language after tympanostomy tube placement especially for children with developmental delays.7The efficacy of tympanostomy tubes for preventing recurrent AOM is unclear with systematic reviews reporting insufficient evidence6 small shortterm benefits89 or moderate benefits of similar magnitude to antibiotic prophylaxis.10 Part of this debate relates to inclusion criteria for RCTs in the reviews some of which excluded children with chronic OME between AOM episodes and others that did not. When limited to trials with AOM that clears between episodes without chronic OME the effect is no longer significant. No studies have evaluated the effects of tympanostomy tubes for managing severe or persistent AOM because of difficulties enrolling these children in RCTs. Increasing problems with bacterial resistance11 however have created a role for tympanostomy tube placement to allow drainage of infected secretions obtain middle ear fluid for culture and provide a direct route for delivering antibiotic eardrops to the middle ear. Similarly when children with tympanostomy tubes continue to experience AOM episodes they can usuallybe managed with topical antibiotic drops6 avoiding the adverse effects of systemic therapy.HARMS AND ADVERSE EVENTS OF TONSILLECTOMY Potential benefits of tubes must be balanced against the associated risks including general anesthesia and direct tuberelated sequelae. The incidence of anesthesiarelated death for children undergoing diverse surgical procedures including tympanostomy tube insertion ranges from 1 in 10000 to 1 in 45000 anesthetics delivered.12 In the perioperative period children are more prone to laryngospasm and bronchospasm than adults are which may increase the risk of anesthetic complications.The most common sequela of tympanostomy tubes is otorrhea TTO seen in approximately 16 of children within 4 weeks of surgery and 26 of children at any time the tympanostomy tube remains in place.13 Most tympanostomy tubes used in the United States remain in place for 12 to 14 months during which approximately 7 of children experience recurrent TTO. Other complications include blockage of the tympanostomy tube lumen in 7 of intubated ears granulation tissue in 4 premature extrusion of the tympanostomy tube in 4 and tympanostomy tube displacement into the middle ear in 0.5.13Longerterm sequelae of tympanostomy tube placement include visible changes in the appearance of the tympanic membrane. Myringosclerosis consists of white patches in the ear drum from deposits of calcium and can be seen while the tube is in place or after extrusion. Myringosclerosis is more common in intubated ears than in controls4613 is usually confined to the drum and very rarely causes clinically significant hearing issues. Tympanic membrane atrophy atelectasis and retraction pockets are all more commonly observed in children with otitis media who are treated with tympanostomy tubes than in those who are not.14 These tympanic membrane changes with the exception of tympanosclerosis appear to resolve over time in many children and rarely require medical or surgical treatment. Persistent perforation of the tympanic membrane is seen in 1 to 6 of ears after tympanostomy tubes are placed.6 When perforations persist surgical closure may be required.The longterm impact of tympanostomy tubes on hearing acuity has been studied. Children in a longitudinal otitis media study had their hearing measured at 6 years of age.15 Children who had tympanostomy tubes in the past had a 1 to 2dB worsening in hearing thresholds compared with those who did not have tympanostomy tubes. This hearing worsening is trivial and it should be noted that the mean HLs in these children with or without a history of tubes was 4.3 to 6.2dB HL which is well within the range of normal hearing. Another study of children aged 8 to 16 years who had participated in an RCT of tympanostomy tubes versus medical treatment for otitis media 6 to 10 years prior found hearing thresholds 2.1 to 8.1 dB poorer in those children who had a history of tympanostomy tubes. The greatest hearing deficits were seen when testing lowfrequency tones.16In summary tympanostomy tubes do produce visible changes in the appearance of the tympanic membrane and may cause measurable longterm hearing loss. These outcomes do not appear to be clinically important or require intervention in the overwhelming majority of patients. The posttympanostomy tube sequela most likely to require intervention is persistent perforation with 80 to 90 success rates for surgical closure with a single outpatient procedure.17Some investigators have questioned the appropriateness of tympanostomy tube surgery based on audits and chart review.1819 Most criticism has centered on surgery in children with OME of less than 3 months duration determined by extrapolation of findings at discrete office visits. Additional criticism concerns the appropriateness of tympanostomy tubes for recurrent AOM. The frequency of tube surgery associated health care burden and concerns over the appropriateness of surgery create a clear need for evidencebased surgical indications and management strategies regarding tympanostomy tube placement.

Describe why this topic is important.

Insertion of tympanostomy tubes is the most common ambulatorysurgery performed on children in the United States. The tympanostomy tube which is approximately 120th ofan inch in width is placed in the childs eardrum tympanic membrane to ventilate the middle ear space. Each year 667000 children younger than 15 years receive tympanostomy tubes accounting for more than 20 of all ambulatory surgery in this group.20 By the age of 3 years nearly 1 of every 15 children 6.8 will have tympanostomy tubes increasing by more than 2fold with day care attendance.21

How will an answer to your research question be used or help inform decisions for you or your group?

The AAOHNSF published a clinical practice guideline CPG on Tympanostomy Tubes in 2013. This CPG will need to be updated in 2018 therefore a systematic review would inform the update.

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Professional Society
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Research Quality Improvement at the American Academy ofOtolaryngology Head and Neck Surgery Foundation AAOHNSF
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Stephanie Chang MD MPH
Tympanostomy Tubes in Children with Otitis Media