Research Gaps-Tympanostomy Tubes in Children

Research Gaps-Tympanostomy Tubes in Children

The Clinical Practice Guideline: Tympanostomy Tubes in Children was based on the current body of evidence regarding tympanostomy tubes. As determined by the Guideline Development Group's review of the literature, assessment of current clinical practices, and determination of evidence gaps, research needs were determined as follows:

Chronic Otitis Media with Effusion (OME) with Hearing Difficulty

Identify alternatives to formal audiologic assessment, including clinical measures, so that we can identify children with hearing difficulties
Study of the benefits of postoperative assessment (when, how often, by whom) 

  1. Better understand variations in access to audiometry services, particularly access to pediatric audiometry 
  2. Better understand differential effect on speech and language outcomes based on children's age at intervention for hearing loss 
  3. Study of actual clinical significance of effects of tympanostomy tubes on long-term HLs and the presence of tympanic membrane structural changes
  4. Chronic OME with Symptoms 
  5. Study of differences in effects of OME on children of varying ages 
  6. Study of effects of unilateral versus bilateral OME 
  7. Better understand the effect of unilateral OME on outcomes: vestibular, school performance, behavior, and ear discomfort
  8. Among children with OME, obtain data on the magnitude and effect size of the long-term hearing deficits well as the presence of tympanic membrane structural changes 
  9. Among children with OME, study of the long-term effects of middle ear fluid on the ear drum in absence of hearing issues—determine the natural history of asymptomatic middle ear fluid
  10. Recurrent acute otitis media (AOM) without middle ear effusion (MEE) 
  11. Research is needed to develop criteria to identify the subset of recurrent AOM patients, without current effusion, who will develop additional ear infections or long-term effusions in the future
  12. Recurrent AOM with MEE 
  13. Improve documentation of AOM diagnosis and recurrent AOM diagnostic accuracy 
  14. Determine whether the precision with which AOM is diagnosed changes the predicted effectiveness of tympanostomy tubes for recurrent AOM; determine whether studies that demand such diagnostic accuracy and stricter entry criteria show a greater benefit for tympanostomy tubes in children with recurrent AOM 
  15. Characterize quality of life (QOL) for recurrent AOM with tympanostomy tubes versus without tube placement 
  16. Randomized controlled trials to provide effect sizes for benefit of surgery over observation among this patient population; existing studies are deficient in that they have not clearly separated patients with AOM based on presence or absence of fluid at diagnosis

Distinguishing At-Risk Children

  1. Need better data on the prevalence of at-risk conditions and strategies to identify at-risk children 
  2. Need epidemiological evidence for the prevalence of MEE and sequelae of MEE in at-risk children with conditions other than Down syndrome or cleft palate as well as the acceptability, effectiveness, and consequences of various treatment strategies 
  3. Among at-risk children with OME of medium duration, clarify the role for more aggressive management of ear disease

Tympanostomy Tubes and At-Risk Children

  1. Better understand the impact of tympanostomy tube placement among children with speech/language delay
  2. Better understand the indications and outcomes for tympanostomy tube placement in children with Down syndrome or with cleft palate, since existing randomized trials cannot be generalized to these populations; ideally, these studies should be prospective, include long-term follow-up, distinguish children younger than 24 months from older children, and have children treated with tympanostomy tubes matched to control children by age and HLs 
  3. Additional data regarding the efficacy of tubes in preventing sequelae of MEE in at-risk patients 
  4. Compare the efficacy of hearing aids versus tympanostomy tubes for at-risk children with chronic OME and hearing loss
  5. Determine the role of long-term versus short-term tubes in children with cleft palate or Down syndrome 
  6. Develop educational materials for patients, parents/caregivers, and primary care providers and surgical/medical specialists to raise awareness of the at-risk status of these patients 
  7. Assess whether at-risk children have the same risk profile for surgical and anesthetic complications

Hearing Resting

  1. Potential implementation hurdles with regard to access to hearing testing and audiometry; need a study to understand possible barriers to audiologic testing
  2. Determine the role for formal audiologic testing versus a hearing screening test—such as performed by primary care physicians—for follow-up for otherwise low-risk children 
  3. Validation of a clinical proxy for detecting the probable presence of hearing loss when audiology is not available or is unreliable
  4. Assess the validity of parental/caregiver reports regarding improved hearing following tube placement and whether there is added benefit of objective assessment 
  5. Evidence for best use of postoperative audiologic assessment; determine patient population needs postoperative audiologic assessment: assess all children, only those with preoperative hearing loss, or only those children with parent/caregiver concern regarding persistent hearing loss

Acute Tympanostomy Tube Otorrhea  (TTO)

  1. Determine the impact of tympanostomy tube placement on middle ear bacteriology and whether these changes affect selection of treatment of AOM after tympanostomy tubes
  2. Determine the ideal duration of topical therapy for posttympanostomy otorrhea 
  3. In the setting of recurrent, persistent, or chronic otorrhea, determine when is it advisable to remove a tube
  4. Water Precautions 
  5. Studies of clinical indicators (swimming locale, host factors such as age, number of AOM episodes, immune status, etc) for more routine recommendation of water precautions after tubes
  6. Perioperative Education 
  7. Research is needed to characterize the effectiveness of various methods of perioperative education about tubes; modalities to include voice, written, video, web-based, other; timing to include preoperative, at surgery, postoperative; educators to include nurse, surgeon, primary care physician, other

Anesthesia

  1. Need for more information about the morbidity and mortality of general mask anesthesia for tympanostomy tube placement in children