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CPG: Otitis Media with Effusion (Update) – Research Needs

CPG: Otitis Media with Effusion (Update) – Research Needs

Research Needs section from Otitis Media with Effusion CPG


  1. Further standardize the definition of OME and distinctions with regard to fluid from varying etiologies.
  2. Assess the performance characteristics of pneumatic otoscopy as a diagnostic test for OME when performed by primary care physicians and advanced practice nurses in the routine office setting.
  3. Determine the optimal methods for teaching pneumatic otoscopy to residents and clinicians.
  4. Develop a brief, reliable, objective method for diagnosing OME, beyond pneumatic otoscopy.
  5. Develop cost-effective tympanometry that facilitates testing in non-audiology settings.
  6. Develop a classification method for identifying the presence of OME for practical use by clinicians that is based on quantifiable tympanometric characteristics.
  7. Assess the usefulness of algorithms combining pneumatic otoscopy and tympanometry for detecting OME in clinical practice.
  8. Conduct additional validating cohort studies of acoustic reflectometry as a diagnostic method for OME, particularly in children <2 years old.

Newborn Hearing Screen

  1. Determine whether neonatal middle ear fluid has a differential rate of resolution or natural history than fluid in older infants and children
  2. Optimization of counseling to maximize rates of return for follow-up for those who fail neonatal hearing screening and have OME.

At-Risk Children

  1. Better define the child with OME who is at-risk for speech, language, and learning problems.
  2. Conduct large, multicenter observational cohort studies to identify the child at-risk who is most susceptible to potential adverse sequelae of OME.
  3. Conduct large, multicenter observational cohort studies to analyze outcomes achieved with alternative management strategies for OME in children at risk.

Watchful Waiting

  1. Define the anticipated rate of spontaneous resolution of OME in infants and young children (existing data are limited primarily to children aged ≥2 years).
  2. Conduct large-scale prospective cohort studies to obtain current data on the spontaneous resolution of newly diagnosed OME of unknown prior duration (existing data are primarily from the late 1970s and early 1980s).
  3. Develop prognostic indicators to identify the best candidates for watchful waiting.
  4. Determine if the lack of impact from prompt insertion of tympanostomy tubes on speech and language outcomes seen in asymptomatic young children with OME identified by screening or intense surveillance can be generalized to older children with OME or to symptomatic children with OME referred for evaluation.
  5. Determine whether children with an OME duration exceeding 1 to 2 years have an increased risk of hearing loss, balance problems, discomfort, or other findings that would prompt intervention.
  6. Define straightforward and efficient metrics to elucidate OME-related vestibular disturbance in patients too young to articulate related symptoms. Develop better tools for monitoring children with OME, suitable for routine clinical care.
  7. Assess the value of new strategies for monitoring OME, such as acoustic reflectometry performed at home by the parent or caregiver.
  8. Promote early detection of structural abnormalities in the tympanic membrane associated with OME that may require surgery to prevent complications.
  9. Clarify and quantify the role of parent or caregiver education, socioeconomic status, and quality of the caregiving environment as modifiers of OME developmental outcomes.
  10. Develop methods for minimizing loss to follow-up during OME watchful waiting.


  1. Evaluate previously unstudied discrete patient subgroups that may have a differential effect in response to antimicrobials, steroids, antihistamines, or a combination thereof for OME.
  2. Investigate the lack of efficacy of nasal steroids for OME in relation to their demonstrated capacity to decrease adenoid size
  3. Investigate the efficacy of adenoidectomy in children >4 years of age.
  4. Investigate the role of mucosal surface biofilms in refractory or recurrent OME and develop targeted interventions.

Hearing, Speech, and Language

  1. Conduct longitudinal studies on the natural history of hearing loss accompanying OME.
  2. Develop improved methods for describing and quantifying the fluctuations in hearing of children with OME over time.
  3. Conduct prospective controlled studies on the relation of hearing loss associated with OME to later auditory, speech, language, behavioral, and academic sequelae.
  4. Develop reliable, brief, objective methods for estimating hearing loss associated with OME.
  5. Develop reliable, brief, objective methods for estimating speech, language, or literacy delay associated with OME.
  6. Agree on the aspects of speech, language, and literacy that are vulnerable to, or affected by, hearing loss caused by OME, and reach a consensus on the best tools for measurement.
  7. Determine if OME and associated hearing loss place children from special populations at greater risk for speech and language delays.


  1. Define the role of adenoidectomy in children aged ≤3 years as a specific OME therapy.
  2. Conduct controlled trials on the efficacy of tympanostomy tubes for developmental outcomes in children with hearing loss, other symptoms, or speech and language delay.
  3. Conduct RCTs of surgery versus no surgery that emphasize patient-based outcome measures (QOL, functional health status) in addition to objective measures (effusion prevalence, HLs, AOM incidence, reoperation).
  4. Identify the optimal ways to incorporate parent or caregiver preference into surgical decision making.

Allergy Management

  1. Evaluate whether there is a causal role of atopy in OME.
  2. Evaluate whether age affects any relationship between allergy and OME.
  3. Conduct RCTs on the efficacy of immunotherapy and nonantihistamine allergy therapy for OME that are generalizable to the primary care setting.
  4. Determine whether the subgroup with active allergy manifestations and positive allergy testing has a distinct natural history or response to interventions, including immunotherapy, as compared with children without allergy.
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