Rationale and Background:

Otitis media (OM) is a health condition characterized by fluid in the middle ear with (acute otitis media [AOM]) or without (otitis media with effusion [OME]) signs of acute infection. The condition accounts for 11% of office visits in primary care practices, and is the most common reason for referral to pediatric specialty care (9% of all referrals made). About 90% of children experience OM before they start school, making it one of the most common pediatric illnesses. OME may result from an upper respiratory tract infection or as a sequelae of acute otitis media. Most cases of OME resolve spontaneously within 90 days without any medical treatment; however, 1 in 3 patients will experience repeated episodes. Persistent OME may serve as a barrier to sound conduction and can lead to conductive hearing loss and delays in speech and language acquisition in young children. In fact, OME is the most common cause of hearing loss for children residing in high income countries.

Diagnosis of OME is most often made with pneumatic otoscopy. In situations where the diagnosis is uncertain, it is recommended that clinicians obtain tympanometry. Use of steroids, antibiotics, antihistamines, or decongestants is not recommended.6In certain situations, however, children with recurrent or chronic OME should undergo myringotomy with tympanostomy tube insertion (TTI) in order to drain middle ear fluid. For the proposed project, tympanostomy tubes are the target device of interest.

Purpose of the Project:

There have been no large-scale, comprehensive comparative analyses of the clinical and health services outcomes of children following TTI using real-world data (i.e., not collected as part of a clinical trial or a prospective clinical research study). Real-world data for TTI reflects what actually happens to children undergoing these procedures in everyday medical settings. This type of information would be useful in a premarket analysis of the potential impact of new devices or approaches for the treatment of OME. The proposed project endeavors to address this need.

Study Objectives:

The main goal of the proposed project is to fully characterize outcomes following TTI. To address this goal, the project aims are:

Aim 1: To describe the epidemiology of OM, TTI, and OM-related complications in children.

Aim 2: To contrast OM-related and health services outcomes among children undergoing TTI, overall and by whether the patient met recommended guidelines for TTI, had a concomitant adenoidectomy, or a concomitant tonsillectomy.

Data will come from PEDSnet (pedsnet.org) and HealthCore (healthcore.com). PEDSnet provides Electronic Health Record (EHR)data for nearly 7 million children, and HealthCore provides health plan claims data for millions of children as well. Both are national in scope.