This study will use real-world data (RWD) from electronic health records (EHR) and health plan claims to examine the outcomes following the insertion of tympanostomy tubes – the device of interest –among children. Tympanostomy tube insertion (TTI) accounts for nearly 1 in 4 pediatric surgeries in the United States, making it the most common invasive procedure done in children. Although there have been numerous studies on the effects of TTI on future otitis media episodes and hearing improvement, there have been no comprehensive descriptive and comparative analyses of the clinical and health services outcomes of children following TTI using data from real-world settings.
The purpose of this project is to describe the clinical and health services outcomes of TTI with and without tonsillectomy and adenoidectomy. This study will be the largest ever conducted on TTI, providing the most in-depth evaluation of the clinical and health services outcomes for this procedure. The study’s findings are anticipated to be of great interest to patients and their families, primary care physicians, ENT surgeons, and health system leaders who deal with real-world issues related to ear infections and their management. The investigative team plans to retrospectively review all patients who received TTI procedures at participating PEDSnet institutions. The team will collect demographics and procedure data and will perform statistical analyses to describe the outcomes of patients overall and compare by procedure type (e.g., TTI alone versus TTI with tonsillectomy/adenoidectomy).