Title: Pediatric Clinical and Health Services Outcomes following Tympanostomy Tube Insertion

Technology of Interest: Ear Tubes

Disease Area: Ear, Nose, & Throat

Duration: 12 months

Network Collaborator(s): PEDSnet; HealthCore

This study will use real-world data (RWD) from electronic health records (EHR) and health plan claims to examine the pre-operative clinical care pathway and outcomes following 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 the real-world issues related to ear infections and their management.

NESTcc was instrumental in identifying this study topic, providing a framework for linkage of an industry partner with academic medical centers and researchers, and providing rapid and low burden administrative start-up resources.

Follow us @NESTccMedTech

Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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