Otitis Media With Effusion and Type 2 Inflammation Diseases

Otitis Media With Effusion Among Patients With Type 2 Inflammation Diseases

Otitis media with effusion (OME) is thought to be associated with comorbidities such as allergic rhinitis, gastroesophageal reflux disease, asthma, and more. Many of these comorbidities can be caused by type 2 inflammation (T2I). This study aims to characterize the risk of undergoing OME surgery. This retrospective, matched-cohort study involved the retrospective recruitment of patients from 2009 to 2020, using the Taiwan National Health Insurance Research Database (NHIRD)

Study Overview

• Status: Completed
• Conditions: Otitis Media With Effusion

• Study Type: Observational
• Enrollment (Actual): 100622

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All study subjects with OME-confirmed by at least two outpatient visits or one hospitalization record within NHIRD database. We excluded cases that did not meet the following criteria: patients who had undergone OME surgery before the index date, individuals younger than 4 years old, patients with unknown demographic information, individuals in the comparison cohort with a history of T2I diseases, and patients with a history of ear surgery or congenital ear anomalies.

Description

Inclusion Criteria:

• Diagnosis of OME
• At least two outpatient visits or one hospitalization record
• Medical records within the database

Exclusion Criteria:

• Participants younger than 4 years old
• Participants with unclear demographic information
• Participants with a history of ear surgery or congenital ear anomalies
• Participants who had undergone OME surgery before the index date

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of participants with OME who requiring surgical intervention	surgical intervention including procedures such as myringotomy and adenoidectomy	10 years

Collaborators and Investigators

• Sponsor: Hearing and Language Healthcare Center, China Medical University Hsinchu Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Otorhinolaryngologic Diseases; Ear Diseases; Inflammation; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: OME-S-24-00723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No