An analysis of registered clinical trials in otolaryngology from 2007 to 2010:

Journal Article (Journal Article)

OBJECTIVE: To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. STUDY DESIGN: Database analysis. SETTING: Trial registration data downloaded from and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. METHODS: Data extraction from was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to for further analysis. Chi-square tests were used to explore differences between groups. RESULTS: A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. CONCLUSIONS: Analysis of otolaryngology-related clinical research as listed in can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

Full Text

Duke Authors

Cited Authors

  • Witsell, DL; Schulz, KA; Lee, WT; Chiswell, K

Published Date

  • November 2013

Published In

Volume / Issue

  • 149 / 5

Start / End Page

  • 692 - 699

PubMed ID

  • 24107478

Pubmed Central ID

  • PMC4121965

Electronic International Standard Serial Number (EISSN)

  • 1097-6817

Digital Object Identifier (DOI)

  • 10.1177/0194599813506545


  • eng

Conference Location

  • England