INTRODUCTION: Topical antibiotics are commonly prescribed following tympanostomy tube (TT) placement to treat otorrhea. Administration of ear drops to young children can pose challenges to caregivers such as compliance, administration technique, dose accuracy, and penetration of drops into the middle ear. The Otitis Media-6 (OM-6) survey measures health-related quality of life for children with otitis media but does not address ear drop administration.
OBJECTIVE: To develop a questionnaire that assesses caregiver burden of administering post-TT ear drops to young children.
METHODS: Eligible participants were adult caregivers of children who received TT for bilateral middle ear effusion within the previous 2-4 weeks and prescribed ear drops. Upon IRB approval, two phases of caregiver interviews were conducted. First, concept elicitation interviews were done to understand the burden of ear drops from caregivers’ perspective. From this, a preliminary item pool for the questionnaire was created. Second, cognitive debriefing interviews using a "think-aloud" format gathered caregivers’ interpretation of each item, importance of each item, and thought process used to develop each response.
RESULTS: 16 caregivers participated (concept elicitation n=5; cognitive debriefing, n=11). Most were female (81.2%); mean age 32.3 years (range 23-45 years); 50% white; and 37.5% Medicaid enrollees. An 11-item ED-CBQ was developed and will be further evaluated in an upcoming Phase 3b study. The final questionnaire will be presented.
CONCLUSIONS: This research resulted in the first questionnaire to specifically measure burden of ear drop administration following TT placement based on caregiver input.
