Caregiver-reported short-term effect and quality of life improvements after tympanostomy tube insertion in children with chronic otitis media with effusion
Abstract
BACKGROUND
Chronic otitis media with effusion (COME) is a leading indication for tympanostomy tube insertion (TTI) in young children. While long-term developmental effects of TTI appear limited, short-term outcomes are less well described.
OBJECTIVES
To assess caregiver-reported outcomes of TTI in children aged 1-4 years with COME, including reasons for consultation, baseline quality of life (QoL), and perceived changes one month after surgery.
METHODS
This prospective study included 60 children with COME recruited from two non-referral ENT clinics in Denmark. Participants were randomized 1:1 to TTI or one-month observation. Controls who still met guideline criteria after one month were offered TTI. Caregivers completed the OM-6 questionnaire and two global QoL numerical rating scales at baseline and one month after TTI. Paired t-tests and Spearman correlations were used.
RESULTS
Fifty-four children completed follow-up; 52 underwent TTI. Sleep disturbance was the most frequent caregiver-reported complaint (74%). Mean baseline OM-6 score was 3.16 (SD 1.0); the lowest item score was activity limitation (2.5), the only OM-6 item reflecting sleep. At one month, child QoL improved from 6.2 to 8.5 (Δ2.6; p < 0.0005) and family QoL from 6.7 to 8.1 (Δ1.7; p < 0.0005). OM-6 correlated with child (ρ = -0.56) and family QoL (ρ = -0.55). Caregivers reported improvement in sleep (58%), hearing (60%), and language (72%); overall satisfaction was 96%.
CONCLUSION
TTI was associated with…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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