The effect of ventilation tube insertion on quality of life in children with persistent otitis media with effusion

Objectives To determine the effect of ventilation tube (VT) surgery on quality of life (QoL) in children with persistent otitis media with effusion (OME). Design Secondary analysis of trial data (oral steroids versus placebo for persistent OME), comparing QoL by history of VT surgery performed between 5 weeks and 12 months post-randomisation. Multilevel regression models were used to identify the association between VT surgery and QoL scores at 12 months, controlling for pre-exposure risk factors associated with surgery, including pre-surgery hearing level. Setting Ear, nose and throat (ENT), paediatric audiology and audiovestibular medicine (AVM) departments in Wales and England. Participants A total of 327 children aged 2-8 years with OME symptoms for at least three months and audiometry-proven bilateral hearing loss with VT surgery status. Main outcome measures Otitis Media questionnaire (OM8-30) and Paediatric Quality of Life Inventory (PedsQL) total and subscale scores, and the Health Utilities Index Mark 3 (HUI3) at 12 months post-randomisation. Results Participants who had VT surgery had no significant difference in OM8-30, PedsQL or HUI total scores. OM8-30 hearing difficulty (HD) subscale scores at 12 months were better in those who had VT surgery (adjusted mean difference (aMD) = -0.46 (95% confidence interval: -0.69 to -0.23), P < .001), and this varied by when the surgery occurred (aMD for surgery between 5 weeks and 6 months = -0.4 [-0.67 to -0.13], P = .004 and between 6 and 12 months = -0.54, [-0.87 to -0.22], P = .001). Conclusion Ventilation tube surgery was associated with an improvement in HD-related functional health status but no change in overall QoL.