Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2020
The effect of ventilation tube insertion on quality of life in children with persistent otitis media with effusion.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Sanyaolu Leigh N, Cannings-John Rebecca, Butler Christopher C, Francis Nick A
Аннотация
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.
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.