title: An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care.
abstract: BACKGROUND
  Otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment.
  
  
  OBJECTIVE
  To determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children.
  
  
  METHODS
  A pragmatic, two-arm, open randomised controlled trial.
  
  
  METHODS
  Forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013.
  
  
  METHODS
  School children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears.
  
  
  METHODS
  Three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone.
  
  
  METHODS
  The proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes.
  
  
  RESULTS
  At 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included otalgia in 4% of treated children compared with 1% in the control group. Minor nosebleeds (14% vs. 15%) and respiratory tract infections (18% vs. 13%) were noted.
  
  
  CONCLUSIONS
  We found the use of autoinflation in young children with OME to be feasible in primary care and effective in both clearing effusions and improving child and parent ear-related QoL and symptoms. This method has scope to be used more widely. Further research is needed for very young children, and to inform prudent use in different health settings.
authors.affiliation: Primary Medical Care, University of Southampton, Southampton, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Williamson
authors.affiliation: Primary Medical Care, University of Southampton, Southampton, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Vennik
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Harnden
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Merryn
authors.initials: M
authors.lastname: Voysey
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Rafael
authors.initials: R
authors.lastname: Perera
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Maria
authors.initials: M
authors.lastname: Breen
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Brendan
authors.initials: B
authors.lastname: Bradley
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: Sadie
authors.initials: S
authors.lastname: Kelly
authors.affiliation: Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Guiqing
authors.initials: G
authors.lastname: Yao
authors.affiliation: Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: James
authors.initials: J
authors.lastname: Raftery
authors.affiliation: University of Oxford, Nuffield Department of Primary Care Health Sciences, Oxford, UK.
authors.forename: David
authors.initials: D
authors.lastname: Mant
authors.affiliation: Primary Medical Care, University of Southampton, Southampton, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
mesh_terms: D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007327:Insufflation / Q000295:instrumentation / Q000379:methods*; D008297:Male; D009666:Nose; D010034:Otitis Media with Effusion / Q000628:therapy*; D011320:Primary Health Care / Q000379:methods; D011788:Quality of Life; D016896:Treatment Outcome; D006113:United Kingdom