title: Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial.
abstract: BACKGROUND
  Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting.
  
  
  METHODS
  We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4-11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1-3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation.
  
  
  RESULTS
  Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in ear-related quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score -0.42, 95% CI -0.63 to -0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups.
  
  
  CONCLUSIONS
  Autoinflation in children aged 4-11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life.
  
  
  BACKGROUND
  ISRCTN, No. 55208702.
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK igw@soton.ac.uk.
authors.forename: Ian
authors.initials: I
authors.lastname: Williamson
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Vennik
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Harnden
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Merryn
authors.initials: M
authors.lastname: Voysey
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Rafael
authors.initials: R
authors.lastname: Perera
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Sadie
authors.initials: S
authors.lastname: Kelly
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Guiqing
authors.initials: G
authors.lastname: Yao
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: James
authors.initials: J
authors.lastname: Raftery
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: David
authors.initials: D
authors.lastname: Mant
authors.affiliation: Primary Care and Population Sciences (Williamson, Vennik, Little), Faculty of Medicine, University of Southampton, Aldermoor Close, Southampton, UK; Nuffield Department of Primary Care Health Sciences (Harnden, Voysey, Perera, Kelly, Mant), University of Oxford, Oxford, UK; Faculty of Medicine (Yao, Raftery), University of Southampton, Southampton General Hospital, Southampton, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Little
mesh_terms: D002648:Child; D002675:Child, Preschool; D005194:Family Practice; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D010034:Otitis Media with Effusion / Q000628:therapy*; D011320:Primary Health Care / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome