The Research Question Autoinflation as a treatment of Otitis Media with Effusion in primary care: a randomized controlled trial Williamson I, Vennik J,

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Presentation transcript:

The Research Question Autoinflation as a treatment of Otitis Media with Effusion in primary care: a randomized controlled trial Williamson I, Vennik J, Harnden A, Voysey M, Perera R, Kelly S, Yao G, Raftery J, Mant D, Little P What is the clinical effectiveness of nasal balloon autoinflation in resolving effusions and improving symptoms and quality of life in children ? Why is this important? Otitis media with effusion (OME) is a very common problem that lacks an evidence-based non-surgical treatment option. Health costs for this condition are estimated at $4 billion per annum. Wider use of the balloon method may improve child health and development and reduce unnecessary antibiotics . BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler

What the Researchers Did Population/Subjects: 320 children aged 4-11 years (43 UK family practices), with a recent history of OME symptoms or concerns, and a confirmatory B tympanogram in one or both ears. Children were excluded if attending specialists. Design: Pragmatic two arm randomised controlled trial Methods: Assessors were blinded to allocation Main outcomes: The proportion of children with tympanometric resolution of effusion at 1 and 3 months. Secondary outcomes: condition specific quality of life (OMQ-14) , weekly symptom diaries. Intervention: Blowing a nasal balloon (Otovent) three times a day for 1-3 months plus standard care versus standard care only. aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days.

What the Researchers Found Children showing normal (resolved) tympanograms: 1 MO - 47·3% (62/131) v 35·6% (47/132) for controls (adjusted RR 1·36, 95%CI 0·99-1·88). 3 MO - 49·6% (62/125) v 38·3% (46/120) (adjusted RR 1·37, 1·03 to 1·83; NNT 9). Individual ears: 1 MO - Relative Risk of resolution of 1.38 (1.01-1.87). 3 MO - RR 1.41 (1.05-1.88). Improved OMQ-14 at 3 months (adjusted score difference) -0·42 95%CI -0.63 to-0.22 p=<·001. Effect-Size of 0.48 S.D favouring intervention. Reported compliance was good: 89% in the first month and 80% in months 2-3.The ITT and per-protocol analyses were comparable.

What This Means for Clinical Practice Evidence based reviews have previously failed to find an effective non-surgical treatment for OME that could be used in primary care where most children are initially seen (e.g. antibiotics have a NNT>20 and other disadvantages). Our results show that autoinflation can be successfully applied to a large sample of children aged 4-11 years in primary care, And indicate that autoinflation is likely to be more clinically beneficial (NNT~9) than standard care during an observation period of 1- 3 months. We conclude that balloon autoinflation should be more widely used.