1 / 4

The Research Question

This randomized controlled trial examines the effectiveness of nasal balloon autoinflation in resolving effusions and improving symptoms and quality of life in children with otitis media with effusion. The results suggest that balloon autoinflation can be successfully applied in primary care and may be more clinically beneficial than standard care.

victoriarose
Download Presentation

The Research Question

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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 .

  2. 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: • Assessorswereblinded to allocation • Main outcomes: The proportion of childrenwithtympanometricresolution of effusion at 1 and 3 months. • Secondaryoutcomes: condition specificquality of life (OMQ-14) , weeklysymptomdiaries. • Intervention:Blowinga nasal balloon (Otovent) three times a day for 1-3 months plus standard care versus standard care only.

  3. What the Researchers Found • Childrenshowing 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.

  4. 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.

More Related