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10.3310/hta19720

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C4781307!4781307!26377389
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suck abstract from ncbi


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pmid26377389      Health+Technol+Assess 2015 ; 19 (72): 1-150
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  • An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care #MMPMID26377389
  • Williamson I; Vennik J; Harnden A; Voysey M; Perera R; Breen M; Bradley B; Kelly S; Yao G; Raftery J; Mant D; Little P
  • Health Technol Assess 2015[Sep]; 19 (72): 1-150 PMID26377389show ga
  • 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. DESIGN: A pragmatic, two-arm, open randomised controlled trial. SETTING: Forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013. PARTICIPANTS: 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. INTERVENTION: 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. MAIN OUTCOME MEASURES: 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. CONCLUSION: 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.
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