Effect of Nasal Balloon Autoinflation in Children with Otitis Media with Effusion in Primary Care: an Open Randomized Controlled Trial
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CMAJ Research Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial Ian Williamson MD, Jane Vennik MRes, Anthony Harnden MBChB MSc, Merryn Voysey MBiostat, Rafael Perera DPhil, Sadie Kelly PhD, Guiqing Yao PhD, James Raftery PhD, David Mant MBChB MA, Paul Little MD CMAJ Podcasts: author interview at soundcloud.com/cmajpodcasts/141608-res See also page 949 and www.cmaj.ca/lookup/doi/10.1503/cmaj.150527 Abstract Competing interests: None declared. Background: Otitis media with effusion is a (47.3% [62/131] v. 35.6% [47/132]; adjusted rel- common problem that lacks an evidence-based ative risk [RR] 1.36, 95% confidence interval [CI] This article has been peer nonsurgical treatment option. We assessed the 0.99 to 1.88) and at 3 months (49.6% [62/125] v. reviewed. clinical effectiveness of treatment with a nasal 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 Accepted: June 10, 2015 balloon device in a primary care setting. to 1.83; number needed to treat = 9). Autoin- Online: July 27, 2015 flation produced greater improvements in ear- Correspondence to: Methods: We conducted an open, pragmatic related quality of life (adjusted between-group randomized controlled trial set in 43 family prac- Ian Williamson, difference in change from baseline in OMQ-14 [email protected] tices in the United Kingdom. Children aged 4–11 [an ear-related measure of quality of life] score years with a recent history of ear symptoms and –0.42, 95% CI –0.63 to –0.22). Compliance was CMAJ 2015. DOI:10.1503 / cmaj.141608 otitis media with effusion in 1 or both ears, con- 89% at 1 month and 80% at 3 months. Adverse firmed by tympanometry, were allocated to events were mild, infrequent and comparable receive either autoinflation 3 times daily for 1–3 between groups. months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months Interpretation: Autoinflation in children aged was assessed by experts masked to allocation. 4–11 years with otitis media with effusion is feasible in primary care and effective both in Results: Of 320 children enrolled, those receiv- clearing effusions and improving symptoms ing autoinflation were more likely than con- and ear-related child and parent quality of trols to have normal tympanograms at 1 month life. Trial registration: ISRCTN, No. 55208702. titis media with effusion, also known as the United States, there were 2.2 million diag- glue ear, is an accumulation of fluid in nosed episodes in 2004, costing an estimated the middle ear, without symptoms or $4.0 billion.16 Rates of ventilation tube surgery O 17–19 signs of an acute ear infection. It is often associ- show variability between countries, with a ated with viral infection.1–3 The prevalence rises declining trend in the UK.20 to 46% in children aged 4–5 years,4 when hear- Initial clinical management consists of reason- ing difficulty, other ear-related symptoms and able temporizing or delay before considering sur- broader developmental concerns often bring the gery.13 Unfortunately, all available medical treat- condition to medical attention.3,5,6 Middle-ear ments for otitis media with effusion such as fluid is associated with conductive hearing losses antibiotics, antihistamines, decongestants and of about 15–45 dB HL.7 Resolution is clinically intranasal steroids are ineffective and have unpredictable,8–10 with about a third of cases unwanted effects, and therefore cannot be recom- showing recurrence.11 In the United Kingdom, mended.21–23 Not only are antibiotics ineffective, about 200 000 children with the condition are but resistance to them poses a major threat to seen annually in primary care.12,13 Research sug- public health.24,25 Although surgery is effective gests some children seen in primary care are as for a carefully selected minority,13,26,27 a simple badly affected as those seen in hospital.7,9,14,15 In low-cost, nonsurgical treatment option could ben- ©2015 8872147 Canada Inc. or its licensors CMAJ, September 22, 2015, 187(13) 961 Research efit a much larger group of symptomatic children, ing primary care trusts gave National Health Ser- with the purpose of addressing legitimate clinical vice approval. concerns without incurring excessive delays. Autoinflation using a nasal balloon device is Eligibility criteria a low-cost intervention with the potential to be Children were eligible for inclusion if they were used more widely in primary care, but current attending school and aged 4–11 years (deemed an evidence of its effectiveness is limited to several age likely to be able to comply with autoinfla- small hospital-based trials28 that found a higher tion); had a history of hearing loss or other rele- rate of tympanometric resolution of ear fluid at vant ear-related problems in the previous 1 month.29–31 Evidence of feasibility and effec- 3 months; and had objective otoscopic and tym- tiveness of autoinflation to inform wider clinical panometric confirmation of otitis media with use is lacking.13,28 Thus we report here the find- effusion in at least 1 ear (i.e., had 1 or 2 type-B ings of a large pragmatic trial of the clinical tympanograms using a modified Jerger classifica- effectiveness of nasal balloon autoinflation in a tion) at the point of randomization (Table 1).32,33 spectrum of children with clinically confirmed Children were excluded if they had current clini- otitis media with effusion identified from pri- cal features of acute otitis media (e.g., ear pain, mary care. fever or otoscopic features of acute inflamma- tion), recent or planned ear surgery, a known Methods latex allergy or a recent nosebleed. Study design and participants Randomization and masking We carried out an open, pragmatic randomized An independent external agency provided a cen- controlled trial in primary care. We examined tralized Web-based computer-generated ran- the difference in effectiveness between autoinfla- domization system (www.sealedenvelope.com) tion 3 times daily for 1–3 months plus usual care for nurses to access while recruiting children. and usual care alone. The Oxford Primary Care Clinical Trials Unit The study was piloted in 4 practices. The independently managed, coordinated, analyzed main study recruited children from 43 general and checked the data validity. The randomiza- practices from 17 primary care trusts (indepen- tion involved an algorithm with minimization dent local groups) in the UK, between January based on 3 variables: age, sex and baseline 2012 and February 2013. Most (89%) children severity (bilateral v. unilateral type-B tympano- were identified by practice-based computer grams).9 Because of the nature of the interven- search, and the rest were recruited through op- tion, use of placebo was not possible, and there- portunistic case finding by practitioners, nurses fore nurses, children and families were not and health visitors. Tympanometry and recruit- masked to treatment allocation. ment were undertaken by practice-based nurses. The study protocol is available in Appendix 1 at Procedures www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj. All participating parents and children received 141608/-/DC1. information sheets, and parents gave written The National Research Ethics Service gave informed consent for screening to the research ethics approval for this study. The 17 participat- nurse. Children were invited to give written assent. Table 1: Tympanometric classification*† (based on a modified Jerger classification32,33) and interpretation34 Type Middle-ear pressure, daPa Tympanogram Interpretation A 200 to –99 Peak in this range Normal C1 –100 to –199 Peak in this range Normal C2 –200 to –399 Peak in this range Positive predictive value of 54% for otitis media with effusion B ≥ –400 Flat trace without a Positive predictive value of discernible peak 88% for otitis media with effusion Note: daPa = decapascal. *As used in primary care trials9,10 and a Cochrane systematic review.28 †With normal canal volumes. Excessive wax, perforation and grommets excluded. 962 CMAJ, September 22, 2015, 187(13) Research The simple autoinflation method involved choice for primary care studies13,35 and are used inflating a purpose-manufactured balloon in meta-analysis.28 Two members of the trial (Otovent) by blowing through each nostril into team, trained in tympanometry and masked to a connecting nozzle31 (Figure 1). Children allocation, independently reviewed anonymized receiving treatment were instructed by watch- tympanometry printouts. The expert interrater ing the nurse or parent demonstrate the proce- agreement was 89%, and disagreement was set- dure after stretching the balloon. The schedule tled by a third independent audiologist. We found involved inflating the balloon 3 times daily for a Cohen k of 0.7 for the level of agreement an initial period of 1 month. Children still between nurses and masked experts. recording a type-B tympanogram in either ear Ear-related quality of life was measured at at 1 month were advised to continue with auto- 3 months using the OMQ-14, an instrument inflation for a further 2 months. At the end of developed by a process of refinement and itera- the study, affected children in the arm receiv- tion from large clinical and trial datasets of otitis ing usual care were offered a 1-month treat- media with effusion that optimized item map- ment pack. ping onto the Health Utilities Index.7,9,15,36 In All nurses received training in the study addition, parents completed weekly diaries to methods, including tympanometry and interpre- record symptoms, adverse events and compli- tation (from an audiologist), updates on otoscopy ance. Days during which parents reported their and ways of maximizing study compliance. child had hearing loss, earache, days off school, Hand-held calibrated MTP10 tympanometers days requiring pain relief and sleep disturbance (with printout facilities) were used.