Trial reportCMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne2015
Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial.
Trial report in CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 52 citations in OpenAlex.
- Autoinflation for otitis media with effusion (OME) in children.The Cochrane database of systematic reviews · 2023Pooled it
- Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial.Lancet (London, England) · 2018Trial
- Therapeutic efficacy of azithromycin and acetylcysteine in chronic otitis media with effusion.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2017Trial
- Trial
- Contribution of Treatment with Ear Popper for Hearing in Children with Middle Ear Effusion.Children (Basel, Switzerland) · 2024Article
- Article
- Can party balloons replace autoinflation balloons to treat glue ear? A technical comparison.BJGP open · 2021Article
- The P.E.A.N.U.T. Method: Update on an Integrative System Approach for the Treatment of Chronic Otitis Media with Effusion and Adenoid Hypertrophy in Children.Antibiotics (Basel, Switzerland) · 2021Article
- Motile ciliopathies.Nature reviews. Disease primers · 2020Review
- Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials.BMC medical research methodology · 2020Review
- [Standard treatment of otitis media with effusion in children].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2020Article
- Panel 5: Impact of otitis media on quality of life and development.International journal of pediatric otorhinolaryngology · 2020Review
- Nasal balloon autoinflation for glue ear in primary care: a qualitative interview study.The British journal of general practice : the journal of the Royal College of General Practitioners · 2019Article
- Autoinflation reduces middle ear effusion in children with otitis media with effusion.Evidence-based medicine · 2016Article
- Autoinflation: an effective nondrug intervention for glue ear.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2015Article
- Feasibility of a Novel Autoinflation Device to Treat Pediatric Otitis Media With Effusion At-Home.OTO openArticle
- Autoinflation for the Treatment of Persistent Otitis Media With Effusion in Children.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-facialeArticle
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Authors and funding
10 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundOtitis 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.
methodsWe 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.
resultsOf 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.
interpretationAutoinflation 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.
trial registrationISRCTN, No. 55208702.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.