Evidence map›Paper›PMID 35421984›Full record

ArticleTrials2022

INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children.

Robyn Walsh, Jennifer Reath, Hasantha Gunasekera, Amanda Leach, Kelvin Kong, Deborah Askew, Federico Girosi, Wendy Hu, Timothy Usherwood, Sanja Lujic and 9 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 30% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Autoinflation for otitis media with effusion (OME) in children.The Cochrane database of systematic reviews · 2023
    Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 12 institutions in 1 country.

Robyn WalshSchool of Medicine, Western Sydney University, Sydney, Australia.ORCID http://orcid.org/0000-0003-0879-387X
Jennifer ReathSchool of Medicine, Western Sydney University, Sydney, Australia.
Hasantha GunasekeraFaculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Amanda LeachMenzies School of Health Research, Darwin, Australia.
Kelvin KongSchool of Medicine and Public Health, The University of Newcastle, Newcastle, Australia.
Deborah AskewFaculty of Medicine, The University of Queensland, Brisbane, Australia.
Federico GirosiSchool of Medicine, Western Sydney University, Sydney, Australia.
Wendy HuSchool of Medicine, Western Sydney University, Sydney, Australia.
Timothy UsherwoodFaculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Sanja LujicCentre for Big Data Research in Health, The University of New South Wales, Sydney, Australia.
Geoffrey SpurlingFaculty of Medicine, The University of Queensland, Brisbane, Australia.
Peter MorrisMenzies School of Health Research, Darwin, Australia.
Chelsea WategoFaculty of Health, Queensland University of Technology, Brisbane, Australia.
Samantha HarkusHearing Australia, Sydney, Australia.
Cheryl WoodallTharawal Aboriginal Corporation, Sydney, Australia.
Claudette TysonFaculty of Health, Queensland University of Technology, Brisbane, Australia.
Letitia CampbellKalwun Development Corporation, Gold Coast, Australia.
Sylvia HusseyTownsville Aboriginal and Islander Health Service, Townsville, Australia.
Penelope AbbottSchool of Medicine, Western Sydney University, Sydney, Australia. p.abbott@westernsydney.edu.au.
Western Sydney University · AUMenzies School of Health Research · AUQueensland University of Technology · AUThe University of Sydney · AUAustralian Hearing · AUGold Coast City Council · AUQueensland Health · AUTharawal Aboriginal · AUThe University of Queensland · AUTownsville Hospital · AUUniversity of Newcastle Australia · AUUNSW Sydney · AU

Funding

National Health and Medical Research Council GNT1120317
6 · The paper itself

Abstract

backgroundOtitis media with effusion (OME) is common and occurs at disproportionately higher rates among Indigenous children. Left untreated, OME can negatively affect language, development, learning, and health and wellbeing throughout the life-course. Currently, OME care includes observation for 3 months followed by consideration of surgical ventilation tube insertion. The use of a non-invasive, low-cost nasal balloon autoinflation device has been found beneficial in other populations but has not been investigated among Aboriginal and Torres Strait Islander children. METHODS/

designThis multi-centre, open-label, randomised controlled trial will determine the effectiveness of nasal balloon autoinflation compared to no nasal balloon autoinflation, for the treatment of OME among Aboriginal and Torres Strait Islander children in Australia. Children aged 3-16 years with unilateral or bilateral OME are being recruited from Aboriginal Health Services and the community. The primary outcome is the proportion of children showing tympanometric improvement of OME at 1 month. Improvement is defined as a change from bilateral type B tympanograms to at least one type A or C1 tympanogram, or from unilateral type B tympanogram to type A or C1 tympanogram in the index ear, without deterioration (type A or C1 to type C2, C3, or B tympanogram) in the contralateral ear. A sample size of 340 children (170 in each group) at 1 month will detect an absolute difference of 15% between groups with 80% power at 5% significance. Anticipating a 15% loss to follow-up, 400 children will be randomised. The primary analysis will be by intention to treat. Secondary outcomes include tympanometric changes at 3 and 6 months, hearing at 3 months, ear health-related quality of life (OMQ-14), and cost-effectiveness. A process evaluation including perspectives of parents or carers, health care providers, and researchers on trial implementation will also be undertaken. DISCUSSION: INFLATE will answer the important clinical question of whether nasal balloon autoinflation is an effective and acceptable treatment for Aboriginal and Torres Strait Islander children with OME. INFLATE will help fill the evidence gap for safe, low-cost, accessible OME therapies.

trial registrationAustralia New Zealand Clinical Trials Registry ACTRN12617001652369 . Registered on 22 December 2017. The Australia New Zealand Clinical Trials Registry is a primary registry of the WHO ICTRP network and includes all items from the WHO Trial Registration data set. Retrospective registration.

Indexed as

Health Services, IndigenousOtitis MediaOtitis Media with EffusionAdolescentAustralian Aboriginal and Torres Strait Islander PeoplesChildChild, PreschoolHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAboriginal and Torres Strait IslanderChildrenEar diseaseIndigenousNasal autoinflationOtitis mediaOtitis media with effusionOtolaryngologyRandomised controlled trial

Identifiers

PMID35421984
PMCPMC9009496
OpenAlexW4223889788

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.