Evidence map›Paper›PMID 42592875›Full record

Trial reportThe Medical journal of Australia2026

Watchful Waiting Compared With Immediate Antibiotics for Urban Aboriginal and Torres Strait Islander Children With Uncomplicated Acute Otitis Media (WATCH): A Non-Inferiority Randomised Controlled Trial.

Jennifer S Reath, Hasantha Gunasekera, Sanja Lujic, Amanda J Leach, Letitia Campbell, Robyn Walsh, Tim Usherwood, Geoffrey K Spurling, Claudette A Tyson, Deborah A Askew and 5 more

Abstract readRandomized Controlled TrialEquivalence TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Medical journal of Australia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Jennifer S ReathWestern Sydney University, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-0676-4402
Hasantha GunasekeraUniversity of Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0003-4900-1277
Sanja LujicUNSW Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-9555-0261
Amanda J LeachMenzies School of Health Research, Darwin, Northern Territory, Australia.ORCID https://orcid.org/0000-0002-4638-8392
Letitia CampbellWestern Sydney University, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0003-3440-7864
Robyn WalshWestern Sydney University, Sydney, New South Wales, Australia.
Tim UsherwoodUniversity of Sydney, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-7522-0345
Geoffrey K SpurlingQueensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Brisbane, Queensland, Australia.ORCID https://orcid.org/0000-0002-3525-4663
Claudette A TysonQueensland Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Brisbane, Queensland, Australia.
Deborah A AskewUniversity of Queensland, Brisbane, Queensland, Australia.ORCID https://orcid.org/0000-0003-3943-620X
Kelvin KongUNSW Sydney, Sydney, New South Wales, Australia.
Chelsea J WategoQueensland University of Technology, Brisbane, Queensland, Australia.ORCID https://orcid.org/0000-0002-5246-235X
Peter MorrisMenzies School of Health Research, Darwin, Northern Territory, Australia.
Wendy HuWestern Sydney University, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0002-1711-3808
Penelope A AbbottWestern Sydney University, Sydney, New South Wales, Australia.

Funding

Ainsworth Foundation (Western Sydney University)National Health and Medical Research Council #1046266
6 · The paper itself

Abstract

objectiveDetermine whether watchful waiting is non-inferior to immediate oral antibiotics for uncomplicated acute otitis media among urban Aboriginal and Torres Strait Islander children. STUDY TYPE: Non-inferiority unblinded randomised controlled trial. SETTING AND

participantsEight Aboriginal Medical Services across three Australian states and territories between 25 August 2014 and 2 June 2023. Children (aged 1.5-16 years) with type B tympanograms and bulging tympanic membrane or acute pain/irritability were randomised by site and age (1.5-6 years and 7-16 years), with stratification using randomly allocated, permuted blocks of four and six in length.

main outcome measuresWatchful waiting compared with immediate oral antibiotics using modified intention-to-treat (using only available data) and per-protocol analyses of Day 7 clinical resolution with non-inferiority threshold set at 10 percentage points.

resultsChildren were randomly allocated to watchful waiting (134), six of whom were lost to follow-up or immediate antibiotics (129) with three lost to follow-up. Resolution occurred in 57/106 (53.8%) watchful waiting and 68/113 (60.2%) immediate antibiotic group of those with complete Day 7 data (-6.4 percentage points difference; 90% confidence interval [CI], -17.4 to 4.6) (modified intention-to-treat analysis). Per-protocol analysis similarly demonstrated reduced resolution in the watchful waiting group (49/97; 50.5%) compared with immediate antibiotics (67/112; 59.8%) with -9.3 percentage points difference (90% CI, -20.6 to 2.0). There was less Day 3 diarrhoea in watchful waiting (3/90; 3.3%) than in the immediate antibiotic group (13/93 [14.0%]; -10.7 percentage points difference; 95% CI, -18.6 to -2.7) but no other differences in vomiting, diarrhoea or rash (Days 3-14). Day 7 analgesia use was higher in the watchful waiting (53/107 [49.5%]) than immediate antibiotic group (37/116 [31.9%]; 17.6 percentage points difference; 95% CI, 4.9 to 30.1). There were no intervention-related severe adverse events or perforations.

conclusionAlthough our results are numerically similar to those reported in other low-risk populations and no unexpected safety signals were observed in the watchful waiting arm, non-inferiority was not established. Larger, adequately powered trials are required to determine whether watchful waiting is non-inferior in this population.

trial registrationAustralian New Zealand Clinical Trials Registry ACTRN#12613001068752.

Indexed as

Anti-Bacterial AgentsOtitis MediaWatchful WaitingAcute DiseaseAdolescentAustraliaAustralian Aboriginal and Torres Strait Islander PeoplesChildChild, PreschoolFemaleHumansInfantMaleAnti-Bacterial Agentsanti‐infective agentschild healthear diseases

Identifiers

PMID42592875
PMCPMC13470832

What OpenQuestion holds

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Registered trials

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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.