{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T13:59:03Z","timestamp":1790776743974,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T00:00:00Z","timestamp":1786579200000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["#1046266"],"award-info":[{"award-number":["#1046266"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100018822","name":"Western Sydney University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100018822","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Medical Journal of Australia"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Determine whether watchful waiting is non\u2010inferior to immediate oral antibiotics for uncomplicated acute otitis media among urban Aboriginal and Torres Strait Islander children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Type<\/jats:title>\n                    <jats:p>Non\u2010inferiority unblinded randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting and Participants<\/jats:title>\n                    <jats:p>Eight Aboriginal Medical Services across three Australian states and territories between 25 August 2014 and 2 June 2023. Children (aged 1.5\u201316\u2009years) with type B tympanograms and bulging tympanic membrane or acute pain\/irritability were randomised by site and age (1.5\u20136\u2009years and 7\u201316\u2009years), with stratification using randomly allocated, permuted blocks of four and six in length.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measures<\/jats:title>\n                    <jats:p>Watchful waiting compared with immediate oral antibiotics using modified intention\u2010to\u2010treat (using only available data) and per\u2010protocol analyses of Day 7 clinical resolution with non\u2010inferiority threshold set at 10 percentage points.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Children were randomly allocated to watchful waiting (134), six of whom were lost to follow\u2010up or immediate antibiotics (129) with three lost to follow\u2010up. Resolution occurred in 57\/106 (53.8%) watchful waiting and 68\/113 (60.2%) immediate antibiotic group of those with complete Day 7 data (\u22126.4 percentage points difference; 90% confidence interval [CI], \u221217.4 to 4.6) (modified intention\u2010to\u2010treat analysis). Per\u2010protocol analysis similarly demonstrated reduced resolution in the watchful waiting group (49\/97; 50.5%) compared with immediate antibiotics (67\/112; 59.8%) with \u22129.3 percentage points difference (90% CI, \u221220.6 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%]; \u221210.7 percentage points difference; 95% CI, \u221218.6 to \u22122.7) but no other differences in vomiting, diarrhoea or rash (Days 3\u201314). 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\u2010related severe adverse events or perforations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Although our results are numerically similar to those reported in other low\u2010risk populations and no unexpected safety signals were observed in the watchful waiting arm, non\u2010inferiority was not established. Larger, adequately powered trials are required to determine whether watchful waiting is non\u2010inferior in this population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>Australian New Zealand Clinical Trials Registry ACTRN#12613001068752<\/jats:p>\n                  <\/jats:sec>","DOI":"10.5694\/mja2.70260","type":"journal-article","created":{"date-parts":[[2026,8,13]],"date-time":"2026-08-13T11:24:01Z","timestamp":1786620241000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Watchful Waiting Compared With Immediate Antibiotics for Urban Aboriginal and Torres Strait Islander Children With Uncomplicated Acute Otitis Media (\n                    <scp>WATCH<\/scp>\n                    ): A Non\u2010Inferiority Randomised Controlled Trial"],"prefix":"10.5694","volume":"224","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0676-4402","authenticated-orcid":false,"given":"Jennifer S.","family":"Reath","sequence":"first","affiliation":[{"name":"Western Sydney University  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4900-1277","authenticated-orcid":false,"given":"Hasantha","family":"Gunasekera","sequence":"additional","affiliation":[{"name":"University of Sydney  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9555-0261","authenticated-orcid":false,"given":"Sanja","family":"Lujic","sequence":"additional","affiliation":[{"name":"UNSW Sydney  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4638-8392","authenticated-orcid":false,"given":"Amanda 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