Trial reportThe New England journal of medicine2021
Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.
Erratum issued Registry-linked trialOpen access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph
Trial report in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02567825 (Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.
0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
12.5field-weighted citation impact, top 1% of its field
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.
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.
- A Systematic Review and Meta-Analysis of the Efficacy of Antimicrobial Chemoprophylaxis for Recurrent Acute Otitis Media in Children.Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2025Pooled it
- Cost-Effectiveness of Management Strategies in Recurrent Acute Otitis Media.The Journal of pediatrics · 2023Trial
- The Gut-Ear Axis: From Dysbiosis to Auditory and Vestibular Disorders.International journal of molecular sciences · 2026Review
- Global burden and trends of depression among women of childbearing age, 1990-2021.Public health in practice (Oxford, England) · 2026Article
- Article
- Utilizing temporal imaging to enhance early diagnosis of eosinophilic otitis media in clinical practice.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 · 2025Article
- Ciprofloxacin-Coated Tympanostomy Tubes with Sustained-Release Varnish: A Novel Strategy to Combat Biofilm Formation byMicroorganisms · 2025Article
- Allergic rhinitis and asthma: drivers of otitis media and associated tympanostomy tube placement.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 · 2025Article
- Health state utilities associated with invasive pneumococcal disease, pneumonia, and recurrent acute otitis media in young children.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Impact of Concomitant Tonsillectomy on the Management and Outcomes of Pediatric Adenoidectomy.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2025Article
- Modification of an outcome measure to follow symptoms of children with acute otitis media.Pediatric research · 2025Article
- Reduction of Antibiotic-Associated Conditions After Tympanostomy Tube Placement in Children.The Laryngoscope · 2025Article
- Dynamic Nanopeptide Assemblies for Trans-Tympanic Drug Delivery.International journal of nanomedicine · 2025Article
- Comparison of four ventilation tubes commonly used in the pediatric population: A retrospective cohort study.Laryngoscope investigative otolaryngology · 2024Article
- A ruthenium single atom nanozyme-based antibiotic for the treatment of otitis media caused byFrontiers in chemistry · 2024Article
- ISOM 2023 Research Panel 5: Interventions- Vaccines and prevention, medical and surgical treatment, and impact of COVID-19 pandemic.International journal of pediatric otorhinolaryngology · 2024Review
- Moraxella Catarrhalis Infrequently Cultured from Middle Ear Fluid of Children with Acute Otitis Media.The Pediatric infectious disease journal · 2023Article
- In Vivo Optical Characterization of Middle Ear Effusions and Biofilms During Otitis Media.Journal of the Association for Research in Otolaryngology : JARO · 2023Observational
- Biofilm-Forming Bacteria Implicated in Complex Otitis Media in Children in the Post-Heptavalent Pneumococcal Conjugate Vaccine (PCV7) Era.Microorganisms · 2023Article
- A Peculiar Case of Ossicular Chain Fixation and Enlarged Vestibular Aqueduct.Children (Basel, Switzerland) · 2023Article
Corrections and comments
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- Erratum issued
Authors and funding
21 authors at 4 institutions in 1 country.
Alejandro HobermanFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).ORCID 0000-0001-6793-8798
Diego PreciadoFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Jack L ParadiseFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
David H ChiFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
MaryAnn HaralamFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Stan L BlockFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Diana H KearneyFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Sonika BhatnagarFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Gysella B Muñiz PujaltFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).ORCID 0000-0003-2476-4008
Timothy R ShopeFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Judith M MartinFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Daniel E FeltenFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Marcia Kurs-LaskyFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Hui LiuFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Kristin YahnerFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Jong-Hyeon JeongFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Norman L CohenFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Brian CzervionkeFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Jennifer P NaggFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Joseph E DoharFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).
Nader ShaikhFrom the Departments of Pediatrics (A.H., J.L.P., M.H., D.H.K., S.B., G.B.M.P., T.R.S., J.M.M., M.K.-L., H.L., K.Y., J.P.N., N.S.) and Otolaryngology (D.H.C., J.E.D.), University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (J.-H.J.), and Children's Community Pediatrics (N.L.C., B.C.) - all in Pittsburgh; Children's National Medical Center, Washington, DC (D.P., D.E.F.); and Kentucky Pediatric and Adult Research, Bardstown (S.L.B.).ORCID 0000-0002-1602-343X
Children's Hospital of Pittsburgh · USChildren's National · USOhio Pediatric Research Association · USUniversity of Pittsburgh · US
Funding
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9MUniversity of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8MEfficacy of Tympanostomy Tubes for Children with Recurrent Acute Otitis MediaU01DC013995 · NIDCD · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI HOBERMAN, ALEJANDRO, PRECIADO, DIEGO · 2015 to 2019
$4.7MNCATS NIH HHS UL1 TR000005NCRR NIH HHS UL1 RR024153NIDCD NIH HHS 1 U01 DC013995-01A1NIDCD NIH HHS U01 DC013995
Abstract
backgroundOfficial recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.
methodsWe randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.
resultsIn our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial.
conclusionsAmong children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).
Indexed as
Middle Ear VentilationAcute DiseaseAnti-Bacterial AgentsChild, PreschoolDrug Resistance, BacterialFemaleHumansInfantIntention to Treat AnalysisKaplan-Meier EstimateMaleOtitis MediaOtitis Media with EffusionQuality of LifeRecurrenceAnti-Bacterial Agents
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Registered trials
NCT02567825ClinicalTrials.gov
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.