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Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.
Hoberman, Alejandro; Preciado, Diego; Paradise, Jack L; Chi, David H; Haralam, MaryAnn; Block, Stan L; Kearney, Diana H; Bhatnagar, Sonika; Muñiz Pujalt, Gysella B; Shope, Timothy R; Martin, Judith M; Felten, Daniel E; Kurs-Lasky, Marcia; Liu, Hui; Yahner, Kristin; Jeong, Jong-Hyeon; Cohen, Norman L; Czervionke, Brian; Nagg, Jennifer P; Dohar, Joseph E; Shaikh, Nader.
Afiliação
  • Hoberman A; From 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
  • Preciado D; From 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
  • Paradise JL; From 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
  • Chi DH; From 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
  • Haralam M; From 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
  • Block SL; From 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
  • Kearney DH; From 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
  • Bhatnagar S; From 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
  • Muñiz Pujalt GB; From 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
  • Shope TR; From 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
  • Martin JM; From 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
  • Felten DE; From 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
  • Kurs-Lasky M; From 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
  • Liu H; From 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
  • Yahner K; From 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
  • Jeong JH; From 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
  • Cohen NL; From 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
  • Czervionke B; From 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
  • Nagg JP; From 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
  • Dohar JE; From 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
  • Shaikh N; From 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
N Engl J Med ; 384(19): 1789-1799, 2021 05 13.
Article em En | MEDLINE | ID: mdl-33979487
ABSTRACT

BACKGROUND:

Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.

METHODS:

We 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.

RESULTS:

In 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.

CONCLUSIONS:

Among 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.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Otite Média / Ventilação da Orelha Média / Antibacterianos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Child, preschool / Female / Humans / Infant / Male Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Otite Média / Ventilação da Orelha Média / Antibacterianos Tipo de estudo: Clinical_trials / Guideline / Prognostic_studies Limite: Child, preschool / Female / Humans / Infant / Male Idioma: En Ano de publicação: 2021 Tipo de documento: Article