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Effectiveness of Tympanostomy Tubes for Otitis Media: a Meta-Analysis

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Effectiveness of Tympanostomy Tubes for Otitis Media: a Meta-Analysis Dale W. Steele, MD, MS, a, b, c, d Gaelen P. Adam, MLIS, a Mengyang Di, MD, PhD, a Christopher H. EffectivenessHalladay, ScM, a Ethan M. Balk, MD, MPH, a, b Thomasof Tympanostomy A. Trikalinos, MD, PhDa, b Tubes for Otitis Media: A Meta-analysis CONTEXT: abstract Tympanostomy tube placement is the most common ambulatory surgery performed OBJECTIVES: on children in the United States. The goal of this study was to synthesize evidence for the effectiveness of tympanostomy tubes in children with chronic otitis media with effusion and recurrent acute DATA SOURCES: otitis media. Searches were conducted in Medline, the Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews, Embase, and the Cumulative Index to Nursing and STUDY SELECTION: Allied Health Literature. Abstracts and full-text articles were independently screened by 2 DATA EXTRACTION: investigators. A total of 147 articles were included. When feasible, random effects network RESULTS: meta-analyses were performed. Children with chronic otitis media with effusion treated with tympanostomy tubes − − compared with watchful waiting had a net decrease in mean hearing threshold of 9.1 dB − (95% credible interval: 14.0 to 3.4) at 1 to 3 months and 0.0 (95% credible interval: 4.0 to 3.4) by 12 to 24 months. Children with recurrent acute otitis media may have fewer episodes after placement of tympanostomy tubes. Associated adverse events are poorly LIMITATIONS: defined and reported. CONCLUSIONS: Sparse evidence is available, applicable only to otherwise healthy children. Tympanostomy tubes improve hearing at 1 to 3 months compared with watchful waiting, with no evidence of benefit by 12 to 24 months. Children with recurrent acute otitis media may have fewer episodes after tympanostomy tube placement, but the evidence base is severely limited. The benefits of tympanostomy tubes must be weighed against a variety of associated adverse events. aEvidence-based Practice Center, Center for Evidence Synthesis in Health, bDepartment of Health Services, Policy and Practice, School of Public Health, cDepartment of Emergency Medicine, Section of Pediatrics–Hasbro Children’s Hospital, and dDepartment of Pediatrics, Alpert Medical School, Brown University, Providence, Rhode Island Dr Steele conceptualized and designed the review, designed data collection instruments and supervised data collection, performed data analysis and interpretation of data, and drafted and revised the manuscript; Ms Adam performed the literature search, participated in data collection, performed analysis and interpretation of data, and critically reviewed the manuscript; Dr Di and Mr Halliday participated in data collection, analysis, and interpretation of data, and reviewed and revised the manuscript; Dr Balk assisted in conceptualization and design, reviewed data collection, collected data, and critically reviewed the manuscript; and Dr Trikalinos oversaw protocol conception and design and analysis and interpretation of data, performed supplemental analysis, and critically reviewed and revised the manuscript. All authors approved the final manuscript as submitted. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the US Department of Health and Human Services. To cite: Steele DW, Adam GP, Di M, et al. Effectiveness of Tympanostomy Tubes for Otitis Media: A Meta-analysis. Pediatrics. 2017;139(6):e20170125 Downloaded from www.aappublications.org/news by guest on October 2, 2021 PEDIATRICS Volume 139, number 6, June 2017:e20170125 REVIEW ARTICLE Myringotomy with tympanostomy to clear middle ear4 fluid after an studies) with at least 1000 subjects tube placement is the most common episode of AOM. were included. ambulatory surgery performed on 1 In the present systematic review, Literature searches without language children in the United States, with we synthesized the available restrictions were conducted in 667000 children aged <15 years evidence regarding the effectiveness Medline, the Cochrane Central Trials undergoing tympanostomy tube 2 of tympanostomy tubes (with or Registry and Cochrane Database of placement in 2006. The effectiveness without adenoidectomy) compared Systematic Reviews, Embase, and of tympanostomy tubes for chronic with watchful waiting in children the Cumulative Index to Nursing otitis media with effusion (OME) and with chronic OME and children with and Allied Health Literature (from recurrent acute otitis media (AOM) recurrent AOM. We also summarized inception) to identify primary is likely influenced by the many the frequency of adverse events research studies meeting the study factors that affect the prognosis associated with tympanostomy tubes. criteria. Citations found by literature for middle ear disease in children. searches were independently These factors include current age, This review is derived from an – screened by 2 researchers, using age at first diagnosis, frequency of Agency for Healthcare Research and the open-source, online software respiratory tract infections, and day Quality commissioned comparative 3 abstrackr (http:// abstrackr. cebm. care exposure. effectiveness review (Tympanostomy 7 brown. edu/ ). Conflicts were – Tubes in Children With Otitis Media) The American Academy of resolved by discussion until a group conducted by the Brown Evidence- Otolaryngology Head and Neck consensus was reached. based Practice Center. The full review Data Extraction and Analysis Surgery clinical practice guideline and review protocol (PROSPERO recommends that clinicians should registry number: CRD42015029623) offer bilateral tympanostomy tube ≥ are available at http:// www. Each study was extracted by 1 insertion to children with bilateral effectivehealthcare. ahrq. gov. methodologist; the extractions were OME for 3 months and who have reviewed and confirmed by at least 1 documented hearing difficulties. They METHODS other methodologist. We conducted may offer tympanostomy tubes to quantitative analysis for outcomes children with unilateral or bilateral with at least 5 studies which report OME with symptoms that are likely The approaches outlined in the ’ results that could be combined in attributable to OME which include, Agency for Healthcare Research a meta-analysis. Bayesian network but are not limited to, vestibular and Quality s Methods Guide for gemtc meta-analysis was performed problems, poor school performance, Comparative Effectiveness Reviews 8 6 by using the R package. behavioral problems, ear discomfort, were followed. 4 Search Strategy and Study Selection Estimation was performed with or reduced quality of life. ’ Markov chain Monte Carlo9 methods The American Academy of Pediatrics via the JAGS software, using initial clinical practice guideline for This study evaluated published, peer- values drawn randomly from the diagnosis and management of reviewed studies in which at least marginal distributions of the priors AOM states that clinicians may 1 arm included children receiving of respective parameters. We fit 4 offer tympanostomy tubes for tympanostomy tubes; conference Markov chain Monte Carlo chains. recurrent AOM (3 episodes in 6 abstracts were excluded. We included After a burn-in of 5000 iterations, months or 4 episodes in 1 year randomized controlled trials (RCTs) we monitored the convergence with 1 episode in the preceding 6 and nonrandomized comparative of random effects means and 5 – months). The American Academy studies (NRCS), prospective and variances automatically by checking of Otolaryngology Head and Neck retrospective, in which treatment every 10000 iterations whether Surgery clinical practice guideline with tympanostomy tubes was the Gelman-Rubin diagnostic was further recommends that clinicians assigned on a per-patient basis. <1.05 with 95% probability for not perform tympanostomy tube Studies with per-ear assignment all monitored parameters. After insertion when middle ear effusion is were excluded (eg, tympanostomy convergence was reached, an not present at the time of assessment tubes placed by design in 1 ear only). additional 10000 iterations were for tube placement; they argue that For adverse events, prospective run. All models converged within the presence of effusion serves as surgical studies enrolling at least 10000 iterations. Model fit was ≥ both a marker for the accuracy of the 50 subjects (including arms of RCTs assessed by comparing the posterior diagnosis of AOM and an indicator or NRCS with 50 patients) and mean of the residual deviance versus of underlying Eustachian tube population-based retrospective the number of data points. The ratio dysfunction with decreased ability single-group studies (registry of residual deviance to number of Downloaded from www.aappublications.org/news by guest on October 2, 2021 2 STEELE et al adenoidectomy alone, oral antibiotic prophylaxis, and watchful waiting). Hearing thresholds were measured in 16 RCTs. In 10 of these RCTs, mean hearing thresholds were reported according to study arm at various time points. For the network meta- analysis of these RCTs, we classified “ ” hearing thresholds obtained at 1 to 3 months as early ; hearing “ ” thresholds obtained between 12 and 24 months were classified as late. Not all studies had interventions at both early and late time points. Thus, the network of comparators differs for early and late comparisons. Figure 2 illustrates the effectiveness of various interventions at 1 to 3 months compared with watchful
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