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Related Research Report: Supplemental Project to Assess the Transparency of Reporting Requirements: Tympanostomy Tubes in Children With Otitis Media (2017)
Purpose of Review
To assess effectiveness and harms of tympanostomy tube (TT) surgery in children with persistent middle ear fluid or recurrent ear infections.
- Compared to watchful waiting, TT surgery for persistent middle ear fluid results in short-term hearing improvements.
- A period of watchful waiting does not seem to affect speech and language development, behavior, or quality of life in otherwise healthy children.
- Children with recurrent acute ear infections may have fewer episodes after surgery, but more research is needed.
- Benefits of TT placement must be weighed against a variety of adverse events.
- Water precautions (avoidance of swimming or ear plugs) after TT surgery appear to be unnecessary.
- If bothersome drainage from TT occurs, evidence supports treating with ear drops rather than oral antibiotics.
The objectives for the systematic review are to synthesize information on the effectiveness of tympanostomy tubes (TT) in children with chronic otitis media with effusion and recurrent acute otitis media, summarize the frequency of adverse effects or complications associated with TT placement, synthesize information on the necessity for water precautions in children with TT, and assess the effectiveness of available treatments for otorrhea in children who have TT.
We conducted literature searches in MEDLINE®, the Cochrane Central Trials Registry and Cochrane Database of Systematic Reviews, Embase®, and CINAHL®. Additionally, we perused the reference lists of published relevant clinical practice guidelines and narrative and systematic reviews, and examined Scientific Information Packages from manufacturers. Citations were independently screened by two researchers.
Each study was extracted by one methodologist and confirmed by at least one other methodologist. Data were extracted into customized forms in the Systematic Review Data Repository (SRDR) online system. All included studies were summarized in narrative form and in summary tables. We conducted random effects meta-analyses of comparative studies that were sufficiently similar in population, interventions, and outcomes, and network meta-analyses to compare treatment alternatives across studies. Specific methods and metrics (summary measures) meta-analyzed were chosen based on available reported study data. The PROSPERO protocol registration number is CRD42015029623.
Results and conclusions
The literature search yielded 13,334 citations, of which 172 articles are included in the report. Overall, the evidence suggests that TT placed in children with persistent middle-ear effusion improve hearing at 1 to 3 months compared to watchful waiting, but there is no benefit at 12 to 24 months. TT did not consistently improve language, cognition, behavior, or quality of life. However, evidence is sparse, limiting definitive conclusions, and is applicable only to otherwise healthy children. The current evidence base provides little guidance for the treatment of children with cleft palate or Down syndrome. Children with recurrent acute otitis media may have fewer episodes after TT placement, but the evidence base is limited and there is insufficient evidence to assess the impact on quality of life. The benefits of TT placement must be weighed against a variety of adverse events. There is no compelling evidence for children with TT to avoid swimming or bathing, or use earplugs or bathing caps. Should otorrhea develop, the evidence supports topical treatment rather than oral antibiotics or watchful waiting.
Steel D, Adam GP, Di M, Halladay C, Pan I, Coppersmith N, Balk EM, Trikalinos TA. Tympanostomy Tubes in Children With Otitis Media. Comparative Effectiveness Review No. 185. (Prepared by the Brown Evidence-based Practice Center under Contract No. 290-2015-00002-I.) AHRQ Publication No. 17-EHC003-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2017. doi: https://doi.org/10.23970/AHRQEPCCER185.
Steele DW, Adam GP, Di M, Halladay CW, Balk EM, Trikalinos TA. Prevention and Treatment of Tympanostomy Tube Otorrhea: A Meta-analysis. Pediatrics May 2017, e20170667; DOI: 10.1542/peds.2017-0667.