Objectives: 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.
Data sources: 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.
Review methods: 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.