Draft Key Questions
Disposition of Comments Report
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To compare benefits and harms of strategies currently in use for managing otitis media with effusion (OME). Treatment for OME may include single approaches alone or combinations of two or more approaches. We compared benefits and harms among these treatments: tympanostomy tubes (TT), myringotomy (myr), adenoidectomy (adenoid), autoinflation (auto), oral or nasal steroids, complementary and alternative medicine (CAM), and watchful waiting (WW). We included comparisons of treatment effectiveness in subgroups of patients with OME, and whether outcome differences were related to factors affecting health care delivery or the receipt of pneumococcal vaccine inoculation.
We identified five recent systematic reviews a priori and searched MEDLINE,® Embase,® the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL®), from root through August 13, 2012, for additional studies. Eligible studies included randomized controlled trials (RCTs), nonrandomized trials, and cohort studies.
Eligible studies included at least two arms comparing the treatments described above. Pairs of reviewers independently selected, extracted data from, and rated the risk of bias of relevant studies; they graded the strength of evidence using established criteria. We incorporated meta-analyses from the earlier reviews and synthesized additional evidence qualitatively.
We identified 59 studies through the earlier reviews and our independent searches. Generally, studies examined interventions in otherwise healthy, noninfant children. We did not find any eligible studies covering CAM. Findings are reported for clinical and functional outcomes, and harms. Variation in length of TT retention corresponded to whether TT were designed to be short versus long term, but variation in TT type was not related to improved OME and hearing outcomes. TT decreased OME for 2 years compared with WW or myr, and improved hearing for 6 months compared with WW. OME resolution was more likely with adenoid than no treatment at 12 months. Adenoid and myr were superior to myr alone in relation to OME and hearing outcomes at 24 months. Adenoid and TT were superior to WW for hearing outcomes at 24 months. Auto was superior to standard treatment at improving OME at 1 month. We found no benefits from oral steroids at 2 months, or topical steroids at 9 months. In relation to functional outcomes, TT and WW did not differ in long-term language, cognitive or academic outcomes. Tympanosclerosis and otorrhea were more common in ears with TT. Adenoid increased the risk of postsurgical hemorrhage. In one study of a subgroup, adults receiving auto were more likely to recover from OME than those in the control group at one month. We found no studies examining the influence of any health care factors on treatment effectiveness.
There is evidence that both TT and adenoid reduce OME and improve hearing in the short term, but both treatments also have associated harms. Large, well-controlled studies could help resolve the risk-benefit ratio by measuring AOM recurrence, functional outcomes, quality of life measures, and long-term outcomes. Finally, additional research is needed to support treatment decisions in subpopulations, particularly those with comorbidities and those who have received a pneumococcal vaccine inoculation.