The effectiveness of short-term ventilation tube Insertion versus surveillance In the management of chronic otitis media with effusion In children with non-syndromic cleft lip and palate

Abstract

Chronic otitis media with effusion is a common finding in children with cleft lip and palate. It is thought to be due to associated eustachian tube dysfunction and can lead to impaired hearing, and speech and language development if not appropriately managed. The mainstay treatment is drainage of the effusion with short-term ventilation tubes, but some centres are increasingly choosing to manage cases conservatively with active surveillance following palate repair surgery. Each of these approaches has its advantages but there is currently no consensus on the most appropriate management, therefore a systematic review of effectiveness was conducted using JBI methodology. Firstly, an a priori protocol was developed and published which included a pre-defined search strategy. A systematic search of MEDLINE (PubMed), CINAHL (Ovid), Embase (Ovid) and Scopus (Elsevier) databases was then conducted in July 2021 to find published literature. Grey literature searches were conducted through Central Register of Controlled Trials (CENTRAL), Clinicaltrials.gov and ProQuest (ProQuest Platform) databases. The search was limited to studies published in English. Eligible studies featured children less than 18 years with cleft lip and palate, not associated with a genetic syndrome, who had been diagnosed with chronic otitis media with effusion. Studies that considered the use of short-term ventilation tubes were included with surveillance as the comparator. Two reviewers screened and conducted critical appraisal of eligible studies, assessed the methodological quality, and extracted the data. Where possible, studies were pooled for analysis with heterogeneity being assessed using the standard Chi-squared and I2 tests. GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) evidence assessment was also reported. Four studies met the inclusion criteria for the review included in this thesis, three retrospective cohort studies and one prospective. The overall study quality was low with a moderate risk of bias. Only data for hearing thresholds could be pooled for analysis using two studies. Narrative synthesis was used for the remaining outcomes. Lack of data and inconsistent reporting of outcomes significantly limited capacity for pooled analysis. Certainty of evidence for all variables was deemed to be low to very low using GRADE criteria. No definitive conclusions could be drawn regarding effectiveness of short-term ventilation tubes versus surveillance in the management of chronic otitis media with effusion in children with non-syndromic cleft lip and palate. Short-term ventilation tubes appear to be associated with a higher rate of otological complications, and a conservative approach does not lead to worse hearing outcomes. Due to the methodological limitations of the included studies, a gaps analysis of the collated evidence was performed. It highlighted that incomplete data sets and inadequate reporting standards were common across all the included studies. The findings of this thesis support the need for a well-designed and adequately powered multi-centre randomised controlled trial for further investigation.