A model-based cost-effectiveness analysis of a grommets-led care pathway for children with cleft palate affected by otitis media with effusion.

There is a paucity of evidence to guide the management of otitis media with effusion (OME), which is a common problem causing significant hearing impairment in children with cleft palate. The insertion of grommets is currently being used to correct hearing impairment and prevent complications of unmanaged OME, but there is ongoing discussion about whether the benefits of grommets outweigh the costs and risks. A decision-tree model was developed to assess the surgical insertion of grommets with two non-surgical alternatives (hearing-aids and do-nothing strategies) in cleft palate children with persistent bilateral OME. The model assumed a 2-year time horizon and a UK National Health Service perspective. Outcomes were valued using quality-adjusted life-years (QALYs) estimated by linking utility values with potential hearing gains measured in decibels. Multiple data sources were used, including reviews of the clinical effectiveness, resource use and utility literature, and supplemented with expert opinion. Uncertainty in the model parameters was assessed using probabilistic sensitivity analysis. Expected value of perfect information analysis was used to calculate the potential value of future research. The results from the probabilistic sensitivity analysis indicated that the grommets strategy was associated with an incremental cost-effectiveness ratio of £9,065 per QALY gained compared with the do-nothing strategy, and the hearing-aids strategy was extended dominated by the grommets strategy. The population expected value of perfect information was £5,194,030 at a willingness to pay threshold of £20,000 per QALY, implying that future research could be potentially worthwhile. This study found some evidence that the insertion of grommets to manage cleft palate children with bilateral OME is likely to be cost-effective, but further research is required to inform this treatment choice.