The management of Otitis Media with Effusion in children with cleft palate (mOMEnt): a feasibility study and economic evaluation

Abstract

BackgroundCleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate.ObjectivesTo identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies.DesignThe management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP.SettingThe survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients’ homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting.ParticipantsClinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association.ResultsThe clinician survey revealed that care was predominantly delivered via a ‘hub-and-spoke’ model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research.ConclusionsThere exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered.FundingThe National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

Centre‐level variation in outcomes and treatment for otitis media with effusion and hearing loss and the association of hearing loss with developmental outcomes at ages 5 and 7 years in children with non‐syndromic unilateral cleft lip and palate: The Cleft Care UK study. Part 2

“…The National Institute for Health and Care Excellence state that insertion of grommets at palate closure is not recommended as routine practice and should only be completed after careful otological and audiological assessment. A recent clinician survey indicated that it is not current practice to insert grommets at palate repair and this is consistent with our findings with the practice only occurring at higher rates in two centres.…”

“…who described their centre's approach to managing OME and hearing loss in children with cleft palate as “non‐interventionist” relying predominantly on the provision of hearing aids with grommets used only in limited circumstances. Although the National Institute for Health and Care Excellence recommends both grommets and hearing aids as suitable interventions for OME and hearing loss, both of which have associated risks and benefits, there is uncertainty among clinicians about the best strategy for managing OME in children with cleft palate . The centres with higher rates of hearing aid fitting could be those that share treatment decision‐making with parents, and it is the parents rather than clinicians who are choosing hearing aids over grommets.…”

Use of a structured elicitation exercise to estimate the prevalence of OME in children with cleft palate

“…Children with a cleft palate (CP) have an increased tendency towards OME because the muscles originating from the palate that act to open the Eustachian tube orifice do not work correctly . There is a lack of robust prospective trial‐based evidence to indicate which of the several approaches to the management of OME in children with CP, including watchful waiting, the provision of hearing aids and the insertion of ventilation tubes, is the best option …”

“…However, a prospective trial would need to define a relevant age group of children to focus recruitment strategies. A feasibility study suggested that a trial should focus on an eligible population that represented 2‐year‐old children with clefts about to require an intervention for OME . There was no epidemiological data available that indicate how many 2‐year‐old children with CP have OME, or will still have OME, after the current recommended ‘watchful waiting’ period of 3 months before considering intervention .…”

Development of a Core Outcome Set for studies evaluating the effects of anaesthesia on perioperative morbidity and mortality following hip fracture surgery

“…The aim of this study was to develop a COS for studies comparing anaesthetic techniques in hip fracture surgery using the Delphi method. A similar approach has been successful for COS development in other fields, such as rheumatology, 4 cleft palate surgery, 5 oncology, 6,7 critical care, 6,8 and, most recently, upper gastrointestinal surgery. 36…”