4 Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future. The Guideline Development Group's full set of research recommendations is detailed in the full guideline (see section 5).

4.1 Effectiveness of surgical procedures for treating OME

There is a need for good-quality randomised controlled trials documenting the effect of adjuvant adenoidectomy with ventilation tubes compared to ventilation tubes alone in the management of persistent bilateral OME in children. Trials should be sufficiently powered (large) to accurately document a probably small but continuing difference due to adjuvant adenoidectomy, and to identify subgroups that would particularly benefit from surgical intervention.

Why this is important

Despite a lack of robust scientific evidence, adjuvant adenoidectomy with ventilation tube insertion is routinely performed for recurrent or chronic persistent OME. There is, therefore, a need for good quality, randomised controlled trials with large samples which address the power deficit in measuring any additional difference derived from adjuvant adenoidectomy. In particular, the proportion of time spent with middle ear fluid and any corresponding benefit to hearing should be investigated. The trials need to follow up study participants beyond 6–12 months after ventilation tube insertion. This is because a high proportion of tubes would have fallen out during this period, and therefore any advantage that may exist for adjuvant adenoidectomy would become, in principle, demonstrable. Up to 2 years is a feasible follow-up period without high sample attrition. Further trials should also evaluate benefit to children's respiratory and general health, and additional benefits (for example, re-insertion of ventilation tubes) which would add precision to cost-effectiveness or cost–utility comparisons.

4.2 Presentation of OME

A combination of randomised trials, cohort studies and qualitative research is needed to accurately measure the developmental impact of persistent bilateral OME in children.

Why this is important

Current studies are limited by the almost exclusive predominance of hearing level as an outcome measure. Developmental outcomes can be measured using various approaches (for example, validated questionnaires and objective reports) and incorporated into well-controlled longitudinal studies, which, to maximise their value, could form part of a larger population cohort study. One particular embedded trial[1] used speech reception in noise as a measure of auditory disability, and reported a greater benefit in children with larger baseline deficits on the same test. Such a result is promising for linking sequelae with treatment, but needs to be generalised via a larger sample size and adequately powered stratification. Other markers of developmental impact between hearing (narrow, probably short-term) and speech/language and behaviour (broad, probably long-term) should also be considered.

4.3 OME in children with Down's syndrome and children with cleft palate

Studies and national audit should evaluate the acceptability, effectiveness and consequences of the various treatment strategies for OME in children with Down's syndrome and children with cleft palate.

Why this is important

There are particular difficulties in organising research of children with Down's syndrome and those with cleft palate. These problems have contributed to the lack of high-quality evidence in these populations. Randomised controlled trials are not necessarily the most cost-effective investment, and would need to be conducted on a multicentre basis. In contrast, high-quality and well-designed national audits with appropriate statistical control for baseline characteristics would enable a fuller understanding of the natural history of these disorders and their subtypes, particularly in children with cleft palate. Such studies may also provide an informative and unbiased account of the consequences of different management practices that may vary by region.

[1] MRC Multicentre Otitis Media Study Group (2004) Speech reception in noise: an indicator of benefit from otitis media with effusion surgery. Clinical Otolaryngology and Allied Sciences 29: 497–504.

  • National Institute for Health and Care Excellence (NICE)