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National Collaborating Centre for Women’s and Children’s Health (UK). Surgical Management of Otitis Media with Effusion in Children. London: RCOG Press; 2008 Feb. (NICE Clinical Guidelines, No. 60.)

Cover of Surgical Management of Otitis Media with Effusion in Children

Surgical Management of Otitis Media with Effusion in Children.

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2Summary of recommendations and care pathways

2.1. Key priorities for implementation (key recommendations)

Formal assessment of a child with suspected OME should include:

  • clinical history taking, focusing on:

    poor listening skills

    indistinct speech or delayed language development

    inattention and behaviour problems

    hearing fluctuation

    recurrent ear infections or upper respiratory tract infections

    balance problems and clumsiness

    poor educational progress

  • clinical examination, focusing on:

    otoscopy

    general upper respiratory health

    general developmental status

  • hearing testing, which should be carried out by trained staff using tests suitable for the developmental stage of the child, and calibrated equipment

Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) should be considered for surgical intervention.

Once a decision has been taken to offer surgical intervention for OME in children, the insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms.

The following treatments are not recommended for the management of OME:

  • antibiotics
  • topical or systemic antihistamines
  • topical or systemic decongestants
  • topical or systemic steroids
  • homeopathy
  • cranial osteopathy
  • acupuncture
  • dietary modification, including probiotics
  • immunostimulants
  • massage.

Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable.

Hearing aids should normally be offered to children with Down’s syndrome and OME with hearing loss.

Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment.

Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss.

2.2. Summary of recommendations

Presentation

Concerns from parents/carers or from professionals about features suggestive of OME should lead to initial assessment and referral for formal assessment if considered necessary. These features include:

  • hearing difficulty (for example, mishearing when not looking at you, difficulty in a group, asking for things to be repeated)
  • indistinct speech or delayed language development
  • repeated ear infections or earache
  • history of recurrent upper respiratory tract infection or frequent nasal obstruction
  • behavioural problems, particularly lack of concentration or attention, or being withdrawn
  • poor educational progress
  • less frequently, balance difficulties (for example, clumsiness), tinnitus and intolerance of loud sounds.

All children with Down’s syndrome and all children with cleft palate should be assessed regularly for OME.

Diagnosis

Formal assessment of a child with suspected OME should include:

  • clinical history taking, focusing on:

    poor listening skills

    indistinct speech or delayed language development

    inattention and behaviour problems

    hearing fluctuation

    recurrent ear infections or upper respiratory tract infections

    balance problems and clumsiness

    poor educational progress

  • clinical examination, focusing on:

    otoscopy

    general upper respiratory health

    general developmental status

  • hearing testing, which should be carried out by trained staff using tests suitable for the developmental stage of the child, and calibrated equipment

Co-existing causes of hearing loss (for example, sensorineural, permanent conductive and non-organic causes) should be considered when assessing a child with OME and managed appropriately.

Timing of clinical intervention

The persistence of bilateral OME and hearing loss should be confirmed over a period of 3 months before intervention is considered. The child’s hearing should be re-tested at the end of this time.

During the active observation period, advice on educational and behavioural strategies to minimise the effects of the hearing loss should be offered.

Which children will benefit from surgical intervention

Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) should be considered for surgical intervention.

Exceptionally, healthcare professionals should consider surgical intervention in children with persistent bilateral OME with a hearing loss less than 25–30 dBHL where the impact of the hearing loss on a child’s developmental, social or educational status is judged to be significant.

Effectiveness of surgical interventions

Once a decision has been taken to offer surgical intervention for OME in children, the insertion of ventilation tubes is recommended. Adjuvant adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms.

Children who have undergone insertion of ventilation tubes for OME should be followed up and their hearing should be re-assessed.

Effectiveness of non-surgical interventions

The following treatments are not recommended for the management of OME:

  • antibiotics
  • topical or systemic antihistamines
  • topical or systemic decongestants
  • topical or systemic steroids
  • homeopathy
  • cranial osteopathy
  • acupuncture
  • dietary modification, including probiotics
  • immunostimulants
  • massage.

Autoinflation may be considered during the active observation period for children with OME who are likely to cooperate with the procedure.

Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention where surgery is contraindicated or not acceptable.

Children with Down’s syndrome

The care of children with Down’s syndrome who are suspected of having OME should be undertaken by a multidisciplinary team with expertise in assessing and treating these children.

Hearing aids should normally be offered to children with Down’s syndrome and OME with hearing loss.

Before ventilation tubes are offered as an alternative to hearing aids for treating OME in children with Down’s syndrome, the following factors should be considered:

  • the severity of hearing loss
  • the age of the child
  • the practicality of ventilation tube insertion
  • the risks associated with ventilation tubes
  • the likelihood of early extrusion of ventilation tubes.

Children with cleft palate

The care of children with cleft palate who are suspected of having OME should be undertaken by the local otological and audiological services with expertise in assessing and treating these children in liaison with the regional multidisciplinary cleft lip and palate team.

Insertion of ventilation tubes at primary closure of the cleft palate should be performed only after careful otological and audiological assessment.

Insertion of ventilation tubes should be offered as an alternative to hearing aids in children with cleft palate who have OME and persistent hearing loss.

Information for children, parents and carers

Parents/carers and children should be given information on the nature and effects of OME, including its usual natural resolution.

Parents/carers and children should be given the opportunity to discuss options for treatment of OME, including their benefits and risks.

Verbal information about OME should be supplemented by written information appropriate to the stage of the child’s management.

2.3. Research recommendations

Effectiveness of surgical procedures for treating OME

There is a need for good-quality randomised controlled trials documenting the adjuvant effect of adenoidectomy with ventilation tubes compared with 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 sub-groups that would particularly benefit from surgical intervention.

Why this is important

Adjuvant adenoidectomy along with ventilation tube insertion is routinely performed in many countries for recurrent episodes of OME and chronic persistent OME, but the practice is not backed by sufficiently precise scientific evidence. A good number of trials have compared ventilation tube insertion alone with ventilation tubes plus adjuvant adenoidectomy, but differences in the study designs, population characteristics, outcomes measured and duration of follow-up among the trials, and particularly insufficient sample sizes to document a probably small but continuing difference, have made it difficult to come to any definite conclusion on the benefit of adjuvant adenoidectomy. There is a need for good-quality randomised controlled trials on larger samples than hitherto, addressing their power deficit not just for the proportion of time with ear fluid but also for the corresponding longer term benefits in hearing level. For this, the trials need to follow up children beyond 6–12 months after ventilation tube insertion as a high proportion of tubes would have fallen out during this time period, and so any advantage that may exist for adjuvant adenoidectomy becomes in principle demonstrable. Up to 2 years is a feasible follow-up period for formal outcome measurement, without high sample attrition. Because adenoidectomy is not risk-free, trials need particularly to be large enough to address sub-groupings that may receive particular benefit. The trials should also evaluate any benefits to respiratory and general health; these are expected from benefits seen in other ENT disease, but not so far demonstrated in uncomplicated OME. However, additional reductions in health care (such as reduced re-insertions of ventilation tubes) can also be documented and would add precision to the cost-effectiveness or cost–utility comparisons. Research is also needed to plot the balance between benefits and harms of ventilation tube insertion, as a function of the length of time for which the tube remains in place and functioning (due to the type of tube design).

Presentation and impact 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

This scientific issue is core to many of the aspects of chronic OME that the GDG considered. Clinically, it has implications both for the baseline assessment (indications for intervention) and appropriate outcomes in the studies. The GDG felt hampered by the almost exclusive predominance of hearing level as outcome measure in the available trials. A diversity of approaches (such as validated questionnaires, corroborated reports and performance tests) to measure the developmental outcomes should be incorporated in statistically well-controlled longitudinal studies to overcome this problem. The value of such a study relative to research costs might be maximised by bolting it on to a larger population cohort study, for example as a subset selected on a stratified basis. The GDG noted an embedded trial* (of good quality but with a small sample size) of ventilation tubes with speech recognition in noise as a measure of auditory disability: this study showed a greater benefit in children who had a larger baseline deficit on the same test. This result is promising for linking the rationales for sequelae and for treatment, but it needs to be generalised via a larger sample and adequately powered stratification, for example by age. Other markers of developmental impact between hearing (narrow, probably short-term) and speech/language and behaviour (broad, probably long-term) should also be considered, and the possibility that facets of OME other than hearing could contribute to developmental outcomes should not be ignored.

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

The GDG noted particular difficulties in organising research with children with Down’s syndrome and those with cleft palate, and this seems to contribute to the lack of high-quality evidence for the questions of this guideline. Randomised controlled trials may not necessarily be the most cost-effective investment, and if undertaken would need to be conducted on a multicentre basis. However, high-quality designed national audits with statistical control for baseline characteristics would enable a fuller understanding of natural histories and sub-types, particularly in cleft palate, and could provide an informative and unbiased account of the consequences of locally varying management practices.

Effectiveness of non-surgical interventions for OME

A comparative study on a representative sample of children with OME is required to assess the overall effectiveness of provision of hearing aids as an alternative to surgical treatment.

2.4. Care pathways

The care pathways on pages 11–13 are taken from the NICE Quick Reference Guide version of this guideline (www.nice.org.uk/CG060).

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Care pathway 1. Children with suspected OME (PDF, 47K)

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Care pathway 2. Children with Down’s syndrome (PDF, 44K)

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Care pathway 3. Children with cleft palate (PDF, 44K)

Footnotes

*

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

Copyright © 2008, National Collaborating Centre for Women’s and Children’s Health.

No part of this publication may be reproduced, stored or transmitted in any form or by any means, without the prior written permission of the publisher or, in the case of reprographic reproduction, in accordance with the terms of licences issued by the Copyright Licensing Agency in the UK [www.cla.co.uk]. Enquiries concerning reproduction outside the terms stated here should be sent to the publisher at the UK address printed on this page.

The use of registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant laws and regulations and therefore for general use.

Bookshelf ID: NBK51747

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