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<meta name="citation_keywords" content="Middle Ear Ventilation">
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class="bkr_bib"><h1 id="_NBK595327_"><span itemprop="name">Evidence reviews for adenoidectomy for children with OME</span></h1><div class="subtitle">Otitis media with effusion in under 12s</div><p><b>Evidence review F</b></p><p><i>NICE Guideline, No. 233</i></p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2023 Aug</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-5336-3</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div></div><div class="bkr_clear"></div></div><div id="niceng233er6.s1"><h2 id="_niceng233er6_s1_">Adenoidectomy for children with otitis media with effusion (OME)</h2><div id="niceng233er6.s1.1"><h3>Review question</h3><p>What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</p><div id="niceng233er6.s1.1.1"><h4>Introduction</h4><p>The aim of this review is to assess the effectiveness of adenoidectomy (with or without ventilation tubes) in managing OME with associated hearing loss in children under 12 years.</p><p>At the start of development, the term ventilation tube (VT) was used to refer to tubes inserted during surgery for OME. However, the committee later agreed that the term grommet should be used as this is likely to be the term that is more familiar to readers of the guideline and would avoid confusion with tubes used to assist with breathing. Therefore, both terms appear in this evidence review.</p></div><div id="niceng233er6.s1.1.2"><h4>Summary of the protocol</h4><p>See <a class="figpopup" href="/books/NBK595327/table/niceng233er6.tab1/?report=objectonly" target="object" rid-figpopup="figniceng233er6tab1" rid-ob="figobniceng233er6tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng233er6tab1"><a href="/books/NBK595327/table/niceng233er6.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng233er6tab1" rid-ob="figobniceng233er6tab1"><img class="small-thumb" src="/books/NBK595327/table/niceng233er6.tab1/?report=thumb" src-large="/books/NBK595327/table/niceng233er6.tab1/?report=previmg" alt="Table 1. Summary of the protocol (PICO table)." /></a><div class="icnblk_cntnt"><h4 id="niceng233er6.tab1"><a href="/books/NBK595327/table/niceng233er6.tab1/?report=objectonly" target="object" rid-ob="figobniceng233er6tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol (PICO table). </p></div></div><p>For further details see the review protocol in <a href="#niceng233er6.appa">appendix A</a>.</p></div><div id="niceng233er6.s1.1.3"><h4>Methods and process</h4><p>During the development of this guideline, a registered Cochrane protocol was identified which matched the committee’s intended PICOs.</p><p>The Cochrane review team completed a review investigating the effectiveness of adenoidectomy for OME in children (<a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a>) during guideline development and presented their results to the committee, who used them to make recommendations. Cochrane’s methods are closely aligned to standard NICE methods, minor deviations (defining primary and secondary outcomes as opposed to critical and important, assessing the risk of bias in primary studies using version 1 (as opposed to version 2) of the Cochrane Risk of Bias tool, how clinically important differences are determined, and including countries from a broader range of income categories than the majority of the other reviews in the guideline) relevant to the topic area were highlighted to the committee and taken into account in discussions of the evidence. Full details of the Cochrane review, including methods, are available in the review of adenoidectomy for children with OME, see <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p><p>We thank the Cochrane ENT Group for their assistance in providing the literature searches and data for review questions relating to Otitis media with effusion in under 12s.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng233er6.s1.1.4"><h4>Effectiveness evidence</h4><div id="niceng233er6.s1.1.4.1"><h5>Included studies</h5><p>A Cochrane review (<a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a>) including 8 randomised controlled trials (Dempster 1993; Fiellau-Nikolajsen 1982; Gates 1989; Haggard 2012; Hao 2019; Jabeen 2019; Maw 1993; Sagnelli 1990) is considered in this report. This review was used for making recommendations by the committee, as it was considered sufficiently relevant, high quality and up to date.</p><p>Two studies included children aged up to 4 years (Fiellau-Nikolajsen 1982; Gates 1989), and 6 studies included children aged over 4 years (Dempster 1993; Haggard 2012; Hao 2019; Jabeen 2019; Maw 1993; Sagnelli 1990). All studies did not report data on whether participants had allergy, previous adenoidectomy, previous grommets, or Down’s syndrome (Dempster 1993; Fiellau-Nikolajsen 1982; Gates 1989; Haggard 2012; Hao 2019; Jabeen 2019; Maw 1993; Sagnelli 1990).</p><p>The Cochrane review is summarised in <a class="figpopup" href="/books/NBK595327/table/niceng233er6.tab2/?report=objectonly" target="object" rid-figpopup="figniceng233er6tab2" rid-ob="figobniceng233er6tab2">Table 2</a>.</p><p>See the Cochrane review for the literature search strategies ) and study selection flow charts, at <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div><div id="niceng233er6.s1.1.4.2"><h5>Excluded studies</h5><p>See the lists of excluded studies in the Cochrane review with reasons for their exclusions, at <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div><div id="niceng233er6.s1.1.5"><h4>Summary of included studies</h4><p>Summaries of the studies that were included in this review are presented in <a class="figpopup" href="/books/NBK595327/table/niceng233er6.tab2/?report=objectonly" target="object" rid-figpopup="figniceng233er6tab2" rid-ob="figobniceng233er6tab2">Table 2</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng233er6tab2"><a href="/books/NBK595327/table/niceng233er6.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng233er6tab2" rid-ob="figobniceng233er6tab2"><img class="small-thumb" src="/books/NBK595327/table/niceng233er6.tab2/?report=thumb" src-large="/books/NBK595327/table/niceng233er6.tab2/?report=previmg" alt="Table 2. Summary of included studies." /></a><div class="icnblk_cntnt"><h4 id="niceng233er6.tab2"><a href="/books/NBK595327/table/niceng233er6.tab2/?report=objectonly" target="object" rid-ob="figobniceng233er6tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of included studies. </p></div></div><p>See the Cochrane review for characteristics of studies tables and forest plots, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div><div id="niceng233er6.s1.1.6"><h4>Summary of the evidence</h4><p>The Cochrane review of adenoidectomy for children with OME investigated 4 comparisons, with the following findings:
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<ul><li class="half_rhythm"><div class="half_rhythm">Comparison 1: Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting</div><div class="half_rhythm">Adenoidectomy (with or without myringotomy) had an important benefit in terms of reducing time with effusion in the long-term compared with no treatment/watchful waiting, but the certainty of the evidence was very low. The comparison showed no evidence of important differences for hearing returned to normal in the short-term and medium-term, haemorrhage, presence/persistence of OME in the short-term, medium-term and long-term, and number of doctor-diagnosed AOM episodes in the medium-term. The certainty of the evidence was low to very low for these outcomes. No evidence was available for any of the other outcomes specified in the protocol.</div></li><li class="half_rhythm"><div class="half_rhythm">Comparison 2: Adenoidectomy and bilateral grommet versus bilateral grommet only Adenoidectomy and bilateral grommet had an important benefit in terms of reducing presence/persistence of OME in the short-term compared with bilateral grommet only; however, the certainty of the evidence was very low. There was no evidence of important differences for the other outcomes identified: hearing threshold in the short-term, medium-term and long-term, haemorrhage, presence/persistence of OME in the medium-term and long-term, and time with effusion in the long-term. The certainty of the evidence for these outcomes was very low. No evidence was available for any of the other outcomes specified in the protocol.</div></li><li class="half_rhythm"><div class="half_rhythm">Comparison 3: Adenoidectomy and unilateral grommet versus unilateral grommet only</div><div class="half_rhythm">Adenoidectomy and unilateral grommet had an important benefit in terms of reducing presence/persistence of OME in the short-term and medium-term compared with unilateral grommet only. There was no evidence of important differences for hearing returned to normal and hearing threshold (change from baseline) in the medium-term, presence/persistence of OME in the long-term, and tympanosclerosis. The certainty of the evidence for all outcomes identified was very low. There was no evidence available for this comparison for any of the other outcomes specified in the protocol.</div></li><li class="half_rhythm"><div class="half_rhythm">Comparison 4: Adenoidectomy and grommet versus no treatment/watchful waiting Adenoidectomy and grommet had an important benefit in terms of improvement in hearing threshold in the short-term and reducing time with effusion in the long-term compared with no treatment/watchful waiting. This comparison showed no evidence of important differences for hearing threshold in the medium-term and long-term, and presence/persistence of OME in the long-term. The certainty of the evidence for all outcomes identified was very low, and no evidence was available for any of the other outcomes specified in the protocol.</div></li></ul></p><p>There were two comparisons in the Cochrane review protocol that were not reported on by any studies: adenoidectomy (with or without myringotomy) versus non-surgical treatment, and adenoidectomy and grommets versus non-surgical treatment.</p><p>See the Cochrane review for summary of findings tables and full results, including all primary</p><p>and secondary outcomes and sub-group analyses, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div><div id="niceng233er6.s1.1.7"><h4>Economic evidence</h4><div id="niceng233er6.s1.1.7.1"><h5>Included studies</h5><p>A global health economic search was undertaken to cover all the review questions considered in this guideline, but no economic studies were identified which were applicable to this review question.</p></div><div id="niceng233er6.s1.1.7.2"><h5>Excluded studies</h5><p>Economic studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng233er6.appj">appendix J</a>.</p></div></div><div id="niceng233er6.s1.1.8"><h4>Economic model</h4><p>An economic model was undertaken which compared hearing aids, grommets and grommets with adjuvant adenoidectomy in children with hearing loss associated with OME. This model is discussed in Evidence review E.</p></div><div id="niceng233er6.s1.1.9"><h4>The committee’s discussion and interpretation of the evidence</h4><div id="niceng233er6.s1.1.9.1"><h5>The outcomes that matter most</h5><p>The primary outcomes were hearing, disease-specific quality of life, and serious haemorrhage and its consequences. The committee agreed these outcomes were critical: hearing loss is often associated with OME, and this could impact on the child’s development and measuring hearing would be a direct measure of any differential effectiveness associated with adenoidectomy. Disease-specific quality of life is a global measure of wellbeing that takes into account both beneficial and adverse effects of the interventions. Adenoidectomy may have adverse events associated with it, the most likely being serious haemorrhage and its consequences.</p><p>All other outcomes listed in the protocol (presence or persistence of OME, adverse events (other than serious haemorrhage and its consequences), receptive language skills, speech development or expressive language skills, cognitive development, psychosocial outcomes, listening skills, generic health-related quality of life, parental stress, vestibular function and number of doctor-diagnosed acute otitis media (AOM) episodes were agreed to be important outcomes by the committee. Presence or persistence of OME after adenoidectomy can directly indicate the effectiveness of the intervention, and adverse events other than serious haemorrhage and its consequences (including tympanic membrane changes such as atrophy; and patient-related complications such as recurring haemorrhage), that may be relatively common with adenoidectomy, are important to measure because they capture risks associated with the intervention. OME can be associated with impairment of receptive and expressive language skills, cognitive development, psychological outcomes, listening skills, and vestibular function, which could impact on the child’s development and quality of life. Therefore, the committee agreed these were important outcomes. The committee agreed that generic health-related quality of life was important because this would measure the well-being of the child more generally than disease-specific scales. The parents of children who have OME may have high level of stress, and thus parental stress was an important outcome to see if adenoidectomy can help reduce this stress. Number of doctor-diagnosed AOM episodes was also an important outcome because adenoidectomy may have a protective role for recurrent AOM.</p></div><div id="niceng233er6.s1.1.9.2"><h5>The quality of the evidence</h5><p>The quality of the evidence was assessed using GRADE methodology. Apart from presence or persistence of OME up to 3 and 12 months for the comparison between adenoidectomy and no treatment or watchful waiting, which was low quality, the evidence for all outcomes identified in this review was very low quality, because of high or moderate risk of bias assessed using version 1 of the Cochrane risk of bias tool, and serious or very serious imprecision. Publication bias was also strongly suspected for some outcomes due to retrospective registration of trials.</p></div><div id="niceng233er6.s1.1.9.3"><h5>Benefits and harms</h5><p>The committee discussed that hearing is the most important outcome in children with OME in terms of measuring the effectiveness of interventions. There was very limited and very low-quality evidence that adenoidectomy and grommet had an important benefit in terms of hearing threshold, when measured in the short term, compared with no treatment or watchful waiting, but there was no evidence of important differences when this outcome was measured in the medium or long term, or in hearing outcomes for the remaining comparisons (adenoidectomy without grommet compared with no treatment or watchful waiting, adenoidectomy and bilateral grommet compared with bilateral grommet only, or adenoidectomy and unilateral grommet compared with unilateral grommet only). Therefore, the committee agreed that there was no evidence that adenoidectomy itself resulted in clinically important benefits in hearing outcomes. However, there was very low-quality evidence that adenoidectomy with unilateral or bilateral grommet reduced presence or persistence of OME compared with unilateral or bilateral grommet alone, although there was some variation in whether an important benefit was found for persistence of OME depending on the length of follow-up. There was very low-quality evidence that adenoidectomy and grommet also reduced time with effusion compared with no treatment or watchful waiting. The committee discussed that if adenoidectomy improves the OME, in their experience it may also have beneficial effects on hearing. They also acknowledged that there was no evidence of important differences in rates of haemorrhage or tympanosclerosis for any of the comparisons and that surgical approaches to adenoidectomy are safer now than when some of the studies were conducted, as there is a lower risk of significant bleeding with ablation, which is now commonly used, compared with curettage. Therefore, if someone is already having general anaesthesia for grommet, the added risk of doing adenoidectomy too is likely to be very small. Therefore, on balance, the committee agreed that the potential of improving OME, and in turn hearing, outweighed any risk associated with performing adenoidectomy in children underdoing grommet surgery. However, the committee were aware that adenoidectomy is likely to lead to velopharyngeal insufficiency/dysfunction or nasal regurgitation in children with an abnormality with the palate so they agreed that adenoidectomy would not be appropriate for this group. The committee also discussed whether adenoidectomy should only be considered if there are nasal symptoms or nasal obstruction, or if a stronger recommendation should be made in support of adenoidectomy for children with nasal obstruction. However, they were aware that adenoids can act as a reservoir for bacteria, and thus the presence of adenoids at all may be a risk factor for OME, which may be reduced by removing the adenoids, regardless of the size of adenoids and the presence of nasal symptoms or nasal obstruction. Therefore, they agreed that adjuvant adenoidectomy should be considered in children undergoing grommet surgery.</p><p>The committee were aware of potential risks of adenoidectomy, such as haemorrhage and velopharyngeal insufficiency. Although the risks of these occurring are small in children without anomalies with the palate, in their experience they are not routinely discussed with the child and their family or carers, and it is important that they are aware of the benefits and risks and are supported to make shared decisions around adenoidectomy. Therefore, the committee recommended that the benefits and risks of adenoidectomy should be discussed with the family.</p></div><div id="niceng233er6.s1.1.9.4"><h5>Cost effectiveness and resource use</h5><p>The committee considered an original economic evaluation undertaken for the guideline to compliment the clinical evidence review. A fully incremental analysis, in line with the NICE reference case, compared no intervention, hearing aids, grommet insertion alone and grommet insertion with adjuvant adenoidectomy. It found that grommet insertion with adjuvant adenoidectomy was generally more cost-effective than no intervention, although it’s cost-effectiveness relative to grommet insertion alone or hearing aids was less clear cut. In many of the scenarios presented adjuvant adenoidectomy had the highest probability of being cost-effective but this was very dependent on assumptions made with respect to the natural history of OME and relative treatment effect. Given the limitations of the analysis and inherent uncertainty in the model inputs, the committee concluded that there was not a single intervention that was clearly the most cost-effective but considered there was sufficient evidence to support a recommendation to consider adjuvant adenoidectomy. Whilst this is a change from previous NICE guidance the committee, based on their own experience, did not think it would dramatically change current NHS practice especially as the strength of the recommendation, they made was weak. They reasoned that their recommendation was unlikely to have a significant resource impact. They also noted that the evidence that grommet insertion with adjuvant adenoidectomy may lead to reduced presence or persistence of OME and reduced time with effusion and the natural history of OME with hearing loss could lead to wider societal benefits and savings than the NHS perspective considered in the analysis.</p></div></div><div id="niceng233er6.s1.1.10"><h4>Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.6.3 and 1.6.4.</p></div></div><div id="niceng233er6.s1.rl.r1"><h3>References – included studies</h3><ul class="simple-list"><div id="niceng233er6.s1.rl.r1.1"><h4>Effectiveness</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng233er6.s1.ref1"><p id="p-137">
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<strong>MacKeith 2023b</strong>
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</p>MacKeith
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S, Mulvaney
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CA, Galbraith
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K, Webster
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KE, Paing
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A, Connolly
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R, Marom
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T, Daniel
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M, Venekamp
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RP, Schilder
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AGM. Adenoidectomy for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews
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2023. Art. No.: CD015252. DOI: 10.1002/14651858.CD015252.pub2 [<a href="/pmc/articles/PMC10521168/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10521168</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/37750500" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 37750500</span></a>] [<a href="http://dx.crossref.org/10.1002/14651858.CD015252.pub2" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></p></li></ul></div></ul></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng233er6.appa"><h3>Appendix A. Review protocols</h3><div id="niceng233er6.appa.s1"><h4>Review protocol for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>See the Cochrane review protocol, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div><div id="niceng233er6.appb"><h3>Appendix B. Literature search strategies</h3><p id="niceng233er6.appb.et1"><a href="/books/NBK595327/bin/niceng233er6-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Literature search strategies for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</a><span class="small"> (PDF, 112K)</span></p></div><div id="niceng233er6.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><div id="niceng233er6.appc.s1"><h4>Study selection for: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><div id="niceng233er6.appc.s1.1"><h5>Clinical search</h5><p>See Results of the search – figure 1 from the Cochrane review, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div></div><div id="niceng233er6.appd"><h3>Appendix D. Characteristics of studies tables</h3><div id="niceng233er6.appd.s1"><h4>Characteristics of studies tables for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>See the Characteristics of included studies tables from the Cochrane review, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div><div id="niceng233er6.appe"><h3>Appendix E. Data and analyses tables</h3><div id="niceng233er6.appe.s1"><h4>Data and analyses tables for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>See the Data and analyses tables from the Cochrane review, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div><div id="niceng233er6.appf"><h3>Appendix F. Summary of findings tables</h3><div id="niceng233er6.appf.s1"><h4>Summary of findings tables for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>See the Summary of findings tables from the Cochrane review, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div></div><div id="niceng233er6.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng233er6.appg.et1"><a href="/books/NBK595327/bin/niceng233er6-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</a><span class="small"> (PDF, 175K)</span></p></div><div id="niceng233er6.apph"><h3>Appendix H. Economic evidence tables</h3><div id="niceng233er6.apph.s1"><h4>Economic evidence tables for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>No evidence was identified which was applicable to this review question.</p></div></div><div id="niceng233er6.appi"><h3>Appendix I. Economic model</h3><div id="niceng233er6.appi.s1"><h4>Economic model for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>An economic model relevant to this review question is reported in Evidence review E.</p></div></div><div id="niceng233er6.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng233er6.appj.s1"><h4>Excluded studies for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4></div><div id="niceng233er6.appj.s2"><h4>Excluded effectiveness studies</h4><p>See the Characteristics of excluded studies table from the Cochrane review, <a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a> at <a href="https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">https://www.nice.org.uk/guidance/indevelopment/gid-ng10193/documents</a>.</p></div><div id="niceng233er6.appj.s3"><h4>Excluded economic studies</h4><p>No economic evidence was identified for this review.</p></div></div><div id="niceng233er6.appk"><h3>Appendix K. Research recommendations – full details</h3><div id="niceng233er6.appk.s1"><h4>Research recommendations for review question: What is the effectiveness of adenoidectomy (with or without ventilation tubes) for managing OME with associated hearing loss in children under 12 years?</h4><p>No research recommendations were made for this review question.</p></div></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence reviews underpinning recommendations 1.6.3 and 1.6.4 in the NICE guideline</p><p>This evidence review was developed by NICE</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2023.</div><div class="small"><span class="label">Bookshelf ID: NBK595327</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/37792991" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">37792991</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng233er6tab1"><div id="niceng233er6.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol (PICO table)</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595327/table/niceng233er6.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng233er6.tab1_lrgtbl__"><table class="no_bottom_margin"><tbody><tr><th id="hd_b_niceng233er6.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng233er6.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p><b>Inclusion:</b> Children aged 6 months to 12 years with unilateral or bilateral otitis media with effusion (OME).
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<ul><li class="half_rhythm"><div>If a study includes children aged younger than 6 months and older than 12 years, we will only include the study if the majority of children fit our inclusion criteria or only if the trialists present outcome data by age group.</div></li><li class="half_rhythm"><div>Include all children regardless of any comorbidity such as Down syndrome or cleft palate</div></li><li class="half_rhythm"><div>Include studies where children have had OME for at least three months</div></li></ul></p>
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<p>Clinical diagnosis of OME will be confirmed by otoscopy and/or tympanometry</p></td></tr><tr><th id="hd_b_niceng233er6.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng233er6.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adenoidectomy (either alone or in combination with grommets)</td></tr><tr><th id="hd_b_niceng233er6.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_niceng233er6.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Adenoidectomy (with or without myringotomy) versus no treatment/watchful waiting;</div></li><li class="half_rhythm"><div>Adenoidectomy (with or without myringotomy) versus non-surgical treatment;</div></li><li class="half_rhythm"><div>Adenoidectomy and bilateral grommets versus bilateral grommets only;</div></li><li class="half_rhythm"><div>Adenoidectomy and unilateral grommet versus unilateral grommet only.</div></li><li class="half_rhythm"><div>Adenoidectomy and grommets vs no treatment/watchful waiting</div></li><li class="half_rhythm"><div>Adenoidectomy and grommets vs non-surgical treatment.</div></li></ul>
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If study participants have received other treatments in addition to the main intervention, for example intranasal steroids, oral steroids, antibiotics, mucolytics or decongestants, we will include these studies if both arms of the study received identical treatment.</td></tr><tr><th id="hd_b_niceng233er6.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</th><td headers="hd_b_niceng233er6.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">We will analyse the following outcomes in the review, but we will not use them as a basis for including or excluding studies. We will assess all outcomes in the very short term (< 6 weeks for postoperative adverse events), short term (</= 3 months), medium term (> 3 months to </= 1 year) and long term (> 1 year).
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<h5><span class="title">Critical</span></h5><ul><li class="half_rhythm"><div>Hearing
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<ul class="circle"><li class="half_rhythm"><div>proportion of children whose hearing has returned to normal;</div></li><li class="half_rhythm"><div>mean final hearing threshold (determined for the child or ear, depending on the unit of analysis);</div></li><li class="half_rhythm"><div>change in hearing threshold from baseline (determined for the child or ear, depending on the unit of analysis).</div></li></ul></div></li><li class="half_rhythm"><div>Disease-specific quality of life measured using a validated instrument, for example:
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<ul class="circle"><li class="half_rhythm"><div>OM8-30;</div></li><li class="half_rhythm"><div>Otitis Media-6.</div></li></ul></div></li><li class="half_rhythm"><div>Adverse events: Serious haemorrhage and its consequences.</div></li></ul>
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<h5><span class="title">Important</span></h5><ul><li class="half_rhythm"><div>Presence/persistence of OME</div></li><li class="half_rhythm"><div>Adverse events - measured by the number of participants affected.
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<ul class="circle"><li class="half_rhythm"><div>Tympanic membrane changes, such as:
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<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">atrophy;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">atelectasis or retraction;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">myringosclerosis;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">tympanosclerosis.</p></dd></dl></dl></div></li><li class="half_rhythm"><div>Patient-related:
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<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">recurring haemorrhage;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">transient postoperative velopharyngeal insufficiency;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">pain</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">infection;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">lip/tooth/tongue injury;</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">velopharyngeal reflux/nasal escape</p></dd></dl><dl class="bkr_refwrap"><dt>–</dt><dd><p class="no_top_margin">other surgical complications</p></dd></dl></dl></div></li></ul></div></li><li class="half_rhythm"><div>Receptive language skills, measured using a validated scale, for example:
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<ul class="circle"><li class="half_rhythm"><div>Peabody Picture Vocabulary Test – Revised;</div></li><li class="half_rhythm"><div>Reynell Developmental Language Scales (relevant domains);</div></li><li class="half_rhythm"><div>Preschool Language Scale (PLS) (relevant domains);</div></li><li class="half_rhythm"><div>Sequenced Inventory of Communication (SCID) (relevant domains).</div></li></ul></div></li><li class="half_rhythm"><div>Speech development, or expressive language skills, measured using a validated scale, for example:
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<ul class="circle"><li class="half_rhythm"><div>Schlichting test;</div></li><li class="half_rhythm"><div>Lexi list;</div></li><li class="half_rhythm"><div>Reynell Developmental Language Scales (relevant domains);</div></li><li class="half_rhythm"><div>PLS (relevant domains);</div></li><li class="half_rhythm"><div>SCID (relevant domains).</div></li></ul></div></li><li class="half_rhythm"><div>Cognitive development, measured using a validated scale, for example:
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<ul class="circle"><li class="half_rhythm"><div>Griffiths Mental Development Scales;</div></li><li class="half_rhythm"><div>McCarthy General Cognitive Index;</div></li><li class="half_rhythm"><div>Bayley Scales of Infant and Toddler Development.</div></li></ul></div></li><li class="half_rhythm"><div>Psychosocial outcomes, measured using a validated scale, for example:
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<ul class="circle"><li class="half_rhythm"><div>Social Skills Scale of the Social Skills Rating System;</div></li><li class="half_rhythm"><div>Child behaviour Checklist;</div></li><li class="half_rhythm"><div>Strengths and Difficulties Questionnaire;</div></li><li class="half_rhythm"><div>Pediatric Symptom Checklist.</div></li></ul></div></li><li class="half_rhythm"><div>Listening skills, for example, listening to stories and instructions effectively. Given that there are few validated scales to assess listening skills in children with OME, we will include any methods used by trialists.</div></li><li class="half_rhythm"><div>Generic health-related quality of life assessed using a validated instrument, for example:
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<ul class="circle"><li class="half_rhythm"><div>EQ-5D;</div></li><li class="half_rhythm"><div>TNO AZL Children’s QoL (TACQOL);</div></li><li class="half_rhythm"><div>TNO AZL Pre-school children QoL (TAPQOL);</div></li><li class="half_rhythm"><div>TNO AZL Infant Quality of Life (TAIQOL);</div></li><li class="half_rhythm"><div>Infant Toddler Quality of Life Questionnaire (ITQOL);</div></li><li class="half_rhythm"><div>Child Heath Questionnaire (CHQ).</div></li></ul></div></li><li class="half_rhythm"><div>Parental stress, measured using a validated scale, for example:
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<ul class="circle"><li class="half_rhythm"><div>Parenting Stress Index.</div></li></ul></div></li><li class="half_rhythm"><div>Vestibular function
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<ul class="circle"><li class="half_rhythm"><div>balance;</div></li><li class="half_rhythm"><div>coordination.</div></li></ul></div></li><li class="half_rhythm"><div>Number of doctor-diagnosed AOM episodes within a specified time frame</div></li></ul></td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">AOM: acute otitis media; CHQ: Child Heath Questionnaire; EQ: EuroQol; ITQOL: Infant Toddler Quality of Life; OM: otitis media; OME: otitis media with effusion; PLS: Preschool Language Scale; QoL: quality of life; SCID: Sequenced Inventory of Communication; TACQOL: TNO AZL Children’s Quality of Life Questionnaire; TAIQOL: TNO AZL Infant Quality of Life; TAPQOL: TNO AZL Pre-school children’s Quality of Life questionnaire; TNO AZL: Netherlands Organisation for Applied Scientific Research Academic Medical Centre</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng233er6tab2"><div id="niceng233er6.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of included studies</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK595327/table/niceng233er6.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng233er6.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng233er6.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng233er6.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_niceng233er6.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comparison</th><th id="hd_h_niceng233er6.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th></tr></thead><tbody><tr><td headers="hd_h_niceng233er6.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng233er6.s1.ref1" rid="niceng233er6.s1.ref1">MacKeith 2023b</a>
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</p>
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<p>Systematic review</p>
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<p>UK</p>
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</td><td headers="hd_h_niceng233er6.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Children aged 2.2 years to 7.7 years with unilateral or bilateral otitis media with effusion for a duration of at least three months.</p>
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<p>Number of studies: 8</p>
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<p>Number of participants: 1529</p>
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</td><td headers="hd_h_niceng233er6.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<b>Adenoidectomy (with or without myringotomy) vs no treatment/watchful waiting</b>
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</p>
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<p>3 trials, N=366 children with OME (Fiellau-Nikolajsen 1982; Gates 1989; Sagnelli 1990)</p>
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<p>
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<b>Adenoidectomy and bilateral grommet vs bilateral grommet only</b>
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</p>
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<p>4 trials, N=560 children with OME (Gates 1989; Haggard 2012; Hao 2019; Jabeen 2019)</p>
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<p>
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<b>Adenoidectomy and unilateral grommet vs unilateral grommet only</b>
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</p>
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<p>2 trials, N=189 children with OME (Dempster 1993; Maw 1993)</p>
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<p>
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<b>Adenoidectomy and grommet vs no treatment/watchful waiting</b>
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</p>
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<p>2 trials, N=527 children with OME (Gates 1989; Haggard 2012)</p>
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</td><td headers="hd_h_niceng233er6.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><p>Primary:
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<ul><li class="half_rhythm"><div>Hearing as
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<dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>(i)</dt><dd><p class="no_top_margin">return to normal;</p></dd></dl><dl class="bkr_refwrap"><dt>(ii)</dt><dd><p class="no_top_margin">mean threshold; and</p></dd></dl><dl class="bkr_refwrap"><dt>(iii)</dt><dd><p class="no_top_margin">change from baseline</p></dd></dl></dl></div></li><li class="half_rhythm"><div>Adverse events: serious haemorrhage</div></li></ul></p>
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<p>Secondary:
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<ul><li class="half_rhythm"><div>Presence/Persistence of OME</div></li><li class="half_rhythm"><div>Adverse events: Tympanic membrane changes (tympanosclerosis)</div></li><li class="half_rhythm"><div>Number of doctor-diagnosed AOM episodes</div></li></ul></p>
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</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">AOM: acute otitis media; OME: otitis media with effusion;</p></div></dd></dl></dl></div></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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