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Original research
Natural history of otitis media with effusion without hearing loss in children under 12 years: a systematic review
  1. Aye Paing1,
  2. Laura Elliff-O’Shea1,
  3. Tamsin Holland Brown2,3,
  4. Stephanie Arnold4,
  5. John Day5,
  6. Jennifer Royds6,
  7. Veronica Kennedy7
  1. 1Centre for Gudelines, National Institute for Health and Care Excellence, London, UK
  2. 2Department of Paediatrics, University of Cambridge, Cambridge, Cambridgeshire, UK
  3. 3Community Paediatrics, Cambridgeshire Community Services NHS Trust, Saint Ives, Cambridgeshire, UK
  4. 4National Institute for Health and Care Excellence, London, UK
  5. 5Betsi Cadwaladr University Health Board, Bangor, UK
  6. 6Not applicable as Jennifer Royds is lay member, London, UK
  7. 7Paediatric Audiology Department, Bolton NHS Foundation Trust, Bolton, UK
  1. Correspondence to Dr Aye Paing; aye.paing{at}nice.org.uk

Abstract

Objective This study aimed to evaluate the natural history of otitis media with effusion (OME) without hearing loss in children under 12 years.

Methods We performed a systematic search in Embase, CINAHL, MEDLINE, INAHTA database, CENTRAL, CDSR, Epistemonikos and PsycINFO to identify observational single group studies and comparative studies with untreated control arms published in English up to June 2022, reporting natural history of OME without hearing loss. The JBI (Joanna Briggs Institute) checklist and Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology were used to assess risk of bias and overall quality of evidence, respectively.

Results Nineteen studies with samples ranging from 16 to 816 children met the inclusion criteria. The quality of evidence ranged from low to very low. Resolution of current episode of OME without hearing loss was 10–66% by 1 month, 3–93% by 3 months, 10–98% by 6 months, 20–92% by 9 months and 78–99% by 12 months, depending on populations and how resolution was defined across studies. Resolution of OME (defined as change from type B to non-B tympanogram) was only 10% by 6 months in Aboriginal infants. Recurrence of OME was 7% by 3 months, 8–18% by 6 months, 10–28% by 9 months and 8–35% by 12 months.

Conclusions There was a trend towards greater resolution of OME without hearing loss and recurrence of OME over longer follow-up periods; however, they did not seem to follow a linear pattern, potentially due to differences in populations and definitions of resolution across studies.

  • Audiology
  • Child Health
  • Epidemiology
  • Paediatrics

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study. All data relevant to the study are included in the article or uploaded as supplementary information.

https://doi.org/10.1136/archdischild-2024-327464

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • Otitis media with effusion (OME) is a common condition in children and can be associated with hearing loss that may pose a risk to childhood development.

    • Understanding the natural history of OME, including progression to OME with associated hearing loss, may enable the development of effective management strategies.

    WHAT THIS STUDY ADDS

    • There was significant variability in resolution and recurrence of OME without hearing loss, depending on sample characteristics and how resolution and recurrence were defined.

    • Resolution of OME without hearing loss was 10–66% by 1 month, 3–93% by 3 months, 10–98% by 6 months, 20–92% by 9 months and 78–99% by 12 months.

    • Recurrence of OME was 7% by 3 months, 8–18% by 6 months, 10–28% by 9 months and 8–35% by 12 months.

    • There is no evidence available on progression to OME with associated hearing loss.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • This systematic review was conducted as part of the development of the 2023 National Institute for Health and Care Excellence guideline on ‘Otitis media with effusion in under 12s’ and recommendations for practice were developed by the guideline committee.

    Introduction

    Otitis media with effusion (OME) is common in children and can be associated with hearing loss that can significantly impact the child’s speech and language, communication and social development.1–5 Interventions for OME include management of hearing loss (bone conduction devices or air conduction hearing aids), auto-inflation and surgical management (grommets and adjuvant adenoidectomy).6 An awareness of the natural history of OME without hearing loss may allow prediction of its patterns and help to identify children who may develop hearing loss and require intervention. This paper examines evidence on the progression, resolution and recurrence of OME without hearing loss at presentation in children under 12 years, and it was conducted as part of the 2023 National Institute for Health and Care Excellence (NICE) guideline on ‘Otitis media with effusion in under 12s’.6

    Methods

    Protocol

    The full review protocol is published in evidence review C of the 2023 NICE guideline on ‘Otitis media with effusion in under 12s’ available at https://www.nice.org.uk/guidance/ng233/evidence.6 This review was conducted following NICE methods and processes as defined in ‘Developing NICE guidelines: the manual’.7

    Criteria for considering studies for this review

    Eligible studies were systematic reviews or primary observational studies of single groups (non-comparative), untreated control arms from comparative observational studies, systematic reviews or primary studies of untreated control arms from comparative experimental studies (if insufficient observational studies), and case series (if insufficient observational studies and comparative experimental studies) conducted in children under 12 years with OME confirmed by tympanometry, without associated hearing loss. Studies from high- and middle-income countries (according to the Organisation for Economic Co-operation and Development) were included, but individual case studies, conference abstracts and non-English language articles were excluded. Eligible studies were required to have minimum follow-up of 3 months and investigate one of the following outcomes: progression to OME with associated hearing loss, time to progression to OME with associated hearing loss, resolution of current episode of OME, time to resolution of current episode of OME, total resolution (no further recurrences) of OME, time to resolution of OME and recurrence of OME (following spontaneous resolution) confirmed by tympanometry.

    Search methods for identification of studies

    The search strategy for this review was part of a wider search strategy that also addressed the natural history of OME with hearing loss.8 Searches were conducted in Embase, CINAHL, MEDLINE, the International Network of Agencies for Health Technology Assessment (INAHTA) database, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR), Epistemonikos and PsycINFO up to June 2022 (online supplemental table1).

    Study selection and data extraction

    The screening of titles and abstracts and data extraction were conducted by the first author, and potentially relevant full texts for inclusion were assessed by the first and second authors. The final list of included and excluded studies and data extraction were also examined by the second author. The following characteristics were extracted for each included study: country/ies where study was carried out, study dates and type, inclusion and exclusion criteria, patient characteristics, duration of follow-up, source of funding, sample size and outcomes.

    Risk of bias assessment

    We planned to use the Joanna Briggs Institute (JBI) checklist and the risk of bias in systematic reviews (ROBIS) checklist to assess the risk of bias in prevalence studies and systematic reviews, respectively.9 10 However, we did not identify systematic reviews. The JBI checklist assesses bias in nine domains.10

    Data synthesis

    Meta-analyses of proportion data were conducted using the metafor package in R that allows for meta-analysis of data from single group studies.11

    The evidence was stratified by duration of OME before the study or follow-up, definition of recurrence or resolution used, unit of analysis (ear or child) and duration of follow-up. In the event of heterogeneity, evidence was subgrouped according to country and age, but there was insufficient information reported or variation across studies to subgroup or stratify according to the other factors (such as craniofacial anomalies, type or episode of OME, previous intervention, ethnicity and measurement of hearing) specified in the protocol.

    Our intention was to pool time-to-event data and report the result as summary survival curves using the metaSurvival package in R.12 However, only one study reported time-to-event data, and summary survival curve could not be generated. To allow for direct comparison with the data from other studies, time-to-event data were converted to proportion data.

    Quality of evidence

    To evaluate the quality of evidence, an adapted Grading of Recommendations Assessment, Development and Evaluation (GRADE)13 methodology was used. GRADE methodology was designed for intervention reviews and uses five domains (study limitations, inconsistency, indirectness, imprecision and publication bias) to assess the quality of evidence for each outcome, resulting in a grade of very low to high quality evidence based on the confidence that the true effect lies close to that of the estimated effect and whether further research is likely to change this confidence. The GRADE approach can be applied to epidemiological reviews with minor adaptations. Inconsistency, indirectness and imprecision can be interpreted in the same way for epidemiological reviews as they are for intervention reviews. However, epidemiological studies were not downgraded for their study design from the outset (ie, started as high quality and adjusted based on ratings in other domains) as randomised controlled trials are not the gold standard for epidemiological studies. This is a deviation from the GRADE approach to intervention reviews, where non-randomised studies typically start as low quality.

    Results

    Results of the search

    The search strategy identified 3625 papers. After duplicates were removed, 2178 papers remained for the title and abstract review. Of these papers, 211 were identified for full-text review. Of these, 19 were included in this review and 192 were excluded for not meeting inclusion criteria (see figure 1 for PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram and online supplemental table 2 for the excluded studies).

    Figure 1
    Figure 1

    PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram of the study selection process.

    Characteristics and methodological quality of included studies

    Characteristics of the included studies are summarised in table 1, and online supplemental table 3 provides the full details. Fourteen observational single group (non-comparative) studies,14–27 four untreated control arms from comparative experimental studies28–31 and one untreated control arm from comparative observational study were included.32

    View this table:
    Table 1

    Characteristics of the included studies

    Eighteen studies reported resolution of current episode of OME.14–26 28–32 One study reported time to resolution of current episode of OME,27 and eight studies reported recurrence of OME (following spontaneous resolution).16–18 20 23–25 28

    The risk of bias associated with each of the included studies are summarised in online supplemental table 5, and online supplemental table 3 provides the full details. The most common issues were inadequate sample size, lack of appropriate participant sampling and inadequate information about characteristics and setting.

    The quality of evidence for all outcomes ranged from low to very low because of risk of bias and imprecision due to small number of events (online supplemental tables 4.1-4.7).

    Synthesis of results

    Summary of outcomes is reported in online supplemental table 6, and online supplemental tables 4.1-4.7 and online supplemental figures 7.1-7.7 provide the full details.

    Resolution of current episode of OME

    Resolution of OME of <2 weeks, <1 month and <3 months duration before follow-up

    For Aboriginal infants with OME (defined as type B tympanogram) of less than 2 weeks duration, resolution (defined as change from type B to non-type B tympanogram) was 10% by 6 months.29

    A study conducted in 3-year-old Danish children showed that resolution of OME (undefined) of <1 month duration before follow-up was 72% by 2 months and 90% by 5 months.17 Resolution of OME (undefined) of <3 months duration before follow-up was 67% by 3 months.17

    Resolution of OME of >3 months and >4 months duration before follow-up

    OME of >3 months duration before follow-up (change from type B to non-B) had 7% resolution by 3 months and 29% resolution by 6 months.30

    OME of >4 months duration before follow-up had 47% resolution (undefined) by 3 months.26

    Resolution of OME of unknown duration before follow-up

    At 1 month follow-up, resolution ranged from 10% to 66% depending on unit of analysis (ear or child) and definition of resolution.14–18 20 31

    Resolution was 28–48% by 1.5 months (change from type B to non-B),14 15 30–69% by 2 months (change from type B to non-B),14 15 20 78% by 2 months (resolution undefined) and 35–59% by 2.5 months (change from type B to non-B).14 15

    At 3 months, in children aged under 4 years, resolution was 18% (change from type B to type A),18 23 30% (change from type B to type A or C1)18 23 and 60% (change from type B to non-B).23 27 In children aged 4 years and over, resolution was 3% (change from type B to type A),24 14% (change from type B to type A or C1)24 and 56% (change from type B to non-B).14 15 19 24 Resolution (change from type B to non-B) was 45% in children aged under 6 years,21 and 73% in children aged 6 years and over.20 Resolution was 52% when defined as change from type B or C2 to type A or C1 tympanogram,31 and 37% to 93%, depending on unit of analysis and study design, when it was undefined.16 17 28

    At 4 and 5 months’ follow-up, resolution (change from type B to non-B) was 44–81% and 84%, respectively.20 25 Resolution was 96% by 4 months and 97% by 5 months, when it was undefined.16

    At 6 months, resolution (change from type B to type A) was 34% in children aged under 4 years,18 23 and 20% in children aged 4 years and over.24 Resolution defined as change from type B to non-B tympanogram was 67–85% in children aged under 4 years23 27 and 65% in children aged 4 years and over.19 24 Resolution was 68–98%, when it was undefined.16 17

    At 8 months, resolution defined as change from type B to non-B tympanogram was 76–78%.25

    At 9 months, resolution was 47% when defined as change from type B to type A tympanogram,23 and 65% when defined as change from type B or C2 to type A or C1 tympanogram.31 In children aged under 4 years, resolution was 67% (change from type B to type A or C1)23 and 86–92% (change from type B to non-B).23 27 In children aged 4 years and over, resolution was 45% (change from type B to type A or C1) and 73% (change from type B to non-B).24 In children who had tracheostomy for respiratory failure and airway obstruction, resolution defined as change from type B to non-B tympanogram was only 20% by 9 months.32

    At 12 months’ follow-up, resolution (change from type B to non-B) was 95% in children aged under 4 years,27 and 78–91% in children aged 4 years and over.24 25 Two studies also reported 90–99% of resolution by 12 months.20 25

    Resolution (change from type B to non-B) was 97% by 15 months, 98% by 18 months and 21 months, 99% by 24 months and 83% by 27 months.22 27

    Recurrence of OME (following spontaneous resolution)

    Recurrence of OME (change from non-B to type B) was 8% by 6 months and 10% by 9 months in children aged under 4 years,23 and 17% by 6 months and 28% by 9 months in children aged 4 years and over.24 At 12 months, recurrence (change from non-B to type B) was 8–35%.20 24 25

    Recurrence was 7% by 3 months, 18% by 6 months and 34% by 12 months, when it was undefined.16 17 28

    Discussion

    Main findings

    This review reported evidence on resolution of current episode of OME and recurrence of OME. The evidence showed that resolution of current episode of OME could be 3–93% by 3 months. Both resolution of current episode of OME and recurrence of OME showed a trend towards greater resolution and recurrence over longer follow-up periods. However, they did not seem to follow a linear pattern, potentially due to variations in populations and definitions across studies. Resolution rate seemed lower in Aboriginal infants and children who had tracheostomy for respiratory failure and airway obstruction. Resolution rate seemed higher and recurrence rate seemed lower in children aged under 4 years compared with children aged 4 years and over. This finding suggests that the natural history of OME without hearing loss may be influenced by age. This was also supported by previous studies stating that age could be an important prognostic factor, and a study found that age of the child being less than 7 years is a potential risk factor for OME.1 33 As expected, higher resolution rates were reported with resolution defined as change from type B to non-type B tympanogram than change from type B to type A, and this finding is consistent with findings from a previous study.34

    This review did not identify evidence on progression from OME without hearing loss to OME with associated hearing loss, time to progression to OME with associated hearing loss, total resolution (no further recurrences) of OME and time to total resolution of OME.

    Strengths and limitations

    This review followed rigorous NICE methodology,7 including several stages of quality assurance and stakeholder consultation. However, this review has some limitations. The sample size is small in most of the included studies. The comparability of the studies was limited because there were wide variations in how resolution and recurrence were defined. Spontaneous resolution could be higher as the duration of OME increases14 15; however, a large number of included studies did not specify the duration of OME before the follow-up period began. Differences in the length of OME before follow-up also limited the comparability of the studies.

    Conclusions and implications

    The committee recruited to develop the 2023 NICE guideline on OME in under 12s discussed that, in current practice, there is no intervention for OME if there is no associated hearing loss, but understanding the progression to OME with associated hearing loss will help identify children who may develop hearing loss and benefit from targeted recommendations. However, there is no evidence available on progression to OME with associated hearing loss, and as a result, it is not possible to predict which children may develop hearing loss.

    As any differences in the study populations may affect the natural history, the committee acknowledged that it would be reasonable to prioritise studies with the population of interest for the guideline in development (children in the UK). However, studies conducted in the UK used small sample sizes (n=50–112),21 25 31 and based on the committee’s experience, the included children (age 5–8 years and 4–11 years) were older than those typically seen in practice.25 31 Therefore, consideration of the evidence from the UK specifically also did not provide robust evidence to inform recommendations and thus the committee did not make any recommendations in addition to those made based on the review of the natural history of OME-related hearing loss.

    As the current evidence base is limited, future studies are needed to evaluate the natural history of OME without hearing loss, particularly to identify which children are most likely to develop hearing loss. Previous studies showed that OME is more common in certain groups of children, such as children with craniofacial anomalies, and many factors, such as respiratory tract infection and exposure to other children, could predict development of OME. Natural history of OME without hearing loss may be influenced by these factors, and future studies should investigate this.35–37 Researchers should consider study designs that would increase the availability of high-quality evidence and study planning may be helped by consideration of the risk of bias tools and GRADE approach used in this review. Standardisation of measurement, analysis and reporting across studies through collaboration is also encouraged to minimise variations between studies to allow meta-analysis and strengthen future guidance.

    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study. All data relevant to the study are included in the article or uploaded as supplementary information.

    Ethics statements

    Patient consent for publication

    Ethics approval

    Not applicable.

    Acknowledgments

    The authors would like to thank NICE, the committee for the 2023 NICE guideline on ‘Otitis media with effusion in under 12s’ (National Institute for Health and Care Excellence, 2023), and Odette Megnin-Viggars who contributed to data extraction.

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    Supplementary materials

    Footnotes

    • X @ayechanpaing411, @hearglueear

    • Contributors All authors (AP, LE-O’S, THB, SA, JD, JR and VK) contributed to the study concept and design and interpretation of results. SA was responsible for designing and carrying out the search strategy. AP conducted the study selection, data extraction and quality assessment, and drafted the manuscript. LE-O’S contributed to the study selection, data extraction, quality assessment and data analysis. All authors contributed to the revision of the manuscript and approved the final manuscript. AP is the guarantor of this work.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests A full list of interests for the whole committee for the 2023 NICE guideline on ‘Otitis media with effusion in under 12s’ (National Institute for Health and Care Excellence, 2023) is available at https://www.nice.org.uk/guidance/ng233/history. JR is a trustee and founder of a charity called Glue Ear Together which is funded by grants and public fundraising, and THB has been involved in assistive technology research and development (without financial gain) of a device, app and website (www.hearglueear.co.uk) to help children once they have glue ear. The other authors declare no potential conflicts of interest associated with this article.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.