Recommendations for clinical care guidelines on the management of Otitis Media in Aboriginal and Torres Strait Islander Populations

Using the Recommendations for Clinical Care Guidelines on Otitis Media

Page last updated: 14 October 2011

The original ‘Recommendations for Clinical Care Guidelines on the Management of Otitis Media’1 were directly linked to the Systematic Review of Existing Evidence and Primary Care Guidelines on the Management of Otitis Media in Aboriginal and Torres Strait Islander Populations (March 2001).2 This updated version is based on the 2001 Guidelines and relevant research studies published since 2001. It results from a synthesis of information derived from a process of explicit searching of the medical literature and critical appraisal. The literature search was last updated on the 1st April 2010. Recommendations in each of the sections are grouped according to their clinical relevance.

Our intended users are health care professionals who work with Aboriginal and Torres Strait Islander populations. This includes Aboriginal Health Workers, Aboriginal ear health workers, primary care and specialist physicians, nurses, remote area nurses and nurse practitioners, audiologists, audiometrists, speech therapists, and child development specialists (including Advisory Visiting Teachers and Teachers of the Deaf). Aboriginal and Torres Strait Islander health staff working with Aboriginal and Torres Strait Islander families are likely to have the greatest impact on severe otitis media. The guidelines are also suitable to be adopted for use in local clinical practice guidelines and standard treatment protocols (e.g. Central Australian Rural Practitioners Association Standard Treatment Manual,3 Queensland Primary Clinical Care Manual4 etc).

Otitis media (OM) refers to inflammation and infection of the middle ear space. It is a complex condition associated with both illness and hearing loss. It is best to regard OM as a spectrum of disease that ranges from mild (otitis media with effusion, OME) to severe (chronic suppurative otitis media, CSOM). In all populations, every child will experience episodic OME (fluid behind the tympanic membrane) at some time.5 Nearly all children will experience at least one episode of acute otitis media (AOM). In developed countries, most children will improve spontaneously.5 Concerns about OM arise in children who suffer frequent episodic AOM or persistent OME. This is usually a problem in the first 6 years of life (with spontaneous resolution more likely in older children).6 Children who develop CSOM (the most severe form of OM) are most likely to suffer problems as adults.7 Unfortunately, for some of these affected individuals, OM (and its associated hearing loss) is a lifelong problem.

OM causes conductive hearing loss (CHL). Episodic OME and AOM can cause a mild hearing loss while there is fluid in the middle ear space. Chronic disease (persistent OME and CSOM) can cause moderate hearing loss.8,9 Additionally, the hearing loss can fluctuate depending on the health of the middle ear. CHL is often regarded as a temporary condition because its causes are generally amenable to medical or surgical treatment. However, it will be a chronic problem in chronically diseased ears. In addition, sensorineural hearing loss can occur secondary to long-term chronic OM.7

The target populations for these recommendations are Aboriginal and Torres Strait Islander Australians.10 While OM is a common illness in all populations, Indigenous Australians have the highest rates of severe and persistent OM described in the medical literature.7 In some areas (generally rural and remote Indigenous communities), the clinical course of OM is characterised by early age of onset and high prevalence of severe disease. This is quite different from the clinical course described in most well-designed studies involving other children (where spontaneous resolution of disease is common).11 This high natural cure rate has meant that intervention studies are limited in their ability to detect sustained clinical improvement over time. For children at high risk of CSOM, we recommend interventions where there is strong evidence of short-term benefit even if the long-term benefits were less clear.

Each recommendation has been explicitly linked to the source of the original relevant evidence (type and level) and any evidence-based guidelines that have made the same recommendation. Two main information sources of information have been used: i) evidence-based clinical practice guidelines, evidence summaries, and systematic reviews, and ii) high quality primary research on OM and hearing loss. While the recommendations have been based on the best available evidence, their applicability will also be dependent on local factors. Most important are the personal preferences of the affected individuals, and the local resources available to assist in the management of OM. These local factors should always be considered when developing an ear health program and when advising families about their management options. In some cases, strict adherence to the guidelines will not be appropriate.

Most of the recommendations were regarded as interventions and classified according to the levels of evidence for Prevention, Management and Health Care Delivery shown in Table 2.12 Additional tables describing levels of evidence for diagnostic accuracy studies and prognosis studies have been included for the relevant sections (see Tables 4 and 5).12 Recommendations are also linked to any other available evidence-based clinical practice guidelines that addressed the same issue. The criteria used for identifying clinical practice guidelines that have a high likelihood of scientific validity are shown in Table 6.

Overall, we identified 51 evidence-based guidelines, reviews and summaries: 12 evidence-based guidelines,13-24 10 clinical evidence reports,5-7;25-31 1 evidence-based text-book,8 21 Cochrane Systematic Reviews,32-52 and 7 other systematic reviews.2;53-58 Nearly all of these were new publications. There are likely to be other evidence-based documents in the grey literature that we were not able to identify with our search strategy.


Grading of Recommendations According to NHMRC12 (Table 1)

Each recommendation has been graded according to the most recent National Health and Medical Research Council (NHMRC) grading system 2010.12 Grade A recommendations are based on several level I or II studies with low risk of bias where all studies show consistent results. Grade A recommendations are applicable to the Australian health care context. Grade B recommendations are based on one or two level II studies with low risk of bias or a systematic review of level III studies with low risk of bias. In addition, the results of most of the studies are consistent. Grade B recommendations are applicable to the Australian health care context with few caveats. Grade C recommendations are based on Level III studies with low risk of bias or level I or level II studies with moderate risk of bias. For Grade C recommendations, some inconsistencies reflect genuine uncertainty around the clinical question. Grade C recommendations are probably applicable to the Australian health care context with some caveats. Grade D recommendations are based on level IV studies or level I, II and III studies with high risk of bias. Grade D recommendations should be applied cautiously in the Australian health care context.

Table 1. NHMRC Grade of Recommendations12

Grade of RecommendationDescription
A
Body of evidence can be trusted to guide practice.
B
Body of evidence can be trusted to guide practice in most situations.
C
Body of evidence provides some support for recommendation but care should be taken in its application.
D
Body of evidence is weak and recommendation must be applied with caution.
GPP
No reliable evidence exists directly addressing the impact of the recommendation. The recommendation (a Good Practice Point) reflects the consensus view of the multidisciplinary guidelines group and is based on clinical experience.

Table 2. NHMRC Levels of Evidence for Prevention, Management and Health Care Delivery12

Level of Evidence:Level Based on:
l
a systematic review of level ll studies.
ll
a randomised controlled trial.
lll-1
a pseudo-randomised controlled trial (i.e. alternate allocation or some other method).
lll-2
a comparative study with concurrent controls:
  • non-randomised experimental trial
  • cohort study
  • interrupted time series with a control group.
lll-3
a comparative study without concurrent controls:
  • historical control study
  • two or more single arm study
  • interrupted time series without a parallel control group.
lV
a case series with either post-test or pre-test/post-test outcomes.

Table 3. NHMRC Levels of Evidence for Aetiology12

Level of Evidence:Level Based on:
l
a systematic review of level ll studies.
ll
a prospective cohort study.
lll-1
an ‘all or none’ study.
lll-2
a retrospective cohort study.
lll-3
a case-control study.
lV
a cross-sectional study or case series.

Table 4. NHMRC Levels of Evidence for Diagnostic Accuracy12

Level of Evidence:Level Based on:
l
a systematic review of level ll studies.
ll
a study of test accuracy with an independent, blinded comparison with a valid reference standard, among consecutive persons with a defined clinical presentation.
lll-1
a study of test accuracy with an independent, blinded comparison with a valid reference standard, among non–consecutive persons with a defined clinical presentation.
lll-2
a comparison with reference standard that does not meet the criteria required for Level II and III-1 evidence.
lll-3
a diagnostic case–control study.
lV
a study of diagnostic yield (no reference standard).

Table 5. NHMRC Levels of Evidence for Prognosis12

Level of Evidence:Level Based on:
l
a systematic review of level ll studies.
ll
a prospective cohort study.
lll-1
an ‘all or none’ study.
lll-2
an analysis of prognostic factors amongst persons in a single arm of a randomised controlled trial.
lll-3
a retrospective cohort study.
lV
a case series, or a cohort study of persons at different stages of disease.

Table 6. Criteria for Evidence-based Clinical Practice Guidelines12

Level of Guideline:Level Based on:
l~A
a guideline composed by a national or external guideline development group representing all relevant disciplines based on the best available evidence, where the process of retrieving that evidence has been clearly described (i.e. an explicit search strategy), and where recommendations are directly linked to evidence.
l~B
a guideline composed by a national or external guideline development group representing all relevant disciplines and based on the best available evidence, and where recommendations are directly linked to evidence.