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Abstract
Background Acute otitis media (AOM) is a common childhood disease, with an enormous economic and healthcare-related burden. Guidelines and consensus papers for AOM diagnosis and management were published in many countries. Our objective was to study the differences and similarities between these protocols in developing and developed countries.
Methods The keywords: ‘acute otitis media’ AND ‘children’ AND [‘treatment’ or ‘management’] AND [‘guideline’ or ‘consensus’] were used in various electronic databases between 1 January 1989 through 31 December 2015. Overall, 99 sources from 62 countries were retrieved: 53 from 22 developed countries, and 46 from 40 developing countries. Representative guidelines from America (the USA, Argentina), Europe (Italy, Moldova), Africa (South Africa, Tanzania, Ethiopia), Asia (Japan, Afghanistan, Sri Lanka),and Oceania (South Australia, Fiji) were compared.
Results Paediatric societies publish guidelines in most developed countries; in developing countries, the Ministry of Health usually initiates guideline formulation. Most guidelines use the same diagnostic criteria and offer watchful waiting in mild–moderate scenarios. Amoxicillin is the suggested first-line antibiotic, whereas options for second-line and third-line therapies vary. Duration of therapy varies and is usually age dependent: 5–7 days for children <2 years and 10 days for children >2 years in developed countries, while duration and age groups vary greatly in developing countries. Reduction of AOM risk factors is encouraged in developed countries, but rarely in developing countries.
Conclusions Guidelines for AOM from developing and developed countries are similar in many aspects, with variation in specific recommendations, due to local epidemiology and healthcare accessibility. Formulation of regional guidelines may help reduce AOM burden.
- acute otitis media
- guidelines
- concensus
- treatment
- recommendation
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What is already known on this topic?
Acute otitis media (AOM) is a common childhood disease, which creates a major healthcare and economic burden.
In developed and developing countries, national guidelines and consensus papers address AOM diagnostic and therapeutic issues in order to reduce overdiagnosis and overtreatment.
There is a huge diversity of AOM diagnosis and management guidelines.
What this study adds?
AOM guidelines from developed and developing countries have more similarities than differences.
Introduction
Acute otitis media (AOM) is one of the most common childhood diseases, representing the most common indication for antibiotic prescription and outpatient visits in children in the USA and other countries.1–5 AOM is a substantial cause of health services use (office visits, antibiotic costs), potential complications (ie, acute mastoiditis, meningitis) and indirect costs (ie, absence from school or work). Reduced susceptibility to antibiotics among bacteria commonly causing AOM is also a major concern.6 ,7 In order to reduce the burden of AOM and limit antibiotic prescriptions, various professional guidelines and consensus statements have been published. These position papers were created in order to assist physicians to accurately diagnose AOM and offer treatment options, reduce risk factors and encourage vaccination.
The first AOM management guidelines were published in the Netherlands in 1989.8 The guidelines were drafted following the studies of van Buchem et al,9 ,10 who opposed the traditional approach of antibiotic therapy administration to all children presenting with AOM, and offered a ‘watchful waiting’ approach in selected scenarios. The Dutch guidelines were aimed at general practitioners, who treat the majority of children with AOM.
Many countries followed the innovative Dutch practice and published their own guidelines based on local epidemiology data and accessibility to healthcare facilities. A few guidelines were revised, following changes in the epidemiology, antibiotic susceptibility of pathogens and implementation of preventive interventions, such as vaccines. These guidelines and consensus statements differ in various aspects, such as the methodology of AOM diagnosis, age range included; times when antibiotic therapy can be withheld; the types of antibiotic therapy, dosage and duration; and the option for additional therapy (table 1). When comparing the content of some guidelines with others, there are even some conflicting statements. To date, there are no papers that reviewed this topic.
Differences in acute otitis media (AOM) guidelines worldwide
Due to the increasing number of AOM guidelines in different countries, we studied the unifying and diverging points of guidelines from selected developing and developed countries in order to detect common elements, as well as differences.
Materials and methods
We searched for the following keywords: ‘acute otitis media’ AND ‘children’ AND [‘treatment’ or ‘management’] AND [‘guideline’ or ‘consensus’] in various electronic databases: MEDLINE (via PubMed), Ovid Medline, Google Scholar and Clinical Evidence (BMJ Publishing). These databases were searched from 1 January 1989 through 31 December 2015 (see online supplementary table S1). Publications that described the diagnosis/treatment of other forms of otitis media (ie, otitis media with effusion), AOM in adults and papers focusing on AOM-related complications (ie, acute mastoiditis) were excluded.
Supplementary table
The initial search yielded 99 national guidelines, consensus papers and position documents from 62 countries, in addition to 3 official position papers published by the WHO,2 the Agency for Healthcare Research and Quality, from the US Department of Health and Human Services (Rockville, Maryland, USA)1 (figure 1 and online supplementary table S2). We categorised countries as either ‘developed’ or ‘developing’ according to the definitions of the 2014 United Nations Statistical Annex (accessed 30 June 2016: http://www.un.org/en/development/desa/policy/wesp/wesp_current/2014wesp_country_classification.pdf). According to this classification, 53 guidelines were from 22 developed countries, and 46 from 40 developing countries. Some AOM guidelines were incorporated within upper respiratory tract infections guidelines.
Countries with consensus papers and/or national guidelines for acute otitis media diagnosis and treatment (blackened).
Since it was impossible to compare all the retrieved guidelines, we initially sought to compare guidelines from one developed country and one developing country from each continent. However, due to the large variability between guidelines in developing countries we decided to include more guidelines from developing countries. Ultimately, 12 representative guidelines from 7 developing and 5 developed countries were compared. Our eligibility criteria for guideline selection were if guidelines (1) were published or revised within the last 5 years; in order to assess the impact of the introduction of different vaccines; (2) were in English or could be found on the web and easily translated; (3) were issued by a local expert society(ies) or association(s) or by the local Ministry of Health; (4) had a title, abstract and content that were detailed and consistent with similar clinical guidelines; and (5) if we had full access to the text and references.
Developed countries
Two reviewers independently chose to compare AOM guidelines from Italy (Europe),11 the USA (Americas),12 Japan (Asia),13 ,14 South Australia (Oceania),15 and South Africa (Africa).16 We were forced to make these exceptions: (1) for Oceania, guidelines from the state of South Australia were chosen, which were the most appropriate detailed publication from this region, but cannot be considered as a national guideline; (2) for Europe, several countries met the inclusion criteria, such as Italy, the UK, Spain and the Netherlands. We decided to analyse the Italian guidelines, which were the most comprehensive; and (3) for Africa, South Africa was selected as a developed country, although categorised as being only partly developed due to the lack of other developed countries in this continent.
Developing countries
The same reviewers chose Tanzania (Africa),17 Ethiopia (Africa),18 Moldova (Europe),19 Argentina (America),20 Fiji (Oceania),21 Afghanistan (Asia)22 and Sri Lanka (Asia).23 We were forced to make these exceptions: (1) for Oceania, Fiji was chosen because its guidelines were the most recent and comprehensive ones from that region; (2) for Europe, Moldova (written in the local native language) was chosen as a representative since there are almost no developing countries in Europe; and (3) For America, Argentina was chosen as a representative developing country, although published in Spanish.
For selected guidelines, we compared their characteristics, criteria for AOM diagnosis, treatment options and recommended preventive measures, if there were any. We believe that selected guidelines represent not only the geographical region in terms of the local demographics and access to healthcare facilities but also regarding AOM epidemiology and disease burden.
Results
Founders of guidelines
Bibliographic details of the selected AOM guidelines are presented in tables 2 and 3. Most guidelines were drafted by professional paediatric societies since paediatricians are the primary healthcare providers for children with AOM. For developed countries, Japan is an exception: since otolaryngologists are the primary healthcare providers for children with AOM, they drafted the local guidelines. In contrast, the Ministry of Health was usually the author of guidelines in developing countries, except in Argentina, where the professional Paediatric Society and the Society of Infectious Diseases issued the local guidelines.
Guidelines for acute otitis media (AOM) management from five developed countries
Guidelines for acute otitis media management from seven developing countries
Age
Not all age groups are covered, even in detailed guidelines (eg, the USA). Very young infants are excluded in 2/5 of the selected guidelines from developed countries (<2 months, Italy; <6 months, the USA). These exclusions do not exist in guidelines from developing countries. In developed countries, the upper age limit was either early adolescence (12 years for the USA and Italy, 15 years in Japan) or undefined in 2/5, while in developing countries the upper age limit was not mentioned. In 4/5 selected developed countries guidelines, there were age subgroups: younger children (<2 years) and older children (>2 years), which emphasises the higher incidence of AOM in younger children. Age categorisation was more detailed in 2/5 guidelines from developing countries (<2 or <6 months, 2–12 months or 6–24 months and >1 or >2 years). Other guidelines from developing countries used other age limits (<5 years or older (Afghanistan, Tanzania), <3 years or older (Moldova), <2 years or older (Argentina)).
Diagnosis
All guidelines from developed countries highlighted the need for accurate AOM diagnosis and encouraged the removal of blocking cerumen (tables 4 and 5). However, removing earwax is not discussed in guidelines from developing countries. In previous guidelines, indirect means for AOM diagnosis were accepted (ie, tympanometry). Current guidelines from developed countries recommend that diagnosis should be based on three major criteria: (1) constitutional signs and symptoms (fever, ear tugging, otalgia), (2) tympanic membrane (TM) bulging and (3) presence of middle ear effusion. The Japanese guidelines broadly detailed the TM examination, preferably by using oto-microscopy or oto-endoscopy, and allow the diminished light reflex and/or TM bullar formation to serve as supplemental criteria for diagnosis. In developing countries, these criteria are listed in most guidelines. The use of pneumatic otoscopy is discussed and allowed in 3/7 guidelines (Sri Lanka, Argentina and Moldova).
Diagnostic criteria in guidelines for acute otitis media (AOM) management from five developed countries
Diagnostic criteria in guidelines for acute otitis media management from seven developing countries
Treatment
Watchful waiting in mild–moderate AOM scenarios is now the standard of care in all guidelines from developed countries (tables 6 and 7), where follow-up is possible. In comparison, watchful waiting is an option in 3/7 guidelines from developing countries (Sri Lanka, Argentina and Moldova). Amoxicillin is universally accepted as the first-line antibiotic therapy, both in developing and developed countries, but in different doses (30–100 mg/kg/day), usually given three times a day. There is a wide variety of suggested second-line and third-line antibiotic therapies, as well as for the recommended duration and dosage. Unlike earlier guidelines, newer guidelines encourage the use of systemic (but not topical) analgesia. Myringotomy is reserved for more advanced, complicated cases, which are unresponsive to antibiotic therapies (the USA, Japan, South Africa). Other treatments, such as steroids, antihistamines, nasal steroid sprays or local/systemic decongestants, are either discouraged or ignored in all guidelines from developed countries, but are mentioned in guidelines from two developing countries (Moldova and Sri Lanka). Of note, the Japanese guidelines are the only ones that mention the use of local/systemic decongestants in children with AOM, and complementary and alternative medicine in the form of probiotic products containing Lactobacillus bifidus or Clostridium butyricum is recommended as a concomitant treatment. Ventilation tube insertion is discussed in 4/5 guidelines from developed countries and is proposed for children with recurrent AOM.
Treatment options in guidelines for acute otitis media management from five developed countries
Treatment options in guidelines for acute otitis media (AOM) management from seven developing countries
Prevention
Some, but not all, guidelines from developed countries mention important means for prevention by reduction of AOM risk factors (ie, limiting exposure to cigarette smoke or encouraging breast feeding), and call for childhood immunisation with pneumococcal conjugate vaccines (PCVs) and yearly influenza vaccinations (tables 8 and 9). Of note, prevention methods for AOM are mentioned only in one guideline from developing countries (Afghanistan; reducing exposure to cigarette smoke).
Preventive strategies in guidelines for acute otitis media (AOM) management from five developed countries
Preventive strategies in guidelines for acute otitis media management from seven developing countries
Discussion
Our study of selected guidelines revealed that AOM diagnosis and management guidelines from industrialised, developed countries and developing countries share many common principles. Minor differences exist due to differences in local epidemiology, healthcare policy, accessibility to health facilities and health expenditure. The use of antibiotics in the treatment of AOM remains controversial. The ‘watchful waiting’ option is popular in developed countries, but less in developing countries, where follow-up is sometimes not possible. The major differences between developing and developed countries are the suggestions for prevention, mostly in guidelines from developed countries.
Recommending amoxicillin as the first-line therapy has been found to positively affect the resistance patterns of Streptococcus pneumoniae isolated from middle ear fluid or AOM-associated otorrhoea in French and Israeli PCV immunised children.24 ,25 Disagreement on the dosage and duration of antibiotic therapy were noted in the studied guidelines. In addition, there is disagreement concerning the second-line and third-line antibiotic treatments. This could be because local epidemiology and healthcare costs largely contribute to these decisions. In addition, local data on antibiotic resistance patterns among causative bacteria of AOM may mean national guidelines to suggest certain antibiotic therapies over others. One common antibiotic found in second-line and third-line treatments is ceftriaxone (in 5/12 guidelines). This third-generation cephalosporin has an excellent activity against Gram-positive bacteria, the major causative agents of AOM.
In our opinion, healthcare authorities in developing countries could also focus on AOM prevention in their guidelines. The relative high costs of PCVs and influenza vaccinations may make these preventive measures unaffordable in some developing countries.
In most guidelines from developing countries, there is a statement about when to transfer a child to hospital. This indicates that many physicians work in remote areas, where access to advanced healthcare facilities is limited. Guidelines from developing countries do not address the option of surgical therapy for recurrent AOM cases, which require specialised facilities and trained physicians, of which some or all may not be found in developing countries.
To our knowledge, there are no AOM guidelines in large developing countries like China or Russia, and even the Indian guidelines are not accepted nationwide. Studies from developing countries provide some disturbing data on extensive unjustified use of antibiotics for AOM, high antibiotic resistance of S pneumoniae isolated from AOM cases, including multidrug resistance phenotypes, and high complication rate.26–29 In Russian children with pneumococcal AOM, 45% of the pneumococci were penicillin-non-susceptible and 30% had multidrug resistance phenotype.26 Another Russian study found that the rate of unjustified outpatient antibiotic prescriptions in children with respiratory infections was estimated at 40%.27 In PCV-unimmunised Chinese children with pneumococcal AOM, a significant proportion of clones were also resistant to antibiotics.28 In India, otolaryngologists reported that they treated 98% of AOM episodes with antibiotics, and amoxicillin/clavulanic acid was the first-line therapy.29 We acknowledge limitations in our study: (1) we focused on only 12 guidelines. However, our main findings are similar to guidelines we did not review in detail (data not shown); and (2) there are known differences in the paediatric outpatient antibiotic prescribing rate internationally. For example, in European countries, Holstiege et al30 looked at the prescription rates between 2005 and 2008, and found significant differences, with Italy (chosen in this study to represent Europe) having the highest rate, while the Netherlands (which pioneered the guidelines) having the lowest.
Due to the global nature of AOM, if developing countries with large populations do not implement strategies to reduce AOM and limit antibiotic uses, we expect to see an increase in bacterial resistance, which may spread worldwide. In contrast, countries that implemented AOM guidelines have already reported reduced rates of appropriate antibiotic prescription for AOM and low resistance rates in isolated pathogens.24 ,25 ,31
Conclusions
The analysed AOM guidelines from developing and developed countries revealed many unifying notions but some diversity. Ideally, it could be suggested that the similar parts of the guidelines could serve as the basis for future international cooperation in the formulation of ‘global’ guidelines, which need to be in line with the local epidemiology. The use of stringent criteria in AOM diagnosis, restraint in antibiotic use, adoption of the ‘watchful waiting’ approach as the primary option for most uncomplicated cases and the integration of preventative methods (including environmental changes and childhood vaccination) is recommended in these future guidelines.
Acknowledgments
The authors are grateful to Dr Rupa Vedantam, from the Christian Medical College Hospital, Vellore, India, for reviewing this manuscript and her helpful comments.
References
Footnotes
Contributors SOT and TM conceptualised the study, collected the data, performed analysis and wrote the manuscript. SS and YO collected the data, performed analysis and critically revised the manuscript. All the authors approved the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.