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American Family Physician Sep 2019Acute otitis media (AOM) is the most common diagnosis in childhood acute sick visits. By three years of age, 50% to 85% of children will have at least one episode of... (Review)
Review
Acute otitis media (AOM) is the most common diagnosis in childhood acute sick visits. By three years of age, 50% to 85% of children will have at least one episode of AOM. Symptoms may include ear pain (rubbing, tugging, or holding the ear may be a sign of pain), fever, irritability, otorrhea, anorexia, and sometimes vomiting or lethargy. AOM is diagnosed in symptomatic children with moderate to severe bulging of the tympanic membrane or new-onset otorrhea not caused by acute otitis externa, and in children with mild bulging and either recent-onset ear pain (less than 48 hours) or intense erythema of the tympanic membrane. Treatment includes pain management plus observation or antibiotics, depending on the patient's age, severity of symptoms, and whether the AOM is unilateral or bilateral. When antibiotics are used, high-dose amoxicillin (80 to 90 mg per kg per day in two divided doses) is first-line therapy unless the patient has taken amoxicillin for AOM in the previous 30 days or has concomitant purulent conjunctivitis; amoxicillin/clavulanate is typically used in this case. Cefdinir or azithromycin should be the first-line antibiotic in those with penicillin allergy based on risk of cephalosporin allergy. Tympanostomy tubes should be considered in children with three or more episodes of AOM within six months or four episodes within one year with one episode in the preceding six months. Pneumococcal and influenza vaccines and exclusive breastfeeding until at least six months of age can reduce the risk of AOM.
Topics: Acute Disease; Adult; Amoxicillin; Anti-Bacterial Agents; Child; Child, Preschool; Evidence-Based Medicine; Family Practice; Female; Humans; Infant; Male; Middle Ear Ventilation; Otitis Media; Pain Management; Severity of Illness Index
PubMed: 31524361
DOI: No ID Found -
Expert Review of Anti-infective Therapy May 2023Acute otitis media (AOM) affects most (80%) children by 5 years of age and is the most common reason children are prescribed antibiotics. The epidemiology of AOM has... (Review)
Review
INTRODUCTION
Acute otitis media (AOM) affects most (80%) children by 5 years of age and is the most common reason children are prescribed antibiotics. The epidemiology of AOM has changed considerably since the widespread use of pneumococcal conjugate vaccines, which has broad-reaching implications for management.
AREAS COVERED
In this narrative review, we cover the epidemiology of AOM, best practices for diagnosis and management, new diagnostic technology, effective stewardship interventions, and future directions of the field. Literature review was performed using PubMed and ClinicalTrials.gov.
EXPERT OPINION
Inaccurate diagnoses, unnecessary antibiotic use, and increasing antimicrobial resistance remain major challenges in AOM management. Fortunately, effective tools and interventions to improve diagnostic accuracy, de-implement unnecessary antibiotic use, and individualize care are on the horizon. Successful scaling of these tools and interventions will be critical to improving overall care for children.
Topics: Child; Humans; Infant; Acute Disease; Otitis Media; Anti-Bacterial Agents; Pneumococcal Vaccines
PubMed: 37097281
DOI: 10.1080/14787210.2023.2206565 -
The New England Journal of Medicine May 2021Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media. (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media.
METHODS
We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period.
RESULTS
In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial.
CONCLUSIONS
Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).
Topics: Acute Disease; Anti-Bacterial Agents; Child, Preschool; Drug Resistance, Bacterial; Female; Humans; Infant; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Middle Ear Ventilation; Otitis Media; Otitis Media with Effusion; Quality of Life; Recurrence
PubMed: 33979487
DOI: 10.1056/NEJMoa2027278 -
Auris, Nasus, Larynx Aug 2020"Clinical Practice Guidelines for the Diagnosis and Management of Acute Otitis Media in Children-2018 update (2018 Guidelines)" aim to provide appropriate...
OBJECTIVE
"Clinical Practice Guidelines for the Diagnosis and Management of Acute Otitis Media in Children-2018 update (2018 Guidelines)" aim to provide appropriate recommendations about the diagnosis and management of children with acute otitis media (AOM), including recurrent acute otitis media (recurrent AOM), in children under 15 years of age. These evidence-based recommendations were created with the consensus of the subcommittee members, taking into consideration unique characteristics of bacteriology and antimicrobial susceptibilities of AOM pathogens in Japan, as well as global advances in vaccines.
METHODS
The subcommittee re-evaluated key clinical issues based on SCOPE (a master plan of the guidelines) and created clinical questions (CQ) about the diagnosis and management of AOM patients. A literature search of the publications from 2013 to 2016 were added to the Guidelines 2013, not only to assess the evidence on the effectiveness of vaccines, but also to provide up to date information of the bacteriology and antimicrobial susceptibilities of AOM causative pathogens in Japan.
RESULTS
We have proposed guidelines for disease severity-based management of AOM patients, after classifying AOM severity into mild, moderate, and severe, based on age, clinical manifestations, and otoscopic findings.
CONCLUSIONS
Precise otoscopic findings are essential for judging AOM severity, which can lead to appropriate management of AOM patients.
Topics: Adolescent; Anti-Bacterial Agents; Child; Child, Preschool; Disease Management; Drug Resistance, Microbial; Humans; Infant; Infant, Newborn; Japan; Otitis Media; Otoscopy; Practice Guidelines as Topic; Recurrence; Severity of Illness Index; Watchful Waiting
PubMed: 32576390
DOI: 10.1016/j.anl.2020.05.019 -
BMJ Open May 2020To appraise European guidelines for acute otitis media (AOM) in children, including methodological quality, level of evidence (LoE), astrength of recommendations (SoR),...
OBJECTIVES
To appraise European guidelines for acute otitis media (AOM) in children, including methodological quality, level of evidence (LoE), astrength of recommendations (SoR), and consideration of antibiotic stewardship.
DESIGN
Systematic review of the literature.
DATA SOURCES
Three-pronged search of (1) databases: Medline, Embase, Cochrane library, Guidelines International Network and Trip Medical Database; (2) websites of European national paediatric associations and (3) contact of European experts. Data were collected between January 2017 and February 2018.
ELIGIBILITY CRITERIA
National guidelines of European countries for the clinical management of AOM in children aged <16 years.
DATA EXTRACTION AND SYNTHESIS
Data were extracted using tables constructed by the research team. Guidelines were graded using AGREE II criteria. LoE and SoR were compared. Guidelines were assessed for principles of antibiotic stewardship.
RESULTS
AOM guidelines were obtained from 17 or the 32 countries in the European Union or European Free Trade Area. The mean AGREE II score was ≤41% across most domains. Diagnosis of AOM was based on similar signs and symptoms. The most common indication for antibiotics was tympanic membrane perforation/otorrhoea (14/15; 93%). The majority (15/17; 88%) recommended a watchful waiting approach to antibiotics. Amoxicillin was the most common first-line antibiotic (14/17; 82%). Recommended treatment duration varied from 5 to 10 days. Seven countries advocated high-dose (75-90 mg/kg/day) and five low-dose (30-60 mg/kg/day) amoxicillin. Less than 60% of guidelines used a national or international scale system to rate level of evidence to support recommendations. Under half of the guidelines (7/17; 41%) referred to country-specific microbiological and antibiotic resistance data.
CONCLUSIONS
Guidelines for managing AOM were similar across European countries. Guideline quality was mostly weak, and it often did not refer to country-specific antibiotic resistance patterns. Coordinating efforts to produce a core guideline which can then be adapted by each country may help improve overall quality and contribute to tackling antibiotic resistance.
Topics: Acute Disease; Adolescent; Anti-Bacterial Agents; Child; Child, Preschool; Europe; Humans; Infant; Infant, Newborn; Otitis Media; Practice Guidelines as Topic
PubMed: 32371515
DOI: 10.1136/bmjopen-2019-035343 -
Danish Medical Journal Oct 2020Although acute otitis media (AOM) is a very frequent illness in children, it remains unclear to what extent children with AOM benefit from antibiotics (ABX). This...
INTRODUCTION
Although acute otitis media (AOM) is a very frequent illness in children, it remains unclear to what extent children with AOM benefit from antibiotics (ABX). This systematic review aimed to clarify this subject by including randomised clinical trials (RCTs) from the pneumococcal vaccine era only.
METHODS
We performed a systematic literature search in four databases from 1 January 2000 to 1 January 2019 for RCTs comparing ABX to placebo in patients with AOM. Pain was registered as the main outcome. Adverse events (AE), development of contralateral otitis media, tympanic membrane perforation, late AOM recurrence, abnormal tympanometry and time to resolution of middle ear effusion were registered as secondary outcomes.
RESULTS
Six publications based on five RCTs with 1,862 patients were included. The number needed to treat (NNT) to reduce pain varied from seven (pain at day 7-10) to 28 (pain at day 2-3). The NNT for preventing contralateral otitis was ten. AE were seen in every 13th patient treated with ABX.
CONCLUSIONS
ABX appears to have a limited effect on both primary and secondary outcomes compared with placebo. A substantial number of patients experienced AE. New RCTs are needed to further clarify the effect. Ideally, RCTs could be conducted in Danish general practices in collaboration with practicing ear, nose and throat specialists to obtain large unselected populations with high rates of vaccine coverage. Until more evidence is provided, ABX should be considered among children younger than two years of age with severe symptoms of AOM, i.e. fewer and affected well-being.
Topics: Acute Disease; Anti-Bacterial Agents; Child; Humans; Infant; Neoplasm Recurrence, Local; Otitis Media; Tympanic Membrane Perforation
PubMed: 33215607
DOI: No ID Found -
Auris, Nasus, Larynx Oct 2023This is an update of the 2015 Guidelines developed by the Japan Otological Society and Oto-Rhino-Laryngeal Society of Japan defining otitis media with effusion (OME) in... (Review)
Review
UNLABELLED
This is an update of the 2015 Guidelines developed by the Japan Otological Society and Oto-Rhino-Laryngeal Society of Japan defining otitis media with effusion (OME) in children (younger than 12 years old) and describing the disease rate, diagnosis, and method of examination. Recommended therapies that received consensus from the guideline committee were updated in consideration of current therapies used in Japan and based on available evidence.
METHOD
Regarding the treatment of OME in children, we developed Clinical Questions (CQs) and retrieved documents on each theme, including the definition, disease state, method of diagnosis, and medical treatment. In the previous guidelines, no retrieval expression was used to designate a period of time for literature retrieval. Conversely, a literature search of publications from March 2014 to May 2019 has been added to the JOS 2015 Guidelines. For publication of the CQs, we developed and assigned strengths to recommendations based on the collected evidence.
RESULTS
OME in children was classified into one group lacking the risk of developing chronic or intractable disease and another group at higher risk (e.g., children with Down syndrome, cleft palate), and recommendations for clinical management, including follow-up, is provided. Information regarding management of children with unilateral OME and intractable cases complicated by adhesive otitis media is also provided.
CONCLUSION
In clinical management of OME in children, the Japanese Clinical Practice Guidelines recommends management not only of complications of OME itself, such as effusion in the middle ear and pathologic changes in the tympanic membrane, but also pathologic changes in surrounding organs associated with infectious or inflammatory diseases.
Topics: Child; Humans; Otitis Media with Effusion; Japan; Nigeria; Otitis Media; Adenoidectomy; Middle Ear Ventilation
PubMed: 36577619
DOI: 10.1016/j.anl.2022.12.004 -
The Cochrane Database of Systematic... Jan 2020Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Topical antibiotics, the most common treatment for CSOM, act to kill or inhibit the growth of micro-organisms that may be responsible for the infection. Antibiotics can be used alone or in addition to other treatments for CSOM, such as antiseptics or ear cleaning (aural toileting).
OBJECTIVES
To assess the effects of topical antibiotics (without steroids) for people with CSOM.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 1 April 2019.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with at least a one-week follow-up involving participants (adults and children) who had chronic ear discharge of unknown cause or CSOM, where the ear discharge had continued for more than two weeks. The interventions were any single, or combination of, topical antibiotic agent(s) of any class, applied directly into the ear canal as ear drops, powders or irrigations, or as part of an aural toileting procedure. The two main comparisons were topical antibiotic compared to a) placebo or no intervention and b) another topical antibiotic (e.g. topical antibiotic A versus topical antibiotic B). Within each comparison we separated studies where both groups of participants had received topical antibiotic a) alone or with aural toileting and b) on top of background treatment (such as systemic antibiotics).
DATA COLLECTION AND ANALYSIS
We used the standard Cochrane methodological procedures. We used GRADE to assess the certainty of the evidence for each outcome. Our primary outcomes were: resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at between one week and up to two weeks, two weeks to up to four weeks and after four weeks; health-related quality of life using a validated instrument; ear pain (otalgia) or discomfort or local irritation. Secondary outcomes included hearing, serious complications and ototoxicity measured in several ways.
MAIN RESULTS
We included 17 studies with a total of 2198 participants. Twelve studies reported the sample size in terms of participants (not ears); these had a total of 1797 participants. The remaining five studies reported both the number of participants and ears, representing 401 participants, or 510 ears. A: Topical antibiotics versus placebo or no treatment (with aural toilet in both arms and no other background treatment) One small study compared a topical antibiotic (ciprofloxacin) with placebo (saline). All participants received aural toilet. Although ciprofloxacin was better than saline in terms of resolution of discharge at one to two weeks: 84% versus 12% (risk ratio (RR) 6.74, 95% confidence interval (CI) 1.82 to 24.99; 35 participants, very low-certainty evidence), the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other. The study authors reported that "no medical side-effects and worsening of audiological measurements related to this topical medication were detected" (very low-certainty evidence). B: Topical antibiotics versus placebo or no treatment (with use of oral antibiotics in both arms) Four studies compared topical ciprofloxacin to no treatment (three studies; 190 participants) or topical ceftizoxime to no treatment (one study; 248 participants). In each study all participants received the same antibiotic systemically (oral ciprofloxacin, injected ceftizoxime). In at least one study all participants received aural toilet. Useable data were only available from the first three studies; ciprofloxacin was better than no treatment, resolution of discharge occurring in 88.2% versus 60% at one to two weeks (RR 1.47, 95% CI 1.20 to 1.80; 2 studies, 150 participants; low-certainty evidence). None of the studies reported ear pain or discomfort/local irritation. C: Comparisons of different topical antibiotics The certainty of evidence for all outcomes in these comparisons is very low. Quinolones versus aminoglycosides Seven studies compared an aminoglycoside (gentamicin, neomycin or tobramycin) with ciprofloxacin (734 participants) or ofloxacin (214 participants). Whilst resolution of discharge at one to two weeks was higher in the quinolones group the very low certainty of the evidence means that it is very uncertain whether or not one intervention is better or worse than the other (RR 1.95, 95% CI 0.88 to 4.29; 6 studies, 694 participants). One study measured ear pain and reported no difference between the groups. Quinolones versus aminoglycosides/polymyxin B combination ±gramicidin We identified three studies but data on our primary outcome were only available in one study. Comparing ciprofloxacin to a neomycin/polymyxin B/gramicidin combination, for an unknown treatment duration (likely four weeks), ciprofloxacin was better (RR 1.12, 95% CI 1.03 to 1.22, 186 participants). A "few" patients experienced local irritation upon the first instillation of topical treatment (numbers/groups not stated). Others Other studies examined topical gentamicin versus a trimethoprim/sulphacetamide/polymixin B combination (91 participants) and rifampicin versus chloramphenicol (160 participants). Limited data were available and the findings were very uncertain.
AUTHORS' CONCLUSIONS
We are uncertain about the effectiveness of topical antibiotics in improving resolution of ear discharge in patients with CSOM because of the limited amount of low-quality evidence available. However, amongst this uncertainty there is some evidence to suggest that the use of topical antibiotics may be effective when compared to placebo, or when used in addition to a systemic antibiotic. There is also uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine with any certainty whether or not quinolones are better or worse than aminoglycosides. These two groups of compounds have different adverse effect profiles, but there is insufficient evidence from the included studies to make any comment about these. In general, adverse effects were poorly reported.
Topics: Administration, Topical; Anti-Bacterial Agents; Chronic Disease; Humans; Otitis Media, Suppurative; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31896168
DOI: 10.1002/14651858.CD013051.pub2 -
Boletin Medico Del Hospital Infantil de... 2022Acute otitis media (AOM) is one of the most prevalent acute conditions in the pediatric population worldwide. This work aimed to elaborate a Clinical Practice Guideline...
BACKGROUND
Acute otitis media (AOM) is one of the most prevalent acute conditions in the pediatric population worldwide. This work aimed to elaborate a Clinical Practice Guideline with clinical recommendations systematically developed to assist decision-making of specialists, patients, caregivers, and public policymakers involved in managing patients with AOM in children.
METHODS
This document was developed by the College of Pediatric Otorhinolaryngology and Head, and Neck Surgery of Mexico (COPEME) in compliance with international standards. The SIGN quality of evidence classification was used. On behalf of the COPEME, the Guideline Development Group (GDG) was integrated, including otolaryngologists, infectologists, pediatricians, general practitioners, and methodologists with experience in systematic literature reviews and the development of clinical practice guidelines.
RESULTS
A consensus was reached on 18 clinical questions, covering what was previously established by the GDG in the scope document of the guidelines. Scientific evidence answering each of these clinical questions was identified and critically evaluated. The GDG agreed on the final wording of the clinical recommendations using the modified Delphi panel technique. Specialists and patient representatives conducted an external validation.
CONCLUSIONS
This Clinical Practice Guideline presents clinical recommendations for the prevention, diagnosis, and management of AOM to assist shared decision-making among physicians, patients, and caregivers and improve the quality of clinical care.
Topics: Acute Disease; Child; Humans; Mexico; Otitis Media
PubMed: 35943405
DOI: 10.24875/BMHIM.21000168 -
The Journal of Pediatrics Dec 2022The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate,...
OBJECTIVES
The objective of the study was to compare the antibiotic treatment failure and recurrence rates between antibiotic agents (amoxicillin, amoxicillin-clavulanate, cefdinir, and azithromycin) for children with uncomplicated acute otitis media (AOM).
STUDY DESIGN
We completed a retrospective cohort study of children 6 months-12 years of age with uncomplicated AOM identified in a nationwide claims database. The primary exposure was the antibiotic agent, and the primary outcomes were treatment failure and recurrence. Logistic regression was used to estimate ORs, and analyses were stratified by primary exposure, patient age, and antibiotic duration.
RESULTS
Among the 1 051 007 children included in the analysis, 56.6% were prescribed amoxicillin, 13.5% were prescribed amoxicillin-clavulanate, 20.6% were prescribed cefdinir, and 9.3% were prescribed azithromycin. Most prescriptions (93%) were for 10 days, and 98% were filled within 1 day of the medical encounter. Treatment failure and recurrence occurred in 2.2% (95% CI: 2.1, 2.2) and 3.3% (3.2, 3.3) of children, respectively. Combined failure and recurrence rates were low for all agents including amoxicillin (1.7%; 1.7, 1.8), amoxicillin-clavulanate (11.3%; 11.1, 11.5), cefdinir (10.0%; 9.8, 10.1), and azithromycin (9.8%; 9.6, 10.0).
CONCLUSIONS
Despite microbiologic changes in AOM etiology, treatment failure and recurrence were uncommon for all antibiotic agents and were lower for amoxicillin than for other agents. These findings support the continued use of amoxicillin as a first-line agent for AOM when antibiotics are prescribed.
Topics: Child; Humans; Infant; Amoxicillin; Azithromycin; Cefdinir; Retrospective Studies; Acute Disease; Treatment Outcome; Anti-Bacterial Agents; Otitis Media; Amoxicillin-Potassium Clavulanate Combination
PubMed: 35944719
DOI: 10.1016/j.jpeds.2022.07.053