Topical or oral antibiotics for children with acute otitis media presenting with ear discharge: study protocol of a randomised controlled non-inferiority trial.

BACKGROUND: Around 15%-20% of children with acute otitis media present with ear discharge due to a spontaneous tear or perforation of the eardrum (AOMd). Current guidance recommends clinicians to consider oral antibiotics as first-line treatment in this condition. The opening in the eardrum however should allow topical antibiotics to enter the middle ear directly. Local administration of antibiotics does not expose children to systemic side effects and may put less selective resistance pressure on bacteria. Evidence on the effectiveness of this approach in children with AOMd is lacking. METHODS AND ANALYSIS: A primary care-based, open, individually randomised, controlled, non-inferiority trial. The trial aims to recruit 350 children aged 6 months to 12 years with AOMd and ear pain and/or fever. Participants will be randomised to 7 days of hydrocortisone-bacitracin-colistin eardrops five drops three times daily or amoxicillin oral suspension 50 mg/kg body weight per day, divided over three doses. Parents will keep a daily diary of AOM symptoms, adverse events and complications for 2 weeks. In addition, they will record AOM recurrences, healthcare utilisation and societal costs for 3 months. The primary outcome is the proportion of children without ear pain and fever at day 3. Secondary outcomes include ear pain and fever intensity/severity; days with ear discharge; eardrum perforation at 2 weeks; adverse events during first 2 weeks; costs; and cost effectiveness at 2 weeks and 3 months. The primary analyses will be intention-to-treat and per-protocol analyses will be conducted as well. ETHICS AND DISSEMINATION: The medical research ethics committee Utrecht, The Netherlands has given ethical approval (17-400/G-M). Parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings. TRIAL REGISTRATION NUMBER: The Netherlands National Trial Register; NTR6723. Date of registration: 27 November 2017.

Prevalence and Antimicrobial Resistance of Bacteria in Children With Acute Otitis Media and Ear Discharge: A Systematic Review.

BACKGROUND: Of children with acute otitis media (AOM), 15%-20% present with acute onset ear discharge due to a spontaneous perforation of the tympanic membrane (AOMd). This review aims to quantify the prevalence and antimicrobial resistance (AMR) status of bacteria in children with AOMd in the pneumococcal conjugate vaccine (PCV) era. METHODS: Systematic searches were performed in PubMed, EMBASE and Cochrane Library from inception to June 7, 2019. Two reviewers extracted relevant data and assessed risk of bias independently. All English studies reporting any prevalence and/or AMR data of bacterial middle ear isolates from children with AOMd were included. Risk of bias was assessed using the Joanna Briggs Institute Critical Appraisal checklist. RESULTS: Of 4088 unique records retrieved, 19 studies (10,560 children) were included. Overall quality was judged good. Streptococcus pneumoniae (median 26.1%, range 9.1%-47.9%), Haemophilus influenzae (median 18.8%, range 3.9%-55.3%), Staphylococcus aureus (median 12.3%, range 2.3%-34.9%) and Streptococcus pyogenes (median 11.8%, range 1.0%-30.9%) were the most prevalent bacteria. In 76.0% (median, range 48.7%-100.0%, 19 studies, 1,429 children) any bacterium was identified. AMR data were sparse and mainly limited to S. pneumoniae. We found no evidence of a clear shift in the prevalence of bacteria and AMR over time. CONCLUSIONS: In children with AOMd, S. pneumoniae and H. influenzae are the 2 predominant bacteria, followed by S. aureus and S. pyogenes in the post-PCV era. AMR data are sparse and no clearly change over time was observed. Ongoing surveillance of the microbiology profile in children with AOMd is warranted to guide antibiotic selection and to assess the impact of children's PCV status.

Respiratory Microbiota Predicts Clinical Disease Course of Acute Otorrhea in Children With Tympanostomy Tubes.

BACKGROUND: Acute otitis media (AOM) is one of the most common childhood infections, generally thought to be caused by ascension of bacteria from the nasopharynx (NP) to the middle ear. Using 16S ribosomal RNA-based sequencing, we evaluated the relationship between the NP and middle ear fluid (MEF) microbiota in children with AOM with tympanostomy tubes (AOMT) as a proxy for AOM and explored whether microbiota profiling predicts natural disease course. METHODS: Microbiota profiles of paired NP and MEF samples of 94 children below 5 years of age with uncomplicated AOMT were determined. RESULTS: Local diversity (P < 0.001) and overall microbiota composition (P < 0.001) of NP and MEF samples differed significantly, although paired NP and MEF samples were much more similar than unpaired samples (P < 0.001). High qualitative agreement between the presence of individual bacteria in both niches was observed. Abundances of Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes, Turicella otitidis, Klebsiella pneumoniae and Haemophilus spp. were strongly correlated between the 2 niches. Additionally, P. aeruginosa, S. aureus, T. otitidis and Streptococcus pneumoniae abundance in NP were predictive of the presence of a range of oral types of bacteria in MEF. Interestingly, there was no association between Moraxella catarrhalis in NP and MEF samples, which was highly present in NP but virtually absent in MEF. Finally, the NP microbiota composition could predict duration of AOMT, even better than MEF microbiota. CONCLUSIONS: We observed substantial correlations between paired NP and MEF microbiota in children with AOMT. Our data also suggest that NP microbiota profiling deserves further exploration as tool for future treatment decisions.

Tympanostomy tube otorrhea in children: prevention and treatment.

PURPOSE OF REVIEW: One in two children treated with tympanostomy tubes, experience episodes of otorrhea whilst their tubes are in place. In this review, we present the results of the most recent publications on prevention and treatment of tympanostomy tube otorrhea (TTO). RECENT FINDINGS: Recent systematic reviews on water precautions for children with tympanostomy tubes support the American Academy of Otolaryngology - Head and Neck Surgery guideline recommendation against such preventive measures as there is no evidence that it protects against TTO. Studies on tympanostomy tube design and material suggest that silicone tubes have a lower TTO risk and that biofilms appear to be mainly located in the perpendicular junction of the T-tubes and the round rims of the Paparella-type tubes. Another study shows that the biofilm-component DNAB-II protein is present in otorrhea of half of children with TTO. Targeting this protein could lead to a collapse of the biofilm structure and as such a potential new treatment for chronic TTO. New systematic reviews show that antibiotic eardrops are the most effective first-line treatment of acute TTO and suggest that an antibiotic-corticosteroid combination is more effective than antibiotic only. Although in many countries, quinolone eardrops are the preferred choice because of being non-ototoxic, one study found a higher risk of persistent perforation after tube extrusion in children treated with quinolone eardrops as compared with children treated with aminoglycoside eardrops. SUMMARY: Recent evidence confirms that water precautions for children with tympanostomy tubes are not effective in preventing TTO. Antibiotic-corticosteroid eardrops are the most effective treatment of acute TTO.

Panel 1: Epidemiology and Diagnosis.

Objective To create a literature review between 2011 and June 1, 2015, on advances in otitis media (OM) epidemiology and diagnosis (including relevant audiology studies). Data Sources Electronic search engines (PubMed, EMBASE, and Cochrane Library) with a predefined search strategy. Review Methods Articles with appropriate epidemiologic methodology for OM, including acute mastoiditis and eustachian tube dysfunction. Items included OM worldwide and in high-risk populations, OM-related hearing loss, news in OM diagnostics, prenatal risk factors and comorbidities, postnatal risk factors, genetics, microbiological epidemiology, guidelines, and quality of life. Conclusions Diagnostic evidence and genetic studies are increasing; guidelines are introduced worldwide; and there is evidence of benefit of pneumococcal conjugate vaccines. New risk factors and comordities are identified in the study period, and quality of life is affected in children and their families. Implications for Practice Chronic suppurative OM occurs worldwide and contributes to lifelong hearing loss. Uniform definitions are still lacking and should be provided. An association between HIV and chronic suppurative OM has been found. Tympanometry is recommended for diagnosis, with or without pneumatic otoscopy. Video otoscopy, algorithms, and validated questionnaires may assist clinicians. Childhood obesity is associated with OM. Heritability accounts for 20% to 50% of OM diagnoses. OM-prone children seem to produce weaker immunologic responses to pneumococcal conjugate vaccines. Clinicians tend to individualize treatment without adhering to guidelines.

Antibiotics for otitis media with effusion in children.

BACKGROUND: Otitis media with effusion (OME) is characterised by an accumulation of fluid in the middle ear behind an intact tympanic membrane, without the symptoms or signs of acute infection. Since most cases of OME will resolve spontaneously, only children with persistent middle ear effusion and associated hearing loss potentially require treatment. Previous Cochrane reviews have focused on the effectiveness of ventilation tube insertion, adenoidectomy, nasal autoinflation, antihistamines, decongestants and corticosteroids in OME. This review, focusing on the effectiveness of antibiotics in children with OME, is an update of a Cochrane review published in 2012. OBJECTIVES: To assess the benefits and harms of oral antibiotics in children up to 18 years with OME. SEARCH METHODS: The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2016, Issue 3); PubMed; Ovid EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 14 April 2016. SELECTION CRITERIA: Randomised controlled trials comparing oral antibiotics with placebo, no treatment or therapy of unproven effectiveness in children with OME. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: Twenty-five trials (3663 children) were eligible for inclusion. Two trials did not report on any of the outcomes of interest, leaving 23 trials (3258 children) covering a range of antibiotics, participants, outcome measures and time points for evaluation. Overall, we assessed most studies as being at low to moderate risk of bias.We found moderate quality evidence (six trials including 484 children) that children treated with oral antibiotics are more likely to have complete resolution at two to three months post-randomisation (primary outcome) than those allocated to the control treatment (risk ratio (RR) 2.00, 95% confidence interval (CI) 1.58 to 2.53; number needed to treat to benefit (NNTB) 5). However, there is evidence (albeit of low quality; five trials, 742 children) indicating that children treated with oral antibiotics are more likely to experience diarrhoea, vomiting or skin rash (primary outcome) than those allocated to control treatment (RR 2.15, 95% CI 1.29 to 3.60; number needed to treat to harm (NNTH) 20).In respect of the secondary outcome of complete resolution at any time point, we found low to moderate quality evidence from five meta-analyses, including between two and 14 trials, of a beneficial effect of antibiotics, with a NNTB ranging from 3 to 7. Time periods ranged from 10 to 14 days to six months.In terms of other secondary outcomes, only two trials (849 children) reported on hearing levels at two to four weeks and found conflicting results. None of the trials reported data on speech, language and cognitive development or quality of life. Low quality evidence did not show that oral antibiotics were associated with a decrease in the rate of ventilation tube insertion (two trials, 121 children) or in tympanic membrane sequelae (one trial, 103 children), while low quality evidence indicated that children treated with antibiotics were less likely to have acute otitis media episodes within four to eight weeks (five trials, 1086 children; NNTB 18) and within six months post-randomisation (two trials, 199 children; NNTB 5). It should, however, be noted that the beneficial effect of oral antibiotics on acute otitis media episodes within four to eight weeks was no longer significant when we excluded studies with high risk of bias. AUTHORS' CONCLUSIONS: This review presents evidence of both benefits and harms associated with the use of oral antibiotics to treat children up to 16 years with OME. Although evidence indicates that oral antibiotics are associated with an increased chance of complete resolution of OME at various time points, we also found evidence that these children are more likely to experience diarrhoea, vomiting or skin rash. The impact of antibiotics on short-term hearing is uncertain and low quality evidence did not show that oral antibiotics were associated with fewer ventilation tube insertions. Furthermore, we found no data on the impact of antibiotics on other important outcomes such as speech, language and cognitive development or quality of life.Even in situations where clear and relevant benefits of oral antibiotics have been demonstrated, these must always be carefully balanced against adverse effects and the emergence of bacterial resistance. This has specifically been linked to the widespread use of antibiotics for common conditions such as otitis media.

Cost-effectiveness of treatment of acute otorrhea in children with tympanostomy tubes.

BACKGROUND: Acute otorrhea is a common problem in children with tympanostomy tubes. We recently demonstrated that treatment with antibiotic-glucocorticoid eardrops is clinically superior to oral antibiotics and initial observation. The aim of this study was to assess the cost-effectiveness of these three common treatment strategies for this condition. METHODS: We performed an open-label pragmatic trial in which 230 children with acute uncomplicated tympanostomy-tube otorrhea were randomly allocated to receive 1 of 3 treatments: hydrocortisone-bacitracin-colistin eardrops, oral amoxicillin-clavulanate suspension, and initial observation (no assigned medication prescription to fill). Parents kept a daily diary capturing ear-related symptoms, health care resource use, and non-health care costs for 6 months. At 2 weeks and 6 months, the study doctor visited the children at home performing otoscopy. Using a societal perspective, treatment failure (otoscopic presence of otorrhea at 2 weeks) and number of days with otorrhea as reported in the daily diary were balanced against the costs. RESULTS: Antibiotic-glucocorticoid eardrops were clinically superior to oral antibiotics and initial observation both at 2 weeks and 6 months. At 2 weeks, mean total cost per patient was US$42.43 for antibiotic-glucocorticoid eardrops, US$70.60 for oral antibiotics, and US$82.03 for initial observation. At 6 months, mean total cost per patient was US$368.20, US$420.73, and US$640.44, respectively. Because of the dominance of eardrops, calculating incremental cost-effectiveness ratios was redundant. CONCLUSIONS: Antibiotic-glucocorticoid eardrops are clinically superior and cost less than oral antibiotics and initial observation in children with tympanostomy tubes who develop otorrhea.

Acute otorrhea in children with tympanostomy tubes: prevalence of bacteria and viruses in the post-pneumococcal conjugate vaccine era.

BACKGROUND: Acute tympanostomy-tube otorrhea is a common sequela in children with tympanostomy tubes. Acute tympanostomy-tube otorrhea is generally a symptom of an acute middle ear infection, whereby middle ear fluid drains through the tube. The widespread use of pneumococcal conjugate vaccination (PCV) has changed the bacterial prevalence in the upper respiratory tract of children, but its impact on bacterial and viral pathogens causing acute tympanostomy-tube otorrhea is yet unknown. METHODS: This study was performed in the post-PCV7 era parallel to a randomized clinical trial of the clinical and cost-effectiveness of ototopical and systemic antibiotics and initial observation in 230 children aged 1 to 10 years with untreated, uncomplicated acute tympanostomy-tube otorrhea. Otorrhea and nasopharyngeal samples were collected at baseline (before treatment) and at 2 weeks (after treatment). Conventional bacterial culture was performed followed by antimicrobial-resistance assessment. Viruses were identified by polymerase chain reaction. RESULTS: At baseline, Haemophilus influenzae (41%), Staphylococcus aureus (40%) and Pseudomonas aeruginosa (18%) were the most prevalent bacteria in otorrhea, followed by Streptococcus pneumoniae (7%) and Moraxella catarrhalis (4%). Most pneumococci were non-PCV7 serotypes. Viruses were detected in 45 otorrhea samples at baseline (21%). Most infections were polymicrobial and overall antimicrobial resistance was low. CONCLUSIONS: H. influenzae, S. aureus and P. aeruginosa are the most common microorganisms in children with untreated uncomplicated acute tympanostomy-tube otorrhea. Prevalence of S. pneumoniae has decreased since the introduction of PCV and most pneumococci are nonvaccine serotypes.

A trial of treatment for acute otorrhea in children with tympanostomy tubes.

BACKGROUND: Recent guidance for the management of acute otorrhea in children with tympanostomy tubes is based on limited evidence from trials comparing oral antibiotic agents with topical antibiotics. METHODS: In this open-label, pragmatic trial, we randomly assigned 230 children, 1 to 10 years of age, who had acute tympanostomy-tube otorrhea to receive hydrocortisone-bacitracin-colistin eardrops (76 children) or oral amoxicillin-clavulanate suspension (77) or to undergo initial observation (77). The primary outcome was the presence of otorrhea, as assessed otoscopically, 2 weeks after study-group assignment. Secondary outcomes were the duration of the initial otorrhea episode, the total number of days of otorrhea and the number of otorrhea recurrences during 6 months of follow-up, quality of life, complications, and treatment-related adverse events. RESULTS: Antibiotic-glucocorticoid eardrops were superior to oral antibiotics and initial observation for all outcomes. At 2 weeks, 5% of children treated with antibiotic-glucocorticoid eardrops had otorrhea, as compared with 44% of those treated with oral antibiotics (risk difference, -39 percentage points; 95% confidence interval [CI], -51 to -26) and 55% of those treated with initial observation (risk difference, -49 percentage points; 95% CI, -62 to -37). The median duration of the initial episode of otorrhea was 4 days for children treated with antibiotic-glucocorticoid eardrops versus 5 days for those treated with oral antibiotics (P<0.001) and 12 days for those who were assigned to initial observation (P<0.001). Treatment-related adverse events were mild, and no complications of otitis media, including local cellulitis, perichondritis, mastoiditis, and intracranial complications, were reported at 2 weeks. CONCLUSIONS: Antibiotic-glucocorticoid eardrops were more effective than oral antibiotics and initial observation in children with tympanostomy tubes who had uncomplicated acute otorrhea. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1481.).

Parent-reported otorrhea in children with tympanostomy tubes: incidence and predictors.

PURPOSE: Although common in children with tympanostomy tubes, the current incidence of tympanostomy tube otorrhea (TTO) is uncertain. TTO is generally a sign of otitis media, when middle ear fluid drains through the tube. Predictors for otitis media are therefore suggested to have predictive value for the occurrence of TTO. OBJECTIVE: To determine the incidence of TTO and its predictors. METHODS: We performed a cohort study, using a parental web-based questionnaire to retrospectively collect data on TTO episodes and its potential predictors from children younger than 10 years of age with tympanostomy tubes. RESULTS: Of the 1,184 children included in analyses (total duration of time since tube placement was 768 person years with a mean of 7.8 months per child), 616 children (52%) experienced one or more episodes of TTO. 137 children (12%) had TTO within the calendar month of tube placement. 597 (50%) children had one or more acute TTO episodes (duration <4 weeks) and 46 children (4%) one or more chronic TTO episodes (duration ≥4 weeks). 146 children (12%) experienced recurrent TTO episodes. Accounting for time since tube placement, 67% of children developed one or more TTO episodes in the year following tube placement. Young age, recurrent acute otitis media being the indication for tube placement, a recent history of recurrent upper respiratory tract infections and the presence of older siblings were independently associated with the future occurrence of TTO, and can therefore be seen as predictors for TTO. CONCLUSIONS: Our survey confirms that otorrhea is a common sequela in children with tympanostomy tubes, which occurrence can be predicted by age, medical history and presence of older siblings.

Resistance to complement-mediated killing and IgM binding to non-typeable Haemophilus influenzae is not altered when ascending from the nasopharynx to the middle ears in children with otitis media.

We have previously found that non-typeable Haemophilus influenzae (NTHi) collected from the middle ear of children with otitis media (OM) exhibit increased levels of complement resistance compared to NTHi collected from the nasopharynx. However, it is unknown whether bacteria develop complement resistance in the middle ear, or whether resistance is present when residing in the nasopharynx. The objective of this study was to investigate whether the levels of complement resistance of isolates collected from the middle ear were similar to those of isolates from the nasopharynx with an identical MLST type. We included 62 children with recurrent acute OM, chronic OM with effusion or acute tympanostomy tube otorrhea. NTHi was simultaneously isolated from the nasopharynx and middle ear fluid. MLST, resistance to complement-mediated killing, IgG binding, IgM binding and phosphorylcholine expression was determined. In 41 children, NTHi isolated from the middle ear and nasopharynx showed to have an identical MLST type. Isolates collected from the middle ear showed a highly similar level of complement resistance and IgM binding with isolates collected from the nasopharynx, whereas this was not the case for IgG binding and phosphorylcholine incorporation into lipooligosaccharide. Resistance to complement-mediated killing and IgM binding of NTHi isolates with an identical MLST type collected from the middle ear and nasopharynx of children with OM was highly similar.

Evaluation of concordance between the microorganisms detected in the nasopharynx and middle ear of children with otitis media.

Studies of microorganisms involved in otitis media in children often use a nasopharyngeal sample as a proxy for the middle ear fluid to test for bacteria and viruses. The question is whether such studies provide an accurate estimate of the prevalence of microorganisms involved in otitis media. We performed a systematic review of the literature reporting on the concordance between test results of nasopharyngeal and middle ear fluid samples for the most prevalent microorganisms in children with otitis media. Our findings show that the concordances vary from 68% to 97% per microorganism. For the most prevalent microbes, positive predictive values are around 50%. Most negative predictive values are moderate to high, with a range from 68% up to 97%. These results indicate that test results from nasopharyngeal samples do not always provide an accurate proxy for those of the middle ear fluid. It is important to interpret and use results of such studies carefully.

Antibiotics for otitis media with effusion in children.

BACKGROUND: Otitis media with effusion (OME) is characterised by an accumulation of fluid in the middle ear behind an intact tympanic membrane, without the symptoms or signs of acute infection. In approximately one in three children with OME, however, a bacterial pathogen is identified in the middle ear fluid. In most cases, OME causes mild hearing impairment of short duration. When experienced in early life and when episodes of (bilateral) OME persist or recur, the associated hearing loss may be significant and have a negative impact on speech development and behaviour. Since most cases of OME will resolve spontaneously, only children with persistent middle ear effusion and associated hearing loss potentially require treatment. Previous Cochrane reviews have focused on the effectiveness of ventilation tube insertion, adenoidectomy, autoinflation, antihistamines, decongestants, and oral and topical intranasal steroids in OME. This review focuses on the effectiveness of antibiotics in children with OME. OBJECTIVES: To assess the effects of antibiotics in children up to 18 years with OME. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 22 February 2012. SELECTION CRITERIA: Randomised controlled trials comparing oral antibiotics with placebo, no treatment or therapy of unproven effectiveness. Our primary outcome was complete resolution of OME at two to three months. Secondary outcomes included resolution of OME at other time points, hearing, language and speech, ventilation tube insertion and adverse effects. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data using standardised data extraction forms and assessed the quality of the included studies using the Cochrane 'Risk of bias' tool. We presented dichotomous results as risk differences as well as risk ratios, with their 95% confidence intervals. If heterogeneity was greater than 75% we did not pool data. MAIN RESULTS: We included 23 studies (3027 children) covering a range of antibiotics, participants, outcome measures and time points of evaluation. Overall, we assessed the studies as generally being at low risk of bias.Our primary outcome was complete resolution of OME at two to three months. The differences (improvement) in the proportion of children having such resolution (risk difference (RD)) in the five individual included studies ranged from 1% (RD 0.01, 95% CI -0.11 to 0.12; not significant) to 45% (RD 0.45, 95% CI 0.25 to 0.65). Results from these studies could not be pooled due to clinical and statistical heterogeneity.Pooled analysis of data for complete resolution at more than six months was possible, with an increase in resolution of 13% (RD 0.13, 95% CI 0.06 to 0.19).Pooled analysis was also possible for complete resolution at the end of treatment, with the following increases in resolution rates: 17% (RD 0.17, 95% CI 0.09 to 0.24) for treatment for 10 days to two weeks, 34% (RD 0.34, 95% CI 0.19 to 0.50) for treatment for four weeks, 32% (RD 0.32, 95% CI 0.17 to 0.47) for treatment for three months, and 14% (RD 0.14, 95% CI 0.03 to 0.24) for treatment continuously for at least six months.We were unable to find evidence of a substantial improvement in hearing as a result of the use of antibiotics for otitis media with effusion; nor did we find an effect on the rate of ventilation tube insertion. We did not identify any trials that looked at speech, language and cognitive development or quality of life. Data on the adverse effects of antibiotic treatment reported in six studies could not be pooled due to high heterogeneity. Increases in the occurrence of adverse events varied from 3% (RD 0.03, 95% CI -0.01 to 0.07; not significant) to 33% (RD 0.33, 95% CI 0.22 to 0.44) in the individual studies. AUTHORS' CONCLUSIONS: The results of our review do not support the routine use of antibiotics for children up to 18 years with otitis media with effusion. The largest effects of antibiotics were seen in children treated continuously for four weeks and three months. Even when clear and relevant benefits of antibiotics have been demonstrated, these must be balanced against the potential adverse effects when making treatment decisions. Immediate adverse effects of antibiotics are common and the emergence of bacterial resistance has been causally linked to the widespread use of antibiotics for common conditions such as otitis media.

Good agreement between parents and physician in the assessment of ear discharge in children.

Physicians often rely on parental observation of ear discharge in the follow-up after its treatment, but little is known about the reliability of this assessment. Follow-up data of trial participants treated for acute or chronic ear discharge showed a good agreement between parents' and physician's assessment, with high positive predictive values, but lower negative predictive values.

Bone metabolic activity in hyperostosis cranialis interna measured with 18F-fluoride PET.

PURPOSE: (18)F-Fluoride PET/CT is a relatively undervalued diagnostic test to measure bone metabolism in bone diseases. Hyperostosis cranialis interna (HCI) is a (hereditary) bone disease characterised by endosteal hyperostosis and osteosclerosis of the skull and the skull base. Bone overgrowth causes entrapment and dysfunction of several cranial nerves. The aim of this study is to compare standardised uptake values (SUVs) at different sites in order to quantify bone metabolism in the affected anatomical regions in HCI patients. METHODS: Nine affected family members, seven non-affected family members and nine non-HCI non-family members underwent (18)F-fluoride PET/CT scans. SUVs were systematically measured in the different regions of interest: frontal bone, sphenoid bone, petrous bone and clivus. Moreover, the average (18)F-fluoride uptake in the entire skull was measured by assessing the uptake in axial slides. Visual assessment of the PET scans of affected individuals was performed to discover the process of disturbed bone metabolism in HCI. RESULTS: (18)F-Fluoride uptake is statistically significantly higher in the sphenoid bone and clivus regions of affected family members. Visual assessment of the scans of HCI patients is relevant in detecting disease severity and the pattern of disturbed bone metabolism throughout life. CONCLUSION: (18)F-Fluoride PET/CT is useful in quantifying the metabolic activity in HCI and provides information about the process of disturbed bone metabolism in this specific disorder. Limitations are a narrow window between normal and pathological activity and the influence of age. This study emphasises that (18)F-fluoride PET/CT may also be a promising diagnostic tool for other metabolic bone disorders, even those with an indolent course.