Acute Otitis Media Severity Research Articles

Exploring the Impact of Dietary Interventions on the Incidence and Severity of Acute Otitis Media: A Randomized Controlled Trial

Exploring the Impact of Dietary Interventions on the Incidence and Severity of Acute Otitis Media: A Randomized Controlled Trial

Improving Prescribing for Otitis Media in a Pediatric Emergency Unit: A Quality Improvement Initiative.

We performed a quality improvement project to improve antibiotic prescribing in a tertiary pediatric EU over 16 months, focusing on shorter prescription durations and WSPs. We assessed AOM management via chart review, then implemented interventions, including clinician education, a guideline card, visual reminders, and updated emails. In addition, we contacted a percentage of families after their visit to assess their child's outcome and parental satisfaction. Our baseline data showed that only 39% of patients prescribed antibiotics were prescribed an appropriate duration based on age and estimated AOM severity, and only 3% were prescribed WSPs. Via 2 plan-do-study-act (PDSA) cycles, we increased the percentage of patients who received appropriate antibiotics to an average of 67%, sustained for >6 months. Follow-up phone calls suggested no difference in satisfaction or need for nonroutine follow-up care based on prescription length. We did not see a substantial increase in WSPs. AOM management in our children's hospital's EU was often inconsistent with AAP guidelines. Two PDSA cycles improved the rate of appropriate duration antibiotics, and follow-up phone calls suggested no difference in satisfaction or need for nonroutine follow-up care based on prescription length. The next steps involve developing an order set and implementing individualized feedback.

347. SARS-CoV-2 and Acute Otitis Media in Children: A Case Series

BackgroundReports in adults with COVID-19 and acute otitis media (AOM) show that severe symptoms and hearing loss may be more common than with the clinical presentation of typical AOM. However, the association of SARS-CoV-2 with AOM in children is poorly understood. MethodsCases were identified as a subpopulation enrolled in the NOTEARS prospective AOM study in Denver, CO from March-December 2020. Children enrolled were 6-35 months of age with uncomplicated AOM and prescribed amoxicillin. Children diagnosed with AOM and SARS-CoV-2, detected by polymerase chain reaction assay, were included in the case series. Data was obtained from electronic medical records and research case report forms. Patients completed surveys at enrollment and 5, 14 and 30 days after enrollment that included the Acute Otitis Media Severity of Symptoms (AOM-SOS©) scale. All patients had nasopharyngeal otopathogen testing completed.ResultsA total of 108 patients had been enrolled through December 2020 (all of whom were subsequently tested for SARS CoV-2). During the study period for this case series, 16 patients were enrolled, and 7 (43.6%) were identified with AOM/SARS-CoV-2 co-infection. Among these 7 patients, fever was present in 3 children (29%). Four children (57%) attended daycare. Only 2 children (29%) had testing for SARS CoV-2 as part of their clinical workup. Mean AOM-SOS© scores were similar among the SARS CoV-2 positive and negative patients with no statistical significance noted with two-sided t-tests: 13.6 (± 4.5) vs 14.2 (± 4.9) at enrollment, 1.4 (± 1.8) vs 4.2 (±4.9) on Day 5, and 0.6 (± 0.9) vs. 2.5 (±6.1) on Day 14 (Table 1). Among the 7 patients, no child had an AOM treatment failure or recurrence. Of the 6 patients in whom bacterial and viral testing have been completed, a bacterial otopathogen was identified in 6 (100%), and a viral pathogen in 3 (50%) children (Table 2).Table 1. Clinical features of children with concurrent SARS-CoV-2 and AOM Table 2. Laboratory findings of children with concurrent SARS-CoV-2 and AOM. ConclusionSARS-CoV-2 can occur in children with AOM. It is important that providers maintain a high index of suspicion for COVID-19 even in patients with clinical evidence of AOM, particularly to ensure families are appropriately advised on isolation and quarantine requirements. AOM with SARS-CoV-2 does not appear to be more severe than AOM without SARS-CoV-2. Disclosures Samuel R. Dominguez, MD, PhD, BioFire Diagnostics (Consultant, Research Grant or Support)DiaSorin Molecular (Consultant)Pfizer (Grant/Research Support) Samuel R. Dominguez, MD, PhD, BioFire (Individual(s) Involved: Self): Consultant, Research Grant or Support; DiaSorin Molecular (Individual(s) Involved: Self): Consultant; Pfizer (Individual(s) Involved: Self): Grant/Research Support

Streptococcus pneumoniae Serotypes Carried by Young Children and Their Association With Acute Otitis Media During the Period 2016-2019.

Background: Streptococcus pneumoniae (Sp) is a major cause of acute otitis media (AOM). Pneumococcal conjugate vaccine (PCV) programs have altered pneumococcal serotype epidemiology in disease and carriage. In this study, we used samples collected during a cross-sectional study to examine if the clinical picture of acute otitis media (AOM) in young children exposed to the PCV program in Belgium was related to the carried pneumococcal strains, and if their carriage profile differed from healthy children attending daycare centers.Material/Methods: In three collection periods from February 2016 to May 2018, nasopharyngeal swabs and background characteristics were collected from children aged 6–30 months either presenting at their physician with AOM (AOM-group) or healthy and attending day care (DCC-group). Clinical signs of AOM episodes and treatment schedule were registered by the physicians. Sp was detected, quantified, and characterized using both conventional culture analysis and real-time PCR analysis.Results: Among 3,264 collected samples, overall pneumococcal carriage and density were found at similar rates in both AOM and DCC. As expected non-vaccine serotypes were most frequent: 23B (AOM: 12.3%; DCC: 17.4%), 11A (AOM: 7.5%; DCC: 7.4%) and 15B (AOM: 7.5%; DCC: 7.1%). Serotypes 3, 6C, 7B, 9N, 12F, 17F, and 29 were more often found in AOM than in DCC (p-value < 0.05), whereas 23A and 23B were less often present in AOM (p-value < 0.05). Antibiotic non-susceptibility of Sp strains was similar in both groups. No predictors of AOM severity were identified.Conclusion: In the present study, overall carriage prevalence and density of S. pneumoniae were found similar in young children with AOM and in healthy children attending day-care centers in Belgium. Certain serotypes not currently included in the PCV vaccines were found to be carried more often in children with AOM than in DCC, a finding that might suggest a relationship between these serotypes and AOM.

Clinical practice guidelines for the diagnosis and management of acute otitis media in children—2018 update

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. MethodsThe 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. ResultsWe 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. ConclusionsPrecise otoscopic findings are essential for judging AOM severity, which can lead to appropriate management of AOM patients.

Hot Off the Press: Video for Acute Otitis Media Discharge Instructions.

Acute otitis media (AOM) in children is a common illness that results in numerous visits to health care providers for the management of pain and fever. Children often continue to experience pain, fever, or both up to a week after their initial visit, which has a significant effect on the patient and their caregiver. Unfortunately, less than 30% of parents receive instructions on pain management. Thus, there is a clear need to improve the delivery of discharge instructions for AOM.

Survey on the severity of acute otitis media in outpatient children at an otolaryngology clinic

Survey on the severity of acute otitis media in outpatient children at an otolaryngology clinic

Updated Guidelines for the Management of Acute Otitis Media in Children by the Italian Society of Pediatrics: Diagnosis.

In recent years, new progress has been made regarding the diagnosis, treatment and prevention of acute otitis media (AOM). The Italian Pediatric Society therefore decided to issue an update to the previous guidelines published in 2010. Literature searches were conducted on MEDLINE by Pubmed, including studies in children, in English or Italian, published between January 1, 2010, and December 31, 2018. The quality of the included studies was assessed using the grading of recommendations, assessment, development and evaluations (GRADE) methodology. In particular, the quality of the systematic reviews was evaluated using the AMSTAR 2 appraisal tool. The guidelines were formulated using the GRADE methodology by a multidisciplinary panel of experts. The diagnosis of AOM is based on acute clinical symptoms and otoscopic evidence; alternatively, the presence of otorrhea associated with spontaneous tympanic membrane perforation allows the AOM diagnosis. The diagnosis of AOM must be certain and the use of a pneumatic otoscope is of fundamental importance. As an alternative to the pneumatic otoscope, pediatricians can use a static otoscope and a tympanometer. To objectively establish the severity of the episode for the formulation of a correct treatment program, an AOM severity scoring system taking into account clinical signs and otoscopic findings was developed. The diagnosis of AOM is clinical and requires the introduction of specific medical training programs. The use of pneumatic otoscopes must be promoted, as they are not sufficiently commonly used in routine practice in Italy.

Video Discharge Instructions for Acute Otitis Media in Children: A Randomized Controlled Open-label Trial.

Thirty percent of children with acute otitis media (AOM) experience symptoms<7 days after initiating treatment, highlighting the importance of comprehensive discharge instructions. We randomized caregivers of children 6 months to 17 years presenting to the emergency department (ED) with AOM to discharge instructions using a video on management of pain and fever to a paper handout. The primary outcome was the AOM Severity of Symptom (AOM-SOS) score at 72 hours postdischarge. Secondary outcomes included caregiver knowledge (10-item survey), absenteeism, recidivism, and satisfaction (5-item Likert scale). A total of 219 caregivers were randomized and 149 completed the 72-hour follow-up (72 paper and 77 video). The median (IQR) AOM-SOS score for the video was significantly lower than paper, even after adjusting for preintervention AOM-SOS score and medication at home (8 [7-11] vs. 10 [7-13], respectively; p=0.004). There were no significant differences between video and paper in mean (±SD) knowledge score (9.2 [±1.3] vs. 8.8 [±1.8], respectively; p=0.07), mean (±SD) number of children that returned to a health care provider (8/77 vs. 10/72, respectively; p=0.49), mean (±SD) number of daycare/school days missed by child (1.2 [±1.5] vs. 1.1 [±2.1], respectively; p=0.62), mean (±SD) number of workdays missed by caregiver (0.5 [±1] vs. 0.8 [±2], respectively; p=0.05), or median (IQR) satisfaction score (5 [4-5] vs. 5 [4-5], respectively; p=0.3). Video discharge instructions in the ED are associated with less perceived AOM symptomatology compared to a paper handout.

Probiotics for preventing acute otitis media in children.

Acute otitis media (AOM), or acute middle ear infection, is one of the most frequently occurring childhood diseases, and the most common reason given for prescribing antibiotics in this age group. Guidelines often recommend antibiotics as first-line treatment for severe AOM. However, antibiotics also lead to antibiotic resistance, so preventing episodes of AOM is an urgent priority. To assess the effects of probiotics to prevent the occurrence and reduce the severity of acute otitis media in children. We searched CENTRAL, PubMed, Embase, and three other databases (October 2018), two trial registers (October 2018), and conducted a backwards and forwards citation analysis (August 2018). We did not apply any language, publication date, or publication status restrictions. Randomised controlled trials (RCTs) of children (aged up to 18 years), comparing probiotics with placebo, usual care, or no probiotic. Two review authors independently assessed the eligibility of trials for inclusion and risk of bias of the included trials, and extracted data using pre-piloted data extraction forms. We analysed dichotomous data as either risk ratio (RR) or odds ratios (OR) and continuous data as mean differences (MD). We included 17 RCTs involving 3488 children, of which 16 RCTs were included in the meta-analyses. Of the 16 RCTs that reported the mean age of children, mean age overall was 2.4 years; in 4 RCTs the mean age of children participating in the trial was less than 1 year old; in 2 RCTs the mean age was between 1 and 2 years old; and in 10 RCTs the mean age was older than 2 years. Probiotic strains evaluated by the trials varied, with 11 of the included RCTs evaluating Lactobacillus-containing probiotics, and six RCTs evaluating Streptococcus-containing probiotics.The proportion of children (i.e. the number of children in each group) experiencing one or more episodes of AOM during the treatment was lower for those taking probiotics (RR 0.77, 95% confidence interval (CI) 0.63 to 0.93; 16 trials; 2961 participants; number needed to treat for an additional beneficial outcome (NNTB) = 10; moderate-certainty evidence).Post hoc subgroup analysis found that among children not prone to otitis media, a lower proportion of children receiving probiotics experienced AOM (RR 0.64, 95% CI 0.49 to 0.84; 11 trials; 2227 participants; NNTB = 9; moderate-certainty evidence). However, among children who were otitis prone, there was no difference between probiotic and comparator groups (RR 0.97, 95% CI 0.85 to 1.11; 5 trials; 734 participants; high-certainty evidence). The test for subgroup differences was significant (P = 0.007).None of the included trials reported on the severity of AOM.The proportion of children experiencing adverse events did not differ between the probiotic and comparator groups (OR 1.54, 95% CI 0.60 to 3.94; 4 trials; 395 participants; low-certainty evidence).Probiotics decreased the proportion of children taking antibiotics for any infection (RR 0.66, 95% CI 0.51 to 0.86; 8 trials; 1768 participants; NNTB = 8; moderate-certainty evidence). Test for subgroup differences (use of antibiotic specifically for AOM, use of antibiotic for infections other than AOM) was not significant.There was no difference in the mean number of school days lost (MD -0.95, 95% CI -2.47 to 0.57; 5 trials; 1280 participants; moderate-certainty evidence). There was no difference between groups in the level of compliance in taking the intervention (RR 1.02, 95% CI 0.99 to 1.05; 5 trials; 990 participants).Probiotics decreased the proportion of children having other infections (RR 0.75, 95% CI 0.65 to 0.87; 11 trials; 3610 participants; NNTB = 12; moderate-certainty evidence). Test for subgroup differences (acute respiratory infections, gastrointestinal infections) was not significant.Probiotic strains trialled and their dose, frequency, and duration of administration varied considerably across studies, which likely contributed to the substantial levels of heterogeneity. Sensitivity testing of funnel plots did not reveal publication bias. Probiotics may prevent AOM in children not prone to AOM, but the inconsistency of the subgroup analyses suggests caution in interpreting these results. Probiotics decreased the proportion of children taking antibiotics for any infection. The proportion of children experiencing adverse events did not differ between the probiotic and comparator groups. The optimal strain, duration, frequency, and timing of probiotic administration still needs to be established.

Probiotics for preventing acute otitis media in children

Background Acute otitis media (AOM), or acute middle ear infection, is one of the most frequently occurring childhood diseases, and the most common reason given for prescribing antibiotics in this age group. Guidelines often recommend antibiotics as first-line treatment for severe AOM. However, antibiotics also lead to antibiotic resistance, so preventing episodes of AOM is an urgent priority. Objectives To assess the effects of probiotics to prevent the occurrence and reduce the severity of acute otitis media in children. Search methods We searched CENTRAL, PubMed, Embase, and three other databases (October 2018), two trial registers (October 2018), and conducted a backwards and forwards citation analysis (August 2018). We did not apply any language, publication date, or publication status restrictions. Selection criteria Randomised controlled trials (RCTs) of children (aged up to 18 years), comparing probiotics with placebo, usual care, or no probiotic. Data collection and analysis Two review authors independently assessed the eligibility of trials for inclusion and risk of bias of the included trials, and extracted data using pre-piloted data extraction forms. We analysed dichotomous data as either risk ratio (RR) or odds ratios (OR) and continuous data as mean differences (MD). Main results We included 17 RCTs involving 3488 children, of which 16 RCTs were included in the meta-analyses. Of the 16 RCTs that reported the mean age of children, mean age overall was 2.4 years; in 4 RCTs the mean age of children participating in the trial was less than 1 year old; in 2 RCTs the mean age was between 1 and 2 years old; and in 10 RCTs the mean age was older than 2 years. Probiotic strains evaluated by the trials varied, with 11 of the included RCTs evaluating Lactobacillus-containing probiotics, and six RCTs evaluating Streptococcus-containing probiotics.The proportion of children (i.e. the number of children in each group) experiencing one or more episodes of AOM during the treatment was lower for those taking probiotics (RR 0.77, 95% confidence interval (CI) 0.63 to 0.93; 16 trials; 2961 participants; number needed to treat for an additional beneficial outcome (NNTB) = 10; moderate-certainty evidence).Post hoc subgroup analysis found that among children not prone to otitis media, a lower proportion of children receiving probiotics experienced AOM (RR 0.64, 95% CI 0.49 to 0.84; 11 trials; 2227 participants; NNTB = 9; moderate-certainty evidence). However, among children who were otitis prone, there was no difference between probiotic and comparator groups (RR 0.97, 95% CI 0.85 to 1.11; 5 trials; 734 participants; high-certainty evidence). The test for subgroup differences was significant (P = 0.007).None of the included trials reported on the severity of AOM.The proportion of children experiencing adverse events did not differ between the probiotic and comparator groups (OR 1.54, 95% CI 0.60 to 3.94; 4 trials; 395 participants; low-certainty evidence).Probiotics decreased the proportion of children taking antibiotics for any infection (RR 0.66, 95% CI 0.51 to 0.86; 8 trials; 1768 participants; NNTB = 8; moderate-certainty evidence). Test for subgroup differences (use of antibiotic specifically for AOM, use of antibiotic for infections other than AOM) was not significant.There was no difference in the mean number of school days lost (MD -0.95, 95% CI -2.47 to 0.57; 5 trials; 1280 participants; moderate-certainty evidence). There was no difference between groups in the level of compliance in taking the intervention (RR 1.02, 95% CI 0.99 to 1.05; 5 trials; 990 participants).Probiotics decreased the proportion of children having other infections (RR 0.75, 95% CI 0.65 to 0.87; 11 trials; 3610 participants; NNTB = 12; moderate-certainty evidence). Test for subgroup differences (acute respiratory infections, gastrointestinal infections) was not significant.Probiotic strains trialled and their dose, frequency, and duration of administration varied considerably across studies, which likely contributed to the substantial levels of heterogeneity. Sensitivity testing of funnel plots did not reveal publication bias. Authors' conclusions Probiotics may prevent AOM in children not prone to AOM, but the inconsistency of the subgroup analyses suggests caution in interpreting these results. Probiotics decreased the proportion of children taking antibiotics for any infection. The proportion of children experiencing adverse events did not differ between the probiotic and comparator groups. The optimal strain, duration, frequency, and timing of probiotic administration still needs to be established.

Role of a proprietary propolis-based product on the wait-and-see approach in acute otitis media and in preventing evolution to tracheitis, bronchitis, or rhinosinusitis from nonstreptococcal pharyngitis

Antipyretics and/or anti-inflammatory drugs along with a wait-and-see approach are the only treatments recommended in early acute otitis media (AOM) or viral pharyngitis. Propolis has been widely investigated for its antibacterial, antiviral, and anti-inflammatory properties and could perhaps be administered as an add-on therapy during watchful waiting in AOM or for better control of symptoms in nonstreptococcal pharyngitis. However, propolis has well-known problems of poor solubility and low oral bioavailability. We therefore analyzed a proprietary propolis-based product (Propolisina®) developed to overcome these limitations, in a retrospective, open-label, controlled study of Streptococcus pyogenes-negative children with a diagnosis of AOM or pharyngitis. Our results show that the use of propolis supplement for 72 hours lessens the severity of AOM and viral pharyngitis, reduces the use of antipyretics and anti-inflammatory drugs, and decreases the rate of evolution to tracheitis, bronchitis, and rhinosinusitis. Our study shows that propolis could be used as a safe add-on therapy in case of AOM and/or viral pharyngitis.

The Impact of Childhood Acute Otitis Media on Parental Quality of Life in a Prospective Observational Cohort Study.

Background and ObjectivesAcute otitis media (AOM) not only affects childhood quality of life (QoL), but can also affect parental QoL. We adapted a previously published questionnaire on the effect of childhood recurrent ear, nose and throat infections on parental QoL for use with AOM and used it in an observational, multicentre, prospective study of children with AOM.MethodsThe AOM-specific parental QoL questionnaire grouped 15 items into emotional, daily disturbance, total and overall parental QoL impact scores. The questionnaire was assessed using item-convergent and item-discriminant validity criteria and internal consistency reliability; and then used with parents of children aged <6 years diagnosed with AOM at 73 practices in Germany, Italy, Spain, Sweden and the UK. Bivariate analyses explored the differences in mean parental QoL impact scores by various characteristics.ResultsThe questionnaire demonstrated good to excellent internal consistency reliability for the various components (Cronbach’s α 0.82–0.97). There were 1419 AOM episodes among 5882 healthy children over 1 year, of which 1063 episodes (74.9 %) among 852 children had a questionnaire. Parents reported interrupted sleep (68.4 %), worry (51.0 %), altered daily schedule (44.6 %) and less leisure time (41.5 %) with a score ≥3 (1 = least to 5 = most impact). Factors that adversely affected parental QoL included: increased parental perception of AOM severity, younger child age and multiple AOM episodes.ConclusionsThe AOM-specific parental QoL questionnaire demonstrated good performance across five European countries. Parental QoL was affected by childhood AOM proportionally to severity, number of episodes and younger child age.Electronic supplementary materialThe online version of this article (doi:10.1007/s40261-015-0319-1) contains supplementary material, which is available to authorized users.

Symptoms and Otoscopic Signs in Bilateral and Unilateral Acute Otitis Media

Bilateral acute otitis media (AOM) is considered more severe than unilateral AOM, and several guidelines recommend more active treatment and/or follow-up of bilateral AOM. We studied whether bilateral AOM is a clinically more severe illness than unilateral AOM by comparing symptoms and otoscopic signs between bilateral and unilateral AOM. Two hundred thirty-two children aged 6 to 35 months diagnosed with AOM were eligible. We surveyed the symptoms with a structured questionnaire and recorded the otoscopic signs systematically. Ninety-eight children had bilateral and 134 children unilateral AOM. Children with bilateral AOM were more often <24 months than children with unilateral AOM (87% vs 75%; P = .032). Fever (≥38°C) occurred in 54% and 36% (P = .006) and severe conjunctivitis in 16% and 44% (P = .047) of children with bilateral and unilateral AOM, respectively. In 15 other symptoms, we found no overall differences even when adjusted with age. We observed the following severe otoscopic signs in the bilateral and unilateral AOM group, respectively: moderate/marked bulging of tympanic membrane (63% and 40%; P = .001), purulent effusion (89% and 71%; P = .001), bulla formation (11% and 10%; P = .707), and hemorrhagic redness of tympanic membrane (7% and 10%; P = .386). Bilateral AOM seems to be a clinically only slightly more severe illness than unilateral AOM. Therefore, when assessing AOM severity, bilaterality should not be used as a determining criterion; instead, the child's symptomatic condition together with otoscopic signs should also be taken into consideration.

Acute otitis media severity: Association with cytokine gene polymorphisms and other risk factors

Background We have previously shown an association between polymorphisms of proinflammatory cytokine genes and susceptibility to upper respiratory tract infection and acute otitis media. It has not been known whether polymorphisms or risk factors are associated with the severity of acute otitis media. Objective To evaluate the influences of proinflammatory cytokine gene polymorphisms and other risk factors on severity of acute otitis media following upper respiratory tract infection. Methods In a prospective, longitudinal study, children aged 6–35 months were followed for one year for occurrences of upper respiratory tract infection and acute otitis media. Children were studied for TNFα −308, interleukin (IL)-6 −174 and IL-1β +3953 polymorphisms, taking into account age, gender, race, family history of otitis, tobacco smoke exposure, breast feeding, day of upper respiratory tract infection at the time of diagnosis and pneumococcal vaccine status. Symptoms and signs of acute otitis media were graded according to a validated scale. The association between acute otitis media clinical severity, polymorphic genotypes, and risk factors were analyzed using statistical models that account for multiple episodes of acute otitis media per child. Results A total of 295 episodes of acute otitis media in 128 subjects was included. More severe acute otitis media symptoms were associated with young age ( P = 0.01), family history of acute otitis media ( P = 0.002), tobacco smoke exposure ( P = 0.008), and early diagnosis of otitis after onset of upper respiratory tract infection ( P = 0.02). Among children with a bulging or perforated tympanic membrane (206 episodes, 104 subjects), those who had the IL-1 β +3953 polymorphism, experienced higher symptom scores ( P < 0.02). Conclusion This is the first report of the association between risk factors and acute otitis media severity. Risk factors such as tobacco smoke exposure and a positive family history appear to be more significantly associated with acute otitis media severity than proinflammatory gene polymorphisms. Clinical severity may be an important factor contributing to the incidence and costs of acute otitis media, because children with more severe symptoms might be more likely to be brought for a medical visit, receive a diagnosis of acute otitis media, and be prescribed an antibiotic.

Quality of life of children and their caregivers during an AOM episode: development and use of a telephone questionnaire

BackgroundThe negative consequences of acute otitis media (AOM) on the quality of life (QOL) of children and their families need to be measured to assess benefits of preventive interventions.MethodsA new questionnaire was specifically designed for use in telephone surveys. A random sample of Canadian families was selected using random-digit dialling. Caregivers of children 6-59 months of age who experienced at least one AOM episode during the last 12 months were interviewed. Multidimensional severity and global QOL scores were measured both for affected children and their caregivers. Internal consistency of scores was assessed using standard tests.ResultsOf the 502 eligible caregivers who completed the survey, 161 (32%) reported at least one AOM episode during the last 12 months and these cases were included in the analysis. Average severity was 2.6 for children and 2.4 for caregivers on a 1 to 4 scale (maximum severity). Cronbach alpha values were 0.78 and 0.81 for the severity score of children and caregivers respectively. Average QOL was 3.4 for children and 3.5 for caregivers on a 1 to 5 scale (best QOL). There was moderate to high correlation between severity and QOL scores, and between these scores and duration of AOM episodes.ConclusionsThe questionnaire was easy to use during telephone interviews and results suggest good reliability and validity of the different scores to measure AOM severity and QOL of children and their caregivers during an AOM episode.

Laterality of Acute Otitis Media: Different Clinical and Microbiologic Characteristics

A large individual patient data meta-analysis recently showed that children aged less than 2 years with bilateral, as compared with unilateral, acute otitis media (AOM) were at higher risk for persistent symptoms without antibiotic treatment. Prior studies have shown a propensity for children with bilateral AOM to be infected with bacterial pathogens, specifically Haemophilus influenzae. The objectives of this study were to further characterize risk factors for bilateral AOM and to assess the propensity for specific viral and bacterial pathogens to predispose to bilateral versus unilateral AOM. We performed a secondary data analysis on 1216 cases of AOM diagnosed and treated at our institution: 566 subjects underwent tympanocentesis and middle ear fluid (MEF) culture. We compared subjects with bilateral and unilateral AOM for demographic characteristics, clinical findings, parent/clinician perception of AOM severity, and MEF study results for bacteria and viruses. When compared with children who have unilateral AOM, children with bilateral AOM were more likely to be younger (P < 0.001), have H. influenzae isolated from one or both MEFs (P < 0.0001), and have more severe inflammation of the tympanic membrane on otoscopic examination (P < 0.0001). Compared with children who have unilateral AOM, children with bilateral AOM are more likely to have bacteria in the MEF and have more severe inflammation of the tympanic membrane. This may help explain why children with bilateral AOM are more likely to experience persistent symptoms without antibiotic treatment. Laterality of AOM should be considered when discussing treatment options with parents.

Role of Toll-like receptor 4 in innate immune responses in a mouse model of acute otitis media

Nontypeable Haemophilus influenzae (NTHi) is considered a major pathogen underlying middle ear infection. This study characterized the role of Toll-like receptor 4 in the innate immune responses to acute otitis media induced by NTHi in mice. We used C3H/HeJ mice, which have nonfunctional Toll-like receptor 4, and normal wild-type C3H/HeN mice. NTHi were injected into the tympanic bulla, and middle ear effusions and tissues were collected. In C3H/HeN mice, the severity of acute otitis media decreased promptly with a significant reduction in bacterial recovery from middle ear effusions 48 h after injection. In contrast, all C3H/HeJ mice had otitis media at all time points examined, and increasing bacterial counts from middle ear effusions were detected in C3H/HeJ mice 72 h after injection. Expression of intracellular adhesion molecule-1 by the middle ear mucosa paralleled the number of polymorphonuclear cells in the middle ear in both strains. The findings of transmission electron microscopy revealed that phagocytosis and phagosome maturation of polymorphonuclear cells was impaired in C3H/HeJ mice. Our findings indicate that Toll-like receptor 4 plays a part in the early accumulation and functional promotion of polymorphonuclear cells in the middle ear for eradicating NTHi infection.

Development of a Practical Tool for Assessing the Severity of Acute Otitis Media

Watchful waiting management of nonsevere acute otitis media (AOM) can reduce the use of antibiotics, but it requires a reliable means of assessing clinical severity. We present the development of a pocket AOM card with which the clinician can rapidly assess total AOM severity. The components of the pocket card consisted of a faces scale, to assess parent perception of severity, and a standard set of tympanic membrane photographs, with which the pediatrician can grade the severity of tympanic membrane inflammation. The components of the pocket card were tested for validity, reliability and responsiveness with the use of data from parents, pediatricians and pediatric otolaryngologists. Instruments were assessed for concurrent correlation, sequence validity and reliability against previously published questionnaires with the use of Spearman correlation. Responsiveness was calculated with the use of enrollment, day 12 and day 30 data from a randomized clinical trial. The components of the pocket AOM card demonstrated excellent sequence validity, concurrent correlation and reliability (r = 0.58-0.99). Total AOM card severity, consisting of the sum of the 2 scales, demonstrated better responsiveness to change than any of the scales taken individually. The AOM card combines a parent assessment of symptoms and the clinician assessment of the tympanic membrane to provide an assessment of total AOM severity that can be used to facilitate shared decision making between parent and clinician. The combined score of the AOM card was more responsive to change than any of the instruments used alone. The AOM card provides a useful tool for teaching and research.

Nonsevere Acute Otitis Media: A Clinical Trial Comparing Outcomes of Watchful Waiting Versus Immediate Antibiotic Treatment

The widespread use of antibiotics for treatment of acute otitis media (AOM) has resulted in the emergence of multidrug-resistant pathogens that are difficult to treat. However, it has been shown that most children with nonsevere AOM recover without ABX. The objective of this study was to evaluate the safety, efficacy, acceptability, and costs of a non-ABX intervention for children with nonsevere AOM. Children 6 months to 12 years old with AOM were screened by using a novel AOM-severity screening index. Parents of children with nonsevere AOM received an educational intervention, and their children were randomized to receive either immediate antibiotics (ABX; amoxicillin plus symptom medication) or watchful waiting (WW; symptom medication only). The investigators, but not the parents, were blinded to enrollment status. Primary outcomes included parent satisfaction with AOM care, resolution of symptoms, AOM failure/recurrence, and nasopharyngeal carriage of Streptococcus pneumoniae strains resistant to ABX. Secondary outcomes included medication-related adverse events, serious adverse events, unanticipated AOM-related office and emergency department visits and telephone calls, the child's absence from day care or school resulting from AOM, the parent's absence from school or work because of their child's AOM, and costs of treatment. Subjects were defined as failing (days 0-12) or recurring (days 13-30) if they experienced a higher AOM-severity score on reexamination. A total of 223 subjects were recruited: 73% were nonwhite, 57% were <2 years old, 47% attended day care, 82% had experienced prior AOM, and 83% had not been fully immunized with heptavalent pneumococcal vaccine. One hundred twelve were randomized to ABX, and 111 were randomized to WW. Ninety-four percent of the subjects were followed to the 30-day end point. Parent satisfaction with AOM care was not different between the 2 treatment groups at either day 12 or 30. Compared with WW, symptom scores on days 1 to 10 resolved faster in subjects treated with immediate ABX. At day 12, among the immediate-ABX group, 69% of tympanic membranes and 25% of tympanograms were normal, compared with 51% of normal tympanic membranes and 10% of normal tympanograms in the WW group. Parents of children in the ABX group gave their children fewer doses of pain medication than did parents of children in the WW group. Subjects in the ABX group experienced 16% fewer failures than subjects in the WW group. Of the children in the WW group, 66% completed the study without needing ABX. Immediate ABX resulted in eradication of S pneumoniae carriage in the majority of children, but S pneumoniae strains cultured from children in the ABX group at day 12 were more likely to be multidrug-resistant than strains from children in the WW group. More ABX-related adverse events were noted in the ABX group, compared with the WW group. No serious AOM-related adverse events were observed in either group. Office and emergency department visits, phone calls, and days of work/school missed were not different between groups. Prescriptions for ABX were reduced by 73% in the WW group compared with the ABX group. Costs of ABX averaged $47.41 per subject in the ABX group and $11.43 in the WW group. Sixty-six percent of subjects in the WW group completed the study without ABX. Parent satisfaction was the same between groups regardless of treatment. Compared with WW, immediate ABX treatment was associated with decreased numbers of treatment failures and improved symptom control but increased ABX-related adverse events and a higher percent carriage of multidrug-resistant S pneumoniae strains in the nasopharynx at the day-12 visit. Key factors in implementing a WW strategy were (a) a method to classify AOM severity; (b) parent education; (c) management of AOM symptoms; (d) access to follow-up care; and (e) use of an effective ABX regimen, when needed. When these caveats are observed, WW may be an acceptable alternative to immediate ABX for some children with nonsevere AOM.