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Otitis media with effusion (OME) is a common childhood disease defined as the presence of liquid in the middle ear without signs or symptoms of acute ear infection. Children can be impacted mainly with hearing impairment and/or co-occurring recurrent acute otitis media (AOM) thus requiring treatment. Although many meta-analyses and national guidelines have been issued, management remains difficult to standardize, and use of surgical and medical treatments continue to vary. We convened an international consensus conference as part of the 2017 International Federation of Oto-rhino-laryngological Societies Congress, to identify best practices in OME management. Overall, regional differences were minor and consensual management was obtained on several important issues. At initial assessment, although a thorough medical examination is necessary to seek reflux, allergy or nasal obstruction symptoms; an age-appropriate auditory test is the only assessment required in children without abnormal history. Non-surgical treatments poorly address the underlying problem of an age-dependent dysfunctional Eustachian tube; auto-inflation seems to be the only beneficial, low-risk and low-cost non-surgical therapy. There was a clear international recommendation against using steroids, antibiotics, decongestants or antihistamines to treat OME, because of side-effects, cost issues and no convincing evidence of long-term effectiveness. Decisions to insert tympanostomy ventilation tubes should be based on an auditory test but also take into account the child's context and overall hearing difficulties. Tubes significantly improve hearing and reduce the number of recurrent AOM with effusion while in place. Adjuvant adenoidectomy should be considered in children over four years of age, and in those with significant nasal obstruction or infection.

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OBJECTIVE: To familiarize otolaryngologists with the Agency for Healthcare Research and Quality (AHRQ) Evidence Report on Acute Otitis Media (AOM) that reviews the natural history and role of antibiotics in management. The report, by the Southern California Evidence-Based Practice Center (SC-EPC), is the most recent of 15 literature syntheses published by the AHRQ. DATA SOURCES: MEDLINE (1966 to present), Cochrane Library, EMBASE, BIOSIS, HealthSTAR, and other computerized databases; manual reference search of proceedings, articles, reports, and guidelines. STUDY SELECTION: Randomized trials and cohort studies relevant to the natural history of AOM and the efficacy of antimicrobial therapy. AOM was defined by the 11-member technical expert panel (including 2 authors, RMR and MLC) as middle-ear effusion with the rapid onset of signs or symptoms of middle ear inflammation. DATA EXTRACTION: Two physician reviewers at the Southern California Evidence-Based Practice Center independently rated the articles and extracted data. DATA SYNTHESIS: Children receiving placebo or no antimicrobial had a pooled clinical success rate of 81% at 1 to 7 days (95% CI, 72% to 90%), with no increase in suppurative complications when followed closely. Amoxicillin or ampicillin increased the absolute success rate by 12.3% (95% CI, 2.8% to 21.8%) in 5 studies pooled using random effects meta-analysis. The antimicrobial benefit was robust to sensitivity analysis. In contrast, success rates were not influenced by the choice or duration of therapy. CONCLUSIONS: The AHRQ report emphasizes middle-ear effusion as a preeminent criteria for AOM diagnosis and provides extensive evidence tables on natural history and antimicrobial impact. About 8 children must receive antibiotics to avoid 1 clinical failure, but children younger than age 2 years or with severe symptoms may benefit more. The report is a starting point for organizations seeking to develop AOM guidelines, performance measures, and other quality improvement tools.

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OBJECTIVE: To estimate the incidence of tympanostomy tube sequelae based on systematic review of published case series and randomized studies. DATA SOURCES: English-language MEDLINE search from 1966 through April 1999 with manual reference search of proceedings, articles, reports, and guidelines. STUDY SELECTION: Cohort studies with otitis media as the primary indication for tube placement. DATA EXTRACTION: Two reviewers independently extracted data from 134 articles. DATA SYNTHESIS: Transient otorrhea occurred in 16% of patients in the postoperative period and later in 26%; recurrent otorrhea occurred in 7.4% of patients and chronic otorrhea in 3.8%. Sequelae of indwelling tubes included obstruction (7% of ears), granulation tissue (5%), premature extrusion (3.9%), and medial displacement (0.5%). Sequelae after tube extrusion included tympanosclerosis (32%), focal atrophy (25%), retraction pocket (3.1%), cholesteatoma (0.7%), and perforation (2.2% with short-term tubes, 16.6% with long-term tubes). Meta-analysis showed that long-term tubes increased the relative risk of perforation by 3.5 (95% CI, 1.5 to 7.1) and cholesteatoma by 2.6 (95% CI, 1.5 to 4.4). Similarly, intubation increased the relative risk of tympanosclerosis by 3.5 (95% CI, 2.6 to 4.9) and focal atrophy by 1.7 (95% CI, 1.1 to 2.7) over nonintubated control ears (baseline tympanosclerosis and atrophy rates of 10% and 14%, respectively). CONCLUSIONS: Sequelae of tympanostomy tubes are common but are generally transient (otorrhea) or cosmetic (tympanosclerosis, focal atrophy). Nonetheless, the high incidence suggests a need for ongoing otologic surveillance of all patients with indwelling tubes and for a reasonable time period after tube extrusion. Long-term tubes should be used on a selective and individualized basis.

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The observation option for acute otitis media (AOM) refers to deferring antibiotic treatment of selected children for up to 3 days, during which time management is limited to analgesics and symptomatic relief. With appropriate follow-up complications are not increased, and clinical outcomes compare favorably with routine initial antibiotic therapy. Although used commonly in the Netherlands and certain Scandinavian countries, this approach has not gained wide acceptance in Europe and the United States. This article describes an evidence-based toolkit developed by the New York Region Otitis Project for judicious use of the observation option. The toolkit is not intended to endorse the observation option as a preferred method of management, nor is it intended as a rigid practice guideline to supplant clinician judgement. Rather, it presents busy clinicians with the tools needed to implement the observation option in everyday patient care should they so desire.

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INTRODUCTION: Quality of life (QOL) is an important outcome measure in cancer therapy. Neck dissection (ND) morbidity has been well studied, but no study has focused on the quality of life after ND specifically. METHODS: Fifty-one patients who have undergone ND completed a 6-item quality-of-life survey with a 7-point frequency and interference response scale. General QOL and comorbidity biases were evaluated with the SF-12 questionnaire and the Charlson comorbidity index. RESULTS: The following symptoms were the most commonly experienced after surgery: neck tightness (71%), numbness or burning of the ear (57%), and shoulder discomfort (53%). However, interference with daily activities was reported by only 37%, 32%, and 33% of patients with these symptoms, respectively. Within 2 years of surgery, interference with daily activities decreased to 17%, 18%, and 12%, respectively. QOL after ND was negatively associated with previous radiation, previous chemotherapy, tumor stage, and more radical neck surgery but was positively associated with time after surgery. Shoulder discomfort and neck tightness had the greatest affect on QOL. CONCLUSIONS: Our results suggest that patients should receive preoperative counseling regarding the morbidities from ND and the possible short-term and long-term impact on QOL. Further studies evaluating the relationship between primary tumor characteristics and quality of life after ND need to be undertaken.

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OBJECTIVE: To determine the quantitative impact of intravenous dexamethasone on recovery after tonsillectomy using established principles for meta-analysis. STUDY DESIGN/SETTING: Double-blind randomized-control trials in which subjects were treated identically except for the presence or absence of perioperative intravenous dexamethasone. Six articles met inclusion criteria. Two investigators extracted data regarding postoperative emesis and return to a soft/regular diet. RESULTS: Pooled analysis using a random effects model revealed a 27% decrease (P<0.00001) in postoperative emesis attributable to dexamethasone (95% CI, 12% to 42%). Dexamethasone increased the tolerance of a soft/regular diet at 24 hours by 22% (P< 0.001), but studies were heterogenous with low precision (95% CI, 1% to 44%). CONCLUSION: To prevent emesis in 1 child after tonsillectomy, approximately 4 children must receive perioperative dexamethasone. An additional benefit is earlier tolerance of a soft/regular diet, but low precision and heterogeneity among studies preclude definitive conclusions. SIGNIFICANCE: Perioperative dexamethasone administration had a positive impact on recovery from tonsillectomy.

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OBJECTIVE: To validate a disease-specific health-related quality of life (HRQOL) instrument for children with obstructive sleep disorders (OSDs). DESIGN: Prospective cohort study using a 6-item health-related instrument (OSD-6). SUBJECTS: One hundred caregivers of patients with OSDs secondary to adenotonsillar hypertrophy (age range, 2-12 years) from 2 tertiary care, pediatric otolaryngology practices. INTERVENTION: The OSD-6 was administered on initial presentation and 4 to 5 weeks after adenotonsillectomy. A subset of patients repeated the OSD-6 within 3 weeks after presentation to assess test-retest reliability. MAIN OUTCOME MEASURES: Test-retest reliability, internal consistency, construct validity, and responsiveness to clinical change of the OSD-6 score. RESULTS: Test-retest reliability was good (intraclass correlation coefficient = 0.74). Median OSD-6 score was 4.5 (0- to 6-point scale) with higher scores indicating poorer quality of life (QOL). Construct validity was demonstrated by the moderate correlation between OSD-6 score and global adenoid and tonsil-related QOL (R = -0.62), strong correlation between the OSD-6 change score and change in global adenoid and tonsil-related QOL (R = -0.63), and the moderate correlation between the change score and parent estimate of clinical change (R = 0.40). The mean change in OSD-6 score after adenotonsillectomy was 3.0 (95% confidence interval, 2.7-3.4). The mean standardized response was 2.3 (95% confidence interval, 1.9-2.7) indicating the instrument's large responsiveness to clinical change. The change score was very reliable (R = 0.85). CONCLUSIONS: The OSD-6 is a reliable, responsive, easily administered instrument. It is valid for detecting change after adenotonsillectomy in children with OSDs. Arch Otolaryngol Head Neck Surg. 2000;126:1423-1429

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The caregivers of 61 eligible children (6 months to 12 years old) completed a 20-item (OSA-20) health-related quality-of-life survey after polysomnography was performed to psychometrically validate the OSA-20. Excellent test-retest reliability was obtained for the individual survey items (R>0.74). Construct validity was shown by significant correlation of the mean survey score with the respiratory distress index (R = 0.43) and adenoid size (R = 0.43). Two items with poor validity were dropped, reducing the survey to 18 items (OSA-18). The relationship between the OSA-18 summary score and respiratory distress index remained significant when adjusted for tonsil size, adenoid size, body mass index, and child age. On the basis of the total survey score, the impact of OSAS on quality of life was small for 20 children (33%), moderate for 19 (31%), and large for 22 (36%). The OSA-18 is a practical means of office-based determination of quality-of-life impact for obstructive sleep apnea syndrome in children.

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BACKGROUND: The objective benefits of tympanostomy tubes for otitis media are well established, but the subjective impact of surgery on child quality of life (QOL) has not been systematically studied. OBJECTIVES: To determine the subjective impact of tympanostomy tubes on child QOL, and to compare the variability in QOL before surgery with that observed after surgery. DESIGN: Prospective, observational, before-and-after trial. SETTING: Fourteen referral-based pediatric otolaryngology practices in the United States. PATIENTS: Consecutive (64%) and convenience (36%) sample of 248 children (median age, 1.4 years) with otitis media scheduled for bilateral tympanostomy tube placement as an isolated surgical procedure. INTERVENTION: Tympanostomy tubes were inserted as part of routine clinical care. Validated measures of QOL (OM-6 survey), satisfaction with health care decision (Satisfaction With Decision Scale), and satisfaction with office visit; surveys were completed at baseline (visit 1), at surgery (visit 2), and after surgery (visit 3). MAIN OUTCOME MEASURES: Short-term changes in QOL before surgery (visit 1 to visit 2) and after surgery (visit 2 to visit 3). RESULTS: Changes in QOL before surgery were mostly trivial, and were smaller than changes observed after surgery (P<.001). Large, moderate, and small improvements in QOL occurred after surgery in 56%, 15%, and 8% of children, respectively. Physical symptoms, caregiver concerns, emotional distress, and hearing loss were most improved, but significant changes were also seen for activity limitations and speech impairment. Trivial changes occurred in 17% of children, and 4% had poorer QOL. Predictors of poorer QOL were otorrhea 3 or more days (10% of variance) and decreased satisfaction with surgical decision (3% of variance). Hearing status, child age, type of otitis media (recurrent vs chronic), and office visit satisfaction were unrelated to outcome. CONCLUSIONS: Tympanostomy tubes produce large short-term improvements in QOL for most children. The best outcomes occur when postoperative otorrhea is absent or minimal, and when parents are satisfied with their initial decision to have surgery. Further research is needed to document the long-term impact of tubes on child QOL.

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OBJECTIVE: To measure the impact of tonsillectomy and adenoidectomy (T&A) on children's behavioral and emotional problems using a standardized assessment. DESIGN: Prospective study. SETTING: Tertiary care children's hospital. PATIENTS: Thirty-six children, aged 2 through 18 years, with symptoms of nighttime snoring, observed apneas, and daytime mouth breathing and physical examination results demonstrating 3+ or 4+ tonsils scheduled for T&A. INTERVENTION: Parents completed a standard survey of their children's symptoms of sleep apnea and a standardized measure of children's competencies and problems, the Child Behavior Checklist for ages 2 through 3 years or 4 through 18 years, before T&A and 3 months postoperatively. MAIN OUTCOME MEASURE: The Child Behavior Checklist total problem score. RESULTS: The preoperative Child Behavior Checklist total problem score was consistent with abnormal behavior for 10 children (28%). After T&A (n = 15), only 2 scores were abnormal, but the change was not statistically significant. In contrast, the mean total problem score was 7.5 points lower after surgery (95% confidence interval, 5.1-9.7), indicating a significant decrease (P<.001, matched t test). CONCLUSIONS: This pilot study demonstrates a high prevalence (28%) of abnormal behavior in children undergoing T&A for chronic upper airway obstruction. Scores on a standardized measure of behavior improve following T&A, but larger studies with increased statistical power are needed to clarify the degree of improvement and its clinical importance.

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Increasing concerns over drug-resistant bacteria mandate that alternative methods of treatment and prevention, including surgery, be considered to reduce antibiotic usage for acute otitis media (AOM). Meta-analysis of five randomized trials of tubes versus no surgery showed a mean absolute decrease in AOM incidence of 1.0 episode per child-year (95% CI, 0.4-1.6), with a relative decrease of 56%. Similarly, the prevalence of middle-ear effusion decreased by 115 days per child-year (95% CI, 11-220). Within several weeks of tube placement 79% of children had improved quality of life, 17% had trivial change, and 4% were worse. Systematic review of 134 articles revealed transient post-operative otorrhea in 16% of patients with tubes, and later in 26%; recurrent otorrhea occurred in 7.4% of patients and chronic otorrhea in 3.8% Adenoidectomy reduced AOM incidence by 0.32 episodes per child-year (95% CI, 0.03-0.61) for a 3-year period in one study (26% relative decrease), but the effect was only significant for children with prior tubes. Surgical therapy of otitis media offers significant benefits and is an effective prevention strategy in selected children.

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Otitis media with effusion is among the most common illnesses of childhood and is often associated with chronic or persistent middle ear effusion (MEE). Our goal was to develop and validate a self-administered parent survey that would identify children at high risk for mild hearing loss caused by MEE. We evaluated 115 children. Parents rated their child's hearing using the HL-7, a 7-item self-administered survey, and a global visual-analog scale. Static admittance and gradient were recorded. Test-retest reliability, internal consistency, and validity of the HL-7 were compared with the 4-frequency pure-tone average (PTA) hearing level (HL) for the better hearing ear. The HL-7 had good test-retest reliability and internal consistency. Survey scores correlated well with the global hearing rating (R = 0.67, P < 0.001) but did not correlate with PTA (R = 0.10, P = 0.29). Tympanometric gradient was unrelated to ear-specific PTA, but not abnormal static admittance (<0.2 cc), which produced a mean 7-dB HL decrease in hearing (ANOVA, P = 0.02). The HL-7 is a reliable and internally consistent measure of parent perception of child hearing, but unfortunately these perceptions are inaccurate for mild hearing loss. Abnormal static admittance is a risk factor for hearing loss.

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Previous studies have evaluated the effects of comorbidity on survival in patients with cancer. We applied the Charlson comorbidity index (CCI) to a cohort of patients with laryngeal cancer to validate its use and to assess the prognostic impact of age. Our study population consisted of 152 patients with laryngeal cancer who were seen over a 10-year period. Patients were assigned CCI scores and were categorized into low- and high-grade comorbidity groups for comparison. Age adjustments were performed by adding 1 point to the Charlson score for each decade over the median age. Low- vs. high-grade comorbidity was a valid predictor of survival independent of TNM (tumor, nodes, and metastases) stage. Low-grade comorbidity was present in 126 patients; their median survival was 41 months. High-grade comorbidity was present in 26 patients; their median survival was 8 months (p = 0.0002). The addition of the age factor to the CCI did not improve our prognostic ability. There was no difference in CCI groups with respect to tobacco and alcohol use, gender, treatment modality, or mean time to recurrence. The incidence and severity of complications were also similar in the two groups. We conclude that the CCI is a strong predictor of survival in patients with laryngeal cancer. The confounding effects of comorbidity should be considered in the TNM staging of laryngeal cancer to improve our prognostic ability. Further investigations are necessary to assess the validity of this index in patients with other head and neck cancers.

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OBJECTIVE: To determine the accuracy of parent assessment of child hearing. DESIGN: Prospective study. SETTING: Hospital-based pediatric otolaryngology practice in a metropolitan area. PATIENTS: One hundred eighty-six children aged 6 months to 12 years (median age, 3.4 years) with chronic otitis media with effusion or recurrent acute otitis media enrolled in a quality-of-life study. INTERVENTION: Parents rated their child's hearing over the prior 4 weeks using a 7-point response scale. Otoscopic findings, static admittance, tympanometric width, and audiometric thresholds were recorded concurrently. Fifty children were reassessed to monitor changes in hearing. MAIN OUTCOME MEASURE: Correlation of parent hearing assessments with baseline hearing status (pure tone average for the better hearing ear) and with changes in hearing status. RESULTS: The hearing loss questions had good test-retest reliability (R=0.79) but did not correlate with audiometric results (R=-0.13; P=.09). Only when caregivers reported hearing to be an "extreme problem" were median hearing levels (31 dB) significantly greater than the median response (20 dB). Conversely, static admittance and tympanometric gradient were significant predictors of hearing levels (2-way analysis of variance, P<.01) and explained 44% of the ear-specific variations. Abnormal immittance measures in both ears had an 84% predictive value for hearing loss (20-dB hearing level or poorer), and normal immittance measures in both ears had a 76% predictive value for normal hearing. Caregiver assessments of change in hearing status did not correlate with changes in audiometric results (R=0.07; P=.65). CONCLUSIONS: Caregiver assessments of child hearing do not accurately predict hearing levels or changes in hearing status. Immittance measures can help identify children at low or high risk for hearing loss, but cannot substitute for audiometry.

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Effective data interpretation is a habit, not a random event. By applying the seven habits outlined in this article, any otolaryngologist--regardless of the level of statistical knowledge or lack thereof--will be able to use data effectively. The seven habits are (1) check quality before quantity, (2) describe before you analyze, (3) accept the uncertainty of all data, (4) measure error with the right statistical test, (5) put clinical importance before statistical significance, (6) seek the sample source, and (7) view science as a cumulative process. The same habits apply whether interpreting one's own data, interpreting someone else's data, reviewing an unpublished manuscript for a journal, or reviewing a grant application for a funding agency. The basic principles that underlie these habits provide a systematic process for moving from observations to generalizations with predictable degrees of certainty--and uncertainty.

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