Cost-effectiveness evaluation of quadrivalent influenza vaccines for seasonal influenza prevention: a dynamic modeling study of Canada and the United Kingdom.

BACKGROUND: The adoption of quadrivalent influenza vaccine (QIV) to replace trivalent influenza vaccine (TIV) in immunization programs is growing worldwide, thus helping to address the problem of influenza B lineage mismatch. However, the price per dose of QIV is higher than that of TIV. In such circumstances, cost-effectiveness analyses provide important and relevant information to inform national health recommendations and implementation decisions. This analysis assessed potential vaccine impacts and cost-effectiveness of a country-wide switch from TIV to QIV, in Canada and the UK, from a third-party payer perspective. METHODS: An age-stratified, dynamic four-strain transmission model which incorporates strain interaction, transmission-rate seasonality and age-specific mixing in the population was used. Model input data were obtained from published literature and online databases. In Canada, we evaluated a switch from TIV to QIV in the entire population. For the UK, we considered two strategies: Children aged 2-17 years who receive the live-attenuated influenza vaccine (LAIV) switch to the quadrivalent formulation (QLAIV), while individuals aged > 18 years switch from TIV to QIV. Two different vaccination uptake scenarios in children (UK1 and UK2, which differ in the vaccine uptake level) were considered. Health and cost outcomes for both vaccination strategies, and the cost-effectiveness of switching from TIV/LAIV to QIV/QLAIV, were estimated from the payer perspective. For Canada and the UK, cost and outcomes were discounted using 5 % and 3.5 % per year, respectively. RESULTS: Overall, in an average influenza season, our model predicts that a nationwide switch from TIV to QIV would prevent 4.6 % influenza cases, 4.9 % general practitioner (GP) visits, 5.7 % each of emergency room (ER) visits and hospitalizations, and 6.8 % deaths in Canada. In the UK (UK1/UK2), implementing QIV would prevent 1.4 %/1.8 % of influenza cases, 1.6 %/2.0 % each of GP and ER visits, 1.5 %/1.9 % of hospitalizations and 4.3 %/4.9 % of deaths. Discounted incremental cost-utility ratios of $7,961 and £7,989/£7,234 per quality-adjusted life-year (QALY) gained are estimated for Canada and the UK (UK1/UK2), both of which are well within their respective cost-effectiveness threshold values. CONCLUSIONS: Switching from TIV to QIV is expected to be a cost-effective strategy to further reduce the burden of influenza in both countries.

Pure-tone hearing asymmetry: a logistic approach modeling age, sex, and noise exposure history.

BACKGROUND: Asymmetric hearing loss (AHL) can be an early sign of vestibular schwannoma (VS). However, recognizing VS-induced AHL is challenging. There is no universally accepted definition of a "medically significant pure-tone hearing asymmetry," in part because AHL is a common feature of medically benign forms of hearing loss (e.g., age- or firearm-related hearing loss). In most cases, the determination that an observed AHL does not come from a benign cause involves subjective clinical judgment. PURPOSE: Our purpose was threefold: (1) to quantify hearing asymmetry distributions in a large group of patients with medically benign forms of hearing loss, stratifying for age, sex, and noise exposure history; (2) to assess how previously proposed hearing asymmetry calculations segregate tumor from nontumor cases; and (3) to present the results of a logistic regression method for defining hearing asymmetry that incorporates age, sex, and noise information. RESEARCH DESIGN: Retrospective chart review. STUDY SAMPLE: Five thousand six hundred and sixty-one patients with idiopathic, age- or noise exposure-related hearing loss and 85 untreated VS patients. DATA COLLECTION AND ANALYSIS: Audiometric, patient history, and clinical impression data were collected from 22,785 consecutive patient visits to the audiology section at Mayo Clinic in Florida from 2006 to 2009 to screen for eligibility. Those eligible were then stratified by VS presence, age, sex, and self-reported noise exposure history. Pure-tone asymmetry distributions were analyzed. Audiometric data from VS diagnoses were used to create four additional audiograms per patient to model the hypothetical development of AHL prior to the actual hearing test. The ability of 11 previously defined hearing asymmetry calculations to distinguish between VS and non-VS cases was described. A logistic regression model was developed that integrated age, sex, and noise exposure history with pure-tone asymmetry data. Regression model performance was then compared to existing asymmetry calculation methods. RESULTS: The 11 existing pure-tone asymmetry calculations varied in tumor detection performance. Age, sex, and noise exposure history helped to predict benign forms of hearing asymmetry. The logistic regression model outperformed existing asymmetry calculations and better accounted for normal age-, sex-, and noise exposure-related asymmetry variability. CONCLUSIONS: Our logistic regression asymmetry method improves the clinician's ability to estimate risk of VS, in part by integrating categorical patient history and numeric test data. This form of modeling can enhance clinical decision making in audiology and otology.

Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial.

OBJECTIVE: To determine the efficacy of intranasal aqueous triamcinolone acetonide in treating the tympanometric signs and symptoms of eustachian tube dysfunction, such as otitis media with effusion and negative middle ear pressure. DESIGN: Randomized, placebo-controlled, double-blind prospective clinical trial. SETTING: Tertiary referral clinic. PATIENTS: Adults (≥18 years) and children (6-17 years) presenting with otitis media with effusion, negative middle ear pressure, or both. INTERVENTIONS: The 2 treatment arms consisted of aqueous triamcinolone or matching placebo administered once daily intranasally for 6 weeks. All subjects underwent tympanometry, otologic examination, and completion of a symptom questionnaire before and after treatment. MAIN OUTCOME MEASURES: Resolution of abnormal tympanometry and change in symptom scores (severity and frequency). RESULTS: Ninety-one patients presenting from September 1, 2005, through December 31, 2008, with otitis media with effusion or with negative middle ear pressure were enrolled and randomly assigned to treatment or placebo in a double-blind manner. No statistically significant difference in normalization of abnormal tympanometric signs was demonstrated with the active treatment arm compared with placebo on either a per-patient basis (19% vs 32%; P = .18) or a per-ear basis (22% vs 35%; P = .15). There was also no significant difference in the overall poststudy symptom score between the 2 treatment arms, after adjusting for the prestudy overall symptom score in an analysis of covariance model (P = .27). CONCLUSION: These findings do not support the use of intranasal steroid sprays to treat the manifestations of eustachian tube dysfunction. Trial Registration clinicaltrials.gov Identifier: NCT00279916.

Hearing loss in rheumatoid arthritis.

OBJECTIVE: The objective of this study was to evaluate whether patients with rheumatoid arthritis (RA) are more likely to have subclinical hearing loss compared with persons without RA. METHODS: This is a case-control cross-sectional study of 29 patients with RA with disease duration greater than 5 years. Five males and five females were recruited into each decade category (age 40-49, 50-59, and 60-69). These cases were matched in a 1:1 ratio by sex and age to 30 control subjects. A comprehensive set of audiometric and disease severity assessments were performed. RESULTS: Seventeen (59%) of 29 patients with RA had abnormal hearing for at least one frequency (four in one ear, 13 in two ears) by audiometry as did 14 (47%) of 30 control subjects (five in one ear, nine in two ears). The percentage of patients with hearing loss (% RA vs. % control subjects) was: 45% versus 40% sensorineural, 10% versus 7% conductive, and 3% versus 0% mixed hearing loss. In RA versus control subjects, acoustic reflex threshold was abnormal in 17% versus 7%; speech reception threshold was abnormal in 10% versus 3%. Tympanometry and otoacoustic emission findings were similar in both groups. Word recognition did not differ between patients with RA and control subjects. In patients with RA/control subjects, hearing handicap, dizziness, and health assessment questionnaires were abnormal in 28%/7%, 14%/3%, and 72%/7%, respectively. CONCLUSION: There was no difference found in objective audiometric measurements in patients with RA compared with non-RA control subjects. Subjectively patients with RA were more likely to perceive themselves as having hearing disturbances, which may be related to overall disease related functional impairment.

Patient outcomes after vestibular schwannoma management: a prospective comparison of microsurgical resection and stereotactic radiosurgery.

OBJECTIVE: The best management for patients with small- to medium-sized vestibular schwannomas (VS) is controversial. METHODS: : A prospective cohort study of 82 patients with unilateral, unoperated VS less than 3 cm undergoing surgical resection (n = 36) or radiosurgery (n = 46). Patients undergoing resection were younger (48.2 yr versus 53.9 yr, P = 0.03). The groups were similar with regard to hearing loss, associated symptoms, and tumor size. The mean follow-up period was 42 months (range, 12-62 mo). RESULTS: Normal facial movement and preservation of serviceable hearing was more frequent in the radiosurgical group at 3 months (P < 0.001), 1 year (P < 0.001), and at the last follow-up examination (P < 0.01) compared with the surgical resection group. Patients undergoing surgical resection had a significant decline in the following subscales of the Health Status Questionnaire 3 months after surgery: physical functioning (P = 0.006), role-physical (P < 0.001), energy/fatigue (P = 0.02), and overall physical component (P = 0.004). Patients in the surgical resection group continued to have a significant decline in the physical functioning (P = 0.04) and bodily pain (P = 0.04) subscales at 1 year and in bodily pain (P = 0.02) at the last follow-up examination. The radiosurgical group had no decline on any component of the Health Status Questionnaire after the procedure. The radiosurgical group had lower mean Dizziness Handicap Inventory scores (16.5 versus 8.4, P = 0.02) at the last follow-up examination. There was no difference in tumor control (100 versus 96%, P = 0.50). CONCLUSION: Early outcomes were better for VS patients undergoing stereotactic radiosurgery compared with surgical resection (Level 2 evidence). Unless long-term follow-up evaluation shows frequent tumor progression at currently used radiation doses, radiosurgery should be considered the best management strategy for the majority of VS patients.

Intratympanic steroid treatment: a review.

OBJECTIVE: To review published literature regarding the use of intratympanic steroids in the treatment of Meniere's disease and sudden sensorineural hearing loss and to make recommendations regarding their use based on the literature review. DATA SOURCES: Literature review from 1996 to 2003, PubMed, Medline Plus, and Web of Science. STUDY SELECTION: Retrospective case series and uncontrolled prospective cohort studies were the only types of studies available for review. CONCLUSION: On the basis of the available literature, a weak recommendation is made to use intratympanic steroid treatment of sudden hearing loss if oral steroid therapy fails or is contraindicated. The available studies regarding intratympanic steroid treatment of Meniere's disease and tinnitus are inadequate to answer the question of the efficacy of this treatment for these conditions. Higher quality studies are needed.

Psychologic profile of tinnitus patients using the SCL-90-R and Tinnitus Handicap Inventory.

OBJECTIVE: To correlate the Tinnitus Handicap Inventory and the Symptom Checklist-90-R results on a group of tinnitus patients and to compare the average scores of the Tinnitus Handicap Inventory and SCL-90-R for help-seeking and non-help-seeking patients with tinnitus. STUDY DESIGN: A prospective study in which tinnitus patients were administered the Tinnitus Handicap Inventory and the Symptom Checklist-90-R. SETTING: Tertiary referral center. PATIENTS: Patients with tinnitus seeking audiological services. INTERVENTIONS: Rehabilitative. MAIN OUTCOME MEASURES: Results of Tinnitus Handicap Inventory and Symptom Checklist-90-R. RESULTS: Fifty-three consecutive patients having tinnitus were administered the Tinnitus Handicap Inventory and the Symptom Checklist-90-R. There was a significant correlation between the Symptom Checklist-90-R and the Tinnitus Handicap Inventory (rs = 0.43). Furthermore, 25% of these patients scored abnormally high on the Symptom Checklist-90-R, which is substantially more than the general medical population of patients. CONCLUSIONS: Based on this sample of 53 patients, the Symptom Checklist-90-R does seem to be a useful tool in identifying distress among tinnitus patients. The Global Severity Index of the Symptom Checklist-90-R has a defined cutoff score indicating significant distress levels, which makes it a useful screening tool for identifying those who would benefit from psychologic or psychiatric intervention.

Tinnitus impact: three different measurement tools.

The impact of tinnitus and overall levels of distress were measured with three assessment tools for patients with tinnitus. The Tinnitus Handicap Inventory (THI), the Symptom Checklist-90-Revised (SCL-90-R) and an activities limitations questionnaire were administered to 53 audiology patients reporting tinnitus. Forty-three percent of these patients experienced either quality of life reductions associated with tinnitus, substantial perceived handicap, and/or a high level of distress. Results from the General Severity Index (GSI) of the SCL-90-R indicated that 25% of these patients displayed distress greater than that of the general medical population. The SCL-90-R can be a useful tool for audiologists working with tinnitus patients in assessing needs for referral for psychological or psychiatric counseling.

Diagnostic implications of stimulus polarity effects on the auditory brainstem response.

The purpose of this study was to determine whether clicks presented in rarefaction or condensation modes produce more accurate diagnostic information. Subjects were 20 consecutive patients who were seen at the Mayo Clinic for unilateral acoustic neuromas. The nontumor ear served as a control to minimize intersubject variability in the latencies. A standard audiologic evaluation was followed by an auditory brainstem response (ABR) test for which the stimuli were rarefaction and condensation clicks. Responses were analyzed for the presence of waves I, III, and V; absolute latencies of waves I, III, and V; interpeak intervals I-III, III-V, and I-V; and interaural latency difference for wave V. The results indicated that measures from both polarities were similar in this set of patients and that neither click polarity provided diagnostic advantages over the other. Recommendations are to collect ABRs to both click polarities individually to obtain the full complement of waves on which to base the diagnostic impression.