Clinical Practice Guideline: Ménière's Disease.

OBJECTIVE: Ménière's disease (MD) is a clinical condition defined by spontaneous vertigo attacks (each lasting 20 minutes to 12 hours) with documented low- to midfrequency sensorineural hearing loss in the affected ear before, during, or after one of the episodes of vertigo. It also presents with fluctuating aural symptoms (hearing loss, tinnitus, or ear fullness) in the affected ear. The underlying etiology of MD is not completely clear, yet it has been associated with inner ear fluid (endolymph) volume increases, culminating in episodic ear symptoms (vertigo, fluctuating hearing loss, tinnitus, and aural fullness). Physical examination findings are often unremarkable, and audiometric testing may or may not show low- to midfrequency sensorineural hearing loss. Conventional imaging, if performed, is also typically normal. The goals of MD treatment are to prevent or reduce vertigo severity and frequency; relieve or prevent hearing loss, tinnitus, and aural fullness; and improve quality of life. Treatment approaches to MD are many and typically include modifications of lifestyle factors (eg, diet) and medical, surgical, or a combination of therapies. PURPOSE: The primary purpose of this clinical practice guideline is to improve the quality of the diagnostic workup and treatment outcomes of MD. To achieve this purpose, the goals of this guideline are to use the best available published scientific and/or clinical evidence to enhance diagnostic accuracy and appropriate therapeutic interventions (medical and surgical) while reducing unindicated diagnostic testing and/or imaging.

Clinical Practice Guideline: Ménière's Disease Executive Summary.

OBJECTIVE: Ménière's disease (MD) is a clinical condition defined by spontaneous vertigo attacks (each lasting 20 minutes to 12 hours) with documented low- to midfrequency sensorineural hearing loss in the affected ear before, during, or after one of the episodes of vertigo. It also presents with fluctuating aural symptoms (hearing loss, tinnitus, or ear fullness) in the affected ear. The underlying etiology of MD is not completely clear, yet it has been associated with inner ear fluid volume increases, culminating in episodic ear symptoms (vertigo, fluctuating hearing loss, tinnitus, and aural fullness). Physical examination findings are often unremarkable, and audiometric testing may or may not show low- to midfrequency sensorineural hearing loss. Imaging, if performed, is also typically normal. The goals of MD treatment are to prevent or reduce vertigo severity and frequency; relieve or prevent hearing loss, tinnitus, and aural fullness; and improve quality of life. Treatment approaches to MD are many, and approaches typically include modifications of lifestyle factors (eg, diet) and medical, surgical, or a combination of therapies. PURPOSE: The primary purpose of this clinical practice guideline is to improve the quality of the diagnostic workup and treatment outcomes of MD. To achieve this purpose, the goals of this guideline are to use the best available published scientific and/or clinical evidence to enhance diagnostic accuracy and appropriate therapeutic interventions (medical and surgical) while reducing unindicated diagnostic testing and/or imaging.

Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control.

BACKGROUND: : Effective management of allergic rhinitis requires ongoing monitoring of its control. This article describes the qualitative phase of development of a patient-completed instrument, the Rhinitis Control Assessment Test (RCAT), designed to assist patients and providers in the detection of problems with rhinitis symptom control. OBJECTIVE: : To identify concepts to be measured and to develop initial questionnaire items to be tested further in the next phase of development. METHODS: : A literature review and input from patient focus groups were utilized to generate concepts to be measured in the draft questionnaire. The draft items were subjected to cognitive testing to ensure that the items were understood by patients and to eliminate ambiguity as well as to select an optimal recall period and meaningful response scales. Patients aged ≥18 years self-reporting a rhinitis diagnosis who had experienced rhinitis symptoms in the past 12 months were eligible for participation in the focus groups (n = 39) and the cognitive interviews (n = 23). RESULTS: : This qualitative process yielded a draft instrument with 26 items assessing five constructs of rhinitis symptom control: frequency and bothersomeness of nasal and non-nasal symptoms, symptom impact, activity interference, symptom control, and medication use. A five-point Likert response scale and a 1-week recall period for each item were adopted based on patient input. CONCLUSION: : The qualitative phase of development of the RCAT produced constructs and items for an instrument that is anticipated to facilitate accurate assessment of rhinitis control and improve the quality of care for patients with allergic rhinitis.

Preliminary evaluation of a novel bone-conduction device for single-sided deafness.

HYPOTHESIS: A new intraoral bone-conduction device has advantages over existing bone-conduction devices for reducing the auditory deficits associated with single-sided deafness (SSD). BACKGROUND: Existing bone-conduction devices effectively mitigate auditory deficits from single-sided deafness but have suboptimal microphone locations, limited frequency range, and/or require invasive surgery. A new device has been designed to improve microphone placement (in the ear canal of the deaf ear), provide a wider frequency range, and eliminate surgery by delivering bone-conduction signals to the teeth via a removable oral appliance. METHODS: Forces applied by the oral appliance were compared with forces typically experienced by the teeth from normal functions such as mastication or from other appliances. Tooth surface changes were measured on extracted teeth, and transducer temperature was measured under typical use conditions. Dynamic operating range, including gain, bandwidth, and maximum output limits, were determined from uncomfortable loudness levels and vibrotactile thresholds, and speech recognition scores were measured using normal-hearing subjects. Auditory performance in noise (Hearing in Noise Test) was measured in a limited sample of SSD subjects. Overall comfort, ease of insertion, and removal and visibility of the oral appliance in comparison with traditional hearing aids were measured using a rating scale. RESULTS: The oral appliance produces forces that are far below those experienced by the teeth from normal functions or conventional dental appliances. The bone-conduction signal level can be adjusted to prevent tactile perception yet provide sufficient gain and output at frequencies from 250 to 12,000 Hz. The device does not damage tooth surfaces nor produce heat, can be inserted and removed easily, and is as comfortable to wear as traditional hearing aids. The new microphone location has advantages for reducing the auditory deficits caused by SSD, including the potential to provide spatial cues introduced by reflections from the pinna, compared with microphone locations for existing devices. CONCLUSION: A new approach for SSD has been proposed that optimizes microphone location and delivers sound by bone conduction through a removable oral appliance. Measures in the laboratory using normal-hearing subjects indicate that the device provides useful gain and output for SSD patients, is comfortable, does not seem to have detrimental effects on oral function or oral health, and has several advantages over existing devices. Specifically, microphone placement is optimized for reducing the auditory deficit caused by SSD, frequency bandwidth is much greater, and the system does not require surgical placement. Auditory performance in a small sample of SSD subjects indicated a substantial advantage compared with not wearing the device. Future studies will involve performance measures on SSD patients wearing the device for longer periods.

Sleep, quality of life, and productivity impact of nasal symptoms in the United States: findings from the Burden of Rhinitis in America survey.

Rhinitis is a common chronic condition that has been shown in observational and interventional studies to have a substantial impact on the sufferer. This study was performed to describe the impact of symptoms of allergic rhinitis (AR) on sleep, quality of life, and productivity in a U.S. population. A cohort of AR sufferers and non-AR sufferers was assembled by screening a representative sample of 15,000 households with a self-administered questionnaire in January 2004. A subsample of respondents received a detailed follow-up questionnaire in the May/June pollen season. Of the 7024 individuals with complete data, 3831 met the case definition of AR sufferer; 3193 were non-AR sufferers. Overall, AR sufferers had consistently poorer average scores on the sleep, quality of life, cognition, and productivity scales compared with non-AR sufferers. Subjects with AR symptoms had more sleep impairment (51.2) compared with subjects with non-AR symptoms and those with no symptoms (59.8 and 63.3, respectively). Only 3.6% of subjects with AR symptoms experienced 100% sleep adequacy compared with 11.7% of subjects with non-AR symptoms and 19.2% of subjects with no symptoms. Quality of life and cognition scores were worse in subjects with AR symptoms compared with subjects with non-AR or no symptoms. Work and school productivity was significantly reduced in subjects with AR symptoms in the past 4 weeks compared with subjects with no symptoms (p < 0.05). Individuals who suffer from AR symptoms experience a substantial burden on their ability to sleep, quality of life, cognitive function, and school/workplace productivity.

Physician perceptions of the treatment and management of allergic and nonallergic rhinitis.

Historically, rhinitis has been perceived by many clinicians in respiratory medicine as an unimportant condition. The purpose of this study was to evaluate physicians' perceptions of the impact of allergic rhinitis and chronic or nonallergic rhinitis on patients' health. This cross-sectional survey involved U.S. physicians identified from a claims database as treating patients with allergic rhinitis or chronic rhinitis during a 13-month period. Responses were stratified by physicians' overall assessment of their patients' rhinitis severity, presence or absence of an allergy specialist at the practice, and agreement or disagreement that allergic rhinitis and nonallergic rhinitis should be managed similarly. Of 2614 physicians invited to participate, 766 responded. Physicians who perceived the majority of their patients as having moderate-to-severe symptoms were more likely to be prescribed more than one class of medication and physicians whose patients had mostly mild symptoms were more likely to recommend nonprescription products. Physicians whose practice included an allergy specialist compared with physicians without an allergy specialist at their practice were more likely to report that higher percentages of their patients were prescribed more than one class of medication, more likely to rate patients' descriptions of symptom severity and quality-of-life-related issues as extremely important in treatment decisions, and less likely to believe that allergic rhinitis and nonallergic rhinitis have the same symptoms. Physicians who did not agree that allergic rhinitis and nonallergic rhinitis should be managed similarly were more likely to prescribe more than one class of medication and to rate patients' descriptions of symptom severity and quality-of-life impact as extremely important in their treatment decisions. This physician survey provides insight into perceptions of the impact of allergic rhinitis and nonallergic rhinitis on patients' quality of life and symptom severity.

Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease.

OBJECTIVE: To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED). STUDY DESIGN: Prospective data collected as part of a multicenter, randomized, controlled trial for the treatment of corticosteroid-responsive AIED with methotrexate. SETTING: Tertiary referral centers. PATIENTS: One hundred sixteen patients with rapidly progressive, bilateral sensorineural hearing loss. INTERVENTION: All patients completed a 1-month course of prednisone (60 mg/d). In Phase 2, 67 patients with improvement in hearing underwent a monitored 18-week prednisone taper, resulting in 22 weeks of prednisone therapy at an average dose of 30 mg per day. Thirty-three patients were randomized to receive methotrexate in Phase 2. Thirty-four patients received prednisone and placebo. MAIN OUTCOME MEASURE: Adverse events (AE) in patients treated with prednisone only. RESULTS: Of 116 patients, 7 had to stop prednisone therapy during the 1-month challenge phase due to AE. Of 34 patients, 5 were unable to complete the full 22-week course of prednisone due to AE. The most common AE was hyperglycemia, which occurred in 17.6% of patients participating in Phase 2. Weight gain was also common, with a mean increase in body mass index of 1.6 kg/m2 (95% confidence interval, 0.77-2.3) during the 22-week steroid course. Patients entering Phase 2 were followed for a mean of 66 weeks. No fractures or osteonecrosis were reported. CONCLUSION: Although high-dose corticosteroids are associated with known serious side effects, prospective data in the literature are limited. The present study suggests that with appropriate patient selection, monitoring, and patient education, high-dose corticosteroids are a safe and effective treatment of AIED.

Rhinitis symptoms and comorbidities in the United States: burden of rhinitis in America survey.

OBJECTIVE: To assess the burden of nasal symptoms in the United States (U.S.) and the comorbid conditions associated with nasal symptoms. SUBJECTS AND METHODS: A self-administered screening questionnaire and follow-up survey was sent to targeted households from a representative sample of 15,000 households in the U.S. Subjects with comorbid asthma completed the Asthma Control Test (ACT). RESULTS: Out of 7024 evaluable subjects who responded, 3831 subjects were classified as rhinitis "sufferers." Individuals with active rhinitis symptoms were 1.5 to 4.5 times more likely to suffer from comorbid conditions including asthma, conjunctivitis, otitis media, sinusitis, eczema, food and insect bite allergies, migraine, and depression. Almost half of all respondents with moderate or severe rhinitis symptoms and comorbid asthma had poorly controlled asthma as defined by an ACT score of < or =19. CONCLUSIONS: A strong relationship exists between rhinitis symptoms and various comorbidities, including asthma, in the U.S. population. Poorly controlled rhinitis contributes to the public health burden of rhinitis and asthma.

The prevalence of nasal symptoms attributed to allergies in the United States: findings from the burden of rhinitis in an America survey.

Although the annual prevalence of physician-diagnosed hay fever has been previously reported, the prevalence of allergic rhinitis symptoms in the United States is uncertain. The purpose of this study was to estimate the prevalence of allergic rhinitis symptoms in the United States. A self-administered 10-item screening questionnaire regarding nasal symptoms was sent to representative households in the United States in January 2004. A total of 8,708 members (44.3%) reported nasal symptoms on > or =7 days in the past 12 months. The majority of these responders described their symptoms as seasonal or perennial allergies (n = 5,944) compared with cold or flu only (n = 1,841), cold or flu and vasomotor rhinitis (n = 175), or vasomotor rhinitis only (n = 748). The prevalence of self-reported seasonal and perennial allergic rhinitis symptoms on > or =7 days in the past 12 months was 30.2%, which corresponds to 89.6 million persons in the United States. The prevalence of self-reported physician-diagnosed seasonal or perennial allergic rhinitis with symptoms on > or =7 days was 22%, or approximately 65 million persons nationwide. Among responders with a higher burden of nasal symptoms (> or =30 days), the prevalence of physician-diagnosed hay fever, allergic rhinitis, or nasal allergies was 11.9% of the total population. The prevalence of nasal symptoms attributed to rhinitis related to seasonal and perennial allergies in the United States ranged between 11.9 and 30.2% depending on duration of symptoms and physician diagnosis. Almost one-half of Americans experience troublesome nasal symptoms on at least 7 days throughout the year, with most attributing their symptoms to allergies.

Treatment of corticosteroid-responsive autoimmune inner ear disease with methotrexate: a randomized controlled trial.

CONTEXT: A number of therapies have been proposed for the long-term management of corticosteroid-responsive, rapidly progressive, bilateral sensorineural hearing loss (autoimmune inner ear disease [AIED]). Methotrexate has emerged as the benchmark agent but has not been rigorously evaluated for hearing improvement in patients with AIED. OBJECTIVE: To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted from February 3, 1998, to November 5, 2001, of 67 patients with rapidly progressive, bilateral sensorineural hearing loss at 10 tertiary care centers in the United States. INTERVENTION: Randomization to either oral methotrexate (15 to 20 mg/wk; n = 33) or placebo (n = 34), in combination with an 18-week prednisone taper. Follow-up examinations, including audiometric evaluation, were performed at 4, 8, 12, 24, 36, 48, and 52 weeks, or until hearing loss was documented. MAIN OUTCOME MEASURE: Maintenance of hearing improvement achieved from prednisone treatment. RESULTS: Sixty-seven patients (57.8%) enrolled in the prednisone challenge experienced hearing improvement. Twenty-five patients (37%) experienced hearing improvements in both ears. Of the individuals who reached study end points, 24 (80%) of 30 end points were because of measured hearing loss in the methotrexate group and 29 (93.5%) of 31 end points were because of measured hearing loss in the placebo group (P =.15). Methotrexate was no more effective than placebo in maintaining the hearing improvement achieved with prednisone treatment (hazard ratio, 1.31; 95% confidence interval, 0.79-2.17; P =.30). CONCLUSION: Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED.