Gamma Knife surgery of vestibular schwannomas: longitudinal changes in vestibular function and measurement of the Dizziness Handicap Inventory.

OBJECT: Gamma Knife surgery (GKS) is one of the methods available to treat vestibular schwannomas (VSs), in addition to microsurgical resection; however, clear information regarding balance function outcomes and the impact of treatment on patients' quality of life over time remains an important clinical need. The purpose of this study was to assess the longitudinal balance outcomes and Dizziness Handicap Inventory (DHI) following GKS for VSs. METHODS: This was a prospective clinical study of balance outcomes in all patients with VSs treated in the Acoustic Neuroma and Skull Base Surgery Program at a tertiary referral center by the senior author and the Gamma Knife team between June 2000 and May 2008. The main outcome measures included preoperative vestibular testing and postoperative caloric testing performed at 6-month intervals to determine vestibular function. The DHI questionnaires were administered retrospectively to assess the impact of GKS on self-perceived disability. RESULTS: Between June 2000 and May 2008, 55 sporadic VSs were treated. There was a >or= 60-month follow-up available in 27 of these patients, >or= 48 months in 32, >or= 36 months in 38, >or= 24 months in 43, >or= 12 months in 51, and >or= 6 months in 54 (1 patient was excluded from the analysis because the follow-up was < 6 months). Various patterns of changes in vestibular function were observed in either positive or negative directions. A significant difference in total DHI score was seen only in the elderly (> 65 years old) patients pre-GKS compared with post-GKS (t = 1.34, p = 0.05). CONCLUSIONS: Longitudinal changes in vestibular function occur over time, with the largest changes seen in the first 6 months after treatment. Potential for clinical intervention, such as vestibular rehabilitation therapy, exists during this interval; however, larger cohorts must be studied to determine the timing and efficacy of this intervention. The statistically significant improvement in the DHI score in the patient cohort > 65 years old treated with GKS suggests that this group may benefit from this option when considering the symptom of dizziness.

Quality of life after tonsillectomy in adults with recurrent or chronic tonsillitis.

OBJECTIVE: To describe changes in disease-specific and global quality of life (QOL) for adults with recurrent or chronic tonsillitis at 6 months and 1 year after tonsillectomy using two instruments: the Tonsil and Adenoid Health Status Instrument (TAHSI) and the SF-12 Health Survey (12-item short form of SF-36 Health Survey). STUDY DESIGN AND SETTING: Multicenter, prospective observational outcomes study. RESULTS: Seventy-two adults, mean age 28.0 years (SD 7.2 years), were enrolled with follow-up available for 42 adults at 6 months and for 40 adults at 1 year. Patients showed significant improvements in all six subscales of the TAHSI: airway and breathing, infection, health care utilization, cost of care, eating and swallowing, and behavior (all P < 0.0001). Significant improvements were also found in the physical functioning subscale of the SF-12 at 1 year. CONCLUSION: After tonsillectomy for recurrent and chronic tonsillitis, we found large improvements in disease-specific and global QOL. SIGNIFICANCE: Most prior studies on tonsillectomy for recurrent tonsillitis have assessed only the frequency of infections as an outcome measure. This study describes the changes in QOL measured in our cohort of reporting adults after tonsillectomy for chronic or recurrent tonsillitis. This study provides prospective evidence of the effectiveness of tonsillectomy on adult QOL.

Quality of life after tonsillectomy in children with recurrent tonsillitis.

OBJECTIVE: To describe changes in disease-specific and global quality of life (QOL) for children with recurrent or chronic tonsillitis at 6 months and 1 year after tonsillectomy using two validated instruments, the Tonsil and Adenoid Health Status Instrument (TAHSI) and the Child Health Questionaire-PF28 (CHQ-PF28). STUDY DESIGN AND SETTING: A multicenter, prospective observational outcomes study. RESULTS: Ninety-two children, mean age (SD) 10.6 (3.4) years, enrolled with follow-up available for 58 children at 6 months and 38 children at 1 year. The children showed significant improvements in all subscales of the TAHSI including airway and breathing, infection, health care utilization, cost of care, eating and swallowing (all P < 0.001), and behavior (P = 0.01). Significant improvements were also found on several subscales of the CHQ-PF28, such as general health perceptions, physical functioning, parental impact, and family activities (all P < 0.001). CONCLUSION/SIGNIFICANCE: This uncontrolled study provides prospective evidence of improved disease-specific and global QOL in children after tonsillectomy.

Treatment of tinnitus with gabapentin: a pilot study.

OBJECTIVE: To evaluate the effectiveness of gabapentin (Neurontin) improve the disease-specific quality of life in patients with moderate tinnitus. STUDY DESIGN: Randomized, double blind, placebo-controlled clinical trial. SETTING: Single-center academic outpatient otolaryngology practice. INTERVENTION: Gabapentin 1800 mg daily versus placebo. MAIN OUTCOME MEASURES: The study design is a randomized, double blind placebo controlled single site trial conducted in an academic medical center. Inclusion criteria included patients between ages 18 and 70 with a complaint of nonpulsatile, subjective tinnitus, bilateral or unilateral, greater than 3 months in duration. The primary outcome measure is the Tinnitus Handicap Inventory; secondary measures include the Profile of Mood States (POMS) rating scale, subjective tinnitus severity. The null hypothesis addressed in this study is that the drug would not result in significant alleviation of the symptom of tinnitus. RESULTS: Seventy-six patients completed the trial; of these 52 received the drug. No significant differences were found between the two groups after 5 weeks of treatment with gabapentin. CONCLUSION: There is insufficient evidence to support the effectiveness of gabapentin in the treatment of tinnitus.

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the effectiveness of medical and surgical treatment for patients with chronic rhinosinusitis.

OBJECTIVE: To assess outcomes for patients with chronic rhinosinusitis. STUDY DESIGN AND SETTING: Prospective, multicenter study; 31 otolaryngologists enrolled 276 adult patients with chronic rhinosinusitis; patients completed surveys at 3-month intervals, and physicians provided clinical and treatment data. The primary outcome measure was the Chronic Sinusitis Survey-Duration (CSS-D). RESULTS: One hundred seventeen adult patients completed 12-month follow-up. Most patients reported sinus symptoms lasting longer than 3 years (74%). Patients showed significant improvement (group P < 0.0001) in the CSS-D score at each follow-up interval. Baseline CSS-D ( P < 0.0001), surgical intervention ( P < 0.003), and Lund-McKay score ( P < 0.04) were predictive of clinical success in regression analysis. CONCLUSIONS: Patients referred to an otolaryngologist have a severe sinus illness. Treatment by an otolaryngologist was associated with significant improvement in sinus-related symptoms. SIGNIFICANCE: The study demonstrated the feasibility of multicenter outcome studies in chronic rhinosinusitis and generated testable hypotheses for future investigation. EBM RATING: C.

The Cooperative Outcomes Group for ENT: a multicenter prospective cohort study on the outcomes of tympanostomy tubes for children with otitis media.

OBJECTIVE: Outcomes for patients with otitis media were assessed in this prospective, multicenter study. STUDY DESIGN AND SETTING: Thirty-one otolaryngologists enrolled 272 pediatric patients with otitis media; caregivers completed surveys at 3-month intervals, and clinical and treatment data was also collected. The Otitis Media 6 (OM-6) was the primary outcome measure. RESULTS: One hundred seventy-seven patients (mean age 2.0 years) completed 3-month follow-up. One hundred thirty-seven patients underwent tympanostomy tube placement. Large improvements in disease-specific quality of life (QOL) were seen up to 9 months of follow-up. Baseline OM-6 score was the best predictor of clinical success in regression modeling. CONCLUSIONS: Patients referred to an otolaryngologist for treatment of otitis media see large improvements in disease-specific QOL regardless of treatment rendered. SIGNIFICANCE: The study demonstrates the feasibility of multicenter outcomes studies and confirms appropriate triage of patients with otitis media into surgical versus medical interventions. EBM RATING: C.

Serial audiometry in a clinical trial of AIED treatment.

OBJECTIVE: We analyzed pure-tone and speech audiometric results from a prospective trial of anti-inflammatory treatment of subjects with active autoimmune inner ear disease (AIED). We sought to characterize the pattern and size of the treatment effect as reflected in clinical audiometry and to identify audiometric predictors of response to steroid treatment of AIED. SUBJECTS: Adult participants demonstrated clinically established criteria for AIED (n = 116). Eligibility required audiometric evidence of active AIED as indicated by idiopathic sensorineural hearing loss with threshold elevations within 3 months of enrollment. METHODS: We evaluated audiometric changes after 4 weeks of treatment with pharmacologic doses (60 mg/day) of prednisone. We examined the relationship between audiometric pure-tone thresholds at baseline and changes in word intelligibility score (WIS) using parametric and nonparametric analyses. Magnitudes of change were assessed using independent or paired t-tests. Separate analyses were performed on subgroups that did or did not show improved WIS score with steroid treatment. RESULTS: Overall mean pure-tone averages improved from baseline to closeout of prednisone treatment in better hearing ears from 52.4 to 48.3 dB (p < .0001). Mean WIS improved in the better ear from 71.4% to 78.1% (p < .0001). Of pure-tone measures, only the six-tone average showed significant correlation with both the absolute improvements in WIS and with the percentage change in WIS after treatment. Individual frequencies at baseline showed no significant relationship with changes in WIS score after treatment. In 69 (59.5%) of 116 subjects, WIS improved (range, 2-80%) in the better ear. In these subjects, the baseline pure-tone thresholds and pure-tone averages correlated significantly and positively with improvement in WIS. CONCLUSIONS: Steroid treatment in AIED-mediated hearing loss produce variable but significant hearing gains. Neither a focal, cochleotopic region of greatest vulnerability to AIED nor frequency-specific amenability to treatment were evident. We did observe that analysis of predictors and the degree of treatment effect vary with different approaches to measuring change in the WIS. Depending on the approach adopted, the size of the treatment effect may be greatest across intermediate hearing levels at baseline. These observations offer an audiometric database that may enable greater precision in judging clinically meaningful parameters for future studies of AIED treatment and other interventions for sensorineural hearing loss.

Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale.

OBJECTIVE: The study goal was to validate a disease-specific health status instrument for use in patients with nasal obstruction.Design, settings, and patients The study consisted of a prospective instrument validation conducted at 4 academic medical centers with 32 adults with nasal septal deformity. METHODS: Prospective instrument validation occurred in 2 stages. Stage 1 was the development of a preliminary (alpha-version) instrument of potential items. Stage 2 was a test of the alpha-version for item performance, internal consistency, and test-retest reliability; construct, discriminant, criterion validity, and responsiveness; and creation of the final instrument. RESULTS: Items with poor performance were eliminated from the alpha-version instrument. In testing the final instrument, test-retest reliability was adequate at 0.702; internal consistency reliability was also adequate at 0.785. Validity was confirmed using correlation and comparison analysis, and response sensitivity was excellent. CONCLUSIONS: The Nasal Obstruction Symptom Evaluation Scale is a valid, reliable, and responsive instrument that is brief and easy to complete and has potential use for outcomes studies in adults with nasal obstruction.

Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study.

OBJECTIVE: Our goal was to assess disease-specific quality of life outcomes after nasal septoplasty in adults with nasal obstruction. DESIGN, SETTINGS, AND PATIENTS: We conducted a prospective observational outcomes multicenter study with 14 sites and 16 investigators, including private practice and academic settings. Patients had had septal deviation and symptomatic nasal obstruction for at least 3 months, and medical management had failed. METHODS: Patients with septal deviation completed a validated outcomes instrument (the Nasal Obstruction Septoplasty Effectiveness [NOSE] scale) before and 3 and 6 months after septoplasty, with or without partial turbinectomy. RESULTS: Fifty-nine patients underwent surgery; there was a significant improvement in mean NOSE score at 3 months after septoplasty (67.5 versus 23.1, P < 0.0001), and this improvement was unchanged at 6 months. Patient satisfaction was very high, and patients used significantly fewer nasal medications. CONCLUSIONS: In patients with septal deformity, nasal septoplasty results in significant improvement in disease-specific quality of life, high patient satisfaction, and decreased medication use.

Gamma knife surgery of vestibular schwannomas: volumetric dosimetry correlations to hearing loss suggest stria vascularis devascularization as the mechanism of early hearing loss.

OBJECTIVE: Determine which variables are correlated with early hearing changes after gamma knife surgery of vestibular schwannomas (VSs). STUDY DESIGN: Prospective clinical study of hearing outcomes, radiation dosimetry, conformity, and tumor size of all sporadic unilateral VS patients treated between June 2000 and July 2009. SETTING: Tertiary referral center. PATIENTS: : Fifty-nine VS patients with at least 6 months of follow-up data were studied. INTERVENTIONS: Audiometry and imaging were performed to determine auditory thresholds, speech discrimination, and tumor size. Radiation doses to 5 volumes were measured. MAIN OUTCOME MEASURES: Pretreatment and posttreatment comparisons were performed with regard to change in tumor size; radiation dose to specific volumes including the internal auditory canal, cochlea, basal turn of the cochlea, and modiolus; and conformity of the treatment. RESULTS: The mean follow-up was 63.76 months (standard deviation, ±29.02 mo; range, 9-109 mo). The median follow-up was 65.5 months. A statistically significant association between maximum radiation dose to the cochlea volume and 3-frequency pure-tone average in patients starting with 50 dB or lesser PTA3 was demonstrated using linear regression analysis. CONCLUSION: Longitudinal changes in hearing occur over time, with the largest changes seen in the first 12 months after treatment. With our study outcomes as basis, limiting the dose of radiation to the cochlea to no more than 4 Gy would likely reduce vascular injury to the stria vascularis and improve hearing outcomes. Shielding the cochlea during the treatment planning process would be one mechanism to accomplish this goal.