Tombers, Nicole M.

Objective: In-office tympanostomy tube insertion (TTI) is becoming more available in the practice of pediatric otolaryngology. This study evaluated the tolerability of this procedure in young children. Method: Four methods were used to assess tolerability. (1) Standardized video recordings were collected from 30 patients under 24 months who underwent in-office TTI with a single-pass insertion device with topical anesthesia alone. The videos were then reviewed by 3 independent experts in pediatric care and rated at 5 procedural time points using a defined response scale developed with the U.S. Food and Drug Administration. (2) Separately, overall tolerability was subjectively assessed by the same experts. (3) Patient recovery was assessed by the participating otolaryngologist and support staff. (4) Patient caregivers were surveyed for their impressions of the procedure, including whether they would recommend it to other caregivers. Results: In a total of 90 reviews, 100% of children were successfully treated and were rated as having acceptably tolerated the in-office tympanostomy tube procedure. All patients returned to an acceptable baseline without inappropriate crying and were assessed as fully recovered immediately following the procedure or by the time the child was leaving clinic. For caregivers, 93% agreed or strongly agreed that they would recommend the use of in-office TTI to other caregivers. Conclusions: In-office TTI in young children was determined to be universally well tolerated in young children and is a procedure that patient caregivers would recommend to other caregivers for their children. These results should help reassure otolaryngology specialists and caregivers alike that in-office ear tube placement is a viable option for young children with middle ear disease.

Objective To evaluate the long-term changes in sporadic vestibular schwannoma (VS) disease-specific quality-of-life (QOL) outcomes. Study Design Prospective longitudinal study using the Penn Acoustic Neuroma Quality of Life (PANQOL) Scale. Setting National survey. Patients Patients with sporadic VS who completed a baseline survey before treatment and at least one follow-up survey recruited through the authors’ center and through the Acoustic Neuroma Association. Interventions Observation, microsurgery, radiosurgery. Main Outcome Measures Changes in PANQOL scores from baseline to most recent survey. Results Among 445 eligible patients the mean duration of follow-up was 4.4 (SD, 2.3) years, including 122, 218, and 105 in the observation, microsurgery, and radiosurgery groups, respectively. Patients managed with observation (p = 0.03) or microsurgery (p < 0.001) demonstrated improvement in anxiety scores. Changes in facial function scores differed significantly by management group (p = 0.01), with patients undergoing microsurgery demonstrating a mean decline of 10 points in facial function scores compared with mean declines of 3 for those managed with observation or radiosurgery. Hearing loss scores decreased similarly over time for all three groups (p = 0.3). There were minimal changes in total PANQOL scores over time across all management groups (p = 0.5). Conclusions Long-term changes in total QOL among VS management groups are not significantly different. Microsurgery may continue to confer an advantage regarding improvement in anxiety postoperatively, but with a greater decline in facial function when compared to observation or radiosurgery. Long-term declines in hearing loss scores were not statistically significantly different among groups.

Objective Management of small vestibular schwannoma (VS) remains controversial, as patients are typically candidates for all three management options including microsurgery, stereotactic radiosurgery, or wait-and-scan. This study compares patient satisfaction across treatment modalities in patients with small VS. Study Design Cross-sectional study. Setting Survey distributed to members of the Acoustic Neuroma Association and Mayo Clinic patients. Methods Patients with small (<1 cm in any location) sporadic VS who completed at least one survey regarding treatment history and patient satisfaction were included. Results Among 346 patients with small VS, 106 (31%) underwent microsurgery, 78 (23%) radiosurgery, 152 (44%) wait-and-scan, and 10 (3%) multimodal treatment. Collectively, 307 (89%) patients indicated “Yes, I am happy with my treatment type and in hindsight I would not change anything,” and 39 (11%) indicated “No, in hindsight I would have chosen a different treatment type.” Satisfaction differed significantly by treatment group with 85, 86, 96, and 40% of patients in the microsurgery, radiosurgery, wait-and-scan, and multimodal groups reporting that they were satisfied with treatment, respectively (p < 0.001). Satisfaction also differed significantly among those undergoing upfront treatment with microsurgery or radiosurgery (81%), initial wait-and-scan followed by treatment (88%), and wait-and-scan only groups (96%; p = 0.001). Specifically, the wait-and-scan only group demonstrated greater satisfaction compared with the other two treatment strategies (p < 0.05 for both). Conclusions Patient satisfaction with the management of small VS is generally high. Management with wait-and-scan, even if treatment is eventually pursued, may offer higher patient satisfaction compared with upfront treatment.

OBJECTIVE Facial nerve function, hearing preservation, and tumor control have been the primary benchmarks used to assess vestibular schwannoma (VS) outcomes. Acknowledging the frequent discrepancy between what physicians prioritize and what patients value, there has been increasing prioritization of patient-reported outcome measures when evaluating the impact of VS diagnosis and its treatment. Motivated by reported limitations of prior instruments used to assess quality of life (QOL) in patients with VS, the authors describe the development and validation of a new disease-specific QOL measure: the Vestibular Schwannoma Quality of Life (VSQOL) Index. METHODS The content development phase comprised identification of clinically important domains and prioritization of feelings or concerns individuals with VS may have. The validation phase encompassed determining how items were grouped into domains and eliminating redundant items. Both phases leveraged data from cross-sectional and longitudinal surveys, expertise from a multidisciplinary working group, and patients with a broad range of experiences with VS (n = 42 during content development and n = 263 during validation). Domain scores from the new instrument were assessed for reliability and correlation with other measures of similar constructs. RESULTS The VSQOL Index consists of 40 items that evaluate the impact of VS diagnosis and its management on QOL, treatment satisfaction, and employment and is estimated to take 8–10 minutes to complete. Domain scores range from 0 (worst) to 100 (best) and demonstrate excellent psychometric properties, including content, construct, and convergent validity and both internal consistency (Cronbach’s alphas 0.83 to 0.91) and test-retest reliability (reliability coefficients 0.86 to 0.96). CONCLUSIONS The VSQOL Index is a valid and reliable measure that overcomes several limitations of prior instruments, including omission or underrepresentation of domains that frequently impact well-being, such as pain, cognition, satisfaction or regret surrounding treatment decisions, and occupational limitations, to comprehensively evaluate the impact of VS diagnosis or its treatment on QOL.

Objective To introduce and discuss implementation strategy for the Complete Cochlear Implant Care (CCIC) model, a highly-coordinated cochlear implant (CI) care delivery model requiring a single on-site visit for preoperative workup, surgery, and postoperative programming. Study Design Prospective, nonrandomized, two-arm clinical trial. Setting Tertiary referral CI center. Patients Adults who meet audiologic criteria for cochlear implantation. Interventions Cochlear implantation, coordinated care delivery, including remote programming. Main outcome measures Care delivery model feasibility and process implementation. Results Patients determined to be likely CI candidates based on routine audiometry are eligible for enrollment. The CCIC model uses telemedicine and electronic educational materials to prepare patients for same-day on-site consultation with CI surgery, same or next-day activation, and postoperative remote programming for 12 months. Implementation challenges include overcoming inertia related to the implementation of a new clinical workflow, whereas scalability of the CCIC model is limited by current hardware requirements for remote programming technology. A dedicated CCIC process coordinator is critical for overcoming obstacles in implementation and process improvement through feedback and iterative changes. Team and patient-facing materials are included and should be tailored to fit each unique CI program looking to implement CCIC. Conclusion The CCIC model has the potential to dramatically streamline hearing healthcare delivery. Implementation requires an adaptive approach, as obstacles may vary according to institutional infrastructure and policies.

ObjectiveThe degree to which various treatment modalities modify vestibular schwannoma (VS)–associated symptoms has received limited attention. The purpose of this study was to determine how different treatment modalities affect subjective symptoms in those presenting with VS.Study DesignProspective survey.SettingTertiary neurotology referral center.MethodsPatients with sporadic VS who received treatment at our institution were prospectively surveyed with a VS symptom questionnaire. Those who completed a baseline survey prior to treatment and at least 1 posttreatment survey were included. The prospective survey evaluated the severity of self‐reported symptoms (Likert scale, 1‐10), including tinnitus, dizziness or imbalance, headaches, and hearing loss.ResultsA total of 244 patients were included (mean age, 57 years). The mean duration of follow‐up was 2.1 years, and the median number of surveys completed was 2 (interquartile range, 1‐3). Seventy‐eight (32%) cases were managed with observation, 118 (48%) with microsurgery, and 48 (20%) with radiosurgery. Multivariable analyses revealed no statistically significant difference in the change in tinnitus (P =. 15), dizziness or imbalance (P = 0.66), or headaches (P =. 24) among treatment groups. Evaluation of clinically important differences demonstrated that microsurgery leads to significant bidirectional changes in headaches.ConclusionsLimited prospective data exist regarding the progression or resolution of subjective symptoms in those presenting with VS. This study suggests that tinnitus, dizziness or imbalance, and headaches are unlikely to be significantly modified by treatment modality and generally should not be used to direct treatment choice.

Background: Previous cross-sectional studies analyzing quality of life (QOL) outcomes in patients with sporadic vestibular schwannoma (VS) have shown surprisingly little difference among treatment modalities. To date, there is limited prospective QOL outcome data available comparing baseline to posttreatment scores. Study Design: Prospective longitudinal study using the disease-specific Penn Acoustic Neuroma Quality of Life (PANQOL) scale. Setting: Large academic skull base center. Patients: Patients diagnosed with unilateral VS who completed a baseline survey before treatment and at least one posttreatment survey. Main Outcome Measures: Change in PANQOL scores from baseline to most recent survey. Results: A total of 244 patients were studied, including 78 (32%) who elected observation, 118 (48%) microsurgery, and 48 (20%) stereotactic radiosurgery. Patients who underwent microsurgery were younger (p < 0.001) and had larger tumors (p < 0.001) than those who underwent observation or radiosurgery; there was no significant difference in duration of follow-up among management groups (mean 2.1 yrs; p = 0.28). When comparing the total PANQOL score at baseline to the most recent survey, the net change was only –1.1, –0.1, and 0.3 points on a 100-point scale for observation, microsurgery, and radiosurgery, respectively (p = 0.89). After multivariable adjustment for baseline features, there were no statistically significant changes when comparing baseline to most recent scores within each management group for facial function, general health, balance, hearing loss, energy, and pain domains or total score. However, the microsurgical group experienced a 10.8-point improvement (p = 0.002) in anxiety following treatment, compared with 1.5 (p = 0.73) and 5.3 (p = 0.31) for observation and radiosurgery, respectively. Conclusions: In this prospective longitudinal study investigating differences in QOL outcomes among VS treatment groups using the disease-specific PANQOL instrument, treatment did not modify QOL in most domains. Microsurgery may confer an advantage with regard to patient anxiety, presumably relating to the psychological benefit of “cure” from having the tumor removed.

ObjectiveTo examine the impact of treatment on disease‐specific health‐related quality of life (HRQOL) among patients with sporadic vestibular schwannoma (VS).Study DesignNational cross‐sectional study.SettingTertiary referral center and the Acoustic Neuroma Association.Subjects and MethodsAdult patients with VS who completed the Penn Acoustic Neuroma Quality of Life (PANQOL) survey. Patients were classified by treatment at the most recent survey as microsurgery, radiosurgery, observation, or recently diagnosed (RD). PANQOL scores were compared among VS treatment groups and with nontumor controls using analysis of covariance.ResultsA total of 1362 respondents with VS were analyzed. Total PANQOL scores differed significantly by treatment (P =. 024) with adjusted means of 60, 63, 65, and 62 for the microsurgery, radiosurgery, observation, and RD groups, respectively. Subdomain scores for facial function, balance, hearing loss, and pain differed significantly (P <. 05) by treatment. Comparisons that surpassed thresholds for clinical significance included microsurgery compared to radiosurgery and observation for facial function, microsurgery compared to observation and RD for hearing loss, and microsurgery compared to radiosurgery and observation for pain. Subdomain scores for anxiety, facial function, balance, hearing loss, energy, and pain and total PANQOL scores for nontumor controls were significantly higher (ie, more favorable) compared to the VS groups (P <. 05). General health scores did not differ significantly between the nontumor controls and the VS groups (P =. 19).ConclusionDifferences in HRQOL among treatment modalities are small and variably exceed the minimal clinically important difference. The impact of a VS diagnosis on HRQOL supersedes that of the treatment type.

ObjectiveTo ascertain the relationship among vestibular schwannoma (VS) tumor volume, growth, and hearing loss.Study DesignRetrospective cohort study.SettingSingle tertiary center.Subjects and MethodsAdults with observed VS and serviceable hearing at diagnosis were included. The primary outcome was the development of nonserviceable hearing as estimated using the Kaplan‐Meier method. Associations of tumor volume with baseline hearing were assessed using Spearman rank correlation coefficients. Associations of volume and growth with the development of nonserviceable hearing over time were assessed using Cox proportional hazards models and summarized with hazard ratios (HRs).ResultsOf 230 patients with VS and serviceable hearing at diagnosis, 213 had serial volumetric tumor data for analysis. Larger tumor volume at diagnosis was associated with increased pure‐tone average (PTA) (P <. 001) and decreased word recognition score (WRS) (P =. 014). Estimated rates of maintaining serviceable hearing at 6 and 10 years following diagnosis were 67% and 49%, respectively. Larger initial tumor volume was associated with development of nonserviceable hearing in a univariable setting (HR for 1‐cm3 increase: 1.36, P =. 040) but not after adjusting for PTA and WRS. Tumor growth was not significantly associated with time to nonserviceable hearing (HR, 1.57; P =. 14), although estimated rates of maintaining serviceable hearing during observation were poorer in the group that experienced growth.ConclusionLarger initial VS tumor volume was associated with poorer hearing at baseline. Larger initial tumor volume was also associated with the development of nonserviceable hearing during observation in a univariable setting; however, this association was not statistically significant after adjusting for baseline hearing status.