Hearing Aid Use in Children With Unilateral Hearing Loss: A Randomized Crossover Clinical Trial.

OBJECTIVES/HYPOTHESIS: In children with mild to moderately severe unilateral hearing loss (UHL), assess whether subject-reported quality of life (QOL) and teacher- and parent-reported perception of listening difficulty are affected by use of a hearing aid (HA) with baseline accommodations, compared to children receiving only baseline accommodations. STUDY DESIGN: Randomized crossover clinical trial. METHODS: Thirty-seven children 6-12 years of age with mild to moderately severe UHL and ≥80% word recognition scores in the poorer hearing ear were randomized into arm 1, using baseline accommodations (frequency-modulated system and strategic seating) for 12 weeks, followed by addition of a HA for 12 weeks. The other participants were randomized into the reverse methodology: arm 2, using a HA in addition to baseline accommodations for 12 weeks, followed by baseline accommodations alone. Surveys of QOL (Hearing Environments and Reflection on Quality of Life) and listening difficulties or challenges with hearing amplification (CHILD and LIFE-R questionnaires) were administered at 6-week intervals. Differences in mean survey scores, percent change, and improvement over time were computed between the two arms and inter-arm intervals. Per-protocol analysis was used. RESULTS: Of the 37 children enrolled, 34 children underwent the study interventions and were included in the analysis, (arm 1 = 20, arm 2 = 14) (mean [standard deviation] age = 8 [1.5] years; 21 boys [61.8%]). Survey scores averaged across both arms during the HA interval (77.79 [15.13]) were significantly higher than during the baseline-only interval (69.67 [14.69], P = .036). There was no significant difference between trial arms in mean scores between the two HA intervals (P = .450) and two baseline-only intervals (P = .539). CONCLUSIONS: Hearing-related QOL and listening ability improved in children who met eligibility criteria with mild to moderately severe UHL with HA use compared with baseline accommodations alone. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02269124. LEVEL OF EVIDENCE: 1 Laryngoscope, 132:881-888, 2022.

Improvement in Snoring-Related Quality-of-Life Outcomes After Functional Nasal Surgery.

Importance: Sleep-disordered breathing (SDB) represents a spectrum of sleep-related disorders associated with significant medical comorbidities. Nasal airway surgery has been shown to improve SDB but no large-scale studies exist that describe the long-term impact of surgery on patient perception of snoring and nasal obstruction. Objective: To characterize longitudinal snoring symptoms and nasal obstruction after functional nasal surgery for patients with SDB, stratified by history of snoring or obstructive sleep apnea (OSA). Design, Setting, and Participants: In this prospective cohort study, patients undergoing nasal surgery between 2013 and 2017 at a tertiary academic center were surveyed using Snoring Outcome Survey (SOS) and Nasal Obstruction Symptom Evaluation (NOSE) questionnaires through 24 months postoperatively. Patient demographics, history of snoring, diagnosis of OSA, and prior nasal surgeries were analyzed. A total of 625 patients were recruited with 325 females (52.0%) and mean age of 36.3 years (SD 15.6), with 74.9% patients reported snoring (n = 468) and 10.7% patients (n = 67) with OSA. Patients undergoing dual functional and cosmetic septorhinoplasty with or without turbinate surgery were included. Those undergoing concomitant sinus surgery were excluded. Intervention: Functional nasal surgery. Main Outcomes and Measures: SOS and NOSE scores were collected at 2, 4, 6, 12, and 24 months postoperatively. Results: Patients undergoing nasal surgery had statistically and clinically significant improvement in NOSE score at 24 months (mean improvement 29.0 points, p < 0.0001). Patients with snoring history also had significant improvement in SOS score through 24 months (mean improvement 10.7 points, p < 0.0001). Nonsnorers demonstrated no significant change. OSA patients achieved clinically significant improvement in SOS scores through 24 months (mean improvement 31.9; p > 0.05, minimum clinically important difference = 7.6 points). Conclusions and Relevance: Nasal surgery improves long-term nasal obstruction as measured by NOSE score and, for those with comorbid snoring and OSA, can lead to a sustained improvement in snoring-related quality of life (QOL) based on SOS score. Nonsnorers did not have a significant change in snoring symptoms. SOS can be used as a practical and effective instrument to measure snoring-related QOL outcomes after nasal airway surgery. Future studies using objective measures of snoring are needed to quantify the physiologic change in snoring after treatment of nasal obstruction. Level of Evidence: 2c.

The Impact of Nasal Obstruction and Functional Septorhinoplasty on Sleep Quality.

Importance: Functional septorhinoplasty (FSRP) has been shown to improve both global and disease-specific quality of life (QOL). However, the mechanism by which FSRP improves QOL has not been fully defined. We reasoned that NAO may impact sleep quality and, therefore, studied the relationship using validated patient-reported outcome measures. Objective: To investigate the correlation between NAO and sleep quality using Nasal Obstruction Symptom Evaluation (NOSE) and Functional Outcomes of Sleep Quality (FOSQ-10) questionnaires, and to evaluate the effect of FSRP on NAO and sleep quality. Design, Setting, and Participants: This is a prospective longitudinal study of 125 patients undergoing FSRP for the repair of NAO between November 2017 and April 2019 in a university-based tertiary care medical center. The individuals (mean age = 38 ± 15.6 years, 65 females; 52%) were invited to complete the FOSQ-10 survey preoperatively and at 2, 4, 6, and 12 months postoperatively, and 122 of these patients also completed the NOSE questionnaire. Sixty individuals who reported a history of snoring also completed the Snoring Outcomes Survey (SOS). Twelve of 125 patients had obstructive sleep apnea. Patient demographics, nasal surgery, and medical histories and outcomes were analyzed. Intervention: Functional septorhinoplasty. Main Outcomes and Measures: Comparison of pre- and postoperative sleep and NAO scores to determine the correlation between the severity of NAO and sleep quality and the impact of correction of NAO on sleep quality. Results: A total of 125 patients completed FOSQ-10 questionnaire with a median score of 18.00 (IQR = 15.33-19.66) at baseline. Among these individuals, 122 patients completed the NOSE questionnaire with a median score of 65 (IQR = 45-75). A negative correlation between NOSE and FOSQ-10 scores was found at baseline (r = -0.380, p < 0.001). There was a significant difference in baseline FOSQ-10 scores between individuals with (n = 12, mean FOSQ-10 score = 13.28 ± 3.19) (p < 0.001) and without sleep apnea (n = 100, mean FOSQ-10 score = 17.24 ± 3.21). After FSRP, the NOSE and FOSQ-10 scores improved at each postoperative follow-up time point. The change in FOSQ-10 scores was statistically significant at months 2, 4, and 6 (p < 0.001) but not at month 12 (p = 0.161). The NOSE scores were statistically different from baseline level for each postoperative follow-up visits (p < 0.001-months 2, 4, and 6 and p = 0.031-month 12). The distribution of NOSE scores was not different statistically (p = 0.984). The negative correlation between NOSE and FOSQ-10 mean scores that was demonstrated at baseline increases postoperatively (r = 0.508, p < 0.001). Conclusions and Relevance: FSRP can improve both symptoms of NAO and sleep quality. The increased correlation between NAO and sleep quality after surgery is consistent with the hypothesis that improvement in NAO improves sleep quality and QOL.

Analysis of Patient-Perceived Nasal Appearance Evaluations Following Functional Septorhinoplasty With Spreader Graft Placement.

IMPORTANCE: Spreader grafts have been shown to improve nasal airway obstruction in patients with nasal valve dysfunction; however, their use has been limited by concerns over their aesthetic penalty of widening the nasal dorsum. OBJECTIVE: To evaluate the association of functional septorhinoplasty (FSRP) using spreader graft placement with patient satisfaction with nasal appearance postoperatively. DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study was conducted in a university-based tertiary care medical center. All participants were patients undergoing FSRP for the treatment of nasal obstruction who had spreader grafts placed between June 2016 and May 2018. EXPOSURES: The Nasal Obstruction Symptom Evaluation (NOSE) scale and the FACE-Q Satisfaction With Nose, FACE-Q Satisfaction With Nostrils, and FACE-Q Social Functioning scales were administered to patients preoperatively and at 2, 4, 6, and 12 months postoperatively. Patient demographics, nasal history, and outcomes were analyzed. MAIN OUTCOMES AND MEASURES: Comparison of preoperative and postoperative NOSE and FACE-Q scores. RESULTS: A total of 154 patients (72 male [46.8%]) with mean (SD) age of 36.8 (15.4) years underwent FSRP with spreader graft placement. Mean (SD) last follow-up was 5.8 (4.1) months postoperatively (range, 2-12 months). Fifty-seven patients had 6 months follow-up, and 42 patients had at least 12 months of follow-up. At time of last follow-up, mean (SD) NOSE and FACE-Q Satisfaction With Nose, Satisfaction With Nostrils, and Social Functioning scores significantly improved from 62.7 (20.7) to 22.8 (21.0) (P < .001), 54.7 (22.2) to 76.2 (25.1) (P < .001), 59.4 (27.9) to 83.6 (24.8) (P < .001), and 73.6 (21.8) to 81.7 (21.9) (P < .001), respectively. When separated into those with only spreader grafts (n = 89) and those with spreader grafts plus other graft types (n = 65), there was no significant difference between score improvements in the 2 groups. There were no significant differences in final nasal appearance scores between patients undergoing functional vs dual functional and cosmetic FSRP. CONCLUSIONS AND RELEVANCE: Despite concerns that placement of spreader grafts for the treatment of nasal obstruction due to nasal valve dysfunction during FSRP may have a negative impact on nasal aesthetics, this study shows that both nasal obstruction and patient satisfaction with their nasal appearance were significantly improved following surgery. LEVEL OF EVIDENCE: 3.

Peak nasal inspiratory flow is a useful measure of nasal airflow in functional septorhinoplasty.

OBJECTIVE: To evaluate the utility of peak nasal inspiratory flow (PNIF) as a measure of nasal airflow and functional septorhinoplasty (FSRP) outcomes. METHODS: Patients with nasal obstruction were administered Nasal Obstruction Symptom Evaluation (NOSE) questionnaire and PNIF testing between January 2015 and 2018. Surgical patients repeated these tests at 2, 4, 6, 12, and 24 months postoperatively. Patient demographics and operative techniques were recorded. RESULTS: A total of 610 patients were evaluated for nasal obstruction with mean (standard deviation [SD]) NOSE score of 61.5 (23.2) and PNIF of 74.1 (35.4) liters per minute (L/min); correlation -0.16 (P < 0.001). Predictors of lower PNIF were female gender (ß = -13.3, 95% confidence interval [CI] 7.7 to 18.2, P < .001) and higher NOSE scores (ß = -0.43, 95% CI 0.19 to 0.68, P < 0.001). A total of 281 patients underwent FSRP with statistically and clinically significant improvements in both mean NOSE and PNIF scores that were stable out to 2 years. NOSE scores changed -41.0 (25.5) points, and PNIF improved 20.7 (35.5) L/min at last follow-up. Grafting material did not affect outcomes, whereas spreader grafts improved PNIF values (ß = 25.46, 95% CI 5.5 to 45.4, P = 0.013). Clinically significant changes between NOSE and PNIF were concordant, although the correlation was weak (r = -0.26, P = 0.02). CONCLUSION: Peak nasal inspiratory flow is a rapid, cheap, and easily performed test that detects nasal obstruction and clinically significant improvements in airflow following FSRP. Although PNIF does not correlate well enough with the patient experience of nasal obstruction to be used as a diagnostic tool, it does provide unique and complementary information useful for evaluating, understanding, and improving the effects of surgical techniques. LEVEL OF EVIDENCE: 2C Laryngoscope, 129:594-601, 2019.

Improvement in nasal obstruction and quality of life after septorhinoplasty and turbinate surgery.

OBJECTIVES: To evaluate the long-term impact of functional septorhinoplasty (SRP) with and without inferior turbinate reduction (ITR) on disease-specific symptom severity and general health-related quality of life (QOL). STUDY DESIGN: Prospective cohort study at a tertiary referral center. METHODS: Patients undergoing functional SRP with and without ITR were administered the Nasal Obstruction Symptom Evaluation (NOSE) scale to assess severity of nasal obstruction and the EuroQol-5 Dimension Questionnaire Visual Analog Scale (EQ-5D VAS) to assess general health-related QOL preoperatively and at 2, 4, 6, 12, 24, and 36 months postoperatively. Patient demographics, surgical technique, symptom severity, and QOL outcomes were analyzed. RESULTS: A total of 567 patients were included, with 391 patients undergoing functional SRP alone (54.0% female; mean age 36.0 years [standard deviation (SD):16.2]) and 176 patients undergoing functional SRP with ITR (50.0% female; mean age 35.6 years [SD:13.6]). There was a significant decrease in NOSE and increase in EQ-5D VAS scores in both groups through at least 24 months postoperatively. Change in NOSE scores was negatively correlated with change in EQ-5D VAS (r = -0.38, P < 0.01). Compared to patients undergoing SRP, patients also undergoing ITR had a statistically but nonclinically significant improvement in NOSE, with similar trends for EQ-5D VAS that were not significant. CONCLUSION: SRP results in a sustained, long-term improvement in nasal obstruction based on disease-specific and general health-related QOL measures, with incremental improvement in outcomes with addition of ITR. This study provides the foundation for defining health outcomes and the health utility value of surgical interventions that address nasal obstruction. LEVEL OF EVIDENCE: 2c Laryngoscope, 129:1554-1560, 2019.

Functional septorhinoplasty in the pediatric and adolescent patient.

OBJECTIVES: To describe pediatric and adolescent patients undergoing functional septorhinoplasty and to analyze both subjective and objective outcomes. METHODS: Retrospective review of prospective cohort study of patients ≤18 years old undergoing functional septorhinoplasty between 2013 and 2016 at a tertiary care center. Patient demographics, nasal exam, procedure, and pre- and postoperative nasal obstruction symptom evaluation (NOSE) score, EuroQOL 5-dimension (EQ5D), and peak nasal inspiratory flow (PNIF) scores were analyzed. RESULTS: 39 patients, 48.7% male, mean age 15.9 years (range 7-18), with nasal obstruction underwent functional septorhinoplasty with mean follow up of 8.5 months. Patients reported a history of allergies (46.5%), nasal fracture (59.0%), and previous nasal surgery (25.6%). Most common exam findings included internal nasal valve narrowing (92.3%), superior/dorsal septal deviation (74.4%), external nasal valve narrowing (43.6%), caudal septal deviation (35.9%), and a narrow middle vault (33.3%). Septal cartilage grafts were placed in 79.5% of patients and PDS plate was used in 28.2%. Most common procedures included spreader grafts (84.6%), columellar strut graft (30.8%), and swinging door (23.1%). Of patients with both baseline and postoperative scores, at last follow up NOSE scores (SD) decreased from 59.0 (23.7) to 21.2 (8.8) (n = 26, p < 0.001), EQ5D VAS scores increased from 76.2 (17.7) to 85.8 (13.5), (n = 19, p = 0.056), and PNIF scores increased from 66.2 (25.3) to 90.8 (46) L/min, (n = 13, p < 0.01); all mean differences met the minimal clinically important difference for each score. 2 patients underwent revision surgery and there was one complication of a nasal abscess. CONCLUSIONS: Functional septorhinoplasty is safe and effective in select pediatric and adolescent patients with significant nasal obstruction and results in significant improvements in both subjective and objective outcomes measures.

Integrating Data Collection Into Office Work Flow and Electronic Health Records for Clinical Outcomes Research.

Meticulous collection of clinical outcomes metrics in patients undergoing elective surgery is important to ensure quality care; it is also increasing in importance as the Centers for Medicare & Medicaid Services moves to tie reimbursement to outcomes and insurance approval. This study assesses a systematic method for gathering preoperative and postoperative data on patients with nasal obstruction who undergo functional septorhinoplasty that was developed at the Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts. The electronic database was initiated in July 2013, patients continue to be actively enrolled, and follow-up data continue to be collected. This procedure represents a systematic method for the initial visit evaluation, collection of patient-reported outcome measures, documentation of surgical management, and follow-up of patients. For consistency and ease of data collection, as well as data interpretation, this method is integrated into a RedCap survey database and the institution's electronic health record system. During the 4 years that this process has been in place, outcomes data have been collected on more than 1000 patients at 7 time points to create an institutional database. This system allows the tracking of patients' outcomes data and the mining of the institutional database for future research. As Centers for Medicare & Medicaid Services moves from a volume-driven health care model to a value-driven health care model, demonstration of measurable outcomes in patients undergoing elective surgery will be of paramount importance.

Polydioxanone plates are safe and effective for L-strut support in functional septorhinoplasty.

OBJECTIVES/HYPOTHESIS: To evaluate the safety, efficacy, and result stability of polydioxanone (PDS) plate use for L-strut stabilization. STUDY DESIGN: Retrospective analysis of a prospective cohort. METHODS: Patients who underwent functional septorhinoplasty with the use of PDS plates between January 2013 and January 2017 were administered the Nasal Obstruction Symptom Evaluation (NOSE) scale pre- and postoperatively at 2, 4, 6, and 12 months. Patient demographics, reason for PDS use, graft type, complications, and outcomes were analyzed. RESULTS: Eighty-eight patients aged 34.3 years (standard deviation [SD] = 15.7 years; range, 7.5-71.5 years) were included. All patients were found to have a fracture and/or severe deviation of the L-strut for which the PDS plate was used for rigid support. Mean preoperative NOSE score 65.2 (SD = 22.1) significantly decreased to 19.6 (SD = 21.6) at 7.2 months (SD = 5.5 months) postoperatively. There were no significant differences in NOSE scores between follow-up time points. There was one complication, a septal abscess, and one revision. CONCLUSIONS: A PDS plate is a safe and effective material to be utilized in functional septorhinoplasty for patients with a fracture or iatrogenic injury to the septal L-strut or poor quality septal cartilage that requires stability without additional width. Outcomes are stable at 6 and 12 months, after the plate has dissolved. The use of a PDS plate may decrease the need for rib grafting in patients with a history of previous septoplasty and persistent nasal obstruction with a dorsal or caudal C-shaped septal deformity or fracture of the L-strut. LEVEL OF EVIDENCE: 2c. Laryngoscope, 127:2725-2730, 2017.

Assessment of the EuroQol 5-Dimension Questionnaire for Detection of Clinically Significant Global Health-Related Quality-of-Life Improvement Following Functional Septorhinoplasty.

IMPORTANCE: Nasal airway obstruction is a common presenting complaint among patients in otolaryngology practices, and its treatment necessitates critical outcomes evaluation and cost-utility analysis. OBJECTIVE: To evaluate the utility and applicability of the EuroQol 5-Dimension (EQ5D) global health-related quality-of-life (HRQoL) questionnaire for the assessment of clinical outcomes in functional septorhinoplasty. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort study at a university-based tertiary medical center of patients undergoing functional septorhinoplasty for treatment of nasal obstruction. INTERVENTIONS: Patient demographic characteristics, operative intervention, and preoperative and postoperative Nasal Obstruction Symptom Evaluation (NOSE) and EQ5D scores were collected and analyzed between November 2013 and June 2016. MAIN OUTCOMES AND MEASURES: Comparison of preoperative and postoperative EQ5D and NOSE scores at 2 and 6 or more months following surgery (long-term follow-up). RESULTS: A total of 135 patients (56.3% male; mean [SD] age, 36.8 [14.8] years) completed EQ5D and NOSE surveys preoperatively and postoperatively, with mean (SD) follow-up of 5.82 (4.1) months. Of these, 117 completed the 2-month survey and 64 completed their last survey at 6 or more months. Baseline NOSE and EQ5D visual analog scale (VAS) scores were moderately correlated (r = -0.37, P < .001) as were changes in NOSE and EQ5D VAS scores at long-term follow-up (r = -0.33, P = .007). Mean baseline NOSE score of 64.3 (95% CI, 60.5-68.2) decreased to 24.8 (95% CI, 18.8-30.9) at long-term follow-up (P < .001). The frequency of patients reporting problems in the EQ5D domains of pain/discomfort and usual activity decreased by more than half in the long-term follow-up group (30 [47%] vs 14 [22%] and 11 [17%] vs 4 [6%]; P = .002 and .02, respectively). The minimal clinically important difference of the EQ5D VAS score was calculated at 9.5. The EQ5D VAS scores had statistically and clinically significant improvement at long-term follow-up in patients with NOSE score improvements of 30 to 60 points (EQ5D VAS increased from mean [SD] of 72.3 [20] to 85.9 [10]; P < .001) and 65 to 100 points (EQ5D VAS increased from mean [SD] of 66.2 [25] to 82.0 [13]; P = .01). CONCLUSIONS AND RELEVANCE: The EQ5D, a global HRQoL instrument, was able to detect clinically significant improvement following functional septorhinoplasty for nasal obstruction. Nasal valve correction improved not only disease-specific quality of life but also global HRQoL. The ability to calculate health utility values from the EQ5D and its low response burden make it an attractive tool for septorhinoplasty outcomes research. LEVEL OF EVIDENCE: 4.