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Background Elexacaftor-tezacaftor-ivacaftor (ETI) improves pulmonary health and chronic rhinosinusitis (CRS) for people with cystic fibrosis (PwCF), however its impact on olfaction has not been investigated. Olfactory dysfunction impairs quality-of-life (QOL). This study evaluated the impact of ETI on multiple olfactory metrics. Methods Adult PwCF/CRS with CF transmembrane conductance regulator genotype F508del/F508del or F508del/minimal function who clinically initiated ETI participated in a prospective, observational study. Endpoints included changes after 6 months of ETI in quantitative olfactory function (Smell Identification Test, SIT), olfactory QOL (Questionnaire of Olfactory Disorders, QOD) and percent olfactory cleft opacification (%OCO), representing superior nasal cavity inflammation where afferent olfactory neurons are concentrated. Results 30 PwCF/CRS met inclusion criteria; 25 completed the study. Mean ETI adherence was 93%. At baseline, participants were hyposmic (mean SIT 31.3), had significant %OCO (mean 65.6%), yet reported non-impaired olfactory QOL (mean QOD 6.1). At follow-up, mean SIT worsened mildly (p=0.009), mean %OCO remained stable (p=0.46), and mean QOD improved modestly (p=0.008). No outcomes were impacted by prior modulator use, genotype, nasal polyps, or CF-related diabetes. Prior sinus surgery was associated with QOD improvement (p=0.04). Increased (worse) baseline QOD scores and %OCO were associated with greater improvements (p Conclusions ETI was not associated with improvement in quantitative olfaction or olfactory cleft opacification after 6 months. PwCF/CRS have hyposmia but do not report impairment in olfactory QOL. Further study to investigate mechanisms explaining olfactory dysfunction and whether olfaction improves with greater duration of ETI or in younger age groups is warranted.

Cystic fibrosis (CF) is a multisystem disease that often requires otolaryngology care. Individuals with CF commonly have chronic rhinosinusitis but also present with hearing loss and dysphonia. Given these manifestations of CF, otolaryngologists are frequently involved in the care of patients with CF; however, there is limited consensus on optimal management of sinonasal, otologic, and laryngologic symptoms.The Cystic Fibrosis Foundation convened a multidisciplinary team of otolaryngologists, pulmonologists, audiologists, pharmacists, a social worker, a nurse coordinator, a respiratory therapist, two adults with CF, and a caregiver of a child with CF to develop consensus recommendations. Workgroups developed draft recommendation statements based on a systematic literature review, and a ≥80% consensus was required for acceptance of each recommendation statement.The committee voted on 25 statements. Eleven statements were adopted recommending a treatment or intervention, while five statements were formulated recommending against a specific treatment or intervention. The committee recommended eight statements as an option for select patients in certain circumstances, and one statement did not reach consensus.These multidisciplinary consensus recommendations will help providers navigate decisions related to otolaryngology consultation, medical and surgical management of CF-CRS, hearing, and voice in individuals with CF. A collaborative and multidisciplinary approach is advocated to best care for our patients with CF. Future clinical research is needed utilizing standardized, validated outcomes with comprehensive reporting of patient outcome, effects of modulator therapies, and genetic characteristics to help continue to advance care, decrease morbidity, and improve the quality of life for individuals with CF.

Rationale Elexacaftor, tezacaftor, and ivacaftor (ETI) in triple combination improves pulmonary health for people with cystic fibrosis (PwCF). However, its impact on objective measures of sinus disease and health utility is unestablished. Objectives To evaluate the impact of ETI on chronic rhinosinusitis (CRS) and general health status incorporating computed tomography (CT), quality-of-life (QOL) and productivity loss. Methods Adult PwCF+CRS with CF transmembrane conductance regulator genotype F508del/F508del or F508del/minimal function who clinically initiated ETI participated in a prospective, observational study. The primary endpoint was change in percent sinus CT opacification (%SO) after 6 months of ETI assessed via deep learning-based methods. Secondary endpoints included changes in sinonasal QOL, health utility value and productivity loss, which were evaluated monthly via validated metrics. Results 30 PwCF provided baseline data; 25 completed the study. At baseline, the cohort had substantial CRS, with mean 22-question SinoNasal Outcome Test (SNOT-22) score 33.1 and mean sinus CT %SO 63.7%. At 6-month follow-up, %SO improved by mean 22.9% (P

Despite the significant morbidity associated with chronic rhinosinusitis in individuals with asthma (CRSwA) there is a paucity of codified, evidence-based management strategies for CRS in this population.Using PubMed, EMBASE, and Cochrane Review Databases, a systematic review was performed covering management strategies for CRSwA. 5,903 articles were screened; 70 were included for full-text analysis. After application of exclusion criteria, 53 articles comprised the qualitative synthesis. The level of evidence was graded, and benefit-harm assessments, as well as value judgment and recommendations were provided RESULTS: : Strong evidence confirms the benefit of oral and topical medications on sinonasal-specific outcomes in individuals with CRSwA; there is low-grade evidence demonstrating that these agents improve lung function and/or asthma control. Moderate-to-strong evidence suggests that endoscopic sinus surgery (ESS) improves both sinonasal- and asthma-specific quality of life. Although there is insufficient-to-low evidence to indicate that ESS improves pulmonary function in this population, data indicate a positive impact of this intervention on asthma control. Biologic medications strongly improve both subjective and objective sinonasal- and asthma-specific outcomes.Evidence supports managing CRS in individuals with CRSwA in a stepwise fashion, starting with traditional non-biologic oral and topical medication, and escalating to second-line treatments, such as ESS and biologics. Optimal treatment of individuals who suffer from CRSwA often requires concurrent, directed management of asthma, as not all CRS interventions impact asthma status. This article is protected by copyright. All rights reserved.

Background: Comorbid chronic rhinosinusitis (CRS) of adulthood is increasing among patients with cystic fibrosis (CF) due to improved median survival. However, little is known about the natural history of endoscopic sinus surgery (ESS) in this cohort. The objective of this study was to evaluate the revision rate of ESS and associated risk factors among adults with CRS and CF (CRSwCF). Methods: The Utah Population Database was queried for patients age >18 with CRS who underwent at least one ESS between 1996 and 2018. Demographic information and ESS history were collected and compared for CRSwCF versus CRS without CF (CRSsCF) using chi-square and t-tests. Risk factors for revision were analyzed using Cox proportional hazard models and logistic regression analysis. Results: A total of 34 050 patients (33 639 CRSsCF and 411 CRSwCF) were included in the final analysis. The mean duration of follow-up was 9.3 and 9.3 years, respectively ( P = .98). Adult patients with CF were significantly more likely to undergo revision ESS (18.7%) than those without CF (13.4%; P

BACKGROUND The impact of multiple coexisting medical comorbidities on treatment outcomes in chronic rhinosinusitis (CRS) is unknown. In this study we sought to evaluate the effect of comorbidities on sinonasal quality of life (QOL) and general health utility values by utilizing the Functional Comorbidity Index (FCI) in CRS patients. METHODS Patients with CRS were prospectively enrolled in a cross-sectional study of medical and surgical therapies. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Medical Outcomes Study Short-Form 6D (SF-6D) scores were recorded at enrollment and 6-month follow-up; Lund-Kennedy endoscopy and Lund-Mackay computed tomography scores were recorded at enrollment. The FCI was calculated using the electronic medical record. The impact of cumulative comorbidity burden on baseline and posttreatment outcomes was assessed using univariate and bivariate correlations. RESULTS A total of 428 participants with CRS were included. The average (mean standard ± deviation) FCI score was 3.03 ± 2.28 (range, 0-12). Significant linear correlations were identified between increasing FCI score and baseline SNOT-22 and SF-6D scores (R = 0.166, p = 0.001 and R = -0.245, p

BACKGROUND Management of sinonasal malignancy (SNM) often includes surgical resection as part of the multimodality treatment. Treatment-related surgical morbidity can occur, yet risk factors associated with complications in this population have not been sufficiently investigated. METHODS Adult patients with histologically confirmed SNM whose primary treatment included surgical resection were prospectively enrolled into an observational, multi-institutional cohort study from 2015 to 2020. Sociodemographic, disease, and treatment data were collected. Complications assessed included cerebrospinal fluid leak, orbital injury, intracranial injury, diplopia, meningitis, osteoradionecrosis, hospitalization for neutropenia, and subsequent chronic rhinosinusitis. The surgical approach was categorized as endoscopic resection (ER) or open/combined resection (O/CR). Associations between factors and complications were analyzed using Student's t test, Fisher's exact test, and logistic regression modeling. RESULTS Overall, 142 patients met the inclusion criteria. Twenty-three subjects had at least 1 complication (16.2%). On unadjusted analysis, adjuvant radiation therapy was associated with developing a complication (91.3% vs 65.5%, p = 0.013). Compared with the ER group (n = 98), the O/CR group (n = 44) had a greater percentage of higher T-stage lesions (p = 0.004) and more frequently received adjuvant radiation (84.1% vs 64.4%, p = 0.017) and chemotherapy (50.0% vs 30.6%, p = 0.038). Complication rates were similar between the ER and O/CR groups without controlling for other factors. Regression analysis that retained certain factors showed O/CR was associated with increased odds of experiencing a complication (odds ratio, 3.34; 95% confidence interval, 1.06-11.19). CONCLUSIONS Prospective, multicenter evaluation of SNM treatment outcomes is feasible. Undergoing O/CR was associated with increased odds of developing a complication after accounting for radiation therapy. Further studies are warranted to build upon these findings.

Background The Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) is a 17-item instrument measuring olfactory-specific quality of life (QOL). However, in clinical research patients can be overwhelmed with multiple questionnaires. We recently developed the 7-item brief QOD-NS (B-QOD). Our objective was to evaluate the psychometric properties of the B-QOD in both the development (D) sample, and in a separate replication (R) sample. Methods Testing on D (n = 203) and R (n = 281) samples included initial exploratory factor analysis (EFA), followed by internal reliability, information loss, and confirmatory factor analysis (CFA). Finally, incremental predictive utility analysis (IPUA) was performed by correlating the B-QOD with the 22-item Sino-Nasal Outcome Test (SNOT-22) survey. Results EFAs of both D and R demonstrated an underlying single-factor structure (eigenvalue = 4.17 and 3.57, respectively) with comparable loading factors (R > 0.30 for both). B-QOD also had good internal reliability in both D and R (Cronbach's alpha = 0.88 and 0.83, respectively). Also, there is minimal information loss with B-QOD compared to QOD-NS in both D and R (R = 0.98 and 0.96, respectively). CFA indicates that the B-QOD single-factor model has good overall fit as measured by the Comparative Fit Index (CFI) and the Standardized Root Mean Squared Residuals (SRMSR) in the D and R samples (CFI = 0.99 and 0.97; SRMSR = 0.035 and 0.053). IPUA shows that the QOD-NS offers no additional predictive benefit of SNOT-22 scores when compared with B-QOD. Conclusion The 7-item B-QOD captures a structurally coherent and reliable single dimension, with minimal information loss and excellent external predictive utility when compared to the QOD-NS.

I. Executive summary BACKGROUND: The 5 years since the publication of the first International Consensus Statement on Allergy and Rhinology: Rhinosinusitis (ICAR-RS) has witnessed foundational progress in our understanding and treatment of rhinologic disease. These advances are reflected within the more than 40 new topics covered within the ICAR-RS-2021 as well as updates to the original 140 topics. This executive summary consolidates the evidence-based findings of the document. Methods ICAR-RS presents over 180 topics in the forms of evidence-based reviews with recommendations (EBRRs), evidence-based reviews, and literature reviews. The highest grade structured recommendations of the EBRR sections are summarized in this executive summary. Results ICAR-RS-2021 covers 22 topics regarding the medical management of RS, which are grade A/B and are presented in the executive summary. Additionally, 4 topics regarding the surgical management of RS are grade A/B and are presented in the executive summary. Finally, a comprehensive evidence-based management algorithm is provided. Conclusion This ICAR-RS-2021 executive summary provides a compilation of the evidence-based recommendations for medical and surgical treatment of the most common forms of RS.

This study investigates the impact of postoperative gabapentin on opioid consumption and pain control following endoscopic sinus surgery (ESS) and/or septoplasty.Patients who underwent ESS and/or septoplasty at a single institution from 2021 to 2022 were enrolled. All patients received postoperative hydrocodone-acetaminophen for pain control. Half of the patients were also prescribed gabapentin for the first postoperative day in addition to hydrocodone-acetaminophen. Subjects completed the Revised American Pain Society Patient Outcome Questionnaire 24 h and 7 days after surgery. We conducted a multivariable regression analysis to assess opioid consumption and improvement in pain scores in the first week between gabapentin and non-gabapentin groups.A total of 102 subjects, 51 in each arm, were enrolled. The mean age was 52 years and 53% of participants were female. Controlling for important baseline demographic, clinical, and surgically related variables, the addition of postoperative gabapentin was associated with a 44% (9.5 mg from 21.6 mg) reduction in opioids consumed in the first postoperative week (B = -9.54, 95% C.I. = [-17.84, -1.24], p = 0.025). In addition, patients in both arms exhibited similar improvement in pain severity and sleep interference in the first 7 days (B = -1.59, 95% C.I. = [-5.03, 1.84], p = 0.36).To the best of our knowledge, this is the first study to investigate the impact of postoperative gabapentin on opioid consumption and pain control following ESS and/or septoplasty. Our analysis demonstrated that postoperative gabapentin effectively reduced opioid use during the first postoperative week without compromising pain control.3 Laryngoscope, 2022.

Background Many patients with chronic rhinosinusitis (CRS) have persistent olfactory dysfunction (OD) following endoscopic sinus surgery (ESS). Few studies compare outcomes to control subjects so it is unknown if residual OD is due to persistent CRS. Objective Compare postoperative measures of OD in case patients with CRS to healthy controls without sinonasal disease. Methods Prospective, observational, multicenter cohort study between October, 2016 and May, 2019. Case participants were selected from referred adult patients diagnosed with CRS, with or without nasal polyposis (NP), electing ESS as subsequent treatment modality. Controls voluntarily enrolled from a community-based sample without a history of CRS. Primary outcomes included measures of preoperative and postoperative OD using “Sniffin’ Stick” pens which summarize odorant threshold (T), discrimination (D), and identification (I) scores. Secondary outcomes included the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) survey and olfactory cleft endoscopy scores (OCES). Results Outcomes were compared between 113 cases and 164 controls of similar average age and gender. Cases reported significantly worse baseline Sniffin’ Sticks TDI total scores (−6.8[SE ± 1.0]; 95% CI: −4.9 to −8.7), QOD-NS (8.9[SE ± 1.1]; 95% CI: 6.8–10.9), and OCES (3.5[SE ± 0.4]; 95% CI: 2.9–4.2) on average. Cases reported significant postoperative improvement in TDI total score (3.7[SD ± 8.2]; 95% CI: 2.2–5.2), QOD-NS (−5.9[SD ± 8.7]; 95% CI: −7.6 to −4.3), and OCES (−1.7[SD ± 3.8]; 95% CI: −2.7 to −0.8) on average, while 63% of anosmics reported improved postoperative olfaction. Multivariate regression identified that NP (OR = 0.4; 95% CI: 0.2–1.0) and previous ESS (OR = 0.3; 95% CI: 0.1–0.8) decreased the odds of postoperative improvement equal to mean TDI scores of controls, while septoplasty increased those odds (OR = 4.5; 95% CI: 1.5–13.7). Conclusion ESS improved olfactory metrics and restored olfactory function in approximately 50% of patients with CRS to that of healthy controls. Concurrent septoplasty increased the likelihood of achieving normal olfaction, while NP and previous ESS decreased those odds.

Objectives: We report a case of acutely worsening allergic fungal sinusitis in a patient receiving immunotherapy with pembrolizumab, a programmed cell death protein 1 (PD-1) inhibitor. Methods: A 53-year-old man with a history of metastatic melanoma and recent initiation of pembrolizumab therapy presented with acutely worsening headaches, left abducens nerve palsy, and neuroimaging demonstrating an erosive skull base lesion with bilateral cavernous sinus involvement. Results: Intraoperative findings were consistent with non-invasive allergic fungal sinus disease. Microbiology and histopathologic data ruled out malignancy and demonstrated Aspergillus fumigatus without concern for angioinvasion. After treatment with antifungal therapy, the patient’s symptoms and abducens nerve palsy resolved. Symptoms were well-controlled 7 months after his initial presentation. Conclusions: Inflammatory sinusitis in patients receiving anti-PD-1 therapy may be secondary to T-cell infiltration, a similar pathophysiology as immune-related adverse events, and warrants appreciation by otolaryngologists given our increasing exposure to immunotherapy and its head and neck manifestations.

BACKGROUND Inflammatory profiles for patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) vary between North American and Asian populations. An elevated ethmoid-to-maxillary (E/M) opacification ratio on preoperative imaging is associated with certain postoperative outcomes in Asian populations and populations that are non-type 2 dominant. In this study we explore this factor in North American/type 2-based populations. METHODS Adult patients (n = 165) from a North American population with CRSwNP who underwent endoscopic sinus surgery (ESS) were prospectively enrolled into an observational, multi-institutional study. The 22-item Sino-Nasal Outcome Test (SNOT-22), Brief Smell Identification Test (BSIT), and Lund-Kennedy (LK) endoscopic scores were obtained pre- and postoperatively. Patients were stratified according to increasing E/M ratios based on Lund-Mackay (LM) scores. RESULTS On average, significant within-subject postoperative improvement was found in all patients for SNOT-22 total and domain scores, and also BSIT results (p ≤ 0.019). Preoperatively, elevated E/M ratio correlated with worse BSIT scores (r = -0.343, p < 0.001). Postoperatively, elevated E/M ratio correlated with BSIT improvement (r = 0.284, p = 0.002), but did not correlate with SNOT-22 improvement or polyp recurrence. An elevated E/M ratio was associated with greater likelihood of reporting a minimal clinically important difference in BSIT scores (χ2 = 9.96, p = 0.041). CONCLUSION Elevated E/M ratios were found to associated with worse baseline olfaction and an increased likelihood of achieving a clinically meaningful postoperative improvement in olfaction in this North American population with CRSwNP. Elevated E/M ratios did not predict postoperative changes in SNOT-22 measures or polyp recurrence. This suggests that prognostic factors may vary according to geography and generalized inflammatory profiles (type 2 vs non-type 2) in patients with CRS.

BACKGROUND Computed tomography (CT) plays a key role in evaluation of paranasal sinus inflammation, but improved, and standardized, objective assessment is needed. Computerized volumetric analysis has benefits over visual scoring, but typically relies on manual image segmentation, which is difficult and time-consuming, limiting practical applicability. We hypothesized that a convolutional neural network (CNN) algorithm could perform automatic, volumetric segmentation of the paranasal sinuses on CT, enabling efficient, objective measurement of sinus opacification. In this study we performed initial clinical testing of a CNN for fully automatic quantitation of paranasal sinus opacification in the diagnostic workup of patients with chronic upper and lower airway disease. METHODS Sinus CT scans were collected on 690 patients who underwent imaging as part of multidisciplinary clinical workup at a tertiary care respiratory hospital between April 2016 and November 2017. A CNN was trained to perform automatic segmentation using a subset of CTs (n = 180) that were segmented manually. A nonoverlapping set (n = 510) was used for testing. CNN opacification scores were compared with Lund-MacKay (LM) visual scores, pulmonary function test results, and other clinical variables using Spearman correlation and linear regression. RESULTS CNN scores were correlated with LM scores (rho = 0.82, p < 0.001) and with forced expiratory volume in 1 second (FEV1 ) percent predicted (rho = -0.21, p < 0.001), FEV1 /forced vital capacity ratio (rho = -0.27, p < 0.001), immunoglobulin E (rho = 0.20, p < 0.001), eosinophil count (rho = 0.28, p < 0.001), and exhaled nitric oxide (rho = 0.40, p < 0.001). CONCLUSION Segmentation of the paranasal sinuses on CT can be automated using a CNN, providing truly objective, volumetric quantitation of sinonasal inflammation.

Chronic rhinosinusitis (CRS) has a substantial impact on patients' quality of life (QOL). Among the many metrics available for measuring treatment success in CRS, patient-reported outcome measures that quantify changes in QOL are the most widely used methods. In addition, objective data from imaging, endoscopy, and olfactory testing are useful adjunct measures to diagnose and prevent progression of disease, although these metrics have mixed correlations with symptoms and QOL. In the future, molecular biology, and multiomics techniques may change how successful CRS treatment is defined.

BACKGROUND: Cystic fibrosis (CF) chronic rhinosinusitis (CRS) has emerged as a distinct diagnostic entity, unique from other endotypes of CRS in its presentation, pathophysiology, diagnosis, treatment, and outcomes. As the sinonasal health of this patient population may have broad effects on pulmonary health and quality of life, a comprehensive understanding of the diagnostic and therapeutic approach to CF CRS is essential. Recognizing recent scientific advances and unique treatment modalities specific to this challenging patient population, this review systematically evaluates the scientific literature and provides an evidenced-based review with recommendations (EBRR) for fundamental management principles of CF CRS. METHODS: A systematic review of the literature was performed. Studies evaluating interventions for the management of CF CRS were included. An iterative review process was implemented in accordance with EBRR guidelines. A treatment recommendation was generated based on an assessment of the benefits, harms and the overall grade of evidence. RESULTS: This review evaluated the published literature on five unique topics. Each of the following therapeutic categories was investigated explicitly with regard to treatment outcomes in patients with CF CRS: 1) nasal saline; 2) intranasal corticosteroids (INCS); 3) topical antibiotics; 4) cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy; and 5) endoscopic sinus surgery (ESS). CONCLUSION: Based on the currently available evidence, nasal saline, ESS, and CFTR modulators are recommended in the management of CF CRS when appropriate. INCS and topical antibiotics are options. Clinical judgment and experience are essential in caring for patients with this uniquely challenging disorder.

Background: Despite significant morbidity, there remains a critical need for prospective analyses to investigate the impact of comorbid chronic rhinosinusitis (CRS) with asthma (CRSwA) on patient centered outcomes. The objective of this study was to ascertain critical stakeholder feedback from patients that could inform future study design based on patient preferences, in an effort to optimize patient enrollment. Methods: A prospective, descriptive study was performed in order to determine the importance of various factors on CRSwA treatment among critical stakeholders. A Likert-scale survey highlighting various aspects of treatment of CRSwA and elucidating patient enthusiasm for clinical enrollment was constructed and prospectively administered to patients with CRSwA. A univariate analysis was instituted to understand the significance of the different trial design preferences. Results: Survey responses were collected from a total of 17 patients with CRSwA. With Likert scores >4/5, responses indicated significant stakeholder interest in research focused on understanding symptom triggers, including the impact of air quality and allergens. Importantly, the highest mean scores noted were for studies focused on improving (1) overall quality of life (4.8/5) and (2) lung function (4.8/5). Patients appeared least interested in participation in a randomized trial, whereas the greatest support was communicated for a purely observational trial ( P = .08). Conclusion: Patients with CRSwA demonstrate enthusiasm for participation in research that focuses on improving patient centered outcomes—specifically quality of life and lung function. Stakeholder feedback also indicates a preference for observational study design over randomized control trials.

A 41-year-old female was referred to our rhinology service after prior endoscopic sinus surgery. Her medical history was significant for chronic rhinosinusitis and allergic rhinitis. Postoperatively, she developed left-sided epiphora that did not resolve for 2 months and had persistent symptoms related to rhinosinusitis. Endoscopic examination revealed an injury to the left nasolacrimal duct at the level of the head of the middle turbinate. This was confirmed on computed tomography scan, which also demonstrated ongoing sinus inflammation. Evaluation by the ophthalmology service demonstrated nasolacrimal duct obstruction during lacrimal irrigation. After a discussion of treatment options, the patient proceeded with endoscopic dacryocystorhinostomy and revision sinus surgery, which resolved the epiphora and other symptoms.

BACKGROUND Social determinants of health can have a substantial impact on treatment outcomes. Prior study has shown that socioeconomic status influences the likelihood of improvement in quality-of-life (QOL) following endoscopic sinus surgery (ESS). However, the impact of socioeconomic factors on changes in productivity loss and health utility after ESS remains unknown. METHODS Adult patients (≥18 years of age) with chronic rhinosinusitis (CRS) who underwent ESS were prospectively enrolled into a multi-institutional cohort study. Productivity losses were calculated using the human capital approach and monetized using U.S. government-estimated wage rates. Health utility values (HUVs) were derived from the Medical Outcomes Study Short-Form-12 survey using University of Sheffield algorithms. Independent socioeconomic factors of interest included: age, gender, ethnicity, insurance status, educational attainment, and household income categorized via the Thompson-Hickey model. RESULTS A total of 229 patients met inclusion criteria, and 163 (71%) provided postoperative follow-up. All subjects reported significant, within-subject improvement in both mean monetized productivity loss (p < 0.001) and HUV postoperatively (p < 0.001). Using paired sample statistics, patients with lowest income (≤$25,000/year) and with Medicare insurance did not report significant improvement in productivity loss (p ≥ 0.112) or HUV (p ≥ 0.081), although sample size limitations may have contributed to this finding. Patients in higher income tiers ($25,001 to $100,000/year and $100,001+/year) and those with employer-provided/private health insurance reported significant postoperative improvements in productivity loss and HUV (all p ≤ 0.003). CONCLUSION Socioeconomic factors, including income and insurance provision, may impact improvements in productivity loss and HUV following ESS. Further research to validate these findings, ascertain mechanisms behind these results, and improve these outcomes is warranted.

BACKGROUND Racial and ethnic disparities in cancer outcomes have been demonstrated for several different malignancies. In this study we aimed to quantify disease-specific survival (DSS) and the 5-year conditional disease-specific survival (CDSS, the change in life expectancy with increasing survivorship) for paranasal sinus cancer by race and ethnicity. METHODS Patients with sinus cancer between 1973 and 2015 were extracted from the Surveillance, Epidemiology, End Results (SEER) registry. Kaplan-Meier analysis for DSS was stratified by race and ethnicity. Cox regression models of DSS were generated controlling for stage, age, race, and ethnicity. CDSS was calculated using Cox models. Logistic regression was conducted to identify risk factors for younger age at diagnosis, late-stage at diagnosis, and likelihood of receiving surgical intervention when recommended. RESULTS The analysis included a total of 5202 patients. DSS was significantly different when stratified by race (p

BACKGROUND Multiple hypotheses are evolving that suggest several, potentially overlapping etiologies for olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). Understanding inflammatory cytokine profiles of the olfactory cleft (OC) and their association with olfactory function is foundational for future clinical care and research. METHODS This cross-sectional, case-control study evaluates associations among OC mucus inflammatory proteins, psychophysical olfactory testing, and computed tomography (CT) analysis of the OC and sinuses. Normative reference intervals were determined for each protein and odds ratios (ORs) were used to compare proportions of altered expression between CRS without nasal polyposis (CRSsNP) and CRS without nasal polyposis (CRSwNP). RESULTS Case subjects with CRS (n = 151) and controls (n = 74) were evaluated. A majority of OC proteins tested were found within detectable ranges for cases and controls. The CRS cohort had significantly higher concentrations for 23 of 26 proteins. CRS cases with abnormal levels of C-C motif chemokine ligand 2 (CCL2), CCL3, interleukin 5 (IL5), IL10, and IL13 associated with greater olfactory deficits. The prevalence of elevated IL5 and IL13 in anosmic patients was 64.6% and 62.5%, respectively (p < 0.004). CRS cases with the highest odds of elevated expression in CRSwNP were IL5 (OR = 10.83) and IL13 (OR = 8.36). However, both IL5 and IL13 were still elevated in approximately 14% of CRSsNP patients. The highest magnitude of correlation between the total percent of OC opacification was found to be with IL5 (r = 0.543; p < 0.001), whereas other moderate correlations were noted with immunoglobulin E (IgE), IL10, and IL13. CONCLUSION This study confirmed that OC inflammatory proteins vary both by disease phenotype and in their association with OD. Type 2 inflammatory mediators are increased in CRS, especially within the CRSwNP group. However, a substantial proportion of CRSsNP also express type 2 inflammatory mediators. Further research is necessary to understand the complex roles OC mucous inflammatory proteins might play in defining endotype and in impacting CRS-related OD. ©2021 ARSAAOA, LLC.

IMPORTANCE: The distance traveled by patients for medical care is associated with patient outcomes (ie, distance bias) and is a limitation in outcomes research. However, to date, distance bias has not been examined in rhinologic studies. OBJECTIVE: To evaluate the association of distance traveled by a cohort of patients with chronic rhinosinusitis with baseline disease severity and treatment outcomes. DESIGN, SETTING, AND PARTICIPANTS: A total of 505 patients with chronic rhinosinusitis were prospectively enrolled in a multi-institutional, cross-sectional study in academic tertiary care centers between April 2011 and January 2020. Participants self-selected continued appropriate medical therapy or endoscopic sinus surgery. The 22-item Sinonasal Outcome Test (SNOT-22) and Medical Outcomes Study Short Form 6-D (SF-6D) health utility value scores were recorded at enrollment and follow-up. Data on the distances traveled by patients to the medical centers, based on residence zip codes, and medical comorbid conditions were collected. EXPOSURES: Distance traveled by patient to obtain rhinologic care. MAIN OUTCOMES AND MEASURES: SNOT-22 and SF-6D scores. Scores for SNOT-22 range from 0 to 110; and for SF-6D, from 0.0 to 1.0. Higher SNOT-22 total scores indicate worse overall symptom severity. Higher SF-6D scores indicate better overall health utility; 1.0 represents perfect health and 0.0 represents death. RESULTS: The median age for the 505 participants was 56.0 years (IQR, 41.0-64.0 years), 261 were men (51.7%), 457 were White (90.5%), and 13 were Hispanic or Latino (2.6%). These categories were collected according to criteria described and required by the National Institutes of Health and therefore do not equal the entire cohort. Patients traveled a median distance of 31.6 miles (50.6 km) (IQR, 12.2-114.5 miles [19.5-183.2 km]). Baseline (r = 0.00; 95% CI, 0.00-0.18) and posttreatment (r = 0.01; 95% CI, –0.07 to 0.10) SNOT-22 scores, as well as baseline (r = –0.12; 95% CI, –0.21 to –0.04) and posttreatment (r = 0.07; 95% CI, –0.02 to 0.16) SF-6D scores, were not associated with distance. There was no clinically meaningful correlation between distance traveled and mean comorbidity burden. Nevertheless, patients with a history of endoscopic sinus surgery were more likely to travel longer distances to obtain care (Cliff delta = 0.28; 95% CI, 0.19-0.38). CONCLUSIONS AND RELEVANCE: Although this cross-sectional study found that some patients appear more willing to travel longer distances for chronic rhinosinusitis care, results suggest that distance traveled to academic tertiary care centers was not associated with disease severity, outcomes, or comorbidity burden. These findings argue for greater generalizability of study results across various cohorts independent of distance traveled to obtain rhinologic care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02720653

BACKGROUND: Olfactory dysfunction (OD) associated with chronic rhinosinusitis (CRS) remains quite challenging. Instruments to precisely assess olfactory cleft anatomy and their association with olfaction are needed. METHODS: The olfactory cleft endoscopy scale (OCES) was used to assess the olfactory cleft in healthy control subjects and a cohort of patients with CRS. Psychophysical and psychosocial olfactory function were assessed and correlations with OCES scores were measured. RESULTS: Control subjects (N=164) and subjects with CRS with nasal polyps (CRSwNP, N=127) and CRS without nasal polyps (CRSsNP, N=114) were enrolled. OCES correlated with both psychophysical and psychosocial olfaction, as measured by threshold, discrimination and identification (TDI) scores (R= −0.533, p

BACKGROUND The Sinus Control Test (SCT) is a 4-question, patient-reported questionnaire that assesses disease control in chronic rhinosinusitis (CRS). This prospective, multicenter study examines SCT outcomes following endoscopic sinus surgery (ESS), further validating its use as a control instrument for CRS. METHODS Adults with CRS undergoing ESS were prospectively enrolled from 5 centers across North America. The SCT was administered at baseline and once 6 months after surgery. Quality of life and disease burden were evaluated using the 22-item Sino-Nasal Outcome Test (SNOT-22) and Lund-Kennedy endoscopy scores. Linear regression was used to determine whether specific demographic, comorbidity, or disease severity measures were independently associated with changes in SCT scores postoperatively. RESULTS A total of 218 patients, 111 females (50.9%) and 107 males (49.1%), were enrolled, with mean ± standard deviation age of 50.1 ± 15.6 years. Mean SCT score improved from 8.9 ± 3.5 to 4.3 ± 3.7 postoperatively (p < 0.001). Preoperatively, 21.6% were uncontrolled, 71.5% partially controlled, and 6.9% controlled. Postoperatively, 6.0% were uncontrolled, 42.6% partially controlled, and 51.4% controlled (p < 0.001). Change in SCT score correlated independently with change in SNOT-22 (r = 0.500, p < 0.001) and endoscopy scores (r = 0.310, p < 0.001). Endoscopy scores did not correlate with control status among patients with CRS without nasal polyposis (CRSsNP) nor between uncontrolled and partially controlled patients. Demographics and comorbidities were not associated with changes in SCT. CONCLUSION Improvement in disease control following ESS as measured by the SCT correlated with improvements in SNOT-22 and endoscopy scores. The SCT is an easily administered instrument that provides information complementary to existing patient-reported and objective measures of disease severity.

Importance More than a quarter-million cases of endoscopic sinus surgery (ESS) are performed annually in the United States. Most surgeons use image-guided systems as an adjunct during surgery in certain situations. Understanding the association of image-guided surgery (IGS) with surgical outcomes, complications, and surgeon factors is paramount. Observations Three systematic or evidenced-based review articles demonstrated no clear evidence that IGS improves surgical outcomes for chronic rhinosinusitis, including completeness of surgical dissection, patient-reported outcomes, or rates of revision surgery. Results from 2 systematic reviews suggest that major and total surgical complications may be decreased with use of IGS in certain cases, although bias may confound these findings. When complications were analyzed individually, there was no definitive evidence that IGS is associated with decreased rates of orbital, intracranial, or hemorrhagic complications. The rarity of complications in ESS, developing surgical experience, evolving training strategies, and selective use of IGS in more complex cases make future study on the association of IGS with complications challenging. Limited data on the influence of IGS on surgeon satisfaction and stress level suggests that more experienced surgeons might glean benefits in these realms, whereas junior surgeons may feel additional stress when using the technology. Conclusions and Relevance Level 2A evidence from systematic reviews suggests that in certain cases IGS may be associated with decreased major and total surgical complications, though the potential for bias and confounding exists in these conclusions. It is possible that, among more experienced surgeons, the use of IGS is associated with improvements in stress and satisfaction, although evidence in this realm is limited and there may be additional stresses associated with IGS for surgeons early in their career. The choice to use IGS in any endoscopic procedure remains best determined by the operating surgeon based on factors including case complexity and surgeon comfort.

BACKGROUND Olfactory dysfunction (OD) in chronic rhinosinusitis (CRS) is common. It is likely that numerous factors such as sex, race, age, allergies, asthma, smoking, and other comorbidities play a role in CRS-related OD. In order to determine which aspects of OD are due solely to CRS and which are associated with other confounders, control populations are needed to allow appropriate risk assessments. METHODS Prospective, multi-institutional enrollment of patients with CRS and control subjects without CRS was performed. Demographic information, comorbidities, and olfactory testing (Sniffin' Sticks) of threshold (T), discrimination (D), and identification (I) scores (TDI) was collected. RESULTS A total of 224 patients with CRS and 164 control subjects were enrolled. Olfaction was worse in CRS patients compared to controls (mean ± standard deviation (SD) TDI = 22.4 ± 9.5 vs 28.8 ± 7.0, respectively, p < 0.001). Only 27% of CRS patients were normosmic compared to 49% of controls (p < 0.001). When stratifying by nasal polyp (NP) status, CRSwNP patients had significant impairments in TDI, T, D, and I compared to controls with mean differences of 11.2, 3.3, 3.5, and 4.4 points, respectively (all p < 0.001). In contrast, CRSsNP patients only had impaired T when compared to controls with a mean difference of 2.2 points (p < 0.001). Multivariate modeling of TDI scoring showed that OD was driven by polyps, asthma, diabetes, and age. CRSsNP was not independently associated with worse TDI scores. CONCLUSION OD in CRS patients is multifactorial. Independent drivers appear to be polyp status, asthma, diabetes, and age. OD in patients with CRSsNP is similar to controls with the exception of impaired thresholds.

OBJECTIVES/HYPOTHESIS Endoscopic sinus surgery (ESS) is frequently performed for recurrent acute rhinosinusitis (RARS). Appropriate indications for surgery among patients with RARS have not yet been rigorously determined. The objective of this study was to define appropriateness criteria for ESS in the management of adult RARS. STUDY DESIGN Application of RAND-UCLA appropriateness methodology. METHODS A panel of nine multidisciplinary experts in RARS was formed to evaluate RARS scenarios generated from current evidence. The panel completed two rounds of a modified Delphi-ranking process and a teleconference. RESULTS A total of 32 clinical scenarios were ranked in each round. For adult patients with RARS, ESS can appropriately be offered as a treatment option when patients experience ≥ four annual episodes, and there is confirmation of at least one episode via computed tomography or nasal endoscopy, and the patient and clinician jointly participate in shared decision making, and the patient has either failed a trial of topical nasal steroids or experienced RARS-related productivity loss. CONCLUSIONS This study has defined appropriateness criteria for ESS as a management option for adult patients with RARS. These criteria are intended to represent a minimum threshold for which ESS should be considered in the treatment of RARS and do not suggest that all patients who meet these criteria should undergo surgery. These criteria may serve as a baseline set of indications for ESS in patients with RARS. LEVEL OF EVIDENCE NA Laryngoscope, 129:37-44, 2019.

BACKGROUND Chronic rhinosinusitis (CRS) is associated with substantial productivity losses. Prior cross-sectional study has identified risk factors and symptom subdomains contributing to baseline productivity loss. This study evaluates correlations between posttreatment changes in symptom subdomain and productivity loss. METHODS A total of 202 adult patients with refractory CRS were prospectively enrolled into an observational, multi-institutional cohort study between August 2012 and June 2015. Respondents provided pretreatment and posttreatment 22-item Sino-Nasal Outcome Test (SNOT-22) scores. Productivity losses were monetized using measures of absenteeism, presenteeism, lost leisure time, and U.S. government-estimated wage and labor rates. RESULTS A total of 39 (19%) participants elected continued appropriate medical therapy (CAMT) and 163 (81%) elected endoscopic sinus surgery (ESS). CAMT patients experienced improvement in SNOT-22 total and rhinologic subdomain scores (both p ≤ 0.039). ESS patients reported improvement in SNOT-22 total scores and all subdomains (all p < 0.001). Mean monetized productivity losses were nearly unchanged following CAMT (-$200, p = 0.887) but significantly reduced following ESS (-$5,015, p < 0.001). Mean productivity losses were reported in CAMT patients reporting worse mean posttreatment extra-rhinologic, psychological, and sleep symptom severity scores; however, no statistically significant linear correlations (r ≤ 0.249; p ≥ 0.126) were reported. CONCLUSION Treatment modalities associate with different posttreatment productivity changes. Patients electing ESS experienced postoperative improvement in productivity distributed across all SNOT-22 symptom domains, suggesting productivity improvement correlates with multiple symptom domains. Patients electing CAMT had better baseline productivity compared to patients electing ESS, and this productivity level was maintained through treatment. Greater productivity loss occurred in patients with worse SNOT-22 scores in the extra-rhinologic, psychological, and sleep subdomains.

Background To better understand upper airway tissue regeneration, the exposed cartilage and bone at donor sites of tissue flaps may serve as in vivo "Petri dishes" for active wound healing. The pedicled nasoseptal flap (NSF) for skull-base reconstruction creates an exposed donor site within the nasal airway. The objective of this study is to evaluate whether grafting the donor site with a sinonasal repair cover graft is effective in promoting wound healing. Methods In this multicenter, prospective trial, subjects were randomized to intervention (graft) or control (no graft) intraoperatively after NSF elevation. Individuals were evaluated at 2, 6, and 12 weeks postintervention with endoscopic recordings. Videos were graded (Likert scale) by 3 otolaryngologists blinded to intervention on remucosalization, crusting, and edema. Scores were analyzed for interrater reliability and cohorts compared. Biopsy and immunohistochemistry at the leading edge of wound healing was performed in select cases. Results Twenty-one patients were randomized to intervention and 26 to control. Subjects receiving the graft had significantly greater overall remucosalization (p = 0.01) than controls over 12 weeks. Although crusting was less in the small intestine submucosa (SIS) group, this was not statistically significant (p = 0.08). There was no overall effect on nasal edema (p = 0.2). Immunohistochemistry demonstrated abundant upper airway basal cell progenitors in 2 intervention samples, suggesting that covering grafts may facilitate tissue proliferation via progenitor cell expansion. Conclusion This prospective, randomized, controlled trial indicates that a porcine SIS graft placed on exposed cartilage and bone within the upper airway confers improved remucosalization compared to current practice standards.

OBJECTIVES Appropriateness criteria to determine surgical candidacy for chronic rhinosinusitis (CRS) have recently been described. This study stratified patients who underwent endoscopic sinus surgery (ESS) according to these new appropriateness criteria and evaluated postoperative improvements among appropriateness categories. METHODS Adult patients with uncomplicated CRS electing ESS were prospectively enrolled in a multi-institutional cohort study between March 2011 and June 2015 to assess outcomes. Subsequently, appropriateness criteria that consider preoperative medical therapy, 22-item SinoNasal Outcome Test (SNOT-22) scores, and Lund-Mackay computed tomography scores were retrospectively applied. RESULTS A total of 92.6% (436 of 471) were categorized as "appropriate" ESS candidates, 3.8% (18 of 471) as "uncertain," and 3.6% (17 of 471) as "inappropriate." Among uncertain patients, two-thirds (12 of 18) had identifiable reasons for undergoing ESS, most commonly oral corticosteroid intolerance (n = 6). Postoperative follow-up was available for 79% (n = 372). Clinically significant SNOT-22 improvements occurred in both appropriate and uncertain groups (all P

Objectives Venous thromboembolism (VTE) contributes to significant patient morbidity, yet the incidence of VTE following endoscopic sinus surgery (ESS) is unknown. Quality improvement criteria are prompting increased standardization of perioperative VTE prophylaxis. Risk stratification for VTE may better define best practice measures to balance limiting VTE development with avoiding unnecessary chemoprophylaxis. Study Design Retrospective cohort study. Setting Tertiary institution. Subjects and Methods Adult patients who underwent ESS without perioperative chemoprophylaxis from 2008 to 2016 were evaluated. Identification of VTE was performed via screening diagnosis and procedure codes and clinical records, with subsequent confirmation of true-positive VTE. Data for individual Caprini scores were abstracted from electronic medical records. The primary outcome was development of VTE within 30 days following ESS relative to the Caprini score. Results A total of 2369 ESS cases were evaluated. While initial screening identified multiple potential VTE events, in-depth medical record review confirmed only 4 true VTE (0.17%). The VTE rate among cases with a Caprini score of8 (0.09%, 2/2278) was significantly less ( P = .008) than the rate with a score of ≥8 (2.2%, 2/91). Beyond overall score, specific risk factors associated with development of postoperative VTE included stroke, central venous access, sepsis, and inpatient status (all P.025), while prior VTE and hypercoagulability were not associated with postoperative VTE (all P.5). Conclusions In the absence of perioperative chemoprophylaxis, postoperative VTE following ESS is extremely rare, particularly for patients carrying low-to-moderate Caprini scores. Risk stratification based on these data can assist in the design of VTE prophylaxis guidelines for ESS patients.

Background Although the majority of patients with chronic rhinosinusitis without nasal polyposis (CRSsNP) suffer from bilateral disease, a subset suffer from unilateral disease. Currently, outcomes following endoscopic sinus surgery (ESS) for medically recalcitrant CRS are inferred from outcomes for patients with bilateral disease. This study compares outcomes of ESS between patients with unilateral and bilateral disease. Methods Patients with CRSsNP who failed appropriate medical therapy and elected ESS were enrolled between 2011 and 2015. Patients were dichotomized according to radiographic evidence of unilateral disease (Lund-Mackay [LM] score = 0 for 1 side) or bilateral disease (LM ≥ 1 for both sides). The primary outcome of interest was the 22-item Sino-Nasal Outcome Test (SNOT-22), with secondary outcomes including the Brief Smell Identification Test (BSIT) and the Lund-Kennedy (LK) endoscopy staging system. Results A total of 190 patients met inclusion criteria consisting of 19 with unilateral (10%) and 171 with bilateral CRSsNP (90%). Both groups were similar across all preoperative demographic factors, SNOT-22, and BSIT scores. Postoperatively, patients with bilateral disease reported greater improvement in mean SNOT-22 scores compared to unilateral disease, but this difference was not statistically or clinically significant (−24.3 ± 21.1 vs −21.5 ± 24.0, p = 0.582). Mean LK scores improved for patients with bilateral disease but not unilateral disease, without a difference between groups (−2.0 ± 3.5 vs −0.4 ± 2.4, p = 0.090). Conclusion Patients with unilateral CRSsNP experience improvement after ESS comparable to patients with bilateral disease on patient reported outcome measures.

Chronic rhinosinusitis (CRS) is an inflammatory sinonasal condition with multiple etiologic factors that is associated with a vast economic cost. Treatment is most frequently pharmacologic and has centered on agents that ameliorate inflammation, decrease bacterial or pathogen load, and facilitate egress of mucus or purulence from the sinonasal cavity. Nasal saline irrigations, topical nasal steroids, certain antibiotics, and systemic steroids have shown some efficacy in the management of CRS. Recently, biologic therapeutics that target specific inflammatory pathways associated with subsets of CRS have been developed and evaluated. Early data evaluating these biologic treatments suggest a potential role in treating a subset of CRS with refractory, poorly controlled disease. Additional studies are necessary to identify which patients would benefit most from biologic therapies and to assess the cost of these therapies compared with the benefit they provide. This review describes the pathophysiology of CRS and summarizes both established and novel biologic pharmacologic treatments.

Objective: To compare the management of pediatric chronic rhinosinusitis (PCRS) between members of the American Rhinologic Society (ARS) and the American Society of Pediatric Otolaryngology (ASPO). Study Design: Comparison of surveys. Methods: A web-based survey was distributed to ASPO membership twice in September-October 2016. Data were compared to previously published data from ARS membership in March-April 2016. Results: ASPO survey completion rate was 22%. ARS members were more likely to employ oral steroids in initial ( P = .025) and maximal medical management ( P = .001). ASPO members more commonly performed adenoidectomy before computed tomography (CT) ( P < .001). Both groups commonly included adenoidectomy as part of initial surgical management (90% vs 94%, P = .316), while ASPO members more frequently performed adenoidectomy alone (70% vs 43%, P = .001). If initial surgical treatment failed, both groups commonly performed endoscopic sinus surgery (ESS; 81% vs 88%, P = .56) with a similar extent including frontal ( P ≥ .207) and sphenoid ( P ≥ .304) surgery. Conclusions: Pediatric chronic rhinosinusitis management is similar between groups, yet there are differences including oral steroid use, relative order of CT versus adenoidectomy, and performing concomitant procedures with adenoidectomy. Both groups commonly perform ESS with similar surgical extent if prior surgical treatment fails. Management by both groups is largely in agreement with published consensus statements.

Identifying high-value management strategies is increasingly important in a health care system with finite resources. This review describes the importance of robust data collection in determining treatment outcomes and valuations using examples in otolaryngology. There has been a shift in both health care systems and US government payers toward providing health care with significant benefit at reasonable cost. Systematic data collection has been employed in multiple areas of otolaryngology to measure outcomes and quantify the value of many interventions. Multiple methods exist to investigate the value of treatment strategies, including cost effectiveness analysis and applying appropriateness criteria. Robust data collection is the foundation of outcomes research and enables the assessment of the value of a treatment strategy. With current health care trends, providing high-value care will become all but mandatory across otolaryngology and other medical fields.