Cost-effectiveness analysis of biologics for the treatment of chronic rhinosinusitis with nasal polyps in Canada.

BACKGROUND: Dupilumab, omalizumab, and mepolizumab are the three biologics currently approved for use in CRSwNP in Canada. Despite evidence of efficacy, their cost-effectiveness, which is a key factor influencing prescribing patterns, has not yet been compared to each other. METHODS: A cost-effectiveness model using quality-adjusted life years (QALYs) was constructed using a Decision Tree Markov analysis. A third-party healthcare payer perspective and a 10-year time horizon was used. A willingness-to-pay (WTP) threshold of 50,000 Canadian dollars (CAD) per QALY was used to determine cost-effectiveness. Dupilumab, omalizumab, and mepolizumab were each compared to each other. RESULTS: Omalizumab was the most cost-effective biologic using current estimates of cost and efficacy in CRSwNP. Using omalizumab as a baseline, dupilumab had an ICER of $235,305/QALY. Mepolizumab was dominated by omalizumab and dupilumab at the current drug prices and estimates of efficacy. Sensitivity analyses determined that when increasing the WTP threshold to $150,000/QALY, dupilumab became cost-effective compared to omalizumab in 22.5% of simulation scenarios. Additionally, altering dosing frequency had a significant effect on cost-effectiveness. CONCLUSION: When comparing the relative cost-effectiveness of biologics in recalcitrant CRSwNP, omalizumab currently appears to be the most cost-effective option. Future reductions in drug prices, adjustments to currently approved dosing regimens, better patient selection, and improvements in sinus surgery outcomes will challenge the current cost-effectiveness models and necessitate reassessment as treatments for CRSwNP continue to evolve.

Post-operative surveillance for somatotroph, lactotroph and non-functional pituitary adenomas after curative resection: a systematic review.

CONTEXT: Pituitary tumors are the third most common brain tumor and yet there is no standardization of the surveillance schedule and assessment modalities after transsphenoidal surgery. EVIDENCE ACQUISITION: OVID, EMBASE and the Cochrane Library databases were systematically screened from database inception to March 5, 2020. Inclusion and exclusion criteria were designed to capture studies examining detection of pituitary adenoma recurrence in patients 18 years of age and older following surgical resection with curative intent. EVIDENCE SYNTHESIS: A total of 7936 abstracts were screened, with 812 articles reviewed in full text and 77 meeting inclusion criteria for data extraction. A pooled analysis demonstrated recurrence rates at 1 year, 5 years and 10 years for non-functioning pituitary adenomas (NFPA; N = 3533 participants) were 1%, 17%, and 33%, for prolactin-secreting adenomas (PSPA; N = 1295) were 6%, 21%, and 28%, and for growth-hormone pituitary adenomas (GHPA; N = 1257) were 3%, 8% and 13%, respectively. Rates of recurrence prior to 1 year were 0% for NFPA, 1-2% for PSPA and 0% for GHPA. The mean time to disease recurrence for NFPA, PSPA and GHPA were 4.25, 2.52 and 4.18 years, respectively. CONCLUSIONS: This comprehensive review of the literature quantified the recurrence rates for commonly observed pituitary adenomas after transsphenoidal surgical resection with curative intent. Our findings suggest that surveillance within 1 year may be of low yield. Further clinical trials and cohort studies investigating cost-effectiveness of surveillance schedules and impact on quality of life of patients under surveillance will provide further insight to optimize follow-up.

Cost-effectiveness of direct surgery versus preoperative octreotide therapy for growth-hormone secreting pituitary adenomas.

PURPOSE: The objective of this study was to compare the cost-effectiveness of preoperative octreotide therapy followed by surgery versus the standard treatment modality for growth-hormone secreting pituitary adenomas, direct surgery (that is, surgery without preoperative treatment) from a public third-party payer perspective. METHODS: We developed an individual-level state-transition microsimulation model to simulate costs and outcomes associated with preoperative octreotide therapy followed by surgery and direct surgery for patients with growth-hormone secreting pituitary adenomas. Transition probabilities, utilities, and costs were estimated from recent published data and discounted by 3% annually over a lifetime time horizon. Model outcomes included lifetime costs [2020 United States (US) Dollars], quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). RESULTS: Under base case assumptions, direct surgery was found to be the dominant strategy as it yielded lower costs and greater health effects (QALYs) compared to preoperative octreotide strategy in the second-order Monte Carlo microsimulation. The ICER was most sensitive to probability of remission following primary therapy and duration of preoperative octreotide therapy. Accounting for joint parameter uncertainty, direct surgery had a higher probability of demonstrating a cost-effective profile compared to preoperative octreotide treatment at 77% compared to 23%, respectively. CONCLUSIONS: Using standard benchmarks for cost-effectiveness in the US ($100,000/QALY), preoperative octreotide therapy followed by surgery may not be cost-effective compared to direct surgery for patients with growth-hormone secreting pituitary adenomas but the result is highly sensitive to initial treatment failure and duration of preoperative treatment.

Canadian real-world study of access and clinical results using dupilumab for chronic rhinosinusitis with polyps.

BACKGROUND: Dupilumab is the first monoclonal antibody therapy to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The goal of the study was to assess its effectiveness and efficacy in a real-world setting. This study aims to assess how clinical outcomes of biologic therapy in real-world application (effectiveness) correspond to outcomes in clinical trials (efficacy) and to look into factors that might explain an efficacy-effectiveness gap. METHODS: A retrospective study evaluating disease specific sinonasal outcomes routinely collected for clinical care. This study included patients who were evaluated for coverage of dupilumab at a tertiary care rhinology clinic for the treatment of CRSwNP in the first year since dupilumab was approved in Canada for this indication. Sinonasal outcomes were be evaluated by collecting data on the Sino-Nasal Outcome Test (SNOT)-22 questionnaire. RESULTS: Eighty-five patients were considered for dupilumab therapy during the study period, 49% patients were able to attain coverage for the requested therapy. The mean SNOT-22 score at baseline was 60.56 (SD 21.63). After 16 weeks of treatment the mean SNOT-22 score decreased by 37 points to 23.36; at 28 weeks the mean SNOT-22 was 23.47. After 1 year, the mean SNOT-22 score was 14.37. CONCLUSION: Patients treated with dupilumab for CRSwNP at out tertiary rhinology clinic showed substantial clinical symptom improvement that is similar to that observed in prior randomised clinical trials. No serious adverse effects related to dupilumab were reported in this cohort. Long-term follow-up is needed to inform effectiveness analyses beyond the 1 year clinical trial duration.

Cost-effectiveness of Endoscopic Polypectomy in Clinic compared to Endoscopic Sinus Surgery: A modelling study.

OBJECTIVE: To compare costs and quality-adjusted life years of patients receiving endoscopic polypectomy in the clinic those receiving endoscopic sinus surgery from the perspective of Canada's health system. METHOD: We developed a Markov model to simulate costs and quality-adjusted life years among a cohort of patients with chronic rhinosinusitis with polyps who received endoscopic polypectomy in clinic or endoscopic sinus surgery, over a patient's lifetime. Our study focused on patients with chronic rhinosinusitis with polyps who have the predominant symptom of bilateral nasal obstruction. Cost data were obtained from Canadian sources. Health utility values were derived from Sino-nasal Outcome Test (SNOT-22) scores reported in the published literature. A cycle length of six months was used. Both costs and quality-adjusted life years were discounted using an annual rate of 1.5%. We conducted one-way and probabilistic sensitivity analyses to assess the robustness of the study findings. RESULTS: Endoscopic polypectomy in clinic was a cost-saving option as it had a lower cost (C$736 vs. C$6,728) and produced more quality-adjusted life years (13.85 vs 13.06) compared to endoscopic sinus surgery. Our findings were, however, highly sensitive to health utility values. Results from probabilistic sensitivity analysis showed that endoscopic polypectomy in clinic had a lower cost and was more effective compared to endoscopic sinus surgery in 99.86% of iterations. CONCLUSION: From the perspective of the publicly funded healthcare system, endoscopic polypectomy in clinic was economically attractive compared to endoscopic sinus surgery for chronic rhinosinusitis with polyps patients who have a primary symptom of bilateral nasal obstruction. The cost-effectiveness results are, however, highly dependent on the relative impact of endoscopic polypectomy in the clinic and endoscopic sinus surgery on post-surgery health utility values.

Prospective pilot study of Floseal® for the treatment of anterior epistaxis in patients with hereditary hemorrhagic telangiectasia (HHT).

BACKGROUND: Epistaxis is the most common symptom of hereditary hemorrhagic telangiectasia (HHT), affecting more than 98% of adults with HHT, with significant impact on quality of life. Floseal® has been shown to be effective for the management of anterior epistaxis, but has yet to be thoroughly evaluated in this population. Our goal was to evaluate the efficacy of Floseal® for managing acute anterior epistaxis in patients with HHT. METHODS: A pilot prospective clinical trial was conducted at two tertiary referral centres, St. Michael's Hospital, Toronto, Canada and The Ottawa Hospital, Ottawa, Canada. All patients with HHT presenting with acute anterior epistaxis to the two study centres, who enrolled in the study, received Floseal® treatment. The primary outcome measures were achievement of hemostasis and changes in the Epistaxis Severity Score (ESS) between baseline and one-month follow up. Secondary outcome measure included clinical assessment of the nasal cavity. RESULTS: Seven patients were included in the final analysis. All patients underwent treatment of anterior epistaxis with Floseal® and achieved control of epistaxis within 15-min post-application. Application of Floseal® was well tolerated, with patients reporting a pain score of 3 ± 3.13 out of 10. There was no statistically significant difference noted in ESS scores pre-treatment and one-month follow up, 6.27 ± 2.42 vs. 4.50 ± 2.44, p = 0.179. There was a significant improvement clinically on exam of the nasal cavity between baseline and at one-month follow up, indicated by a decrease in the clinical assessment score, 17.29 ± 7.70 vs. 9.57 ± 7.81 (p = 0.0088). CONCLUSIONS: Patients with HHT presenting with acute epistaxis were able to achieve hemostasis with one application of Floseal®, with the procedure being very well tolerated with minimal pain. Although there was no significant change in ESS scores, clinical assessment of the nasal cavity revealed significant improvement at one-month follow up post treatment with Floseal®. TRIAL REGISTRATION: This multi-centered prospective clinical trial was registered with ClinicalTrials.gov ( NCT02638012 ). Registered on December 22, 2015.

Complete Recovery of Sensorineural Hearing Loss Following Endoscopic Transsphenoidal Surgery for a Petrous Apex Cholesterol Granuloma: Case Report.

BACKGROUND Cholesterol granulomas of the petrous apex may impinge surrounding cranial nerves, leading to neurological impairments such as hearing loss. Less invasive endoscopic techniques are gaining popularity as the mainstay of therapy for this lesion. CASE REPORT We present a case of petrous apex cholesterol granuloma causing mild sensorineural hearing loss. An endoscopic endonasal transsphenoidal approach was successfully performed to partially resect and aerate the lesion. The auditory function on the affected side was completely restored after surgery. The patient experienced no post-operative complications. CONCLUSIONS This case report highlights the advantages of using an endoscopic transsphenoidal surgical approach in cases of petrous apex cholesterol granuloma, including the potential for this less invasive technique to restore sensorineural hearing loss.

Determining the hospital cost of anterior epistaxis treatment modalities at a Canadian tertiary care centre.

OBJECTIVE: To estimate the hospital costs of managing anterior epistaxis in the Emergency Department at a Tertiary Care centre in Canada. MATERIAL AND METHODS: A cost analysis was conducted based on a retrospective review of Emergency Department visits from January 2012 to May 2014. A consecutive sample of adult patients with a diagnosis of anterior epistaxis was included. Anterior epistaxis was managed via one of: Nasal clip, Merocel®, Silver Nitrate cautery, Vaseline packing, other treatment or no treatment. Both the direct and indirect hospital costs ($CDN) for anterior epistaxis treatment were calculated from the hospital's perspective. Generalized linear models were used to assess the association between treatment modalities and total hospital costs while controlling for potential confounding factors. RESULTS: Three hundred and fifty-three patients (49% female) with a mean age of (69.9 ± 18.5) years were included in the analysis. The median (interquartile ranges) costs of treatment ranged from C$227.83 (C$167.96, C$328.69) for observation to C$763.98 (C$632.25,C$830.23) for Merocel®. The overall median total hospital costs incurred across all modalities was C$566.24 (C$459.61, C$753.46) for the management of anterior epistaxis. Silver Nitrate, nasal clip, and observation were statistically associated with a lower cost when compared to Merocel® (P < 0.001) even after potential confounding factors were controlled. CONCLUSIONS: Our results show wide difference in the hospital cost of epistaxis across treatment modalities. These cost estimates can help inform future economic evaluation studies aiming to guide the allocation of health care resources for patients with epistaxis.

Socioeconomic status and anterior epistaxis in adult population.

OBJECTIVE: Little was known about the role of socioeconomic status as a risk factor for epistaxis in adult population. The objective of this study was to determine whether socioeconomic status influences the presentation to emergency department for anterior epistaxis in an adult population. METHODS: Retrospective review of emergency department visits from January 2012 to May 2014. The setting is in an emergency department of a Canadian tertiary care centre. Adult patients with primary diagnosis of anterior epistaxis in the emergency department were included in this study. The main outcome was emergency department visits for anterior epistaxis visits. RESULTS: A total of 351 cases of anterior epistaxis were included. The mean age was 70 years and 51% of patients were male. The patients were stratified into two groups based on whether their age was equal to and above, or below 75 years. Our analysis indicated that those 75 years or older in higher income quintiles have an increased risk of anterior epistaxis compared to the subjects in the lower income quintiles (P < 0.05). This association did not hold true for those younger than 75 years or for all age groups combined. CONCLUSION: There is an association between higher socioeconomic status and the presentation to the emergency department with anterior epistaxis in the population older than 75 years but not in younger patients.

Economic evaluation of floseal compared to nasal packing for the management of anterior epistaxis.

OBJECTIVES/HYPOTHESIS: To evaluate the cost-effectiveness of Floseal, a topically applied hemostatic agent, and nasal packing for the management of epistaxis in Canada. STUDY DESIGN: Outcomes research, a cost-utility analysis. METHODS: We developed a Markov model to compare the costs and health outcomes of Floseal with nasal packing over a lifetime horizon from the perspective of a publicly funded healthcare system. A cycle length of 1 year was used. Efficacy of Floseal and packing was sought from the published literature. Unit costs were gathered from a hospital case costing system, whereas physician fees were extracted from the Ontario Schedule of Benefits for Physician Services. Results were expressed as an incremental cost per quality-adjusted life year (QALY) gained. A series of one-way sensitivity and probabilistic sensitivity analyses were performed. RESULTS: From the perspective of a publicly funded health are system, the Floseal treatment strategy was associated with higher costs ($2,067) and greater QALYs (0.27) than nasal packing. Our findings were highly sensitive to discount rates, the cost of Floseal, and the cost of nasal packing. The probabilistic sensitivity analysis suggested that the probability that Floseal treatment is cost-effective reached 99% if the willingness-to-pay threshold was greater than $120,000 per QALY gained. CONCLUSIONS: Prior studies have demonstrated Floseal to be an effective treatment for anterior epistaxis. In the Canadian healthcare system, Floseal treatment appears to be a cost-effective treatment option compared to nasal packing for anterior epistaxis. LEVEL OF EVIDENCE: 2c Laryngoscope, 1778-1782, 2018.

Development and validation of an administrative data algorithm to identify adults who have endoscopic sinus surgery for chronic rhinosinusitis.

BACKGROUND: This was a diagnostic accuracy study to develop an algorithm based on administrative database codes that identifies patients with Chronic Rhinosinusitis (CRS) who have endoscopic sinus surgery (ESS). METHODS: From January 1st, 2011 to December 31st, 2012, a chart review was performed for all hospital-identified ESS surgical encounters. The reference standard was developed as follows: cases were assigned to encounters in which ESS was performed for Otolaryngologist-diagnosed CRS; all other chart review encounters, and all other hospital surgical encounters during the timeframe were controls. Algorithm development was based on International Classification of Diseases, version 10 (ICD-10) diagnostic codes and Canadian Classification of Health Interventions (CCI) procedural codes. Internal model validation was performed with a similar chart review for all model-identified cases and 200 randomly selected controls during the following year. RESULTS: During the study period, 347 cases and 185,007 controls were identified. The predictive model assigned cases to all encounters that contained at least one CRS ICD-10 diagnostic code and at least one ESS CCI procedural code. Compared to the reference standard, the algorithm was very accurate: sensitivity 96.0% (95%CI 93.2-97.7), specificity 100% (95% CI 99.9-100), and positive predictive value 95.4% (95%CI 92.5-97.3). Internal validation using chart review for the following year revealed similar accuracy: sensitivity 98.9% (95%CI 95.8-99.8), specificity 97.1% (95%CI 93.4-98.8), and positive predictive value 96.9% (95%CI 93.0-99.8). CONCLUSION: A simple model based on administrative database codes accurately identified ESS-CRS encounters. This model can be used in population-based cohorts to study longitudinal outcomes for the ESS-CRS population.

The Role of Helicobacter pylori in Laryngopharyngeal Reflux.

Objective The primary objective was to determine the prevalence of Helicobacter pylori among patients with laryngopharyngeal reflux. The secondary objective was determining if H pylori eradication leads to greater symptom improvement in patients with laryngopharyngeal reflux as compared with standard proton pump inhibitor therapy alone. Data Sources EMBASE, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, World Health Organization International Clinical Trials Registry Platform, European Union Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov. Review Methods A systematic review was performed of studies assessing the diagnosis or treatment of H pylori among patients with laryngopharyngeal reflux. Randomized controlled trials, cohort studies, case-control studies, and case series were included. A meta-analysis of prevalence data and assessment of heterogeneity was performed on relevant studies. Results Fourteen studies were analyzed in the review, with 13 eligible for the meta-analysis. We determined that the prevalence of H pylori among patients with laryngopharyngeal reflux was 43.9% (95% confidence interval, 32.1-56.5). The heterogeneity of studies was high, with an overall I2 value of 92.3%. We were unable to quantitatively assess findings for our secondary outcome, since H pylori identification and treatment were not the primary focus of the majority of studies. Conclusion There is a high rate of H pylori infection among patients with laryngopharyngeal reflux. The infection rate in North America and Western Europe has not been adequately studied. There is insufficient evidence to make a recommendation regarding the testing and treatment of H pylori infection among patients with laryngopharyngeal reflux.

Bilateral Vocal Cord Paralysis and Cervicolumbar Radiculopathy as the Presenting Paraneoplastic Manifestations of Small Cell Lung Cancer: A Case Report and Literature Review.

Introduction. Bilateral vocal cord paralysis (BVCP) is a potential medical emergency. The Otolaryngologist plays a crucial role in the diagnosis and management of BVCP and must consider a broad differential diagnosis. We present a rare case of BVCP secondary to anti-Hu paraneoplastic syndrome. Case Presentation. A 58-year-old female presented to an Otolaryngology clinic with a history of progressive hoarseness and dysphagia. Flexible nasolaryngoscopy demonstrated BVCP. Cross-sectional imaging of the brain and vagus nerves was negative. An antiparaneoplastic antibody panel was positive for anti-Hu antibodies. This led to an endobronchial biopsy of a paratracheal lymph node, which confirmed the diagnosis of small cell lung cancer. Conclusion. Paraneoplastic neuropathy is a rare cause of BVCP and should be considered when more common pathologies are ruled out. This is the second reported case of BVCP as a presenting symptom of paraneoplastic syndrome secondary to small cell lung cancer.

Chronic rhinosinusitis identification in administrative databases and health surveys: A systematic review.

OBJECTIVES/HYPOTHESIS: Much of the epidemiological data on chronic rhinosinusitis (CRS) are based on large administrative databases and health surveys. The accuracy of CRS identification with these methods is unknown. METHODS: A systematic review was performed to identify studies that measured the accuracy of CRS diagnoses in large administrative databases or within health surveys. The Quality Assessment of Diagnostic Accuracy Studies 2 tool was used to assess study quality. RESULTS: Of 512 abstracts initially identified, 122 were selected for full-text review; only three studies (2.5%) measured the accuracy of CRS patient identification. In a single, large administrative database study with a CRS prevalence of 54.8%, a single International Classification of Diseases-9th Revision diagnostic code for CRS had a positive predictive value (PPV) of only 34%. A diagnostic code algorithm identified CRS patients with a PPV of 91.3% (95% confidence interval [CI], 85.3-95.1); in a population with a CRS prevalence of 5%, this algorithm had a PPV of 31%. In health survey studies having an estimated CRS prevalence of 25% to 46%, self-reported symptom-based CRS diagnosis had a PPV of 62% (95% CI, 50.2-72.1) when nasal endoscopy was the gold standard for CRS diagnosis, and 70% (95% CI, 57.4-80.8) when otolaryngologist-based CRS diagnosis (after interview and nasal endoscopy) was the gold standard. CONCLUSION: Most health administrative data and health surveys examining CRS did not consider the accuracy of case identification. For unselected populations, administrative data and health surveys using self-reported diagnoses inaccurately identify patients with CRS. Epidemiological results based on such data should be interpreted with these results in mind. Laryngoscope, 126:1303-1310, 2016.

Technique modifications for septodermoplasty: an illustrative case.

BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an autosomal dominant disease that results in telangiectasia of the sinonasal tract, gastro-intestinal tract as well as possible arteriovenous malformations of the lung, liver and brain. One of the most common disease manifestations of HHT is epistaxis. Severe recurrent epistaxis necessitating iron therapy and blood transfusion is often managed with septodermoplasty. Its initial description was as an open surgical technique requiring nasal packing. CASE PRESENTATION: We describe a modified approach to septodermoplasty done completely endoscopically and without nasal packing for a patient with severe epistaxis due to HHT. CONCLUSION: The described technique modifications for the presented case allowed for same day discharge following surgery, complete take of the skin graft and resultant epistaxis control that ended thepatient's transfusion dependency. The merits of these modifications should be further evaluated in a clinical trial.

Anti-IgE monoclonal antibody therapy for the treatment of chronic rhinosinusitis: a systematic review.

BACKGROUND: Several options are available for the treatment of chronic rhinosinusitis (CRS), but disease control remains elusive for many patients. Recently, literature has emerged describing anti-IgE monoclonal antibody as a potential therapy for CRS. However, its effectiveness and safety are not well known. The purpose of this systematic review was to assess the effectiveness and safety of anti-IgE therapy and to identify evidence gaps that will guide future research for the management of CRS. METHODS: Methodology was registered with PROSPERO (No. CRD42014007600). A comprehensive search was performed of standard bibliographic databases, Google Scholar, and clinical trials registries. Only randomized controlled trials assessing anti-IgE therapy in adult patients for the treatment of CRS were included. Two independent reviewers extracted data using a pre-defined extraction form and performed quality assessment using the Cochrane risk of bias tool and the GRADE framework. RESULTS: Two studies met our inclusion criteria. When comparing anti-IgE therapy to placebo, there was a significant difference in Lund-McKay score (p = 0.04) while no difference was seen for percent opacification on computed tomography (CT). At 16 weeks, treatment led to a decrease in clinical polyp score. No significant difference was seen with regard to quality of life (Total Nasal Symptom Severity (TNSS), p < 0.21; Sinonasal Outcome Test 20 (SNOT-20), p < 0.60), and no serious complications were reported in either trial. Based on the quality assessment, studies were deemed to be of moderate risk of bias and a low overall quality of evidence. CONCLUSIONS: There is currently insufficient evidence to determine the effectiveness of anti-IgE monoclonal antibody therapy for the treatment of CRS.

Direct costs of adult chronic rhinosinusitis by using 4 methods of estimation: Results of the US Medical Expenditure Panel Survey.

BACKGROUND: Chronic rhinosinusitis (CRS) is an inflammatory disease that affects 2% to 16% of the US population. Despite its increasing prevalence, there are currently limited data in the literature evaluating the economic burden of this disease. OBJECTIVE: This study aimed to determine the direct health care costs of CRS from the perspective of the US government. METHODS: A prevalence-based approach was used to estimate cost of illness for CRS from the 2011 Medical Expenditure Panel Survey database by using a 4-part model: (1) an estimated sum of all health care expenditures, (2) an attribution model for disease-specific estimation of expenditures, (3) an estimation based on a propensity score model, and (4) estimated disease-specific expenditure by using a linear regression-based approach. A disease prevalence of 3.5% was used. RESULTS: The mean CRS-specific annual expenditure was $5955 (95% CI, $5087-$6823) by using method 1 compared with $5560 (95% CI, $4689-$6431) by using method 2 and $5560 (95% CI, $4653-$6467) by using method 3. The annual expenditure, as estimated by using method 4, was $5589 (95% CI, $4986-$6192). Ambulatory expenses accounted for the largest proportion of expenditures, followed by prescription and in-hospital expenses. CONCLUSIONS: This study provided a range of estimates of the direct medical expenditures associated with CRS. We demonstrated that the economic burden attributable to this disease was an estimated $60.2 to $64.5 billion US dollars in 2011, with a wide variation in the total and incremental direct expenditures depending on the type of estimation model used and the prevalence assumed.

Atypical presentation of sinonasal cellular schwannoma: a nonsolitary mass with osseous, orbital, and intracranial invasion.

Objective Sinonasal cellular schwannoma represents < 4% of head and neck schwannomas. These benign tumors are typically confined to the nasal cavity or ethmoid sinus. We describe an atypical case of sinonasal cellular schwannoma with diffuse paranasal sinus involvement and both intraorbital and intracranial extension. Results A 62-year-old woman presented with a 6-month history of right orbital proptosis and right-sided headache. Subsequent imaging revealed an invasive paranasal sinus mass extending through the skull base and displacing the right orbit. Preoperative biopsies were not diagnostic but revealed a spindle cell lesion suspicious for malignancy based on lack of encapsulation, infiltration of the sinonasal submucosa, and osseous invasion. The patient underwent open skull base surgery, and pathology confirmed a S100-positive nonencapsulated cellular schwannoma. Conclusion An atypical case of sinonasal cellular schwannoma with intracranial extension is reported. Its presentation is contrary to the common view that these are isolated solitary lesions of the nasoethmoid region. We suggest that sinonasal cellular schwannoma be considered in the differential diagnosis of a poorly defined invasive paranasal sinus mass, particularly following biopsy.

Preoperative concerns of patients undergoing endoscopic sinus surgery.

BACKGROUND: Patient-centered care is recognized as being fundamental to successful medical practice. The effectiveness of patient-centered care has classically been measured by posttreatment outcomes, such as patient compliance and psychosocial responses. Systematic assessment of patient concerns prior to treatment has been limited, to date. Endoscopic sinus surgery (ESS) is an elective procedure for chronic rhinosinusitis that carries a clear, defined set of risks. The objective of this prospective observational study was to determine the concerns of patients undergoing ESS for chronic rhinosinusitis. METHODS: A total of 180 patients undergoing ESS for chronic rhinosinusitis with or without polyposis were recruited at 2 Canadian tertiary care centers. They completed a validated survey assessing their concerns regarding the risks and outcomes of surgery. Data was analyzed using descriptive statistics and analysis of variance. RESULTS: Patients had a low degree of concern prior to undergoing surgery (overall score 2.8/9), though individual variability existed. Subjects felt the greatest level of concern regarding potential need for revision surgery as well as the wait time for surgery. Patients were least concerned about psychological factors (mean = 1.8/9). No differences with respect to age or gender were identified. Mean scores for cerebrospinal fluid leak and orbital injury were 3 and 3.2, respectively. CONCLUSION: Patients' level of concern prior to undergoing elective surgery is generally low. Patients' areas of greatest concern may not align with those perceived by the physician. This study provides insight into patient concerns prior to undergoing elective sinus surgery and emphasizes the importance of the patient-centered approach to care.

Prospective clinical trial of gelatin-thrombin matrix as first line treatment of posterior epistaxis.

OBJECTIVES/HYPOTHESIS: To evaluate the effectiveness of gelatin-thrombin matrix for first line treatment of posterior epistaxis. Secondarily, we evaluated discomfort during treatment and the cost savings of treatment with gelatin-thrombin matrix compared to posterior packing, endoscopic, or endovascular treatment at our institution. STUDY DESIGN: Prospective pilot, nonblinded, noncontrolled registered clinical trial (NCT01098578). METHODS: Twenty patients with posterior epistaxis were enrolled into this study. Gelatin-thrombin matrix was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion. Patients were discharged within 2 hours of being successfully treated. A visual analog scale (range 0-10) was used to assess treatment discomfort. Patients were evaluated in clinic 5 and 30 days after treatment to assess for intranasal complications and recurrent epistaxis. RESULTS: Gelatin-thrombin matrix successfully treated epistaxis in 80% of the patients. The procedure was associated with a mean discomfort of 3.6 (range 0-9.7). The institutional per case cost of treatment of patients with posterior epistaxis with gelatin-thrombin matrix is 80.3%, 87.4%, and 89.4% less than with endoscopic surgery, posterior packing, or embolization, respectively. There were no complications. CONCLUSION: This pilot study demonstrated that gelatin-thrombin matrix is a safe and both a clinically effective and cost-saving means of treating posterior epistaxis. In this study, its use is associated with a low level of discomfort. This treatment method may improve the quality of care for patients with posterior epistaxis.