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.

Canadian Real-World Study Long-Term Clinical Results Using Dupilumab for Chronic Rhinosinusitis With Polyps.

BACKGROUND: Dupilumab, an anti-IL4 receptor-α monoclonal antibody, was the first biologic to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). In phase III clinical trials, it has demonstrated to be effective in reducing nasal polyp size and the severity of symptoms, improve disease-specific quality of life, and to have an acceptable safety profile. This study aims to present long-term follow-up data on disease-specific sinonasal outcomes of patients with CRSwNP who have been treated with dupilumab for up to 3 years in a real-world setting. METHODS: Retrospective review of electronic medical records of a single Canadian rhinology center evaluating disease-specific sinonasal outcomes that are routinely collected for clinical care. This study included all patients who received dupilumab for the treatment of CRSwNP and who had completed at least one follow-up visit. The Sino-Nasal Outcome Test (SNOT)-22 was used to evaluate treatment symptom improvement. RESULTS: Ninety-nine patients started dupilumab therapy during the study period. The mean SNOT-22 at the start of therapy was 61.1 (±22.91) At the time of the review, 65 patients had completed 1 year of therapy, 40 had completed 2 years of therapy, and 18 had completed 3 years of therapy. The mean SNOT-22 score at these timepoints was 16.75 (±13.86), 15.02 (±14.40), and 10.22 (±11.56), respectively. CONCLUSION: This real-world study shows that in patients with CRSwNP treated with dupilumab, improvement in disease-specific quality of life seen after 1 year continues and can be maintained at 3 years of treatment.

Medical ID use by international patients with Aspirin-Exacerbated Respiratory Disease.

BACKGROUND: Patients widely use medical identification (ID) to indicate their food and drug allergies, and chronic medical conditions. One chronic condition for which patients are recommended to use a form of medical ID is Aspirin-Exacerbated Respiratory Disease (AERD), a disease characterized by the presence of asthma, chronic rhinosinusitis with nasal polyps and sensitivity to aspirin and other COX-1 inhibitors, including nonsteroidal anti-inflammatory drugs (NSAIDs). The uptake of medical ID use in AERD is unknown and has not been widely studied in this population. METHODS: We conducted a cross-sectional survey study to measure the perception of the need to use a medical ID and its use by patients with AERD internationally. RESULTS: 245 members of an online AERD support group completed an online survey. The majority (80%, n = 198) of the participants did not use any form of medical ID. The participants reported that the lack of knowledge and awareness about the importance of using a medical ID was the most common reason for not using it. CONCLUSION: This international survey found that the majority of the AERD patient respondents did not use a medical ID. The most common reasons for nonuse were not knowing that it is recommended for their condition and that the patients did not consider it necessary. The results highlight the need for further patient and health care provider education.

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.

Recovery of Cranial Nerve Deficits in Patients Presenting with Pituitary Apoplexy: A Case Series.

Background Pituitary apoplexy (PA) is a rare complication of pituitary tumors that can present with a myriad of symptoms, including sudden onset cranial nerve deficits. After patient stabilization and hormone replacement, surgical decompression is often recommended. The timing of surgical decompression remains controversial. In this case series, we describe our institutional experience pertaining to the cranial nerve recovery in patients who underwent endoscopic endonasal transsphenoidal (EETS) surgery for PA while evaluating outcome based on tumor stage using the suprasellar infrasellar parasellar anterior posterior (SIPAP) classification. Design Present study is a single-institution retrospective cohort. Methods A retrospective review of all EETS cases for pituitary tumor resection between November 2009 and August 2018. Queries of the hospital database were completed by trained personnel to identify cases of PA treated using the EETS approach. Baseline characteristics, tumor type, endocrine data, and SIPAP classification based on preoperative magnetic resonance imaging (MRI) and operation characteristics were extracted from medical records. Postoperative results were extracted for the duration of the follow-up period available for each patient. Results Fifteen cases of PA were identified. Patient follow-up period was a mean of 30 months. The cranial nerve deficits present at admission were visual deficit (33%); unilateral third nerve palsy (47%) and unilateral sixth nerve palsy (27%). No fourth nerve palsies were observed. Following EETS, 60% of patients with preoperative visual deficit had normal visual fields. For those with third and sixth nerve palsies preoperatively, 43 and 75%, respectively, had return to normal function postoperatively. SIPAP tumor characteristics were not related to postoperative cranial nerve recovery. Conclusion In this series of surgically treated patients with pituitary apoplexy, all cranial nerve deficits normalized or improved following surgery. The tumor SIPAP classification was not associated with patient outcome. Though in a small series, the presented results suggest surgical treatment is beneficial for these patients.

Olfactory recovery following infection with COVID-19: A systematic review.

Olfactory loss has been identified as one of the common symptoms related to COVID-19 infection. Although olfactory loss is recognized, our understanding of both the extent of loss and time to olfactory recovery following infection is less well known. Similarly, knowledge of potential impactful patient factors and therapies that influence olfactory recovery is desirable but is not overtly clear in the literature. Our systematic review sought to fill this knowledge gap. We included studies that: involved either an observational or an interventional design that reported data on patients with olfactory dysfunction due to Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnosed COVID-19 infection; and reported data regarding olfactory recovery measured by an objective olfactory test, Likert scale and/or visual analog scale (VAS). The study methods were determined a priori and registered in PROSPERO (Registration Number CRD42020204354). An information specialist searched Medline, Embase, LitCovid and the Cochrane Register of Controlled Trials up to March 2021, and two reviewers were involved in all aspects of study selection and data collection. After screening 2788 citations, a total of 44 studies of assorted observational designs were included. Patients had undergone objective COVID-19 testing, and most were adult patients with mild to moderate COVID-19. Olfactory recovery was found to occur as early as 7 days, with most patients recovering olfaction within 30 days. Few studies included prolonged follow-up to 6 months or longer duration. Poor olfaction at initial presentation was associated with poor recovery rates. Only a small number of studies assessed olfactory retraining and steroid therapy. Additional trials are underway.

Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial.

INTRODUCTION: Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP. METHODS AND ANALYSIS: We designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period. ETHICS AND DISSEMINATION: This study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board. TRIAL REGISTRATION NUMBER: NCT02975310.

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.

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.

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.

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.