Canadian Rhinology Working Group consensus statement: biologic therapies for chronic rhinosinusitis.

BACKGROUND: Recent evidence suggests that biologic therapy with targeted activity within the Type 2 inflammatory pathway can improve the clinical signs and symptoms of chronic rhinosinusitis with nasal polyposis (CRSwNP). There remains a population in CRSwNP that despite medical therapy and endoscopic sinus surgery have persistent signs and symptoms of disease. Therefore, biologics, monoclonal antibody agents, could be beneficial therapeutic treatments for these patients. There have been eight randomized, double-blind, placebo-controlled trails performed for CRSwNP targeted components of the Type 2 inflammatory pathway, notably interleukin (IL)-4, IL-5 and IL-13, IL-5R, IL-33, and immunoglobulin (Ig)E. However, there are no formal recommendations for the optimal use of biologics in managing Chronic Rhinosinusitis (CRS) within the Canadian health care environment. METHODS: A Delphi Method process was utilized involving three rounds of questionnaires in which the first two were completed individually online and the third was discussed on a virtual platform with all the panelists. 17 fellowship trained rhinologists across Canada evaluated the 28 original statements on a scale of 1-10 and provided comments. A rating within 1-3 indicated disagreement, 8-10 demonstrated agreement and 4-7 represented being neutral towards a statement. All ratings were quantitively reviewed by mean, median, mode, range and standard deviation. Consensus was defined by removing the highest and lowest of the scores and using the "3 point relaxed system". RESULTS: After three rounds, a total of 11 statements achieved consensus. This white paper only contains the final agreed upon statements and clear rationale and support for the statements regarding the use of biologics in patients with CRS. CONCLUSION: This white paper provides guidance to Canadian physicians on the use of biologic therapy for the management of patients with CRS, but the medical and surgical regimen should ultimately be individualized to the patient. As more biologics become available and additional trials are published we will provide updated versions of this white paper every few years.

Chondrosarcoma in the Petrous Apex: Case Report and Review.

Introduction Surgical treatment of petrous apex chondrosarcoma is challenging due to the location of the tumor. Using an endoscopic technique for tumor resection is favored since it provides a minimally invasive approach. Case Presentation A 57 years old female was admitted for acute onset of left abducens nerve palsy and occasional headache mainly on the left side of the retro-orbital area with some radiation to the left occiput. Magnetic resonance imaging (MRI) and computed tomography (CT), at the time of admission, were showed lytic lesion on the left petrous apex and left part of the clivus. Results of metastatic workup were negative. The surgical procedure considered was expanded endoscopic endonasal transclival approach to the left of the petrous apex and reconstruction with a pedicled nasoseptal flap with image guidance system. The pathology confirmed chondrosarcoma on myxoid background. The surgical procedure was uncomplicated. The abducens nerve palsy was resolved in few weeks and no new deficits occurred. Postoperative MRI showed complete resection of the tumor. Conclusion Expanded endoscopic endonasal transclival approach to petrous apex and reconstruction appears to be safe and feasible technique, capable of achieving total removal of identified lesions near the petrous apex. Nonetheless, future studies with a greater number of patients are crucial to confirm and consolidate this initial impression.

Eustachian tube symptoms are frequent in chronic rhinosinusitis and respond well to endoscopic sinus surgery.

BACKGROUND: Symptoms of Eustachian tube (ET) dysfunction are seldom assessed in patients with chronic rhinosinusitis (CRS). The Sino-Nasal Outcome Test (SNOT-22) quality-of-life tool includes two questions that specifically screen for symptoms of ET dysfunction (Ear Fullness; Ear Pain). OBJECTIVE: The purpose of this study was to determine the extent to which these ET symptoms were present in patients with CRS, and whether these symptoms respond to endoscopic sinus surgery (ESS). METHODOLOGY: SNOT-22 data collected prospectively at time of recruitment into IRB-approved clinical trials or case-control studies in CRS was pooled to provide a cross section of the frequency and severity of ET dysfunction. When applicable to the trials, the SNOT-22 was repeated at least 3 months following ESS. RESULTS: Five trials rendering 131 patients were available for assessment. The control group comprised of 251 participants from two case-control studies. Ear Fullness of equal/greather than 1 was reported in 80/131 CRS patients compared to 45/251 control patients. Ear Pain of equal/greather than 1 was reported in 39/131 CRS patients compared to 33/251 control patients. Following ESS, mean Ear Fullness and Ear Pain scores decreased to 1.17 and 0.73, respectively. CONCLUSION: Symptoms suggestive of ET dysfunction are frequent in CRS, and for most patients the symptoms will decrease post-ESS to a level comparable with a non-CRS population. Patients whose ET symptoms do not respond to ESS may represent a target population for emerging therapeutic options for ET dysfunction.

Case-control study of endoscopic polypectomy in clinic (EPIC) versus endoscopic sinus surgery for chronic rhinosinusitis with polyps.

INTRODUCTION: Endoscopic Polypectomy In Clinic (EPIC) is a recently described deescalated form of endoscopic sinus surgery (ESS) performed in the outpatient clinic for patients with chronic rhinosinusitis with polyps (CRSwNP). The quality of life benefit of EPIC in comparison to ESS is not known. The purpose of this study was to determine if the disease specific quality of life measured with the SNOT-22 attained with EPIC is similar to that attained with ESS for patients with CRSwNP. METHODS: A multi-institutional observational case-control study was performed to evaluate quality of life improvement in patients treated with ESS and EPIC for CRSwNP with a 3 month follow-up. Predicted probability of undergoing EPIC was calculated by fitting a logistic regression model using clinically relevant variables. EPIC patients were matched to ESS patients in a 1:1 fashion. RESULTS: 24 pairs were analyzed after matching. There was no statistical difference in the post-treatment SNOT-22 scores or proportion of patients achieving a minimal clinically important difference. CONCLUSIONS: In appropriate CRSwNP patients, the EPIC procedure may provide disease specific quality of life improvement similar to that seen with patients who undergo traditional ESS.

Better arthritis care: What training do community-based health professionals need to improve their care of people with arthritis? A Delphi study.

OBJECTIVE: The aim of the present study was to identify the competencies that non-specialist community-based nurses and allied health professionals (AHPs) need to enable them to assess, care for and manage arthritis appropriately. METHODS: A Delphi survey with an expert panel of 43 rheumatology specialists and expert patients was used to identify the competencies needed by community-based nurses and AHPs to enable them to improve their care of people with arthritis. The process was informed by feedback from focus groups with arthritis patients, community-based nurses and AHPs. RESULTS: The core competencies in arthritis care needed by non-specialist community-based nurses and AHPs were identified. The key goals identified were to increase the understanding of arthritis and its impact on patients' lives, and to increase the ability to help patients to self-manage their condition and access support. Competencies included an understanding of the pathology underlying inflammatory and non-inflammatory arthritis, the ability to distinguish between the two and the ability to recognize early warning signs, with an emphasis on osteoarthritis (OA), rheumatoid arthritis, gout and septic arthritis. Essential competencies included the ability to engage in shared decision making, goal setting and signposting, to provide patients with education and information and to make appropriate referrals. CONCLUSIONS: Health professionals working in the community commonly encounter arthritis as a presenting problem or as a co-morbidity. The quality of care provided to people with inflammatory arthritis and OA in the community is currently variable. The present study identified the core competencies that all community-based nurses and AHPs should have in relation to OA and inflammatory arthritis.

Better arthritis care: Patients' expectations and priorities, the competencies that community-based health professionals need to improve their care of people with arthritis?

OBJECTIVE: The aim of the present study was to identify the competencies that patients think non-specialist community-based nurses and allied health professionals (AHPs) need to enable them to assess, care for and manage arthritis appropriately. METHODS: Four face-to-face focus groups were held with a total of 16 women and nine men with arthritis, to discuss the care they received from community-based health professionals, the skills and knowledge they expected from community-based health professionals and what they prioritized. RESULTS: People with arthritis wanted health providers to have an understanding of the difference between inflammatory arthritis (IA) and osteoarthritis (OA), of how serious OA can be, and of the unpredictability of IA and flares. They emphasized the need for nurses and AHPs to understand the psychosocial impact of arthritis on individuals, family and friends, and the psychological adjustment needed when diagnosed with IA. They wanted community-based health professionals to have some knowledge of the types of drug treatments that people with IA receive and the implications of taking immunosuppressive drugs. They also wanted them to understand the pain associated with arthritis, particularly OA, which participants felt was not taken seriously enough. They wanted nurses and AHPs in the community to be able to give basic advice on pacing and pain management, to make multidisciplinary referrals, to communicate effectively between referral points and to be able to signpost people to sources of help and good, reliable sources of education and information (especially for OA). They also wanted them to understand that patients who have had a diagnosis for a long time are the experts in their own disease. Other areas which were emphasized as being important were good communication skills and taking a holistic approach to caring for people with arthritis. CONCLUSIONS: OA and IA differ significantly, both in their nature and their management. However, patients with arthritis want health professionals working in the community to be able to take a holistic approach to arthritis, with an understanding not just of the physical effects, but also their impact on the lives of patients, their family and their wider social circle, and on their ability to participate. People with OA want their condition to be taken seriously and to be offered appropriate management options, while people with IA want professionals to understand the unpredictability of their condition and to have a basic understanding of the drugs used for its treatment.

Long-term low-dose macrolides for chronic rhinosinusitis in adults - a systematic review of the literature.

BACKGROUND: Chronic rhinosinusitis is a very common inflammatory disease that impairs quality of life and is associated with high healthcare spending. Chronic rhinosinusitis treatment commonly involves the use of intranasal corticosteroids, oral antibiotics, and surgery. Macrolides have been identified as a potential treatment option for chronic rhinosinusitis due to their immunomodulatory effects; however, the evidence supporting their use is still conflicting. OBJECTIVE: The purpose of this systematic review was to evaluate new evidence along with previously reported studies of the use of macrolides in the treatment of chronic rhinosinusitis. SEARCH STRATEGY: Medline, EMBASE, Cochrane CENTRAL, LILACS, clinicaltrials.gov, and the International Clinical Trials Registry Platform were all searched (until June 2015 Medline and EMBASE searches were updated January 2016). Randomised controlled trials comparing low-dose macrolide antibiotics versus placebo, as an adjunct to other therapies, or low-dose macrolide therapy alone versus other therapies were included in this review. EVALUATION METHOD: Quality of the evidence was evaluated using the Cochrane risk of bias tool. Continuous outcomes were expressed as mean differences or standardised mean differences with 95% confidence interval. Data were pooled using fixed-effects models. RESULTS: Nine randomised controlled trials met the inclusion criteria. Studies were classified into three distinct comparisons: Low-dose macrolide therapy vs. placebo, low-dose macrolide +/- nasal steroids vs. nasal steroid and low-dose macrolides vs. other therapies. The overall quality of the evidence is low due to limitations in study design, imprecision, and indirectness. CONCLUSIONS: Positive results were seen with the use of macrolide therapy in the postoperative period in patients with nasal polyps. A firm conclusion with respect to the effectiveness of the use of macrolides for the treatment of chronic rhinosinusitis cannot be reached based on the available evidence. Further study using a placebo-controlled design evaluating the use of macrolides in clearly defined chronic rhinosinusitis populations is needed.

An outcomes analysis of anterior epistaxis management in the emergency department.

BACKGROUND: Many treatment options exist for the management of anterior epistaxis. However, little is known about treatment outcomes. The objective was to identify the currently utilised methods of management and outcomes for patients with anterior epistaxis presenting to the emergency department (ED) at a Canadian tertiary care center. METHODS: A retrospective review of ED visits from January 2012-May 2014 for adult patients with a diagnosis of anterior epistaxis was performed. Patient demographic data, comorbidities, and treatment methods were documented. The effectiveness of different treatment modalities was determined. RESULTS: Three hundred fifty-three primary anterior epistaxis cases were included. Mean patient age was 70 years and 49% of patients were female. Comorbidities included hypertension (56%), diabetes (19%), CAD (28%), and atrial fibrillation (27%). A large proportion of the cohort (61%) was on at least one anticoagulant or antiplatelet therapy. The most common utilised treatment modalities were silver nitrate cauterization, Merocel®, petroleum gauze packing, nasal clip and 15% were simply observed. Initial treatment success was achieved in 74% of cases. Of patients receiving specific treatment modalities, silver nitrate cauterization had the highest success rate at 80%. 26% of patients returned to the ED for recurrence of epistaxis with highest rates occurring in the nasal clip (59%), Merocel® (26%), and petroleum gauze packing (42%) groups. CONCLUSIONS: The differences in recurrence rate among the different treatment modalities observed may be due to true differences in effectiveness or differences in treatment selection by the ED physicians based on severity of epistaxis. Cauterization with silver nitrate, however, offers the added benefit of no need for follow up. Further study is needed to elucidate the most efficacious treatment modality based on epistaxis severity.

Economic evaluation of a computed tomography directed referral strategy for chronic rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) is a prevalent chronic inflammatory disease. The basis of a clinical diagnosis of CRS for primary care physicians (PCPs) is based upon the recognition of a symptom constellation that manifests with the disease. However, because the symptomatology of CRS may overlap with other diagnoses, the referral of patient to the most appropriate specialist may not always occur, leading to further delays in evaluation and treatment. METHODS: Given the emphasis on improving the value of health care in Canada, a decision tree model was designed to evaluate whether an upfront computed tomography (CT) scan of the paranasal sinuses ordered by the PCP for a suspected case of CRS would be more cost-effective when compared to symptom-based specialist referral practice. RESULTS: The CT-based strategy resulted in the patient arriving at the most appropriate specialist 95% (±5%) of the time while the symptom-based referral strategy resulted in the patient arriving at the correct specialist 77% (±18%) of the time. The incremental cost effectiveness ratio (ICER) for the CT-based strategy was $1522 per patient arriving at the correct specialist. CONCLUSION: These results suggest that PCPs can improve the effectiveness of their referrals for CRS by utilising an upfront CT referral strategy. However, it would create an additional cost of approximately $1500 per patient referred. Given these findings, the potential clinical benefits of using an upfront CT scan in the Canadian primary care setting should be further studied to determine the value of the additional money spent to improve the effectiveness of CRS referral.

Endoscopic polypectomy in the clinic: a pilot cost-effectiveness analysis.

OBJECTIVE: The purpose of this pilot economic evaluation was to assess the cost-effectiveness of the endoscopic polypectomy in the clinic (EPIC) procedure compared to formal endoscopic sinus surgery (ESS) for the treatment of select chronic rhinosinusitis (CRS) patients with nasal polyposis. DESIGN: Cost-effectiveness analysis using a Markov decision tree model with a 30-year time horizon. The two comparative treatment groups were as follows: (i) EPIC and (ii) ESS. Costs and effects were discounted at a rate of 3.5%. A probabilistic sensitivity analysis was performed. SETTING: Economic perspective of the Canadian government third-party payer. PARTICIPANTS: CRS patients with nasal polyposis who have predominantly isolated symptoms of nasal obstruction with or without olfactory loss. MAIN OUTCOME MEASURES: Incremental cost per quality adjusted life year (QALY). RESULTS: Over a time period of 30 years, the reference case demonstrated that the ESS strategy cost a total of $21,345 and produced 13.17 QALYs while the EPIC strategy cost a total of $5591 and produced 12.93 QALYs. The ESS versus EPIC incremental cost-effectiveness ratio was $65,641/QALY. The probability that EPIC is cost-effective compared to ESS at a maximum willingness-to-pay threshold of $30,000 and $50,000/QALY is 66% and 60%, respectively. CONCLUSIONS: Outcomes from this study have demonstrated that the EPIC procedure may be a cost-effective treatment strategy for 'select' patients with nasal polyposis. Data from this study were obtained from a small pilot trial, and we feel the results warrant a future randomised controlled trial to strengthen the outcomes.

Squeeze bottle versus saline spray after endoscopic sinus surgery for chronic rhinosinusitis: a pilot multicentre trial.

BACKGROUND: There is a need for controlled trials to guide the perioperative management of patients undergoing endoscopic sinus surgery (ESS). The authors performed a pilot multicenter trial to compare two types of saline delivery devices in this population. METHODS: Patients were randomized to high volume saline irrigation with a squeeze bottle and low volume saline spray after ESS in patients with chronic rhinosinusitis (CRS). Surgeons were blinded to treatment, and one-month postoperative scores for sinonasal outcomes [Sinonasal Outcome Test-22 (SNOT-22)] scale, nasal and sinus symptom score (NSS), and perioperative sinus endoscopy (POSE) scale were compared with preoperative scores. RESULTS: Nine centers provided data for 86 patients. All three outcomes measures improved significantly for both groups. Saline spray: SNOT-22 48.8 versus. 23.7, treatment effect 25.1 (95% confidence interval [CI], 17.9-32.2), POSE 21.1 versus. 8.4, treatment effect 12.7 (95% CI, 9.2-16.1), and NSS 8.2 versus 5.0, treatment effect 3.1 (95% CI, 1.4-4.9) pre- and postoperatively, respectively (all p < 0.0001). Squeeze bottle: SNOT-22 49.5 versus 23.6, treatment effect 25.9 (95% CI, 20.3-31.6), POSE 18.6 versus 9.2, treatment effect 9.3, (95% CI 6.7-12.0), and NSS 9.0 versus 5.7, treatment effect 3.3 (95% CI, 2.3-4.3) pre- and postoperatively, respectively (all p < 0.0001). Analysis of variance did not identify a difference between the two treatment groups. Subgroup analysis based on preoperative disease severity did not change the nonassociation of saline bottle with outcome measures. Post hoc sample size calculation determined that 176 patients is required to detect an 8.9-point difference in SNOT-22 scores. CONCLUSION: In this pilot multicenter trial examining patients with chronic rhinosinusitis undergoing ESS, both squeeze bottle and saline spray showed significant improvement in SNOT-22, POSE, and NSS scores at one-month postoperatively. Because the study was nonpowered, we cannot rule out a potential difference between the two treatment groups.

Maxillary sinus atelectasis (silent sinus syndrome): treatment with balloon sinuplasty.

INTRODUCTION: Maxillary sinus atelectasis is a form of chronic rhinosinusitis of uncertain aetiology. Previously, the conventional treatment for this condition has been standard endoscopic surgery. There are no reports in the literature of successful treatment using balloon sinuplasty. METHODS: A case of a patient with right maxillary sinus atelectasis is presented, who was treated using the balloon sinuplasty technique. RESULTS: The patient's right maxillary sinus atelectasis was successfully treated using balloon sinuplasty. Three-month follow-up evaluation documented retention of the remodelled form of the uncinate process, and of maxillary sinus os patency. CONCLUSION: This is the first report of successful use of the balloon sinuplasty technique for the treatment of maxillary sinus atelectasis. Follow up demonstrated resolution of the underlying pathophysiology. Further study of the balloon sinuplasty technique for the treatment of maxillary sinus atelectasis is required to determine whether it has widespread applicability, given the current standard treatment.

A double-blind randomised controlled trial assessing the efficacy of topical lidocaine in extended flexible endoscopic nasal examinations.

OBJECTIVE: To test the hypothesis that using lidocaine nasal spray will result in improved pain and comfort outcomes during an extended flexible endoscopic nasal examination. DESIGN: A split-body, double-blind, placebo-controlled randomised trial. After receiving a rinse of oral mouthwash (Listerine(®)), patients were randomised to receive placebo in one nasal cavity and 30 mg of topical lidocaine in the other. SETTING: A tertiary care centre outpatient Otolaryngology clinic. PARTICIPANTS: Twenty-two patients who required an extended bilateral flexible endoscopic nasal examination. An extended nasal examination consisted of an examination of a minimum of two osteomeatal regions on each side of the nasal cavity. MAIN OUTCOME MEASURES: Discomfort and pain were assessed using a 100-mm Visual Analogue Scale (VAS). Our study utilised the definition of pain based on International Association for the Study of Pain. Pain was defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Discomfort was defined as the overall unpleasant experience of the procedure. This included all aspects of the examination such as the pain or other negative sensations associated with the examination, any side effects associated with the application of the nasal sprays as well as any anxiety associated with the examination. A Wilcoxon sign-rank test was used for the primary outcome measures. RESULTS: There was a significant reduction in discomfort scores on the treatment side of the nasal cavity compared with the control side (median VAS score of 18.6 mm versus 44.6 mm; P = 0.01). The change in pain between the treatment side compared with the control side did not reach our definition of statistical significance (5.1 mm versus 9.2 mm; P = 0.05). Patients with an active or uncontrolled inflammatory disorder of the nasal cavity experienced a significantly greater reduction in pain compared to those without an inflammatory condition (median change of the VAS score, -15.6 versus +1.0; P = 0.01). CONCLUSIONS: After a rinse with oral mouthwash, the use of lidocaine results in a significant reduction in the discomfort associated with an extended bilateral flexible endoscopic nasal examination. Patients undergoing such an examination would benefit from the application of lidocaine after masking the negative flavour using oral mouthwash.

Oral contraceptives and breast disease. An epidemiological study.

A case-control study of the relationship between use of oral contraceptives and cancer of the breast, cancer of the corpus uteri, cancer of the ovary, and benign breast diseases was undertaken among women in the age group 20--44 years who had been admitted to several large hospitals in Connecticut. No significant association was seen between use of oral contraceptives and breast cancer. It was found that the longer a woman had used sequential oral contraceptives, the lower her relative risk of benign breast disease. Use of combination oral contraceptives, however, did not appear to influence the risk of benign breast diseases. The numbers of cases with cancer of the ovary and of the corpus uteri in this age group were too small for any conclusions to be reached.