Dupilumab reduces systemic corticosteroid use and sinonasal surgery rate in CRSwNP.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease with a high symptom burden and poor quality of life. Treatment options include recurrent surgeries and/or frequent systemic corticosteroids (SCS). Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key drivers of type 2-mediated inflammation. We report results of pooled analyses from 2 randomised, double-blind, placebo-controlled phase 3 studies (SINUS 24 [NCT02912468]; SINUS-52 [NCT02898454]) to evaluate dupilumab effect versus placebo in adults with CRSwNP with/without SCS use and sinonasal surgery. METHODOLOGY: SINUS-24 patients were randomised 1:1 to subcutaneous dupilumab 300 mg (n=143) or placebo (n=133) every 2 weeks (q2w) for 24 weeks. SINUS-52 patients were randomised 1:1:1 to 52 weeks of subcutaneous dupilumab 300 mg q2w (n=150), 24 weeks q2w followed by 28 weeks of dupilumab 300 mg every 4 weeks (n=145) or 52 weeks of placebo q2w (n=153). RESULTS: Dupilumab reduced the number of patients undergoing sinonasal surgery (82.6%), the need for in-study SCS use (73.9%), and SCS courses (75.3%). Significant improvements were observed with dupilumab vs placebo regardless of prior sinonasal surgery or SCS use in nasal polyp, nasal congestion, Lund-MacKay, and Sinonasal Outcome Test (22-items) scores, and the University of Pennsylvania Smell Identification Test. CONCLUSIONS: Dupilumab demonstrated significant improvements in disease signs and symptoms and reduced the need for sino-nasal surgery and SCS use versus placebo in patients with severe CRSwNP, regardless of SCS use in the previous 2 years, or prior sinonasal surgery.

Optimizing DyNaChron instrument for assessing chronic nasal dysfunction symptoms by Rasch analysis.

BACKGROUND: The DyNaChron (Dysfonctionnement Nasal Chronique) questionnaire is a self-reporting 78-item instrument assessing six symptoms and their consequences of chronic nasal dysfunction. Patients complete items of a symptom domain only when it is present but in case the patient presents several or all symptoms, its length can limit its use. Here, we aimed to optimize, or shorten, the DyNaChron for clinical use. METHODS: A total of 640 patients in 14 rhinology outpatient clinics all over France completed the original DyNaChron questionnaire before the first rhinologic clinic and 15 days later. The optimization process involved Rasch analysis and then qualitative content analyses. Rasch analysis flagged items with a floor/ceiling effect or with important differential item functioning and an expert committee decided whether to retain the flagged items on the basis of clinical importance and statistical characteristics. The psychometric properties of the optimized version were studied according to classical test theory and Rasch analysis. RESULTS: Rasch analysis revealed 4 items with underfit, 6 with an extreme score, 2 that were highly locally dependent and 16 with differential item functioning which 5 of these 16 items were retained after content analysis. In total, 19 flagged items were removed. Factorial analysis confirmed the preservation of the initial instrument structure in the optimized scale; psychometrics properties and scale calibration were the same as or better than the original version. CONCLUSION: The shortened DyNaChron optimizes the quality of assessment by deleting redundant items and reduces the burden on respondents; the structure is preserved and the psychometrics properties are improved.

Sinonasal symptom-related sleep disorders before and after surgery for nasal polyposis.

BACKGROUND: Patients with nasal polyposis (NP) complain of several sinonasal symptoms that impact their sleep and quality of life. However, data on sleep disorders related to NP symptoms, before and after surgery, is poor. The aim of the present study was to analyze sleep complaints related to each NP symptom, before and after surgery, using the Dynachron questionnaire. METHODOLOGY: 63 patients operated for NP were included in this prospective study. They filled the DyNaChron questionnaire one day before surgery (V0), 6 weeks (V1) and 7 months (V2) after surgery. The self-ratings (0-10 point visual analog scale) of nasal obstruction, anterior rhinorrhea, postnasal discharge, cough and 5 items related to sleep disturbances, due to each symptom of chronic nasal dysfunction, were extracted from the questionnaire and analyzed. RESULTS: There was significant improvement of symptoms and symptom-related sleep disturbance scores at V1 and V2 compared to baseline scores. Before surgery, moderate/severe sleep disorders that patients attributed to nasal obstruction (the patient thinks it is due to nasal obstruction rather than a clinical test to show nasal obstruction) or anterior rhinorrhea were reported in two thirds of patients, postnasal discharge in one half, and chronic cough in one third. After surgery, less than 10% of patients reported moderate/severe sleep disorders at V1. There was a mild increase of patients who rated moderate/severe sleep disorders at V2 in comparison to V1. The correlation between scores of nasal obstruction and its impacts on sleep quality was weak before surgery and strong afterwards. CONCLUSION: Nasalization improved sleep quality significantly at 6 weeks and at 7 months after surgery. However, there was a mild increase of complaints related to postnasal discharge and cough at 7 months after surgery.

Experience of French patients with olfactory disorders.

OBJECTIVES: To assess the experience of subjects with olfactory disorders in their daily life and medical management, and their expectations and proposals for improvement. MATERIAL AND METHODS: A cross-sectional observational study was conducted over the period January 2020 to December 2021, with 300 subjects with olfactory disorders: 222 female, 78 male; mean age 46±15 years. In total, 126 were patients consulting in ENT, and 174 were members of the Anosmie.org patients' association. Participants filled out a questionnaire; free texts were analyzed thematically and coded for various qualitative variables. RESULTS: Olfactory disorders considerably impacted health, safety and quality of life. Non-COVID-19 acute etiologies (non-COVID-19 viral infection, cranial trauma) showed particularly high risk of psychological, social, safety-related and nutritional consequences. Almost all patients (94%) were dissatisfied with their medical management: 28% had received little explanation, and 23% felt their dysosmia was completely neglected, with no exploration and no etiology suggested. Patients wished above all to have follow-up and accompaniment. CONCLUSION: Despite significant impact on health and quality of life, olfactory disorders are neglected by the medical community. Patients should be given an ENT assessment with olfactometry, to establish diagnosis and prognosis. Global multidisciplinary management is necessary, including therapeutic education, and psychological, social and nutritional follow-up.

Writing in the European Annals of Otorhinolaryngology Head & Neck Diseases. Dos and Don'ts!

Too many articles are still rejected by scientific medical journals due to lack of preparation of the manuscript and of knowledge of the modern editorial rules that govern scientific medical writing. Therefore, the editorial board of the European Annals of Otorhinolaryngology Heads & Neck Diseases summarized studies published by its members since 2020 in the columns of the scientific journal of the French Society of Otorhinolaryngology and the International Francophone Society of Otorhinolaryngology and data from the PubMed indexed literature dedicated to scientific medical writing in otolaryngology in the 21st century. The authors hope that this review, in the form of a list of "Dos and Don'ts", will provide authors with a practical guide facilitating publication of rigorous, reproducible and transparent scientific studies, in accordance with the movement toward better science that society as a whole has been fighting for since the beginning of this century.

Septorhinoplasty by disarticulation: early assessment of a new technique for morphological correction of crooked noses.

OBJECTIVE: This study was aimed to assess the early morphological results of a new septorhinoplasty technique based on disarticulation (SRD) between bony and cartilaginous nose structures. METHODOLOGY: A retrospective, multi-judge, blind comparison of pre- and post-operative photographs displayed on Google documents was designed. A nasal morphology analysis grid based on 10 items was fulfilled independently by 6 judges to assess pre- and post-operatively, two times with a 15 day interval, the severity of each deformity by a score between 0 and 2. The sum of all deformities in a single patient produced the individual global score of nasal deformity, which was set between 0 and 20 for each patient. Pre- and post-operative individual global scores were compared using Student`s t test on paired samples. Percentages of post-operative improvement and deterioration were calculated for each item. RESULTS: Thirty-five SRD were analyzed. Before surgery, 80% of noses were humped and 86% were crooked; three months after surgery, 64% of noses had a rectilinear nasal crest on profile and 57% on facial view. The mean global score of deformities drop- ped from 11.1 before surgery to 5.8 after surgery, an improvement of 47% . Improvement rates of 82% and 74.3% were obtained, respectively, for hump profiles and orbitonasal lines. DISCUSSION: The early morphological results of SRD allow to propose this technique as a possible solution to correct crooked noses with humps.

Maxillary ostium preservation in ethmoidectomy.

The paranasal sinuses play a role in producing and storing nitric oxide (NO). NO is a powerful antiviral and antibacterial gas which may be involved in the non-specific immune defenses of the respiratory tract. Conducted by the inspiratory current at the alveolar-capillary membrane, it increases pulmonary venous blood oxygenation. NO is actively released in the form of independent boluses in the respiratory tract, thanks to a sphincter function that can be identified during ethmoidectomy under general anesthesia. Safeguarding paranasal sinus physiology necessarily involves conserving this ostial sphincter function, which is essential to the respiratory role of the paranasal sinuses. Although it has not yet been demonstrated that the destruction of this ostial function has measurable consequences for respiratory function, it makes sense to avoid systematic antrostomy and to preserve this ostial function whenever possible, depending on the clinical conditions. This technical note describes step-by-step how to conserve the maxillary ostium, in the example of radical ethmoidectomy with mucosal ablation for nasal polyposis (nasalization). It is illustrated by two videos. The discussion focuses on the respective indications for ostial preservation and middle meatotomy (antrostomy).

Minimal clinically important differences on the DyNaChron questionnaire after surgery.

OBJECTIVES: To determine minimal clinically important differences (MCIDs) for the DyNaChron chronic rhinosinusitis quality-of-life questionnaire. INTRODUCTION: MCIDs are the smallest changes in a quality-of-life score that are of clinical relevance for the patient. They allow treatment benefit to be estimated. MCIDs have not previously been determined for DyNaChron. MATERIAL AND METHODS: A single-center retrospective study analyzed DyNaChron questionnaires filled out between June 2016 and December 2021 by all patients consulting for chronic nasal dysfunction. Five hundred and thirteen of the 2390 patients were operated on for nasal polyposis (NP; n=282) or septo(rhino)plasty+inferior turbinoplasty (SPIT; n=231). Standard error of measurement was used to determine MCIDs. RESULTS: MCID for DyNaChron global score was 60 in NP and 58 in SPIT. MCIDs per symptom domain in NP and SPIT respectively were: 15 and 13 for nasal obstruction, 21 and 21 for anterior rhinorrhea, 20 and 19 for posterior rhinorrhea, and 17 and 17 for olfaction. In agreement with global MCID, 257 NPs (91%) and 149 SPITs (65%) showed clinical improvement. CONCLUSION: MCID helps assess response to treatment. In the DyNaChron questionnaire, MCIDs enable global and symptom-specific assessment of chronic nasal dysfunction and its impact on quality of life in a single patient or in groups.

Chronic nasal dysfunction: A clinical case illustrating the concept in practice.

INTRODUCTION: We illustrate the diagnostic method for chronic nasal dysfunction by an observation in which the clinical history was compared to preoperative responses on the DyNaChron self-administered questionnaire, with ENT interpretation of the sinonasal CT scan preceding and guiding nasal endoscopy. CASE REPORT: The initial suspicion of rhinitis medicamentosa was transformed by the radiological and endoscopic findings of chronic respiratory rhinitis signs. Prick tests showing sensitivity to dust mites then suggested an allergic origin of the mucosal inflammation, which affected neither the olfactory nose nor the paranasal sinuses. A septal deviation hampering visualization of the right ethmoidal reliefs completed the clinical picture. Inferior turbinate hypertrophy secondary to allergic inflammation could have been aggravated by prolonged daily use of nasal vasoconstrictors. Failure of medical treatment combining nasal lavage, topical corticosteroids and an attempt at weaning led to effective medical and surgical management combining septoplasty, bilateral inferior turbinoplasty, continuation of topical corticosteroids and initiation of allergen immunotherapy. In addition to complete relief of nasal obstruction and abandonment of nasal vasoconstrictors, improved sense of smell completed the restoration of nasal comfort. DISCUSSION: It is helpful to conceive the nose as being anatomically and pathophysiologically a triple organ and to evaluate therapy in terms of improvement in each symptom.

Keys for successful publication in Eur Ann Otorhinolaryngol Head Neck Dis: A STROBE analysis of peer reviews of articles submitted in 2020-2021.

OBJECTIVE: To evaluate reviewing and editorial decision for articles submitted to the European Annals of Otorhinolaryngology Head & Neck Diseases. MATERIALS AND METHODS: A retrospective analysis was made of reviewers' comments on 1,133 scientific articles (700 original articles, 96 literature reviews, and 337 case reports), originating from 69 countries, consecutively submitted on-line between January 1st, 2020 and December 31st, 2021. The main objective was to document the acceptance rate and decision time. Accessory objectives were to synthesize the main comments and to screen for correlations between acceptance and the main characteristics of first authors, articles and reviewers' comments. RESULTS: In total, 4.1% of submitted articles were accepted. Median decision time differed significantly (P<0.0001), at 1 month in case of refusal and 4 months in case of acceptance. Reviewers mentioned failure to adhere to the journal's authors' guide, to use the appropriate EQUATOR guidelines and to adopt the recommended P<0.005 significance threshold in 94.8%, 54.2%, and 39.9% of cases, respectively. On multivariate analysis, 3 variables significantly impacted acceptance, which increased from 1.3% to 44.6% (P<0.0001) when an appropriate EQUATOR guideline was used and from 0.3% to 57.4% (P<0.0001) when the significance threshold was set at P<0.005, and decreased from 10.5% to 1.1% (P=0.0001) when the article did not originate from a French-speaking country (member of the Francophonie organization). CONCLUSION: Adhesion to modern scientific medical writing rules increased acceptance rates for articles in the European Annals of Otorhinolaryngology Head & Neck Diseases. Teaching modern scientific medical writing needs to be enhanced in otorhinolaryngology.

Critical review of diagnosis in rhinology and its therapeutical implications.

Diagnosis in rhinology is currently based on the concept of inflammation (chronic rhinosinusitis [CRS]) or the clinical concept of chronic nasal dysfunction (CND). The complementarity between these two approaches can be discussed by a critical review of the literature structured by the analysis of the fundamental and diagnostic bases and the therapeutic implications linked to each. The concept of CRS is based on the anatomical continuity of the nasal and sinus respiratory mucosa and molecular biology data, seeking to analyze the mechanisms of chronic inflammation and to identify proteins and biomarkers involved in the different supposed endotypes of chronic inflammation of this mucosa. The concept of CND seeks to analyze medical, instrumental or surgical diagnostic and therapeutic strategies, taking account of both inflammatory and non-inflammatory causes impacting the anatomy or physiology of each of the three noses (olfactory, respiratory and sinus) that make up the mid-face sinonasal organ of evolution-development (Evo-Devo) theory. Thus, the concept of CRS offers an endotypic approach, based on biological characterization of mucosal inflammation, while the concept of CND offers a compartmentalized phenotypic and pathophysiological approach to sinonasal diseases. The joint contribution of these two concepts in characterizing nasal functional pathology could in future improve the medical service provided to patients.

Chronic respiratory rhinitis: Toward endoscopic diagnosis of nasal allergy? An observational study.

OBJECTIVE: The study objective was to assess the functional, endoscopic and tomodensitometric semiology of a cohort of patients with chronic respiratory rhinitis (CRR). The concept of CRR is based on the anatomical, pathophysiological and semiological individualization of the respiratory nose within the sinonasal organ, in which three noses are distinguished by the parallel study of evolution and development in the "evo-devo" theory of the origins of the nose, anterior base of the skull and middle third of the face. MATERIAL AND METHOD: A single-center retrospective study included a cohort of 28 patients (16 men and 12 women, aged 19 to 69years) with CRR. The main objective was to describe symptoms clinically, endoscopically and on CT. The secondary objective was to compare clinical symptomatology and CT data between CRR and a control group of 31 patients with nasal polyposis (NP). The endoscopic semiology of CRR was analyzed consensually on video recordings using a pre-established grid. The DyNaChron self-administered questionnaire was used to compare symptom intensity and deterioration in quality of life. Olfaction was compared using the Sniffin' Sticks test. CT opacities were compared between CRR and NP on Lund-Mackay sinus score and a specific ethmoid opacities score. RESULTS: In CRR, endoscopy found a constant association of inflammatory or edematous signs in the inferior or middle turbinates with signs of hypersecretion. Ethmoid opacities in CRR were discrete and significantly smaller than in NP (P<0.0001), and were mainly located in the medial compartment in contact with the olfactory cleft (P<0.0001). Allergological assessment was positive in 17 of the 28 cases of CRR. Chronic nasal dysfunction was similar in CRR and NP, but olfactory impairment was significantly lower in CRR (P<0.0001). CONCLUSION: The CRR entity clinically resembles atopic central compartment disease. In both entities, endoscopy reveals inflammatory lesions restricted to the nasal cavities without significant ethmoid opacity on CT, an observation which seems to contradict the pathophysiological united airway concept.

From ethmoidal air cells to ethmoturbinal passages.

The concept of ethmoidal sinuses composed of ethmoidal air cells does not appear to fit with the embryological origin of the ethmoid. Post-natal formation of the paranasal sinuses, as visualized by MRI, appears to be fundamentally different from the embryological development of the ethmoid sinus. These two organs also appear to have very distinct functions: paranasal sinuses play a role in respiration and sanitization of the respiratory tract, while the ethmoid sinus plays a role in olfaction. However, human acquisition of bipedalism resulted in ethmoidal compartmentalization into olfactory clefts lined by olfactory mucosa and the ethmoidal labyrinth formed by a meshwork of ethmoturbinals that have lost their olfactory mucosa. Ethmoturbinals are septa that increase the surface area of olfactory mucosa in mammalian olfactory chambers. Embryological development of the human ethmoid sinus can be seen as the result of curved stacking of ethmoturbinal septa forming passages. Surgically, these passages can be accessed via the middle, superior and supreme meati. An ethmoidectomy technique following the ethmoturbinal passages can therefore be described. This structure of the ethmoidal labyrinth is both useful and necessary for the teaching of ethmoidal surgery.

Validation of a self-questionnaire for assessing the control of allergic rhinitis.

BACKGROUND: Allergic rhinitis affects the lives of patients for whom discomfort is, in most cases, significantly improved by pharmacological treatment. OBJECTIVE: To develop and validate a self-assessment global score for allergic rhinitis control (five items scored from 1 to 5 assessing the rhinitis over the 2 previous weeks). METHODS: Study of acceptability, reliability, validity and sensitivity to change during a prospective observational study in 902 patients selected by 411 general practitioners or allergists. RESULTS: The score correlated significantly to the clinical picture and to the impact of the rhinitis on social and sports activities at inclusion (P<0.0001). A significant improvement in the score was observed after 15 days of treatment: 14.9 ± 4.0 at inclusion and 21.5 ± 2.9 at re-evaluation after 15 days of treatment (P<0.0001). Using receiver operating characteristics curve, a score of 20 was the cut-off for poor vs. well-controlled rhinitis; a score strictly higher than 20 (best being 25) had a sensitivity of 67%, a specificity of 82%, a negative predictive value of 32% and a positive predictive value of 95%. CONCLUSION AND CLINICAL RELEVANCE: The self-assessment score for allergic rhinitis control appeared to be sensitive to change and correlated to the clinical expression of rhinitis and also to its involvement with treatment. These results suggest that this self-completion questionnaire could be used in daily practice at each consultation to determine, in a standardized manner, the level of control of the allergic rhinitis of an individual patient.

Pathology of tumours originating in the olfactory cleft.

UNLABELLED: PROBLEMS/OBJECTIVE: This study describes the variety of tumours originating in the olfactory cleft which have been treated with endonasal endoscopic surgery. METHODOLOGY: The study is a retrospective review covering a seven-year period (2004-2010) of the medical records of all patients in whom a tumour originating in the olfactory cleft was excised (72 patients: 63 men and 9 women; age: average of 61 years; range, 19 to 90 years). RESULTS: The most common tumours in the series were adenocarcinoma (43 [60%] patients), inverted papilloma (7 [10%] patients), respiratory epithelial adematoid hamartoma (6 [8%] patients) and olfactory neuroblastoma (5 [7%] patients). CONCLUSIONS: The olfactory cleft can be identified as a new surgical field for endonasal endoscopic surgery. This anatomic region is amenable to endoscopic evaluation and the excision of tumours. Exenteration of the olfactory cleft appears to be a key technique for removing adenocarcinoma and can be extended to exenteration of the olfactory groove in cases with intracranial extension. Partial exenteration of the olfactory cleft would seem to be a suitable way of removing benign tumours like inverted papilloma or respiratory epithelial adematoid hamartoma.

Mastering the descriptive statistics used in otorhinolaryngology.

As a key player in modern scientific methodology, statistics, the science of collecting, processing and analyzing data from observation of random phenomena (i.e., in which chance is a factor), is an essential part of the process of formulating a research hypothesis, choosing the study variables and research method, analyzing the results and drawing conclusions. In this technical note, the authors touch on the main notions to be mastered for optimal use of descriptive statistics in this process, facilitating publication of articles submitted to the European Annals of Otorhinolaryngology, Head and Neck Diseases.

The relationship between spontaneous cerebrospinal fluid leak and idiopathic intracranial hypertension.

Surgical treatment of spontaneous cerebrospinal fluid (CSF) leak is now performed by ENT surgeons, endonasal endoscopy being preferred to craniotomy as less invasive. However, it is often the symptom of underlying idiopathic intracranial hypertension, which lies outside the traditional sphere of ENT competence. Surgery is a necessary step, but should not obscure the need to treat the underlying pathology. This treatment is complex, and requires multidisciplinary team-work between otorhinolaryngologist, ophthalmologist, neurologist, neurosurgeon, radiologist, dietician, endocrinologist and psychotherapist. The present update details this multidisciplinary management to which the ENT surgeons must be attentive before and after spontaneous CSF leak repair.

Septorhinoplasty by disarticulation.

Septorhinoplasty by disarticulation is an esthetic and functional solution for naturally occuring nasal pyramid dysmorphia, releasing the anatomic traces of growth-related stresses. Disarticulating the septolateral cartilage from its bony framework via a closed approach to the septal pocket is associated to Rethi's external approach in order to disarticulate the fibrocartilaginous nasal dorsum, while conserving its integrity, under the bony dorsum. The bony pyramid is then disarticulated down to the nasion, after resecting any bone hump, by 2 paramedian and 2 low lateral osteotomies in the basal groove. The lateral sides of the bony pyramid are then fractured at their posterior edges by percutaneous pinching to close the open roof and realign them along the midline. The septolateral cartilage, reduced as necessary at the inferior and anterior edges, is thereafter repositioned on the premaxillary bone. Traction on its anterior edge restores rectilinear frontal and lateral tension in the fibrocartilaginous dorsum, fully conserved from its attachment to the nasion. This technique corrects any septal deformity and restores frontal and lateral dorsum straightness.

Simulation-based training in endoscopic endonasal surgery: Assessment of the cyrano simulator.

PURPOSE: Endoscopic endonasal surgery requires many skills: a learning program was developed with progressive steps, on a surgical simulator (Cyrano) designed to train junior surgeons in the acquisition of basic endoscopic surgery skills and to assess their progress. The main objective of this study was to establish the construct validity of these exercises and to refine objective criteria to establish students' level. MATERIAL AND METHODS: Thirty volunteers with varying experience in endoscopic endonasal surgery were blindly evaluated on 4 modules according to objective and subjective criteria. RESULTS: Ten beginner, 11 intermediate and 9 expert level participants were included. For each exercise, at least one criterion was discriminant for level of expertise. Weighted scores succeeded in discriminating groups. Interpretation of a single criterion must remain cautious and evaluation should rather rely on composite scores, which better reflect the participants' level. Useful criteria and their reference values are specific of each exercise. Face and content validity were rated at 3.92/5 and 4.59/5 respectively (5-level Likert scale). CONCLUSION: The construct/face/content validity of the proposed modules have been verified. Most of the modules tested here were physically not realistic, but they were all rated as highly relevant for surgical training by the participants.