Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey.

INTRODUCTION: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids, in adjunct with saline solution rinses. Surgical management is proposed in patients who failed after medical treatment. In France, two biologics are reimbursed in case of severe uncontrolled CRSwNP despite medical treatment and endoscopic sinus surgery. Waiting for head-to-head biologics comparison, studies should report the efficacy and safety of biologics in large real-life cohorts. This study protocol describes the aims and methods of a prospective, observational, national, multicentric cohort of patients with CRSwNP treated with biologics. METHODS AND ANALYSIS: The BIOlogics in severe nasal POlyposis SurvEy is a French multicentre prospective observational cohort study. The main aim is to assess the efficacy and tolerance of biologics in patients with CRSwNP, with or without association with other type 2 diseases, and to determine the strategies in case of uncontrolled disease under biologics. Patients over 18 years old requiring biologics for CRSwNP in accordance with its marketing approval in France (ie, severe nasal polyposis, with lack of control under nasal corticosteroid, systemic corticosteroids and surgery) are invited to participate. Collected data include topical history of surgical procedures and biologics, medication and use of systemic corticosteroids, visual analogical scales for specific symptoms, Sino-Nasal Outcome Test-22 questionnaire, nasal polyp score, asthma control test, Lund-Mackay score on CT scan and IgE concentration and eosinophilic count on blood sample. TRIAL REGISTRATION: NCT05228041/DRI_2021/0030.

Advances and residual knowledge gaps in the neck management of head and neck squamous cell carcinoma patients with advanced nodal disease undergoing definitive (chemo)radiotherapy for their primary.

PURPOSE: Substantial changes have been made in the neck management of patients with head and neck squamous cell carcinomas (HNSCC) in the past century. These have been fostered by changes in cancer epidemiology and technological progress in imaging, surgery, or radiotherapy, as well as disruptive concepts in oncology. We aimed to review changes in nodal management, with a focus on HNSCC patients with nodal involvement (cN+) undergoing (chemo)radiotherapy. METHODS: A narrative review was conducted to review current advances and address knowledge gaps in the multidisciplinary management of the cN+ neck in the context of (chemo)radiotherapy. RESULTS: Metastatic neck nodes are associated with poorer prognosis and poorer response to radiotherapy, and have therefore been systematically treated by surgery. Radical neck dissection (ND) has gradually evolved toward more personalized and less morbid approaches, i.e., from functional to selective ND. Omission of ND has been made feasible by use of positron-emission tomography/computed tomography to monitor the radiation response in cN+ patients. Human papillomavirus-driven oropharyngeal cancers and their cystic nodes have shown dramatically better prognosis than tobacco-related cancers, justifying a specific prognostic classification (AJCC) creation. Finally, considering the role of lymph nodes in anti-tumor immunity, de-escalation of ND and prophylactic nodal irradiation in combination are intense areas of investigation. However, the management of bulky cN3 disease remains an issue, as aggressive multidisciplinary strategies or innovative combined treatments have not yet significantly improved their prognosis. CONCLUSION: Personalized neck management is an increasingly important aspect of the overall therapeutic strategies in cN+ HNSCC.

Reconstructive flap surgery in head and neck cancer patients: an interdisciplinary view of the challenges encountered by radiation oncologists in postoperative radiotherapy.

Background: Major advances have been made in reconstructive surgery in the last decades to reduce morbidity in head and neck cancer. Flaps are now present in 80% of patients with oral cavity cancer to cover anatomic, functional, and cosmetic needs. However, gaps in interdisciplinary innovation transfer from surgery to postoperative radiotherapy (poRT) remain challenging. We aimed to provide an interdisciplinary view of the challenges encountered by radiation oncologists in planning head and neck postoperative radiotherapy. Methods: A systematic and critical review was conducted to address areas of optimization in surgery and radiology that may be relevant to poRT. Results: Despite extensive surgical literature on flap techniques and salvage surgery, 13 retrospective series were identified, where flap outcomes were indirectly compared between surgery alone or poRT. These low-evidence studies suggest that radiotherapy accelerates flap atrophy, fibrosis, and osteoradionecrosis and deteriorates functional outcomes. Preliminary evidence suggests that tumor spread occurs at the flap-tissue junction rather than in the flaps. One prospective 15-patient study showed 31.3% vs. 39.2% flap volume reduction without or with poRT. In an international consensus, experts recognized the needs for optimized flap-sparing poRT against flap-related functional deterioration and bone damage. CT, MRI, and PET-CT modalities show potential for the delineation of the junction area between native tissues and flap for flap segmentation and to characterize flap-specific changes quantitatively and correlate them with patterns of relapse or complications. Conclusion: Flap management in poRT is insufficiently documented, but poRT seems to damage flaps. Current gaps in knowledge underscore the need for prospective flap assessment and interdisciplinary trials investigating flap morbidity minimization by flap-sparing poRT planning.

[Issues and implementation of postoperative radiotherapy after flap reconstructive surgery in head and neck cancers]. / Enjeux et mise en œuvre de radiothérapie postopératoire après chirurgie reconstructrice avec lambeau dans les cancers de la tête et du cou.

The management of head and neck cancers is multidisciplinary, often relying on the use of combined treatments to maximize the chances of cure. Combined treatments are however also responsible for cumulative side effects. The aim of reconstructive surgery with a flap is to restore a function lost with the loss of substance from the tumor resection. However, changes in reconstructive surgery have impact of postoperative radiotherapy planning. The optimization of imaging protocols for radiotherapy planning should make it possible to identify postoperative changes and to distinguish flaps from surrounding native tissues to delineate the flaps and document the spontaneous evolution of these flaps or dose-effect relationships in case of radiotherapy. Such changes include atrophy, fibrosis of soft tissue flaps and osteoradionecrosis of bone flaps. Radiotherapy optimization also involves standardization of the definition of target volumes in situations where a flap is present, a situation that is increasingly common in routine care. This evolution of practice, beyond the essential multidisciplinary consultation meetings defining treatment indications, requires a close radio surgical collaboration with respect to technical aspects of the two disciplines. Doing so, anticipation of relapse and toxicity profiles could possibly lead to propose strategies for personalized de-escalation of multimodal treatments through interdisciplinary trials.

[Prevention, diagnosis and management of osteoradionecrosis: Where do we stand?] / Prévention, diagnostic et prise en charge de l'ostéoradionécrose : où en est-on ?

Osteoradionecrosis (ORN) is a late secondary iatrogenic complication of external radiotherapy for cancers of the upper aero-digestive tract. Despite the systematization of intensity-modulated radiotherapy and its potential for preserving salivary secretion and limiting the dose delivered to the supporting bone, ORN remains a feared and frequent complication. The objective of this literature review was to provide an overview of the management of ORN and to determine the key points that would make it possible to improve patient care. The diagnosis of ORN requires to eliminate tumor recurrence then is based on clinical arguments and imaging by CT or Cone Beam evolving in a chronic mode (more than 3-6 months). The harmonization of its classifications aims to offer comprehensive and multidisciplinary care as early as possible. Primary prevention is based on pre-therapeutic oral and dental preparation, then associated with fluoroprophylaxis if salivary recovery is insufficient and requires supervision of invasive dental care and prosthetic rehabilitation. Semi-automatic contouring tools make it possible to identify doses delivered to dental sectors and guide dental care with personalized dosimetric mapping. Conservative medical treatment is offered at an early stage where innovative medical treatments, highlighted by early studies, could be of interest in the future. In the event of advanced ORN, a non-conservative treatment is then proposed and frequently consists of interruptive mandibulectomy associated with reconstruction by bony free flap, the conditions of implantation remaining to be defined with the support of prospective clinical trials.

The Prognostic Value of Olfactory Dysfunction in Patients with COVID-19: The COVIDORA Study.

BACKGROUND: Among all studies describing COVID-19 clinical features during the first wave of the pandemic, only a few retrospective studies have assessed the correlation between olfac-tory dysfunction (OD) and the evolution of disease severity. The main aim was to assess whether OD is a predictive factor of COVID-19 severity based on the patient's medical management (outpa-tient care, standard hospital admission, and ICU admission). METHODS: A national, prospective, mul-ticenter cohort study was conducted in 20 public hospitals and a public center for COVID-19 screen-ing. During the first wave of the pandemic, from 6 April to 11 May 2020, all patients tested positive for COVID-19 confirmed by RT-PCR underwent two follow-up ENT consultations within 10 days of symptom onset. The main outcome measures were the evolution of medical management (out-patient care, standard hospital admission, and ICU admission) at diagnosis and along the clinical course of COVID-19 disease. RESULTS: Among 481 patients included, the prevalence of OD was 60.7%, and it affected mostly female patients (74.3%) under 65 years old (92.5%), with fewer comor-bidities than patients with normal olfactory function. Here, 99.3% (290/292) of patients with OD presented with non-severe COVID-19 disease. Patients reporting OD were significantly less hospi-talized than the ones managed as outpatients, in either a standard medical unit or an ICU. Conclu-sions: As regards the clinical course of COVID-19 disease, OD could predict a decreased risk of hospitalization during the first wave of the pandemic.

Dupilumab prevents nasal epithelial function alteration by IL-4 in vitro: Evidence for its efficacy.

BACKGROUND: Chronic rhinosinusitis with nasal polyp (CRSwNP) is a typical type 2 inflammation involving interleukin (IL)-4 and IL-13. Dupilumab is a fully human monoclonal antibody targeting IL-4 receptor α subunit, thereby blocking signaling by both cytokines. Our hypothesis was that IL-4 and IL-13, by inducing a severe epithelial dysregulation, are involved in CRSwNP pathogenesis. This study aimed to evaluate the in vitro direct effect of IL-4, IL-13, and dupilumab on nasal epithelial functions. METHODS: Nasal polyps and control mucosa from 28 patients, as well as human nasal epithelial cells (HNEC) from 35 patients with CRSwNP were used. Three major epithelial functions were investigated: the epithelial barrier function (characterized by transepithelial electrical resistance measurements and tight junction protein expression), the ciliary motion (characterized by the ciliary beating efficiency index), and wound healing (characterized by the wound repair rate) under various stimulations (IL-4, IL-13, and dupilumab). The main outcome was a significant change in epithelial functions following exposure to IL-4, IL-13, and dupilumab for 48 h in the basal media. RESULTS: IL-4 (1, 10, and 100 ng/mL) but not IL-13 induced a significant decrease in occludin and zonula-occludens protein expression, ciliary beating efficiency, and wound repair rate in HNEC. Dupilumab (0.04 mg/mL) had no effect on HNEC and specifically restored all epithelial functions altered when cells were exposed to a 48-h IL-4 stimulation. CONCLUSION: Dupilumab, in vitro, restored epithelial integrity by counteracting the effect of IL-4 on the epithelial barrier (increased epithelial permeability, decreased ciliary beating efficiency, and decreased wound repair rate).

Obstructive sleep apnea syndrome: A frequent and difficult-to-detect complication of radiotherapy for oropharyngeal cancers.

This pilot study reveals a higher prevalence of obstructive sleep apnea syndrome (OSAS) in patients treated for oropharyngeal squamous cell carcinoma with radiotherapy compared to the general population. OSAS indicators such as the Epworth Sleepiness Scale seem insufficient in the diagnostic approach to OSAS in this population and systematic screenings should be considered.

Chat GPT for the management of obstructive sleep apnea: do we have a polar star?

PURPOSE: This study explores the potential of the Chat-Generative Pre-Trained Transformer (Chat-GPT), a Large Language Model (LLM), in assisting healthcare professionals in the diagnosis of obstructive sleep apnea (OSA). It aims to assess the agreement between Chat-GPT's responses and those of expert otolaryngologists, shedding light on the role of AI-generated content in medical decision-making. METHODS: A prospective, cross-sectional study was conducted, involving 350 otolaryngologists from 25 countries who responded to a specialized OSA survey. Chat-GPT was tasked with providing answers to the same survey questions. Responses were assessed by both super-experts and statistically analyzed for agreement. RESULTS: The study revealed that Chat-GPT and expert responses shared a common answer in over 75% of cases for individual questions. However, the overall consensus was achieved in only four questions. Super-expert assessments showed a moderate agreement level, with Chat-GPT scoring slightly lower than experts. Statistically, Chat-GPT's responses differed significantly from experts' opinions (p = 0.0009). Sub-analysis revealed areas of improvement for Chat-GPT, particularly in questions where super-experts rated its responses lower than expert consensus. CONCLUSIONS: Chat-GPT demonstrates potential as a valuable resource for OSA diagnosis, especially where access to specialists is limited. The study emphasizes the importance of AI-human collaboration, with Chat-GPT serving as a complementary tool rather than a replacement for medical professionals. This research contributes to the discourse in otolaryngology and encourages further exploration of AI-driven healthcare applications. While Chat-GPT exhibits a commendable level of consensus with expert responses, ongoing refinements in AI-based healthcare tools hold significant promise for the future of medicine, addressing the underdiagnosis and undertreatment of OSA and improving patient outcomes.

SimLife®: A New Dynamic Model for Head and Neck Surgical Oncology Simulation.

The SimLife® model consists in a human cadaver dynamized by pulsatile vascularization. The objective was to evaluate the face, contents, and constructs validity of the SimLife® model in head and neck surgical oncology simulation. Head and neck surgical oncology simulation sessions on SimLife® models were organized with lateral neck dissection and total laryngectomy. Face and contents validity were addressed by questionnaires. Constructs validity was assessed by objective structured assessment of technical skills (OSATS) score. High realism was demonstrated for consistency of tissues (7.1 ± 1.4), color of arteries and veins (7.3 ± 1.9, 8.5 ± 1.1, respectively), and vein consistency (8.5 ± 1.2). The mean OSATS score was 19.7 ± 5.4 for residents and 32.7 ± 1.9 for senior surgeon (P = .0022). SimLife® is a hyperrealistic model for head and neck surgical oncology simulation and it might become a core component of the surgical resident curriculum.

Cross-cultural adaptation of the CRS-PRO questionnaire into French.

BACKGROUND: Chronic rhinosinusitis (CRS), encompasses many different clinical patterns with variable response to treatment. Precise criteria specifying disease severity and control are lacking in the current literature. Our aim was to perform a cross-cultural adaptation of the CRS-PRO, creating a French version for use as a routine questionnaire in the assessment of patients with CRS. METHODS: The CRS-PRO questionnaire was translated according to the recommendations of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) through a three-step procedure including a backward translation. RESULTS: Seven of 12 items were initially discordant between the three translators before achieving consensus (Step 1). Two of 12 items were discordant between the backward translation and the initial CRS-PRO version regarding the word "mucus"(Step 2). Step 3 allowed the creation of a French proof-read version of the CRS-PRO questionnaire. Thirty patients were included for initial validation, mean age of 49.2 ± 15 years and 63.3% (19/30) male. It took them 67 ± 23 s to complete the questionnaire without any patients requiring more than 2 min. CONCLUSION: This study presents the French version of the CRS-PRO questionnaire-an adapted, validated, and well-accepted instrument to evaluate the CRS symptoms in the French speaking population.

Predictors of Success of Pharyngeal Surgery in the Treatment of Obstructive Sleep Apnea: A Narrative Review.

(1) Background: This narrative review aims to explore the predictors of success for pharyngeal surgery in the treatment of obstructive sleep apnea (OSA). An extensive literature search was conducted, identifying relevant studies published up to June 2023, utilizing various databases and key search terms related to OSA, surgical interventions, and predictors of success. The review encompasses both retrospective and prospective studies, case series, and cohort studies to provide a broad understanding of the topic; (2) Methods: Review of English scientific literature on phenotypes of OSA related to predictors of success of pharyngeal surgery; (3) Results: Of 75 articles, 21 were included, in these the following were determined to be factors for surgical success: body mass index (BMI) (8 articles), apnea/hypopnea index (AHI) (8 articles), cephalometry (8 articles), palatine tonsil size (7 articles), Modified Mallampati score (2 articles), genioglossus electromyography (2 articles), Friedman score or upper airway anatomy (3 articles), nasopharyngolaryngoscopy (2 articles), drug-induced sleep endoscopy (DISE) (1 article), oral cavity anatomy (1 article) and oxygen desaturation index (ODI) (1 article); (4) Conclusions: The lack of standardized protocols for the indication of pharyngeal surgery is a reality, however identifying known predictors of surgical success may facilitate homogenizing indications.

Anatomical variations of interest for posterior nasal nerve cryotherapy in the treatment of chronic rhinitis: A radioanatomic study.

KEY POINTS: An unfavorable insertion of the middle turbinate for cryotherapy was present in 74.2% of cases. Placing cryoprobe 15-30 mm above the nasal floor targets the nerves in 95.8% of cases. Centering the cryoprobe 38 mm behind the inferior turbinate axilla targets the nerves in 94.6% of cases.

Management of 80 sinonasal undifferentiated carcinomas. Retrospective multicentre study of the French Network of Rare Head and Neck Cancers (REFCOR).

OBJECTIVES: Sinonasal undifferentiated carcinoma (SNUC) is a rare and aggressive disease requiring multimodal treatment, and multiple new entities once included in the spectrum of SNUC, such as SWI/SNF-deficient carcinomas, are emerging. We aimed to provide new data regarding the role of chemotherapy and surgery and the prognostic factors of disease-free survival. METHODS: This study was based on data from the REFCOR database and included patients with SNUC treated with curative intent from 2007 to 2021 across 22 centres in France. RESULTS: A total of 80 patients were included in the analysis. Among the entire cohort, the 5-year disease-free survival (DFS) and overall survival (OS) rates were 58% and 63%, respectively. Of 100% of the patients treated with irradiation, 29% underwent surgery, 56% neoadjuvant chemotherapy (82% had either a partial or a complete response) and 76% chemoradiotherapy. No treatment modality was associated with a better OS or DFS, including surgery (p = 0.34). There was a trend for a better DFS for the patients treated with chemotherapy (neoadjuvant or concomitant, p = 0.062). Overall survival at 3 years was 58% for SWI/SNF deficient group and 86% for non deficient group (p = 0.14). The locoregional relapse rate without distant metastases was 21% in the exclusive radiotherapy group and 26% in the surgery group. Grade 3 or higher toxicities concerned 9%, 32% and 29% of patients for surgery, radiotherapy and chemotherapy respectively. CONCLUSION: In the management of localised SNUC among all patients treated with irradiation, surgery yielded no benefit, whereas the addition of chemotherapy tended to improve disease-free survival.

French translation and validation of the OSATS tool for the assessment of surgical skill.

AIM OF THE STUDY: The OSATS rating scale is one of the tools most widely used in the scientific literature for assessing technical surgical skill. The aim of this study was to translate this scale into French (OSATS-FR) and validate it. METHODS: OSATS was translated into French by two independent translators. The two translations were pooled and back-translated by a third translator into English to produce a consensus version (OSATS-FR). Three independent assessors then used it to assess surgical skill in tracheostomy videos. The reproducibility of the scoring was measured. RESULTS: The OSATS-FR version was easily understood and used by all three assessors. In all, 18 procedures were assessed, performed by 14 interns and 4 senior surgeons. The mean OSATS-FR score was 18.6±4.08 for the interns and 31.6±1.62 for the seniors (p<0.0001). The Pearson correlation coefficient was 0.937 CI95% [0.867-1.269] between assessors 1 and 2, 0.977 CI95% [0.899-1.149] between assessors 1 and 3, and 0.965 CI95% [0.876-1.196] between assessors 2 and 3. Cronbach's alpha was greater than 0.9 for each assessor. CONCLUSION: OSATS-FR can distinguish between two groups with different surgical expertise and assess surgical skill with an inter-assessor reproducibility and internal consistency comparable to those of the English version.

Porcine model for tracheostomy training: evaluation of the content and construct validity.

PURPOSE: Tracheostomy is a key procedure that residents in Oto-Rhino-Laryngology, Head and Neck surgery must master as a fundamental component of their training. Swine is a potential model for tracheostomy training as it mimics human anatomy and provides realistic haptic feedback. The purpose of this study is to evaluate its content and construct validity in surgical tracheostomy training. METHODS: We carried out training sessions on dead swine with three groups of volunteers: young residents [postgraduate year (PGY)-1 to 3], experienced residents (PGY-4 to 6) and senior surgeons. Content validity was studied using questionnaires sent to senior surgeons. Construct validity was assessed by comparing the OSATS score on video analysis, between the three groups. RESULTS: 19 individuals participated in the training sessions. OSATS score were statistically different between groups (p < 0.05) with a mean score of 19 for young residents, 24.7 for experienced residents and 31.3 for senior surgeon, with a good inter-rater reliability (Pearson coefficient > 0.9). Experienced surgeons agreed that the model was a useful training tool, strongly agreed that it improved performance, and that it would be used to train their students. CONCLUSIONS: The dead pig is a suitable model to train for human tracheotomy, with good content and construction validity.

Transverse Venous Sinus Stenosis in Patients With Nasal Cerebrospinal Fluid Leak and Idiopathic Intracranial Hypertension.

OBJECTIVE: Spontaneous nasal cerebrospinal fluid (CSF) leaks are frequently linked to idiopathic intracranial hypertension (IIH). The objectives of our study were: (1) to determine the rate of transverse venous sinus stenosis (TVSS) in patients with spontaneous nasal CSF leak and in patients with IIH without CSF (controls), and (2) to study the correlation between spontaneous nasal CSF leak and brain imaging features. STUDY DESIGN: A multicenter retrospective case-control study. SETTING: Six French tertiary hospitals. METHODS: Patients with spontaneous nasal CSF leaks and patients with IIH without nasal CSF leaks (controls) were included. The transverse venous sinus patency was analyzed by magnetic resonance imaging to identify possible stenosis or hypoplasia. RESULTS: Thirty-two patients with spontaneous nasal CSF leaks and 32 controls were included. TVSS was significantly more frequent in patients with spontaneous nasal CSF leaks than in controls (p = .029). Univariate analysis indicated that TVSS (odds ratio, OR: 4.2; 95% confidence interval, CI [1.352-14.915]; p = .017) and arachnoid granulations (OR: 3; 95% CI [1.065-8.994]; p = .042) were risk factors for spontaneous nasal CSF leak. In multivariate analysis, TVSS and arachnoid granulations were independent risk factors of nasal CSF leak (OR: 5.577, 95% CI [1.485-25.837], p = .016; and OR: 4.35, 95% CI [1.234-17.756], p = .029, respectively). CONCLUSION: This multicenter case-control study shows that TVSS is an independent risk factor for CSF leak in patients with IIH. Stenosis management by interventional radiology may be proposed postoperatively to increase the success of IIH surgical treatment or preoperatively to reduce the need for surgery.