Recent Levels of Evidence in Otolaryngology Journals.

OBJECTIVE: The development of evidence-based medicine has contributed to improved patient outcomes. This study aims to identify the trends in levels of evidence in otolaryngology journals over time, as represented by the 4 most widely circulated peer-reviewed otolaryngology journals. METHODS: A review of all articles from 2007, 2010, 2013, 2016, and 2019, in 4 major otolaryngology journals. Data points included journal source, year of publication, country of origin, first author sex, and subspecialty category within otolaryngology. Level of evidence was determined based on the study's primary research question and was graded on a scale of 1 (strongest) to 4 (weakest) based on the Oxford Centre of Evidence-based Medicine - Levels of Evidence guideline. Comparison of levels of evidence was performed using Kruskal-Wallis analysis of variance for ordinal data. RESULTS: About 4297 articles were identified over 12 years. The number of research articles remained consistent over the 12 years of this study. Clinical research increased from 78.6% to 85.1%. Female first authorship increased from 20.3% in 2007 to 31.0% in 2019. Of 3558 articles that constituted clinical research from 2007 to 2019, level 1 studies increased from 0.9% to 3.6%, with level 4 studies remaining stable at an overall rate of 60.3%. Randomized controlled trials remained stable at 4.6% of all studies. Systematic reviews increased from 3.2% to 8.4%. CONCLUSION: This article provides an update on the levels of evidence to allow for an honest self-assessment of otolaryngology as a scientific field.

The negative predictive value of FDG PET/CT staging in early oropharyngeal squamous cell carcinoma and implications to transoral robotic surgery patient selection.

OBJECTIVES: Our objective was to determine the negative predictive value (NPV) of preoperative FDG PET/CTfor detecting locoregional nodal disease. The aim was to help inform the decision-making process when identifying patients with early-stage OPSCC that would be suitable for transoral robotic surgery (TORS) as a single-modality treatment. MATERIALS AND METHODS: A retrospective cohort study was conducted of adults with primary stage cT1-2 OPSCC with up to one metastatic neck lymph node (cN0-1) planned for TORS. Patients with a preoperative PET/CT and who had undergone staging neck dissection (ND) were included. Clinical and pathological nodal staging was established based on PET/CT and ND, respectively. The primary outcome was the frequency of occult (not seen on PET/CT) nodal disease on ND. RESULTS: Eighty-eight patients were included (N = 88). The rate of occult nodal disease was 28.4 % (n = 25). The NPV of PET/CT in the clinically negative neck was 79 % and 66 % in cases with a single clinical node. Following staging ND, thetreatment plan changed in 27 % of cases overall, 7 % in cN0 and 36.7 % in cN1. Among these, 18 % met criteria for radiotherapy and 9 % for CRT. This represented a decrease in the number of ideal candidates for TORS as single-modality treatment from 88 to 64 (73 %). CONCLUSIONS: PET/CT is a useful tool in the workup of patients for primary TORS. However, about one third of patients with early-stage OPSCC might benefit from adjuvant therapy not predicted by preoperative PET/CT. A staging ND helps confirm candidates for single-modality treatment with TORS.

Surgeon-performed ultrasound changes surgical management in patients with thyroid cancer.

BACKGROUND: A comprehensive neck ultrasound (US) is essential in the operative planning of patients with thyroid disease. Recent literature has shown surgeon-performed US (SUS) can be more accurate than radiology-performed US for the purpose of surgical planning. Missed findings on radiology-performed ultrasound may lead to inadequate surgical management. METHODS: A retrospective cohort study of patients undergoing total thyroidectomy with lateral neck dissection for thyroid cancer, with both radiology-performed US and SUS performed by a Head and Neck surgeon. Ultrasound findings and adherence to American Thyroid Association (ATA) guidelines were compared, and changes in management based on SUS findings were identified. RESULTS: A total of 26 patients who underwent total thyroidectomy with lateral neck dissection met the inclusion criteria. Preconsultation US investigations fulfilled criteria as recommended by the American Thyroid Association (ATA) guidelines in 57.7%% of cases. The central and lateral neck compartments were assessed in 57.7% and 84.6% of preconsultation US investigations respectively. Central and lateral metastatic neck metastases were incorrectly reported or not reported in 78.6% and 42.3% of cases. The SUS findings prompted a change in surgical management in 65.4% of cases. CONCLUSION: SUS changed surgical management in two thirds (65.4%) of patients. Reliance on radiology-performed ultrasound alone may result in incorrect staging. Awareness of the additional benefits of SUS is important for surgeons treating patients with thyroid disease to prevent inadequate surgery being performed.

Use of telemedicine consultations in head and neck cancer: patient perceptions, acceptability and accessibility.

BACKGROUNDS: Telemedicine has been effective in the management of various medical conditions, however, there is limited knowledge of its use in head and neck oncosurveillance. This is of importance currently while trying to mitigate the risk of transmission during the COVID-19 pandemic. This study aims to evaluate acceptability, satisfaction and perceptions of telemedicine technology among outpatients for head and neck oncologic surveillance. METHODS: A cross-sectional study was conducted for head and neck surgical oncology patients who attended telemedicine consultations between March and October 2020 at the Peter MacCallum Cancer Centre. Data on demographic, socioeconomic and acceptability variables was collected, utilizing Likert scale questions. The primary outcome measures were patient satisfaction and perceptions, while the secondary outcome was access to technology. RESULTS: One hundred and fifteen patients were invited to participate, and 100 were included in the final analysis; 95% of patient's had a positive experience with telemedicine appointments and were willing to have future telemedicine appointments. Regional and rural patients were more accepting of telemedicine consultations, citing savings in travel time and the minimal disruption to normal day-to-day activities. All participants had access to telecommunication devices, with 63% having three or more devices. Issues identified include a lack of physical examination by clinician for 65% of participants and the inability to self-examine for 88% of participants. CONCLUSION: The study demonstrates patients' acceptance of telemedicine appointments as a component of outpatient surveillance for head and neck surgical oncology. This has benefits during the COVID-19 pandemic in addition to increasing accessibility for rural patients.

The One-Bone Forearm: A Review.

The one-bone forearm (OBF) is a salvage technique that may be used to correct global forearm instability secondary to osseous defects. This study aims to provide an overview of the contemporary literature regarding the OBF. A literature review was conducted electronically across MEDLINE, Embase, and PubMed databases in May 2020. Studies were eligible for inclusion if published in the English language; detailed the use of the OBF procedure to correct forearm instability; and were original data studies reporting qualitative or quantitative outcomes. Thirty-four studies, describing a cohort of 210 patients undergoing 211 OBFs, were documented in the literature. The primary etiology necessitating the OBF was trauma, followed by genetic/congenital disorders and infections. Technically, the OBF was most frequently achieved via an end-to-end osteosynthesis with plate fixation. In total, 85.0% (154/182) of OBF were fused in neutral rotation or varying degrees of pronation. Union was achieved in more than 80.0% (174/211) of OBFs. The OBF is a feasible salvage technique that has been used for a wide spectrum of pathology, providing satisfactory outcomes in most cases.

Effect of endoscopic sinus surgery on clinical outcomes in DeltaF508 cystic fibrosis patients.

OBJECTIVES: Chronic rhinosinusitis (CRS) is prevalent in the Cystic Fibrosis (CF) population. CRS exacerbations in CF are thought to contribute to pulmonary exacerbations. Literature regarding the impact of endoscopic sinus surgery (ESS) is inconclusive. This study examines rates of lung function decline and pulmonary exacerbation in CF patients who have undergone ESS. DESIGN: Retrospective review of medical records. SETTING: Academic Hospital. PARTICIPANTS: 40 adult CF patients. MAIN OUTCOME MEASURES: Rate of lung function decline (% predicted Forced Expiratory Volume in 1 second [ppFEV1 ]), number of pulmonary exacerbations (IV/oral antibiotic therapy ± hospital admission) and total number days hospitalised 2-year postoperatively was collected. CRS patients undergoing ESS were matched to those without ESS by gender, age, and F508del genotype. RESULTS: Forty patients (mean age 37.4, 60% male) were reviewed. No significant difference was found between the surgical group and controls in baseline ppFEV1 (72.5% vs. 72.7%, P = .98), 2-year preoperative number of pulmonary exacerbations (3.05 vs. 1.65, P = .10), or Lund-Mackay scores (12.25 vs. 11.55, P = .71). No significant difference was found in 1-year (70.5% vs. 72.8%, P = .84) or 2-year (70.4% vs. 72.6% P = .80) postoperative ppFEV1 and 2-year postoperative pulmonary exacerbations (1.7 vs. 1.45, P = .87). A significant increase was identified in total number days hospitalised postoperatively (4.85, P = .02). In the surgical group, no significant difference was identified between preoperative and postoperative ppFEV1 , 1 year (-2.51%, P = .32) and 2 years after ESS (-3.10%, P = .51), postoperative rate of pulmonary exacerbations (-1.28, P = .11), or in total number days hospitalised (3.74, P = .14). CONCLUSIONS: In this study, ESS does not appear to significantly improve ppFEV1 or decrease the number of pulmonary exacerbations postoperatively.

Botulinum Toxin in the Management of Children with Cerebral Palsy.

During the past 25 years, botulinum toxin type A (BoNT-A) has become the most widely used medical intervention in children with cerebral palsy. In this review we consider the gaps in our knowledge in the use of BoNT-A and reasons why muscle morphology and function in children with cerebral palsy are impaired. We review limitations in our knowledge regarding the mechanisms underlying the development of contractures and the difficulty in preventing them. It is clear from this review that injection of BoNT-A in the large muscles of both the upper and lower limbs of children with cerebral palsy will result in a predictable decrease in muscle activity, which is usually reported as a reduction in spasticity, for between 3 and 6 months. These changes are noted by the use of clinical tools such as the Modified Ashworth Scale and the Modified Tardieu Scale. Decreased muscle over-activity usually results in improved range of motion in distal joints. Injection of the gastrocnemius muscle for toe-walking in a child with hemiplegia or diplegia usually has the effect of increasing the passive range of dorsiflexion at the ankle. In our review, we found that this may result in a measurable improvement in gait by the use of observational gait scales or gait analysis, in some children. However, improvements in gait function are not always achieved and are small in magnitude and short lived. We found that some of the differences in outcomes in clinical trials may relate to the use of adjunctive interventions such as serial casting, orthoses, night splints and intensive therapy. We note that the majority of clinical trials of the use of BoNT-A in children with cerebral palsy have focussed on a single injection cycle and this is insufficient to understand the balance between benefit and harm. Most outcomes were reported in terms of changes in muscle tone and there were fewer studies with robust methodology that reported improvements in function. Changes in the domains of activities and participation have rarely been reported in studies to date. There were no clinical reviews to date that consider the findings of studies in human volunteers and in experimental animals and their relevance to clinical protocols. In this review we found that studies in human volunteers and in experimental animals show muscle atrophy after an injection of BoNT-A for at least 12 months. Muscle atrophy was accompanied by loss of contractile elements in muscle and replacement with fat and connective tissue. It is not currently known if these changes, mediated at a molecular level, are reversible. We conclude that there is a need to revise clinical protocols by using BoNT-A more thoughtfully, less frequently and with greatly enhanced monitoring of the effects on injected muscle for both short-term and long-term benefits and harms.

Environmental Triggers Associated With Empty Nose Syndrome Symptoms: A Cross-Sectional Study.

OBJECTIVES: Empty nose syndrome (ENS) is thought to have multiple etiologies, one of which is a postsurgical phenomenon resulting from excessive loss of nasal tissues, particularly the inferior turbinate. Given that the inferior turbinate is instrumental in maintaining nasal homeostasis in different environments, it is believed that ENS symptoms arise only in more arid regions of the world. The aim of this study was to recruit an international population of individuals with ENS to investigate the association of local climate factors on the incidence and severity of ENS-specific symptoms. METHODS: A cross-sectional study was performed of individuals from an international ENS database. ENS status was determined on the basis of a positive ENS questionnaire score (Empty Nose Syndrome 6-Item Questionnaire) and sinus computed tomographic imaging with supporting medical documentation. Participants completed a survey encompassing demographic, geographic, and symptom indicators. Climate variables were collected from global climate databases. Participant location was classified according to the Köppen-Geiger climate system. Pearson correlation analysis was performed using α = 0.05 to determine significance. RESULTS: Fifty-three individuals with ENS were included. Participants were distributed across 5 continents and 15 countries (representing 4 distinct Köppen-Geiger zones). Although local climate factors varied significantly within this cohort, no significant association was found between Empty Nose Syndrome 6-Item Questionnaire symptom severity and these climate factors. However, most study participants reported exacerbation of their ENS symptoms in response to dry air (94%), air conditioning (64%), changes in season and weather (60%), and transitioning between indoors and outdoors (40%). This suggests that everyday local environmental factors may influence the well-being of these patients more than global, climate-level shifts. CONCLUSIONS: ENS symptom severity does not appear to be related to climate or geographic factors. These findings deviate from the traditional dogma that ENS is experienced only in arid regions (or precluded in humid regions) and highlight the importance of recognizing this condition independent of geographic location.

Optimization of the Surgical Field in Endoscopic Sinus Surgery: an Evidence-Based Approach.

PURPOSE OF REVIEW: The advent of endoscopic sinus surgery (ESS) has enabled the development of minimally invasive surgical procedures in Rhinology. However, proficiency with ESS techniques can still be hampered by poorly controlled bleeding limiting visibility of the surgical field (VSF). This can lead to increased operating time and, more importantly, increased risk of major and minor complications. To optimize the VSF and mitigate the risk of complications, many strategies have been explored. RECENT FINDINGS: This is a narrative review of the relative risks and benefits of pre- and intra-operative interventions aimed at optimizing intraoperative conditions during ESS. The value of these interventions is determined based on their impact on intraoperative blood loss, time of surgery, and the VSF, and weighed against their adverse event profile. This review provides a comprehensive overview of the evidence relating to the safety and efficacy of interventions used to improve intraoperative conditions during ESS.

The association of Leptospermum honey with cytokine expression in the sinonasal epithelium of chronic rhinosinusitis patients.

OBJECTIVE: To identify the differences in cytokine expression between sinonasal tissue from patients treated with Leptospermum (Manuka) honey (LH) irrigation versus normal saline irrigation twice-daily for twelve weeks following sinus surgery (FESS). METHODS: Forty-six CRS patients were recruited. Sinus tissue biopsies were collected during FESS and then at 5 and 12 weeks postoperatively during the course of treatment. A multi-plex cytokine assay quantified the abundance of 17 cytokines in biopsied tissue. Cytokine expression fold-change was analyzed between each time point using a robust linear regression model and compared between the two treatment groups. RESULTS: Compared to the saline irrigation group, five cytokines were differently expressed (CI = 95%) in sinonasal tissue obtained from subjects in the LH irrigation group during the 12-week treatment period. Cytokines IL-6 (P = 0.0400), IL-8 (P = 0.0398), MCP-1 (P = 0.0284), and MIP-1ß (P = 0.016) were significantly increased in the LH irrigation group compared to the saline irrigation group. IL-13 was significantly increased in the saline irrigation group compared to the LH group (P = 0.0086). CONCLUSION: LH may potentially act to modulate the expression of IL-6, IL-8, IL-13, MCP-1 and MIP-1ß in sinonasal tissue.

Evaluation of sheep sinonasal endoscopic anatomy as a model for rhinologic research.

OBJECTIVES: Despite many publications describing sheep models for functional endoscopic sinus surgery (FESS) procedures, accurate endoscopic anatomical studies are lacking. There are no publications correlating computed tomography (CT) and 3D models with endoscopic anatomical descriptions. This study evaluates and describes the endoscopic anatomy of a sheep model. METHODS: Ten live sheep (20-sides) were included. Two cadaveric specimens, imaged using thin slice CT for 3D reconstruction correlation were also included. Using endoscopy, anatomical structures were measured and described. Measurement of the same structures was carried out using the 3D imaging model. RESULTS: Three sets of turbinates were identified at 2.3, 5.1 and 8.5 cm from the anterior nasal sill. Frontal recess and uncinate process were identified at 12.7 cm. The septum has a bony and cartilaginous component and measures 10.5 cm. The sphenopalatine foramen was measured at 12.1 cm. All anatomical measurements were correlated with the measurements on the CT scan 3D volume-rendering model, thereby allowing for an accurate description of the sheep sinonasal anatomy. CONCLUSION: This study describes the endoscopic sinonasal anatomical measurements of the adult sheep. It is the first study to evaluate the sheep CT and endoscopic anatomy in order to determine its feasibility as an animal model for research in FESS.

Potential risk factors associated with the development of synechiae following functional endoscopic sinus surgery.

PURPOSE: Synechiae formation in the middle meatus is the most common complication of functional endoscopic sinus surgery (FESS). Our objectives were to determine the incidence of synechiae occurring in a cohort of patients that have undergone FESS and identify characteristics associated with the development of synechiae postoperatively. METHODS: A retrospective chart review was conducted of CRS patients, with or without nasal polyposis, that had undergone bilateral FESS in the past. All patients had received non-absorbable spacers intraoperatively that were left in situ for 6 days. Demographic and preoperative variables were analyzed to identify synechiae risk factors. A multivariable logistic regression model was constructed to estimate the probability of developing synechiae, given demographic and preoperative variables. RESULTS: Two hundred cases of bilateral FESS were retrospectively reviewed. Thirty-eight (19.0%, 95% CI 13.6-24.4%) patients developed synechiae. Individuals receiving primary FESS and nasal septal reconstruction (NSR) were strongly associated with the development of synechiae (OR 3.5, 95% CI 1.5-8.5; OR 3.0, 95% CI 1.3-6.9). A multivariable logistic regression model adjusting for NSR, recurrent FESS, concha bullosa, requirement of anterior and posterior ethmoidectomy, Lund-Mackay CT score and gender, identified the likelihood of developing synechiae with a sensitivity of 68%, specificity of 73%, positive predictive value of 38% and likelihood ratio of 2.5. CONCLUSION: Patients undergoing primary FESS and NSR are at greatest odds of developing postoperative synechiae. Methods of assessing risk factors and preventing synechiae formation in this population should be evaluated in future prospective investigations.

Comparing the efficacy of Silastic and gloved-Merocel middle meatal spacers for functional endoscopic sinus surgery: a randomized controlled trial.

BACKGROUND: Spacers are inserted into the middle meatal space (MMS) following functional endoscopic sinus surgery (FESS) to prevent lateralization of the middle turbinate, scarring, and synechiae. Our objective was to determine if the incidence of postoperative synechiae, facial pain/discomfort, pain during spacer removal, scarring, and discharge differed between nasal cavities receiving Silastic or gloved-Merocel (GM) spacers following FESS. METHODS: A double-blind, randomized controlled trial (RCT) was conducted in adults requiring bilateral FESS for chronic rhinosinusitis (CRS) ± nasal polyposis. Participants served as their own controls, with each subject receiving both a Silastic and GM spacer. Spacers were inserted into the MMS during FESS and left in situ for 6 days. Participants were reviewed at 6 days, 5 weeks, and 12 weeks postoperatively. The presence of synechiae and scarring were evaluated endoscopically. Inflammation, discharge, and pain during spacer removal were assessed using a visual analogue scale (VAS). RESULTS: Forty-eight participants (96 nasal cavities) were recruited. Preoperatively, Lund-Mackay computed tomography (CT) scores were similar between Silastic-treated and GM-treated cavities (6.38 ± 2.35 vs 6.18 ± 2.17). The incidence of synechiae and scarring did not differ significantly between spacers up to 12 weeks postoperatively. Pain during spacer removal was significantly greater for Silastic than GM spacers (2.13 ± 1.34 vs 1.51 ± 1.23, p = 0.020). Facial pain prior to removal and extent of discharge did not differ significantly between spacers. CONCLUSION: Following FESS, patients report less pain during removal of GM than Silastic spacers. However, the likelihood of synechiae and scarring did not differ between either of the spacers.

The functional and psychological burden of empty nose syndrome.

BACKGROUND: Empty nose syndrome (ENS) is a debilitating disorder thought to arise as a postsurgical phenomenon from excessive loss of nasal tissues. Affected patients often report a profound impact on all aspects of life, but the extent of this burden has not been quantified. We sought to determine the association of ENS with mental health and functional impairments. METHODS: A cross-sectional study was performed of individuals with ENS recruited from online ENS forums. ENS status was validated based on a positive 6-item Empty Nose Syndrome Questionnaire (ENS6Q) score and sinus computed tomography imaging or supporting medical documentation. Subjects completed the ENS6Q, the 9-item Patient Health Questionnaire (PHQ-9) for depression, the 7-item Generalized Anxiety Disorder questionnaire (GAD-7), the Epworth Sleepiness Scale for daytime somnolence (ESS), the Work Productivity and Impairment questionnaire (WPAI), and the 5-dimension EuroQol General Health State Survey (EQ-5D-5L). Pearson correlation analysis was performed with α = 0.05 to determine significance. RESULTS: Fifty-three ENS individuals were included in the study. Overall, participants reported symptoms consistent with moderate anxiety (µ = 12.7; standard deviation [SD], 5.9) and moderately severe depression warranting treatment (µ = 17.9; SD, 6.8). Participants also noted a 62% reduction in productivity at work (n = 24) and 65% in all other activities (n = 53). ENS6Q symptom severity was correlated with more severe depression (p < 0.001), anxiety (p < 0.001), overall pain/discomfort (p = 0.002), and impairment in activities of daily living (p = 0.003). CONCLUSION: ENS individuals carry a clinically significant psychological burden and experience marked difficulties with many activities of daily living. A multimodal approach to address the tissue loss with surgery and cognitive-behavioral therapy for the psychological burden may provide the most optimal outcome.

Safety of long-term intranasal budesonide delivered via the mucosal atomization device for chronic rhinosinusitis.

BACKGROUND: Although short-term use (≤2 months) of atomized topical nasal steroids has been shown to be safe and effective, the long-term safety has yet to be demonstrated. The aim of this study was to determine the impact of long-term topical budesonide treatment via the mucosal atomization device (MAD) on the hypothalamic-pituitary-adrenal axis (HPAA) and intraocular pressure (IOP). METHODS: A cross-sectional study of patients with chronic rhinosinusitis (CRS), with or without nasal polyposis, managed with daily nasal budesonide via MAD was conducted at a tertiary rhinology center. Patients using systemic steroids within 3 months of assessment were excluded. HPAA impact was assessed using the cosyntropin stimulation test for adrenal function and a survey of relevant symptomatology. Patients also underwent tonometry to assess for elevated IOP potentially related to corticosteroid use. RESULTS: A total of 100 CRS patients were recruited with a mean budesonide treatment duration of 23.5 months (range, 6-37 months). Stimulated cortisol response was diminished in 3 patients (3%). No patients with adrenal suppression had relevant symptomatology. IOP was elevated in 6 patients (6%). CONCLUSION: These findings suggest that there is a risk of adrenal suppression and raised IOP associated with the long-term use of topical nasal budesonide via MAD. Otolaryngologists should consider periodic surveillance for these adverse events in this patient cohort.

Rapid hemostasis in a sheep model using particles that propel thrombin and tranexamic acid.

OBJECTIVES/HYPOTHESIS: Bleeding during endoscopic sinus surgery and open surgeries can easily obstruct the surgeons' field of view and increase morbidity and risk of intraoperative complications. Intraoperative bleeding could potentially be addressed by a hemostatic agent that safely disperses itself through the escaping blood. We tested the safety and efficacy of a self-propelling formulation of thrombin and tranexamic acid (SPTT) in stopping bleeding in a paranasal sinus injury and in an open surgical carotid injury sheep model. STUDY DESIGN: Interventional animal study. METHODS: SPTT was tested in the sinonasal space following endoscopic injury to the inferior turbinate of six sheep, and to the common carotid artery following open surgical injury in eight sheep. In the nasal cavity, bleeding time and local inflammation were measured and compared to plain gauze. Following carotid arteriotomy, successful hemostasis and markers of thrombosis and coagulopathy were compared to Floseal. RESULTS: SPTT significantly decreased bleeding times in the sinonasal space compared to plain gauze (mean difference = 3.8 minutes, P = .002). All of the carotid bleeds (100%) were successfully controlled with SPTT after 10 minutes of application under pressure, compared to 25% with Floseal. No adverse events were noted, and there was no evidence of thromboembolism. CONCLUSIONS: SPTT significantly reduced bleeding time in a sheep model of surgical sinus bleeding and successfully stopped bleeding following catastrophic carotid artery injury, with no adverse events observed. LEVEL OF EVIDENCE: NA Laryngoscope, 127:787-793, 2017.