SimTube: A National Simulation Training and Research Project.

OBJECTIVE: To test the feasibility and impact of a simulation training program for myringotomy and tube (M&T) placement. STUDY DESIGN: Prospective randomized controlled. SETTING: Multi-institutional. SUBJECTS AND METHODS: An M&T simulator was used to assess the impact of simulation training vs no simulation training on the rate of achieving competency. Novice trainees were assessed using posttest simulator Objective Structured Assessment of Technical Skills (OSATS) scores, OSATS score for initial intraoperative tube insertion, and number of procedures to obtain competency. The effect of simulation training was analyzed using χ2 tests, Wilcoxon-Mann-Whitney tests, and Cox proportional hazards regression. RESULTS: A total of 101 residents and 105 raters from 65 institutions were enrolled; however, just 63 residents had sufficient data to be analyzed due to substantial breaches in protocol. There was no difference in simulator pretest scores between intervention and control groups; however, the intervention group had better OSATS global scores on the simulator (17.4 vs 13.7, P = .0003) and OSATS task scores on the simulator (4.5 vs 3.6, P = .02). No difference in OSATS scores was observed during initial live surgery rating (P = .73 and P = .41). OSATS scores were predictive of the rate at which residents achieved competence in performing myringotomy; however, the intervention was not associated with subsequent OSATS scores during live surgeries (P = .44 and P = .91) or the rate of achieving competence (P = .16). CONCLUSIONS: A multi-institutional simulation study is feasible. Novices trained using the M&T simulator achieved higher scores on simulator but not initial intraoperative OSATS, and they did not reach competency sooner than those not trained on the simulator.

Sinus Surgery Is Associated with a Decrease in Aspirin-Induced Reaction Severity in Patients with Aspirin Exacerbated Respiratory Disease.

BACKGROUND: Nasal polyps influence the burden of aspirin-exacerbated respiratory disease (AERD) by contributing to eicosanoid production. AERD is diagnosed through graded aspirin challenges. It is not known how sinus surgery affects aspirin challenge outcomes. OBJECTIVE: To investigate the effects of endoscopic sinus surgery (ESS) on aspirin-induced reaction severity and on the levels of eicosanoids associated with these reactions. METHODS: Twenty-eight patients with AERD were challenged with aspirin before and 3 to 4 weeks after ESS. Respiratory parameters and plasma and urine levels of eicosanoids were compared before and after challenges. RESULTS: Before ESS, AERD diagnosis was confirmed in all study patients by aspirin challenges that resulted in hypersensitivity reactions. After ESS, reactions to aspirin were less severe in all patients and 12 of 28 patients (43%, P < .001) had no detectable reaction. A lack of clinical reaction to aspirin was associated with lower peripheral blood eosinophilia (0.1 K/µL [interquartile range (IQR) 0.1-0.3] vs 0.4 K/µL [IQR 0.2-0.8]; P = .006), lower urinary leukotriene E4 levels after aspirin challenge (98 pg/mg creatinine [IQR 61-239] vs 459 pg/mg creatinine [IQR 141-1344]; P = .02), and lower plasma prostaglandin D2 to prostaglandin E2 ratio (0 [±0] vs 0.43 [±0.2]; P = .03), compared with those who reacted. CONCLUSIONS: Sinus surgery results in decreased aspirin sensitivity and a decrease in several plasma and urine eicosanoid levels in patients with AERD. Diagnostic aspirin challenges should be offered to patients with suspected AERD before ESS to increase diagnostic accuracy. Patients with established AERD could undergo aspirin desensitizations after ESS as the severity of their aspirin-induced hypersensitivity reactions lessens.

Diagnostic flexible pharyngo-laryngoscopy: development of a procedure specific assessment tool using a Delphi methodology.

PURPOSE: Proper training and assessment of skill in flexible pharyngo-laryngoscopy are central in the education of otorhinolaryngologists. To facilitate an evidence-based approach to curriculum development in this field, a structured analysis of what constitutes flexible pharyngo-laryngoscopy is necessary. Our aim was to develop an assessment tool based on this analysis. METHODS: We conducted an international Delphi study involving experts from twelve countries in five continents. Utilizing reiterative assessment, the panel defined the procedure and reached consensus (defined as 80% agreement) on the phrasing of an assessment tool. RESULTS: FIFTY PANELISTS COMPLETED THE DELPHI PROCESS. THE MEDIAN AGE OF THE PANELISTS WAS 44 YEARS (RANGE 33-64 YEARS). MEDIAN EXPERIENCE IN OTORHINOLARYNGOLOGY WAS 15 YEARS (RANGE 6-35 YEARS). TWENTY-FIVE WERE SPECIALIZED IN LARYNGOLOGY, 16 WERE HEAD AND NECK SURGEONS, AND NINE WERE GENERAL OTORHINOLARYNGOLOGISTS. AN ASSESSMENT TOOL WAS CREATED CONSISTING OF TWELVE DISTINCT ITEMS.: Conclusion The gathering of validity evidence for assessment of core procedural skills within Otorhinolaryngology is central to the development of a competence-based education. The use of an international Delphi panel allows for the creation of an assessment tool which is widely applicable and valid. This work allows for an informed approach to technical skills training for flexible pharyngo-laryngoscopy and as further validity evidence is gathered allows for a valid assessment of clinical performance within this important skillset.

Antibiotic use patterns in endoscopic sinus surgery: a survey of the American Rhinologic Society membership.

BACKGROUND: There is a paucity of data supporting antibiotic use in endoscopic sinus surgery (ESS). The objective of this study is to determine perioperative antibiotic use patterns and factors which influence use in ESS. METHODS: An online-based survey was distributed to members of the American Rhinologic Society (ARS). Outcomes included timing of perioperative antibiotic use, practice environment, years of experience, and patient factors that influenced antibiotic use. RESULTS: There were 204 responses (response rate 18.3%); 36.8% of respondents were in academic positions, 32.8% were in private practice, and 30.4% were in academic-affiliated private practice; 20.6% routinely gave preoperative antibiotics, most commonly to reduce bacterial burden (59.5%) and mucosal inflammation (59.5%); 54.4% routinely gave intraoperative antibiotics, most commonly to reduce the risk of postoperative infection (63.1%); 62.3% routinely gave postoperative antibiotics, citing the need to reduce the risk of postoperative infection (75.6%). Diagnosis influenced postoperative antibiotic use in 63.0%. Preoperative antibiotics were more likely to be prescribed by respondents with more than 5 years of experience (odds ratio [OR] 2.97; 95% confidence interval [CI], 1.04 to 8.54; p = 0.043). Compared to private practitioners, academicians were more likely to give intraoperative antibiotics (OR 2.68; 95% CI, 1.39 to 5.17; p = 0.003), but not preoperative or postoperative antibiotics. Use of nonabsorbable packing was significantly associated with use of postoperative antibiotics (OR 2.01; 95% CI, 1.07 to 3.77; p = 0.031). CONCLUSION: This study demonstrates the significant variation in perioperative antibiotic use among otolaryngologists. These results provide support for the establishment of evidence-based practice guidelines for perioperative antibiotic use in ESS.

Endoscopic modified Lothrop procedure after failure of primary endoscopic sinus surgery: a meta-analysis.

BACKGROUND: The endoscopic modified Lothrop procedure (EMLP) has been used as a salvage technique for frontal sinusitis following failed endoscopic sinus surgery (ESS). We aim to examine the safety and efficacy of the EMLP following failure of primary ESS. METHODS: All English-language publications from 2000 to 2016 reporting the use of EMLP after primary ESS were identified using the PubMed database and evaluated per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Random effects summaries of patient demographics, comorbidities, and surgical outcomes were obtained through meta-analysis. RESULTS: Eleven studies constituting 778 patients were included and 86.5% had chronic rhinosinusitis (CRS). Mean follow-up duration was 28.4 months. The mean number of surgeries prior to EMLP was 3.5. Symptom improvement was reported in 82.3%. Subgroup analysis of 7 studies in which all 357 patients had CRS revealed a mean follow-up of 31.5 months. Symptom improvement occurred in 75.9% of cases and 23.1% experienced polyp recurrence. The cerebrospinal fluid leak rate was 2.5%. Restenosis of the neo-ostium occurred in 17.1% with complete closure occurring in 3.9% of cases. The reoperation rate after EMLP was 9.0%. Aspirin sensitivity was associated with an increased risk of cerebrospinal fluid (CSF) leak (p = 0.0339) and a reduced incidence of neo-ostium closure (p = 0.0001). Aspirin sensitivity and asthma were associated with a reduced incidence of reoperation (p ≤ 0.001) and increased symptom improvement (p < 0.005). Restenosis or closure of the frontal neo-ostium was associated with less symptom improvement (p < 0.04) but not with reoperation. CONCLUSION: The EMLP is an effective salvage procedure for refractory frontal sinusitis based on data from higher-volume centers.

Improving Rhinology Skills with Simulation.

The convergence of technology and medicine has led to many advances in surgical training. Novel surgical simulators have led to significantly improved skills of graduating surgeons, leading to decreased time to proficiency, improved efficiency, decreased errors, and improvement in patient safety. Endoscopic sinus surgery poses a steep learning curve given the complex 3-dimensional anatomy of the nasal and paranasal cavities, and the necessary visual-spatial motor skills and bimanual dexterity. This article focuses on surgical simulation in rhinological training and how innovative high-fidelity and low-fidelity simulators can maximize resident training and improve procedural skills before operating in the live environment.

Leadership Training in Otolaryngology Residency.

Although residency training offers numerous leadership opportunities, most residents are not exposed to scripted leadership instruction. To explore one program's attitudes about leadership training, a group of otolaryngology faculty (n = 14) and residents (n = 17) was polled about their attitudes. In terms of self-perception, more faculty (10 of 14, 71.4%) than residents (9 of 17, 52.9%; P = .461) considered themselves good leaders. The majority of faculty and residents (27 of 31) thought that adults could be taught leadership ability. Given attitudes about leadership ability and the potential for improvement through instruction, consideration should be given to including such training in otolaryngology residency.

Plasma 15-Hydroxyeicosatetraenoic Acid Predicts Treatment Outcomes in Aspirin-Exacerbated Respiratory Disease.

BACKGROUND: Aspirin desensitization followed by daily aspirin provides therapeutic benefits to patients with aspirin-exacerbated respiratory disease (AERD). It is not well understood how eicosanoid levels change during aspirin treatment. OBJECTIVE: To investigate associations between clinical outcomes of aspirin treatment and plasma eicosanoid levels in patients with AERD. METHODS: Thirty-nine patients with AERD were offered aspirin treatment (650 mg twice daily) for 4 weeks. Respiratory parameters and plasma levels of multiple eicosanoids were recorded at baseline and after 4 weeks of aspirin therapy using the Asthma Control Test and Rhinoconjunctivitis Quality of Life Questionnaire. Respiratory function was evaluated using the FEV1 and nasal inspiratory peak flow. RESULTS: After aspirin treatment, respiratory symptoms improved in 16 patients, worsened in 12 patients, and did not change in 4 patients. Seven patients were unable to complete the desensitization protocol. Patients with symptom improvement had higher baseline plasma 15-hydroxyeicosatetraenoic acid (15-HETE) levels than did patients with symptom worsening: 7006 pg/mL (interquartile range, 6056-8688 pg/mL) versus 4800 pg/mL (interquartile range, 4238-5575 pg/mL), P = .0005. Baseline 15-HETE plasma levels positively correlated with the change in Asthma Control Test score (r = 0.61; P = .001) and in FEV1 after 4 weeks of aspirin treatment (r = 0.49; P = .01). It inversely correlated with Rhinoconjunctivitis Quality of Life Questionnaire score (r = -0.58; P = .002). Black and Latino patients were more likely to have symptom worsening on aspirin or fail to complete the initial desensitization than white, non-Latino patients (P = .02). CONCLUSIONS: In patients with AERD, low baseline 15-HETE plasma levels and black or Latino ethnicity are associated with worsening of respiratory symptoms during aspirin treatment.

Case-control study evaluating competing risk factors for angioedema in a high-risk population.

OBJECTIVES/HYPOTHESIS: Black race is a risk factor for angioedema. The primary aim was to examine the relationship between race-ethnicity and risk factors for angioedema. STUDY DESIGN: Using a retrospective case-control study design, data was extracted with the Clinical Looking Glass utility, a data collection and management tool that captures data from electronic medical record systems within the Montefiore Healthcare System. Cases were emergency department (ED) visits with primary or secondary International Classification of Diseases, Ninth Revision, code diagnoses of angioedema in adults aged ≥ 18 years from January 2008 to December 2013 at three Montefiore centers in Bronx, New York. Controls were a random sampling of adult ED visits during the same period. METHODS: In primary analyses, angiotensin-converting enzyme inhibitor (ACE-I) and black race were evaluated for synergy. The influence of different risk factors in the development of angioedema was evaluated using logistic regression models. Finally, race-ethnicity was further explored by evaluating for effect modification by stratification of models by race-ethnicity categories. RESULTS: There were 1,247 cases and 6,500 controls randomly selected from a larger control pool. ACE-I use (odds ratio [OR] 3.70, 95% confidence interval [CI] 2.98, 4.60), hypertension (OR 1.88, 95% CI 1.55, 2.29), and black race (OR 2.25, 95% CI 1.86, 2.72) were the strongest risk factors. ACE-I use and black race were not synergistic (OR 1.10, 95% CI 0.80, 1.51). Race-ethnicity was an effect modifier for certain risk factors. CONCLUSION: Race-ethnicity acts as an effect modifier for particular angioedema risk factors. The two strongest risk factors, ACE-I use and black race, were not synergistic. LEVEL OF EVIDENCE: 3b. Laryngoscope, 126:1823-1830, 2016.

Simulation Activity in Otolaryngology Residencies.

OBJECTIVES: Simulation has become a valuable tool in medical education, and several specialties accept or require simulation as a resource for resident training or assessment as well as for board certification or maintenance of certification. This study investigates current simulation resources and activities in US otolaryngology residency programs and examines interest in advancing simulation training and assessment within the specialty. STUDY DESIGN: Web-based survey. SETTING: US otolaryngology residency training programs. SUBJECTS AND METHODS: An electronic web-based survey was disseminated to all US otolaryngology program directors to determine their respective institutional and departmental simulation resources, existing simulation activities, and interest in further simulation initiatives. Descriptive results are reported. RESULTS: Responses were received from 43 of 104 (43%) residency programs. Simulation capabilities and resources are available in most respondents' institutions (78.6% report onsite resources; 73.8% report availability of models, manikins, and devices). Most respondents (61%) report limited simulation activity within otolaryngology. Areas of simulation are broad, addressing technical and nontechnical skills related to clinical training (94%). Simulation is infrequently used for research, credentialing, or systems improvement. The majority of respondents (83.8%) expressed interest in participating in multicenter trials of simulation initiatives. CONCLUSION: Most respondents from otolaryngology residency programs have incorporated some simulation into their curriculum. Interest among program directors to participate in future multicenter trials appears high. Future research efforts in this area should aim to determine optimal simulators and simulation activities for training and assessment as well as how to best incorporate simulation into otolaryngology residency training programs.

Endoscopic Endonasal Transsphenoidal Resection for Pituitary Apoplexy during the Third Trimester of Pregnancy.

Pituitary apoplexy is an uncommon phenomenon typically characterized by vascular insufficiency or acute hemorrhage into a pituitary adenoma. The overall incidence of pituitary apoplexy ranges between 1 and 25% of all pituitary adenomas. With the widespread use of MRI technology, the diagnosis of asymptomatic intratumoral hemorrhage is closer to 10%. The authors report a case of a 27-year-old female in her 36th week of pregnancy who presented with severe onset headache and acute left-sided vision loss. MRI of the brain revealed a large hemorrhagic mass occupying the sella turcica. The patient underwent an emergent endoscopic endonasal transsphenoidal resection for pituitary apoplexy. Postoperatively, the patient's neurologic deficit resolved. Minimally invasive endoscopic endonasal transsphenoidal resection of pituitary apoplexy can be safely utilized in third trimester pregnant women presenting with acute severe neurologic deficits.

Structural and functional vocal fold epithelial integrity following injury.

OBJECTIVES/HYPOTHESIS: An intact epithelium is an important part of vocal fold defense. Damage to the epithelium can compromise vocal fold homeostasis and protection of the host tissue from viral and bacterial invasion. Elucidating the effects of damage on epithelial architectural and barrier integrity provides insight into the role of epithelium in protecting vocal folds. Using an animal model, we evaluated the time course of structural and functional epithelial restoration following injury. STUDY DESIGN: Prospective, controlled animal study. METHODS: Forty rats underwent surgery to remove vocal fold mucosa unilaterally. Larynges were harvested at five time intervals between 3 to 90 days postinjury and were prepared for histological and permeability analyses. RESULTS: Rapid restoration of structural integrity was demonstrated by return of a multilayerd epithelium, intercellular junctions, and basement membrane at 5 days postinjury. Atypical epithelial permeability was observed up to 5 weeks postinjury. CONCLUSION: Restoration of epithelial barrier integrity lags epithelial structural restoration. Consequently, epithelial regeneration cannot be equated with return of functional barrier integrity. Rather, ongoing leakiness of regenerated epithelium indicates that vocal folds remain at risk for damage, pathogen invasion, and remodeling postinjury. LEVEL OF EVIDENCE: N/A. Laryngoscope, 124:2764-2769, 2014.

Risk factors associated with severe and recurrent angioedema: an epidemic linked to ACE-inhibitors.

OBJECTIVES/HYPOTHESIS: To evaluate the etiology and risk factors for severe manifestation and recurrent episodes of angioedema; to evaluate efficacy of short-term and long-term management strategies for angioedema among a high-risk population. STUDY DESIGN: Institutional review board-approved retrospective review of a large, urban population. METHODS: Data from 875 adult patients treated from January 2008 to December 2013 with the diagnosis of angioedema were obtained using the Clinical Looking Glass utility and review of medical records. Demographic and clinicopathologic risk factors were recorded. The major outcomes evaluated were hospital admission, need for airway intervention, and recurrent episodes of angioedema following the first presentation. Initial treatment strategy and follow-up recommendations were also recorded. RESULTS: The most common cause of angioedema was angiotensin converting enzyme inhibitor (ACEi)-induced (496 [56.6%]). Significant risk factors for severe cases of angioedema included older age, Hispanic race, ACEi-induced angioedema type, American Society of Anesthesiologists class III or above, coexistent cardiopulmonary disease, and a positive smoking history. A total of 17.2% of patients experienced recurrent attacks of angioedema; of those patients, 25.9% were still taking an ACEi at subsequent presentation. Risk factors for recurrent episodes included older age, idiopathic angioedema type, and coexistent cardiopulmonary disease. Only 54.1% of patients who experienced ACEi-induced angioedema had electronic medical record documentation of these allergies. CONCLUSIONS: Knowledge of risk factors for severe and recurrent episodes of angioedema and improved education for both healthcare providers and patients, specifically related to ACEi use and allergy documentation, may significantly decrease the burden and morbidity of angioedema among high risk populations. LEVEL OF EVIDENCE: 2b.

Hoarseness evaluation: a transatlantic survey of laryngeal experts.

OBJECTIVES/HYPOTHESIS: Hoarseness is a symptom of laryngeal dysfunction, without an existing consensus regarding its appropriate evaluation. A survey of laryngeal specialists is proposed to establish expert opinion on the methodology for evaluation of hoarseness, and to identify divergence of opinion regarding appropriate management. STUDY DESIGN: Cross-sectional survey. METHODS: A 13-item questionnaire was submitted electronically to the membership of the American Laryngological Association, the American Broncho-Esophagological Association, and the European Laryngological Society. Responses were collated anonymously and subjected to cross-tabulated data analysis. RESULTS: A total of 195 responses were included for review. The majority of respondents identified themselves as laryngologists/phoniatricians (54.9%). Two-thirds (64.1%) of the providers dedicated more than 25% of their practice to voice management, and 48.8% managed more than 10 dysphonic patients weekly. Most respondents defined hoarseness and dysphonia as symptoms and not diseases. The panel recommended a mandated time to laryngoscopy of 1 week to 1 month from the onset of symptoms for most acutely dysphonic patients, regardless of risk factors for malignancy, while it was not advised to defer laryngoscopy beyond 2 months of symptom persistence in any situation. A majority (96.2%) felt that an otolaryngologist ought to perform the initial laryngoscopy of a newly hoarse patient. CONCLUSION: This survey demonstrates an agreement to expedite specialized laryngeal visualization for cases of hoarseness not subsiding within 1 month, and exemplifies controversies stemming from a recently published clinical practice guideline. Ongoing research and practice evaluation will contribute to set forth improved standards of care and to appropriately counsel dysphonic patients.

Commentary on the role of expert opinion in developing evidence-based guidelines.

Evidence-based clinical practice guidelines (CPGs) help guide busy practitioners in clinical decision making. CPGs are evidence-based in that recommendations are based on available knowledge derived from published clinical trials. The challenges presented by the tasks of finding, assessing, interpreting, and assembling the information in these reports are herculean. Missing or imperfect evidence may lead to the publication of suboptimal guidelines, even when the other components of the development process have been flawlessly performed. This commentary highlights the requirement that expert opinion must be explicitly recognized by CPG authoring groups when the published evidence is missing or inadequate.

The use of image-guided surgery in endoscopic sinus surgery: an evidence-based review with recommendations.

BACKGROUND: The frequency of endoscopic sinus surgery (ESS) appears to be increasing, and the use of image-guided surgery (IGS) in these procedures is becoming more widespread. The use of IGS in ESS and anterior skull base surgery is predicated on the notion that its ability to aid in anatomic identification during surgery will lead to fewer complications and improved surgical outcomes. The purpose of this article is to provide an evidence-based examination of the benefits of IGS in ESS. METHODS: A systematic review of the literature was performed and recommendations were created based on the Clinical Practice Guideline Manual, Conference of Guideline Standardization (COGS), and the Appraisal of Guidelines and Research Evaluation (AGREE) instruments. RESULTS: This review identified and evaluated literature regarding the effect of IGS on surgical complications and on postoperative outcomes in ESS. Currently, there is grade C evidence to support the use of IGS in ESS. CONCLUSION: Based on the best available evidence in the literature, the use of IGS has not clearly been shown to decrease surgical complications or improve surgical outcomes. These evidence-based recommendations are based on limited literature with suboptimal research methodology. However, the importance, utility, and acceptance of IGS through expert opinion and consensus are supported by the available literature. Therefore, the use of IGS in ESS is an option and should be based on clinical judgment and applied on a case-by-case basis.