Overlapping Surgery Verbiage in Informed Consent Documents.

OBJECTIVE: To assess informed consent documents from United States (US) institutions for verbiage regarding overlapping surgery. SUMMARY BACKGROUND DATA: Overlapping surgery remains a controversial practice. Recent guidance from the Senate Finance Committee and American College of Surgeons emphasizes transparency with patients regarding this practice through the informed consent process, but it remains unclear how many institutions adopted their recommendations. METHODS: Informed consent documents were collected from a national sample of 104 institutions and assessed for verbiage regarding overlapping surgery and/or attending absence during a surgical case. The verbiage of these forms was further analyzed for inclusion of key terms (e.g., "overlapping surgery," "critical portions") as well as transparency regarding surgeon absence. RESULTS: Thirty (29%) forms included verbiage regarding overlapping surgery and/or surgeon absence during a case. Most of these 30 utilized the terms "overlapping surgery" or "critical portions" (18 [60%] and 25 [83%], respectively), although only 3 (10%) explicitly stated that portions of the procedure that may be performed in the absence of the attending surgeon. Six forms (20%) specifically stated who may perform the procedure without the attending present, and 3 forms (10%) had patients acknowledge this section of the consent form with an additional signature or initial. Only 2 of the forms (7%) fulfilled all of the criteria set forth by the SFC. CONCLUSION: Detailed information regarding overlapping surgery is infrequently included in hospitals' procedure informed consent documents. Forms that include this information rarely provide explicit statements of attending presence and trainee participation, raising concerns regarding surgeon-patient transparency.

A New Patient-reported Outcomes Measure for Surgically Treated Epiphora: Tearing Assessment and Rating Scale-12 (TEARS-12).

BACKGROUND: No widely accepted, validated instrument currently exists to measure clinical outcomes in patients who undergo dacryocystorhinostomy (DCR) for treatment of epiphora. OBJECTIVE: To develop a patient-reported outcome measure applicable to this population. METHODS: Psychometric evaluations, consultation with experts, and review of the literature informed item generation of a 12-question questionnaire to incorporate the most relevant symptoms experienced by patients with nasolacrimal duct obstruction. This questionnaire, known as the Tearing Assessment and Rating Scale-12 (TEARS-12), was administered to 32 patients before and after intervention, in the form of endoscopic DCR. Statistical analysis was performed to measure internal consistency, responsiveness, and test-retest reliability. RESULTS: Pre-operative and post-operative TEARS-12 scores (28.2 [standard error (SE) 3.19] vs 11.8 [SE 3.25], respectively, P = 0.001) demonstrated improved patient outcome within 6 weeks following endoscopic DCR. Cronbach's alpha for the questionnaire was 0.90, indicating high overall reliability. Additionally, each question demonstrated internal reliability, with a corrected item-total correlation greater than 0.30. The intraclass correlation between the two pre-operative scores was 0.858 (P < 0.001), indicating high test-retest reliability. CONCLUSION: TEARS-12 is a statistically valid, easy-to-administer instrument to measure clinical outcomes in patients who undergo endoscopic DCR.

Evolving Utilization of Topical Budesonide Following Endoscopic Sinus Surgery.

Topical budesonide irrigations are frequently prescribed after endoscopic sinus surgery (ESS) to manage mucosal inflammation. However, this off-label indication may conflict with health insurance formularies. We sought to quantify the relative frequency of postoperative budesonide prescriptions to determine if this could be considered common practice after ESS. We extracted and analyzed postoperative prescription data for patients undergoing ESS from 2016 to 2022 within our health care system. Overall, among 8157 ESS patients, 15.9% and 22.1% received topical budesonide prescriptions within 30 or 180 days postoperatively, respectively. On a year-over-year basis, budesonide prescription frequency increased significantly over time, culminating at 20.3% and 24.9% in 2022. Conversely, postoperative oral corticosteroid (OCS) prescriptions showed a decreasing frequency over the same time period (P < .001). Our results show topical budesonide irrigations are increasingly frequently prescribed after ESS and may offset postoperative OCS requirements. This argues for coverage of topical budesonide as a formulary medication after ESS.

Prediction of Effectiveness and Toxicities of Immune Checkpoint Inhibitors Using Real-World Patient Data.

PURPOSE: Although immune checkpoint inhibitors (ICIs) have improved outcomes in certain patients with cancer, they can also cause life-threatening immunotoxicities. Predicting immunotoxicity risks alongside response could provide a personalized risk-benefit profile, inform therapeutic decision making, and improve clinical trial cohort selection. We aimed to build a machine learning (ML) framework using routine electronic health record (EHR) data to predict hepatitis, colitis, pneumonitis, and 1-year overall survival. METHODS: Real-world EHR data of more than 2,200 patients treated with ICI through December 31, 2018, were used to develop predictive models. Using a prediction time point of ICI initiation, a 1-year prediction time window was applied to create binary labels for the four outcomes for each patient. Feature engineering involved aggregating laboratory measurements over appropriate time windows (60-365 days). Patients were randomly partitioned into training (80%) and test (20%) sets. Random forest classifiers were developed using a rigorous model development framework. RESULTS: The patient cohort had a median age of 63 years and was 61.8% male. Patients predominantly had melanoma (37.8%), lung cancer (27.3%), or genitourinary cancer (16.4%). They were treated with PD-1 (60.4%), PD-L1 (9.0%), and CTLA-4 (19.7%) ICIs. Our models demonstrate reasonably strong performance, with AUCs of 0.739, 0.729, 0.755, and 0.752 for the pneumonitis, hepatitis, colitis, and 1-year overall survival models, respectively. Each model relies on an outcome-specific feature set, though some features are shared among models. CONCLUSION: To our knowledge, this is the first ML solution that assesses individual ICI risk-benefit profiles based predominantly on routine structured EHR data. As such, use of our ML solution will not require additional data collection or documentation in the clinic.

Surgical Navigation in the Anterior Skull Base Using 3-Dimensional Endoscopy and Surface Reconstruction.

Importance: Image guidance is an important adjunct for endoscopic sinus and skull base surgery. However, current systems require bulky external tracking equipment, and their use can interrupt efficient surgical workflow. Objective: To evaluate a trackerless surgical navigation system using 3-dimensional (3D) endoscopy and simultaneous localization and mapping (SLAM) algorithms in the anterior skull base. Design, Setting, and Participants: This interventional deceased donor cohort study and retrospective clinical case study was conducted at a tertiary academic medical center with human deceased donor specimens and a patient with anterior skull base pathology. Exposures: Participants underwent endoscopic endonasal transsphenoidal dissection and surface model reconstruction from stereoscopic video with registration to volumetric models segmented from computed tomography (CT) and magnetic resonance imaging. Main Outcomes and Measures: To assess the fidelity of surface model reconstruction and accuracy of surgical navigation and surface-CT model coregistration, 3 metrics were calculated: reconstruction error, registration error, and localization error. Results: In deceased donor models (n = 9), high-fidelity surface models of the posterior wall of the sphenoid sinus were reconstructed from stereoscopic video and coregistered to corresponding volumetric CT models. The mean (SD; range) reconstruction, registration, and localization errors were 0.60 (0.24; 0.36-0.93), 1.11 (0.49; 0.71-1.56) and 1.01 (0.17; 0.78-1.25) mm, respectively. In a clinical case study of a patient who underwent a 3D endoscopic endonasal transsphenoidal resection of a tubercular meningioma, a high-fidelity surface model of the posterior wall of the sphenoid was reconstructed from intraoperative stereoscopic video and coregistered to a volumetric preoperative fused CT magnetic resonance imaging model with a root-mean-square error of 1.38 mm. Conclusions and Relevance: The results of this study suggest that SLAM algorithm-based endoscopic endonasal surgery navigation is a novel, accurate, and trackerless approach to surgical navigation that uses 3D endoscopy and SLAM-based algorithms in lieu of conventional optical or electromagnetic tracking. While multiple challenges remain before clinical readiness, a SLAM algorithm-based endoscopic endonasal surgery navigation system has the potential to improve surgical efficiency, economy of motion, and safety.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2022.

Objective: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022. Data Sources: Publicly available FDA data on drugs and devices approved in 2022. Review Methods: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery's (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis. Conclusion: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic. Implications for Practice: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.

Content and Readability of US Procedure Consent Forms.

This qualitative study uses data from the American Hospital Association National Survey Database to analyze the content and readability of a sample of US procedures consent forms.

Local cytokine levels associate with SNOT-22 and UPSIT scores in chronic rhinosinusitis.

KEY POINTS: Elevated IL-5, IL-13, IL-33, and CCL2 correlate with lower UPSIT scores in CRS and AERD patients. Elevated IL-5, IL-13, TNF-α, CCL2, and CXCL-8 correlate with higher SNOT-22 scores in CRS and AERD patients.

Not just snot: Local inflammatory profiles in patients with aspirin-exacerbated respiratory disease differ from patients with aspirin-tolerant chronic rhinosinusitis.

KEY POINTS: IL-5, CCL2, and CXCL8 in sinus mucous are higher in patients with AERD relative to aspirin-tolerant patients with CRS These mediators are pleiotropic, leading to widescale inflammatory processes contributing to AERD AERD is not only a T2 disease but heterogeneous: this may explain the refractory nature of AERD.

Neck scar perception after neck dissection in HPV-associated oropharyngeal squamous cell carcinoma.

IMPORTANCE: While there has been an increased understanding of the impact of visible neck scars in some patients with certain diseases, this has not yet been explored in the HPV+ OPSCC population. OBJECTIVE: To understand patients' perception of their scar and the impact on their quality of life (QOL) at least 6 months after neck dissection (ND) for HPV+ oropharyngeal squamous cell carcinoma (OPSCC). DESIGN, SETTING, AND PARTICIPANTS: In this retrospective case-control study, patients who underwent primary transoral robotic surgery (TORS) and ND for HPV+ OPSCC between 2016 and 2021 at a single tertiary care center were identified. Data analysis was performed in January 2022. MAIN OUTCOMES AND MEASURES: Dermatology Life Quality Index was modified (mDLQI) to assess patients' perceptions of their scars. The primary outcome was the mean mDLQI survey score with higher scores corresponding to worse perceptions. Three questions adapted from the Self-Consciousness Scale (SCS) were also included to assess awareness of appearance. All questions were scaled on a 0-3 Likert Scale. Tweedie generalized linear model was used to understand the relationship between mDLQI score and patient- and procedure-specific factors (including the three SCS survey questions). An additional exploratory logistic regression was performed to understand the risk factors for clinically significant mDLQI score change. RESULTS: A total of 67 patients (response rate 57 %) completed the survey with a mean mDLQI survey score of 0.84 (max 30). Although there was a statistically significant negative association between private insurance and mDLQI survey score (95 % Confidence Interval [CI]: -2.72 - -0.38), and a positive association between the SCS score and mDLQI survey score (95 % CI: 0.23-0.81) (p < 0.05), these variables were not found to be risk factors for a clinically significant difference in mDLQI on multivariable analysis. CONCLUSION: The majority of patients felt their neck scars did not interfere with their daily lives. Patient perceptions of neck scars were consistent despite differing patient characteristics and treatment regimens.

The Impact of Ambient and Wildfire Air Pollution on Rhinosinusitis and Olfactory Dysfunction.

PURPOSE OF REVIEW: With increasing industrialization, exposure to ambient and wildfire air pollution is projected to increase, necessitating further research to elucidate the complex relationship between exposure and sinonasal disease. This review aims to summarize the role of ambient and wildfire air pollution in chronic rhinosinusitis (CRS) and olfactory dysfunction and provide a perspective on gaps in the literature. RECENT FINDINGS: Based on an emerging body of evidence, exposure to ambient air pollutants is correlated with the development of chronic rhinosinusitis in healthy individuals and increased symptom severity in CRS patients. Studies have also found a robust relationship between long-term exposure to ambient air pollutants and olfactory dysfunction. Ambient air pollution exposure is increasingly recognized to impact the development and sequelae of sinonasal pathophysiology. Given the rising number of wildfire events and worsening impacts of climate change, further study of the impact of wildfire-related air pollution is a crucial emerging field.

Risk of inpatient epistaxis admission related to oral anticoagulation medication use.

We utilized a case control study to determine if novel oral anticoagulants were associated with a higher risk of inpatient epistaxis admission. Adult patients admitted with a principal diagnosis of epistaxis in 2019-2021 were identified as well as a control group of patients matched 1:1 for age, sex, race, and medical comorbidities. For both cohorts, the presence or absence of an oral anticoagulant, classified as vitamin K inhibitors, direct oral anticoagulants (DOAC) or platelet inhibitors, was identified. 158 adult unique inpatient admissions with a principal diagnosis of epistaxis were identified. Vitamin K inhibition was present in 5.7% of cases versus 0.6% of controls (p = 0.02; OR 9.48, range 1.19-75.77), DOACs in 4.4% of cases versus 5.1% of controls (p = 1.0) and platelet inhibitors in 2.5% of cases versus 3.8% of controls (p = 0.75). We concluded vitamin K inhibitors, compared to DOACs and platelet inhibitors, may be associated with higher likelihood of epistaxis admission.

Balance Disorder Trends in US Adults 2008-2016: Epidemiology and Functional Impact.

Objective: To quantify the changes in prevalence and impact of dizziness and balance disorders in adults from 2008 to 2016. Study Design: Epidemiological survey analysis. Setting: United States. Methods: The balance modules of the adult 2008 and 2016 National Health Interview Surveys were examined, and persons reporting dizziness or balance problems identified. The prevalence of balance problems was determined and compared over time, adjusting for age and sex. Among those with balance problems, associated symptoms and self-reported functional limitations were quantified and compared over time. Results: In 2016, 36.8 ± 1.0 million (15.5% ± 0.3%) adults reported a balance problem in the past year, versus 24.2 ± 0.7 million (11.% ± 0.3%) in 2008 (p < .001). After adjustment for age and sex, this percentage increase remained significant (odds ratio 1.435 [1.332-1.546], p < .001). Among those with balance problems, significantly more patients reported specific issues with feeling: off-balance (69.4% vs. 65.4%; p = .005), faint (48.5% vs. 40.3%; p < .001), or vertiginous (45.9% vs. 39.3%; p < .001) in 2016 than 2008. More adults experienced anxiety (29.4% vs. 19.4%; p < .001) and depression (16.3% vs. 12.9%; p = .002) with their balance problems in 2016 than in 2008. In 2016, adults with balance problems were limited in ability to drive motor vehicles (13.0%), exercise (14.4%), or walk downstairs (12.8%). These rates were not significantly different from 2008 (all p > .05). Conclusion: In this nationally representative analysis, we found a significantly increasing prevalence of balance problems and associated psychiatric symptom burden. This merits attention with respect to present and future health care resource allocation.

Smell and Taste Loss Associated with COVID-19 Infection.

OBJECTIVE: The aim of this study was to quantify the impact of COVID-19 on olfactory and gustatory function in US adults. METHODS: From the 2021 Adult National Health Interview Survey, demographic and survey-specific module data concerning COVID-19 diagnoses, testing and disease severity, and data quantifying disturbances and eventual recovery of smell and taste were extracted. Sample weights were applied to obtain nationally representative statistics. The overall rate of COVID-19 infection was determined, and those diagnosed with COVID-19 were analyzed with respect to disease severity, smell and taste disturbance, and respective recoveries. RESULTS: In 2021, 35.8 million or 14% of the adult population (95% CI 13.5-14.7%; mean age, 43.9 years; 53.8% female) had been diagnosed with COVID-19. Among those, 60.5% (58.6-62.5%) and 58.2% (56.2-60.1%) reported accompanying losses  in smell or taste, respectively; there was a significant association between overall COVID-19 symptom severity and smell (p < 0.001) and taste disturbance (p < 0.001). Following infection, 72.2% (69.9-74.3%), 24.1% (22.2-26.2%), and 3.7% (3.0-4.6%) of the patients experienced complete, partial, and no smell recovery, respectively. Recovery rates for gustatory function paralleled olfaction, with 76.8% (74.6-78.9%), 20.6% (18.7-22.7%), and 2.6 (1.9-3.4%) reporting complete, partial, and no recovery of taste, respectively. When sensory disturbance was present, severity of overall symptomatology was negatively associated with smell and taste recovery (p < 0.001 for each). CONCLUSION: The majority of adults infected with COVID-19 in 2021 experienced olfactory or gustatory dysfunction with a non-negligible population reporting incomplete or no near-term sensory recovery. Our results are useful for providers counseling patients and suggest that interventions lessening overall COVID-19 symptom burden may prevent prolonged sensory dysfunction. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2357-2361, 2023.

Rates of Antidepressant, Anxiolytic, and ADHD Medication Use Among Patients Undergoing ESS.

Patients with chronic rhinosinusitis (CRS) are estimated to have psychiatric comorbidity at a higher rate than the general population; however, self-report of depression diagnoses or symptoms often underestimates true prevalence in many populations. In the present study, a cohort of 2279 patients undergoing endoscopic sinus surgery (ESS) were matched to an equal number of non-CRS control subjects by age, sex, race and health status. Overall, the rate of antidepressant/anxiolytic utilization among ESS patients was 22.1%versus 11.3% for controls (P < .001, OR = 2.23, 95% CI 1.90-2.63). The rate of ADHD medication utilization among ESS patients was 3.6%versus 2.0% for controls (P = .001, OR = 1.85, 95% CI 1.28-2.68). This study suggests that patients undergoing ESS exhibit significantly higher rates of antidepressant and ADHD medication utilization relative to a matched control population.

Clinically meaningful changes in efficacy outcomes in chronic rhinosinusitis with nasal polyposis.

PURPOSE OF REVIEW: Chronic rhinosinusitis with nasal polyps (CRSwNP) carries a high disease burden, and many studies have been done investigating the efficacy of various medical and surgical therapies. However, outcome metrics have varied across these studies, making it difficult to compare therapeutic efficacy on a large scale. In this article, we discuss various outcome metrics used across prior studies as well as the relationship between these measures. RECENT FINDINGS: Outcome metrics in CRSwNP studies include both clinically assessed and patient-reported outcome measures (PROMs). The former includes olfaction testing, scoring systems based on imaging and endoscopic evaluation, and histopathological and immunohistochemical evaluation of sinus tissue, and the latter includes quality-of-life instruments, symptom severity scales, and disease-control instruments. Recent studies evaluating the efficacy of new biologics have used a combination of both types of metrics. SUMMARY: Both clinical metrics and patient-reported outcomes provide utility in evaluating disease severity and control in patients with CRSwNP, although there are nuances when comparing therapies in this population as patients with CRSwNP are heterogeneous and may have symptoms across several domains. However, PROMs in conjunction with clinical metrics provide useful information to assess patient symptoms and response to interventions.

The Role of Sialendoscopy in Parotid Duct Stenosis in Graft-Versus-Host Disease.

Sialendoscopy, a minimally invasive procedure for concurrent diagnosis and treatment of salivary gland ductal pathologies, was used to alleviate recurrent left parotid gland swelling and dry mouth in a 58-year-old man with chronic graft-versus-host disease. Laryngoscope, 133:279-281, 2023.

Cost-Effectiveness of Intraoperative CT Scanning in Cochlear Implantation in Fee-for-Service and Bundled Payment Models.

OBJECTIVE: Electrode array tip fold-over is a complication of cochlear implant surgery that results in poor hearing outcomes and often leads to revision surgery. However, tip fold-over can be corrected immediately if identified through intraoperative computed tomography, which also potentially provides information about final intracochlear positioning. Our objective was to provide the first economic analysis of intraoperative computed tomography by generating models in fee-for-service and bundled payment reimbursement structures of payer and institutional cost-effectiveness of this technology used in cochlear implantation over 1, 5, and 10-year time periods. METHODS: Cost data specific to a commerically available intraoperative computed tomography machine was obtained from the manufacturer, Xoran Technologies. Institutional tip fold-over rate was obtained from already published data. Medicare reimbursement rate for cochlear implantation was obtained from institutional accountants. Private payer reimbursement for and cost of revision cochlear implantation were estimated based on available data. RESULTS AND CONCLUSION: At large volume centers, cost-effectiveness of this technology is possible in both fee-for-service and bundled payment reimbursement structures at various time points dependent on payer mix. Even low volume cochlear implantation centers (<150 per year) can financially benefit from intraoperative computed tomography in bundled payment models at 5- and 10-year periods regardless of payer mix. This model demonstrates key factors at play in determining cost-effectiveness of this technology including institutional factors and payer type and suggests this technology can align incentives both to improve patient care and outcomes with institutional and payer financial well-being.

A Survey of Overlapping Surgery Policies at U.S. Hospitals.

The authors surveyed hospitals across the country on their policies regarding overlapping surgery, and found large variation between hospitals in how this practice is regulated. Specifically, institutions chose to define "critical portions" in a variety of ways, ultimately affecting not only surgical efficiency but also the autonomy of surgical trainees and patient experiences at these different hospitals.