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Background: Health registries have become extremely powerful tools for cancer research. Unfortunately, certain details and the ability to adapt to new information are necessarily limited in current registries, and they cannot address many controversial issues in cancer management. This is of particular concern in differentiated thyroid cancer, which is rapidly increasing in incidence and has many unknowns related to optimal treatment and surveillance recommendations. Summary: In this study, we review different types of health registries used in cancer research in the United States, with a focus on their advantages and disadvantages as related to the study of thyroid cancer. This analysis includes population-based cancer registries, health systems-based cancer registries, and patient-based disease registries. It is important that clinicians understand the way data are collected in, as well as the composition of, these different registries in order to more critically interpret the clinical research that is conducted using that data. In an attempt to address shortcoming of current databases for thyroid cancer, we present the potential of an innovative web-based disease management tool for thyroid cancer called the Thyroid Cancer Care Collaborative (TCCC) to become a patient-based registry that can be used to evaluate and improve the quality of care delivered to patients with thyroid cancer as well as to answer questions that we have not been able to address with current databases and registries. Conclusion: A cancer registry that follows a specific patient, is integrated into physician workflow, and collects data across different treatment sites and different payers does not exist in the current fragmented system of healthcare in the United States. The TCCC offers physicians who treat thyroid cancer numerous time-saving and quality improvement services, and could significantly improve patient care. With rapid adoption across the nation, the TCCC could become a new paradigm for database research in thyroid cancer to improve our understanding of thyroid cancer management. [ABSTRACT FROM AUTHOR]

Background: The current systems of healthcare delivery in the United States suffer from problems that often leave patients with inadequate quality of care. In their report entitled 'Crossing the Quality Chasm,' the Institute of Medicine (IOM) identified reasons for poor and/or inconsistent quality of healthcare delivery and provided recommendations to improve it. The purpose of this review is to describe features of an innovative web-based program called the Thyroid Cancer Care Collaborative (TCCC) and see how it addresses IOM recommendations to improve the quality of healthcare delivery. Summary: The TCCC addresses the three actionable IOM recommendations directed at healthcare organizations and clinicians to redesign the care process. It does so by exploiting information technology (IT) in ways suggested by the IOM, and it fits within a set of 10 rules provided by the IOM. Some features of the TCCC include: (i) automated disease staging based on three validated scoring systems; (ii) highly illustrated educational videos on all aspects of thyroid cancer care; (iii) personalized clinical decision-making modules for clinicians and physicians; (iv) portability of data to share among treating physicians; (v) virtual tumor boards, 'ask the expert,' and frequently asked questions modules; (vi) physician workflow integration; and (vii) data for comprehensive analysis to answer difficult questions in thyroid cancer management. Conclusion: The TCCC has the potential to improve thyroid cancer care delivery and offers several benefits to patients, clinicians, and researchers. The TCCC is a valuable example of how IOM initiatives can improve the healthcare system. [ABSTRACT FROM AUTHOR]

Objectives: To characterize the representation of women in clinical trials directing the National Comprehensive Cancer Network (NCCN) guidelines for chemotherapy use in head and neck squamous cell carcinoma (HNSCC), as well as the relationship between gender and chemotherapy administration in the definitive treatment of HNSCC in the United States.Methods: A review of all HNSCC chemotherapy clinical trials cited by the 2018 NCCN guidelines was performed. Sex-based proportions were compared with the corresponding proportions in the general U.S. population of patients with HNSCC between 1985 and 2015, derived from the Surveillance, Epidemiology, and End Results (SEER) program. A second analysis using the National Cancer Database (NCDB), identified 63,544 adult patients diagnosed with stages III-IVB HNSCC between 2004 and 2014 and treated with definitive radiotherapy or chemoradiotherapy. Univariable and multivariable logistic regression analyses were used to identify predictors of chemotherapy administration.Results: While women comprised 26.2% of U.S. patients with HNSCC between 1985 and 2015, they comprised only 17.0% of patients analyzed in U.S. NCCN-cited chemotherapy clinical trials between 1985 and 2017. On multivariable analysis, women had decreased odds of receiving chemotherapy (Odds Ratio [OR]: 0.875; 95% Confidence Interval [CI]: 0.821-0.931; p < 0.001).Conclusion: Women are underrepresented in HNSCC chemotherapy clinical trials cited by the national guidelines. Additionally, women are less likely than men to receive definitive chemoradiotherapy as oppose to definitive radiotherapy. Reasons for these disparities warrant further investigation as well as re-evaluation of eligibility criteria and enrollment strategies, in order to improve relevance of clinical trials to women with HNSCC. [ABSTRACT FROM AUTHOR]

Objective: Characterizing factors associated with palliative care (PC) use in patients with stage III and VI head and neck cancer using Anderson's behavioral model of health service use., Study Design: A retrospective study of the 2004 to 2020 National Cancer Database.gg METHODS: We used multivariate logistic regression to assess the association of predisposing, enabling, and need factors with PC use. We also investigated the association of these factors with interventional PC type (chemotherapy, radiotherapy, surgery) and refusal of curative treatment in the last 6 months of life., Results: Five percent of patients received PC. "Predisposing factors" associated with less PC use include Hispanic ethnicity (adjusted odds ratio [aOR], 086; 95% confidence interval [CI], 0.76-0.97) and white and black race (vs white: aOR, 1.14; 95% CI, 1.07-1.22). "Enabling factors" associated with lower PC include private insurance (vs uninsured: aOR, 064; 95% CI, 0.53-0.77) and high-income (aOR, 078; 95% CI, 0.71-0.85). "Need factors" associated with higher PC use include stage IV (vs stage III cancer: aOR, 2.25; 95% CI, 2.11-2.40) and higher comorbidity index (vs Index 1: aOR, 1.58; 95% CI, 1.42-1.75). High-income (aOR, 0.78; 95% CI, 0.71-0.85) and private insurance (aOR, 0.6; 95% CI, 0.53, 0.77) were associated with higher interventional PC use and lower curative treatment refusal (insurance: aOR, 0.82; 95% CI, 0.55, 0.67; income aOR, 0.48; 95% CI, 0.44, 0.52)., Conclusion: Low PC uptake is attributed to patients' race/culture, financial capabilities, and disease severity. Culturally informed counseling, clear guidelines on PC indication, and increasing financial accessibility of PC may increase timely and appropriate use of this service., (© 2024 American Academy of Otolaryngology–Head and Neck Surgery Foundation.)

Objective(s): Describe recent national trends in overall treatment modalities for T1 glottic squamous cell carcinomas (SCC), and identify factors associated with treatment regimens., Methods: National Cancer Database from 2004-2020 was queried for all patients with glottic cT1N0M0 SCC. Treatment patterns over time were analyzed using the Cochran-Armitage test for trend. Multivariable logistic regressions were used to determine the factors associated with treatment regimens., Results: Of the 22,414 patients identified, most patients received RT only (57%), 21% received surgery only, and 22% received dual-modality treatment ("over-treatment"). Over the time period, there was a decreasing trend in rates of over-treatment for T1 glottic SCC (p < 0.001) and an increasing trend in surgery only (p < 0.001). Treatment in 2016-2018 (OR: 1.168 [1.004 to 1.359]), 2013-2015 (OR: 1.419 [1.221 to 1.648]), 2010-2012 (OR: 1.611 [1.388 to 1.871]), 2007-2009 (OR: 1.682 [1.450 to 1.951]), or 2004-2006 (OR: 1.795 [1.548 to 2.081]) versus 2019-2020 was associated with greater likelihood of over-treatment. T1b tumors were less likely to be over-treated (OR: 0.795 [0.707 to 0.894]) versus T1a tumors, and less likely to receive surgery first (OR: 0.536 [0.485 to 0.592]) versus T1a tumors., Conclusion: Over-treatment for T1 glottic SCC has been declining, with increasing rates of surgery only. Year of treatment was significantly associated with the receipt of dual-modality treatment. Finally, patients with T1b disease were more likely to receive RT as the first and only treatment., Level of Evidence: 3 Laryngoscope, 134:3633-3644, 2024., (© 2024 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives: To describe disease characteristics and treatment and to analyze survival and mortality for extranodal mantle cell lymphoma (MCL) of the head and neck., Methods: Patients with extranodal MCL-excluding primary sites in the salivary glands, eye, and adnexa-were identified from the Surveillance, Epidemiology, and End Results (SEER) 18 Registries (2000-2015). Overall survival (OS) and cumulative incidence of MCL and non-MCL mortality were calculated. Factors associated with MCL and non-MCL mortality were analyzed with cause-specific hazard models., Results: Five hundred nine patients met criteria for descriptive analysis and 294 patients met criteria for survival analysis, with a median follow-up of 58 months. The most common sites for MCL were the oropharynx (66.0%), nasopharynx (19.1%), and oral cavity (8.4%). The most common treatment received was chemotherapy alone (48.9%), followed by chemoradiation therapy (16.9%), and radiation therapy alone (10.4%). The proportion of cases diagnosed as early-stage disease ranged from 31% of sinonasal MCLs to 83% of laryngeal MCLs. At 5 years, OS was 63% (95% CI: 57%-69%). There was no significant difference in OS ( P  = .79), cumulative incidence of MCL mortality ( P  = .76), or cumulative incidence of non-MCL mortality ( P  = .98) by anatomic site. Comparing early-stage to late-stage disease, there was no significant difference in OS ( P  = .38), cumulative incidence of MCL mortality ( P  = .07), or cumulative incidence of non-MCL mortality ( P  = .14). Multivariate analysis showed increased hazard of MCL mortality for patients that were older or that presented with stage III or stage IV disease., Conclusion: The oropharynx is the most common subsite of head and neck MCLs, followed by the nasopharynx. Primary head and neck MCLs appear to present at an earlier stage than MCLs of other regions. In particular, laryngeal and hypopharyngeal MCLs may present as stage I or II disease.

Objective: To assess knowledge regarding head and neck cancers (HNCs) in 2020, factors associated with knowledge of the role of human papillomavirus (HPV) in HNCs, and factors associated with exposure to Oral, Head and Neck Cancer Awareness Week (OHANCAW)., Study Design: Cross-sectional survey., Setting: Online., Methods: The survey was distributed to 517 participants via a paid panel and utilized US Census-built quotas to represent the US population., Results: Participants surpassed 50% awareness rates in only 5 of 10 (50.0%), 2 of 6 (33.3%), and 5 of 9 (55.5%) preselected answer choices for subsites, risk factors, and signs/symptoms of HNCs, respectively. Knowledge of HPV's role in oropharyngeal cancer was also low, at 30.6%. However, of the controlled variables, exposure to OHANCAW was closely associated with knowledge of HPV's role in HNC (odds ratio, 10.25; 95% CI, 5.36-19.62). Women and elderly individuals were less likely to be exposed to OHANCAW, while those with higher education, those who drink heavily (>4 drinks/d), and current but not former tobacco users were more likely to be exposed., Conclusions: Knowledge of HNCs and the causal role of HPV remains suboptimal, though our results suggest that OHANCAW remains a viable educational pathway. However, certain at-risk populations, such as former smokers and older individuals, whom we may not be effectively reaching and screening, represent a priority for future outreach efforts.

Objective: To describe malpractice payments made on behalf of otolaryngologists, analyze trends over time, and test the association of payment amount with severity of alleged malpractice and patient age., Study Design: Retrospective cross-sectional analysis., Setting: National Practitioner Data Bank., Subjects and Methods: This study comprised all payments made on behalf of otolaryngologists from 1991 to 2018 that were reported to the National Practitioner Data Bank. Descriptive statistics were calculated within and across years. Trends in payments were analyzed with the Mann-Kendall test. Generalized linear regression was utilized to test for association of payment amount with severity of the alleged injury and patient age., Results: From 1991 to 2018, there was a significant decrease in the number of payments (272 to 81) and number of otolaryngologists on whose behalf payments were made (250 to 77). Mean and median payments increased significantly from $248,848 to $420,386 and from $96,813 to $275,000, respectively. By severity of alleged injury, mean payments ranged from $39,755 (95% CI, $20,957-$75,412) for insignificant injury to $754,349 (95% CI, $624,847-$910,692) for patients who were left quadriplegic, sustained brain damage, or required lifelong care. By patient age, mean payments for patients ≥60 years old were $191,465 (95% CI, $159,880-$229,292) versus $247,878 (95% CI, $209,416-$293,402) for patients aged 20 to 39 years and $232,225 (95% CI, $197,691-$272,793) for patients aged 40 to 59 years., Conclusion: The annual number and total value of malpractice payments decreased, while the annual mean and median payments increased. Payment amount was associated with severity of alleged malpractice and patient age.

Background: In the past two decades, new evidence and guidelines have emerged to refine recommendations for the use of radioactive iodine (RAI) therapy after thyroidectomy for cancer. We aim to describe national trends in RAI utilization, assess the impact of individual hospitals on RAI utilization, and examine whether variation in prescribing habits has declined over time. Methods: The National Cancer Database (NCDB) was queried from 2004 to 2016 for patients with papillary thyroid cancer (PTC) who received total thyroidectomy. Trends were analyzed using Joinpoint analysis. Hospital-specific effects and variation in prescribing habits were assessed through a hierarchical, mixed regression model. Results: RAI utilization declined from 61.0% in 2004 to 43.9% in 2016. RAI use declined most profoundly in patients with T1a, N0/X, M0 PTC without extrathyroidal extension (34.8% in 2004 to 9.5% in 2015), but continues to be used commonly in patients with advanced disease for whom it is routinely recommended (73.4% in 2004 to 72.0% in 2015). Furthermore, ∼80% of hospitals in 2016 utilized at or below the median utilization rate in 2006. Variation in RAI utilization across hospitals decreased by ∼50% from 2004 to 2016 (Levene's test p  < 0.001), with a significant decline ( p  = 0.002) in the variation after 2012 (confidence interval: 2010 to 2014). Conclusions: Recommendations for whom to prescribe RAI appear to have impacted both the number of patients receiving RAI and the variation in prescribing habits across hospitals. Hospital selection has contributed less to the probability of receiving RAI over time.

Objective: We aimed to evaluate trends and outcomes of surgical approaches to thyroid surgery. We hypothesized that there have been changes over time in the utilization of approaches to thyroidectomy, including endoscopic, robotic, and open approaches, and that patient outcomes may differ between open surgery and endoscopic or robotic approaches., Study Design: Retrospective analysis., Setting: The National Cancer Database (NCDB) was queried between 2010 and 2016., Subjects and Methods: National cohort of patients. Descriptive statistics were performed using χ 2 test, Mann-Whitney U test, t test and analysis of variance. To investigate complication rates, patient matching was performed with subsequent analysis using simple and multivariable logistic regressions., Results: We identified 217,938 patients within the NCDB. While endoscopic thyroid surgery increased, relatively, in use over time (0.93% to 2.34% of cases in 2010 and 2016, respectively), robotic thyroid surgery started to decline relatively to other approaches from 2013 to 2016 (0.39% to 0.25% of cases, respectively). The endoscopic approach was performed more commonly than the robotic approach within individual facilities that have reported both procedures ( P = .025). Robotic thyroid surgery was associated with increased risk of positive margins ( P = .046), while endoscopic thyroid surgery was associated with a higher rate of unplanned hospital readmission (OR, 1.55; 95% CI, 1.09-2.22), longer inpatient stays (OR, 1.55; 95% CI, 1.19-2.02), and higher 90-day postoperative mortality (OR, 4.45; 95% CI, 1.58-12.6)., Conclusion: Endoscopic thyroid surgery has increased in utilization since 2004 but may have worse morbidity and mortality outcomes compared to open surgery.

Objective: To characterize industry research payments to otolaryngologists., Study Design: Cross-sectional retrospective analysis., Methods: We examined research payments made to otolaryngologists 2014 through 2017 included in the Open Payments Database. Trends in payment values over time were characterized and compared to other surgical specialties. Geographical and temporal trends in payments to specific principal investigators, along with the ties to specific companies, were analyzed., Results: Among surgical specialties, otolaryngology was the second lowest paid in terms of total compensation from industry for research per active U.S. physician. The median (mean) payment to otolaryngologists was $819 ($5,514), $548 ($3,083), $771 ($3,484), and $1,000 ($5,768) in 2014, 2015, 2016, and 2017, respectively. There was typically a higher mean and median payment per otolaryngologists in the Northeast, although significant differences between each region varied by year. The 40 most highly funded recipients had total compensation that was on average spread over 3.35 years of the database, 2.975 different companies, and 7.35 distinct scientific studies-all significantly higher compared to otolaryngologists with less funding., Conclusion: Research payments to otolaryngologists are concentrated in a small number of otolaryngologists; however, many of the most highly funded principal investigators worked on numerous studies with a variety of different companies over many years. Our characterization of the Open Payments Database over 4 years illustrates the depth of relationship between otolaryngology research and industry as well as raises awareness regarding the ease of connecting otolaryngologists to research payments., Level of Evidence: NA Laryngoscope, 130:314-320, 2020., (© 2019 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives: To determine national positive margin rates in transoral laser microsurgery, to compare patients with positive and negative margins, and to identify factors associated with positive margins., Study Design: Retrospective review of the National Cancer Database., Setting: Population based., Subjects/methods: Patients included those with TIS-T3 laryngeal squamous cell carcinoma (2004-2014). Univariable and multivariable logistic regression were used to identify predictors., Results: A total of 1959 patients met inclusion criteria. The national positive margin rate was 22.3%. Sixty-five percent of patients had T1 disease; 94.3% were N-negative; and 74.0% had glottic tumors. Fifty-eight percent of patients were treated at academic centers, and 60.6% were treated at facilities performing <2 cases per year. On multivariable analysis, factors associated with margin status included facility volume (odds ratio [95% CI]; in cases per year: 0.93 [0.89-0.97], P = .001), academic status (vs nonacademic; academic: 0.70 [0.54-0.90], P = .008), T-stage (vs T1; T2: 2.74 [2.05-3.65], T3: 5.53 [3.55-8.63], TIS: 0.59 [0.38-0.92], P < .001), and N-stage (vs N0; N1: 3.42 [1.79-6.54], N2: 2.01 [1.09-3.69], P < .001). Tumor subsite was not associated with margin status., Conclusion: The national positive margin rate for laryngeal laser surgery is 22%, which is concerning given the equivalent survival benefit offered by surgery and primary radiation and the increased likelihood of bimodal therapy in the situation of positive margins. Cases treated at nonacademic centers and those with lower caseloads had a higher likelihood of positive margins. There was a linear association between T-stage and likelihood of positive margins, with T3 tumors being 5 times as likely as T1 to yield positive margins. This study highlights the importance of proper patient selection for transoral laser microsurgery resections.

Objectives: To characterize cases of croup presenting to emergency departments (EDs) nationwide, analyze trends, and determine readmission rates., Methods: Retrospective review of the Nationwide Emergency Department Sample (2007-2014) and the National Hospital Ambulatory Medical Care Survey (2008-2015)., Results: Both databases provided similar descriptive statistics. Annual mean of 352,388 (weighted) cases in the National Emergency Department Sample (1.35% of ED cases). Average age and male:female ratio 2.50 years and 1.95:1, respectively. Peak incidence was in autumn (October = 13.7%) with troughs in the summer (July = 3.7%). 21.3% received nebulizers, <1% laryngoscopic or airway procedures, 75.1% steroids, and 13.3% antibiotics. Of the patients receiving antibiotics, 16.0% had isolated croup. 3.0% of cases were admitted to the hospital. No trend was identified in the incidence of croup, mean age, or antibiotic and steroid usage. Hospital admission rates decreased (4.0%-2.3%) and nebulizer usage increased (14.6%-27.5%; p < 0.05). 5% of patients represented repeat admissions (were seen within 72 h prior)., Conclusions: Croup imposes a significant burden on the ED. Although hospital admissions decreased, annual incidence in the ED remained stable. The majority of cases are in males less than three years old, and 5.0% of patients represented readmissions. Only three-quarters received glucocorticoids despite the proven benefits, including reducing readmission rates. Antibiotic usage was high, with a large number representing potential cases of inappropriate antibiotic use., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Objective: To associate pharmaceutical industry payments to brand-name prescriptions by otolaryngologists., Study Design: Retrospective cross-sectional analysis., Setting: Open Payments Database and the Medicare Part D Participant User File 2013-2016., Subjects and Methods: We identified otolaryngologists receiving nonresearch industry payments and prescribing to Medicare Part D recipients. Records were linked by physician name and state. The value of industry payments and the percentage of brand-name drugs prescribed per hospital referral region (HRR) were characterized as medians. Industry payments were correlated to the rate of brand-name prescription by Kendall's τ correlation. This was repeated at the individual physician level and stratified by payment type., Results: In total, 8167 otolaryngologists received a median of $434 (interquartile range, $138-$1278) in industry compensation over 11 (3-26) payments. Brand-name drugs made up a median of 12.9% (8.6%-18-4%) of each physician's drug claims. The number (τ = 0.05, P < .001) and dollar amount (τ = 0.04, P < .001) of industry payments were correlated with the rate of brand-name drug prescription at the individual physician level. The number of industry payments was also associated with the rate of brand-name prescription by HRR (τ = 0.14, P < .001), but the dollar amount was not. By HRR, food and beverage payments received by physicians were associated with the rate of brand-name drug prescription (τ = 0.04, P < .001), but travel and lodging payments were not., Conclusions: Industry financial transactions are associated with brand-name drug prescriptions in otolaryngologists, and these associations are stronger at the regional level than at the individual physician level. These correlations are of modest strength and should be interpreted cautiously by readers.

Objective: To characterize drug and device industry payments to otolaryngologists in 2017 and compare them with payments from 2014 to 2016., Study Design: Retrospective cross-sectional analysis., Setting: 2017 Open Payments Database., Subjects and Methods: We identified otolaryngologists in the Open Payments Database receiving nonresearch industry payments in 2017. We determined the total number and value of payments and the mean and median payments per compensated otolaryngologist. We characterized payments by census region, nature of payment, and sponsor subspecialty., Results: A total of 8131 otolaryngologists received 66,414 payments totaling to $11.2 million in industry compensation in 2017. This is decreased from $14.5 million in 2016. The mean and median payment per compensated otolaryngologist was $1383 ($10,459) and $159 ($64-$420), respectively. Of the total compensation, 85% was received by the top 10th percentile of otolaryngologists. Speaking fees accounted for $3.1 million (28% of total payments), and food and beverage was the most common payment type (57,691 payments; 87%). Consulting fees decreased by $1 million from 2016 to 2017, and ownership interests decreased by $1.2 million from 2016 to 2017. The south had the highest total compensation value ($4.2 million), while the west had the highest mean payment value ($1561). Rhinology accounted for the highest proportion of payments of all otolaryngology subspecialties at $3.9 million (34%)., Conclusion: Industry payments to otolaryngologists decreased to $11.2 million in 2017 from $14.5 million in 2016. Much of the decrease can be attributed to decreases in consulting fees and ownership payments. It is important that otolaryngologists remain aware of changes in industry funding with each release of the Open Payments Database.

Objectives: To compare long-term oncologic outcomes and adjuvant therapies for patients treated with transoral robotic surgery (TORS), nonrobotic surgery, or transoral laser microsurgery (TLM)., Study Design: A retrospective analysis of the National Cancer Database (2010-2014)., Methods: Patients with clinical tumor (T)1 and T2 oropharyngeal squamous cell carcinomas (OPSCC) were classified into those receiving TORS versus nonrobotic surgery versus TLM. Univariate and multivariate survival analyses were conducted with chi-square tests; Kaplan-Meier log-rank test; and Cox multivariate, logistic regression, and multinomial regression modeling., Results: We identified 2,224 OPSCC TORS patients; 6,697 nonrobotic surgery patients; and 333 TLM patients. The majority of patients were white males with a mean age of approximately 59 years. No significant difference was noted between the cohorts in tumor stage; however, TORS patients were more likely to have nodal (N)1 to N3 disease than nonrobotic surgery and TLM patients, respectively (69.8% vs. 62.0% vs. 59.7%, P < 0.001). TORS was associated with a lower likelihood of positive margins when compared to nonrobotic surgery, although not TLM (nonrobotic surgery: hazard ratio [HR] 1.51, P < 0.001, TLM: HR 1.13, P = 0.582). TORS was associated with lower likelihood of postsurgical chemoradiotherapy (TLM: HR 2.07, P < 0.001, nonrobotic surgery: 1.65, P < 0.001) but not adjuvant radiotherapy alone (TLM: HR 1.06, P = 0.569, nonrobotic surgery: 0.96, P = 0.655). On multivariate Cox analysis of overall survival, the use of TORS was not associated with increased survival (TLM: HR 1.31, P = 0.233, nonrobotic surgery: HR 1.12, P < 0.303)., Conclusion: The advantages of TORS for early-stage OPSCC may be a lower likelihood of postsurgical positive margins and subsequent need for adjuvant chemoradiotherapy., Level of Evidence: NA Laryngoscope, 129:1844-1855, 2019., (© 2018 The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: To characterize the association between industry payments and prescriptions of 2 brand-name proton-pump inhibitors (PPIs)., Study Design: Cross-sectional retrospective., Setting: Physicians nationwide., Subjects and Methods: We identified all physicians receiving industry payments for Dexilant and Nexium 2014-2015 from the Open Payments database. We linked this to records of prescriptions for PPIs paid for by Medicare Part D these same years and compared the proportion of prescriptions written for Dexilant and Nexium in industry-compensated vs nonindustry compensated physicians. The number and dollar amount of payments were associated with the rate of drug prescriptions., Results: We identified 254,452 physicians prescribing PPIs; 8586 and 2766 physicians received industry payments for Dexilant and Nexium, respectively. A total of 5052 of 7876 (64%) physicians compensated for Dexilant prescribed Dexilant vs 39,778 of 246,571 (16%) noncompensated physicians ( P < .001). For Nexium, 2525 of 2654 (95%) compensated physicians prescribed Nexium, compared to 123,913 of 252,067 (49%) noncompensated physicians. For both Dexilant and Nexium, there was a significant correlation between the number (ρ = 0.22, P < .001 and ρ = 0.12, P < .001) and dollar amount (ρ = 0.22, P < .001 and ρ = 0.13, P < .001) of payments and the percentage of prescriptions written for the compensated drug. Industry payments for Nexium remained associated with rate of prescription even after generic esomeprazole became available., Conclusion: Both the number and dollar amount of industry payments were associated with increased prescriptions for both Dexilant and Nexium. Although unable to show causality, this study suggests that industry payments may increase physician prescriptions of costly, brand-name drugs.

Objective: To characterize treatment delays in laryngeal cancer and associate delays with patient, tumor, and treatment factors and with overall survival., Methods: We identified 33,819 adults with laryngeal squamous cell carcinoma (LSCC) in the National Cancer Database from 2004 to 2013. We calculated durations of diagnosis-to-treatment initiation, surgery-to-adjuvant treatment, radiotherapy duration, total treatment package, and diagnosis-to-treatment end intervals. Delays were associated with patient, tumor, and treatment characteristics via multivariable logistic regression and with overall survival by Cox proportional hazards regression., Results: Median durations of diagnosis-to-treatment initiation, surgery-to-radiation initiation, radiation treatment, total treatment package, and diagnosis-to-treatment end were 28, 42, 48, 91, and 107 days in surgical patients; median durations of diagnosis-to-treatment initiation, radiation treatment, and diagnosis-to-treatment end were 33, 50, and 85 days in nonsurgical patients. Race and insurance status were linked to delays in most intervals. Academic and high-volume facilities had less delayed radiation treatment but increased delays in most other intervals. Delayed surgery-to-radiation and total treatment package intervals were associated with overall survival in surgical patients (hazard ratio [HR] = 1.15 [1.03-1.29], P = 0.015; HR = 1.16 [1.02-1.31], P = 0.025). Diagnosis-to-treatment initiation and diagnosis-to-treatment end intervals were associated with overall survival in nonsurgical patients (HR = 1.08 [1.02-1.14], P = 0.007; HR = 1.09 [1.03-1.16], P = 0.003, respectively) but not in surgical patients (HR = 0.96 [0.87-1.06] P = 0.440; HR = 1.13 [0.99-1.29], P = 0.062). Radiation delays were associated with overall survival in surgical and nonsurgical patients (HR = 1.21 [1.09-1.36], P = 0.001; HR = 1.37 [1.30-1.44], P < 0.001)., Conclusion: These durations can serve as national benchmarks. Delays could be considered quality indicators in LSCC., Level of Evidence: 2b Laryngoscope, 128:2751-2758, 2018., (© 2018 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives To characterize industry payments to otolaryngologists in 2016 versus 2014 and 2015. Study Design Cross-sectional retrospective analysis. Setting Open Payments Database. Subjects and Methods Using the Open Payments Database, we identified otolaryngologists receiving payments from industry sponsors from 2014 to 2016. We characterized the number and value of payments per physician overall and by census region, as well as by sponsor subspecialty and payment type. Study years were compared via analysis of variance and Kruskal-Wallis tests. Trends in payments to otolaryngologists were compared with trends in 21 other specialties. Results Payment to otolaryngologists increased 67% from 2014 to 2016-from $8.7 million in 2014 to $9.9 and $14.5 million in 2015 and 2016, respectively ( P < .001). While mean payment per compensated otolaryngologist increased ($1095, $1243, and $1834 in 2014, 2015, and 2016, respectively, P < .001), median payments stayed relatively constant ($169, $165, and $172), suggesting an increasingly unequal distribution. Much of the increase is accounted for by an increased number of payments for consulting fees and physician ownership. Most payments were made by companies specializing in rhinology. Otolaryngology received the lowest industry compensation per physician among the surgical specialties examined and lower compensation than most nonsurgical specialties. The increase in payments to otolaryngologists was proportionally greater than all but 1 of the other 21 specialties examined. Conclusions Industry compensation to otolaryngologists is increasing and increasingly unequal, although it is still less than that in most other specialties. In otolaryngology, the Open Payments Database has not decreased physician-industry relationships as intended.

Objective To characterize treatment times in salivary cancer; associate treatment times with patient, tumor, and treatment characteristics; and examine the association of treatment times and overall survival. Study Design Retrospective cohort. Setting Commission-on-Cancer Accredited Hospitals 2004-2013. Subjects and Methods In total, 5953 patients with salivary cancer included in the National Cancer Database were identified. For each treatment interval, patients in the fourth quartile ("prolonged") were compared to patients in the first and second quartiles ("not prolonged"). Patient, tumor, and treatment characteristics were associated with prolonged times via multivariable binary logistic regression. Prolongation of each interval was associated with overall survival via multivariable Cox proportional hazards regression, controlling for clinically relevant factors. Results Median durations for diagnosis-to-treatment initiation, surgery-to-radiation treatment (RT), RT duration, total treatment package, and diagnosis-to-treatment end were 31, 44, 47, 92, and 110 days, respectively. Race, insurance status, comorbidities, age, T and N stage, facility volume and location, and a facility care transition from diagnosis to initial treatment were associated with prolonged treatment time. Prolonged RT duration was associated with decreased overall survival (OS) (62% vs 75% 5-year OS, HR = 1.26 [95% confidence interval (CI), 1.09-1.47]; P = .002), but prolonged diagnosis-to-treatment initiation, surgery-to-RT, total treatment package, and diagnosis-to-treatment end intervals were not (70% vs 67% 5-year OS, HR = 1.11 [95% CI, 0.92-1.34], P = .284; 72% vs 68%, HR = 0.93 [95% CI, 0.79-1.09], P = .370; 70% vs 70%, HR = 1.00 [95% CI, 0.84-1.20], P = .974; 66% vs 71%, HR = 0.99 [95% CI, 0.84-1.18], P = .920, respectively). Conclusion The median durations identified here can serve as reference points. Radiation therapy duration is associated with overall survival in salivary cancer and could be considered a quality indicator.

Background: Evidence surrounding the effect of adjuvant treatment in salivary gland cancers is limited. The benefit of adding chemotherapy to adjuvant treatment is also of interest. We investigated the association of these treatments with survival and whether this differed by stage or the presence of adverse features., Methods: A retrospective study of adult salivary gland cancer cases diagnosed from 2004 to 2013 in the National Cancer Data Base (NCDB) was conducted., Results: Treatment with adjuvant radiotherapy was associated with improved survival for both patients with early-stage (hazard ratio [HR] 0.744; P = .004) and late-stage (HR 0.688; P < .001) disease with adverse features. Further addition of chemotherapy to the adjuvant treatment of patients with late-stage disease with adverse features was not associated with a survival benefit (HR 1.028; P = .705)., Conclusion: Adjuvant radiotherapy is associated with improved survival for patients with adverse features, regardless of stage. The addition of chemotherapy to the adjuvant treatment of patients with late-stage disease with adverse features is not associated with improved outcomes., (© 2018 Wiley Periodicals, Inc.)

Objective To characterize, describe, and compare nonresearch industry payments made to otolaryngologists in 2014 and 2015. Additionally, to describe industry payment variation within otolaryngology and among other surgical specialties. Study Design Retrospective cross-sectional database analysis. Setting Open Payments Database. Subjects and Methods Nonresearch payments made to US otolaryngologists were characterized and compared by payment amount, nature of payment, sponsor, and census region between 2014 and 2015. Payments in otolaryngology were compared with those in other surgical specialties. Results From 2014 to 2015, there was an increase in the number of compensated otolaryngologists (7903 vs 7946) and in the mean payment per compensated otolaryngologist ($1096 vs $1242), as well as a decrease in the median payment per compensated otolaryngologist ($169 vs $165, P = .274). Approximately 90% of total payments made in both years were attributed to food and beverage. Northeast census region otolaryngologists received the highest median payment in 2014 and 2015. Compared with other surgical specialists, otolaryngologists received the lowest mean payment in 2014 and 2015 and the second-lowest and lowest median payment in 2014 and 2015, respectively. Conclusion The increase in the mean payment and number of compensated otolaryngologists can be explained by normal annual variation, stronger industry-otolaryngologist relationships, or improved reporting; additional years of data and improved public awareness of the Sunshine Act will facilitate determining long-term trends. The large change in disparity between the mean and median from 2014 to 2015 suggests greater payment variation. Otolaryngologists continue to demonstrate limited industry ties when compared with other surgical specialists.

Objective After radiation failure for early T-stage larynx cancer, national guidelines recommend salvage surgery. Total laryngectomy and conservation laryngeal surgery with an open or endoscopic approach are both used. Beyond single-institution studies, there is a lack of evidence concerning the outcomes of these procedures. We aim to study whether treatment with conservation laryngeal surgery is associated with poorer outcomes than treatment with total laryngectomy as salvage surgery after radiation failure for T1/T2 larynx cancers. Study Design A retrospective study was conducted of adult squamous cell larynx cancer cases in the National Cancer Database diagnosed from 2004 to 2012. Setting Commission on Cancer cancer programs in the United States. Methods Demographic, facility, tumor, and survival variables were included in the analyses. Multivariate survival regressions as well as univariate Kaplan-Meier analyses were conducted. Results Slightly more than 7% of patients receiving radiotherapy for T1/T2 larynx cancers later received salvage surgery. Salvage with partial laryngectomy was not associated with diminished survival as compared with total laryngectomy. However, positive surgical margins were associated with worse outcomes (hazard ratio, 1.782; P = .001), and a larger percentage of patients receiving partial laryngectomy had positive margins than those receiving total laryngectomy. Facility characteristics were not associated with differences in salvage surgery type or outcomes. Conclusion In recognition of the inherent selection bias, patients who experienced recurrences after radiation for T1/T2 larynx cancer and underwent conservation salvage laryngeal surgery demonstrated clinical outcomes similar to those of patients undergoing salvage total laryngectomy. Increased rates of positive surgical margins were observed among patients undergoing salvage conservation surgery.

Objective To characterize the relationship between industry payments and use of paranasal sinus balloon catheter dilations (BCDs) for chronic rhinosinusitis. Study Design Cross-sectional analysis of Medicare B Public Use Files and Open Payments data. Setting Two national databases, 2013 to 2014. Subjects and Methods Physicians with Medicare claims with Current Procedural Terminology codes 31295 to 31297 were identified and cross-referenced with industry payments. Multivariate linear regression controlling for age, race, sex, and comorbidity in a physician's Medicare population was performed to identify associations between use of BCDs and industry payments. The final analysis included 334 physicians performing 31,506 procedures, each of whom performed at least 11 balloon dilation procedures. Results Of 334 physicians, 280 (83.8%) received 4392 industry payments in total. Wide variation in payments to physicians was noted (range, $43.29-$111,685.10). The median payment for food and beverage was $19.26 and that for speaker or consulting fees was $409.45. One payment was associated with an additional 3.05 BCDs (confidence interval [95% CI],1.65-4.45; P < .001). One payment for food and beverages was associated with 3.81 additional BCDs (95% CI, 2.13-5.49; P < .001), and 1 payment for speaker or consulting fees was associated with 5.49 additional BCDs (95% CI, 0.32-10.63; P = .04). Conclusion Payments by manufacturers of BCD devices were associated with increased use of BCD for chronic rhinosinusitis. On separate analyses, the number of payments for food and beverages as well as that for speaker and consulting fees was associated with increased BCD use. This study was cross-sectional and cannot prove causality, and several factors likely exist for the uptrend in BCD use.

Background: Treatment durations and factors associated with delays for oral cavity squamous cell carcinoma (SCC) have previously been described but are not fully understood. Impact of delays on overall survival (OS) remains unclear., Methods: The National Cancer Data Base (NCDB) was used to analyze 4868 patients with oral cavity SCC from 1998 to 2011. Diagnosis-to-surgery, surgery-to-radiotherapy (RT) start , RT duration, total treatment package (surgery-to-RT end ), and diagnosis-to-RT end were evaluated. Associations between delays and various factors were analyzed using binary logistic regression. Associations with OS were analyzed using the Cox proportional hazards model., Results: Medians for diagnosis-to-surgery, surgery-to-RT start , RT duration, total treatment package, and diagnosis-to-RT end were 30, 50, 49, 101, and 136 days, respectively. Age ≥60 years, uninsured or Medicaid insurance, comorbidity, late pT, and treatment at an academic/research institution were associated with diagnosis-to-surgery delays. Only delays in RT duration were significantly associated with decreased OS (hazard ratio [HR] = 1.21; p = .02)., Conclusion: Numerous factors are associated with treatment delays. RT duration is significantly associated with OS. © 2017 Wiley Periodicals, Inc. Head Neck 39: 639-646, 2017., (© 2017 Wiley Periodicals, Inc.)

Background: The current study was performed to characterize trends and survival outcomes for chemotherapy in the definitive and adjuvant treatment of hypopharyngeal cancer in the United States., Methods: A total of 16,248 adult patients diagnosed with primary hypopharyngeal cancer without distant metastases between 1998 and 2011 were identified in the National Cancer Data Base. The association between treatment modality and overall survival was analyzed using Kaplan-Meier survival curves and 5-year survival rates. A multivariate Cox regression analysis was performed on a subset of 3357 cases to determine the treatment modalities that predict improved survival when controlling for demographic and clinical factors., Results: There was a significant increase in the use of chemotherapy with radiotherapy both as definitive treatment (P<.001) and as adjuvant chemoradiotherapy with surgery (P=.001). This was accompanied by a decrease in total laryngectomy/pharyngectomy rates (P<.001). Chemoradiotherapy was associated with improved 5-year survival compared with radiotherapy alone in the definitive setting (31.8% vs 25.2%; log rank P<.001). Similarly, in multivariateanalysis, definitive radiotherapy was found to be associated with compromised survival compared with definitive chemoradiotherapy (hazard ratio, 1.51; P<.001)., Conclusions: Survival analysis revealed that overall 5-year survival rates were higher for chemoradiotherapy compared with radiotherapy alone in the definitive setting, but were comparable between surgery with chemoradiotherapy and surgery with radiotherapy. Cancer 2016;122:1853-60. © 2016 American Cancer Society., (© 2016 American Cancer Society.)

Objective: The dramatic increase in papillary thyroid carcinoma (PTC) is primarily a result of early diagnosis of small cancers. Active surveillance is a promising management strategy for papillary thyroid microcarcinomas (PTMCs). However, as this management strategy gains traction in the U.S., it is imperative that patients and clinicians be properly educated, patients be followed for life, and appropriate tools be identified to implement the strategy., Methods: We review previous active surveillance studies and the parameters used to identify patients who are good candidates for active surveillance. We also review some of the challenges to implementing active surveillance protocols in the U.S. and discuss how these might be addressed., Results: Trials of active surveillance support nonsurgical management as a viable and safe management strategy. However, numerous challenges exist, including the need for adherence to protocols, education of patients and physicians, and awareness of the impact of this strategy on patient psychology and quality of life. The Thyroid Cancer Care Collaborative (TCCC) is a portable record keeping system that can manage a mobile patient population undergoing active surveillance., Conclusion: With proper patient selection, organization, and patient support, active surveillance has the potential to be a long-term management strategy for select patients with PTMC. In order to address the challenges and opportunities for this approach to be successfully implemented in the U.S., it will be necessary to consider psychological and quality of life, cultural differences, and the patient's clinical status.

Objective: The US Food and Drug Administration (FDA) grants initial marketing clearance for novel high-risk medical devices via the premarket approval (PMA) pathway, which requires clinical data demonstrating safety and effectiveness. Manufacturers may subsequently file supplemental PMA applications (supplements) to implement incremental device changes, usually without additional clinical data. Given the potentially significant clinical implications of using new device models, this study characterized the frequency and nature of changes to high-risk therapeutic otolaryngic devices cleared via the PMA pathway., Study Design: Retrospective cohort study., Setting: FDA PMA database., Methods: Original high-risk therapeutic otolaryngic devices and supplements were identified. Supplements were characterized by clearance date, change type, and review track, including real-time (design-minor) and 180-day (design-major) tracks. Median device lineage life span (postmarket period over which changes occurred) and median number of changes per original device were calculated., Results: Through 2014, the FDA cleared 14 original high-risk therapeutic otolaryngic devices via the PMA pathway and 528 incremental changes via supplements. Devices were modified over a median 10.5-year life span (interquartile range, 4.4-15.8; range, 0.7-24.1), and they underwent a median 22 changes (interquartile range, 10-70; range, 2-108). Over half (272 of 528; 52%) altered device design, most of which were reviewed via the 180-day track (199 of 272; 73%) intended for major design changes. Few real-time design changes (11 of 73; 15%) were designated by the FDA as "minor.", Conclusion: A substantial number of incremental changes have been made to high-risk therapeutic otolaryngic devices over time, including many major design changes without supporting clinical data., (© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.)

Importance: Most patients with oral cavity squamous cell cancer (OCSCC) are initially seen at an early stage (I and II). Although patient and tumor prognostic features have been analyzed extensively, population-level data examining how variations in treatment factors impact survival are lacking to date., Objective: To analyze associations between treatment variables and survival in stages I and II oral cavity squamous cell carcinoma., Design, Setting, and Participants: Retrospective study of cases in the National Cancer Data Base. Patients diagnosed as having stage I or II OCSCC between January 1, 2003, and December 31, 2006, and treated with surgery were identified. Univariate and multivariable analyses of overall survival based on patient, disease, and treatment characteristics were conducted., Main Outcomes and Measures: Overall survival and survival at 5 years., Results: In total, 6830 patients were included. Survival at 5 years was 69.7% (4760 patients). On univariate analysis, treatment factors associated with improved survival included treatment at academic or research institutions, no radiation therapy, no chemotherapy, and negative margins (P < .001 for all). Neck dissection was associated with improved survival (P = .001), reflecting pathologic restaging and elimination of patients with occult nodal disease. Patients treated at academic or research institutions were more likely to receive neck dissection and less likely to receive radiation therapy or have positive margins. On multivariable analysis, neck dissection (hazard ratio [HR], 0.85; 95% CI, 0.76-0.94; P = .003) and treatment at academic or research institutions (HR, 0.88; 95% CI, 1.01-1.26; P = .03) were associated with improved survival, whereas positive margins (HR, 1.27; 95% CI, 1.08-1.49; P = .005), insurance through Medicare (HR, 1.45; 95% CI, 1.25-1.69; P < .001) or Medicaid (HR, 1.96; 95% CI, 1.60-2.39; P < .001), and adjuvant radiation therapy (HR, 1.31; 95% CI, 1.16-1.49; P < .001) or adjuvant chemotherapy (HR, 1.34; 95% CI, 1.03-1.75; P = .03) were associated with compromised survival., Conclusions and Relevance: Prognostic impacts of treatment factors in early OCSCC are presented. Overall survival for early OCSCC varies with demographic and tumor characteristics but also varies with treatment and system factors, which may represent targets for improving outcomes in this disease.

Objective: To characterize nonresearch payments made by industry to otolaryngologists in order to explore how the potential for conflicts of interests varies among otolaryngologists and compares between otolaryngologists and other surgical specialists., Study Design: Retrospective cross-sectional database analysis., Setting: Open Payments program database recently released by Centers for Medicare and Medicaid Services., Subjects: Surgeons nationwide who were identified as receiving nonresearch payment from industry in accordance with the Physician Payment Sunshine Act., Methods: The proportion of otolaryngologists receiving payment, the mean payment per otolaryngologist, and the standard deviation thereof were determined using the Open Payments database and compared to other surgical specialties. Otolaryngologists were further compared by specialization, census region, sponsor, and payment amount., Results: Less than half of otolaryngologists (48.1%) were reported as receiving payments over the study period, the second smallest proportion among surgical specialties. Otolaryngologists received the lowest mean payment per compensated individual ($573) compared to other surgical specialties. Although otolaryngology had the smallest variance in payment among surgical specialties (SD, $2806), the distribution was skewed by top earners; the top 10% of earners accounted for 87% ($2,199,254) of all payment to otolaryngologists. Otolaryngologists in the West census region were less likely to receive payments (38.6%, P < .001)., Conclusion: Over the study period, otolaryngologists appeared to have more limited financial ties with industry compared to other surgeons, though variation exists within otolaryngology. Further refinement of the Open Payments database is needed to explore differences between otolaryngologists and leverage payment information as a tool for self-regulation., (© American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.)

Objectives/hypothesis: Head and neck surgeons can be involved in the management of germ cell tumor (GCT) metastatic to the neck from initial diagnosis through postchemotherapy management of residual neck masses. This article reports on 34 consecutive patients with GCT metastatic to the neck., Study Design: Retrospective chart review., Methods: A single-institution retrospective chart review of 34 consecutive patients with GCT metastatic to the neck who underwent postchemotherapy neck surgery between 1991 and 2009 was performed., Results: Seventy-four percent of patients had a neck mass at initial diagnosis, with 50% of patients having a neck mass as the presenting symptom leading to a diagnosis of GCT. Of the 37 neck procedures, positive nodes were found in 22. No significant relationship between preoperative tumor markers and neck pathology (P = .35) was identified. No patients had neck recurrence. No patients had permanent nerve injury or chyle leak. As a secondary end point, survival analysis related to cervical pathology showed that viable tumor in the neck predicted disease-specific survival (P = .01). Five- and 10-year disease-specific survival was 82.3% (median, 52-month follow-up)., Conclusions: Operative management for patients with metastatic GCT to the neck can achieve long-term durable cervical control with limited complications., (Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.)

Objective: Hearing loss ranks high among disabilities in the United States. The epidemiologic parameters of hearing impairment in the United States have not been systematically studied and important historic data have not diffused to relevant stakeholders; even otolaryngologists are unfamiliar with epidemiologic data. We wished to compile known studies to establish an epidemiologic baseline beginning with pediatric data., Data Sources: Relevant literature was retrieved from medical databases and Centers for Disease Control and Prevention reports., Methods: Candidate articles and national data sets encompassing pediatric hearing loss were analyzed and compared. Whenever possible, group analyses were performed., Results: The average incidence of neonatal hearing loss in the United States is 1.1 per 1000 infants, with variation among states (0.22 to 3.61 per 1000). Childhood and adolescent prevalence rates demonstrate variability. The prevalence of mild hearing impairment or worse (>20 dB) is 3.1 percent based on the average of comparable audiometric screening studies; self-reporting prevalence is 1.9 percent. Hispanic Americans demonstrate a higher prevalence of hearing impairment than other children. Low-income households demonstrate a higher prevalence of hearing loss compared to households with higher income levels. Genetic causes were attributed to 23 percent across studies., Conclusions: Analysis of the data reveals gaps in our knowledge of the epidemiology of hearing loss and stresses the importance of consistent definitions of hearing impairment for systematic assessment of changes over time. Hearing loss in childhood deserves further epidemiologic investigation and elevated awareness among health care professionals and the public. Genetic etiologies are likely underestimated in this review.