Objective:Stated preference research methods, including discrete choice experiments (DCEs), conjoint analysis (CA), best-worst scaling (BWS), and willingness-to-pay/contingent valuation (WTP/CV) studies, are excellent tools for understanding patient preferences in healthcare. Their application in otolaryngology has yet to be described. This work encompasses a scoping review assessing the field of stated preference research in otolaryngology, to identify gaps in the current literature and identify areas of future applications of such methodologies. Data Sources:Embase, Medline, and Web of Science. Review Methods:A search of three databases for all relevant publications through 2023 was performed using relevant search terms. Eligibility criteria for included studies included the use of one of four methodologies (DCE, CA, BWS, and WTA/CV). After screening and full-text review by two authors, data were extracted, including relevant methodologic parameters including type of study, survey development characteristics, sample size, and outcome. Data were analyzed using descriptive statistics. Results:Of 3064 search results, 57 were included for full data extraction from inception to 2023, across 14 countries, with an increasing number of studies in recent years. WTP/CV was the most common method (58%), followed by DCE (30%), CA (23%), and BWS studies (5%). Otology was the most frequently studied subspeciality (36.8%). Treatment options were more commonly studied than diagnostics or health state preferences. Many studies did not specify survey development methods (38.6%). Conclusion:Stated preference research in otolaryngology is relatively sparse, and there is significant methodological inconsistency in the development and implementation of these methods. This review provides research priorities for stated preference research in otolaryngology in an era of patient-centered care. Level of Evidence:Level 4.
OBJECTIVE:This study aims to evaluate the influence of pre-treatment PET/CT imaging on survival outcomes in individuals with locally advanced head and neck squamous cell carcinoma (HNSCC) STUDY DESIGN: Secondary analysis of the Radiation Therapy Oncology Group 0522 trial. SETTING:Phase III randomized clinical trial with multi-institutional enrollment. METHODS:Of the 940 patients enrolled, 891 met inclusion criteria and were included in the analysis. Overall survival, locoregional failure, distant metastasis, and progression-free survival were assessed using Kaplan-Meier and cumulative incidence models. Subgroup analyses were performed based on primary cancer site and p16 status. RESULTS:Patients who underwent pre-treatment PET/CT had improved overall survival compared to those who did not in unadjusted analyses (unadjusted HR 0.77, 95% CI 0.6-0.98) but this difference was no longer significant after adjusting for demographic and clinical characteristics (adjusted HR 0.89, 95% CI 0.68-1.18). Improved survival was also observed in participants with p16-negative oropharyngeal, larynx, and hypopharynx carcinoma who underwent pre-treatment PET/CT (unadjusted HR 0.72, 95% CI 0.52-0.99) but significance was lost after adjustment (adjusted HR 0.82 95% CI 0.57-1.18). No significant differences were found in progression-free survival, locoregional failure or distant metastasis in the overall or subgroup analyses. CONCLUSION:Pre-treatment PET/CT imaging was not independently associated with improved survival outcomes in adjusted analyses. After adjustment, pre-treatment PET/CT did not independently influence survival outcomes.
Hospital mergers have increased significantly since 2010, driven by factors such as healthcare policy changes, reimbursement, economies of scale, and quality improvement goals. However, limited evidence exists about how these mergers affect the quality of care and cancer outcomes. We conducted a difference-in-differences analysis to assess the impact of hospital consolidation on cancer outcomes. Using data from the Surveillance, Epidemiology, and End Results (SEER) program, we identified cancer patients diagnosed between 2008 and 2016, then used the Health Cost Institute's Healthy Marketplace Index to assess hospital consolidation as measured by the Herfindahl-Hirschman Index (HHI). The HHI is a measure of market concentration and competition between firms in a given industry. We found that increases in hospital consolidation were associated with a higher likelihood of early-stage cancer diagnosis compared to control areas (-1.1%, 95% confidence interval (CI) -2.3 to 0.0%), and improved overall survival (hazard ratio 0.94, CI 0.90-0.98). These improvements were restricted to cancers with screening recommendations. Our study suggests that hospital consolidation may have some benefits for cancer patients. However, these benefits may not be evenly distributed across all cancer types. Further research is needed to confirm these findings and to understand the mechanisms by which hospital consolidation affects cancer outcomes.
OBJECTIVE:This study evaluates the impact of platinum-based neoadjuvant chemotherapy (NACT) on response rates (RR), overall survival (OS), disease-free survival (DFS), and adverse events (AE) in head and neck squamous cell carcinoma (HNSCC) to inform treatment strategies. DATA SOURCES:A comprehensive literature search was conducted across PubMed, Embase, and Cochrane databases to identify randomized controlled trials (RCTs) comparing NACT with upfront surgery. REVIEW METHODS:Search terms including variations of 'head and neck squamous cell carcinoma', 'neoadjuvant therapy', and 'randomized controlled trial' were used. Eligible RCTs were analyzed using a random-effects model RESULTS: Out of 6104 screened studies, 12 studies describing nine unique RCTs (n = 1601) were included. The pooled RR with NACT was 63 % (95 % CI: 46-78 %). Meta-analysis showed no significant differences in OS (HR 0.95, 95 % CI 0.82-1.11) or DFS (HR 0.87, 95 % CI 0.70-1.08) between the NACT and upfront surgery groups. However, NACT regimens comprised of a platinum and fluorouracil with or without a taxane (TPF/PF) showed a significant improvement in DFS (HR 0.76, 95 % CI 0.61-0.94) but not in OS (HR 0.86, 95 % CI 0.70-1.06). The estimated rate of grade 3-5 AEs following NACT was 31 % (95 % CI: 21-43 %). CONCLUSIONS:NACT did not significantly improve OS or DFS among all studies. However, TPF/PF regimens showed a significant DFS benefit, suggesting a potential advantage in using regimens for patients with HNSCC.
ObjectiveTo review current literature and guidelines on antiseptic surgical site preparations for preventing surgical site infections with consideration of contraindications specific to head and neck surgery.Data sourcesPubMed/MEDLINE, clinicaltrials.gov, accessdata.fda.gov, Manufacturer websites.Review methodsA scoping review on the literature and clinical studies comparing the efficacy of different surgical site preparations. Studies were included if they were a randomized controlled trial (RCT) comparing at least two commonly used and available antiseptic preparations. Additionally, a compilation of warnings and contraindications from manufacturer labels and articles are included. Due to the lack of randomized controlled trials concerning antiseptic preparation use in head and neck surgery specifically, an additional search was executed for articles not limited to randomized controlled trials that compared different antiseptic preparation used in surgeries concerning the head and neck.ResultsOf 56,983 resulting abstracts and 3798 of them being screened, 25 RCTs were included. These RCTs included a variety of surgeries including gastrointestinal, obstetric, gynecologic, orthopedic, and vascular procedures. When searching for abstracts concerning head and neck surgeries, 9 studies were found and included.ConclusionsTo reduce surgical site infections and avoid application in situations with contraindications, practicing surgeons need to be familiar with the existing literature regarding different surgical preparations and what warnings manufacturers have listed on the products. Optimal surgical site preparation for head and neck surgery is challenging as proximity to oxygen contraindicates newer alcohol-based options that are potentially flammable. We summarize evidence-based surgical site preparation for head and neck surgery.
BACKGROUND:Hematological markers, such as neutrophils (ANC), lymphocyte (ALC), and neutrophil-lymphocyte ratio (NLR), may serve as indicators of systemic inflammation and immune response in head and neck squamous cell carcinoma (HNSCC). However, their prognostic significance across HNSCC subtypes remains to be fully elucidated. METHODS:We conducted a secondary analysis of a randomized clinical trial involving patients with surgically resected HNSCC with either positive margins or extranodal extension. These patients received either adjuvant chemoradiation with or without lapatinib. We explored the correlation between pre-therapy ANC, ALC, and NLR levels and overall survival (OS) as well as disease-free survival (DFS). A sub-group analysis examined potential links between these markers, primary tumor location, and HPV status. RESULTS:Of the 688 patients in the trial, we included 681 patients with documented pre-therapy ANC and ALC values. High pre-therapy ANC and ALC were significantly associated with reduced OS (HR, 1.56; 95% CI: 1.19-2.05) and (HR, 1.34; 95% CI: 1.01-1.79), respectively. High NLR did not significantly affect OS (HR, 1.09; 95% CI: 0.81-1.47). Subgroup analysis indicated significantly reduced OS in patients with high ANC across oropharyngeal, non-oropharyngeal, and HPV-negative subtypes. High ANC, ALC, and NLR did not impact DFS notably. CONCLUSION:Elevated pre-therapy ANC is strongly associated with decreased survival across all patients and subgroups, ALC was only significant in the general patient analysis. NLR's association with reduced OS was not statistically significant. These biomarkers may provide greater prognostic value in patients with oropharyngeal cancer and seemed to be more strongly associated with OS than DFS. TRIAL REGISTRATION:Clinicaltrials.gov identifier: NCT00424255; URL: https://clinicaltrials.gov/ct2/show/study/NCT00424255.
PURPOSE Increasingly, states outsource administration of Medicaid insurance to privately administered Medicaid managed care organizations. However, on January 1, 2012, Connecticut transitioned from a privately to publicly administered Medicaid system. New Jersey retained a private model. METHODS Our objective was to assess rates of early-stage cancer diagnosis and cancer survival in two states with similar sociodemographic characteristics but differing exposures to Medicaid privatization. Using data from the SEER Program between 2007 and 2016, Connecticut and New Jersey Medicaid patients with 10 common solid cancers including breast, lung, colorectal, prostate, kidney, bladder, cervix, uterus, head and neck cancer, and melanoma were included. A difference-in-differences analysis of stage of cancer presentation and cancer survival in Connecticut (intervention) was compared with New Jersey (control). RESULTS Among 29,328 patients (14,424 patients from Connecticut and 14,904 patients from New Jersey) parallel trends were verified in early cancer diagnosis and survival for both states under privately administered Medicaid (pre-exposure). Connecticut's transition from privately to publicly administered Medicaid was associated with an adjusted 4.0% increase in overall early-stage cancer diagnosis (95% CI, +1.7% to +6.2%) and a 4.7% increase in early-stage cancer diagnosis for cancers with US Preventive Services Taskforce A/B recommendations for cancer screening (95% CI, 1.6% to 7.8%). Public administration of Medicaid was also associated with improved overall survival after cancer diagnosis (hazard ratio, 0.92 [95% CI, 0.85 to 0.99]). No changes were observed in New Jersey. CONCLUSION Transition from private to public administration of Medicaid in Connecticut was associated with earlier-stage cancer diagnosis and improved cancer survival.
To investigate air pollution's effect in the form of PM2.5 (particulate matter measuring less than 2.5 microns) on head and neck aerodigestive cancer incidence, an epidemiological cohort analysis was performed using data from the Surveillance Epidemiology and End Results national cancer database from the years 2002-2012. The relationship between US county mean PM2.5 levels and head and neck cancer (HNC) incidence rates were examined using a linear mixed model. Lagged effect of the pollutant's effect on HNC incidence was analyzed. Our results showed a significant association between the incidence of HNC and certain subtypes with PM2.5 exposure after controlling for demographic characteristics, smoking and alcohol use. We observed the highest association at a 5-year lag period (beta = 0.24, p value < 0.001). We observed significant associations at no lag (beta = 0.16, p value = 0.02) and up to a 20-year lag period (beta = 0.15, p value < 0.001). PM2.5 exposure is associated with an increased incidence of HNC, with the strongest association at a 5-year lag period. To better understand the relationships between exposure and cancer pathogenesis, further subgroup analysis is needed.
The persistent challenge of high pharmaceutical prices has led to the emergence of vertically integrated direct-to-consumer distributors like Mark Cuban Cost Plus Drug Company (MCCPDC). This study aims to evaluate a cost-saving alternative method for medication sourcing. The most frequently prescribed medications by otolaryngologists were identified through analysis of Medicare Part D data, utilizing prescriber type as a filter. Medications were assessed for availability on the MCCPDC website and drug form consistency. Cost analysis was conducted comparing current pharmaceutical spending against MCCPDC pricing. Potential otolaryngology-driven savings were estimated at $55.6 million and $1 billion if in effect across all specialties. Our findings suggest considerable potential savings for Medicare by purchasing generic medications at MCCPDC prices.
BackgroundSurvival outcomes are generally better for human papillomavirus-associated oropharyngeal squamous cell carcinoma (HPV+ OPSCC) than other forms of head and neck cancer. However, less is known about oncologic outcomes, late adverse events, and gastrostomy tube dependence associated with salvage surgery after the failure of definitive chemoradiation in patients with HPV+ OPSCC. MethodsA secondary analysis of the Radiation Therapy Oncology Group 1016 randomized trial, which compared radiotherapy plus cetuximab to radiotherapy plus cisplatin in patients with HPV+ OPSCC, was performed. The oncologic and adverse event outcomes for patients who underwent salvage surgery were examined. ResultsAmong the 805 patients who were assigned to treatment and were eligible for analysis, 198 developed treatment failure. Salvage surgery was required for 61 patients (7.6%), with 33 patients undergoing salvage surgery after locoregional failure (LRF) and 28 patients undergoing salvage neck dissection within the 20 weeks after treatment. Patients with LRF who underwent salvage surgery experienced improved overall survival in comparison with patients with LRF who did not undergo surgery (45% vs. 17% at 5 years after treatment; hazard ratio, 0.41; 95% confidence interval [CI], 0.23-0.74). Surgical salvage after LRF was associated with similar frequencies of late grade 3/4 dysphagia in comparison with LRF without surgery (24% [95% CI, 13%-41%] vs. 20% [95% CI, 12%-32%]; p = .64) and with similar gastrostomy tube dependence at 2 years (29% [95% CI, 15%-49%] vs. 13% [95% CI, 5%-28%]; p = .12). ConclusionsSalvage surgery in patients with HPV+ OPSCC is associated with favorable survival and adverse event outcomes.
BACKGROUND:Alcohol-based skin preparations were first approved for surgical use in 1998 and have since become standard in most surgical fields. The purpose of this report is to examine incidence of surgical fires because of alcohol-based skin preparation and to understand how approval and regulation of alcohol-based skin preparations impacted trends in fires over time. METHODS:We identified all reported surgical fires resulting in patient or staff harm from 1991 through 2020 reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. We examined incidence of fires because of these preparations, trends after approval and regulation, and common causes. RESULTS:We identified 674 reports of surgical fires resulting in harm to patients and surgical personnel, in which 84 involved an alcohol-based preparation. The time-adjusted model shows that from 1996 through 2006, there was a 26.4% increase in fires followed by a 9.7% decrease from 2007 to 2020. The decrease in fires was most rapid for head and neck and upper aerodigestive tract surgeries. Qualitative content analysis revealed improper surgical site preparation as well as close proximity of surgical sites to an oxygen source as the most common causes of fires. CONCLUSION:Since FDA approval, alcohol-based preparation solutions have been associated with a significant percentage of surgical fires. Warning label updates from 2006 to 2012 coupled with increased awareness efforts of associated risks of alcohol-based surgical solutions likely contributed to the decrease in fires. Improper surgical site preparation technique and close proximity of surgical sites to oxygen continue to be risk factors for fires. LEVEL OF EVIDENCE:4 Laryngoscope, 134:607-613, 2024.
The Centers for Disease Control and Prevention (CDC) recently published a 2022 guideline on opioid prescribing for acute, subacute, and chronic pain. This information is relevant to surgeons because many patients receive their first opioid prescription after surgery. When prescribing opioids, surgeons walk the line between benefit and harm. Many of the CDC recommendations mirror the AAO-HNS Clinical Practice Guideline: Opioid Prescribing for Analgesia After Common Otolaryngology Operations. For example, opioids are not recommended as first-line therapy for acute pain from otolaryngology-head, and neck surgery procedures. New insights include safeguards and strategies to mitigate the risk of complications in patients with chronic pain undergoing surgical procedures. Consultation with a pain specialist should be considered for patients transitioning from acute to chronic pain, cognizant of the risks of abrupt discontinuation of opioids in patients with opioid use disorder. This article summarizes key considerations for providing individualized, evidence-based perioperative pain management.
Importance:Clear surgical margins reduce the risk of local recurrence, improve survival, and determine decision-making with regard to adjuvant treatment of squamous cell carcinoma of the head and neck (SCCHN). However, the definitions of clear, close, or positive surgical margins vary in both the literature and in practice. Objective:To examine whether the association between surgical margin distance and survival varies by primary tumor site. Design, Setting, and Participants:This was a secondary analysis of a multi-institutional, multinational randomized clinical trial. The trial enrolled patients from January 22, 2007, to March 29, 2013, with stage II to IVA resected SCCHN with extranodal extension (ENE) or positive margins (<5 mm from invasive tumor to the resected margin). The current analysis included those patients with known ENE and margin status and was conducted from April 29, 2022, to December 19, 2022. Interventions:Patients received adjuvant chemoradiotherapy plus either placebo or lapatinib. Main Outcomes and Measures:Overall survival (OS) was calculated to examine association with surgical margin distance, primary site, and survival, with stratification by ENE status. Results:Among 688 patients enrolled in the trial, 630 patients with known ENE and margin status were included. Exact patient ages were not made available; 523 (83%) patients were male, and 415 (66%) patients were White. Patients with 1 high-risk feature (positive margins or ENE) had significantly better OS vs 2 high-risk features (hazard ratio [HR], 0.65; 95% CI, 0.49-0.87), although most other results were not statistically significant. For example, in the cohort with ENE-negative disease, multivariable adjusted analysis showed nonsignificant improvements with shorter surgical margin distance (1- to 5-mm margins), and no association with OS was found in the cohort with ENE-positive status (either >5 mm margins or 1-5 mm margins). The association between survival and margin distance varied based on primary site, human papillomavirus (HPV) status, and ENE status. For example, HPV-positive status was associated with a significant and clinically meaningful increase in survival (adjusted HR, 0.33; 95% CI, 0.11-0.97). The improvement was greatest, although not significantly so, in patients with ENE- and HPV-negative oropharynx (OP), hypopharynx (HP), and larynx cancer (HR, 0.57; 95% CI, 0.30-1.10). No survival benefit was seen in ENE-negative oral cavity cancer (HR, 0.89; 95% CI, 0.45-1.77), nor was an association observed between margins and OS in HPV-positive OP cancer. Conclusions and Relevance:In this secondary analysis of a randomized clinical trial, the presence of high-risk features (extranodal extension, positive margins, or both) was associated with worse survival; longer survival was observed with greater surgical margin distance among patients with oral cavity tumors and human papillomavirus-negative tumors of the OP, larynx, or HP. No other significant differences were found. These findings support variable interpretation of surgical margin distance based on the primary site and HPV status. Trial Registration:ClinicalTrials.gov Identifier: NCT00424255.
Background: Despite fire prevention protocols and perioperative staff training, surgical fires continue to cause patient harm, disability, and death.Methods: We identified surgical fires that were reported to the Food and Drug Administration's Manu-facturer and User Facility Device Experience database between 2000 and 2020 that resulted in patient or surgical personnel harm. Quantitative and descriptive content analyses were performed on free-text responses to identify contributing factors of surgical fire patient and personnel harm events.Results: We identified 565 surgical fire events resulting in patient or surgical personnel harm over a 20-year study period (median 25 events/year; range, 8-53). Surgical fires were significantly more likely to occur during upper aerodigestive tract (unadjusted odds ratio 15.96; 95% confidence interval, 11.93-21.34) and head and neck (unadjusted odds ratio 5.47; confidence interval 4.14-7.22) procedures compared with abdomen and pelvis procedures. Upper aerodigestive tract and head and neck procedures had the highest incidence of life-threatening injury (41% and 21%, respectively). An electrosurgical device was the ignition source in 82% of events. Content analysis revealed 7 common categories identified as root causes of surgical fires: preparation of surgical site (n = 55, 29%); device malfunction (n = 51, 26%), surgical accident (n = 47, 24%), medical judgement (n = 44 reports, 23%), equipment care and handling (n = 18, 9%), patient factors (n = 10, 5%), and communication (n = 3, 2%).Conclusion: Surgical fires resulting in harm to patient and surgical personnel continue to occur. The common themes identified in this study will prepare and empower surgeons and surgical personnel to prevent surgical fires in the future.(c) 2022 Elsevier Inc. All rights reserved.
Objectives: To evaluate the impact of oral cancer screening if applied to the United States (US) population or various high-risk populations in the US. Methods: We modeled the effects of applying an oral cancer screening program to the US population assuming a similar mortality reduction as seen in the randomized Kerala trial. We combined data on the incidence of oral cancer in the Surveillance, End Results, and Epidemiology database, data on the relative risk in various high-risk groups from the Prostate, Lung, Cervical, and Ovarian screening trial, and the National Lung Screening Trial and data on the prevalence of cigarette use from the National Health Interview Survey. Results: When extrapolating to the US population we predict the number needed to screen to prevent one oral cancer death (NNS) = 9,845 in all individuals aged 35 + . Screening efficiency would increase if applied to higher-risk populations. If oral cancer screening were applied to male >= 60 pack-year current smokers or former smokers who have quit within 15 years aged 50-79 we predict a 4.6% reduction in oral cancer mortality with an NNS = 1,485. Conclusions: Targeted screening of individuals at high risk for oral cancer has the potential to maximize the efficiency of screening and meaningfully impact oral cancer mortality. We suggest a future screening trial in high-risk individuals be considered to clarify the role of oral cancer screening in the US.
W. Edwards Deming, widely acknowledged as the Father of Quality Management, observed that “Uncontrolled variation is the enemy of quality” and much of the progress in improving the quality of patient care can be attributed to standardization (1). Yet few aspects of healthcare exhibit more global variation than the administration of opioids for head and neck cancer. For example, one study of pain management practices after major head and neck surgery found that 87% of American patients received opioids in contrast to <1% in Hong Kong (2). The United States’ (U.S.) outlier status in opioid prescribing behavior is well-documented (3), and these patterns might reflect not only different cultural perceptions but also different beliefs regarding the safety, efficacy, and risks of opioid medications (4).
This cohort study uses data from the Surveillance, Epidemiology, and End Results database to examine the association between changes in Medicaid dental insurance coverage in California between 2009 and 2014 and rates of localized oral cavity cancer diagnoses.