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PURPOSE: The uninsured rate began rising after 2016, which some have attributed to health policies undermining aspects of the Affordable Care Act. Our primary objectives were to assess the changes in insurance coverage and forgoing medical care because of cost in cancer survivors from pre-enactment (2016) through postenactment of those policies (2019) and determine whether there were subgroups that were disproportionately affected. METHODS: The 2016-2019 Behavioral Risk Factor Surveillance System surveys were queried for 18- to 64-year-old cancer survivors. Survey-weighted logistic regression was used to assess temporal changes in (1) insurance coverage and (2) forgoing medical appointments because of cost in the preceding 12 months. RESULTS: A total of 62,669 cancer survivors were identified. The percentage of insured cancer survivors decreased from 92.4% in 2016 to 90.4% in 2019 (odds ratio for change in insurance coverage or affordability per one-year increase [ORyear], 0.92; 95% CI, 0.86 to 0.98; P = .01), translating to 161,000 fewer cancer survivors in the United States with insurance coverage. There were decreases in employer-sponsored insurance coverage (ORyear, 0.89) but increases in Medicaid coverage (ORyear, 1.17) from 2016 to 2019. Forgoing medical appointments because of cost increased from 17.9% in 2016 to 20.0% in 2019 (ORyear, 1.05; 95% CI, 1.01 to 1.1; P = .025), affecting an estimated 169,000 cancer survivors. The greatest changes were observed among individuals with low income, particularly those residing in nonexpansion states. CONCLUSION: Between 2016 and 2019, there were 161,000 fewer cancer survivors in the United States with insurance coverage, and 169,000 forwent medical care because of cost.

Background: Addressing patients’ social determinants of health is a national priority for cancer treatment centers. Transportation insecurity is one major challenge for patients undergoing active cancer treatment, and missing treatments can result in worse cancer treatment outcomes, including worse morbidity and mortality. How cancer treatment centers are addressing transportation insecurity is understudied. Methods: In January and February 2022, the NCCN Best Practices Committee conducted a survey of NCCN’s 31 Member Institutions (currently 32 member institutions as of April 2022) to assess how centers were addressing patient transportation insecurity: how they screen for transportation insecurity, coordinate transportation, and fund transportation initiatives, and their plans to address transportation insecurity in the future. Results: A total of 25 of 31 (81%) NCCN Member Institutions responded to the survey, of which 24 (96%) reported supporting the transportation needs of their patients through screening, coordinating, and/or funding transportation. Patients’ transportation needs were most often identified by social workers (96%), clinicians (83%), or patients self-declaring their needs (79%). Few centers (33%) used routine screening approaches (eg, universal screening of social risk factors) to systematically identify transportation needs, and 54% used the support of technology platforms or a vendor to coordinate transportation. Transportation was predominantly funded via some combination of philanthropy (88%), grants (63%), internal dollars (63%), and reimbursement from insurance companies (58%). Over the next 12 months, many centers were either going to continue their current transportation programs in their current state (60%) or expand existing programs (32%). Conclusions: Many NCCN Member Institutions are addressing the transportation needs of their patients. Current efforts are heterogeneous. Few centers have systematic, routine screening approaches, and funding relies on philanthropy more so than institutional dollars or reimbursement from insurers. Opportunities exist to establish more structured, scalable, and sustainable programs for patients’ transportation needs.

ImportanceOncologic treatment is costly to the health care system and to individuals, but patients with head and neck cancer (HNC) also have long-term care needs after treatment. Survivors of HNC require specific consideration given their rapidly growing numbers. This subpopulation of cancer survivors often experiences long-term treatment-associated morbidity.ObjectiveTo describe the total and out-of-pocket (OOP) costs associated with HNC survivorship and the risk factors for financial toxicity among this population.Design, Setting, and ParticipantsThis was a retrospective review and economic evaluation of a cohort of US adults with a diagnosis of HNC from 2006 to 2018. The study used data the from IBM MarketScan Commercial Claims Database. Data were analyzed from November 2020 to June 2022.ExposuresTreatment for HNC.Main Outcomes and MeasuresTotal and OOP medical costs were assessed monthly and reported relative to the date of HNC diagnosis. The primary outcome was the difference between a patient’s mean monthly survivorship costs (13-60 months after diagnosis) and mean monthly baseline costs (7-12 months before diagnosis). Univariate and multivariable linear regression models were created for total and OOP costs to generate coefficient estimates with 95% CIs.ResultsThe study cohort of this economic evaluation included 19 098 patients with HNC (median [range] age, 56 [18-64] years; 14 144 [74.1%] men and 4954 [25.9%] women; race and ethnicity were not considered). Throughout the survivorship period, median total and OOP costs were $372 per month and $31 per month higher than baseline costs, respectively, with variation in expenses by demographic information, health plan type, and oncologic variables. In the multivariable model, greater total and OOP excess survivorship costs were associated with female sex ($343/mo; 95% CI, $126 to $560 and $9/mo; 95% CI, $4 to $14). Highest and lowest total excess survivorship costs associated with cancer site were seen for hypopharyngeal ($1908/mo; 95% CI, $1102 to $2714) and oropharyngeal cancers (−$703/mo; 95% CI, −$967 to −$439) vs oral cavity cancers. Compared with surgery or radiation therapy alone, multimodal treatment was generally associated with excess OOP survivorship costs.Conclusions and RelevanceThe findings of this retrospective economic evaluation review suggest that the costs of HNC survivorship remain persistently elevated above baseline costs for at least 5 years after diagnosis. High survivorship costs were associated with female sex, hypopharyngeal tumors, and treatment with multimodal therapy. Practitioners should seek to minimize costs for these patients at higher-risk of financial toxicity after treatment and work to provide directed supportive services.

Health-care–related transportation insecurity is common in the United States. Patients with cancer are especially vulnerable because cancer care is episodic in nature, occurs over a prolonged period, is marked by frequent clinical encounters, requires intense treatments, and results in substantial financial hardship. As a result of transportation insecurity, patients with cancer may forego, miss, delay, alter, and/or prematurely terminate necessary care. Limited data suggest that these alterations in care have the potential to increase the rates of cancer recurrence and mortality and exacerbate disparities in cancer incidence, severity, and outcomes. Transportation insecurity also negatively impacts at the informal caregiver, provider, health system, and societal levels. Recognizing that transportation is a critical determinant of outcomes for patients with cancer, there are ongoing efforts to develop evidence-based protocols to identify at-risk patients and address transportation insecurity at federal policy, health system, not-for-profit, and industry levels. In 2021, the National Cancer Policy Forum of the National Academies of Science, Engineering, and Medicine sponsored a series of webinars addressing key social determinants of health including food, housing, and transportation among patients with cancer. This commentary summarizes the formal presentations and discussions related to transportation insecurity and will 1) discuss the heterogeneous nature of transportation insecurity among patients with cancer; 2) characterize its prevalence along the cancer continuum; 3) examine its multilevel consequences; 4) discuss measurement and screening tools; 5) highlight ongoing efforts to address transportation insecurity; 6) suggest policy levers; and 7) outline a research agenda to address critical knowledge gaps.

Several types of immune checkpoint inhibitors (ICIs) are approved to treat advanced melanoma, but their effectiveness has not been compared in older patients treated outside of a clinical trial. Moreover, evidence suggests that a patient's response to ICI therapy may vary by age and type of ICI. The purpose of this study was to compare survival by ICI type in older patients with melanoma and to investigate treatment effect modification by age.Using the SEER-Medicare database, we identified patients with cutaneous melanoma (2012-2015) treated with an ICI (CTLA-4, PD-1, or combination CTLA-4 + PD-1 inhibitors). Cox proportional hazards regression was used to estimate hazard ratios (HRs) with 95% confidence intervals (CI) for ICI types. We used an interaction term and stratified models to test for treatment effect modification by age.Of the 1435 patients included in our analysis, 790 (55.1%) received CTLA-4 inhibitors, 512 (35.7%) received PD-1 inhibitors, and 133 (9.3%) were treated with combination ICIs. Median survival ranged from 13.4 months (95%CI: 10.7-16.3) for CTLA-4 inhibitors to 23.5 months (95%CI: 16.2-30.0) for combination ICIs. In multivariable models, the risk of death was lower with PD-1 inhibitors compared to CTLA-4 inhibitors (HR = 0.78, 95%CI: 0.68-0.89). An age*ICI type interaction term was significant (p 0.001), and survival gains were greater the older age group (≥80) compared to the younger group (65-79).In a population-based setting, we identified important differences in survival by ICI type in older patients with melanoma treated with ICIs, with prolonged survival associated with PD-1 inhibitors compared to CTLA-4 inhibitors.

To systematically review management of flap loss in head and neck construction with free tissue transfer as compared with locoregional flap or conservative management.Medline, Embase, Scopus, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and ClinicalTrials.gov were searched up to October 2019.Candidate articles were independently reviewed by 2 authors. Articles were considered eligible if they included adequate reporting of flap management after flap loss and outcomes for survival of reconstruction, length of hospitalization, and perioperative complications.A total of 429 patients had acute flap failure in the perioperative period. The overall success with a secondary free flap was 93% (95% CI, 0.89-0.97; n = 26 studies,Salvage reconstruction with free tissue transfer has a high success rate. Second free flaps following flap failure had a similar length of hospitalization and lower overall complication rate than locoregional reconstruction or conservative management. A second free tissue transfer, when feasible, is likely a more reliable and effective procedure for salvage reconstruction.

This Viewpoint examines the approval of the first quality metric for head and neck oncology and potential outcomes for improving quality of care for patients with head and neck squamous cell carcinoma.

ImportanceTimely initiation of postoperative radiation therapy (PORT) is associated with reduced recurrence rates and improved overall survival in patients with head and neck squamous cell carcinoma (HNSCC). Measurement of the association of social-ecological variables with PORT delays is lacking.ObjectiveTo assess individual and community-level factors associated with PORT delay among patients with HNSCC.Design, Setting, and ParticipantsThis prospective cohort study carried out between September 2018 and June 2022 included adults with untreated HNSCC who were enrolled in a prospective registry at a single academic tertiary medical center. Demographic information and validated self-reported measures of health literacy were obtained at baseline visits. Clinical data were recorded, and participant addresses were used to calculate the area deprivation index (ADI), a measure of community-level social vulnerability. Participants receiving primary surgery and PORT were analyzed. Univariable and multivariable regression analysis was performed to identify risk factors for PORT delays.ExposuresSurgical treatment and PORT.Main Outcomes and MeasuresThe primary outcome was PORT initiation delay (>42 days from surgery). Risk of PORT initiation delay was evaluated using individual-level (demographic, health literacy, and clinical data) and community-level information (ADI and rural-urban continuum codes).ResultsOf 171 patients, 104 patients (60.8%) had PORT delays. Mean (SD) age of participants was 61.0 (11.2) years, 161 were White (94.2%), and 105 were men (61.4%). Insurance was employer-based or public among 65 (38.5%) and 75 (44.4%) participants, respectively. Mean (SD) ADI (national percentile) was 60.2 (24.4), and 71 (41.8%) resided in rural communities. Tumor sites were most commonly oral cavity (123 [71.9%]), with 108 (63.5%) classified as stage 4 at presentation. On multivariable analysis, a model incorporating individual-level factors with health literacy in addition to community-level factors was most predictive of PORT delay (AOC= 0.78; R2, 0.18).Conclusions and RelevanceThis cohort study provides a more comprehensive assessment of predictors of PORT delays that include health literacy and community-level measures. Predictive models that incorporate multilevel measures outperform models with individual-level factors alone and may guide precise interventions to decrease PORT delay for at-risk patients with HNSCC.

Objectives To provide a consensus statement describing best practices and evidence regarding head and neck cancer survivorship. Methods Key topics regarding head and neck cancer survivorship were identified by the multidisciplinary membership of the American Head and Neck Society Survivorship, Supportive Care & Rehabilitation Service. Guidelines were generated by combining expert opinion and a review of the literature and categorized by level of evidence. Results Several areas regarding survivorship including dysphonia, dysphagia, fatigue, chronic pain, intimacy, the ability to return to work, financial toxicity, lymphedema, psycho‐oncology, physical activity, and substance abuse were identified and discussed. Additionally, the group identified and described the role of key clinicians in survivorship including surgical, medical and radiation oncologists; dentists; primary care physicians; psychotherapists; as well as physical, occupational, speech, and respiratory therapists. Conclusion Head and neck cancer survivorship is complex and requires a multidisciplinary approach centered around patients and their caregivers. As survival related to head and neck cancer treatment improves, addressing post‐treatment concerns appropriately is critically important to our patient's quality of life. There continues to be a need to define effective and efficient programs that can coordinate this multidisciplinary effort toward survivorship.

PURPOSE: More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy. METHODS: NDURE was developed using the six steps of intervention mapping (IM). Subsequently, NDURE was evaluated by enrolling consecutive patients with locally advanced HNSCC undergoing surgery and PORT (n = 15) into a single-arm clinical trial with a mixed-methods approach to process evaluation. RESULTS: NDURE is a navigation-based MLI targeting barriers to timely, guideline-adherent PORT at the patient, healthcare team, and organizational levels. NDURE is delivered via three in-person navigation sessions anchored to case identification and surgical care transitions. Intervention components include the following: (1) patient education, (2) travel support, (3) a standardized process for initiating the discussion of expectations for PORT, (4) PORT care plans, (5) referral tracking and follow-up, and (6) organizational restructuring. NDURE was feasible, as judged by accrual (88% of eligible patients [100% Blacks] enrolled) and dropout (n = 0). One hundred percent of patients reported moderate or strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for Black patients. CONCLUSION: NDURE is a navigation-based MLI that is feasible, is acceptable, and has the potential to improve the timely, equitable, guideline-adherent PORT.

Background Although Medicaid expansion is associated with decreased uninsured rates and earlier cancer diagnoses, no study has demonstrated an association between Medicaid expansion and cancer mortality. Our primary objective was to quantify the relationship between early Medicaid expansion and changes in cancer mortality rates. Methods We obtained county-level data from the National Center for Health Statistics for adults aged 20-64 years who died from cancer from 2007 to 2009 (preexpansion) and 2012 to 2016 (postexpansion). We compared changes in cancer mortality rates in early Medicaid expansion states (CA, CT, DC, MN, NJ, and WA) vs nonexpansion states through a difference-in-differences analysis using hierarchical Bayesian regression. An exploratory analysis of cancer mortality changes associated with the larger-scale 2014 Medicaid expansions was also performed. Results In adjusted difference-in-differences analyses, we observed a statistically significant decrease of 3.07 (95% credible interval = 2.19 to 3.95) cancer deaths per 100 000 in early expansion vs nonexpansion states, which translates to an estimated decrease of 5276 cancer deaths in the early expansion states during the study period. Expansion-associated decreases in cancer mortality were observed for pancreatic cancer. Exploratory analyses of the 2014 Medicaid expansions showed a decrease in pancreatic cancer mortality (−0.18 deaths per 100 000, 95% confidence interval = −0.32 to −0.05) in states that expanded Medicaid by 2014 compared with nonexpansion states. Conclusions Early Medicaid expansion was associated with reduced cancer mortality rates, especially for pancreatic cancer, a cancer with short median survival where changes in prognosis would be most visible with limited follow-up.

Head and neck cancer (HNC) survivors and caregivers face significant challenges after treatment. This study's objective was to evaluate the effects of a dyadic survivorship care planning (SCP) intervention on survivor and caregiver outcomes.This randomized controlled trial enrolled HNC survivors and caregivers within 18 months post-treatment, randomized dyads to SCP (one-session with written SCP and follow-up telephone call) or usual care and administered baseline and 6-month surveys. Multivariable linear regression examined intervention effects on depression and unmet needs in dyads and burden on caregiverss and a set of secondary outcomes. Rating scales and open-ended questions assessed acceptability.We randomized 89 survivor-caregiver dyads (42 usual care, 47 SCP dyads). Fidelity to SCP was high for most survivorship domains except discussing care barriers (13%). The most commonly discussed referrals included nutrition (83%) and behavioral medicine (38%), but referral uptake was low. The SCP intervention did not improve depression or unmet needs among dyads or burden among caregivers at 6 months relative to usual care (p's .05). Nurses and dyads rated SCP favorably with 80% positive ratings for session length and care plan content. Qualitative findings highlighted that SCP helped consolidate complex clinical information and strengthened survivor-caregiver-clinician relationships.An HNC SCP intervention was acceptable but ineffective in improving dyads' outcomes.Post-treatment SCP in HNC dyads was ineffective in improving outcomes in survivors and caregivers as delivered in this study. More research is needed to understand how to capitalize on the acceptability of the SCP approach and enhance its effectiveness to support dyads.

OBJECTIVE. Pathologic extranodal extension (ENE) is an important adverse feature for human papillomavirus (HPV)–negative head and neck squamous cell carcinoma (HNSCC), but the prognostic significance of microscopic ENE (ENE(mi)) and role of adjuvant concurrent chemoradiation (CRT) for ENE(mi) remain unclear. This study evaluates (1) the prognostic significance of ENE(mi) in HPV-negative HNSCC and (2) whether adjuvant CRT is associated with improved overall survival (OS) for these patients. STUDY DESIGN. Retrospective cohort study. SETTING. Commission on Cancer (CoC)–accredited facilities. METHODS. This retrospective cohort study included patients in the National Cancer Database from 2009 to 2015 with pathologic node-positive (pN+) HPV-negative HNSCC with either pathologic ENE(mi) or no ENE who had undergone margin-negative surgery. The association of ENE(mi) with OS was evaluated using Cox proportional hazard analyses. Analyses were repeated in patients with ENE(mi) receiving adjuvant therapy to evaluate the association of adjuvant CRT with OS. RESULTS. We included 5483 patients with pN+ HPV-negative HNSCC, of whom 24% had ENE(mi). On multivariable analysis, ENE(mi) was associated with decreased OS relative to no ENE (adjusted hazard ratio [aHR], 1.43; 95% CI, 1.28-1.59). Among patients with ENE(mi) who received ≥60 Gy of adjuvant radiation therapy (RT) (n = 617), adjuvant CRT was not associated with improved OS relative to RT (aHR, 0.91; 95% CI, 0.66-1.27). CONCLUSION. For patients with HPV-negative HNSCC, pN+ with ENE(mi) is associated with worse OS than pN+ without ENE. However, for patients with ENE(mi), concurrent CRT is not associated with improved OS relative to RT. The optimal adjuvant paradigm for ENE(mi) requires additional investigation.

PURPOSE: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) are common, contribute to excess mortality, and are a modifiable target for improving survival. However, the barriers that prevent the delivery of timely, guideline-adherent PORT remain unknown. This study aims to identify the multilevel barriers to timely, guideline-adherent PORT and organize them into a conceptual model. MATERIALS AND METHODS: Semi-structured interviews with key informants were conducted with a purposive sample of patients with HNSCC and oncology providers across diverse practice settings until thematic saturation (n = 45). Thematic analysis was performed to identify the themes that explain barriers to timely PORT and to develop a conceptual model. RESULTS: In all, 27 patients with HNSCC undergoing surgery and PORT were included, of whom 41% were African American, and 37% had surgery and PORT at different facilities. Eighteen clinicians representing a diverse mix of provider types from 7 oncology practices participated in key informant interviews. Five key themes representing barriers to timely PORT were identified across 5 health care delivery levels: (1) inadequate education about timely PORT, (2) postsurgical sequelae that interrupt the tight treatment timeline (both intrapersonal level), (3) insufficient coordination and communication during care transitions (interpersonal and health care team levels), (4) fragmentation of care across health care organizations (organizational level), and (5) travel burden for socioeconomically disadvantaged patients (community level). CONCLUSION: This study provides a novel description of the multilevel barriers that contribute to delayed PORT. Interventions targeting these multilevel barriers could improve the delivery of timely, guideline-adherent PORT and decrease mortality for patients with HNSCC.

Acute pain management following major head and neck (HN) surgery is complex. Multimodal analgesia (MMA) regimens including acetaminophen, nonsteroidal anti-inflammatory drugs, gabapentinoids, and locoregional anesthetics are safe and effective in this population (including patients undergoing HN free flap surgery). Special considerations for patients undergoing HN free flap surgery include judicious use of steroids and attention to donor site pain. Evidence for specific analgesic regimens following transoral robotic surgery is limited but should include MMA and perioperative dexamethasone. Further study is required to optimize combinations, dosages, and duration of perioperative analgesia medications, opioid and nonopioid, for patients undergoing major HN surgery.

Mandibular reconstruction for segmental defects is a well-studied topic. However, there are conflicting data on the risks of delayed plate-related complications. The objective of this systematic review and meta-analysis was to assess long-term plate-related complications following reconstruction of the mandible with soft tissue and a plate as compared with immediate vascularized bony reconstruction.A medical librarian created search strategies with a combination of keywords and controlled vocabulary in Ovid Medline (1946-), Embase (1947-), Scopus (1960-), Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Clinicaltrials.gov.Candidate articles were independently reviewed by 2 authors. Inclusion/exclusion criteria were uniformly applied. Articles were considered eligible if they included adequate reporting of plate extrusion and/or fracture and had follow-up ≥12 months.A total of 2379 patients were included. The risk of plate fracture was low in cases of soft tissue with a plate (5%; 95% CI, 0.03-0.08) and osseous reconstruction (1%). The risk of extrusion following soft tissue and plate reconstruction was 20% (95% CI, 0.15-0.27). In the osseous reconstruction group, the risk of extrusion was 10% (95% CI, 0.06-0.18). Revision surgery was performed twice as often following soft tissue with a plate as compared with vascularized bony reconstruction (32% [95% CI, 0.25-0.40] vs 14% [95% CI, 0.09-0.21], respectively).Delayed plate-related complications remain a significant problem following segmental defect reconstruction. Soft tissue and plate reconstruction techniques may increase the risk of plate removal and revision surgery.

The COVID‐19 pandemic has profoundly disrupted head and neck cancer (HNC) care delivery in ways that will likely persist long term. As we scan the horizon, this crisis has the potential to amplify preexisting racial/ethnic disparities for patients with HNC. Potential drivers of disparate HNC survival resulting from the pandemic include (a) differential access to telemedicine, timely diagnosis, and treatment; (b) implicit bias in initiatives to triage, prioritize, and schedule HNC‐directed therapy; and (c) the marked changes in employment, health insurance, and dependent care. We present four strategies to mitigate these disparities: (a) collect detailed data on access to care by race/ethnicity, income, education, and community; (b) raise awareness of HNC disparities; (c) engage stakeholders in developing culturally appropriate solutions; and (d) ensure that surgical prioritization protocols minimize risk of racial/ethnic bias. Collectively, these measures address social determinants of health and the moral imperative to provide equitable, high‐quality HNC care.

Distress with self-perceived changes in appearance and function can result in body image disturbance (BID), which is common in head and neck cancer (HNC) survivors and a major source of psychosocial morbidity. To address the lack of psychometrically sound patient-reported outcome measures (PROMs) of HNC-related BID, we aim to create and validate the Inventory to Measure and Assess imaGe disturbancE-HeadNeck (IMAGE-HN).Survey study.Multiple academic centers.Following item development, HNC survivors from 4 academic centers completed the IMAGE-HN. Item responses were psychometrically analyzed using confirmatory factor analysis (CFA) and Rasch analysis.Item development resulted in a 31-item PROM consisting of 5 individual domains and a global domain. In total, 305 HNC survivors of diverse ages, HNC subsites, and reconstructive paradigms completed the initial items. After removal of 3 items for local dependence, CFA confirmed the unidimensionality and local independence (item residual correlations|0.20|) for each domain. Rasch analysis indicated acceptable fit (infit and outfit mean squares2.0), monotonicity of all rating scale categories, and low person misfit (4%). Person separation indices and person reliability were adequate for each domain except appearance concealment, which was removed (4 items). This resulted in the IMAGE-HN, a psychometrically acceptable 24-item PROM of HNC-related BID consisting of a global scale and 4 subscales measuring unique constructs and comprised independent items.IMAGE-HN is a novel, psychometrically sound, multidomain PROM of HNC-related BID for use in clinical and research settings.

Patients on chronic pharmacologic immunosuppressive therapy are at increased risk of wound infection and complications after surgery. There is a paucity of data examining perioperative complications after microvascular free tissue transfer (MVFTT) reconstruction of the head and neck in this patient population.Retrospective cohort study performed at two tertiary referral centers between August 2016 and May 2020.Nine hundred and seventy-nine patients underwent MVFTT during the study period; of these 47 (5%) patients were taking chronic immunosuppressive medications. The most common indications for immunosuppression were solid organ transplant and autoimmune disease. Fourteen (30%) patients had surgical complications within 30 days of surgery: 8 (17%) wound dehiscences, 6 (12%) hematomas, and 2 (4%) surgical site infections. There was one total and one partial flap failure with a 30-day reoperation rate of 4%.MVFTT of the head and neck appears to be safe in patients on chronic pharmacologic immunosuppression.

ImportanceAlthough 1 in 4 head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a psychosocial morbidity that adversely affects quality of life, effective interventions for these patients are lacking.ObjectiveTo evaluate the acceptability and preliminary efficacy of BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief tele–cognitive behavioral therapy, at reducing BID among HNC survivors.Design, Setting, and ParticipantsThis parallel-group pilot randomized clinical trial recruited adult HNC survivors with BID between August 13, 2020, and December 9, 2021, from the Medical University of South Carolina HNC clinic during a routine survivorship encounter. Data were analyzed from May 3 to June 16, 2022.InterventionsBRIGHT consisted of 5 weekly psychologist-led video tele–cognitive behavioral therapy sessions. Attention control (AC) consisted of dose- and delivery-matched survivorship education.Main Outcomes and MeasuresChange in HNC-related BID was assessed using IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE–Head and Neck), a validated patient-reported outcome (score range, 0-84, with higher scores indicating greater HNC-related BID). Clinical response rate was measured as the proportion of patients with a clinically meaningful change in IMAGE-HN scores.ResultsOf the 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), the median (range) age was 63 (41-80) years, and 27 patients (61%) were female. Patients rated BRIGHT’s acceptability highly (all metrics had a mean rating of ≥4.5/5), and 19 of 20 patients (95%) receiving BRIGHT were likely or highly likely to recommend it to other HNC survivors with BID. BRIGHT decreased HNC-related BID from baseline to 1 month postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, –7.9 points; 90% CI, –15.9 to 0.0 points) and from baseline to 3 months postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, –17.1 points; 90% CI, −25.6 to −8.6 points). At 3 months postintervention, the clinical response rate of BRIGHT was 6.6-fold higher than AC (model-based odds ratio, 6.6; 90% CI, 2.0-21.8). The improvement in HNC-related BID for BRIGHT vs AC at 3 months was clinically significant, and the effect size was large (Cohen d, −0.9; 90% CI, −1.4 to −0.4).Conclusions and RelevanceIn this pilot randomized clinical trial, BRIGHT was acceptable, may result in a clinically meaningful improvement in HNC-related BID, and showed a high clinical response rate. These promising preliminary data support conducting a large efficacy trial to establish BRIGHT as the first evidence-based treatment for HNC survivors with BID.Trial RegistrationClinicalTrials.gov Identifier: NCT03831100

Patients with cancer are at an increased suicide risk, and socioeconomic deprivation may further exacerbate that risk. The Affordable Care Act (ACA) expanded insurance coverage options for low-income individuals and mandated coverage of mental health care. Our objective was to quantify associations of the ACA with suicide incidence among patients with cancer.We identified US patients with cancer aged 18-74 years diagnosed with cancer from 2011 to 2016 from the Surveillance, Epidemiology, and End Results database. The primary outcome was the 1-year incidence of suicide based on cumulative incidence analyses. Difference-in-differences (DID) analyses compared changes in suicide incidence from 2011-2013 (pre-ACA) to 2014-2016 (post-ACA) in Medicaid expansion relative to non-expansion states. We conducted falsification tests with 65-74-year-old patients with cancer, who are Medicare-eligible and not expected to benefit from ACA provisions.We identified 1,263,717 patients with cancer, 812 of whom died by suicide. In DID analyses, there was no change in suicide incidence after 2014 in Medicaid expansion vs. non-expansion states for nonelderly (18-64 years) patients with cancer (p = .41), but there was a decrease in suicide incidence among young adults (18-39 years) (- 64.36 per 100,000, 95% CI = - 125.96 to - 2.76, p = .041). There were no ACA-associated changes in suicide incidence among 65-74-year-old patients with cancer.We found an ACA-associated decrease in the incidence of suicide for some nonelderly patients with cancer, particularly young adults in Medicaid expansion vs. non-expansion states. Expanding access to health care may decrease the risk of suicide among cancer survivors.

Importance Surveillance imaging and visits are costly and have not been shown to improve oncologic outcomes for patients with head and neck cancer (HNC). However, the benefit of surveillance visits may extend beyond recurrence detection. To better understand surveillance and potentially develop protocols to tailor current surveillance paradigms, it is important to elicit the perspectives of the clinicians who care for patients with HNC. Objective To characterize current surveillance practices and explore clinician attitudes and beliefs on deintensifying surveillance for patients with HNC. Design, Setting, and Participants This qualitative study was performed from January to March 2021. Guided by an interpretive description approach, interviews were analyzed to produce a thematic description. Data analysis was performed from March to April 2021. Otolaryngologists and radiation oncologists were recruited using purposive and snowball sampling strategies. Main Outcomes and Measures The main outcomes were current practice, attitudes, and beliefs about deintensifying surveillance and survivorship as well as patients’ values and perspectives collected from interviews of participating physicians. Results Twenty-one physicians (17 [81%] men) were interviewed, including 13 otolaryngologists and 8 radiation oncologists with a median of 8 years (IQR, 5-20 years) in practice. Twelve participants (57%) stated their practice comprised more than 75% of patients with HNC. Participants expressed that there was substantial variation in the interpretation of the surveillance guidelines. Participants were open to the potential for deintensification of surveillance or incorporating symptom-based surveillance protocols but had concerns that deintensification may increase patient anxiety and shift some of the burden of recurrence monitoring to patients. Patient and physician peace of mind, the importance of maintaining the patient-physician relationship, and the need for adequate survivorship and management of treatment-associated toxic effects were reported to be important barriers to deintensifying surveillance. Conclusions and Relevance In this qualitative study, clinicians revealed a willingness to consider altering cancer surveillance but expressed a need to maintain patient and clinician peace of mind, maintain the patient-clinician relationship, and ensure adequate monitoring of treatment-associated toxic effects and other survivorship concerns. These findings may be useful in future research on the management of posttreatment surveillance.

Session Description: The COVID-19 pandemic brought many otolaryngology and head and neck practices into sharp focus. Critical resources were diverted to acute care specialties on the front lines. Head and neck cancer care was upended, and surgeons witnessed treatment delays resulting in worse oncologic outcomes and the exacerbation of existing health care disparities. Caring for patients with head and neck cancer under severe acute resource constraint and infection risk of COVID-19 required health care systems and clinicians to develop innovative care delivery strategies to optimize timely, equitable, head and neck cancer care delivery. As a result, several approaches emerged to minimize treatment delays, develop ethical frameworks for prioritization of care and resources, enhance access, and minimize viral transmission;these important innovations are likely to persist into the foreseeable future. Lessons learned during this experience will prepare head and neck surgeons for potential subsequent events that may similarly strain health care resources. The goal of this interactive panel presentation is to understand important lessons learned about cancer care delivery and outcomes during the COVID-19 pandemic in various jurisdictions. These expert panelists will discuss the ethical considerations of surgical prioritization and the clinical practice changes that were implemented. The panelists will provide a framework for ongoing decision making with the goal of minimizing health care disparities and optimizing oncologic outcomes while resources are restricted. Outcome Objectives: (1) Understand the effects of the COVID-19 pandemic on head and neck cancer patients in various health care systems and regions. (2) Recognize the components of attendees' health care systems that may contribute to inequities and demonstrate knowledge of the ethical considerations when caring for cancer patients during a pandemic. (3) Apply the lessons learned to address disparities and care gaps even after the resolution of the COVID-19 pandemic and in possible future disaster situations.

INTRODUCTION: Osteocutaneous microvascular free tissue transfer (OMFTT) is the current standard in reconstruction of large bony defects of the oral cavity. Although being able to swallow ranks as a top priority for patients undergoing OMFTT, factors associated with achieving an oral diet following surgery remain unclear. We sought to describe the rate of total oral diet achievement, and to identify possible pre-, intra-, and post-operative factors associated with achievement in patients undergoing OMFTT. METHODS: Retrospective review between January 1, 2010 and March 31, 2018 at two tertiary academic centers. RESULTS: 249 patients (67% male, mean age 58 years) met inclusion criteria, with a median follow up of 15 months. Overall, 142 (57%) of patients achieved a total PO diet post-operatively, with median time to achievement of 3.2 months. Multivariate analysis identified that lack of concurrent glossectomy (SHR 1.72 [1.09-2.70], p=0.02), N0/1 disease (SHR 1.92 [1.16-3.13], p=0.011), avoidance of post-operative fistula formation (SHR 1.96 [1.22-3.23], p=0.005), preoperative G-tube independence (SHR 3.33 [1.69-6.25], p

This cohort study aims to identify factors associated with omission of adjuvant postoperative radiotherapy in patients with advanced-stage oral squamous cell cancers in the US.

Importance Body image–related distress (BID) is common among head and neck cancer (HNC) survivors and associated with significant morbidity. Risk factors for HNC-related BID remain poorly characterized because prior research has used outcome measures that fail to fully capture BID as experienced by HNC survivors. Objective To assess the association of demographic and oncologic characteristics with HNC-related BID using the Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN), a validated, multidomain, patient-reported outcome measure of HNC-related BID. Design, Setting, and Participants This cross-sectional study assessed 301 adult survivors of surgically managed HNC at 4 academic medical centers. Main Outcomes and Measures The primary outcome measure was IMAGE-HN scores, for which higher scores reflect more severe HNC-related BID. Multivariable linear regression analyses were performed to evaluate the association of patient characteristics with IMAGE-HN global and 4 subdomain (other-oriented appearance concerns, personal dissatisfaction with appearance, distress with functional impairments, and social avoidance) scores. Results Of the 301 participants (212 [70.4%] male; mean [SD] age, 65.3 [11.7] years), 181 (60.1%) underwent free flap reconstruction. Graduation from college (β = −9.6; 95% CI, −17.5 to −1.7) or graduate school (β = −12.6; 95% CI, −21.2 to −3.8) was associated with lower IMAGE-HN social avoidance scores compared with less than a high school education. Compared with paid work, unemployment was associated with higher IMAGE-HN other-oriented appearance (β = 10.7; 95% CI, 2.0-19.3), personal dissatisfaction with appearance (β = 12.5; 95% CI, 1.2-23.7), and global (β = 8.0; 95% CI, 0.6-15.4) scores. Compared with no reconstruction, free flap reconstruction was associated with higher IMAGE-HN global scores (β = 11.5; 95% CI, 7.9-15.0) and all subdomain scores (other-oriented appearance: β = 13.1; 95% CI, 8.6-17.6; personal dissatisfaction with appearance: β = 15.4; 95% CI, 10.0-20.7; distress with functional impairment: β = 12.8; 95% CI, 8.1-17.4; and social avoidance and isolation: β = 10.2; 95% CI, 5.8-14.6). Higher IMAGE-HN distress with functional impairment scores were found in those who received surgery and adjuvant radiation (β = 7.8; 95% CI, 2.9-12.7) or chemoradiotherapy (β = 6.5; 95% CI, 1.8-11.3) compared with surgery alone. The multivariable regression model accounted for a modest proportion of variance in IMAGE-HN global (R2 = 0.18) and subdomain scores (R2 = 0.20 for other-oriented appearance, 0.14 for personal dissatisfaction with appearance, 0.21 for distress with functional impairment, and 0.13 for social avoidance and isolation). Conclusions and Relevance In this cross-sectional study, factors associated with risk of HNC-related BID included free flap reconstruction, lower educational attainment, unemployment, and multiple treatment modalities. These characteristics explain a modest proportion of variance in IMAGE-HN scores, suggesting that other characteristics may be the major risk factors for HNC-related BID and should be explored in future studies.

The overwhelming majority of head and neck cancers and related deaths occur in low- and middle-income countries, which have challenges related to burden of disease versus access to care. Yet the additional health care burden of the COVID-19 pandemic has also impacted access to care for patients with head and neck cancer in the United States. This article focuses on challenges and innovation in prioritizing head and neck cancer care in Sub-Saharan Africa, the Indian experience of value-added head and neck cancer care in busy and densely populated regions, and strategies to optimize the management of head and neck cancer in the United States during the COVID-19 pandemic.

This cross-sectional study assesses the association between observer-rated disfigurement and body image–related distress among survivors of head and neck cancer.

OBJECTIVE. In the chronic phase of COVID-19 pandemic, questions have arisen regarding care of patients with tracheostomy and downstream management. This review addresses gaps in the literature regarding post-tracheostomy care, emphasizing safety of multidisciplinary teams, coordinating complex care needs, and identifying and managing late complications of prolonged intubation and tracheostomy. DATA SOURCES. PubMed, Cochrane Library, Scopus, Google Scholar, Institutional guidance documents REVIEW METHODS. Literature through June 2020 on care of tracheostomy patients was reviewed, including consensus statements, clinical practice guidelines, institutional guidance, and scientific literature on COVID and SARS-CoV-2 virology and immunology. Where data were lacking, expert opinions were aggregated and adjudicated to arrive at consensus recommendations. CONCLUSIONS. Best practices in caring for patients after tracheostomy during the COVID-19 pandemic are multifaceted, encompassing precautions during aerosol generating procedures; minimizing exposure risks to healthcare workers, caregivers, and patients; ensuring safe, timely tracheostomy care; and identifying and managing laryngotracheal injury, such as vocal fold injury, posterior glottic stenosis, and subglottic stenosis that may affect speech, swallowing, and airway protection. We present recommended approaches to tracheostomy care, outlining modifications to conventional algorithms, raising vigilance for heightened risks of bleeding or other complications, and offering recommendation for personal protective equipment (PPE), equipment, care protocols, and personnel. IMPLICATIONS FOR PRACTICE. Management of patients with tracheostomy in COVID-19 pandemic requires foresight and may rival procedural considerations in tracheostomy in their complexity. By considering patient-specific factors, mitigating transmission risks, optimizing clinical environment, and detecting late manifestations of severe COVID-19, clinicians can ensure due vigilance and quality care.

To characterize pharyngocutaneous fistula (PCF) rates and functional outcomes following microvascular free tissue transfer (MVFTT) reconstruction of salvage total laryngectomy (STL) with a review of two different flap inset techniques and a review of the literature.Retrospective review.Review of the literature revealed 887 patients who underwent STL MVFTT from 14 references. Ninety-six STL MVFTTs were performed by the authors, with 36 (38%) patients undergoing multilayer fascial underlay (MLFU) closure and 60 (62%) a standard single layer closure (SLC). One (3%) PCF occurred in the MLFU group compared to 12 (20%) in the SLC cohort (P = .03). Postoperative gastrostomy (G)-tube dependence was lower following MLFU closure compared to SLC (25% vs. 57%, P .01), whereas pharyngoesophageal stricture (PES) (28% vs. 38%), tracheoesophageal puncture (TEP) placement (42% vs. 42%), and TEP usage (87% vs. 88%) did not significantly differ (P .05). Compared to pooled rates from the literature, patients who underwent a MLFU MVFTT inset technique demonstrated significantly lower PCF incidence (3% vs. 23%, P .01) without significant differences in PES (28% vs 23%, P = .55), G-tube dependence (25% vs. 23%, P = .25), or TEP placement (42% vs. 59%, P = .09).Despite MVFTT reconstruction after STL, G-tube dependence, PCF formation, and limitations of speaking rehabilitation (TEP) remain a significant issue. Modification of MVFTT inset may provide an opportunity to reduce PCF incidence without affecting other functional outcomes.4 Laryngoscope, 131:E875-E881, 2021.

Background In the wake of the coronavirus disease 2019 (COVID‐19) pandemic, access to surgical care for patients with head and neck cancer (HNC) is limited and unpredictable. Determining which patients should be prioritized is inherently subjective and difficult to assess. The authors have proposed an algorithm to fairly and consistently triage patients and mitigate the risk of adverse outcomes. Methods Two separate expert panels, a consensus panel (11 participants) and a validation panel (15 participants), were constructed among international HNC surgeons. Using a modified Delphi process and RAND Corporation/University of California at Los Angeles methodology with 4 consensus rounds and 2 meetings, groupings of high‐priority, intermediate‐priority, and low‐priority indications for surgery were established and subdivided. A point‐based scoring algorithm was developed, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN‐HN). Agreement was measured during consensus and for algorithm scoring using the Krippendorff alpha. Rankings from the algorithm were compared with expert rankings of 12 case vignettes using the Spearman rank correlation coefficient. Results A total of 62 indications for surgical priority were rated. Weights for each indication ranged from −4 to +4 (scale range; −17 to 20). The response rate for the validation exercise was 100%. The SPARTAN‐HN demonstrated excellent agreement and correlation with expert rankings (Krippendorff alpha, .91 [95% CI, 0.88‐0.93]; and rho, 0.81 [95% CI, 0.45‐0.95]). Conclusions The SPARTAN‐HN surgical prioritization algorithm consistently stratifies patients requiring HNC surgical care in the COVID‐19 era. Formal evaluation and implementation are required. Lay Summary Many countries have enacted strict rules regarding the use of hospital resources during the coronavirus disease 2019 (COVID‐19) pandemic. Facing delays in surgery, patients may experience worse functional outcomes, stage migration, and eventual inoperability.Treatment prioritization tools have shown benefit in helping to triage patients equitably with minimal provider cognitive burden.The current study sought to develop what to the authors' knowledge is the first cancer–specific surgical prioritization tool for use in the COVID‐19 era, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN‐HN). This algorithm consistently stratifies patients requiring head and neck cancer surgery in the COVID‐19 era and provides evidence for the initial uptake of the SPARTAN‐HN., To the authors' knowledge, the Surgical Prioritization and Ranking Tool and Navigation Aid for Head and Neck Cancer (SPARTAN‐HN) is the first cancer surgery–specific prioritization tool for use during the coronavirus disease 2019 (COVID‐19) pandemic. The SPARTAN‐HN algorithm is reliable and valid for the stratification of patients with head and neck cancer who require urgent cancer care in resource‐restricted practice environments.

Objective Nonphysician health care workers are involved in high-risk patient care during the COVID-19 pandemic, placing them at high risk of mental health burden. The mental health impact of COVID-19 in this crucial population has not been studied thus far. Thus, the objective of this study is to assess the psychosocial well-being of these providers. Study Design National cross-sectional online survey (no control group). Setting Academic otolaryngology programs in the United States. Subjects and Methods We distributed a survey to nonphysician health care workers in otolaryngology departments across the United States. The survey incorporated a variety of validated mental health assessment tools to measure participant burnout (Mini-Z assessment), anxiety (Generalized Anxiety Disorder–7), distress (Impact of Event Scale), and depression (Patient Health Questionnaire–2). Multivariable logistic regression analysis was performed to determine predictive factors associated with these mental health outcomes. Results We received 347 survey responses: 248 (71.5%) nurses, 63 (18.2%) administrative staff, and 36 (10.4%) advanced practice providers. A total of 104 (30.0%) respondents reported symptoms of burnout; 241 (69.5%), symptoms of anxiety; 292 (84.1%), symptoms of at least mild distress; and 79 (22.8%), symptoms of depression. Upon further analysis, development of these symptoms was associated with factors such as occupation, practice setting, and case load. Conclusion Frontline otolaryngology health care providers exhibit high rates of mental health complications, particularly anxiety and distress, in the wake of COVID-19. Adequate support systems must be put into place to address these issues.

Importance The standard of care for initiation of postoperative radiotherapy (PORT) in head and neck squamous cell carcinoma (HNSCC) is within 6 weeks of surgical treatment. Delays in guideline-adherent PORT initiation are common, associated with mortality, and a measure of quality care, but patient-specific tools to estimate the risk of these delays are lacking. Objective To develop and validate 2 nomograms (that use presurgical and postsurgical data) for predicting delayed PORT initiation. Design, Setting, and Participants This cohort study obtained patient data from January 1, 2004, to December 31, 2015, from the National Cancer Database. Adults aged 18 years or older with a newly diagnosed HNSCC who underwent surgical treatment and PORT at a Commission on Cancer–accredited facility were included. Data analysis was conducted from June 2, 2019, to January 29, 2020. Exposures Surgical treatment and PORT. Main Outcomes and Measures The primary outcome measure was PORT initiation more than 6 weeks after the surgical intervention. Multivariable logistic regression models were created in a random selection of 80% of the sample (derivation cohort) and were internally validated with bootstrapping, assessed for discrimination by calibration plots and the concordance (C) index, and externally validated in the remaining 20% of the sample (validation cohort). Results The study included 60 766 adults with HNSCC who were grouped into derivation and validation cohorts. The derivation cohort comprised 48 625 patients (mean [SD] age, 59.59 [11.3] years; 36 825 men [75.7%]) selected randomly from the full sample, whereas 12 151 patients (mean [SD] age, 59.63 [11.2] years; 9266 men [76.3%]) composed the validation cohort. The rate of PORT delay was 55.8% (n=27140) in the derivation cohort and 56.7% (n=6900) in the validation cohort. Both nomograms created to predict the risk of PORT initiation delay used variables, including race/ethnicity, insurance type, tumor site, and facility type. The nomogram based on presurgical variables included clinical stage and severity of comorbidity, whereas the nomogram with postsurgical variables included US region, length of stay, and care fragmentation between surgical and radiotherapy facilities. For the presurgical nomogram, the concordance indices were 0.670 (95% CI, 0.664-0.676) in the derivation cohort and 0.674 (95% CI, 0.662-0.685) in the validation cohort. For the nomogram with postsurgical variables, the concordance indices were 0.691 (95% CI, 0.686-0.696) in the derivation cohort and 0.694 (95% CI, 0.685-0.704) in the validation cohort. Conclusions and Relevance This study found that a nomogram developed with presurgical data to generate personalized estimates of PORT initiation delay may improve pretreatment counseling and the delivery of interventions to patients at high risk for such a delay. A nomogram including postsurgical data can drive institutional quality improvement initiatives and enhance risk-adjusted comparisons of delay rates across facilities.

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.

Background Following salvage total laryngectomy (STL) with microvascular-free tissue transfer (MFTT), patients are at high risk for swallowing dysfunction, but risk factors for persistent gastrostomy tube (G-tube) dependence are unknown. Methods Retrospective review of 33 patients who underwent STL with MFTT. Results A total oral diet was achieved by 81% of patients with ≥6 months of postoperative follow-up. Approximately 27% of patients were G-tube dependent preoperatively with 67% achieving a total oral diet postoperatively. Factors associated with persistent G-tube dependence included pT4 tumor, pN2+ status, more extensive pharyngectomy, and re-irradiation. Strictures occurred in 30% of patients and were associated with more extensive pharyngectomy and tubed reconstruction. Conclusions For patients undergoing STL with MFTT, the majority of patients achieve a total oral diet regardless of their preoperative swallowing function. Advanced-stage recurrent tumors and increased extent of pharyngectomy contribute to poorer swallowing outcomes.

Objectives/hypothesis To investigate patterns of tracheostomy-associated death in the United States. Study design Retrospective database review. Methods We used Multiple Cause-of-Death data from the Centers for Disease Control and Prevention to determine cumulative national mortality associated with tracheostomy complications in the United States from 2007 to 2016. Using International Classification of Diseases, Tenth Revision data, we investigated how frequently tracheostomy-related complications were reported in cause of death data. We then compared the characteristics of patients with tracheostomy-related mortality to patients reported to have died of other causes. Results Over the 10-year period studied, we identified 623 tracheostomy-related deaths (537 adults and 86 children) out of 25,587,306 total deaths reported. Although absolute mortality was higher in adults, the reported base rate of tracheostomy complication-associated mortality was tenfold higher in children. Most tracheostomy-related deaths occurred in a hospital facility (74.5% in adults). Deaths associated with tracheostomy complications were significantly more common for African American children (odds ratio [OR]: 2.02, 95% confidence interval [CI]: 1.26-3.24) and adults (OR: 1.59, 95% CI: 1.29-1.96) or in Hispanic adults (OR: 1.42, 95% CI: 1.06-1.89). Deaths related to a tracheostomy complication more commonly occurred on the weekend (OR: 1.24, 95% CI: 1.04-1.49) and in the most recent 2-year period (OR: 1.31, 95% CI: 1.03-1.68). Adults with a bachelor's, master's or doctorate degree were significantly less likely to have mortality associated with a tracheostomy-related complication (OR: 0.54, 95% CI: 0.39-0.75). Conclusions Tracheostomy-related complications were implicated in the deaths of a significant number of individuals. Several demographic groups had increased likelihood of tracheostomy-related mortality. Future research is necessary to develop targeted interventions to decrease harm. Level of evidence NA Laryngoscope, 129:619-626, 2019.