Validity of a single-item indicator of treatment side effect bother in patients with head and neck cancer.

PURPOSE: Patients with head/neck squamous cell carcinomas (HNSCC) experience significant tumor- and treatment-related side effects. No efficient summary measure capturing the totality of side effect burden currently exists. We examined associations between a single patient-reported outcome (PRO) item evaluating side effect bother (FACT GP5, "I am bothered by side effects of treatment") with overall side effects in HNSCC. METHODS: We performed a retrospective secondary analysis of development of the Functional Assessment of Cancer Therapy (FACT) Head/Neck Symptom Index (FHNSI-10), which included completing FACT-HN (including Head/Neck Cancer Subscale (HNCS) and Trial Outcome Index (TOI)) and the pain intensity numeric rating scale (NRS). We calculated Spearman's correlations between GP5 and these measures of patient-reported global health, head/neck side effects, and pain intensity NRS. A correlation of > 0.4 was considered sufficient evidence of association. RESULTS: Ninety-seven patients completed baseline and 85 completed 3-month follow-up surveys. GP5 was highly correlated with FACT-HN total score (baseline r = 0.66, 3 months r = 0.67) and FHNSI-10 (baseline r = 0.63, 3 months r = 0.65). GP5 correlated with multiple FACT-HN subscales including FACT-G, physical well-being, functional well-being, HNCS, and TOI (range baseline r = 0.53-0.77, range 3 months r = 0.49-0.77). Worsening GP5 score was associated with worsening overall HNCS (p = 0.002), worsening FHNSI-10 score (p < 0.001), and worsening mean pain intensity (p < 0.001). CONCLUSION: GP5 exhibited validity within HNSCC, exhibiting substantial correlations with a number of HNSCC-related PRO measures including FACT-HN and FHNSI-10. Worsening GP5 was associated with worsening HNCS, FHNSI summary score, and pain intensity. GP5 has promise as a summary indicator of symptom and side effect bother in HNSCC.

Patient Safety/Quality Improvement Primer, Part IV: How to Measure and Track Improvements.

Patient safety and quality improvement (PS/QI) has become an integral part of the health care system, and the ability to effectively use data to track, understand, and communicate performance is essential to designing and implementing quality initiatives, as well as assessing their impact. Though many otolaryngologists are proficient in the methodologies of traditional research pursuits, educational gaps remain in the foundational principles of PS/QI measurement strategies. Part IV of this PS/QI primer discusses the fundamentals of measurement design and data analysis methods specific to PS/QI. Consideration is given to the selection of appropriate measures when designing a PS/QI project, as well as the method and frequency for collecting these measures. In addition, this primer reviews key aspects of tracking and analyzing data, providing an overview of statistical process control methods while highlighting the construction and utility of run and control charts. Lastly, this article discusses strategies to successfully develop and execute PS/QI initiatives in a way that facilitates the ability to appropriately measure their effectiveness and sustainability.

Changing Epidemiology of Oral Cavity Cancer in the United States.

OBJECTIVE: We aim to more accurately characterize the current distribution and rates of squamous cell carcinoma (SCC) cases across various oral cavity subsites in the United States. STUDY DESIGN: Retrospective cohort. SETTING: Database study evaluating cancer incidence in the United States from 2001 to 2017. METHODS: We utilized the US Cancer Statistics Public Use Database, which includes deidentified cancer data reported to the Centers for Disease Control and Prevention's National Program of Cancer Registries and the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results), capturing 97% of newly diagnosed cancers. We restricted our analysis to SCC arising from oral cavity subsites from 2001 to 2017. We calculated trends in annual cancer incidence rates using SEER*Stat, as well as annual and average annual percentage change and joinpoints with the National Cancer Institute's Joinpoint program. RESULTS: Most oral cavity SCC cases arise from the oral tongue (41.7%), followed equally by lip and floor of mouth (each 16.5%), gingival (10.6%), buccal (6.7%), retromolar trigone (5.6%), and hard palate (2.3%) involvement. The overall incidence of oral tongue SCC continues to rise with an average annual percentage change of 1.8% (95% CI, 1.6%-2.1%; P < .001), with a 2.3% increase among women. This increase is seen among males and females of all age groups. Cancers involving the gum, buccal mucosa, and hard palate were also found to be increasing in rate, albeit to a lesser degree and with substantially lower incidence. CONCLUSIONS: The tongue is the most frequently involved subsite of oral cavity SCC and is increasing in incidence among males and females of all ages.

Evaluating dysphagia and xerostomia outcomes following transoral robotic surgery for patients with oropharyngeal cancer.

BACKGROUND: We assessed long-term patient-reported dysphagia and xerostomia outcomes following definitive surgical management with transoral robotic surgery (TORS) in patients with oropharyngeal cancer (OPC) via a cross-sectional survey study. METHODS: Patients with OPC managed with primary oropharyngeal surgery as definitive treatment at least 1 year ago between 2015 and 2019 were identified. The M. D. Anderson Dysphagia Inventory (MDADI) and Xerostomia Inventory (XI) scores were compared across treatment types (i.e., no adjuvant therapy [TORS-A] vs. adjuvant radiotherapy [TORS+RT] vs. adjuvant chemoradiotherapy [TORS+CT/RT]). RESULTS: The sample had 62 patients (10 TORS-A, 30 TORS+RT, 22 TORS+CT/RT). TORS-A had clinically and statistically significantly better MDADI scores than TORS+RT (p = 0.03) and TORS+CT/RT (p = 0.02), but TORS+RT and TORS+CT/RT were not significantly different. TORS-A had clinically and statistically significantly less XI than TORS+RT (p < 0.01) and TORS+CT/RT (p < 0.01). CONCLUSIONS: Patients with OPC who have undergone TORS+RT or TORS+CT/RT following surgery face clinically worse dysphagia and xerostomia outcomes relative to patients who undergo TORS-A.

The role of age in treatment decisions for oral cavity squamous cell carcinoma: Analysis of the National Cancer Database.

BACKGROUND: The number of elderly patients with oral squamous cell carcinoma (OCSCC) is increasing as the elderly population increases. Unfortunately, evidence to guide the management of these patients is lacking. METHODS: Patients with OCSCC identified from the National Cancer Database (NCDB) were stratified into age-based cohorts. Demographics, comorbidities, and treatment patterns were analyzed. Patients were stratified into early stage (Stage I/II) and advanced stage (Stage III/IV) disease. The likelihood of receiving multimodality therapy by age was calculated using multinomial logistic regression for each stratum while controlling for potential confounders. Cox proportional hazard regression was used to calculate 5-year mortality risk while controlling for potential confounders. RESULTS: Surgery alone or palliative options were offered to older patients more frequently. After controlling for confounders, older patients were less likely to receive multimodality therapy for both early stage and advanced stage disease. Patients with advanced disease across all age cohorts had improved 5-year survival with surgery and adjuvant therapy. CONCLUSION: Our analyses suggest that elderly patients have unique demographic and pathologic features. They frequently receive less treatment than similarly staged younger patients, yet they benefit from multimodality therapy when feasible. These data suggest an urgent need to critically appraise the care of elderly OCSCC patients within the broader context of their individual comorbidity burden, functional status, and treatment goals.

The prognostic significance of race in nasopharyngeal carcinoma by histological subtype.

BACKGROUND: Race has been shown to have variable prognostic importance in nasopharyngeal carcinoma (NPC). However, previous studies are limited by a lack of comprehensive treatment, epidemiologic, and comorbidity data. METHODS: This was a retrospective cohort study utilizing the National Cancer Database from 2004 to 2016. Multivariable Cox proportional hazards regressions were used to calculate adjusted hazard ratios (aHR) for overall survival. RESULTS: A cohort of 9995 patients met inclusion and exclusion criteria. Race, insurance, comorbidity, treatment, stage, age, and histology were independent prognosticators. Among patients with keratinizing NPC, Asians and Hispanics had superior survival (aHR 0.58 [95% confidence interval (CI) 0.48-0.69], aHR 0.76 [95% CI 0.61-0.96]) compared to white patients. Among patients with non-keratinizing differentiated NPC, Asians and black patients had improved survival (aHR 0.71 [95% CI 0.56-0.91], aHR 0.72 [95% CI 0.54-0.95]) compared to white patients. Race was not prognostic in non-keratinizing undifferentiated NPC. CONCLUSION: The prognostic significance of race varies across histological subtypes of NPC.

Oral Intubation Attempts in Patients With a Laryngectomy: A Significant Safety Threat.

It is impossible to secure the airway of a patient with "neck-only" breathing transorally or transnasally. Surgical removal of the larynx (laryngectomy) or tracheal rerouting (tracheoesophageal diversion or laryngotracheal separation) creates anatomic discontinuity. Misguided attempts at oral intubation of neck breathers may cause hypoxic brain injury or death. We present national data from the American Academy of Otolaryngology-Head and Neck Surgery, the American Head and Neck Society, and the United Kingdom's National Reporting and Learning Service. Over half of US otolaryngologist respondents reported instances of attempted oral intubations among patients with laryngectomy, with a mortality rate of 26%. UK audits similarly revealed numerous resuscitation efforts where misunderstanding of neck breather status led to harm or death. Such data underscore the critical importance of staff education, patient engagement, effective signage, and systems-based best practices to reliably clarify neck breather status and provide necessary resources for safe patient airway management.

Gender and race interact to influence survival disparities in head and neck cancer.

Gender and race disparities in head and neck squamous cell carcinoma (HSNCC) survival are independently well documented, but no prior studies have examined the joint effect of these factors on HSNCC outcomes. We aim to comprehensively estimate the effect of gender and race on overall survival in HNSCC. We constructed a retrospective cohort from the National Cancer Database for primary HNSCC of the larynx, hypopharynx, oral cavity, and oropharynx from 2010 to 2015. We used Kaplan-Meier curves and Cox proportional hazards regressions to calculate hazard ratios adjusting for treatment type, age, insurance, staging classifications, and comorbidities. Oral cavity cancer was significantly more common among Hispanic and White females compared to other sites. Female non-oropharyngeal HNSCC cases had better five-year overall survival than males (56.3% versus 54.4%, respectively), though Black females (52.8%) had poorer survival than both White (56.2%) and Hispanic (57.9%) males. There were significant differences in oropharyngeal cancer by HPV status. Notably, Black females with HPV-positive oropharyngeal OPSCC had far worse survival than any other race and gender group. These results persisted even when adjusting for potential mediating factors. Clearly gender is a significant prognosticator for HNSCC and has meaningful interactions with race. The distinct site distributions across gender and race reveal important insights into HNSCC among females. Taking into account these gender disparities while considering race is essential to providing appropriate care to head and neck patients and accurately counselling these individuals on prognosis and outcomes.

Genetic Mutations in Young Nonsmoking Patients With Oral Cavity Cancer: A Systematic Review.

OBJECTIVE: This investigation aims to review the known genetic mutations associated with oral cavity squamous cell carcinoma (OCSCC) in young adults with limited environmental risk factors (YLERs). DATA SOURCES: A comprehensive search strategy was designed to identify studies in MEDLINE (Ovid), Embase (Ovid), and Scopus from database inception to May 2017 that included adults ≤50 years of age with OCSCC and minimal tobacco use history (≤10 pack-years) who had their tumors genetically sequenced or mutational profiles analyzed. REVIEW METHODS: Identified articles were screened by 2 reviewers. Quality of evidence was graded by the MINORS criteria for case-control studies; other studies were graded by assigning a level of evidence for gene mutation literature. RESULTS: Thirteen studies met our inclusion criteria, and 130 patients met our criteria for age and tobacco history. TP53 was the most commonly evaluated gene (10 of 13 studies) and the most frequently observed mutation. One study reported that nonsmokers had significantly fewer TP53 mutations, while 9 studies found no difference in the prevalence of TP53 mutations. No other mutations were found specific to this cohort. CONCLUSIONS: TP53 mutations may occur at a similar rate in YLERs with OCSCC as compared with older patients or those with risk factors. However, few studies have aimed to characterize the genetic landscape of oral cavity tumors in this population, often with small sample sizes. Future studies are needed to explore unidentified genetic alterations leading to tumor susceptibility or alternative mechanisms of carcinogenesis.

Efficiency of microvascular free flap reconstructive surgery: An observational study.

OBJECTIVE: We aimed to assess operative workflow and efficiency in microvascular free flaps via a direct observational study based on Lean principles of quality improvement (QI). METHODS: Observers monitored the workflow of twenty-three free flaps. Pre-operative preparation and surgical duration was recorded with supplemental data provided from our institution's surgical tracking database. Traffic patterns of operating room (OR) staff were documented as "entries" and "exits" from the OR and classified by role and the reason that the entry or exit was required. Patient data was obtained via chart review. RESULTS: The mean surgical time was 9.0 h. Approximately 20% of OR time was dedicated to the pre-incision process, averaging 1.6 h per case. One third of entries and exits occurred during this period. In total, 180.2 surgical hours were observed during which 6215 "entries" and "exits" occurred. The mean number of entries and exits per case was 270; the most common reasons were supplies and communication. No association was observed between elapsed surgical time or total number of entries and exits with post-operative infection rates. CONCLUSION: Comprehensive observational workflow studies of free flaps are challenging to execute due to lengthy procedure times. At our high-volume institution, a significant portion of OR time is devoted to the pre-incision period, largely due to inadequate supply availability and pre-operative communication. These findings will serve as a foundation for QI interventions at our institution, while our observational model provides a broadly applicable framework for assessing surgical efficiency.

Molecular margins in head and neck cancer: Current techniques and future directions.

Complete tumor extirpation with clear surgical margins remains a central tenet of oncologic head and neck surgery. Rates of locoregional recurrence and survival are both significantly worse when clear margins are unable to be obtained. Current clinical practice relies on the use of frozen sections intra-operatively, followed by traditional histopathologic analysis post-operatively to assess the surgical margin. However, with improved understanding of tumor biology and advances in technology, new techniques have emerged to analyze margins at a molecular level. Such molecular margin analysis interrogates tissue for genetic, epigenetic, or proteomic changes that may belie tumor presence or aggressive features not captured by standard histopathologic techniques. Intra-operatively, this information may be used to guide resection, while post-operatively, it may help to stratify patients for adjuvant treatment. In this review, we summarize the current state of molecular margin analysis and describe directions for future research.

Duration of radiation therapy is associated with worse survival in head and neck cancer.

INTRODUCTION: Delays in radiation are multifactorial, frequent, and associated with poor outcomes. This study investigates the effect of both primary and adjuvant radiation therapy duration and their interaction with other measures of treatment delay on survival in head and neck squamous cell carcinoma (HNSCC). METHODS: We built a retrospective cohort using the National Cancer Database, consisting of primary oral cavity, hypopharynx, larynx and oropharynx squamous cell carcinoma without distant metastasis and with at least six weeks of radiation. The primary exposure was the duration of radiation therapy (DRT), and the primary outcome was death. We estimated the association between DRT and 5-year overall survival (OS) using Kaplan-Meier curves and hazard ratios (HRs) with Cox proportional hazard regression. RESULTS: In both primary (definitive) and adjuvant (post-surgical) radiation settings, increased DRT results in decreased survival. In the primary radiation cohort, 5-year OS was 59.7% [59.1%-60.3%] among those with 47-53 days DRT, which decreased significantly with each subsequent week to completion (81+ days: 38.4% [36.2%-40.7%]). In the surgical cohort, survival decreased 16.5% when DRT extended beyond 75 days (40-46 days: 68.2% [67.3%-69.1%] vs. 75+ days: 53.3% [50.1%-56.7%]). Multivariate analyses showed increased hazard of death with increased DRT (primary radiation: 81+ days HR: 1.69 [1.58-1.81]); surgical: 75+ days HR: 1.61 [1.37-1.88]), with effects intensifying when restricting to those receiving full-dose radiation. CONCLUSION: A prolonged DRT was associated with worse OS in head and neck cancer. Radiation treatment delays of even a week lead to a significant survival disadvantage. DRT had a stronger association with survival than time to initiation of postoperative adjuvant radiotherapy.

An Evaluation of the Program-Specific Paragraph in the Otolaryngology Residency Application.

OBJECTIVES/HYPOTHESIS: The recent addition of mandatory program-specific paragraphs within the personal statement during the otolaryngology match process has been controversial. It is unclear whether applicants customize these paragraphs for programs, or if they are largely uniform across applications. The objective of our study was to assess the degree of variability among program-specific paragraphs. STUDY DESIGN: Retrospective cohort analysis. METHODS: An analysis of deidentified program-specific paragraphs of 2016 otolaryngology residency applicants at two institutions was performed. Applicants who applied to both and had program-specific paragraphs were included. Paragraphs were assessed for 24 parameters, including quantitative content analysis. Subjective and objective similarity scores were assigned to each pair, using a five-point scale and Levenshtein distance function respectively. Differences between institutions were calculated using χ2 and two-sided t tests. RESULTS: Two hundred eight-five applications were reviewed, and 181 applied to both programs and had program-specific paragraphs. The median subjective similarity score among all paragraphs was "mildly similar" (2/5). The mean objective similarity score was 0.59. There were statistical differences between institutions in 13 parameters. One institution garnered more applicants who mentioned interest in research or global surgery (71.3% vs. 57.5%, P = .006; 17.7% vs. 4.4%, P < .0001, respectively), whereas the other attracted mention of clinical aspects and geographical ties (80.0% vs. 45.3%, P < .0001; 72.4% vs. 45.3%, P < .0001, respectively). CONCLUSIONS: Our study suggests that applicants tailor program-specific paragraphs to the individual residency programs. These findings may aid programs and students in understanding the role of this new element of the application. LEVEL OF EVIDENCE: 4 Laryngoscope, 2508-2513, 2018.