Association of Household Income at Diagnosis With Financial Toxicity, Health Utility, and Survival in Patients With Head and Neck Cancer.

Importance: While several studies have documented a link between socioeconomic status and survival in head and neck cancer, nearly all have used ecologic, community-based measures. Studies using more granular patient-level data are lacking. Objective: To determine the association of baseline annual household income with financial toxicity, health utility, and survival. Design, Setting, and Participants: This was a prospective cohort of adult patients with head and neck cancer treated at a tertiary cancer center in Toronto, Ontario, between September 17, 2015, and December 19, 2019. Data analysis was performed from April to December 2021. Exposures: Annual household income at time of diagnosis. Main Outcome and Measures: The primary outcome of interest was disease-free survival. Secondary outcomes included subjective financial toxicity, measured using the Financial Index of Toxicity (FIT) tool, and health utility, measured using the Health Utilities Index Mark 3. Cox proportional hazards models were used to estimate the association between household income and survival. Income was regressed onto log-transformed FIT scores using linear models. The association between income and health utility was explored using generalized linear models. Generalized estimating equations were used to account for patient-level clustering. Results: There were 555 patients (mean [SD] age, 62.7 [10.7] years; 109 [20%] women and 446 [80%] men) included in this cohort. Two-year disease-free survival was worse for patients in the bottom income quartile (<$30 000: 67%; 95% CI, 58%-78%) compared with the top quartile (≥$90 000: 88%; 95% CI, 83%-93%). In risk-adjusted models, patients in the bottom income quartile had inferior disease-free survival (adjusted hazard ratio, 2.13; 95% CI, 1.22-3.71) and overall survival (adjusted hazard ratio, 2.01; 95% CI, 0.94-4.29), when compared with patients in the highest quartile. The average FIT score was 22.6 in the lowest income quartile vs 11.7 in the highest quartile. In adjusted analysis, low-income patients had 12-month FIT scores that were, on average, 134% higher (worse) (95% CI, 16%-253%) than high-income patients. Similarly, health utility scores were, on average, 0.104 points lower (95% CI, 0.026-0.182) for low-income patients in adjusted analysis. Conclusions and Relevance: In this cohort study, patients with head and neck cancer with a household income less than CAD$30 000 experienced worse financial toxicity, health status, and disease-free survival. Significant disparities exist for Ontario's patients with head and neck cancer.

Construct Validity of the EuroQoL-5 Dimension and the Health Utilities Index in Head and Neck Cancer.

OBJECTIVE: The objective of this study was to evaluate the construct validity of 2 health utility instruments-the EuroQoL-5 Dimension (EQ-5D) and the Health Utilities Index-Mark 3 (HUI-3)-and to compare them with disease-specific measures in patients with head and neck cancer. STUDY DESIGN: Prospective cross-sectional analysis. SETTING: Princess Margaret Cancer Centre. METHODS: Patients were administered the EQ-5D, HUI-3, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its head and neck cancer module (EORTC QLQ-H&N35), and the University of Washington Quality of Life Questionnaire (UWQoL). Several a priori expected relations were examined. The correlative and discriminative properties of the various instruments were examined. RESULTS: A total of 209 patients completed the 4 questionnaires. A significant ceiling effect was observed among EQ-5D responses (23% reported a maximum score of 1). The EQ-5D (rho = 0.79) and HUI-3 (rho = 0.60) had a strong correlation with the social-emotional domain of the UWQoL. The EQ-5D had a moderate correlation with the physical domain of the UWQoL (rho = 0.42), whereas the HUI-3 had a weak correlation (rho = 0.29). The EQ-5D and HUI-3 were able to distinguish among levels of health severity measured on the EORTC QLQ-C30 though not the QLQ-H&N35. Comparatively, the UWQoL was able to distinguish levels of disease severity on the EORTC QLQ-C30 and QLQ-H&N35. CONCLUSION: The results of this study demonstrate that disease-specific domains from head and neck quality-of-life instruments are not strongly correlated with the EQ-5D and HUI-3. Consideration should be put toward development of a disease-specific preference-based measure for health economic evaluation. LEVEL OF EVIDENCE: 4.

The Edmonton Symptom Assessment System: A narrative review of a standardized symptom assessment tool in head and neck oncology.

OBJECTIVE: Symptom burden is common in head and neck cancer patients though it frequently remains undetected and untreated. The Edmonton Symptom Assessment System - revised version (ESAS-r) is a generic symptom scale deployed in many outpatient settings worldwide. The ESAS-r is meant to improve symptom detection and management. We sought to review the ESAS-r and its psychometric properties in a head and neck oncology population. METHODS: Narrative Review. RESULTS: Over the past 30 years, the ESAS-r has emerged as one of the most used symptom scales for cancer patients. Its psychometric properties in a heterogenous cancer population are well supported, proving to be reliable and valid in a variety of settings. The linking of ESAS-r scores with Ontario administrative health data has led to a detailed assessment of validity in head and neck cancer. The ESAS-r can discriminate between high and low levels of symptom burden and is responsive to change over time in this patient population. ESAS-r scores have also been shown to be a strong predictor of future emergency department use and unplanned hospitalization in head and neck cancer patients. CONCLUSIONS: The ESAS-r is reliable and valid in the head and neck cancer population and may serve as a useful clinical endpoint in research studies.

A cost-utility analysis comparing CT surveillance, PET-CT surveillance, and planned postradiation neck dissection for advanced nodal HPV-positive oropharyngeal cancer.

BACKGROUND: The cost utility of image-guided surveillance using computed tomography (CT) and positron emission tomography (PET)-CT to planned postradiation neck dissection (PRND) was compared for the management of advanced nodal human papillomavirus-positive oropharyngeal cancer following chemoradiation. METHODS: A universal payer perspective was adopted. A Markov model was designed to simulate four treatment approaches with 3-month cycles over a lifetime horizon: 1) CT surveillance, 2) standard PET-CT surveillance, 3) a novel PET-CT approach with repeat PET at 6 months postchemoradiation for equivocal responders, and 4) PRND. Parameters including probabilities of CT nodal progression/resolution, PET avidity, recurrence, and survival were obtained from the literature. Costs were reported in 2019 Canadian dollars and utilities were expressed in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses were performed to evaluate model uncertainty. RESULTS: PET-CT surveillance dominated CT surveillance and PRND in the base case scenario, and the novel PET-CT approach was the most cost-effective strategy across a wide range of variables tested in one-way sensitivity analysis. On probabilistic sensitivity analysis, novel PET-CT surveillance was the most cost-effective strategy in 78.1% of model iterations at a willingness-to-pay of $50,000/QALYs. Novel PET-CT surveillance resulted in a 49% lower rate of neck dissection compared with traditional PET-CT, and yielded an incremental benefit of 0.14 QALYs with average cost savings of $1309. CONCLUSIONS: Image-guided surveillance including PET-CT and CT are more cost effective than PRND. The novel PET-CT approach with repeat PET for equivocal responders was the dominant strategy and yielded both higher benefit and lower costs compared with standard PET-CT surveillance.

Elective neck dissection versus positron emission tomography-computed tomography-guided management of the neck in clinically node-negative early oral cavity cancer: A cost-utility analysis.

BACKGROUND: In early oral cavity cancer, elective neck dissection (END) for the clinically node-negative (cN0) neck improves survival compared with observation. This paradigm has been challenged recently by the use of positron emission tomography-computed tomography (PET-CT) imaging in the cN0 neck. To inform this debate, we performed an economic evaluation comparing PET-CT-guided therapy with routine END in the cN0 neck. METHODS: Patients with T1-2N0 lateralized oral tongue cancer were analyzed. A Markov model over a 40-year time horizon simulated treatment, disease recurrence, and survival from a US health care payer perspective. Model parameters were derived from a review of the literature. RESULTS: The END strategy was dominant, with a cost savings of $1576.30 USD, an increase of 0.055 quality-adjusted life years (QALYs), a net monetary benefit of $4303 USD, and a 0.22 life-year advantage. END was sensitive to variation in cost and utilities in deterministic and probabilistic sensitivity analyses. PET-CT became the preferred strategy when decreasing occult nodal disease to 18% and increasing the negative predictive value (NPV) of PET-CT to 89% in 1-way sensitivity analyses. In probabilistic sensitivity analysis, assuming a cost effectiveness threshold of $50,000 USD/QALY, END was dominant in 64% of simulations and cost effective in 69.8%. CONCLUSION: END is a cost-effective strategy compared with PET-CT in patients who have node-negative oral cancer. Although lower PET standardized uptake value thresholds would result in fewer false negatives and improved NPV, it is still uncertain that PET-CT would be cost effective, as this would likely result in more false positive tests.

Decision Modeling for Economic Evaluation in Otolaryngology-Head and Neck Surgery: Review of Techniques.

Decision making in health care is complex, and substantial uncertainty can be involved. Structured, systematic approaches to the integration of available evidence, assessment of uncertainty, and determination of choice are of significant benefit in an era of "value-based care." This is especially true for otolaryngology-head and neck surgery, where technological advancements are frequent and applicable to an array of subspecialties. Decision analysis aims to achieve these goals through various modeling techniques, including (1) decision trees, (2) Markov process, (3) microsimulation, and (4) discrete event simulation. While decision models have been used for decades, many clinicians and researchers continue to have difficulty deciphering them. In this review, we present an overview of various decision analysis modeling techniques, their purposes, how they can be interpreted, and commonly used syntax to promote understanding and use of these approaches. Throughout, we provide a sample research question to facilitate discussion of the advantages and disadvantages of each technique.

Needs assessment for a decision support tool in oral cancer requiring major resection and reconstruction: a mixed-methods study protocol.

INTRODUCTION: Advanced oral cancer and its ensuing treatment engenders significant morbidity and mortality. Patients are often elderly with significant comorbidities. Toxicities associated with surgical resection can be devastating and they are often highlighted by patients as impactful. Given the potential for suboptimal oncological and functional outcomes in this vulnerable patient population, promotion and performance of shared decision making (SDM) is crucial.Decision aids (DAs) are useful instruments for facilitating the SDM process by presenting patients with up-to-date evidence regarding risks, benefits and the possible postoperative course. Importantly, DAs also help elicit and clarify patient values and preferences. The use of DAs in cancer treatment has been shown to reduce decisional conflict and increase SDM. No DAs for oral cavity cancer have yet been developed.This study endeavours to answer the question: Is there a patient or surgeon driven need for development and implementation of a DA for adult patients considering major surgery for oral cancer? METHODS AND ANALYSIS: This study is the first step in a multiphase investigation of SDM during major head and neck surgery. It is a multi-institutional convergent parallel mixed-methods needs assessment study. Patients and surgeon dyads will be recruited to complete questionnaires related to their perception of the SDM process (nine-item Shared Decision-Making Questionnaire, SDM-Q-9 and SDM-Q-Doc) and to take part in semistructured interviews. Patients will also complete questionnaires examining decisional self-efficacy (Ottawa Decision Self-Efficacy Scale) and decisional conflict (Decisional Conflict Scale). Questionnaires will be completed at time of recruitment and will be used to assess the current level of SDM, self-efficacy and conflict in this setting. Thematic analysis will be used to analyse transcripts of interviews. Quantitative and qualitative components of the study will be integrated through triangulation, with matrix developed to promote visualisation of the data. ETHICS AND DISSEMINATION: This study has been approved by the research ethics boards of the Nova Scotia Health Authority (Halifax, Nova Scotia) and the University Health Network (Toronto, Ontario). Dissemination to clinicians will be through traditional approaches and creation of a head and neck cancer SDM website. Dissemination to patients will include a section within the website, patient advocacy groups and postings within clinical environments.

Predictors of surgical readmission, unplanned hospitalization and emergency department use in head and neck oncology: A systematic review.

OBJECTIVE: To identify predictors of unplanned hospitalization and emergency department (ED) use among head and neck oncology patients. METHODS: Peer reviewed publications were identified through a systematic search of MEDLINE, Embase and Cochrane CENTRAL. Studies describing a cohort of HNC patients that detailed predictors of unplanned hospitalization or ED use in risk-adjusted models were eligible for inclusion. The methodologic quality of included studies was assessed using the Quality In Prognostic Studies (QUIPS) tool and an adapted version of the GRADE framework. RESULTS: Of the 932 articles identified, 39 studies met our inclusion criteria with 31/39 describing predictors of surgical readmission and 10/39 describing predictors of ED use or unplanned hospitalization during radiation/chemoradiation treatment. Risk factors were classified into either 'patient-related', 'cancer severity' or 'process' factors. In the subset of studies looking at readmission following surgery wound complications (10/14 studies), presence of comorbidity (16/28 studies), low socioeconomic status (8/17 studies), cancer stage (9/14 studies), and prolonged hospital stay (7/18 studies) were the variables most frequently associated with readmission on multivariable analysis. Presence of comorbidity (6/10) and chemotherapy use (4/10) were more frequently associated with ED use and unplanned hospitalization. CONCLUSIONS: Several consistent predictors have been identified across a variety of studies. This work is a critical first step towards the development of readmission and ED prediction models. It also enables meaningful comparison of hospital readmission rates with risk adjustment in HNC patients.

Nonsurgical management of resectable oral cavity cancer in the wake of COVID-19: A rapid review and meta-analysis.

OBJECTIVE: Surgery is the preferred treatment modality for oral squamous cell carcinoma (OSCC). However, due to limited resources, re-assessment of treatment paradigms in the wake of the Coronavirus Disease 2019 (COVID-19) pandemic is urgently required. In this rapid review, we described contemporary oncological outcomes for OSCC using non-surgical modalities. METHODS: A systematic literature search was conducted for articles published between January 1, 2010 and April 1, 2020 on MEDLINE and Cochrane CENTRAL. Studies were included if they contained patients with OSCC treated with either neoadjuvant, induction, or definitive radiotherapy, chemotherapy, immunotherapy, or combination thereof, and an outcome of overall survival. RESULTS: In total, 36 articles were included. Definitive radiotherapy or chemoradiotherapy were the focus of 18 articles and neoadjuvant chemotherapy or chemoradiotherapy were the focus of the other 18 articles. In early stage OSCC, definitive radiotherapy, with or without concurrent chemotherapy, was associated with a significantly increased hazard of death compared to definitive surgery (HR: 2.39, 95% CI: 1.56-3.67, I2: 63%). The hazard of death was non-significantly increased with definitive chemoradiotherapy in studies excluding early disease (HR: 1.98, 95% CI: 0.85-4.64, I2: 84%). Two recent randomized control trials have been conducted, demonstrating no survival advantage to neoadjuvant chemotherapy. CONCLUSION: This review suggests that primary radiotherapy and chemoradiotherapy are inferior to surgical management for OSCC. Strategies for surgical delay warranting consideration are sparse, but may include several neoadjuvant regimens, recognizing these regimens may not offer a survival benefit over definitive surgery alone.