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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.

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.

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.

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.

Objective The goal of this study is to determine the effect of primary surgery vs radiotherapy (RT) on overall survival (OS) in patients with early stage oral cavity squamous cell carcinoma (OCSCC). In addition, this study attempts to identify factors associated with receiving primary RT. Study Design Retrospective cohort study. Setting National Cancer Database (NCDB, 2004-2013). Subjects and Methods Reviewing the NCDB from 2004 to 2013, patients with early stage I to II OCSCC were identified. Kaplan-Meier estimates of survival, Cox regression analysis, and propensity score matching were used to examine differences in OS between primary surgery and primary RT. Multivariable logistic regression analysis was performed to identify factors associated with primary RT. Results Of the 20,779 patients included in the study, 95.4% (19,823 patients) underwent primary surgery and 4.6% (956 patients) underwent primary RT. After adjusting for covariates, primary RT was associated with an increased risk of mortality (adjusted hazard ratio [aHR], 1.97; 99% confidence interval [CI], 1.74-2.22). On multivariable analysis, factors associated with primary RT included age ≥70 years, black race, Medicaid or Medicare insurance, no insurance, oral cavity subsite other than tongue, clinical stage II disease, low-volume treatment facilities, and earlier treatment year. Conclusion Primary RT for early stage OCSCC is associated with increased mortality. Approximately 5% of patients receive primary RT; however, this percentage is decreasing. Patients at highest risk for receiving primary RT include those who are elderly, black, with public insurance, and treated at low-volume facilities.

Noncompliance with federal regulations, as monitored through institutional review boards for the ethical conduct of clinical research, can occur, even to seasoned investigators. The cause of this noncompliance can be that an investigator is overloaded, does not know the regulations, or does not take the time to pay attention to the details. Sometimes it happens just because of inevitable human error that can befall us all at any time. The authors begin by citing the inherent differences between clinical practice and clinical research. This is followed by an illustration of common noncompliance errors, with examples, followed by general and specific concepts and methods to minimize noncompliance events. The objective of this article is to condense the myriad details involved in conducting clinical research into a set of manageable recommendations that can be recalled easily before and during the research. The material supporting these recommendations comes from years of institutional review board work at several institutions and consultation with experienced principal investigators and their research coordinators.

"Comparative effectiveness research" (CER) is not a new concept; however, recently it has been popularized as a method to develop scientifically sound actionable data by which patients, physicians, payers, and policymakers may make informed health care decisions. Fundamental to CER is that the comparative data are derived from large diverse populations of patients assembled from point-of-care general primary care practices and that measured outcomes include patient value judgments. The challenge is to obtain scientifically valid data to be acted upon by decision-making stakeholders with potentially quite diversely different agenda. The process requires very thoughtful research designs modulated by complex statistical and analytic methods. This article is composed of a guiding narrative with an extensive set of tables outlining many of the details required in performing and understanding CER. It ends with short discussions of three example papers, limitations of the method, and how a practicing physician may view such reports.

With recent changes in the landscape of health care, clinical practice guidelines (CPGs) have proliferated. Attitudes about guidelines differ considerably, forming 2 competing viewpoints with considerable tension between them. Some feel CPGs are unneeded or are efforts to create automated "cookie cutter" medical practice; at best, they are perceived as suggestions that may be altered by experience. Others feel they are mandates that must be followed to the letter. This article attempts to explain how and why we have arrived at this point and to explain the origins of the differing viewpoints. We begin by describing the 2 viewpoints and proceed to define the origin of medicine as a profession and to chronicle the evolution of health insurance, medical education, and scientific methods for evaluating evidence.

Conjunctive consolidation, one method of multivariable analysis by arranging data into clusters, is intuitive and transparent. An unexpected consequence in writing this article was the discovery of just how useful it is in critically analyzing articles and in designing new projects. It has stimulated a fresh understanding as to the value of multivariable thinking in all clinical research. This article is organized into the sequential steps for performing conjunctive consolidation for critically analyzing an article of interest and for completing the process, pending all required data are available. Investigators, particularly those who perform clinical research, should consider conjunctive consolidation as a valuable method of multivariable analysis with which to report data.