Publications by authors named "John D Cramer"

46 Publications

Quality metrics for head and neck cancer treated with definitive radiotherapy and/or chemotherapy.

Head Neck 2021 Feb 17. Epub 2021 Feb 17.

Department of Otolaryngology - Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan, USA.

Background: The standardization of quality measures has been key in advancing the aims of the National Quality Forum established to improve health outcomes.

Methods: The National Cancer Database was used to identify eligible patients. Two quality metrics were evaluated including time to treatment initiation (TTI) and chemotherapy in locoregionally head and neck squamous cell carcinoma (HNSCC).

Results: TTI was significantly associated with mortality reflected by a hazard ratio (HR) of 1.13 for 60-90 days of TTI (95% CI 1.08-1.17), 1.19 for >90 days of TTI (95% CI 1.13-1.26). Patients with locoregionally advanced HNSCC had an 87% adherence to chemotherapy, which correlated with reduced mortality (HR 0.57; 95% CI 0.55-0.59). Patients treated at high quality centers had a 9% increase in survival (HR 0.91; 95% CI 0.88-0.93).

Conclusion: We identified that both TTI and chemotherapy for locoregionally advanced HNSCC meet criteria for valid quality metrics potentially suitable for national adoption.
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http://dx.doi.org/10.1002/hed.26640DOI Listing
February 2021

Acute epiglottitis: Analysis of U.S. mortality trends from 1979 to 2017.

Am J Otolaryngol 2021 Mar-Apr;42(2):102882. Epub 2021 Jan 4.

Department of Otolaryngology - Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI, USA; Barbara Ann Karmanos Cancer Institute, Detroit, MI, USA.

Purpose: Evaluate trends in mortality due to acute epiglottitis before and after adoption of Haemophilus influenza Type b vaccination (Hib) in pediatric and adult populations.

Materials And Methods: Patients who died from acute epiglottis from 1979 to 2017 identified using National Vital Statistics System. Mortality rates calculated using age-adjusted US census data expressed in rate per 100,000 individuals. Trends analyzed using the National Cancer Institute Joinpoint Regression Program (version 4.7.0; Bethesda, Maryland).

Results: 1187 epiglottitis-related deaths were identified over thirty-nine years. Total deaths decreased from 65 in 1979 to 15 in 2017. Adult deaths accounted for 63.5% and decreased from 0.015 per 100,000 individuals (24 deaths) in 1979 to 0.006 per 100,000 individuals (14 deaths) in 2017. Best fitting log-liner regression model showed APC of -3.5% (95% CI, -4.2 to -2.7%) from 1979 to 2017. Pediatric and adolescent deaths accounted for 443 (37.3%) deaths, decreasing from 0.064 per 100,000 individuals (41 deaths) in 1979 to 0.001 per 100,000 individuals (1 death) in 2017. APC was -11.1% (95% CI, -13.8% to -8.3%) in 1979 to 1990; 46.5% (95% CI, -16.6% to 157.3%) in 1990 to 1993; -61.6% (95% CI, -88% to 23%) in 1993 to 1996; and 1.1% (95% CI, -2.4% to 4.7%) in 1996 to 2017.

Conclusions: Mortality from acute epiglottitis decreased after widespread adoption of Hib vaccination in the US. Adults are now more likely than children to die of acute epiglottitis. Further research including multi-institutional cohort studies must be done to elucidate causative factors contributing to remaining cases of mortality.
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http://dx.doi.org/10.1016/j.amjoto.2020.102882DOI Listing
January 2021

Intraoperative Sentinel Events in the Era of Surgical Safety Checklists: Results of a National Survey.

OTO Open 2020 Oct-Dec;4(4):2473974X20975731. Epub 2020 Dec 9.

University of Michigan Medical School, Ann Arbor, Michigan, USA.

Objective: Despite the implementation of advanced health care safety systems including checklists, preventable perioperative sentinel events continue to occur and cause patient harm, disability, and death. We report on findings relating to otolaryngology practices with surgical safety checklists, the scope of intraoperative sentinel events, and institutional and personal response to these events.

Study Design: Survey study.

Setting: Anonymous online survey of otolaryngologists.

Methods: Members of the American Academy of Otolaryngology-Head and Neck Surgery were asked about intraoperative sentinel events, surgical safety checklist practices, fire safety, and the response to patient safety events.

Results: In total, 543 otolaryngologists responded to the survey (response rate 4.9% = 543/11,188). The use of surgical safety checklists was reported by 511 (98.6%) respondents. At least 1 patient safety event in the past 10 years was reported by 131 (25.2%) respondents; medication errors were the most commonly reported (66 [12.7%] respondents). Wrong site/patient/procedure events were reported by 38 (7.3%) respondents, retained surgical items by 33 (6.4%), and operating room fire by 18 (3.5%). Although 414 (79.9%) respondents felt that time-outs before the case have been the single most impactful checklist component to prevent serious patient safety events, several respondents also voiced frustrations with the administrative burden.

Conclusion: Surgical safety checklists are widely used in otolaryngology and are generally acknowledged as the most effective intervention to reduce patient safety events; nonetheless, intraoperative sentinel events do continue to occur. Understanding the scope, causes, and response to these events may help to prioritize resources to guide quality improvement initiatives in surgical safety practices.
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http://dx.doi.org/10.1177/2473974X20975731DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7731722PMC
December 2020

Tracheostomy During the COVID-19 Pandemic: Comparison of International Perioperative Care Protocols and Practices in 26 Countries.

Otolaryngol Head Neck Surg 2020 Nov 3:194599820961985. Epub 2020 Nov 3.

Department of Otolaryngology-Head & Neck Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has led to a global surge in critically ill patients requiring invasive mechanical ventilation, some of whom may benefit from tracheostomy. Decisions on if, when, and how to perform tracheostomy in patients with COVID-19 have major implications for patients, clinicians, and hospitals. We investigated the tracheostomy protocols and practices that institutions around the world have put into place in response to the COVID-19 pandemic.

Data Sources: Protocols for tracheostomy in patients with severe acute respiratory syndrome coronavirus 2 infection from individual institutions (n = 59) were obtained from the United States and 25 other countries, including data from several low- and middle-income countries, 23 published or society-endorsed protocols, and 36 institutional protocols.

Review Methods: The comparative document analysis involved cross-sectional review of institutional protocols and practices. Data sources were analyzed for timing of tracheostomy, contraindications, preoperative testing, personal protective equipment (PPE), surgical technique, and postoperative management.

Conclusions: Timing of tracheostomy varied from 3 to >21 days, with over 90% of protocols recommending 14 days of intubation prior to tracheostomy. Most protocols advocate delaying tracheostomy until COVID-19 testing was negative. All protocols involved use of N95 or higher PPE. Both open and percutaneous techniques were reported. Timing of tracheostomy changes ranged from 5 to >30 days postoperatively, sometimes contingent on negative COVID-19 test results.

Implications For Practice: Wide variation exists in tracheostomy protocols, reflecting geographical variation, different resource constraints, and limited data to drive evidence-based care standards. Findings presented herein may provide reference points and a framework for evolving care standards.
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http://dx.doi.org/10.1177/0194599820961985DOI Listing
November 2020

Explaining Racial Disparities in Surgically Treated Head and Neck Cancer.

Laryngoscope 2020 Oct 27. Epub 2020 Oct 27.

Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan, U.S.A.

Objectives/hypothesis: To assess the causative factors that contribute to racial disparities in head and neck squamous cell carcinoma (HNSCC) and establish the role of hospital factors in racial disparities.

Study Design: Retrospective database analysis.

Methods: Patients with surgically treated HNSCC were identified using the National Cancer Database (2004-2014). Logistic and proportional-hazard regression models were used to characterize the factors that contribute to racial disparities. Differences in quality of care received were compared among black and white patients using previously validated metrics.

Results: We identified 69,186 eligible patients. Black patients had a 48% higher mortality than white patients (HR 1.48; 95% confidence interval [CI], 1.41-1.54). Black patients had a lower mean quality score (67.6%; 95% CI, 66.8%-69.4%) compared with white patients (71.2%: 95% CI, 71.0%-71.4%) for five quality metrics. After adjusting for differences in patient, oncologic, and hospital factors we were able to explain 60% of the excess mortality for black patients. Oncologic factors at presentation accounted for 57.7% of observed mortality differences, whereas hospital characteristics and quality of care accounted for 11.5%. After adjusting for these factors, black patients still had a 19% higher mortality (HR 1.19; 95% CI, 1.14-1.24).

Conclusions: Oncologic factors at presentation are a major contributor to racial disparities in outcomes for HNSCC. Hospital factors, such as quality, volume, and safety-net status, constitute a minor factor in the mortality difference. Resolving existing disparities will require detecting head and neck cancer at an earlier stage and improving the quality of care for black patients.

Level Of Evidence: 3. Laryngoscope, 2020.
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http://dx.doi.org/10.1002/lary.29197DOI Listing
October 2020

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

Otolaryngol Head Neck Surg 2020 Oct 13:194599820960728. Epub 2020 Oct 13.

American Board of Otolaryngology-Head and Neck Surgery, Houston, Texas, USA.

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.
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http://dx.doi.org/10.1177/0194599820960728DOI Listing
October 2020

Multidisciplinary Safety Recommendations After Tracheostomy During COVID-19 Pandemic: State of the Art Review.

Otolaryngol Head Neck Surg 2020 Sep 22:194599820961990. Epub 2020 Sep 22.

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA; Global Tracheostomy Collaborative, Raleigh, North Carolina, USA.

Objective: In the chronic phase of the COVID-19 pandemic, questions have arisen regarding the care of patients with a tracheostomy and downstream management. This review addresses gaps in the literature regarding posttracheostomy 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 the care of patients with a tracheostomy was reviewed, including consensus statements, clinical practice guidelines, institutional guidance, and scientific literature on COVID-19 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 a tracheostomy during the COVID-19 pandemic are multifaceted, encompassing precautions during aerosol-generating procedures; minimizing exposure risks to health care 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 recommendations for personal protective equipment, equipment, care protocols, and personnel.

Implications For Practice: Treatment of patients with a tracheostomy in the COVID-19 pandemic requires foresight and may rival procedural considerations in tracheostomy in their complexity. By considering patient-specific factors, mitigating transmission risks, optimizing the clinical environment, and detecting late manifestations of severe COVID-19, clinicians can ensure due vigilance and quality care.
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http://dx.doi.org/10.1177/0194599820961990DOI Listing
September 2020

Nonopioid, Multimodal Analgesia as First-line Therapy After Otolaryngology Operations: Primer on Nonsteroidal Anti-inflammatory Drugs (NSAIDs).

Otolaryngol Head Neck Surg 2020 Aug 18:194599820947013. Epub 2020 Aug 18.

Department of Otolaryngology-Head & Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

Objective: To offer pragmatic, evidence-informed advice on nonsteroidal anti-inflammatory drugs (NSAIDs) as first-line therapy after surgery. This companion to the American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS) clinical practice guideline (CPG), "Opioid Prescribing for Analgesia After Common Otolaryngology Operations," presents data on potency, bleeding risk, and adverse effects for ibuprofen, naproxen, ketorolac, meloxicam, and celecoxib.

Data Sources: National Guidelines Clearinghouse, CMA Infobase, National Library of Guidelines, NICE, SIGN, New Zealand Guidelines Group, Australian National Health and Medical, Research Council, TRIP database, PubMed, Guidelines International Network, Cochrane Library, EMBASE, CINAHL, BIOSIS Previews, ISI Web of Science, AHRQ, and HSTAT.

Review Methods: AAO-HNS opioid CPG literature search strategy, supplemented by PubMed/MEDLINE searches on NSAIDs, emphasizing systematic reviews and randomized controlled trials.

Conclusion: NSAIDs provide highly effective analgesia for postoperative pain, particularly when combined with acetaminophen. Inconsistent use of nonopioid regimens arises from common misconceptions that NSAIDs are less potent analgesics than opioids and have an unacceptable risk of bleeding. To the contrary, multimodal analgesia (combining 500 mg acetaminophen and 200 mg ibuprofen) is significantly more effective analgesia than opioid regimens (15 mg oxycodone with acetaminophen). Furthermore, selective cyclooxygenase-2 inhibition reliably circumvents antiplatelet effects.

Implications For Practice: The combination of NSAIDs and acetaminophen provides more effective postoperative pain control with greater safety than opioid-based regimens. The AAO-HNS opioid prescribing CPG therefore prioritizes multimodal, nonopioid analgesia as first-line therapy, recommending that opioids be reserved for severe or refractory pain. This state-of-the-art review provides strategies for safely incorporating NSAIDs into acute postoperative pain regimens.
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http://dx.doi.org/10.1177/0194599820947013DOI Listing
August 2020

Quality Improvement in Pain Medicine.

Otolaryngol Clin North Am 2020 Oct 16;53(5):905-913. Epub 2020 Jul 16.

Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, 4201 St Antoine Street, UHC 5E, Detroit, MI 48201, USA. Electronic address:

In the last 30 years, pain control in the United States has undergone several evolutions impacting the care of surgical patients. More recently, safe pain control has been a subject of quality improvement efforts by otolaryngologists focusing on minimizing opioid consumption. This article discusses the rising overprescription of opioids, influenced by legislation and governmental agencies, and the steps taken to correct and reform policies to decrease the amount of opioids prescribed. Lastly, specific institutional examples of quality improvement protocols implemented to help decrease opioid consumption and prescription are discussed.
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http://dx.doi.org/10.1016/j.otc.2020.05.020DOI Listing
October 2020

Completion lymph node dissection for merkel cell carcinoma.

Am J Surg 2020 10 15;220(4):982-986. Epub 2020 Feb 15.

Department of Otolaryngology - Head and Neck Surgery, UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Background: Sentinel lymph node biopsy (SLNB) is widely used for Merkel cell carcinoma (MCC), however in SLNB positive MCC the role of completion lymph node dissection (CLND) with or without adjuvant radiation therapy is unclear.

Objective: Our goal was to determine the impact of CLND and adjuvant radiation therapy on survival in SLNB positive MCC.

Materials And Methods: We examined 447 patients with MCC with a positive SLNB in the National Cancer Data Base from 2012 to 2015. We compared patients who underwent CLND versus observation with or without adjuvant radiation.

Results: Compared with CLND and adjuvant radiation (reference) treatment with observation (HR 3.54, CI 1.36-9.18) or CLND alone (HR 2.54, CI 1.03-6.27) were associated with worse overall survival after adjusting for clinicopathologic differences. In contrast treatment with adjuvant radiation alone without CLND was not associated with worse overall survival (HR 1.70, CI 0.74-3.92) compared with CLND and adjuvant radiation (reference).

Conclusions: In SLNB positive MCC, CLND alone is associated with worse survival compared with treatment with adjuvant radiation or both CLND and adjuvant radiation.
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http://dx.doi.org/10.1016/j.amjsurg.2020.02.018DOI Listing
October 2020

Predictors of occult lymph node metastases in lip cancer.

Am J Otolaryngol 2020 May - Jun;41(3):102419. Epub 2020 Feb 7.

Department of Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, MI, USA. Electronic address:

Objective: The incidence of lymph node metastases (LNM) in squamous cell carcinoma of the lip is modest (8%), making it challenging to identify patients that may benefit from elective pathologic staging evaluation of the neck. We evaluated predictors of LNM in patients with lip cancer in order to potentially refine selection of patients for pathologic staging evaluation of the neck.

Study Design: Retrospective cohort study.

Subjects: Clinically N0 patients with squamous cell carcinoma of the lip that underwent definitive surgical resection and pathologic evaluation of lymph node metastases in the National Cancer Data Base from 2006 to 2013.

Methods: Multivariable binomial logistic-regression was used to assess the relationship between occult pathologic lymph node metastasis and potential preoperative predictors including; patient demographics, T-stage, location, and pathologic details.

Results: Among 786 patients the overall rate of LNM was 12.1%. Patients were more likely to have LNM with T2 (odds ratio (OR) 2.05; (95% confidence interval (CI) 1.19-3.54) or T3-4 (OR 2.36; CI 1.32-4.22) moderately differentiated (OR 2.65; CI 1.30-5.38) or poorly differentiated (OR 4.37; CI 1.97-9.71), or involvement of the mucosal surface (OR 1.82; CI 1.09-3.03). We created a prediction model based on proportional odd ratios from multivariant binomial logistic-regression analysis from statistically significant factors; incorporating T2-4, moderate/poorly differentiated, or mucosal site.

Conclusion: Our prediction model found that patients with two or more risk factors were the best candidates for elective pathologic nodal evaluation.
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http://dx.doi.org/10.1016/j.amjoto.2020.102419DOI Listing
September 2020

Acute Upper Airway Obstruction.

N Engl J Med 2020 02;382(8):783

Johns Hopkins University School of Medicine, Baltimore, MD.

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http://dx.doi.org/10.1056/NEJMc1916484DOI Listing
February 2020

Minimizing Excess Opioid Prescribing for Acute Postoperative Pain.

JAMA Otolaryngol Head Neck Surg 2020 03;146(3):228-230

Department of Otolaryngology-Head and Neck Surgery, University of Illinois College of Medicine, Chicago.

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http://dx.doi.org/10.1001/jamaoto.2019.4209DOI Listing
March 2020

Object-Related Aspiration Deaths in Children and Adolescents in the United States, 1968 to 2017.

JAMA 2019 11;322(20):2020-2022

Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.

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http://dx.doi.org/10.1001/jama.2019.15375DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6902204PMC
November 2019

Immunotherapy for head and neck cancer: Recent advances and future directions.

Oral Oncol 2019 12 1;99:104460. Epub 2019 Nov 1.

Department of Otolaryngology, University of Pittsburgh, Pittsburgh, PA, USA; Department of Immunology, University of Pittsburgh, Pittsburgh, PA, USA; UPMC Hillman Cancer Center, Pittsburgh, PA, USA. Electronic address:

Three randomized phase III trials have now conclusively proven that exposure to a PD-1 inhibitor prolongs survival in recurrent/metastatic (R/M) HNSCC, and it is clear that such agents should be used in the management of all patients who do not have contraindications to their use. Two of these phase III randomized trials showed that the anti-PD1 antibodies nivolumab and pembrolizumab were superior to investigators' choice chemotherapy in second-line platinum-refractory R/M HNSCC. Recently, a third phase III randomized trial, KEYNOTE-048, showed that pembrolizumab with chemotherapy was superior to the EXTREME regimen (cis- or carboplatin, 5-fluorouracil (5-FU) and cetuximab) in all patients, and pembrolizumab monotherapy was superior in patients whose tumors express PD-L1 in first-line R/M HNSCC. Pembrolizumab is now approved as monotherapy in PD-L1 expressing disease (combined positive score ≥1) or in combination with chemotherapy for all patients with R/M HNSCC. Thus, PD-L1 biomarker testing will be routinely used in R/M HNSCC, and this employs a scoring system that incorporates immune cell staining, referred to as the combined positive score (CPS). Additionally, for the 85% of patients with PD-L1 CPS ≥1, clinical judgment will guide the choice of pembrolizumab monotherapy or pembrolizumab plus chemotherapy, until more detailed clinical data are forthcoming to better inform this decision. In this article we discuss the clinical trials leading to these therapeutic advances and we will review initial results from clinical trials in previously untreated, locally advanced disease, and those using novel combinations of checkpoint inhibitors, co-stimulatory agonists, and therapeutic vaccines.
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http://dx.doi.org/10.1016/j.oraloncology.2019.104460DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749717PMC
December 2019

Postoperative radiation therapy vs observation for pN1 oral cavity squamous cell carcinoma.

Head Neck 2019 12 7;41(12):4136-4142. Epub 2019 Oct 7.

Department of Otolaryngology - Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan.

Background: American Society of Clinical Oncology guidelines recommend that the decision to give postoperative radiotherapy (PORT) for pN1 oral cavity squamous cell carcinoma (OCSCC) without other adverse features be based on the adequacy of the neck dissection (<18 or ≥18 nodes).

Methods: We conducted a cohort study of the National Cancer Database examining how PORT affects survival. We stratified analyses by the adequacy of the neck dissection and lymph node (LN) size.

Results: Our cohort comprised 1909 patients (898 received PORT). PORT conferred a survival benefit in the overall cohort (adjusted hazard ratio 0.82, 95% CI 0.72-0.94). There was similar benefit in patients receiving inadequate and adequate neck dissections. Patients with >10 mm LN metastasis derived greater benefit compared with patients with smaller metastases.

Conclusions: In pN1 OCSCC without other adverse features, the size of the LN metastases may predict benefit from PORT, whereas the adequacy of the neck dissection may not.
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http://dx.doi.org/10.1002/hed.25958DOI Listing
December 2019

The changing therapeutic landscape of head and neck cancer.

Nat Rev Clin Oncol 2019 11 12;16(11):669-683. Epub 2019 Jun 12.

Department of Otolaryngology, University of Pittsburgh, Pittsburgh, PA, USA.

Head and neck cancers are a heterogeneous collection of malignancies of the upper aerodigestive tract, salivary glands and thyroid. In this Review, we primarily focus on the changing therapeutic landscape of head and neck squamous cell carcinomas (HNSCCs) that can arise in the oral cavity, oropharynx, hypopharynx and larynx. We highlight developments in surgical and non-surgical therapies (mainly involving the combination of radiotherapy and chemotherapy), outlining how these treatments are being used in the current era of widespread testing for the presence of human papillomavirus infection in patients with HNSCC. Finally, we describe the clinical trials that led to the approval of the first immunotherapeutic agents for HNSCC, and discuss the development of strategies to decrease the toxicity of different treatment modalities.
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http://dx.doi.org/10.1038/s41571-019-0227-zDOI Listing
November 2019

Development and Assessment of a Novel Composite Pathologic Risk Stratification for Surgically Resected Human Papillomavirus-Associated Oropharyngeal Cancer.

JAMA Otolaryngol Head Neck Surg 2019 May 1. Epub 2019 May 1.

Department Otolaryngology-Head and Neck Surgery, Wayne State University School of Medicine, Detroit, Michigan.

Importance: Human papillomavirus-associated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC) is a distinct form of head and neck squamous cell carcinoma (HNSCC) with its own American Joint Committee on Cancer staging system. However, pathologic risk stratification for HPV+ OPSCC largely remains based on the experience with HPV-unassociated HNSCC.

Objective: To compare the survival discrimination of traditional pathologic risk stratification for both HPV+ OPSCC and HPV-unassociated HNSCC and derive a novel pathologic risk stratification system for HPV+ OPSCC with improved survival discrimination.

Design, Setting, And Participants: In this retrospective cohort study, we used the National Cancer Database to identify 15 324 patients diagnosed with nonmetastatic HNSCC between January 1, 2010, and December 31, 2013, who were treated with upfront surgery and neck dissection. We compared traditional pathologic risk stratification for HPV+ OPSCC and HPV-unassociated HNSCC and then derived a novel pathologic risk stratification system. Analyses were performed from July 1, 2018, to January 31, 2019.

Exposures: Definitive primary surgical resection and neck dissection.

Main Outcomes And Measures: Survival discrimination of pathologic risk stratification systems measured with concordance indices.

Results: This retrospective cohort study included 15 324 patients (10 779 men and 4545 women; mean [SD] age, 59.9 [11.8] years) with surgically treated nonmetastatic HNSCC. Separation of survival curves for HPV-unassociated HNSCC using traditional pathologic risk stratification (5-year overall survival for the low-, intermediate-, and high-risk groups) were 76.2%, 54.5%, and 40.9%, respectively. Separation curves for HPV+ OPSCC were 93.2%, 88.9%, and 83.7%, respectively. Human papillomavirus-unassociated HNSCC had a concordance index of 0.68, whereas HPV+ OPSCC had a concordance index of 0.58. A novel risk stratification system for HPV+ OPSCC that more closely fits actual survival rates for HPV+ OPSCC was derived. The system incorporated the composite number of pathologic adverse features. This composite risk stratification system was associated with an improved concordance index of 0.67 for HPV+ OPSCC. Adjuvant treatment with radiation was not associated with improved survival for patients categorized as low risk according to the new risk stratification system, but this treatment was associated with improved survival for patients in the intermediate- and high-risk groups.

Conclusions And Relevance: Traditional pathologic risk stratification shows poor survival discrimination for HPV+ OPSCC and classifies many patients with an excellent prognosis as high risk. We derived a novel composite pathologic risk stratification system for HPV+ OPSCC that may be associated with improved survival discrimination.
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http://dx.doi.org/10.1001/jamaoto.2019.0820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6495356PMC
May 2019

In Response to Letter to the Editor Regarding "Mortality Associated With Tracheostomy Complications in the United States: 2007-2016".

Laryngoscope 2019 06 18;129(6):E199. Epub 2019 Mar 18.

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.

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http://dx.doi.org/10.1002/lary.27922DOI Listing
June 2019

Impact of postoperative radiation therapy for deeply invasive oral cavity cancer upstaged to stage III.

Head Neck 2019 05 18;41(5):1178-1183. Epub 2019 Feb 18.

Department of Otolaryngology-Head and Neck Surgery, UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

Background: This article is about the eighth edition staging guidelines for upstaged patients with oral cavity squamous cell carcinoma (OCSCC) with >10 mm depth to pT3. This upstages some patients from stage I-II to stage III, a point at which patients are traditionally considered for postoperative radiation therapy (PORT). The role of PORT in patients upstaged for >10 mm depth is unknown.

Methods: We identified patients with surgically resected stage I-II OCSCC with >10 mm depth who were upstaged to stage III. We used Cox proportional hazard modeling to compare patients who received PORT to those who did not (median follow-up 38.6 months).

Results: We observed that 3.6% of patients with OCSCC were upstaged to stage III for depth >10 mm including 823 eligible patients. On adjusted analyses, PORT was associated with improved overall survival in patients upstaged to stage III (adjusted hazard ratio [aHR] 0.47, 95% confidence interval [CI] 0.30-0.73).

Conclusion: PORT is associated with improved survival for patients with OCSCC upstaged to stage III for >10 mm depth.
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http://dx.doi.org/10.1002/hed.25498DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533633PMC
May 2019

Variation in the Quality of Head and Neck Cancer Care in the United States.

JAMA Otolaryngol Head Neck Surg 2019 02;145(2):188-191

Department of Otolaryngology-Head and Neck Surgery, UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.

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http://dx.doi.org/10.1001/jamaoto.2018.3632DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439588PMC
February 2019

Primary surgery for human papillomavirus-associated oropharyngeal cancer: Survival outcomes with or without adjuvant treatment.

Oral Oncol 2018 12 13;87:170-176. Epub 2018 Nov 13.

Department of Otolaryngology - Head and Neck Surgery, UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.

Objectives: Human papillomavirus-associated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC) is a unique form of head and neck cancer with improved prognosis. We assessed survival for stage I patients with low- or intermediate-risk pathologic features with surgery alone compared with surgery with adjuvant radiation (RT) or chemoradiation (CRT).

Materials And Methods: We identified patients with stage I HPV+ OPSCC (after restaging with 8th edition staging system) treated with surgery alone, adjuvant RT or CRT in the National Cancer Data Base from 2010 to 2013. We compared survival for low-risk patients (≤1 metastatic lymph nodes with no adverse features) and intermediate-risk patients (2-4 metastatic lymph nodes, microscopic extranodal extension (ENE) or lymphovascular invasion).

Results: We examined 1677 patients with median follow-up of 43.9 months. In the intermediate-risk group, 4-year overall survival was 94.0% with surgery alone, 91.5% with adjuvant RT and 92.0% with adjuvant CRT (p = 0.72). There were similar rates of overall survival in the low-risk group. In multivariable models accounting for clinicopathologic differences the dose of adjuvant RT was not associated with mortality. On Cox proportional hazard modeling, adjuvant RT (HR 0.94; CI 0.43-2.08) or CRT (HR 0.96; CI 0.45-2.11) did not significantly improved survival compared with surgery alone in the intermediate-risk group (reference). Similar results were seen in the low-risk group. The composite number of pathologic risk features significantly improved risk stratification.

Conclusion: We provide observational evidence that adjuvant RT or CRT does not provide a survival benefit for stage I HPV+ OPSCC with low- or intermediate-risk pathologic features.
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http://dx.doi.org/10.1016/j.oraloncology.2018.10.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533632PMC
December 2018

Mortality associated with tracheostomy complications in the United States: 2007-2016.

Laryngoscope 2019 03 19;129(3):619-626. Epub 2018 Nov 19.

Department of Otolaryngology-Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan, U.S.A.

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.
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http://dx.doi.org/10.1002/lary.27500DOI Listing
March 2019

Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Stage I to II Oral Cavity Cancer.

Laryngoscope 2019 01 3;129(1):162-169. Epub 2018 Oct 3.

Department of Otolaryngology-Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, U.S.A.

Objectives: Sentinel lymph node biopsy (SLNB) has been shown to be an accurate technique for staging the neck in early-stage oral cavity squamous cell carcinoma (OCSCC) and has been incorporated in treatment guidelines as an option instead of elective neck dissection (END). However, utilization of SLNB in the United States remains unclear, and existing prospective studies did not directly compare survival between SLNB and END.

Methods: We conducted a retrospective cohort study of patients with stage I to II OCSCC (cT1-2cN0cM0) who underwent staging of the neck in the National Cancer Data Base from 2012 to 2015. We compared the practice patterns and outcomes of patients who underwent SLNB versus END.

Results: We identified 8,328 eligible patients with a median follow-up of 35.4 months. SLNB was used for 240 patients, or 2.9% of stage I to II OCSCC. Completion neck dissection was avoided in 63.8% of patients undergoing SLNB. SLNB was associated with reduced perioperative morbidity, with median length of hospital stay of 1.0 days versus 3.0 days after END (P < 0.001). Perioperative 30-day mortality was 0% after SLNB versus 0.7% after END (P = 0.42). Overall 3-year survival was 82.0% after SLNB and 77.5% after END (P = 0.40). After adjustment, overall survival was equivalent between patients who underwent SLNB versus END (adjusted hazard ratio 1.03, confidence interval 0.67-1.59).

Conclusions: SLNB for stage I to II OCSCC is associated with reduced length of hospital stay and equivalent overall survival compared with END. Despite these attributes, SLNB remains rarely used in the United States.

Level Of Evidence: NA Laryngoscope, 129:162-169, 2019.
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http://dx.doi.org/10.1002/lary.27323DOI Listing
January 2019

Pain in Head and Neck Cancer Survivors: Prevalence, Predictors, and Quality-of-Life Impact.

Otolaryngol Head Neck Surg 2018 11 26;159(5):853-858. Epub 2018 Jun 26.

2 Department of Acute and Tertiary Care, School of Nursing, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

Objectives: Pain is common among patients with cancer, stemming from both malignancy and side effects of treatment. The extent to which pain persists after treatment has received little attention. We examined the prevalence, predictors, and impact on quality of life (QOL) caused by pain among survivors of head and neck cancer.

Study Design: Cohort study.

Setting: Tertiary head and neck cancer survivorship clinic.

Subjects And Methods: We identified survivors of head and neck cancer ≥1 year after diagnosis and examined the prevalence and risk factors for development of pain. Pain and QOL were assessed with multiple QOL instruments. Ordinal regression modeling examined predictors of pain in survivors.

Results: We identified 175 patients at a median of 6.6 years after diagnosis. Among survivors, 45.1% reported pain, and 11.5% reported severe pain. Among patients with current pain, 46% reported low overall QOL versus only 12% of those without pain ( P < .001). On multivariable analysis after adjustment for age, sex, and stage of disease, pain was associated with trimodality treatment (odds ratio [OR], 3.55; 95% CI, 1.06-12.77). Multivariable analysis of QOL issues revealed that pain was associated with major depression (OR, 3.91; 95% CI, 1.68-9.11), anxiety (OR, 4.22; 95% CI, 2.28-7.81), poor recreation (OR, 3.31; 95% CI, 1.70-6.48), and low overall QOL (OR, 2.20; 95% CI, 1.12-4.34).

Conclusions: Years after head and neck cancer treatment, pain remains a significant problem and is associated with worse QOL. Future efforts should focus on preventing pain from treatment and comprehensive management.
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http://dx.doi.org/10.1177/0194599818783964DOI Listing
November 2018

Comparison of the seventh and eighth edition american joint committee on cancer oral cavity staging systems.

Laryngoscope 2018 10 15;128(10):2351-2360. Epub 2018 Apr 15.

Department of Otolaryngology-Head and Neck Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, U.S.A.

Objective: For the first time in 30 years, the eighth edition of the American Joint Committee on Cancer (AJCC) Staging Manual offers major changes in the staging of oral cavity cancer. We evaluated the predictive ability of the new staging system for oral cavity cancer to validate these changes and hypothesized that the new system would improve prognostic accuracy.

Methods: We conducted a retrospective cohort study of patients with oral cavity squamous cell carcinoma in the National Cancer Data Base from 2009 to 2013 and applied the seventh and eighth edition staging AJCC staging systems to all patients. Stage-specific overall survival was calculated using the Kaplan-Meier method and concordance indices to measure the system's prognostic accuracy.

Results: We identified 39,361 patients with a median follow-up of 27.1 months (range 0.1-80.4 months). In the seventh edition, there were 43.0%, 15.0%, 10.6%, and 25.7% of patients with pathologic stage I, II, III, and IV disease, respectively. After restaging based on eighth edition pathological guidelines, 10.0% of patients were upstaged (38.1%, 18.1%, 14.2%, and 25.2%, respectively, with stage I, II, III, and IV disease, respectively). The survival concordance index improved from the seventh to eighth edition for pathological staging (concordance index 0.699 and 0.704, respectively) and for clinical staging (concordance index 0.714 and 0.715, respectively).

Conclusion: We provide validation of the new AJCC staging system for oral cavity cancer. Eighth edition AJCC staging guidelines upstage a substantial number of patients with greater depth of invasion or extranodal extension. This resulted in slightly improved prognostication.

Level Of Evidence: 2c. Laryngoscope, 128:2351-2360, 2018.
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http://dx.doi.org/10.1002/lary.27205DOI Listing
October 2018

Teach the teacher: Training otolaryngology fellows to become academic educators.

Laryngoscope 2018 09 9;128(9):2034-2048. Epub 2018 Mar 9.

Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

Objectives/hypothesis: Fellowship is the capstone of academic training and serves as preparation for an academic career. Fellows are expected to educate medical students and residents during and long after fellowship. However, little time is typically spent teaching fellows to become effective educators. We investigate a formal curriculum addressing teaching skills among fellows in otolaryngology-head and neck surgery (OHNS).

Study Design: E-mail survey.

Methods: We developed and implemented an educational program called Teach the Teacher to build skills as educators for fellows in OHNS. We conducted a survey of fellows from 2014 to 2017 in OHNS who participated in the course. The survey evaluated demographics, teaching experiences, and teaching limitations structured as yes/no and Likert-style questions (1 = strongly disagree, 5 = strongly agree).

Results: Thirty fellows were surveyed with a response rate was 80%. Fellowship was rated highly as an experience that will make fellows a better academic educator (mean ± standard deviation: 4.54 ± 0.64). The most important components of teaching during fellowship were role modeling (4.67 ± 0.62), followed by teaching psychomotor skills in the operating room (4.29 ± 0.89), diagnostic reasoning (4.25 ± 0.66), and evidence-based medicine (4.25 ± 0.83). The Teach the Teacher course specifically was rated as a helpful experience (4.00 ± 0.90). The primary limitations to developing teaching skills during fellowship identified were lack of time, patient safety, and inexperience with hospital culture.

Conclusions: Fellowship is a key time to improve skills as academic educators. Fellows value formal efforts to teach academic skills.

Level Of Evidence: NA. Laryngoscope, 128:2034-2048, 2018.
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http://dx.doi.org/10.1002/lary.27156DOI Listing
September 2018

Antithrombotic Therapy for Venous Thromboembolism and Prevention of Thrombosis in Otolaryngology-Head and Neck Surgery: State of the Art Review.

Otolaryngol Head Neck Surg 2018 04 27;158(4):627-636. Epub 2018 Feb 27.

2 Department of Otolaryngology-Head and Neck Surgery, School of Medicine, University of Michigan, Ann Arbor, Michigan, USA.

Objective The aim of this report is to present a cohesive evidence-based approach to reducing venous thromboembolism (VTE) in otolaryngology-head and neck surgery. VTE prevention includes deep venous thrombosis and pulmonary embolism. Despite national efforts in VTE prevention, guidelines do not exist for otolaryngology-head and neck surgery in the United States. Data Sources PubMed/MEDLINE. Review Methods A comprehensive review of literature pertaining to VTE in otolaryngology-head and neck surgery was performed, identifying data on incidence of thrombotic complications and the outcomes of regimens for thromboprophylaxis. Data were then synthesized and compared with other surgical specialties. Conclusions We identified 29 articles: 1 prospective cohort study and 28 retrospective studies. The overall prevalence of VTE in otolaryngology appears lower than that of most other surgical specialties. The Caprini system allows effective individualized risk stratification for VTE prevention in otolaryngology. Mechanical and chemoprophylaxis ("dual thromboprophylaxis") is recommended for patients with a Caprini score ≥7 or patients with a Caprini score of 5 or 6 who undergo major head and neck surgery, when prolonged hospital stay is anticipated or mobility is limited. For patients with a Caprini score of 5 or 6, we recommend dual thromboprophylaxis or mechanical prophylaxis alone. Patients with a Caprini score ≤4 should receive mechanical prophylaxis alone. Implications for Practice Otolaryngologists should consider an individualized and risk-stratified plan for perioperative thromboprophylaxis in every patient. The risk of bleeding must be weighed against the risk of VTE when deciding on chemoprophylaxis.
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http://dx.doi.org/10.1177/0194599818756599DOI Listing
April 2018