Publications by authors named "Leila J Mady"

49 Publications

Sex-based differences in outcomes among surgically treated patients with HPV-related oropharyngeal squamous cell carcinoma.

Oral Oncol 2021 Oct 29;123:105570. Epub 2021 Oct 29.

Department of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, United States. Electronic address:

Objectives: Sex differences in surgically treated HPV-associated oropharyngeal squamous cell carcinoma are not defined due to the low number of affected women. We explored the oncologic outcomes of men and women with p16-positive oropharyngeal squamous cell carinoma treated with primary surgery.

Materials And Methods: Retrospective analysis of patients with HPV-related oropharyngeal cancer treated with surgery and pathology guided adjuvant therapy from 2007 to 2017. Primary end point was recurrence-free and overall survival.

Results: Of 468 men (86.7%) and 72 women (13.3%), women presented more often with clinical N0 nodal disease (25% vs 12.2%). There were no differences in adverse pathologic features or T stage, although women were more likely to present with N0 disease (16.7% vs 10%), less N2 disease (6.9% vs 17.7%, p = 0.03), and more stage I disease (88.9% vs 75%). As a result, women were more likely to undergo surgery alone (30.6% vs 14.1%) while men were more likely to require adjuvant radiation therapy (47.2% vs 36.1%). Four women (5.6%) and 30 men (6.4%, p = 0.8) died during follow-up. Multivariate analysis controlling for age, sex, treatment, and pathologic stage demonstrated no differences in overall survival between men and women. There were no differences in recurrence-free or overall survival between men and women at two and five years.

Conclusions: Although women undergoing transoral robotic surgery for HPV+ oropharyngeal squamous cell carcinoma may have less advanced disease, upfront surgery with pathology-guided adjuvant therapy produces similar oncologic results in men and women while accounting for disease burden.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105570DOI Listing
October 2021

Surgical factors associated with patient-reported quality of life outcomes after free flap reconstruction of the oral cavity.

Oral Oncol 2021 Oct 26;123:105574. Epub 2021 Oct 26.

Department of Otolaryngology - Head & Neck Surgery, University of Pittsburgh Medical Center, United States; Department of Plastic Surgery, University of Pittsburgh Medical Center, United States. Electronic address:

Objectives: To determine which surgical factors are associated with quality-of-life (QOL) outcomes in oral cavity cancer survivors after free flap reconstruction of the oral cavity.

Patients And Methods: A cross-sectional study was conducted from a multidisciplinary head and neck cancer (HNC) survivorship clinic. Oral cavity cancer survivors with at least 6-months of postoperative follow-up from ablation and free flap reconstruction were included. Primary outcome measures were validated patient-reported outcome measures (PROMs) including the Eating Assessment Tool-10 (EAT-10) measure of swallowing-specific QOL, University of Washington Quality of Life (UW-QOL) physical and social-emotional subscale scores and feeding tube dependence.

Results: Extent of tongue resection was associated with EAT-10 and the UW-QOL Physical subscale scores. Patients with oral tongue defects reported worse scores than with composite defects in the EAT-10 and UW-QOL physical domain (p = 0.0004, 0.0025, respectively). This association no longer applies when controlling for differences in extent of tongue resection. Patients with anterior composite resections reported worse EAT-10 scores than lateral resections (p = 0.024). This association no longer applies when controlling for extent of tongue resection (p = 0.46). Gastric tube dependence demonstrates similar trends to PROMs.

Conclusion: Extent of tongue resection was strongly associated with poor QOL outcomes after free tissue reconstruction of the oral cavity and mediates the associations between other defect characteristics and QOL. These findings demonstrate the need for emphasis on expected oral tongue defects when counseling patients and highlight the need to address QOL in a multidisciplinary fashion post-operatively.
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http://dx.doi.org/10.1016/j.oraloncology.2021.105574DOI Listing
October 2021

Is mandibular osteomyelitis a sequela of SSRI-induced dental implant failure? A systematic review & case report.

Am J Otolaryngol 2021 Sep 15;43(1):103236. Epub 2021 Sep 15.

Department of Otolaryngology, Veteran's Affairs Hospital, Pittsburgh, PA, United States of America; Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh PA, United States of America. Electronic address:

Background: To determine if the utilization of selective serotonin reuptake inhibitors (SSRIs) increases the risk of osteomyelitis as a sequela of dental implant failure. We also report the case of a patient on long-term SSRIs who presented with dental implant failure and subsequently developed mandibular osteomyelitis.

Methods: We performed a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) in PubMed, Google Scholar and Embase, for all records pertaining to SSRIs, dental implants, and mandibular osteomyelitis.

Results: SSRIs are associated with increased risk of dental implant failure, and our results suggest that they may be independently associated with mandibular osteomyelitis in the setting of implant failure. Though there was no evidence of mandibular osteomyelitis specifically following SSRI-related dental implant failure, there were a few case reports on osteomyelitis resulting from failed dental implant osseointegration.

Conclusions: In the context of long-term SSRI utilization, our findings suggest that osteomyelitis should be considered in the differential diagnosis of patients with recent dental implant placement or failure.
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http://dx.doi.org/10.1016/j.amjoto.2021.103236DOI Listing
September 2021

Chronic Neck Pain After Oromandibular Reconstruction.

JAMA Otolaryngol Head Neck Surg 2021 09;147(9):826-827

Department of Otolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia.

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http://dx.doi.org/10.1001/jamaoto.2021.1685DOI Listing
September 2021

Impact of Race and Insurance Status on Primary Treatment for HPV-Associated Oropharyngeal Squamous Cell Carcinoma.

Otolaryngol Head Neck Surg 2021 Jul 13:1945998211029839. Epub 2021 Jul 13.

Department of Otolaryngology-Head and Neck Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Objective: To assess the impact of sociodemographic factors on primary treatment choice (surgery vs radiotherapy) in patients with human papillomavirus-associated (HPV+) oropharyngeal squamous cell carcinoma (OPSCC).

Study Design: Retrospective analysis of the National Cancer Database.

Setting: Data from >1500 Commission on Cancer institutions (academic and community) via the National Cancer Database.

Methods: Our sample consists of patients diagnosed with HPV+ OPSCC from 2010 to 2015. The primary outcome of interest was initial treatment modality: surgery vs radiation. We performed multivariable logistic models to assess the relationship between treatment choice and sociodemographic factors, including sex, race, treatment facility, and insurance status.

Results: Of the 16,043 patients identified, 5894 (36.7%) underwent primary surgery while 10,149 (63.3%) received primary radiotherapy. Black patients were less likely than White patients to receive primary surgery (odds ratio [OR], 0.80; 95% CI, 0.66-0.96). When compared with privately insured patients, those who were uninsured or on Medicaid or Medicare were also less likely to receive primary surgery (OR, 0.70 [95% CI, 0.56-0.86]; OR, 0.77 [95% CI, 0.65-0.91]; OR, 0.85 [95% CI, 0.75-0.96], respectively). Patients receiving treatment at an academic/research cancer program were more likely to undergo primary surgery than those treated at comprehensive community cancer programs (OR, 1.33; 95% CI, 1.14-1.56).

Conclusion: In this large sample of patients with HPV+ OPSCC, race and insurance status affect primary treatment choice. Specifically, Black and nonprivately insured patients are less likely to receive primary surgery as compared with White or privately insured patients. Our findings illuminate potential disparities in HPV+ OPSCC treatment.
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http://dx.doi.org/10.1177/01945998211029839DOI Listing
July 2021

The cost of cure: Examining objective and subjective financial toxicity in head and neck cancer survivors.

Head Neck 2021 10 8;43(10):3062-3075. Epub 2021 Jul 8.

Department of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Background: Little is documented regarding objective financial metrics and their impact on subjective financial toxicity in head and neck cancer (HNC) survivors.

Methods: In a cross-sectional analysis, 71 survivors with available claims data for HNC-specific out-of-pocket expenses (OOPE) completed a survey including patient-reported, subjective financial toxicity outcome tools: the Comprehensive Score for financial Toxicity (COST) and the Financial Distress Questionnaire (FDQ).

Results: Worse COST scores were significantly associated with lower earnings at survey administration (coefficient = 3.79; 95% CI 2.63-4.95; p < 0.001); loss of earnings after diagnosis (coefficient = 6.03; 95% CI 0.53-11.52; p = 0.032); and greater annual OOPE as a proportion of earnings [log10(Annual OOPE:Earnings at survey): coefficient = -5.66; 95% CI -10.28 to -1.04; p = 0.017]. Similar results were found with FDQ.

Conclusion: Financial toxicity is associated with particular socioeconomic characteristics which, if understood, would assist the development of pre-treatment screening tools to detect at-risk individuals and intervene early in the HNC cancer survivorship trajectory.
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http://dx.doi.org/10.1002/hed.26801DOI Listing
October 2021

Anterolateral thigh osteomyocutaneous flap in head and neck: Lessons learned.

Microsurgery 2021 Jun 26. Epub 2021 Jun 26.

Departments of Oral and Maxillofacial Surgery and Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Background: Concerns regarding iatrogenic femur fracture may deter adoption of the anterolateral thigh osteomyocutaneous (ALTO) flap as an alternative reconstructive technique for large composite defects of the head and neck. We describe the evolution of our experience with this flap and the lessons learned in femur management.

Methods: Records from a prospective database (July 2009-January 2020) were reviewed to identify patients with composite osseous free tissue reconstructions. Venous thromboembolic events (VTE), femur fracture, estimated blood loss (EBL), procedure time, blood transfusions, and length of stay (days) were compared for ALTO flaps prior to and after the adoption of intramedullary fixation protocol.

Results: ALTO represented 10.5% (n = 23) of total osseus (n = 219) flaps. For large composite reconstructions with either ALTO flap, double flap (n = 2), or subscapular mega flaps (n = 14), ALTO flaps were most frequently used (59%, n = 23/59). There were no differences in operative time prior to and after implementation of prophylactic fixation [median (range): 5.4 (1.7-19.2) vs. 5.8 (1.7-15.0), p = .574]. Additionally, there were no differences in VTE, femur fracture, EBL, blood transfusion, or length of stay (p > .05) with adoption of prophylactic intramedullary fixation.

Conclusions: The ALTO flap represents a useful tool to consider in the armamentarium of reconstructive options for large through and through defects of the head and neck. In our experience, the ALTO flap is a reasonable alternative to subscapular or double flap reconstructions and especially in the setting of unusable fibular flaps or when bone need exceeds that available from the scapula.
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http://dx.doi.org/10.1002/micr.30779DOI Listing
June 2021

Consensus of free flap complications: Using a nomenclature paradigm in microvascular head and neck reconstruction.

Head Neck 2021 10 18;43(10):3032-3041. Epub 2021 Jun 18.

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

Background: We aim to define a set of terms for common free flap complications with evidence-based descriptions.

Methods: Clinical consensus surveys were conducted among a panel of head and neck/reconstructive surgeons (N = 11). A content validity index for relevancy and clarity for each item was computed and adjusted for chance agreement (modified kappa, K). Items with K < 0.74 for relevancy (i.e., ratings of "good" or "fair") were eliminated.

Results: Five out of nineteen terms scored K < 0.74. Eliminated terms included "vascular compromise"; "cellulitis"; "surgical site abscess"; "malocclusion"; and "non- or mal-union." Terms that achieved consensus were "total/partial free flap failure"; "free flap takeback"; "arterial thrombosis"; "venous thrombosis"; "revision of microvascular anastomosis"; "fistula"; "wound dehiscence"; "hematoma"; "seroma"; "partial skin graft failure"; "total skin graft failure"; "exposed hardware or bone"; and "hardware failure."

Conclusion: Standardized reporting would encourage multi-institutional research collaboration, larger scale quality improvement initiatives, the ability to set risk-adjusted benchmarks, and enhance education and communication.
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http://dx.doi.org/10.1002/hed.26789DOI Listing
October 2021

Locoregional Recurrence in p16-Positive Oropharyngeal Squamous Cell Carcinoma After TORS.

Laryngoscope 2021 12 2;131(12):E2865-E2873. Epub 2021 Jun 2.

Department of Otorhinolaryngology: Head and Neck Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.

Objective: To analyze the patterns, risk factors, and salvage outcomes for locoregional recurrences (LRR) after treatment with transoral robotic surgery (TORS) for HPV-associated oropharyngeal squamous cell carcinoma (HPV+ OPSCC).

Study Design: Retrospective analysis of HPV+ OPSCC patients completing primary TORS, neck dissection, and NCCN-guideline-compliant adjuvant therapy at a single institution from 2007 to 2017.

Methods: Features associated with LRR, detailed patterns of LRR, and outcomes of salvage therapy were analyzed. Disease-free survival (DFS) and overall survival (OS) were calculated for subgroups of patients receiving distinct adjuvant treatments.

Results: Of 541 patients who completed guideline-indicated therapy, the estimated 5-year LRR rate was 4.5%. There were no identifiable clinical or pathologic features associated with LRR. Compared to patients not receiving adjuvant therapy, those who received indicated adjuvant radiation alone had a lower risk of LRR (HR 0.28, 95% CI [0.09-0.83], P = .023), but there was no difference in DFS (P = .21) and OS (P = .86) between adjuvant therapy groups. The 5-year OS for patients who developed LRR was 67.1% vs. 93.9% for those without LRR (P < .001). Patients who initially received adjuvant chemoradiation and those suffering local, in-field, and/or retropharyngeal node recurrences had decreased disease control after salvage therapy.

Conclusion: LRR rates are low for HPV+ OPSCCs completing TORS and guideline-compliant adjuvant therapy. Patients without indication for adjuvant therapy more often suffer LRR, but these recurrences are generally controllable by salvage therapy. Improved understanding of the patterns of recurrence most amenable to salvage therapy may guide treatment decisions, counseling, and adjuvant therapy de-escalation trials.

Level Of Evidence: 3 Laryngoscope, 131:E2865-E2873, 2021.
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http://dx.doi.org/10.1002/lary.29659DOI Listing
December 2021

Palliative care in metastatic head and neck cancer.

Head Neck 2021 09 21;43(9):2764-2777. Epub 2021 May 21.

Department of Otorhinolaryngology: Head and Neck Surgery, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

Background: Due to inherent impact on quality of life, metastatic head and neck cancer patients are well-suited to benefit from palliative care (PC). Our objective was to examine factors that shape PC utilization and implications for overall survival in stage IVc head and neck cancer patients.

Methods: A retrospective study of patients with stage IVc head and neck cancer in the National Cancer Database from 2004 and 2015 was conducted.

Results: 7794 cases met inclusion criteria, of which 19.3% received PC. PC use was associated with more recent years of diagnosis, Northeast facility geography, and non-private insurances (p < 0.05). Compared to no PC, "interventional" PC, defined as palliative surgery, radiation, and/or chemotherapy, and "pain management only" PC were associated with lower overall survival (p < 0.05).

Conclusions: PC use increased over time and was associated with demographic and clinical factors. There remains opportunity for improvement in optimal implementation of palliative care.
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http://dx.doi.org/10.1002/hed.26761DOI Listing
September 2021

Exploring caregiver burden and financial toxicity in caregivers of tracheostomy-dependent children.

Int J Pediatr Otorhinolaryngol 2021 Jun 18;145:110713. Epub 2021 Apr 18.

Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.

Objective: Measure the prevalence of and factors associated with financial toxicity (FT) and caregiver burden in families of tracheostomy-dependent children. FT is defined as the objective and subjective patient-level impact of the costs of medical care and has been associated with lower quality of life, decreased compliance with treatment, and increased mortality.

Methods: A medical record review was performed on all children with a tracheostomy tube placed from 2009 to 2018 at a tertiary children's hospital to identify and include children younger than 18 years old, not deceased, and not decannulated at the time of review. Eligible children's caregivers were contacted to fill out a 36-item questionnaire and three validated instruments: The Comprehensive Score for Financial Toxicity (COST) and the Financial Distress Questionnaire (FDQ), both addressed to the parent/primary caregiver, and the Burden Scale for Family Caregivers - short version (BSFC-s).

Results: Of the 140 eligible tracheostomy patients identified, 45 caregivers (32.1%) returned the survey. The average COST score was 18 ± 1.7 with 73.3% of caregivers reporting high toxicity based on FDQ, and 75.6% having severe-to-very severe caregiver burden. Significant increase in FT was seen in households where an adult had to leave a paid position (p = 0.047) or work less (p = 0.002) because of their child's condition; or needed to omit some of the child's medical services or medications due to cost-prohibitive reasons (p<0.001). Financial toxicity was associated with caregiver burden (by BSFC-s) [r = -596; beta coefficient = -0.95, t(43) = -4.87, p<0.001] and financial distress (by FDQ; p<0.001).

Conclusion: Caregivers of children with medically complex, tracheostomy-dependent conditions suffer from FT and caregiver burden. As a result, harmful financial coping mechanisms such as missing necessary care components or forgoing prescribed treatments, may be adopted for cost-prohibitive reasons.
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http://dx.doi.org/10.1016/j.ijporl.2021.110713DOI Listing
June 2021

Enhanced recovery after surgery for head and neck free flap reconstruction: A systematic review and meta-analysis.

Oral Oncol 2021 02 23;113:105117. Epub 2020 Dec 23.

Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania, Philadelphia, PA, United States; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States. Electronic address:

Introduction: Head and neck free flap reconstruction requires multidisciplinary and coordinated care in the perioperative setting to ensure safe recovery and success. Several institutions have introduced enhanced recovery after surgery (ERAS) protocols to attenuate the surgical stress response and improve postoperative recovery. With multiple studies demonstrating mixed results, the success of these interventions on clinical outcomes has yet to be determined.

Objective: To evaluate the impact of ERAS protocols and clinical care pathways for head and neck free flap reconstruction.

Methods: We searched PubMed, SCOPUS, EMBASE, and grey literature up to September 1st, 2020 to identify studies comparing patients enrolled in an ERAS protocol and control group. Our primary outcomes included hospital length of stay (LOS) and readmission. Mortality, reoperations, wound complication and ICU (intensive care unit) LOS comprised our secondary outcomes.

Results: 18 studies met inclusion criteria, representing a total of 2630 patients. The specific components of ERAS protocols used by institutions varied. Nevertheless, patients enrolled in ERAS protocols had reduced hospital LOS (MD -4.36 days [-7.54, -1.18]), readmission rates (OR 0.64 [0.45;0.92]), and wound complications (RR 0.41 [0.21, 0.83]), without an increase in reoperations (RR 0.65 [0.41, 1.02]), mortality (RR 0.38 [0.05, 2.88]), or ICU LOS (MD -2.55 days [-5.84, 0.74]).

Conclusion: There is growing body of evidence supporting the role of ERAS protocols for the perioperative management of head and neck free flap patients. Our findings reveal that structured clinical algorithms for perioperative interventions improve clinically-meaningful outcomes in patients undergoing complex ablation and microvascular reconstruction procedures.
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http://dx.doi.org/10.1016/j.oraloncology.2020.105117DOI Listing
February 2021

In-vivo efficacy of biodegradable ultrahigh ductility Mg-Li-Zn alloy tracheal stents for pediatric airway obstruction.

Commun Biol 2020 12 18;3(1):787. Epub 2020 Dec 18.

Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA, 15261, USA.

Pediatric laryngotracheal stenosis is a complex congenital or acquired airway injury that may manifest into a potentially life-threatening airway emergency condition. Depending on the severity of obstruction, treatment often requires a combination of endoscopic techniques, open surgical repair, intraluminal stenting, or tracheostomy. A balloon expandable biodegradable airway stent maintaining patency while safely degrading over time may address the complications and morbidity issues of existing treatments providing a less invasive and more effective management technique. Previous studies have focused on implementation of degradable polymeric scaffolds associated with potentially life-threatening pitfalls. The feasibility of an ultra-high ductility magnesium-alloy based biodegradable airway stents was demonstrated for the first time. The stents were highly corrosion resistant under in vitro flow environments, while safely degrading in vivo without affecting growth of the rabbit airway. The metallic matrix and degradation products were well tolerated by the airway tissue without exhibiting any noticeable local or systemic toxicity.
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http://dx.doi.org/10.1038/s42003-020-01400-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7749127PMC
December 2020

Rare Presentation of Progressive Saddle Nose Deformity.

JAMA Otolaryngol Head Neck Surg 2020 10;146(10):956-957

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

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http://dx.doi.org/10.1001/jamaoto.2020.1756DOI Listing
October 2020

Molecular Profile of Locally Aggressive Well Differentiated Thyroid Cancers.

Sci Rep 2020 05 15;10(1):8031. Epub 2020 May 15.

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

Knowledge of the genetic landscape of aggressive well differentiated thyroid cancers (WDTC) is lacking. Retrospective review of institutional database was performed to identify locally-invasive thyroid carcinomas and a comparison cohort of low-risk WDTC. ThyroSeq v2 next-generation sequencing was performed on available tissue. Survival time was analyzed by Kaplan-Meier methods and compared between groups via the log-rank test. Time to recurrence, treating death as a competing risk, was analyzed by cumulative incidence and compared between groups. Of 80 T4 tumors, 29 (36%) were met inclusion criteria, of which, 25 had genetic and clinicopathologic data. Most (24/25, 96%) harbored at least one genetic alteration, most commonly BRAF V600E (19, 76%), followed by mutations in the promoter region of TERT (14, 56%). Co-occurrence of BRAF and TERT was identified in 12 (48%) and associated with significantly higher risk of recurrence (p < 0.05). Conversely, co-occurrence of BRAF and TERT was present in only 5 of 102 (5%) patients presenting with early-stage WDTC. Compared to early-stage WDTC, co-occurrence of BRAF and TERT mutations are common in locally advanced (T4) thyroid cancer and are associated with an increased risk of recurrence. This knowledge may help predict aggressive behavior pretreatment and inform perioperative decision-making.
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http://dx.doi.org/10.1038/s41598-020-64635-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229018PMC
May 2020

Subglottic Stenosis: Development of a Clinically Relevant Endoscopic Animal Model.

Otolaryngol Head Neck Surg 2020 06 12;162(6):905-913. Epub 2020 May 12.

Department of Otolaryngology, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

Objective: Develop a clinically relevant and reproducible endoscopic animal model for subglottic stenosis amenable to testing of minimally invasive therapeutic modalities.

Study Design: Cohort study.

Setting: Division of Laboratory Animals Research, University of Pittsburgh.

Subjects And Methods: Subglottic stenosis was induced endoscopically via microsuspension laryngoscopy in 26 New Zealand white rabbits. A trimmed polypropylene brush connected to a novel electronic stenosis induction apparatus was used to create circumferential trauma to the subglottis. By using open source image analysis software, the cross-sectional areas of the stenotic and native airways were compared to calculate the percentage of stenosis and the Myer-Cotton classification grade.

Results: Of the 26 rabbits, 24 (92%) exhibited stenosis after the first attempt. The mean percentage of airway stenosis was 57% (range, 34%-85%; SD, 15%). Five rabbits (19.2%) died on the day of stenosis induction from procedural complications. Of the 21 rabbits, 2 demonstrated no stenosis 7 days after initial injury and so underwent reinduction of airway injury, upon which they developed stenosis. Overall, 14 of the 21 rabbits (67%) exhibited moderate to severe stenosis (grade 2 or 3).

Conclusion: The stenosis induction apparatus reliably induced stenosis with a low mortality rate as compared with that of other methods in the literature. The device could be improved to generate a predetermined potentially reproducible grade of stenosis as desired by the operator. This method sets the stage for a clinically relevant and reproducible subglottic stenosis disease model that is amenable to testing of minimally invasive treatment modalities.
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http://dx.doi.org/10.1177/0194599820921404DOI Listing
June 2020

Major head and neck reconstruction during the COVID-19 pandemic: The University of Pittsburgh approach.

Head Neck 2020 06 27;42(6):1243-1247. Epub 2020 Apr 27.

Department of Otolaryngology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.

The 2019 novel coronavirus (COVID-19) pandemic has created significant challenges to the delivery of care for patients with advanced head and neck cancer requiring multimodality therapy. Performing major head and neck ablative surgery and reconstruction is a particular concern given the extended duration and aerosolizing nature of these cases. In this manuscript, we describe our surgical approach to provide timely reconstructive care and minimize infectious risk to the providers, patients, and families.
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http://dx.doi.org/10.1002/hed.26207DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7267335PMC
June 2020

Potential impact of the COVID-19 pandemic on financial toxicity in cancer survivors.

Head Neck 2020 06 28;42(6):1332-1338. Epub 2020 Apr 28.

Department of Otolaryngology - Head and Neck Surgery, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

Background: In the context of COVID-19, cancer survivors represent a particularly vulnerable population that may be "doubly hit" by both costs of cancer treatment and financial strain imposed by the pandemic.

Methods: We performed a review of the literature pertaining to cancer, financial toxicity, and economic challenges.

Results: Multiple societies have put forth recommendations to modify delivery of cancer care in order to minimize patient exposure to the virus. Cancer survivors, especially patients with head and neck cancer, have been disproportionately affected by rising unemployment levels and economic recessions in the past, both of which are linked to higher cancer mortality. Patients who rely on employer-provided insurance and do not qualify for Medicaid may lose access to life-saving treatments.

Conclusions: It is essential to implement interventions and policy changes in order to mitigate the effects of this pandemic but also to ensure this becomes a nonissue during the next one.
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http://dx.doi.org/10.1002/hed.26187DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7264615PMC
June 2020

Quality and Readability Assessment of Websites on Human Papillomavirus and Oropharyngeal Cancer.

Laryngoscope 2021 01 13;131(1):87-94. Epub 2020 Apr 13.

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

Objectives/hypothesis: The incidence of human papillomavirus-positive (HPV+) oropharyngeal cancer is rising, but public knowledge about this diagnosis remains low. This study aimed to investigate the quality and readability of online information about HPV+ oropharyngeal cancer.

Study Design: Cross-sectional website analysis.

Methods: This study conducted a total of 12 web searches across Google, Yahoo, and Bing to identify websites related to HPV+ oropharyngeal cancer. The QUality Evaluation Scoring Tool (QUEST) was used to measure quality based on seven website criteria. The Flesch Reading Ease Score (FRES) and Flesch-Kincaid Grade Level (FKGL) were used to measure readability, with scores estimating the education level a reader would require to understand a piece of text. Readability improves as FRES increases and FKGL decreases.

Results: Twenty-seven unique web pages were evaluated. The mean USA reading grade level as measured by FKGL was 10.42 (standard deviation = 1.54). There was an inverse relationship between quality and readability, with a significant positive correlation between QUEST score and FKGL (r = 0.343, P = .040) and a significant negative correlation between QUEST score and FRES (r = -0.537, P = .002).

Conclusions: With a mean USA reading grade level more than four grades above the American Medical Association's recommendation and results indicating that readability suffers as quality improves, these findings suggest that the currently available online information about HPV+ oropharyngeal cancer is insufficient. Improved patient education practices and resources about this diagnosis are needed.

Level Of Evidence: NA Laryngoscope, 131:87-94, 2021.
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http://dx.doi.org/10.1002/lary.28670DOI Listing
January 2021

What is the Role of Air Pollution in Chronic Rhinosinusitis?

Immunol Allergy Clin North Am 2020 05 20;40(2):215-222. Epub 2020 Feb 20.

University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Otolaryngology-Head and Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address:

Chronic rhinosinusitis (CRS) is a heterogeneous inflammatory disorder, and several environmental factors may be contributing to disease pathophysiology, including air pollutants. Tobacco smoke and occupational exposures also have been associated with CRS, and environmental exposures may contribute to the variability seen in disease endotype. Animal models that investigate the potential of air pollutants to induce chronic inflammation provide further insight into plausible triggers and modifiers of disease, including contributions to barrier disruption, alterations in the microbiome, and immune dysfunction. Additional studies are needed to further elucidate the role of environmental exposures on CRS pathophysiology and patient outcomes.
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http://dx.doi.org/10.1016/j.iac.2019.12.011DOI Listing
May 2020

Association of Preoperative Patient Frailty and Operative Stress With Postoperative Mortality.

JAMA Surg 2020 01 15;155(1):e194620. Epub 2020 Jan 15.

Center for Health Equity Research and Promotion, Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.

Importance: Patients with frailty have higher risk for postoperative mortality and complications; however, most research has focused on small groups of high-risk procedures. The associations among frailty, operative stress, and mortality are poorly understood.

Objective: To assess the association between frailty and mortality at varying levels of operative stress as measured by the Operative Stress Score, a novel measure created for this study.

Design, Setting, And Participants: This retrospective cohort study included veterans in the Veterans Administration Surgical Quality Improvement Program from April 1, 2010, through March 31, 2014, who underwent a noncardiac surgical procedure at Veterans Health Administration Hospitals and had information available on vital status (whether the patient was alive or deceased) at 1 year postoperatively. A Delphi consensus method was used to stratify surgical procedures into 5 categories of physiologic stress.

Exposures: Frailty as measured by the Risk Analysis Index and operative stress as measured by the Operative Stress Score.

Main Outcomes And Measures: Postoperative mortality at 30, 90, and 180 days.

Results: Of 432 828 unique patients (401 453 males [92.8%]; mean (SD) age, 61.0 [12.9] years), 36 579 (8.5%) were frail and 9113 (2.1%) were very frail. The 30-day mortality rate among patients who were frail and underwent the lowest-stress surgical procedures (eg, cystoscopy) was 1.55% (95% CI, 1.20%-1.97%) and among patients with frailty who underwent the moderate-stress surgical procedures (eg, laparoscopic cholecystectomy) was 5.13% (95% CI, 4.79%-5.48%); these rates exceeded the 1% mortality rate often used to define high-risk surgery. Among patients who were very frail, 30-day mortality rates were higher after the lowest-stress surgical procedures (10.34%; 95% CI, 7.73%-13.48%) and after the moderate-stress surgical procedures (18.74%; 95% CI, 17.72%-19.80%). For patients who were frail and very frail, mortality continued to increase at 90 and 180 days, reaching 43.00% (95% CI, 41.69%-44.32%) for very frail patients at 180 days after moderate-stress surgical procedures.

Conclusions And Relevance: We developed a novel operative stress score to quantify physiologic stress for surgical procedures. Patients who were frail and very frail had high rates of postoperative mortality across all levels of the Operative Stress Score. These findings suggest that frailty screening should be applied universally because low- and moderate-stress procedures may be high risk among patients who are frail.
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http://dx.doi.org/10.1001/jamasurg.2019.4620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6865246PMC
January 2020

Association of air pollutants, airborne occupational exposures, and chronic rhinosinusitis disease severity.

Int Forum Allergy Rhinol 2020 02 29;10(2):175-182. Epub 2019 Oct 29.

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

Background: Previous work has shown that chronic rhinosinusitis (CRS) severity may be associated with particulate matter 2.5 (PM ) and black carbon (BC) in CRS patients without nasal polyps (CRSsNP). Data regarding occupational exposures, however, are lacking. We assessed the impact of PM , BC, as well as occupational airborne exposure on CRS disease severity.

Methods: Patients with CRS with nasal polyps (CRSwNP), CRSsNP, and aspirin-exacerbated respiratory disease (AERD) were identified from an institutionwide database. Spatial modeling from 37 pollutant monitoring sites in Allegheny County was used to estimate exposures. Patient occupations using the 2010 Standard Occupation Classification (SOC10) and airborne occupation exposures to vapors, gases, dusts, fumes, fibers and mists (VGDFFiM) or diesel fumes were recorded. Disease severity was measured by modified Lund-Mackay score (LMS), systemic corticosteroid therapy, and incidence of functional endoscopic sinus surgery (FESS).

Results: Two hundred thirty-four patients were included (CRSwNP, n = 113; CRSsNP, n = 96; AERD, n = 25). The prevalence of AERD among those with CRSwNP was 18%. Patients exposed to VGDFFiM or diesel fumes required higher steroid doses vs nonexposed patients (p = 0.015 and p = 0.03, respectively); patients with VGDFFiM levels >5% were more likely to undergo FESS vs nonexposed patients (p = 0.0378). There was no difference in PM and BC with regard to disease severity and FESS between CRSwNP, CRSsNP, and AERD patients. Steroid use was significantly higher in CRSwNP and AERD vs CRSsNP (p = 0.001). LMS was significantly higher in AERD as compared with CRSwNP and CRSsNP (p = 0.001).

Conclusion: Occupational airborne exposure to VGDFFiM correlated with increased prevalence of FESS and need for corticosteroids in CRS patients. There was no difference in PM and BC levels and disease severity outcome measures between CRS subtypes in this subset.
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http://dx.doi.org/10.1002/alr.22477DOI Listing
February 2020

Impact of Neck Disability on Health-Related Quality of Life among Head and Neck Cancer Survivors.

Otolaryngol Head Neck Surg 2020 01 15;162(1):64-72. Epub 2019 Oct 15.

Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.

Objective: Although neck impairment has been described following surgical resection, limited studies have investigated its prevalence in nonsurgical treatment. The purpose of this study is to determine the prevalence and predictors of neck disability following head and neck cancer (HNC) treatment and to explore its association with quality of life (QOL).

Study Design: Cross-sectional study.

Setting: HNC survivorship clinic.

Subjects And Methods: We identified 214 survivors who completed treatment ≥1 year prior to evaluation in the clinic. Self-reported neck impairment was measured using the Neck Disability Index. QOL was measured using the University of Washington QOL Questionnaire, with physical and social subscale scores calculated. Regression analysis and trend tests were employed to explore associations.

Results: Over half of survivors (54.2%) reported neck disability. The odds of neck disability in survivors who received nonsurgical treatment and those who received surgery plus adjuvant treatment were 3.46 and 4.98 times higher compared to surgery alone ( = .008, = .004). Survivors who underwent surgery only had higher physical and social QOL than those who received nonsurgical treatment (physical QOL: < .001, social QOL: = .023) and those who received surgery plus adjuvant treatment (physical QOL: < .001, social QOL: = .039).

Conclusion: This study revealed a high prevalence of neck disability following nonsurgical treatment. While neck disability is an established sequela of surgical resection, the impact of nonsurgical treatment has gone unrecognized. Early identification and intervention to prevent progression of neck disability are crucial to optimize QOL.
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http://dx.doi.org/10.1177/0194599819883295DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263303PMC
January 2020

Understanding financial toxicity in head and neck cancer survivors.

Oral Oncol 2019 08 28;95:187-193. Epub 2019 Jun 28.

Department of Otolaryngology - Head and Neck Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States; Department of Acute and Tertiary Care, University of Pittsburgh School of Nursing, Pittsburgh, PA, United States.

Objectives: (1) Describe financial toxicity (FT) in head and neck cancer (HNC) survivors and assess its association with personal/health characteristics and health-related quality of life (HRQOL); (2) examine financial coping mechanisms (savings/loans); (3) assess relationship between COmprehensive Score for financial Toxicity (COST) and Financial Distress Questionnaire (FDQ).

Patients And Methods: Cross-sectional survey from January - April 2018 of insured patients at a tertiary multidisciplinary HNC survivorship clinic who completed primary treatment for squamous cell carcinoma of the oral cavity, oropharynx, or larynx/hypopharynx.

Results: Of 104 survivors, 30 (40.5%) demonstrated high FT. Patients with worse FT were more likely (1) not married (COST, 25.33 ± 1.87 vs. 30.61 ± 1.34, p = 0.008); (2) of lower education levels (COST, 26.12 ± 1.47 vs. 34.14 ± 1.47, p < 0.001); and (3) with larynx/hypopharynx primaries (COST, 22.86 ± 2.28 vs. 30.27 ± 1.50 vs. 32.72 ± 1.98, p = 0.005). Younger age (4.23, 95%CI 2.20 to 6.26, p < 0.001), lower earnings at diagnosis (1.17, 95%CI 0.76 to 1.58, p < 0.001), and loss in earnings (-1.80, 95%CI -2.43 to -1.16, p < 0.001) were associated with worse FT. COST was associated with HRQOL (0.08, p = 0.03). Most survivors (63/102, 60%) reported using savings and/or loans. Worse FT was associated with increased likelihood of using more mechanisms (COST, OR1.06, 95%CI 1.02 to 1.10, p = 0.004). Similar results were found with FDQ.

Conclusions: We found differences in FT by primary site, with worst FT in larynx/hypopharynx patients. This finding illuminates potential site-specific factors, e.g. workplace discrimination or inability to return to work, that may contribute to increased risk. FDQ correlates strongly with COST, encouraging further exploration as a clinically-meaningful screening tool.
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http://dx.doi.org/10.1016/j.oraloncology.2019.06.023DOI Listing
August 2019

Burden of treatment: Reported outcomes in a head and neck cancer survivorship clinic.

Laryngoscope 2019 12 15;129(12):E437-E444. Epub 2019 Jan 15.

Department of Otolaryngology, University of Pittsburgh, School of Medicine, Pittsburgh, Pennsylvania, U.S.A.

Objective: With the intensification and utilization of multimodal treatment, acute toxicities have increased; however, the frequency of treatment sequelae in long-term head and neck cancer (HNC) survivors are poorly described. The purpose of this analysis was to determine the prevalence and predictors of patient-reported late and long-term treatment-related sequelae in HNC survivors.

Methods: We performed a cross-sectional analysis of patient-reported outcomes from 228 survivors attending a multidisciplinary HNC survivorship clinic. The primary outcomes comprised quality of life (QOL), symptoms of anxiety and depression, and swallowing dysfunction.

Results: Male gender, tumor sites in the oropharynx and larynx, longer time since treatment, and treatment with surgery alone were associated with higher physical QOL (P < .05). Male gender, longer time since treatment, and treatment with surgery alone were associated with higher social-emotional QOL (P < .05). A reduction in anxiety symptoms and a higher QOL were related to longer time since treatment; however, a reduction in swallowing dysfunction symptoms was only related to longer time since treatment until approximately 6 years. After 6 years, survivors reported worse swallowing dysfunction (P < .05). One hundred thirty-two survivors (56%) reported at least three treatment-related effects that impacted their daily life. Finally, advanced stage disease at diagnosis (stage III-IV) was also associated with severe swallowing dysfunction (P = .004).

Conclusion: These data indicate the remarkable prevalence of treatment-related effects in HNC survivors. These results highlight the need for de-intensification of therapies, where appropriate, and for a better understanding of pathophysiology and new approaches to mitigating treatment effects.

Level Of Evidence: 4 Laryngoscope, 129:E437-E444, 2019.
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http://dx.doi.org/10.1002/lary.27801DOI Listing
December 2019

Head and Neck Cancer in the Elderly: Frailty, Shared Decisions, and Avoidance of Low Value Care.

Clin Geriatr Med 2018 05 22;34(2):233-244. Epub 2018 Feb 22.

Department of Otolaryngology, University of Pittsburgh, School of Medicine, Eye and Ear Institute, Suite 500, 203 Lothrop Street, Pittsburgh, PA 15213, USA; Department of Radiation Oncology, University of Pittsburgh, School of Medicine, 5230 Centre Avenue, Pittsburgh, PA 15232, USA; Department of Oral and Maxillofacial Surgery, University of Pittsburgh, School of Dental Medicine, 3501 Terrace Street, Pittsburgh, PA 15261, USA; Department of Communication Science and Disorders, University of Pittsburgh, School of Health and Rehabilitation Sciences, Forbes Tower, 3600 Atwood Street, Pittsburgh, PA 15260, USA. Electronic address:

Head and neck cancer (HNC) is a disease of older adults. Recurrent and metastatic head and neck squamous cell carcinoma portends a poor prognosis, with median overall survival of less than 12 months. Within this vulnerable population, significant treatment-related toxicities and physical and psychosocial sequelae can be devastating to quality of life at the end of life. Shared decision making and early comprehensive palliative and support services are at the crux of the approach to older adults with HNC. In doing so, low-value care that fails to meet the goals of patients and their caregivers at the end-of-life may be avoided.
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http://dx.doi.org/10.1016/j.cger.2018.01.003DOI Listing
May 2018

Comparative effectiveness of allergy testing method in driving immunotherapy outcomes.

Int Forum Allergy Rhinol 2018 05 20;8(5):563-570. Epub 2017 Dec 20.

Department of Otolaryngology, University of Pittsburgh School of Medicine, Pittsburgh, PA.

Background: Skin-prick testing (SPT), in vitro testing (IVT), and intradermal-dilutional testing (IDT) are methods to detect patient sensitivities to specific allergens and direct immunotherapy dosing. We used objective and subjective measures of improvement to compare outcomes based on test method.

Methods: Patients underwent 1 of 3 protocols: SPT, screening SPT followed by IDT, or IVT. We used institution billing data to do a cost analysis of these tests. The time to maintenance (TTM) therapy was analyzed and patients were stratified into high and low reactors. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was used to quantify symptoms pre-maintenance and post-maintenance.

Results: Of 177 patients (SPT, n = 40; IVT, n = 91; IDT, n = 46), 115 (SPT, n = 35; IVT, n = 39; IDT, n = 41) were high reactors. Out of 90 patients (SPT, n = 17; IVT, n = 37; IDT, n = 36) reaching maintenance, 58 were high reactors (SPT, n = 15; IVT, n = 12; IDT, n = 31). Overall, SPT, IVT, and IDT median TTM were 542, 329, and 578.5 days, respectively. IDT TTM was shorter compared to IVT overall and in high reactors (hazard ratio [HR] = 1.91, p = 0.02; HR = 2.12, p = 0.03), but was not significant compared to SPT high reactors (p = 0.33). The IDT cost was $62.66, translating to an incremental cost-effectiveness ratio of $0.23 per day of shortened TTM. Median RQLQ change for the SPT, IVT, and IDT groups was 6.5, 1, and 1.5, respectively, but was not significant (p = 0.60).

Conclusion: IDT reached maintenance immunotherapy quicker than IVT but there was no difference compared to SPT. TTM did not correlate with improvements in patient symptoms between testing methods. This study represents a novel comparison of outcomes based on initial allergy testing method.
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http://dx.doi.org/10.1002/alr.22061DOI Listing
May 2018

The association of air pollutants and allergic and nonallergic rhinitis in chronic rhinosinusitis.

Int Forum Allergy Rhinol 2018 03 11;8(3):369-376. Epub 2017 Dec 11.

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

Background: There has been little investigation regarding air quality and rhinitis in the pathophysiology of upper airway disease. In this study, we assessed the impact of inhalant pollutants (particulate matter 2.5 [PM ] and black carbon [BC]) on allergic rhinitis and chronic rhinosinusitis (CRS) disease severity.

Methods: CRS patients with nasal polyps (CRSwNP) and without polyps (CRSsNP) were identified. Spatial modeling from pollutant monitoring sites was used to estimate exposures for patients meeting the inclusion criteria (total, n = 125; CRSsNP, n = 67; CRSsNP, n = 58). Skin-prick, intradermal dilutional, and in-vitro testing methods were utilized to determine aeroallergen sensitization. Disease severity indicators were measured by modified Lund-Mackay score (LMS), the 22-item Sino-Nasal Outcome Test (SNOT-22), systemic steroid therapy, and number of functional endoscopic sinus surgeries (FESS).

Results: Thirty-six percent (n = 45) of patients who described rhinitis symptoms demonstrated no reactivity to aeroallergen testing. Sixty-four percent (n = 80) tested positive for at least 1 allergen, with no differences found between CRSsNP and CRSwNP (62.1% vs 67.2%). There were significant differences in air pollutants between patients testing negative and positive for allergies (nonallergic vs allergic: PM , 11.32 vs 11.07 μg/m , p = 0.030; BC, 0.81 vs 0.76 absorbance, p =0.044). Nonallergic CRSwNP demonstrated higher PM compared with allergic counterparts (11.48 vs 11.09 μg/m , p = 0.032). A similar pattern was observed with BC (0.82 vs 0.75 absorbance, p = 0.017). In CRSsNP, BC correlated significantly with SNOT-22 (r = 0.55, p = 0.042).

Conclusion: Our results suggest that small inhalant pollutants may contribute to nonallergic symptomatology in patients with and without nasal polyps. Regardless of allergy status, BC may play a role in CRS symptom severity.
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http://dx.doi.org/10.1002/alr.22060DOI Listing
March 2018

Air pollutants may be environmental risk factors in chronic rhinosinusitis disease progression.

Int Forum Allergy Rhinol 2018 03 6;8(3):377-384. Epub 2017 Dec 6.

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

Background: Little is known about the role of environmental exposures in the pathophysiology of chronic rhinosinusitis (CRS). In this study, we measured the impact of air pollutants (particulate matter 2.5 [PM ] and black carbon [BC]) on CRS with nasal polyposis (CRSwNP) and CRS without nasal polyposis (CRSsNP).

Methods: Spatial modeling from pollutant monitoring sites was used to estimate exposures surrounding residences for patients meeting inclusion criteria (total patients, n = 234; CRSsNP, n = 96; CRSwNP, n = 138). Disease severity outcome measures included modified Lund-Mackay score (LMS), systemic steroids, number of functional endoscopic sinus surgeries (FESS), and 22-item Sino-Nasal Outcome Test (SNOT-22) score. PM and BC exposures were correlated with outcome measures.

Results: Mean PM and BC findings were not significantly different between CRSwNP and CRSsNP patients or patients with and without asthma. Among those with CRSsNP, PM was significantly associated with undergoing FESS. For each unit increase in PM , there was a 1.89-fold increased risk in the proportion of CRSsNP patients who required further surgery (p = 0.015). This association was not identified in CRSwNP patients (p = 0.445). BC was also significantly associated with SNOT-22 score in the CRSsNP group. For each 0.1-unit increase in BC, there was a 7.97-unit increase in SNOT-22 (p = 0.008). A similar, although not significant, increase in SNOT-22 was found with increasing BC in the CRSwNP group (p = 0.728).

Conclusion: Air pollutants correlate with CRS symptom severity that may be influenced by exposure levels, with a more pronounced impact on CRSsNP patients. This study is the first to demonstrate the possible role of inhalant pollutants in CRS phenotypes, addressing a critical knowledge gap in environmental risk factors for disease progression.
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http://dx.doi.org/10.1002/alr.22052DOI Listing
March 2018
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