Transoral robotic surgery with neck dissection versus nonsurgical treatment in stage I and II human papillomavirus-negative oropharyngeal cancer.

BACKGROUND: Surgery + adjuvant therapy was shown to have improved overall survival (OS) versus nonsurgical treatment in T1-T2N1-N2b human papillomavirus (HPV)-negative oropharyngeal cancer (OPC). Our objective was to compare OS in transoral robotic surgery (TORS) with neck dissection versus nonsurgical treatment for T1-T2N0 HPV-negative OPC. METHODS: Patients with T1-T2N0 HPV-negative OPC were identified in the National Cancer Database. OS was compared between groups: (1) TORS with neck dissection +/- adjuvant therapy, (2) primary radiotherapy (>60 Gy) +/- chemotherapy using Kaplan-Meier and multivariable Cox proportional hazards models. RESULTS: There were 665 (78.4%) patients treated nonsurgically and 183 (21.6%) patients in the TORS group. Adjusting for age, comorbidity score, facility type, tumor subsite, and tumor stage, primary nonsurgical treatment was associated with worse OS (hazard ratio: 1.90, 95% CI: 1.34-2.69). CONCLUSION: For T1-T2N0 HPV-negative OPC, TORS with neck dissection may be associated with a survival benefit over nonsurgical treatment.

National Analysis of Oropharyngeal Salivary Gland Malignancies Treated With Transoral Robotic Surgery.

OBJECTIVES: (1) To compare perioperative outcomes and overall survival of patients with oropharyngeal salivary gland malignancies (OPSGMs) treated with transoral robotic surgery (TORS) versus other approaches. (2) To identify clinical factors associated with a robotic surgical approach. STUDY DESIGN: Retrospective analysis of the National Cancer Database (NCDB). SETTING: NCDB. METHODS: Data obtained from the NCDB were analyzed between 2010 and 2017 for patients with T1-T4a OPSGMs without distant metastases treated surgically. Patients were stratified by surgical approach (TORS vs nonrobotic), and clinicopathologic factors were compared with the t test or chi-square test for continuous or categorical variables, respectively. Overall survival was analyzed by patient demographics and clinical factors according to Kaplan-Meier and Cox proportional hazards models. Factors associated with TORS were assessed with logistic regression. RESULTS: A total of 785 patients were analyzed. A non-soft palate primary site (odds ratio, 12.9; 95% CI, 6.6-25.2) and treatment at an academic facility (odds ratio, 2.0; 95% CI, 1.2-3.5) were independently associated with TORS. There were no significant differences in the positive margin rate, 30-day mortality, or overall survival between the groups. The 30-day unplanned readmission rate was higher in patients treated with TORS versus nonrobotic resections (5.8% vs 1.7%, P = .0004). When stratified by tumor subsite, there was a significant decrease in hospital length of stay in patients with tongue base tumors undergoing TORS versus nonrobotic resections (P = .029). CONCLUSION: This study suggests that TORS may be a viable treatment modality for appropriately selected patients with OPSGM.

Extraprimary Local Recurrence of Esthesioneuroblastoma: Case Series and Literature Review.

OBJECTIVES: Esthesioneuroblastoma (ENB) is a rare sinonasal malignancy arising from olfactory neuroepithelium. Recurrence typically occurs locoregionally at the primary site or in the form of cervical metastasis. Delayed local recurrence away from the initial primary site is exceedingly rare. METHODS: Retrospective review of 4 patients with histologically confirmed extraprimary local recurrence of ENB was performed with review of the literature. RESULTS: All cases initially presented with ENB isolated to the cribriform plate(s) treated with primary surgical resection and adjuvant radiotherapy. The first patient had ENB recurrence 8 years posttreatment involving the right orbit. She later developed metastases to the spine, neck, and mandible requiring composite resection and 4 courses of radiotherapy. The second patient had ENB recurrence of the dorsal septum 9 years posttreatment with cervical metastases requiring septectomy, bilateral neck dissection, and radiotherapy. The third patient had ENB recurrence 7 years posttreatment in the posterior nasopharynx requiring endonasal nasopharyngectomy. Finally, the fourth patient had ENB recurrence 12 years posttreatment in the sphenopalatine foramen, which was endoscopically resected. At the time of this review, all 4 patients were disease free at 32, 21, 4, and 24 months posttreatment follow-ups, respectively. CONCLUSIONS: This case series describes the rare phenomenon of delayed extraprimary local recurrence of histologically confirmed ENB. Treatment of extraprimary recurrences, analogous to other forms of ENB, should include primary surgical resection with adjuvant radiotherapy for generally favorable outcomes. Long-term close follow-up based on symptoms, endoscopy, and imaging is essential because of the risk of delayed recurrence.

Snapshot Impact of COVID-19 on Mental Wellness in Nonphysician Otolaryngology Health Care Workers: A National Study.

OBJECTIVE: Nonphysician health care workers are involved in high-risk patient care during the COVID-19 pandemic, placing them at high risk of mental health burden. The mental health impact of COVID-19 in this crucial population has not been studied thus far. Thus, the objective of this study is to assess the psychosocial well-being of these providers. STUDY DESIGN: National cross-sectional online survey (no control group). SETTING: Academic otolaryngology programs in the United States. SUBJECTS AND METHODS: We distributed a survey to nonphysician health care workers in otolaryngology departments across the United States. The survey incorporated a variety of validated mental health assessment tools to measure participant burnout (Mini-Z assessment), anxiety (Generalized Anxiety Disorder-7), distress (Impact of Event Scale), and depression (Patient Health Questionnaire-2). Multivariable logistic regression analysis was performed to determine predictive factors associated with these mental health outcomes. RESULTS: We received 347 survey responses: 248 (71.5%) nurses, 63 (18.2%) administrative staff, and 36 (10.4%) advanced practice providers. A total of 104 (30.0%) respondents reported symptoms of burnout; 241 (69.5%), symptoms of anxiety; 292 (84.1%), symptoms of at least mild distress; and 79 (22.8%), symptoms of depression. Upon further analysis, development of these symptoms was associated with factors such as occupation, practice setting, and case load. CONCLUSION: Frontline otolaryngology health care providers exhibit high rates of mental health complications, particularly anxiety and distress, in the wake of COVID-19. Adequate support systems must be put into place to address these issues.

Mental health among otolaryngology resident and attending physicians during the COVID-19 pandemic: National study.

BACKGROUND: Otolaryngologists are among the highest risk for COVID-19 exposure. METHODS: This is a cross-sectional, survey-based, national study evaluating academic otolaryngologists. Burnout, anxiety, distress, and depression were assessed by the single-item Mini-Z Burnout Assessment, 7-item Generalized Anxiety Disorder Scale, 15-item Impact of Event Scale, and 2-item Patient Health Questionnaire, respectively. RESULTS: A total of 349 physicians completed the survey. Of them, 165 (47.3%) were residents and 212 (60.7%) were males. Anxiety, distress, burnout, and depression were reported in 167 (47.9%), 210 (60.2%), 76 (21.8%), and 37 (10.6%) physicians, respectively. Attendings had decreased burnout relative to residents (odds ratio [OR] 0.28, confidence interval [CI] [0.11-0.68]; P = .005). Females had increased burnout (OR 1.93, CI [1.12.-3.32]; P = .018), anxiety (OR 2.53, CI [1.59-4.02]; P < .005), and distress (OR 2.68, CI [1.64-4.37]; P < .005). Physicians in states with greater than 20 000 positive cases had increased distress (OR 2.01, CI [1.22-3.31]; P = .006). CONCLUSION: During the COVID-19 pandemic, the prevalence of burnout, anxiety, and distress is high among academic otolaryngologists.

Predictors of nodal metastasis in sinonasal squamous cell carcinoma: A national cancer database analysis.

OBJECTIVE: We present the largest population based study of sinonasal squamous cell carcinoma (SCC) to identify risk factors for presentation with nodal metastasis. METHODS: The National Cancer Database (NCDB) was used for this study. Location codes corresponding to the nasal cavity and paranasal sinuses and histology codes representing SCC malignancy were queried. Logistic regression analysis was performed to identify factors associated with presentation with nodal metastasis. RESULTS: 6448 cases met inclusion criteria. Nodal metastasis at presentation was seen in 13.2% of patients, with the sinus subsite (19.3%) being a significant risk factor for nodal metastasis at presentation when compared to the nasal cavity (7.9%). Logistic regression analysis showed black, uninsured and Medicaid patients were more likely than white and privately insured patients, respectively, to present with nodal metastasis. CONCLUSIONS: In sinonasal SCC, the sinus subsite has a significantly increased risk of nodal metastasis compared to the nasal cavity. Black race, uninsured and Medicaid patients are more likely to have nodal metastasis at presentation.

Ethical surgical triage of patients with head and neck cancer during the COVID-19 pandemic.

BACKGROUND: Coronavirus has serially overtaken our metropolitan hospitals. At peak, patients with acute respiratory distress syndrome may outnumber mechanical ventilators. In our Miami Hospital System, COVID-19 cases have multiplied for 4 weeks and elective surgery has been suspended. METHODS: An Otolaryngologic Triage Committee was created to appropriately allocate resources to patients. Hospital ethicists provided support. Our tumor conference screened patients for nonsurgical options. Patients were tested twice for coronavirus before performing urgent contaminated operations. N95 masks and protective equipment were conserved when possible. Patients with low-grade cancers were advised to delay surgery, and other difficult decisions were made. RESULTS: Hundreds of surgeries were canceled. Sixty-five cases screened over 3 weeks are tabulated. Physicians and patients expressed discomfort regarding perceived deviations from standards, but risk of COVID-19 exposure tempered these discussions. CONCLUSIONS: We describe the use of actively managed surgical triage to fairly balance our patient's health with public health concerns.

Pectoralis major muscle flap use in a modern head and neck free flap practice.

PURPOSE: Pectoralis major muscle flaps (PMMF) are a commonly used reconstructive modality to repair head and neck defects. As the use of free flap reconstruction is increasingly practiced in the head and neck, the role of the PMMF may be changing as well. This study sought to analyze indications and outcomes for PMMF following head and neck resections from one surgeon's experience. MATERIALS AND METHODS: Retrospective review from December 1, 2013 through September 30, 2017 at a tertiary care academic medical center. Indications for the PMMF were examined as well as surgical outcomes. Basic demographic data, patient head and neck cancer history, history of radiation and/or chemotherapy, and history of previous reconstructive procedures were obtained and compared across all subjects. RESULTS: Forty patients underwent a PMMF within the designated time frame. The majority of patients were male (83%) and the average age was 65 years (range 55.4-74.6 years). Of the 40 cases, 9 of the PMMFs were performed as primary reconstruction of the defect. In the remaining 31 cases, these flaps were utilized as a secondary reconstructive option following fistula formation (13), dehiscence (6), need for an additional flap for recurrent disease (6) infection (4), or major bleeding (2). In every case that it was utilized, the PMMF was the definitive reconstruction. Within the same time frame, 429 free flaps were performed by the same surgeon, with an average of 125 free flaps performed yearly. The rate of total flap failure overall was 3.9%. The other failed free flap reconstructive options used besides a PMMF were secondary free flaps (11), local wound care (4), or obturator placement (2). The secondary pectoralis flaps occurred following 7.2% of free flaps with total or partial failure that were performed within the same time range. The indications for the PMMF did not change or evolve during the time frame of the study. CONCLUSIONS: Although free flaps were performed with far greater frequency than PMMFs at our institution, the PMMF demonstrated continued utility as a secondary reconstructive option. For a surgeon who performs a high volume of free flaps, preservation of the pectoralis muscle and associated vasculature for possible later secondary reconstruction should be considered due to its strong efficacy.

Social determinants of health and survivorship in parotid cancer: An analysis of the National Cancer Database.

BACKGROUND: Given the rarity of parotid cancer, there is relatively few data published regarding outcomes. Utilizing the large sample population of the National Cancer Database (NCDB), we aim to examine the relationship between two key social determinants of health, demographics and socioeconomic status (SES), and parotid malignancy survival rates. METHODS: Our analytic sample consists of patients with a diagnosis of primary malignancy of the parotid gland between 2004 and 2012 in the NCDB. We used univariable and multivariable Cox proportional hazard models to evaluate the relationship between overall survival rate and two key social determinants of health: demographics and SES. RESULTS: 15,815 cases met inclusion criteria. Average age was 60.1 years and 8255 were male (52.2%). Median overall survival was 121 months with 5-year overall survival of 67.4%. Male sex and older age at diagnosis were associated with poorer overall survival (p < 0.0001). We found that Asian Americans compared to whites had better overall survival (HR 0.75; 95% CI [0.58-0.95]). Black patients had improved survival compared to whites on univariate (HR 0.71; 95% CI [0.64-0.79]); but not multivariate analysis. Hispanic ethnicity and higher education level were protective (HR 0.76 95% CI [0.63-0.91] and HR 0.84 95% CI [0.74-0.96], respectively). We found no significant survival association based on income level. CONCLUSION: In this national sample of patients with parotid malignancy, a rare form of cancer, we found a significant correlation between important social determinants of health and overall survival rate. Females, Asian-Americans, Hispanics, and patients with higher education level have better overall survival.

Nasopharyngeal Angiofibroma: A Forgotten Entity in Older Patients.

INTRODUCTION: Nasopharyngeal angiofibroma (NA) characteristically affects adolescent men. Although benign, these tumors can cause local destruction and surgical resection is warranted. OBJECTIVE: We present a case of a 62-year-old man with nasal congestion and epistaxis, found to be a right NA on pathology. We also present a review of the available NA staging systems. FINDINGS: In this case of NA, imaging revealed an aggressive, hypervascular mass in the nasal cavity with involvement of the middle cranial fossa and cavernous sinus. The patient underwent complete endoscopic surgical resection following vascular embolization. CONCLUSIONS: Although it is rare, NA should not be disregarded in the elderly population.

Intraoperative Imaging with Second Window Indocyanine Green for Head and Neck Lesions and Regional Metastasis.

While optical imaging with near-infrared (NIR) fluorescent dye has been used in oncologic surgery, its use in the head and neck has not been established. We aimed to evaluate the feasibility of using NIR to visualize primary tumor and regional metastasis in head and neck malignancy. Patients undergoing resection of primary head and neck tumors were included in this pilot study. Each patient was injected with indocyanine green dye (ICG) the day prior to surgery. The VisionSense Iridium camera system was used to visualize the primary lesion, its margins, and neck dissection specimen intraoperatively. Fourteen patients were enrolled. Eighty-six percent of primary tumors showed fluorescence as compared with surrounding tissues. ICG positivity showed 100% sensitivity for pathologic nodes in 7 neck dissection specimens; however, for 3 patients, nonpathologic nodes also showed ICG positivity. NIR imaging with ICG dye can be considered for intraoperative imaging of head and neck lesions.

Impact of payer status on survival in parotid malignancy.

OBJECTIVE: In the setting of current national healthcare reform, it becomes especially relevant to understand the current state of healthcare disparities with regards to insurance status. To determine the impact of payer status on survival in parotid malignancy, we utilized the National Cancer Database (NCDB). STUDY DESIGN: Retrospective database review. SETTING: National Cancer Database (2004-2012). SUBJECTS AND METHODS: The NCDB was queried for cases of primary malignancy of the parotid gland between 2004 and 2012. The impact of payer status on overall survival was evaluated, as well as the relationship of insurance status with patient and tumor variables. RESULTS: 15,815 cases met inclusion criteria. A majority had private insurance (47.8%), followed by Medicare (40.9%), Medicaid (5.0%), uninsured (3.2%) and other government sources (1.3%). Medicare patients had the lowest 5 and 10-year survival rates (50.7% (95% CI [49.3-52.1]) and 27.8% (95% CI [25.0-30.9]), respectively). On multivariable analysis, uninsured, Medicare, and Medicaid patients had worse overall survival than the privately insured (HR 1.42, 95% CI [1.17-1.74]; HR 1.29, 95% CI [1.17-1.42]; HR 1.36, 95% CI [1.13-1.62], respectively). Uninsured and Medicaid patients were more likely than the privately insured to present with advanced stage disease, nodal metastasis and longer times to treatment following diagnosis. CONCLUSION: In parotid malignancy, uninsured, Medicaid, and Medicare patients have worse survival outcomes compared to those with private insurance. Uninsured and Medicaid patients also present with more advanced stage disease and have increased wait times before definitive treatment is initiated.

Management of the Airway for Transoral Robotic Supraglottic Partial Laryngectomy.

Introduction: Over the last several decades, transoral resection techniques for treatment of supraglottic lesions have become increasingly favored to reduce the need for either open transcervical resection or primary chemoradiation. Transoral robotic surgery (TORS) offers advantages in visualization, dissection control, and access to remove bulky tumors en bloc. However, the management of the airway for these cases tends to vary, without clear guidelines as to when a tracheostomy is necessary. Materials and Methods: A retrospective review of all patients who underwent transoral robotic supraglottic partial laryngectomy at a large academic center from May 2005 through December 2016 was performed. Airway management was examined, specifically as it pertains to whether a tracheostomy was performed at the time of surgery or otherwise. Demographic and tumor characteristics were also evaluated. Results: Sixty-three patients were included. Forty (63%) were male, the average age at surgery was 63.6, and the majority (90.5%) underwent resection for squamous cell carcinoma of the supraglottis. Thirty-nine patients (62%) underwent the procedure with standard endotracheal intubation using a wire-reinforced tube. Of these, four patients required subsequent tracheostomy- 2 for laryngeal edema postoperatively, one for airway management during a postoperative bleeding event, and one for laryngeal edema following initiation of adjuvant chemoradiation. Twenty patients (32%) underwent tracheostomy at the time of transoral resection for airway management, 17 of whom were decannulated an average of 12.2 weeks following surgery. Those who underwent tracheostomy at the time of surgery had a higher percentage of tumors involving multiple supraglottic subsites (p = 0.031), 85 vs. 54% in the group who did not undergo tracheostomy. No difference in age, BMI, clinical T-stage, or clinical N stage was found between the two groups. Conclusion: Performing a tracheostomy at the time of surgery should be considered for those patients with more extensive malignant disease (≥T2 tumors). While avoiding tracheostomy is often preferred by the patient, the maintenance of the patent airway peri-operatively should be first priority when considering airway management. Furthermore, as the majority of those patients receiving tracheostomy are decannulated within 4 months of surgery, the tracheostomy could be considered a short-term adjunct to the procedure.

Mucoepidermoid carcinoma of the parotid gland: A National Cancer Database study.

OBJECTIVE: To describe the demographics, tumor characteristics, and prognostic features of mucoepidermoid carcinoma of the parotid gland. MATERIALS AND METHODS: A retrospective study of the National Cancer Database was reviewed for all mucoepidermoid carcinomas of the parotid gland between 2004 and 2012). Patient demographics and tumor characteristics were abstracted and analyzed. Univariate and multivariate Cox multivariate regression models were used to identify predictors of survival. RESULTS: A total of 4431 patients met inclusion criteria. Average age at diagnosis was 57 years (median 62, SD 19), with no overall sex preference (52% female), and majority white (78%). The 1-year overall survival was 92.9% (95% CI [92.1-93.6]) and 5-year overall survival was 75.2% (95% CI [73.8-76.7%]). Median overall survival was not reached at 5 years. Factors associated with decreased survival were increasing age, comorbidities, high tumor grade, advanced pathologic group stage, and positive surgical margins. Female sex was the only factor associated with improved survival. Controlling for either histopathologic grade or pathologic stage to determine how patient demographics and tumor characteristics affected overall survival yielded similar results. Of note, intermediate grade tumors, although not independently associated with worse survival, when seen in conjunction with tumors ≥T2 and/or ≥N2, a negative impact on overall survival was seen. CONCLUSION: Although mucoepidermoid carcinoma of the parotid gland is the most common parotid gland malignancy, it is still a rare tumor with a lack of large population-based studies. Advanced stage and high-grade tumors are significant predictors of decreased survival. Females have improved survival compared to males.

Determining If Sex Bias Exists in Human Surgical Clinical Research.

Importance: Sex is a variable that is poorly controlled for in clinical research. Objectives: To determine if sex bias exists in human surgical clinical research, to determine if data are reported and analyzed using sex as an independent variable, and to identify specialties in which the greatest and least sex biases exist. Design, Setting, and Participants: For this bibliometric analysis, data were abstracted from 1303 original peer-reviewed articles published from January 1, 2011, through December 31, 2012, in 5 surgery journals. Main Outcomes and Measures: Study type, location, number and sex of participants, degree of sex matching of included participants, and inclusion of sex-based reporting, statistical analysis, and discussion of data. Results: Of 2347 articles reviewed, 1668 (71.1%) included human participants. After excluding 365 articles, 1303 remained: 17 (1.3%) included males only, 41 (3.1%) included females only, 1020 (78.3%) included males and females, and 225 (17.3%) did not document the sex of the participants. Although female participants represent more than 50% (n = 57 688 606) of the total number (115 377 213) included, considerable variability existed with the number of male (46 111 818), female (58 805 665), and unspecified (10 459 730) participants included among the journals, between US domestic and international studies, and between single vs multicenter studies. For articles included in the study, 38.1% (497 of 1303) reported these data by sex, 33.2% (432 of 1303) analyzed these data by sex, and 22.9% (299 of 1303) included a discussion of sex-based results. Sex matching of the included participants in the research overall was poor, with 45.2% (589 of 1303) of the studies matching the inclusion of both sexes by 50%. During analysis of the different surgical specialties, a wide variation in sex-based inclusion, matching, and data reporting existed, with colorectal surgery having the best matching of male and female participants and cardiac surgery having the worst. Conclusions and Relevance: Sex bias exists in human surgical clinical research. Few studies included men and women equally, less than one-third performed data analysis by sex, and there was wide variation in inclusion and matching of the sexes among the specialties and the journals reviewed. Because clinical research is the foundation for evidence-based medicine, it is imperative that this disparity be addressed so that therapies benefit both sexes.

Temporal patterns of 18 F-fluorodeoxyglucose positron emission tomography/computed tomography sinonasal uptake after treatment of sinonasal malignancy.

BACKGROUND: Current guidelines have identified 10 to 12 weeks posttreatment as the ideal time-point for improved diagnostic accuracy of positron emission tomography/computed tomography (PET/CT) for deep tissue sites of the head and neck. After treatment, the sinonasal skull base is predisposed to prolonged inflammation that may render this time-point inappropriate for initial posttreatment imaging surveillance for sinonasal malignancies. The purpose of this study is to evaluate temporal trends in 18 F-fluorodeoxyglucose (18 FDG) sinonasal uptake after treatment for sinonasal malignancies to better elucidate the optimal time-point for initial PET/CT posttreatment evaluation in this patient population. METHODS: A retrospective analysis of all successfully treated and non-locally recurrent sinonasal malignancies over a 15-year study period (2000 to 2015) was performed at our institution. Posttreatment 18 FDG PET/CT standardized uptake value data were collected and compared between various time-points (2 to 4 months, 5 to 12 months, 5 to 24 months, and 13 to 24 months) using an independent-samples t test. RESULTS: A statistically significant difference was noted between the posttreatment time windows 2 to 4 and 5 to 12 months (p = 0.048) as well as 2 to 4 and 5 to 24 months (p = 0.02). A trend toward significance was seen when comparing 2 to 4 and 13 to 24 months (p = 0.083). CONCLUSION: Our analysis of PET/CT in patients previously treated for sinonasal malignancy suggests that the posttreatment sinonasal skull base is characterized by a prolonged period of hypermetabolism that endures beyond the period previously described for deep tissue sites of the head and neck. These findings prompt a reevaluation of the previously described 10- to 12-week cutoff point for initial posttreatment PET/CT for head and neck squamous cell carcinoma as applied to sinonasal malignancies.

Measurement and comparison of health utility assessments in chronic rhinosinusitis.

BACKGROUND: Chronic rhinosinusitis (CRS) is a common condition encountered in primary care medicine and is estimated to affect 12.5% of the United States population. This study aims to compare methods of assessing health utility in CRS. METHODS: A cross-sectional sample of CRS patients (n = 137) were interviewed using direct health utility assessment measures: the visual analogue scale (VAS), time trade-off (TTO), and standard gamble (SG). General quality of life (QOL) scores were obtained via the 36-item Short Form Health Survey (SF-36) and converted to SF-6D health utility values using a Bayesian algorithm. Disease-specific QOL was measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). A selected subgroup of patients (n = 51) not initiating surgery or new treatment for CRS were re-interviewed within 3 weeks. RESULTS: The mean ± SD health utilities were VAS 0.69 ± 0.19; TTO 0.80 ± 0.27; SG 0.93 ± 0.11; and SF-6D 0.72 ± 0.12; they differed significantly (p < 0.001). Only VAS scores differed based on disease state classification or the presence of nasal polyposis. Correlations between methods of determining health utility were weak, but significant. VAS, TTO, and SF-6D scores were significantly associated with SNOT-22 (p < 0.001 for all); however, SG and SNOT-22 were poorly correlated (Spearman correlation = -0.33). The test-retest reliability of TTO (Spearman correlation = 0.71) and SG (0.73) was strong. CONCLUSION: CRS patients show significant impairment in QOL, with health utility values similar to those of patients with acquired immune deficiency syndrome (AIDS) or intermittent claudication using similar methods. The method of ascertainment significantly affects measured health utility, but the degree of impairment warrants improved recognition and appropriate treatment of the condition.

Sex bias exists in basic science and translational surgical research.

BACKGROUND: Although the Revitalization Act was passed in 1993 to increase enrollment of women in clinical trials, there has been little focus on sex disparity in basic and translational research. We hypothesize that sex bias exists in surgical biomedical research. METHODS: Manuscripts from Annals of Surgery, American Journal of Surgery, JAMA Surgery, Journal of Surgical Research, and Surgery from 2011 to 2012 were reviewed. Data abstracted included study type, sex of the animal or cell studied, location, and presence of sex-based reporting of data. RESULTS: Of 2,347 articles reviewed, 618 included animals and/or cells. For animal research, 22% of the publications did not specify the sex of the animals. Of the reports that did specify the sex, 80% of publications included only males, 17% only females, and 3% both sexes. A greater disparity existed in the number of animals studied: 16,152 (84%) male and 3,173 (16%) female (P < .0001). For cell research, 76% of the publications did not specify the sex. Of the papers that did specify the sex, 71% of publications included only males, 21% only females, and 7% both sexes. Only 7 (1%) studies reported sex-based results. For publications on female-prevalent diseases, 44% did not report the sex studied. Of those reports that specified the sex, only 12% studied female animals. More international than national (ie, United States) publications studied only males (85% vs 71%, P = .004), whereas more national publications did not specify the sex (47% vs 20%, P < .0001). A subanalysis of a single journal showed that across three decades, the number of male-only studies and usage of male animals has become more disparate over time. CONCLUSION: Sex bias, be it overt, inadvertent, situational, financial, or ignorant, exists in surgical biomedical research. Because biomedical research serves as the foundation for subsequent clinical research and medical decision-making, it is imperative that this disparity be addressed because conclusions derived from such studies may be specific to only one sex.