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The Food and Drug Administration and the National Institutes of Health (NIH) have asserted that diverse demographic representation in clinical trials is essential. In light of these federal guidelines, the objective of this study is to assess the racial, ethnic, and gender demographics of patients enrolled in clinical trials registered with the NIH that evaluate chronic rhinosinusitis with nasal polyposis (CRSwNP) relative to the demographics of the US population.Cross-sectional study.Not applicable.ClinicalTrials.gov was queried to identify all prospective clinical trials for CRSwNP. Individual study and pooled data were compared with national US census data.Eighteen studies were included comprising 4125 patients and evaluating dupilumab, mepolizumab, omalizumab, fluticasone/OptiNose, MediHoney, mometasone, and SINUVA. Women constituted 42.7% of clinical trial participants. Of the 4125 participants, 69.6% identified as White, 6.6% as Black, 20.8% as Asian, 0.1% as Pacific Islander, 0.4% as American Indian, 8.0% as Hispanic, and 2.4% as other. The racial, ethnic, and gender composition of the pooled study population differs significantly from national US census data, with underrepresentation of Black, Hispanic, Pacific Island, and American Indian individuals, as well as females (The racial, ethnic, and gender demographics of patients enrolled in CRSwNP clinical trials registered with the NIH differ significantly from the demographics of the US population, despite federal guidelines advising demographically representative participation. Proactive efforts to enroll participants that better represent anticipated treatment populations should be emphasized by researchers, institutions, and editorial boards.

Objective Wide variation exists regarding reported outcomes after endoscopic sinus surgery (ESS) for chronic rhinosinusitis with nasal polyps (CRSwNP). This study seeks to combine data across studies to generate a summary measure and explore factors that might lead to variation. Data Sources OVID Medline, Scopus, EbscoHost, Database of Abstracts and Reviews of Effects, Health Technology Assessment, and National Health Service Economic Evaluation Database. Review Methods A search was performed following the PRISMA guidelines. Two independent researchers conducted a search using the mentioned data sources. Studies published before August 29, 2016, that involved ESS to treat CRSwNP were included. Mean changes in Sinonasal Outcome Test-22 (SNOT-22) scores were determined through metaregression of the following independent variables: publication year, sex, age, allergy status, asthma, tobacco use, prior surgery, follow-up length, and preoperative SNOT-22. Results Fifteen articles with 3048 patients treated with ESS met inclusion criteria. Pooled analyses of SNOT-22 scores revealed a mean change of 23.0 points (95% CI, 20.2-25.8; P < .001). A metaregression of patient factor effects on the mean change of SNOT-22 scores demonstrated that age ( r = 0.71, P = .01), asthma ( r = 0.21, P = .01), prior ESS ( r = 0.29, P = .01), and preoperative SNOT-22 score ( r = 0.4, P < .01) correlated with greater improvement in SNOT-22 scores. Tobacco use ( r = -0.91, P = .01) and longer lengths of follow-up ( r = -0.45, P < .01) were associated with less improvement in SNOT-22 scores. Conclusions Quality-of-life outcomes are significantly improved after ESS among patients with CRSwNP. Patient-specific factors may affect the degree of SNOT-22 change after surgery.

To assess delayed nasoseptal flaps as a viable reconstructive option for sellar defects, evaluate postoperative vascularity of delayed nasoseptal flaps, and compare cerebrospinal fluid leak and surgery-specific complication rates of primary to delayed nasoseptal flaps.Case series with chart review.University of Pittsburgh Medical Center.All patients undergoing transsellar approaches for skull base tumors from 2009 to 2013 were evaluated. In cases where the necessity of a vascularized reconstructive flap was made evident only after tumor resection, the nasoseptal flap was raised after tumor resection and/or cerebrospinal fluid leak development, thus constituting a delayed nasoseptal flap. Outcome measures include postoperative magnetic resonance imaging (MRI) findings, cerebrospinal leak rates, and complication rates.During this timeframe, 437 patients underwent transsellar approaches. Primary nasoseptal flaps were used to reconstruct 179 patients while 32 patients had delayed flaps. All available postoperative MRI scans of delayed nasoseptal flap patients maintained vascularity on examination of T1 postcontrast images. There was no significant difference in cerebrospinal fluid leak rate between primary (3.4%) and delayed flaps (3.1%) (P = .95). There was no significant difference in surgery-specific complication rates between primary flaps (10.6%) and delayed flaps (3.1%; P = .14). Logistic regression analysis demonstrated no significant effect of flap type, age, or sex on cerebrospinal fluid leak rates.Delayed nasoseptal flaps are a viable reconstructive option for sellar skull base defects. They maintain vascularity as evidenced on postoperative MRI and are comparable to primary nasoseptal flaps with regard to cerebrospinal fluid leak rates and complication rates.

Objectives:Determine the efficacy and safety of acetaminophen plus ibuprofen in treatment of post-tonsillectomy pain compared to acetaminophen plus opioids in children.Methods:A retrospective medical record review was performed of children (n = 575) who underwent adenotonsillectomy at a tertiary care children’s hospital between September 2012 and January 2013. All patients received acetaminophen. 342 (59%) received ibuprofen, and 233 (41%) received opioids (oxycodone or hydrocodone) without ibuprofen. In the ibuprofen group, 109 (32%) received opioids. None received codeine. Descriptive analysis, two-tailed t-tests, and multivariate regression controlling for age and diagnosis analyzed differences of outcomes: 1) postoperative hemorrhage, 2) nurse phone calls from families, and 3) emergency department (ED) visits for pain, dehydration, or bleeding.Results:For the entire group, 7% had postoperative hemorrhage. 43% of these required operative intervention. There were 73 ED visits and 216 nurse calls. No sig...

Objective: 1) Investigate the correlation between percentage of metastatic tumor in lymph nodes from patients with squamous cell carcinoma (SCC) of the head and neck and level of expression of 3 marker genes: pemphigus vulgaris antigen (PVA), parathyroid hormone related peptide (PTHrP), and tumor-associated calcium signal transducer (TACSTD1). 2.) Understand the relation of these markers and clinical outcomes.Method: Four hundred forty-eight grossly negative lymph nodes from 92 patients with SCC were evaluated for expression of the gene markers PVA, PTHrP, and TACSTD1 using real-time PCR. Confirmation of metastasis was determined by histological examination. The expression of these markers was analyzed versus tumor percentage using correlation and linear regression.Results: All 3 markers were studied independently and were statistically significant predictors of tumor percentage in the lymph nodes at a significance level of 0.05. PVA had the strongest correlation with tumor percent with a correlation coef...