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Objectives: Fine needle aspiration (FNA) biopsy of thyroid nodules provides cytologic specimens whose interpretation can direct patients toward either thyroidectomy or observation. Approximately 20% of FNA specimens yield an indeterminate result. Recent studies have characterized differences in gene expression between benign and malignant conditions, most often using whole tissue. Our goal was to determine the feasibility of quantitative polymerase chain reaction (qPCR)-based gene expression analysis in cytologic samples. For five genes shown to be over-expressed in thyroid carcinomas (fibronectin, galectin-3, Met/HGFR, MUC1, and GA733-precursor), we compared expression among pathologic states. Study Design: Prospective laboratory analysis of 20 thyroidectomy specimens. Methods: Routine microscopy was performed. Cytologic samples were obtained from the dominant nodules, and RNA was extracted. Preliminary analysis using fluorometry and reverse-transcriptase (RT)-PCR was performed. Expression levels of the test genes in nodules and from control samples were measured by real-time qPCR. Fold changes in gene expression were compared. Results: Only one specimen did not yield sufficient intact RNA for gene expression analysis. RT-PCR revealed satisfactory RNA recovery in all other specimens. qPCR showed significant over-expression of fibronectin in the papillary carcinomas compared with the goiters (P = .0013), follicular adenomas (P = .0014), and follicular carcinomas (P = .0001). Differences in both fibronectin and MUC1 expression between the follicular carcinomas and the follicular adenomas were also significant (P = .025 and .045, respectively). Conclusions: Cytologic specimens were a satisfactory source of tissue for qPCR-based gene expression analysis. Both fibronectin and MUC1 were differentially expressed in follicular adenomas and follicular carcinomas, and fibronectin expression differed in papillary carcinomas compared with the other lesions. These results may form the basis of a clinical predictor for lesions with indeterminate or suspicious cytology. [ABSTRACT FROM AUTHOR]

Background: Well-differentiated thyroid cancer includes papillary thyroid, follicular thyroid, and Hurthle cell cancers, comprising approximately 95% of all thyroid cancers in the United States. This study aims to understand well-differentiated thyroid cancer in the Asian population., Methods: We analyzed the National Cancer Database from 2004 to 2019, categorizing the Asian population based on the available ethnicities. Multivariable logistic regression assessed the associations between ethnic groups and disease stage/nodal positivity. Survival outcomes were evaluated using the Kaplan-Meier and Cox regression analyses., Results: A total of 364,604 adult patients were analyzed. The Asian ethnic groups included were Chinese (n = 3,851), Japanese (n = 740), Filipino (n = 3,466), Korean (n = 1,567), Vietnamese (n = 1,517), Laotian (n = 101), Hmong (n = 50), Kampuchean (n = 166), Thai (n = 160), Asian Indian (n = 1,526), Pakistani (n = 167), and Pacific Islander (n = 446). Japanese, Korean, and Laotian had higher percentages of stage III disease, whereas Japanese, Filipino, and Laotian had higher proportions of stage IV disease than the White population. Most Asian ethnicities had more patients with metastasis than the White population. Korean patients exhibited a 15% increased likelihood of metastasis (odds ratio: 1.15, confidence interval: 1.03-1.28, P < .05), whereas Pakistani patients were at 40% higher odds (odds ratio: 1.40, confidence interval: 1.03-1.91, P < .05), compared with White patients. Japanese, Laotian, and Kampuchean patients experienced worse 5- and 10-year overall survival than the White population., Conclusion: Our study revealed substantial variation in well-differentiated thyroid cancer characteristics and outcomes among diverse Asian ethnicities. This challenges the notion of Asians as a homogeneous population, emphasizing tailored disease management for this heterogeneous group of patients., Competing Interests: Conflict of Interest/Disclosure The authors have indicated that they have no conflicts of interest regarding the content of this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Parathyroidectomy has been shown to be superior to medical management in treating hypercalcemia and preserving renal allograft function in patients with tertiary hyperparathyroidism after kidney transplant. Despite this evidence, parathyroidectomy remains underused. We aimed to evaluate outcomes in patients with tertiary hyperparathyroidism after kidney transplant based on management strategy (cinacalcet or parathyroidectomy) and optimal timing of parathyroidectomy., Methods: Data from TriNetX Dataworks included adult kidney transplant patients diagnosed with tertiary hyperparathyroidism between 1998 and 2021. Patients who underwent parathyroidectomy were compared with those receiving cinacalcet. Subgroups based on parathyroidectomy timing after transplant were analyzed (within 6 months, 6 months to 1 year, and between 1 and 3 years). Descriptive statistics and relative risks were calculated using TriNetX Live., Results: Patients receiving cinacalcet (n = 162) had a 77% higher risk of persistent hypercalcemia and a 73% higher risk of elevated parathyroid hormone levels than those who underwent parathyroidectomy (n = 338) within 3-10 years after the index event (start of cinacalcet or surgery). Parathyroidectomy performed 1 year after transplant (n = 132) was associated with a 57% lower risk of kidney stone formation and patients were 2 times more likely to maintain normal glomerular filtration rate than parathyroidectomy performed 1-3 years after transplant (n = 57). Even earlier parathyroidectomy (within 6 months of kidney transplant, n = 55) showed a 62% lower risk of persistent hypercalcemia, hyperphosphatemia, and kidney stone formation than surgery between 6 months and 1 year after transplant (n = 77)., Conclusion: Parathyroidectomy is more effective than cinacalcet in managing tertiary hyperparathyroidism after kidney transplant. In addition, opting for early parathyroidectomy (within 6 months after transplant) could enhance long-term outcomes., Competing Interests: Conflict of Interest/Disclosure The authors have indicated that they have no conflicts of interest regarding the content of this article., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Doctor of Pharmacy programs are charged with developing students' empathy by the 2016 Accreditation Council for Pharmacy Education (ACPE) Standard 3 and the 2022 Curriculum Outcomes and Entrustable Professional Activities (COEPA). Although empathy is essential to optimal patient care, its subjective nature makes it challenging to teach and therefore literature is lacking on best teaching practices. The authors of this paper describe a novel simulated approach to elicit and assess empathy in a pharmacy classroom. This study evaluated the impact of a decision-making game in a pharmacy skills lab course on the development of students' empathy using a validated empathy scale., Methods: This is a cohort-based quality improvement project in which third year pharmacy students participated in a 3-h classroom empathy game experience that simulated a month in a patient's life including issues related to the cycle of poverty. Prior to the game, students completed a voluntary, anonymous baseline demographics survey. They also completed a pre- and post-survey of the validated empathy tool, the Kiersma-Chen Empathy Scale (KCES-R), to assess change in the empathy score following the decision-making game. Students also provided narrative comments in the post-survey. Statistical tests used included descriptive statistics for demographic data, Shapiro-Wilk test of normality, and Wilcoxon Signed-Rank test for survey scores (SPSS Version 29)., Results: Pharmacy students (n = 37) showed an overall increase in composite KCES-R scores after participating in the empathy game class session (z = -5.071, p < 0.001). The scores of each of the 14 KCES-R items also increased after the learning experience (p < 0.05). Students' narrative comments were all positive and indicated that the activity offered new insights on self-perceived empathy development., Conclusion: The empathy game simulation was a successful approach to increase empathy scores in third-year pharmacy students., Competing Interests: Declaration of competing interest The authors declare no potential conflicts of interest with respect to the study, authorship and/or publication of this article. No funding was received to support the research project nor the preparation of this manuscript., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Few studies have examined the disparities in access to care for pediatric thyroid cancers. We sought to clarify socioeconomic and patient factors that affect access to care for pediatric differentiated thyroid cancer and aggressive variants of papillary thyroid cancer., Methods: Using the National Cancer Database, we performed a retrospective study on pediatric differentiated thyroid cancer and aggressive variants of papillary thyroid cancer (2004-2019). Patients were divided into three periods (2004-2008, 2009-2013, 2014-2019) to assess for trends. The χ 2 analysis and Kruskal-Wallis test were used to test for independence of groupings for each socioeconomic and disease-related factor., Results: In all, 6,275 patients with pediatric differentiated thyroid cancer and 182 with aggressive variants of papillary thyroid cancer were analyzed. Differentiated thyroid cancer patients with Medicaid (median 18.0 miles) and those from lower-income households (median 21-30 miles) had to travel greater distances for care in recent years (2014-2019). Racial/ethnic disparities were evident; Black and Hispanic patients have higher odds of waiting >30 days for surgery (odds ratio 1.39, 1.49, P < .05, respectively) than White patients. Black patients with differentiated thyroid cancer had a higher risk of mortality compared with White and Hispanic patients (hazard ratio 4.31, 95% confidence interval: 1.95-9.51, P < .05). Nodal positivity was higher in Hispanic patients with differentiated thyroid cancer (60%, P < .05, White patients 51% and Black patients 36%). Socioeconomic factors did not significantly affect survival or nodal positivity in aggressive variants of papillary thyroid cancer., Conclusion: This study highlights disparities in access to care and survival outcomes in pediatric differentiated thyroid cancer and aggressive variants of papillary thyroid cancer. Race, income status, and type of insurance all play a role in these disparities. Understanding the complex etiologies and developing interventions to improve access and patient outcomes are crucial., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Pediatric thyroid carcinoma is on the rise. We sought to better characterize patient factors associated with this and evaluate for trends based on age groups. Additionally, we examined surgical management over time, and whether it aligns with recommendations made by the American Thyroid Association. Using the National Cancer Database (NCDB), we examined cases of thyroid cancer from 2004 to 2017, ages 1-18 years. We subdivided this cohort by age group: those <10y, 10-15y, and >15y. NCDB query yielded 5,814 cases. The annual proportion of total cases ranged from 3% to 8% for <10y, 31%-40% for 10-15y, and 52%-66% for >15y. 80-90% of cases in all age groups did indeed receive total thyroidectomy which is consistent with ATA guidelines. Our results verify an overall increase in pediatric thyroid cancer cases, occurring mostly in the 10-18 years old age range with the largest year-to-year increases in the >15y group., Competing Interests: Declaration of competing interest None of the authors have conflict of interest., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Although guidelines recommend open adrenalectomy for most resectable adrenal malignancies, minimally invasive adrenalectomies are performed. Robotic adrenalectomies have become more popular recently, but there is a paucity of literature comparing laparoscopic and robotic resections., Methods: Patients who underwent a planned minimally invasive adrenalectomy for adrenal malignancies (adrenocortical carcinoma, malignant pheochromocytoma, other carcinoma) were identified in the National Cancer Database. The primary outcome was the conversion rate from minimally invasive to open. Other post-operative outcomes and survival were compared., Results: 416 patients (76.5%) underwent a laparoscopic adrenalectomy and 128 (23.5%) underwent a robotic operation. Demographics and clinical characteristics were similar. Approximately 19% of tumors resected by a minimally invasive approach were > 10 cm. The intra-operative conversion rate was decreased among robotic adrenalectomies relative to laparoscopic on univariate (7.8% vs. 18.3%, p = 0.005) and multivariable (odds ratio 0.39, p = 0.01) analyses. Using marginal standardization, there was a stepwise increase in the conversion rate as tumor size increased (< 5, 5-10, > 10 cm) for laparoscopic (7.5%, 18.0%, 33.2%) and robotic (3.1%, 8.3%, 17.3%) adrenalectomies. Operations which required conversion had a greater margin positivity rate, greater length of stay, and an association with poor overall survival., Conclusion: In contrast to most clinical guidelines, minimally invasive adrenalectomies are being performed on large malignant tumors. A laparoscopic approach was associated with a greater conversion rate and subsequent poor outcomes. If a surgeon is not planning an open adrenalectomy, but adrenal malignancy is a possibility, robotic adrenalectomy may be the preferred approach for resectable adrenal tumors., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Purpose: There has been an increased use of active learning pedagogies in pharmacy curricula. Structured, complex pedagogies such as problem-based learning (PBL) may require rigorous training for students to be successful. We aim to describe the development and implementation of an introductory PBL course for first-year pharmacy students. We describe the theoretical framework for course development, including the educational philosophies informing the course design. Development of PBL skills and professional behavior were evaluated using student self-assessment throughout the course., Educational Activity and Setting: This introductory PBL course was developed using educational philosophies to scaffold student learning of the pedagogy and development of PBL skills. A student self-assessment was administered at two time points throughout the course. The self-assessment contained items related to PBL skills and professional behaviors. Self-assessment scores were compared with facilitator evaluations of student performance to determine reliability of self-assessment results., Findings: Eighty-eight students completed both self-assessments (93.6% response rate). Self-assessment of PBL skills increased significantly. There was no improvement in self-assessed professional behaviors. Self-assessment scores did not correlate with facilitator assessment of student performance in a small group., Summary: Integrating a scaffolded, theoretically sound educational approach to introduce students to the PBL pedagogy improves students' self-assessed PBL skills but not professional behavior., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: A recent study demonstrated that pharmacists presented with multiple estimating equations deviated from recommended dosing guidance more often than pharmacists who were presented with a single estimate on clinical vignettes., Objectives: To identify characteristics associated with an increased tendency to deviate from approved recommendations., Methods: Participant data were split into 2 cohorts: pharmacists who chose a dose that was inconsistent with dosing recommendations on at least 1 of the 4 vignettes and pharmacists who did not deviate on a single case. Bivariate analysis of demographic- and practice-related variables were conducted between groups using the χ 2 , Mann-Whitney U , or Student t -test for nominal, ordinal, and continuous variables, respectively. Statistically different covariates between groups ( P < 0.05) were assessed using multivariable linear regression., Results: Survey data from 154 inpatient pharmacists, 71 of whom deviated on at least 1 clinical vignette, were analyzed. On univariate analysis, deviator pharmacists were more likely to have completed postgraduate residency training (68% vs 41%; P < 0.05) and board certification (39% vs 20%; P < 0.05). Deviator pharmacists were also more likely to have been presented with multiple renal estimates as opposed to a single estimate and had differing renal dosing practices at baseline ( P < 0.05). Following multivariable regression, residency training, mismatched baseline renal practices, and multiple renal estimates remained independent predictors ( P < 0.05) of dosing deviation., Conclusion and Relevance: Higher clinical training, practice variation, and multiple renal estimates may affect renal dosing practices. Prospective, statistically powered studies are needed to verify these hypotheses.

The history and evolution of parathyroid hormone is a true testament to inter-disciplinary collaboration among anatomists, biochemists and surgeons. The parathyroid glands were the last endocrine glands to be discovered in the mid-1800s. Over the next century, progress in the evaluation of primary hyperparathyroidism, the identification of parathyroid hormone (PTH) and its application for use in the field of parathyroid surgery have led to a significant improvement in surgical cure rates, accompanied by a shift toward minimally invasive surgical options. This chapter provides a historical lens through which we can view these relatively recent advancements, as well as the current role of parathyroid hormone, both with regards to pre-operative localization and intra-operative detection of abnormal glands. Furthermore, we discuss the importance of parathyroid hormone in the management of complex multiglandular disease and reoperative cases, as well as the significance of persistently elevated PTH levels post-parathyroidectomy., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Malignant pheochromocytoma is often managed with adrenalectomy. Most literature focusing on postoperative outcomes are from single institutions. This study aimed to describe outcomes of adrenalectomy for malignant pheochromocytoma using a national database. We hypothesized that minimally invasive approaches might be associated with improved short-term outcomes but potentially inferior oncologic efficacy., Methods: Patients who underwent adrenalectomy for malignant pheochromocytoma were identified in the National Cancer Database (2010-2016). Patients were categorized as minimally invasive adrenalectomy or open adrenalectomy. Short- and long-term outcomes were compared., Results: A total of 276 patients underwent adrenalectomy for malignant pheochromocytoma: 50.7% open adrenalectomy and 49.3% minimally invasive adrenalectomy. Demographics were similar, except those who underwent open adrenalectomy had larger tumors compared to minimally invasive adrenalectomy (8.2 cm vs 4.7 cm; P < .001). Tumor size ≥6 cm was associated with a reduced likelihood of minimally invasive adrenalectomy (relative to open adrenalectomy) on multivariable regression (odds ratio = 0.23; P < .001). Open adrenalectomy was associated with longer duration of stay relative to minimally invasive adrenalectomy (6 vs 3 days; P < .001). Rates of positive margins, unplanned readmissions, or 30-/90-day mortalities were similar based on operative approach. Five-year survival rates were similar (open adrenalectomy 74.3%, minimally invasive adrenalectomy 79.1%). There was no association between overall survival and operative approach on multivariable Cox analysis when controlling for tumor size, laterality, and clinicodemographic variables., Conclusion: Patients with larger malignant pheochromocytomas were more likely to undergo an open adrenalectomy. With the exception of an increased duration of stay, there was no difference in short- or long-term postoperative outcomes. These data suggest that minimally invasive adrenalectomy appears safe among tumors <6 cm., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Adrenocortical carcinoma (ACC) is often a contraindication to minimally invasive adrenalectomy (MIA). We used an administrative data set to analyze postoperative outcomes. We hypothesized that small tumors would have better short- and long-term outcomes, independent of the operative approach., Methods: The National Cancer Database (2010-2016) identified patients with ACC who underwent adrenalectomy. Tumors were grouped: <5 cm (n = 125), 5-10 cm (n = 431), and >10 cm (n = 443). The primary and secondary outcomes were margin positivity and overall survival, respectively., Results: Nine hundred and ninety-nine patients were analyzed: 37% MIA and 63% open adrenalectomy (OA). As the size increased, the rate of attempted MIA decreased. Larger tumors were associated with conversion to open. Although tumors with local invasion and those which required conversion to open were associated with an increased likelihood of a positive margin, tumor size was not. Although "complete" MIA (vs. OA) and tumor size were not associated with differences in survival, conversion (HR = 1.83, p = .02), positive margins (HR = 1.54, p = .01), and local invasion (HR = 1.84, p < .001) were associated with poor survival., Conclusion: Positive margins are associated with poor survival in ACC. Tumors ≥ 5 cm were associated with an increased conversion rate and subsequent increase in margin positivity. MIA may be considered for select patients with small tumors but adequate oncologic resection is critical., (© 2021 Wiley Periodicals LLC.)

Background: Numerous equations are used for estimation of renal function, and many electronic medical records report multiple clearance estimates to assist with drug dosing. It is unknown whether the presence of multiple clearance estimates affects clinical decision-making., Objective: To determine whether the presence of multiple renal clearance estimates affects pharmacist drug dosing decisions., Methods: A randomized trial in the form of an electronic survey including 4 clinical vignettes was delivered to hospital pharmacists. Vignettes consisted of a patient presenting with an acute pulmonary embolism requiring enoxaparin therapy. Pharmacists were randomized to receive a single estimate of renal function or multiple estimates for all vignettes. The primary outcome was deviation from approved recommendations on at least 1 vignette. The χ 2 test was used to detect differences in deviation rates between groups. Logistic regression was performed to adjust for the effects of potentially confounding variables., Results: A total of 154 studies were completed (73 in the multiple-estimate group and 81 in the single-estimate group). Pharmacists presented with multiple renal estimates were significantly more likely to deviate from recommended dosing regimens than pharmacists presented with a single estimate (54.7% vs 38.2%; P = 0.04). The results were driven primarily by the 2 vignettes that included discordance among Cockcroft-Gault equation creatinine clearance estimates. Logistic regression identified multiple estimates as the only independent predictor of deviation ( P = 0.04)., Conclusion and Relevance: Pharmacists provided with a single renal clearance estimate were more likely to adhere to approved dosing recommendations than pharmacists provided with multiple estimates.

Background: Chronic obstructive pulmonary disease (COPD) guidelines recommend both long-acting and dual bronchodilator therapy. It is unclear if there are differences in efficacy and safety., Objective: This meta-analysis evaluates the efficacy of dual therapy with long-acting β-agonist (LABA) + long acting muscarinic antagonist (LAMA) compared with monotherapy with LAMA for COPD., Methods: We searched PubMed, CINAHL, and Web of Science databases from inception through March 2020 to identify English-language, prospective randomized controlled trials (RCTs) that compared dual therapy with monotherapy in adult patients with COPD. Risk of bias was assessed using the Jadad score. Overall analysis was performed using Review Manager 5.3. Treatment effect was determined with the random-effects model using the Mantel-Haenszel method and was reported as mean difference (MD) with 95% CI., Results: A total of 18 RCTs were included (n = 6086; median Jadad score 5/5) that compared LAMA + LABA with LAMA. There was a greater improvement in forced expiratory volume at 1 s (FEV 1 ) with dual therapy compared with LAMA: MD = 0.08; 95% CI = [0.05, 0.11]. There was no difference in St George Respiratory Questionnaire (SGRQ) scores between groups: OR = -0.85; 95% CI = [-1.83, 0.13]. There were no differences in overall adverse events (OR = 1.00; 95% CI = 0.92, 1.09), serious adverse events (OR = 1.01; 95% CI = 0.86, 1.18), or cardiovascular events (OR = 0.88; 95% CI = 0.58, 1.34)., Conclusion and Relevance: Dual therapy improves FEV 1 and is as safe as LAMA. Dual therapy does not improve SGRQ scores more than LAMA.

Enoxaparin is a low molecular weight heparin commonly used in the treatment of venous thromboembolisms (VTEs); however, evidence on optimal empiric dosing recommendations are lacking in patients with morbid obesity. Utilization of an absolute dose cap, anti-Xa monitoring, and reduced empiric dosing are among the techniques used in this population. We describe a case of a morbidly obese man (body-mass index, BMI: 68.2 kg/m 2 , total body weight: 236 kg) who required therapeutic enoxaparin for suspected pulmonary embolism (PE) and critical limb ischemia as a bridge therapy during warfarin initiation. An initial empiric dose of 200 mg Q12 hours (0.85 mg/kg) resulted in an anti-Xa level of 1.01 IU/mL following the fifth dose, and no dose modification was deemed necessary. He experienced no adverse effects from treatment. This report adds to a growing body of evidence illustrating the need for reduced empiric weight-based doses of enoxaparin in the morbidly obese population and raises the question of whether dose capping is an appropriate practice in the clinical setting of morbidly obese patients with acute VTE., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2018.)

Objective: Cannabinoid hyperemesis syndrome (CHS) is characterized by cyclic vomiting, abdominal pain, and alleviation of symptoms via hot showers in chronic cannabinoid users. Capsaicin is recommended as a reasonable first-line treatment approach for CHS despite limited clinical evidence regarding its use. The objective of this study is to systematically review the efficacy data for capsaicin in CHS. Data Sources: A literature search using keywords related to cannabinoids, emesis, and capsaicin was performed in MEDLINE, CINAHL, and EMBASE from inception through March 31, 2019. Study Selection and Data Extraction: Studies and published abstracts in which capsaicin was used for CHS and clinical outcomes were reported were eligible for inclusion. Data Synthesis: A total of 241 articles were screened, of which 5 full-text articles and 6 conference abstracts were included. Full-text case reports (n = 3) and case series (n = 2) found capsaicin to be effective in a total of 18 patients. Published abstracts were in the form of case reports (n = 1), case series (n = 3), and retrospective cohort studies (n = 2). Relevance to Patient Care and Clinical Practice: Capsaicin use was described as beneficial in all case series and case reports; however, both retrospective cohort studies were unable to find a significant benefit for capsaicin on primary outcomes (emergency department length of stay). Conclusion: Current data for capsaicin efficacy in CHS is of low methodological quality. However, the limited data on alternative antiemetic therapies and capsaicin's favorable risk-benefit profile make it a reasonable adjunctive treatment option.

Parathyroid cancer is one of the rarest causes of primary hyperparathyroidism and tends to present with more severe symptoms than its more benign counterparts. This article details various aspects of the disease process, including epidemiology, clinical presentation, and a step-wise diagnostic process for parathyroid cancer. This includes laboratory assessments as well as a proposed staging system. The en bloc principle of surgical intervention is detailed, as well as the current role of adjuvant treatments. A general guide to surveillance and the natural history of the disease is also outlined., Competing Interests: The authors declare no conflict of interest. The Authors have nothing to disclose.

Objective. To validate a problem-based learning (PBL) evaluation checklist to assess individual Doctor of Pharmacy (PharmD) students' performance in a group. Methods. In 2013, a performance checklist was developed and standardized. To evaluate the reliability and discriminant validity of the checklist, pharmacy students' evaluation scores from 2015-2016 were assessed along with overall program grade point averages (GPA), and scores on knowledge and problem-solving examinations. Predictive analysis software was used to analyze the data. Results. Seventy facilitators generated 1506 evaluation reports for 191 (90 third-year and 101 second-year) students over eight PBL cases. The mean (SD) total score was 40.6 (2.5) for P3s and 39.1 (2.7) for P2s out of a possible 44.2 points. Students' scores improved each semester. Interrater reliability based on intraclass correlation coefficient for all cases was 0.67. Internal reliability as determined by Cronbach alpha was >0.7 for all binary checklist items across all cases. Discriminant validity assessed using Pearson correlation coefficient showed that the total score from the checklist did not correlate with knowledge or problem-solving examination scores. Conclusion. This unique PBL checklist proved to be a reliable and valid tool to assess student performance in small group sessions in a PharmD curriculum., (© 2019 American Association of Colleges of Pharmacy.)

Primary hyperparathyroidism (PHPT) is a common endocrine disorder, resulting from the autonomous production of parathyroid hormone from 1 or more abnormal parathyroid glands. Disease presentation ranges from asymptomatic to multiorgan involvement (skeletal, renal, neurocognitive, and gastrointestinal). This article outlines the epidemiology, clinical presentation, and diagnostic algorithm for PHPT. Key laboratory assessments are discussed, as are imaging studies for preoperative localization. Indications for surgical intervention are detailed, as are potential indications for surveillance. Sporadic and genetic syndromes associated with PHPT are also described., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: To determine the pharmacological treatment methods available to anemic Jehovah's Witnesses (JW)., Data Sources: MEDLINE and PubMed were searched from inception through February 2018 using the search terms Jehovah's Witnesses, treatment, erythropoietin, hemoglobin-based oxygen carrier, Sanguinate, Hemopure, bleeding, and anemia., Study Selection and Data Extraction: All clinical trials, cohort studies, case-control studies, and observational trials involving pharmacotherapy in anemic JW patients were evaluated. Case reports and bibliographies were also analyzed for inclusion., Data Synthesis: Two studies involving the use of erythropoietin (EPO) and one study involving recombinant factor VIIa were included. Information was also included from other pharmacotherapeutic modalities that had case report data only. Current published evidence is limited with regard to evidence-based management of JW patients. High-dose EPO, intravenous iron supplementation, and hemostatic agents have demonstrated good clinical outcomes in case reports. EPO doses as high as 40 000 units daily have been advocated by some experts; however, pharmacokinetic studies do not support dose-dependent effects. Hemoglobin-based oxygen carriers (HBOCs) are currently not Food and Drug Administration approved. They are available through expanded access programs and may represent a lifesaving modality in the setting of severe anemia., Conclusions: There are currently not enough data to make definitive recommendations on the use of pharmacological agents to treat severe anemia in the JW population. Further evidence utilizing EPO and HBOCs will be beneficial to guide therapy.

Objective: To review the mechanism and association of infectious risk among the tumor-necrosis factor α (TNF-α) antagonists used in inflammatory bowel disease., Data Sources: A PubMed literature search was performed using the following search terms: infliximab, adalimumab, certolizumab, golimumab, inflammatory bowel disease, crohn's, ulcerative colitis, adverse effects, adverse events, safety, and infection., Study Selection and Data Extraction: Meta-analyses and cohort studies with outcomes pertaining to quantitative infectious risk were reviewed. Case reports and case series describing association between TNF-α inhibitors and infection were also reviewed., Data Synthesis: A total of 7 recent meta-analyses of randomized trials demonstrate inconclusive association of infection with TNF-α antagonists. Registry data suggest that medications carry an independent risk of opportunistic infections. Risk factors for infection include older age, malnutrition, diabetes, and possibly combination therapy. Reported infections vary widely but include intracellular and granulomatous bacteria, viruses, and fungi., Conclusion: TNF-α antagonists are associated with an increased risk of opportunistic infection, although this risk has not been demonstrated conclusively in randomized controlled trials. Knowledge of concomitant risk factors, mechanism of infectious risk, and available treatment options can improve patient care in the clinical setting.

Purpose: The Global Initiative for Chronic Obstructive Lung Disease guidelines provide recommendations to manage chronic obstructive lung disease (COPD) exacerbations. This study assessed the management of inpatient COPD exacerbations at an urban teaching hospital., Methods: A retrospective cohort analysis of adults admitted between December 2010 and August 2012 with a COPD exacerbation was conducted. Patient demographics, length of stay (LOS), Charlson comorbidity score, inpatient pulmonary medications, and 30-day readmission were collected. Descriptive statistics characterized guideline adherence and readmission., Results: 94 patients were included with median LOS of 3 days (interquartile range [IQR]: 1-5 days) and median Charlson comorbidity score of 6 (IQR: 5-8). All patients received an inhaled short-acting beta agonist, and 52 (55.3%) also received an inhaled short-acting anticholinergic. Seventy-eight (83%) received systemic corticosteroids, of which 3 received guideline-recommended doses. Sixty-four (68.1%) received antibiotics for a pulmonary indication, of which 71.9% received appropriate antibiotics per indication. Of the 94 patients, 2 were managed in complete adherence with GOLD recommendations. A total of 24 (25.5%) patients were readmitted within 30 days of discharge, 9 of these for COPD., Conclusion: COPD exacerbation treatment deviated from GOLD recommendations. This provides opportunities for further optimization of treatment of COPD exacerbations.

Introduction: Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states. Clinicians use these products with caution secondary to lack of clinical experience. Areas Covered: The authors performed a literature search using the following keywords: CT-P13, biosimilar, adalimumab, infliximab, ABP 501, and inflammatory bowel disease. Bibliographies were also reviewed for pertinent articles. Articles pertaining to the clinical efficacy of biosimilars in IBD were included. Expert commentary: The phase 3 trials, which provided the clinical justification to bring TNF- α biosimilars to market, were in rheumatoid arthritis and ankylosing spondylitis; however, new clinical data suggests that biosimilar products have equivalent safety and efficacy to reference products in IBD. This has led to an increased acceptance amongst practicing gastroenterologists and a potential reduction in healthcare costs.

Aims: Aspirin use for primary prevention of cardiovascular disease (CVD) is controversial, especially in patients with diabetes. The objective of this meta-analysis was to evaluate aspirin's safety and efficacy for primary prevention of CVD [fatal or nonfatal myocardial infarction (MI), fatal or nonfatal stroke, angina, transient ischemic attack (TIA), peripheral artery disease (PAD) and revascularization] in patients with diabetes., Methods: A literature search was conducted using the terms cardiovascular disease, aspirin, diabetes mellitus to identify trials of patients with diabetes who received aspirin for primary prevention of CVD. Study sample size, and ischemic and bleeding events were extracted and analyzed using RevMan 5.2.7., Results: In total, 6 studies (n=10,117) met criteria. Aspirin doses ranged from 100mg every other day to 650mg daily. Follow-up ranged from 3.6 to 10.1years. In patients with diabetes, there was no difference between aspirin and placebo with respect to the risk of all cause mortality (OR 0.93, 95% CI 0.81-1.06), or individual atherosclerotic events compared to placebo. There were no differences in bleeding (OR 2.53, 95% CI 0.77-8.34), GI bleeding (OR 2.14, 95% CI 0.63-7.33) or hemorrhagic stroke rates (OR 0.90, 0.34-2.33) between groups., Conclusions: It remains unclear whether aspirin may reduce the occurrence of a first atherosclerotic event or mortality in patients with diabetes. More research on this use of aspirin in patients with diabetes is required to supplement currently available research., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Importance: Primary hyperparathyroidism (pHPT) is a common clinical problem for which the only definitive management is surgery. Surgical management has evolved considerably during the last several decades., Objective: To develop evidence-based guidelines to enhance the appropriate, safe, and effective practice of parathyroidectomy., Evidence Review: A multidisciplinary panel used PubMed to review the medical literature from January 1, 1985, to July 1, 2015. Levels of evidence were determined using the American College of Physicians grading system, and recommendations were discussed until consensus., Findings: Initial evaluation should include 25-hydroxyvitamin D measurement, 24-hour urine calcium measurement, dual-energy x-ray absorptiometry, and supplementation for vitamin D deficiency. Parathyroidectomy is indicated for all symptomatic patients, should be considered for most asymptomatic patients, and is more cost-effective than observation or pharmacologic therapy. Cervical ultrasonography or other high-resolution imaging is recommended for operative planning. Patients with nonlocalizing imaging remain surgical candidates. Preoperative parathyroid biopsy should be avoided. Surgeons who perform a high volume of operations have better outcomes. The possibility of multigland disease should be routinely considered. Both focused, image-guided surgery (minimally invasive parathyroidectomy) and bilateral exploration are appropriate operations that achieve high cure rates. For minimally invasive parathyroidectomy, intraoperative parathyroid hormone monitoring via a reliable protocol is recommended. Minimally invasive parathyroidectomy is not routinely recommended for known or suspected multigland disease. Ex vivo aspiration of resected parathyroid tissue may be used to confirm parathyroid tissue intraoperatively. Clinically relevant thyroid disease should be assessed preoperatively and managed during parathyroidectomy. Devascularized normal parathyroid tissue should be autotransplanted. Patients should be observed postoperatively for hematoma, evaluated for hypocalcemia and symptoms of hypocalcemia, and followed up to assess for cure defined as eucalcemia at more than 6 months. Calcium supplementation may be indicated postoperatively. Familial pHPT, reoperative parathyroidectomy, and parathyroid carcinoma are challenging entities that require special consideration and expertise., Conclusions and Relevance: Evidence-based recommendations were created to assist clinicians in the optimal treatment of patients with pHPT.

Background: Vancomycin is used to treat serious infections caused by methicillin-resistant Staphylococcus aureus (MRSA). It is unclear whether MRSA isolates with minimum inhibitory concentration (MIC) 1.5 to 2 µg/mL are successfully treated with vancomycin. Objective: Evaluate vancomycin failure rates in MRSA bacteremia with an MIC <1.5 versus ≥1.5 µg/mL, and MIC ≤1 versus ≥2 µg/mL. Methods: A literature search was conducted using MESH terms vancomycin, MRSA, bacteremia, MIC, treatment and vancomycin failure to identify human studies published in English. All studies of patients with MRSA bacteremia treated with vancomycin were included if they evaluated vancomycin failures, defined as mortality, and reported associated MICs determined by E-test. Study sample size, vancomycin failure rates, and corresponding MIC values were extracted and analyzed using RevMan 5.2.5. Results: Thirteen studies including 2955 patients met all criteria. Twelve studies including 2861 patients evaluated outcomes using an MIC cutoff of 1.5 µg/mL. A total of 413 of 1186 (34.8%) patients with an MIC <1.5 and 531 of 1675 (31.7%) patients with an MIC of ≥1.5 µg/mL experienced treatment failure (odds ratio = 0.72, 95% confidence interval = 0.49-1.04, P = .08). Six studies evaluated 728 patients using the cutoffs of ≤1 and ≥2 µg/mL. A total of 384 patients had isolates with MIC ≤1 µg/mL, 344 had an MIC ≥2 µg/mL. Therapeutic failure occurred in 87 and 102 patients, respectively (odds ratio = 0.61, 95% confidence interval = 0.34-1.10, P = .10). As heterogeneity between the studies was high, a random-effects model was used. Conclusion: Vancomycin MIC may not be an optimal sole indicator of vancomycin treatment failure in MRSA bacteremia., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2015.)

Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn's disease (CD), 2 conditions characterized by chronic inflammation. Approximately 1.17 million people in the United States are affected by these 2 conditions. It is theorized that a genetic susceptibility coupled with environmental factors, such as smoking, antibiotics, oral contraceptives, appendectomy, or diet, may influence the development of IBD. Patients with UC and CD may exhibit similar symptoms, and the conditions are often misclassified, as there is a lack of standard criteria for diagnosing IBD. Therefore, it is important for clinicians to rule out any diarrhea-related conditions for an accurate diagnosis. UC and CD typically manifest in early adulthood, and the chronic nature of these conditions greatly impacts a patient's perception, body image, and quality of life. The inability to participate in social activities due to UC and CD impacts not only patients, but also those with whom they have close relationships.

Hepatitis C is a chronic infection associated with considerable morbidity and mortality. In recent years, there has been a shift in treatment paradigm with the discovery and approval of agents that target specific proteins vital for hepatitis C replication. The NS3/4A inhibitors simeprevir and paritaprevir, the NS5A inhibitors ombitasvir, ledipasvir, and daclatasvir, and the NS5B inhibitors sofosbuvir and dasabuvir have been newly FDA approved and incorporated as first-line agents into the latest IDSA-AASLD guidelines for Hepatitis C treatment. Used in combination, these agents produce higher rates of sustained virologic response and less adverse effects than historical options, along with limited rates of resistance. Pertinent clinical data, pharmacology, and pharmacokinetics are reviewed for these new direct acting antiviral agents.

Background: It is common practice to perform flexible laryngoscopy (FL) to ensure true vocal cord (TVC) mobility in patients with previous neck operations or patients with suspected VC dysfunction. Vocal cord ultrasonography (VCUS) is accurate in identifying TVC paralysis. The goal of this study is to evaluate the impact of VCUS as the initial study to confirm TVC mobility in patients requiring preoperative FL., Methods: A total of 194 consecutive patients with indications for preoperative FL underwent VCUS. In group 1, 52 patients had FL regardless of the results of VCUS, whereas in group 2, 142 patients had VCUS followed by FL only when VCUS was unsatisfactory., Results: VCUS visualized TVC/arytenoids in 164 of 194 (85%) patients. TVC visualization was more common in women (95%) and in patients without thyroid cartilage calcification (92%) (P < .0005). VCUS predicted all paralyzed TVC. In group 2, 76% of patients had adequate VCUS and avoided preoperative FL. Among 24% of patients in whom VCUS was inadequate, 16 had preoperative FL attributable to a lack of TVC visualization, 6 had abnormal TVC mobility, 11 needed additional confirmations, and 2 had previous FL for another reason., Conclusion: VCUS changed surgeon practices by avoiding the need for preoperative FL in the majority of patients. This noninvasive and sensitive method demonstrates TVC mobility and safely precludes preoperative FL in most patients., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Study Objective: As resistance of Helicobacter pylori to standard first-line therapy is increasing globally, alternative treatment regimens, such as a fluoroquinolone-based sequential regimen, have been explored. The objective of this meta-analysis was to compare the efficacy of fluoroquinolone-based sequential therapy with standard first-line treatment for H. pylori infection., Design: Meta-analysis of six randomized controlled trials., Patients: A total of 738 H. pylori-infected, treatment-naive adults who received fluoroquinolone-based sequential therapy (5-7 days of a proton pump inhibitor [PPI] and amoxicillin therapy followed by 5-7 days of a PPI, a fluoroquinolone, and metronidazole or tinidazole or furazolidone therapy) and 733 H. pylori-infected, treatment-naive adults who received guideline-recommended, first-line therapy with standard triple therapy (7-14 days of a PPI plus amoxicillin and clarithromycin) or standard sequential therapy (5 days of a PPI plus amoxicillin, followed by an additional 5 days of triple therapy consisting of a PPI, clarithromycin, and metronidazole or tinidazole)., Measurements and Main Results: A systematic literature search of the MEDLINE, PubMed, and Cochrane Central Register of Controlled Trials databases (from inception through January 2015) was conducted to identify randomized controlled trials that compared fluoroquinolone-based sequential therapy with guideline-recommended, first-line treatment regimens in H. pylori-infected, treatment-naive adults. All selected trials confirmed H. pylori infection prior to treatment as well as post-treatment eradication. A meta-analysis was performed by using Review Manager 5.2. Treatment effect was determined with a random-effects model by using the Mantel-Haenszel method and was reported as a risk ratio (RR) with 95% confidence interval (CI). In the six randomized controlled trials that met the inclusion criteria, 648 (87.8%) of 738 patients receiving fluoroquinolone-based sequential therapy and 521 (71.1%) of 733 patients receiving standard regimens achieved eradication (RR 1.21, 95% CI 1.09-1.35). The frequencies of adverse effects that were reported in three of the trials were comparable for all treatments (RR 0.99, 95% CI 0.76-1.29). In addition, no statistically significant difference was noted in the number of patients who experienced adverse effects that prompted discontinuation of therapy (RR 1.03, 95% CI 0.34-3.09). The H. pylori eradication rate appeared similar among the six trials with respect to duration of therapy and daily dose of the fluoroquinolone., Conclusion: Fluoroquinolone-based sequential therapy is a reasonable treatment alternative to first-line eradication therapy for treatment of H. pylori., (© 2015 Pharmacotherapy Publications, Inc.)

Background: The purpose of this study was to evaluate the role of frozen section examination (FSE) for determining the extent of thyroidectomy in patients with nodular thyroid disease and fine-needle aspiration categorized as atypia/follicular lesion of undetermined significance (AFLUS)., Methods: A retrospective review of all patients operated on for a thyroid nodule and AFLUS was completed to determine the role of clinical examination and FSE in intraoperative decision making., Results: One hundred twenty patients with AFLUS underwent thyroidectomy; 18 (15%) had carcinoma. FSE altered management in 36 (62%) of the 58 patients-32 with benign disease and 4 with cancer who underwent lobectomy and total thyroidectomy, respectively. Total thyroidectomy without FSE was performed in 61 (51%) patients with sonographically confirmed bilateral disease. FSE had a 36.4% sensitivity, 100% specificity, 100% positive predictive value, 87% negative predictive value, and 88% accuracy., Conclusion: Ultrasound in combination with FSE is of value for determining the extent of thyroidectomy in patients with AFLUS., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Background: Transcutaneous vocal cord ultrasonography (TVCUS) is a noninvasive study used to identify true vocal cord (TVC) mobility. Its sensitivity in predicting TVC paralysis when compared with indirect flexible laryngoscopy (IFL) ranges from 62 to 93%. This study aimed to evaluate the feasibility of surgeon-performed TVCUS in assessing TVC mobility in the outpatient setting., Methods: At 5 institutions, 510 consecutive patients underwent 887 TVCUS performed by 8 surgeons during initial surgical evaluation. IFL was obtained in selected patients. TVCUS was repeated during the first postoperative visit, and IFL was obtained only when judged necessary. Clinical parameters were collected and later correlated with TVC visualization., Results: TVC visualization was possible in 688 of 887 TVCUS (77%); visibility ranged from 41 to 86% among performing surgeons. IFL was done in 81 patients (16%) and TVCUS predicted TVC paralysis in all cases when TVC were seen. TVC visualization was possible more often in females than males (83% vs 17%; P < .0005) and in patients without thyroid cartilage calcification than those with calcification (83% vs 42%; P < .0005)., Conclusion: Experienced surgeon-ultrasonographers can use TVCUS to visualize TVC in most female patients and less so in males. TVCUS is highly sensitive, but operator dependent. This study demonstrates the feasibility of TVCUS and directs further attention to defining its optimal role in assessment of TVC mobility., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Regorafenib, a novel multikinase inhibitor, has recently demonstrated overall survival benefits in metastatic colorectal cancer (CRC) patients. Our study aimed to gain further insight into the molecular mechanisms of regorafenib and to assess its potential in combination therapy. Regorafenib was tested alone and in combination with irinotecan in patient-derived (PD) CRC models and a murine CRC liver metastasis model. Mechanism of action was investigated using in vitro functional assays, immunohistochemistry and correlation with CRC-related oncogenes. Regorafenib demonstrated significant inhibition of growth-factor-mediated vascular endothelial growth factor receptor (VEGFR) 2 and VEGFR3 autophosphorylation, and intracellular VEGFR3 signaling in human umbilical vascular endothelial cells (HuVECs) and lymphatic endothelial cells (LECs), and also blocked migration of LECs. Furthermore, regorafenib inhibited proliferation in 19 of 25 human CRC cell lines and markedly slowed tumor growth in five of seven PD xenograft models. Combination of regorafenib with irinotecan significantly delayed tumor growth after extended treatment in four xenograft models. Reduced CD31 staining indicates that the antiangiogenic effects of regorafenib contribute to its antitumor activity. Finally, regorafenib significantly delayed disease progression in a murine CRC liver metastasis model by inhibiting the growth of established liver metastases and preventing the formation of new metastases in other organs. In addition, our results suggest that regorafenib displays antimetastatic activity, which may contribute to its efficacy in patients with metastatic CRC. Combination of regorafenib and irinotecan demonstrated an increased antitumor effect and could provide a future treatment option for CRC patients., (© 2013 The Authors. Published by Wiley Periodicals, Inc. on behalf of UICC.)

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy, and safety of the newly approved drug, teduglutide, for the treatment of short bowel syndrome (SBS)., Data Sources: Literature was retrieved through PubMed (1966-March 2014) using the search term teduglutide. The authors applied the filters Humans and English language, resulting in 47 publications., Study Selection and Data Extraction: The authors reviewed the 47 citations to extract those that were published clinical trials. Bibliographies of recent review articles and editorials were evaluated for additional pertinent publications for inclusion. The methods and results from each of the trials were extracted., Data Synthesis: Teduglutide has been studied in SBS in 3 phase III trials. Teduglutide decreases parenteral nutrition (PN) volume requirements, with 1 study showing a reduction of 4.4 ± 3.8 L/wk with teduglutide 0.05 mg/kg versus 2.3 ± 2.7 L/wk with placebo; P < 0.001. In another study, teduglutide improved graded response scores, which are based on the intensity and duration of the reduction of PN use (16/35 assigned to teduglutide 0.05 mg/kg vs 1/16 assigned to placebo; P = 0.007). The dosing range studies have indicated that the optimal dose of teduglutide is 0.05 mg/kg daily subcutaneously. There are a number of adverse effects reported in the trials, including abdominal pain or distention, injection site reactions, nausea, headaches, and fluid overload among others. There is also a concern for the development of malignancy with teduglutide, and therefore, it is not recommended in patients with active gastrointestinal malignancies., Conclusions: Overall, teduglutide appears to be a promising agent for the treatment of SBS., (© The Author(s) 2014.)