Analysis of Trends in Race and Gender Disparities in Incidence-Based Mortality in Patients Diagnosed with Soft Tissue Sarcomas from 2000 to 2016.

BACKGROUND: The clinical course of soft tissue sarcomas is often dependent on the grade of the tumor. The variability of incidence-based mortality in low-grade and high-grade soft tissue sarcomas (STS) with respect to gender and race over the past decade has not been well studied. This study analyzes the rates of incidence-based mortality from the years 2000 to 2016 amongst the grades, genders and racial groups of patients with STS. METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was queried to conduct a nation-wide analysis for the years 2000 to 2016. Incidence-based mortality for all stages of low-grade and high-grade soft tissue sarcomas was queried and the results were grouped by race (Caucasian/White vs African American/Black) and gender. All stages and ages were included in the analysis and trend from 2000 to 2016 was analyzed. RESULTS: The incidence-based mortality rates for Caucasians are similar to African Americans in both grades and genders. Rates were not analyzed for American Indian and Asian/Pacific Islanders due to small sample size. Mortality rates of high-grade soft tissue sarcomas were significantly higher compared to low-grade tumors. A higher rate of mortality is noted in Caucasian males compared to African Americans males despite past observations of higher incidence in African Americans. There was no significant change in the rate when trended over the past decade (2007 to 2016). CONCLUSION: This study highlights the higher rate of incidence-based mortality in Caucasian males compared to African American males in the past 15 years despite a lower incidence reported in the 1995 to 2008 period. With no significant change in mortality rates/year noted during this time period, this study implies that soft tissue sarcomas in Caucasian males have worse outcomes. Further research is needed to understand the mechanism underlying this disparity.

Visibility Versus Privacy of Physicians in the Age of Social Media.

As access to the internet has grown over the years, social media has become an important resource in the health care sector. Third-party physician-rating websites in particular have gained popularity. However, there are ethical implications of such websites. These websites provide a platform for patients to evaluate and review physicians and likewise increase visibility and advertisement of physicians, but they also violate the rights to privacy that these doctors should have. This paper aims to study and assess the ethical implications of these websites on the visibility and privacy of physicians. After presenting the ethical dilemma associated with such websites, it provides guidelines that can be incorporated by both physicians and third-party sites to help maintain physician privacy while providing public service in the form of advertisement and visibility.

Trends in the crossover of patients in phase III oncology clinical trials in the USA.

BACKGROUND: The incorporation of crossover in randomised controlled trials is accepted as an ethical obligation, especially in cancer clinical trials. The more common type of crossover is crossover allowance, which allows patients assigned to one arm to switch to another arm if there is an established benefit in the crossover arm. In contrast, crossover-designed studies involve switching patients from all arms to a different arm as part of the study design. Crossover allowance may have advantages in patient recruitment and incorporating crossover after initial positive results fulfil ethical requirements. However, crossover can also contribute to confounding major endpoints of studies, such as overall survival or the second progression-free survival interval. For this reason, it is important to investigate and identify potential trends of crossover in clinical trials testing novel therapies. METHODS: Data about cancer clinical trials were extracted from clinicaltrials.gov. The search query was limited to completed phase III studies in adult populations. Location was limited to the USA. Date range extended from 1990 to 2019. Search query included the terms: cancer; completed- recruitment status; age: 18-65+ years; sex: all; location: USA; and study phase: phase 3. Studies were then excluded if they were not randomised controlled trials (RCTs) with the primary purpose of treatment and if they did not test cancer-related interventions. RESULTS: A total of 744 clinical trials were identified. There were 459 RCTs aimed at treatment, and of those, 35 utilised crossover. The start dates of these crossover trials ranged from 1997 to 2012. Thirty studies utilised crossover allowance. Prostate, breast and gastrointestinal stromal tumour cancers were the most represented cancer types in crossover studies. Among the 30 studies, the median proportion of patients who crossed over relative to the original arm assignment ranged from 2% to 88%, with a median of 57.5%. CONCLUSIONS: The proportion of identified clinical trials with crossover compared to those without is extremely small. Crossover in clinical trials studying cancer treatment does not appear to be a widespread practice. Even though statistical approaches to mitigate confounding exist, crossover can still skew accurate reporting of the impact of experimental therapies on overall survival.

Outcomes of hospitalized patients with myocardial infarction and immune thrombocytopenic purpura: a cross sectional study over 15 years.

BACKGROUND: Immune Thrombocytopenic Purpura (ITP) is an autoimmune disorder characterized by low platelet counts and mucocutaneous bleeding. The outcomes of hospitalized patients with ITP and myocardial infarction (MI) have not been extensively studied and may help identify risk factors associated with adverse outcomes in this unique patient population. METHODS: Patients with ITP who were admitted with MI using the National Inpatient Database for the years 2000 to 2014. Patient demographics, hospital characteristics and medical comorbidities were studied. Chi square test was used to determine associations with statistical significance and logistic regression was used to determine independent predictors of mortality. RESULTS: A total of 753732 hospitalized patients with ITP were identified over the time period of 2000 to 2014, of which 37695 patients had both ITP and acute MI. There were more females with ITP in general (60% females vs. 40 males), but more males with ITP and acute MI (55.8% males vs. 44.2% females; P=0.0000). Caucasians were affected the most (5.5%) amongst all races and the age group of 65-79 years had the highest percentage of patients with ITP and MI (7.3%). The classical risk factors of hypertension, hyperlipidemia, and diabetes were also noted to be highly prevalent in patients with ITP and MI. 10.05% of patients with ITP and acute MI died during hospitalization, while 4% of all patients with ITP died during hospitalization (P<0.05). Multiple regression showed that stent placement, female gender, blood transfusions, platelet transfusion, 80+ age group and higher Charlson's score were independent predictors of mortality in patients with ITP which have MI. CONCLUSIONS: MI is associated with an increased rate of in-hospital death in patients with ITP. Both blood transfusions and platelet transfusions adversely affect outcomes in the management of AMI in ITP patients.

Analysis of outcomes in hospitalized pregnant patients with acute myeloid leukemia.

BACKGROUND: There have been significant advances in the management of acute myeloid leukemia (AML) in the past decade. However, management of AML in the pregnant patient has been challenging as most interventions are contraindicated in pregnancy. Medical termination of pregnancy is advocated over chemotherapy in the first trimester as delaying chemotherapy could often be fatal. Chemotherapy during second and third trimesters may be provided with close surveillance of fetal abnormalities. The outcomes in these patients have not been systematically studied and have been limited to case reports and case series in medical literature. METHODS: Patients hospitalized with a diagnosis of AML were identified using the International Classification of Disease (ICD-9) codes in the National Inpatient Sample database. This database is maintained by the Agency of Healthcare Research Quality under the United States Department of Health and Human Services. It represents 20% of all hospitalizations occurring in the United States every year. Amongst these AML patients, all patients who were pregnant were identified and their demographic information was extracted. Other details related to their hospitalization, hospital size, location, region and teaching status were also determined. The association of outcomes with common medical comorbidities was studied. Pregnancy related outcomes, mode of delivery and mortality rates were calculated for the 15 year time period. RESULTS: During the time period of 2000 to 2014, 678942 hospitalizations involved AML patients of which 5076 were noted to be from pregnant women. The hospitalization trend gradually increased over these years and was noted to be the highest in the age group of 18-34 years. The highest hospitalization rates were noted in African American and Native American patient populations. Hypertension, hyperlipidemia, chronic kidney disease and smoking were noted to be more prevalent in pregnant women with AML. A majority of these patients had a Charlson's comorbidity index of 1-3. 3.5% of patients underwent medical termination of pregnancy, 16.25% suffered from pregnancy related complications, 0.6% suffered from puerperal infection, 4% of patients had normal vaginal delivery, 2.8% of patients had caesarian section and 5.7% of patient died. The rate of mortality was the highest in Native Americans followed by Caucasians. Multiple regression showed that odds of mortality have decreased from 2000 to 2015 and that a higher Charlson's comorbidity score was an independent predictor of mortality. CONCLUSIONS: This is the first nationwide study to document the outcomes of pregnancy in hospitalized AML patients. AML in pregnancy is rare and this study shows that the mortality has been improving over the past 15 years. Notably, vaginal delivery has been more common than caesarian section in pregnant AML patients. Native Americans have high prevalence and high mortality rates, a likely result of healthcare disparity. Pregnant AML patients with high Charlson's comorbidity score may benefit from aggressive management of their comorbidities. Further studies are required to better characterize outcomes in pregnant women with AML.

A nationwide analysis of outcomes of stroke in hospitalized patients with essential thrombocythemia: 2006 to 2014.

BACKGROUND: Essential thrombocythemia (ET) is a subtype of myeloproliferative neoplasm associated with an increased risk of thrombohemorrhagic complications such as stroke. However, studies of prevalence and outcomes of stroke in hospitalized patients with ET have been limited to case series. METHODS: Data from the National Inpatient Sample was utilized to identify outcomes in hospitalized patient with ET who were admitted for stroke. Utilizing the current procedural terminology code (CPT) for ET, outcomes of patients with ET who were hospitalized with stroke were studied for the years 2006 to 2014. Patient demographics of age, gender and race were collected and hospital characteristics of location and size were correlated to outcomes. Chi square test was used to determine odds ratios and multiple logistic regression was used to determine independent predictors of mortality. RESULTS: Between the years of 2006 to 2014, a total of 552422 hospitalizations involved patients with a diagnosis of ET, 20650 of which were due to stroke. The percentage of stroke in these hospitalizations varied between 3.64 to 4.29 over 9 years and mortality in these patients did not significantly change during this time period. The prevalence of stroke was highest amongst Asians and Caucasians (4.7% and 3.86%) with a statistically significant difference (P=0.0000). A majority of ET patients with stroke were discharged to skilled nursing facilities. Multiple regression showed that female gender, atrial fibrillation, stroke, higher Charlson's comorbidity score and 80+ age were independent predictors of mortality (OR: 0.75, 1.35, 1.8, 2 to 5.7, 13.9 respectively). CONCLUSIONS: This study demonstrated that Female gender, atrial fibrillation, stroke, higher Charlson's comorbidity score and 80+ age group were found to be statistically significant independent predictors of mortality (OR: 0.75, 1.35, 1.8, 2 to 5.7, 13.9 respectively) in patients with ET and stroke. Inclusion of these factors in the risk stratification of patients with ET may decrease the morbidity and mortality associated with the disease.

Impact of immunotherapy use in patients with stage IV pancreatic carcinoma.

BACKGROUND: Most patients with pancreatic cancer have non-resectable disease at the time of diagnosis and usually die within 6-12 months. Despite indications in other solid tumors, the role of immunotherapy (IO) is unknown for late stage, advanced pancreatic cancer. METHODS: Using the National Cancer Database (NCDB), cases of Stage IV pancreatic cancers diagnosed in the period of 2014-2016 with at least 30-day follow up were retrospectively analyzed. The following clinical demographics were included: age (younger than 70 vs. older than 70), sex (male vs. female), race (whites vs. others), insurance (uninsured vs. insured), type of institution (academic vs. nonacademic), liver metastasis (yes vs. no), lung metastasis (yes vs. no), external beam radiation (yes vs. no), systemic chemotherapy (yes vs. no) and IO (yes vs. no). survival analysis was performed using Kaplan-Meier curves and Log-rank tests. Multivariable Cox proportional hazard models and propensity score matching analysis were also utilized. A P value <0.05 was considered significant. RESULTS: Among 25,596 eligible cases, 163 patients were treated with IO. A significant association between the use of IO and several clinical demographics (age <70, academic institution, adenocarcinoma, lung metastasis, radiation, chemotherapy) was noted. Chemotherapy was administered in 133 (82%) and 16,342 (64%) of cases in the IO and non-IO groups, respectively. Use of IO was associated with improved overall survival (OS) in both univariate and multivariate analyses (P<0.0001 for each). Median OS (in months) was 12.2 in the IO group vs. 5.8 in the non-IO group. Landmark analysis in the IO group showed 12 and 24-month survival of 51.0% and 20.0% respectively, as compared with 28.2% and 11.9% in the non-IO group. Propensity score matching analysis also demonstrated a trend toward improved OS in IO group (P=0.0753). Median survival was 12.2 and 8.9 months, respectively. CONCLUSIONS: This retrospective data analysis using a large cancer database suggests that use of IO could improve survival in patients with advanced pancreatic cancer. More studies will be needed in the future to validate these results.

Induced Pluripotent Stem Cell-Derived T Cells for Cancer Immunotherapy.

Adoptive T cell therapy for solid malignancies is limited because obtaining sufficient numbers of less-differentiated tumor-specific T cells is difficult. This roadblock can be theoretically overcome by the use of induced pluripotent stem cells (iPSCs), which self-renew and provide unlimited numbers of autologous less-differentiated T cells. iPSCs can generate less-differentiated antigen-specific T cells that harbor long telomeres and increased proliferative capacity, and exhibit potent antitumor efficacy. Although this strategy holds great promise for adoptive T cell therapy, highly reproducible and robust differentiation protocols are required before the translation of iPSC technology into the clinical setting.

Transesophageal Echocardiography-Guided Epicardial Left Ventricular Lead Placement by Video-Assisted Thoracoscopic Surgery in Nonresponders to Biventricular Pacing and Previous Chest Surgery.

OBJECTIVE: The aim of the study was to study the feasibility, safety, and efficacy of transesophageal echocardiography-guided intraoperative left ventricular lead placement via a video-assisted thoracoscopic surgery approach in patients with failed conventional biventricular pacing. METHODS: Twelve patients who could not have the left ventricular lead placed conventionally underwent epicardial left ventricular lead placement by video-assisted thoracoscopic surgery. Eight patients had previous chest surgery (66%). Operative positioning was a modified far lateral supine exposure with 30-degree bed tilt, allowing for groin and sternal access. To determine the optimal left ventricular location for lead placement, the left ventricular surface was divided arbitrarily into nine segments. These segments were transpericardially paced using a hand-held malleable pacing probe identifying the optimal site verified by transesophageal echocardiography. The pacing leads were screwed into position via a limited pericardiotomy. RESULTS: The video-assisted thoracoscopic surgery approach was successful in all patients. Biventricular pacing was achieved in all patients and all reported symptomatic benefit with reduction in New York Heart Association class from III to I-II (P = 0.016). Baseline ejection fraction was 23 ± 3%; within 1-year follow-up, the ejection fraction increased to 32 ± 10% (P = 0.05). The mean follow-up was 566 days. The median length of hospital stay was 7 days with chest tube removal between postoperative days 2 and 5. CONCLUSIONS: In patients who are nonresponders to conventional biventricular pacing, intraoperative left ventricular lead placement using anatomical and functional characteristics via a video-assisted thoracoscopic surgery approach is effective in improving heart failure symptoms. This optimized left ventricular lead placement is feasible and safe. Previous chest surgery is no longer an exclusion criterion for a video-assisted thoracoscopic surgery approach.

The Prevalence of Extended-Spectrum Beta-Lactamase-Producing Multidrug-Resistant Escherichia Coli in Poultry Chickens and Variation According to Farming Practices in Punjab, India.

BACKGROUND: Agricultural use of antimicrobials in subtherapeutic concentrations is increasing in response to the rising demand for food animal products worldwide. In India, the use of antimicrobials in food animal production is unregulated. Research suggests that many clinically important antimicrobials are used indiscriminately. This is the largest study to date in India that surveys poultry production to test for antimicrobial resistance and the occurrence of extended-spectrum ß-lactamases (ESBLs) modulated by farming and managerial practices. OBJECTIVES: Our goal was to survey poultry production for resistance to eleven clinically relevant antimicrobials and phenotypic occurrence of ESBLs as modulated by farming and managerial practices. METHODS: Eighteen poultry farms from Punjab were surveyed, and 1,556 Escherichia coli isolates from 530 birds were tested for susceptibility to 11 antimicrobials using the disk diffusion method and validated using VITEK 2 (bioMérieux, Marcy-L'Étoile, France). Samples from 510 of these birds were phenotypically tested for ESBL production using the combination disk method and confirmed using VITEK 2. Generalized linear mixed models were used to infer differences in resistance profiles associated with different farming practices and facility types. RESULTS: Resistance profiles were significantly different between broiler and layer farms. Broiler farms were 2.2 [ampicillin (AMP), p=0.017] to 23 [nalidixic acid (NX), p<0.001] times more likely to harbor resistant E. coli strains than layer farms. Adjusting for farm type (broiler vs. layer), the odds of resistance (although not statistically significant) to all antimicrobials except nitrofurantoin (NIT) were higher in independent facilities (IUs) as compared to contracted facilities (CFs). Increased prevalence of multidrug resistance (MDR; 94% compared to 60% in layers), including prevalence of ESBL-producing strains (87% compared to 42% in layers), was observed in broiler farms. CONCLUSIONS: Our findings suggest that unregulated use of clinically relevant antimicrobials in Indian broiler and layer farms may contribute to the emergence of resistance and support the need to curb the nontherapeutic use of medically important antimicrobials in food animal production. https://doi.org/10.1289/EHP292.