Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.

The expanding availability of real-world data (RWD) has led to an increase in both the interest and possibilities for using this information in postmarketing safety analyses and signal management. While there is enormous potential value from the safety insights generated through RWD, the analysis preparation, execution, and communication required to reliably deliver the evidence can be time consuming. Since the safety signal assessment process is a regulated and timebound process, any supporting RWD analyses require a rapid turnaround of well-designed and informative results.

Genomic epidemiology of the primary methicillin-resistant clones causing invasive infections in Paraguayan children.

Unlabelled: Methicillin-resistant (MRSA) is one of the major human pathogens. It could carry numerous resistance genes and virulence factors in its genome, some of which are related to the severity of the infection. An observational, descriptive, cross-sectional study was designed to molecularly analyze MRSA isolates that cause invasive infections in Paraguayan children from 2009 to 2013.

Validation of an Algorithm to Identify Venous Thromboembolism in Health Insurance Claims Data Among Patients with Rheumatoid Arthritis.

Purpose: Health insurance claims databases provide an opportunity to study uncommon events, such as venous thromboembolism (VTE), in large patient populations. This study evaluated case definitions for identifying VTE among patients treated for rheumatoid arthritis (RA) using (ICD-10-CM) codes in claims data.

Patients And Methods: Study participants were insured adults who received treatment for and had a diagnosis of RA between 2016 and 2020.

Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases.

Introduction: The aim of this work is to evaluate baricitinib safety with respect to venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infection relative to tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA).

Methods: Patients with RA from 14 real-world data sources (three disease registries, eight commercial and three government health insurance claims databases) in the United States (n = 9), Europe (n = 3), and Japan (n = 2) were analyzed using a new user active comparator design. Propensity score matching (1:1) controlled for potential confounding.

Terpenes Combinations Inhibit Biofilm Formation in by Interfering with Initial Adhesion.

The biofilm is a conglomerate of cells surrounded by an extracellular matrix, which contributes to the persistence of infections. The difficulty in removing the biofilm drives the research for new therapeutic options. In this work, the effect of terpenes (−)-trans-Caryophyllene, (S)-cis-Verbenol, (S)-(−)-Limonene, (R)-(+)-Limonene, and Linalool was evaluated, individually and in combinations on bacterial growth, by assay with resazurin; the formation of biofilm, by assay with violet crystal; and the expression of associated genes, by real-time PCR, in two clinical isolates of Staphyloccocus aureus, ST30-t019 and ST5-t311, responsible for more than 90% of pediatric infections by this pathogen in Paraguay.

Analysis of antibiotic resistance and genetic profile of conjunctival bacteria flora before and after cataract surgery.

Purpose: To analyze antibiotic resistance and genetic profile of conjunctival bacteria flora before and after cataract surgery with the focus on coagulase-negative staphylococci (CNS) during cataract surgery and discuss the implications of this colonization as a potential risk of acquiring endophthalmitis.

Methods: After approval of the institutional review board and informed consent from patients had been obtained, conjunctival swabs for culture from 59 patients undergoing cataract surgery were taken of the fellow eye at baseline (C0) and from the eye to be operated before (T0) and after (T1) irrigation with povine-iodine 5%, and at the end of surgery (T2). Genes responsible for virulence (mecA, ica and atlE) and antibiotic profile were determined; strain clonality of persistent colonizing Staphylococcus epidermidis strains was established by the Multi-locus sequence typing (MLST).

Association Between Serum Lactate and Unsatisfactory Outcomes in Critically Ill Children in the Immediate Post-operative Period of Liver Transplantation.

Objectives: Serum lactate is a useful biomarker of tissue perfusion in critically ill patients. We evaluated the behavior of serum lactate in children in the pediatric intensive care unit (PICU) immediately after liver transplantation and its association with surgical complications, graft dysfunction and 90-day mortality.

Materials And Methods: A prospective observational study carried out between November 2009 and December 2019.

antibacterial activity, biofilm formation inhibition and chromatographic profile of methanolic extracts of two species against MRSA.

The methanolic extracts of and were assayed for antibacterial activity and biofilm formation inhibition of four community-acquired-MRSA isolates representative of ST30 t975, ST30 t021, ST5 t311, and ST4335 t008 clones that are responsible for invasive infections in Paraguayan children. Both extracts showed significant antibacterial activity with a minimum inhibitory concentration of 200 µg/mL against the four isolates. showed inhibition of biofilm formation for the four isolates, whereas showed inhibition for three of them.

Prevalence of Renal Impairment in a US Commercially Insured Rheumatoid Arthritis Population: A Retrospective Analysis.

Introduction: Global prevalence estimates for chronic kidney disease (CKD) in rheumatoid arthritis (RA) vary. This study assessed real-world prevalence estimates of renal impairment, based on estimated glomerular filtration rate (eGFR), among commercially insured patients with RA in the United States (US).

Methods: In this retrospective cohort study, we used administrative claims data from the HealthCore Integrated Research Database (HIRD) between January 2013 and December 2018.

Community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) clones from Paraguayan children.

Introduction: Staphylococcus aureus is considered one of the most important human pathogens, and its levels of resistance to methicillin have increased even in strains isolated from people without nosocomial risk factors. Molecular analysis is essential for understanding the patterns of dissemination. The objective of this study was to identify community-acquired methicillin-resistant S.

Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis.

Objective: To assess the frequency of cardiovascular and venous thromboembolic events in clinical studies of baricitinib, an oral, selective JAK1 and JAK2 inhibitor approved in more than 50 countries for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

Methods: Data were pooled from 9 RA studies. Placebo comparison up to 24 weeks included data from 6 studies.

Effect of a Sepsis Educational Intervention on Hospital Stay.

Objectives: To evaluate adherence to the sepsis bundle before and after an educational strategy and its impact on hospital stay.

Design: A prospective, analytic, before-and-after study of children with severe sepsis and septic shock who presented to the emergency department.

Setting: Carried out from January to December 2014 in the emergency department of a quaternary care hospital.

Mobile phone text messaging improves antihypertensive drug adherence in the community.

Antihypertensive drug adherence (ADA) is a mainstay in blood pressure control. Education through mobile phone short message system (SMS) text messaging could improve ADA. The authors conducted a randomized study involving 314 patients with hypertension with <6 months of antihypertensive treatment from the Preventive Health Program of 12 different primary care centers in Santiago, Chile.

[Assessment of adherence to antihypertensive therapy].

Background: Lack of adherence with medications is the main cause of antihypertensive treatment failure.

Aim: To assess adherence to antihypertensive drugs and its determinants.

Material And Methods: The Morinsky-Green questionnaire to determine treatment adherence was applied to 310 hypertensive patients from primary care centers, aged 60 ± 10 years (65% females) in treatment for 4 ± 1 months.

Prostate cancer in young men: an important clinical entity.

Prostate cancer is considered a disease of older men (aged >65 years), but today over 10% of new diagnoses in the USA occur in young men aged ≤55 years. Early-onset prostate cancer, that is prostate cancer diagnosed at age ≤55 years, differs from prostate cancer diagnosed at an older age in several ways. Firstly, among men with high-grade and advanced-stage prostate cancer, those diagnosed at a young age have a higher cause-specific mortality than men diagnosed at an older age, except those over age 80 years.

Identification of a novel NBN truncating mutation in a family with hereditary prostate cancer.

Nibrin (NBN), located on chromosome 8q21 is a gene involved in DNA double-strand break repair that has been implicated in the rare autosomal recessive chromosomal instability syndrome known as Nijmegen Breakage Syndrome (NBS). NBS is characterized by specific physical characteristics (microcephaly and dysmorphic facies), immunodeficiency, and increased risk of malignancy. Individuals who are heterozygous for NBN mutations are clinically asymptomatic, but may display an elevated risk for certain cancers including, but not limited to, ovarian and prostate cancer as well as various lymphoid malignancies.

Early onset prostate cancer has a significant genetic component.

Background: Prostate cancer (PCa) affects more than 190,000 men each year with ∼10% of men diagnosed at ≤55 years, that is, early onset (EO) PCa. Based on historical findings for other cancers, EO PCa likely reflects a stronger underlying genetic etiology.

Methods: We evaluated the association between EO PCa and previously identified single nucleotide polymorphisms (SNPs) in 754 Caucasian cases from the Michigan Prostate Cancer Genetics Project (mean 49.

Genetic polymorphisms in inflammation pathway genes and prostate cancer risk.

Background: Chronic inflammation is an important mechanism for the development and progression of prostate cancer (PC). To better understand the potential relationship between genes in the inflammation pathway and PC risk, we evaluated variants in 16 candidate genes.

Methods: A total of 143 tagging and amino acid altering single nucleotide polymorphisms (SNPs) were genotyped in Caucasian and African American men participating in one of two population-based, case-control studies (n = 1,458 cases and 1,351 controls).

Use of aspirin and other nonsteroidal antiinflammatory medications in relation to prostate cancer risk.

Recent interest has focused on the role that inflammation may play in the development of prostate cancer and whether use of aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs) affects risk. In a population-based case-control study designed to investigate the relation between these medications and prostate cancer risk, detailed exposure data were analyzed from 1,001 cases diagnosed with prostate cancer between January 1, 2002, and December 31, 2005, and 942 age-matched controls from King County, Washington. A significant 21% reduction in the risk of prostate cancer was observed among current users of aspirin compared with nonusers (95% confidence interval (CI): 0.

Genetic variation in DNA repair genes and prostate cancer risk: results from a population-based study.

Objective: DNA repair pathways are crucial to prevent accumulation of DNA damage and maintain genomic stability. Alterations of this pathway have been reported in many cancers. An increase in oxidative DNA damage or decrease in DNA repair capacity with aging or due to germline genetic variation may affect prostate cancer risk.

Prostate cancer specific mortality and Gleason 7 disease differences in prostate cancer outcomes between cases with Gleason 4 + 3 and Gleason 3 + 4 tumors in a population based cohort.

Purpose: Reports of biochemical recurrence after prostate cancer primary therapy show differences between Gleason 4 + 3 and 3 + 4 tumors. To our knowledge these findings have not been explored for prostate cancer specific mortality. In this population based cohort we determined prostate cancer outcomes at different Gleason scores, particularly the different Gleason 7 patterns.

Analysis of recently identified prostate cancer susceptibility loci in a population-based study: associations with family history and clinical features.

Purpose: Two recent genome-wide association studies have highlighted several single nucleotide polymorphisms (SNPs) purported to be associated with prostate cancer risk. We investigated the significance of these SNPs in a population-based study of Caucasian men, testing the effects of each SNP in relation to family history of prostate cancer and the clinicopathologic features of the disease.

Experimental Design: We genotyped 13 SNPs in 1,308 prostate cancer patients and 1,267 unaffected controls frequency matched to cases by five-year age groups.

Evaluation of 8q24 and 17q risk loci and prostate cancer mortality.

Purpose: Variants at chromosomal loci 8q24 and 17q are established risk factors for prostate cancer. Many studies have confirmed the findings for risk, but few have examined aggressiveness and other clinical variables in detail. Additionally, Gleason score is typically used as a surrogate for the primary end point of prostate cancer mortality.

Clinical utility of five genetic variants for predicting prostate cancer risk and mortality.

Background: A recent report suggests that the combination of five single-nucleotide polymorphisms (SNPs) at 8q24, 17q12, 17q24.3 and a family history of the disease may predict risk of prostate cancer. The present study tests the performance of these factors in prediction models for prostate cancer risk and prostate cancer-specific mortality.