Reducing central line-associated bloodstream infection with a dedicated CLABSI prevention registered nurse role.

Background: Following a 200% increase in the central line-associated bloodstream infection (CLABSI) standardized infection ratio in a private teaching hospital between 2019 and 2020, a program with the utilization of a CLABSI Prevention Registered Nurse was implemented to reduce CLABSIs through a variety of focused prevention efforts and education.

Methods: The CLABSI P-RN project consisted of a dedicated team of RNs that performed interventions that included an audit of all central lines daily, real-time education and remediation, bi-weekly educational handouts, and assistance with 2-person dressing changes. Audit data were utilized to identify trends in gaps in compliance with the CLABSI bundle (ie, daily bathing, dressing integrity).

Signal Detection in EUROmediCAT: Identification and Evaluation of Medication-Congenital Anomaly Associations and Use of VigiBase as a Complementary Source of Reference.

Introduction: Knowledge on the safety of medication use during pregnancy is often sparse. Pregnant women are generally excluded from clinical trials, and there is a dependence on post-marketing surveillance to identify teratogenic medications.

Aims: This study aimed to identify signals of potentially teratogenic medications using EUROmediCAT registry data on medication exposure in pregnancies with a congenital anomaly, and to investigate the use of VigiBase reports of adverse events of medications in the evaluation of these signals.

SEWA DB: A Rich Database for Audio-Visual Emotion and Sentiment Research in the Wild.

Natural human-computer interaction and audio-visual human behaviour sensing systems, which would achieve robust performance in-the-wild are more needed than ever as digital devices are increasingly becoming an indispensable part of our life. Accurately annotated real-world data are the crux in devising such systems. However, existing databases usually consider controlled settings, low demographic variability, and a single task.

Studying the Evolving Knowledge of Adverse Drug Reactions in Order to Facilitate the Rational Use of Medicines in Paediatric Patients.

Pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems, generates knowledge to facilitate the rational use of medicines. When a medicine is first marketed, there is limited information on adverse drug reactions (ADRs), especially in paediatrics, where medicines are less likely to have been extensively studied. Knowledge in drug safety is built up over time when more (in number, and more heterogeneous) patients are treated than were studied in the randomised controlled trials preceding the marketing of a medicine.

Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre.

Purpose: The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics.

Methods: Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years.

Retrospective review of paediatric case reports of Stevens-Johnson syndrome and toxic epidermal necrolysis with lamotrigine from an international pharmacovigilance database.

Objectives: This study aims to characterise paediatric reports with lamotrigine (LTG) and Stevens-Johnson syndrome or toxic epidermal necrolysis (SJS/TEN), and to explore whether potential risk factors can be identified.

Design: This is a retrospective review of suspected adverse drug reaction (ADR) reports. Reported time from LTG start to SJS/TEN onset, indication for use and dose was explored.

Pharmacovigilance in pediatrics.

The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs).

Safety Concerns Reported by Patients Identified in a Collaborative Signal Detection Workshop using VigiBase: Results and Reflections from Lareb and Uppsala Monitoring Centre.

Introduction: Patient reporting in pharmacovigilance is important and contributes to signal detection. However, descriptions of methodologies for using patient reports in signal detection are scarce, and published experiences of how patient reports are used in pharmacovigilance are limited to a few individual countries.

Objective: Our objective was to explore the contribution of patient reports to global signal detection in VigiBase.

Improvements to the APBS biomolecular solvation software suite.

The Adaptive Poisson-Boltzmann Solver (APBS) software was developed to solve the equations of continuum electrostatics for large biomolecular assemblages that have provided impact in the study of a broad range of chemical, biological, and biomedical applications. APBS addresses the three key technology challenges for understanding solvation and electrostatics in biomedical applications: accurate and efficient models for biomolecular solvation and electrostatics, robust and scalable software for applying those theories to biomolecular systems, and mechanisms for sharing and analyzing biomolecular electrostatics data in the scientific community. To address new research applications and advancing computational capabilities, we have continually updated APBS and its suite of accompanying software since its release in 2001.

A method for data-driven exploration to pinpoint key features in medical data and facilitate expert review.

Purpose: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors.

Methods: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings.

Energy Minimization of Discrete Protein Titration State Models Using Graph Theory.

There are several applications in computational biophysics that require the optimization of discrete interacting states, for example, amino acid titration states, ligand oxidation states, or discrete rotamer angles. Such optimization can be very time-consuming as it scales exponentially in the number of sites to be optimized. In this paper, we describe a new polynomial time algorithm for optimization of discrete states in macromolecular systems.

Adverse drug reactions in Nigerian children: a retrospective review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012.

Background: Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase.

Objective: To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012.

Adverse drug reaction reports for cardiometabolic drugs from sub-Saharan Africa: a study in VigiBase.

Objective: Identifying key features in individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) with cardiometabolic drugs from sub-Saharan Africa (SSA) compared with reports from the rest of the world (RoW).

Methods: Reports on suspected ADRs of cardiometabolic drugs (ATC: A10[antidiabetic], B01[antithrombotics] and C[cardiovascular]) were extracted from WHO Global database, VigiBase(®) (1992-2013). We used vigiPoint, a logarithmic odds ratios (log2 OR)-based method to study disproportional reporting between SSA and RoW.

Longitudinal medical records as a complement to routine drug safety signal analysis.

Purpose: To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.

Methods: Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated.

Structured assessment for prospective identification of safety signals in electronic medical records: evaluation in the health improvement network.

Background: Pharmacovigilance signal detection largely relies on individual case reports, but longitudinal health data are being explored as complementary information sources. Research to date has focused on the ability of epidemiological methods to distinguish established adverse drug reactions (ADRs) from unrelated adverse events.

Objective: The aim of this study was to evaluate a process for structured clinical and epidemiological assessment of temporally associated drugs and medical events in electronic medical records.

Valproic acid and fatalities in children: a review of individual case safety reports in VigiBase.

Introduction: Valproic acid is an effective first line drug for the treatment of epilepsy. Hepatotoxicity is a rare and potentially fatal adverse reaction for this medicine.

Objective: Firstly to characterise valproic acid reports on children with fatal outcome and secondly to determine reporting over time of hepatotoxicity with fatal outcome.

Pharmacovigilance for children's sake.

Child age-specific information on efficacy and risk of medicines can be limited for healthcare professionals and patients. It is therefore very important to make the best use of a risk planned approach to the pharmacological treatment of children. This means pharmacovigilance in the broadest sense of gaining the best data from the use of medicines in clinical practice.

Copper-based conductive composites with tailored thermal expansion.

We have devised a moderate temperature hot-pressing route for preparing metal-matrix composites which possess tunable thermal expansion coefficients in combination with high electrical and thermal conductivities. The composites are based on incorporating ZrW2O8, a material with a negative coefficient of thermal expansion (CTE), within a continuous copper matrix. The ZrW2O8 enables us to tune the CTE in a predictable manner, while the copper phase is responsible for the electrical and thermal conductivity properties.

Histologic features in colon biopsies can discriminate mycophenolate from GVHD-induced colitis.

Mycophenolate mofetil (MMF) is a T-cell inhibitor frequently used in the treatment of acute allograft rejection. MMF may cause colitis that clinically and histologically resembles graft-versus-host disease (GVHD). The aim of this study was to evaluate a wide range of histologic features that may help differentiate MMF from GVHD-induced colitis and to validate significant features on a cohort of bone marrow transplant patients who were also taking MMF as part of their immunosuppressive regimen and developed a diarrheal illness due to colitis.

The impact of duration of treatment on reported time-to-onset in spontaneous reporting systems for pharmacovigilance.

Within pharmacovigilance, knowledge of time-to-onset (time from start of drug administration to onset of reaction) is important in causality assessment of drugs and suspected adverse drug reactions (ADRs) and may indicate pharmacological mechanisms involved. It has been suggested that time-to-onset from individual case reports can be used for detection of safety signals. However, some ADRs only occur during treatment, while those that do occur later are less likely to be reported.

Outlier removal to uncover patterns in adverse drug reaction surveillance - a simple unmasking strategy.

Purpose: This study aimed to develop an algorithm for uncovering associations masked by extreme reporting rates, characterize the occurrence of masking by influential outliers in two spontaneous reporting databases and evaluate the impact of outlier removal on disproportionality analysis.

Methods: We propose an algorithm that identifies influential outliers and carries out parallel analysis after their omission. It considers masking of drugs as well as of adverse drug reactions (ADRs), uses a direct measure of the masking effect and makes no assumptions regarding the number of outliers per drug or ADR.

Challenges of safe medication practice in paediatric care--a nursing perspective.

Aim: To explore nurses' experiences of handling medications in paediatric clinical practice, with a focus on factors that hinder and facilitate safe medication practices.

Methods: Twenty nurses (registered nurses) from four paediatric wards at two hospitals in Sweden were interviewed in focus groups. The interviews were analysed using content analysis.