A study protocol for quantifying patient preferences in neuromuscular disorders: a case study of the IMI PREFER Project.

Patient preference studies are increasingly used to inform decision-making during the medical product lifecycle but are rarely used to inform early stages of drug development.  The primary aim of this study is to quantify treatment preferences of patients with neuromuscular disorders, which represent serious and debilitating conditions with limited or no treatment options available. This quantitative patient preferences study was designed as an online survey, with a cross-over design.

Ninety-Day Follow-up Is Inadequate for Diagnosis of Fracture-related Infections in Patients with Open Fractures.

Background: Fracture-related infection (FRI) is a challenging complication in musculoskeletal trauma surgery and often complicates the management of open fractures. The CDC currently advocates a surveillance period of 90 days after fracture fixation, but it is unclear what duration of follow-up constitutes adequate surveillance for FRI. Inadequate follow-up will underestimate infections and, in clinical research, will make any interventions studied appear better than they really are, thereby resulting in misleading conclusions.

Bosentan Alters Endo- and Exogenous Bile Salt Disposition in Sandwich-Cultured Human Hepatocytes.

Bosentan, a well-known cholestatic agent, was not identified as cholestatic at concentrations up to 200 µM based on the drug-induced cholestasis (DIC) index value, determined in a sandwich-cultured human hepatocyte (SCHH)-based DIC assay. To obtain further quantitative insights into the effects of bosentan on cellular bile salt handling by human hepatocytes, the present study determined the effect of 2.5-25 µM bosentan on endogenous bile salt levels and on the disposition of 10 µM chenodeoxycholic acid (CDCA) added to the medium in SCHHs.

Personalized and long-term electronic informed consent in clinical research: stakeholder views.

Background: The landscape of clinical research has evolved over the past decade. With technological advances, the practice of using electronic informed consent (eIC) has emerged. However, a number of challenges hinder the successful and widespread deployment of eIC in clinical research.

Reproducibility of fluid status measured by bioelectrical impedance analysis in healthy volunteers: a key requirement to monitor fluid status in the intensive care unit.

Introduction: Little is known about the use of bioelectrical impedance analysis (BIA) in critically ill patients. The objective of this study was to evaluate the reproducibility of BIA measurements by comparing non-dominant versus dominant body-side measurements at 2 separate time points in healthy volunteers in order to extrapolate key elements that may be of relevance in critically ill patients.

Material And Methods: A prospective observational validation experiment was carried out in healthy volunteers.

Monocyte-driven atypical cytokine storm and aberrant neutrophil activation as key mediators of COVID-19 disease severity.

Epidemiological and clinical reports indicate that SARS-CoV-2 virulence hinges upon the triggering of an aberrant host immune response, more so than on direct virus-induced cellular damage. To elucidate the immunopathology underlying COVID-19 severity, we perform cytokine and multiplex immune profiling in COVID-19 patients. We show that hypercytokinemia in COVID-19 differs from the interferon-gamma-driven cytokine storm in macrophage activation syndrome, and is more pronounced in critical versus mild-moderate COVID-19.

Meropenem Pharmacokinetics and Target Attainment in Critically Ill Patients Are Not Affected by Extracorporeal Membrane Oxygenation: A Matched Cohort Analysis.

Existing evidence is inconclusive whether meropenem dosing should be adjusted in patients receiving extracorporeal membrane oxygenation (ECMO). Therefore, the aim of this observational matched cohort study was to evaluate the effect of ECMO on pharmacokinetic (PK) variability and target attainment (TA) of meropenem. Patients admitted to the intensive care unit (ICU) simultaneously treated with meropenem and ECMO were eligible.

The Potential Role of Bacteriophages in the Treatment of Recalcitrant Chronic Rhinosinusitis.

Chronic rhinosinusitis is a common condition affecting 5-12% of the general population worldwide. In a limited number of cases, the disease is recalcitrant to medical and surgical interventions, causing a major impact on physical, social and emotional well-being and increasing pressure on healthcare systems. Biofilm formation and dysbiosis caused by and play a role in the pathogenesis of recalcitrant chronic rhinosinusitis.

Antibiotic prescriptions in the context of suspected bacterial respiratory tract superinfections in the COVID-19 era: a retrospective quantitative analysis of antibiotic consumption and identification of antibiotic prescription drivers.

This study aims to quantify antibiotic consumption for suspected respiratory tract superinfections in COVID-19 patients, while investigating the associated drivers of antibiotic prescribing in light of the current signs of antibiotic overuse. Adult patients with a positive COVID-19 diagnosis admitted to a Belgian 721-bed university hospital were analyzed retrospectively (March 11th-May 4th, 2020), excluding short-term admissions (< 24 h). Antibiotic prescriptions were analyzed and quantified, using Defined Daily Doses (DDD) per admission and per 100 bed days.

Evaluation of interprofessional care processes for patients treated with oral anticancer drugs.

Information on interprofessional team composition and functioning in the care for patients on oral anticancer drugs (OACDs), and how healthcare professionals (HCPs) evaluate in-hospital care processes is scarce. We aimed to investigate interprofessional care processes for OACD-patients in a partially mixed-methods study. A combination of (a) the CareProces Self-Evaluation Tool (CPSET), completed by HCP-team members by health profession who were either currently involved in care processes (oncologists and nurses) or potentially involved in future care (pharmacists, psychologists, social workers), and by hospital managers ( = 87) and (b) semi-structured interviews in a subsample of oncologists, nursing staff, and pharmacists ( = 26) were used.

Pharmacokinetic/Pharmacodynamic Target Attainment Based on Measured versus Predicted Unbound Ceftriaxone Concentrations in Critically Ill Patients with Pneumonia: An Observational Cohort Study.

The impact of ceftriaxone pharmacokinetic alterations on protein binding and PK/PD target attainment still remains unclear. We evaluated pharmacokinetic/pharmacodynamic (PK/PD) target attainment of unbound ceftriaxone in critically ill patients with severe community-acquired pneumonia (CAP). Besides, we evaluated the accuracy of predicted vs.

Off-Patent Biological and Biosimilar Medicines in Belgium: A Market Landscape Analysis.

Best-value biological medicines may generate competition in the off-patent biologicals market, resulting in having more resources available to provide patients with access to necessary medicines while maintaining high-quality care. Belgium is a country known to have low biosimilar market shares, suggesting a malfunctioning market for off-patent biologicals. This study aims to gain an in-depth understanding of the Belgian off-patent biologicals market, by looking at the evolution in volumes and costs of the relevant products in the market.

Meropenem Stability in Human Plasma at -20 °C: Detailed Assessment of Degradation.

There are concerns about the stability of meropenem in plasma samples, even when frozen at -20 °C. Previous smaller studies suggested significant degradation of meropenem at -20 °C after 3-20 days. However, in several recent clinical studies, meropenem plasma samples were still stored at -20 °C, or the storage temperature and/or time were not mentioned in the paper.

Assessing the reporting quality of simulated patient studies in pharmacy research using a novel checklist (CRiSP).

Background: Use of simulated patients (SP) to assess the quality of pharmacy services and impact of interventions is increasing. The CRiSP (Checklist for Reporting research using Simulated Patient methodology) checklist was recently developed, assisting researchers to report items necessary to meet a minimum agreed standard.

Objective(s): To identify which CRiSP items were reported in SP studies for community pharmacy research, identify any gaps in reporting and describe the overall quality of reporting for the SP studies identified.

Strengthening the global network for sharing of marine biological collections: recommendations for a new agreement for biodiversity beyond national jurisdiction.

Biological collections are fundamental to marine scientific research and understanding of biodiversity at various scales. Despite their key importance, sample collections and the institutes that house them are often underfunded and receive comparatively little attention in the discussions associated with global biodiversity agreements. Furthermore, access to collections can be limited by inadequate systems, infrastructure, and networks.

Animal Models for In Vivo Lactation Studies: Anatomy, Physiology and Milk Compositions in the Most Used Non-Clinical Species: A Contribution from the ConcePTION Project.

The present review aims to summarize the main features of mammary gland anatomy, and the physiology of lactation and colostrum/milk in the most commonly used animal species for regulatory toxicity. The final goal is the selection of a preferred animal species to be enrolled in studies investigating the potential transfer of drugs and exogenous molecules through milk, within the Innovative Medicines Initiative (IMI) funded project ConcePTION. Reference data regarding humans were also collected and analyzed in order to highlight critical similarities and differences with the studied species.

Vaccine Willingness and Impact of the COVID-19 Pandemic on Women's Perinatal Experiences and Practices-A Multinational, Cross-Sectional Study Covering the First Wave of the Pandemic.

The COVID-19 pandemic may be of particular concern for pregnant and breastfeeding women. We aimed to explore their beliefs about the coronavirus and COVID-19 vaccine willingness and to assess the impact of the pandemic on perinatal experiences and practices. A multinational, cross-sectional, web-based study was performed in six European countries between April and July 2020.

Defining polypharmacy: in search of a more comprehensive determination method applied in a tertiary psychiatric hospital.

Aims: This cross-sectional pharmacoepidemiologic study examined the prevalence of polypharmacy and psychotropic polypharmacy among inpatients in a tertiary psychiatric hospital in Belgium.

Methods: Current prescriptions of all inpatients suffering from mental disorders were extracted from the hospital Computerized Physician Order Entry. Two methods were used to examine definitive polypharmacy (defined as the concomitant use of at least five medicines): number of medicines per active component and per prescription.