A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen

Background Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care

PLM Functionalities in the Fashion Industry. Preliminary Results of a Classification Framework

Part 10: Maturity Implementation and AdoptionInternational audienceAs widely known, Product Lifecycle Management (PLM) is a set of business solutions and tools for the management of the entire lifecycle of a product, from its conception to its disposal. Despite PLM was born in traditional contexts, recently it is increasingly used in other sectors such as the fashion industry, even if it shows several features that distances it from the traditional approach to PLM deployment. Request for customized products, rapid changes in customer’s preference and the consequent shorter product lifecycles make the fashion environment very complex. Within this scenario, PLM has the potential to enable fashion industry to reduce time to market and to increase competitiveness in the global scenario, but quite often clear guidelines are not available. Literature is not exhaustive, as we can’t find articles covering the whole set of functionalities. Quite often only few features have been mentioned and the same functionalities have been differently called. To overcome this gap, the purpose of this research is the definition of a framework on PLM functionalities in fashion, classified according to the macro-processes where they are involved. The result is an overview of the PLM functionalities organized in macro-processes, moving from the development of the creative idea to the arrival in the stores, validated by experts of PLM software houses working within the fashion industry. From a managerial point of view, it represents a clear guideline to support companies and vendors to identify the whole range of PLM functionalities and the processes positively involved during their implementation

Antiretroviral concentrations in the presence and absence of valproic acid

Objectives: An unexpected drug–drug interaction has been recently reported between dolutegravir, an HIV integrase inhibitor, and valproic acid. Despite there being several potential underlying mechanisms, plasma protein displacement has been suggested. The aim of this study was to assess plasma concentrations of several antiretrovirals when administered with or without valproic acid. Methods: We performed a therapeutic drug monitoring registry analysis and identified patients concomitantly taking antiretrovirals and valproic acid and without clinical affecting conditions or interacting drugs. Results: One hundred and thirty-four patients were identified. Median (IQR) age and BMI were 49.7 years (45–56) and 23.4 kg/m2 (20.8–26.3) and 78 were male (58.2%). Despite small groups, we observed no major effect on antiretroviral exposure, even when considering highly protein-bound compounds (such as etravirine), with the exception of dolutegravir trough concentrations [median (IQR) = 132 ng/mL (62–227) in individuals on valproic acid versus 760 ng/mL (333–1407) in those not receiving valproic acid]. Conclusions: Valproic acid does not have a major effect on antiretrovirals other than dolutegravir. The mechanism of this unexpected drug–drug interaction may be the combination of protein displacement, reduced absorption and CYP3A4 induction