Digital Reset: Redirecting Technologies for the Deep Sustainability Transformation

Governments worldwide hope that digital technologies can provide key solutions. Yet this report shows that digitalisation, in its current and mainstream form, is rather aggravating than solving many of the pressing social and environmental crises at hand. What is needed instead is a deep sustainability transformation that fundamentally reorganises the economy and all its sectors - agriculture, mobility, energy, buildings, industry, and consumption. The Report »Digital Reset« shows how digital technologies can support the quest for such a deep sustainability transformation. The report provides a blueprint for the European Union on how to reconceptualise digitalisation so that it first and foremost contributes to achieving carbon neutrality, resource autonomy and economic resilience while supporting equity and fully respecting citizen's rights and privacy. The report is the outcome of a two-year international science-policy dialogue, »Digitalization for Sustainability« (D4S), and presents an up-to-date comprehensive analysis of opportunities, risks and governance options regarding digitalization and sustainability

Pharmacokinetics of intramuscular maropitant in pigs (Sus scrofa domesticus)

Pigs are at risk of vomiting from medical conditions as well as the emetic side effects of drugs administered for peri-operative manipulations, but there is a lack of pharmacokinetic data for potential anti-emetic therapies, such as maropitant, in this species. The main objective of this study was to estimate plasma pharmacokinetic parameters for maropitant in pigs after a single intramuscular (IM) administration dosed at 1.0 mg/ kg. A secondary objective was to estimate pilot pharmacokinetic parameters in pigs after oral (PO) administration at 2.0 mg/kg. Maropitant was administered to six commercial pigs at a dose of 1.0 mg/kg IM. Plasma samples were collected over 72 h. After a 7-day washout period, two pigs were administered maropitant at a dose of 2.0 mg/ kg PO. Maropitant concentrations were measured via liquid chromatography/mass spectrometry (LC–MS/ MS). A non-compartmental analysis was used to derive pharmacokinetics parameters. No adverse events were noted in any of the study pigs after administration. Following single IM administration, maximum plasma concentration was estimated at 412.7 ± 132.0 ng/mL and time to maximum concentration ranged from 0.083 to 1.0 h. Elimination half-life was estimated at 6.7 ± 1.28 h, and mean residence time was 6.1 ± 1.2 h. Volume of distribution after IM administration was 15.9 L/ kg. Area under the curve was 1336 ± 132.0 h*ng/mL. The relative bioavailability of PO administration was noted to be 15.5% and 27.2% in the two pilot pigs. The maximum systemic concentration observed in the study pigs after IM administration was higher than what was observed after subcutaneous administration in dogs, cats, or rabbits. The achieved maximum concentration exceeded the concentrations for anti-emetic purposes in dogs and cats; however, a specific anti-emetic concentration is currently not known for pigs. Further research is needed into the pharmacodynam

Simulation Training to Improve Informed Consent and Pharmacokinetic/Pharmacodynamic Sampling in Pediatric Trials

Background: Pediatric trials to add missing data for evidence-based pharmacotherapy are still scarce. A tailored training concept appears to be a promising tool to cope with critical and complex situations before enrolling the very first patient and subsequently to ensure high-quality study conduct. The aim was to facilitate study success by optimizing the preparedness of the study staff shift. Method: An interdisciplinary faculty developed a simulation training focusing on the communication within the informed consent procedure and the conduct of the complex pharmacokinetic/pharmacodynamic (PK/PD) sampling within a simulation facility. Scenarios were video-debriefed by an audio-video system and manikins with artificial blood simulating patients were used. The training was evaluated by participants' self-assessment before and during trial recruitment. Results: The simulation training identified different optimization potentials for improved informed consent process and study conduct. It facilitated the reduction of avoidable errors, especially in the early phase of a clinical study. The knowledge gained through the intervention was used to train the study teams, improve the team composition and optimize the on-ward setting for the FP-7 funded “LENA” project (grant agreement no. 602295). Self-perceived ability to communicate core elements of the trial as well as its correct performance of sample preparation increased significantly (mean, 95% CI, p ≤ 0.0001) from 3 (2.5–3.5) to four points (4.0–4.5), and from 2 (1.5–2.5) to five points (4.0–5.0). Conclusion: An innovative training concept to optimize the informed consent process and study conduct was successfully developed and enabled high-quality conduct of the pediatric trials as of the very first patient visit

ASPIRA: Employing a Serious Game in an mHealth App to Improve Asthma Outcomes

This paper presents the design, implementation and evaluation of a home based intervention targeting economically disadvantaged children to improve asthma clinical outcomes. The monitoring and intervention activities were delivered within an embedded astronaut-themed game to promote user acceptance and compliance to the clinical protocol. An iterative, user-centered design process was used to prototype the asthma home monitoring system (ASPIRA) involving a tablet application, digital spirometer and a particulate monitor linked to a data management server. Children of low socio-economic demographic populations were the main target group for this study as they have significantly high asthma rates and lack of condition awareness. ASPIRA is the first intervention of its kind that provides the target audience an easy to use and low-cost in-home monitoring application. ASPIRA\u27s design is grounded in the principles of social cognitive theory and aims to increase use, participation and efficacy in the target population. We present the results of a pilot study to determine feasibility and preliminary efficacy of the resulting high-fidelity ASPIRA prototype among four families with asthmatic children living in the Seattle metropolitan area