Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery.

INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.The OPTIMISE II trial is supported by Edwards Lifesciences (Irvine, CA) and the UK National Institute for Health Research through RMP’s NIHR Professorship

Long term follow-up of a simplified and less burdened pancreatic duct ligation model of exocrine pancreatic insufficiency in Goettingen Minipigs

$\bf Background$ Pancreatic duct ligation in a minipig model leads to exocrine pancreatic insufficiency (EPI). This allows the study of digestive processes and pancreatic enzyme replacement therapies. However, detailed descriptions of the surgical procedure, perioperative management, a determination of exocrine pancreatic insufficiency are scarce in the literature. Data of the long-term health status of minipigs upon EPI induction are still not available. Therefore, the present study describes in detail an experimental approach to the induction of exocrine pancreatic insufficiency via pancreatic duct ligation in minipigs and the long term follow up of the animal’s health state. $\bf Methods$ 14 Goettingen minipigs underwent pancreatic duct ligation via midline laparotomy for the induction of exocrine pancreatic insufficiency. Fecal fat content, fat absorption, chymotrypsin levels, body weight and blood vitamin and glucose levels were determined. $\bf Results$ Exocrine pancreatic insufficiency was successfully induced in 12 Goettingen minipigs. Two minipigs failed to develop exocrine insufficiency most likely due to undetected accessory pancreatic ducts. All animals tolerated the procedure very well and gained weight within 8 weeks after surgery without requiring pancreatic enzyme replacement therapy. The follow up for approx. 180 weeks showed a stable body weight and health state of the animals with normal blood glucose levels (Table 1). From approx. 130 weeks post pancreatic duct ligation, all animals were supplemented with pancreatic enzymes and vitamins resulting in blood concentrations almost within the reference range. $\bf Conclusions$ Pancreatic duct ligation in minipigs is an excellent method of inducing exocrine pancreatic insufficiency. It is important to identify and ligate accessory pancreatic ducts since persistence of accessory ducts will lead to maintenance of exocrine pancreatic function. The EPI model caused no persistent side effects in the animals and has the potential to be used in long-term EPI studies with up to 100 weeks post-OP without supplementation with enzymes and vitamins

Change management for learning analytics : Sustainable innovation in productive higher education environments

Learning analytics draw on an eclectic set of methodologies and data to provide summative, real-time, and predictive insights for improving learning, teaching, organisational efficiency, and decision-making. The implementation of learning analytics at higher education institutions may have broad implications for the organisation and its stakeholders (e.g. students, academic staff, administrators) including changes in learning culture and educational decision-making. Hence, change management seems to be an essential prerequisite when implementing learning analytics, while change management includes approaches to prepare and support organisations and its stakeholders in making sustainable and beneficial organisational change. This chapter presents two case studies which exemplify the process of staff and technological change management processes required for successful implementation of learning analytics. Implications of the case study include insights into functioning implementation strategies highlighting the importance of open communication structures, transparency of decision-making, and the importance of systems thinking approaches

Educational Theories and Learning Analytics: From Data to Knowledge: The Whole Is Greater Than the Sum of Its Parts

The study of learning is grounded in theories and research. Since learning is complex and not directly observable, it is often inferred by collecting and analysing data based on the things learners do or say. By virtue, theories are developed from the analyses of data collected. With the proliferation of technology, large amounts of data are generated when students learn online. Therefore, researchers not only have data on students’ learning performance, but they also have data on the actions students take to achieve the desired learning outcomes. These data could help researchers to understand how students learn and the conditions needed for successful learning. In turn, the information can be translated to instructional and learning design to support students. The aim of the chapter is to discuss how learning theories and learning analytics are important components of educational research. To achieve this aim, studies employing learning analytics are qualitatively reviewed to examine which theories have been used and how the theories have been investigated. The results of the review show that self-regulated learning, motivation, and social constructivism theories were used in studies employing learning analytics. However, the studies at present are mostly correlational. Therefore, experimental studies are needed to examine how theory-informed practices can be implemented so that students can be better supported in online learning environments. The chapter concludes by proposing an iterative loop for educational research employing learning analytics in which learning theories guide data collection and analyses. To convert data into knowledge, it is important to recognize what we already know and what we want to examine.Green Open Access added to TU Delft Institutional Repository ‘You share, we take care!’ – Taverne project https://www.openaccess.nl/en/you-share-we-take-care Otherwise as indicated in the copyright section: the publisher is the copyright holder of this work and the author uses the Dutch legislation to make this work public.Web Information System