Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation -a look beyond the excellent results

In this overview we address the three phase III studies that compared new oral anticoagulants (dabigatran, rivaroxaban and apixaban) with warfarin in the setting of stroke prevention in atrial fibrillation. Strengths and weaknesses of the studies were examined in detail through indirect comparison. We analyze and comment the inclusion and exclusion criteria, the characteristics of randomized patients, the primary efficacy and safety end points and side effects. All new oral anticoagulants resulted in being non-inferior to vitamin K antagonists in reducing stroke or systemic embolism in patients with atrial fibrillation. Dabigatran 150 mg and apixaban were superior to vitamin K antagonists. Importantly, new oral anticoagulants significantly reduced hemorrhagic stroke in all three studies. Major differences among new oral anticoagulants include the way they are eliminated and side effects. Both dabigatran and apixaban were tested in low- to moderate-risk patients (mean CHADS2 [Congestive heart failure, Hypertension, Age, Diabetes, Stroke] score = 2.1-2.2) whereas rivaroxaban was tested in high-risk patients (mean CHADS2 score = 3.48) and at variance with dabigatran and apixaban was administered once daily. Apixaban significantly reduced mortality from any cause. The choice of a new oral anticoagulant should take into account these and other differences between the new drugs

Emerging Technologies as Enabler of Sustainable Business Model Innovation: Evidence from Space Tech New Ventures

The growing humanitarian and environmental challenges our planet and society are facing today made the United Nations ratify the so-called 2030 Agenda for Sustainable Development, which encapsulates 17 Sustainable Development Goals (SDGs) with the aim of promoting social, environmental, and economic objectives. For commercial companies, embarking into sustainability is not an easy task, because of different tensions between profit and impact that make it difficult to fully align the commercial activities with the sustainability ones within the company’s business model. By mean of a multiple-case study analyzing 11 startups in the New Space Economy domain, this research sheds light on the use of the emerging satellite technology as enabler of sustainable business model innovation, adopting a technology-perspective in the mitigation of the so-called transaction obstacles to sustainability, making it clear how emerging technologies’ features may represent a solution to embed SDGs in firms’ business model

Raconter, c’est résister

Souvent, dans des discussions, des tables rondes, ou des critiques, je suis qualifiée de “romancière engagée”, et je suis surprise, à chaque fois. Engagement, pour moi le mot est fort, un mot à respecter, j’entends lui garder tout son contenu et toute sa couleur. S’engager, pour moi, c’est entrer avec d’autres dans un combat collectif, pour des objectifs communs. C’est choisir les contraintes et les bonheurs de l’action collective, parce que l’on croit à sa nécessité et son efficacité pour ch..

Exploring the Role of Technological Change in the Relationship Between Strategic Innovation and Business Model Innovation: Evidence from a Cross-Industry Multiple Case Study

Business Model Innovation (BMI) has recently caught the eye of academics and practitioners in the broad fields of Strategy and Technology Management. However, the relationship between BMI and Strategic Innovation (SI) remains an open issue. Thus, this study aims at investigating the relationship between SI and BMI, focusing on the role technological change plays in it. To this end, we first propose a classification of Technological Change types according to three dimensions: trajectory, intent and effect. Second, based on this classification, we conduct a cross-industry multiple case study with 16 companies to understand how the relationship between SI and BMI is mediated or triggered by the nature of Technological Change taking place, giving rise to eight “innovation paths”. We also shed light on the key role played by different actors – top, middle and low management and key employees – in SI and BMI, according to their level of “technological change empowerment

El impacto de los filtros de las redes sociales en la autoimagen y la dismorfia corporal y su predisposición a la cirugía estética: una revisión sistemática

En nuestro día a día, utilizamos constantemente las redes sociales y las herramientas que contienen, entre ellos, los filtros de belleza. El constante uso de estos filtros de belleza ha creado muchas incógnitas sobre las consecuencias que pueden tener sobre la autoimagen, la autopercepción y la autoestima y, además, algunos investigadores se han preguntado si es posible que sean un factor de riesgo para desarrollar alguna patología como el Trastorno Dismórfico Corporal, lo que puede ocasionar un aumento de la intencionalidad y de la aceptación de realizarse cirugías estéticas para parecerse a la persona que vemos a través del filtro. Todo esto ha dado lugar a varias investigaciones que miden las consecuencias en la autoimagen, la dismorfia corporal y la predisposición a someterse a cirugías estéticas. En esta revisión se han utilizado 12 artículos, tanto revisiones como investigaciones, que cumplen debidamente los criterios de inclusión desarrollados. En los hallazgos recientes se ha observado una relación entre el uso de filtros y una mayor insatisfacción con la imagen corporal, muchas veces mediada por la comparación social, mayores síntomas de dismorfia corporal, debido, en parte, al nacimiento de la dismorfia de Snapchat donde los pacientes enseñan a sus cirujanos la foto filtrada a la que se quieren parecer, y mayor predisposición hacia la cirugía estética, observando que las mujeres están más afectadas que los hombres en todas las variables analizadas.Universidad Europea de ValenciaMáster Universitario en Psicología General SanitariaPresencia

Computerized advice on drug dosage to improve prescribing practice

International audienceComputerized advice on drug dosage to improve prescribing practice (Review) 1 Copyright © 2013 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd. Data collection and analysis Two review authors independently extracted data and assessed study quality.We grouped the results from the included studies by drug used and the effect aimed at for aminoglycoside antibiotics, amitriptyline, anaesthetics, insulin, anticoagulants, ovarian stimulation, anti-rejection drugs and theophylline. We combined the effect sizes to give an overall effect for each subgroup of studies, using a random-effects model. We further grouped studies by type of outcome when appropriate (i.e. no evidence of heterogeneity). Main results Forty-six comparisons (from 42 trials) were included (as compared with 26 comparisons in the last update) including a wide range of drugs in inpatient and outpatient settings. All were randomized controlled trials except two studies. Interventions usually targeted doctors, although some studies attempted to influence prescriptions by pharmacists and nurses. Drugs evaluated were anticoagulants, insulin, aminoglycoside antibiotics, theophylline, anti-rejection drugs, anaesthetic agents, antidepressants and gonadotropins. Although all studies used reliable outcome measures, their quality was generally low. This update found similar results to the previous update and managed to identify specific therapeutic areas where the computerized advice on drug dosage was beneficial compared with routine care: 1. it increased target peak serum concentrations (standardized mean difference (SMD) 0.79, 95% CI 0.46 to 1.13) and the proportion of people with plasma drug concentrations within the therapeutic range after two days (pooled risk ratio (RR) 4.44, 95% CI 1.94 to 10.13) for aminoglycoside antibiotics; 2. it led to a physiological parameter more often within the desired range for oral anticoagulants (SMD for percentage of time spent in target international normalized ratio +0.19, 95% CI 0.06 to 0.33) and insulin (SMD for percentage of time in target glucose range: +1.27, 95% CI 0.56 to 1.98); 3. it decreased the time to achieve stabilization for oral anticoagulants (SMD -0.56, 95% CI -1.07 to -0.04); 4. it decreased the thromboembolism events (rate ratio 0.68, 95% CI 0.49 to 0.94) and tended to decrease bleeding events for anticoagulants although the difference was not significant (rate ratio 0.81, 95%CI 0.60 to 1.08). It tended to decrease unwanted effects for aminoglycoside antibiotics (nephrotoxicity: RR 0.67, 95% CI 0.42 to 1.06) and anti-rejection drugs (cytomegalovirus infections: RR 0.90, 95% CI 0.58 to 1.40); 5. it tended to reduce the length of time spent in the hospital although the difference was not significant (SMD -0.15, 95% CI -0.33 to 0.02) and to achieve comparable or better cost-effectiveness ratios than usual care; 6. there was no evidence of differences in mortality or other clinical adverse events for insulin (hypoglycaemia), anaesthetic agents, antirejection drugs and antidepressants. For all outcomes, statistical heterogeneity quantified by I2 statistics was moderate to high. Authors’ conclusions This review update suggests that computerized advice for drug dosage has some benefits: it increases the serum concentrations for aminoglycoside antibiotics and improves the proportion of people for which the plasma drug is within the therapeutic range for aminoglycoside antibiotics. It leads to a physiological parameter more often within the desired range for oral anticoagulants and insulin. It decreases the time to achieve stabilization for oral anticoagulants. It tends to decrease unwanted effects for aminoglycoside antibiotics and anti-rejection drugs, and it significantly decreases thromboembolism events for anticoagulants. It tends to reduce the length of hospital stay compared with routine care while comparable or better cost-effectiveness ratios were achieved. However, there was no evidence that decision support had an effect on mortality or other clinical adverse events for insulin (hypoglycaemia), anaesthetic agents, anti-rejection drugs and antidepressants. In addition, there was no evidence to suggest that some decision support technical features (such as its integration into a computer physician order entry system) or aspects of organization of care (such as the setting) could optimize the effect of computerized advice. Taking into account the high risk of bias of, and high heterogeneity between, studies, these results must be interpreted with caution. P L A I N L A N G U A G E S U M M A R Y Computerized advice on drug dosage to improve prescribing practice (Review) 2 Copyright © 2013 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd. Computerized advice on drug dosage to improve prescribing practice Background Physicians and other healthcare professionals often prescribe drugs that will only work at certain concentrations. These drugs are said to have a narrow therapeutic window. This means that if the concentration of the drug is too high or too low, they may cause serious side effects or not provide the benefits they should. For example, blood thinners (anticoagulants) are prescribed to thin the blood to prevent clots. If the concentration is too high, people may experience excessive bleeding and even death. In contrast, if the concentration is too low, a clot could form and cause a stroke. For these types of drugs, it is important that the correct amount of the drug be prescribed. Calculating and prescribing the correct amount can be complicated and time-consuming for healthcare professionals. Sometimes determining the correct dose can take a long time since healthcare professionals may not want to prescribe high doses of the drugs initially because they make mistakes in calculations. Several computer systems have been designed to do these calculations and assist healthcare professionals in prescribing these types of drugs. Study characteristics We sought clinical trial evidence from scientific databases to evaluate the effectiveness of these computer systems. The evidence is current to January 2012. We found data from 42 trials (40 randomized controlled trials (trials that allocate people at random to receive one of a number of drugs or procedures) and two non-randomized controlled trials). Key results Computerized advice for drug dosage can benefit people taking certain drugs compared with empiric dosing (where a dose is chosen based on a doctor’s observations and experience)without computer assistance.When using the computer system, healthcare professionals prescribed appropriately higher doses of the drugs initially for aminoglycoside antibiotics and the correct drug dose was reached more quickly for oral anticoagulants. It significantly decreased thromboembolism (blood clotting) events for anticoagulants and tended to reduce unwanted effects for aminoglycoside antibiotics and anti-rejection drugs (although not an important difference). It tended to reduce the length of hospital stay compared with routine care with comparable or better cost-effectiveness. There was no evidence of effects on death or clinical side events for insulin (low blood sugar (hypoglycaemia)), anaesthetic agents, anti-rejection drugs (drugs taken to prevent rejection of a transplanted organ) and antidepressants. Quality of evidence The quality of the studies was low so these results must be interpreted with caution

The expert in hemostasis and thrombosis in the Italian health system: role and requirements for a specific clinical and laboratory expertise

Hemorrhagic and thrombotic diseases are highly heterogeneous disorders that may affect a large proportion of the population, as in the case of patients taking antithrombotic drugs. The appropriate management of such conditions requires the availability of specific diagnostic assays, together with knowledge of the possible clinical syndromes and of their appropriate treatment. This can only be achieved through second-level specialized laboratories supervised by trained personnel. Such diagnostic and therapeutic organization is not widely available in Italy except in a very limited number of those large hospitals that are centers of excellence on a national scale. Increasing the availability of such resources would be of great benefit to patients, and could also be cost-effective for the national healthcare system. This document is promoted by the Italian Society for the Study on Hemostasis and Thrombosis (SISET) and by the main Italian scientific societies involved in the field during the years 2011-2012. It aims to identify the level of scientific and professional training required to define a physician as a Hemostasis and Thrombosis Expert, graded according to the levels of skill required for different clinical settings

A novel detector system for KATRIN to search for keV-scale sterile neutrinos

International audienceSterile neutrinos appear in minimal extensions of the Standard Model of particle physics. If their mass is in the keV regime, they are viable dark matter candidates. One way to search for sterile neutrinos in a laboratory-based experiment is via the analysis of β-decay spectra, where the new neutrino mass eigenstate would manifest itself as a kink-like distortion of the β-decay spectrum. The objective of the TRISTAN project is to extend the KATRIN setup with a new multi-pixel silicon drift detector system to search for a keV-scale sterile neutrino signal. In this paper we describe the requirements of such a new detector, and present first characterization measurement results obtained with a 7 pixel prototype system