Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Het versnellen van productontwikkeling

Bedrijven hebben er belang bij om nieuwe producten snel op de markt te brengen. Om die producten de gewenste kwaliteit te geven moet men de invloed van diverse instelbare factoren op de producteigenschappen in kaart brengen. Vaak gebeurt dat door experimenten te doen. Eric Schoen laat in dit artikel zien dat een programma van experimenten opgezet met behulp van een orthogonaal array helpt om in een beperkt aantal experimenten de gewenste informatie te krijgen.Eric Schoen werkt behalve bij TNO ook aan de Faculteit Wiskunde en Informatica van de Technische Universiteit Eindhoven

Optimum designs versus orthogonal arrays for main effects and two-factor interactions

Designs with full estimation capacity permit estimation of all main effects and all two-factor interactions. By allowing correlation among the effects, the run size of such designs can be smaller than required for a resolution of 5. To construct a design, one can either use commercial software for designs with optimized D-efficiencies or a catalog of orthogonal arrays. In the context of a wood construction experiment, we discuss how to choose between these approaches. We enumerate mixed-level and multilevel resolution-4 designs with run size up to 72 and with the maximum number of factors compatible with a full estimation capacity. Algorithmically constructed benchmark designs were generated with commercial software. Our study results in a list of recommended designs

All Orthogonal Arrays with 18 Runs

All combinatorially inequivalent orthogonal arrays with 18 runs and eight or less factors are generated. Their potential as practical experimental designs is evaluated by a classification using generalized word-length patterns of the original arrays and those of their projections into less factors. Arrays of special interest are given explicitly. This paper includes the statistical analysis of results from a real-life experiment based on one of the arrays. © 2008 John Wiley & Sons, Ltd

Use of factorial designs in combination toxicity studies

The use of factorial designs, in which n chemicals are studied at x(n) dose levels (x treatment groups), has been put forward as one of the valuable statistical approaches for hazard assessment of chemical mixtures. Very recently a '25 study' was presented to describe interactions between the carcinogenic activity of five polycyclic aromatic hydrocarbons and a '53 study' was used to identify the non-additive effects of three compounds on developmental toxicity. Full factorial designs, however, lead to very costly experiments and, even if only two dose levels are used, it is not always possible to perform conventional toxicity tests using 2(n) test groups to identify possible interactions between all chemicals of interest. One way to deal with this problem is the use of fractionated factorial designs. These fractionated designs still identify most of the interactions between the compounds and determine which compounds are important in causing effects, but have the advantage that the number of test groups is manageable. Fractional factorial designs have been shown to be an efficient (i.e. cost-effective) approach to: (a) identify interactive effects between seven trace elements and cadmium accumulation in the body; and (b) describe cases of non-additivity in a mixture of nine chemicals tested in a 4-wk toxicity study in rats

PROLOGUE Deliverable 2.2 Methodological and organizational issues and requirements for ND studies

Naturalistic driving observation is a relatively new method for studying road safety issues, a method by which one can objectively observe various driver- and accident related behaviour. Typically, participants get their own vehicles equipped with some sort of data logging device that can record various driving behaviours such as speed, braking, lane keeping/variations, acceleration, deceleration etc., as well as one or more video cameras. In this way normal drivers are observed in their normal driving context while driving their own vehicles. Optimally, this allows for observation of the driver, vehicle, road and traffic environments and interaction between these factors. The main objective of PROLOGUE is to demonstrate the usefulness, value, and feasibility of conducting naturalistic driving observation studies in a European context in order to investigate traffic safety of road users, as well as other traffic related issues such as eco-driving and traffic flow/traffic management. The current deliverable describes the methodological issues related to naturalistic driving studies. It describes the experimental procedures, variables to be measured, experimental design, statistical analysis methods, organizational issues and legal and ethical issues for naturalistic studies. Maximal use is made of the extensive knowledge and experience that comes from the EU projects FESTA and EuroFOT, the 100car study and the SHRP2 preparatory safety studies

Assessment of some critical factors in the freezing technique for the cryopreservation of precision-cut rat liver slices

A number of studies on the cryopreservation of precision-cut liver slices using various techniques have been reported. However, the identification of important factors that determine cell viability following cryopreservation is difficult because of large differences between the various methods published. The aim of this study was to evaluate some important factors in the freezing process in an effort to find an optimized approach to the cryopreservation of precision-cut liver slices. A comparative study of a slow and a fast freezing technique was carried out to establish any differences in tissue viability for a number of endpoints. Both freezing techniques aim at the prevention of intracellular ice formation, which is thought to be the main cause of cell death after cryopreservation. Subsequently, critical variables in the freezing process were studied more closely in order to explain the differences in viability found in the two methods in the first study. For this purpose, a full factorial experimental design was used with 16 experimental groups, allowing a number of variables to be studied at different levels in one single experiment. It is demonstrated that ATP and K content and histomorphology are sensitive parameters for evaluating slice viability after cryopreservation. Subsequently, it is shown that freezing rate and the cryopreservation medium largely determine the residual viability of liver slices after cryopreservation and subsequent culturing. It is concluded that a cryopreservation protocol with a fast freezing step and using William's Medium E as cryopreservation medium was the most promising approach to successful freezing of rat liver slices of those tested in this study