24 research outputs found
Recommended from our members
Quality assurance plan for the Objective Supply Capability Adaptive Redesign (OSCAR) project
This document establishes the Quality Assurance Plan (QAP) for the National Guard Bureau Objective Supply Capability Adaptive Redesign (OSCAR) project activities under the Oak Ridge National Laboratory (ORNL) management. It defines the requirements and assigns responsibilities for ensuring, with a high degree of confidence, that project objectives will be achieved as planned. The QAP outlined herein is responsive to and meets the Quality Assurance Program standards for the U.S. Department of Energy (DOE), Lockheed Martin Energy Research Corporation and ORNL and the ORNL Computing, Robotics, and Education Directorate (CRE). This document is intended to be in compliance with DOE Order 5700.6C, Quality Assurance Program, and the ORNL Standard Practice Procedure, SPP X-QA-8, Quality Assurance for ORNL Computing Software. This standard allows individual organizations to apply the stated requirements in a flexible manner suitable to the type of activity involved. Section I of this document provides an introduction to the OSCAR project QAP; Sections 2 and 3 describe the specific aspects of quality assurance as applicable to the OSCAR project. Section 4 describes the project approach to risk management. The Risk Management Matrix given in Appendix A is a tool to assess, prioritize, and prevent problems before they occur. Therefore, the matrix will be reviewed and revised on a periodic basis
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
Recommended from our members
Project management plan for the Objective Supply Capability Adaptive Redesign (OSCAR) project
This document establishes the project management plan for design and development of the Object Supply Capability Adaptive Redesign (OSCAR) Project. The purpose of the project management plan is to document the plans, goals, directions, commitments, approaches, and decisions that relate to guiding a project throughout its life cycle. Special attention is given to project goals, deliverables, sponsor and project standards, project resources, schedule, and cost estimates
Recommended from our members
Configuration management plan for the Objective Supply Capability Adaptive Resdesign (OSCAR) project
The Configuration Management Plan for the Object Supply Capability Adaptive Redesign (OSCAR) documents the methods used for the OSCAR project to implement configuration management and control. Specific areas addressed include the establishment of baselines and change control procedures