Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Total Pages: 385
Release: 2014-04-01
Genre: Medical
ISBN: 1587634333

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Agile Software Development Quality Assurance

Agile Software Development Quality Assurance
Author: Stamelos, Ioannis G.
Publisher: IGI Global
Total Pages: 266
Release: 2007-02-28
Genre: Computers
ISBN: 1599042185

"This book provides the research and instruction used to develop and implement software quickly, in small iteration cycles, and in close cooperation with the customer in an adaptive way, making it possible to react to changes set by the constant changing business environment. It presents four values explaining extreme programming (XP), the most widely adopted agile methodology"--Provided by publisher.

Clinical Data Management

Clinical Data Management
Author: Richard K. Rondel
Publisher: John Wiley & Sons
Total Pages: 386
Release: 2000-02-03
Genre: Medical
ISBN: 9780471983293

Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research.

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 88
Release: 1999-07-27
Genre: Medical
ISBN: 0309172802

In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Software Quality Assurance

Software Quality Assurance
Author: Ivan Mistrik
Publisher: Morgan Kaufmann
Total Pages: 417
Release: 2015-10-12
Genre: Computers
ISBN: 0128025417

Software Quality Assurance in Large Scale and Complex Software-intensive Systems presents novel and high-quality research related approaches that relate the quality of software architecture to system requirements, system architecture and enterprise-architecture, or software testing. Modern software has become complex and adaptable due to the emergence of globalization and new software technologies, devices and networks. These changes challenge both traditional software quality assurance techniques and software engineers to ensure software quality when building today (and tomorrow's) adaptive, context-sensitive, and highly diverse applications. This edited volume presents state of the art techniques, methodologies, tools, best practices and guidelines for software quality assurance and offers guidance for future software engineering research and practice. Each contributed chapter considers the practical application of the topic through case studies, experiments, empirical validation, or systematic comparisons with other approaches already in practice. Topics of interest include, but are not limited, to: quality attributes of system/software architectures; aligning enterprise, system, and software architecture from the point of view of total quality; design decisions and their influence on the quality of system/software architecture; methods and processes for evaluating architecture quality; quality assessment of legacy systems and third party applications; lessons learned and empirical validation of theories and frameworks on architectural quality; empirical validation and testing for assessing architecture quality. - Focused on quality assurance at all levels of software design and development - Covers domain-specific software quality assurance issues e.g. for cloud, mobile, security, context-sensitive, mash-up and autonomic systems - Explains likely trade-offs from design decisions in the context of complex software system engineering and quality assurance - Includes practical case studies of software quality assurance for complex, adaptive and context-critical systems

Quality Assurance

Quality Assurance
Author: D. H. Stamatis
Publisher: CRC Press
Total Pages: 644
Release: 2015-09-04
Genre: Business & Economics
ISBN: 1498728707

Although regularly introducing new products or services is the lifeblood of most industries, bringing them to market can be fraught with peril. Timing, cost, and quality all play important roles in a successful product launch and avoiding expensive- often in more than just dollars- recalls and redesigns. Quality Assurance: Applying Methodologies fo