Registries for Evaluating Patient Outcomes: A User's Guide

Registries for Evaluating Patient Outcomes: A User's Guide

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Registries for Evaluating Patient Outcomes: A User's Guide by U.S. Agency for Health Care Research and Quality/AHRQ

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.

Product Details

ISBN-13: 9781587634345
Publisher: U.S. Dept. of Health and Human Services
Publication date: 04/30/2014
Sold by: Barnes & Noble
Format: NOOK Book
Pages: 308
File size: 2 MB
Age Range: 18 Years

About the Author

The Agency for Health Care Research and Quality (AHRQ), the agency that contracted for this publication, has a mandate to support research designed to improve the quality of health care, broaden access to health services, and reduce costs. AHRQ’s programs of research bring science-based information to a variety of health care audiences. This guide supports this effort.

Table of Contents

Table of Contents:
Executive Summary
Section I. Creating Registries
Chapter 1. Patient Registries
Chapter 2. Planning a Registry
Chapter 3. Registry Design
Chapter 4. Data Elements for Registries
Chapter 5. Use of Patient-Reported Outcomes in Registries
Chapter 6. Data Sources for Registries
Section II. Legal and Ethical Considerations for Registries
Chapter 7. Principles of Registry Ethics, Data Ownership, and Privacy
Chapter 8. Informed Consent for Registries
Chapter 9. Protecting Data: Confidentiality and Legal Concerns of Providers, Manufacturers, and Health Plans
Section III. Operating Registries
Chapter 10. Recruiting and Retaining Participants in the Registry
Chapter 11. Data Collection and Quality Assurance
Chapter 12. Adverse Event Detection, Processing, and Reporting
Chapter 13. Analysis, Interpretation, and Reporting of Registry Data To Evaluate Outcomes
Chapter 14. Modifying and Stopping Registries

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