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.
Agency/Author Bio:
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:
Section IV. Technical, Legal, and Analytic Considerations for Combining Registry Data With Other Data Sources
Chapter 15. Interfacing Registries With Electronic Health Records
Chapter 16. Linking Registry Data With Other Data Sources To Support New Studies
Chapter 17. Managing Patient Identity Across Data Sources
Chapter 18. Analysis of Linked Registry Data Sets
Section V. Special Applications in Patient Registries
Chapter 19. Use of Registries in Product Safety Assessment
Chapter 20. Rare Disease Registries
Chapter 21. Pregnancy Registries
Chapter 22. Quality Improvement Registries
Chapter 23. Registries for Medical Devices
Chapter 24. Public-Private Partnerships
Section VI. Evaluating Registries
Chapter 25. Assessing Quality
Contributors
Reviewers
Case Example Contributors
Contributor and Reviewer Affiliations
Appendixes
This book is intended primarily for investigators who would consult a reference for establishing, maintaining, and evaluating the success of registries created to collect data about patient outcomes. It will also be useful for health professionals and members of the general public seeking a better understanding of patient registries.
Product Details
- Richard E. Gliklich, senior editor; Nancy A. Dreyer, senior editor, Michelle B. Leavy, editor
