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Abstract

Patient registries are observational studies that focus on understanding how the treatments, tests, and services that are used in routine clinical care and by specialists affect patient health outcomes. A registry that is appropriately designed, conducted, and analyzed will provide unique scientific information about the effectiveness, safety, and quality of the health-care service or intervention that is being studied. In recent years, the use of registries as a method for generating new scientific evidence has grown considerably. This trend is likely to continue in the future, particularly as manufacturers, regulators, and other decisionmakers seek objective information to augment what is known from clinical trials and other research studies about the harms and benefits of tests and therapies. In 2005, the Agency for Healthcare Research and Quality (AHRQ) recognized this need, and, in conjunction with the Centers for Medicare and Medicaid Services, commissioned a guide to provide practical, scientific advice on the design, operation, analysis, and evaluation of patient registries. The guide, entitled "Registries for Evaluating Patient Outcomes: A User's Guide," was published in 2007 and has become a resource for researchers on the common methodological principles and operational practices that are needed to design and implement a registry.

The science of registries is rapidly advancing, and health-care stakeholders are increasingly using registries as an approach to generating evidence that can be used to inform health-care decisionmaking. In response to these advancements, the 2007 User's Guide was updated in collaboration with individuals from academia, government, and industry. This update enhanced the Guide with new information from researchers, professionals, and recent publications, as well as more in-depth discussions of some topics covered in the original Guide. Additionally, new sections were added on emerging challenges and controversies in registry planning, design, ethics, management, analysis, and evaluation that were informed by a series of expert meetings and working papers.

Summary of Revisions

"Registries for Evaluating Patient Outcomes: A User's Guide" (2007) was published as a reference for establishing, maintaining, and evaluating the success of registries created to collect data about patient outcomes. The primary focus of the Guide revision was to incorporate information on new methodological or technological advances into the existing chapters and to add new sections to address emerging topics in registry science. Specifically, the revised Guide includes four new sections: 1) "When To Stop a Registry," 2) "Use of Registries in Product Safety Assessment," 3) "Linking Registry Data," and 4) "Interfacing Registries and Electronic Health Records." The section on "When To Stop a Registry" (Chapter 2 sidebar) discusses the decisionmaking process for ending a registry and key considerations for registry closure. The section on the "Use of Registries in Product Safety Assessment" (Chapter 4) describes the utility and challenges of designing a registry to assess safety. The section on "Linking Registry Data" (Chapter 7) covers the technical and legal issues surrounding the linkage of registry data with other data sources. Lastly, the section on "Interfacing Registries With Electronic Health Records (EHRs)" (Chapter 11) describes the current state of EHR integration technology and maps out potential options for developing interfaces between registries and EHRs. These sections were written as draft white papers, were reviewed by experts, and released for public comment on the AHRQ Effective Health Care Program Web site. The final revised white papers, which reflect many of the suggestions from expert reviews and public comments, are now incorporated into the updated Guide. The disposition of comments for the four original white papers can be found here.

This revised Guide also includes updates to chapters included in the 2007 publication. In general, all chapters were updated to address the use of registries for comparative effectiveness research. All chapters underwent some level of revision; for some chapters, more extensive revisions were made. "Registry Design" (Chapter 3) and "Analysis and Interpretation" (Chapter 13) were reorganized to be more closely aligned. Discussions of new data standards were added to "Data Elements" (Chapter 5), and summaries of new legislation and regulations were added to "Principles of Registry Ethics, Data Ownership, and Privacy" (Chapter 8). The section on "Evaluating Registries" (Chapter 14) was updated to include good practices related to the new Guide sections (e.g., good practices related to closing a registry; using a registry for product safety assessment; linking registry data with other data sources; interfacing a registry with EHRs). The tables in this chapter were also reorganized to group the good practices by concept. In addition, the revised Guide includes 20 new case examples.

Table of Contents:
Executive Summary
Chapter 1: Patient Registries
Chapter 2: Planning a Registry
Chapter 3: Registry Design
Chapter 4: Use of Registries in Product Safety Assessment
Chapter 5: Data Elements
Chapter 6: Data Sources for Registries
Chapter 7: Linking Registry Data: Technical and Legal Considerations
Chapter 8: Principles of Registry Ethics, Data Ownership, and Privacy
Chapter 9: Recruiting and Retaining Participants in the Registry
Chapter 10: Data Collection and Quality Assurance
Chapter 11: Interfacing Registries With Electronic Health Records (EHRs)
Chapter 12: Adverse Event Detection, Processing, and Reporting
Chapter 13: Analysis and Interpretation of Registry Data To Evaluate Outcomes
Chapter 14: Assessing Quality