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Registries for Evaluating Patient Outcomes: A User's Guide

Abstract

The AHRQ publication, "Registries for Evaluating Patient Outcomes: A User's Guide" was first published in 2007 by AHRQ as a reference handbook with practical information on the design, operation, and analysis of patient registries. In 2010, the User's Guide was updated with a focus on collecting information to assess patient outcomes. The third edition, published in 2014, expands the User's Guide to address 11 new topics in registry methodology and update the existing chapters to cover new legislation and other changes in registry science. Two addendums and a series of white papers were published in 2018 and 2019 to address registry methodology topics of special interest.

The fourth edition, published in September 2020, provides concise, practical information to help registries address these and other changes. The fourth edition focuses on the fundamentals of registry planning, design, operations, and analysis, with a particular emphasis on how registries can use existing data sources and how to collaborate with patients across the registry lifecycle. Recognizing the move toward data standards, the fourth edition includes a new chapter on using common data elements and standardized outcome measures. A new chapter on governance addresses issues around reusing existing data sources and shares insights on effective engagement with a wide range of stakeholders, including patient representatives. The chapters on ethics, privacy, and informed consent were also updated extensively to address the revised Common Rule. Lastly, the chapter on evaluating registries was revised to reflect the many new considerations related to using existing data sources and the increasing interest in using registries as sources of real-world data and real-world evidence for informing decision making.

The first and second editions of the User's Guide are also available.