This user’s guide helps researchers and others establish, manage, and analyze patient registries to evaluate the real-life impact of health care treatments and evaluate patient outcomes. Originally published in 2007, the purpose of this revised and expanded second edition is to incorporate information on new methodological or technological advances into the existing chapters and to add new chapters to address emerging topics in registry science.

Topics covered include:

• Patient registries
• Planning a registry
• Registry design
• Use of registries in product safety assessment
• Data elements for registries
• Data sources for registries
• Linking registry data: technical and legal considerations
• Principles of registry ethics, data ownership, and privacy
• Recruiting and retaining participants in the registry
• Data collection and quality assurance
• Interfacing registries with electronic health records
• Adverse event detection, processing, and reporting
• Analysis and interpretation of registry data to evaluate outcomes
• Assessing quality