21st Century Patient Registries, Ebook Addendum to Registries for Evaluating Patient Outcomes: A User's Guide, 3rd Edition

This document, in the form of an e-book supplement to the third edition of "Registries for Evaluating Patient Outcomes: A User's Guide", provides an in-depth summary of the increasing focus on the patient in clinical research, as applicable to the conduct of patient registries.The User's Guide defines a patient registry as "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."1Registries may be developed to fulfill a wide variety of purposes, including describing the natural history of disease, determining the clinical and/or cost-effectiveness of health care products and services, measuring or monitoring safety and harm, and measuring quality of care.Many registries are designed to fulfill more than one purpose.The purpose of the User's Guide is to serve as a reference for establishing, maintaining, and evaluating the success of registries created to collect data about patient outcomes.As a supplement to the third edition, this e-book expands on the existing document by exploring how patient registries may incorporate the concepts of patient-centered research.Through a review of the anticipated benefits, current challenges, best practices, and new frontiers in patientcentered research, this e-book provides assistance to researchers and stakeholders involved in the design and implementation of registries and other research.Where topics are well covered in other materials, references and/or links are provided.Case examples have been incorporated to illustrate particular points or challenges.