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.

The demand for health information continues to increase, but the ability of health professionals to provide it clearly remains variable. The aim of this book is (1) to summarize and synthesize research on the selection and presentation of data pertinent to public health, and (2) to provide practical suggestions, based on this research summary and synthesis, on how scientists and other public health practitioners can better communicate data to the public, policy makers, and the press in typical real-world situations. Because communication is complex and no one approach works for all audiences, the authors emphasize how to communicate data "better" (and in some instances, contrast this with how to communicate data "worse"), rather than attempting a cookbook approach. The book contains a wealth of case studies and other examples to illustrate major points, and actual situations whenever possible. Key principles and recommendations are summarized at the end of each chapter. This book will stimulate interest among public health practitioners, scholars, and students to more seriously consider ways they can understand and improve communication about data and other types of scientific information with the public, policy makers, and the press. Improved data communication will increase the chances that evidence-based scientific findings can play a greater role in improving the public's health.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.