Registries for Evaluating Patient Outcomes: A User's Guide. Effective Health Care

摘要

The purpose of this document is to serve as a guide to the design, implementation, analysis, interpretation, and evaluation of the quality of a registry for understanding patient outcomes. For the purpose of this handbook, 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 a predetermined scientific, clinical, or policy purpose(s). The registry database is the file (or files) derived from the registry. Although registries can serve many purposes, this handbook focuses on registries that are 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.