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AHRQ publishes landmark Federal handbook on the use of patient registries

The Agency for Healthcare Research and Quality (AHRQ) released a new handbook that represents a groundbreaking Federal initiative to help researchers and others use patient registries to evaluate the real-life impact of health care treatments. A patient registry is a database of confidential patient information that can be analyzed to understand and compare the outcomes and safety of health care.

The data may originate from multiple sources, including hospitals, pharmacy systems, physician practices, and insurance companies. Some registries include patients who have the same disease. Others are comprised of patients who have undergone a common surgical procedure or received a newly approved medication.

An analysis of patient registry data may offer insights that can improve health care and public health. For example, doctors may use a registry database to monitor disease patterns or identify unexpected adverse events in specific populations. Physician groups may analyze treatments to identify opportunities for quality improvement. Health insurers may review treatment trends before making coverage decisions. Researchers from academia, industry, and government may use registries to monitor the long-term comparative benefits, safety, and harms of medications or medical devices.

The new 219-page document, Registries for Evaluating Patient Outcomes: A User's Guide, is the first government-supported handbook for establishing, managing, and analyzing patient registries. Development of the handbook was cofunded by AHRQ and the Centers for Medicare & Medicaid Services. Thirty-nine contributors from industry, academia, and government collaborated to create the handbook.

Unlike randomized clinical trials, which study patients under strict eligibility and treatment protocols, patient registries document the experiences of patients in everyday clinical practice. Observing those patients' responses to treatment can provide important insights into which health care strategies work best in actual practice.

Many patient registries are already in use. One of the best-known registries is the Surveillance Epidemiology and End Results Program, which is managed by the National Cancer Institute. That registry collects and publishes data on cancer patients, including demographics and information about their tumors, treatment, and followup status. Other registries, meanwhile, are analyzing treatment outcomes for illnesses such as depression, emphysema, Parkinson's disease, and heart disease.

Overall, the quality of current patient registries varies widely. AHRQ's new handbook identifies the best scientific practices for operating registries. Covered topics include: how registries should be designed, what types of data sources may be accessed, and how to encourage participation among patients and health care providers. Also included are chapters on detecting adverse events, interpretation of data, and how to handle issues related to ethics and publication of research papers. The handbook's summary chapter serves as a checklist for best practices.

The patient registry guide is a product of the DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) network, an arm of AHRQ's Effective Health Care (EHC) Program. Development and editing of the document was led by Outcome Sciences of Cambridge, Massachusetts, a member of the DEcIDE network. The project's principal investigators were Richard Gliklich, M.D., and Nancy Dreyer, Ph.D., of Outcome Sciences.

The guide is downloadable from the EHC Web site,, and soon will be available in two printed forms—as a full-length document and as a 13-page summary that includes the best practices checklist. Copies may also be ordered from the AHRQ Publications Clearinghouse.

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