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AHRQ Launches Project To Develop Guide for Patient Registries

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Press Release Date: December 7, 2005

The Agency for Healthcare Research and Quality (AHRQ) announced today that it is developing a "how-to" reference guide to help health care organizations in creating patient registries to track the outcomes of medical treatments, including drugs.

AHRQ Director Carolyn M. Clancy, M.D., said she hopes the guide will help bring about wider use of registries in order to learn more about the effectiveness of specific medical treatments.

"Patient registries can play an important role as we build the foundation for evidence-based medical practice, and this guide will help ensure that registries produce useful results," Dr. Clancy said. "Registries can serve payers who need data for coverage decisions, and they can also serve more broadly to provide better information to support treatment decisions."

The guide will help both the government and private-sector entities in designing and operating successful registries. It will also provide criteria for evaluating registries and the quality of their data, as well as guidance on how registry data can be used to conduct valid scientific research.

The guide will help the Medicare program when it elects to provide coverage for a treatment accompanied by development of further evidence about the treatment. In some instances of such "coverage with evidence development," Medicare collaborates with health professional organizations and other stakeholders to provide expanded coverage for a medical intervention. One requirement is that the covered patients are enrolled in a registry so that further information about the appropriateness of treatment outcomes can be obtained.

"By obtaining additional data through registries as part of coverage with evidence development in select instances, Medicare can more rapidly extend coverage for new treatments and assure that treatment is reasonable and necessary while also helping health professionals obtain better evidence for patient care," said Mark B. McClellan, M.D., Ph.D., administrator of the Centers for Medicare & Medicaid Services (CMS). "A reference guide will help ensure high-quality results from patient registries."

The guide will be developed through an inclusive process that will call on the expertise of researchers and others who have successfully developed and used patient registries.

Experts will submit a series of papers to inform the project, and a national workshop will be conducted next spring.

The project will be organized by Outcome Science, Inc. of Cambridge, MA, under a contract with AHRQ. Additional scientific advice will be provided by Duke University.

The reference guide on patient registries is to be completed by the end of 2006 and will reside on both the AHRQ and CMS Web sites. It is being developed as part of AHRQ's new Effective Health Care program.

Information about the Effective Health Care program is available at

For more information, please contact AHRQ Public Affairs: (301) 427-1922 or (301) 427-1855.


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