The Agency for Healthcare Research and Quality is developing a "how-to" reference guide to help health care organizations in creating patient registries to track the outcomes of medical treatments, including pharmaceutical therapies. 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.
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 is being developed as part of AHRQ's new Effective Health Care program (http://www.effectivehealthcare.ahrq.gov).