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Medical registries have been used for many different purposes, including surveillance of rates of different diseases, rates of adverse events associated with medical interventions, rates of short-and long-term outcomes associated with medical interventions, quality improvement activities, post-marketing pharmaceutical intervention outcomes, diffusion of medical interventions and regional, racial and gender disparities.
ROCKVILLE, MD.-Medical registries have been used for many different purposes, including surveillance of rates of different diseases, rates of adverse events associated with medical interventions, rates of short-and long-term outcomes associated with medical interventions, quality improvement activities, post-marketing pharmaceutical intervention outcomes, diffusion of medical interventions and regional, racial and gender disparities.
Now, private and public sector healthcare payers are interested in registries to monitor the quality, safety, and effectiveness of certain interventions in everyday healthcare practice. The Agency for Healthcare Research and Quality (AHRQ) is helping users and developers of registries to learn more about the effectiveness of specific medical treatments by developing a "how-to" reference guide to help healthcare organizations create patient registries.
"The 'efficacy' of a drug or other medical interventions demonstrated during a randomized controlled trial may differ greatly from the 'effectiveness' observed in actual clinical practice," according to Jean R. Slutsky, director, Center for Outcomes and Evidence, AHRQ. "Randomized controlled trials are rigorous studies that minimize the bias in results from differing characteristics of patients and setting. However, these studies typically examine the safety and efficacy within a relatively small number of affected patients and in a highly controlled setting."
Patient registries can play an important role as the foundation for evidence-based medicine is built, says Slutsky. "Registries are an important approach to collect data that can complement information obtained from randomized clinical trials," she says. "Registries provide a way of collecting additional information to learn about the effectiveness of medical interventions in everyday healthcare practice.
"As part of some recent coverage decisions, the Centers for Medicare & Medicaid Services [CMS] has decided that some medical interventions will only be covered for certain patients when the patients are enrolled in a registry-Coverage with Evidence Development or CED," Slutsky continues. "This project is a collaboration with CMS. The project will also have extensive participation by stakeholders from other areas of the government, academia, industry, health plans and physician specialty societies."
To foster the design of successful registries for CMS, and other private sector payers and providers, as well as the best use of the data obtained from registries, AHRQ, in collaboration with CMS, envisions creation of a comprehensive document that serves as a reference for establishing, maintaining and evaluating the success of registries created to collect data about patient outcomes. The guide is intended for groups designing registries, evaluating proposals to develop new registries and analyzing data collected through a registry. Contributors to the document will be writers from academia, industry and government. An outline of the guide will be available at http://effectivehealthcare.ahrq.gov/ for public comments. Future versions of the document will be posted for comment.