AHRQ Effective Health Care Program - New Research

Registries for Evaluating Patient Outcomes Version II
Draft Abstract published 18 Nov 2008

Abstract
Patient registries are observational studies that focus on real-world medical treatments and services. Properly designed and conducted, patient registries can provide unique insights into real-world clinical practice, effectiveness, safety, and quality. In recent years, there has been an increasing demand for the types of data that can by captured by a registry. This trend is likely to continue, particularly as manufacturers and regulators turn to real-world data to support risk management and pharmacovigilance activities, and as health care providers and payers seek to improve health care quality. However, there was a lack of information available on common methodological principles and operational best practices that are necessary for registry data to be broadly accepted by decision makers for certain uses. In 2005, the Agency for Healthcare Research and Quality (AHRQ) recognized this need, and, in conjunction with CMS, commissioned a guide to provide practical, scientific advice on the design, operation, analysis, and evaluation of patient registries. The guide, "Registries for Evaluating Patient Outcomes: A User's Guide," was published in 2007; it has been well received by health care stakeholders, who have acknowledged that the document fulfilled a need for sound scientific information in this area.

The science of registries is rapidly advancing, and health care stakeholders are increasingly turning to registries as a source of real-world data that can support evidence-based medicine and decision-making. In response to the changing research environment, AHRQ has recognized a need to issue an update of the User's Guide. The purpose of this project is to update and expand the User's Guide with new information from researchers and other professionals and from recent publications. The updated guide will include more in-depth discussions of some topics covered in the original guide as well as additional sections on emerging challenges and controversies in registry planning, design, ethics, management, analysis, and evaluation. A series of expert meetings and working papers will be used to identify and address these emerging challenges and areas of controversy.

In addition, health care stakeholders have noted a need for a "registry of registries" database. Such a database would contain information on existing registries, similar to the clinical trials registry database (http://www.clinicaltrials.gov). This project will include the development of a white paper that discusses the feasibility and design issues related to creating a web-accessible "registry of registries" database.

Developing a Registry of Patient Registries: Options for the Agency for Healthcare Research and Quality

Working White Papers: Emerging IssuesAs part of our ongoing project on Registries for Evaluating Patient Outcomes, AHRQ has commissioned four white papers. The purpose of these white papers is to stimulate discussion and building of consensus on emerging issues in the development and implementation of registries that cross technical, legal and ethical disciplines. As for the full registry handbook, first drafts of these white papers were developed by several authors and reviewers representing various points of view including academia, industry and clinical practice. We are now posting these drafts for public comment for an initial period of four weeks. We encourage critical comments and evaluation of the information in these papers to be submitted to AHRQ. Comments that are received by AHRQ will be organized by theme and a disposition of comments and response by the authors will be posted before November 2009. Where the comments received through public comment indicate broad consensus, parts of these white papers will be incorporated into the next version of the full registries handbook, which will be posted in draft form for public review at the same time as the disposition of comments from the draft white papers. Where the comments indicate disagreement on the technical implementation or legal or ethical implications of different topics, we are planning to post new drafts of the white papers for a new round of public comment as part of the next phase of the ongoing registries methods project. We hope that this process will help to clarify critical issues in the development and use of registries.

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AHRQ Effective Health Care Program - New Research