Registries for Evaluating Patient Outcomes: A User’s Guide

Volume 1

Registries for Evaluating Patient Outcomes: A User's Guide

Third Edition

The Effective Health Care Program of the Agency for Healthcare Research and Quality (AHRQ) conducts and supports research focused on the outcomes, effectiveness, comparative clinical effectiveness, and appropriateness of pharmaceuticals, devices, and health care services. More information on the Effective Health Care Program can be found at effectivehealthcare.. This report was produced under contract to AHRQ by the Outcome DEcIDE Center (Developing Evidence to Inform Decisions about Effectiveness) under Contract No. 290-2005-00351 TO7. The AHRQ Task Order Officer for this project was Elise Berliner, Ph.D.

The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ or the U.S. Department of Health and Human Services. Therefore, no statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.

Copyright Information:

?2014 United States Government, as represented by the Secretary of the Department of Health and Human Services, by assignment. All rights reserved. The Agency for Healthcare Research and Quality (AHRQ) permits members of the public to reproduce, redistribute, publicly display, and incorporate this work into other materials provided that it must be reproduced without any changes to the work or portions thereof, except as permitted as fair use under the U.S. Copyright Act. This work contains certain tables and figures noted herein that are subject to copyright owned by third parties. These tables and figures may not be reproduced, redistributed, or incorporated into other materials independent of this work without permission of the third-party copyright owner(s). This work may not reproduced, reprinted, or redistributed for a fee, nor may the work be sold for profit or incorporated into a profit-making venture without the express written permission of AHRQ. This work is subject to the restrictions of Section 1140 of the Social Security Act, 42 U.S.C. ? 1320b-10. When parts of this work are used or quoted, the following citation should be used:

Citation:

Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User's Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014. registries-guide-3.cfm.

Registries for Evaluating Patient Outcomes: A User's Guide Third Edition Volume 1

Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850

Contract No. 290-2005-00351 TO7

Prepared by: Outcome Sciences, Inc., A Quintiles Company Cambridge, MA

Senior Editors Richard E. Gliklich, M.D. Nancy A. Dreyer, M.P.H., Ph.D.

Editor Michelle B. Leavy, M.P.H.

AHRQ Publication No. 13(14)-EHC111 April 2014

Acknowledgements

The editors would like to acknowledge the efforts of the following individuals who contributed to the third edition of this document: Daniel Campion and Laura Khurana of Quintiles Outcome and Elise Berliner, Scott R. Smith, Sandy Cummings, Chris Heidenrich, and Frances Eisel of the Agency for Healthcare Research and Quality. We would especially like to thank Marion Torchia, who served as the managing editor for AHRQ for this User's Guide.

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Preface

This project was performed under a contract from the Agency for Healthcare Research and Quality (AHRQ) in collaboration with the Centers for Medicare & Medicaid Services (CMS) through the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network of AHRQ's Effective Health Care (EHC) Program. The purpose of the project was to update and expand Registries for Evaluating Patient Outcomes: A User's Guide. The User's Guide was first published in 2007 as a reference for establishing, maintaining, and evaluating the success of registries created to collect data about patient outcomes. The second edition, which provided updates to the existing topics and addressed four new topics, was published in 2010. The purpose of this revised and expanded third edition is to incorporate information on new methodological and technological advances into the existing chapters and to add 11 new chapters to address emerging topics in registry science.

Both the 2007 and 2010 versions and this third edition were created with support from a large group of stakeholders. Following award of the initial project on September 29, 2005, we created a draft outline for the document, which was posted for public comment on AHRQ's Effective Health Care Web site () from January through March 2006. During that same period, we worked with AHRQ to create a process for selecting contributors and reviewers. We broadly solicited recommendations from a range of stakeholders, including government agencies, industry groups, medical professional societies, and other experts in the field; conducted a review of the pertinent literature; and contacted the initial list of contributors to confirm their interest and area of expertise and to seek further recommendations. Through that process and in collaboration with AHRQ and CMS, we arrived at a set of contributors and reviewers based on subject/content expertise, practical experience, and interest and availability, with balanced representation from key stakeholder groups for nearly all chapters. In addition, a request for submission of real-world case examples that could be used in the user's guide to illustrate issues and challenges in implementing registries was posted on the Effective Health Care Web site. The primary selection criteria for these examples concerned their utility in illustrating a practical challenge and its resolution.

An initial meeting of contributors was convened in February 2006. A second meeting including contributors and chapter reviewers was held in June 2006, following creation of an initial draft document and focused review by the reviewers. The collaborative efforts of contributors, reviewers, and editors resulted in a draft document that was posted for public comment on the Effective Health Care Web site in October and November 2006. In all, 39 contributors and 35 individual reviewers participated in the creation of the first document, which was released in April 2007 and has been published online and in print.

In August 2008, the user's guide update project was awarded. The project involved revising the existing chapters and case examples, creating new content to address four topics, and soliciting new case examples. From September to November 2008, we worked with AHRQ to select contributors and content reviewers for the new user's guide. We followed a process similar to that used in the creation of the original user's guide to arrive at a set of contributors and reviewers with subject matter expertise and a broad range of perspectives. The contributors drafted white papers on four topics: use of registries in product safety assessment, when to stop a registry, interfacing registries and electronic health records, and linking registry data. The white papers were reviewed and discussed at a meeting in April 2009. The papers were then posted for public comment in August and September 2009. After the papers were revised in response to public comments, the final papers were included in the expanded user's guide.

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