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Registries for Evaluating Patient Outcomes: A User's Guide, 2nd edition
Senior Editors: Richard E Gliklich, MD and Nancy A Dreyer, MPH, PhD.
Outcome Sciences, Inc., d/b/a Outcome
Rockville (MD): Agency for Healthcare Research and Quality (US); September 2010.
Publication No.: 10-EHC049
Excerpt
This user’s guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or costeffectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care.
Contents
- Preface
- Executive Summary
- Defining Patient Registries
- Planning a Registry
- Registry Design
- Use of Registries for Product Safety Assessment
- Data Elements
- Data Sources
- Linking Registry Data
- Ethics, Data Ownership, and Privacy
- Patient and Provider Recruitment and Management
- Data Collection and Quality Assurance
- Interfacing Registries and Electronic Health Records
- Adverse Event Detection, Processing, and Reporting
- Analysis and Interpretation of Registry Data
- Evaluating Registries
- Section I. Creating Registries
- 1. Patient Registries
- 2. Planning a Registry
- 3. Registry Design
- Introduction
- Research Questions Appropriate for Registries
- Translating Clinical Questions Into Measurable Exposures and Outcomes
- Finding the Necessary Data
- Resources and Efficiency
- Study Designs for Registries
- Choosing Patients for Study
- Sampling
- Registry Size and Duration
- Internal and External Validity
- Summary
- References for Chapter 3
- 4. Use of Registries in Product Safety Assessment
- 5. Data Elements for Registries
- 6. Data Sources for Registries
- 7. Linking Registry Data: Technical and Legal Considerations
- 8. Principles of Registry Ethics, Data Ownership, and Privacy
- Section II. Operating Registries
- Section III. Evaluating Registries
- Contributors
- Reviewers
- Case Example Contributors
- Appendix A An Illustration of Sample Size Calculations
- Appendix B Copyright Law
- Appendix C Relevant Entities in Health Information Technology Standards
- Appendix D Linking Clinical Registry Data With Insurance Claims Files
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Acknowledgements: The editors would like to acknowledge the efforts of the following individuals who contributed to the second edition of this document: Daniel Campion of Outcome Sciences, Inc. and Elise Berliner, Scott R. Smith, Margaret Rutherford, Marion Torchia, and Frances Eisel of the Agency for Healthcare Research and Quality. We would especially like to thank Michelle Leavy of Outcome Sciences, Inc., who served as the managing editor for this User’s Guide.
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. HHSA29020050035I TO3. Prepared by: Outcome Sciences, Inc., d/b/a Outcome.
Suggested citation:
Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. 2nd ed. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. d/b/a Outcome] under Contract No. HHSA29020050035I TO3.) AHRQ Publication No.10-EHC049. Rockville, MD: Agency for Healthcare Research and Quality. September 2010.
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 and electronic copies of this report can be found at www.effectivehealthcare.ahrq.gov. This report was produced under contract to AHRQ by the Outcome DEcIDE Center (Developing Evidence to Inform Decisions about Effectiveness) under Contract No. HHSA29020050035I TO3. 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.
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540 Gaither Road, Rockville, MD 20850. www
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