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
    • Introduction
    • Current Uses for Patient Registries
    • Taxonomy for Patient Registries
    • Patient Registries and Policy Purposes
    • Global Registries
    • Summary
    • References for Chapter 1
  • 2. Planning a Registry
    • Introduction
    • Steps in Planning a Registry
    • Planning for the End of a Patient Registry
    • What Happens When a Registry Ends?
    • Summary
    • References for Chapter 2
  • 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
    • Introduction
    • Registries Specifically Designed for Safety Assessment
    • Registries Designed for Purposes Other Than Safety
    • Ad Hoc Data Pooling
    • Signal Detection in Registries and Observational Studies
    • Potential Obligations for Registry Developers in Reporting Safety Issues
    • Summary
    • References for Chapter 4
  • 5. Data Elements for Registries
    • Introduction
    • Identifying Domains
    • Selecting Data Elements
    • Registry Data Map
    • Pilot Testing
    • References for Chapter 5
  • 6. Data Sources for Registries
    • Introduction
    • Types of Data
    • Data Sources
    • Other Considerations for Secondary Data Sources
    • Summary
    • References for Chapter 6
  • 7. Linking Registry Data: Technical and Legal Considerations
    • Introduction
    • Technical Aspects of Data Linkage Projects
    • Legal Aspects of Data Linkage Projects
    • Risk Mitigation for Data Linkage Projects
    • Summary
    • Summary of Legal and Technical Planning Questions
    • References for Chapter 7
  • 8. Principles of Registry Ethics, Data Ownership, and Privacy
    • Introduction
    • Ethical Concerns Relating to Health Information Registries
    • Applicable Regulations
    • Registry Transparency, Oversight, and Data Ownership
    • Conclusions
    • Summary of Privacy Rule and Common Rule Requirements
    • References for Chapter 8
• Section II. Operating Registries
  • 9. Recruiting and Retaining Participants in the Registry
    • Introduction
    • Recruitment
    • Retention
    • Pitfalls in Recruitment and Retention
    • International Considerations
    • References for Chapter 9
  • 10. Data Collection and Quality Assurance
    • Introduction
    • Data Collection
    • Quality Assurance
    • Resource Considerations
    • References for Chapter 10
  • 11. Interfacing Registries With Electronic Health Records
    • Introduction
    • EHRs and Patient Registries
    • The Vision of EHR-Registry Interoperability
    • Interoperability Challenges
    • Partial and Potential Solutions
    • Summary
    • References for Chapter 11
  • 12. Adverse Event Detection, Processing, and Reporting
    • Introduction
    • Identifying and Reporting Adverse Drug Events
    • Collecting AE Data in a Registry
    • AE Reporting by the Registry
    • Coding
    • Adverse Event Management
    • Adverse Event Required Reporting for Registry Sponsors
    • Special Case: Risk Evaluation and Mitigation Strategies (REMS)
    • References for Chapter 12
  • 13. Analysis and Interpretation of Registry Data To Evaluate Outcomes
    • Introduction
    • Hypotheses and Purposes of the Registry
    • Patient Population
    • Data Quality Issues
    • Data Analysis
    • Interpretation of Registry Data
    • References for Chapter 13
• Section III. Evaluating Registries
  • 14. Assessing Quality
    • Introduction
    • Defining Quality
    • Measuring Quality
    • Quality Domains
    • References for Chapter 14
• 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

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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