Contents

• Acknowledgments
• Preface
• Executive Summary
  • Defining Patient Registries
  • Planning a Registry
  • Registry Design
  • Selecting and Defining Outcome Measures for Registries
  • Data Elements
  • Data Sources
  • Ethics, Data Ownership, and Privacy
  • Informed Consent for Registries
  • Registry Governance
  • Patient and Provider Recruitment and Management
  • Obtaining Data and Quality Assurance
  • Adverse Event Detection, Processing, and Reporting
  • Analysis, Interpretation, and Reporting of Registry Data
  • Evaluating Registries
• Section I. Creating Registries
  • Chapter 1. Patient Registries
    • 1. Introduction
    • 2. Current Uses for Patient Registries
    • 3. Taxonomy for Patient Registries
    • 4. Patient Registries and Policy Purposes
    • 5. Global Registries
    • 6. Future of Registries
    • 7. Summary
    • References for Chapter 1
  • Chapter 2. Planning a Registry
    • 1. Introduction
    • 2. Steps in Planning a Registry
    • 3. Anticipating and Preparing for Change
    • 4. Special Considerations
    • 5. Resources for Registries
    • 6. Summary
    • References for Chapter 2
    • Case Examples for Chapter 2
  • Chapter 3. Registry Design
    • 1. Introduction
    • 2. Research Questions Appropriate for Registries
    • 3. Translating Clinical Questions Into Measurable Exposures and Outcomes
    • 4. Finding the Necessary Data
    • 5. Resources and Efficiency
    • 6. Study Designs for Registries
    • 7. Choosing Patients for Study
    • 8. Registry Size and Duration
    • 9. Internal and External Validity
    • 10. Special Considerations
    • 11. Summary
    • References for Chapter 3
    • Case Examples for Chapter 3
  • Chapter 4. Selecting and Defining Outcome Measures for Registries
    • 1. Introduction
    • 2. Outcome Measures Framework
    • 3. Types of Outcome Measures
    • 4. Selecting Patient-Reported Outcomes
    • 5. Standardized Outcome Measures
    • 6. Conclusions
    • References for Chapter 4
    • Case Examples for Chapter 4
  • Chapter 5. Data Elements for Registries
    • 1. Introduction
    • 2. Identifying Domains
    • 3. Selecting Data Elements
    • 4. Registry Data Map
    • 5. Pilot Testing
    • 6. Summary
    • References for Chapter 5
    • Case Examples for Chapter 5
  • Chapter 6. Data Sources for Registries
    • 1. Introduction
    • 2. Intended Uses for Data Elements
    • 3. Types of Data
    • 4. Data Sources
    • 5. Other Considerations for Secondary Data Sources
    • 6. Summary
    • References for Chapter 6
    • Case Examples for Chapter 6
• Section II. Legal and Ethical Considerations for Registries
  • Chapter 7. Principles of Registry Ethics, Data Ownership, and Privacy
    • 1. Introduction
    • 2. Ethical Concerns Relating to Health Information Registries
    • 3. Applicable Regulations
    • 4. Registry Transparency, Oversight, and Data Ownership
    • 5. Conclusions
    • References for Chapter 7
  • Chapter 8. Informed Consent
    • 1. Introduction
    • 2. Distinguishing Research and Other Activities
    • 3. Growth of Database Research
    • 4. Regulatory Consent Requirements
    • 5. Approaches to Registry Consents
    • 6. Consent Guidance
    • References for Chapter 8
    • Case Examples for Chapter 8
  • Chapter 9. Registry Governance
    • 1. Introduction
    • 2. Governance Roles
    • 3. Governance Structure and Functions
    • 4. Special Applications
    • 5. Key Principles for Successful Governance
    • References for Chapter 9
    • Case Examples for Chapter 9
• Section III. Operating Registries
  • Chapter 10. Recruiting and Retaining Participants in the Registry
    • 1. Introduction
    • 2. Recruitment
    • 3. Retention
    • 4. Pitfalls in Recruitment and Retention
    • References for Chapter 10
    • Case Examples for Chapter 10
  • Chapter 11. Obtaining Data and Quality Assurance
    • 1. Introduction
    • 2. Obtaining Data
    • 3. Quality Assurance
    • 4. Resource Considerations
    • References for Chapter 11
  • Chapter 12. Adverse Event Detection, Processing, and Reporting
    • 1. Introduction
    • 2. Identifying and Reporting Adverse Drug Events
    • 3. Collecting AE Data in a Registry
    • 4. AE Reporting by the Registry
    • 5. Coding
    • 6. Adverse Event Management
    • 7. Adverse Event Required Reporting for Registry Sponsors
    • 8. Special Case: Risk Evaluation and Mitigation Strategies (REMS)
    • 9. Reporting Breaches of Confidentiality or Other Risks
    • References for Chapter 12
  • Chapter 13. Analysis, Interpretation, and Reporting of Registry Data To Evaluate Outcomes
    • 1. Introduction
    • 2. Research Questions and Registry Purposes
    • 3. Patient Population
    • 4. Data Quality
    • 5. Data Analysis
    • 6. Interpretation and Reporting of Registry Data
    • 7. Summary
    • References for Chapter 13
    • Case Examples for Chapter 13
• Section IV. Evaluating Registries
  • Chapter 14. Assessing Quality
    • 1. Introduction
    • 2. Defining Quality
    • 3. Measuring Quality
    • 4. Quality Domains
    • References for Chapter 14
• Contributors and Reviewers
  • Contributors
  • Reviewers
  • Case Example Contributors
• Appendixes
  • Appendix A. An Illustration of Sample Size Calculations
  • Appendix B. Copyright Law

Suggested citation:

Gliklich RE, Leavy MB, Dreyer NA (sr eds). Registries for Evaluating Patient Outcomes: A User’s Guide. 4th ed. (Prepared by L&M Policy Research, LLC, under Contract No. 290-2014-00004-C with partners OM1 and IQVIA) AHRQ Publication No. 19(20)-EHC020. Rockville, MD: Agency for Healthcare Research and Quality; September 2020. Posted final reports are located on the Effective Health Care Program search page. DOI: https://doi.org/10.23970/AHRQEPCREGISTRIES4.

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 healthcare services. More information on the Effective Health Care Program can be found at www.effectivehealthcare.ahrq.gov. This report was produced under contract to the Agency for Healthcare Research and Quality, Rockville, MD by L&M Policy Research, LLC, and partners OM1 and IQVIA under Contract No. 290-2014-00004-C. 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. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. All statements in this report, including its findings and conclusions, are solely those of the authors. The authors participated as individuals and not necessarily as representatives of their organizations. No statement in this document should be construed as an official position of any organization represented here.