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 cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care.

Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure.

Contents

• Acknowledgements
• Preface
• Executive Summary
• Volume 1
  • Section I. Creating Registries
    • 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 Summary
      • References for Chapter 1
    • 2. Planning a Registry
      • 1 Introduction
      • 2 Steps in Planning a Registry
      • 3 Summary
      • Case Example for Chapter 2
      • References for Chapter 2
    • 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 Sampling
      • 9 Registry Size and Duration
      • 10 Internal and External Validity
      • 11 Summary
      • Case Examples for Chapter 3
      • References for Chapter 3
    • 4. Data Elements for Registries
      • 1 Introduction
      • 2 Identifying Domains
      • 3 Selecting Data Elements
      • 4 Registry Data Map
      • 5 Pilot Testing
      • 6 Summary
      • Case Examples for Chapter 4
      • References for Chapter 4
    • 5. Use of Patient-Reported Outcomes in Registries
      • 1 Introduction
      • 2 The Role of PROs in Registries
      • 3 What Methods Are Available To Collect PROs and Which Is Best?
      • 4 Which PRO Measure(s) Should Be Selected?
      • 5 Example of PRO Use in a Registry
      • Case Examples for Chapter 5
      • References for Chapter 5
    • 6. Data Sources for Registries
      • 1 Introduction
      • 2 Types of Data
      • 3 Data Sources
      • 4 Other Considerations for Secondary Data Sources
      • 5 Summary
      • Case Example for Chapter 6
      • References for Chapter 6
  • Section II. Legal and Ethical Considerations for Registries
    • 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
      • 6 Summary of Privacy Rule and Common Rule Requirements
      • Case Example for Chapter 7
      • References for Chapter 7
    • 8. Informed Consent for Registries
      • 1 Introduction
      • 2 Registries, Research, and Other Activities
      • 3 Current Challenges for Registries
      • 4 Regulatory Consent Requirements
      • 5 A Proposed Framework for Registry Consents
      • 6 Consent Guidance
      • Case Examples for Chapter 8
      • References for Chapter 8
    • 9. Protecting Data: Confidentiality and Legal Concerns of Providers, Manufacturers, and Health Plans
      • 1 Background
      • 2 Relevant Laws and Regulations: Variety of Sources, But Limited Protection
      • 3 Summary
      • Case Examples for Chapter 9
      • References for Chapter 9
  • Section III. Operating Registries
    • 10. Recruiting and Retaining Participants in the Registry
      • 1 Introduction
      • 2 Recruitment
      • 3 Retention
      • 4 Pitfalls in Recruitment and Retention
      • 5 International Considerations
      • Case Examples for Chapter 10
      • References for Chapter 10
    • 11. Data Collection and Quality Assurance
      • 1 Introduction
      • 2 Data Collection
      • 3 Quality Assurance
      • 4 Resource Considerations
      • Case Examples for Chapter 11
      • References for Chapter 11
    • 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
    • 13. Analysis, Interpretation, and Reporting of Registry Data To Evaluate Outcomes
      • 1 Introduction
      • 2 Hypotheses and Purposes of the Registry
      • 3 Patient Population
      • 4 Data Quality Issues
      • 5 Data Analysis
      • 6 Summary of Analytic Considerations
      • 7 Interpretation of Registry Data
      • Case Examples for Chapter 13
      • References for Chapter 13
    • 14. Modifying and Stopping Registries
      • 1 Introduction
      • 2 Registry Transitions
      • 3 Planning for the End of a Patient Registry
      • Case Examples for Chapter 14
      • References for Chapter 14
• Volume 2
  • Section IV. Technical, Legal, and Analytic Considerations for Combining Registry Data With Other Data Sources
    • 15. Interfacing Registries With Electronic Health Records
      • 1 Introduction
      • 2 EHRs and Patient Registries
      • 3 EHRs and Evidence Development
      • 4 Current Challenges in a Preinteroperable Environment
      • 5 The Vision of EHR-Registry Interoperability
      • 6 Interoperability Challenges
      • 7 Partial and Potential Solutions
      • 8 Momentum Toward a Functional Interoperability Solution
      • 9 The Next Increment
      • 10 What Has Been Done
      • 11 Distributed Networks
      • 12 Summary
      • Case Examples for Chapter 15
      • References for Chapter 15
    • 16. Linking Registry Data With Other Data Sources To Support New Studies
      • 1 Introduction
      • 2 Technical Aspects of Data Linkage Projects
      • 3 Legal Aspects of Data Linkage Projects
      • 4 Risk Mitigation for Data Linkage Projects
      • 5 Legal and Technical Planning Questions
      • 6 Summary
      • Case Examples for Chapter 16
      • References for Chapter 16
    • 17. Managing Patient Identity Across Data Sources
      • 1 Introduction
      • 2 PIM Strategies
      • 3 Emerging Strategies and Related Ideas
      • 4 Major Challenges and Barriers
      • 5 Summary
      • Case Examples for Chapter 17
      • References for Chapter 17
    • 18. Analysis of Linked Registry Data Sets
      • 1 Introduction
      • 2 Fundamentals of Design and Analysis in Retrospective Database Research
      • 3 Important Considerations
      • 4 Special Opportunities
      • 5 Summary
      • Case Examples for Chapter 18
      • References for Chapter 18
  • Section V. Special Applications in Patient Registries
    • 19. Use of Registries in Product Safety Assessment
      • 1 Introduction
      • 2 Registries Specifically Designed for Safety Assessment
      • 3 Registries Designed for Purposes Other Than Safety
      • 4 Ad Hoc Data Pooling
      • 5 Signal Detection in Registries and Observational Studies
      • 6 Potential Obligations for Registry Developers in Reporting Safety Issues
      • 7 Summary
      • Case Examples for Chapter 19
      • References for Chapter 19
    • 20. Rare Disease Registries
      • 1 Introduction
      • 2 Genesis of a Rare Disease Registry
      • 3 Implementation of a Rare Disease Registry
      • 4 The Future of Rare Disease Registries
      • Case Examples for Chapter 20
      • References for Chapter 20
    • 21. Pregnancy Registries
      • 1 Introduction
      • 2 Justification
      • 3 Pregnancy Registry Objectives
      • 4 Design
      • 5 Study Population: Who and When
      • 6 Enrollment and Followup
      • 7 Exposure Ascertainment
      • 8 Exposure Definition
      • 9 Covariates: What Else To Collect?
      • 10 Outcome Ascertainment
      • 11 Outcome(s) Definition
      • 12 Reference Group(s): Internal or External, Exposed or Unexposed?
      • 13 Analysis of Registry Data
      • 14 Statistical Power, Registry Size, and Duration
      • 15 Biases
      • 16 External Validity or Generalizability
      • 17 Operations
      • 18 Advantages of Pregnancy Registries
      • 19 Limitations of Pregnancy Registries
      • 20 Evaluation of Reports From Pregnancy Registries
      • 21 Summary
      • Case Examples for Chapter 21
      • References for Chapter 21
    • 22. Quality Improvement Registries
      • 1 Introduction
      • 2 Planning
      • 3 Legal and Institutional Review Board Issues
      • 4 Design
      • 5 Operational Considerations
      • 6 Quality Improvement Tools
      • 7 Quality Assurance
      • 8 Analytical Considerations
      • 9 Reporting to Providers and the Public
      • 10 Use of QI Registry Data for Research Studies
      • 11 Limitations of Current QI Registries
      • 12 Summary
      • Case Examples for Chapter 22
      • References for Chapter 22
    • 23. Registries for Medical Devices
      • 1 Introduction
      • 2 Differences Between Drugs and Devices
      • 3 Design and Data Collection Considerations
      • 4 Regulatory Uses and Considerations
      • 5 Potential Uses of Emerging Technology
      • 6 Summary
      • Case Examples for Chapter 23
      • References for Chapter 23
    • 24. Public-Private Partnerships
      • 1 Introduction
      • 2 Definition of a Public-Private Partnership
      • 3 PPP Models
      • 4 Considerations for Setting Up a PPP
      • 5 Evolution of PPPs
      • 6 Considerations for Managing a PPP
      • 7 Special Considerations for International PPPs
      • 8 Key Factors for Success and Potential Challenges
      • 9 Summary
      • Case Examples for Chapter 24
      • References for Chapter 24
  • Section VI. Evaluating Registries
    • 25. Assessing Quality
      • 1 Introduction
      • 2 Defining Quality
      • 3 Measuring Quality
      • 4 Quality Domains
      • References for Chapter 25
• Contributors
• Reviewers
• Case Example Contributors
• Contributor and Reviewer Affiliations
• 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

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services¹, Contract No. 290-2005-00351 TO7. Prepared by: Outcome Sciences, Inc., A Quintiles Company, Cambridge, MA

Suggested 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. http://www.effectivehealthcare.ahrq.gov/registries-guide-3.cfm.

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 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. 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.

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