Registries for evaluating patient outcomes. Volume 1 : a user's guide / editor, Michelle B. Leavy.

Format:

Book

Contributor:

Leavy, Michelle B., editor.

Series:

AHRQ publication ; Number 13(14)-EHC111.

AHRQ Publication ; Number 13(14)-EHC111

Language:

English

Subjects (All):

Diseases--Reporting.

Diseases.

Physical Description:

1 online resource (463 pages) : illustrations.

Edition:

Third edition.

Place of Publication:

Rockville, Maryland : U.S. Department of Health and Human Services, 2014.

Summary:

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. The User's Guide was created by researchers affiliated with AHRQ's Effective Health Care Program, particularly those who participated in AHRQ's DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Contents:

Cover

Copyright

Contents

Executive Summary

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. Summary

References for Chapter 1

Chapter 2. Planning a Registry

2. Steps in Planning a Registry

3. Summary

Case Example for Chapter 2

Case Example 1. Creating a Registry To Fulfill Multiple Purposes and Using a Publications Committee To Review Data Requests

References for Chapter 2

Chapter 3. Registry Design

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

Case Example 2. Designing a Registry for a Health Technology Assessment

Case Example 3. Developing Prospective Nested Studies in Existing Registries

Case Example 4. Designing a Registry To Address Unique Patient Enrollment Challenges

References for Chapter 3

Chapter 4. Data Elements for Registries

2. Identifying Domains

3. Selecting Data Elements

4. Registry Data Map

5. Pilot Testing

Case Examples for Chapter 4

Case Example 5. Selecting Data Elements for a Registry

Case Example 6. Understanding the Needs and Goals of Registry Participants

Case Example 7. Using Standardized Data Elements in a Registry

References for Chapter 4

Chapter 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

Case Example 8. Developing and Validating a Patient-Administered Questionnaire

Case Example 9. Using Validated Measures To Collect Patient-Reported Outcomes

Case Example 10. Challenges in the Collection of PROs in a Longitudinal Registry

Case Example 11. Collecting PRO Data in a Sensitive Patient Population

References for Chapter 5

Chapter 6. Data Sources for Registries

2. Types of Data

3. Data Sources

4. Other Considerations for Secondary Data Sources

5. Summary

Case Example for Chapter 6

Case Example 12. Using Claims Data Along With Patient-Reported Data To Identify Patients

References for Chapter 6

Section II. Legal and Ethical Considerations for Registries

Chapter 7. Principles of Registry Ethics, Data Ownership, and Privacy

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

Case Example 13. Obtaining a Waiver of Informed Consent

References for Chapter 7

Chapter 8. Informed Consent for Registries

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

Case Example 14. Issues With Obtaining Informed Consent

Case Example 15. Operationalizing Informed Consent for Children.

Case Example 16. Using a Patient-Centered Study Design To Collect Informed Consent, Maximize Recruitment and Retention, and Provide Meaningful Clinical Data

References for Chapter 8

Chapter 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

Case Examples for Chapter 9

Case Example 17. Handling Discovery Requests for Registry Data

Case Example 18. Meeting the Confidentiality and Quality Improvement Needs of Providers Through a Patient Safety Organization

Case Example 19. Protections Available to Registry Data From Institutional Review Boards and Academic Institutions

References for Chapter 9

Section III. Operating Registries

Chapter 10. Recruiting and Retaining Participants in the Registry

2. Recruitment

3. Retention

4. Pitfalls in Recruitment and Retention

5. International Considerations

Case Examples for Chapter 10

Case Example 20. Building Value as a Means To Recruit Hospitals

Case Example 21. Using Registry Tools To Recruit Sites

Case Example 22. Using a Scientific Advisory Board To Support Investigator Research Projects

Case Example 23. Identifying and Addressing Recruitment and Retention Barriers in an Ongoing Registry

References for Chapter 10

Chapter 11. Data Collection and Quality Assurance

2. Data Collection

3. Quality Assurance

4. Resource Considerations

Case Examples for Chapter 11

Case Example 24. Developing a Performance-Linked Access System

Case Example 25. Using Audits To Monitor Data Quality

References for Chapter 11

Chapter 12. Adverse Event Detection, Processing, and Reporting

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

9. Reporting Breaches of Confidentiality or Other Risks

References for Chapter 12

Chapter 13. Analysis, Interpretation, and Reporting of Registry Data To Evaluate Outcomes

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

Case Example 26. Using Registry Data To Evaluate Outcomes by Practice

Case Example 27. Using Registry Data To Study Patterns of Use and Outcomes

References for Chapter 13

Chapter 14. Modifying and Stopping Registries

2. Registry Transitions

3. Planning for the End of a Patient Registry

Case Examples for Chapter 14

Case Example 28. Determining When To Stop an Open-Ended Registry

Case Example 29. Challenges in Transitions and Changes in Data Collection

Case Example 30. Transitioning From Startup to Ongoing Registry Funding With Public and Private Partners

Case Example 31. Modifying a Registry Due to Changes in Standards of Care

References for Chapter 14.

Notes:

"Effective Health Care Program"--Cover.

Includes bibliographical references at the end of each chapters.

Description based on online resource; title from PDF title page (ebrary, viewed June 7, 2017).

ISBN:

1-58763-433-3

OCLC:

988174729