21st Century Patient Registries: Addendum to Registries for Evaluating Patient Outcomes: A User's Guide, 3rd Edition

21st Century Patient Registries: Addendum to Registries for Evaluating Patient Outcomes: A User's Guide, 3rd Edition
USA Price: 
Digital Download
GPO Stock Number:

This Addendum to the Third Edition of the Registries for Evaluating Patient Outcomes: A User’s Guide presents new, emerging themes related to designing and conducting registries. First published in 2007, the User’s Guide, with translations available in Chinese and Korean, serves as a reference for planning, developing, maintaining, and evaluating registries developed to collect data about patient outcomes. The second (2010) and third (2014) editions incorporated updates to existing topics and included new chapters on methodological and technological advances in registry science.  

This Addendum has five new chapters that address emerging topics in registries, including increasing the focus on patients in registries including engaging with patients throughout the design and conduct of registries, methodological considerations for using digital health technologies, designing patient-centric studies, and building registry networks.

Agency website: https://www.ahrq.gov/


Table of Contents

Chapter 1. The Increasing Focus on the Patient in Patient Registries  1
Authors (alphabetical) 1
Introduction 1
Definitions of Patient-Centered Care and Patient-Centered Clinical Research 2
Evolving Role of Patients in Medicine, Research, and Policy 3
Patient-Centeredness and Patient Registries 5
Ability of Registries To Meet the Needs of Patient-Centered Research 6
Key Features of Registries Relevant To Patient-Centeredness 6
Patient Perspectives on Registry Participation 7
Challenges in Developing and Operating Patient-Centric Registries 9
Challenges to Gathering Patient Perspectives During Registry Design 9
Challenges To Incorporating Patient Perspectives Over the Registry Life Cycle 12
Challenges Associated With Representation of Minorities Among Patient Stakeholders 13
Challenges in Responsiveness Tto Multiple Stakeholders’ Needs 13
Challenges in Disseminating Registry Findings To Patients in a Useful Manner 14
Ethical Challenges in Patient-Centered Registries 14
Resources for Building Patient-Centric Registries 15
PCORI Methodology Report and Related Guidelines 15
AHRQ Registry User’s Guide Handbook 16
Inventory of Registry Networks and the Registry of Patient Registries (RoPR) 16
Patient-Advocate Organizations or Voluntary Health Agencies and Nonprofits 16
Conclusion 17
References for Chapter 1 17
Chapter 2. Engaging Patients as Partners Throughout the Registry Life Cycle  20
Authors (alphabetical) 20
Introduction 20
Rationale for Engaging Patients as Partners 21
Opportunities for Engaging Patient Partners Throughout the Registry Process 22
Examples Demonstrating the Need for Patient Partner Engagement 23
Engaging Patient Partners in Planning a Registry 25
Considerations for Early Engagement of Patient Partners 26
Methods of Engaging Patient Stakeholders 28
Barriers to Patient Partner Participation 30
Patient Partner and Community Engagement During Registry Operations 31
Implementation 31
Ongoing Engagement 31
Dissemination of Data 32
Challenges, Opportunities, and Need for Further Research 33
Challenges to Patient Partner Engagement in Registries 33
Areas for Future Research in Patient Engagement 35
Conclusions 36
References for Chapter 2 37
Chapter 3. Digital Health and Patient Registries: Today, Tomorrow, and the Future  41
Authors (alphabetical) 41
Abstract 41
Introduction 41
The Rise of Digital Health 42
Utilization of Digital Health in Clinical Research 44
Patient-Reported Data 44
Vital Signs 45
Activity Tracking 46
Education 47
Mobile Research Systems 47
Examples of Digital Health Uses in Global Patient Registries 48
Advantages of Using Digital Health in Patient Registries 51
Passive Monitoring and Social Listening 51
Greater Access to Minority Populations Via Mobile Devices 53
Reduced Time and Potential for Increased Retention and Long-Term Followup of Patients 54
Current Limitations and Challenges To Using Digital Health in Patient Registries 54
Including Patient Insights on Digital Health Approaches in the Registry Design Process 54
Communicating to Patients Through Digital Technologies 56
Longitudinal Nature of Registries: Challenges Due to the Speed of New Technology 56
Changing Digital Health Approaches From an “Additive” Solution to a “Primary” Solution 57
Integration of a Digital Health Approach Within the Study Operations 57
A Look at the Future of Digital Health 58
Conclusion 60
Digital Health Approach Worksheet 62
References for Chapter 3 63
Chapter 4. Direct-to-Patient Registry and Other Patient-Centric Designs  68
Authors (alphabetical) 68
Abstract 68
Introduction 68
Types of Direct-to-Patient Registry Designs 71
Direct-to-Patient Enrollment and Data Collection 71
Direct-to-Patient Enrollment and Data Collection Supplemented With Existing Data 73
Site-Based Patient Enrollment and Data Collection Supplemented With Patient-Reported Data 74
Design and Operational Considerations 76
Generalizability 76
Validity 77
Patient Reimbursement, Recruitment, and Retention 78
Reimbursement for Participation 79
Recruitment and Retention 79
Creating Standing Cohorts 81
Ethical Considerations 81
Direct-to-Patient Recruitment Material 81
Informed Consent for Participation 82
Patient Consent for Access To Medical Records 82
Conclusions 83
References for Chapter 4 83
Chapter 5. Registry  Networks 86
Authors (alphabetical) 86
Introduction 86
Types of Registry Networks 87
General 87
Clinically Focused 87
Research 88
Major Activities of Registry Networks 89
Knowledge Sharing 89
Creating Common Infrastructure 89
Creating New Knowledge From Registry Networks 90
Creating a Professional Home for Registry Practice 90
Creating a Registry of Registries 92
Setting Up a Registry Network 93
Governance 93
Membership Rules and Expectations 94
Member Recruitment 94
Staff Support and Succession Planning 94
Infrastructure, Communications, Monitoring Use and Value 95
Funding and Sustaining a Registry Network 96
Considerations for International Networks 97
International Consortium of Orthopedic Registries (ICOR) 97
International Consortium of Cardiovascular Registries (ICCR) 98
International Medical Device Regulators Forum (IMDRF) Registry Working Group 98
International Consortium for Health Outcomes Measurement (ICHOM) 98
Conclusion 99
References for Chapter 5 100
List of Reviewers 102


This book is intended for people who design and conduct patient registries. It is also useful for academia, industry, government, technology, and patient organizations.

Product Details

Agency for Healthcare Research and Quality (AHRQ)
Back to Top