Skip Navigation Archive: U.S. Department of Health and Human Services U.S. Department of Health and Human Services
Archive: Agency for Healthcare Research Quality
Archival print banner

This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: Let us know the nature of the problem, the Web address of what you want, and your contact information.

Please go to for current information.

Registries for Evaluating Patient Outcomes: A User's Guide (Third Edition)

Slide presentation from the AHRQ 2011 conference.

On September 19, 2011, Rich Gliklich made this presentation at the 2011 Annual Conference. Select to access the PowerPoint® presentation (160 KB). Plugin Software Help.

Slide 1

Registries for Evaluating Patient Outcomes: A User's Guide
Third Edition

Richard Gliklich, M.D., Senior Editor
September 19, 2011

Slide 2

Purpose of the User's Guide

  • To guide the design and implementation of patient registries, the analysis and interpretation of data from patient registries, and the evaluation of the quality of a registry or one of its components.

Slide 3

First and Second Editions

  • First edition (2007) and second edition (2010) have been widely used as a reference for designing, operating, and evaluating patient registries:
    • Numerous citations (>60) in literature and in significant government publications (e.g., Federal Register, FCC Report to the President, etc.).
  • As registries continue to evolve, many new methodological and practical issues have arisen.

Slide 4

Purpose of the Third Edition

  • Update the second edition content to reflect information from recent publications and reported experiences.
  • Expand the guide to address 11 emerging issues, some identified through public comment, that deserve further in-depth discussion.

Slide 5

11 New Topics for the Third Edition

  1. Registry transitions.
  2. Informed consent for patient registries.
  3. Rare disease registries.
  4. Statistical techniques for analyzing combined data.
  5. Protection of registry data and data sources.
  6. Device registries.
  7. Patient identity management.
  8. Public-private partnerships.
  9. Pregnancy registries.
  10. Quality improvement registries.
  11. Patient reported outcomes in registries.

Slide 6

Process for Creating the Guide

  • Topics identified based on public comments received for the second edition and reported experiences.
  • New chapters:
    • Author and reviewer teams assembled with representatives from academia, government, and industry.
    • Posted for public comment and revision.
  • Original chapters:
    • Original authors and reviewers were invited to participate. Additions made for new topic areas when necessary.
    • Full, revised handbook posted for public comment.
  • Open call for case examples.

Slide 7


Fall 2011:

  • White papers posted for public comment.
  • Call for case examples issued.

Winter 2012:

  • White papers revised following public comment.
  • Case examples drafted.

Spring 2012:

  • Papers incorporated into User's Guide.
  • User's Guide content updated.

Summer 2012:

  • Author/reviewer meeting for updated User's Guide.

Fall 2012:

  • Revised User's Guide posted for public comment.

Summer 2013

  • Third edition published.

Slide 8

Opportunities for Participation

  • Review and comment on the white papers during the public comment period.
  • Submit a case example abstract.
  • Review and comment on the updated User's Guide during the public comment period.

Slide 9

Quality Improvement Registries

Slide 10


  • Quality improvement registries (QI registries) use systematic data collection and other tools to improve quality of care.
  • Key features of a QI registry:
    • At least one purpose is quality improvement.
    • An exposure of interest is to health care providers/health care systems.
    • QI tools are used in conjunction with data collection to improve quality.

Slide 11

Types of QI Registries

QI registries generally fall into 2 categories:

  1. Patients are exposed to a particular health service (e.g., a procedure registry).
  2. Patients have a disease/condition tracked over time through multiple health care providers and services.

Slide 12

Planning a QI Registry

  • Planning a QI registry follows most of the steps outlined in Chapter 2.
  • Major differences:
    • Active, engaged participants, often called "champions" are critical for early success.
    • Actionable information that can be used to modify behaviors, processes, or systems of care must be readily available—this usually comes from process of care or quality measures.

Slide 13

Selecting Measures for a QI Registry

  • Measure selection requires balancing the goals of the registry with the desire to meet other needs for providers (e.g., reporting to payers, accreditation).
  • Parameters for selecting measures:
    • Measures are clinically relevant.
    • Measures examine an area for which improvement is needed.
    • Data for the measure can be captured without requiring significant changes to the care process.

Slide 14

Change Management

  • QI registries must be able to adapt to two continual sources of change:
    • New evidence that changes how care should be managed.
    • Participants manage what they measure, so measures become less relevant over time as care improves. They must then be replaced by other measures.
  • In some QI registries, major changes happen more than once per year.

Slide 15

Legal and Ethical Issues

  • QI registries face unique challenges in that many institutions' legal groups and IRBs are less familiar with these types of registries.
  • The distinction between QI registries and research can be unclear.
  • This leads to questions as to whether QI registries need IRB approval, require informed consent, etc., and different interpretations by different IRBs.

Slide 16

QI Registry Design

  • QI registries that collect data within a single institution differ from those that collect data from multiple institutions regionally or nationally.
  • Design is driven by the purpose of the registry:
    • Is the goal to improve quality of care for patients with a disease or for patients presenting with a singular event in the course of their disease?.

Slide 17

Major Design Considerations

  • Selecting data elements:
    • Use measures to determine 'core data'.
    • Limit data collection to essential information, or consider a 'core data set' and 'enhanced data set'.
  • Reporting:
    • Registries may report blinded or unblinded data at the individual patient, provider, or institution level.
  • Sampling strategies:
    • Provide representativeness while ensuring that the registry data collection is feasible.
    • Often requires ongoing assessment.

Slide 18

Operational Considerations

  • Integration with other data sources:
    • Many data elements are already collected for other purposes (e.g., claims, medical records, etc.).
    • Integration can reduce data entry burden.
  • Recruitment and retention:
    • Motivations for participation differ from other types of registries.
    • Incentives focus on QI—e.g., recognition programs, support for QI activities, QI tools, benchmarking reports.

Slide 19

Quality Improvement Tools—Examples

Major GoalQI ToolDescription
Care delivery and coordinationPatient listsLists of patients with a particular condition who may be due for an exam, procedure, etc.
Automated notificationsPrompts provider or patient when an exam or other action is needed.
Decision support toolsProvide recommendations for care for an individual patient using evidence-based guidelines.
Population measurementPopulation level standardized reportsProvides an analysis of population-level compliance with QI measures or other summaries (e.g., patient outcomes across the population)
Benchmarking reportsCompares population-level data for various types of providers.
Population level dashboardsProvides snapshot look at QI progress and areas for continued improvement.

Slide 20

Examples of QI Registries and QI Tools

RegistryDisease/Condition AreaFunctionalities Implemented
AHA Get With The GuidelinesHeart failure
  • Decision support (guidelines).
  • Communication tools.
  • Patient education materials.
  • Real-time quality reports with benchmarks.
  • Transmission to 3rd parties.
MaineHealth Clinical Improvement RegistryDiabetes
  • Patient care 'gap' reports.
  • Decision support.
  • Transmission to 3rd parties.
National Comprehensive Cancer Network (NCCN)Cancer
  • Patient care 'gap' reports.
  • Center level reports.
  • Education materials.

Slide 21

Quality Assurance

  • Unique issues in QI registries:
    • Often linked to economic incentives, which may lead to data quality issues, such as 'cherry picking'.
  • Auditing may be useful for QI registries:
    • A risk based approach may be cost-effective.
    • Consider what percentage of sites to audit, what percentage of data to audit, how sites are selected, and on-site vs. remote audits.

Slide 22

Reporting to Providers and the Public

  • Reporting information to providers, and, in some cases, the public, is an important component of QI registries.
  • Many options for reporting exist:
    • Public reporting, confidential provider feedback, professional collaborations, state regulatory oversight.
  • Benefits must be weighed against potential negative consequences:
    • Most common negative consequence is risk aversion, i.e., provider reluctance to accept high-risk patients.

Slide 23

Limitations of QI Registries

  • Often focus on isolated conditions or procedures, rather than overall care.
  • Usually collect data only for a short time-frame (e.g., in-hospital or for 30 days after an admission).
  • Linkages with other data sources could improve utility of the data, but linkage is complicated by lack of standardized data sets and difficulty matching patients.

Slide 24


  • Many QI registries exist at the local, regional, national, and international level.
  • QI registries face unique challenges in design, operations, and analysis.
  • Data linkage and integration of QI registries with other data sources (e.g., EHRs) are likely to become more common.

Slide 25


Questions / Discussion

Page last reviewed October 2014
Internet Citation: Registries for Evaluating Patient Outcomes: A User's Guide (Third Edition). October 2014. Agency for Healthcare Research and Quality, Rockville, MD.


The information on this page is archived and provided for reference purposes only.


AHRQ Advancing Excellence in Health Care