Registries for Evaluating Patient Outcomes: A User's Guide (Third Edition)
Registries for Evaluating Patient Outcomes: A User's Guide
Richard Gliklich, M.D., Senior Editor
September 19, 2011
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.
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.
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.
11 New Topics for the Third Edition
- Registry transitions.
- Informed consent for patient registries.
- Rare disease registries.
- Statistical techniques for analyzing combined data.
- Protection of registry data and data sources.
- Device registries.
- Patient identity management.
- Public-private partnerships.
- Pregnancy registries.
- Quality improvement registries.
- Patient reported outcomes in registries.
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.
- White papers posted for public comment.
- Call for case examples issued.
- White papers revised following public comment.
- Case examples drafted.
- Papers incorporated into User's Guide.
- User's Guide content updated.
- Author/reviewer meeting for updated User's Guide.
- Revised User's Guide posted for public comment.
- Third edition published.
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.
Quality Improvement Registries
- 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.
Types of QI Registries
QI registries generally fall into 2 categories:
- Patients are exposed to a particular health service (e.g., a procedure registry).
- Patients have a disease/condition tracked over time through multiple health care providers and services.
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.
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.
- 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.
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.
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?.
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'.
- 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.
- 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.
Quality Improvement Tools—Examples
|Major Goal||QI Tool||Description|
|Care delivery and coordination||Patient lists||Lists of patients with a particular condition who may be due for an exam, procedure, etc.|
|Automated notifications||Prompts provider or patient when an exam or other action is needed.|
|Decision support tools||Provide recommendations for care for an individual patient using evidence-based guidelines.|
|Population measurement||Population level standardized reports||Provides an analysis of population-level compliance with QI measures or other summaries (e.g., patient outcomes across the population)|
|Benchmarking reports||Compares population-level data for various types of providers.|
|Population level dashboards||Provides snapshot look at QI progress and areas for continued improvement.|
Examples of QI Registries and QI Tools
|Registry||Disease/Condition Area||Functionalities Implemented|
|AHA Get With The Guidelines||Heart failure|
|MaineHealth Clinical Improvement Registry||Diabetes|
|National Comprehensive Cancer Network (NCCN)||Cancer|
- 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.
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.
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.
- 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.
Questions / Discussion