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

1. Registries for Evaluating Patient Outcomes: A User’s GuideThird Edition Richard Gliklich, M.D., Senior Editor September 19, 2011

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

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

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

5. 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

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

7. Timeline

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

9. Quality Improvement Registries

10. Definition • 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

11. 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

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

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

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

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

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?

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

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

19. Quality Improvement Tools – Examples

20. Examples of QI Registries and QI Tools

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

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

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

24. Conclusion • 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

25. Questions / Discussion