1. Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential. Registries for Evaluating Patient Outcomes: A User’s Guide Third Edition Richard Gliklich, M.D., Senior Editor September 19, 2011

2. Proprietary and Confidential Purpose of the User’s Guide 1 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. Proprietary and Confidential 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 First and Second Editions 2

4. Proprietary and Confidential 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 Purpose of the Third Edition 3

5. Proprietary and Confidential 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 11 New Topics for the Third Edition 4

6. Proprietary and Confidential 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 Process for Creating the Guide 5

7. Proprietary and Confidential Timeline 6 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

8. Proprietary and Confidential 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 Opportunities for Participation 7

9. Proprietary and Confidential©2011 Outcome Sciences, Inc. All rights reserved. Proprietary and Confidential. Quality Improvement Registries

10. Proprietary and Confidential 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 Definition 9

11. Proprietary and Confidential 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 Types of QI Registries 10

12. Proprietary and Confidential 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 Planning a QI Registry 11

13. Proprietary and Confidential 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 Selecting Measures for a QI Registry 12

14. Proprietary and Confidential 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 Change Management 13

15. Proprietary and Confidential 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 Legal and Ethical Issues 14

16. Proprietary and Confidential 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? QI Registry Design 15

17. Proprietary and Confidential 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 Major Design Considerations 16

18. Proprietary and Confidential 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 Operational Considerations 17

19. Proprietary and Confidential Major GoalQI ToolDescription Care delivery and coordination Patient listsLists 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 toolsProvide 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 reportsCompares population-level data for various types of providers. Population level dashboards Provides snapshot look at QI progress and areas for continued improvement. Quality Improvement Tools – Examples

20. Proprietary and Confidential RegistryDisease/Condition AreaFunctionalities Implemented AHA Get With The Guidelines Heart failure Stroke  Decision support (guidelines)  Communication tools  Patient education materials  Real-time quality reports with benchmarks  Transmission to 3 rd parties MaineHealth Clinical Improvement Registry Diabetes  Patient care ‘gap’ reports  Decision support  Transmission to 3 rd parties National Comprehensive Cancer Network (NCCN) Cancer  Patient care ‘gap’ reports  Center level reports  Education materials Examples of QI Registries and QI Tools 19

21. Proprietary and Confidential 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 Quality Assurance 20

22. Proprietary and Confidential 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 Reporting to Providers and the Public 21

23. Proprietary and Confidential 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 Limitations of QI Registries 22

24. Proprietary and Confidential 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 Conclusion 23

25. Proprietary and Confidential Questions / Discussion 24