Increasing the Value of Data: EMRs and Disease Registries Elise Berliner, PhD Director, Technology Assessment Program Center for Outcomes and Evidence

Outline AHRQ’s work on registries AHRQ’s work on registries Examples of state initiatives Examples of state initiatives Future collaboration opportunities Future collaboration opportunities

AHRQ Effective Healthcare Program The Effective Health Care Program: The Effective Health Care Program: – Reviews and synthesizes published and unpublished scientific evidence. – Generates new scientific evidence and analytic tools. – Compiles research findings that are synthesized and/or generated and translates them into useful formats for various audiences. Original research reports Original research reports – These reports are based on clinical research and studies that use health-care databases and other scientific resources and approaches to explore practical questions about the effectiveness — or benefits and harms — of treatments

Online at effectivehealthcare.ahrq.gov To order printed copy: AHRQ Publication No. 10-EHC049

Second Edition: Table of Contents 1.Patient Registries (Overview) 2.Planning a Registry 3.Registry Design (includes Planning for the End of a Patient Registry) 4.Use of Registries in Product Safety Assessment 5.Data Elements for Registries 6.Data Sources for Registries 7.Linking Registry Data: Technical and Legal Considerations 8.Principles of Registry Ethics, Data Ownership, and Privacy 9.Recruiting and Retaining Participants in the Registry 10.Data Collection and Quality Assurance 11.Interfacing Registries With Electronic Health Records 12.Adverse Event Detection, Processing, and Reporting 13.Analysis and Interpretation of Registry Data To Evaluate Outcomes 14.Assessing Quality

Third Edition of the Registries Handbook Development began in Fall 2010; expected completion Fall 2013 Development began in Fall 2010; expected completion Fall new chapters 11 new chapters – Patient reported outcomes – Registries for rare diseases – Quality improvement registries – Device registries – Best practices in obtaining informed consent – Patient identify management – Protection of data from litigation/data protection concerns (combined) – Public-private partnerships – Statistical techniques for analyzing combined data – Pregnancy registries – Registry transitions

Registry of Patient Registries Create a web based repository of information on patient registries Create a web based repository of information on patient registries Develop a framework and prototype syntax for entering definitions of outcomes into online resources such as the registry of patient registries Develop a framework and prototype syntax for entering definitions of outcomes into online resources such as the registry of patient registries Develop a white paper on the feasibility of creating a repository for expired registries that may be linked to the registry of patient registries Develop a white paper on the feasibility of creating a repository for expired registries that may be linked to the registry of patient registries Develop a white paper on possible strategies to create a web based collaborative space for registries development, a forum for methods, and a research project workspace Develop a white paper on possible strategies to create a web based collaborative space for registries development, a forum for methods, and a research project workspacewww.effectivehealthcare.ahrq.gov

What is a Registry? “A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes”

Registry Goals Improve quality of care for individual patients Improve quality of care for individual patients – Tracking and reminders for individual patients Improve quality of care across the health care system Improve quality of care across the health care system – Tracking and reminders for processes in the health system – Tracking outcomes over time such as hospital readmission rates Research Research – Understanding disease progression – Postmarket studies of new drugs and devices – Comparative effectiveness of clinical and process interventions

EHRs vs. Registries EHRs EHRs – Focused on individuals – Designed to collect, share and use information for the benefit of the patient Registries Registries – Focused on populations – Designed to fulfill specific purposes defined before the data are collected and analyzed

Challenges to Research using EMRs Requirements for informed consent Requirements for informed consent Preserving patient privacy when sharing data Preserving patient privacy when sharing data Types of information collected Types of information collected Completeness of information collected Completeness of information collected Variable vocabularies used Variable vocabularies used

Privacy Laws Federal Level: HIPAA Federal Level: HIPAA State Level: each state has it’s own laws State Level: each state has it’s own laws – Example: ownership of medical records Alabama: medical practice owns medical records Alabama: medical practice owns medical records New Hampshire: patient owns medical records New Hampshire: patient owns medical records Source: Center for Medical Records Rights and Privacy, Georgetown University

Provider Participation in Registries Benefits Benefits – Meet requirements for quality reporting – Meet legal requirements – Meet requirements for reimbursement Costs Costs – Cost of participation

Massachusetts/Cardiac Procedures 2000: legislation to “develop standards and criteria to be used by the department of public health for the purpose of collecting, monitoring and validating patient specific outcome data for all hospitals in the commonwealth that perform open heart surgery or angioplasty.” 2000: legislation to “develop standards and criteria to be used by the department of public health for the purpose of collecting, monitoring and validating patient specific outcome data for all hospitals in the commonwealth that perform open heart surgery or angioplasty.” 2001: state legislature mandated Mass. Dept of Health to collect patient specific outcome data and evaluate state programs 2001: state legislature mandated Mass. Dept of Health to collect patient specific outcome data and evaluate state programs 2002: regulations that data be collected through existing professional society registries for ALL procedures in the state 2002: regulations that data be collected through existing professional society registries for ALL procedures in the state Data sent to Mass Data Analysis Center (Mass DAC) at Harvard Medical School Data sent to Mass Data Analysis Center (Mass DAC) at Harvard Medical School Source: Mass DAC website:

Lessons Learned In Mass Surgeons and regulators may have different preferred approaches but a common goal of assuring the highest quality care Surgeons and regulators may have different preferred approaches but a common goal of assuring the highest quality care Implementation of the national professional society databases better option than “home-grown” options Implementation of the national professional society databases better option than “home-grown” options Choice of statistical techniques may vary from state to state depending on the expertise of statistical consultants and the preferences of local regulators and advisory boards Choice of statistical techniques may vary from state to state depending on the expertise of statistical consultants and the preferences of local regulators and advisory boards Cardiac surgeons prefer confidential QI initiatives but demand for public accountability is growing Cardiac surgeons prefer confidential QI initiatives but demand for public accountability is growing Need education of the media on the limitations of the analysis Need education of the media on the limitations of the analysis Source: Shahian DM, Torchiana DF and Normand SLT “Implementation of a Cardiac Surgery Report Card: Lessons from the Massachusetts Experience” Ann Thorac Surg 2005; 80:

CDC Stroke Registry 2001: Congress charged CDC with implementing state based stroke registries in efforts of improving quality of care 2001: Congress charged CDC with implementing state based stroke registries in efforts of improving quality of care 2004: CDC grants to GA, IL, MA, NC 2004: CDC grants to GA, IL, MA, NC 2007: CDC new five year grants to GA, MA, MI, MN, OH, NC 2007: CDC new five year grants to GA, MA, MI, MN, OH, NC 2007: Coordination between CDC and AHA/ASA Get with the Guidelines program to develop standardized stroke performance measures 2007: Coordination between CDC and AHA/ASA Get with the Guidelines program to develop standardized stroke performance measures Paul Coverdell National Acute Registry States, 2009 Source:

NJ Stroke Registry New Jersey New Jersey – 2004: “Stroke Center Act” to designate hospitals that meet certain standards as “Primary” or “Comprehensive” stroke centers – 2006: NJ Department of Health and Senior Service rules that designated stroke centers maintain a database that supports outcomes measurement and CQI. – 2007: Launch of state registry with data elements that closely match Coverdell registry Source:

Washington State: Spinal Procedure Wash State workers compensation did not cover spinal cord stimulation (SCS) for back and leg pain after surgery Wash State workers compensation did not cover spinal cord stimulation (SCS) for back and leg pain after surgery The Wash Department of Labor and Industries (WLI) agreed to reimburse for SCS if patients agree to data collection to track outcomes in patients receiving SCS The Wash Department of Labor and Industries (WLI) agreed to reimburse for SCS if patients agree to data collection to track outcomes in patients receiving SCS Study included a control group of patients not receiving SCS Study included a control group of patients not receiving SCS Results Results – Low rate of successful for all groups; similar between SCS and control at 12 months and 19 months – Adverse events associated with SCS – Some subgroups (higher mental health scores) had better outcomes SOURCE: Turner JA, Hollingsworth W, Comstock BA and Deyo RA Spinal cord stimulation for failed back surgery syndrome: Outcomes in a workers’ compensation setting PAIN 148 (2010)

AHA Recommendations for the Future of Registries AHA recommends that data quality reports from clinical registries should be made public AHA recommends that data quality reports from clinical registries should be made public AHA recommends that policy makers should promote the linkage of clinical registries to supplemental data AHA recommends that policy makers should promote the linkage of clinical registries to supplemental data – Key issue: interoperability among clinical registries, health information technology systems and databases with administrative claims, lab data and imaging data AHA recommends that government entities and private payers should financially support clinical registries as a means to promote efficient and high quality care AHA recommends that government entities and private payers should financially support clinical registries as a means to promote efficient and high quality care – Key issue: Savings from standardized data collection rather than individual data collection for pay-for-performance system – AHA recommends that these registries be leveraged for comparative effectiveness research and for postmarket evaluation by device and pharmaceutical companies SOURCE; Bufalino VJ et al. The American Heart Association’s Recommendations for Expanding the Applications of Existing and Future Clinical Registries: A Policy Statement From the American Heart Association. Circulation 2011, 123:

Summary Points Registries are an important tool to understand the outcomes of health interventions Registries are an important tool to understand the outcomes of health interventions State health initiatives provide important incentives for participation in registries State health initiatives provide important incentives for participation in registries Coordination and interoperability are key to leverage the investment in registries for research on other important questions Coordination and interoperability are key to leverage the investment in registries for research on other important questions

Opportunities for Collaboration Coordination between states and between state, federal and private initiatives Coordination between states and between state, federal and private initiatives – Harmonization of data elements and definitions – Leveraging national registries to meet state needs – Analysis and comparison of data across different states – Sharing lessons learned

Contact Elise Berliner