Increasing the Value of Data: EMRs Increasing the Value of Data: EMRs and Disease Registriesand Disease Registries

Elise Berliner, PhD

Director, Technology Assessment Program

Center for Outcomes and Evidence

OutlineOutline

AHRQAHRQ’’s work on registriess work on registries Examples of state initiativesExamples of state initiatives Future collaboration opportunitiesFuture collaboration opportunities

AHRQ Effective Healthcare AHRQ Effective Healthcare ProgramProgram

The Effective Health Care Program:The Effective Health Care Program:– Reviews and synthesizes published and unpublished scientific evidence.Reviews and synthesizes published and unpublished scientific evidence.

– Generates new scientific evidence and analytic tools.Generates new scientific evidence and analytic tools.

– Compiles research findings that are synthesized and/or generated and translates Compiles research findings that are synthesized and/or generated and translates them into useful formats for various audiences.them into useful formats for various audiences.

Original research reportsOriginal research reports– These reports are based on clinical research and studies that use health-care These reports are based on clinical research and studies that use health-care

databases and other scientific resources and approaches to explore practical databases and other scientific resources and approaches to explore practical questions about the effectiveness — or benefits and harms — of treatmentsquestions about the effectiveness — or benefits and harms — of treatments

www.effectivehealthcare.ahrq.govwww.effectivehealthcare.ahrq.gov

Online at effectivehealthcare.ahrq.gov

To order printed copy: email AHRQPubs@ahrq.hhs.gov

AHRQ Publication No. 10-EHC049

Second Edition: Table of Second Edition: Table of ContentsContents

1.1. Patient Registries Patient Registries (Overview)(Overview)

2.2. Planning a RegistryPlanning a Registry3.3. Registry Design Registry Design

(includes (includes Planning for Planning for the End of a Patient the End of a Patient RegistryRegistry))

4.4. Use of Registries in Use of Registries in Product Safety Product Safety AssessmentAssessment

5.5. Data Elements for Data Elements for RegistriesRegistries

6.6. Data Sources for Data Sources for RegistriesRegistries

7.7. Linking Registry Data: Linking Registry Data: Technical and Legal Technical and Legal ConsiderationsConsiderations

8.8. Principles of Registry Ethics, Principles of Registry Ethics, Data Ownership, and PrivacyData Ownership, and Privacy

9.9. Recruiting and Retaining Recruiting and Retaining Participants in the RegistryParticipants in the Registry

10.10. Data Collection and Quality Data Collection and Quality AssuranceAssurance

11.11. Interfacing Registries With Interfacing Registries With Electronic Health RecordsElectronic Health Records

12.12. Adverse Event Detection, Adverse Event Detection, Processing, and ReportingProcessing, and Reporting

13.13. Analysis and Interpretation of Analysis and Interpretation of Registry Data To Evaluate Registry Data To Evaluate OutcomesOutcomes

14.14. Assessing QualityAssessing Quality

Third Edition of the Third Edition of the Registries HandbookRegistries Handbook

Development began in Fall 2010; expected completion Development began in Fall 2010; expected completion Fall 2013Fall 2013

11 new chapters11 new chapters– Patient reported outcomesPatient reported outcomes– Registries for rare diseasesRegistries for rare diseases– Quality improvement registriesQuality improvement registries– Device registriesDevice registries– Best practices in obtaining informed consentBest practices in obtaining informed consent– Patient identify managementPatient identify management– Protection of data from litigation/data protection concerns Protection of data from litigation/data protection concerns

(combined)(combined)– Public-private partnershipsPublic-private partnerships– Statistical techniques for analyzing combined dataStatistical techniques for analyzing combined data– Pregnancy registriesPregnancy registries– Registry transitionsRegistry transitions

Registry of Patient RegistriesRegistry of Patient Registries

• Create a web based repository of information on Create a web based repository of information on patient registriespatient registries

• Develop a framework and prototype syntax for Develop a framework and prototype syntax for entering definitions of outcomes into online resources entering definitions of outcomes into online resources such as the registry of patient registriessuch as the registry of patient registries

• Develop a white paper on the feasibility of creating a Develop a white paper on the feasibility of creating a repository for expired registries that may be linked to repository for expired registries that may be linked to the registry of patient registriesthe registry of patient registries

• Develop a white paper on possible strategies to create Develop a white paper on possible strategies to create a web based collaborative space for registries a web based collaborative space for registries development, a forum for methods, and a research development, a forum for methods, and a research project workspace project workspace

www.effectivehealthcare.ahrq.govwww.effectivehealthcare.ahrq.gov

What is a Registry?What is a Registry?

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

Registry GoalsRegistry Goals

Improve quality of care for individual patientsImprove quality of care for individual patients– Tracking and reminders for individual patientsTracking and reminders for individual patients

Improve quality of care across the health care systemImprove quality of care across the health care system– Tracking and reminders for processes in the health systemTracking and reminders for processes in the health system– Tracking outcomes over time such as hospital readmission ratesTracking outcomes over time such as hospital readmission rates

ResearchResearch– Understanding disease progressionUnderstanding disease progression– Postmarket studies of new drugs and devicesPostmarket studies of new drugs and devices

– Comparative effectiveness of clinical and process interventions Comparative effectiveness of clinical and process interventions

EHRs vs. RegistriesEHRs vs. Registries

EHRsEHRs– Focused on Focused on

individualsindividuals

– Designed to collect, Designed to collect, share and use share and use information for the information for the benefit of the benefit of the patientpatient

RegistriesRegistries– Focused on Focused on

populationspopulations

– Designed to fulfill Designed to fulfill specific purposes specific purposes defined before the defined before the data are collected data are collected and analyzedand analyzed

Challenges to Research Challenges to Research using EMRsusing EMRs

Requirements for informed consentRequirements for informed consent Preserving patient privacy when sharing dataPreserving patient privacy when sharing data Types of information collectedTypes of information collected Completeness of information collectedCompleteness of information collected Variable vocabularies usedVariable vocabularies used

Privacy LawsPrivacy Laws

Federal Level: HIPAAFederal Level: HIPAA State Level: each state has itState Level: each state has it ’’s own lawss own laws

– Example: ownership of medical recordsExample: ownership of medical records Alabama: medical practice owns medical recordsAlabama: medical practice owns medical records New Hampshire: patient owns medical recordsNew Hampshire: patient owns medical records

Source: Center for Medical Records Rights and Privacy, Georgetown Source: Center for Medical Records Rights and Privacy, Georgetown UniversityUniversity

http://hpi.georgetown.edu/privacy/records.html

Provider Participation in Provider Participation in RegistriesRegistries

BenefitsBenefits– Meet requirements for quality reportingMeet requirements for quality reporting

– Meet legal requirementsMeet legal requirements

– Meet requirements for reimbursementMeet requirements for reimbursement

CostsCosts– Cost of participationCost of participation

Massachusetts/Cardiac Massachusetts/Cardiac ProceduresProcedures

2000: legislation to 2000: legislation to ““develop standards and criteria to be used by the department develop standards and criteria to be used by the department of public health for the purpose of collecting, monitoring and validating patient of public health for the purpose of collecting, monitoring and validating patient specific outcome data for all hospitals in the commonwealth that perform open specific outcome data for all hospitals in the commonwealth that perform open heart surgery or angioplasty.heart surgery or angioplasty.””

2001: state legislature mandated Mass. Dept of Health to collect patient specific 2001: state legislature mandated Mass. Dept of Health to collect patient specific outcome data and evaluate state programs outcome data and evaluate state programs

2002: regulations that data be collected through existing professional society 2002: regulations that data be collected through existing professional society registries for ALL procedures in the stateregistries for ALL procedures in the state

Data sent to Mass Data Analysis Center (Mass DAC) at Harvard Medical SchoolData sent to Mass Data Analysis Center (Mass DAC) at Harvard Medical School

Source: Mass DAC website: www.massdac.orgSource: Mass DAC website: www.massdac.org

Lessons Learned In MassLessons Learned In Mass

Surgeons and regulators may have different preferred approaches but a common goal of Surgeons and regulators may have different preferred approaches but a common goal of assuring the highest quality careassuring the highest quality care

Implementation of the national professional society databases better option than Implementation of the national professional society databases better option than ““home-grownhome-grown”” options options

Choice of statistical techniques may vary from state to state depending on the expertise of 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 boardsstatistical consultants and the preferences of local regulators and advisory boards

Cardiac surgeons prefer confidential QI initiatives but demand for public accountability is Cardiac surgeons prefer confidential QI initiatives but demand for public accountability is growinggrowing

Need education of the media on the limitations of the analysisNeed education of the media on the limitations of the analysis

Source: Shahian DM, Torchiana DF and Normand SLT Source: Shahian DM, Torchiana DF and Normand SLT ““Implementation of a Cardiac Surgery Implementation of a Cardiac Surgery Report Card: Lessons from the Massachusetts ExperienceReport Card: Lessons from the Massachusetts Experience”” Ann Thorac Surg 2005; 80:1146- Ann Thorac Surg 2005; 80:1146-1150. 1150.

CDC Stroke RegistryCDC Stroke Registry

2001: Congress charged CDC with 2001: Congress charged CDC with implementing state based stroke implementing state based stroke registries in efforts of improving quality registries in efforts of improving quality of careof care

2004: CDC grants to GA, IL, MA, NC 2004: CDC grants to GA, IL, MA, NC 2007: CDC new five year grants to 2007: CDC new five year grants to

GA, MA, MI, MN, OH, NCGA, MA, MI, MN, OH, NC 2007: Coordination between CDC and 2007: Coordination between CDC and

AHA/ASA Get with the Guidelines AHA/ASA Get with the Guidelines program to develop standardized program to develop standardized stroke performance measuresstroke performance measures

Paul Coverdell National Acute Paul Coverdell National Acute Registry States, 2009Registry States, 2009

Source: http://www.cdc.gov/dhdsp/programs/stroke_registry.htm

NJ Stroke RegistryNJ Stroke Registry

New JerseyNew Jersey– 2004: 2004: ““Stroke Center ActStroke Center Act”” to designate hospitals that meet certain to designate hospitals that meet certain

standards as standards as ““PrimaryPrimary”” or or ““ComprehensiveComprehensive”” stroke centers stroke centers– 2006: NJ Department of Health and Senior Service rules that designated 2006: NJ Department of Health and Senior Service rules that designated

stroke centers maintain a database that supports outcomes measurement stroke centers maintain a database that supports outcomes measurement and CQI. and CQI.

– 2007: Launch of state registry with data elements that closely match 2007: Launch of state registry with data elements that closely match Coverdell registryCoverdell registry

Source: Source: http://www.nj.gov/health/healthcarequality/stroke/initiatives.shtml http://www.nj.gov/health/healthcarequality/stroke/acute_registry.shtml

Washington State: Spinal Washington State: Spinal ProcedureProcedure

Wash State workers compensation did not cover spinal cord stimulation (SCS) for back and Wash State workers compensation did not cover spinal cord stimulation (SCS) for back and leg pain after surgeryleg pain after surgery

The Wash Department of Labor and Industries (WLI) agreed to reimburse for SCS if patients 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 SCSagree to data collection to track outcomes in patients receiving SCS

Study included a control group of patients not receiving SCSStudy included a control group of patients not receiving SCS ResultsResults

– Low rate of successful for all groups; similar between SCS and control at 12 months and 19 Low rate of successful for all groups; similar between SCS and control at 12 months and 19 monthsmonths

– Adverse events associated with SCSAdverse events associated with SCS– Some subgroups (higher mental health scores) had better outcomesSome subgroups (higher mental health scores) had better outcomes

SOURCE: Turner JA, Hollingsworth W, Comstock BA and Deyo RA Spinal cord stimulation for failed SOURCE: Turner JA, Hollingsworth W, Comstock BA and Deyo RA Spinal cord stimulation for failed back surgery syndrome: Outcomes in a workersback surgery syndrome: Outcomes in a workers’’ compensation setting PAIN 148 (2010) 14-25. compensation setting PAIN 148 (2010) 14-25.

AHA Recommendations for the AHA Recommendations for the Future of RegistriesFuture of Registries

AHA recommends that data quality reports from clinical registries should be made publicAHA 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 AHA recommends that policy makers should promote the linkage of clinical registries to supplemental

datadata– Key issue: interoperability among clinical registries, health information technology systems and databases Key issue: interoperability among clinical registries, health information technology systems and databases

with administrative claims, lab data and imaging datawith administrative claims, lab data and imaging data

AHA recommends that government entities and private payers should financially support clinical AHA recommends that government entities and private payers should financially support clinical registries as a means to promote efficient and high quality careregistries 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-Key issue: Savings from standardized data collection rather than individual data collection for pay-for-

performance systemperformance system– AHA recommends that these registries be leveraged for comparative effectiveness research and for AHA recommends that these registries be leveraged for comparative effectiveness research and for

postmarket evaluation by device and pharmaceutical companiespostmarket evaluation by device and pharmaceutical companies

SOURCE; Bufalino VJ et al. The American Heart AssociationSOURCE; Bufalino VJ et al. The American Heart Association’’s Recommendations for Expanding the Applications s Recommendations for Expanding the Applications of Existing and Future Clinical Registries: A Policy Statement From the American Heart Association. of Existing and Future Clinical Registries: A Policy Statement From the American Heart Association. Circulation 2011, 123: 2167-2179.Circulation 2011, 123: 2167-2179.

Summary PointsSummary Points

Registries are an important tool to understand the Registries are an important tool to understand the outcomes of health interventionsoutcomes of health interventions

State health initiatives provide important State health initiatives provide important incentives for participation in registriesincentives for participation in registries

Coordination and interoperability are key to Coordination and interoperability are key to leverage the investment in registries for research leverage the investment in registries for research on other important questionson other important questions

Opportunities for Opportunities for CollaborationCollaboration

Coordination between states and between Coordination between states and between state, federal and private initiativesstate, federal and private initiatives– Harmonization of data elements and definitionsHarmonization of data elements and definitions– Leveraging national registries to meet state needsLeveraging national registries to meet state needs– Analysis and comparison of data across different Analysis and comparison of data across different

statesstates– Sharing lessons learnedSharing lessons learned

ContactContact

Elise BerlinerElise Berliner

elise.berliner@ahrq.hhs.govelise.berliner@ahrq.hhs.gov

301-427-1612301-427-1612