Collaborative Networks for Conducting Collaborative Networks for Conducting Comparative Effectiveness ResearchComparative Effectiveness Research

Tuesday September 9, 2008Tuesday September 9, 20088:00 – 9:30 am8:00 – 9:30 am

Session OutlineSession Outline

8:00 – 8:15 AHRQ introduction – George 8:00 – 8:15 AHRQ introduction – George NeyarapallyNeyarapally

8:15 – 8:50 CO Distributed Research Network 8:15 – 8:50 CO Distributed Research Network (DRN) project – Wilson Pace, David West(DRN) project – Wilson Pace, David West

8:50 – 9:25 HMORN Distributed Research Network 8:50 – 9:25 HMORN Distributed Research Network (DRN) project – Rich Platt, David Magid(DRN) project – Rich Platt, David Magid

9:25 – 9:30 Questions9:25 – 9:30 Questions

Introduction: AHRQ’s Distributed Introduction: AHRQ’s Distributed Research Network Initiative in Research Network Initiative in

DEcIDEDEcIDE

George NeyarapallyGeorge NeyarapallyPharmD, MPH, RPhPharmD, MPH, RPh

AHRQ, Center for Outcomes and EvidenceAHRQ, Center for Outcomes and Evidence

3

OutlineOutline

BackgroundBackground

Rationale for Distributed Research Network Rationale for Distributed Research Network InitiativeInitiative

Goals of the Task OrderGoals of the Task Order

Benchmarks of SuccessBenchmarks of Success

DEcIDE Research NetworkDEcIDE Research Network

Established as part of MMA in 2005 and Established as part of MMA in 2005 and incorporated in the Effective Health Care program.incorporated in the Effective Health Care program.

13-center research network that is designed to be 13-center research network that is designed to be a data and scientific resource to external public & a data and scientific resource to external public & private health organizations (particularly CMS) to private health organizations (particularly CMS) to provide unbiased, actionable information to inform provide unbiased, actionable information to inform decision makers.decision makers.

Main goal of DEcIDE is to develop new knowledge Main goal of DEcIDE is to develop new knowledge about the clinical and comparative effectiveness about the clinical and comparative effectiveness and safety of treatments and technologies in a and safety of treatments and technologies in a valid, transparent, and scientifically rigorous valid, transparent, and scientifically rigorous manner.manner.

Distributed Research Network Distributed Research Network Prototypes for Population-based Prototypes for Population-based

StudiesStudies

Two pilot project models of distributed research networks will be created & Two pilot project models of distributed research networks will be created & evaluated.evaluated.

The aim is to develop a distributed network prototype that supports secure The aim is to develop a distributed network prototype that supports secure analyses of electronic information across multiple organizations to study analyses of electronic information across multiple organizations to study risks, effects, and outcomes of various medical therapies.risks, effects, and outcomes of various medical therapies.

The long-term goal is a coordinated partnership of multiple research The long-term goal is a coordinated partnership of multiple research networks that provide information that can be quickly queried and networks that provide information that can be quickly queried and analyzed. analyzed.

Unique Aspects of Effective Unique Aspects of Effective Health Care ProgramHealth Care Program

User-driven research & systematic reviews. User-driven research & systematic reviews.

Transparent methods, with process for reviewing Transparent methods, with process for reviewing COI with every project.COI with every project.

Research for public health:Research for public health:– Focused on improving quality of Medicaid, Focused on improving quality of Medicaid,

Medicare, SCHIP.Medicare, SCHIP.– Programs with rising costs.Programs with rising costs.

Partnership with stakeholders & public nomination.Partnership with stakeholders & public nomination.

Rationale for Task OrderRationale for Task Order

Silo investigators and databases. Lack of coordination of Silo investigators and databases. Lack of coordination of research across multiple institutions.research across multiple institutions.

Researchers and decision-makers are disconnected, often Researchers and decision-makers are disconnected, often working independent of each other.working independent of each other.

Small studies often with limited external validity / generalizability Small studies often with limited external validity / generalizability which constrains good decision making.which constrains good decision making.

Vast collections of data that are infrequently shared.Vast collections of data that are infrequently shared. Length to study completion does not meet the needs of Length to study completion does not meet the needs of

policymakers, providers or patients.policymakers, providers or patients. Perceived inability of government to respond quickly to emerging Perceived inability of government to respond quickly to emerging

clinical questions & public health problems that face regulators, clinical questions & public health problems that face regulators, payers, providers, & individual patients.payers, providers, & individual patients.

Current Research Paradigm?Current Research Paradigm?

Rationale for AHRQ’s Distributed Rationale for AHRQ’s Distributed Research Network InitiativeResearch Network Initiative

LeverageLeverage existing resources including intellectual (scientists) and existing resources including intellectual (scientists) and data resources.data resources.

Create a Create a pipelinepipeline for conducting rapid cycle research related to for conducting rapid cycle research related to clinical effectiveness and comparative effectiveness.clinical effectiveness and comparative effectiveness.

Reduce the timelineReduce the timeline for providing valid evidence that can inform for providing valid evidence that can inform clinical decisions and public health problems.clinical decisions and public health problems.

Prepare for the Prepare for the future needsfuture needs of federal government to address of federal government to address questions of public policy in real time.questions of public policy in real time.

ExamplesExamples

Simple: Simple: – How many patients receive carotid stents as compared to medical How many patients receive carotid stents as compared to medical

management?management?

More complex: More complex: – Are patients who take dual therapy with ACE inhibitors and Are patients who take dual therapy with ACE inhibitors and

angiotensin receptor blockers at increased risk for adverse angiotensin receptor blockers at increased risk for adverse outcomes? outcomes?

– What is the balance of risks and benefits of combination therapy?What is the balance of risks and benefits of combination therapy?

Major Components of Major Components of AHRQ’s DRNIAHRQ’s DRNI

Two pilot projectsTwo pilot projects– HMORN HMORN

– University of Colorado & AAFPUniversity of Colorado & AAFP

Internal working group including HIT staff and Internal working group including HIT staff and coordination with FDA and other federal coordination with FDA and other federal health agencies.health agencies.

General Goals of RFTOGeneral Goals of RFTO

Develop a scalable, evolvable, model that initially differentiates Develop a scalable, evolvable, model that initially differentiates itself from other distributed networks by its capability to itself from other distributed networks by its capability to support user-driven research on the safety, clinical support user-driven research on the safety, clinical effectiveness, and effectiveness, and comparative effectiveness of treatments.comparative effectiveness of treatments.

Develop a research cooperative and governance structure that Develop a research cooperative and governance structure that advances the traditional model to assist decision makers.advances the traditional model to assist decision makers.

– This advancement is essential for the continuation of This advancement is essential for the continuation of public trust and funding from public and private payers.public trust and funding from public and private payers.

General Goals of RFTOGeneral Goals of RFTO

Understand the extent to which the distributed research paradigm can be applied to Understand the extent to which the distributed research paradigm can be applied to problems facing policymakers, clinicians, & patients.problems facing policymakers, clinicians, & patients.

– Where does the model exist in the continuum of research?Where does the model exist in the continuum of research?

Establish program governance.Establish program governance.

– Not only address the technical aspects but the “sociologic” aspects of a Not only address the technical aspects but the “sociologic” aspects of a research cooperative research cooperative

– Minimize barriers to collaboration and close coordination with scientific staff at Minimize barriers to collaboration and close coordination with scientific staff at AHRQ.AHRQ.

– Relationship building.Relationship building.

Four Phases of ProjectsFour Phases of Projects

Technical Specifications – Spring to Fall 2008Technical Specifications – Spring to Fall 2008

Pilot testing – Spring 2008 to Winter 2008Pilot testing – Spring 2008 to Winter 2008

Research Study – Summer 2008 to early 2009Research Study – Summer 2008 to early 2009

Blueprint Prospectus – Spring 2009Blueprint Prospectus – Spring 2009

Elements of the Ideal SystemElements of the Ideal System

Create an open architecture that is technically and socially scalable to extend Create an open architecture that is technically and socially scalable to extend participation and collaboration with other AHRQ programs to meet the MMA participation and collaboration with other AHRQ programs to meet the MMA mandates.mandates.

Develop a system which allows timely access to real time information and ensure a Develop a system which allows timely access to real time information and ensure a rapid response to questions facing clinicians, patients, and policy makers.rapid response to questions facing clinicians, patients, and policy makers.

Make technical and procedural burdens as light as possible without sacrificing Make technical and procedural burdens as light as possible without sacrificing scientific integrity.scientific integrity.

Closer connection between researchers and decision makers.Closer connection between researchers and decision makers.

Low-cost, lightweight system that requires modest infrastructure, easy maintenance, Low-cost, lightweight system that requires modest infrastructure, easy maintenance, and a coordinated research agenda.and a coordinated research agenda.

Short-term BenchmarksShort-term Benchmarks

Provide new information that helps advance a distributed Provide new information that helps advance a distributed model in health care research.model in health care research.

Enrich AHRQ’s current capacity to conduct observational Enrich AHRQ’s current capacity to conduct observational research on CE, specifically in DEcIDE & CERTs.research on CE, specifically in DEcIDE & CERTs.

Form a close partnership with AHRQ and stakeholders so Form a close partnership with AHRQ and stakeholders so that useful information is derived from this large investment that useful information is derived from this large investment of resources.of resources.

DRN Projects 2.0DRN Projects 2.0

Future DRN projects – how will we build Future DRN projects – how will we build upon these pilot projects?upon these pilot projects?