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Maximizing the Impact of Comparative Maximizing the Impact of Comparative Effectiveness Research: Effectiveness Research:

The Role of the DEcIDE ConsortiaThe Role of the DEcIDE Consortia

Scott R. Smith, PhDScott R. Smith, PhD

AHRQ Center for Outcomes & AHRQ Center for Outcomes &

EvidenceEvidence

US Department of Health & Human US Department of Health & Human ServicesServices

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Effective Health Care (EHC) Effective Health Care (EHC) Program, 2Program, 2003 – Present

Authorized in 2003 by Section 1013 of the Authorized in 2003 by Section 1013 of the Medicare Prescription Drug, Improvement, and Medicare Prescription Drug, Improvement, and Modernization Act Modernization Act

Conducts objective comparisons of the Conducts objective comparisons of the effectiveness of different health care interventionseffectiveness of different health care interventions

Goal: To support informed health care decisions Goal: To support informed health care decisions by patients, clinicians, and policymakers and by patients, clinicians, and policymakers and improve the quality, effectiveness, and efficiency improve the quality, effectiveness, and efficiency of health care to support evidence-based practiceof health care to support evidence-based practice

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Effective Health Care Effective Health Care Program Program

A.A. Evidence synthesis (EPC program)Evidence synthesis (EPC program)– Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness.Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness.– Identifying relevant knowledge gaps.Identifying relevant knowledge gaps.

B.B. Evidence generation (DEcIDE, CERTs)Evidence generation (DEcIDE, CERTs)– Development of new scientific knowledge to address knowledge gaps. Development of new scientific knowledge to address knowledge gaps. – Accelerate practical studies.Accelerate practical studies.

C.C. Evidence communication/translation (Eisenberg Center)Evidence communication/translation (Eisenberg Center)– Translate evidence into improvements Translate evidence into improvements – Communication of scientific information in plain language to policymakers, patients, and Communication of scientific information in plain language to policymakers, patients, and

providers.providers.

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Congressional Budget Office, 2007Congressional Budget Office, 2007

CBO Comparative CBO Comparative Effectiveness DefinitionEffectiveness Definition

Comparative EffectivenessComparative Effectiveness

“…“…a rigorous evaluation of a rigorous evaluation of the impact of different the impact of different

options that are available options that are available for treating a given for treating a given

medical condition for a medical condition for a particular set of patients.”particular set of patients.”

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Priority Conditions for the Priority Conditions for the Effective Health Care ProgramEffective Health Care Program

Arthritis and non-Arthritis and non-traumatic joint disorderstraumatic joint disorders

CancerCancer Cardiovascular disease, Cardiovascular disease,

including stroke and including stroke and hypertensionhypertension

Dementia, including Dementia, including Alzheimer’s DiseaseAlzheimer’s Disease

Depression and other Depression and other mental health disordersmental health disorders

Developmental delays, Developmental delays, attention-deficit attention-deficit hyperactivity disorder, hyperactivity disorder, and autism and autism

Diabetes MellitusDiabetes Mellitus Functional limitations Functional limitations

and disabilityand disability Infectious diseases, Infectious diseases,

including HIV/AIDSincluding HIV/AIDS ObesityObesity Peptic ulcer disease Peptic ulcer disease

and dyspepsiaand dyspepsia Pregnancy, including Pregnancy, including

pre-term birthpre-term birth Pulmonary Pulmonary

disease/Asthmadisease/Asthma Substance abuseSubstance abuse

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Available EHC ProductsAvailable EHC Products

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Evidence GenerationEvidence Generation

DEcIDE (Developing Evidence to Inform DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network. Decisions about Effectiveness) Network.

– Capitalizing on dataCapitalizing on data

– New methodsNew methods

– Answers for questions that don’t require multi-Answers for questions that don’t require multi-year, multi-million $ trialsyear, multi-million $ trials

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What Does DEcIDE What Does DEcIDE PrimarilyPrimarily Do? Do?

A. Analyze existing health care databases to compare the effectiveness & outcomes of treatment.

B. Analyze existing disease, device, and other registries.

C. Conduct methodological studies to improve research on clinical effectiveness of treatments.

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Summary &“Unofficial” Summary &“Unofficial” DEcIDE StatisticsDEcIDE Statistics

13 DEcIDE centers.13 DEcIDE centers.

Over 60 core clinical scientists.Over 60 core clinical scientists.

Over 500 affiliated personnel.Over 500 affiliated personnel.

Access to >120 different health databases.Access to >120 different health databases.

Health data on over 50 million Americans.Health data on over 50 million Americans.

Nation’s largest network of researchers in therapeutic effectiveness.Nation’s largest network of researchers in therapeutic effectiveness.

AHRQ DEcIDE Research Centers

1010

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Diabetes

Can

cer

TBDADHD

Cardiovascular

DEcIDE Focus Areas in DEcIDE Focus Areas in Comparative EffectivenessComparative Effectiveness

Data

Analyt

ics

MethodsDis

tribute

d

Network

s

Stakeholders

ComparativeEffectiveness

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Comparative Effectiveness Comparative Effectiveness and the Recovery Actand the Recovery Act

The American Recovery and Reinvestment The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for Act of 2009 includes $1.1 billion for comparative effectiveness research:comparative effectiveness research:– AHRQ: $300 millionAHRQ: $300 million

– NIH: $400 million (appropriated to AHRQ and NIH: $400 million (appropriated to AHRQ and transferred to NIH)transferred to NIH)

– Office of the Secretary: $400 million (allocated Office of the Secretary: $400 million (allocated at the Secretary’s discretion)at the Secretary’s discretion)

Funding for health IT, prevention and other areas Funding for health IT, prevention and other areas could have implications for the Agency could have implications for the Agency

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Today’s SpeakersToday’s Speakers

3:15-3:35

Cardiovascular Consortium Eric D. Peterson, MD, MPH, FAHA, FACCProfessor of Medicine, Division of Cardiology Duke University Medical Center

3:35-3:55

Diabetes Consortium Joe Selby, MD, MPH &Director, Division of ResearchKaiser Permanente, North California

3:55-3:10 Cancer Consortium Deborah Schrag, MD & Caprice Greenberg, MD,MP Dana-Farber Cancer InstituteDepartment of Medicine, Harvard Medical School

3:10-3:25 Audience Questions to Panel

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Recovery Act Timeline: AHRQRecovery Act Timeline: AHRQ

20092009

March 19: March 19: Establishment of Establishment of

Federal Federal Coordinating Coordinating Council for Council for

Comparative Comparative Effectiveness Effectiveness

ResearchResearch

February 17: February 17: The American The American Recovery and Recovery and Reinvestment Reinvestment Act of 2009 is Act of 2009 is

signed into lawsigned into law

JanuaryJanuary AprilApril JulyJuly

June 30: Due June 30: Due date for IOM date for IOM

submission of a submission of a list of national list of national

priority priority conditionsconditions**

May 1: Due May 1: Due date for Agency date for Agency

wide and wide and program-program-specific specific

Recovery Act Recovery Act plansplans

OctoberOctober

November 1: November 1: AHRQ AHRQ

FY ‘10 FY ‘10 operations operations

plan dueplan due

July 30: July 30: AHRQ to AHRQ to submit submit

FY ’09 FY ’09 Operations Operations

PlanPlan

20102010

December December 31, 2010: All 31, 2010: All

Recovery Recovery Act funding Act funding

to be to be obligatedobligated

* * Stakeholder input requiredStakeholder input required

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CER Moving Forward: CER Moving Forward: Issues to Consider Issues to Consider

Comparative Effectiveness is a useful tool in a much larger Comparative Effectiveness is a useful tool in a much larger toolkit – it is not “the answer”toolkit – it is not “the answer”

Comparative Effectiveness does not make policy or health Comparative Effectiveness does not make policy or health care decisions, tell doctors how to practice medicine or care decisions, tell doctors how to practice medicine or make final decisions about what kind of treatments insurers make final decisions about what kind of treatments insurers will pay forwill pay for

Comparative Effectiveness does weigh the evidence and Comparative Effectiveness does weigh the evidence and present it in a way that helps consumers and their doctors present it in a way that helps consumers and their doctors make the best possible decisions about health care choicesmake the best possible decisions about health care choices

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The FutureThe Future

Public-private funding and participation likely a Public-private funding and participation likely a necessitynecessity

More effort to get better conditional More effort to get better conditional reimbursement study designs/protocolsreimbursement study designs/protocols

Patients should be engaged as partners at the Patients should be engaged as partners at the local and national levelslocal and national levels

Need to tackle important issuesNeed to tackle important issues– EthicalEthical– When to know when the evidence is sufficientWhen to know when the evidence is sufficient– TransparencyTransparency– Setting prioritiesSetting priorities