ahrq’s perspective on comparative effectiveness research jean slutsky director, center for...
TRANSCRIPT
AHRQ’S Perspective on Comparative AHRQ’S Perspective on Comparative Effectiveness ResearchEffectiveness Research
Jean SlutskyJean SlutskyDirector, Center for Outcomes and EvidenceDirector, Center for Outcomes and EvidenceAgency for Healthcare Research and QualityAgency for Healthcare Research and Quality
TEACH 2011TEACH 2011NYAMNYAM
August 10, 2011August 10, 2011
OverviewOverview
Role of effectiveness research in Role of effectiveness research in decision makingdecision making
Understanding effectiveness researchUnderstanding effectiveness research Comparative effectiveness research at Comparative effectiveness research at
AHRQAHRQ Lessons learned throughoutLessons learned throughout
Why the Need for Why the Need for Effectiveness Research?Effectiveness Research?
Interventions that are efficacious under a Interventions that are efficacious under a
highly specific set of circumstances highly specific set of circumstances
often often fail to replicatefail to replicate across a wide across a wide
variety of settings, conditions, patients.variety of settings, conditions, patients.
Glasgow, 2003
What Healthcare Decision What Healthcare Decision Makers Need To KnowMakers Need To Know
CanCan it work? it work? WillWill it work? it work?
– For this patient?For this patient?
– In this setting?In this setting?
Is it Is it worthworth it? it?– Do benefits outweigh harms?Do benefits outweigh harms?
– Do benefits justify costs? Do benefits justify costs?
– Does it offer important advantages over existing Does it offer important advantages over existing alternatives?alternatives?
adapted from adapted from Brian Brian HaynesHaynes
ACP Journal ClubACP Journal Club
CER – Helping to Make Better CER – Helping to Make Better Health Care Decisions?Health Care Decisions?
Improve research baseImprove research base– RelevanceRelevance
– QualityQuality
Improve use of data in decision makingImprove use of data in decision making Informed decision makingInformed decision making
Uses of Evidence Uses of Evidence for Decisionmakingfor Decisionmaking
Product approvalProduct approval Product purchasing and formulary selectionProduct purchasing and formulary selection Benefit and coverage decisionsBenefit and coverage decisions Practice guidelinesPractice guidelines Quality review and improvementQuality review and improvement Clinician/patient decision-makingClinician/patient decision-making Choosing plans or providersChoosing plans or providers Organizational and management decisionsOrganizational and management decisions Program financing and priority settingProgram financing and priority setting
Alternatives to Evidence-Alternatives to Evidence-Based MedicineBased Medicine
Eminence-basedEminence-based Vehemence-basedVehemence-based Eloquence-basedEloquence-based Providence-basedProvidence-based Diffidence-basedDiffidence-based Nervousness-basedNervousness-based Confidence-basedConfidence-based Reimbursement-basedReimbursement-based Celebrity-basedCelebrity-based Gastronomically-basedGastronomically-based K-street-basedK-street-based
Isaacs and Fitzgerald. BMJ 1999 319(7225): 1618. Isaacs and Fitzgerald. BMJ 1999 319(7225): 1618.
Some Perspective on Comparative Some Perspective on Comparative Effectiveness Research at AHRQEffectiveness Research at AHRQ
Comparative Effectiveness: AHRQComparative Effectiveness: AHRQEffective Health Care ProgramEffective Health Care Program
Created in 2005, authorized by Created in 2005, authorized by Section 1013 of the Medicare Section 1013 of the Medicare Prescription Drug, Improvement, Prescription Drug, Improvement, and Modernization Act (MMA) of and Modernization Act (MMA) of 2003 2003
To improve the quality, To improve the quality, effectiveness, and efficiency of effectiveness, and efficiency of health care delivered through health care delivered through Medicare, Medicaid, and Medicare, Medicaid, and Children’s programs by focusing Children’s programs by focusing onon– What is known What is known now now
– What research What research gapsgaps are critical to fill are critical to fill
– Clinical effectivenessClinical effectiveness
Horizon Horizon ScanningScanning
EvidenceEvidence NeedNeed
IdentificationIdentification
Evidence Evidence SynthesisSynthesis
EvidenceEvidence GenerationGeneration
StrategiesStrategiesInterventionsInterventionsConditionsConditionsPopulationsPopulations
TranslationTranslation
DisseminationDissemination
ImplementationImplementation
ImprovementsImprovements inin
Health CareHealth Care
Research PlatformResearch PlatformInfrastructure – Methods Development – Training Infrastructure – Methods Development – Training
A Framework for CER at AHRQ
StakeholderStakeholder EngagementEngagement
Engaging the Public
Categorical Investments Categorical Investments in Evidence Generationin Evidence Generation
Distributed data networks and related Distributed data networks and related infrastructure development infrastructure development
Methods development Methods development Non-experimental/observational studies, both Non-experimental/observational studies, both
retrospective and prospectiveretrospective and prospective Sponsorship of pragmatic clinical trials addressing Sponsorship of pragmatic clinical trials addressing
key foci of comparative effectivenesskey foci of comparative effectiveness
Recovery Act: Recovery Act: Grants by Priority Condition*Grants by Priority Condition*
** Grants by Priority Condition, AHRQ Effective Health Care Program, May 2011Grants by Priority Condition, AHRQ Effective Health Care Program, May 2011
AHRQ Recovery Act AHRQ Recovery Act Evidence Generation ActivitiesEvidence Generation Activities
Request for Registries: the creation or enhancement of Request for Registries: the creation or enhancement of national patient registries, with a primary focus on the 14 national patient registries, with a primary focus on the 14 priority conditionspriority conditions
DEcIDE Consortium Support: Expansion of multi-center DEcIDE Consortium Support: Expansion of multi-center research system and funding for distributed data network research system and funding for distributed data network models that use clinically rich data from electronic health models that use clinically rich data from electronic health recordsrecords
Clinical and Health Outcomes Initiative in Comparative Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE): Coordinated national effort to Effectiveness (CHOICE): Coordinated national effort to establish a series of 10 pragmatic clinical comparative establish a series of 10 pragmatic clinical comparative effectiveness studieseffectiveness studies
iADAPT: Innovative dissemination and implementation iADAPT: Innovative dissemination and implementation grants for CERgrants for CER
A Word About TranslationA Word About Translation
Why is Translation Why is Translation Needed?Needed?
““Evidence may be necessary, but it is Evidence may be necessary, but it is certainly not sufficient. The findings of certainly not sufficient. The findings of research need to be translated into research need to be translated into information that is useful for each health information that is useful for each health care decision maker.”care decision maker.”
EisenbergEisenberg JAMA 1999; 282:1865-9.JAMA 1999; 282:1865-9.
If Researchers Ruled the If Researchers Ruled the WorldWorld
Food in grocery stores would be alphabetizedFood in grocery stores would be alphabetized Holiday sales would be advertised in peer Holiday sales would be advertised in peer
reviewed journalsreviewed journals School room size would be directly related to School room size would be directly related to
sample size needed for NNL (numbers needed sample size needed for NNL (numbers needed to learn)to learn)
Sagan EffectSagan Effect
One of the most frequently cited reasons for scientists’ One of the most frequently cited reasons for scientists’ reluctance to talk to the press is the so-called Carl Sagan reluctance to talk to the press is the so-called Carl Sagan effect, that is, renowned scientist Carl Sagan was criticized by effect, that is, renowned scientist Carl Sagan was criticized by his fellow scientists who assumed that because Sagan was his fellow scientists who assumed that because Sagan was spending so much time communicating with the public, he spending so much time communicating with the public, he must not have been devoting enough time to his research.must not have been devoting enough time to his research.
J. Hartz and R. Chappel, Worlds Apart: How the Distance Between Science and Journalism J. Hartz and R. Chappel, Worlds Apart: How the Distance Between Science and Journalism Threatens America’s Future. Nashville, TN: Freedom Forum First Amendment Center, 1997.Threatens America’s Future. Nashville, TN: Freedom Forum First Amendment Center, 1997.
Fact or FictionFact or Fiction
Throughout his career, Sagan averaged a Throughout his career, Sagan averaged a scientific peer-reviewed paper per scientific peer-reviewed paper per month.month.
Michael B. Shermer (August 2002). Social Studies of Science 32/4:489-525.Michael B. Shermer (August 2002). Social Studies of Science 32/4:489-525.
A Quantitative Analysis of Carl A Quantitative Analysis of Carl Sagan’s Scientific and Popular Sagan’s Scientific and Popular
Articles by YearArticles by Year
It is Hard to Change BeliefsIt is Hard to Change Beliefs
Popularization…is traditionally seen as a low Popularization…is traditionally seen as a low status activity, unrelated to research work, status activity, unrelated to research work, which scientists are often unwilling to do and for which scientists are often unwilling to do and for which they are ill-equipped…Essentially, which they are ill-equipped…Essentially, popularization is not viewed as part of the popularization is not viewed as part of the knowledge production and validation process knowledge production and validation process but as something external to research which but as something external to research which can be left to non-scientists, failed scientists or can be left to non-scientists, failed scientists or ex-scientists …ex-scientists …
Richard Whitley (1995), ‘Knowledge producers and knowledge acquirers: popularizations Richard Whitley (1995), ‘Knowledge producers and knowledge acquirers: popularizations as a relation between scientific fields and their publics,’ in Terry Shinn and Richard as a relation between scientific fields and their publics,’ in Terry Shinn and Richard Whitley (eds.), Expository Science: Forms and Functions of Popularization. Whitley (eds.), Expository Science: Forms and Functions of Popularization. Dordrecht/Boston, MA: D. Reidel PublishingDordrecht/Boston, MA: D. Reidel Publishing
Educating CliniciansEducating Clinicians
ConciseConcise ActionableActionable Paired with Paired with
consumer guidesconsumer guides Convey level of Convey level of
uncertainty/certainty uncertainty/certainty of findingsof findings
Informing Patients and Informing Patients and ConsumersConsumers
There is a suspicious area
on my mammogram
and my doctor said I need to have a breast
biopsy to tell if it is cancer. What are my
options?
Continuing Medical Continuing Medical Education/Continuing Education Education/Continuing Education
ActivitiesActivities
www.effectivehealthcare.ahrq.gov
What We’ve Learned (1)What We’ve Learned (1)
It is necessary to:It is necessary to:– Understand policy and practice context Understand policy and practice context
– Involve stakeholders earlyInvolve stakeholders early
– Broaden approach to evidenceBroaden approach to evidence
– Link evidence gaps to future researchLink evidence gaps to future research
– Translate findings for different audiencesTranslate findings for different audiences
What Have We LearnedWhat Have We Learned
Often, there are no clear Often, there are no clear winners and loserswinners and losers
Need to think of questions Need to think of questions years in advance of years in advance of decision makers askingdecision makers asking
It is amazing what we don’t It is amazing what we don’t know about common and know about common and ubiquitous treatmentsubiquitous treatments
ContactContact
Jean SlutskyJean SlutskyDirector, Center for Outcomes and EvidenceDirector, Center for Outcomes and EvidenceAgency for Healthcare Research and QualityAgency for Healthcare Research and Quality