Slide 1 What Can the Healthcare System Learn from 30 Years of Comparative Effectiveness Research in the VA?

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What Can the Healthcare System Learn from 30
Years of Comparative Effectiveness Research in
the VA?
Joel Kupersmith, MD Chief Research Development
Officer
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Rich 60 Year History

• Mission To discover knowledge and create
  innovations that advance the health and care of
  veterans and the nation.
• 3 Nobel Laureates, 6 Lasker Award Winners
• Many important discoveries and inventions
• Cardiac Pacemaker, First liver transplant,
  Radioimmunoassay, CT Scanner
• Clinical Trials
• First large scale clinical trial TB
• Cooperative Studies Program
• Trials strongly influence medical practice

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Comparative Effectiveness Research
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Comparative Effectiveness Research Definition
(FCC)

• Comparative effectiveness research is the conduct
  and synthesis of research comparing the benefits
  and harms of different interventions and
  strategies to prevent, diagnose, treat and
  monitor health conditions in real world
  settings. The purpose of this research is to
  improve health outcomes by developing and
  disseminating evidence-based information to
  patients, clinicians, and other decision-makers,
  responding to their expressed needs, about which
  interventions are most effective for which
  patients under specific circumstances.
• To provide this information, comparative
  effectiveness research must assess a
  comprehensive array of health-related outcomes
  for diverse patient populations and sub-groups.
• Defined interventions compared may include
  medications, procedures, medical and assistive
  devices and technologies, diagnostic testing,
  behavioral change, and delivery system
  strategies.
• This research necessitates the development,
  expansion, and use of a variety of data sources
  and methods to assess comparative effectiveness
  and actively disseminate the results..

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• MedPac Report to Congress June, 2008
• IOM (2008) Recommended that Congress direct
  Secretary of HHS to establish a single national
  clinical effectiveness assessment program,.
• AHIP (2007) Recommended a new publicprivate
  organization to compare the clinical and cost
  effectiveness of new and existing health care
  services..
• CBO (2007) Discussed expanding the role of an
  existing agency such as AHRQ or NIH creating
  or spinning off a new agency, either within
  HHS or as an independent body that is part of
  either the executive or the legislative branch
  augmenting an existing quasi-governmental
  organization such as IOM or the National Research
  Council or establishing a new publicprivate
  partnership, such as an FFRDC.
• Commonwealth Fund (2007) Recommended a
  quasi-governmental entity possessing legal
  characteristics of both the public and private
  sector, so that it could receive funding (and
  participation and support) from both.
• Wilensky (2006) Concluded that placing the CER
  center within a quasi-governmental entity was the
  most attractive alternative and that an FFRDC
  associated with either AHRQ or other HHS board
  were worth exploring.
• AcademyHealth (2005) Recommended establishing
  an entity either within or outside of AHRQ and
  reviewed four options
• Kupersmith et al. (2005) Recommended a
  publicprivate consortium to include federal
  agencies, payers, insurers, drug companies,
  device companies, patient advocacy and interest
  groups, professional societies, hospitals,
  academics, and health foundations. Under this
  proposal, new federal appropriations would fund
  the consortium, with the expectation that the
  private sector would also contribute
• Reinhardt (2004) Endorsed the creation of
  nonprofit independent institutions to analyze the
  cost effectiveness of drugs.

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Learning about Comparative Effectiveness Research
from the VA
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Relevance of VA Comparative Effectiveness Research
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Relevance of VA Research

• IOM Committee funded by ARRA listed the top 100
  priority items for CER funding
• VA s
• Priority items - 100
• N/A to VA 8
• VA research implemented 70 (76)
• 81, 79, 68 and 77 in each quartile
• In addition, VA studies have general
  applicability and have stood the test of time and
  repeatability
• Best journals, in Guidelines, etc

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VA Cooperative Studies Program -- Examples

• Computerized Tomography vs Positron Emission
  Tomography in solitary pulmonary nodule (PET
  better)
• Journal of Nuclear Medicine, 2008
• Sotolol vs Amiodarone in atrial fibrillation
  (similar)
• New England Journal of Medicine, May 5, 2005
• Standard care with without Phlebotomy in stable
  peripheral artery disease (no sign difference)
• Journal of the American Medical Association,
  February 14, 2007
• Medical therapy vs Coronary revascularization
  prophylaxis prior to elective vascular surgery
  (no sign difference)
• New England Journal of Medicine, December 30,
  2004

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VA Capability in Comparative Effectiveness
Research
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VA Capability

• VA capability
• Structure Infrastructure for CER
• Clinical Healthcare System
• Research embedded in the Healthcare System
• Process Research Programs and Results
• Outcomes Translation/Implementation
• Ultimately, impact on health

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StructureInfrastructure
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Large Healthcare System

• 5.5 million patients/yr, 7.8 million enrollees
• gt1200 Sites of Care
• 153 Medical Centers
• 768 Community-based Outpatient Clinics
• 232 Readjustment Counseling Centers
• Practice Network

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Large Capacity for Research

• Intramural research system - a unique strength
• Community of 3000 VA researchers embedded in the
  health care system
• 117 VAMCs have Federal Wide Assurances for
  research
• 2100 VA funded projects
• Electronic Health Record
• Infrastructure for clinical trials, Health
  Services Research and EHR analysis

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VA Infrastructure Reflects Needs in FCC CER
Report

• FCC CER report outlined infrastructure needs for
  CER
• These infrastructure capabilities already exist
  in VA (priority investments)
• Clinical research network
• Registries, surveillance databases,
  research-quality observational datasets
• Administrative databases
• EHRs distributed data networks
• Tools for dissemination and translation of
  research findings
• Human and scientific capital
• Clinician/Researchers 70 of VA researchers
• Training (eg Research Career Development Awards)
• Patient/consumer engagement

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ProcessResearch Programs for CER
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VA Programs in Comparative Effectiveness Research

• Research Processes for CER
• Cooperative Studies Program
• Clinical trials
• Health Services Research
• Health system oriented research

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VA Cooperative Studies Program

• Large VA clinical trials program
• Major vehicle for Comparative Effectiveness
  Research
• Method of funding projects
• Letter of intent submitted
• Ideas based on clinical practice observations,
  gaps in literature, etc
• Project review by experts who collaborate with
  the proposer
• Include clinicians, clinical researchers,
  trialists, biostaticians, pharmacists, others
• Review considerations include clinical and policy
  considerations
• Clinical relevance and importance to VHA
  population, methodology, feasibility (testable
  hypothesis, sample size), ethics, resources
  needed, investigator qualifications
• After approval, steps in a procedure include
• Central IRB approval

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Health Services Research - Ongoing

• Health systems oriented projects
• Laboratory based vs Home evaluation of sleep
  apnea
• Examples of studies vs usual care control
• Collaborative care model for depression
• Site randomization of Outpatient Clinics (CBOCs)
• Plain language decision aid for patient decision
  making in prostate cancer
• Collaborative care using primary care physician,
  RN and PharmD for hypertension/diabetes to
  implement strike risk management
• Patient preference tailored information
  concerning colon cancer screening
• Training caregivers with a Home Safety Toolkit in
  Alzheimers Disease

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EHR Analysis

• Analysis of EHR
• Compare treatments and approaches to care in
  clinically rich data in EHR
• Immediacy of results
• Less costly studies
• However, there are methodologic issues
• Example - EHR diabetes cohort database shows no
  difference in mortality among oral anti-diabetic
  drugs (Diabetes Care, July 2007)

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OutcomesImplementation/Translation
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Outcomes

• Implementation/Translation
• Quality Enhancement Research Initiative program
• Evidence Synthesis program
• Quality Research Enhancement Initiative
• Mission - Systematically implement/ translate
  evidence-based clinical practices research
  findings into routine clinical practice

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OutcomesImplementation/Translation

• Evidence Synthesis Program
• Reviewing the evidence on a topic
• Policy oriented synthesis of evidence to inform
  medical practice and health systems planning
• Informed by policy considerations with input by
  Patient Care Services
• Recent topics
• Drug management of BPH Led to Formulary change
• Osteoporosis Incorporated into Guideline on
  screening male veterans
• Pain in Polytrauma Need more research

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Influence of the Interest in CER on the Research
Establishment
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Influence of CER on the Research Establishment

• Interest in and movement to Comparative
  Effectiveness Research will change the way
  research is conducted
• How research projects are identified and chosen
• What research methodology is accepted
• Moving beyond the Randomized Controlled Trial
• VA has already moved in these areas

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Use of Comparative Effectiveness Research
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Results of Comparative Effectiveness Research

• Informed choices for
• Patients
• Providers
• Healthcare system
• Informed choices will in fact be via a complex of
  interdigitating and interacting research
  vehicles
• Comparative Effectiveness Research
• Research related to Personalized/Individualized
  Medicine
• Genomics and other approaches to examine the
  individual in his person and setting (genetic
  make-up, coexisting conditions, location, etc)

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VA Research Improving Veterans Lives Thank You