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Overview of the DEcIDE Research Network

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Title: Overview of the DEcIDE Research Network


1
Overview of the DEcIDE Research Network
Agency for Healthcare Research Quality Center
for Outcomes Evidence December, 2005
2
Terms of Use
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    program affiliates, but it is requested that in
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    (AHRQ) be given appropriate acknowledgement. In
    addition, a disclaimer should be provided stating
    no official endorsement by AHRQ or DHHS is
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  • Individuals not authorized to use the AHRQ logo
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  • If you use some or all of these slides, please
    send a brief email to effectivehealthcare_at_ahrq.gov
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    your suggestions. Thank you!

3
New authorization by MMA.
  • Authorizes AHRQ to conduct research to improve
    the quality, effectiveness, and efficiency of
    Medicare, Medicaid, and State Children Health
    Insurance (SCHIP) programs.
  • Evidence synthesis
  • Transparent process of systematically reviewing
    and synthesizing evidence on treatment
    effectiveness.
  • Identifying relevant knowledge gaps.
  • Evidence generation
  • Development of new scientific knowledge to
    address knowledge gaps.
  • Evidence communication/translation
  • Communication of scientific information in plain
    language to policymakers, patients, and providers.

3
4
4
5
Evidence Generation
  • new DEcIDE Research Network
  • Developing Evidence to Inform Decisions about
    Effectiveness
  • The main purpose of the DEcIDE network is to
    expeditiously develop valid scientific evidence
    about the outcomes, comparative clinical
    effectiveness, safety, and appropriateness of
    health care items and services
  • The network is comprised of academic, clinic, and
    practice-based centers with access to electronic
    health information databases and the capacity to
    conduct accelerated research.

5
6
What Will DEcIDE Do?
6
7
2005-06 Priority List
  • Arthritis and non-traumatic joint disorders
  • Cancer
  • Chronic obstructive pulmonary disease/asthma.
  • Dementia, including Alzheimer's disease
  • Depression and other mood disorders
  • Diabetes mellitus
  • Ischemic heart disease
  • Peptic ulcer/dyspepsia
  • Pneumonia
  • Stroke, including control of hypertension

8
Why the Need for Effectiveness Research?
  • Interventions that are efficacious under a highly
    specific set of circumstances often fail to
    replicate across a wide variety of settings,
    conditions, patients.

Glasgow, 2003
9
A Guiding Principle Within the Center for
Outcomes Evidence
  • Perhaps a more salient question is what we can
    do now, within the current infrastructure, to
    move effectiveness research forward so that
    everyone can reap the benefits of the most
    unprecedented bounty of biomedical research
    findings in our lifetime.

Clancy C and Slutsky J. JOURNAL OF INVESTIGATIVE
MEDICINE Volume 53 Number 2 February 2005
9
10
Overview of Slide Series
  • For Each DEcIDE Center, the following information
    is provided in the subsequent slides.
  • DEcIDE Name
  • Core Personnel Expertise
  • Affiliations and Partnerships
  • Research Interests Center Strengths
  • Key Database Holdings
  • DEcIDE Project(s)
  • Program Center Goals

11

DEcIDE Research Centers
http//effectivehealthcare.ahrq.gov/decide/index.
cfm
11
12
DEcIDE Centers
  • Acumen, LLC.
  • Brigham and Womens Hospital
  • Duke University
  • Harvard Pilgrim Health Care, Inc.
  • Johns Hopkins University
  • Outcome Sciences
  • RTI International
  • University of Colorado at Denver and Health
    Sciences Center
  • University of Illinois at Chicago
  • University of Maryland at Baltimore
  • University of North Carolina at Chapel Hill
  • University of Pennsylvania School of Medicine
  • Vanderbilt University Medical Center

13
13
14
14
15
Acumen DEcIDE Center
  • Thomas MaCurdy, PhD
  • Principal Investigator

16
Acumen - Core Personnel Expertise
  • Dr. Thomas MaCurdy, Ph.D. Economics Health
    policy research, program evaluation using
    administrative and survey data, statistical
    modeling, behavioral research, economic analysis,
    financing of health care (Acumen LLC, Stanford
    University)
  • Dr. John Hornberger, M.D., M.S. Health
    economics, comparative effectiveness, decision
    analysis, technology assessment, cross-cultural
    medicine (Acumen LLC)
  • Dr. Sandra Wilson, Ph.D. Psychology Design and
    assessment of care delivery systems, chronic
    disease care, vulnerable populations,
    caregiver-patient interaction (PAMFRI)

17
Acumen - Core Personnel Expertise (cont)
  • Dr. Mark Holodniy, M.D. Infectious Disease.
    Outcomes research. Variation in practice patterns
    and outcomes. Epidemic preparedness and control.
    (Palo Alto VA)
  • Dr. Grecia Marrufo, Ph.D. Economics Health
    policy research, econometrics, large database
    management, program evaluation (Acumen LLC)
  • Dr. Alan Garber, M.D. Ph.D. Econmics Health
    economics. Guideline development, evidence
    reviews, cost-effectiveness analysis, assessment
    of innovative technologies and strategies
    (Stanford University)

18
Acumen - Affiliations and Partnerships
  • VA Public Health Strategic Health Care Group
    (PHSHG), VA Palo Alto Health Care System
  • Palo Alto Medical Foundation Research Institute.
    (Sutter Health affiliate)
  • Center for Primary Care and Outcomes Research,
    Stanford University

19
Acumen - Research Interests Center Strengths
  • Methodology
  • Development of research databases and
    computerized surveillance and monitoring systems
  • Econometrics, decision analyses,
    cost-effectiveness analyses
  • Risk adjustment
  • Pay for performance, influence of incentives on
    behavior
  • Policy and program evaluation

20
Acumen - Research Interests Center Strengths
  • Programmatic
  • Medicare, Medicaid, SCHIP, VA
  • State and county health agencies
  • Managed care organizations
  • Fields
  • Health service delivery finance systems
  • Novel pharmaceuticals, diagnostics, devices

21
Acumen - Key Database Holdings
  • 100 files of Medicare claims and enrollment data
    for 1997-2004
  • Inpatient, outpatient, SNF, home health, hospice,
    DME carrier (Standard Analytical Files)
  • Denominator DSH (1991- ), MedPar (1984- ),
    MCBS, HISKEW, Provider, UPIN, CAHPS, HOS
  • 100 files of enrollment, FFS claims and county
    operated health system data for California
    Medicaid 1994-2004

22
Acumen - Key Database Holdings VA PHSHG and
PAMFRI
  • HIV clinical case registry (HIV CCR)
  • All HIV infected veteran VA utilization data
    (1992-present)
  • Hepatitis C virus (HCV) clinical case registry
    (HCV-CCR)
  • All HCV infected veteran VA utilization data
    (1996-present)
  • Clinical, registration, billing, enrollment and
    cost data for all PAMF patients (2002-present,
    some 1991-present)

23
Acumen - DEcIDE Project
  • Data Development for Patient Safety A Pilot
    Study using Medicare Part B Drug Data
  • Establish data structures based on Medicare
    claims linking interventions and outcomes
    relevant for the surveillance of adverse drug
    events
  • Creation of statistical approaches for analyzing
    claims data to detect adverse events
  • Pilot framework with Part B data to accommodate
    use with Part D data

24
ABSTRACT Data Development for Patient Safety A
Pilot Study using Medicare Part B Drug Data
  • Abstract Medicare administrative claims data
    offer a valuable informational source for the
    surveillance of adverse drug events, but there
    are substantial challenges in exploiting these
    data to screen for potential patient safety
    problems. The merits of these data include large
    samples covering the spectrum of the elderly and
    disabled and data accessible at relatively low
    costs. Medicare claims provide a broad picture of
    the health services received by individuals, with
    considerable diagnosis information recorded
    across many provider types. As Medicare Part D
    records become available, the claims data will
    also incorporate the use of pharmaceuticals. In
    sharp contrast to clinical trials and
    experimental data, one can draw on claims data to
    assess potential safety problems on a rapid
    turnaround basis, investigating both current and
    recent past experiences to uncover adverse
    outcomes. There are two central challenges in
    using claims data for the surveillance of drug
    safety (1) The development of frameworks to
    organize claims data into structures that link
    relevant interventions, outcomes and patient
    characteristics for the study of pharmaceuticals
    under investigation and (2) The formulation of
    statistical approaches to analyze these data to
    detect adverse events. This project will develop
    a data system and empirical framework for
    identifying and capturing adverse drug events
    using elements contained in the Medicare claims
    files. The analysis will exploit information
    available in Part B claims on drugs, to produce a
    framework that can be readily adapted to
    incorporate Part D claims when they come on line
    next year.

25
Acumen - Program Goals
  • Goals for Acumen DEcIDE Center
  • Formulate empirical approaches to reliably
    conduct comparative effectiveness and patient
    safety analyses using medical claims/records
  • Structure findings to inform policy decisions
  • Develop practical computerized surveillance and
    monitoring systems for tracking adverse events
    associated with medical interventions

26
Brigham and Womens Hospital DEcIDE Research
Center at Harvard Medical School, Boston
  • Sebastian Schneeweiss, MD, ScD

27
BW - Core Personnel Expertise
  • Sebastian Schneeweiss, MD, ScD (Pharmacoepidemiolo
    gy)
  • Jerry Avorn, MD (Geriatric Health Services)
  • David Bates, MD, MPH (Medication Safety)
  • Robert Glynn, PhD, ScD (Biostatistics)
  • Jennifer Haas, MD, MPH (Health Services)
  • Peter Neumann, ScD, (Pharmacoeconomics)
  • Daniel Solomon, MD, MPH (Antiinflammatories)
  • Philip Wang, MD, DPH, (Psychotropics)

28
BW - Affiliations and Partnerships
  • Brigham Womens Hospital
  • - Pharmacoepidemiology
  • - General Internal Medicine
  • Harvard School of Public Health
  • - Harvard Center for Risk Analysis
  • New England Medical Center
  • - The Health Institute

29
BW - Research Interests Center Strengths
  • Comparative effectiveness of
  • Psychotropics
  • NSAIDs
  • Biologic agents
  • and a range of other drugs
  • Developing methods for comparative effectiveness
    research using observational data
  • Drug policy evaluation and development
  • Academic outreach for improved prescribing

30
BW - Key Database Holdings
  • Medicare (2 states, linked to pharmacy assistance
    programs, deaths with causes, geocoded physician
    information)
  • - Medicaid (1 state)
  • - MCBS, MEPS
  • Province of British Columbia (all residents, drug
    use independent of payor, hospitalization,
    physician services and specialty deaths with
    causes, long-term care)
  • Partners Health Care Longitudinal EMR of
    hospital and outpatient care

31
BW - DEcIDE Project(s)
  • Health Outcomes of Antipsychotic Treatment in
    Older Adults
  • Atypical vs. conventional APMs
  • Outcomes Death, MI, cardiac arrhythmia,
    pneumonia
  • Medicare population of low income status
  • General elderly population in BC
  • Multivariate analyses, Propensity score,
    Instrumental Variables

32
Health Outcomes of Antipsychotic Treatment in
Older Adults
  • Abstract In April 2005 the US Food and Drug
    Administration (FDA) issued an Advisory that
    atypical antipsychotic medications (APMs)
    increase mortality in older patients with
    dementia. However, the Advisory and the Black
    Box warnings added to the labels of atypical
    APMs did not cover older conventional APMs.
    Concerns have been raised that, in their search
    for therapeutic alternatives, physicians may
    simply switch their elderly patients from
    atypical APMs to these older conventional agents.
    Unfortunately, the safety of these conventional
    APMs in elderly populations is not well
    understood. Specific Aim To investigate whether
    the risk of death as well as possible
    intermediary outcomes such as acute myocardial
    infarction (MI), cardiac arrhythmia, and
    pneumonia, differ for conventional vs. atypical
    APM use by elderly with dementia or in nursing
    homes. Study design We propose two cohort
    studies of initiators of antipsychotics in a
    state Medicare and in British Columbia. Many
    individuals in the state Medicare population gt65
    are vulnerable elderly patients with low incomes
    and high levels of comorbid illness severity. To
    increase generalizability we will conduct a
    parallel analysis in British Columbia, which is
    truly population representative for patients 65
    years or older. A 180-day follow-up period was
    chosen based upon the duration of trials in the
    FDAs reanalysis, which ranged from 4-26 weeks.
    Study outcomes Death as identified in vital
    statistics data including cause of death acute
    MI, ventricular arrhythmia, and pneumonia as
    identified in claims data. Analysis Unadjusted
    and multivariable Cox proportional hazards models
    will be constructed. In confirmatory analyses, we
    will repeat Cox models using propensity score
    adjustments to balance independent risk factors
    for outcomes between drug user groups. We will
    also use instrumental variable analysis to
    provide unbiased estimates even if important
    confounding variables are unmeasured.

33
BW - Program Goals
  • PI goals for BWH DEcIDE Research Center
  • Develop comparative effectiveness research in
    older adults using health care utilization
    databases
  • Drug policy evaluation in light of MMA

34
http//www.brighamandwomens.org/pharmacoepid/Facul
ty.asp
35
Duke University DEcIDE Center
  • David Matchar, MD
  • SLIDES PENDING

36
Duke University
  • Project Treatment of In-Stent Restenosis
  • SLIDES PENDING

37
HMO Research Network CERTs DEcIDE Center at
Harvard Pilgrim / Harvard Medical School
  • Richard Platt, MD

38
HMORN - Core Personnel Expertise
  • Richard Platt, MD, MS Pharmacoepidemiology,
    infectious disease epidemiology.
  • Alan Go, MD Internist, clinical epidemiologist
    focus on cardiovascular and renal disease.
  • Eric B. Larson, MD improving quality of care,
    technology assessment, aging and dementia.
  • Joe V. Selby, MD, MPH family physician, diabetes,
    primary care delivery, and quality improvement
    research.

39
HMORN - Core Personnel Expertise
  • Edward H. Wagner, MD, MPH -PI Cancer Research
    Network
  • Mark C. Hornbrook, PhD, health economics, health
    status measurement, and managed care data
    systems. 
  • Stephen B. Soumerai, ScD effectiveness of
    interventions to improve drug prescribing
    economic access to medications effects of
    cost-containment and coverage policies among
    vulnerable populations. 

40
HMORN - Core Personnel Expertise
  • Tracy Lieu, MD, MPH pediatrician / health
    services researcher
  • Jerry H. Gurwitz, MD geriatric medicine and the
    use of drug therapy in the elderly
  • Michael Von Korff, ScD chronic illness
  • Gregory Simon, MD, MPH psychiatry, psychotherapy
  • John Hsu, MD, MBA medical decision making, impact
    of prescription drug cost-sharing

41
HMORN - Affiliations and Partnerships
  • HMORN Multi-center collaborations
  • NIH Collaborative Clinical Studies Network
  • CDC Vaccine Safety Datalink
  • NCI Cancer Research Network
  • HMORN Participating HMOs
  • Meyers Primary Care Institute UMass /Fallon
    Community Health Plan, Worcester MA
  • Group Health Cooperative, Seattle, WA
  • Kaiser Permanente Hawaii, Northwest, Colorado,
    Southern California, Northern California and
    Georgia regions
  • HealthPartners Research Foundation, Minneapolis,
    MN
  • Henry Ford Health System, Detroit, MI
  • Lovelace Clinic Foundation, Albuquerque, New
    Mexico

42
HMORN - Research Interests Center Strengths
  • The HMORN DEcIDE Center will maximize its access
    to health plans resources to develop information
    about therapeutic effectiveness within typical
    clinical settings. We will work directly with
    health plan decision makers, providers and health
    plan members to create and implement novel
    analytical tools and intervention capabilities to
    improve public health.

43
HMORN - Key Database Holdings
  • Automated data of 11 health plans with 7.7
    million combined members.
  • Accessible data includes
  • electronic medical records,
  • claims systems (utilization, pharmacy, lab), and
  • membership demographic /eligibility data.

44
HMORN - DEcIDE Project(s)
  • TO 1 Effectiveness of ?-Adrenergic Antagonists
    on the Risk of Rehospitalization in Adults with
    Diagnosed Heart Failure
  • Among adults hospitalized for heart failure
    between 2001- 2003 and followed through 2004
    within two large health plans we will
  • examine the rates and predictors of prescription
    of different ß-blockers following discharge.
  • evaluate the association between different
    ß-blockers and the risks of heart
    failure-specific and all-cause re-hospitalization.

45
Comparable Effectiveness of Beta-Adrenergic
Antagonists on the Risk of Rehospitalization in
Adults with Diagnosed Heart Failure
  • Abstract We propose to study a contemporary
    cohort of adults hospitalized for heart failure
    between 2001-2003 and followed through 2004
    within two large health plans. Specifically, we
    propose to accomplish the following two Specific
    Aims Aim 1. To examine the rates and predictors
    of prescription of different ß-blockers following
    discharge in persons hospitalized for heart
    failure. Hypothesis 1a Despite the lack of
    randomized clinical trial evidence for ß-blockers
    other than extended-release metoprolol,
    carvedilol and bisoprolol, atenolol and
    shorter-acting metoprolol will be prescribed
    substantially more often in persons recently
    discharged for heart failure who receive
    ß-blocker therapy. Hypothesis 1b Older age,
    gender, coexisting illnesses, prior use and type
    of ß-blocker therapy, use of digoxin (as a proxy
    for reduced systolic function), and previous
    hospitalizations for heart failure will be
    predictors of the type of ß-blocker received. Aim
    2. To evaluate the association between receipt of
    different ß-blockers and the risks of heart
    failure-specific and all-cause rehospitalization
    among persons hospitalized for heart failure who
    are treated with ß-blocker therapy after
    discharge. Hypothesis 2a The rate of
    rehospitalization will not vary among patients
    receiving different types of ß-blockers, after
    adjustment for potential confounders and
    propensity score. Hypothesis 2b The associations
    between different ß-blockers and risk of
    rehospitalization will be consistent across
    categories of age, gender, concurrent use of
    digoxin (as a proxy for reduced systolic
    function), and the presence or absence of
    diabetes mellitus or hypertension. The proposed
    study will provide important initial insights
    about the comparable utility of different
    ß-blockers within a large, diverse population of
    patients with heart failure cared for in typical
    clinical care settings.

46
HMORN - Program Goals
  • Develop and disseminate strategies for the
    appropriate and equitable delivery of
    therapeutics

47
Johns Hopkins University DEcIDE Center
  • Albert W. Wu, MD, MPH, PI
  • Eric B. Bass, MD, MPH, Co-PI

48
JHU - Core Personnel Expertise
  • Gerard Anderson, PhD Health Policy
  • Eric Bass, MD, MPH Technology Assessment
  • Sydney Dy, MD, MPH Quality of Care
  • Dan Ford, MD Mental Health Outcomes
  • Laura Morlock, PhD Organization Management
  • Jodi Segal, MD Clinical Epidemiology
  • Don Steinwachs, PhD Health Services Research
  • Albert Wu, MD, MPH Patient Outcomes
  • Scott Zeger, PhD Statistical Methods

49
JHU - Affiliations and Partnerships
  • Johns Hopkins Bloomberg School of Public Health
  • Johns Hopkins Medical Institutions
  • Johns Hopkins School of Medicine
  • Johns Hopkins School of Nursing
  • Ingenix, Inc.

50
JHU - Research Interests Center Strengths
  • Analyses of utilization and outcomes using large
    administrative datasets
  • Analysis of clinical outcomes using cohort data
  • Quality of care and patient safety
  • Cost-effectiveness of medications and new
    technologies
  • Systematic reviews of evidence
  • Analytic methods for longitudinal data and risk
    adjustment
  • Chronic conditions including hypertension,
    cardiovascular dsease,  diabetes mellitus, and
    hematologic disorders

51
JHU - Key Database Holdings
  • Multi-year Medicare longitudinal databases
  • 5 sample for 1997-2003
  • 100 sample for 1999-2002
  • US Pharmacopeia MEDMARX
  • Intensive Care Unit Safety Reporting System
    (ICU-SRS)
  • i3Magnifi (an Ingenix company) pharmacy claims
    databases

52
JHU - DEcIDE Project(s)
  • Comparative Effectiveness and Safety of New
    Therapies for Glucose Control in Diabetes
    Mellitus
  • Aims of this project are to develop methodology
    to allow for the rapid evaluation of new
    therapies, using large administrative databases
    and to analyze such a dataset to evaluate the
    safety and effectiveness of inhaled insulin (or
    other new treatment) for diabetes.

53
Comparative Effectiveness and Safety of New
Therapies for Glucose Control in Diabetes
Mellitus
  • Abstract Investigators will be evaluating the
    comparative effectiveness and safety of a new
    therapy for treatment of diabetes mellitus (DM).
    To do so, the team will devise appropriate and
    novel methodology for the study of the
    effectiveness of inhaled insulin using large
    administrative datasets. The study team will
    include experts in the design of observational
    studies and analysis of large data sets, as well
    as experts in DM research. The project will use
    unique databases, which include information on
    patient characteristics, medication use, clinical
    outcomes, and resource utilization. The study
    will examine the initial pattern of use of
    inhaled insulin. The study will identify
    comparison groups of patients with DM, and
    estimate outcome rates during a three to six
    month period, focusing on clinical outcomes such
    as medication-related adverse events, and
    resource utilization including hospitalization
    rates and costs. The study will compare the
    outcome rates in the comparison populations to
    the rates among recipients of the new therapy.
    An important question will be to identify
    potential adverse events related to treatment,
    including pulmonary complications. As these will
    be observational studies, the investigators will
    carefully address risk adjustment by using
    propensity scores, sensitivity analyses or other
    methods. The study will be one of the first
    efforts to use a large administrative dataset to
    evaluate the diffusion, effectiveness and safety
    of a new medication in its first year of use.
    The methods developed and results obtained should
    have wide applicability for future research,
    policy, and practice.

54
JHU - Program Goals
  • PI goals for DEcIDE Center
  • To develop the capacity to conduct rapid
    evaluations of the use, effectiveness and safety
    of new treatments using large administrative
    datasets
  • To foster policy relevant research involving
    scientists and clinicians across the University
  • To develop new research tools that can be used
    for effectiveness and outcomes research using
    large datasets

55
Outcome DEcIDE Center at Outcome Sciences, Inc.
  • Richard E. Gliklich, MD

56
Outcome - Core Personnel Expertise
  • Richard Gliklich MD, Principal Investigator
  • 21 years experience in real-world observational
    and investigational studies. Designed and
    implemented more than 70 registries and high
    quality prospective data programs.
  • Nancy A. Dreyer, MPH, PhD, Program Director
  • 30 years experience in epidemiology and drug
    safety.
  • Fiona Smith, MPH Project Manager
  • 7 years experience working on projects with CMS
    and AHRQ.

57
Outcome - Core Personnel Expertise
  • Additional core and collaborative personnel with
    expertise in
  • program design
  • informatics
  • privacy
  • quality
  • pharmacoeconomics and
  • analytics related to registries, post-approval
    studies, quality initiatives and safety
    surveillance programs.

58
Outcome - Affiliations and Partnerships
  • American Heart Association (AHA)
  • Largest independent supporter of cardiovascular
    disease research. Partner for Get With The
    Guidelines (sm) programs.
  • Primary Care Network (PCN)
  • Association of 72,000 health care providers and
    professionals
  • Consortium of Rheumatology Researchers of North
    America (CORRONA)
  • Nationwide network of practicing rheumatologists
  • Other Affiliations
  • Many additional partnerships and affiliations
    with large health care provider networks and
    medical specialty associations

59
Outcome - Research Interests Center Strengths
  • The Outcome DEcIDE Center is particularly
    well-suited to developing and implementing
    registries and other prospective data capture and
    surveillance programs.
  • Expertise and experience in developing and
    managing registries (more than 70 initiated)
  • Existing, productive networks in several of the
    Priority Conditions connected through a common
    information platform
  • gt2500 hospitals and several thousand physician
    offices and pharmacies are currently
    participating in prospective data programs
  • Informatics expertise and infrastructure for
    collecting data directly from practitioners and
    patients via web, IVR, fax, and from existing
    health information systems
  • Rapid, large scale prospective study execution in
    real-world clinical sites

60
Outcome - Key Database Holdings
  • Existing data from
  • Cardiovascular disease and stroke registries
  • Rheumatologic disease registries
  • Oncology registries

61
Outcome - DEcIDE Project(s)
  • Establishing Registries for Evaluating Patient
    Outcomes Defining Standards
  • Produce a reference for the design and use of
    successful registries both for registries that
    may be required by CMS and registries set up for
    other purposes in both the public and private
    sectors. It will focus on establishing standards
    for
  • Creation and operation of registries
  • Evaluation of registries
  • Scientific evaluation of outcomes using registry
    data

62
Establishing Registries for Evaluating Patient
Outcomes Defining Standards
  • Abstract The purpose of this project is to
    produce a reference for the design and use of
    successful registries. The project will produce a
    web-based reference document defining standards
    and best practices. It will be organized into
    three sections creation and operation of
    registries designed to answer scientific
    questions about patient outcomes of treatment
    evaluation of registries and scientific
    evaluation of outcomes using registry data.
    During the course of the project a workshop will
    be convened that will include scientists and
    technologists with expertise in the design,
    implementation and analysis of registries data.

63
Outcome - Program Goals
  • PI goals for DEcIDE Center
  • Promote rapid generation of high-quality
    prospective data to better evaluate health care
    products, therapies and services
  • Serve as a resource to and collaborator with
    other DEcIDE Centers
  • PI suggested goals for the AHRQ DEcIDE Network
  • Become the primary pathway for evidence
    development within HHS through a consistent track
    record of excellence, speed and efficiency

64

201 Broadway Cambridge, MA 02139
65
RTI DEcIDE Center
  • Kathleen N. Lohr, Ph.D., Principal Investigator
  • Lucy A. Savitz, Ph.D., MBA, Co-PI
  • RTI International (www.rti.org)
  • 3040 Cornwallis Drive
  • Research Triangle Park, NC USA

66
RTI - Core Personnel and Expertise
  • Kathleen Lohr, PhD evidence-based practice,
    quality of care, quality of life assessment,
    health policy
  • Lucy Savitz, PhD, MBA patient safety, quality
    improvement, health informatics, organizational
    development, research translation
  • Linda Lux, MPA evidence-based practice, chronic
    disease, project management

67
RTI - Affiliations and Partnerships
  • Intermountain Health Care Brent James, MD,
    M.Stat.
  • Baylor Health Care System David Ballard, MD,
    Ph.D.
  • Providence Health System K. Bruce Bayley, Ph.D.
  • HealthInsight (UT-NV QIO) Scott Williams, MD,
    MPH
  • Utah Department of Health Wu Xu, Ph.D.
  • VA IDEAS Center Matthew Samore, MD, MPH
  • National Association of Health Data
    Organizations
  • Denise Love, MBA, RN
  • Governor Scott M. Matheson Center for Health Care
  • Studies, University of Utah Richard Sperry,
    Ph.D.

68
RTI - Research Interests and Center Strengths
  • Research Interests
  • Clinical and therapeutic effectiveness studies
  • Quality of care and patient safety
  • Pharmaceutical and Medicare Part D studies
  • Strategies for improving the efficiency and
    effectiveness
  • (organization, management, delivery) of
    health care
  • Center Strengths
  • Cohesive research laboratory for registry and
    database analyses, using GIS and sophisticated
    statistical applications
  • Extensive network of health systems and public
    and private sector organizations
  • Special capabilities in clinical medicine,
    patient safety, quality improvement,
    evidence-based practice, and health information
    technology
  • Deep knowledge of, experience with related AHRQ
    programs
  • Keen grasp of pressing Medicare, Medicaid,SCHIP
    issues

69
RTI - Key Database Holdings
  • Intermountain Health Care (IHC) EMR EDW with
    prepared data marts case mix system health
    plans database, Master Member Index
  • Providence Health System (PHS) EMR EDW case
    mix system unusual occurrence (event) reporting
    database health risk screen Databases cardiac
    care and stroke registries health plans
    database
  • Baylor Health Care System (BHCS) EMR EDW with
    prepared data marts case mix system
  • HealthInsight Medicare and Medicaid databases,
    cost report data
  • SLC Veterans Affairs Medical Center (VA) EMR
    for all inpatient and outpatient case services
  • Utah Department of Health, Office of Health Care
    Statistics Utah Population Database Utah
    Hospital, All Payer, Inpatient Discharge Database
    (with Ambulatory Surgery Database Emergency
    Department Encounter Database subsets)
  • EMR electronic medical record EDW enterprise
    data warehouse

70
RTI - DEcIDE Project(s)
  • Medicare Prescription Drug Data Development
    Methods for Improving Patient Safety and
    Pharmacovigilance Using Observational Data
  • Critically assess current techniques and methods
    for pharmacoepidemiologic and pharmacovigilance
    research, standardize drug prescription
    statistics and drug safety measures, create
    simulated database, and conduct pilot studies
  • Judith Shinogle, Ph.D., Project Director
  • Effective Health Care Patient Safety and
    Therapeutic Effectiveness
  • Support the EHC program by planning a series of 3
    DEcIDE meetings and developing a journal
    supplement on these topics
  • Lucy Savitz, Ph.D., MBA, Project Director

71
Medicare Prescription Drug Data
Development Methods for Improving Patient Safety
and Pharmacovigilance Using Observational Data
  • Abstract The Medicare Modernization Act and the
    Medicare Part D benefit offers new resources in
    pharmacoepidemiology. The investigators will
    develop a methodological toolbox and data
    analytical framework for pharmacoepidemiologic
    research using population-based claims and
    administrative data sources. The investigators
    will first perform a critical assessment of
    current techniques and methods used in
    pharmacoepidemiologic and pharmacovigilance
    research. From this literature review and with
    input stakeholders, the investigators will
    develop an evidence-based approach to
    standardizing drug prescription statistics and
    process or outcome measures of the safety of
    drugs or drug classes for specific clinical
    conditions. In conjunction with our DEcIDE
    partners, we will develop a database that links
    pharmacy, outpatient, inpatient, physician
    office, and emergency department claims. This
    simulated database will be similar to the one
    that will be available from the Centers for
    Medicare and Medicaid Services once the Medicare
    Prescription Drug Benefit is operable. Finally,
    using these data, the investigators will conduct
    pilot studies to examine the feasibility of
    prototypical measures pertaining to specific
    drugs or classes of drugs identified from the
    earlier tasks.

72
Effective Health Care Patients Safety and
Therapeutic Effectiveness
  • Abstract The investigators will carry out a
    three-faceted task on Effective Health Care
    Therapeutic Effectiveness and Patient Safety.
    Investigators will first attend and summarize
    three AHRQ meetings on Genomics and Medicine,
    Medication Therapy Management (MTM) Programs,
    and Health Care for Older Adults with Multiple
    Health Conditions. Second, drawing on critical
    issues identified at these AHRQ meetings, the
    investigators will then plan and convene a major
    evidence showcase meeting on therapeutic
    effectiveness (particularly pharmaceuticals,
    especially in light of the Medicare Modernization
    Act and the onset of the Medicare Part D benefit
    for outpatient drugs) and patient safety. The
    third element of the project is to solicit or
    invite papers as possible manuscripts for a
    journal supplement to be published in late 2006
    to early 2007. The overall theme of the journal
    supplement will be effective health care,
    particularly the links between therapeutic
    benefits and harms, on the one hand, and patient
    safety, on the other. Papers may come from the
    evidence showcase meeting, other DEcIDE Centers,
    and other AHRQ-supported organizations.

73
RTI - Program Goals
  • Goals for RTI DEcIDE Center
  • 1. Conduct rapid-cycle research in therapeutic
    effectiveness, patient safety, and quality of
    care issues with a focus on Medicare, Medicaid,
    and SCHIP Program populations.
  • 2. Develop methods to advance data collection,
    database design, analysis, and information
    dissemination to improve quality of care and
    patient safety through applied health services
    research.
  • 3. Working with our partners, AHRQ, other
    DEcIDE Centers, and other AHRQ programs, create
    tools and analytic approaches to accomplish
    DEcIDE program goals.
  • Suggested Goals for AHRQ DEcIDE Network
  • 1. Achieve fruitful collaborations between AHRQ
    and other federal agencies, across the DEcIDE
    Centers, and across AHRQ programs in comparative
    effectiveness studies.
  • 2. Identify and pursue mechanisms for shared
    learning and accelerated diffusion of research
    findings.
  • 3. Translate research results into practical
    tools and strategies to promote safe and high
    quality health care delivery.

74
RTI - DEcIDE Center
74
75
CO-DEcIDE Collaboration at the University of
Colorado at Denver and Health Sciences Center
  • John F. Steiner, MD, MPH
  • Principal Investigator

76
CO - Core Personnel Expertise
  • John F. Steiner, MD, MPH primary care,
    adherence
  • David West, PhD Medicaid, primary care
  • Karl Hammermeister, MD cardiovascular disease
  • William Henderson, PhD surgical/ perioperative
    care
  • Andrew Kramer, MD post-acute/nursing home care,
    Medicare policy
  • Richard Hamman, MD, DrPH diabetes, epidemiology
  • Robert Valuck, PhD Medicaid, mental health
  • Wilson Pace, MD primary care, practice-based
    research
  • And others….

77
CO - Affiliations and Partnerships
  • University of Colorado Health Sciences Center
  • Colorado Health Outcomes Program
  • Childrens Outcomes Research Program
  • SNOCAP Practice-based Research Network
  • Department of Preventive Medicine/Biometrics
  • School of Pharmacy
  • Division of Healthcare Policy and Research
  • Abt Associates
  • Medical Group Management Association
  • Robert Graham Center
  • American Academy of Family Physicians National
    Research Network

78
CO - Research Interests Center Strengths
  • Quality and Safety of drugs and devices in
  • Primary Care
  • Child Health (Medicaid, SCHIP)
  • Post-acute and Long-term Care
  • Mental Health Care
  • Cardiovascular Diseases
  • Diabetes
  • Underserved Populations
  • Palliative Care
  • Organization delivery of pharmaceutical care

79
CO - Key Database Holdings
  • National Surgical Quality Improvement Programs
  • VA, Private Sector
  • Primary Care Research Unit secondary
  • dataset library (NAMCS, MEPS, HCUP, etc.)
  • National Home Care and Hospice Survey
  • Medicare Datasets MCBS, OASIS, Medicare
  • claims, MEDPAR stroke data
  • PHARMetrics integrated outcomes database
  • Multi-state Medicaid database

80
CO - DEcIDE Project(s)
  • Task Order 1 Medical Management of
  • Congestive Heart Failure and the
    Effectiveness of Isosorbide Dinitrate and
    Hydralazine

81
Medical Management of Congestive Heart Failure
and the Effectiveness of Isosorbide Dinitrate and
Hydralazine
  • Abstract Heart failure results in significant
    mortality and morbidity despite the benefits ACE
    inhibitors, beta-blockers, and aldosterone
    inhibition. This has led to investigation of
    adjunctive therapies, including the combination
    of hydralazine and isosorbide. The recent A-HeFT
    trial found that this combination was effective
    in reducing mortality and heart failure
    hospitalizations in self-identified African
    Americans receiving conventional therapy for
    heart failure. The study created additional
    questions about the effectiveness of this
    combination in unselected community-based
    African-American patients with systolic heart
    failure, its effect in other racial/ethnic
    subgroups, and the impact of co-administered
    agents for heart failure on this effect. The
    study aims for this task order are 1) to assess
    the association between treatment with
    isosorbide/hydralazine and the outcomes of death
    and re-hospitalization in community-based
    populations with heart failure, after adjustment
    for patient, provider, and hospital
    characteristics 2) to assess the strength of
    this association in patients treated with various
    combinations of evidence-based therapies,
    including ACE-inhibitors, beta-blockers, and
    aldosterone antagonists and 3) to compare this
    association between African-American and patients
    from other racial groups. These aims will be
    explored using two datasets national VA pharmacy
    and clinical data, and the CMS-sponsored National
    Heart Care Project.

82
CO - Program Goals
  • PI goals for DEcIDE Center
  • Conduct pharmaceutical effectiveness
  • research in areas of clinical expertise
  • Develop and expand existing partnerships
  • PI suggested goals for the AHRQ DEcIDE Network
  • Identify and develop methodological best
  • practices for effectiveness research

83
Chicago-Area DEcIDE Center Coordinating
Site Center for Pharmacoeconomic Research at
the University of Illinois at Chicago
  • Glen T. Schumock, PharmD, MBA (PI)

84
Chicago - Consortium Partners
  • University of Illinois at Chicago
  • Colleges of Pharmacy, Medicine, Nursing, and
    Allied Health, and School of Public Health
  • University of Chicago
  • Northwestern University
  • VA Midwest Center for Health Services and
    Policy Research
  • Blue Cross/Blue Shield Association Technology
    Assessment Center and EPC

85
Chicago - Center Organization
  • Steering Committee
  • Site Coordinators
  • UIC, NU, UC, BCBSA, VA MCHSRP
  • Cores
  • clinical support, data acquisition, data analysis
    and quality assurance
  • Management and support staff
  • Over 40 key personnel

86
Chicago - Selected Key Personnel
87
Chicago - Selected Key Personnel
88
Chicago - Research Interests Center Strengths
  • Cost Effectiveness Analysis
  • Pharmacoeconomics
  • Medication Safety
  • Medication Use Policy
  • Pharmacoepidemiology
  • Pharmacy Practice

89
Chicago - Key Database Holdings
  • VA National Patient Database
  • VA Medicare Database
  • Walgreens Co Retail Database
  • Walgreens Co PBM Database
  • Marketscan Commercial Database
  • Marketscan Medicare Supplemental Database
  • Illinois Department of Healthcare and Family
    Services Database
  • Commercial Food Workers Union Database

90
Chicago - Key Database Holdings
91
Chicago - Key Database Holdings
92
Chicago - DEcIDE Project(s)
  • Outcomes of COPD Management administrative
    database evaluation of outcomes in COPD patients
    treated with beta-agonists and/or corticosteroids
    (proposed, lead investigator T. Lee).
  • Design and Evaluation of a Medication Therapy
    Management Program comparative evaluation of 3
    levels of MTM (proposed, lead investigator D.
    Touchette).

93
Outcomes of COPD Management
  • Abstract The prevalence of chronic obstructive
    pulmonary disease (COPD) is high in the United
    States and continues to increase. Medication
    management is an integral part of treatment for
    patients with COPD. However, there remains a
    great deal of uncertainty in the optimal
    medication management of patients with COPD and a
    need for long-term evaluations of medication
    treatment outcomes in patients with COPD to
    better inform decisions when caring for these
    patients. The goal of this project is to identify
    and prioritize key questions related to the
    management of patients with COPD and conduct an
    analysis of the key question(s). The specific
    objectives for this project are 1) Identify,
    review and assess major administrative,
    utilization, and/or claims databases, under the
    auspice of federal/state governments, third party
    payers, health plans/networks, or provider
    consortiums, that contain relevant prescription
    drug, surgical, outcome and utilization data for
    people with COPD 2) Identify a set of clinically
    relevant key questions relating to effectiveness
    of medical therapy for patients with COPD which
    can be adequately evaluated using the identified
    data sets and 3) Conduct a secondary data
    analysis to evaluate the key question(s), for
    outcomes including mortality, outpatient and
    inpatient hospitalization, and COPD-related
    hospitalizations and ED visits. The project will
    be completed in three phases, with a phase
    dedicated to each of the specific aims. The
    project has the potential to provide information
    relevant to health care provider organizations in
    policy formation about pharmacotherapy for COPD.

94
Design Evaluation of a Medication Therapy
Management Program
  • Abstract Nearly one third of Medicare
    beneficiaries have four or more chronic illnesses
    and 50 of patients over 65 receive 5 or more
    medications. Medication Therapy Management (MTM)
    programs may improve medication use and outcomes
    in beneficiaries with multiple medications and
    multiple chronic conditions. However, little is
    known about the effectiveness of MTM programs.
    The specific objectives of this project are to
    determine if different methods of delivering MTM
    services result in different outcomes and to
    identify what patient characteristics affect
    response to MTM programs. The aims of the study
    are 1) to identify and describe existing MTM
    programs 2) to develop, implement, and evaluate
    the impact of MTM programs of differing intensity
    on clinical, humanistic, and economic outcomes
    and 3) to determine which patient factors have
    the greatest impact on MTM program success. This
    evaluation of the MTM programs will employ a
    randomized, single-blinded, controlled,
    prospective, parallel group design with three
    groups of varying intensity of intervention
    (controls, telephonic MTM, and face-to-face MTM).
    Endpoints include adherence to therapy, adverse
    drug events, clinical markers of chronic
    illnesses, potentially serious adverse events
    avoided, patient and provider satisfaction, and
    resource utilization. The impact of patient
    demographics and other characteristics on
    adherence and adverse drug events will be
    assessed. The long-term goal of our research
    program is to identify efficient practice models
    to improve outcomes in complex patients with
    chronic conditions.

95
Chicago - Program Goals
  • PI goals for DEcIDE Center
  • Assist AHRQ in conduct of research that is
    relevant and meaningful to health care consumers
    and decision-makers in the US
  • Create an environment that fosters collaborative,
    high quality, and innovative research for the
    benefit of the Consortium institutions and
    individuals

96
Chicago - Program Goals
  • PI suggested goals for the AHRQ DEcIDE Network
  • Develop a record of producing both high quality
    and quantity of useful research that influences
    health care policy and outcomes
  • Ensure that the success of the Network is
    communicated broadly

97
Chicago Additional Information
  • University of Illinois at Chicago
    http//www.uic.edu/index.html/
  • Center for Pharmacoeconomic Research
    http//www.uic.edu/pharmacy/research/cpr/
  • University of Chicago http//www.uchicago.edu/
  • Northwestern University http//www.northwestern.
    edu/
  • VA Midwest Center for Health Services and Policy
    Research http//www.vard.org/links/gov.html
  • Blue Cross/Blue Shield Association Technology
    Assessment Center and EPC http//www.bcbs.com/tec
    /

98

The University of Maryland Baltimore (UMB) DEcIDE
Center
  • Bruce Stuart, PhD (PI)

99
UMB
  • The UMB DEcIDE Center brings together the
    talents of more than 50 investigators and senior
    staff from
  • School of Pharmacy
  • School of Medicine
  • School of Nursing

100
UMB
  • These UMB investigators are available to
    collaborate and provide data for this effort
    including
  • Comparative Drug Effectiveness
  • Treatment Safety and Efficacy in Elderly and
    Disabled Patients
  • Innovative Research Designs using
    Observational Databases

101
UMB
  • The UMB DEcIDE Center has several partners who
    are providing data for this effort including
  • Centers for Medicare and Medicaid Services (CMS)
  • Baltimore Veterans Healthcare Administration
    System (VHA)
  • Thomson Medstat
  • Omnicare

102
UMB
  • An Executive Management Team has overall program
    management responsibilities. This team will be
    led by Executive Director Bruce Stuart, PhD from
    the School of Pharmacys Peter Lamy Center.
  • Executive Management Team Associate Directors
    are
  • Ilene Zuckerman, PharmD, PhD from the School of
    Pharmacys Peter Lamy Center
  • Charlene Quinn, RN, PhD from the School of
    Medicine and the Baltimore Veterans
    Administration Medical Center (VAMC)

103
UMB
  • The Center is structured around the Executive
    Management Team and 5 core groups
  • Clinical Epidemiology Core
  • Pharmacotherapy Core
  • Data Core
  • Methods and Statistics Core
  • Information Dissemination Core

104
  • UMB DEcIDE Center
  • Organizational Structure

105
University of Maryland Baltimore

Peter Lamy Center on Drug Therapy and Aging
School of Pharmacy School of Medicine
Executive Management Team
Administrative Resources
Pharmacotherapy Core
Data Core
Methods and Statistics Core
Dissemination Core
Clinical Epidemiology Core
106
UMB Task Order 1 Methods for Studying Dementia
Treatment and Outcomes in Observational Databases
107
UMB
  • This task order is being led by Ann
    Gruber-Baldini, PhD, an experienced researcher
    with a specialty in dementia diagnosis and
    outcomes in long-term care.
  • Assisting Dr. Gruber-Baldini are
  • clinical experts
  • methodological experts
  • a support network of administrative personnel
    dedicated to high performance and scientific
    integrity

108
UMB
  • Dr. Gruber-Baldini and her team are providing
    three deliverables for this task order
  • a literature review on the effectiveness of drug
    therapies used to treat dementia
  • an assessment of sample sizes and measures for
    conducting comparative effectiveness studies of
    dementia treatments
  • the development of a research project plan using
    one or more of these datasets

109
Methods for Studying Dementia Treatment and
Outcomes in Observational Databases
  • Abstract The three main deliverables for this
    project are (1) an update and evaluation of the
    scientific literature on the effectiveness of
    drug therapies used to treat dementia, (2) an
    assessment of sample sizes and measures for
    conducting comparative effectiveness studies of
    dementia treatments in each of the accessible
    datasets, and (3) the development of a research
    project plan using one or more of these datasets.
    The literature review and evaluation will serve
    both to update systematic reviews conducted by
    AHRQ and others and to inform the development and
    focus of our Research Project Plan and future
    work conducted by the DEcIDE network. This will
    include an assessment of systematic reviews of
    studies conducted since 2000 augmented by a
    literature review of high quality observational
    studies conducted since 2000. The database
    assessment task is designed to establish the
    range of possible comparative effectiveness
    studies that could be conducted with data
    available to the investigating DEcIDE Center.
    Since these datasets include overlapping source
    information (e.g., Medicare claims) we are
    focusing this aspect of the study on data file
    types (e.g., enrollment files, medical claims,
    pharmacy claims, Minimum Data Set (MDS), medical
    records, plan benefit design, and surveys),
    population coverage and sample sizes, and the
    unique opportunities provided through data
    linkages.
  • In the final phase of the study, we are using the
    knowledge gained in the literature review and
    database assessment tasks to design a research
    project focused on the effectiveness of drugs
    used to treat dementia. In order to provide a
    high quality comparative effectiveness study of
    dementia treatment options, we are splitting this
    task into two components (1) a benchmarking
    study using the Medicare Current Beneficiary
    Survey (MCBS) data to establish prevalence rates
    for dementia and dementia treatments for
    community-dwelling and institutionalized Medicare
    beneficiaries, and (2) a fully fleshed out study
    design for future comparative drug treatment
    studies using one or more of our databases.

110
UNC DEcIDE Center at The Cecil G. Sheps Center
for Health Services Research The University of
North Carolina
  • Suzanne L. West, MPH, PhD
  • Principal Investigator
  • Michael (Mick) D. Murray, PharmD, MPH
  • Co-Principal Investigator

111
UNC - Core Personnel Expertise (1)
  • Suzanne West, MPH, PhD
  • Pharmacoepidemiology, systematic reviews,
    psychiatric epidemiology
  • Mick Murray, PharmD, MPH
  • Health outcomes of pharmaceutical interventions,
    medication adherence
  • Tim Carey, MD, MPH
  • Clinical epidemiology, internal medicine,
    evidence-based practice, back pain
  • Harry Guess, MD, PhD
  • Pediatrics, pharmacoepidemiology, patient
    reported outcomes

112
UNC - Core Personnel Expertise (2)
  • Michele Jonsson Funk, PhD
  • HIV, advanced epidemiologic methods
  • Maryann Oertel, PharmD
  • Drug safety, drug information
  • John Paul, PhD
  • Healthcare policy, outcomes research
  • Susan Blalock, MPH, PhD
  • Adherence to treatment, inappropriate drug use
  • Nikki McKoy, BS
  • Systematic reviews, project management

113
UNC - Affiliations and Partnerships
  • Center for Health Services Research in Primary
    Care, VAMC, Durham, NC
  • Medicines Monitoring Unit at the University of
    Dundee, Scotland
  • NC AccessCare
  • not-for-profit Medicaid disease management
    coalition
  • Quality in Pediatric Subspecialty Care (QPSC)
  • Collaboration between the American Board of
    Pediatrics, American Academy of Pediatrics UNC

114
UNC - Research Interests Center Strengths
  • Pharmacoepidemiologic methods
  • Drug utilization review
  • Systematic reviews
  • Medication adherence
  • Pharmacoeconomics
  • Medical text information clustering and mining
  • CERT focused on pediatrics
  • Racial disparities
  • Rural health

115
UNC - Key Database Holdings
  • Veterans Administration data
  • NC State Employees Health Plan data
  • NC Medicaid data
  • Health Choice (NC SCHIP)

116
UNC - DEcIDE Project(s)
  • Conduct a literature scan focusing on
    inappropriate medication use
  • Establish an initial process measure set that
    will address misuse, over- and under-use of
    prescription medications
  • Assess the validity of the measure set using NC
    Medicaid data

117
Research and Surveillance Methods for Improving
Patient Safety Through Medicare Claims Databases
  • Abstract The specific objective of the project
    is to establish an initial measure set that will
    encompass surveillance for process measures such
    as misuse, over- and under-use of prescription
    medications based on dispensing claims in
    outpatient, inpatient, nursing home, and
    transitional settings such as rehabilitation
    centers. The process measures will be developed
    using an evidence-based approach, i.e., by
    scanning the literature for published papers that
    have addressed these issues. We will consult with
    advisors to determine the integrity of the
    initial measure set selected and determine which
    indicators will be the focus of the validation
    phase. We will assess the validity of the measure
    set using state Medicaid data. The tasks for this
    project will be described in more detail bel
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