overview of the decide research network agency for healthcare research & quality center for...

Overview of the DEcIDE Overview of the DEcIDE Research NetworkResearch Network

Agency for Healthcare Research & QualityAgency for Healthcare Research & Quality

Center for Outcomes & EvidenceCenter for Outcomes & Evidence

December, 2005December, 2005

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distributed and copied by AHRQ program affiliates, but it is requested distributed and copied by AHRQ program affiliates, but it is requested that in subsequent use the Agency for Healthcare Research (AHRQ) that in subsequent use the Agency for Healthcare Research (AHRQ) be given appropriate acknowledgement. In addition, a disclaimer be given appropriate acknowledgement. In addition, a disclaimer should be provided stating no official endorsement by AHRQ or DHHS should be provided stating no official endorsement by AHRQ or DHHS is intended or should be inferred by these slides. is intended or should be inferred by these slides.

• Media requests for information about the AHRQ programs should be Media requests for information about the AHRQ programs should be directed to AHRQ’s Office of Communication & Knowledge Transfer.directed to AHRQ’s Office of Communication & Knowledge Transfer.

• Individuals not authorized to use the AHRQ logo or other images in Individuals not authorized to use the AHRQ logo or other images in these slides, should remove them prior to use.these slides, should remove them prior to use.

• If you use some or all of these slides, AHRQ would like to hear about If you use some or all of these slides, AHRQ would like to hear about the purpose and the audience so we can develop future slide sets that the purpose and the audience so we can develop future slide sets that are useful to the public. are useful to the public.

• If you use some or all of these slides, please send a brief If you use some or all of these slides, please send a brief email to email to [email protected]@ahrq.gov to let us know about to let us know about the use, the audience, and your suggestions. the use, the audience, and your suggestions. Thank youThank you!!

mailto:[email protected]

New authorization by MMA. 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.

A.A. Evidence synthesisEvidence synthesis– Transparent process of systematically reviewing and

synthesizing evidence on treatment effectiveness.– Identifying relevant knowledge gaps.

B.B. Evidence generationEvidence generation– Development of new scientific knowledge to address

knowledge gaps.

C.C. Evidence communication/translation Evidence communication/translation – Communication of scientific information in plain language

to policymakers, patients, and providers.. 3

AHRQ

Scientific Resource Center OHSU

Evidence Synthesis

BCBS

Duke

Hopkins

McMaster

Hopkins

Outcome Sciences

RTI

Colorado

Evidence GenerationEisenberg

Center

StakeholdersPublic Input

Maryland

UNC

Penn

DEcIDE NETWORK

EVIDENCE-BASED PRACTICE CENTERS

Acumen, LLC

BWH

Duke

HMORN

UIC

Vanderbilt

OHSU

RTI-UNC

So Cal

Stanford-UCSF

Alberta

Minnesota

Ottawa

ECRI

Tufts-NEMC

AHRQ Effective Health Care Program

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Evidence GenerationEvidence 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

What Will DEcIDE Do?What Will DEcIDE Do?Perform secondary database analysis to compare health outcomes

Conduct methodological studies

Develop algorithms to identify inappropriate drug prescribing patterns

Evaluate the effects of benefit and formulary structure on health outcomes

Conduct clinical economics studies

Evaluate patient and prescriber decision-making tools

Analyze existing disease registries or prescription databases

Studies comparing the clinical effectiveness of common treatment options

Conduct simulations and modeling

Carry out evaluations of innovative healthcare services

Design & implement prospective studies

Examine clinical benefits of genetics testing. 6

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2005-06 Priority List2005-06 Priority List• Arthritis and non-traumatic joint disorders Arthritis and non-traumatic joint disorders

• Cancer Cancer

• Chronic obstructive pulmonary disease/asthma. Chronic obstructive pulmonary disease/asthma.

• Dementia, including Alzheimer's disease Dementia, including Alzheimer's disease

• Depression and other mood disordersDepression and other mood disorders

• Diabetes mellitus Diabetes mellitus

• Ischemic heart diseaseIschemic heart disease

• Peptic ulcer/dyspepsia Peptic ulcer/dyspepsia

• PneumoniaPneumonia

• Stroke, including control of hypertension Stroke, including control of hypertension

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Why the Need for Why the Need for Effectiveness Research?Effectiveness Research?

Interventions that are efficacious Interventions that are efficacious

under a highly specific set of under a highly specific set of

circumstances often circumstances often fail to replicatefail to replicate

across a wide variety of settings, across a wide variety of settings,

conditions, patients.conditions, patients.

Glasgow, 2003

““Perhaps a more salient question is Perhaps a more salient question is

what we can do what we can do nownow, within the , within the currentcurrent

infrastructure, to move effectiveness infrastructure, to move effectiveness

research forward so that everyone can research forward so that everyone can

reap the benefits of the most reap the benefits of the most

unprecedented bounty of biomedical unprecedented bounty of biomedical

research findings in our lifetime.”research findings in our lifetime.”

Clancy C and Slutsky J. JOURNAL OF INVESTIGATIVE MEDICINE • Volume 53 Number 2 • February 2005

A Guiding Principle Within the A Guiding Principle Within the Center for Outcomes & EvidenceCenter for Outcomes & Evidence

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Overview of Slide SeriesOverview of Slide Series

• For Each DEcIDE Center, the following For Each DEcIDE Center, the following information is provided in the subsequent slides.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

http://effectivehealthcare.ahrq.gov/decide/index.cfm

DEcIDE Research CentersDEcIDE Research Centers

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DEcIDE CentersDEcIDE Centers

• Acumen, LLC.

• Brigham and Women’s 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

DEcIDEDEcIDE Initial Study

AcumenAcumen Data Development for Part DData Development for Part D

Brigham & Brigham & Women’sWomen’s Antipsychotic Treatment in Older AdultsAntipsychotic Treatment in Older Adults

DukeDuke Treatment of In-Stent RestenosisTreatment of In-Stent Restenosis

HMORNHMORN Effectiveness of Beta-Blocker Use in CHFEffectiveness of Beta-Blocker Use in CHF

HopkinsHopkins Effectiveness of New Agents for DiabetesEffectiveness of New Agents for Diabetes

OutcomeOutcome Guide for Patient RegistriesGuide for Patient Registries

RTIRTI Methodological Toolbox For Methodological Toolbox For Pharmacoepidemiologic Research Pharmacoepidemiologic Research 13

DEcIDEDEcIDE Initial Study

UCHSC UCHSC Effectiveness of Isosorbide & Hydralazine Effectiveness of Isosorbide & Hydralazine in African-Americansin African-Americans

UICUIC Outcomes of COPD ManagementOutcomes of COPD Management

UMBUMB Dementia Treatment and Outcomes in Dementia Treatment and Outcomes in Observational DatabasesObservational Databases

UNCUNC Surveillance Methods for Improving Surveillance Methods for Improving Patient Safety in Medicare ClaimsPatient Safety in Medicare Claims

UPENNUPENN Antidepressants and the Risk of Antidepressants and the Risk of Aspiration Pneumonia in the AgedAspiration Pneumonia in the Aged

VanderbiltVanderbilt Factors Modulating Treatment Outcomes Factors Modulating Treatment Outcomes of Rheumatoid Arthritisof Rheumatoid Arthritis

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Acumen DEcIDE CenterAcumen DEcIDE Center

Thomas MaCurdy, PhDThomas MaCurdy, PhD

Principal InvestigatorPrincipal Investigator

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Acumen - Core Acumen - Core Personnel & ExpertisePersonnel & Expertise

• Dr. Thomas MaCurdyDr. Thomas MaCurdy, Ph.D. Economics: Health policy , Ph.D. Economics: Health policy research, program evaluation using administrative and research, program evaluation using administrative and survey data, statistical modeling, behavioral research, survey data, statistical modeling, behavioral research, economic analysis, financing of health care (Acumen LLC, economic analysis, financing of health care (Acumen LLC, Stanford University)Stanford University)

• Dr. John HornbergerDr. John Hornberger, M.D., M.S.: Health economics, , M.D., M.S.: Health economics, comparative effectiveness, decision analysis, technology comparative effectiveness, decision analysis, technology assessment, cross-cultural medicine (Acumen LLC)assessment, cross-cultural medicine (Acumen LLC)

• Dr. Sandra WilsonDr. Sandra Wilson, Ph.D. Psychology : , Ph.D. Psychology : Design and Design and assessment of care delivery systems, chronic disease assessment of care delivery systems, chronic disease care, vulnerable populations, caregiver-patient care, vulnerable populations, caregiver-patient interaction (PAMFRI)interaction (PAMFRI)

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Acumen - Core Personnel Acumen - Core Personnel & Expertise (cont)& Expertise (cont)

• Dr. Mark HolodniyDr. Mark Holodniy, M.D.: Infectious Disease. , M.D.: Infectious Disease. Outcomes research. Variation in practice patterns and Outcomes research. Variation in practice patterns and outcomes. Epidemic preparedness and control. (Palo outcomes. Epidemic preparedness and control. (Palo Alto VA)Alto VA)

• Dr. Grecia MarrufoDr. Grecia Marrufo, Ph.D. Economics: Health policy , Ph.D. Economics: Health policy research, econometrics, large database management, research, econometrics, large database management, program evaluation (Acumen LLC)program evaluation (Acumen LLC)

• Dr. Alan Garber, Dr. Alan Garber, M.D. Ph.D. Econmics: M.D. Ph.D. Econmics: Health Health economics. Guideline development, evidence reviews, economics. Guideline development, evidence reviews, cost-effectiveness analysis, assessment of innovative cost-effectiveness analysis, assessment of innovative technologies and strategies (Stanford University)technologies and strategies (Stanford University)

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Acumen - Affiliations Acumen - Affiliations and Partnershipsand Partnerships

• VA Public Health Strategic Health Care Group VA Public Health Strategic Health Care Group (PHSHG), VA Palo Alto Health Care System(PHSHG), VA Palo Alto Health Care System

• Palo Alto Medical Foundation Research Palo Alto Medical Foundation Research Institute. (Sutter Health affiliate)Institute. (Sutter Health affiliate)

• Center for Primary Care and Outcomes Center for Primary Care and Outcomes Research, Stanford UniversityResearch, Stanford University

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Acumen - Research Interests & Acumen - Research Interests & Center StrengthsCenter Strengths

• MethodologyMethodology

– Development of research databases and Development of research databases and computerized surveillance and monitoring computerized surveillance and monitoring systems systems

– Econometrics, decision analyses, cost-Econometrics, decision analyses, cost-effectiveness analyseseffectiveness analyses

– Risk adjustmentRisk adjustment

– Pay for performance, influence of incentives on Pay for performance, influence of incentives on behaviorbehavior

– Policy and program evaluationPolicy and program evaluation

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Acumen - Research Interests Acumen - Research Interests & Center Strengths& Center Strengths

• ProgrammaticProgrammatic– Medicare, Medicaid, SCHIP, VAMedicare, Medicaid, SCHIP, VA– State and county health agenciesState and county health agencies– Managed care organizationsManaged care organizations

• FieldsFields– Health service delivery & finance Health service delivery & finance

systems systems – Novel pharmaceuticals, diagnostics, & Novel pharmaceuticals, diagnostics, &

devicesdevices

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Acumen - Key Database Acumen - Key Database Holdings: Holdings:

• 100% files 100% files of Medicare claims and of Medicare claims and enrollment data for 1997-2004enrollment data for 1997-2004

– Inpatient, outpatient, SNF, home health, hospice, Inpatient, outpatient, SNF, home health, hospice, DME carrier (Standard Analytical Files)DME carrier (Standard Analytical Files)

– Denominator & DSH (1991- ), MedPar (1984- ), Denominator & DSH (1991- ), MedPar (1984- ), MCBS, HISKEW, Provider, UPIN, CAHPS, HOSMCBS, HISKEW, Provider, UPIN, CAHPS, HOS

• 100% files of enrollment, FFS claims and 100% files of enrollment, FFS claims and county operated health system data for county operated health system data for California Medicaid 1994-2004California Medicaid 1994-2004

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Acumen - Key Database Acumen - Key Database Holdings: VA PHSHG and PAMFRI Holdings: VA PHSHG and PAMFRI

• HIV clinical case registry (HIV CCR)HIV clinical case registry (HIV CCR)

– All HIV infected veteran VA utilization data (1992-All HIV infected veteran VA utilization data (1992-present)present)

• Hepatitis C virus (HCV) clinical case registry (HCV-Hepatitis C virus (HCV) clinical case registry (HCV-CCR): CCR):

– All HCV infected veteran VA utilization data (1996-All HCV infected veteran VA utilization data (1996-present)present)

• Clinical, registration, billing, enrollment and cost Clinical, registration, billing, enrollment and cost data for all PAMF patients (2002-present, some data for all PAMF patients (2002-present, some 1991-present1991-present))

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Acumen - DEcIDE ProjectAcumen - DEcIDE Project

““Data Development for Patient Safety: A Pilot Data Development for Patient Safety: A Pilot Study using Medicare Part B Drug Data”Study using Medicare Part B Drug Data”

• Establish data structures based on Medicare claims Establish data structures based on Medicare claims linking interventions and outcomes relevant for the linking interventions and outcomes relevant for the surveillance of adverse drug eventssurveillance of adverse drug events

• Creation of statistical approaches for analyzing Creation of statistical approaches for analyzing claims data to detect adverse events claims data to detect adverse events

• Pilot framework with Part B data to accommodate Pilot framework with Part B data to accommodate use with Part D datause with Part D data

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ABSTRACT: Data Development for ABSTRACT: Data Development for Patient Safety: A Pilot Study using Patient Safety: A Pilot Study using

Medicare Part B Drug DataMedicare 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.

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Acumen - Program GoalsAcumen - Program Goals

• Goals for Acumen DEcIDE CenterGoals for Acumen DEcIDE Center

– Formulate empirical approaches to reliably Formulate empirical approaches to reliably conduct comparative effectiveness and conduct comparative effectiveness and patient safety analyses using medical patient safety analyses using medical claims/records claims/records

– Structure findings to inform policy decisions Structure findings to inform policy decisions

– Develop practical computerized Develop practical computerized surveillance and monitoring systems for surveillance and monitoring systems for tracking adverse events associated with tracking adverse events associated with medical interventionsmedical interventions

Brigham and Women’s Hospital Brigham and Women’s Hospital DEcIDE Research CenterDEcIDE Research Center at Harvard Medical School, Bostonat Harvard Medical School, Boston

Sebastian Schneeweiss, MD, ScDSebastian Schneeweiss, MD, ScD

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B&W - Core Personnel & B&W - Core Personnel & ExpertiseExpertise

Sebastian Schneeweiss, MD, ScD Sebastian Schneeweiss, MD, ScD (Pharmacoepidemiology)(Pharmacoepidemiology)

Jerry Avorn, MD (Geriatric Health Services)Jerry Avorn, MD (Geriatric Health Services)

David Bates, MD, MPH (Medication Safety)David Bates, MD, MPH (Medication Safety)

Robert Glynn, PhD, ScD (Biostatistics)Robert Glynn, PhD, ScD (Biostatistics)

Jennifer Haas, MD, MPH (Health Services)Jennifer Haas, MD, MPH (Health Services)

Peter Neumann, ScD, (Pharmacoeconomics)Peter Neumann, ScD, (Pharmacoeconomics)

Daniel Solomon, MD, MPH (Antiinflammatories)Daniel Solomon, MD, MPH (Antiinflammatories)

Philip Wang, MD, DPH, (Psychotropics)Philip Wang, MD, DPH, (Psychotropics)

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B&W - Affiliations and B&W - Affiliations and PartnershipsPartnerships

• Brigham & Women’s HospitalBrigham & Women’s Hospital

- - Pharmacoepidemiology Pharmacoepidemiology

- General Internal Medicine- General Internal Medicine

• Harvard School of Public Health Harvard School of Public Health

- - Harvard Center for Risk AnalysisHarvard Center for Risk Analysis

• New England Medical CenterNew England Medical Center

- - The Health InstituteThe Health Institute

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B&W - Research Interests B&W - Research Interests & Center Strengths& Center Strengths

• Comparative effectiveness ofComparative effectiveness of– PsychotropicsPsychotropics– NSAIDsNSAIDs– Biologic agents Biologic agents – and a range of other drugsand a range of other drugs

• Developing methods for comparative Developing methods for comparative effectiveness research using observational dataeffectiveness research using observational data

• Drug policy evaluation and developmentDrug policy evaluation and development

• Academic outreach for improved prescribingAcademic outreach for improved prescribing

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B&W - Key Database B&W - Key Database HoldingsHoldings

• MedicareMedicare (2 states, linked to pharmacy assistance (2 states, linked to pharmacy assistance programs, deaths with causes, geocoded physician programs, deaths with causes, geocoded physician information)information)

- Medicaid (1 state)- Medicaid (1 state)

- MCBS, MEPS- MCBS, MEPS

• Province of British ColumbiaProvince of British Columbia (all residents, drug (all residents, drug use independent of payor, hospitalization, physician use independent of payor, hospitalization, physician services and specialty deaths with causes, long-term services and specialty deaths with causes, long-term care)care)

• Partners Health CarePartners Health Care: Longitudinal EMR of hospital : Longitudinal EMR of hospital and outpatient careand outpatient care

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B&W - DEcIDE Project(s)B&W - DEcIDE Project(s)

• Health Outcomes of Antipsychotic Health Outcomes of Antipsychotic Treatment in Older AdultsTreatment in Older Adults

– Atypical vs. conventional APMsAtypical vs. conventional APMs

– Outcomes: Death, MI, cardiac arrhythmia, Outcomes: Death, MI, cardiac arrhythmia, pneumoniapneumonia

– Medicare population of low income statusMedicare population of low income status

– General elderly population in BCGeneral elderly population in BC

– Multivariate analyses, Propensity score, Multivariate analyses, Propensity score, Instrumental VariablesInstrumental Variables

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Health Outcomes of Antipsychotic Health Outcomes of Antipsychotic Treatment in Older Adults Treatment in Older Adults

• Abstract: In April 2005 the US Food and Drug Administration (FDA) issued an Advisory that 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 atypical antipsychotic medications (APMs) increase mortality in older patients with dementia. However, the Advisory and the ‘Black Box’ warnings added to the labels of 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 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 their search for therapeutic alternatives, physicians may simply switch their elderly patients from atypical APMs to these older conventional agents. Unfortunately, the safety 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 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 investigate whether the risk of death as well as possible intermediary outcomes such as acute myocardial infarction (MI), cardiac arrhythmia, and pneumonia, differ for acute myocardial infarction (MI), cardiac arrhythmia, and pneumonia, differ for conventional vs. atypical APM use by elderly with dementia or in nursing homes. Study 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 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 >65 are and in British Columbia. Many individuals in the state Medicare population >65 are vulnerable elderly patients with low incomes and high levels of comorbid illness severity. 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 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 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 FDA’s reanalysis, which ranged period was chosen based upon the duration of trials in the FDA’s reanalysis, which ranged from 4-26 weeks. Study outcomes: Death as identified in vital statistics data including 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 cause of death; acute MI, ventricular arrhythmia, and pneumonia as identified in claims data. Analysis: Unadjusted and multivariable Cox proportional hazards models will be data. Analysis: Unadjusted and multivariable Cox proportional hazards models will be constructed. In confirmatory analyses, we will repeat Cox models using propensity score constructed. In confirmatory analyses, we will repeat Cox models using propensity score adjustments to balance independent risk factors for outcomes between drug user groups. 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 We will also use instrumental variable analysis to provide unbiased estimates even if important confounding variables are unmeasured.important confounding variables are unmeasured.

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B&W - Program GoalsB&W - Program Goals

• PI goals for BWH DEcIDE Research PI goals for BWH DEcIDE Research CenterCenter

– Develop comparative effectiveness Develop comparative effectiveness research in older adults using health care research in older adults using health care utilization databasesutilization databases

– Drug policy evaluation in light of MMADrug policy evaluation in light of MMA

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http://www.brighamandwomens.org/pharmacoepid/Faculty.asp



Duke University DEcIDE Center Duke University DEcIDE Center

David Matchar, MDDavid Matchar, MD

SLIDES PENDINGSLIDES PENDING

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Duke UniversityDuke University

Project: Treatment of In-Stent Project: Treatment of In-Stent RestenosisRestenosis

SLIDES PENDINGSLIDES PENDING

HMO Research Network CERTs HMO Research Network CERTs DEcIDE Center DEcIDE Center

at Harvard Pilgrim / Harvard Medical Schoolat Harvard Pilgrim / Harvard Medical School

Richard Platt, MDRichard Platt, MD

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HMORN - Core Personnel HMORN - Core Personnel & Expertise& Expertise

• Richard Platt, MD, MS Richard Platt, MD, MS Pharmacoepidemiology, infectious disease Pharmacoepidemiology, infectious disease epidemiology.epidemiology.

• Alan Go, MDAlan Go, MD Internist, clinical epidemiologist Internist, clinical epidemiologist focus on cardiovascular and renal disease. focus on cardiovascular and renal disease.

• Eric B. Larson, MDEric B. Larson, MD improving quality of care, improving quality of care, technology assessment, aging and dementia.technology assessment, aging and dementia.

• Joe V. Selby, MD, MPHJoe V. Selby, MD, MPH family physician, family physician, diabetes, primary care delivery, and quality diabetes, primary care delivery, and quality improvement research.improvement research.

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• Edward H. Wagner, MD, MPHEdward H. Wagner, MD, MPH -PI Cancer -PI Cancer Research Network Research Network

• Mark C. HornbrookMark C. Hornbrook,, PhD PhD, health economics, , health economics, health status measurement, and managed care health status measurement, and managed care data systems. data systems.

• Stephen B. Soumerai, ScDStephen B. Soumerai, ScD effectiveness of effectiveness of interventions to improve drug prescribing; interventions to improve drug prescribing; economic access to medications; effects of economic access to medications; effects of cost-containment and coverage policies among cost-containment and coverage policies among vulnerable populations. vulnerable populations.

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• Tracy Lieu, MD, MPHTracy Lieu, MD, MPH pediatrician / health pediatrician / health services researcher services researcher

• Jerry H. Gurwitz, MDJerry H. Gurwitz, MD geriatric medicine and geriatric medicine and the use of drug therapy in the elderlythe use of drug therapy in the elderly

• Michael Von Korff, ScDMichael Von Korff, ScD –chronic illness –chronic illness

• Gregory Simon, MD, MPHGregory Simon, MD, MPH psychiatry, psychiatry, psychotherapy psychotherapy

• John Hsu, MD, MBAJohn Hsu, MD, MBA medical decision making, medical decision making, impact of prescription drug cost-sharingimpact of prescription drug cost-sharing

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HMORN - Affiliations and HMORN - Affiliations and PartnershipsPartnerships

HMORN Multi-center collaborationsHMORN Multi-center collaborations::• NIH Collaborative Clinical Studies Network NIH Collaborative Clinical Studies Network • CDC Vaccine Safety Datalink CDC Vaccine Safety Datalink • NCI Cancer Research Network NCI Cancer Research Network

HMORN Participating HMOsHMORN Participating HMOs::• Meyers Primary Care Institute UMass /Fallon Community Meyers Primary Care Institute UMass /Fallon Community

Health Plan, Worcester MAHealth Plan, Worcester MA• Group Health Cooperative, Seattle, WA Group Health Cooperative, Seattle, WA • Kaiser Permanente: Hawaii, Northwest, Colorado, Southern Kaiser Permanente: Hawaii, Northwest, Colorado, Southern

California, Northern California and Georgia regionsCalifornia, Northern California and Georgia regions• HealthPartners Research Foundation, Minneapolis, MNHealthPartners Research Foundation, Minneapolis, MN• Henry Ford Health System, Detroit, MI Henry Ford Health System, Detroit, MI • Lovelace Clinic Foundation, Albuquerque, New Mexico Lovelace Clinic Foundation, Albuquerque, New Mexico

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HMORN - Research Interests HMORN - Research Interests & Center Strengths& Center Strengths

The HMORN DEcIDE Center will maximize The HMORN DEcIDE Center will maximize

its access to health plans’ resources to its access to health plans’ resources to

develop information about therapeutic develop information about therapeutic

effectiveness within typical clinical effectiveness within typical clinical

settings. We will work directly with health settings. We will work directly with health

plan decision makers, providers and health plan decision makers, providers and health

plan members to create and implement plan members to create and implement

novel analytical tools and intervention novel analytical tools and intervention

capabilities to improve public health.capabilities to improve public health.

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HMORN - Key Database HMORN - Key Database HoldingsHoldings

Automated data of 11 health plans Automated data of 11 health plans with 7.7 million combined members. with 7.7 million combined members.

Accessible data includes: Accessible data includes:

– electronic medical records, electronic medical records,

– claims systems (utilization, claims systems (utilization, pharmacy, lab), and pharmacy, lab), and

– membership demographic /eligibility membership demographic /eligibility data.data.

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HMORN - DEcIDE HMORN - DEcIDE Project(s)Project(s)

TO #1: Effectiveness of Β-Adrenergic TO #1: Effectiveness of Β-Adrenergic Antagonists on the Risk of Rehospitalization Antagonists on the Risk of Rehospitalization in Adults with Diagnosed Heart Failurein Adults with Diagnosed Heart Failure

Among adults hospitalized for heart failure between Among adults hospitalized for heart failure between 2001- 2003 and followed through 2004 within two 2001- 2003 and followed through 2004 within two large health plans we will: large health plans we will:

• examine the rates and predictors of prescription examine the rates and predictors of prescription of different β-blockers following discharge.of different β-blockers following discharge.

• evaluate the association between different β-evaluate the association between different β-blockers and the risks of heart failure-specific blockers and the risks of heart failure-specific and all-cause re-hospitalization.and all-cause re-hospitalization.

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Comparable Effectiveness of Beta-Adrenergic Comparable Effectiveness of Beta-Adrenergic Antagonists on the Risk of Rehospitalization in Antagonists on the Risk of Rehospitalization in

Adults with Diagnosed Heart FailureAdults 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 β-blockers following discharge in persons hospitalized for heart failure. Hypothesis 1a: Despite the lack of randomized clinical trial evidence for β-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 β-blocker therapy. Hypothesis 1b: Older age, gender, coexisting illnesses, prior use and type of β-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 β-blocker received. Aim 2. To evaluate the association between receipt of different β-blockers and the risks of heart failure-specific and all-cause rehospitalization among persons hospitalized for heart failure who are treated with β-blocker therapy after discharge. Hypothesis 2a: The rate of rehospitalization will not vary among patients receiving different types of β-blockers, after adjustment for potential confounders and propensity score. Hypothesis 2b: The associations between different β-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 β-blockers within a large, diverse population of patients with heart failure cared for in typical clinical care settings.

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HMORN - Program HMORN - Program GoalsGoals

• Develop and disseminate strategies Develop and disseminate strategies for the appropriate and equitable for the appropriate and equitable delivery of therapeutics delivery of therapeutics

Johns Hopkins University Johns Hopkins University DEcIDE CenterDEcIDE Center

Albert W. Wu, MD, MPH, PIAlbert W. Wu, MD, MPH, PI

Eric B. Bass, MD, MPH, Co-PIEric B. Bass, MD, MPH, Co-PI

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JHU - Core Personnel JHU - Core Personnel & Expertise& Expertise

• Gerard Anderson, PhD – Health PolicyGerard Anderson, PhD – Health Policy

• Eric Bass, MD, MPH – Technology AssessmentEric Bass, MD, MPH – Technology Assessment

• Sydney Dy, MD, MPH – Quality of CareSydney Dy, MD, MPH – Quality of Care

• Dan Ford, MD – Mental Health OutcomesDan Ford, MD – Mental Health Outcomes

• Laura Morlock, PhD – Organization & ManagementLaura Morlock, PhD – Organization & Management

• Jodi Segal, MD – Clinical EpidemiologyJodi Segal, MD – Clinical Epidemiology

• Don Steinwachs, PhD – Health Services ResearchDon Steinwachs, PhD – Health Services Research

• Albert Wu, MD, MPH – Patient OutcomesAlbert Wu, MD, MPH – Patient Outcomes

• Scott Zeger, PhD – Statistical MethodsScott Zeger, PhD – Statistical Methods

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JHU - Affiliations and JHU - Affiliations and PartnershipsPartnerships

Johns Hopkins Bloomberg School of Johns Hopkins Bloomberg School of Public HealthPublic Health

Johns Hopkins Medical InstitutionsJohns Hopkins Medical Institutions

Johns Hopkins School of Medicine Johns Hopkins School of Medicine

Johns Hopkins School of NursingJohns Hopkins School of Nursing

Ingenix, Inc.Ingenix, Inc.

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JHU - Research Interests JHU - Research Interests & Center Strengths& Center Strengths

• Analyses of utilization and outcomes using large Analyses of utilization and outcomes using large administrative datasetsadministrative datasets

• Analysis of clinical outcomes using cohort dataAnalysis of clinical outcomes using cohort data

• Quality of care and patient safetyQuality of care and patient safety

• Cost-effectiveness of medications and new Cost-effectiveness of medications and new technologiestechnologies

• Systematic reviews of evidenceSystematic reviews of evidence

• Analytic methods for longitudinal data and risk Analytic methods for longitudinal data and risk adjustmentadjustment

• Chronic conditions including hypertension, Chronic conditions including hypertension, cardiovascular dsease, diabetes mellitus, and cardiovascular dsease, diabetes mellitus, and hematologic disordershematologic disorders

51

JHU - Key Database JHU - Key Database HoldingsHoldings

• Multi-year Medicare longitudinal Multi-year Medicare longitudinal databasesdatabases

– 5% sample for 1997-20035% sample for 1997-2003

– 100% sample for 1999-2002100% sample for 1999-2002

• US Pharmacopeia MEDMARXUS Pharmacopeia MEDMARX

• Intensive Care Unit Safety Reporting Intensive Care Unit Safety Reporting System (ICU-SRS) System (ICU-SRS)

• i3Magnifi (an Ingenix company) pharmacy i3Magnifi (an Ingenix company) pharmacy claims databasesclaims databases

52

JHU - DEcIDE JHU - DEcIDE Project(s)Project(s)

• Comparative Effectiveness and Comparative Effectiveness and Safety of New Therapies for Glucose Safety of New Therapies for Glucose Control in Diabetes Mellitus 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 Comparative Effectiveness and Safety of New Therapies for Glucose Control in New Therapies for Glucose Control in

Diabetes MellitusDiabetes Mellitus • Abstract: Investigators will be evaluating the comparative effectiveness and Abstract: Investigators will be evaluating the comparative effectiveness and

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

54

JHU - Program GoalsJHU - Program Goals

• PI goals for DEcIDE CenterPI goals for DEcIDE Center

– To develop the capacity to conduct rapid To develop the capacity to conduct rapid evaluations of the use, effectiveness and evaluations of the use, effectiveness and safety of new treatments using large safety of new treatments using large administrative datasetsadministrative datasets

– To foster policy relevant research involving To foster policy relevant research involving scientists and clinicians across the Universityscientists and clinicians across the University

– To develop new research tools that can be To develop new research tools that can be used for effectiveness and outcomes research used for effectiveness and outcomes research using large datasetsusing large datasets

Outcome DEcIDE CenterOutcome DEcIDE Center at at

Outcome Sciences, Inc.Outcome Sciences, Inc.

Richard E. Gliklich, MDRichard E. Gliklich, MD

56

Outcome - Core Outcome - Core Personnel & ExpertisePersonnel & Expertise

• Richard Gliklich MD, Principal InvestigatorRichard Gliklich MD, Principal Investigator

– 21 years experience in real-world observational and 21 years experience in real-world observational and investigational studies. Designed and implemented investigational studies. Designed and implemented more than 70 registries and high quality more than 70 registries and high quality prospective data programs.prospective data programs.

• Nancy A. Dreyer, MPH, PhD, Program DirectorNancy A. Dreyer, MPH, PhD, Program Director

– 30 years experience in epidemiology and drug 30 years experience in epidemiology and drug safety.safety.

• Fiona Smith, MPH Project ManagerFiona Smith, MPH Project Manager

– 7 years experience working on projects with CMS 7 years experience working on projects with CMS and AHRQ.and AHRQ.

57

Outcome - Core Outcome - Core Personnel & ExpertisePersonnel & Expertise

Additional core and collaborative personnel Additional core and collaborative personnel with expertise inwith expertise in

– program designprogram design– informaticsinformatics– privacyprivacy– qualityquality– pharmacoeconomics and pharmacoeconomics and – analytics related to registries, post-analytics related to registries, post-

approval studies, quality initiatives and approval studies, quality initiatives and safety surveillance programs.safety surveillance programs.

58

Outcome - Affiliations Outcome - Affiliations and Partnershipsand Partnerships

• American Heart Association (AHA)American Heart Association (AHA)– Largest independent supporter of cardiovascular disease Largest independent supporter of cardiovascular disease

research. Partner for Get With The Guidelines (sm) research. Partner for Get With The Guidelines (sm) programs.programs.

• Primary Care Network (PCN)Primary Care Network (PCN)– Association of 72,000 health care providers and Association of 72,000 health care providers and

professionalsprofessionals

• Consortium of Rheumatology Researchers of North Consortium of Rheumatology Researchers of North America (CORRONA) America (CORRONA)

– Nationwide network of practicing rheumatologistsNationwide network of practicing rheumatologists

Other Affiliations:Other Affiliations:

Many additional partnerships and affiliations with large health care Many additional partnerships and affiliations with large health care provider networks and medical specialty associationsprovider networks and medical specialty associations

59

Outcome - Research Interests Outcome - Research Interests & Center Strengths& Center Strengths

The Outcome DEcIDE Center is particularly well-suited to The Outcome DEcIDE Center is particularly well-suited to developing and implementing registries and other prospective developing and implementing registries and other prospective data capture and surveillance programs.data capture and surveillance programs.

– Expertise and experience in developing and managing registries Expertise and experience in developing and managing registries (more than 70 initiated)(more than 70 initiated)

– Existing, productive networks in several of the Priority Conditions Existing, productive networks in several of the Priority Conditions connected through a common information platformconnected through a common information platform

>2500 hospitals and several thousand physician offices and >2500 hospitals and several thousand physician offices and pharmacies are currently participating in prospective data pharmacies are currently participating in prospective data programsprograms

– Informatics expertise and infrastructure for collecting data directly Informatics expertise and infrastructure for collecting data directly from practitioners and patients via web, IVR, fax, and from existing from practitioners and patients via web, IVR, fax, and from existing health information systemshealth information systems

– Rapid, large scale prospective study execution in real-world clinical Rapid, large scale prospective study execution in real-world clinical sitessites

60

Outcome - Key Database Outcome - Key Database HoldingsHoldings

•Existing data fromExisting data from

– Cardiovascular disease and stroke Cardiovascular disease and stroke registriesregistries

– Rheumatologic disease registriesRheumatologic disease registries

– Oncology registriesOncology registries

61

Outcome - DEcIDE Outcome - DEcIDE Project(s)Project(s)

• Establishing Registries for Evaluating Establishing Registries for Evaluating Patient Outcomes – Defining StandardsPatient Outcomes – Defining Standards

– Produce a reference for the design and use Produce a reference for the design and use of successful registries both for registries of successful registries both for registries that may be required by CMS and registries that may be required by CMS and registries set up for other purposes in both the public set up for other purposes in both the public and private sectors. It will focus on and private sectors. It will focus on establishing standards forestablishing standards for Creation and operation of registriesCreation and operation of registries

Evaluation of registriesEvaluation of registries

Scientific evaluation of outcomes using registry Scientific evaluation of outcomes using registry datadata

62

Establishing Registries for Evaluating Establishing Registries for Evaluating Patient Outcomes – Defining StandardsPatient Outcomes – Defining Standards

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

63

Outcome - Program GoalsOutcome - Program Goals


– Promote rapid generation of high-quality prospective Promote rapid generation of high-quality prospective data to better evaluate health care products, data to better evaluate health care products, therapies and servicestherapies and services

– Serve as a resource to and collaborator with other Serve as a resource to and collaborator with other DEcIDE CentersDEcIDE Centers

• PI suggested goals for the AHRQ DEcIDE PI suggested goals for the AHRQ DEcIDE NetworkNetwork

– Become the primary pathway for evidence Become the primary pathway for evidence development within HHS through a consistent track development within HHS through a consistent track record of excellence, speed and efficiencyrecord of excellence, speed and efficiency

64

201 BroadwayCambridge, MA 02139

RTI DEcIDE CenterRTI DEcIDE Center

Kathleen N. Lohr, Ph.D., Principal InvestigatorKathleen N. Lohr, Ph.D., Principal Investigator

Lucy A. Savitz, Ph.D., MBA, Co-PILucy A. Savitz, Ph.D., MBA, Co-PI

RTI International (www.rti.org)RTI International (www.rti.org)

3040 Cornwallis Drive3040 Cornwallis Drive

Research Triangle Park, NC USAResearch Triangle Park, NC USA

66

RTI - Core Personnel RTI - Core Personnel and Expertiseand Expertise

• Kathleen Lohr, PhD:Kathleen Lohr, PhD: evidence-based evidence-based practice, quality of care, quality of life practice, quality of care, quality of life assessment, health policyassessment, health policy

• Lucy Savitz, PhD, MBALucy Savitz, PhD, MBA: : patient safety, patient safety, quality improvement, health informatics, quality improvement, health informatics, organizational development, research translationorganizational development, research translation

• Linda Lux, MPA:Linda Lux, MPA: evidence-based practice, evidence-based practice, chronic disease, project managementchronic disease, project management

67

RTI - Affiliations and RTI - Affiliations and PartnershipsPartnerships

• Intermountain Health Care:Intermountain Health Care: Brent James, MD, M.Stat. Brent James, MD, M.Stat.

• Baylor Health Care System:Baylor Health Care System: David Ballard, MD, Ph.D. David Ballard, MD, Ph.D.

• Providence Health System:Providence Health System: K. Bruce Bayley, Ph.D. K. Bruce Bayley, Ph.D.

• HealthInsight HealthInsight (UT-NV QIO): Scott Williams, MD, MPH (UT-NV QIO): Scott Williams, MD, MPH

• Utah Department of HealthUtah Department of Health: Wu Xu, Ph.D. : Wu Xu, Ph.D.

• VA IDEAS CenterVA IDEAS Center: Matthew Samore, MD, MPH : Matthew Samore, MD, MPH

• National Association of Health Data Organizations:National Association of Health Data Organizations:

Denise Love, MBA, RN Denise Love, MBA, RN

• Governor Scott M. Matheson Center for Health Care Governor Scott M. Matheson Center for Health Care

Studies, University of UtahStudies, University of Utah: Richard Sperry, Ph.D. : Richard Sperry, Ph.D.

68

RTI - Research Interests RTI - Research Interests and Center Strengthsand Center Strengths

• Research InterestsResearch Interests– Clinical and therapeutic effectiveness studiesClinical and therapeutic effectiveness studies– Quality of care and patient safetyQuality of care and patient safety– Pharmaceutical and Medicare Part D studiesPharmaceutical and Medicare Part D studies– Strategies for improving the efficiency and effectivenessStrategies for improving the efficiency and effectiveness (organization, management, & delivery) of health care (organization, management, & delivery) of health care

• Center StrengthsCenter Strengths– Cohesive research laboratory for registry and database Cohesive research laboratory for registry and database

analyses, using GIS and sophisticated statistical applicationsanalyses, using GIS and sophisticated statistical applications– Extensive network of health systems and public and private Extensive network of health systems and public and private

sector organizationssector organizations– Special capabilities in clinical medicine, patient safety, quality Special capabilities in clinical medicine, patient safety, quality

improvement, evidence-based practice, and health information improvement, evidence-based practice, and health information technology technology

– Deep knowledge of, experience with related AHRQ programs Deep knowledge of, experience with related AHRQ programs – Keen grasp of pressing Medicare, Medicaid,SCHIP issuesKeen grasp of pressing Medicare, Medicaid,SCHIP issues

69

RTI - Key Database RTI - Key Database HoldingsHoldings

• Intermountain Health Care (IHC): Intermountain Health Care (IHC): EMR; EDW with EMR; EDW with prepared data prepared data marts; case mix system; health plans database, Master Member Index marts; case mix system; health plans database, Master Member Index

• Providence Health System (PHS):Providence Health System (PHS): EMR; EDW; case mix system; EMR; EDW; case mix system; unusual occurrence (event) reporting database; health risk screen Databases; unusual occurrence (event) reporting database; health risk screen Databases; cardiac care and stroke registries; health plans databasecardiac care and stroke registries; health plans database

• Baylor Health Care System (BHCS):Baylor Health Care System (BHCS): EMR; EDW with prepared EMR; EDW with prepared data marts; case mix systemdata marts; case mix system

• HealthInsight:HealthInsight: Medicare and Medicaid databases, cost report data Medicare and Medicaid databases, cost report data

• SLC Veterans Affairs Medical Center (VA): SLC Veterans Affairs Medical Center (VA): EMR for all EMR for all inpatient and outpatient case servicesinpatient and outpatient case services

• Utah Department of Health, Office of Health Care Utah Department of Health, Office of Health Care Statistics: Statistics: Utah Population Database; Utah Population Database; Utah Hospital, All Payer, Inpatient Utah Hospital, All Payer, Inpatient Discharge Database (with Ambulatory Surgery Database; Emergency Discharge Database (with Ambulatory Surgery Database; Emergency Department Encounter DatabaseDepartment Encounter Database subsets) subsets)

EMR: electronic medical record EDW: enterprise data warehouseEMR: electronic medical record EDW: enterprise data warehouse

70

RTI - DEcIDE Project(s)RTI - DEcIDE Project(s)• Medicare Prescription Drug Data Development: Medicare Prescription Drug Data Development:

Methods for Improving Patient Safety and Methods for Improving Patient Safety and Pharmacovigilance Using Observational Data Pharmacovigilance Using Observational Data

– Critically assess current techniques and methods for Critically assess current techniques and methods for pharmacoepidemiologic and pharmacovigilance research, pharmacoepidemiologic and pharmacovigilance research, standardize drug prescription statistics and drug safety standardize drug prescription statistics and drug safety measures, create simulated database, and conduct pilot studies measures, create simulated database, and conduct pilot studies

– Judith Shinogle, Ph.D., Project DirectorJudith Shinogle, Ph.D., Project Director

• Effective Health Care: Patient Safety and Therapeutic Effective Health Care: Patient Safety and Therapeutic EffectivenessEffectiveness

– Support the EHC program by planning a series of 3 DEcIDE Support the EHC program by planning a series of 3 DEcIDE meetings and developing a journal supplement on these topicsmeetings and developing a journal supplement on these topics

– Lucy Savitz, Ph.D., MBA, Project DirectorLucy Savitz, Ph.D., MBA, Project Director

71

Medicare Prescription Drug Data Development:Medicare Prescription Drug Data Development:Methods for Improving Patient Safety and Methods for Improving Patient Safety and

Pharmacovigilance Using Observational DataPharmacovigilance Using Observational Data

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

72

Effective Health Care: Patients Effective Health Care: Patients Safety and Therapeutic Safety and Therapeutic

Effectiveness Effectiveness

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

73

RTI - Program GoalsRTI - Program Goals

• Goals for RTI DEcIDE CenterGoals for RTI DEcIDE Center1. Conduct rapid-cycle research in therapeutic effectiveness, patient 1. Conduct rapid-cycle research in therapeutic effectiveness, patient

safety, and quality of care issues with a focus on Medicare, Medicaid, safety, and quality of care issues with a focus on Medicare, Medicaid, and SCHIP Program populations. and SCHIP Program populations.

2. Develop methods to advance data collection, database design, analysis, 2. Develop methods to advance data collection, database design, analysis, and information dissemination to improve quality of care and patient and information dissemination to improve quality of care and patient safety through applied health services research.safety through applied health services research.

3. Working with our partners, AHRQ, other DEcIDE Centers, and other 3. Working with our partners, AHRQ, other DEcIDE Centers, and other AHRQ programs, create tools and analytic approaches to accomplish AHRQ programs, create tools and analytic approaches to accomplish DEcIDE program goals. DEcIDE program goals.

• Suggested Goals for AHRQ DEcIDE NetworkSuggested Goals for AHRQ DEcIDE Network1. Achieve fruitful collaborations between AHRQ and other federal 1. Achieve fruitful collaborations between AHRQ and other federal

agencies, across the DEcIDE Centers, and across AHRQ programs in agencies, across the DEcIDE Centers, and across AHRQ programs in comparative effectiveness studies.comparative effectiveness studies.

2. Identify and pursue mechanisms for shared learning and accelerated 2. Identify and pursue mechanisms for shared learning and accelerated diffusion of research findings.diffusion of research findings.

3. Translate research results into practical tools and strategies to 3. Translate research results into practical tools and strategies to promote safe and high quality health care delivery.promote safe and high quality health care delivery.

74

Providence HealthSystem in AK, CA, OR, WA

Baylor Health Care System in TX

Intermountain Health CareUT

IntermountainHealth Care in UT

Note: RTI Integrated Delivery System Research Network (IDSRN) Partners shaded

Utah Department of Health

Health Insight(UT-NV CMS QIO)

University of UT Ctr. forHealth Care Studies

Nat’l Assoc. of Health Data Organizations

VA IDEAS Center

Building Blocks ofBreadth & Depth in

RTI DECIDE

Depth in Utah

Breadth in 6 states

RTI - DEcIDE Center

CO-DEcIDE CollaborationCO-DEcIDE Collaborationat the University of Colorado at at the University of Colorado at

Denver and Health Sciences CenterDenver and Health Sciences Center

John F. Steiner, MD, MPHJohn F. Steiner, MD, MPH


76

CO - Core Personnel & CO - Core Personnel & ExpertiseExpertise

• John F. Steiner, MD, MPH – primary care, adherenceJohn F. Steiner, MD, MPH – primary care, adherence

• David West, PhD – Medicaid, primary careDavid West, PhD – Medicaid, primary care

• Karl Hammermeister, MD – cardiovascular diseaseKarl Hammermeister, MD – cardiovascular disease

• William Henderson, PhD – surgical/ perioperative careWilliam Henderson, PhD – surgical/ perioperative care

• Andrew Kramer, MD – post-acute/nursing home care, Medicare Andrew Kramer, MD – post-acute/nursing home care, Medicare policypolicy

• Richard Hamman, MD, DrPH – diabetes, epidemiologyRichard Hamman, MD, DrPH – diabetes, epidemiology

• Robert Valuck, PhD – Medicaid, mental healthRobert Valuck, PhD – Medicaid, mental health

• Wilson Pace, MD – primary care, practice-based research Wilson Pace, MD – primary care, practice-based research

• And others….And others….

77

CO - Affiliations and CO - Affiliations and PartnershipsPartnerships

• University of Colorado Health Sciences CenterUniversity of Colorado Health Sciences Center

– Colorado Health Outcomes ProgramColorado Health Outcomes Program

– Children’s Outcomes Research ProgramChildren’s Outcomes Research Program

– SNOCAP Practice-based Research NetworkSNOCAP Practice-based Research Network

– Department of Preventive Medicine/BiometricsDepartment of Preventive Medicine/Biometrics

– School of Pharmacy School of Pharmacy

– Division of Healthcare Policy and ResearchDivision of Healthcare Policy and Research

• Abt AssociatesAbt Associates

• Medical Group Management AssociationMedical Group Management Association

• Robert Graham CenterRobert Graham Center

• American Academy of Family PhysiciansAmerican Academy of Family Physicians – National Research – National Research NetworkNetwork

78

CO - Research Interests CO - Research Interests & Center Strengths& Center Strengths

• Quality and Safety of drugs and devices in:Quality and Safety of drugs and devices in:

– Primary CarePrimary Care– Child Health (Medicaid, SCHIP)Child Health (Medicaid, SCHIP)– Post-acute and Long-term CarePost-acute and Long-term Care– Mental Health CareMental Health Care– Cardiovascular DiseasesCardiovascular Diseases– DiabetesDiabetes– Underserved PopulationsUnderserved Populations– Palliative Care Palliative Care

• Organization & delivery of pharmaceutical careOrganization & delivery of pharmaceutical care

79

CO - Key Database CO - Key Database HoldingsHoldings

• National Surgical Quality Improvement ProgramsNational Surgical Quality Improvement Programs

VA, Private SectorVA, Private Sector

• Primary Care Research Unit – secondaryPrimary Care Research Unit – secondary

dataset library (NAMCS, MEPS, HCUP, etc.)dataset library (NAMCS, MEPS, HCUP, etc.)

• National Home Care and Hospice SurveyNational Home Care and Hospice Survey

• Medicare Datasets: MCBS, OASIS, MedicareMedicare Datasets: MCBS, OASIS, Medicare

claims, MEDPAR stroke dataclaims, MEDPAR stroke data

• PHARMetrics integrated outcomes databasePHARMetrics integrated outcomes database

• Multi-state Medicaid databaseMulti-state Medicaid database

80

CO - DEcIDE Project(s)CO - DEcIDE Project(s)

• Task Order 1: Medical Management Task Order 1: Medical Management of of

Congestive Heart Failure and the Congestive Heart Failure and the Effectiveness of Isosorbide Effectiveness of Isosorbide Dinitrate and HydralazineDinitrate and Hydralazine

81

Medical Management of Congestive Medical Management of Congestive Heart Failure and the Effectiveness of Heart Failure and the Effectiveness of

Isosorbide Dinitrate and HydralazineIsosorbide Dinitrate and Hydralazine • Abstract: Heart failure results in significant mortality and morbidity despite the Abstract: Heart failure results in significant mortality and morbidity despite the

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

82

CO - Program GoalsCO - Program Goals


Conduct pharmaceutical effectivenessConduct pharmaceutical effectiveness

research in areas of clinical expertiseresearch in areas of clinical expertise

Develop and expand existing partnershipsDevelop and expand existing partnerships

• PI suggested goals for the AHRQ DEcIDE NetworkPI suggested goals for the AHRQ DEcIDE Network

Identify and develop methodological “best Identify and develop methodological “best

practices” for effectiveness researchpractices” for effectiveness research

Chicago-Area DEcIDE CenterChicago-Area DEcIDE Center Coordinating Site:Coordinating Site:

Center for Pharmacoeconomic ResearchCenter for Pharmacoeconomic Research at the University of Illinois at Chicago at the University of Illinois at Chicago

Glen T. Schumock, PharmD, MBA (PI)Glen T. Schumock, PharmD, MBA (PI)

84

Chicago - Consortium Chicago - Consortium PartnersPartners

• University of Illinois at ChicagoUniversity of Illinois at Chicago

– Colleges of Pharmacy, Medicine, Nursing, and Allied Colleges of Pharmacy, Medicine, Nursing, and Allied Health, and School of Public HealthHealth, and School of Public Health

• University of ChicagoUniversity of Chicago

• Northwestern UniversityNorthwestern University

• VA Midwest Center for Health Services and VA Midwest Center for Health Services and Policy ResearchPolicy Research

• Blue Cross/Blue Shield Association Technology Blue Cross/Blue Shield Association Technology Assessment Center and EPCAssessment Center and EPC

85

Chicago - Center Chicago - Center OrganizationOrganization

• Steering CommitteeSteering Committee

• Site CoordinatorsSite Coordinators

– UIC, NU, UC, BCBSA, VA MCHSRPUIC, NU, UC, BCBSA, VA MCHSRP

• CoresCores

– clinical support, data acquisition, data clinical support, data acquisition, data analysis and quality assuranceanalysis and quality assurance

• Management and support staffManagement and support staff

• Over 40 key personnelOver 40 key personnel

86

Chicago - Selected Key Chicago - Selected Key PersonnelPersonnel

N Aronson, PhDN Aronson, PhD BCBSABCBSA Technology Technology assessmentassessment

J Bauman, PharmDJ Bauman, PharmD UICUIC Pharmacy practicePharmacy practice

W Beck, PhDW Beck, PhD UICUIC PharmacogenomicsPharmacogenomics

C Bennett, MD, PhDC Bennett, MD, PhD NUNU Adverse drug eventsAdverse drug events

D Meltzer, MD, PhDD Meltzer, MD, PhD UCUC Health economicsHealth economics

G Schumock, G Schumock, PharmD, MBAPharmD, MBA

UICUIC PharmacoeconomicsPharmacoeconomics

K Weiss, MD, MPHK Weiss, MD, MPH VA & NUVA & NU EpidemiologyEpidemiology

J Zwanziger, PhDJ Zwanziger, PhD UICUIC Health policyHealth policy

87

Chicago - Selected Key Chicago - Selected Key PersonnelPersonnel

C. Alexander, MDC. Alexander, MD UCUC Physician Physician communicationcommunication

C. Beam, PhDC. Beam, PhD UICUIC BiostatisticsBiostatistics

J. Goldstein, MDJ. Goldstein, MD UICUIC Outcomes researchOutcomes research

B. Lambert, PhDB. Lambert, PhD UICUIC Medication safetyMedication safety

T. Lee, PharmD, PhDT. Lee, PharmD, PhD VA & NUVA & NU PharmacoepidemiologyPharmacoepidemiology

S. Pickard, PhDS. Pickard, PhD UICUIC PharmacoeconomicsPharmacoeconomics

J. Stubbings, MHCAJ. Stubbings, MHCA UICUIC Medication policyMedication policy

S. Walton, PhDS. Walton, PhD UICUIC PharmacoeconomicsPharmacoeconomics

88

Chicago - Research Interests Chicago - Research Interests & Center Strengths& Center Strengths

• Cost Effectiveness AnalysisCost Effectiveness Analysis

• PharmacoeconomicsPharmacoeconomics

• Medication SafetyMedication Safety

• Medication Use PolicyMedication Use Policy

• PharmacoepidemiologyPharmacoepidemiology

• Pharmacy PracticePharmacy Practice

89

Chicago - Key Chicago - Key Database HoldingsDatabase Holdings

• VA National Patient DatabaseVA National Patient Database

• VA Medicare DatabaseVA Medicare Database

• Walgreen’s Co Retail DatabaseWalgreen’s Co Retail Database

• Walgreen’s Co PBM DatabaseWalgreen’s Co PBM Database

• Marketscan Commercial DatabaseMarketscan Commercial Database

• Marketscan Medicare Supplemental DatabaseMarketscan Medicare Supplemental Database

• Illinois Department of Healthcare and Family Illinois Department of Healthcare and Family Services DatabaseServices Database

• Commercial Food Workers Union DatabaseCommercial Food Workers Union Database

90


VA National VA National Patient DbPatient Db

Veterans, medical and pharmacy Veterans, medical and pharmacy data, laboratory results, mortalitydata, laboratory results, mortality

VA Medicare DbVA Medicare Db Medicare-eligible Veterans, Medicare-eligible Veterans, medical and pharmacy data, medical and pharmacy data, mortalitymortality

Walgreen’s Co Walgreen’s Co Retail DbRetail Db

Retail prescriptions filled at 5,000 Retail prescriptions filled at 5,000 stores nationwidestores nationwide

Walgreen’s Co Walgreen’s Co PBM DbPBM Db

Medical and pharmacy data for Medical and pharmacy data for enrollees of plans serviced by enrollees of plans serviced by WHI PBMWHI PBM

91


Illinois Medicaid Illinois Medicaid DbDb

Medical and pharmacy data Medical and pharmacy data claims for 2 million citizens, claims for 2 million citizens, includes SeniorCare programincludes SeniorCare program

Commercial Commercial Food Workers Food Workers Union DbUnion Db

Pharmacy and medical claims Pharmacy and medical claims for 300,000 Union members for 300,000 Union members and familiesand families

Marketscan Marketscan Commercial DbCommercial Db

Pharmacy and medical data for Pharmacy and medical data for managed care populationmanaged care population

Marketscan Marketscan Medicare Supp Medicare Supp DbDb

Medical and pharmacy data for Medical and pharmacy data for 1 million individuals in 1 million individuals in Medicare supp programsMedicare supp programs

92

Chicago - DEcIDE Chicago - DEcIDE Project(s)Project(s)

• Outcomes of COPD Management – Outcomes of COPD Management – administrative database evaluation of administrative database evaluation of outcomes in COPD patients treated with outcomes in COPD patients treated with beta-agonists and/or corticosteroids beta-agonists and/or corticosteroids (proposed, lead investigator T. Lee).(proposed, lead investigator T. Lee).

• Design and Evaluation of a Medication Design and Evaluation of a Medication Therapy Management Program – Therapy Management Program – comparative evaluation of 3 levels of MTM comparative evaluation of 3 levels of MTM (proposed, lead investigator D. Touchette).(proposed, lead investigator D. Touchette).

93

Outcomes of COPD Outcomes of COPD Management Management

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

94

Design & Evaluation of a Design & Evaluation of a Medication Therapy Medication Therapy

Management ProgramManagement Program

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

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Chicago - Program GoalsChicago - Program Goals


– Assist AHRQ in conduct of research that is Assist AHRQ in conduct of research that is relevant and meaningful to health care relevant and meaningful to health care consumers and decision-makers in the USconsumers and decision-makers in the US

– Create an environment that fosters Create an environment that fosters collaborative, high quality, and innovative collaborative, high quality, and innovative research for the benefit of the Consortium research for the benefit of the Consortium institutions and individualsinstitutions and individuals

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Chicago - Program GoalsChicago - Program Goals

• PI suggested goals for the AHRQ PI suggested goals for the AHRQ DEcIDE NetworkDEcIDE Network

– Develop a record of producing both Develop a record of producing both high quality and quantity of useful high quality and quantity of useful research that influences health care research that influences health care policy and outcomespolicy and outcomes

– Ensure that the success of the Ensure that the success of the Network is communicated broadly Network is communicated broadly

97

Chicago – Additional Chicago – Additional InformationInformation

• University of Illinois at Chicago: University of Illinois at Chicago: http://www.uic.edu/index.html/http://www.uic.edu/index.html/

– Center for Pharmacoeconomic Research: Center for Pharmacoeconomic Research: http://http://www.uic.edu/pharmacy/research/cprwww.uic.edu/pharmacy/research/cpr//

• University of Chicago: University of Chicago: http://http://www.uchicago.eduwww.uchicago.edu//

• Northwestern University: Northwestern University: http://http://www.northwestern.eduwww.northwestern.edu//

• VA Midwest Center for Health Services and Policy VA Midwest Center for Health Services and Policy Research: Research: http://http://www.vard.org/links/gov.htmlwww.vard.org/links/gov.html

• Blue Cross/Blue Shield Association Technology Blue Cross/Blue Shield Association Technology Assessment Center and EPC: Assessment Center and EPC: http://http://www.bcbs.com/tecwww.bcbs.com/tec//

http://www.uic.edu/index.html/

http://www.uic.edu/pharmacy/research/cpr/



http://www.uchicago.edu/



http://www.northwestern.edu/



http://www.vard.org/links/gov.html

http://www.vard.org/links/gov.html

http://www.bcbs.com/tec/



The University of Maryland Baltimore The University of Maryland Baltimore (UMB) DEcIDE Center(UMB) DEcIDE Center

Bruce Stuart, PhD (PI)Bruce Stuart, PhD (PI)

99

The UMB DEcIDE Center brings together The UMB DEcIDE Center brings together the talents of more than 50 investigators the talents of more than 50 investigators and senior staff from:and senior staff from:

• School of PharmacySchool of Pharmacy

• School of MedicineSchool of Medicine

• School of NursingSchool of Nursing

UMBUMB

100

These UMB investigators are available These UMB investigators are available to collaborate and provide data for this to collaborate and provide data for this effort including:effort including:

• Comparative Drug EffectivenessComparative Drug Effectiveness

• Treatment Safety and Efficacy in Treatment Safety and Efficacy in Elderly and Disabled PatientsElderly and Disabled Patients

• Innovative Research Designs using Innovative Research Designs using Observational Databases Observational Databases

UMBUMB

101

The UMB DEcIDE Center has several partners The UMB DEcIDE Center has several partners who are providing data for this effort who are providing data for this effort including:including:

• Centers for Medicare and Medicaid Centers for Medicare and Medicaid Services (CMS)Services (CMS)

• Baltimore Veterans Healthcare Baltimore Veterans Healthcare Administration System (VHA)Administration System (VHA)

• Thomson MedstatThomson Medstat

• OmnicareOmnicare

UMBUMB

102

An Executive Management Team has overall program An Executive Management Team has overall program management responsibilities. This team will be led management responsibilities. This team will be led by Executive Director by Executive Director Bruce Stuart, PhDBruce Stuart, PhD from the from the School of Pharmacy’s Peter Lamy Center.School of Pharmacy’s Peter Lamy Center.

Executive Management Team Associate Directors Executive Management Team Associate Directors are:are:

• Ilene Zuckerman, PharmD, PhDIlene Zuckerman, PharmD, PhD from the from the School of Pharmacy’s Peter Lamy CenterSchool of Pharmacy’s Peter Lamy Center

• Charlene Quinn, RN, PhDCharlene Quinn, RN, PhD from the School of from the School of Medicine and the Baltimore Veterans Medicine and the Baltimore Veterans Administration Medical Center (VAMC)Administration Medical Center (VAMC)

UMBUMB

103

The Center is structured around the The Center is structured around the Executive Management Team and 5 core Executive Management Team and 5 core groups: groups:

• Clinical Epidemiology CoreClinical Epidemiology Core• Pharmacotherapy CorePharmacotherapy Core• Data CoreData Core• Methods and Statistics CoreMethods and Statistics Core• Information Dissemination CoreInformation Dissemination Core

UMBUMB

104

UMB DEcIDE CenterUMB DEcIDE Center

Organizational StructureOrganizational Structure

University of Maryland Baltimore

Executive Management Team

Thomson Medstat

Baltimore VA Medical Center

Consultants

Administrative Resources

Clinical Epidemiology Core

Pharmacotherapy Core

Data Core Methods and Statistics Core

Dissemination Core

Peter Lamy Center on Drug Therapy

and Aging

School of PharmacySchool of Medicine

106

UMB Task Order #1UMB Task Order #1Methods for Studying Methods for Studying

Dementia Treatment and Dementia Treatment and Outcomes in Observational Outcomes in Observational

DatabasesDatabases

107

This task order is being led by This task order is being led by Ann Ann Gruber-Baldini, PhDGruber-Baldini, PhD,, an experienced an experienced researcher with a specialty in dementia researcher with a specialty in dementia diagnosis and outcomes in long-term care.diagnosis and outcomes in long-term care.

Assisting Dr. Gruber-Baldini are:Assisting Dr. Gruber-Baldini are:

• clinical expertsclinical experts

• methodological expertsmethodological experts

• a support network of administrative a support network of administrative personnel dedicated to high performance personnel dedicated to high performance and scientific integrityand scientific integrity

UMBUMB

108

UMBUMB

Dr. Gruber-Baldini and her team are providing Dr. Gruber-Baldini and her team are providing three deliverables for this task order:three deliverables for this task order:

• a literature review on the effectiveness of a literature review on the effectiveness of drug therapies used to treat dementia drug therapies used to treat dementia

• an assessment of sample sizes and an assessment of sample sizes and measures for conducting comparative measures for conducting comparative effectiveness studies of dementia effectiveness studies of dementia treatments treatments

• the development of a research project plan the development of a research project plan using one or more of these datasetsusing one or more of these datasets

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Methods for Studying Dementia Methods for Studying Dementia Treatment and Outcomes in Treatment and Outcomes in

Observational DatabasesObservational Databases • Abstract: The three main deliverables for this project are: (1) an update and evaluation of the 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 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 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 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 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 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 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 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. 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 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 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 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, 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), 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 population coverage and sample sizes, and the unique opportunities provided through data linkages.linkages.

• In the final phase of the study, we are using the knowledge gained in the literature review and 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 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 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 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 study using the Medicare Current Beneficiary Survey (MCBS) data to establish prevalence rates for dementia and dementia treatments for community-dwelling and institutionalized Medicare 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 beneficiaries, and (2) a fully fleshed out study design for future comparative drug treatment studies using one or more of our databases. studies using one or more of our databases.

UNC DEcIDE CenterUNC DEcIDE Centerat at

The Cecil G. Sheps Center for Health Services ResearchThe Cecil G. Sheps Center for Health Services ResearchThe University of North CarolinaThe University of North Carolina

Suzanne L. West, MPH, PhDSuzanne L. West, MPH, PhD


Michael (Mick) D. Murray, PharmD, MPHMichael (Mick) D. Murray, PharmD, MPH

Co-Principal InvestigatorCo-Principal Investigator

111

UNC - Core Personnel & UNC - Core Personnel & Expertise (1)Expertise (1)

• Suzanne West, MPH, PhDSuzanne West, MPH, PhD

– Pharmacoepidemiology, systematic reviews, psychiatric Pharmacoepidemiology, systematic reviews, psychiatric epidemiologyepidemiology

• Mick Murray, PharmD, MPHMick Murray, PharmD, MPH

– Health outcomes of pharmaceutical interventions, medication Health outcomes of pharmaceutical interventions, medication adherence adherence

• Tim Carey, MD, MPHTim Carey, MD, MPH

– Clinical epidemiology, internal medicine, evidence-based Clinical epidemiology, internal medicine, evidence-based practice, back painpractice, back pain

• Harry Guess, MD, PhDHarry Guess, MD, PhD

– Pediatrics, pharmacoepidemiology, patient reported outcomesPediatrics, pharmacoepidemiology, patient reported outcomes

112

UNCUNC - - Core Personnel & Core Personnel & Expertise (2)Expertise (2)

• Michele Jonsson Funk, PhDMichele Jonsson Funk, PhD

– HIV, advanced epidemiologic methodsHIV, advanced epidemiologic methods

• Maryann Oertel, PharmDMaryann Oertel, PharmD

– Drug safety, drug informationDrug safety, drug information

• John Paul, PhDJohn Paul, PhD

– Healthcare policy, outcomes researchHealthcare policy, outcomes research

• Susan Blalock, MPH, PhDSusan Blalock, MPH, PhD

– Adherence to treatment, inappropriate drug useAdherence to treatment, inappropriate drug use

• Nikki McKoy, BSNikki McKoy, BS

– Systematic reviews, project managementSystematic reviews, project management

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UNC -UNC - Affiliations and Affiliations and PartnershipsPartnerships

• Center for Health Services Research in Primary Center for Health Services Research in Primary Care, VAMC, Durham, NCCare, VAMC, Durham, NC

• Medicines Monitoring Unit at the University of Medicines Monitoring Unit at the University of Dundee, ScotlandDundee, Scotland

• NC AccessCareNC AccessCare

– not-for-profit Medicaid disease management coalition not-for-profit Medicaid disease management coalition

• Quality in Pediatric Subspecialty Care (QPSC) Quality in Pediatric Subspecialty Care (QPSC)

– Collaboration between the American Board of Collaboration between the American Board of Pediatrics, American Academy of Pediatrics & UNCPediatrics, American Academy of Pediatrics & UNC

114

UNC - Research Interests UNC - Research Interests & Center Strengths& Center Strengths

• Pharmacoepidemiologic methodsPharmacoepidemiologic methods

• Drug utilization reviewDrug utilization review

• Systematic reviewsSystematic reviews

• Medication adherenceMedication adherence

• PharmacoeconomicsPharmacoeconomics

• Medical text information clustering and mining Medical text information clustering and mining

• CERT focused on pediatricsCERT focused on pediatrics

• Racial disparitiesRacial disparities

• Rural healthRural health

115

UNCUNC - - Key Database Key Database HoldingsHoldings

• Veterans Administration dataVeterans Administration data

• NC State Employees Health Plan dataNC State Employees Health Plan data

• NC Medicaid dataNC Medicaid data

• Health Choice (NC SCHIP)Health Choice (NC SCHIP)

116

UNC - DEcIDE Project(s)UNC - DEcIDE Project(s)

• Conduct a literature scan focusing on Conduct a literature scan focusing on inappropriate medication useinappropriate medication use

• Establish an initial process measure set Establish an initial process measure set that will address misuse, over- and that will address misuse, over- and under-use of prescription medications under-use of prescription medications

• Assess the validity of the measure set Assess the validity of the measure set using NC Medicaid data using NC Medicaid data

117

Research and Surveillance Methods Research and Surveillance Methods for Improving Patient Safety for Improving Patient Safety

Through Medicare Claims DatabasesThrough Medicare Claims Databases• Abstract: The specific objective of the project is to establish an initial measure set that will encompass 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 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 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 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 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 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 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 below. The investigators will conduct a data. The tasks for this project will be described in more detail below. The investigators will conduct a brief but focused literature scan to identify publications that have dealt with the conceptualization of brief but focused literature scan to identify publications that have dealt with the conceptualization of medication safety using administrative databases as well as studies of specific misuse and underuse of medication safety using administrative databases as well as studies of specific misuse and underuse of medications. Our literature search will focus on Medical Subject Headings and text word searches as medications. Our literature search will focus on Medical Subject Headings and text word searches as appropriate. A preliminary search identified over 600 articles using drug utilization review and health appropriate. A preliminary search identified over 600 articles using drug utilization review and health maintenance organization, insurance claim review, or health maintenance organization. Once we have maintenance organization, insurance claim review, or health maintenance organization. Once we have assembled the literature, have identified examples of process measures (misuse, overuse, and underuse assembled the literature, have identified examples of process measures (misuse, overuse, and underuse of medications) and have developed an initial measure set, we will share this information with of medications) and have developed an initial measure set, we will share this information with collaborators and outside project advisors. We will seek constructive criticism on our conceptualization of collaborators and outside project advisors. We will seek constructive criticism on our conceptualization of the measures and the possible usage situations to evaluate based on the typical structure of Medicare, the measures and the possible usage situations to evaluate based on the typical structure of Medicare, Medicaid, SCHIP, and managed care administrative claims data. We will test the process measures using Medicaid, SCHIP, and managed care administrative claims data. We will test the process measures using data from state Medicaid claims files. We will select a particular clinical situation for evaluation as data from state Medicaid claims files. We will select a particular clinical situation for evaluation as informed by the literature scan and the suggestions of our collaborators and advisors. Investigators will informed by the literature scan and the suggestions of our collaborators and advisors. Investigators will begin with evidence-based clinical guidelines for the treatment of patients with the clinical issue being begin with evidence-based clinical guidelines for the treatment of patients with the clinical issue being studied by reviewing websites and journals from the appropriate clinical society, in addition to the studied by reviewing websites and journals from the appropriate clinical society, in addition to the National Guideline Clearinghouse and other relevant sources. Based on the literature, we will develop National Guideline Clearinghouse and other relevant sources. Based on the literature, we will develop algorithms for identifying usage patterns and their appropriateness for the condition under study along algorithms for identifying usage patterns and their appropriateness for the condition under study along with highly prevalent co-morbidities. We will conduct sensitivity analyses to refine the algorithms and will with highly prevalent co-morbidities. We will conduct sensitivity analyses to refine the algorithms and will characterize the patients in each use pattern after sensitivity analyses, by age and sex. Our final report characterize the patients in each use pattern after sensitivity analyses, by age and sex. Our final report will include a description of the literature scan and the evidence tables; processes for developing the will include a description of the literature scan and the evidence tables; processes for developing the algorithm(s); will discuss any problems encountered; and will provide an assessment of the algorithms’ algorithm(s); will discuss any problems encountered; and will provide an assessment of the algorithms’ overall robustness. overall robustness.

118

UNCUNC - - Program GoalsProgram Goals• PI goals for DEcIDE CenterPI goals for DEcIDE Center

– Expand AHRQ capabilities in the analysis of claims data from CMS Expand AHRQ capabilities in the analysis of claims data from CMS programs: Medicare, Medicaid, and State Children’s Health programs: Medicare, Medicaid, and State Children’s Health Insurance Programs Insurance Programs

– Develop capability in designing and conducting randomized Develop capability in designing and conducting randomized database studiesdatabase studies

• PI suggested goals for the AHRQ DEcIDE NetworkPI suggested goals for the AHRQ DEcIDE Network

– Facilitating public-private partnerships for conducting comparative Facilitating public-private partnerships for conducting comparative effectiveness studies effectiveness studies

– Improve linkages with EPC and CERT networks, also with the Improve linkages with EPC and CERT networks, also with the policy communitypolicy community

– Improve research translation to the policy community in terms Improve research translation to the policy community in terms understandable to themunderstandable to them

University of Pennsylvania University of Pennsylvania School of MedicineSchool of Medicine

PI: Brian L. Strom, MD, MPHPI: Brian L. Strom, MD, MPH

Co-PI: Sean Hennessy, PharmD, PhDCo-PI: Sean Hennessy, PharmD, PhD

120

UPenn - Core UPenn - Core Personnel & ExpertisePersonnel & Expertise

Brian L. Strom, MD, MPHBrian L. Strom, MD, MPH: Pharmacoepidemiology, : Pharmacoepidemiology, Clinical Epidemiology, General Internal Medicine, Clinical Clinical Epidemiology, General Internal Medicine, Clinical PharmacologyPharmacology

Sean Hennessy, PharmD, PhDSean Hennessy, PharmD, PhD: Pharmacoepidemiology, : Pharmacoepidemiology, Clinical Epidemiology, Clinical PharmacyClinical Epidemiology, Clinical Pharmacy

Multidisciplinary Steering CommitteeMultidisciplinary Steering Committee

Research ExpertiseResearch Expertise: Epidemiology, Biostatistics, Health : Epidemiology, Biostatistics, Health Services Research, Pharmacogenetics, etc.Services Research, Pharmacogenetics, etc.

Clinical ExpertiseClinical Expertise: Medicine, Surgery, Psychiatry, : Medicine, Surgery, Psychiatry, Nursing, Pharmacy, etc.Nursing, Pharmacy, etc.

121

UPenn - Affiliations UPenn - Affiliations and Partnershipsand Partnerships

• Geisinger Medical CenterGeisinger Medical Center

• Centers for Education and Research on Centers for Education and Research on TherapeuticsTherapeutics

• Other schools, departments, and centers Other schools, departments, and centers of the University of Pennsylvaniaof the University of Pennsylvania

122

UPenn - Research Interests UPenn - Research Interests & Center Strengths& Center Strengths

• Epidemiologic studies of beneficial and Epidemiologic studies of beneficial and adverse drug effectsadverse drug effects

• Evaluations of efforts to improve Evaluations of efforts to improve medication usemedication use

• Pharmacoepidemiology research Pharmacoepidemiology research methodsmethods

• Pharmacogenetic epidemiologyPharmacogenetic epidemiology

123

UPenn - Key Database UPenn - Key Database HoldingsHoldings

• Medicaid data from 5 large states (13 million Medicaid data from 5 large states (13 million persons; 35% of Medicaid population), linked to persons; 35% of Medicaid population), linked to Medicare and Social Security Death Master FileMedicare and Social Security Death Master File

• UK General Practice Research Database (GPRD; 8 UK General Practice Research Database (GPRD; 8 million persons)million persons)

• The Health Improvement Network (THIN; 4 million The Health Improvement Network (THIN; 4 million persons) persons)

• Inpatient and outpatient data from University of Inpatient and outpatient data from University of Pennsylvania Health SystemPennsylvania Health System

124

UPenn - DEcIDE UPenn - DEcIDE ProjectProject

• Antidepressants and Risk of Antidepressants and Risk of Aspiration Pneumonia in the AgedAspiration Pneumonia in the Aged

125

Antidepressants and Risk of Antidepressants and Risk of Aspiration Pneumonia in the Aged Aspiration Pneumonia in the Aged

• Abstract: Community-acquired pneumonia is a major cause of morbidity Abstract: Community-acquired pneumonia is a major cause of morbidity and mortality in the elderly, with an estimated annual health care cost in and mortality in the elderly, with an estimated annual health care cost in the US of $4.4 billion. Aspiration pneumonia occurs commonly in the US of $4.4 billion. Aspiration pneumonia occurs commonly in institutionalized elderly individuals, the number of whom is expected to institutionalized elderly individuals, the number of whom is expected to grow as the population ages. Recent data suggest the possibility that grow as the population ages. Recent data suggest the possibility that antidepressant medications may increase the risk of aspiration antidepressant medications may increase the risk of aspiration pneumonia. Postulated mechanisms include effects on swallowing and pneumonia. Postulated mechanisms include effects on swallowing and lower esophageal sphincter pressure. However, the effects of lower esophageal sphincter pressure. However, the effects of antidepressant medications on these functions is not well studied, nor is antidepressant medications on these functions is not well studied, nor is the association between antidepressant medications and aspiration the association between antidepressant medications and aspiration pneumonia. We propose to conduct an observational study within the UK pneumonia. We propose to conduct an observational study within the UK General Practice Research Database to examine the association between General Practice Research Database to examine the association between use of antidepressant drug use and community acquired pneumonia in use of antidepressant drug use and community acquired pneumonia in general, and community acquired aspiration pneumonia in particular. In general, and community acquired aspiration pneumonia in particular. In addition, we will develop a proposal for a patient-oriented research study addition, we will develop a proposal for a patient-oriented research study examining the effects of specific antidepressants on swallowing and on examining the effects of specific antidepressants on swallowing and on lower esophageal sphincter pressure.lower esophageal sphincter pressure.

126

UPenn - Program GoalsUPenn - Program Goals

• University of Pennsylvania DEcIDE University of Pennsylvania DEcIDE Center Goal: To improve the health of Center Goal: To improve the health of the public by producing correct answers the public by producing correct answers to clinically important comparative to clinically important comparative effectiveness research questions.effectiveness research questions.

• Suggested Goal for DEcIDE Network: To Suggested Goal for DEcIDE Network: To improve the health of the public by improve the health of the public by producing correct answers to clinically producing correct answers to clinically important comparative effectiveness important comparative effectiveness research questions.research questions.

127

Clinical & Biologic InsightMedicineCardiologyRheumatologyGastro-enterologyOncologyNeurologyEndocrinologyPulmonologyPsychiatryGeneticsPharmacologyPharmacyNursingetc.

Core Research Disciplines

Pharmaco-epidemiologyClinical epidemiologyBiostatisticsHealth services researchHealth economicsHealth informaticsTranslational researchBehavioral researchHealth assessment

etc.

UPenn - Study Addressing a Clinically Relevant Research Question

Research Databases /

Patient Populations

Medicaid / MedicareGPRDTHINUPHSDVCCNGeisingeretc.

Computing & Project

Management Project ManagersProgrammersFiscal Management

DEcIDE about TherapeuticsDEcIDE about Therapeutics at Vanderbiltat Vanderbilt

Marie R. Griffin MD MPHMarie R. Griffin MD MPH

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Vanderbilt - Core Vanderbilt - Core Personnel & ExpertisePersonnel & Expertise

• Marie R Griffin MD MPH, Marie R Griffin MD MPH, NSAIDs, vaccinesNSAIDs, vaccines

• Wayne A Ray PhD, Wayne A Ray PhD, NSAIDs, psychotropic drugsNSAIDs, psychotropic drugs

• William O Cooper MD MPH, William O Cooper MD MPH, drugs for childrendrugs for children

• Carlos G Grijalva MD, Carlos G Grijalva MD, public health, epidemiologypublic health, epidemiology

• Patrick G Arbogast PhD, Patrick G Arbogast PhD, statisticsstatistics

• Edward F Mitchel MA, programming, Edward F Mitchel MA, programming, data analysisdata analysis

• James R Daugherty Jr MSJames R Daugherty Jr MS, programming, programming

• Rebecca Ding MA, Rebecca Ding MA, statisticianstatistician

• Patricia S Gideon RN, data abstractionPatricia S Gideon RN, data abstraction

• Debbie Varnell, Debbie Varnell, administrationadministration

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Vanderbilt - Affiliations Vanderbilt - Affiliations and Partnershipsand Partnerships

• Vanderbilt Center for Education and Research on Vanderbilt Center for Education and Research on Therapeutics (CERT)Therapeutics (CERT)

• Wayne A Ray PIWayne A Ray PI

• Tennessee Medicaid ProgramTennessee Medicaid Program

• VA Geriatric Research and Education Clinical Center VA Geriatric Research and Education Clinical Center (GRECC)(GRECC)

• Robert Dittus PIRobert Dittus PI

• VA Translating Research into PracticeVA Translating Research into Practice

• Theodore Speroff, PITheodore Speroff, PI

• VA Clinical Research Center of ExcellenceVA Clinical Research Center of Excellence

• Marie R Griffin, PIMarie R Griffin, PI

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Vanderbilt - Research Vanderbilt - Research Interests & Center StrengthsInterests & Center Strengths

• PharmacoepidemiologyPharmacoepidemiology

• NSAIDs and COX 2 inhibitors (“coxibs”)NSAIDs and COX 2 inhibitors (“coxibs”)

• Peptic ulcer diseasePeptic ulcer disease

• Vaccines and vaccine preventable diseasesVaccines and vaccine preventable diseases

• AsthmaAsthma

• Sudden deathSudden death

• Child healthChild health

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Vanderbilt - Key Vanderbilt - Key Database HoldingsDatabase Holdings

1.1. Tennessee Medicaid databasesTennessee Medicaid databases

2.2. VA VISN 9 databasesVA VISN 9 databases

3.3. Regional/State population-based Regional/State population-based surveillancesurveillance

1.1. New Vaccine Surveillance Network (NVSN) New Vaccine Surveillance Network (NVSN) acute respiratory infections in children <5 years, acute acute respiratory infections in children <5 years, acute gastroenteritis in children <3 yearsgastroenteritis in children <3 years

2.2. Emerging Infections Program (EIP) Emerging Infections Program (EIP) bacterial infections, food borne illnessesbacterial infections, food borne illnesses

133

Vanderbilt - DEcIDE Vanderbilt - DEcIDE ProjectProject

• Assessment of factors Assessment of factors modulating treatment outcomes modulating treatment outcomes of rheumatoid arthritisof rheumatoid arthritis

Safety and relative effectiveness of Safety and relative effectiveness of biologics for rheumatoid arthritis as biologics for rheumatoid arthritis as compared to older DMARDscompared to older DMARDs

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Relative Safety and Relative Safety and Effectiveness of Therapies for Effectiveness of Therapies for

Rheumatoid ArthritisRheumatoid Arthritis• Abstract: The therapy of rheumatoid arthritis (RA) is based on disease-modifying antirheumatic Abstract: The therapy of rheumatoid arthritis (RA) is based on disease-modifying antirheumatic

drugs (DMARDs). The introduction of novel treatments, including biologics, offers hope for better drugs (DMARDs). The introduction of novel treatments, including biologics, offers hope for better prevention and control of pain and disability associated with rheumatoid arthritis (RA). Although prevention and control of pain and disability associated with rheumatoid arthritis (RA). Although controlled clinical studies to help define optimal use of DMARDs in RA patients are in evolution, controlled clinical studies to help define optimal use of DMARDs in RA patients are in evolution, most clinical trials are of relatively short duration, and are performed in highly selected patients. most clinical trials are of relatively short duration, and are performed in highly selected patients. RA is a life-long disease affecting one percent of the general population. Population-based RA is a life-long disease affecting one percent of the general population. Population-based studies are needed to help quantify important beneficial and adverse clinical outcomes studies are needed to help quantify important beneficial and adverse clinical outcomes associated with use of therapeutics in this disease. Populations that include low-income persons, associated with use of therapeutics in this disease. Populations that include low-income persons, and members of racial and ethnic minorities, are of special interest, since these groups are and members of racial and ethnic minorities, are of special interest, since these groups are typically under-represented in clinical trials. There is currently little information on effectiveness typically under-represented in clinical trials. There is currently little information on effectiveness and safety of new DMARDs as compared to traditional DMARDs. We propose a sequence of and safety of new DMARDs as compared to traditional DMARDs. We propose a sequence of epidemiologic studies aimed at addressing knowledge gaps in relative effectiveness (specific aim epidemiologic studies aimed at addressing knowledge gaps in relative effectiveness (specific aim 1) and safety (specific aims 2 and 3) of specific DMARDs: 1. To define a cohort of patients with 1) and safety (specific aims 2 and 3) of specific DMARDs: 1. To define a cohort of patients with RA among state Medicaid enrollees to determine the prevalence of use of selected DMARDs. We RA among state Medicaid enrollees to determine the prevalence of use of selected DMARDs. We will explore several outcomes as measures of relative effectiveness of specific will explore several outcomes as measures of relative effectiveness of specific agents/combinations: · Prevalence of co-therapy with a) corticosteroids, b) non steroidal anti agents/combinations: · Prevalence of co-therapy with a) corticosteroids, b) non steroidal anti inflammatory drugs (NSAIDs), and c) narcotics. · Adherence to standard regimens and inflammatory drugs (NSAIDs), and c) narcotics. · Adherence to standard regimens and continuation of use · Health care utilization. 2. To determine the incidence of congestive heart continuation of use · Health care utilization. 2. To determine the incidence of congestive heart failure in the RA cohort and test whether RA patients receiving anti TNF-á therapy (etanercept, failure in the RA cohort and test whether RA patients receiving anti TNF-á therapy (etanercept, infliximab and adalimumab) are at increased risk of developing congestive heart failure as infliximab and adalimumab) are at increased risk of developing congestive heart failure as compared to patients receiving conventional DMARDs. 3. To determine the incidence of selected compared to patients receiving conventional DMARDs. 3. To determine the incidence of selected infection outcomes in the RA cohort and test whether RA patients receiving anti TNF-á infection outcomes in the RA cohort and test whether RA patients receiving anti TNF-á (etanercept, infliximab and adalimumab) or anti interleukin-1 (anakinra) are at increased risk of (etanercept, infliximab and adalimumab) or anti interleukin-1 (anakinra) are at increased risk of serious infections as compared to patients receiving conventional DMARDs.serious infections as compared to patients receiving conventional DMARDs.

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Vanderbilt - Program Vanderbilt - Program GoalsGoals

1.1. To perform efficient studies of patterns of utilization To perform efficient studies of patterns of utilization and relative effectiveness in TN Medicaid population and relative effectiveness in TN Medicaid population

2.2. To develop local and national VA databases to To develop local and national VA databases to perform parallel studiesperform parallel studies

3.3. PI suggested goals for the AHRQ DEcIDE NetworkPI suggested goals for the AHRQ DEcIDE Network

• To develop uniform definitions for exposures, To develop uniform definitions for exposures, outcomes, and measures of relative effectiveness outcomes, and measures of relative effectiveness appropriate for observational studiesappropriate for observational studies

Other AHRQ ProgramsOther AHRQ Programsinvolved with involved with

Effective Health Care Initiative & Effective Health Care Initiative &

Research in TherapeuticsResearch in Therapeutics

AHRQ

Scientific Resource Center

Evidence Synthesis

EPC A

EPC B

EPC C

EPC D

DEcIDE A

DEcIDE B

DEcIDE C

DEcIDE D

Evidence GenerationEisenberg

Center

Stake holdersPublic Input

DEcIDE E

DEcIDE F

DEcIDE G

DEcIDE H

CERTsResource

CenterDuke

2002-2007 CERTs

Managed Care Data

HMO Research Network

Medicaid DataVanderbilt

PediatricsUNC-CH

CardiologyDuke

Drug Interations/Women’s

HealthU Arizona

Infectious Diseases

Penn

MusculoskeletalUAB

AgingTBD

Consumers/Adherence

TBD

Mental HealthTBD

DevicesTBD

2005-2010 CERTs

DEcIDE NETWORK

Effective Health Care Program

DRUG COMPARATIVE EFFECT REVIEWS

137

U AlabamaMusculoskeletal

disorders

Duke UniversityHeart & blood

vessels.

U PennInfection &

antibiotic drug resistance

Vanderbilt U Medicaid population

U North CarolinaPediatrics

HMO RNDrug use, safety,Effectiveness in

MCO

ArizonaDrug Interactions,

Esp in Women

AHRQ & FDA

Centers for Education and Research on Centers for Education and Research on Therapeutics (CERTs)Therapeutics (CERTs)

Aging

Mental Health

Consumers/Adherence

Medical Devices

New in 2006

138

Alabama Use of Bayesian-based datamining approach to identify NSAID-related adverse outcomes.

ArizonaEvaluation of pharmacists to monitor and conduct outcome evaluations in community settings.

DukeIn collaboration with the UNC-CERTs & NC QIO will develop inverse probability weighted estimators to evaluate clinical outcomes in patients using different beta-blockers.

Harvard Pilgrim Health Care

Qualitative study to assess comparative effectiveness of licensed therapies that support design, acceptability, and implementation of cluster randomization trials.

North Carolina

In collaboration with the Duke CERT, will develop a software tool for obtaining doubly robust estimates of treatment effects. The software will be freely disseminated electronically.

PennsylvaniaEvaluate feasibility of academic-QIO/CDAC partnership to verify administrative data outcomes using clinical records.

Vanderbilt

Using TennCare database, Vanderbilt CERT will conduct a methodologically novel “new user” design cohort study to examine protective use of proton pump inhibitors with concomitant NSAID use.

139

AHRQ Programs Supporting Studies of AHRQ Programs Supporting Studies of Pharmaceuticals & Other Therapies.Pharmaceuticals & Other Therapies.

IDSRN’sIntegrated Delivery System Research

Network

PBRN’sPrimary Care Practice-based

Research NetworksHIT

Health Information TechnologyState & Rural Partnerships

Effective HealthCare Program

DEcIDEEPC’s

Eisenberg Center

CERTsCenters for Education &

Research on Therapeutics

Translation

Research

EPC’sEvidence-based Practice Centers

Synthesis

Demonstration

PharmOutcomes

140

Scott R. Smith, PhDScott R. Smith, PhDDEcIDE DirectorDEcIDE Director

[email protected]@ahrq.gov

Lia Snyder, MPHLia Snyder, MPHEHC Program ManagerEHC Program Manager

[email protected]@ahrq.gov

More Information More Information http://http://effectivehealthcare.ahrq.goveffectivehealthcare.ahrq.gov/ /

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http://effectivehealthcare.ahrq.gov/



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Acknowledgements Acknowledgements & Thanks& Thanks

DEcIDE CentersDEcIDE Centers PI’s, Co-PI’s, and Affiliated StaffPI’s, Co-PI’s, and Affiliated Staff

Jean SlutskyJean Slutsky Director, AHRQ Center for Director, AHRQ Center for Outcomes & EvidenceOutcomes & Evidence

Scott R. Smith, PhDScott R. Smith, PhD Director, AHRQ Pharmaceutical Director, AHRQ Pharmaceutical Outcomes Research ProgramsOutcomes Research Programs

Lia Snyder, MPHLia Snyder, MPH Program Manager, Effective Health Program Manager, Effective Health Care ProgramCare Program

Mark Helfand, MDMark Helfand, MD Director, Scientific Resource CenterDirector, Scientific Resource Center

David Hickham, MDDavid Hickham, MD Director, Eisenberg CenterDirector, Eisenberg Center

DisclaimerDisclaimerThis presentation and slide set does not represent

the policy of either the Agency for Healthcare Research and Quality (AHRQ) or the US Department

of Health and Human Services (DHHS).

The views expressed herein are those of the presenter, and no official endorsement by AHRQ or

DHHS is intended or should be inferred.

Current information about the DEcIDE program should be obtained from AHRQ or the DEcIDE Program Director and not from these slides.

143

Thank you!

144

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