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An Overview of Marshfield Clinics Research
Program Exploring Opportunities for
Collaborationin the Real World

• Dr. Humberto Vidaillet
• Director of Medical Research, Marshfield Clinic
• Director, Marshfield Clinic Research Foundation
• Clinical Professor of Medicine, UW SMPH
• September 14, 2011

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Objectives Purpose of Forum

• Provide an opportunity for research networks and
  other research groups to learn about each other
  and the projects they conduct.
• Learn about operational and project barriers, and
  successful methods to overcome barriers.
• Facilitate networking and connections between
  people and groups with similar interests.

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Welcome to Marshfield Clinic
Ranked by Forbes in 2010 as the 5th best small
city in the country to raise a family.
Designated in 2008 by Demographics Daily as one
of the nations top 20 Dream Towns
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Marshfield Clinic

• Mission To serve patients through
  accessible, high quality health care,
  
  research and education
• 501(c)(3) organization
• Largest private group practice in WI
• 52 centers in gt35 communities
• gt770 physicians (102 family practice
• physicians) in gt85 specialties
• 6,600 additional personnel
• 3.5 million patient encounters/year
  365,000 unique
  patients/year
• Marshfield Labs (Human Veterinary)
• Lakeview Medical Center, Rice Lake, WI
• Security Health Plan (HMO)

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Why Marshfield Clinic Engages in Research
Education

• Core elements of Marshfield Clinics Mission, its
  status as a nationally recognized Academic
  Medical Center, and its Charitable Trust
• Contribute to knowledge leading to advances in
  patient care, quality metrics and public health,
  improves the quality of human existence and the
  lives of our patients and their loved ones
• Contribute to recruitment of high quality
  physicians and other professionals who want to
  work in an academic environment
• Differentiate Marshfield Clinic from competitors
  patients rightly conclude that care is better at
  centers involved in research education
• For clinicians who do research and teach, it adds
  another dimension to their contributions to
  medicine and improves their clinical practice
  for virtually all Marshfield Clinic employees, a
  sense of shared pride!
• Research and Education have been integral to the
• Clinics culture, sustained growth and quality of
  care since 1916!

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Research Program at Marshfield Clinic

• 400 active studies
• 125-150 clinical investigators and 30 MD/PhD
  scientists
• Major external sponsors NIH, CDC, NIOSH, AHRQ,
  Industry, Philanthropy
• Academic structure IRB, Research Comm.,
  Research Compliance, Conflict of
  Interest, Biosafety, etc.
• Tenure program and Endowed positions
• Marshfield Clinic Research Foundation (MCRF)
• Mission To discover and communicate scientific
  knowledge that substantially improves human
  health and well-being
• - 200 staff

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Research Program Structure
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MCRF Board of Trustees
Oversees MCRF, providing policy direction,
financial oversight, and counsel to MCRF
leadership in a wide range of areas associated
with research structure, process, and resources

• Physician Members
• Jaime Boero, MD. Vice - Chair
• Michael Caldwell, MD, PhD
• Christopher Cold, MD
• Rezwan Islam, MD
• Ram Pathak, MD
• Kent Ray, DO
• Shereif Rezkalla, MD, Treasurer
• Karl Ulrich, MD
• Matthias Weiss, MD
• Scientist Member
• Po-Huang Chyou, Ph.D.

• Community Members
• Rene Daniels
• John Hutchinson
• Brian Kief
• Patricia Kleine, Ph.D.
• John Laird
• Scott Larson, Secretary
• Mark T. Nelson
• Mark Nook, Ph.D., Chair
• Jim Schuh
• James Weber, PhD

Mark Nook, PhD
UW System, Interim Senior Vice President for
Academic Affairs
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Other Capacities

• Publish Clinical Medicine Research
• Publish Journal of Agromedicine
• With Division of Lab Medicine, part of State
  Laboratory Response Network and CDCs Select
  Agent Program provide Laboratory Medicine
  facilities for its RD
• With Clinic Information System, develop new
  clinical medical informatics tools

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Research Strategy and Guiding Principles

• Integration of research into clinical practice
  and clinical practice into research.
• Collaboration with other top-tier medical
  centers, especially UWSMPH (now ICTR) and MCW.
• Dedication to achieving excellence in
  translational research, which requires close
  collaboration among physicians and scientists to
  bring scientific advances into clinical care and
  public health.

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Select Research Collaborations at MCRF (1)
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Select Research Collaborations at MCRF (2)
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Institute for Clinical and Translational Research
(ICTR)

• Founded jointly in 2007 by UW and MC
• Has become framework of strengthening research
  ties between the two institutions
• Awarded a Clinical and Translational Science
  Award by NIH now waiting for renewal
• Unprecedented level of collaboration
  14 funded pilot projects with UW-Madison
  investigators working together with 23 Clinic
  investigators from 16 different departments
• Likely to impact Clinics clinical and
  translational research for decades

PARTNERSHIP Schools of Medicine and Public
Health Pharmacy Nursing Veterinary Medicine and
College of Engineering
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Strength of the Marshfield Clinic - UW Research
PartnershipCollaboration Integration of
Administrative Activities
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The Marshfield-UW Partnership
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Wisconsin IRB Consortium (WIC)
Purpose Facilitate collaboration among member
institutions' Institutional Review Boards (IRBs)
in order to provide more effective and efficient
oversight of multi-site human subject research
protocols In Wisconsin and reduce costs and
duplication of effort among the Member
institutions and affiliated investigators. One
Agreement Allows any member institution to serve
as the IRB of record for another, eliminating
the need to draft individual, study-specific IRB
authorization agreements for each study
reviewed. WIC is in its development/pilot phase
,and as such, is limited to the following
participants Aurora Health Care IRB, Milwaukee
Marshfield Clinic IRB, Marshfield Medical
College of Wisconsin IRB, Milwaukee University
of Wisconsin-Madison Health Sciences IRB, Madison
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Clinical Research Center

• Established in 1998 to provide centralized
  research support for clinician-led research
  throughout system
• Built on a strategy of integrating research and
  clinical practice
• More than 350 active clinical trials
• 125-150 clinician investigators
• gt40 research coordinators and research nurses as
  well as other administrative support staff
• Community Clinical Oncology Program (CCOP) is the
  longest-running clinical research project

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Type-2 Translational Research
The Role of Pharmacist Evaluation in Asthma

• Study Goal
• To conduct a pilot test of a telepharmacy-based
  intervention to improve asthma control through
  medications and disease management in an
  underserved, rural patient population.
• Aims
• To assess the feasibility of providing a
  telepharmacy intervention
• To determine whether a telepharmacy intervention
  is acceptable
• To assess the interventions impact on patients
  asthma control, adherence to medications, and
  patient activation
• To examine the facilitators and barriers
  associated with implementing the intervention.

Local PI Suzanne N. Havican, RN, RPh, BCPS
PI Henry N. Young, PhD UW Madison
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Type-2 Translational Research Tailored Approach
to Genetic Counseling for Cystic Fibrosis Newborn
Screening A New Model
Received additional/outside funding
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Type-2 Translational Research

• Creating Healthy Workplaces An intervention to
  Improve Outcomes for Providers and Patients

• Study Goal
• Test the impact of a novel quality improvement
  strategy on care quality. The quality improvement
  intervention (QIIs) will create healthy
  workplaces by addressing adverse primary care
  work conditions (workflow, work control, and
  organizational culture).
• Aims
• Increase clinician and staff interest in
  participating in QIIs by addressing primary care
  work conditions
• Improve care quality in hypertension and diabetes
  by improving work conditions
• Improve clinician and staff satisfaction,
  decrease stress, and reduce intention to leave

Local PI Steven H. Yale, MD
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Epidemiology Research Center

• Consequential epidemiology focus on applied
  research questions that make a difference in the
  lives of people
• Vaccine safety effectiveness
• Antibiotic resistance
• Cancer surveillance
• Cardiovascular care and outcomes
• Unique resources network collaborations
• Marshfield Epidemiology Study Area (MESA)
• HMO Research Network (HMORN)
• Cancer Research Network (NCI)
• Cardiovascular Disease Research Network (NHLBI)
• Vaccine Safety Datalink (CDC)
• In 2011, Dr. Laura Coleman joined as
  tenure-track scientist

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Marshfield Epidemiologic Study Area (MESA)

• Key Features
• Defined geographic region (24 zip codes)
• Nearly all residents choose to receive health
  care from Marshfield Clinic and affiliated
  hospitals
• Dynamic cohort tracked since 1991
• Links to sophisticated electronic medical record
  system and data warehouse archive
• Low population mobility
• High population coverage and health event
  capture, in MESA Central
• 97 population coverage
• 99 deaths captured
• 95 hospitalizations captures
• 90 outpatient visits captured

25,000 people
60,000 people
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Marshfield Epidemiologic Study Area (MESA)

• There are more than 25 active consults in the
  current year, with many early and mid-career
  stage recipients, including
• a UW Shapiro scholar,
• an ICTR scholar,
• UW Population-Health students,
• UW faculty and medical residents,
• Marshfield faculty and medical residents.

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Collaborations MESA

• Goal To examine the actual mortality burden and
  rates of cardiovascular events among a rural
  population-based cohort of lupus patients

Mortality Cardiovascular Events Among
Rural Systemic Lupus Erythematosus Patients
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HMO Research Network

• Mission Use collective scientific capabilities
  to integrate research and practice for the
  improvement of health and health care among
  diverse populations.
• Consortium of 16 HMO organizations
• MCRF leveraged the MESA cohort and Security
  Health Plan enrollees to facilitate membership in
  the HMORN.

• Focus is on cancer, cardiovascular disease,
  diabetes, genomics, vaccine safety, medical
  product surveillance, health care quality, and
  comparative effectiveness.
• MCRF co-hosted the National HMORN meeting in
  2008, at which the NCRR Director was a plenary
  keynote speaker.

• MCRF investigators are currently leading efforts
  on more than 20 active collaborative research
  projects within the HMORN.

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Survey of the Health of Wisconsin

• First statewide research survey to systematically
  gather data on health status and health
  disparities among Wisconsin adults.
• Marshfield Clinic became the home of a new, third
  recruitment and enrollment center for SHOW,
  joining Madison (Middleton) and Milwaukee.
• MCRF assists SHOW data collection, including
  face-to face interviews, self administered
  questionnaires, and physical exams.
• In the first year of the MCRF, 30 scheduled weeks
  of rural Wisconsin data collection were completed
  in three months due to Marshfield Clinics
  presence in rural WI communities.
• The data collected from SHOW will address
  critical and novel research questions to
  accelerate translation into evidence-based
  policies and health care practices, and improve
  health and reduce health disparities in Wisconsin.

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Center for Human Genetics

• A long history of important discoveries in human
  genetics (short tandem repeat polymorphisms,
  Marshfield linkage maps)
• Mission To conduct translational research in
  medical genetics that substantially improves
  patient care
• In 2009, recruited Dr. Murray Brilliant (Center
  Director, tenured Senior Research Scientist and
  James Weber Endowed Chair)
• in 2010, recruited Dr. Steve Schrodi and
  
  Dr. Deana Cross as tenure-track scientists
• In 2011, joint recruitment of Dr. Brautbar
• Major programs and unique resources
• Personalized Medicine Research Project (PMRP)
• Wisconsin Genomics Initiative (WGI)
• Electronic Medical Records and Genomics (eMERGE)
  Network

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Personalized Medicine Research Project (PMRP)

• In September 2002, Governor McCallum and the
  leadership of MC and MCRF announced enrollment of
  the first research subject
• Initial funds State government (2 million),
  Federal government (800K), and Marshfield Clinic
  (1 million)
• Ultimate Goal Translate genetic data into
  specific knowledge about disease that is
  clinically relevant will enhance patient care
• Key Features
• Nations largest population-based biobank
• Stable population of approximately 20,000 adults
• DNA, plasma and serum samples on each subject
• Access to longitudinal electronic health record
• 99 of PMRP cohort has agreed to be re-contacted
• All genotyped for 50 medically relevant markers,
  5K high-density genotyped samples

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PMRP Community Advisory Group

• The Community Advisory Group (CAG) provides
  advice and guidance from the community
  perspective on the continued development,
  implementation and on-going operations of the
  Personalized Medicine Research Project

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Ongoing Studies

• Genetic Basis of Disease
• Atrial fibrillation/flutter
• Cataracts
• Endometriosis
• Hypertensive heart disease
• Low HDL
• Macular degeneration
• Multiple sclerosis
• Myocardial infarction
• Obesity, genetics and risk of diabetes and
  abnormal lipids
• Prostate cancer
• Venousthromboembolism Dz.

• Pharmacogenetics
• Efficacy and safety of statins
• Efficacy of metformin in patients with type II
  diabetes
• Pharmacogenetics of tamoxifen for breast cancer
• Pharmacogenetics underlying response to beta
  blockers in patients with glaucoma
• Pharmacogenetics of warfarin metabolism
• Sulfa hypersensitivity
• ACE and angioedema

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Wisconsin Genomics Initiative (WGI)

• Announced by Governor Doyle in October 2008
• Received 2 million in State FY10-11 budget
• A historic collaboration of Wisconsins three
  academic medical centers and its major urban
  university created to advance predictive and
  personalized health care
• Vision to be able to predict for individual
  patients in a clinical setting the risk of
  disease susceptibility and treatment response
  using the combined power of cutting edge genetic,
  phenotypic, and environmental analyses

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Wisconsin Genomics Initiative
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Building Accurate Predictive Models

• Complex combinations of variables are required
  for accurate prediction
• The more we know about individual patients,
  greater the probability of prediction

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WGI Funded Demonstration Projects (1)

• Integrating Genomic Data into a Computational
  Model for Improved Breast Cancer Diagnosis
• PIs Elizabeth Burnside, MD4 David Page, PhD4
  
• Collaborators Cathy McCarty, PhD, MPH1 Peggy
  Peissig, MBA1 Adedayo Onitilo, MD1
• Improving the Predictive Modeling of Atrial
  Fibrillation/Flutter (AF/F) and Its Outcomes
• PI Humberto Vidaillet, MD1
• Collaborators Bess Berg, MS4 David Page, PhD4
  Peggy Peissig, MBA1 Percy Karanjia, MD1
• Feasibility of Modular High Throughput Electronic
  Phenotyping
• PI Peggy Peissig, MBA1
• WGI Infrastructure Project Proposal Expand the
  Current Informatics Architecture in Order to
  Capitalize on the Available EMR and Genetic Data
• PI Justin Starren, MD, PhD1
• WGI Exome Sequencing to Identify Coding Variants
  for Myocardial Infarction
• PI Ulrich Broeckel, MD2
• Collaborators Cathy McCarty, PhD, MPH1 David
  Page, PhD4

1MCRF ? 2MCW ? 3UW-Milwaukee ? 4UWSMPH
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WGI Funded Demonstration Projects (2)

• Risk Modeling Post-Hospitalization
  Venousthromboembolism in a Population-Based
  Cohort
• PI Steve Yale, MD1
• Collaborators Mark Craven, PhD4 Deanna Cross,
  PhD1 Stephen Talsness, BA1 Peggy Peissig, MBA1
  Joseph Mazza, MD1
• Sustained Community Engagement in Genetics and
  Genomics Research to Improve Health
  and to Increase Health Equity
• PIs Aaron Buseh PhD, MPH3 Sandra Underwood,
  PhD, RN, FAAN 3
• Development of a Predictive Algorithm for
  Age-related Macular Degeneration
• PI Murray Brilliant, PhD1
• Collaborators David Page, PhD4 Joe Carroll,
  PhD4 Cathy McCarty, PhD, MPH1 Gary Pesicka,
  MD1 Robert Valenzuela1
• Investigation of Genomic Association Between
  Heart Failure Diabetes Mellitus
• PI Nancy Sweitzer, MD, PhD4
• Collaborators Cathy McCarty, PhD, MPH1 Orly
  Vardeny, PharmD4 Zhan Ye, PhD1
• Membrane Metaloproteinase-9 Genotype and Aortic
  Aneurysm
• PI Jay Yang, MD, PhD4
• Collaborators Sijan Wang PhD4 Martha Wynn MD4
  Charles Acher, MD4 Peggy Peissig, MBA1 Ulrich
  Broeckel, MD2

1MCRF ? 2MCW ? 3UW-Milwaukee ? 4UWSMPH
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WGI Project Development of a Predictive
Algorithm for Age-Related Macular Degeneration
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WGI Project Sustained Community Engagement in
Genetics Genomic Research to Improve Health
to Increase Health Equity

• Study Purpose
• Determine effective ways to engage members of
  diverse urban communities in genetic and genomics
  research designed to improve health and achieve
  health equity.

• Aims
• Determine how characteristics of diverse ethnic,
  racial urban communities are related to their
  potential engagement in genetics and genomics
  research
• Describe knowledge and attitudes of members of
  diverse ethnic, racial urban communities toward
  genetics and genomics research for health
• Identify facilitators and barriers to sustained
  engagement of members of diverse ethnic, racial
  urban communities in genetics and genomics
  research for health.

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Collaboration with UW Waisman Center

• Genetic/Complex Disorders
• 1) To estimate the prevalence of premutation of
  FMR1 using the Wisconsin longitudinal Study (WLS)
  cohort (PMRP in the Marshfield cohort
• 2) To describe natural history of premutation
  into adulthood and into old age (18 through 70
  yrs.) with respect to family background, academic
  achievement, IQ, marital history, fertility,
  childbearing patterns, menopause, occupational
  stability, depression and anxiety, health and
  physical symptoms and cognition.
• 3) To compare men and women with the premutation
  with a closely matched comparison group of WLS
  unaffected age peers. Because of the small size
  of the sample with the permutation, this will be
  an exploratory aim.

Marsha Seltzer, PhD Waisman Center
Murray H. Brilliant, PhD MCRF
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Marshfield Clinic Cataracts
Northwestern Type II diabetes
Group Health Cooperative Dementia
Coordinating center
Mayo Clinic Peripheral artery disease
Vanderbilt QRS duration
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MCRFs Oral Systemic Health Research Project (1)

• Goals
• Understand the causes of oral diseases, such as
  periodontal disease and caries (e.g., determining
  the effect of genetics, diet, water source
  well/city fluoridation, and microbiome).
• Understand the connections between oral and
  systemic health, (e.g., mutual enhancement of
  periodontal disease and diabetes).
• Understand how improving oral health aids
  systemic health (comparative effectiveness) and
  bring PHC to the dental arena.

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MCRFs Oral Systemic Health Research Project (2)

• Microbiome contribution to heath is an NIH
  priority and our investigators will be among the
  first to utilize oral microbiome data in
  personalized healthcare
• Will create a unique research infrastructure to
  support the OSHRP
• Initial cohort of 2,000 participants with
  electronic dental and health records coupled with
  a comprehensive biobank (DNA, plasma, serum,
  urine and periodontal microbiome)
• Questionnaire data on environment, diet, etc
• OSHRP builds upon the Personalized Medicine
  Research Project (PMRP)
• gt1,000 participants in PMRP who are also dental
  patients of Marshfield Clinic
  2 MC dental
  facilities in PMRP recruitment area have been
  operating for 1 year
• As the Clinics Electronic Health Record
  contains medical and dental care information,
  this research sub-cohort of PMRP can be used
  today to study the connections between oral and
  systemic health in a population-based cohort
• National Institute of Dental and Craniofacial
  Research (NIDCR) Collaborative Grant Data
  Extraction using Electronic Dental Record in
  Dental Practice Based Research Network
• Collaborating with University of Pittsburgh

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Planned Transition to Personalized Health Care
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• To visit the Marshfield Clinic, a longtime
  innovator in health information technology, is to
  glimpse medicines digital future. Across the
  national spectrum of health care politics there
  is broad agreement that moving patient records
  into the computer age, the way Marshfield and
  some other health systems have already done, is
  essential to improving care and curbing costs.

By Steve Lohr Published December 26, 2008
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Biomedical Informatics Research Center (BIRC)

• Organizational Structure
• Administrative Informatics Support
• Biostatistics
• Usability/ICDI (Interactive Clinical Design
  Institute)
• Informatics Research
• Infrastructure Central Resource
• Research Data Analytics Management

• Established in 2005
• 7 PhDs and 38 other staff
• Mission to accelerate improvements in human
  health and well being through informatics
  research while providing integrated tools,
  services and reliable management of information
  assets in support of Marshfield Clinic missions

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BIRC Multiple Missions
External Funders
Research Outcomes
BIRC
Design Data Analysis
Strategy Prototyping Evaluation
Researchers
Clinic IS
IT Planning Infrastructure Backoffice
Foundation Administration
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BIRC Personnel Growth
Does not include short term students
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BIRC Expansion

• Cost 980,000
• Accommodates 25 additional people in BIRC,
  increasing its staff to 65
  by end FY 2012
• Provides enhanced Biomedical informatics
  infrastructure support for increased
  collaboration with internal external
  investigators
• BIRC expansion will house personnel to support
• MCRFs new tenure track hires grants they will
  generate
• Collaboration w/ MCs IS (RD usability,
  decision support, etc.)
• New Networks in Personalized Care and Population
  Research
• Dental Informatics Oral Systemic Health
  Research Networks

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Dental Informatics Research

• It is a sub-discipline of biomedical informatics.
  
• Dental informatics is the application of computer
  and information science to improve dental
  practice, research, education and management.
• Eisner J. The future of dental
  informatics. Eur J Dent Educ. 19993 Suppl
  161-9.

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Major Dental Informatics Research Projects

• A Standard Information Model for General Dental
  Records
• - Funded by National Institute of Dental and
  Craniofacial Research, NIH
• - Goal is to develop a comprehensive,
  consensus-based Electronic Dental Record
  Information Model (EDRIM) as a reference standard
  for the content and structure of Electronic
  Dental Records
• Multi-institutional Consortium for Comparative
  Effectiveness Research in Diabetes Treatment and
  Prevention
• - Funded by Agency for Healthcare Research and
  Quality, DHHS
• - Goal is to build a national research network
  and a multi-system distributed database for
  conducting comparative effectiveness research
  (CER) in the treatment and prevention of diabetes
  mellitus
• Personnel Dr. Amit Acharya
• Collaboration University of Pittsburgh

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Objectives Purpose of Forum

• Provide an opportunity for research networks and
  other research groups to learn about each other
  and the projects they conduct.
• Learn about operational and project barriers, and
  successful methods to overcome barriers.
• Facilitate networking and connections between
  people and groups with similar interests.