Comparative Effectiveness Research
Key Function Committee
(CER KFC)
Monday, August 20 2012, 11:00 AM-12:00 PM ET
Co-Chairs, Tim Carey and Tom Concannon
PI Liaison, Harry Selker
NIH Coordinator, Rosemarie Filart
PM, Colleen Lawrence (C4)
CTSA CER Key Function Committee (KFC) Monthly Meeting Agenda
Monday, August 20, 2012, 11:00 AM – 12:00 PM ET
Teleconference Only Dial-in: 1 877 568 4109 Access Code: 271-247-588
Go To Meeting Registration (only) link https://student.gototraining.com/r/1271356837225888256
Time (ET)
11:00 AM
(2 min.)
Topic
Welcome, Overview and Announcements
Presenters
Tim Carey and Tom Concannon
Activity Updates
• CCEC/CCSC/SGC4 Updates
• NIH
• Video Project (Jodi Segal’s video)
•
•
Harry Selker ( PI Liaison to CCSC/CCEC/SGC4)
Rosemarie Filart
CER CTSA Presentation:
•
Mick Murray PharmD, MPH, Central Indiana Innovation Network (CI-Net), University of
Indiana School of Medicine
Workgroup/Taskforce Reports
 Dissemination and Implementation Research
 Methods
 Informatics Taskforce
 Capacity and Assessment
1. Paul Meissner and Jonathan Tobin
2. Sean Tunis, Mark Helfand, Jerry Krishnan, Peter Neumann
3. Joel Saltz and Bill Hersh
4. Harold Pincus and Dan Ford
 Liaison Reports
Liaisons
11:50 AM
(8 min.)
Discussion, Action Items and Upcoming Meetings
 Member News and Recruitment
•
ALL
11:58 AM
(2 min)
C4 updates
•
Colleen Lawrence
12:00 PM
Adjournment
Tim Carey, Tom Concannon, and Rosemarie Filart
11:02 AM
(6 min.)
11:08 AM
(8 min.)
11:16 AM
(24 min.)
11:40 AM
(10 min)
Structure of Comparative Effectiveness Research KFC (CER KFC)
Co- Chairs: Tim Carey and Tom Concannon
CER KFC PI Liaison of the SGC & CCSC, Harry Selker
NIH Coordinator, Rosemarie Filart
Project Manager, Colleen Lawrence, C4
Project Assistant, Diane Rohrer, C4
C4 Faculty Liaison, Bob Dittus, C4
Operations Group
(Co-Chairs, Workgroup and Taskforce Co-Leads, PI
Liaison, NIH Coordinator, and C4)
Dissemination and
Implementation Research
(newly merged)
Leads: Paul Meissner and
Jonathan Tobin
KFC Chair: Tom Concannon
CER Methods Workgroup
Lead: Mark Helfand, Sean
Tunis, Jerry Krishnan, and
Peter Neumann
KFC Chair: Tom Concannon
Capacity and Needs
Assessment
Lead: Dan Ford and
Harold Pincus
CER Informatics
Taskforce
Co-Leads: Joel Saltz and
Bill Hersh
KFC Chair: Tim Carey
All Members invited to participate in any group
NIH Updates
Rosemarie Filart
11:02 AM
Seeking Your Input for Productive Outcomes of
Day 1: PCTi Workshop
SGC4 Day 1 Planning Committee Schedule for
Use Case Development and Selection
July-August: Proposed “Use Case” identification and development
KFCs members and stakeholders nominate proposed use cases
Planning Committee works with nominators to develop proposed use cases
Methods, CE, PBRN, Informatics, Evaluation, DIR, and other workgroups identify infrastructure
capacity and needs of proposed use cases
September: “Use Case” selection (Planning Committee)
~4 use cases will be selected to provide learning ground for the CTSA community about PCT
infrastructure
September-November: Continued “Use Case” development
November 19: PCTi Workshop
2012 – 2014: PCT development, Leadership by CTSAs, investigators and stakeholders
CER SCIENTIFIC PRESENTATION
Central Indiana Innovation Network
(CI-Net)
Presented by: MICHAEL MURRAY, PHARMD, MPH
INDIANA UNIVERSITY SCHOOL OF MEDICINE
11:08AM
Central Indiana Innovation
Network (CI-Net)
CTSA CER/HIT KFC
Michael D. (Mick) Murray, PharmD, MPH
Regenstrief Institute
Purdue University College of Pharmacy
Project Objectives
1. Develop the mechanism to facilitate and expand engagement of
physicians throughout Indiana in CER.
2. Test and evaluate the developed CER recruiting mechanism in large
and small practices.
3. Package the components for dissemination to CTSA members who
wish to implement similar participant recruitment programs for
CER trials within their networks.
INTRODUCTION
 The Indiana CTSI is committed to creating a world-class
infrastructure to promote the conduct of randomized clinical trials,
CER, pragmatic trials, and a variety of observational study designs.
 The Central Indiana Innovation Network (CI-Net) and its Research
Planning Team (RPT) was established in 2009 to create several key
components of necessary infrastructure.
History of Data Resources
• Regenstrief tasked in 1972 to “stitch” silos of medical information
together -> the Regenstrief Medical Record System at Wishard
Memorial Hospital
• In 1994, began merging information across institutions and
expanded to statewide coverage called the Indiana Network for
Patient Care (INPC)
• In 2004, the Indiana Health Information Exchange (IHIE) formed as
a data services organization
INPC Data Volume
•
•
•
•
•
•
28 million registration events
13 million unique patients
57 institutions and growing
> 712 million encounter events
> 4.4 billion clinical observations
> 580 million claims observations (Procedures,
prescriptions, etc.)
• 2 million ED visits per year
• 78 million text reports (e.g., chest x-rays,
operative notes)
• Founded in February 2004
• Based on the technology, knowledge, and
experience of Regenstrief Institute
• 70 employees
• Providing services to over hospitals, 19,000
clinicians, and 3 payers
• Serving a growing area with a current
population of 13 million people
INPC Data Management and Services
Data Management
Data Access & Use
Hospitals
Hospital
Payers
Health
Information
Exchange
Physicians
Labs
Labs
Data
Repository
Network
Applications
Outpatient RX
Physician Office
Results delivery
Secure document transfer
Shared EMR
Credentialing
Eligibility checking
•
•
•
•
•
•
Results delivery
Secure document transfer
Shared EMR
CPOE
Credentialing
Eligibility checking
• Results delivery
Public
Health
•
•
•
•
Payer
• Secure document transfer
• Quality Reporting
Public Health
Ambulatory Centers
•
•
•
•
•
Researchers
Surveillance
Reportable conditions
Results delivery
De-identified, longitudinal
clinical data
• De-identified, longitudinal
clinical data
CI-NET Practice and Subject Recruitment
 Trial Recruitment from Large Practices
 Large health systems such as Wishard Health System and
Indiana University Health have advanced information systems
and strong research interests and missions. We have developed
software to facilitate subject recruitment.
 Recruitment from Small Practices
 We are actively exploring using Docs4Docs as a mechanism to
reach into smaller practices to recruit subjects. Docs4Docs
delivers millions of messages to practices including electronic
copies of discharge summaries, operative notes, EKGs, and
radiology reports.
Engaging Smaller Practices
• DOCS4DOCS® developed by Regenstrief Institute is an
electronic results delivery service offered by IHIE.
• Receives results and clinical messages from the
participating data sources such as a hospital’s laboratory.
• Converts these results into a consistent, easy to use report
format, and delivers them to a secure, web-based inbox for
the intended responsible provider.
• Can also be transmitted via HL7 directly to a physician
practice’s EMR.
• Delivers lab results, hospital admission, discharge and
transfer summaries, transcriptions, EKGs, radiology
reports, and others.
• Provides Regenstrief/IHIE with a direct connection to over
19,000 physicians and their patients.
Evaluation Using 4 Mock Studies
1. Open-label Randomized Trial of Torsemide Compared with
Furosemide Therapy for Patients with Heart Failure
2. Estimate the incidence of long-term opioid initiation among
older patients with chronic non-cancer pain and estimate the
incidence of various drug effects
3. Comparative Effectiveness Research Trial of Alzheimer’s
disease [COMET-AD]
4. Intervening Now in Diabetes to Encourage Healthy Eating,
Activity and Linkages to Healthcare [INDE-HEALTH]
Variable Information Needs and Availability
Study 1
Study 2
• Information contained in INPC
• Information collected by ResNet
or interviewers
• Information collected by
practice personnel
Cover Letter and Teleform
SUMMARY
 To enhance the informatics infrastructure in Indiana to conduct
clinical research, Regenstrief Institute has created several programs
to support subject recruitment from the networks of large practices
and is creating the capacity to reach into smaller clinical practices.
 CI-Net is supported by the CTSI and has become a key connection
between the practitioners throughout Indiana and researchers at
Indiana, Purdue, and Notre Dame.
 We envision CI-Net as a valuable resource for CER involving drugs,
devices, diagnostics, and services and pragmatic trials.
2013+ Vision
Natural
Language
Processing
Public
Health
Informatics
Health
Geographics
Health
System
Redesign
Clinical
Epidemiology
CTSI
Informatics and
Data Analysis
Center
Data
Mining
Research
Planning and
Infrastructure
Clinical
Decision
Support
and QI
Bioinformatics
Visual
Analytics
High
Performance
Computing
Security
and
Privacy
Project Team
• Project Management
 Patty McGuire
 Sarah Hoover
 Corey Whitley
• ResNet
– Jane French
– Brenda Hudson
• Data Core
– Evgenia Teal
– Faye Smith
• Software Engineering
– Jeremy Leventhal
– Mike Barnes, MD
– Hui Xiao
• Biomedical Informatics
– Bill Tierney, MD
– Paul Dexter, MD
• Administration
– Anantha Shekhar, MD
UPCOMING CER SCIENTIFIC PRESENTATION
STATISTICAL INFRASTRUCTURE FOR COMBINING MULTIPLE DATA SOURCES IN
CER
October 15th
Presented by: Trivellore Raghunathan, PHD
UNIVERSITY OF MICHIGAN, SCHOOL OF PUBLIC HEALTH
WELCOME VOLUNTEERS or SUGGESTIONS
WORKGROUP REPORTS
11:16AM
DIR Workgroup
co-Leads: Paul Meissner and Jonathan Tobin
October
2011
Merged Collaboration
and Dissemination and
Implementation
Workgroups launched
into one WG: newly
named as
Dissemination and
Implementation
Research WG
Fall –Winter 2011
1. White Paper on Stakeholder Engagement
- Working paper on CTSA wiki
- Submitted for peer review
2. Best Practices in Translational Research
• 7 interviews completed
• Developed preliminary results
• 15 interviews proposed & scheduled
3. Identification of variables of interest for D&I
research from EHRs and other data
sources.
2012
1. White Paper on Stakeholder Engagement –
published JGIM May 2012
2. CTSA Structured Interviews Dissemination
Research –interviews completed, summary
presented, presentations and manuscript
on best practices in progress
3. Stakeholder engagement demonstrations
1. Tufts EPC (5)
2. PPP KFC (1)
3. Other
3. Variables of interest for D&I research – link
with NCI GEM initiative
Completed
To be Completed
4. Rapid D&I Network / Pilot DIR
demonstrations
- Needs leadership
Methods Workgroup
co-Leads: Sean Tunis , Mark Helfand, Jerry Krishnan and
Peter Neumann
June – October 2011
Develop and conduct an Methods
WG Mini-Workshop of the October
2011 CER KFC Annual meeting with
stakeholders. Focus on specific
ways to advance methods research
as detailed in the forthcoming CER
Methods Agenda Paper. Discuss
WG projects in light of the current
CER/PCOR environment.
Completed
To be Completed
October 2011- Jan 2012 Feb 2012-October 2012
Fall 2012
Dec 2011– Jan 2012:
Key informant interviews
on current consortium
efforts to expand national
infrastructure for
conducting communitybased PCTs
Feb-May 2012: Create
prioritized list of projects/
topics for discussion at
CTSA PCTi workshop.
Establish a planning
committee with CER and CE
KFC workgroup leaders.
Jan 2012: Compile
findings from key
informant interviews
October 2012: Workshop to
convene individuals and
groups from CTSA program
and other initiatives with
shared interest in expanding
national infrastructure for
community-based PCTs
Fall 2012: Produce white
paper with strategic plans
for CTSA CER methods
workgroup to contribute to
expansion of national
infrastructure for
community based PCTs
(CTSA PCTi)
CER Informatics Taskforce
Open Discussion:
*Projects
*In-person CER KFC Informatics Taskforce meeting with the CER KFC
Co-Leads: Joel Saltz and Bill Hersh
LIAISON REPORTS
11:40AM
Liaison Member Reports
Committee
Liaison
CTSA
Academy Health
•
AHRQ DARTnet (Distributed Ambulatory Research
in Therapeutics Network)

Jeanne-Marie Guise ,Doug Landsittel ,
Wilson Pace, David West

OHSU, UPMC, Denver
AHRQ CER T32 Program
AHRQ PBRN
Biostatistics / Epidemiology / Research Design
(BERD) KFC


Tim Carey
Paul Meissner


University of North Carolina
Albert Einstein

Frank Harrell and Chang Yu

Vanderbilt University
Novartis DIA CER Bayesian statistical methods grp

Chang Yu

Vanderbilt University
Clinical Research Management (CRM) KFC


Jeffrey Silverstein
TBA: Seeking Additional Volunteer(s)

Mount Sinai
Community Engagement KFC-- Education,
Scholarship and Engagement (ESE) WG

TBA: Seeking Volunteers
CTSA Consortium Child Health Oversight
Committee (CC-CHOC)
Education & Career Development Key Function
Committee




Jill Herndon
Daphne Hsu
Wishwa Kapoor
Pam Mitchell




University of Florida
Albert Einstein
UPMC
University of Washington
Evaluation KFC

Harold Pincus, Arthur Blank, and Jodi Segal

Columbia U, Albert Einstein and JHU
Informatics Key Function Committee (NOTE: This is
distinct from the CER Informatics Taskforce)

Joel Saltz, Bill Hersh, Stephen Pauker

Atlanta CTSI (GA Tech),Tufts University,
Oregon HSC
IOM

Lucy Savitz, Harry Selker, Rosemarie Filart

Utah University, Tufts University, NIH
Public-Private Partnerships (PPP)KFC

Caren Heller

Cornell University
New York CER Regional Group


Harold Pincus
Jerry Krishnan, Neil Barroos, Gavin
Hougham

Columbia

UIC, UC
Midwestern and Chicago CER Regional Groups
Erin Holve and Lisa Simpson
MEMBERSHIP UPDATES, IDEAS, SUGGESTIONS,
AND NEWS
ALL
11:50AM
C4 UPDATES
Colleen Lawrence, CER PM
11:58 AM
CER KFC UPCOMING MEETING SCHEDULE
CER KFC Monthly Meeting: Monday, September 10th from 11 AM-12PM EDT
Capacity and Needs Assessment Workgroup: Monday, August 20th from 4-5 PM EDT
Dissemination and Implementation Research Workgroup: Tuesday, September 25th from 11AM-12 PM
EDT
Methods Workgroup: Thursday, August 23rd from 12-1 PM EDT
Informatics Taskforce: Thursday, September 6th from 12 - 1 PM EDT
Operations Group: Tuesday, August 28th 4-5 PM EDT
*attended by Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison
SGC #4 Bi-Monthly Meeting : Monday, September 24th from 11 AM- 12 PM EDT
*attended by CER and Comm. Eng. KFC Co-Chairs /WG-TF Leads/ KFC Coordinator/PI Liaison
APPENDIX
(PROCEED IF NEEDED)
CTSA Consortium Executive Committee
Three Objectives for SGC #4
Objective 1: (Recognized as the Priority Objective by CCEC) :Develop a CTSA Consortium-wide
strategy for community-engaged and comparative effectiveness research that leads to
improvements in the access, quality, and efficiency of healthcare delivery and the health of
diverse communities and the public. (*Metric followed by CCEC).
Objective 2: Collaborate and create synergies with a wide range of stakeholders (i.e., communities, health
departments, CTSA and other academic medical centers, NIH Institutes and Centers and other
DHHS Federal Partners) in planning and implementing community-engaged and comparative
effectiveness research and in disseminating the research findings.
Objective 3: Facilitate collaborations across CTSA institutions, PBRNs, and a broad cross-section of
practice settings that increase the nation’s capacity for innovative community-engaged and
comparative effectiveness research leading to the development of novel methodologies for
both conducting research and for implementing and disseminating the findings of that research.
CER KFC MISSION AND VISION STATEMENTS
HTTPS://WWW.CTSAWIKI.ORG/WIKI/DISPLAY/CER/COMPARATIVE+EFFECTIVENESS+RESEARCH-+HOME
Mission Statement
The Comparative Effectiveness Research (CER) Key Function Committee builds the
field of comparative effectiveness research (CER) and patient-centered outcomes
research by creating a learning community across CTSA institutions, spurring the
development of methods, expanding training and education, promoting community
and public engagement, applying CER findings and sharing successes and lessons
learned.
Vision Statement
Through collaborative work products, the Comparative Effectiveness Research
(CER) Key Function Committee facilitates the generation and synthesis of evidence
about alternative interventions that results in actionable findings for policymakers,
clinicians, patients, and purchasers to use in improving the quality and outcomes of
patient-centered health care.