introducing pcornet and the greater plains …...introducing pcornet and the greater plains...
TRANSCRIPT
Introducing PCORnet and the Greater Plains
Collaborative: The National Patient-Centered Clinical Research
Network and Our Role
Russ Waitman,
Director, Medical Informatics University of Kansas Medical Center
November 14, 2014
Outline
Context: KUMC HERON data warehousing at a
medical center for Clinical and Translational
Science Award: Frontiers
PCORnet standard introduction
Greater Plains Collaborative and approaches
Current Progress and Status
i2b2 query and babel demo
2
Bennett Spring Trout Park, Lebanon Missouri http://mdc.mo.gov/regions/southwest/bennett-spring
You’re that fisherman: wanting to land data to answer your research hypothesis
The Fish: Diagnoses, Demographics, Observations, Treatments
Why so many fish? Current Goal: Build Hatchery, Manage the Fishery
Photo Credit: HuntFishGuide.com http://www.flickr.com/photos/huntfishguide/5883317106/
Second Goal: If you need help fishing, get a guide
Photo Credit: S. Klathill http://www.flickr.com/photos/sklathill/505464990/
Prepare and Analyze Data
Photo Credit: Steve Velo http://www.flickr.com/photos/juniorvelo/259888572/
Our shared goal: a tasty publication
• I’ll just enter everything in Excel….
• What if I lose or accidentally sort my spreadsheet?
• How to I let students only review de-identified data?
• Hospital/Clinic is making me use this Electronic Medical Record and I get nothing in return...
Little White Salmon River, Washington State, last Summer in July
Nightmare: looks like a nice river, but can’t catch fish
• https://redcap.kumc.edu – It uses the same username
and password as your KUMC email.
– Non-KUMC researchers can request an affiliate account through Frontiers CTSA office
– Check out the training materials under videos
• Case Report Forms – (see left) registries, trials
• Conduct Surveys – Similar to “SurveyMonkey”
Sometimes, You’re willing to enter data/buy fish: REDCap: Research Electronic Data Capture
http://www.flickr.com/photos/wiccked/185270913/lightbox/
REDCap: think Fish Tank you manage
Bonneville Hatchery: Trout, Salmon, Sturgeon, Columbia River, Oregon
I want to go fishing, not fill a fish tank (REDCap) Use HERON: a managed fishery
• Get a License: Develop business agreements, policies, data use agreements and oversight.
• Get a Fishing Rod and Bass Boat: Implement open source NIH funded (i.e. i2b2 https://www.i2b2.org/) initiatives for accessing data.
• Know what your catching: Transform data into information using the NLM UMLS Metathesaurus as our vocabulary source.
• Stock Different Tasty Fish: link clinical data sources to enhance their research utility.
Central CTSA Informatics Aim: Create a data “fishing” platform: HERON, https://heron.kumc.edu
• Fill out System Access Agreements to sponsor students/staff
• Fill out Data Use Agreement to request data export
• No Limit!!! IRB Protocol Not Required to view or pull de-identified data
• Must be on campus or use VPN or https://access.kumed.com
• Check http://frontiersresearch.org/frontiers/HERON-Introduction for more information, status, and training videos
Single sign-on using your email username
Real-time check for current human subjects training
HERON: Getting a Fishing License
The i2b2 “Fishing Rod”: build Diabetes cohort
Drag concepts from upper left into panels on the right
Types of “fish” in folders
i2b2 : AND in Frontiers Research Registry
Dragging over the second condition
i2b2: AND a high Hemoglobin A1C
When you add a numeric concept, i2b2 asks if you want to set a constraint
i2b2 Result: 497 patients in Cohort
Run the Query Query took 4 seconds 497 patient in cohort
I2b2: Explore Cohort, Visualize
http://www.oregon.com/columbia_gorge_attractions/bonneville_hatchery
Catch the data for JAMA, NEJM publication
The dream: landing the big one
Without getting bit
Our national clinical research system is
well-intentioned but flawed
High percentage of decisions not supported by evidence*
Health outcomes and disparities are not improving
Current system is great except:
Too slow
Too expensive
Unreliable
Doesn’t answer questions that matter most to patients
Unattractive to clinicians & administrators
We are not generating the evidence we need to
support the healthcare decisions that patients
and their doctors have to make every day.
*Tricoci P et al. JAMA 2009;301:831-41.
Both researchers and funders now recognize the
value in integrating clinical research networks
Linking existing networks means clinical research can be conducted more effectively
Ensures that patients, providers, and scientists form true “communities of research”
Creates “interoperability” – networks can share sites and data
PCORnet embodies a “community of research” by
uniting systems, patients & clinicians
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11 Clinical Data
Research Networks
(CDRNs)
18 Patient-Powered Research Networks
(PPRNs)
PCORnet:
A national infrastructure for patient-centered clinical research
What will PCORnet do for
research?
25
PCORnet’s goal
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PCORnet seeks to improve the nation’s
capacity to conduct clinical research by
creating a large, highly representative,
national patient-centered network that
supports more efficient clinical trials
and observational studies.
PCORnet’s vision
27
PCORnet will support widespread
capability for the US healthcare
system to learn from research,
meaning that large-scale research
can be conducted with greater speed
and accuracy within real-world care
delivery systems.
Overall objectives of PCORnet: achieving a
single functional research network
Create a secure national research resource that will enable teams of health researchers, patients, and their partners to work together on researching questions of shared interest.
Utilize multiple rich data sources to support research, such as electronic health records, insurance claims data, and data reported directly by patients
Engage patients, clinicians & health system leaders throughout the research cycle from idea generation to implementation
Support observational and interventional research studies that compare how well different treatment options work for different people
Enable external partners to collaborate with PCORI-funded networks
Sustain PCORnet resources for a range of research activities supported by PCORI and other sponsors
28
PCORnet organizational structure
29
29 CDRN and PPRN awards were approved on
December 17th by PCORI’s Board of Governors
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This map depicts
the number of
PCORI funded
Patient-Powered or
Clinical Data
Research Networks
that have coverage
in each state.
CDRN Partners
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Goals for Each Clinical Data Research
Network (CDRN)
Create a research-ready dataset of at least 1 million patients that is:
Secure and does not identify individual patients
Comprehensive, using data from EHRs to describe patients’ care
experience over time and in different care settings
Involve patients, clinicians, and health system leaders in all aspects
of creating and running the network
Develop the ability to run a clinical trial in the participating systems
that fits seamlessly into healthcare operations
Identify at least 3 cohorts of patients who have a condition in
common, and who can be characterized and surveyed
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CDRN highlights
• Networks of academic health centers, hospitals & clinical practices
• Networks of non-profit integrated health systems
• Networks of Federally Qualified Health Centers (FQHCs) serving low-income communities
• Networks leveraging NIH and AHRQ investments (CTSAs)
• Inclusion of Health Information Exchanges
• Wide geographical spread
• Inclusion of under-served populations
• Range from 1M covered lives to 28M
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Clinical &
Translational
Science
Awardees
Health
Information
Exchanges
Safety
Net
Clinics Integrated
Delivery
Systems Academic
Health
Centers
PPRN Partners
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Goals for each Patient-Powered Research
Network (PPRN)
Establish an activated patient population with a condition of interest
(Size >50 patients for rare diseases; >50,000 for common conditions)
Collect patient-reported data for ≥80% of patients in the network
Involve patients in network governance
Create standardized database suitable for sharing with other network
members that can be used to respond to “queries” (ideas for possible
research studies)
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PPRN highlights
Participating organizations and leadership teams include patients, advocacy
groups, clinicians, academic centers, practice-based research networks
Strong understanding of patient engagement
Significant range of conditions and diseases
Variety in populations represented (including pediatrics, under-served
populations)
50% are focused on rare diseases
Varying capabilities with respect to developing research data
Several PPRNs have capacity to work with biospecimens
36
The PCORnet opportunity: making a real
difference for patients and their families
Until now, we have been unable to answer many of the
most important questions affecting health and healthcare
37
By combining the knowledge and insights of patients, caregivers,
and researchers in a revolutionary network with carefully
controlled access to rich sources of health data, we will be able to
respond to patients’ priorities and speed the creation of new
knowledge to guide treatment on a national scale.
The Greater Plains Collaborative Partners
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KS, the University of Kansas Medical Center (KUMC)
MO, Children’s Mercy Hospital
IA, University of Iowa Healthcare
WI, the University of Wisconsin-Madison, the Medical College of Wisconsin, and Marshfield Clinic
MN, the University of Minnesota Medical Center
NE, the University of Nebraska Medical Center
TX, the University of Texas Health Sciences Center at San Antonio and the University of Texas Southwestern Medical Center.
GPC Size, Goals and Structure
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11.8 Million Covered Lives
13 hospitals, 430 clinics, 1800 primary care providers, 7600 specialists
Establish Governance
Measure EHR Meaningful Use standardization and align for 3 use cases: Breast Cancer
ALS (Lou Gerhig’s Disease)
Obesity (Pediatric Inpatient Focus)
Develop Patient Reported Outcome Measure Methods
Develop Comparative Effectiveness Research Trial infrastructure embedded in EHRs
Enhance Patient Recruitment
Support Biospecimen Requests
Comparing How Data are
Organized Across Sites
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http://babel.gpcnetwork.org/i2b2/webclient/
Patient Stakeholder Engagement in the GPC
“Learning Engagment Kickoff”
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The GPC held a “Boot Camp” the day before the sessions with GPC investigators to prepare the patients, patient advocates, and other community representatives in attendance to participate more fully in Cohort working group discussions
Lauren Aaronson, Kim Kimminau and Cheryl Jernigan leading engagement
http://www.gpcnetwork.org/LEK2014
Addressing Complete and Comprehensive Care
for Tertiary Academic Medical Centers
Create a research-ready dataset of at
least 1 million patients that is:
“Comprehensive, using data from EHRs
to describe patients’ care experience over
time and in different care settings”
“Utilize multiple rich data sources to support research, such as electronic health records, insurance claims data, and data reported directly by patients”
We proposed piloting with Medicaid
Discussion and governance:
KDHE as KUMC data partner or add to
HERON agreement?
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Figure 3.1. Comprehensive and complete data
example from KUMC: heat map of percentage of
proposed data elements from the HER and billing
sources recorded in six month intervals
surrounding the data of breast cancer diagnosis
specified by the hospital tumor registry.
Incorporating Patient Reported Outcomes and
Exchanging data with REDCap
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REDCap to collect surveys, patient outcomes, consent
Common denominator: over 1000 institutions in REDCap Consortium.
i2b2 into REDCap: inherit security model, graphical/export tools
Interventional Informatics: “Develop the Ability to
Run a Clinical Trial in Participating Systems that
fits Seamlessly into Healthcare Operations”
Enhanced data integration: not all data in
Epic goes into Clarity database
Ex: Performance Status for Cancer Center in
notes smart data elements
Build needs:
Integrate REDCap/Pioneers/Consent
with MyChart
Alerting for trial recruitment
Adding forms/flowsheets/notes
Randomizing drug selection: orders
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Example: ALS Drooling Study: identify patients, prescreen, consent, randomize drug choices from among approved drug, outcomes, monitor
So…. Why the Greater Plains Collaborative?
http://www.arkive.org/greater-prairie-chicken/tympanuchus-cupido/video-12.html
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Greater Plains Collaborative Supporting future of
Academic Medicine and Learning Health System
Lek: gather in the the Spring on a Booming Ground to attract other Greater Prairie Chickens
If you dance by yourself, you’re not attracting researchers interested in generalizable results
GPC: CTSAs create ideal habitat for clinical researchers to come and study our state’s populations and develop methods to improve our communities health outcomes
Data, IRB, and governance in place so we can enable Comparative Effectiveness Research trials and Patient Reported Outcome collection
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Current Activities
Activating a large diverse network
Marshaling local talents while meeting deadlines
Patient Engagement in all aspects (eg. Data sharing governance)
Establishing Legal/Regulatory Foundation
IRB Reciprocity: final IRB Standard Operating Procedures (SOPs) out for signature this week!
Master Data Sharing Agreement distributed last week (4/10 signed)! • Qualified Faculty, Affiliate Investigators and External Affiliate
Investigators: next step External Affiliate Agreement draft.
Developing SOPs for operating trials
Central PCORI needs versus GPC needs (eg. tumor registry) and supporting PCORNet investigators bottom up
National Analysis Framework and Shipping Data to researchers
Integrating Research into the Patient/Clinical Workflow
Will be a new frontier at many places like KUMC/Epic • Not a technical problem; a cultural/accountability problem
Technical opportunities deploying across multiple EHR environments and evaluating their effectiveness
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GPC Ontologies -> PCORnet Common Data Model (CDM)
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GPC Progress
All sites have counts on Babel
• Study population – 8.4M
Annotated data dictionaries have been completed by all sites
Software has been developed that executes against a GPC i2b2 ontology (containing CDM and additional domains such as labs, meds) to populate the CDM
For several sites, this software was used to populate the data dictionary
Barriers/challenges to data standardization and mitigation plans
Specification for CDM is billing diagnosis (vs. clinical encounter diagnosis); we can supply both
Enrollment; may have “micro” enrollments per condition (eg. Admission; Cancer)
Lack of test data
Doubling of size of data store; will need to track cost/effort
Complete, 32
Overdue, 18Due this month, 5
Due next month, 7
Future, 43GPC Current Status
11/5/2014
GPC Milestone Update Spreadsheet
source: KeyGoalTracking on informatics.gpcnetwork.org
Upcoming Meetings Critical Central Tasks
• November 6 - 7: BC IRB meeting • November 7: Governance &
Collaboration TF • November 7: CDRN PI Call • November 12: GPC Governing Council
Call • November 14: GPC Site PM Call • November 17: Data Privacy TF • November 19: Health Systems
Interaction TF • November 20: CDRN PI Retreat • November 21: PCORnet Steering
Committee • November 24: Ethics & Regulatory TF • November 25: Patient & Consumer
Engagement TF • December 1: DSSNI TF – CDRN • December 1: Rare Disease TF • December 1: Data Privacy TF • December 2: PRO TF • December 2: Obesity TF • December 4: GPC Global Call • December 5: CDRN PI Call
• Align BC survey with DSA (Waitman/Rosenthal/Chrischilles)
• Due Nov 12 • CDM transform (#145) (Connolly/Graham)
• Due Nov 15 • ALS survey in REDCap (Herbelin/Allen)
• Due Nov 26 • Finalization of Phase 1 SOPs
• Due Dec 12 • GPC DROC (Waitman/KUMC team) • Data Management (TBD) • Biorepositories (Brilliant) • Data Security (Sanns/Connolly) • Feasibility (Pollock/Sanns) • Policies (Sokol – KUMC General Counsel) • Consent (Lantos) • Rights (Lantos) • COI (Sabin – KUMC RI) • Misconduct, Deviations (Sabin – KUMC RI) • Recruitment (Barohn) • Patient Engagement in Study Development
(TBD) • i2b2 Data Integration/Standardization
(Waitman/Connolly/Campbell) • Convene GPC DROC (Waitman)
• Due Dec 31
Critical Site Tasks
Milestone Status
Notes: GPC DEV call every Tuesday GPC Obesity Cohort call every Friday
4.8Approved approaches to enhancing patient involvement in
governance implementedAaronson (KU)
4.12Policies about transparency of patient data use in research are
developed and approvedDrezner (WI) / Waitman (KU)
7.7Approaches to enhance the completeness & comprehensiveness of
longitudinal data capture are submittedShireman (KU) / McClay (NE)
Select Overdue Milestones
3.12 Minimum standards (as defined by Data Privacy TF) are met Connolly (KU) / Tachinardi (WI)
7.6Archive data from completed studies & make available for
secondary data analysis by internal & external researchersConnolly (KU) / Tachinardi (WI)
4.9Report #1 summarizing patient involvement in governance is
submitted Aaronson (KU)
4.16Approaches for enabling patients to identify PROs for inclusion
into the DB are developed & submitted Pollock (UTHSCSA) / Chrischilles (IA)
4.20Approaches patient contribution to development & prioritization of
research questions are submittedAaronson (KU)
Due this Month
1.9 Approved approaches for increased diversity goals implemented Waitman (KU) / Rosenthal (IA)
2.2 Approved governance policies for standardizing data implemented Campbell (NE)
2.8 All data domains are harmonized within the CDRN Campbell (NE) / Waitman (KU)3.13 Patient training modules disseminated to patients Tachinardi (WI) / Aaronson (KU)
4.13Approved policies about transparency of patient data use in
research are implementedDrezner (WI)
6.2Approved approaches to defining membership & characterizing
members for obesity cohort are implementedHale (UTHSCSA)
7.5Non-PCORI resources identified to support on-going functionality
of networkRosenthal (IA) / Waitman (KU)
Due next Month
KUMC CMH
UIOWA
WISC
MCW
MCRF
UMN UNMC UTHSC
SA UTSW
i2b2 implemented (counts on babel #1)
#1 #58 #1 #1 #1 #36 #1 Y (#64) #74 #1
Patients Engaged BC, ALS LEK BC, ALS ALS SUST BC BC, ALS ALS ALS ALS
IRB: confirm for Nov 6-7 meeting
Y Y Y Y Y Y Y Y Y Y
Tumor Registry loaded (on babel) by Nov 15
Y n/a #168 Y #169 Y #172 #170 #171 Y
Site REDCap for patient surveys
Y Y Y Y Y #173 Y Y Y* Y
DSA signed by Nov 21
PopMedNet running and staffed
#154 #161 #162 #166 #148 #14 #147 #163 #164 #165
i2b2 aligned with GPC DX, Meds, ... #160
DX #63, Meds #
78
LOINC
LOINC LOIN
C Labs: #158, ~Meds
Demo: #67
Meds #78 HCPC
S
References
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GPC Proposal:
http://frontiersresearch.org/frontiers/sites/default/files/frontiers/documents/GPC-PCORI-CDRN-Research-Plan-Template-KUMCv44.pdf
PCORNet: http://pcornet.org
Peers: http://pcornet.org/clinical-data-research-networks/
GPC: http://www.gpcnetwork.org
GPC Development: http://informatics.gpcnetwork.org
PCORI: http://www.pcori.org/funding-opportunities/pcornet-national-patient-centered-clinical-research-network/