1. Mid-South CDRN Research Opportunities: Intake and Review Process, CDRN Communication, CRGs

2. Types of CDRN Requests 1. CDRN Collaboration Request –via Intake Form
Prep-to-Research
Research on Limited/De-Identified and Identified Data
Comparative Effectiveness Research
Pragmatic Clinical Trials
Access to linked data sources
Stakeholder Engagement
2. Front Door Project Requests - Requests from Investigators for Network Collaborators through the PCORI Front Door sent through the PopMedNet Query Tool
Prep-to-Research - Feasibility counts
Research on Identified Data
Research on Limited/De-Identified Data
3. PCORnet Request (via PopMedNet)– PCORnet study requests sent through the PopMedNet query tool

3. Intake and Review Process

4. CDRN Projects Supported
Number of Projects Processed 66
Phenotype and Data Dictionary Defined 25
Counts and/or Estimate Provided for Grant Submission
Number Funded 17
Data Provided 11

5. Intake Process Improvements
Intake Form Updates
Addition of all CDRN partner sites
Incorporation of Front Door Request form to reduce duplicity

6. Collaboration Request Review Process
Intake Form Received
Navigator has introduction call with PI
Review request at weekly leadership meeting
Navigator send sites intake form and study specific request: ie site PI, counts, etc.
Navigator provides returned results to PI and tracks project
Navigator sends study to SAC for stakeholder review
PCORnet De-ID Queries (counts)
Observational Research
Interventional Research
SAC receive a quarterly report on queries run
SAC receive study details, review, and comment
SAC Reviews and Approves
SAC Coordinator send approval status to Navigator
Stakeholder Review Survey
Navigator reports SAC approval to Leadership and tracks approval for governance purposes

7. Stakeholder Reviews Survey

8. Stakeholder Reviews PI Institution Title Review Date Type of Research
SAC Decision
Feedback to PI
Bill Heerman
VUMC
Short- and Long-term Effects of Antibiotics on Childhood Growth
Observational
Satisfactory Y
Cecilia Chung
AR-PoWER, PPRN Demonstration

9. Intake Process Discussion
Navigator/Site Communication Dissemination
Site owner vs. Team Approach
Identification of collaborators based on study type
De-Identified
Identified
Pragmatic Trials
Other issues, comments, questions

10. PopMedNet Query Workflow and Governance

11. Types of PopMedNet Queries
Pre-Research
Data Characterization Queries
Feasibility Queries from PCORnet/Coordinating Center
Front Door Queries
Observational Studies
Study Specific Data Characterizations
Study Specific Queries
Interventional Studies

12. PCORnet’s Query Workflow
The Researcher sends a question to the PCORnet Coordinating Center through the Front Door
The Coordinating Center converts the question into a query with an underlying executable code, and sends it to PCORnet partners
PCORnet partners review the query and provide a response, which is sent back through the Front Door to the Researcher
Front Door
Response
Researcher
Question
Let’s take a look at how PCORnet works in practice.
If you want to tap PCORnet to answer a research question:
You submit your question to PCORnet
Goes through the Front Door into PCORnet’s Coordinating Center, a network of partners who collaborate to lead PCORnet’s operations and data activities and maintain its infrastructure. These partners include the Harvard Pilgrim Health Care Institute, Duke Clinical Research Institute, and Genetic Alliance.
We begin working with the requestor to make sure we know specifically what information is sought.
Then we convert the question to a query
Phrase it in a way that PCORnet’s system will understand to ensure it gives us the result we need.
We convert it into SAS code and sent securely to PCORnet network partners, who will run the query against their data and send back the result.
The entire process is performed locally at PCORnet partner networks– the data never moves and remains secure.
PCORnet
Coordinating Center
Query

13. Overall CDRN PopMedNet Workflow
Coordinator Center notification of query to PI and PM
Review request at weekly leadership meeting
Query participation established on a site by site basis
Site receives query in PopMedNet
Informatics site lead assesses feasibility (can be discussed at biweekly tech call if needed)
Query run against site CDM
Results securely transferred through PopMedNet to PCORnet

14. IT PM send query info to Site PI for review and approval
CDRN Site Workflow
IT PM send query info to Site PI for review and approval
IT PM informs site programmer if PI approves query
Vanderbilt receives query in PopMedNet
If approved, programmer assesses feasibility (can be discussed at biweekly tech call if needed)
If approved query run against site CDM
Site IT PM sends results to site PI for review and approval
If results are approved, IT PM instructs programmer to send via PopMedNet to PCORnet

15. PopMedNet Queries to Date
Title
Description
Requestor
Site Participation (Analysis Hours)
Weight Cohorts Query
Categorize weight-related data across PCORnet, compare the PCORnet population to national surveillance data examining one 5-year and five 1-year periods for both adults and children
Coordinating Center
VUMC(1) VHAN (1)
Meharry (2)
UNC (1) HSSC (1.5)
Query 1
Calculate background rates of cohorts of patients in 2014 for specified disease conditions
PCORI
VUMC (2) VHAN (2)
UNC (1) HSSC (0.5) Greenway (2)
Bariatric Wave 1 SSDC
Characterizes CDM tables and variables needed for the PCORnet Bariatric Study
PCORnet Bariatric Study
VUMC (3) UNC (0.5)
Front Door Request 1
Calculates background rates from for CVD dx/px of interest and cardiac CT for calcium scoring px
NIH
VUMC(2) VHAN (2) Meharry (2) UNC HSSC (1.5) Greenway (2)
Menu-Driven Query 1 & 2
Use demographic, encounter, diagnosis, and vital information as specified by the requester to return aggregate counts of patients who match the request criteria
TBD
ABX Wave 1 SSDC
Characterizes CDM tables and variables needed for the PCORnet Antibiotic Study
PCORnet Antibiotic Study (ABX)

16. PopMedNet Queries Continued
Title
Description
Requestor
Site Participation (Hours)
PMN Configuration Test
This Configuration Test will: a) ensure that Group 1 DMs are ready to receive and can respond to Menu-Driven Queries through v5.3 of the DataMart Client and b) consist of a query request returning an overall count of patients in the DM.
PCORI
Meharry (1) UNC(0.5) HSSC (0.5) Greenway (0.5) VUMC (4)
VHAN (TBD)
Cycle 1 Data Characterization
The data characterization program characterizes selected fields in the Demographic, Enrollment, Encounter, Procedure, Diagnosis, Vital, and Harvest tables. It will assume SAS data types/fields.
Coordinating Center
Duke VUMC VHAN
Meharry
UNC HSSC Greenway
Beta Testing for Obesity
Categorize weight-related data across PCORnet, compare the PCORnet population to national surveillance data and inform upcoming obesity demonstration projects.
VUMC
Beta Testing for DC
The data characterization program characterizes selected fields in the Demographic, Enrollment, Encounter, Procedure, Diagnosis, Vital, and Harvest tables. It will assume SAS data types/fields. The beta-testing is simply a test of the code
Beta Testing for MDQ
MDQs execute against a DataMart's local RDBMS data in PCORnet CDM V3 format
UNC

17. PopMedNet Query Milestones
Data Infrastructure Milestone
Year
Execute 50 pre-research or research queries per year submitted by the CC
Year 1
Execute 100 pre-research or research queries per year submitted by the CC
Year 2
Execute 200 pre-research or research queries per year submitted by the CC
Year 3

18. PopMedNet Query Discussion
Does the current process for reviewing PopMedNet queries work for each site? Can it be improved upon?
How do we review results for accuracy and appropriateness for both network and study specific queries?
What data can and should be returned to the Coordinating Center?

19. PCORnet Front Door

20. PCORNet “Front Door”
Front Door “opened” with a soft launch in April 2016
Accepting requests for:
Collaborators
PCORnet Study designation
Data (PTR)
Front Door #1 query v0.2 this week
Front Door launches to members September 2016

21. PCORnet Front Door Process
Response to Network Collaborator Request

22. Network Collaborator Request Process
Investigator Request
Investigator initiates a general Front Door request.
Front Door sends the opportunity to the Network Navigators via and post in the weekly newsletter.
For specific CDRN request, Front Door provides the request to the applicable CDRN Navigators.
CDRNS Response
CDRNs submit an online Network Response to Front Door.
Request Response
Front Door compiles submitted Network Responses.
Front Door consults with Research Committee/Coordinating Center Review Team.
Front Door provides responses back to Requestor.
Study Engagement
Requestor initiates conversations, as interested, with responding Network(s)

23. Network Response Form to Front Door

24. Network Response Form to Front Door

25. Navigator Responsibilities
Provide updated Navigator contact information to Front Door at
Serve as Network point of contact for Network Collaborator requests received through the Front Door.
Receive direct communication from the Front Door on opportunities for collaboration.

26. CDRN PCORnet Front Door Process
Request for Network Collaborators posted in PCORnet Weekly Announcement and ed to Network Navigators
Request reviewed and approved by CDRN leadership
If request is from Mid-South investigator, navigator contacts investigator to complete our intake form
If request is from non-CDRN site, Navigator sends opportunity to sites
Sites identify interested collaborator and send names to Navigator
Navigator receives intake form
Navigator sends opportunity to sites
Navigator will ask interested CDRN investigators to complete intake form
Sites identify interested collaborator and send names to Navigator
Navigator sends list of interested CDRN investigators to “Front Door” PI
Navigator sends list of interested CDRN investigators to “Front Door” PI

27. PCORnet Front Door Discussion
Front Door Communication Dissemination
Front Door query prioritization
Other issues, comments, questions

28. Collaborative Research Groups
PCORI will fund CRGs
CRGs will:
Promote research opportunities
Vet potential projects that come to PCORnet
Provide expertise to CDM and PCORnet
Each CRG will receive $100K for initial support
Potential CRGs:
Cardiovascular Disease, Health Systems, Pediatrics, Disparities
Precision Medicine, Sickle Cell, Surgical Quality, Diabetes/Obesity

29. Letter of Intent Phase
Recommendations from Research Committee have been received
Application guidance distributed September 10th
Applications due October 31st
Kick-off meetings being organized

30. CRGs Led by Mid-South CRG Name Leads (Networks) Other Networks
Health Communication and Literacy
E Cope (NephCure)
K Cavanaugh (MidSouth)
CCFA, CPPRN, DuchenneConnect, HealtheHeart, IAN, Mood, MS PPRN, PARTNERS, PMS-DN, PRIDEnet, ADVANCE, CAPriCORN, PaTH, PORTAL, pSCANNER
Precision Medicine
J Peterson (MidSouth)
S Terry (CENA)
PaTH, SCILHS, GPC, PORTAL, CAPRICORN, PEDSnet, ABOUT
Diabetes/Obesity
J Buse (Mid-South)
D Schatz (OneFlorida)
PaTH, REACHnet, SCILHS, iConquerMS, PORTAL, LHSnet
Renal
E Siew (Mid-South)
M Matheny (pScanner)
L Mariani (NephCure)
D Gipson (LHSnet)
CAPriCORN, OneFlorida, PaTH, GPC, Vasculitis, PEDSnet, OneFlorida, CAPRiCORN, PORTAL
Surgical Quality & Outcomes
D Penson (Mid-South)
B Brooke (PaTH)
pSCANNER, AR-Power, OneFlorida, CCFA Partners, Elizabeth McGlynn, NYC-CDRN
Hospital Medicine
Sickle Cell Disease
R Cronin (Mid-South)
none

31. CRGs with Mid-South Participation
CRG Name
Leads (Networks)
Other Networks
Health Disparities
J Puro (ADVANCE)
M Lunn (PRIDEnet)
ADVANCE, REACHnet, NYC, NKN, Mid-South, CPPRN, OneFlorida, HealtheHeart, PaTH, pSCANNER, CENA, CAPriCORN
Pediatrics
C Forrest (PEDSnet)
E Shenkman (OneFlorida)
REN, CENA, DuchenneConnect, ICN, IAN, Mood, Nephcure, Phelan-McDermid, PI-Connect, ADVANCE, CAPriCORN, GPC, PORTAL, Mid-South, LHSnet, REACHnet , NYC, PaTH
Cardiovascular Health
M Pletcher (HealtheHeart)
V Roger (LHSnet)
iConquerMS, OneFlorida, ADVANCE, pScanner, PaTH, MidSouth, CordCenter
Autoimmune
B Nowell (AR-PoWER)
P Merkel (Vasculitis)
CCFA Partners; ImproveCareNow; Multiple Sclerosis; PARTNERS; PI-Connect; CENA; Mid-South
Reproductive Health
C Chuang (PaTH)
E McGlynn (PORTAL)
CAPriCORN, PRIDEnet, CENA
Pulmonary
D Mannino (COPD)
R Bascom (PaTH)
GPC, CAPRiCORN, NYC, CENA, MidSouth
Cancer
E Chrischilles (GPC)
S Friedman (ABOUT)
D Ritzwoller (PORTAL)
CENA, LHSNet, OneFlorida, PaTH, PI CONNECT, REACHnet
Public Health
T Carton (REACHnet)
J Block (PCORnet CC)
R Kaushal (NYC-CDRN)
ADVANCE, CAPriCORN, GPC, PORTAL, REACHnet, Mid-South, PEDSnet, LHSNet, pSCANNER, PaTH, SCILHS, NYC, HealtheHeart

32. CRG Discussion
Issues, comments, questions