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

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

Intake and Review Process

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

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

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

Stakeholder Reviews Survey

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 5-26-16 Observational Satisfactory Y Cecilia Chung AR-PoWER, PPRN Demonstration 7-28-16

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

PopMedNet Query Workflow and Governance

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

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

Overall CDRN PopMedNet Workflow Coordinator Center notification of query email 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

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

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 2012-2014 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)

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

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

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?

PCORnet Front Door

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

PCORnet Front Door Process Response to Network Collaborator Request

Network Collaborator Request Process Investigator Request Investigator initiates a general Front Door request. Front Door sends the opportunity to the Network Navigators via email 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)

Network Response Form to Front Door

Network Response Form to Front Door

Navigator Responsibilities Provide updated Navigator contact information to Front Door at frontdoor@pcornet.org. 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.

CDRN PCORnet Front Door Process Request for Network Collaborators posted in PCORnet Weekly Announcement and emailed 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

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

Collaborative Research Groups PCORI will fund 10-20 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

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

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

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

CRG Discussion Issues, comments, questions