ADAPTABLEThe Aspirin StudyCDRN Data Strategy Call11 March 2016

Hosts: Lesley Curtis, PhD & Schuyler Jones, MD

Agenda for TodayWelcome and OverviewTimeline ReviewCDM Tables Review Tables in ADAPTABLE Populating the PCORNET_TRIAL

CDRN Updates on Phenotyping and Subject Screening ProgressData Characterization Cycles ReviewCDRN Questions/Open Discussion

Timeline to First SubjectDec 8, 2015: Final version of computable phenotype made available to CDRNsFeb 12, 2016: CDRNs provided Complete IRB Submission PackageMarch 2016: Complete all local IRB submissionsMarch 2016: CDRN-DCRI contracts executedFeb/March 2016: CDRNs fine tuning EHR phenotype search/reviewMarch 2016: request ADAPTABLE portal “Golden Tickets”Late March/Early April 2016: 1st IRB approval; custom ICF loaded into the PortalMarch 9, 2016: First IRB Approval-Ochsner/ReachNET !!March/April 2016: Feedback from IRBs and user testing of portalFirst ADAPTABLE patient enrolled

Additional Timeline Information

July 2016: : In addition to the 7 core CDM tables, CDRNs must have populated the LAB_RESULT_CM, DEATH, and either DISPENSING or PRESCRIBING tables. July 2016: ADAPTABLE CDRN/Datamarts will have gone thru data characterization and prep-to-research steps. They should be at a status of “Approved for Research” (aka full data characterization complete). 4th Q 2016: CDRNs/Datamarts that obfuscate dates will need to give patient-level information about how to correct the dates to DCRI for patients enrolled in the trial. This will be a supplemental file (specifications forthcoming).

Data Characterization Current StatusUpdated 3.10.16

July 2016

Diagnostic Query Data Characterization Query Prep‐to‐Research Ready

Full Data Characterization 

CompletedIn Progress Completed On Hold In Progress Completed On Hold

SCILHS (Partners Health) pSCANNER (UCSD) CAPriCORN (U of Illinois) REACHnet (PATH) PORTAL (KPSC)** PORTAL (KPNW)

SCILHS (Boston Children's) PORTAL (KPNC)CAPriCORN (Alliance Chicago) PORTAL (KPMA) PaTH (Geisinger)** Mid‐South (Vanderbilt)

SCILHS (Boston Medical) pSCANNER (UCLA) CAPriCORN (NorthShore) PORTAL (Health Partners) GPC (Marshfield Clinic)

SCILHS (Morehouse) SCILHS (Wake Forest) PORTAL (Denver Health) ADVANCEpSCANNER (UC Davis) PORTAL (KPHI) GPC (U of Nebraska) PORTAL (Group Health)pSCANNER (UCSF) PaTH (Utah) GPC (UT San Antonio)  PEDSnetpSCANNER (VA‐VINCI) GPC (UT SW Med Ctr)   REACHnet (Oschner)

PaTH (Temple University)REACHnet (Baylor Scott White) PORTAL (KPCO)

PaTH (UPMC)PaTH (Johns Hopkins)PaTH (Penn State Med Ctr)pSCANNER (UC Irvine)

Mid‐South (VHAN)

CAPriCORN (U of Chicago)

CAPriCORN (Rush)

CAPriCORN (Loyola)

CAPriCORN (Cook Co)

CAPriCORN (NW Medical)

Mid‐South (Greenway)

GPC (U of Kansas)

Updated weekly on PCORNET iMeet Central

Changes from last week highlighted in pink

Prep-to-Research by July 2016 for ADAPTABLE

CDM TablesDEMOGRAPHIC

ENCOUNTER

DIAGNOSIS

PROCEDURES

VITAL

DISPENSING -or-PRESCRIBING

LAB_RESULT_CM

DEATH

PCORNET_TRIAL

HARVEST

PCORNET_TRIAL

Golden Tickets requested from Mytrus in bulk and assigned by CDRN

Mytrus reports provide CDRNs Golden Tickets, subject IDs, enroll date and other patient identifier information to assist in reconciliation.

CDRN partners responsible for populating PCORNET_TRIAL from reports available through Mytrus ADAPTABLE patient portal: PARTICIPANTID TRIAL_SITEID TRIAL_ENROLL_DATE TRIAL_END_DATE TRIAL_WITHDRAW_DATE TRIAL_INVITE_CODE

Mytrus Golden Ticket

CDM identifierADPTMytrus Subject ID

MytrusReports

PCORNET_TRIAL Patient Identifier MappingID Origin Trigger DescriptionGolden Ticket Mytrus CDRNs request

through MytrusCDRNs request as bulk and receive download that can be used for mail merges

Mytrus Subject ID Mytrus Upon randomization

Unique system generated study number assigned at randomization and sequential

PATID PCORNET CDM Present in the CDM

The unique subject identifier in the PCORNET CDM that CDRNs populate in PCORNET_TRIAL

PARTICIPANTID PCORNET_TRIAL CDRN Populates The ADAPTABLE randomizedparticipant identifier that links the Mytrus randomized participants to the PCORNET CDM

TRIAL_INVITE_CODE PCORNET_TRIAL CDRN Populates The ADAPTABLE invited participant identifier captured in PCORNET_TRIAL

PCORNET_TRIAL Reference TableFIELD_NAME SAS_DATA_TYPE ADAPTABLE_VALUE_SET DEFINITION

PATID SAS Char(x) Replicated from DEMOGRAPHIC Arbitrary person-level identifier used to link across tables.

TRIALID SAS Char(20) ADPT Each TRIALID is assigned by the PCORnet trial’s coordinating center.

PARTICIPANTID SAS Char(x)SUBJECT_ID From MYTRUS

Arbitrary person-level identifier used to uniquely identify a participant in a PCORnet trial.

PARTICIPANTID is never repeated or reused for a specific clinical trial, and is generally assigned by trial-specific processes. It may be the same as a randomization ID.

TRIAL_SITEID SAS Char(x) See SITEIDs Each TRIAL_SITEID is assigned by the PCORnet trial coordinating center.

TRIAL_ENROLL_DATE SAS Date (Numeric) From MYTRUSDate on which the participant enrolled in the trial (generally coincides with trial consent process).

TRIAL_END_DATE SAS Date (Numeric) From MYTRUS Date on which the participant completes participation in the trial.TRIAL_WITHDRAW_DATE SAS Date (Numeric) From MYTRUS If applicable, date on which the participant withdraws consent from the trial.

TRIAL_INVITE_CODE SAS Char(20)Golden Ticket From MYTRUS

Textual strings used to uniquely identify invitations sent to potential participants, and allows acceptances to be associated back to the originating source.

Where used, there should generally be a unique combination of PATID, TRIAL_NAME, and INVITE_CODE within each datamart.

For example, this might include “co-enrollment ID strings” for e-mail invites or “verification codes” for letter invites.

SITE_IDsDataMartID DataMart Description Institution TRIAL_SITEIDC2VAN C2 Mid-South (Vanderbilt) Vanderbilt University A0C9AC C9 CAPriCORN (Alliance Chicago) Alliance Chicago B0C9VA C9 CAPriCORN (Brown & Hines VA) Jesse Brown VA Hospital B1C9VA C9 CAPriCORN (Brown & Hines VA) Hines VA Hospital B8C9CC C9 CAPriCORN (Cook County) Cook County B2C9NS C9 CAPriCORN (Northshore) Northshore B3C9NW C9 CAPriCORN (Northwestern Medical) Northwestern Medical B4C9RU C9 CAPriCORN (Rush) Rush B5C9UC C9 CAPriCORN (U of Chicago) U of Chicago B6C9UI C9 CAPriCORN (U of Illinois) U of Illinois at Chicago B7C6BAY C6 REACHnet (Baylor Scott White) Baylor Scott and White C0C6OCH C6 REACHnet (Ochsner) Oschner C1C6TUL C6 REACHnet (Tulane) Tulane C2C4REG C4 GPC (Indiana U Regenstrief) Indiana University D0C4MCRF C4 GPC (Marshfield Clinic) Marshfield Clinic D1C4UWM C4 GPC (Med Coll Wisconsin) University of Wisconsin-Madison D2C4UMO C4 GPC (U of Missouri HC) University of Missouri D3C4UN C4 GPC (U of Nebraska) University of Nebraska Med Ctr D4C4UI C4 GPC (University of Iowa) University of Iowa D5C4UK C4 GPC (University of Kansas) University of Kansas Medical Center D6C4UTSA C4 GPC (UT San Antonio) University of Texas Health Sciences San Antonio D7C4UTSW C4 GPC (UT SW Med Ctr) University of Texas Southwestern D8

Please start using site numbers and names in all correspondence with the coordinating center!

SITE_IDs (cont.)

DataMartID DataMart Description Institution TRIAL_SITEID

C3UCI C3 pSCANNER (UC Irvine) University of California Irvine E0

C3UCLA C3 pSCANNER (UCLA) University of California Los Angeles E1

C3UCSD C3 pSCANNER (UCSD) University of California San Diego E2

C8NYC C8 NYC CDRN (NYGC) Montefiore Medical Center F0

C8NYC C8 NYC CDRN (NYGC) Mount Sinai Health System F1

C8NYC C8 NYC CDRN (NYGC) Columbia University F2

C8NYC C8 NYC CDRN (NYGC) New York University Langone Medical Center F3

C8NYC C8 NYC CDRN (NYGC) Weill Cornell Medical College F4

C11JHU C11 PaTH (Johns Hopkins) Johns Hopkins G0

C11PSH C11 PaTH (Penn State Med Ctr) Penn State University G1

C11TU C11 PaTH (Temple University) Temple University G2

C11UU C11 PaTH (University of Utah) University of Utah G3

C11UPMC C11 PaTH (UPMC) University of Pittsburgh G4

Please start using site numbers and names in all correspondence with the coordinating center!

Process for Obtaining Golden TicketsGolden Tickets will be available as soon as you need themRequest them before you receive IRB approvalCDRN Partners are responsible to maintaining the linkage between the Golden Ticket invitation codes and the PATID for the PCORNET_TRIAL table

New… ADAPTABLE Patient Portal Web Address!www.AdaptablePatient.com

CDRN Progress

REACHnetGCPNYCpSCANNERCAPriCORNPaTH

REACHnetProgress in Patient Screening and Phenotype Use

SAS computable phenotype Successful run of ADAPTABLE phenotype against OCH SAS

data sets Currently ~12,000 eligible patients in data mart, should

increase when adjustments to include diabetic and smoking patients is complete.

Currently confirming with DCRI if we can use ICD9/10 codes to exclude for atrial fibrillation and atrial flutter

SAS SQL code An initial draft of SQL code was created based on the SAS

computable phenotype. I shared this code with a small group from NY-CDRN and CAPriCORN.

Currently working on plan to perform series of validations.

GPCProgress in Patient Screening and Phenotype Use

Modifying base phenotype adaptation at each site Lead dev team member at KUMC modified base phenotype for use in i2b2 warehouse within GPC Distributed to sites for site-level modification Some sites have returned results, but most have not At Iowa, we have ~8,500 eligible patients who have had a visit within the last 6 months Broke down eligible patients by last visit location, which has assisted in targeted physician outreach

Note: GPC also added two additional search criteria 1) Currently prescribed Aspirin 2) Exclude those on Prasugrel (Effient)

Chart Validation GPC sites will review 20 patient charts to validate phenotype at each site IRB application at most sites is needed

• Not using reliance model, simply requested sites to do an expedited review• Iowa submitted their application last week

NYC-CDRNProgress in Patient Screening and Phenotype Use

NYC-CDRN is focused on finalizing requirements for the phenotype. We’ve included additional exclusion criteria around INR, platelet count, existing conditions, and medications.

pSCANNERProgress in Patient Screening and Phenotype Use

Implemented inclusion/exclusion criteria in SQL against Epic Clarity Additional criterion: At least 1 ambulatory visit since

2013Preliminary results UCLA: 6,890 UC Irvine: 5,768 UCSD: 5,742

Plan to do manual error checking

CAPriCORN and PaTHProgress in Patient Screening and Phenotype Use

CAPriCORN Have not started; pending IRB and internal checks.

PaTH Will not screen until IRB approval obtained. Final phenotype will be included in IRB submission.

Recommendation

Cohort Readiness: Start ahead of time – request waiver from your IRB to jumpstart the search Do some type of chart review After IRB approval- approach a small number first (Test your system!)

Further Discussion? Questions?

Base Phenotype Location

https://github.com/ADAPTABLETRIAL

ADAPTABLE Study Website

http://theaspirinstudy.org/Dual branded with PCORnetRelevant content about the studyUpdated milestones as study progressesLinks to the protocol and informed consent

Other Business

Next Meeting: Friday April 8th (request to move to 11AM or 2PM EST)Following Meeting: Friday May 13th (request to move to 11AM or 2PM EST)ADAPTABLE at AMIA (podium presentation): Thursday, March 24 10:30-12 PSTMaterials from prior meetings posted on PCORnet iMeet Central

https://pcornet.imeetcentral.com/adaptabletrial/