ADAPTABLE. The Aspirin Study CDRN Call. 26 September 2016

Transcription

1 ADAPTABLE The Aspirin Study CDRN Call 26 September 2016

2 Agenda for Today ADAPTABLE Updates ADAPTABLE Specific Data Queries Other Items..

3 ADAPTABLE Updates 3 New sites activated Friday: Utah, Penn State, and Temple (PaTH) OneFlorida contract is finalized Registration for ADAPTABLE Kick-off is ongoing

4 Site Activation & Enrollment Update (9/26) 11 Sites Currently Active from 5 CDRNs: CAPriCORN, GPC, Mid-South, PaTH, REACHnet 612 Golden Tickets Entered into the Patient Portal (30 last week) 251 Subjects Randomized (15 last week) Current enrollment 26% of Projected enrollment by end of September CDRNs still pending IRB approval: NYC and pscanner Approach Expectations: High volume and multi-touch New by site tracker for key study metrics: Sub-contract, local IRB approval, Activation, Enrollment

5 Site Approach & Enrollment Update (9/26) CDRN Site Total Number Approached Golden Tickets Entered % Golden Tickets entered per Approached Enrolled % Enrolled Per Approached % Enrolled Per Golden Ticket Entered Enrolled since last week MidSouth Vanderbilt % 125 8% 46% 7 REACHnet Ochsner % 73 3% 34% 6 GPC Iowa % 8 2% 42% 0 PaTH UPMC % 33 4% 36% 0 Capricorn Northwestern % 12 7% 63% 2 TOTAL % 251 5% 41%

6 ADAPTABLE Follow-up Visits (9/26) Early Visit Early Visit Not Done 3M Visit 3M Not Done CDRN Site Golden Tickets Entered Randomized Complete <21 Days Days Days Days >90 Days Expected Complete <31 Days Days Days >90 Days MidSouth Vanderbilt REACHnet Ochsner PaTH UPMC GPC U Iowa CAPriCORN NorthWestern TOTAL subjects currently late for their Early Visit (23 REACHnet, 19 MidSouth, 5 PaTH, 1 GPC) 8 subjects currently late for their 3 mo check-in (7 REACHnet, 1 Mid-South)

7 ADAPTABLE The Aspirin Study CDM Querying Strategy September 26, 2016 Presenters: Brad Hammill and Laura Qualls

8 Agenda Preparing for CDM Queries CDM Queries Q&A Next Steps

9 CDM Queries PTR Query Population Patients with a history of coronary artery disease Level Aggregated data Concepts Demographics, event rates Tables DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, DEATH Query Date November 2016 Query 1 Population ADAPTABLE participants Level Patient-level Concepts Demographics, event rates Tables PCORNET_TRIAL, DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, VITAL, DEATH Query Date January 2017 Query 2+ Population ADAPTABLE participants Level Patient-level Concepts Demographics; events; medical history; medications; lab results Tables PCORNET_TRIAL, DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, VITAL, DEATH, LAB_RESULT_CM, PRESCRIBING, DISPENSING Query Dates ~April 2017, then regularly

10 Preparing for the CDM Queries

11 Required Tables ADAPTABLE-required tables Core: DEMOGRAPHIC, ENROLLMENT, ENCOUNTER, DIAGNOSIS, PROCEDURES, HARVEST Add l: PCORNET_TRIAL, DEATH, VITAL, LAB_RESULT_CM, PRESCRIBING ± DISPENSING All tables should be populated by Nov 30 th Some concepts of interest Vitals: Height, Weight Labs: Creatinine, LDL, Hemoglobin Medications: Warfarin; Dabigatran; Rivaroxaban; Apixaban; Edoxaban; Ticagrelor; Prasugrel; Clopidogrel; NSAID; Statins; Ezetimibe; ACE Inhibitors; ARBs; Betablockers; Aldosterone antagonists; LCZ; Proton Pump Inhibitors; H2 Blockers Querying the PRESCRIBING table RX_ORDER_DATE and RXNORM_CUI will be needed RXNORM_CUIs should be populated as soon as possible. If the DISPENSING table is not populated, RXNORM_CUIs should be populated by March 2017.

12 CDM refreshes Per the DRN OC DataMarts should be refreshed twice per data characterization cycle DataMart refreshes will include data updates and/or ETL changes Additional refreshes may be required by some studies. Additional refreshes are not currently required for ADAPTABLE, but may be at the end of the trial to ensure complete data capture

13 Date obfuscation The information in the HARVEST table and the ETL Annotated Data Dictionary will be relied upon to understand the techniques employed by each DataMart If dates are shifted PCORNET_TRIAL dates must be internally consistent with all other CDM dates The preferred approach for PCORnet is that partners retain the actual dates reported within their source systems. If it is necessary to use date obfuscation (also known as date shifting), partners should ensure that the obfuscation is internally consistent across all dates for a given patient (i.e., all dates for that patient are shifted by the same amount). This would include dates in the PCORNET_TRIAL table, if populated. Failure to adhere to this guidance will make it all but impossible to use that partner s data in any analytic query. Source: Draft Implementation Guidance, 09/19/16 Date of birth and trial enrollment date in Mytrus will be used to calculate true age and true CDM event dates, respectively CDM query results reported as days from enrollment to event True dates are needed to confirm patient-reported events

14 Populating the PCORNET_TRIAL table Field PATID TRIALID PARTICIPANTID TRIAL_SITEID TRIAL_INVITE_CODE TRIAL_ENROLL_DATE TRIAL_END_DATE TRIAL_WITHDRAW_DATE Source / Notes Pseudoidentier created by the CDRN - Must remain in sync with other CDM tables in the approved DataMart From Mytrus (= ADPT ) From Mytrus From Mytrus From Mytrus From Mytrus - If applicable, must be shifted consistently w/other dates From Mytrus - If applicable, must be shifted consistently w/other dates From Mytrus - If applicable, must be shifted consistently w/other dates The refresh schedule can be determined by each DataMart, but it must current as of ~2 weeks prior to query response (specifics to be provided later this year).

15 Study-specific restrictions Some DataMarts may contain data from sites which are not participating in ADAPTABLE DataMart teams are responsible for ensuring that only data from participating sites are queried For example, DataMart teams could create views or subsets of the approved SAS DataMart tables using a siteid on each table. Please submit your proposed process to your DRN OC liaison (laura.qualls@duke.edu or james.topping@duke.edu). Query distribution will use standard workflows; DataMart teams must execute the study queries against the appropriate DataMart The DRN OC will not characterize and approve results for DataMart restrictions. DataMart teams are encouraged to run the data characterization programs against these restricted DataMarts

16 CDM Queries

17 CDM Queries PTR Query Population Patients with a history of coronary artery disease Level Aggregated data Concepts Demographics, event rates Tables DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, DEATH Query Date November 2016 Query 1 Population ADAPTABLE participants Level Patient-level Concepts Demographics, event rates Tables PCORNET_TRIAL, DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, VITAL, DEATH Query Date January 2017 Query 2+ Population ADAPTABLE participants Level Patient-level Concepts Demographics; events; medical history; medications; lab results Tables PCORNET_TRIAL, DEMOGRAPHIC, ENCOUNTER, DIAGNOSIS, PROCEDURES, VITAL, DEATH, LAB_RESULT_CM, PRESCRIBING, DISPENSING Query Dates ~April 2017, then regularly

18 Concepts included in the CDM queries Domain Metadata Demographics Medical history Medications Lab Values Events Hospitalization detail Data returned Count of encounters pre- and post-trial enrollment Enrollment windows for trial participants Date obfuscation/imputation Min/max dates of service included in the DataMart Table-specific refresh dates Age, sex, race, ethnicity, height and weight at trial enrollment Indicators of conditions present at trial enrollment Indicators of concomitant medications (prescribed or dispensed) at trial enrollment and throughout follow-up (6-month intervals) Specified laboratory result values prior to trial enrollment Trial-defined safety and efficacy events Primary diagnosis, days from trial enrollment, and provider information for all hospitalizations during the trial follow-up period

19 Defining the concepts Algorithms to identify many of these concepts are being developed based on multiple sources Peer-reviewed publications Value Set Authority Center Centers for Medicare and Medicaid Services (CMS) Chronic Conditions Warehouse Coding database search Physician review LexiComp drug database FDA s NDC database RxNorm medication database

20 Event concepts for the PTR query Death Myocardial infarction Stroke Hemorrhagic Stroke Ischemic Stroke Transient Ischemic Attack Combined Coronary Revascularization PTCA or CABG Bleeding Intracranial Bleeding Gastrointestinal Bleeding Bleeding at Other Location Control of Bleeding Procedure Combined Transfusion RBC or whole blood Other or non-specific Combined Major bleeding Bleeding + transfusion Results from the PTR query will inform the algorithms used in Query 1

21 Query Logistics SAS file distribution queries distributed via the DRN Query Tool (PopMedNet) Query results can only be seen by ADAPTABLE team members PTR query will use the PMP1 analytic tool (like Front Door Query 1) Query 1+ will be ad-hoc SAS code

22 Wrap Up Questions? Next Steps Populate CDM tables September November 2016 PTR query responses November 2016 Query 1 responses January 2017

23 Other Items.. All Other Business? Comments on Protocol Amendment due today COB Approach numbers weekly from Active Sites Include total Eligible Kick-off Meeting Oct 28th in Washington DC 4 attendees per CDRN (ADAPTOR, ADAPTABLE PI, Lead Coordinator, person of your choice) Can send additional 1-2 members if travel is covered by CDRN Next Calls CDRN Monday October 3 rd at 2pm (Eastern Time)

24 Enrollment Details

25 Site Activation & Enrollment Update (9/26) Mid-South (4/18/16) 269 Visited System But Not Randomized 144 Randomized 125 REACHnet (4/28/16) 214 Visited System But Not Randomized 143 Randomized 71 GPC (7/18/16) 19 Visited System But Not Randomized 11 Randomized 8 PaTH (7/18/16) 91 Visited System But Not Randomized 58 Randomized 33

26 Site Activation & Enrollment Update (9/26) CAPriCORN (8/30/2016) 19 Visited System But Not Randomized 7 Randomized 12 Pending IRB NYC (Planned 8/15/2016) approval Visited System But Not Randomized Randomized pscanner (Planned 8/15/2016) Pending IRB approval Visited System But Not Randomized Randomized OneFlorida (TBD) Pending Finalized ICF Visited System But Not Randomized Randomized

27 ADAPTABLE Enrollment Projections by CDRN (9/26) Enrollment Apr 16-May 16-Jun 16-Jul 16-Aug 16-Sep 16-Oct PaTH Projected Actual GPC Projected Actual pscanner Projected Actual 0 0 NYCDRN Projected Actual 0 0 ReachNET Projected Actual Mid-South Projected Actual CAPriCORN Projected Actual Florida Projected 0 Actual Total Projected Actual Cumulative Projected Actual

28 Participants Enrolled ADAPTABLE Enrollment Months of Enrollment Projected Actual ClinicalTrials.gov: NCT