ADAPTABLE The Aspirin Study ADAPTABLE Query 1 Updates

ADAPTABLE The Aspirin Study ADAPTABLE Query 1 Updates March 22, 2017 Laura Qualls and Mary Williams

Agenda Updates to Event Definitions Query 1 Preparation § Checklist § PCORNET_TRIAL instructions (recap) § PCORNET_TRIAL Diagnostic Query Open Floor § Comments from beta-testers § Q&A

Event Definitions Changes § Since some partners do not have complete data capture for principal diagnoses codes, we created alternative event definitions which suspend the principal diagnosis requirement. These definitions will be used for a sensitivity analysis § In the PTR query, transfusions were captured at a highly granular level to allow us to understand which codes were being used. These have now been rolled up into 2 categories: • Transfusion, specific • Transfusion, other

ADAPTABLE Events Event Description Death Myocardial Infarction Did this patient die? Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate a myocardial infarction event? Myocardial Infarction (Alternate)* Does this patient have a diagnosis code associated with an inpatient encounter to indicate a myocardial infarction event? Hemorrhagic Stroke Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate a hemorrhagic stroke event? Hemorrhagic Stroke (Alternate)* Does this patient have a diagnosis code associated with an inpatient encounter to indicate a hemorrhagic stroke event? Ischemic Stroke Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate an ischemic stroke event? Ischemic Stroke (Alternate)* Does this patient have a diagnosis code associated with an inpatient encounter to indicate an ischemic stroke event? Transient Ischemic Attack Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate a transient ischemic attack event? Transient Ischemic Attack (Alternate)* Does this patient have a diagnosis code associated with an inpatient encounter to indicate a transient ischemic attack event? Stroke, Combined Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate any of the following events: hemorrhagic stroke, ischemic stroke, or transient ischemic attack? Stroke, Combined (Alternate)* Does this patient have a diagnosis code associated with an inpatient encounter to indicate any of the following events: hemorrhagic stroke, ischemic stroke, or transient ischemic attack? *Alternate definitions will be used for a sensitivity analysis assessing the impact of a requiring a primary diagnosis

ADAPTABLE Events continued Event Description Coronary Revascularization Does this patient have a procedure code to indicate a CABG or PCI coronary revascularization event Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate an intracranial bleeding event? Does this patient have a diagnosis code associated with an inpatient encounter to indicate an intracranial bleeding event? Intracranial Bleeding (Alternate)* Gastrointestinal Bleeding (Alternate)* Bleeding at Other Location (Alternate)* Control of Bleeding Procedure Bleeding, Combined (Alternate)* Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate a gastrointestinal bleeding event? Does this patient have a primary diagnosis code associated with an inpatient encounter to indicate a bleeding at other location event? Does this patient have a procedure code in any setting to indicate a control of bleeding procedure event? Does this patient have a primary diagnosis code associated with an inpatient encounter or a procedure code in any setting to indicate any of the following events: intracranial bleeding, gastrointestinal bleeding, bleeding at another location, or a control of bleeding procedure? Does this patient have any diagnosis code associated with an inpatient encounter or a procedure code in any setting to indicate any of the following events: intracranial bleeding, gastrointestinal bleeding, bleeding at another location, or a control of bleeding procedure? *Alternate definitions will be used for a sensitivity analysis assessing the impact of a requiring a primary diagnosis

Query 1 Preparation

ADAPTABLE Events continued Event Description Transfusion, Specific Does this patient have procedure codes that indicate a blood transfusion with RBC or whole blood? Transfusion, Other Does this patient have diagnosis or procedure codes that indicate a non-specific or other (ie, not RBC, whole blood) transfusion? Transfusion, Any Major Bleeding, Any Transfusion (Alternate)* Major Bleeding, Specific Transfusion Does this patient have diagnosis or procedure codes that indicate any blood transfusion (specific or other)? Does this patient have primary diagnosis codes and procedure codes that indicate both a bleeding event and any transfusion? Does this patient have diagnosis and procedure codes that indicate both a bleeding event and any transfusion? Does this patient have primary diagnosis codes and procedure codes that indicate both a bleeding event and a specific transfusion (RBC, whole blood)? Major Bleeding, Specific Transfusion (Alternate)* Does this patient have diagnosis and procedure codes that indicate both a bleeding event and a specific transfusion (RBC, whole blood)? *Alternate definitions will be used for a sensitivity analysis assessing the impact of a requiring a primary diagnosis

ADAPTABLE Query 1 Checklist Pre & Post Query Run Checklist: Before responding to data characterization refresh 2 (due April 24) Update the PCORNET_TRIAL table to include as many patients as possible Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated. Check that the length of PATID in all tables including PCORNET_TRIAL table matches by running the PCORNET_TRIAL Diagnostic Query. Check that the trial participants are present in the expected tables by running the PCORNET_TRIAL Diagnostic Query Check the completeness of the discharge disposition data for inpatient encounters Check the completeness of the principal diagnosis data for inpatient encounters. Ensure that ICD procedure codes after Oct 2015 are included and classified as ICD 10* Ensure that ICD diagnoses codes after Oct 2015 are included and classified as ICD 10* Before running ADAPTABLE Query 1 Update the PCORNET_TRIAL table to include all patients who enrolled on or before April 15, 2017 Make sure the REFRESH_PCORNET_TRIAL_DATE in the HARVEST table is correctly populated. NOTE: This date should be after April 15, 2017 – see ‘Reminders about populating the PCORENT_TRIAL table’ below. Ensure that PATID, TRIAL_ENROLL_DATE, TRIAL_END_DATE, and TRIAL_WITHDRAW_DATE variables are internally consistent across other CDM tables for the same patient Ensure that only data from participating ADAPTABLE Data. Marts are queried After running ADAPTABLE Query 1 (due May 15) Review output to confirm that the layout and contents conform to the layouts in this work plan and the results you would expect. Section VII Table Shells should be used as a reference. *Partners who had potential problems with code type assignments received a communication from the PCORnet Coordinating Center. Tools to identify these errors are located here: https: //pcornet. imeetcentral. com/p/Zg. AAAAAAh. MVg

Reminders about populating the PCORNET_TRIAL table Field Source / Notes PATID Pseudoidentier created by the CDRN - Must remain in sync with other CDM tables in the approved Data. Mart - Will not be returned in query results TRIALID From Mytrus (= “ADPT”) PARTICIPANTID From Mytrus TRIAL_SITEID From Mytrus TRIAL_INVITE_CODE From Mytrus TRIAL_ENROLL_DATE From Mytrus - If applicable, must be shifted consistently w/other dates TRIAL_END_DATE From Mytrus - Should be left blank at this time TRIAL_WITHDRAW_DATE From Mytrus - If applicable, must be shifted consistently w/other dates The refresh schedule can be determined by each Data. Mart, but it must be current as of ~2 weeks prior to query response

PCORNET_TRIAL Diagnostic Query Introduction The purpose of this program is to help network partners identify and resolve potential issues with the PCORNET_TRIAL table population. This is a self-service program to be used by network partners; output is not returned to the Coordinating Center. The program: § Checks the length of the PATID in all tables used in ADAPTABLE Query 1 since differences in field length can cause errors § Looks for ADAPTABLE trial participants in the Demographic, Enrollment, Encounter, Diagnosis, Procedures, and Vital tables. Patients who are not found in any of these tables are provided in the query output for further investigation if necessary. All trial participants must have a Demographic record, and the majority of trial participants are expected to have Enrollment, Encounter, and Diagnosis records. Trial participants may or may not have any Vital and Procedures records. The Death table is not checked since very few trial participants should be in this table.

PCORNET_TRIAL Diagnostic Query Sample Query Results T Data. Mart. ID T Response Date T Query T Site ID PARTID PATID NOT_IN_DSN T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 AAA 9 diagnosis T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 BBB 10 diagnosis T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 CCC 11 diagnosis T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 DDD 16 encounter T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 EEE 9 procedures T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 EEE 9 vital T 1 AT 1 21 -Mar-17 ADPT_DIAGNOSTIC T 1 FFF 8 vital Query results are saved as a PDF, csv file and SAS dataset.

Open Discussion Comments from beta-testers Questions and answers