PCORI/G PC Standard Data Model

1. PCORI/GPC Standard Data Model Jim Campbell, Dan Connolly, GPC Data standardization team

2. GPC Data Standardization WorkplanAgreed Hackathon 20140224 • I2b2 is our data repository tool; Star schema is the reference information model • Domain ontologies, code sets and value sets will be discussed and agreed by GPC/DEV on staged plan prioritized for our research teams; we will follow ONC advice whenever available • Prioritized plan: • Diagnoses; ICD-9-CM dimension • Clinical Observables including biometrics; Clinical LOINC • Procedures; CPT and HCPCS • Laboratory Observables; Lab LOINC • Medications; RxNORM and NDF-RT • Diagnoses SNOMED CT

3. GPC Data Standardization WorkplanAgreed Hackathon 20140224 • EHR data extract (ETL) development will start with KU/Heron scripts and enhance them to align with model development and to include reference standards • Model development will include population quantification and data quality metrics that will standardize reporting to GPC; test queries for i2b2 research data will be developed by the three research teams as their objectives become clear and supplied to GPC STD/DEV for quality assurance reporting • Data quality queries will be developed for site technical teams to assess their compliance with PCORI CDM

4. GPC Data Standardization WorkplanAgreed Hackathon 20140224 • Sites will either: • create identical ETL functionality in their own load scripts to standardize data model OR • Those not capable of supporting standard test query functionality by virtue of inability to meet standardization scheduling will map their i2b2 repositories to meet query functional requirements at a time agreed upon by GPC/DEV (7/1/2014 for CDM V1)

5. GPC Data Standardization WorkplanPublication PCORI CDM 20140330 • Data attributes required by the PCORI common data model will be supported in GPC • Class definitions required by PCORI will be supported as query extract from GPC data when they are judged to be too restrictive for GPC class definitions

6. i2b2 ‘Out-of-the-box’ Visit_dimension PK Encounter_num Patient_num Start_datetime End_datetime Active_status_CD …optional data (Data history) Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD …optional data • (Data history) Observation_fact Patient_num PK Encounter_num PK Concept_CD PK Provider_ID PK Start_date Modifier_CD Instance_num End_date Valtype_CD Tval_Char Nval_Num ValueFlag_CD Quantity_num Units_CD Location_CD Observation_Blob Confidence_num (Data history) Provider_dimension PK Provider_ID PK Observer_Path Name_char (Data history) Concept_dimension PK Concept_Path Concept_CD Name_char (Data history) Modifier_dimension PK Modifier_Path Modifier_CD Name_char (Data history) I2b2 Design Document; Data Repository (CRC) Cell; Partners Healthcare System; document version 1.7.1

7. PCORnet Common Data Model v1.0

8. GPC V1 Patient dimension Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD …optional data • (Data history) Observation_fact Birth_date Birth_time Death_date Vital_status_CD Sex_CD(HL7/OMB Age in years_num Language_CD(OMB) Race_CD(OMB) Marital_status_CD(OMB) Ethnicity_CD(OMB Concept_dimension Demographics\ \Vital_status LOINC:31210-8 \Birth_date LOINC:21112-8 \Birth_time LOINC:57715-5 \Sex LOINC:21840-4 \Age LOINC:30525-0 \Language LOINC:54899-0 \Residence LOINC:46526-0 \Race LOINC:32624-9 \Marital_status LOINC:45404-1 \Ethnicity LOINC:42784-9 \Religion LOINC:45823-2 \State residence LOINC:46499-0

9. GPC V1 Provider(observer) dimension Provider_dimension PK Provider_ID PK Observer_Path Name_char (Data history) Provider_dimension PK Provider_ID PK Observer_Path Name_char Observation_fact Observer_CD(NPI) LOINC:45952-9

10. GPC V1 Provider(observer) dimension Observer_Path (DRAFT) SNCT25676002|Person| 394619001|Guardian| 58626006|Legal guardian| 262043009|Partner in relationship| |Common-law husband| |Common-law wife| |Domestic partner| |Spouse| 303071001|Person in the family| |Adopted person| |Adopted child| |Relative| |Immediate family member| |Child| |Parent| |Sibling| |Person in healthcare environment| |Caregiver| |Patient| |Healthcare professional| |Medical practitioner| |Physician| |Surgeon| |Health visitors nurses and midwives| |Professional nurse| |Professional midwife| Provider_dimension PK Provider_ID PK Observer_Path Name_char (Data history) Provider_dimension PK Provider_ID PK Observer_Path Name_char Observation_fact Observer_CD(NPI) LOINC:45952-9

11. GPC V1 Visit dimension Observation_fact Inout_CD Facility_location(Zip3) Facility_CD(NPI) Discharge_disposition Discharge_status DRG DRG_type Admission_source Encounter_type_CD Service_type_CD Attending/billing_provider_CD Visit_dimension PK Encounter_num Patient_num Start_datetime End_datetime Active_status_CD …optional data (Data history) Visit_dimension PK Encounter_num Patient_num Start_datetime End_datetime Active_status_CD Concept_dimension Encounters\ \Inout_CD \Facility_location(zip) LOINC:52831-5 \Facility_CD(NPI) LOINC:44960-3 \Discharge_disposition LOINC:46579-9 \Discharge status LOINC:52523-8 \Discharge DRG LOINC: 38999-9 \Admission source \Encounter type_CD \Service type_CD(CPT) \Attending provider_num

12. GPC V1 Concept dimension Demographics: LOINC, SNOMED CT observables Diagnoses: (Encounter dx; problem list; order dx; Nursing dx)SNOMED CT Clinical findings, events and situations / ICD-*-CM Observables: Lab tests: (laboratory, pathology) LOINC Observables: Clinical measurements (demographics; symptoms; physical findings): harmonized SNOMED CT Observables and LOINC Observables: Radiology tests: (Radiology tests and measurements): harmonized SNOMED CT Observables and LOINC Procedures: CPT / HCPCS / ICD* / SNOMED CT Procedures Substance administration: (Administered drugs, immunizations; immunologics ) NDFRT / RxNORM; CVX; MVX Orders\Meds\Procedures: (medication orders; prescriptions; testing) NDFRT/RXNORM; Concept_dimension PK Concept_Path Concept_CD Name_char (Data history)

13. GPC V1 Diagnoses Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Visit_dimension PK Encounter_num Start_datetime End_datetime Active_status_CD ModifiersDiagnosis Type Billing dx \Admission \Discharge principal \Discharge present on adm \Discharge secondary Encounter dx \admission \discharge dx \discharge dx primary \discharge dx secondary Medical history dx Order dx \med order \procedure order Problem list dx \active \deleted \resolved Prof billing dx \primary \secondary Diagnosis_fact1 PK Patient_num PK Encounter_num PK Concept_CD PK Observer_CD PK Start_date PK Modifier_CD PK Instance_num End_date Valtype_CD Tval_Char Nval_Num ValueFlag_CD Observation_Blob Modifier_dimension PK Dx_type_path DiagnosisType_CD Name_CHAR Concept_dimension1 PK Concept_Path Concept_CD (SNCT Clin Finding; Event;Situation) FullySpecifiedName_char Observer_dimension PK Observer_Path Observer_CD (NPI) Name_char Concept_dimension2 PK Concept_Path Concept_CD (ICD-9-CM) FullySpecifiedName_char Concept_dimension3 PK Concept_Path Concept_CD (ICD-10-CM) FullySpecifiedName_char

14. GPC V1 Clinical Measurements(Observable) Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Visit_dimension PK Encounter_num Start_datetime End_datetime Active_status_CD Observation_fact PK Patient_num PK Encounter_num PK Concept_CD PKObserver_CD PK Start_date PK Modifier_CD PK Instance_num End_date Tval_Char Nval_Num ValueFlag_CD Observation_Blob Observer_dimension PK Observer_Path Observer_CD Name_char Concept_dimension Observables\Clinical\ \Height LOINC:8302-2 \Length LOINC:3137-7 \Weight LOINC:3141-9 \BMI LOINC:39156-5 \Systolic BP LOINC:8480-6 \Diastolic BP LOINC:8462-4 Concept_dimension PK Concept_Path Concept_CD(LOINC 2.38+) Name_char Modifier_dimension PK Coded_result_Path Results_CD (SNCT) Name_char (Data history)

15. GPC V1 Procedures Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Visit_dimension PK Encounter_num Start_datetime End_datetime Active_status_CD Observation_fact PK Patient_num PK Encounter_num PK Concept_CD PK Observer_CD PK Start_date PK Modifier_CD PK Instance_num End_date Tval_Char Nval_Num ValueFlag_CD Observation_Blob Observer_dimension PK Observer_Path Observer_CD Name_char Role_CD Concept_dimension PK Concept_Path Concept_CD(CPT) Name_char ModifiersProcedure Type \Billed \Surgical history Concept_dimension PK Concept_Path Concept_CD(HCPCS) Name_char Modifier_dimension PK Proc_type_Path Procedure type_CD Name_CHAR (Data history)

16. GPC V1 Enrollment Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Age_num Gender_CD Race_CD Ethnicity_CD Observation_fact PK Patient_num PK Encounter_num PK Concept_CD PK Observer_CD PK Start_date PK Modifier_CD PK Instance_num End_date Tval_Char Nval_Num ValueFlag_CD Observation_Blob Observer_dimension PK Observer_Path Observer_CD Name_char Role_CD Modifier_dimension PK Proc_type_Path Procedure type_CD Name_CHAR (Data history) Enrollment Type \Insurance \Cohort membership

17. Lab Results (not batteries) Patient_dimension PK Patient_num Birth_date Death_date Vital_status_CD Age_num Gender_CD Race_CD Ethnicity_CD Visit_dimension PK Encounter_num Start_datetime End_datetime Active_status_CD Location_CD EncounterType_CD ServiceType_CD Observation_fact PK Patient_num PK Encounter_num PK Concept_CD PKObserver_CD PK Start_date PK Modifier_CD PK Instance_num End_date Tval_Char Nval_Num ValueFlag_CD Observation_Blob Observer_dimension PK Observer_Path Observer_CD Name_char Role_CD Concept_dimension PK Concept_Path Concept_CD(LOINC 2.38+) Name_char Modifier_dimension PK Coded_result_Path Results_CD (SNCT) Name_char (Data history)