Table 5 Examples of the most frequent data transferred from the CDSIC SDTM to the OMOP CDM
Information transfer required | OMOP CDM solution used | Comments on solution |
|---|---|---|
Additional characteristic of a medical event | • The characteristic of an event recorded as: observation_concept_ID • The assessment of medical event recorded as: value_as_concept_ID • Linking of the characteristic and the assessed medical event via FACT_RELATIONSHIP | The characteristic of an event could be its severity or seriousness or status (stable / unstable). Multiple characteristics can be mapped to allow all data to be captured. For example, a moderate-severity renal function impairment was mapped in the OMOP CDM as: CONDITION_OCCURRENCE: 4030518 - ‘Renal impairment’ OBSERVATION: Observation_concept_ID = 4022772 - ‘Condition severity’ Value_as_concept_ID = 4285732 - ‘Moderate’ FACT_RELATIONSHIP: 4030518 - ‘Renal impairment’; 4022772 - ‘Condition severity’ |
Registry enrolment date | • Registry enrolment fact recorded as: observation_concept_ID • Name of the study recorded as: value_as_string | The following concept_IDs and descriptions can be used: 44807982 - ‘Participant in research study’ 4090379 - ‘Patient entered into trial’ |
Date of informed consent | • Informed consent fact recorded as: observation_concept_ID • Name of the study recorded as: value_as_string | The following concept_IDs and descriptions can be used: 44811375 - ‘Consent given to participate in research study’ 4163733 - ‘Patient consented to clinical trial’ |
Reason for registry discontinuation | • Registry discontinuation fact recorded as: observation_concept_ID • Reason for discontinuation recorded as: value_as_concept_ID | The following concepts can be used: 44810922 - ‘Participation in research study completed’ 44810920 - ‘Withdrawn from research study’ 40482840 - ‘Completion of clinical trial’ 4087907 - ‘Patient withdrawn from trial’ |
Relationship to <entity> of medical event | • The relationship to an entity was recorded as: observation_concept_ID • The kind of relationship was recorded as: value_as_concept_ID • Linking of the kind of relationship and relation to an entity medical event via FACT_RELATIONSHIP | <entity > could include, for example, hospitalization or an adverse event A new custom concept ‘Relationship to < entity > ‘was created since there was no proper concept among existing ones. The value_as_concept_ID field could contain answers like: 45878245 - ‘No’ 45877241 - ‘Unlikely’ 45877994 - ‘Yes’ 4162850 - ‘Possible’ or Specific concepts denoted medical events like: 4322024 - ‘Pulmonary hypertension’ 45885208 - ‘Other reason’ |
Outcome of medical event | • Transferred to the appropriate EVENT table • Linking of the outcome of medical event and the medical event via FACT_RELATIONSHIP | Outcomes can be stored as events in the OMOP CDM event table or specific concept_ID. 4231813 - ‘Adverse incident outcome categories’ can be used in combination with the value_as_concept_ID field that stores the outcome itself. |
Method of measurement | • The measurement recorded as: measurement_concept_id • The method of taking this measurement recorded as: observation_concept_id • Linking of the method of measurement and the assessed measurement via FACT_RELATIONSHIP | For example, a mPAP measurement derived from the thermodilution technique was mapped in the OMOP CDM as: MEASUREMENT to map XP measurement: Measurement_concept_id = 3028074 - ‘Pulmonary artery Mean blood pressure” OBSERVATION to map method: Observation_concept_ID = 4122989 - ‘Thermodilution technique’ FACT_RELATIONSHIP to link XP test to its method of measurement: domain_concept_id_1 = 1147304 - 'Observation' domain_concept_id_2 = 1147330 - 'Measurement' relationship_concept_id = 4152892 - ‘Measurement method’ |