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Table 1 Domain and information objects identified in two clinical use case workflows (GORD and Diabetes) and their relation to PCROM and BRIDG

From: Extension of the primary care research object model (PCROM) as clinical research information model (CRIM) for the learning healthcare system

No Class/domain objects Comment/description PCROM objects BRIDG objects
1 AE Is result of assessment, assessment activity AE, AEreport DefinedAdverseEvent, AdverseEvent, (AdverseEventActionTakenRelationship, AdverseEventOutcomeAssessment, AdverseEventOutcomeResult, AdverseEventSeriousness)
2 Alert (alarm) Is event (defined notification), process activity / study event (e.g. for AE event), alert is reaction to assessment   DefinedNotification,
3 Appointment Is related to care (e.g. GP visit)   
4 Close-out visit (also for follow-up visit) is a study event in a study, consultation Study event StudyActivity (DefinedActivity)
5 Consultation Is related to care   
6 CRF Belongs to data model, display as form covering observation activity, assessment activity and intervention activity   Document (DocumentAuthor)
7 Eligible patient Is person, the result of eligibility search is a process activity Potential participant (singular)  
8 Examination   Examination (is observational activity) PlannedActivity, DefinedActivity
9 GP Is person or role (family doctor, health care provider) GP investigator HealthCareProvider
10 GP visit Is related to care   
11 Inclusion and exclusion criteria   EligibilityCriteria DefinedEligibilityCriterion, DefinedInclusionCriterion, DefinedExclusionCriterion
12 Informed consent Is a activity, potential participant consents (is a relation) Consented as relationship StudySubject, StudyProtocol (not directly dispayed)
13 Invitation of patient Is related to care Notification  
14 Medicinal product Is product, (medicinal intervention as a new class, covers “product”) Intervention (generic), (medical intervention) StudyAgent (Product, Drug)
15 Patient initiation Potential participant, intervention Intervention activity DefinedProcedure
16 Patient recruitment Is process activity, see: eligible patient, participation is result Participant (as result) StudySubject (as result)
17 Randomisation Is a study procedure, process activity Allocation RandomizationBookEntry
18 Reminder Is event (scheduled notification), process activity /study event   DefinedNotification, PlannedNotification, NotificationReceiver
19 Research question Is part of study protocol Study purpose StudyObjective
20 Responsiveness Is assessment of PPI responsiveness = assessment results, assessment activity Assessment results, assessment activity StudyActivity
21 Search (Is in GORD the eligibility search)   
22 Symptoms Result of an observational activity Observation activity result DefinedObservation result
23 Web questionnaire Is active process, e.g. PRO, observation is different from the activity of data input; here it is observation activity   DefinedObservation
24 Class / Domain Objects Use Case Diabetes Comment / Description PCROM objects BRIDG objects
25 TTP Is an organization Organization  
26 Eligible patient Is a person, is also result of eligibility search and therefore a process activity Potential participant (singular)  
27 Inclusion and exclusion criteria   EligibilityCriteria DefinedEligibilityCriterion, DefinedInclusionCriterion, DefinedExclusionCriterion
28 Informed consent Is a activity, the potential participant consents is a relation Consented as relationship StudySubject, StudyProtocol (not directly displayed)
29 Patient Is a person Patient Subject
30 Prescription Is a process activity in medical care (also in T2D: search in prescription data base, belongs to data model) Activity Activity
31 Researcher Is a person Investigator, StudyActor QualifiedPerson, ResearchStaff, ResearchOrganization
32 Search Is a process activity in T2D   
33 Symptoms Result of an observational activity Observation activity result DefinedObservation result
34 Data extraction Is a process activity   
35 Database access Is a process activity   
36 Linkage Is a process activity   
37 Patient selection Is a process activity   
38 Remote analysis Is a process activity   
39 Genetic risk factor   Assessment Result  
40 Dynamic Data Discovery Service Belongs to data model (software concept)   
41 Query Tool Belongs to data model (software concept)   
  1. Class/Domain Objects are mapped to corresponding information objects in PCROM and BRIDG. Objects that could not be mapped are classified as belonging to the “data model” or being a “process activity”. These objects were not considered for the information model but are relevant for the data model of TRANSFoRm. Objects that were used for evaluation but belonged to the data model instead of the information model are not shown in the table.