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