Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
version: 9; Last updated: 2025-07-14 11:06:46+0000
Profile: ParticipantFlowReport
Artifact Description:
Example for EBMonFHIR IG
ArtifactPublicationStatus: Active
url: https://fevir.net/resources/Composition/370512
identifier: FEvIR Object Identifier/370512, FEvIR Linking Identifier/NCT03640312-participant-flow-report
status: Final
type: Participant Flow Report
date: 2025-07-14 11:06:46+0000
author: Joanne Dehnbostel
title: Participant Flow Report for QUARTET USA Trial
custodian: Computable Publishing LLC
relatesTo
type: Cite As
target:
Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-07-14. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/FLI/DocumentForComposition370512.
relatesTo
type: Derived From
Generated Narrative: Group #ScreenedGroup
name: Group Screened for Participation for QUARTET USA Trial
description:
Potentially eligible patients screened for participation in the QUARTET USA Trial
type: Person
membership: Enumerated
quantity: 120
Generated Narrative: Group #FG000
Profiles: ComparatorGroup, ExposureGroup, StudyGroup
name: NCT03640312 Flow Group QUARTET LDQT
description:
Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.
QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
type: Person
membership: Enumerated
quantity: 32
Characteristics
Code Value[x] Exclude Research Study from which this is a flow group NCT03640312 false
Generated Narrative: Group #FG001
name: NCT03640312 Flow Group Candesartan
description:
Patients randomized to the comparison arm took a once daily 8mg candesartan.
Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
type: Person
membership: Enumerated
quantity: 30
Characteristics
Code Value[x] Exclude Research Study from which this is a flow group NCT03640312 false
Generated Narrative: Evidence #ExcludedCount
title: Excluded from QUARTET USA Trial
status: Active
variableDefinition
description:
Screened for Participation
variableRole: Population
observed: Screened for Participation
variableDefinition
description:
Excluded
variableRole: Outcome
observed: Excluded
Statistics
StatisticType Quantity count 58
Generated Narrative: Evidence #ReasonsForExclusion
title: Reasons for exclusion from QUARTET USA Trial
status: Active
variableDefinition
description:
Screened for Participation
variableRole: Population
observed: Screened for Participation
variableDefinition
description:
Reasons for exclusion from QUARTET USA Trial
variableRole: Outcome
statistic
statisticType: count
category: Not meeting inclusion criteria
quantity: 56
statistic
statisticType: count
category: Other reasons: "no-shows" for randomization
quantity: 2
Generated Narrative: Evidence #NCT03640312-flow-milestone-0-Overall-Study-group-FG000
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-0-Overall-Study-group-FG000
title: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: QUARTET LDQT
variableDefinition
variableRole: Outcome
observed: STARTED at Overall Study
Statistics
StatisticType Quantity Count 32
Generated Narrative: Evidence #NCT03640312-flow-milestone-0-Overall-Study-group-FG001
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-0-Overall-Study-group-FG001
title: ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: Candesartan
variableDefinition
variableRole: Outcome
observed: STARTED at Overall Study
Statistics
StatisticType Quantity Count 30
Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG000
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-1-Overall-Study-group-FG000
title: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: QUARTET LDQT
variableDefinition
variableRole: Outcome
observed: 6 Week Follow Up at Overall Study
Statistics
StatisticType Quantity Count 32
Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG001
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-1-Overall-Study-group-FG001
title: ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: Candesartan
variableDefinition
variableRole: Outcome
observed: 6 Week Follow Up at Overall Study
Statistics
StatisticType Quantity Count 28
Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG000
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-2-Overall-Study-group-FG000
title: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: QUARTET LDQT
variableDefinition
variableRole: Outcome
observed: COMPLETED at Overall Study
Statistics
StatisticType Quantity Count 29
Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG001
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-2-Overall-Study-group-FG001
title: ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: Candesartan
variableDefinition
variableRole: Outcome
observed: COMPLETED at Overall Study
Statistics
StatisticType Quantity Count 24
Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG000
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-3-Overall-Study-group-FG000
title: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: QUARTET LDQT
variableDefinition
variableRole: Outcome
observed: NOT COMPLETED at Overall Study
Statistics
StatisticType Quantity Count 3
Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG001
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-milestone-3-Overall-Study-group-FG001
title: ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: Candesartan
variableDefinition
variableRole: Outcome
observed: NOT COMPLETED at Overall Study
Statistics
StatisticType Quantity Count 6
Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG000
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-reason-Overall-Study-group-FG000
title: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: QUARTET LDQT
variableDefinition
variableRole: Outcome
observed: Reasons for withdraw at Overall Study
Statistics
StatisticType Category Quantity Count Lost to Follow-up 3
Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG001
Profile: ParticipantFlowEvidence
identifier: FEvIR Linking Identifier/NCT03640312-flow-reason-Overall-Study-group-FG001
title: ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study
status: Active
author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:
UseContexts
Code Value[x] Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence Communication ParticipantFlowEvidence variableDefinition
variableRole: Population
observed: Candesartan
variableDefinition
variableRole: Outcome
observed: Reasons for withdraw at Overall Study
Statistics
StatisticType Category Quantity Count Lost to Follow-up 6