Participant Flow Report for QUARTET USA Trial - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2

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

Example Composition: Participant Flow Report for QUARTET USA Trial

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/resources/Composition/370512.

relatesTo
type: Derived From
target: Participant Flow Report for NCT03640312

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
observed: Reasons for exclusion from QUARTET USA Trial
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