Evidence Based Medicine on FHIR Implementation Guide
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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/FLI/DocumentForComposition370512.

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

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

-CodeValue[x]Exclude
*Research Study from which this is a flow groupNCT03640312false

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

-CodeValue[x]Exclude
*Research Study from which this is a flow groupNCT03640312false

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

-StatisticTypeQuantity
*count58

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

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: STARTED at Overall Study

Statistics

-StatisticTypeQuantity
*Count32

Generated Narrative: Evidence #NCT03640312-flow-milestone-0-Overall-Study-group-FG001

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: STARTED at Overall Study

Statistics

-StatisticTypeQuantity
*Count30

Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG000

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: 6 Week Follow Up at Overall Study

Statistics

-StatisticTypeQuantity
*Count32

Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG001

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: 6 Week Follow Up at Overall Study

Statistics

-StatisticTypeQuantity
*Count28

Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG000

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: COMPLETED at Overall Study

Statistics

-StatisticTypeQuantity
*Count29

Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG001

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: COMPLETED at Overall Study

Statistics

-StatisticTypeQuantity
*Count24

Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG000

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: NOT COMPLETED at Overall Study

Statistics

-StatisticTypeQuantity
*Count3

Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG001

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: NOT COMPLETED at Overall Study

Statistics

-StatisticTypeQuantity
*Count6

Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG000

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Reasons for withdraw at Overall Study

Statistics

-StatisticTypeCategoryQuantity
*CountLost to Follow-up3

Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG001

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

-CodeValue[x]
*Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication: Evidence CommunicationParticipantFlowEvidence

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Reasons for withdraw at Overall Study

Statistics

-StatisticTypeCategoryQuantity
*CountLost to Follow-up6