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-ballot3 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: Baseline Characteristics Report for QUARTET Trial

version: 12; Last updated: 2025-10-11 10:35:13+0000; Language: en

Profile: BaselineMeasureReport

Artifact Description:

Example for EBMonFHIR IG

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/370510

identifier: FEvIR Object Identifier/370510, FEvIR Linking Identifier/NCT03640312-baseline-measure-report

status: Final

type: Baseline Measure Report

date: 2025-10-11 10:35:13+0000

author: Joanne Dehnbostel

title: Baseline Characteristics Report for QUARTET Trial

custodian: Computable Publishing LLC

relatesTo

type: Cite As

target:

Baseline Characteristics Report for QUARTET Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370510. Revised 2025-10-11. Available at: https://fevir.net/resources/Composition/370510. Computable resource at: https://fevir.net/resources/Composition/370510#json.

relatesTo

type: Derived From

target: Baseline Characteristics Report for NCT03640312


EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Age, Continuous

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Age, Continuous

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Sex: Female, Male

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

category

name: Female

category

name: Male

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Sex: Female, Male

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Race/Ethnicity, Customized

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

category

name: Race/Ethnicity:: Hispanic

category

name: Race/Ethnicity:: Black/Sub Saharan African

category

name: Race/Ethnicity:: White/Caucasian/Other

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Race/Ethnicity, Customized

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Body Mass Index, kg/m^2

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Body Mass Index, kg/m^2

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Heart rate, beats per minute

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Heart rate, beats per minute

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of diabetes, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of diabetes, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of smoking, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of smoking, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of depression, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of depression, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Weekly alcohol use, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Weekly alcohol use, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Systolic Blood Pressure, mm Hg

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Systolic Blood Pressure, mm Hg

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Diastolic Blood Pressure, mm Hg

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Diastolic Blood Pressure, mm Hg

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

name: 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

code: Participants

quantity: 32

Characteristics

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

name: 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

code: Participants

quantity: 30

Characteristics

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

name: Total

description:

Total of all reporting groups

type: Person

membership: Enumerated

code: Participants

quantity: 62

Characteristics

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

name: NCT03640312_BaselineMeasure_0_BG000

title: Age, Continuous for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation12.6 years

name: NCT03640312_BaselineMeasure_0_BG001

title: Age, Continuous for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation10.5 years

name: NCT03640312_BaselineMeasure_0_BG002

title: Age, Continuous for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation11.5 years

name: NCT03640312_BaselineMeasure_1_BG000

title: Sex: Female, Male for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 15 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Male

quantity: 17 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_1_BG001

title: Sex: Female, Male for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 13 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Male

quantity: 17 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_1_BG002

title: Sex: Female, Male for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 28 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Male

quantity: 34 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_2_BG000

title: Race/Ethnicity, Customized for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 24 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 4 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 4 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_2_BG001

title: Race/Ethnicity, Customized for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 21 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 7 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 2 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_2_BG002

title: Race/Ethnicity, Customized for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 45 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 11 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 6 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_3_BG000

title: Body Mass Index, kg/m^2 for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 33 kg/m^2

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation6.9 kg/m^2

name: NCT03640312_BaselineMeasure_3_BG001

title: Body Mass Index, kg/m^2 for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 34 kg/m^2

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation7.9 kg/m^2

name: NCT03640312_BaselineMeasure_3_BG002

title: Body Mass Index, kg/m^2 for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 34 kg/m^2

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation7.3 kg/m^2

name: NCT03640312_BaselineMeasure_4_BG000

title: Heart rate, beats per minute for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.5 beats per minute

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation10 beats per minute

name: NCT03640312_BaselineMeasure_4_BG001

title: Heart rate, beats per minute for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.7 beats per minute

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation11.7 beats per minute

name: NCT03640312_BaselineMeasure_4_BG002

title: Heart rate, beats per minute for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.6 beats per minute

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation10.8 beats per minute

name: NCT03640312_BaselineMeasure_5_BG000

title: History of diabetes, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 10 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_5_BG001

title: History of diabetes, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 7 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_5_BG002

title: History of diabetes, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 17 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_6_BG000

title: History of smoking, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 11 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_6_BG001

title: History of smoking, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_6_BG002

title: History of smoking, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 20 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_7_BG000

title: History of depression, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 7 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_7_BG001

title: History of depression, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_7_BG002

title: History of depression, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 16 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_8_BG000

title: Weekly alcohol use, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 10 Participants

SampleSizes

-KnownDataCount
*32

name: NCT03640312_BaselineMeasure_8_BG001

title: Weekly alcohol use, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

name: NCT03640312_BaselineMeasure_8_BG002

title: Weekly alcohol use, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 19 Participants

SampleSizes

-KnownDataCount
*62

name: NCT03640312_BaselineMeasure_9_BG000

title: Systolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 137.6 mm Hg

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation11.8 mm Hg

name: NCT03640312_BaselineMeasure_9_BG001

title: Systolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 138.7 mm Hg

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation10.8 mm Hg

name: NCT03640312_BaselineMeasure_9_BG002

title: Systolic Blood Pressure, mm Hg for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 138.1 mm Hg

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation11.2 mm Hg

name: NCT03640312_BaselineMeasure_10_BG000

title: Diastolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation9.6 mm Hg

name: NCT03640312_BaselineMeasure_10_BG001

title: Diastolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation11.5 mm Hg

name: NCT03640312_BaselineMeasure_10_BG002

title: Diastolic Blood Pressure, mm Hg for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation10.5 mm Hg