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 Evidence: Mean Change in Serum Sodium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

version: 26; Last updated: 2025-08-18 13:22:42+0000

Profile: ComparativeEvidence

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Evidence/367956

identifier: FEvIR Object Identifier/367956, FEvIR Linking Identifier/NCT03640312-otherOutcomeMeasure-4-OutcomeAnalysis-15-BetweenGroupAnalysis-OG000-OG001

name: NCT03640312_otherOutcomeMeasure_4_OutcomeAnalysis_15_BetweenGroupAnalysis_OG000_OG001

title: Mean Change in Serum Sodium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

citeAs:

Mean Change in Serum Sodium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367956. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367956. Computable resource at: https://fevir.net/resources/Evidence/367956#json.

status: Active

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

description:

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

variableDefinition

note:

Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.

variableRole: Population

intended: Group NCT03640312 Eligibility Criteria

variableDefinition

description:

Group Assignment: QUARTET LDQT vs. Candesartan

variableRole: Exposure

comparatorCategory: Candesartan

observed: Group Assignment: 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. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

variableDefinition

variableRole: Outcome

observed: Mean Change in Serum Sodium at 12 weeks (NCT03640312)

statistic

note:

Outcome Analysis NonInferiority Type: Superiority

statisticType: Mean Difference (Net)

quantity: -0.71 mEq/L

attributeEstimate

type: standard error of the mean

quantity: 0.45 mEq/L

attributeEstimate

note:

Linear mixed model. Random participant effects. Fixed baseline systolic, study arm, and time effects.

type: P-value

quantity: 0.12

attributeEstimate

note:

CI Number of Sides: 2-Sided

type: Confidence interval

level: 0.95

range: -1.61-0.19 mEq/L

ModelCharacteristics

-Code
*Mixed Models Analysis