Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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

: Physical Health T Score at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

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    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 367949</b></p><a name=\"367949\"> </a><a name=\"hc367949\"> </a><div style=\"display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 33; Last updated: 2026-09-24 12:39:55+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-comparative-evidence.html\">ComparativeEvidence</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"Evidence-367949.html\">Evidence Physical Health T Score at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</a></p><p><b>identifier</b>: FEvIR Object Identifier/367949, FEvIR Linking Identifier/NCT03640312-secondaryOutcomeMeasure-7-OutcomeAnalysis-8-BetweenGroupAnalysis-OG000-OG001, <a href=\"http://terminology.hl7.org/7.5.0/NamingSystem-uri.html\" title=\"As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt \r\n\r\nThis oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: \r\n\r\nNote that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.\r\n\r\nThis OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.22.254</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: NCT03640312_secondaryOutcomeMeasure_7_OutcomeAnalysis_8_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Physical Health T Score at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Physical Health T Score 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 367949. Revised 2026-09-24. Available at: https://fevir.net/resources/Evidence/367949. Computable resource at: https://fevir.net/resources/Evidence/367949#json.</p>\n</div><p><b>status</b>: Active</p><p><b>date</b>: 2026-11-05 14:34:28+0000</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href=\"http://www.hl7.org/Special/committees/dss\">http://www.hl7.org/Special/committees/dss</a></p><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>\n</div><p><b>description</b>: </p><div><p>Statistical test for difference in Physical Health T Score</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Data are available on only 28 participants in the intervention group for the mental health T score.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href=\"Group-367881.html\">NCT03640312 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: QUARTET LDQT vs. Candesartan</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Candesartan</p><p><b>observed</b>: 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.\n\nQUARTET 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.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-367890.html\">Health-related Quality of Life at 12 weeks (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Superiority</p>\n</div></blockquote><p><b>statisticType</b>: <span title=\"Codes:\">Mean Difference (Net)</span></p><p><b>quantity</b>: -3.45 score on a scale</p><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000037}\">standard error of the mean</span></p><p><b>quantity</b>: 2.01 score on a scale</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>note</b>: </p><blockquote><div><p>Adjusted for baseline T score</p>\n</div></blockquote><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></p><p><b>quantity</b>: 0.09</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>note</b>: </p><blockquote><div><p>CI Number of Sides: 2-Sided</p>\n</div></blockquote><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: -7.49-0.59 score on a scale</p></blockquote><h3>ModelCharacteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">ANCOVA</span></td></tr></table></blockquote></div>"
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  "title" : "Physical Health T Score at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312",
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