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

: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

<http://hl7.org/fhir/Evidence/6512> a fhir:Evidence ;
  fhir:nodeRole fhir:treeRoot ;
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     fhir:lastUpdated [ fhir:v "2026-08-06T09:26:00.989Z"^^xsd:dateTime ]
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "extensions" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 6512</b></p><a name=\"6512\"> </a><a name=\"hc6512\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 3; Last updated: 2026-08-06 09:26:00+0000</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=\"https://fevir.net/resources/Evidence/6512\">https://fevir.net/resources/Evidence/6512</a></p><p><b>identifier</b>: FEvIR Object Identifier/6512</p><p><b>name</b>: OSFPreprint_PrimaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint</p><p><b>citeAs</b>: </p><div><p>Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint [Database Entry: FHIR Evidence Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 6512. Revised 2021-07-19. Available at: https://fevir.net/resources/Evidence/6512. Computable resource at: https://fevir.net/resources/Evidence/6512#json.</p>\n</div><p><b>status</b>: Active</p><p><b>date</b>: 2021-07-19 21:20:42+0000</p><p><b>author</b>: Brian S. Alper: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Adult symptomatic patients with mild COVID-19 were recruited between May and August 2020 from King Abdulaziz University Hospital in Jeddah, Saudi Arabia.</p>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"Group-5224.html\">Group NCT04401202_Enrollment_Group</a></p><p><b>intended</b>: <a href=\"Group-189713.html\">NCT04401202 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Nigella Sativa Oil (NSO)</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>observed</b>: supplementation with oral capsules of NSO (MARNYS® Cuminmar 500 mg twice daily for 10 days) plus standard of care</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Control</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>observed</b>: standard of care medications alone</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>proportion of patients recovered (free of symptoms for 3 days) within 14 days after randomization</p>\n</div><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-5269.html\">Percentage of Participants With Clinical Recovery Within 14 Days After Randomization</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>description</b>: </p><div><p>There were 47 patients in the treatment group (NSO) and 47 patients in the control group. The proportion of patients recovered in the treatment group was significantly higher than the control group, 37 (79%) versus 21 (45%) (p=0.001).</p>\n</div><p><b>numberAffected</b>: 58</p><h3>SampleSizes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>NumberOfStudies</b></td><td><b>KnownDataCount</b></td></tr><tr><td style=\"display: none\">*</td><td>1</td><td>94</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}\">P-value</span></td><td>0.001</td></tr></table></blockquote></div>"^^rdf:XMLLiteral ]
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  fhir:name [ fhir:v "OSFPreprint_PrimaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001"] ; # 
  fhir:title [ fhir:v "Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint"] ; # 
  fhir:citeAs [ fhir:v "Percentage of Participants With Clinical Recovery Within 14 Days After Randomization Statistical Analysis for Nigella Sativa Oil vs Control in Nigella Sativa for COVID-19 OSF Preprint [Database Entry: FHIR Evidence Resource]. Contributors: Brian S. Alper [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 6512. Revised 2021-07-19. Available at: https://fevir.net/resources/Evidence/6512. Computable resource at: https://fevir.net/resources/Evidence/6512#json."] ; # 
  fhir:status [ fhir:v "active"] ; # 
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  fhir:author ( [
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  fhir:description [ fhir:v "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide."] ; # 
  fhir:variableDefinition ( [
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     fhir:description [ fhir:v "Nigella Sativa Oil (NSO)" ] ;
     fhir:variableRole [ fhir:v "exposure" ] ;
     fhir:observed [
       fhir:display [ fhir:v "supplementation with oral capsules of NSO (MARNYS® Cuminmar 500 mg twice daily for 10 days) plus standard of care" ]
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     fhir:observed [
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         fhir:l fhir:EvidenceVariable
       ] ;
       fhir:display [ fhir:v "Percentage of Participants With Clinical Recovery Within 14 Days After Randomization" ]
     ]
  ] ) ; # 
  fhir:statistic ( [
     fhir:description [ fhir:v "There were 47 patients in the treatment group (NSO) and 47 patients in the control group. The proportion of patients recovered in the treatment group was significantly higher than the control group, 37 (79%) versus 21 (45%) (p=0.001)." ] ;
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           fhir:code [ fhir:v "C44185" ] ;
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         ] )
       ] ;
       fhir:quantity [
         fhir:value [ fhir:v 0.001 ]
       ]
     ] )
  ] ) . # 

<http://hl7.org/fhir/Group/5224> a fhir:Group .

<http://hl7.org/fhir/Group/189713> a fhir:Group .

<http://hl7.org/fhir/EvidenceVariable/5269> a fhir:EvidenceVariable .